Event ID: 1431174
Event Started: 10/8/2009 8:19:21 AM ET
Please stand by for realtime captions.

It seems like we should have some sort of celebration. It is nice to be in this lovely venue. It is a change from the Humphrey Building. Hopefully, everyone will have a chance to enjoy that. I can tell you with the light that I will not be talking about H1N1 all day. The public was made aware through of this meeting through public announcements. We want to welcome all of the members of the public in attendance as well as those attending via the web cast. Thank you for the interest and our work. We will have scheduled public comments at 11:45 this morning and tomorrow again at 10:15 in the morning. As always, we look forward to input from our -- from the public. We have a full agenda for this meeting. Several topics before us and some decisions we need to make. We will begin this morning with an update on implementation of genetic information nondiscriminatory act. We are very pleased with the implementation process and those efforts to promulgate the rules. The rest of today's' meeting will be review and discussion of the committee's final draft report. We have also set aside tomorrow afternoon for this issue if we need it. Our goal is to come to agreement on the recommendations and approve the report for transmittal to the secretary. It will be an important discussion, and I -- I am counting on a lot of interest and views on this topic. Tomorrow we will consider a proposal related to the [ indiscernible ] its implications, discuss the findings and draft recommendations of the genetics education and task force. Our goals are to decide our next have for our priority topic in data sharing, approve the [ indiscernible ] paper to send to the secretary and provide input on the draft recommendations, so we have a lot to accomplish. Before move to our first agenda item, of a bike to inform you of a couple items. First, I want to report that last month I met with Dr. Francis Collins. Given his role in managing SACGHS, I thought it would be important to brief him. As those of you who led been on this committee know, he was a the ex if ratio to this committee until his departure last year. Our meeting was really an opportunity to update him on our work and on the priority issues we have decided to take up. It also give us a chance to get his perspectives on the critical issues within Genetics and genomics and how we can be helpful to the Department's priorities. He emphasized that we should continue to be forward-looking and to anticipate issues that will rise -- oh, I see my name. I have become Barbara, but we can fix that. [ laughter ] We anticipate issues that will arise with genomics. He suggested that it would be truthful to focus on the implications of the affordable genome, comparative effectiveness of value, and was pleased that we are taking up the comparative attractiveness issue and it was important to consider the meaning of benefit. With regards to the implications of the affordable genome sequence, you recall that last year the community identified this as a high priority issue and decided to incorporate it as part of the study area on genetics. The sessions we held earlier this year on the health-care system focused on issues of the more immediate -- immediate nature.

I would like us to consider addressing the implications of affordable genome as a discrete topic. Finally, France's encouraged us to publish a paper highlighting prior SACGHS [ inaudible ]. If we have time at the end of the meeting, we will begin a discussion of these items before we adjourn. In September, we finalize our letter to Secretary on genetic related priorities that support health care reform. These priorities include ensuring that how the informations are capable of storing, transmitting, and receiving data. The effectiveness of intervention may very among genetic some populations in the Centers for Medicare and Medicaid services use transparent and evidence based processes. The volume of genetic services is recognized and this change is considered. At the director has transmitted a letter to the secretary office. I also want to report to the committee [ indiscernible ] held its first teleconference in late July. The members discussed two reports. One prepared by a the I 0M and one by the federal coordinating Council. The task force also discussed NIH and our activities in the area of [ inaudible ]. The task force is awaiting public release of the Secretary's physical year 2009 operating plan for the $700 million in funds. Research allocated under the American recovery and reinvestment act. After review of this plan, the task force plans to identify and adjust particular policies the committee could explore in the area of research. In the meantime, NIH has issued $360 million in grants to support the comparative research. A number of them are focused on genomics. I thought since many of you may not have heard of what was funded, I would give you a few examples. Scott Ramsey at the University of Michigan received funding for his center for comparative affected research in cancer genomics. [ indiscernible ] to nonet Madison. David at Cancer Center and research institute was founded for developing information infrastructure focused on cancer competitiveness. [ indiscernible ] at Wake Forest will be doing work on clinical validity and utility of genomics targeted and prevention of prostate cancer. Katrina [ indiscernible ] at Kaiser will be looking at comparative attractiveness in genomics and personalized medicine for colon cancer. I also wanted to take note of developments of interests. Last week we learned that the Federal Trade Commission investigated two companies for their promotion of a new toward genetic service called myself program, which involves the analysis specific variations. The company's plan that the test results could significantly affect consumer's health outcomes and enable consumers to achieve long-term or permanent [ inaudible ]. According to FTC letters to these companies which were set in August and posted about two weeks ago on the website, at General acts is no longer marketing the program. [ indiscernible ] has ceased operations altogether. We appreciate the actions and hope that investigators will examine other tests with questionable claims. We hope that their actions will serve as a reminder to other companies that claims must be substantiated. Copies of the letters are in your table folders and available for members of the public. We will hear more about them into your's session. I also want to applaud the efforts of the Center for Medicare and Medicaid services for its progress of proposed rulemaking for laboratory proficiency test programs required under the clinical Laboratory Improvement amendment. This effort addresses one of the recommendations of the oversight report. Which plan to reevaluate the current list and mandate proficiency testing for laboratories to use these and analyze. Genetic and, molecular tests will be included in the evaluation as low. CMS will utilize the advisory committee in the process of [ inaudible ]. It has gathered a working group of outstanding individuals and who represent testing programs, laboratories, accrediting agencies, government agencies, and subject matter agencies. For the first working group meeting is planned for early 2010.

Finally, the National Human genome [ indiscernible ] in August. The counseling panel included its draft segments. While family history plays an important role in the practice of medicine, we can motivate positive lifestyle changes. Substantial research will be needed before the systematically collected family history can become an evidence based tool of primary care. The panel recommended research in the following areas, structure and characteristics, process of acquiring family history, and outcome of interpretation and application. Committee members can find the draft statement in the books under tab a spirit for attendees from the public, there is hand out information of where to find a draft statement on the NIH website as well a number of meetings are taking place this month that are of interest to SACGHS. This is in the table folders and provided to the public. October 15th the office of the Secretary is sponsoring a workshop titled identify opportunities to maximize the utilities of genomics Research data to electronic health information -- that's an awful lot for this early in the morning. The purpose of the workshop is to discuss data standard requirements for clinical Genetics and obstacles to their development and adoption. Andrea and [ indiscernible ] will attend this meeting on our behalf. The next meeting of the health information technology standards is October 14th and the Health Information Technology Policy Committee meets at the end of the month, the 27 and 28. The public can participate by web conference. On the 26 and 27, the American Association for the web [ indiscernible ] and Food and Drug Law Institute are cosponsoring a two do [ indiscernible ]. The agenda includes presentations on policies associated with comparative effective research and this is a bio Mark discovery. I also want to highlight a new CDC NIH. It is a collaborative effort initiated by CDC, office of the Public Health genomics in the cancer institute, a division of cancer [ indiscernible ]. It includes partners across the whole sector. The goal is to accelerate and streamline the responsible use of useful knowledge and application [ indiscernible ]. Over the next few years, we will be working to develop models [ inaudible ] information on to gnomic applications. Plan for the inaugural meeting is October 29th and 30th. Mark Williams will be participating in that. Leslie, I also want to introduce a new member of the SACGHS staff. He was awarded fellowship from the American Association for the advancement of Science and will be serving the fellowship here at the NIH office. She has a Ph.D. in medical anthropology from the University of Florida and Gainesville. Her doctors studies were focused on patients empowerment and help literacy genetic disease. She also has a master's in environmental anthropology that focuses on the social impacts of system management. She tells me she has been following our work for a long time and would be a great addition to the staff. She will be working on genomics data sharing, [ indiscernible ]. Wellcome. Now for the highlight of the morning. We will hear from Sarah.

Thank you, Steve. Good morning, everyone. I am going to review just a couple of rules that you have to follow in special government employees. Conflict of interest. Before every meeting, you provide us with information about your personal, professional, and financial interests, which is information we determine to use [ inaudible ] in giving advice during committee meetings. While we wait conflicts of interest for general matters because we believe your ability of the objective will not be affected by your interest in general managers, we also rely to a great degree on the attentiveness during the meeting at that an issue will arise that could affect or it would appear to affect [ inaudible ] in a specific way. We have provided each of you with a list of your financial interests. I also want to remind you about lobbying. Government employees, a special government employees are prohibited from lobbying. If you lobby in your professional capacity or as a private citizen, it is important to keep that activity separate from our work. Just keep in mind that we are an advisory to the Secretary of Health and Human Services, not the congress. As always, I thank you for being so attentive to these roles. We appreciate your consciousness.

Thank you, Sarah. It is important that we identified ourselves, because our note taker does not know all of us by name, so try to identify yourself. Then we can get a properly recorded. Let's begin. We will have an update on genetic information on discrimination act. And now we want to learn about the progress in implementing this important law. First we will hear several presentations on the implementation, which apply to group health plans, health insurance issuers, and the group and individual markets. Title one generally prevents health insurance claims and issuers from collecting medical information. Amy Turner is a senior attorney. Senior counsel with the Internal Revenue Service and she will [ inaudible ]. They will be followed by the director of the director of [ indiscernible ] address individual Insurance and market provision. Robinsue Frohboese, the executive director in the Office of Civil Rights, and Christina Heide the private policy specialists in that office will report on the proposed regulations. Then we will hear from the Kerry Leibig who will review the proposed regulations. Although Kerry presented at the March meeting, we thought it would be good to hear from her again in the context of the other regulations. So, we will begin with Amy.

Well, thank you. Thank you very much. It is nice to be here. Ford's years I have had the pleasure of participating as the Labor Department alternate ex officio member. I feel like I listened for years asking people to from Congress, why can't we get this passed? I had the luxury of not being in the hot seat and I thought, not my turn yet. I'll just listen. Rouen and then it was passed in May 2008 and I heard that some of you were asking, where are those regs? I skipped those meetings, not because I was avoiding answering your questions but because we were actively working on writing those. So, I am happy to announce that yesterday those were published. I don't know if they are in your materials, but I will give you a site in case --

They should be in your folder.

Excellent. Fabulous. You can enjoy them tonight with a glass of chablis in your wonderful suite upstairs at the Park Hyatt. They are fine reading, those regulations. I thought it would start for a few minutes, just in case you are wondering, why are there so many government bureaucrats sitting up there. I my just take a few minutes to explain why there are so many government bureaucrats sitting appear. GINA is a far-reaching law. It does a lot. Sections 101 through 104 deal with nondiscrimination and health coverage. Russ, myself, and Jim all work together and also collaborative leave with the states to administer the health coverage nondiscrimination provisions. The 3105 deals with privacy, and that is the Office of Civil rights. That is why Robinsue and Christine are here. If you're wondering why there is some many of us up here, it is because GINA does a lot, and we are all here to administer and enforce it. So, what I am going to focus on with a Russ and Jim are the health coverage nondiscrimination. I am going to disarm subdivide those. There are group market provisions, individual market provisions, and [ indiscernible ]. The group market provisions are administered jointly by labor, IRS, and CMS. If you are wondering again why so many government bureaucrats, I think not only does that informs the process but it is to make sure that GINA is enforceable. The group markets, that is for individuals who get their health coverage through their employer. You are sort of put into a group. If I work for, you know, widget company, we are all employment based group and we have an employment group market. There are private employers, state and local government employers. The employer is responsible for making sure that his health coverage complies, but they may choose to do what is called self ensuring the plan, particularly if he is big. I do not want to pick on a particular employer, but let's say IBM. Your smaller employers may tend to go to an insurance company and buy an insurance policy. Of those insurance companies are also responsible for complying with GINA. To make sure that the insurers and the employers, whether they are private employers or state and local government employers or church employers the, to make sure that they are all compliant with the law and that the government -- essentially, individuals can enforce them on behalf of themselves. What GINA did was amend all these different laws. It sounds confusing, probably don't have to worry about it too much. I can give an hour presentation on the enforcement structure. I think the main message and want to send in that is it may seem complicated at first, but that is to ensure it works and people get what they are entitled to. That is the group market. The individual market is a little more simple. That is administered solely by HHS and the state. Jim is one to talk about that. The individual market is an individual who calls up blue Cross and says, I want a policy it for me and my family with. We are all involved when people are getting their coverage through their employers. There is also med such policies which Jim will mentioned. I will tell you one more quick -- I just thought of a joke. Russ is here from the IRS. We've worked together for a long time. He is wonderful to work with. I can tell you I've worked with him since 1996 and I'm still yet to be audited. So, you don't have to feel like to have to give him a fake name. Feel free to share your business card. I am not guaranteeing that you will be audited, but you don't have to feel like you have to use a fake name or something like that. The group market provisions that Russ and I are going to focus on build on some protections that were already enacted as part of HIPAA the health coverage through employer cannot impose a pre-existing condition exclusion based solely on the fact that an individual has certain genetic information. Let's say that they have limitation on their genes. They are predisposition or predispose to getting breast cancer or ovarian cancer, but it is not manifested yet. Already in the group market for years since 1997, an individual cannot have pre-existing conditions exclusions based on that genetic predisposition in the [ indiscernible ]. In addition, in a group market already under HIPAA, the individuals -- let's say we all work for the widget company. We are all one group. We cannot be charged for premiums and we cannot be sort of kept out of the plan, sort of denied access to the plan, or have our benefits change between us based on any health factor. Let's say we all work for his widget company. I cannot be charged a higher premium than Russ or Christina based on the fact that I am the one with the bad genes. We all paid the same premium to get the same benefit packages. Then GINA comes in and add some protections. I am going to turn it over to Russ. There are sort of three main areas. All mentioned, before we did these regulations published yesterday, we did do what we call are as I. That is because we are government people and love acronyms. That is a request for information. We published one in October of 2008 that was open for 60 days I believe where we got comments from the public, both consumer groups, the regulated community, which is essentially employers and insurance companies, a wide variety. At the Medical Information Bureau commented. A wide range of, enters sort of give us information in response to specific questions we asked. Also, generally on the statutory regulations. They were actually made available October 1st. I know at least on the Labor Department website, if you go to www.dol.gov/eesa, we also have an addition to the regulation some fact sheets and press releases. That may be helpful information as well. That was made available October 1st. With that, I think I have all the preliminary. I am going to turn it over to Russ.

Thanks, Amy. We are going to talk about the three substantive rules that GINA ads to what in the already summarized is existing in HIPAA and has been required for the last 12 or 13 years. You now can no longer discriminate on the basis of the group rate. An insurance company cannot charge the group higher rate based on genetic information in a group. Insurance companies and plans cannot request or require an individual to undergo a genetic test. Insurance companies and plans cannot request or require a purchased [ indiscernible ] for underwriting purposes. We are going to go in a little more detail about each of those rules, but I wanted to mention three other things that GINA does specifically. The difference from the HIPAA framework that Jim and Amy and I have been operating under for the past 12 or 13 years. These three agencies we have been dealing with, pre-existing condition rules, nondiscrimination requirements, mental health [ indiscernible ] credit we a share on all these provisions. There are certain provisions that are required across all the laws we care. There are three specific roles that go beyond general framework. I thought this audience would be interested in those. One is, there is a general exception to all of these HIPAA requirements. If on the first day of plan year, fewer participants that are employees, they don't have to [ indiscernible ]. And for active employees, there probably are going to limit plan. This is essentially a retiree plan exception. That exception does not apply for GINA. Not only does it apply to the employees, but it applies to plan -- that is one difference. The other two differences I can mention, but I am going to invite in me and Jim to chime in because they are specific to their departments. Of the one for Amy is the Department of Labor. [ indiscernible ] the Department of Labor has enforcement authority, but it is not monetary. Do you want to go into what is or should I mentioned at?

I will just mentioned. Generally like Ross said, the secretary of labor can sue if there is a violation of any of the laws to bring a plan into compliance. Also, under [ indiscernible ], which is a law that we administer, individuals have a private right of Act so they consider themselves to get what they are entitled to or the secretary of labor can. We have not had a monetary penalty authority against plants or insurers. GINA changes that. The secretary of labor also is authorized to impose an excise tax against a plan, which is an unpleasant base plan, kind of like picking on GM. If they are providing health coverage to its employees, they are separate legal entity that is created called the GM plan. There is a separate legal entity called the plan. That plan is responsible for complying. Now the secretary of labor can oppose a civil monetary penalty against the plan administrator if GINA is not being complied with. Also, the Secretary of label can impose a civil monetary penalty. Again, insurance companies and eight M zeros that sell policies to employers that they sell to comply. Again, if you have a small widget company and Russ says, about 20 employees that just bought a policy from Blue Cross, what do I know about GINA? We can't go to Blue Cross and say, you guys knew better. We can pose a [ indiscernible ] against Blue Cross for failure to comply.

Have there been any lawsuits -- [ indiscernible ]. Have there been any lawsuits filed or penalties levied since GINA has been enacted?

On or after May 21st 2009, in general, that means for calendar year plans, they have to start complying January 1st 2010. There may be some plans that are currently subject. It is just too early. I don't think your agency has taken any enforcement actions yet.

[ overlapping speakers ]

It will start becoming effective January 1st 2010.

I have mentioned two of the three special provisions that vary from the General HIPAA structure, the exception for very small plans. There is also provision not just because of mandates or some other reason. I am not sure what the basis was, but state and local government plans generally can opt out of any of the HIPAA requirements if they wish to. I don't know if you want to go into details, Jim, or I can go ahead and talk about it.

Good morning. What Russ is talking about, there is a plan called non federal governmental plan. These are, essentially, plans of state and local government, local counties, municipalities, sheriffs' offices, thousands of these plants throughout the United States. When HIPAA was enacted in 96, Congress dictated that these plans could a formidably opt out of the major HIPAA provisions. And they do that by following [ indiscernible ] for CMS on an annual basis, then they have to notify their enrollees annually. These major HIPAA -- special aroma provisions, the pre-existing conditions exclusion. If they opt out, they don't have to follow these rules. In order to opt out, they have to be self funded. If they buy insurance for their health coverage, they can opt out because the insurance carrier has to follow HIPAA. Fortunately, under HIPAA, they created an exception to this. Under Gina, all [ indiscernible ] have to comply with GINA. All nine federal government plans have to comply with the GINA provisions.

Thanks, Jim. Now we are going to die in a little more detail into the three substantive rules. Plants cannot -- Well, plans for insurance companies -- maybe this is being overly technical. You can have a situation right plan actually covers the employees more than one employer in they could charge different rates to different employers. Technically -- there is a requirement that they couldn't charge a higher rate up to a group based on genetic information of anyone in the group. As we said, the HIPAA rules already prevent that on an individual basis, now it is on a group basis. The statute provides an exception -- Well, clarification -- that if somebody has been diagnosed the -- the [ indiscernible ]. And there is also -- in the regulations issued, we wanted to make clear -- this just came out yesterday. Even though the plan can right up based on the manifestation of a disease or an issuer can, they can do it on a group on the manifestation of the group. They cannot break up additionally on the greater likelihood of family members of that individual developing the disease. Let's say we have a silly old business of -- a family owned business. One of the parents has Huntington's disease. There is a greater likelihood that the children will have it or maybe we have knowledge that they have markers for developing this disease. The insurance companies can write up for the one parent but cannot write up additionally for those children. They can only read up for the one respective for whom the disease has manifested. That is about all say about the group rates.

Okay. The second rule is that plants and issuers can't request or require that an individual undergo a genetic test. There are three exceptions to that. All three exceptions are statutory exceptions. What we did in the regulations was a thing does provide some examples on how that works and additional clarification. The first exception is for health care professionals who provide health care services to an individual. That person can request that an individual undergo a genetic test. Here is the example. Kaiser, subject to the rules. They are an issuer. If I get my -- if I am an employee who works for the widget company and Russ by is an HMO contracts from Kaiser, I've got to my doctor and my doctor might say, your mom has a history of breast cancer, you are getting up there in age. I think it is time for you to -- I would suggest that you get a genetic test to see if you are predisposed to getting breast cancer. My doctor just requested I undergo a genetic test. He is an employee of Kaiser, but he is my doctor. He is active in providing health care services to me. There is an exception for that to make sure that my Kaiser doctor can request that I do that in the best interest of my health and all that good stuff. We have some examples that clarified. One, it has to be in -- this exception only applies if the health care professional is actually providing services to the individual. That wouldn't include a claims reviewer. Somebody who is deciding after words, doing some sort of concurrent review or retrospective reveal to try to figure out whether or not they are going to pay the claim. It has to be somebody I actually see and receive health care services from. So, that is one clarification. Another clarification we made is it is not limited to physicians. It could be someone other than a physician, a physician's assistant, are and, some other health care professional that may suggest a go for a genetic test to also may be a Kaiser employee. That is the first exception from the General prohibition against plans or issuers requesting or requiring that an individual undergo a genetic test. The second is that plants and issuers can obtain and use the results of a genetic test to make a determination regarding payment of claim. That is limited. It can only ask for the limited amount necessary to pay for the claim. Here is an example. Let's say an individual -- I think we have an example where an individual wants to get a test for -- I think it would indicate whether or not they are likely to get celiac disease I think. The person submits a claim to their plan or insurance company and wants to get it paid. The plan may seek some sort of verification that the test was performed if they are going to be asked to pay for it, but they cannot ask for the results of the test. That would go beyond. If they want some sort of statement from this lab that says, yes, we did perform this test before repay the clan, they cannot say, can I have the results of that test? That would go beyond the minimum amount necessary. Also, we clarify that there may be circumstances where what it would be medically appropriate for a plan -- sometimes plan a safe, I think probably any plan says we only pay for items and services medically appropriate. If I just walked into my plan and say, I decided I want this battery of tests because I feel a little under the weather. It doesn't mean that the plan will pay for it. They only pay for things medically appropriate. Sometimes it may be that if they plan is going to pay a claim, they might need to request that an individual undergoes a genetic test in order to make sure that is medically appropriate to pay some other claim. If your head is rolling, here is the example that we have. We understand. We work closely with NIH. I do not see any of those people here, but we have worked closely with them. NIH told us that sometimes individuals after they had breast cancer may be taking -- after it has gone into remission, they may be put on tamoxifen just to sort of try to prevent the reoccurrence. And there are some studies that have shown that tamoxifen may not be helpful in of 27% of breast cancer patients if they had a variation of the see why [ indiscernible ] gene. A plan instead, we are willing to pay for the tamoxifen, the first show me -- I want you to undergo this test and make sure you don't fall and $0.70. If you fall in that 7%, then I am not one to pay for it. It is up to you. If you want to submit claims to me for the tamoxifen, you need to undergo the genetic test to show it is medically appropriate for you to take tamoxifen. If the tests there is not likely to help you, then we will not pay for it. The plan can't require it, but they certainly can request and can contingent payment of the claims based on an individual under going that test and showing that, yes, I don't fall in net 7%. Therefore, it would be medically appropriate for me to take tamoxifen. That is another example that we have to sort of illustrate an exception more plans may request that individuals undergo a genetic test if they want a claim paid. The third statutory exception that we provide some additional clarification on in the regulation is the research exceptions. This is a statutory exceptions. My understanding is it was something added kind of late at the request of I think it was something Keyser was doing or [ indiscernible ] was doing in Northern California where they were essentially doing some genetic research and I have this pool of people sitting there, all of these members, and they want to ask them, do you want to participate in this genetic research? As an issuer, they cannot ask individuals to undergo a genetic test. An exception was added in the legislation, and we provide some additional clarification on that exception that essentially describes one that genetic exception can be claimed. I'm not sure it provided a ton of additional guidance. We repeat the statutory criteria which is that the research has to comply with Part 46 and any other applicable state or local laws that are for the protection of human subjects. Those include the informed consent requirements. There are also disclosures the need to be made to make sure that people being asked to undergo this genetic test understand that it is completely voluntary and any information gathered will be used to discriminate against them. The planner it, issuer cannot discriminate against them. They cannot take that information and use it for underwriting purposes. Also, if they want to claim this exception, they are supposed to file with the government. We have a form available on the Labor Department was said that is a form someone would use to file before they could claim the research exceptions. A those are the three exceptions to sort of the general prohibition as we request or require that an individual undergoes a genetic test. If there is no question, I will send it back to Russ.

Thanks, Amy. Like Amy, I've not been participating -- unlike Amy. Do we have five or ten extra minutes? I will try to rush through what I have.

Take a couple three more and we will move on. We have time for discussion at the end, so we have some flexibility.

The third requirement that we are one to talk about is that plan and the issuer cannot request or require purchase that an individual [ indiscernible ] for underwriting purposes or connection to enrollment. The things to be aware of is underwriting purposes in the insurance market generally is fairly narrow. In GINA is a look of much broader definition. If you change abundance that -- if you change benefits available to them say as part of the disease management program, based on genetic information -- based on their request for genetic information, that would implicate the underwriting purposes, and it would be a violation of the rules to request or require someone to provide that genetic information in order to get the greater benefit. Not only just to get a higher contribution rate or to be denied coverage overall. So, what we have done with that is -- Well, the other rule is that you can't request or require genetic information or purchase it. We end up using the term collect. The timing of that may be important in some instances because people sometimes have to read and roll and a plan every year, so if the plan does connect genetic information but is not using it for underwriting purposes, it won't affect your benefits, what affect the amount you are charged, but the want to know if you are a good candidate for the disease management program, for example. What they can do in that instance is advertised that we have this disease management program, you can enroll if you want to. But they can't start enrolling -- they cannot offer the person additional benefits. They can just say that we have this program. Getting back to the collection requirements. If they are doing that after someone has already a more -- enrolled in the plan and then we said, we are going to request genetic information, you don't have to provide it. If you respond, you may be eligible -- we may find out that you are eligible for some of these disease management programs that we have. If they provided -- we said that you determine whether someone is requesting or requiring genetic information prior to enrollment at the time they are collecting it. This time they are doing it afterwards. It is not one to affect their enrollment status. The fact they may change plans, it ends up being in a strict time cents prior to the time that they later real role in the benefit. It doesn't mean that it was genetic information collected prior to or with [ indiscernible ]. I can see baffled books are people's faces. Call ahead and ask a question. Maybe I can clarify.

I have a health and wellness program -- and this is hypothetical. That health and wellness program selects -- is more effective in people with a risk for some disorder. That risk might be my medical history or might be some aspect of my family history. And can the employer make a determination of my wrist based in part of my family history, and cannot offer any incentives for me to participate in that?

Okay. And they can offer incentives for someone to participate. Let's say that they have a diabetes management program, and they can give you greater benefits. They can reduce the Copiague, reduce -- they can reduce them for diabetes related claims. What they cannot do is scour the plan and find out, do we have any people at greater risk for diabetes? We cannot start asking people, do you have diabetes? They can ask if you have diabetes as an individual. That is not genetic information. The genetic information includes not only the results of genetic tests, family members, and medical conditions of family members. They cannot start asking about family members having the disease. They can't ask about results of genetic tests for family members. What they can do is say, listen, we can -- we will -- okay. I can see Amy leaning up to the microphone. If you have clarification, feel free.

Here is the thing. I see your local of consternation. I feel like you are troubled.

To put it mildly.

And I think maybe I can try to provide a little bit more birds our perspective. You still might be troubled, but I will try to give you a little perspective of what we dealt with. One, HIPAA already prohibited individuals from being discriminated against. The discrimination provisions we're already in HIPAA. I know that when I came to these meetings before -- and I am the only one that calls it that? When I came to the status meeting, before GINA was passed and I listened to the debate about whether or not it was needed, and one of the things debated and talked about was that there weren't necessarily a lot of actual cases of discrimination and health insurance in the group market that people were able to find, but there was the fear that people would be discriminated against. They want to keep their genetic information private. People felt like if they knew that it was private and it wouldn't be asked for and they could keep it private, they were more likely to go get genetic tests, get them with their doctor under their real names so it could be coordinated and good things would happen. So, what Congress did in GINA and a group market is it really didn't write and nondiscrimination rule. If there is a small piece that Russ talks about how the whole group cannot be rated by the insurance company, but had these prophylactic rules. Plants and issuers cannot even ask for this stuff. Doctors can get it. There are all sorts of reasons why people need it. People are afraid of their employers and insurance companies having it, because they don't trust them that they are not going to use it to discriminate against them. Sometimes it is hard to prove why you were fired or why your insurance went up. Congress added these prophylactic rules to say that plans and issuers can request it, that require it, can purchase it. All these words were thrown out to say that they could not touch it. There was [ indiscernible ] debated and there was an assist in the title two provision. Entitle one, it didn't make it into the final legislation. We don't have a wellness exceptions. So, what you have is plants -- if is a health-care professional -- going back to my kaiser example, if you actually hire a doctor providing services, there can be discussions about genetic information and tasks. If the idea is that they just send out a piece of paper and say, tell me your whole family medical history, while that may be used by some plans to do good things, like running through the computer system and figure out what they might be at risk for and said, hey, you may not realize -- I understand they may use it to do good things, but they also may use it to do bad things. That was the fear. The on this exception did not end up in the final legislation. So, what we tried to do is essentially say, there are ways that plans can still ask for this information, but we are sort of walking a fine line. They are probably going to have to make some changes, because the statute says what the statute says. To be honest, although I would like to say we did these great things and had these great ideas the, the fact is it is kind of self implementing. I don't think the real use any regulatory discretions all. If we hadn't published the regulations yesterday, I think that is what the statute does. I think what we really tried to do was issue some examples that would help plans that were trying to do good things so you can still do good things if you make modifications and set it up this way. There is this sort of prohibitions that you can't hand people a piece of paper and say, we want all your family medical history. If you don't fill it out, you're free -- premium is 50 bucks higher. Even if your plan is 20 uses for the good purpose, we have this prophylactic rule. I have to turn over my family medical history or my premium goes up 50 bucks a month. I thought this is why didn't have to worry about anymore after GINA. So, it is a balance.

I am going to try to do this quickly, but there is a fine line that we have drawn. The sequence is the plan can ask for genetic information including family medical history if it is conditioning any benefit or paying you to provide the information. It can ask for genetic information. A contest say, if there is nothing connected to it, we can't ask for genetic information. They could have a separate medical questionnaire that they set out to people apart from one that they may provide some incentives for that says that this is our genetic information questionnaire. You don't have to complete this if you want to come but if you want to, complete it. We may be able to identify certain benefits that are better for you if you do complete it. We are gone to pay for it. You don't get any greater benefits. All this is additional information for us. Once they have done that, they can't ask for that information. If they get that information, the plan can advertise what programs without telling they need to and roll. If the individual seeks to enroll, they can provide enhanced benefits within those programs. Bacon have enhanced benefits if someone emeralds in a diabetes program. They cannot send out a medical questionnaire saying, we will give you additional benefits for diabetes if you complete this genetic information questionnaire. They cannot do that. It is a fine line we are drawing. We also have some exceptions for incidental collection under the statute. That is, basically, if a plan is seeking information from someone, let's say this is on an annual basis they say they want to verify that this is a home address and ease of people enrolled in the plan. If that is all they are doing, and somebody provided genetic information -- somebody says, well, my dad just died of colorectal cancer. To awhile to get back. That would be family medical history that the father had colorectal cancer, but that would be incidental collection. They were not asking for it, just asking for a verification of was in the plan and what the address is. It is just and reasonable to expect that there would provide genetic information there. If they are sending of a general medical questionnaire and it only applies to the individual, they just say, answer this for yourself. But they say, is there any other additional information that you would like us to know? Is reasonable someone might talk about their family history. We have said if you just ask -- If you have general questions that solicit -- that a reasonable person might answer by getting genetic information, that is not one to be subject to be incidental collection unless he specifically say, do not provide any information related to family members, not provided information related to the results of genetic tests. I think that is pretty much it. We will turn the time over to Jim.

Can I ask one follow-up question on this issue? My concern is that the health care system be able to identify people at high risk for things, particularly when you can do something to amend the later development of the disease. And the burdens of that and the costs of that period we could spend money on something better than that.

I think the health care system can if you're talking about health care professionals. When you're talking about the papers, there are some limits. I think as Russ described, plans can ask for that information. If they don't provide an incentive. They do want to provide an incentive -- if they want to provide that, they have to do it a certain way.

Is genetic information and Family Information being. As a special class for this project -- [ indiscernible ]?

Yes.

Okay. It thank you.

Sam from WellPoint. This is something that is very significant from health insurers and employers. I wonder if you have thought this through. I imagine you have seen the various consequences. Today, literally millions of people fill out what are termed health risk assessments. As you know, this is a well if false science in terms of what are the intended consequences of filling out the health risk assessment. In part, it is to help people be far more -- far better informed about risks for them, their potential chronic illnesses, and how they can engage and help avert some of the long-term consequences. It has also been part of the practice of, as you said, creating incentives to get people to fill out these assessments. When people fill them out, they can become much more involved in these programs and others. We all wish we had a perfect health care system where all of us got recommended care 100 percent of the time, but we don't. We only get about half the time. The questions I have, as you have fought for these regulations, you are dealing with changes for millions of people. Many of the unintended consequences could be far less knowledge involvement and preventive activities related to chronic illness. Certainly, you understand what the intent of GINA was. But if you actually look through how many employers encourage and provide incentives for filling of these health risk assessments and what the long-term consequences might be --

A guess would say, and still free to jump in, Russ. This was the number-one issue. Also, this regulation like every regulation that the government does have an economic analysis where we discuss sort of the costs and benefits attributable to the statute and attributable to exercises at regulatory discretion. As far as unintended consequences, I am not sure I can answer that question, because I go back to, was it an unintended consequence of all of the members in Congress who voted for this overwhelmingly are not? I don't know. There was an exception for wellness programs in title one in versions of the bill as they moved through. It was taken out. Whether it was an under -- unintended consequence or an intentional decision, I don't know. I think the statute doesn't provide. It is all the way back to what Russ was saying, a plan is not allowed to request genetic information for underwriting purposes. There is a statutory definition of underwriting services probably broader than you and the insurance industry would have thought underwriting purposes meant. To be honest, we probably would have interpreted it differently. The staff to a jury definition says, if any changes in eligibility, benefits, or and Cecil is an underwriting purpose. As soon as you give people incentives become a cash for turn on premiums, any sort of penalty if they don't comply, it is an underwriting purpose. If you are affecting their eligibility benefits or printed based on day sell out or not, that [ indiscernible ], there is no statutory authority for us to come out any other place. I think we tried to do in the regulations was recognize this point and say, you can have the two separate [ indiscernible ]. You can have a first one and you get 50 bucks if you fill up that one. And there is the second one right behind it. A lot of people might very well fill them both out, but if they want to keep this private -- when people use the word incentive, and I feel like I always smile a little bit inside. One person's a sentence is another person's penalty. That is sort of how we feel it. GINA very clearly says that you cannot very individual benefits based on whether or not they respond to a request for genetic information. We have some ideas of how you might be able to make it disease management programs and offer incentives, but there are some limitations. I think we tried to do the best we could to preserve good things that we recognize that insurers and plans are doing and just tried to sort of draw this line. There is also no -- when you talk about health risk assessment, I know what you're talking about. There could be fly by night insurance companies sitting in a chair over there that also have their health risk assessment that looks very different from yours. There is no way under the statute to distinguish the two. I think we tried to use the idea of separate your health risk assessment in two. One has ever Board, one doesn't. Rely on your health care professionals. Use the disease management program and try to do that good things without running afoul of the statute that says what it says. It is sort of a fine line we tried to walk.

We are going to move on to Jim.

I am going to talk about the individual market. As Amy said, the individual market is exactly what says. When an individual goes directly to an insurance company to purchase health coverage for themselves or their family. GINA is really -- It was really ground-breaking in the individual market. Unlike the group market, up to the point of when GINA was enacted, there was no protections in the individual market in terms of [ indiscernible ]. In the end of middle-market comment if anybody applies for coverage, say an insurance company can have them built up a health form and get medical and permission from their providers. It would write their premium based on their health status. Also, with the exception of very limited class of individuals called HIPAA [ indiscernible ] individuals. GINA is really the first half of this protection where most people in individual market. It what it does is it says insurance companies cannot base eligibility. They cannot impose pre-existing conditions, exclusions, or a rate premium based on the genetic i nformation. We call these provisions the catch up divisions in terms of the prohibition against requiring a genetics test and collection, they are virtually the same as in the group markets. I will not go into those, because what Amy and Russ said about the rules against it [ indiscernible ] also requiring individual markets. What we simply did in the regulations was we basically reiterated the three new protections, the prohibition against [ indiscernible ], a base in eligibility, and premium based on genetic information and premiums. We basically cut and paste in the group market and shifted it over to the it group market. We made some minor changes to make it more relevant to the individual market. That is, essentially, what the individual market regulations do. I just wanted to talk about one instance about the collection. They talk about the health risk assessments. A that is not very common in the individual market. What you are going to see more in individual markets is an individual applying for individual coverage and they fill out released to get the medical records from their providers. When the request and medical records from the provider, it can be expected that there is when to be genetic information in the medical records what they have to do is put a disclaimer in that request saying, please, do not send me any genetic information including the family history. So, when the provider gets back, hopefully what they will do is put the medical records of any genetic information, any reference to family history or any information on genetics tests or services. Even if the provider fails to do that, and the insurance company receives it, as long as they put that disclaimer in there and as long as we do not use that information for underwriting purposes, the insurance companies will be fine because that falls under the incidental collection except Sen. If they did not put that disclaimer in their in their request and get that information, then they violated GINA. We make that really clear in the regulations, and gives the insurance company's specific language they can use for that disclaimer so they can remember to put their disclaimers in those. The only other thing I want to point out is the enforcement. The states of the ones that really have the the enforcement authority of insurance Cos. Each state has the Department of insurance. Basically, in terms of GINA, the state would have to be the primary enforcement authority. CMS has the right to step in if the state does not endorse [ indiscernible ]. In the past year-and-a-half, ever since GINA has been an active, we have been working very closely but the state making sure that they have those state laws in there so they can enforce the GINA provision. We are working with them on an individual basis. It seems like at this point, most states are on track and to get those statutes in order. The only other thing I want to talk about briefly was the Medicare supplemental insurance, also known as Medigap. These are supplemental coverage as the of people and people service Medicare's that can be purchased to help pay it the deductibles for copays in Part 8 and part B. Also, these cover some additional services that Medicare doesn't cover. I think it is Section 104 really imposes the same protections toward people with [ indiscernible ] policies. [ indiscernible ] in terms of raising the premium, basing eligibility, some exclusions, and it has the identical prohibition against collection. Now, the Medigap peace is not addressed in these regulations. Instead, the National Association [ indiscernible ] has what we call medigap model regulations. It basically incorporates all the federal standards and the states are required to adopt these regulations in order to regulate the policies in their state. If they don't do that, CMS is supposed to step in and regulate the policies in that particular state. On September 24th 2008, what they simply did was cut and paste the GINA statute and put it right into the Medigap model. States are required by July 1st of this year, 2009, to incorporate the provisions. Most states have done so. The main -- the remaining states are on track. That is basically the high level overview of the individual market. I am happy to answer any questions.

I am sure there will be some as we get into the discussion. You want to talk about privacy and confidentiality?

Thank you, Steve. I M Robinsue Frohboese like Amy, I have had the privilege of serving on this committee since it was created in 2001. I well remember the early days, because as what would have that, we were seated of pathetically and I sat next to Francis Collins who at that point had not completed the [ indiscernible ] but did shortly there after. Actually, yesterday was at the White House for receiving -- receiving [ indiscernible ]. I remember him speaking very passionately about the need for nondiscrimination legislation for Genetics information. So, I just wanted at this midpoint in the panel for us to sort of step back from the bureaucrats come as Amy has said, and just recognize the importance of this moment of the fact that back in 2001, this committee took on passage of the genetic information nondiscrimination Act as its number one priority one. As a result, the committee held public hearings, gathered testimony about actual discrimination as well as the chilling affect of the fear of use of genetic information. It really was a concerted effort of this committee that although it took seven years resulted in the significance of GINA finally being passed. I think in your packages there is a press release that HHS released with the publication of all or GINA regulations. There you see in the quotes from Secretary [ indiscernible ] who invokes the memory of Ted Kennedy as well as his words that GINA is the first so rights [ indiscernible ] of this century. I am so pleased that the Office for Civil Rights is part of this effort. Our involvement is that Congress wanted to add the extra protection of ensuring that there are the HIPAA privacy protections for genetic information. So, it directed us to do two things in amending our regulation. First, to make it clear that it does include genetic information and second to ensure that genetic information is not used or disclosed for underwriting purposes. So, for the past year, we have been involved in very intensive coordination with our partners in Treasury, Labor, C M S, and EOC to insure consistency in our approach. Our deputy director for health information privacy and civil rights regrets that she cannot be here, but we are fortunate to have the principal author with us, Christina Heide. Also, two other members Ilion up Peters as well as Jennifer wise men who came to us as [ indiscernible ] to work on this regulation. We are very fortunate that now she is a permanent employee with us. With that, let me turn it over to Christina to give a broad overview.

Thank you. Thank you for the invitation to be here today. We're very pleased that our proposed rule was just published yesterday along with the other title one regulations. Our role deals with a different HIPAA, a different piece of HIPAA. We like to think of hours as the big HIPAA, but I know you might think differently. What my, chopped liver? When I talk about HIPAA, I talk about title two. The privacy world role was going -- privacy roll was going. One thing I do want to know, our role is just a proposal. So, we have a 60 day public comment. That closes December 7th period we encourage public comments. The instructions are in a proposed rule itself up front. I do want to underscore one thing that Robinsue mentioned, which was recorded in heavily with the other agencies, particularly the other title one agencies, to ensure that the definitions and other crosscutting issues were the same. You will see that the definitions are substantially if not complete a similar plan across the title one regulations. We also as well consulted with genomics on the technical aspects. So, we had a small piece of GINA, Section 105. Congress recognizes the distinct privacy interest in the use of genetic information by health plans distinct from and nondiscrimination Act. Section 105 requires us to amend the HIPAA privacy rule to do two things as Robinsue briefly mentioned. One is to clarify that genetic information is how the information and thus protected under the rules. Two, to then prohibit certain health plans from using or disclosing that information for underwriting purposes. Our section also includes a broad definition of underwriting, so the definition of underwriting purposes across the regulations is the same period of our regulation does not deal with what information can be requested. We deal with use and disclosure once the health plan has the information. So, just a couple of points. The proposal goes ahead and does those two things. Two things I would like to point out to draw your attention to. [ indiscernible ] out including H M Os and the Medigap issuers to prohibit those plans from using or disclosing genetic information for underwriting purposes. However, under the privacy rule, we cover a number of other types of health plans as well. Including a certain public health benefit plans such as Medicare, state Medicaid agencies, the Virginia program, the military health program, long-term care insurers excluding nursing-home fixed indemnity policies. And certain accepted benefits such as limited scope vision and dental plans that are separate from group health plans. So, our definition of health plan is broader than the plants listed in GINA. Under the privacy currently, and individual privacy interests are protected. At the end of a central information is protected without regard to which type of health plan holds the information. So, pursuant to our general HIPAA authority to regulate the uses and exposure of health plans, we expand the prohibition to all health plans covered by the the HIPAA privacy rule to maintain an individual's uniform protection across all plans that we currently have today. Certainly, most of the public health benefit plans may not do underwriting at all in terms of eligibility in the termination of benefits. We certainly welcome public comments on that the -- an individual has the right to receive a notice of privacy acts. For those health plans that do underwriting they may not use or disclose an individual's genetic information for those purposes. Individuals are put on notice are made aware of this important new right that they have an this limitation. Other than that, we do on our website have the proposed rule. We have a separate page for genetic information now, and we do have the proposed rule link to the other roles as well as some press releases and related matters, so we encourage you to visit our site. I believe is listed in the press release that the agency put out on these rules. Thank you.

Liz Mansfield. It is all genetic information considered medical information? If it is not, where do you draw the line?

We have always -- we have always considered that genetic information is protected health information we say to the extent that the otherwise needs definition. What Congress said was please clarify that is health information. And now we have an explicit reference to genetic information in our definition of health information. And not all health information, however, is protected by the privacy rule. It needs to do two thing. It needs to be maintained by HIPAA covered entity, a cover health-care provider, for example. Two come individually identifiable in order to be protected by the rules. Which clarified the health information. The preamble also goes on to state that it must meet the definition to fall under our privacy rule.

Can I ask you a follow-up question to that? This committee is very interested in directing the consumer [ inaudible ] as well. We have had substantial discussions about [ inaudible ]. To what extent are those laboratories, many which are clear laboratories and subject to the rules you are describing.

Health care -- they would be a health-care provider, but we don't cover all health-care providers. By statute, the HIPAA rules only apply to those health care providers that conduct certain transactions, financial and administrative transactions electronically. For example, billing a health plan. It could become in some cases, that the independent labs that do not, for example, Bill health plans for the services that they provide to individuals may not be paid to cover entities. But to the extent that they do, they would be covered health care providers and subject to the privacy rules. They can use and disclose genetic information for treatment purposes. Obviously, GINA does nothing in that area to prohibit providers in using the information for treatment purposes. It would be dependent -- it is a two part test for health-care providers. One, you need to make it -- you need to be doing one of it up transactions electronically.

Marc Williams. One of the other issues -- I assume that the present time that the definition of identifiable health information does not quite go to global of weighing in on the identification of the DNA.

That is correct. We have not [ indiscernible ] today on what extent if that is all that is there. Obviously, if there are analyses or other identifiers attached to it, that would be a different story. I mean, we avoid certainly -- before we would do something like that, we would need input on what to say from you all and the industry. Today we have not made a determination.

Great. Thank you. Hopefully you can stay for the rest of the discussion. You want to carry on and talk about title two?

Yes. I am fine sitting. Oh, to you want me to do the slide show? Okay? And fancy. All right. I went ahead and provided some power point slides, because I have been traveling around talking about title two, which is the employment discrimination provisions of GINA. She I went ahead and just modify it. Usually this takes about an hour-and-a-half, and then modify it. I am hoping it is about 20 minutes. Giveaways if I am going over. The title two becomes effective on November 21st. We are in the home stretch now of issuing our final regulations. We haven't done so yet. So, today we are going to be talking about our proposed regulations. I will be pointing out topics on which we got a good deal of comments sort of so that you can be aware of where is likely that the final regulation is going to be a little bit different. On this I think everybody has handouts parallel to the slide shows here and you'll see that put in regulatory sites for the various topics. On my way over here, I realized that I just -- I did not put in the whole site. I am so used to talking in shorthand. When these are issued, they will appear at 29 CF are 1635. Basically, we have three rules under title two. It prohibits the use of genetic information to make employment decisions. It restricts the acquisition of genetic information by employers and other entities covered by GINA, and it requires that covered entities keep genetic information confidential subject to limited exception. I cannot move, because I don't have a microphone attached to me, so I am feeling a little awkward here. In any case, in a moment I will give a definition of genetic information for purposes of GINA. But the important thing to see here when we're talking about the three basic rules is that the first rule, which prohibits the use of genetic information, is an absolute rule. Under no circumstances can an employer use genetic information to make an employment decision. This is intended to operate pretty much like title seven of the civil-rights act of 1964 prohibition on using race or, for example, to make employment decisions. You cannot use genetic information to try to hire someone, fire someone, give someone a raise, make any decisions related to terms, conditions, or benefits from unemployment. That includes a prohibition against harassment based on genetic information in an anti retaliation provision if someone takes protected action against GINA. They cannot be retaliated against. So, it is very broad. The second two rules in particular, the Senate rule, which restricts the acquisition of genetic information has a six exceptions. There analyze the complication. [ indiscernible ] we will talk about that in a moment. Usually I am giving this talk to EEOC investigators or of players and they have no idea what we talk about when we say genetic information. Obviously, that is not a problem here. I did want to go ahead and make sure we are on the same page. Obviously, an individual's genetic test, the proposed rule gives the specific definition of this based on the fact sheet. Also, some examples of things that are genetics test. This is an area where we got a lot of Commons where people wanted more examples in the one examples to appear in the regulation as well as the preamble. You can expect to see some of that in the final regular. Obviously, an example would be a test to determine [ indiscernible ]. Genetic information also includes genetic tests such as family members, and family members is very broadly defined. It includes not only your children, spouses, and husband, adopted children, but also took all of your relatives of to the fourth degree. You're great, great grandparents, and your first cousins, one removed. Information about them is -- genetic tests about those is also genetic information. Very importantly, genetic information includes the manifestation of disease or order in family members. In other words, your family medical history. This is important, and this is where we are expecting that we are going to get the charges that we get, because this is an area where employers do have family medical history pre it is probably not that current right now that employers would get information about your genetic tests, but family medical history is a kind of information that employers often half. Finally, a genetic information includes a request for receipt of individual services by an individual or family members. [ indiscernible ] that is what we mean when we can say that you cannot use genetic information. Okay. Do I see a question? Yes.

I have a quick question. I think I heard it nonhuman samples, like you use the example of AIDS virus. I assume you mean AIDS virus gene of typing.

HIV tests.

You get information on the virus itself and therefore not considering that human testing.

That is right. In all these examples where we are talking about genetic information, this is not an area in which EEOC has any expertise or experience. These all came from experts that consulted at NIH.

Did you talk all about information on the two month in a cancer patient in the same way as you're talking about [ indiscernible ]? Did you use any examples in looking at the tumor itself as opposed to a genetic basis of the the individual? Thank you we certainly don't have anything on that in the proposed rule. The final rule is going to add some examples.

[ Captioner transition. Please hang up and answer when the new captioner calls. Thank you. ]

Covered into these are [Indiscernible] any type of exam required of employees. Again we have a lot of comments about this but we're definitely going to have some more examples in the final regulation tried to clarify how this is going to work. But let's keep in mind there's no exception for employer during a post of exam to obtain a family medical history or any other kind of medical information.

-- Genetic information about what about an employer sponsored health services and here's where we get to the issue of Thomas [Indiscernible]. As a meat said, the title one doesn't have expressed for was program, title to the exception for employers of tanning genetic information to llamas program is provided is in the back seat and an employer may request genetic information as part is how or genetic services as long as the CIBIC requirements are met. And this is what we said in a proposed rule. Thomas program must be voluntary that means the employer must not require participation or penalized employers who refuse to participate to go back to have a written request an authorization, the information goes only to health care provider and the individual with the employer getting the information in the aggregate. And the proposed rule, we specifically asked for comments on the scope of the term of voluntary. And. A lot of comments below and these comments ranged from groups that were of the opinion that in order to be considered voluntary, a voluntary dollars program and therefore it was program that was permitted to collect genetic information there should be no financial inducements. We got a number of comments that suggested that approach. And got a number of comments on the other side of the line there that wanted us to adapt the HIPAA 20% of as long the as and eight and is that was limited to the 20% of group or individual health-insurance, then would be considered volunteered to go this is an area in the final regulation we will go to the comments we received. We will discuss them and we will have an answer. But we don't have one yet because the final regulation isn't out there yet.

Questions on that?

I think probably some of you in the audits are people to submit comments on this proposal and you will see that we will address those in the final Reds.

Number three, I'm going to start moving more quickly because these are pretty obvious exceptions. Under the XML a, and other similar state and local laws, and vigils requesting leave often have to provide family medical history because if they're asking for leave to care for a seriously ill relative, they have to describe the relative and the Hamas. That's not like to be a violation of the typical asking an employe to fill out the general SMLA certification form that requires that they give it the information about the relative is not a violation. Of course, any information that an employer does it has to be kept confidential treated as confidential medical records. Exception number four, this was intended to cover it the supervisor who's reading the newspaper one day and comes upon an obituary of an employee's father and it says the past week after a long struggle with lung cancer. That just acquired genetic information. Really, this is sort of a subset of inadvertent acquisition but, this created a separate exception and says that if it permissible for an employer to acquire genetic intimation commercial and publicly available documents such as newspapers, periodicals, magazines and books, also and commission up to enter electronic media such as the television, movies or Internet, and exception does not apply to medical databases, records or research databases available to side as an unrestricted basis. This exception is another area where we got a lot of comments having to do with what about what about the websites, blocks, all sorts of 20 for century media sources. And again, we're going to see and deregulation comes out six in the five-point [Indiscernible] this grant be a lot more detail of how title to works in relation to those kinds of sources. We had against the rights of comment from civil-rights groups to were very concerned about an employer who was searching for the information purpose in looking for genetic information but happen to find it in the newspaper would be able to take advantage of this provision because Billy it's the it's pause be a type of inadvertent acquisition of the employe who is trying to get the information. And we also have employers who are concerned because they use the Internet as a tool when they're doing the application process but they do Google search of want to look at People's Facebook up to determine if they're going to be someone they want to hire. To have a broad range of comments and we will be addressing them. [Indiscernible] permissible to acquire genetic information to genetic monitoring go again, the monitoring has to meet specific requirements. And this is dealing with employers that is because they have to under the ocean or a line and the city Health Administration rules, the have to monitor the biological [Indiscernible] toxins in the workplace or employers who are voluntarily monitoring the effects of some toxin that the employers are exposed to put and Jim has carved out an exception since yes this is okay as long as you notify your employees they give knowing authorization for they voluntarily comply with the genetic monitoring of of course if the monitoring is required by law you have to make a volunteer but the information is protected and only goes to the employee and the health-care provider covered getting the information in the aggregate. The last the exception is a very limited. It only applies to employers engaged in DNA testing for law-enforcement purposes and a forensic lab or purposes of human remains identification. Ms. Employers may require genetic intimation from employees to the extent that genetic information is used for analysis of DNA markers for quality control to detect sample contamination. We didn't really get any comments on this. We did get some informal comments from people who say this kind of DNA marker isn't even genetic information but we are not experts on that. And this is an exception that's in the statute. Obvious that we're putting it in the regulation and this is an exception to the general about acquisition go to summary of that, I want everyone to given mind the rule is that employers cannot acquire genetic information but they're not permitted to acquire it. There are six such circumstances in which they're allowed to get the genetic information these by the General. If they get outside of those six exceptions it's a violation of GINA in and of itself even if they don't use it this is very much like rules under the American disabilities Act as is you are not allowed to ask certain questions, certain disability related questions even if he does use the information because you are not a lot to have it in itself acquiring it is a violation. The third bicycle again beginning November 21st and there at the genetic information that an employer has a must be kept confidential and must be placed in a separate medical file. [Indiscernible] file is okay means that this has been able about medical and commission under the ADA for that update rehabilitation at for years. You can keep the genetic information in the same file you keep your ADA information. But it must be kept separate from personnel records. There are six discloser rules of their goods be listed at 29 zip 565.90. And I don't have time to the interim but there things I didn't close and connected to mention to government officials your investigating compliance with GINA and is close genetic information in response to a court order that specifically asked for genetic information and four other roles that I want to get into. There's a specific Section of Title II the address is the relationship between title one and Title II. Because the fire wall. The proposal would basically say this is to prevent double liability. Its to ensure that a health plan or insure a provision our actions are addressed and remedy to a [Indiscernible] public of Service Act Internal Revenue Code all actions taken by employers and Tuttle to cover entities are remedied through the GINA title typical example we get is an employer who fires an employee because had they learned that it genetic information and anticipate this will increase the person's health plan in the future. So they fired a that's an employment action but the fact it involves health benefits is not remove it from Title II liability. It helps benefits [Indiscernible] and taking an action based on genetic information on its an adverse action have to do in terms Synod violates Title II prevent a the same time, health plan or issuer provisions or actions that have to do with decisions about pre-existing condition exclusions or health premiums, those types of decisions made by health plans are subject exclusively to Title I. And the fire wall is an attempt to make that clear. Most of the comments we got about our firewall discussion word we need more examples. We don't understand how this is going to work. We need more real-life examples and the final regulation is going to have four examples and hopefully clarify some of the questions that were raised in the comments.

That's it. Feel free to ask questions. Yes?

Marc Williams. Just to make sure that I understand the statute and the one exception. So if we imagine the situation where we had information that has specific genetic variants would increase the risk of adverse health outcome an individual that's exposed to something in a workplace environment, in other words, a toxin or something of that nature that they would reasonably be expected to come in contact with if they had a specific job. The employer could not use that information on the front and either in a hiring decision or in a decision about where within the company that individual could work. But they would be able under a monetary program to be aware, in the sense that whoever they have designated to do the monitoring, the health care professionals, would be able to access that in commission and to help the monitoring for toxins out comes related to that. Is that their interpretation?

Yes, you can use genetic into I will have to leave at the top of the hour for another event. and plena decision even if your intent is to protect someone, you certainly want to require by law some of your mind to be doing the monitoring program that allowed. The only example that ever came up of a non totally voluntary genetic monitoring system there's only one, I can remember with the toxin was. Most of the employers for doing this doing it in court because the work required by OSHA. It you can still do this, you get the persons opposition and you if they and of being someone who is likely to be harmed by this, the health care provider would explain that to them. But it has to be voluntary. So if you in response to the monitor and that you did fired them are made them take a different job, that would make it in Bonn to the tariff of that violates GINA because it can use the genetic information even in a situation when you're allowed to acquire it.

Hopefully the person if they work educated properly that you're born to die or get a disease, they will voluntarily choose to not operate in that.

On up, what happens if a person is it presents the has the information decides to keep the job. Employer does not know about this particular enhanced risk, does the employee then have if employees suffers harm subsequently can the comeback at the employer? Or is the employer protected?

Well, we don't address that in the proposal but there was a comment that raised this issue and the problem is if an employer takes action, as big as myself, I don't know what the final regulation is going to say. But when you think about how GINA works and with the AD acquisition exception is, if an employer took action against the employee, there would be retaliated against them. R. S. using genetic information and they're not allowed to do that. GINA doesn't speak to as your talk about an employe who then sues the employer for wrongful death.

Because they accepted the risk because there's been informed of it.

GINA doesn't speak to that. I imagine there could be a situation of an employer is faced with this situation although remember the employer doesn't have specifically a net of five of genetic information. They're not going to now. Would ever, that doesn't always work as a logo let's say the situation where the employer gets it. I suppose the situation didn't want to violate GINA or risk a lawsuit. I done now with the course would do with that. Would hope that there would look at the conditions of GINA see this is a requirement that the employer was following, but I can't say whether that's the case are not. And GINA itself doesn't speak to what would happen.

Is?

So caring that on one step further, again, assuming that an employee develops a health care condition relating to an exposure, are there any comments specific to unemployment benefits disability insurance or any protections around those types of things? From this type of information?

I don't--

The individual has a genetic predisposition to develop a health consequence from exposure at work. Did develop the health consequences become disabled as a consequence of that, and the disability insurance say you shouldn't have been doing that. We are not going to be paying your disability.

Action GINA does his bit to that and [Indiscernible] doesn't have authority over how the disability security works. I don't know of anything and is the one that is that perhaps there already existing security rules on that. Does someone else can speak to.

I do not know.

On the incidence of the acquisition of interests and understanding in the Rose described, is there an obligation by the employer to document that in the separate medical file?

Our once anything that has to do a voice of do are not do with the incidence the acquisition?

Of we call it inadvertence acquisition but I think other title what is called incidental. GINA I need to another increase the supply received in writing has to be kept in a confidential medical file. And the genetic information they receive has to be kept confidential but an employer this is not something they specifically in the proposal but we did receive comments and my sense is that our position is going to be an employer in the not reduce and commission the received or late into a ragged but they did not do it. But there could be a situation where an employer wants to adjust for their own record say we're by to have written down somewhere that this information was received. Here's why it was inadvertent. Just for the purposes of [Indiscernible] the latter part of the deregulation doesn't require them to do it nor does it make it unlawful to do it. It's up to individual employer.

I have a question about the acquisition of the information become you said that if it's available it's okay But if you go to a site to research it's not. If you do a general Web search and come across the information, that's one. And if the information is available on social network in sides, how is that permissible to get that are not?

And the proposed will we didn't address that. We ask for comments about what people thought about the social network insights. Internet based information that is that there and we got a great number of comments. We are going to be addressing and explain the position of Title II and our final regulation but because the final regulation isn't it should yet come I can't get into the specifics. I can tell you a lot of people raise the concern about the employer who wanted to Google applicants, they Google them and part of the regular employment process. A bunch of website, and start cooking away, websites Dave Boyd, what actions did it take and we will be addressing that in the final regulation and when it comes out, hopefully prior to November 21st, and happy to come back at the next meeting and talk in detail about the decisions that were made. And not allowed to talk about it until then.

Is the ASA going to cover the it [Indiscernible] the genetic information on my Facebook page.

That will be discussed. We are going to be, we got comments about Facebook, my space, Lincoln, websites blog come everything you can imagine and we will be talking about that and hopefully answering of the questions.

We have a few minutes ago I want to make sure we get back to the other panelists as well. Either in the other questions? David?

I have a general question about I think in many ways in this discussion we are dealing with the old versions of what might be regarded as genetic information. That is specific tests or test results were as many began to link clinical information with likelihoods of genetic disease or polygenetic this orders, it becomes more complicated. I wondered how because in this area of discrimination, it's so unlikely that of the you don't have a specific test. In fact genetic information is the basis for discrimination, I wonder how broadly you reviewed the issue in the public what where it defines genetic information, a genetic test.

What I can say about EEOC and I think this is probably the case for all of this is that none of the title one or Title II agencies are experts on Madison or genetics or any of that but we took with the statues said and we brought in experts from and I ate and basically did what they said. A comments. It seems to me you aren't asking about family medical history and what your talking about an individual on condition because of its to do with their manifest all certain systems they have, certain collections of conditions they have that you can discern from that genetic condition. Is that you are asking?

I would include family history but also having a genetic phenotype and a clinical phenotype there's a lot of the things and vault in determining the genetic aspects of the outcome for in his or held.

It's going to protected under Title I entitled to to the extent family medical history is relied on because family medical history is defined as genetic medical information. Something else with an individual on medical condition, I don't know. I'm stumped there. I don't know if anyone else has anything to add.

If it's a condition that's manifested, even if it's proved that its genetic basis, let's say you have breast cancer any ticket genetic test and it shows you had the game a that was likely to lead to breast cancer. Went to have the manifested condition, what have breast cancer, in terms of tonnage to, you are no longer protected by GINA. If you have it manifested condition your protected from employment discrimination because of the American disabilities Act if that condition arises to the level of disability go even if the manifested condition you have has a genetic component or genetic basis, was manifested Title II is no longer at play.

Similarly, for the title when provisions, you did say GINA doesn't apply the that's because the HIPAA nondiscrimination prohibit that kind of discrimination against manifested in his of Dome [Indiscernible] it's only when they haven't been manifested that GINA had to step in.

The me thank Robinsue for reminding us how important this legislation was and how far we've come and now we're talking about a lot of the refinements of all of this. Thank you for that and then to all of you for all your work and begin this law to a practical reality with all the implementation. It's extremely important and we do appreciate it. There remain issues and I'm sure we will be talking about this in the future again. We sincerely appreciated. You're getting into a brick. One of the advantages of being here is we have of the facilities. One of the disadvantages is we don't have coffee at every break. In your notebook, you'll see that there's breakfast of coffee available editable places nearby. The Starbucks and the bread and chocolate at 23rd and M. I realize someone will want to is never quickly for their morning dose. But we will meet again in 15 minutes. Think you all and thanks again to the entire panel. We appreciate it.

[Applaud]

[The Committee is on a 15 minute break. It will resume at approximately 11:00 a.m., EDT.]

Are going to now begin. With the next topic on Jean [Indiscernible]. All right. Let's now turn to our session on gene patents which will occupy us for the remainder of the day. The importance of gene patents and their impact on patient access to genetic test. Our last discussion of this issue was in December when we approved a public competition draft report. For release to the public. We received extensive comments and diverse comments as you will hear. From Jim Evans. Jim chair has been chairing the patent task force and is going to discuss the comments received and you have a summary of them in tab for. Is going to walk us through the content of the final draft before we break for lunch today. This is our time mostly to listen to the results of the deliberations of the task force but there were extensive needless to say this has been a topic that has been strongly held feelings on multiple sites. Where stakeholders have really very different points of view. And after lunch when we reconvene we have two individuals who have signed up to provide public comments. And if others would like to participate in that process, please sign up at the registration desk. After the public comment, we're going to put the committee to work. And began an in-depth discussion of the recommendation. Hopefully we can get it done today. We are prepared to keep us here until late in the day. But if we, we do have a little bit of time tomorrow. And at the end, we need to come to some agreement on the recommendations and approve the report for a transmittal to the Secretary. Before I turn this over to Jim, I think everyone needs to know the extraordinary work Jim and his colleagues have done. And strictly Jim and leading this task force. It's been an extraordinary process in terms of the depth of the investigation. The different points of view that needed to be understood and synthesized. SUR Jim, we do appreciate all of your work in bringing it to fruition and now it's your opportunity to bring it to completion of the.

Don't thank me yet. While we are getting the banks though, I do want to say this has been a five-year project will it. As you'll see in a moment. I meant to highlight the contributions of the staff. I think that Sarah [Indiscernible] and Kathy have been absolutely indispensable as they are regularly. I also want to thank members of the task force to in spite of having eight jobs were able to hang in there through conference calls. And now at the start here. We were never so delusional when we started this out as to expect unanimity in regard to this topic. This is an inherently contentious issue and different stakeholders will understandably and naturally have different opinions. It's been a challenge to my conflict averse personality, but I think throughout our deliberations we always tried to keep foremost in our minds the stakeholder that we all tamale all represent. And that is the patient. In spite of some degree of the times very strong [Indiscernible] the are during and debate, was and valuable. And shipping our conclusion. None of us got everything that they wanted. But it's fair to say I think that as a whole, the task force is in firm support of the report and its recommendation. I'm going to run through this slides at this point. We will have [Indiscernible] and will time for discussion after public comment and lunch. Bear with me as I go through this. Or rather rapidly because we only have about 40 minutes to get through it. This is the current composition of the task force with members ad hoc expert come agency experts, given a special nod to Debra wondered who was the original chair of the task force. And when this for started her tenure came up a couple years ago and I took over. The timeline is such that it was about five years ago when are more than that one we had a divide gene patents and licensing as a priority issue. But there was a National Academy of Science reports that was in the works and the deferred activity until after the report. Before and a small group in the fall of 05 to review the report and in March, 06 we endorsed the reports general thrust but there were significant limitations in terms of relevant to patient access but that was not the major focus. We felt that from a standpoint of our charge as a committed, that more information regarding patient access was needed. In June 06 we decided to move forward with an in-depth study. We established the task force and in December of 06, och Duke's Center for gin up an ethics policy was commissioned to assist and carried out a variety of components of the steady most importantly to case studies. In March 07, we organized a [Indiscernible] un JPEG bidding and licensing practices established a foundation of knowledge among members and in July 07, we had a round table International perspective in a patent and licensing practices. The task force continued information gathering process and began developing eReport. And Ultramar, about a year ago, we approved for public consultation a draft report for release. And the public comment. When the standard time. This was in March 9th to May 15th to go and we will hear some of the comments throughout this report now. The overview for this session this next 40 minutes or so is it that we want to familiarize you with the process for having reviewed the comments and creating the final draft report. We want to give you an overview of the report, the presentation of the proposed recommendation and then we will in the active and have a discussion of findings and conclusions. I would urge you all to read as much of the report as you can especially the recommendations with the rationale that follows the recommendations. Towards the end of the report.

We did receive a number of reports, some of them extraordinarily extensive. Some with tables of contents and indexes. And there were 77 Total reports but the came from a wide variety of different sources. The review process for the public comments is extensive, some of us read every single comment in detail, but the binder containing all of the comments was sent to each task force member for their review. Members of the task force were assigned comments to present for group discussion during the teleconferences. And all comments were discussed during conference calls matter how short or no matter how involved and like the. The public comment or a critical supplement, the case studies and a ledger, I think this is all the [Indiscernible] I know that for example with the genetic discrimination process, the public comment were instrumental in forming our thinking and I think that at least for many of us the same can be said with regard to the public comments. I would add that many of us on this task force very much started and ended the process in somewhat different places. Very different places. It was very much a learning experience and the public comments were instrumental in that learning experience. It was of notes that the patient, that the public comment confirmed that patient access issue that had been identified in the case that these were not isolated problems. These came up over and over again in public comments from a variety of sources. And [Indiscernible] problematic for the Medicaid population as you will see momentarily. The public comments highlighted the problem of exclusively blatant so providers. And limitations on their ability to offer for example population wide recommended carrier need more screening. And there were many comments that called for more discussion and report and more discussion among the committee regarding the impact of patent on [Indiscernible] sequencing, multiplex testing and other emerging testing innovation. After receiving all of the comments and going to them, I was absolutely pleasantly surprised there were critical comments from really both ends of the spectrum. Those that advocated dramatic and extensive changes and felt there was extraordinarily problematic activities going on. And those who felt that things really were great and it there should be no change whatsoever. I feel like we have tried to walk a balanced approach here. I'm sure people especially on the ends of the spectrum will not agree with that.

Many that submitted public comments discussed their opinions and perspectives on patents and that certainly extraordinarily valid to do so. This is a subject that people have strong opinions and perspectives on. We especially appreciated comments that had concrete examples of benefits for our. Not platitudinous, not [Indiscernible] but concrete examples. Some of these concerns the impact of patents on this development of some commentators thought that patents are not needed for test development other thoughts the patents are needed for test Development. And again, we thought when ever we could to find evidence that eliminated those issues. Regarding the process of producing this revised report, you'll notice perhaps that this report is much tighter, much shorter than the original report. And that was intentional. After reviewing and discussing the comments we revisited are preliminary conclusions and you will remember that we took a somewhat unorthodox approach and our draft report giving a range of possible recommendations to consider for the recommendation to the Secretary. And what we were hoping and indeed I think transpired was that following the public comment period and the extensive discussions we engaged in, we could then sort through those comments and decide which ones we felt were most appropriate to include in the final report. We revised the conclusions after considering all the evidence. The case studies, the articles, public comment, previous informational sessions and public comments during meetings. I would also point out that there was a wealth of expertise on the task force itself. People who do these tests, people who order and perform these tests as well as those who deal with the consequences of them. We discussed which policy options made sense as the final recommendation, the background Section of the draft report were revised to reflect the task force discussions and considerations. And it would it reorganized according to the key questions we address. Here is a summary of the report main points. First we had to tackle what types of patents are more precisely, patent claims are associated with genetic test. It's important we all be on the same page as we consider these issues. There are patents claiming isolated [Indiscernible] acid molecules and these are the oldest type of what generically referred to as gene patents. These patent claim an isolated [Indiscernible] the sequence may correspond to a gene, to be mutated gene to interject the NA for example the of these patents are sometimes called loosely in our [Indiscernible] and Gene patents and for the sake of simplicity and accuracy, the report refers to these patents as patents and claims on genes. There are other types of claims that really accomplished in many ways the same thing but have subtle and important differences. Patent claims to the act of associating a genotype an event that is something that has gotten much activity and interest in recent years. For example, a patent my claim a method of determining a predisposition to [Indiscernible] comprising testing a body sample of a human for the presence of a mutation in in a. Where in the presence of a mutation in gene H indicates a predisposition. What you can see with this type of claim is that inherent in it is that the cessation of genotype with phenotype and for the sake of simplicity, the report refers to these patents as Association patent claims. Again, these are very much in the news now because of recent court rulings and pending court rulings. And there's another type of claim that is important to define so that we understand the different mechanisms of are attempting to patent this type of information. And that is patent claims the processes for detecting specified genetic sequences, so a method and I put that in quotes for it an important reason or process of detecting a particular sequence including a particular mutation, easy specific probes, specific [Indiscernible] etc. In essence this type of patent is attempting to clamp a specific sequence that you can see that it jumps through certain hooves to do so. And I think it's extraordinarily important to emphasize that this type of patent should not be confused with patents on innovative [Indiscernible] for general DNA analysis. We are not talking about here at all today. Our methods patents for example, [Indiscernible] and type of sequencing, etc. What we are talking about laying claim in some way to a sequence through different avenues. Or to an association. Also there are patent claims to test kits for conducting eight specific genetic test. Patents lead to an exclusive rights but that's the intent of patents. That is why we have patents in the first place. How a patent claim can get exclusive rights to a genetic test is a multi pronged mechanism. In addition to claiming an isolated gene Michael, these patterns may claim for example primers for ever find a gene or a nucleic acid better complementary to the gene. That would be one way.

Because the typical method of testing before 18 in a diagnostic setting involves using either Pat did primers or complementary probes is as a situation, these methods then require the patented Monaco in order to function. The package and a holder ability to exclude others from using a molecule then gives the patent holder exclusive rights to test it. And suspicion patent is a little better because it gives some exclusive rights to a test but with an important subtle difference. A patent of this sort does not claim the molecule itself. It claims the met the day, I would put quotes around that testing him as for particular genetic sequence and associating that genotype with a phenotype go back and is very important. And the cessation Patten says we on the process for testing for this and associate it with a genotype. Really that set. The patent holder has exclusive rights to that process were method which involves the testing and the association of sequence [Indiscernible] and because the genetic testing for Disease X our predisposition for example necessarily involves the process. The patent holder has an exclusive rights to genetic testing in that setting.

There's another way that this can be done, patent claims over a process for detecting a specific cetacean their probe hybridization primer driven application and sequencing course some other means. The patent holder that has exclusive rights to any genetic test that detects that specific mutation through that patented method. So it's very important to keep in mind as we go through this the purpose of the patent system. And this goes back of course, to the U.S. Constitution. Article to Section eight says that patents exist to promote the problems in the science and useful arts. There's a long history and U.S. legal tradition found at originally in the Constitution that a patent system has a very much a utilitarian purpose in our country. Patents in the U.S. are not awarded as natural rights but they have a very utilitarian function in mind. Patents are designed to stimulate scientific progress through a variety of mechanisms. By offering the inventor and exclusive time limited rights to use make or so they invented and other words, a grant of limited monopoly. And this is a trade-off. Society has decided that this trade off is a good thing for us as a whole, and the trade off is between benefits of patents and stimulating scientific progress because as part of the deal when you receive a patent for its civil, you need to the votes that information now others are free to use it to build the next mousetrap. And has to balance that with the harms from patent holders ability to exclude others from an invention. And the report from the outset was intended and we were charged with very clearly the charge of examining both sides of this trade-off. We were not charged initially to just go out and find a harms from patents. That would have been a presumptive and an unfair type of activity. We were -- Not only would it have been present of an unfair, but it wouldn't take into account the basic underlying rationale for patents in this country. Therefore, it was important that we kept in mind throughout the process that we were looking for both benefits and harms where we could find them.

Let's look for a minute examination of the benefits of patents and the genetic testing arena. The patent system as I've said it is intended to promote scientific progress and and, as recognized the men mechanisms for how such progress can be promoted in the scientific arena. One, patents can promote progress by stimulating research for the purpose of making discoveries or inventions. This is what we think of oftentimes as the most over arching benefit to patents. But they also are meant to promote the progress by stimulating disclosure of new discoveries and of adding to public knowledge and finally, patents promote progress by stimulating investment and post discovery development. Because especially in the realm of health care for example by [Indiscernible] recognized do we are not interested in just having discovered, we are interested in implementing those discoveries. We want to drill down and I think it's important to remember that our task force and this committee is charged with looking at a very narrow slice of patents. And that is in the realm of genetic diagnostics. We want to frame these questions in the realm, in the context of a gene testing. One question that we have to ask is the Pattons stimulate genetic research leading to diagnostic test? Regarding disclosure, we need to ask the patents stimulate the discloser of genetic discoveries that the lead to diagnostic tests and finally, the stimulation of investment needs to be focused on whether patents stimulate investment and develop it discovered a major indices the position for example into a genetic test. Taking a look for a moment at these idea that we want to stimulate research and discovery for invention. The case studies were instructed him. And they reveal that patents stimulate some private investors to fund genetic research. However, there was also abundant evidence that academic scientist conduct research not because of patent but because of other motivation. In fact, academic researchers are often times almost willfully ignorant of the patent situation. Government provides vast amounts of funding for basic life sciences research got this is an important piece of the equation when we are thinking about the stimulation of research in this field. And there were no consistent findings by case studies for public comment that patents are necessary to stimulate research they to the availability of genetic test. There were weak indicators here that there was never a strong evidence that patents were necessary. In fact many genetic tests exist out there and which patents were taken place at issue nonexistent of the consideration.

Discloser is another issue which of course we're interested in. Researchers, we felt sufficient existing incentives to disclose genetic discovery. Academic [Indiscernible] encourages open sites and rewards publication as a first discovery and the individual investigator and the academic environment where most of these discoveries are made is after the other things that do not include patents in a typical situation. Patents and jeans and backed by some criteria would appear to diminish public knowledge. Because the results and was followed on research. In a study by it [Indiscernible], with quotes in the report it that strict interpretation of our results suggest that follow on genetic researchers for go about one and ten research projects or more precisely, Research Publications has discloser to the cause of negative impacts on the gene patent grant. Regarding the stimulation of investment to develop genetic test all the Patent and discoveries are developed in the test, and parentage then it discoveries are routinely developed in the clinical genetic testing services. A cancel emphasize this point too strongly. This I think was eight [Indiscernible] data around this issue was a very persuasive point for many of us on the task force. What one sees an example after example with regard to development of genetic test is that the role of [Indiscernible] was primarily used to narrow the offerings out there for genetic testing. Prior to the granting or implementation of patents and exclusive licenses, again, example after example, minilabs offered the test and the red numerous laboratory options for an individual to have a genetic test. After I the was in force, after exclusive licenses were negotiated, what one sees is a clearing of the market. And this phenomenon is likely due to the fact that clinical need is sufficiently high and the developmental costs are sufficiently low. So that genetic test can be implemented when the knowledge is out there and therefore, patents [Indiscernible] consideration do not seem to play an important role in developing test. In fact, what they seem to do an example after example is narrow the market. Does the conclusion of the most of us and the task force word did patents are not needed for the development of testing services. I think there was an instructive public comment from the Director of Laboratory who specializes in rare disease in which he very poignantly said that when they are considering what it is developed as soon as they see that there is IT special exclusive IP that is surrounded a particular test it moves to the bottom of the list in his quote. Again, we will have plenty of time to talk about this in the discussion period, this was not a unanimous feeling among the task force as I mentioned at the outset. But it was certainly the feeling of the majority of the task force.

Our overall conclusion concerning patent benefits are depends do not serve as a powerful incentive to conduct genetic research to disclose genetic discoveries or to invest in the development of genetic test. There exist sufficient incentive and binding for research and development and as such, the benefits of patents in the area of genetic testing are limited. We then turn to examining the cost and when I say cost, I would always insert in your mind the flash cards. We are not talking about just financial issues year. We are talking about arms for costs in the universal sense to patents and the genetic testing arena. So the task force examine whether patents on genes and a tight phenotype Association on methods of detecting specified sequence of are causing one, limitations on the ability -- Availability of genetic test as a result prices and this could be through the combination of assault providers and a multi payer system. Number two, limitations on the ability of researchers to develop new test and a number three, whether one would see problems and the quality of genetic testing because and must be remembered of course, that access to genetic testing doesn't just mean access to any test. It means access to a quality test. That is the highest possible quality that we can reasonably expect. We wanted to interject the? Licensing pressure here because the issue of licensing is an important one when one discusses these issues. To evaluate the cost of patents and licensing practices, there's some background information as required. It license is an agreement through which a patent holder agrees not to exclude a specific licensee from using the invented go there are different types of licenses that exist. On one hand and on one end of the spectrum one has exclusive licenses. This creates a sole provider of a genetic test. That is only that licensee has the right to practice of the invention. There are less exclusive forms of licenses. There are for example, nonexclusive licenses that are extraordinarily broad. Exclusive licenses that permit multiple licensees to use the patent and of a commitment to offer testing. So one of the most surprising features or outcomes of the case study was that the impact on prices for genetic testing. I'd think most of us assume that the outset that there would be some patent premium associated with the holding of a patent and exclusivity in the realm of the genetic test and that did not turn out to be the case. There was not a pattern of overpricing for tests that were patented an exclusively licensed when compared with test the either and planted it or not exclusively license. There were a number of a destructive an interesting kind of experiments of major here to focus for example on the RCA testing. So [Indiscernible] genetics as we all know hold the patent on [Indiscernible] test and exclude others from doing it. When you compare the unit price for that test with either tests that they offer that are not exclusively owned by them, or with test underperformed by other entities, what is not a patent premium. There is evidence or suggestion of a patent premium in the test [Indiscernible] disease versus [Indiscernible] which is a reasonable comparison that could reflect a patents premier. But overall we did not see a pervasive increase in cost. There was a public comment that was instructed suggested a [Indiscernible] who owns the exclusive license on a number of [Indiscernible] irresponsible gene is needlessly expensive not because of a patent premium %, but because it necessitates bundle testing in some certain -- Circumstances. What has to the but the fact that we differ only with genetically [Indiscernible] diseases. It may well be that a condition would like to test the DNA if an exclusive licensee for an exclusive provider of such testing doesn't allow that type of testing and says no, you have to get the whole panel. That can cause an increase in price. It's a different mechanism than a traditional pattern premium. Clinical access to genetic tests was adjudged by trying to do articles, case studies, public comment. Add these indicated that overall patents an exclusive licenses are certainly limited the ability of clinical laboratories to offer genetic testing. This is a non controversial statement in that one can show over and over that laboratories are prohibited from doing testing when IP is in about against them. Licensing practices that limit the number of clinical labs that can offer a test do not necessarily result in patient access problems. However, patient access problems research and the reported and arose when licensing creates the sole provider as probably the major type of context or situation in which problems occurred.

Going on to look at this process, these access problems have generally not occurred for patent protected test that are broadly license. Most problems seem to occur when tests are exclusively licensed and create then a sole provider. For example, the case to the of the [Indiscernible] syndrome it's a legal this order in which individuals have a genetic predisposition to rebuild this arrhythmias and over a period of about 18 months, excesses' 0 X was sublicensees enforce patent rights even though they were not yet offering a test which and the judgment of the case study, probably had a small but tangible negative effect on patient access. Look in at the issue, an issue that was a highly instructive in the round of public comment and in talking to clinicians as well as patients who have dealt with these issues. Is the issue of how the sole provider interacts with health insurance and how that changes for effects of patient access. And what we saw over and over again in the public comments is that the combination of exclusive licensing to create a sole provider combined in the context of a multiple payers system like the U.S. health-care system, often results in patient access problems. And the meat of this type of scenario is the following, so providers oftentimes failed to secure coverage from some major player or payer. And this includes for example, out of state Medicaid programs. As a result, some patients can't [Indiscernible] and of course its indigent patients covered by Medicaid in particular that do not obtain testing. And the way this works for example, is a that a laboratory with exclusive rights to do this test for example, doesn't have a contract with metical, the Medicaid program in California. Metical has numerous contracts with laboratories to have said we'd like to do this test. You have a contract with us and we like to do this test. But they can do it because of the exclusivity ended by the patent and licensing situation. In the hearing of the now which has an exclusive licensing to a number of the genes that are involved in hearing loss. They have not been able to secure coverage from metical for the next -- Connection 27 vacation account for the bulk of nonsense from [Indiscernible] caring loss cases. This quotes from the report access for these consumers therefore depends on the case studies access for these consumers therefore depend on the availability of additional providers who have contracts with Medicaid or entails direct out-of-pocket payments of by consumers. Uncertainty surrounding whether these all to the providers will phase enforcement for will stop testing creates an unstable situation. There are many different ways of dealing with this. If your a lap and you have a contract with the state Medicaid agency, and yet you are prohibited from doing the test, one choice is we want to the test. And that of course is what your legal counsel would tell you specifically not to do. Other laboratories say, we're just going to do the test and hope that nobody in forces. So as you can see, it's a rather unstable situation. There are similar problems for [Indiscernible] testing which was mentioned before.

Cell providers offering testing for Alzheimer's disease and a [Indiscernible] have problems for example securing coverage from particular payers. [Indiscernible] had this problem at the outset but now is secured wide coverage from Medicare with a very reasonable types of regulations about when it applies as well as private insurers, but it should be noted that Medicaid patients still cannot obtain such testing in at least most if not all states. The information from public comment again highlighted this issue. It arose in Georgia, we got several comments regarding the same issue going on in Georgia as going on in California with the end result is that access to a genetic test can be largely influenced by patients socio-economic status and geographic location. In one state where there is a contract it might be covered, if you're in another state, you won't. Health care provided complain that some so providers have not secured coverage by the same mechanism there were problems in Montana. Apparently Devonshire's not covering genetic testing for hearing loss and advocacy groups complained that a thing of the sole provider for a [Indiscernible] testing has not secured coverage from some payers again resulting in access problems. Observations from the public comment include that when there is a sole provider, patients can't obtain second opinion testing. This is another issue that came out in the public comment and has actually been in the news of late because of the [Indiscernible] Orchestra did [Indiscernible]. This issue of second opinion testing is seen as a particularly troubling one when one is in the context of basal provider. Recommended carrier and newborn screening is not possible at times when only one lab offers a test. And it's thought that multiple labs are oftentimes needed to handle the kind of a belly of of testing as well as the temporal factors that are important and newborn screening in which this has to get done quickly in order for interventions to be enacted. Our conclusions regarding patient access are for the most part, patent covered a genetic test and related licensing practices cannot appear to be causing wide toward lasting barriers to patient access. And this census listed out in a number of comments that sometimes what is now listed out is subsequent sentence is which is however the case study in public comment documents several situations in which patient access to genetic test has been any different segments of the population. Especially in the -- And impatience when they're offered by an exclusive provider are limited number of providers enabled by [Indiscernible] and rises in practices.

We struggle for a long time with the issue of quality. As I mentioned, from the outset, our charge was to look at patient access and genetic testing and inherent in that charge was the genetic testing needed to be of high-quality. There are recurring concerns regarding test Quality greatest is offered by Nestle provider. And here we were lied to considerable extent on the expertise up to members of the task force Andrea [Indiscernible] in dollars and Deborah when Eric who do these tests and who are engaged in a day-to-day basis in quality control. And it was pointed out that proficiency testing under a [Indiscernible] quality control in this country for laboratory testing in general, requires that multiple lab offered a particular test. In addition, there's concern that with samples become increasingly file and smaller as we use diapsid techniques for example better less invasive and produce small amounts of material, more local laboratories are needed to handle testing. Samples sent to a distance all providers are subject to degradation. The competition between multiple laboratories' offering a particular test in addition to lead to innovation in the testing method for that test. As a quality I think needs to be looked at from a rather substantial step by. We are not talking about just reproduce ability. About just did the right answer occur. Those are absolutely critical and are addressed optimally by multiple labs Hechinger samples and engage in proficiency testing. [Indiscernible] in order to improve for example the sensitivity and specificity of a test go the most [Indiscernible] example of this that is bought out frequently is the muriatic genetic example where the recent testing lag behind many call for improved testing. In the example of a [Indiscernible] which is instructive, you have a lack of a exclusivity. And this has lead to multiple both private and not private labs. To all compete to offer a variety of things based on innovative testing, quality of testing, sensitivity, specificity, etc. By having not exclusivity, quote one sees is basically a market place in which innovation and quality is enhanced. There is legitimate concern that exclusivity undermines that process. So the existence of the sole provider dictates in addition what method of testing is offered and the testing strategy. For example, bundling is, as we discussed a moment ago. For heterogeneous conditions but not necessarily the most efficient or most cost-effective way for a patient or provider to proceed. And again, in the setting of exclusivity, there is little pressure on a particular laboratory to offer a variety of or ability by which to do that test. Those methods are at the discretion of the single laboratory and I mentioned the issue of Barry and the recent testing. One of the things you might notice if you were able to get you both the draft report and the final report is that we have spent more time in the final report discussing the implications of the current landscape and gene patents and licenses for the emerging world of genetic testing. There were many comments from all across the spectrum that said, you guys need to consider this and that was a major driver in our deliberation over the last couple of months. There is broad consensus I think the medical arena, in the technological arena that genetic testing will increasingly involved multiplex technology. Genetic disease is common disease are genetically heterogeneous there are many genes that go into a predisposition for any given disease. And more over, we are on the verge of [Indiscernible] sequency. There is no question in anyone's mind who is involved in this that within the next few years [Indiscernible] sequencing will be readily available for prices that now is certainly certain bottles of testing for example, FCA bullet speed and cost. It will be cheaper to sequence the entire genome then to sequence and current cost say 11 genes responsible for a single disease. And the advent of multiplex testing, there's already an issue with regard to gene patents and access. Labs of an exclusive licenses are currently blocking labs that do multiplex testing from reporting results pertaining to those patents in genes. And we heard about this in public comment. The potential for blocking situation and [Indiscernible] testing we discussed. The task force study not only the cost or harms of patents on existing test but also the potential of existing patents to block the development of new test. Specifically, multiplex test parallels the Clinton and obliging and clinical whole genome sequencing. I'm going to need to go quickly, people are going to get lunch. There's no precise figure for the number of genes or association protected by patents. Suffice it to say, the typical number and it about is about 20% of the human genome is under patent protection. And concerns have been raised that all of these existing patents on genes and disease [Indiscernible] position have created a [Indiscernible] a developer would be possible licenses to develop a multi gene test. Patents on genes and associations cannot it be invented around an important point and controversy exist regarding the legitimacy of patents on genes and association. Some of the patents on these ads claim and products of nature and you patents on Association as clamming was of major. So with these new methods actually infringe on patents on genes? Multiplex testing involves from molecules would probably infringe corresponding patents in nucleic acid molecules. Multiple parallel sequencing typically involve [Indiscernible] molecules begin, would probably infringe on penitent and click acid molecules. There is interesting uncertainty over whether hold general sequencing would infringe on such patents on genes. Association patent claims on the other hand are by definition quite broad. We've got over the definition of an association patent. Claims such as these did not specify a particular method of testing so any method of testing is protected if one is taking the association and as such, any new form of testing would infringe claims of this [Indiscernible] assuming the test included the gene reference by the patent which of course whole genome sequencing would by definition, necessarily include all genes. Dove into this more with these new methods in France patent claims, it really depends on the particular method in process claim. I'm going to go to the summary slide. New methods would probably in French at least some association patent claim. For example parallel sequence in and multiplex testing appear likely to infringe a patent claims on genes and the methods for detecting specified sequence is. Hold genome sequence in May are may not an average pension plans to James and this is a matter of some debate among a legal scholar in the area. Test developers nevertheless would need multiple licenses to existing patents to develop most of these new innovations. There also challenges to obtaining licenses that have to do with the fact that the human genome has been staked out in many arenas. It's often unclear whether license the rights are available. One way to learn of this is to look at existing licenses however license terms are often undisclosed even if one cannot in all need licenses, all of these licenses can lead to royalty stacking or also transaction simply involved in having to several renegotiate the license. There's costs involved in researching patents separately negotiated each license and too much of license fees that can discourage development. Even if these can be overcome, panelists who refuse to license can prevent this developers from using and packaging volatile or association the menacing the value then of a multi gene test. The blocking problem which one individual laboratory says with got this gene it accounts for 11% of cases, and it's not going to be in this panel or that panel. This of the cannot be invented around. There have been a variety of proposed solutions to patent ticket's including that in polls which are interesting and innovative agreements among multiple patent holders to license all patent rights to the package. Those advantages include the ability to obtain all the rights with one license. That solves the stacking problem. The disadvantages are that patent rules are volunteered to go and biotechnology company and holders have no real inherent incentives to join forces because again, each holder of a gene can offer a single gene test as opposed to on one necessary component of a chip. You can't do anything with that but you can do something if you simply on a single gene. [Indiscernible] participate can limit the value of the pole and most constructively, not proven useful in the genetic testing arena thus far. The questions remain as to the viability of these solutions. CUR and houses are another innovative solution that have promised patent holders join a collective the then charges a standard license some of for its patent and the bandages are they don't need to negotiate its license. We have licensees that are tapped, that are considered and vault, the disadvantages again are the clearing houses are volunteer. Is a possibility of holdout and have not proven useful in the genetic testing arena thus far so again, there's significant questions as to whether this is a viable solution and I think it would be awfully sketchy to rely on these as solutions.

There additional challenges to the development of [Indiscernible] our home brews and the bridge to create [Indiscernible] is not entitled to experimental use exemption. The Senate is pyramidal use provision provides an exemption from patent infringement liability to using intended invention for the purpose of developing and submitting information under federal law regulating drugs. Those using patents and molecules during research to develop a clear lack develop test couldn't invoke this exemption because Cleo is not a federal law that regulates drugs. Conversely, to get approval for a test kit developers must submit information on analytical validity, clinical validity, under the [Indiscernible] so any use of pented molecule Association etc., in a kit would likely be exempt from infringement.

There are a variety of legal developments that are currently in flux. There are various ongoing cases that may well fall to the patent ability of GINA Association and methods of detecting specific sequences. We all probably know about the ACLU case in which a variety of [Indiscernible] are challenging including the claim the [Indiscernible] [Indiscernible] association between Piers be in breast cancer and claims to let this detecting the mutations in these genes. [Indiscernible] has been granted [Indiscernible] by the Supreme Court and will be heard. It may well it's almost surely will affect the Pat ability of processes for correlating a genotype and via type even though Boesky is not in its garrisons without gene. It was a filling of the task force however that it is impossible to predict the outcome of these cases, it's better than to address problems that we see as pressing to recommend policy changes and statutory changes. We reviewed a few other pieces of material including the [Indiscernible]. This is established in foreign-policy of allowing academic institutions to retain Title II a federally funded inventions and the question arose during our task force deliberations over whether log gives [Indiscernible] the 32 required nonexclusive licensing. Clearly even if it does, this is not the norm. In an age does practices for the licensing or reviewed, these have been promulgated to promote for example brought licensor. The nine-point have been promulgated to promote many of the same thing. The OECD guidelines, the licensing of genetic invention, the NIH policy of sharing data, etc. There's no shortage of promulgated suggestion and suggested role. That discourage a exclusivity and for example, in this case, discourage genotype be a type Association. However, these recommendations have existed for a long time and [Indiscernible] to put it mildly, not universal. Finally, before we get to the recommendations come to want to just remind people of something I think the task force was cognizant of all along. And that is there is a moral dimension to this question. The remaining common sense that pointed out that moral and ethical issues are inherent to the consideration of gene patent and licensing. I think we all understand that at a basic level coming into to anyone but this of it, people feel strongly about it. Whether is a moral and ethical dimension. There is strong sentiment in [Indiscernible] that access to one's own should not be limited are prescribed by a patent to of course, that's what a diagnostic testing during. Its achieving information about one's own genetic information. And this is at the root of the present course case that brought against the area. I would also remind is as we think about making changes to a system, that genetic tests are not equivalent to commodity. We are not talking about consumer electronics markets and appliances here. We are talking about human health. And these considerations are important to remember that they affect human lives and human health. To some of, the plan system is designed to. Progress. That is the purpose of the plan and system in the U.S. going back to the Constitution. In the realm of therapeutic, a strong argument, therapeutic for example, drugs. Strong arguments can be made that patents and able innovation drive progress and served an important role because for example, the high up-front cost and investment that are required. In the realm of diagnostics, patents and able [Indiscernible] primarily to multiply and [Indiscernible] results and a narrowing of offering to patients and physicians. If access again the kitchen appliances were the issue, I'm not sure that the situation would be anything more than lamentable. And might not rise to the level which we might advocate change for the what is at stake is patient access important medical inflation and we the task force in general, with some dissent, felt this warrants changes to the system. A as Sarah and the state since we are running late, do you want me to go through the recommendations?

Yes. Can you briefly go through them?

Very quickly. And we're going to go through the and that afterwards. The overarching recommendations are really 12 and perhaps the. Number one, create, it advocates the Secretary's support and works with the Secretary of Commerce to achieve the following statutory changes. And that would create an exemption from liability for infringement of patent claims on genes. For those who make, use, order to up for sale, sale, test that develop under the patent for patient care purposes. What this speaks to do is it six to narrowly dissect the diagnostic use of gene patents from other uses an exempt that use in the medical context. This can be seen in some ways as analogous to the against the frisk bill which exams medical providers infringement claims on a variety of procedures. Number two, is the creation of an exemption from infringement for those who use patent protected genes in the pursuit of research. And a number three is the Secretary should discourage the seeking granting, invoking a symbol Association patent claims. Because it was a feeling that most of the task force that a cessation patent claims represent basic laws of nature that cannot be invented around and should not be on. We are advocating and regular -- Recommendations that promotes inherent to norms and it will need to have a discussion should there be [Indiscernible] put in regulation that seek to get for example, Mondays to a year to norms of licensing, etc. Enhancing transparency and licensing is important. And again, it will be a matter of debate whether or you want to put teeth or simply suggest these things. We have advocated an advisory board that would in an ongoing way to assess problems in the realm of a gene patents. I would add that if we tailored the subsequent recommendations after one, two and three because we recognize that statutory changes take a while, the secretary may not changed and women them and therefore you wanted some other recommendations as a fallback is the. Federal efforts to promote by licensing and patient access we've got recommendations that encourage these things and we can have a discussion about whether this should be more than simple encouragement.

[Captioners transitioning]

We are running late, and it is going to be a little challenging to get everybody back. You have a list of eating areas in your pocket. We allowed 45 minutes. Let's plan to start at 1:00. I think the public comments are able to stay so we can get all of your input, which we need. Why don't we break and see everybody back at 1:00.

[ Break for lunch until 1:00 EST. ]

[ 1:02 EST, Captioner standing by for event to resume. ]

We are ready to go for the heavy lifting this afternoon to go through all of the recommendations on our report. Before we get to that, as I mentioned earlier, we always set aside time for public comments to allow time for you to hear different perspectives, for me to hear different perspectives. Not only on Dino patent and other issues. I ask that the, enters please keep their remarks to five minutes. We should have copies of your false statements, which will be made part of the meeting record. We did have the benefit of many of the perspectives from the same groups earlier as part of the comments when our drafting report was out, but we look forward to hearing your additional perspective today. To begin, we will start with Jennifer lead who is speaking on behalf of the Association for molecular [ indiscernible ]. Do you mind speaking from up here? I know it is a long way away. Welcome. We look forward to hearing your comments.

Hi, my name is Jennifer. I am speaking on behalf of the Association for molecular technology. We would like to express our gratitude for the committee to hiding the concerns and challenges. First come as many of you are aware, AMP is the lead plaintiff in that recent lawsuit. Let me be clear, AMP opposes the passing of DNA, of all DNA. While we have concerns about that, our concern does extend beyond that to the negative impact that can concur to a patient access [ indiscernible ] at associated with the exclusive licensing practices that we observed in many cases including muscular atrophy and [ indiscernible ] jeans. At the last meeting, we did encourage the committee to continue exploring additional cases and are very pleased to see that just before lunch the review of the report findings that the committee did follow that request. We look forward to hearing the discussion this afternoon. AMP completed its physician's statement on genetics testing in 2007 and is posted on our website. AMP the use genetic testing as an integral part of the health care system with a great potential for future test development and use. However, we believe that genetic tests should be provided only through the services of an appropriate health care professional and properly certified laboratory. Additionally, AMP is concerned that genetic tests sold directly to the consumer have [ indiscernible ] and promote the purchase of products not proven. When considering this, AMP requests that the committee review the practices of these companies including the testing offered, the laboratory certification, the claims made about test results, and access to qualified health professionals for up the process. Additionally, they should look at feedback from the average -- everyday consumers to learn about benefits, harms, misconceptions, the genetic literacy, changes in health behavior, and other outcomes. Last, AMP has been a supporter of the nondiscrimination Act for almost 20 years. We have actively participated in the long struggle. We are currently working to ensure that GINA protections are not weekend. It earlier this year in health care reform debate, members of the Senate proposed offering the amendment that would make employer based wellness programs exempt from complying with the Civil Rights Act, Americans with Disabilities Act, and GINA. As we heard this morning, GINA currently allows wellness programs to collect genetic information including family medical history as the program meets the voluntary criteria. As we read this morning, DNA regulations discussed if an employer offers a cash incentive to participate in a wellness program, the program is not involuntary. That incentive is considered not an incentive but actually a penalty to those who choose not to participate. Employers want to offer cash incentives to encourage people to enroll in the programs. Instead of attempting to address the a voluntary regulations, they simply try to circumvent the importance of Rights and privacy protections through the health care reform today. AMP joined 28 organizations in signing a letter urging the Senate Finance Committee to defeat this amendment. Fortunately, the GINA advocates one. We're hopeful the [ indiscernible ] will it eliminate the loopholes for employers and help voice GINA. We were made aware of the genetic tests companies. While I am sure it can inform members about a genetic test without violating GINA, we are concerned that the public is not armed with the knowledge they need to know that they have the rates to decline testing without any consequences to their coverage. AMP encourages the committee to explore the ongoing attempts to weaken or circumvent GINA, pretension to its recent activities, and worked to educate the public. The amendment in the Finance Committee serves as a strong reminder to those that opposed GINA and will continue their fight to weaken the unravel of protection. We supporters [ indiscernible ] in to continue our fight. Thank you.

[ speaker unclear due to low audio ]

We appreciate your input. We have these meetings on a regular basis. Thank you. Were there any questions or comments for Jennifer? Thank you. Our next speaker is from the biotechnology Industry Organization. I may get your name wrong. Is it Tom Dilan? I was advised. Welcome. We appreciate your input. We welcome your comments this afternoon.

Thank you very much. I appreciate the Committee letting us have the opportunity to talk about your report. I want to start by talking a bit about bio. We represent [ indiscernible ] across the entire platform. Health care, biofuels, industrial applications, et cetera. We also represent a lot of academic research. We completely support the mission of this committee. We support enhancing access to patients with genetic tests. That is what our company does every day. The partners we have in the university, that is what they get up and do every day. They want to create products that people can access. So, let's start from that premise is that we complete support that. For our company, and again most of them are private -- they rely on a venture-capital, the private equity markets, to raise the money. It is really valuable research they do. They need to have IP protection. It is a link in every study. With this committee also recognizes that important link through that work. They applied research and development work that they do every day. It is critical, absolutely critical. This committee emphasis on securing access and trying to resolve the problem that they identify is one that we completely agree with. Jennifer, we are big supporters of the GINA Act as well. We are very active in the space and what patients to get the best access to genetic information that they can get. The case studies that you done, the commissions are very valuable. They took an in-depth look at many of these issues. Unfortunately, what they provide is not really any kind of consistent or broad themes or conclusions that can be based. I think that is where we think we part ways with the committee. When you look at those cases, what you see is that there is some good, some bad, some problems that have been fixed. The idea of trying to tie back to patent and licensing is where the committee support is extremely weak, to be quite frank. There is just a very little evidence that the patent is creating these problems. The emphasis of the committee seems to be more unsold source providers in suggesting that somehow there is that link. Of course, that can be true. It is not always true. And the notion that somehow we need to attack the patent and [ indiscernible ] seems to be overkill. It seems to be overreaching. We are deeply concerned that the committee would then kind of turn the question around. The initial question was, our patents likely causing harm? Not being able to find evidence of that, they think that maybe Patton's really are even necessary, so we should restrict them for that reason. We are deeply concerned with that. We don't believe that this committee charge or the methodology it employs relate supports such finding. We don't believe that you can actually look at some case studies and determined on a Broadway whether patents are necessary for innovation in this very diverse area. It may not be true. I am not one to say we always have patent licenses. Many of our companies have nonexclusive licenses. The idea that we can make generalizations up front about when and where it might be appropriate we think is very misguided. We don't think it's worth taking a back that that somehow we don't need patents, that we can start to restrict those without costs. Quite frankly, we may never know the cost of that. But we will love with the losers will be, and that will be the patients. The patience of tomorrow who are waiting for the next wave of innovation. Before we upset 25 years of largely Successful University industry collaboration's, we must have more evidence this. I would encourage you to look at all the data including the data that the committee seems to ignore even though it is a commission, which is a study in your appendix two. It gives with very little discussion. I find it absolutely fascinating. It suggests that the role of patents and licensing and diagnostics is much more complex in the committee -- then the committee summary would lead one to believe. We believe the components have changed, not the other way. We do not believe that burden has been sustained. In some cases, patents do play an important role in this area. Yet the recommendation seems to be all about how do we restrict that? We believe that when you look at the other main assumption, which is that in this particular area of diagnostics, some call patents are necessary because most of it is done by the federal government. Again, we are not sure that the data actually supports that. Quite honestly, a kind of undermines what my members get help every day to go and do. They are the ones discovering, not just academic researchers but companies. They are out there discovering jeans and Jean associations helping people tear disease. It is suggested somehow, well, we don't need to worry about that. Leave it all to the academic researchers who have no profit motive. I don't believe that is what society wants or will lead to the type of innovation we need. And the only really truly broad based study commissioned study is that appendix two. We need to actually wait for the results of that before we make conclusions. We are concerned that the committee relies on a series of conflicting anecdotes and theories of possible future harm to a proposed recommendation that could risk unintended consequences, not just by technology but for patients. We are not saying that every patent that has ever been issued in this area is good or should have been issued. I think it has consistently evolved over time. We are not saying every patent has to be exclusively licensed for it to be developed. That is not true. If the system we have today maintains the flexibility so we can deal with these cases as they arise rather than attempting to except broad rules and federal mandates that people have to work around or get out of, you ought to prove your way out of a system rather than start with flexibility clearly needed. The flexible system seems to work better than the more rigid system as applies to [ indiscernible ]. Data is not conclusive on that and we want to see the data. We want to see what that shows. Stepping back, when you look at the overall system, there is no doubt that this is working very, very well. Ever since we passed the act 25 years ago. The problems have quickly been resolved. Your committee has acknowledged that. In working together, we can address any concerns that arise going forward. My concern here is that these proposals you are recommending are going to drive us further apart. They are divisive and unnecessarily so. The proposals on the mind the patent rights and throw a monkey wrench into the very successful act. This is what Congress intended when it passed the act 25 years ago. It is working well. Concrete -- country to your suggestions, your recommendations [ indiscernible ] on patented articles on the sale of commercially infringing products can find no precedent in any prior patent law or act of congress. The first exemption is nothing like what is being proposed as recommendations. The research use exemption is nothing that you propose. Is nothing like the research exemption. Neither of those [ indiscernible ].

We just have a couple more minutes.

I will sum up. For more than two letter years, we have a created doing -- going down the slippery slope. Certain areas should be patentable. Certain areas shouldn't be. That is based on our strong belief. Wave after wave of innovation that patents do spur innovation, even though they do entail temporary costs. As the editors of Nature recently said specifically on this date, the fundamental premise this shouldn't be discarded purely because there was a big hint the car might occur. I fear it is too late to maybe change some of the member of the committee's mind. [ indiscernible ] in and outside of government. So, this process has not been ideal. I would suggest that there is so many legal implications to what the committee is proposing that this need another scrub. I don't know what kind of legal advice you received on patents. I would be interesting to see what P.T. all have to say about your reference to association claims as being simply laws of nature. I don't think I would agree with that. I don't think they are very valuable, potentially, and need to be supported when appropriate. I wonder also about the U.S. Implications and whether you consulted at all with them. I think they would be very concerned that some of these proposals would violate our international obligations. So, I do caution this committee. I think these issues are hugely important. They need to be thought through very carefully. I would urge you to think about that a little more. I'd like to make one last comment. The access issues that have been identified are truly a concern of ours. We think quite often when you look at those access issues that the best way of resolving those are not trying to change the patent system, but working with us to make sure that the major insurers actually will pay for these diagnostic tests. Whether they are provided by sole source providers or not. It shouldn't have to be provided by the designated Medicaid lab. That is -- let's work together to try to improve access. That is where the rubber meets the road here, right? We want to make sure that pieces are getting covered for these tests. That is critical, and I urge you to work with us to get that accomplished. We will be your partner in that period we cannot be a partner in undermining the patent system.

Thank you. Any questions?

Sorry to keep you up there, Tom. Just on the very last point. I have some familiarity with the reimbursement system, not a huge step of expertise in that period could does, on behalf of your members about how it is that those tests come to be reimbursed by private or public payers? Is a patent and licensing issue interfering directly with the ability for reimbursement to be covered?

That is a good question. Unforced -- unfortunately, I am not an expert. I don't know. To my surmise, and there are some other folks here. Carol, I don't know if you want to come up. I think that the answer to your question -- [ indiscernible ]. My guess is that there are certain designated laboratory isn't that get the bulk of Medicaid. They have contracts with the Medicaid agency. It may be that they are not allowed to use some of these other sole source providers. But I don't know that. Carol, do you have any idea --

Eileen on the diagnostics issue. Diagnostic tests are reimbursed typically through Medicare through a lab fee schedule.

This is mostly about Medicaid, of course.

Medicaid acts is what we have been talking about, not medicare.

I don't know if we want to deal with this issue now, because I think there is a reimbursement issue from Medicare and Medicaid. Also, an issue in terms of what is required for the lab to be able to give free access, because the access system for drugs and therapeutics are not equivalent. Unfortunately, some of them didn't get as much focus in the report as I would like, which is a key issue in terms of having full access particularly for these tests.

I guess one sort of quick follow up. Are the Medicaid care policies consistent across all states? Are they very state -- do they vary state-by-state? What sort of influence does the federal government have directly on a pair policies state-by-state?

Sorry. You can find a lot of variability. People on the committee may have more expertise. In fact, I believe you issued a report a year or two ago that looked at this. Again, my point in raising it was not so much that I know the answer to that but it seems to be much more a Fruitful Avenue for this committee. It seems it would be more appropriate to look at ways [ indiscernible ] can use her authority, which is quite substantial, to look at a laboratory testing and regulations, reimbursement, looking at Medicare and Medicaid. I think that is a much more fruitful area. We will have much more quicker immediate access on patient access.

I appreciate that. I think that is a lot of where my question is why today.

I am just interested in your general position. Is it that every gene and potential poteen in each component of our body should have a patent associated with it?

No, not at all.

Only those with some position or view of opportunity?

Well, what we want to do is try to explore the human genes to figure out which genes and which gene mutations may lead or cause disease . Those are things -- we didn't just invent a the gene. We are trying to figure out what that gene does. That is a critically Important Avenue of inquiry. So, you think about the products like [ indiscernible ]. It grew out of the notion that we discovered that the gene provides this more aggressive form of breast cancer. I am not suggesting every gene be patented. I think someone said about 28% of them are. But they also should be [ inaudible ].

You understand this report just deals with the testing?

Absolutely. I think if you look at the appendix two study, which is not complete, it shows that you cannot tell from the initial patent application with the application of that convention will be. Sometimes it is the very same patent that will go through diagnostic development. Many of the diagnostics --

I am going to ask you to be brief, because --

I am trying to be responsive to the question, which is that in the appendix two, it goes through in some detail how it is difficult to say we are only focusing on diagnostic patents.

I know Jim wants to respond to that.

I just want to mention to the committee in the audience the appendix two issue. Bio has placed a great deal of emphasis on the study that is related to appendix two. I would emphasize to you that the recent it was put in an appendix in a very good reason it did not get a lot of play is that it is by its own admission highly preliminary, which has left out a tremendous amount of data that is yet to be analyzed. Moreover, the design of the study is such that it is essentially looking at the generation of royalties as its barometer for the impact of tests. The venue in which the great majority of diagnostic testing is done in this country is a laboratory development that [ inaudible ]. There are no royalties associated with that. Therefore, this study, while I think a mild interest, the effects will be transparent to this study in the realm where most of this testing is done. Therefore, it does not make much sense to put much stock into the study.

Gwen.

Can I respond to that? Perhaps you may want to offer studies to respond to that.

I have talked about it at length. Laurie definitely admits -- [ overlapping speakers ]

Where most testing is done, that study is unable to address it.

The point of her study, as I understand it correctly, is to look at two thinks. One, was can you tell from the Patent what the application of that invention might be, diagnostic, a team based therapy, otherwise? I think she completely can't. That is very important because you are making broadbased generalizations and recommendations about what we call patents on genes, or in the diagnostics field. Those are things that we don't believe are as simple as the committee report suggests to understands which ones we talk about. That uncertainty is a problem.

That actually is not the point of the study. The metric that was used with a generation of royalties, which was not in metric that is applicable to where most diagnostic tests are done.

I would just like to say as a patient and patient advocate, and this is just a comment, and that we are -- all of us are asked to be open-minded about the issues of patents and about the issues of IP. I have to say that when a patient benefit is just brought up as the justification for certain lines of thinking, I would ask you to be more -- to think about it in a little more depth than just staying patient benefit. I know a lot about the [ indiscernible ] story. I know a lot about the stories having been a patient advocate for many years. Please don't just put out patient benefit to elicit some kind of more [ indiscernible ] response.

I thought that is what this committee was trying to accomplish.

I had one kind of comment/question. As was said a little earlier, maybe like within [ indiscernible ]. The cost of marginal sequencing is going to be bashed individual testing is like to make no sense. How do you address or deal with the issue of patents for specific genes for specific genetic sequences when someone can just get a whole sequence?

[ Captioner Transition ]

In. We all I'm representing the College of American pathologists and National Medical specialty society reference for this and it doesn't ethologist who practice an atomic plant pathology and Laboratory Medicine and an added States and Canada. The college's been a leader in developing quality of the programs for laboratories including programs and molecular pathology and [Indiscernible] Genetics. As a medical specialist and the diagnosis of disease, pathologists have a keen interest in ensuring that gene patents do not restrict the ability of physicians to provide quality diagnostic services to the patients they serve. The College provider written comments on the draft that report to you in May and today would like to reaffirm our view that human health-related in patents have been inhibitory effect on pathologist another of it for a physician's ability to practice medicine and at this and turn impacts patients access to important medical testing services. Pathologist of a long track record of delivering high-quality services to patients to the practice of laboratory medicine and have demonstrated through the introduction of thousands of laboratory test this dilly in clinical practice of it but the best interest of the patients is the primary driver of innovation and laboratory test and the pathologists in particular is more often clinical need manifested by requests from the clinical colleagues whispers novel development and medical testing and not intellectual property. The cause is a clear policy statement in opposition to in patent which has been in effect since 2000. The policy states that the College of American pathologists believe that patent in genes genetic variants and genotype in a tight correlation when forced to restrict diagnostic genetic testing violates a longstanding prohibition against patenting a natural phenomenon. Moreover, because is a naturally occurring substances, we believe the most circumstances they should not be patented. Given the existing patents and pending application, the college supports legislation that will protect positions and other providers of clinical laboratory services from enforcement of any patent on genes and against liability for infringement of patents on genes regardless of the did the visions of the patents. The College believes that gene patents licensed fees related to those patents exclusive license agreements prevent physicians and laboratories from providing DNA and RNA, based diagnostic services to their patients to go the limit access and interfere with medical education and clinical research. Especially troubling is the fact that the pet Protection, the and it is gaining of utility of the test as well as the underlying disease processes and become proprietary. Thereby imposing a profound change in how the profession and public acquire knowledge about these tests and their application. In order to address the impact of Pentagon patient access medical testing, the college believes that the options in the draft report related to is that the Tory changed as outlined in the report are the most likely to succeed. These options clearly addressed the impact of patents and licensing and patient access by addressing the core problem affecting the ability of pathologists and other migratory professionals to provide medical testing services to their patients. The call it understands the challenges that exist to ensure the appropriate balance between curmudgeon innovation and tradition access to genetic testing services and is absolutely committed to that and. The college would request that the committee recognize the vast amounts of innovation occurring to the work of pathologist and clinical laboratory web introduced an of upon the majority of molecular test largely without that protection. Thank you.

Any questions or comments?

Thank you we aren't always delighted to have you. And our next speaker is Michael Henry from [Indiscernible] diagnostics. Michael, welcome.

Clinical diagnostic lab that performs genetic testing for patient care. Our mission is to provide the best possible genetic testing services to physicians who treat patients with a genetic disease. We performed 200 tests week and my sons gene patents for many of protest from universities and in turn will pay royalties to the university's the support for the genetic research. We are providers of high-quality genetic tests. We make every effort to ensure our test are widely available. We connect physician outreach and education to educate them about the benefits and limitations of our test. And because of the volume of the test we conduct, we can be very proficient in the test we perform performing high-quality test and we can offer tests for a very rare diseases. And now I'd like to depart from a written remarks and I would like to talk about some factual inaccuracies from the presentation that Dr. Evans presented this morning. Several of them mentioned of the net and I'd like to correct the inaccuracies. One concerned are a tax if testing. Also called ISBA testing. And bundling. Athena offers testing for it 18 different attacks the genes. Each of these tests is available as a single gene test. There also a number of ataxia test panels available. Anybody can order, any physician or client, can order any one of the signal to us or any combination of the test or they can order the panel's. So that is a factual and at St. I would like to correct. Second was on connection 26 and there was some mention about availability of prenatal testing and newborn screening. Athena has of licensed our connection 26 hearing loss genetic tests to a company formerly called pediatrics which is now called Perkin Elmer genetics. That is the largest provider of newborn screening test services in the United States. And they are offering the connection 26 test as newborn screening test binders of light [Indiscernible] from the neck of the net is not in the newborn screening business which is a different business from testing older patients. A third in accuracy that I would like to correct from today's presentation concerns the [Indiscernible] gene for [Indiscernible] muscular dystrophy. And there was also some mention about commercial labs and the extent to which the deal with indigent patients and Internet family's ability to pay for tests. [Indiscernible] through cooperation between Athena and the muscular dystrophy Association we created a program where the NBA would pay the copays [Indiscernible] test thereby making the test more accessible for indigent patients who would otherwise have been. But finally a broad issue I have with inaccuracies in today's presentation. I didn't hear enough about the benefits of exclusive licensing of genetic test. And that also didn't hear anything about the negatives of nonexclusive licensing. One of the most widely known and tragically one of the least ordered genetic test in the United States today is the the [Indiscernible] metabolism test. The FDA has recommended that all patients started on the [Indiscernible] a blood thinner for heart attack patients at stroke patients the genetically tested with two genes as a [Indiscernible] metabolism test. The patent owners decided to not exclusively licensed the [Indiscernible] test. About ten labs launched the test two or three years ago. Of the not launched [Indiscernible] test and we discontinued the test because received no orders. On exclusive licensing in the case of the [Indiscernible] test is caused today in the night is that perhaps a few hundred were from test to be conducted when over 1 million patients in the U.S. are started on warfarin each year in United States and there have been cost-benefit studies that suggest an addition to patient, come up many millions of dollars can be saved in the system if or friend genetic testing is likely than. This is a negative and a cost to us from nonexclusive licensing. If there was an exclusive license for the warfarin genetic test, that exclusive holder of the patent rights would have invested in widespread marketing to educate physicians about the test. And instead, we do not have that test ordered in any significant way in United States today. SUR returning to written remarks,.

To request, we only have another minute or two.

Yes. Returning to the written remarks we feel that the policy recommendations of the report are not in line with some of the conclusions Dr. Evans mentioned, the conclusion thus far patents covering genetic tests and related licensing practices do not appear to be causing wide are lasting barriers the patient or clinical access. That suggests that policy recommendations to improve access do not follow the research results. And the interest of time, I will cut it off there. Thank you.

I think we have your written comments, contract with the FDA says about warfarin testing?

The warfarin drug label was modified in 2007 to recommend genetic testing to be used the results of which would be used together with consideration of other clinical variables to determine and appropriate warfarin those in the absence of that, I believe doctors have continued to use I and are successfully. To address those two inappropriate those. I don't know that there is existing literature that establishes exactly how those tests should be used in every patient or evidence that use of the test will necessarily reduce adverse events until this more information available, I would suggest that may not be a good example.

We are running short on time. Have Paul, Bahrain, Jan. And Rick. I will try and remember all of this.

I have a comment. My comment is as far as the warfarin test is considered the mother is a clinical a need for better management before or from a patient but that's quite clear. Whether it's the warfarin genetic test or others that they're going to lead to better management of warfarin patients the INR as the current use it in this country is probably not the answer. But my question about the data presentation is for those test for which you hold an exclusive license and are the sole source provider, you have some assessment of how much of the market you are in fact servicing of those people who potentially could use the test? My impression is that it's rather small. A small fraction of the accessible market which would suggest your comments about marketing men not be entirely successful.

I would say that for some of our test we have penetrated the potential market, for others we have not fully penetrated. A good example would be our [Indiscernible] at paraplegic test. This is a very rare disease. We offer a number of genes for this rare disease. And we feel that we've fairly well educated the neurologist the reeducate about our task about art spastic privilege and testing and we've penetrated the market. We also offer some test for other diseases where there's still room to conduct more education and further penetrate the market.

I'd like to come back to the warfarin story. Because you use it as an example of how many lives could be saved. You tell it to the patent story and I think it's a question of clinical utility. It has nothing to do patents, people are struggling to know how to use the format to and the [Indiscernible] genes the management of or from their peak to clinical trials are done, this has nothing to do the patenting. I think you should correct that because it's highly misleading what you just said. Betide that story to the potentially damaging effect of patent and has nothing to do with the.

I just wanted to let you know that we certainly want to be corrected in any factual errors. The issue for the bundling was a quote from a public comment her at its bid to year that the bundling is not compulsory. That's great and we will make sure that gets corrected in the report. With regard to the [Indiscernible], perhaps I didn't communicate clearly a bad thing for whatever reason must misunderstood what the comment was, I don't know if you want to show this on the slide. Slide 34, and add nothing to do with newborn screening. It was a [Indiscernible] in the hearing loss case that the committee was maintained that Athena had not secured coverage for MediCal. It's the same issue of reimbursement which is a significant problem with the sole provider. Anybody, we are not tied to. A thing. So it didn't have anything to do with newborn screening. And the other comment about [Indiscernible], also had to do on slide 36, with the fact that an advocacy group maintained that Athena had not secured coverage from some players. Again, that's the same issue with the difficult when it there's only a single lab that can do a test. It's a very difficult for that lab to secure coverage from all payers. I wanted to clarify that and we will make sure the bundling issue gets corrected.

Thank you. I'm going to guess Sheila, Andrea and [Indiscernible].

I have a follow up on the exact slide. Is the reason you did not get coverage from MediCal because your sole source provider?

[Participant's audio is faint/unclear] wide coverage is an of tin, the issue is that when there is a sole source provider, it is [Indiscernible] much more difficult for all appears to have a contract with that sole source. For example, MediCal has contracts with the number of labs. Many of whom have expressed willingness to do a variety of tests that they are prevented from doing. It's not an issue of MediCal not contracting with a sole source provider Perce. It's the difficulty in getting sufficient pares when there is simply one lab that does the test nationalist estimate and tried to make the connection all the way through that there's a patenting and licensing issue the results and some sold stores lab the results and a lack of access because the lab cannot get reimbursement from everybody. I don't see how the first the issue of the patents follows through to the inability--

[Overlapping speakers]

Where we already have are [Indiscernible] with Medicaid for payment of these. We can provide another avenue where the [Indiscernible] began [Participant's audio is faint/unclear]. That's the issue that we're driving at.

For example, when I talk to a clinician--

[Overlapping speakers]

Patenting or licensing will fix it. Here's the deal, for example, MediCal has a contract for certain tests that with the Mayo Clinic. Email clinic is prevented from doing some test because of a sole source provider prohibits them from doing it. They have a sole source license. That makes it extraordinarily difficult for appears to have multiple contracts at age sole source lab to do test when there is a lab that they have a contract with that's more than happy to do that test but can do it. So clearly the patenting and licensing situation enables the situation in which we have a significant restriction of the ability to get large populations covered.

Changing the patent doesn't isn't the only way to change.

It would fix the problem though.

Potentially.

[Overlapping speakers]

You would not have a sole source provider. [Overlapping speakers]

That's the whole issue of with the mayor can do it.

Which they can.

[Overlapping speakers]

Then if you don't have a contract with them, no you can't.

[Overlapping speakers]

Why do we want to introduce all of these various medications and complications when you let a lab who can do the test and is willing to do the test do it?

We are going to get into this when we get to the recommendations. [Indiscernible] [Overlapping speakers]

Laboratory is still offering warfarin and we have a very good [Indiscernible]. From coverage reimbursement issues and where [Indiscernible] to offer the test until more clinical trials are actually available. The other issue of wanted to bring up is you have a program that helps with the Copiague of the testing. For some of these indigent population is. But I think [Indiscernible] issue you have a copy but you also have the cost of the test and the insurance doesn't cover the cost of the test will be back to the patient go to help with the Copiague but not with the large cost of a test of some of the test are extremely expensive. Thousands of dollars.

Would you like me to address that?

Sure.

And several of a Athena is in three of the eight case studies at least two of those case studies mentioned are patient protection plans which is our copay where we an exchange for a patient agreed to pay 20% of our list price for a test, then we will [Indiscernible] with commercial and patient dash managers will go for reimbursement with the insurance company and regardless of the out, whether we get paid zero up to 80 %, there is no additional obligation by the patient. If we get paid more than 80 %, we refund the portion up to the full amount of the copay back to the patient.

If don't offer that to every place.

These are for patients with commercial insurance.

[Participant's audio is faint/unclear]

There's other reimbursement options.

I would added that I think it's great that you guys are trying to provide some services to allow indigent patients to get the testing. Unfortunately as a clinician who deals with patients who need these tests, it's a difficult cumbersome process that is not applicable to many of the patients. There's still let in spite of their best efforts, with considerable cost that are simply out of range for them. When if for example, there was a contract with the state Medicaid it would be covered. I think it's a good effort, but it's clearly not the answer to this problem.

Mark?

At the risk of piling on the warfarin think, there was a third piece of that that needed to be address which related to cost effectiveness. And it did relate directly to the marketing perspective. As noted, the utility argument in having been involved in some of the larger randomize prospect of control tile has not been answered and the ones cited cost effectiveness analysis that showed cost savings I think is increasingly being viewed as using assumptions that are not accurate. Which has led to basically a bit of a misperception about the value of the test. Which then brings the issue to and again, I don't think this is necessarily a sole provider issue versus a multiple provider issue, but I think extensive marketing of test without value to directly physicians is not a good thing under any circumstances. That ultimately the evidence based has to be available and anything that impairs our ability to a valley with the evidence phase of the is problematic. And one of the issues I would have that I do support it that's within this report and recommendations is to try to have more transparency about the data that's available, the date used in order to really be able to assess what is the utility of this test and it is is something that's been recommended are not for those of us and the business of developing guidelines for physicians.

Two sets of comments. I agree with a lot of what Mark and Jim said but for different reasons. I think the additional transparency which we dealt with in an is committee's report last year about the need to continue to show information on each test out there. To make its something that is important to be done. And number of different agencies have done it and in having that it is not at all related to the patent test, but the ability to have that information available for all testing companies and all test available in any form makes a huge amount of sense and patent doesn't change that. Suddenly, Jim in your comments about the current system, of providing test for indigent patients, is absolutely right. It's incredibly cumbersome process. One that is much more difficult for diagnostic, a thing has talked about this a long time ago and I'm familiar with the. It's a process for which you've got for individual steps. You literally need to go to the patients tax return. And going through a process that is cumbersome to anyone I think it's unfair to criticize and and you said it was clear that the companies to do, but for any academic or commercial lab to do that. That to me is a key recommendation. That should be in the report. Drug companies and Therapeutics as well it will Tivoli easy. And now we have some standards about putting out samples and getting their test other. By definition, virtually all Therapeutics from their beginning until they get generic come in single source. We have learned how to do with the system by either requiring or encouraging the drug companies to get samples out to patients to ensure access. Some drug companies that felt--

You suggesting that blood samples are a viable way?

No, I think that is the start of the process and it's one way that is dealt with the sole source in. But the drug companies have a much more straightforward way to be able to get access to patients. Who cannot otherwise afford it because they are by definition, three generic. Sole source and the what I'm suggesting is we have a process for which the diagnostic companies have asked for in the past to say if a sole sourcing and there's a perception and in some areas a reality that patients can't get it because of the approval by the payers, that the diagnostic company has the ability to any simple and easy way that you as a clinician and the company doesn't need to provide a tremendous amount of a burden some administration to get the patient that test and an expedited basis. I think your assumption that if there were no patents lots of people would pick of the test, is just wrong.

[Overlapping speakers] it's empirically the facts in case after case after case, there are multiple labs performing these test. Hearing loss, BRCA1 and to. FAFSA A, etc. And only after IP claims are enforced and enacted, this one see a narrowing the field goal empirically, that's incorrect. We know that multiple labs develop diagnostic test. That is a fact.

But I think it happens for different reasons. It happens because the innovator with the patent on most of the cases--

It has nothing to do with the patent.

It's put in the education to be there. Will affect the major test there are lots of test out there and smaller markets that nobody has any interest in providing other than a sole source.

If you talk to, we got public comments from the individual who runs to in the tax a rare disease testing.

I read the last.

It's on the bottom of the list because.

[Laughter] we'd move it to the bottom of the list to go over and over this occurs.

[Overlapping speakers] because the cost of both doing the testing in getting to the right positions aren't even there. We dealt with the ones that are the most prominent.

The idea that marketing is going to solve this I think has absolutely no support and I think we have to be very leery of the market in the driving what tests are done.

I'm going to ask, we're going to get into this as we get into the recommendations. Did you have anything else?

I will wait.

Sheila, last word. As a mat and have a question for CMS. If there were no deep patents and no exclusive licenses, would CMS cover every genetic test?

There are two different parts of its innovations to go I'm Jeff Rhodes, the is a mat for Dr. Stop. The question of privilege is almost always addressed and this is based on nearly two years of experience with agency in that area. On simple facts like is this a good test, it doesn't measure would is supposed to measure? Does it help negative as for the patient in terms of the outcome? Is is something that can be done more cheaply or alternately by a different type of test? Is a necessary? And those questions are approached with regard to whether a patent is involved or not. Does that answer your question?

I think so. I guess you are saying that whether or not we make any changes at all to the pen and structure that doesn't have any effect on how CMS would allow it to reimburse under current criteria.

You raised a different question. Coverage decisions are made with regard to patent a however reimbursement decisions are reimbursement based on how much will CMS pay for a specific testing service. Whether it's based on the CP to code or whatever. And those decisions to take into account price, levels, a number of different aspects of the cost that goes into the testing including other cost of doing business such as patent licenses and so on. However, that isn't an area I don't directly work on at CMS and I can check with [Indiscernible] perhaps we can get some here to talk about more knowledgeably.

That would be great because I sought and report and the wasn't a great difference in price and because of past and. Of the SA agreed different and present that we can identify with its a patent or not the would come into play [Indiscernible] and CMS perspective.

I'm happy to [Indiscernible].

Thank you for your forbearance as we wandered far and wide from the comments that he made. We appreciate your qualifications, and put. Clearly lots to talk about. Thank you. R final speaker is Michael limited his with three [Indiscernible] alumni Research Foundation. Welcome Michael and I don't know we have your written comments, if you can provide them to us after the meeting, we can have full advantage of your thoughts.

Thank you very much. My name is Michael Remington. I am a partner in the law firm of [Indiscernible]. Among my other represent patient responsibilities by service Washington D.C. Council for the Wisconsin alumni Research Foundation. And I'm not here to speak about warfarin. [Laughter]. As you know it's a non-profit organization operating better Section five ONC three of the IRS code and as is with an organization of the University of Wisconsin Madison it was founded in 1925 and it's the first organization of its kind to engage in technology transfer associated with the single university. It has been it is today the designated IP management organization for the University of Wisconsin Madison. Under the auspices of the [Indiscernible] Act there is so severe [Indiscernible] which stands for Wisconsin system was or fall for business interests of the entire universe of Wisconsin system. It has enjoyed a number of technology successes that have a significant impact on elf patient tiers, safety and so forth. [Indiscernible] drives no profit from the licensing of its inventions and recycles all Willkie's back into further research and innovation. We appreciate the a opportunity to present a brief remarks on the report and we thank you for is seeking input of stakeholders. Like Arabs and the of the interest the technology transfer organization. To present some and put. We like to specifically to associate ourselves with a comprehensive and insightful comments that were previously submitted by the Council on governmental relations, cover and the cessation of American University a a you which included three principal concerns which hopefully were addressed or are to be addressed in the final report. First black of support for the policy options, to lack of understanding the licensing is a complex process requiring substantial flexibility. And three too much of is on regulation without consideration of possible incentives. As I said, hopefully the final report will have taken some steps to cure these three principal concerns. As a personal aside, I spent 13 years as the IP counsel or professor of sorts for the house Judiciary subcommittee on intellectual property under the chairmanship of Peter Roby now and Jack Brooks. Every day in Congress we had to wait many of the issues you are facing. I just want to review with Ichabods by policy options. We had at one point under the tutelage of some respected law professors we even created a will of Civil procedure with the burden of proof for reform proponents to satisfy. We were receiving submit proposals for reform of Patent and trademark and copyright law without we had to hire the bar a little bit. And we did so. That reform didn't have a long life. But I'd like to leave you with the thought that it's very difficult to amend the law. And we're seeing this today with on of this patent Laurie from. And just a couple cautionary thought, I would not have used an economist definition of promoting the progress of science and useful art as a saw and the slide earlier today. There's nothing wrong with that, the intellectual property is an economic proposition put its an incentive system up, but there are other approaches that you could use like political utility approach designed to challenge certain activities in society for the betterment of the public. The relationship between the courts and Congress generally speaking there's a will that Congress likes to wait for courts to finally decide cases because you are with two independent and interconnected branches of government petard to draft legislation with there's ongoing litigation without receiving in the litigation and resolving the issues that are probably pending in the courts. [Indiscernible] issues raised by Tom are serious. When it comes interceded to decrease infringement liability like you are proposing for the significance societal issue of listing to music and taverns and restaurants, the Irish [Indiscernible] complaint against the United States and we were found to be in violation of a [Indiscernible]. And remember when that happened, the U.S. has to pay a fine or some other segment of our society is punished go in this instance, if you are not WTO complaint, some patients group or other area of the medical sector could be punished by our allies. Besides we don't like to violate international treaties, we often lecture the rest of the world about respecting treaties. The evidence of patent ticket's appear to be fairly maker and that of a point out to that [Indiscernible] significant activities in the Department of Justice and the Federal Trade Commission with Business Review letters been forthcoming in various standard setting organizations. And information technology areas, there's no reason why that wouldn't be approved for genetic research. The enormous successes of the [Indiscernible] Act were given short shrift, and many patients have come out of that success a steady. So collective licensing and not saying that you can get the collective licensing overnight, in genetic research, but I'm counsel to a performing rights organization that licenses several million works in a blanket license for music and universities and other activities to wrap the country for a my dad come a very low price because of that's how you get to listen to your music at football games and student unions become you are in the city on the shifting landscape of law politics and science and to amend very much for hearing these remarks.

Thank you very much. Any questions or comments for Mike?

We keep hearing about this violates a treaty. There's no provision in the joinmack agreement for Irish bars. But there are provisions and make a demand for health. Could you explain in a little more detail how this would violate a treaty?

I was worried that a professor might ask a question. [Laughter]. And raising it as a flat for reconsideration. There are health exceptions in our treaties and I'm not saying it's a bulleted, I'm saying we unwittingly and and only the eight violated the WTO that went all the way through and we still haven't heard it. Twelve years has gone by. Without a cure by the U.S. If you have considered this issue internally, in great depth, I would defer to your consideration. I was just raising the red flag, let's say the yellow intersection proceed slowly on this point.

Thank you.

Relating to the, I was curious to see if you'd even though you are are setting review in your previous job has fallen by the wayside, I was curious if you have applied that to this document and if you were to look at that from the perspective of did we hit the level of scrutiny we needed to be for a patent reform would be considered are we will sort of that? Have we met the threshold or are we above it? Do you have a sense?

The me talk a little bit about the standard. You have to identify in order to elevate something to a policy matter for the Congress, you have to rise to a significant issue affecting society that is appropriate of policymakers consideration and as you know, we have a bicameral legislature and to political parties in each branch. It's very difficult to get something to. The first question is is this a big issue. You have to answer that question for yourselves. The second thing you have to ask is are you proposing the solution that is the best solution for the policy question at hand. Third issue is does it create what we call the law of unintended consequences, for example, if you use the help of the patient health issue as to a standard or the inability of indigenous people to pay for these medical test then you have to ask yourself the question about what will happen when some other parallel area of medicine comes forward that sits similarly because people will say, if this passes, we should do it for this other area. Recall that the fallacy of analogy. This is the way lawyers thing. Is not necessarily a good thing. Hopefully there are many among lawyers of the table. But lawyers are due by analogy. Once you create an analogy, they will argue by for the analogy. And they will use AIDS research, avionics themself, to make a similar argument. They will say we shall not have an exclusive licensing in those areas. We should lower prices or not grant patents or accept infringement liability. Those are questions for you to answer. I am merely suggesting that Congress will ask this question is whether it's a test or not.

Last comment. Paul.

This is not an analogy question but the question of fact. What has been the value of the warfarin patent to the foundation?

I have to come I'm not in house WARF but it's one of the more valuable patents.

Can you give me a ballpark?

Bill, I can't.

At least a publication to say Wisconsin has gotten more from this patent than any other single institution.

That's my impression.

By a long shot.

[Overlapping speakers]

No, WARF most viable Patten has been a vitamin D derivatives by invented by Hector DeLuca. By far. And its most successful patent was probably the cure for [Indiscernible] which is invented by and 1925 and were followed by the attorney general that, it did exist at the time, the university was told that it couldn't even market it. Because that would be violative of the state constitution, a University can't get into marketing. The foundation was created. Rickets was cured in eight years. And.

I do have a question about the debate about WARF because called AC cool to or from Canada and. It's a separate product.

Thank you.

Thank you.

We appreciate it. I think everybody has a clear sense of the diversity of perspectives on these issues. If you haven't had too heavy a lunch. [Laughter]. An addition, one of the ad hoc members provided some additional comments. These comments were provided during the deliberation of the task force that they were sent this morning to their provided to is Brian here?

No, he's not.

They were expressed before the task force has considered them. Most of the folks have been on the task force had an opportunity. We have here is not a unanimous document, the one that best represents--

, was your first clue? [Laughter]

Anyway, with that, I'm going to turn the opportunity back to Dr. Evans who will help walk us through this. Did you want to spend a few minutes?

Yes, I think that we have a goal here. That by the end of the day we will get through the recommendations. I do think given the degree of dissent and given the kind of explosive nature of this issue, that it's only fair if we spend half an hour kind of so people can vent. And then we will tackle the recommendation. I do get some prerogative of the task force chaired so what I'm going to do is spend a couple of minutes, if you can join the slides on. I do want to mention the task force composition and kind of how we can about the things. Of the people who are really deciding kind of policy and the content of the task force, these are the members and ad hoc expert. The agency expert consultants were extraordinarily valuable, but they are consultants basically and here to lend points of fact and information. I did want to give you a feel for the fact that of the members, although Marr was not able to participate extensively in the process, I think Mark is the dissenting voice of the five members. With and the full members to run the task force of the ad hoc expert, I think it's fair to say that is basically Brian who was the dissenting member of the ad hoc expert. As you can see from the document that he wishes to have circulated around. I tell you that's not to single out any particular individual. It's great [Laughter] it's good to have dissent and dissent shaped our conclusions in a very good way. I do want to emphasize that this was not a split decision. This was not a close call. As we went through this. Maybe it will turn out to be a close call in the committee or maybe it won't even [Indiscernible] want Carey in the committee. But I do want you to dash understand that that this was not a few people who ran through a schedule or a minority position. Would I want to do to open up the discussion is I just want to frame briefly again the rationale for our recommendations. We have heard a lot about some claims but those claims include number one, that our original charge had nothing to do with looking at benefits but that is absolutely not the case. We were charged with looking at both Harvard and benefits of the patent and licensing process on patient access to quality genetic test. It's not only I think it's logical to ignore the benefits, but it it would have been contrary to our church. I think number two, we did find harm. As opposed to the statement that is selective quoting saying that we did not find widespread and pervasive harm. The next sentence states that however, there was harm found is sigmas of the population. And when I see members of the population who clearly because of patent enabled exclusivity are unable to get genetic test, that's meaningful to me as a medical provider. Number three, the issue that perhaps struck me most forcefully and I think several on the task force most forcefully was the really almost nonexistent evidence for the need for patents and the development of genetic diagnostic test. Over and over again in every example you can give whether its [Indiscernible] testing, whether its HIV testing for hemochromatosis, whether it's hearing loss, many labs quickly began offering tests and then the field was shut down or narrowed dramatically. When IP was invoked. The combination of harm along with the very difficult ability to show benefits I think is a highly persuasive set of facts. I want to mention that we consider our recommendations to not be dramatic. I think they are narrowly tailored. We should not [Indiscernible] their PIPS with diagnostics. Discover charge was to look at diagnostics. Our recommendations are attempting to tease out the ability of laboratories to perform diagnostic test without fear of infringement and it does not alter, does not touch the therapeutic well. This was for two reasons. One was that it was not part of our charge. The second is that you can make very strong arguments that patents are doing heavy lifting. They are doing work in the realm of their peaks. With a dramatic up-front cost, etc. It's extraordinarily difficult to make that claim for diagnostics and as I would emphasize that these proposed recommendations Carneiro in their scope. They look at trying to tease a part diagnostic testing for health-care related activities. And I would also point out that we cannot forget the issue of heart when it comes to quality of testing. The patent enabled sole source provider is a serious threat to quality given it the infrastructure of quality control for laboratory testing in this country. I've gotten on my soapbox and why don't we just turn it over for about a half an hour and then we will get to the recommendations. And I really am going to keep it a half an hour.

The first question Jim for you, when opening up Pandora's box on diagnostics versus Therapeutics, I for one have never really believed in genetic exceptional is some. Especially in the [Indiscernible] bio-markers and etc. Using the laws of analogy, as our speakers talked about before, could you envision the impact of making a recommendation on other non genetic areas of diagnostics? And maybe you can say we don't care, that's not our charge. I just want us to walk to the system. I sympathize with a lot of the ideas presented today, but I want to explore those applications outside the so-called genetic Irina.

So maybe you can start me off because I certainly have been focused on genetic diagnostics. I'm not sure, I'm not sure where to go with that.

If those recommendations are read without the Germanic lands, and just read them, as a by a marker for an essay or anything for the purpose of diagnosing, predicting, would ever. Think about that genetically.

I think in the way the reason you can't do that is because it may well be that other diagnostic endeavors are very different in the sense of up-front cost, etc. It maybe that the development of Monaco, and bodies that are effective for [Indiscernible] chemistry, it's just a whole other animal. And not try to avoid your question, I guess what I'm trying to do is say that I'm leery that it is relevant in the sense that we are focused on Genetics here where the landscape is we've got a handle on it.

Maybe I can help you out. Within your it [Indiscernible], you gave different subgroups of patent [Indiscernible] Association type the other is the essays, etc. Which ones of these are the easiest to do with? Which ones are the most of the Gulf? I'm a fast forwarding to a time where genetic sequences will be cheap and we will have access to them and I could see some of the hiccuping along the road. If somebody comes up with an amazing new technology that would sort of a single handedly do a 3 billion base pay using amazing new Discovery plus all the [Indiscernible] expression and [Indiscernible] in one big scoop. Do we want to reward that invention?

I think it's a important point to one of the things I would reiterate is the narrowness of these recommendations are such that the last thing they would do is interfere with the pet team of a technique. That's very important point. We are not looking to do anything to undermine the patenting of the next PC are for example. That is absolutely should be patentable. We're talking about very narrow situations which is the analysis of a DNA sequence. That's what this basically boils down to. I think what you say about cost is a right. The cost of DNA sequencing and its decline makes Moore's Law look like a piker. It's going to be very cheap. I think that substantially and forms what we're talking about. With regard to what kind of claims are most difficult to get around, I think it's clear to the association claims. Because association claims are utterly agnostic to the issue of how you analyze this etc. They simply say that if you have this sequence, and we have the patent on thinking about, that's not using hyperbole, claimed 13 of the [Indiscernible] patent with metabolites actual talks about thinking. Association patents associating, thinking about it the genotype phenotype relationship. They are the hardest to get around. One could see problems and other diagnostic crumbs for such associations.

I'm not going to vent. I wanted to talk about to answer Sheila's question but most of the Medicaid coverage and reimbursement for genetic testing is done at the state level. Very few national coverage decisions made on things like that. So having helped state Medicaid make some decisions in our region in the West Coast, one of the things that makes it easier is if there is a reference [Indiscernible] that this multiple genetic test for us because we want to negotiate the context but we are not going to negotiate 50 contracts. Anything that restricts access to testing to sole source providers or labs that are far away for labs that are inaccessible, there's going to be less and less chance that we are going to contact that lab unless it's a really bad public health problem in our state. And then we would because we have to because so many people have the disease or we had to test for the disease. Otherwise we're going to go with the lab with the biggest bank do we can get with the contract for.

So putting the general market issues of that aside, if I think this committee thinks that this is such an important issue in terms of the patient access for a genetic test coming from is also slaps and not knowing the universe a sole source labs, with exclusive licensing agreements, which ended be more straightforward fix to carve out an exception or make Eric Carmen for state Medicaid to contract with these also slabs because in case of genetic testing so there is access for this population? Rather than leaving it it up to each individual state in terms of its own really tried to drive the competitive market between reference labs and sole source labs? I think we should not get into that. I'm thinking how can we do this from an age eight as perspective. Because that's really what I'm, as you know, I'm a fly in the women with this. And want to challenge the group to really rethink how we structure these recommendations into something that the secretary can receive and take action on. And that's one idea I was trying to see if that might be something possible not knowing how is that Medicaid really works. I feel that we are not going to be able to get to the solution and answer that we want to do the way these are structured. Because the simple limitations of the secretary's authority.

I think it's going to be both ways. Is going to take legislation reforming the way but everyone gets the first.

[Overlapping speakers]

Can you administratively make requirements like that?

No.

[Overlapping speakers]

The question again was can't CMS impose what?

Was sort of authority does TMS have to make administrative not statutory a bigger presence for the remake administrative requirements on state Medicaid agencies.

I can go back and see if we can find more information that will help explore that question and not able to answer that now.

I would love it if it there wasn't easy way to ask the Secretary to sign up on this and it is such and such and solve the problem.

I don't know if we could get to that ever.

[Overlapping speakers]

Even if the answer had been yes, no problem with that. The problem is that it only addresses a small part of the problem. It doesn't address for example the quality issues which are a real and problematic when you have so source labs. It also doesn't address the future issues which granted our future and therefore we don't know for sure, but I guess what I'm getting at is I don't think there is a simple easy fix for the problems we've identified. And if we can do it granted in a roundabout way, because--

And not asking for it simply be fixed or in a run about why. If you are talking about quality of [Overlapping speakers]

That was my initial thought. [Laughter]

Actually they don't. In this sense. Not in a practical sense. When I started this process, my view was, quality, that's an oversight issue. That's an issue, let's leave it to the FDA. The problem is in practical terms one cannot insure quality with laboratory test unless there are multiple providers in any kind of optimal way. So the FDA could say from now until the cows come home that there should be stringent requirements. But without the ability to do provisions to testing, without the ability of having several labs, you compromise quality and I think Andrea would confirm that.

What is the quality of the evidence? For that lasted?

I think it is that the entire infrastructure of quality control rests on a proficiency testing.

There are many different factors.

--

Okay, so I will accept the fact that proficiency testing is important and maybe the most important factor in quality. But then you are also making the claim that sells was last done do proficiency testing as well as multi source labs. What's the evidence for that?

Because you simply can't do produces the testing.

You can do a simple exchange for [Indiscernible] and it is typical of having done the testing for over 18 years now, what I have learned in the testing is when you have more laboratories addressing the same testing, you can learn a lot more faster and you can identify issues with your testing. Not only by exchanging specimens between laboratories but try to address with the differences are, but also because you are comparing results from different types of [Indiscernible] not be aware of your testing because your the only so provider of that testing. If you are the only so provider of the testing, and you are rerunning your own specimens and would be to give up some of the issues. There's more to just a learning on the process by comparing results with other laboratories, and we have actually data from the College of American pathology and molecular and colleges proficiency testing program that as we've gone over the years, by comparing results from different [Indiscernible] from different laboratories we have learned about the disorders and testing and significantly continue to improve this. That's by the collaborating with other institutions that are doing the test.

I'm sure that's true, but I would also suggest it's probably true for a lab that does a DNA sequencing test of a breast cancer gene. That they are constantly looking both at the quality of their results for any number of issues, and looking at methods to improve the thruput, cost, the kinds of data it is generating again for their own reasons. So I think my question was where a are you getting the evidence that there's a big quality difference? I think and is comments are part of that evidence. Is that type one evidence come or tied for evidence? Your evidence based medicine guy come and give me some quality of the basis on what you make this conclusion.

For example, you can't do that test when you have the sole source provider. Because nobody else can do the test. You can't compare the results which is a necessary factor in trying to figure out the accuracy, the precision, etc. It simply undoable. It is basically axiomatic that quality is more easily obtainable when you have several labs that are doing the test. Now there may be times when there happens to be the only one of lab, and you have to live with that. And you have to rely on the other processes. I guess my question would be as advocate for one position, why should we hogtie ourselves into that position when what we can do is have a thriving competition between labs to provide quality testing innovations, etc. with lack of Seoul's source.

I want to respond to that but I'm hoping we are not suggesting the is also a slap at this point in time because they can't adapt to the type of proficiency testing are somehow providing a test that is of lesser adequate quality.

The quality is unfortunately not as good as you would in a situation where there was [Overlapping speakers]

We certainly don't know, we don't have any independent ability to verify and that is a very different issue because I think it's very dangerous for us to make pronouncements about the fact the quality is good or not. Personally, I think Paul is mostly right in the sense that it is in their best interest to try and be the highest quality testing that can be done. However as someone that has to look and the outside looking in, I'd much rather be able to look at data to say and that is something that's addressed within the document that it comes back to the transparency issue. I will also note parenthetically and then if you'll allow me I will go into my other comment.

You guys interrupted me. That wasn't my point. Can I say one quick thing and let it go on and on. Not that you go on and on the. [Laughter]

I will accept one on.

Okay, just go on. I was going to get back to my challenge we looking at this because I received these [Indiscernible] are a Mississippi and assuming I accept them. If I am the secretary and advisory committee is suggesting to me that I should go to the president because if we are going to be changing the laws.

What agency or department or another it comes to the administration as a whole which is the White house. If I go to my boss which is the president and say Mr. President, we have an issue here. We have an access issue because sometimes it's the want to contract with the sole source labs. They find it cumbersome, expensive, what ever the case may be. Some people have suggested there are provisions in testing issues. Related to quality with some of these labs. I would like you to propose that we change the intellectual property laws. I would have to say having been in the meetings that are not exactly like that, but somewhat, there would be a lot of challenges made to that. You are looking at a huge hurdle, changing laws and all but changing these laws. I think some of the challenges we would get back your telling me our agency [Indiscernible] can't figure out different ways other than the person testing to prove quality. Yours in we can't figure out another way to get these people that cannot afford to pay for this test.

What I would say to that is number one, absolutely. We are not asking for things that easy to do. I wish there were some things that easy to do that would fix the problems and take care of these issues. But it was a general feeling in the task force and it's my feeling, that targeted changes that are statutory are the best way of dealing with those problems as well as the evidence that is there that we've gone over. Do we don't really need the patent protection for the development of these genetic test. I think the other thing I would touch on is that there is considerable feeling in the community and in the country that perhaps we've gone too far with some of the patent protection for genes in general. You heard that today from two of the public comment tiers. I don't think that suggesting statutory change is necessarily a crazy idea good just because it's hard.

I wouldn't say those other suggestions are easy, but I guess my point is to be more realistic because I think that whether we like it or not, it's a nation of lawyers. And what they do is with the gentleman proposed earlier, what are the consequences and analogize to this and I would suggest that this is not just a hard asked, it is a very, very, very high hurdle and wouldn't it be more effective, rather than causing years of debate which it has already been happening, wouldn't we be better served as this committee to find are targeted again and direct things within the committee authority of the Department [Overlapping speakers]

That's exactly why we divided our recommendations and the basically to levels. To tiers. The first is these are hard. We think these are [Indiscernible]. But we understand as we will get to with the slide when we get to recommendations, that these may not happen. The are very hard. There are issues that you may not even decide to pursue these because of things like unintended consequences and therefore, here are a set of other recommendations where we think we could at least address to some extent these issues. We are taking that approach to an extent.

I have serious problems with that. At the very least, those are the first things I read, and may not get to two, three, four, I would probably say this is going to be quite a challenge and I would call my agency what's going on here.

I think he should read the entire page or to.

I did. I'm saying the person receiving the report may not.

I think we can rely on the secretary of HHS to due diligence and cost [Overlapping speakers]

I would start with talking to my agencies and finding out doing that exact due diligence and by now with the problem is and it sounds like there's open questions. So we want their support, we want when the Secretary to due diligence that the others. [Overlapping speakers]

My point is I hope in terms of doing her due diligence with agency that the questions we have answers to. And we know what they're going to say. [Laughter]

And maybe there are modifications and wording suggestions that you can make that will help insure that the secretary gets to those issues. If we do decide to keep the general structure intact. Mark.

I will give you another on.

I'm going to move off this area and highlight a couple things are reflected on as we heard the public comments in relation to the document. The first is I wanted to remind the group that in the Charter of our committee, one of the specific and explicit tasks that we are asked to address and relate to disparity and so in some ways that elevates the potential for harm in the Medicaid population a little bit higher because I think we are specifically asked to look for where there are potential health disparities within our charter. The second comment relates to the example raised by one of the comet is about [Indiscernible] which I think is a really interesting example for a couple of different reasons. It illustrates several of the points. I think it's very clear that this has been hugely important. Is directly related to the appropriate use of a therapeutic but I think it's also fair to say that where we're really going to see expansion in the next couple of years relating to a few personalize Minister and relates to the use of a tumor markers to characterize and direct chemotherapy. This raises the potential issue relating to some of the points that are made in the document because if some of these two markers and up being sold sourced, there's some pragmatic issues that will have to be addressed. One is is hard to get enough to merit to run the markers we currently have and if we have to divvy it up and send it to different laboratories, that would be extraordinarily problematic. I think we also found that within [Indiscernible] it was only to the collaboration of a lot of different laboratories were identified some of the very significant quality concerns relating to how to do her to testing. That's falls into the realm of a potential harm but I think it is an issue and I know that we are struggling right now in terms of do we have adequate amounts of tissue to do what really is medically appropriate to do it using a provider that provide all the test. The third thing is relating to the patent ticket's come I do think this is a real potential problem. I think we do have evidence that laboratories are now in the position of not being able to report medically significant results because of the concerns about infringing on other patents and the long run, that is harmful to patient care. But I think we also have to think about if we are going to go in this direction and I would favor tried to explore solutions in this area, then we have to understand how we can in sent companies that don't have right now any incentive to really participate I think for good reason, how can we and said that participation so we can really move through this area. And the cow herd that reflected in a couple of the industry representatives that there has to be that type of incentive put forward. Lastly, and this relates to the support for the report. I'm not a sin when about this from the perspective that I think in many ways this is analogous to what we see coming out of committees in the Congress that you can say we had overwhelming support, but it was divided on party lines. If you looked at the composition I think in some ways and I'm not saying we should have tried to have equal representation, that's now we do. But I am concerned that overwhelming support should not be overly emphasized given that there may well have been less representation from people that had more direct interest and panting and the last thing about the composition which think relates to your question, there weren't a number of department and Health and Human Services [Indiscernible] participated in this which I would hope would have raised some of the issues that you are raising about is this something we could do. And I would be very interested in some course of the debate to now with the level of support for the recommendations that would involve some of the very difficult problems.

What I think we ought to do is we can extend it a little beyond the have our. At 3:00 we are scheduled to have a break and way. Let's come back from the brake after we're done. And tackle the recommendation issues.

Not singled out, about the center here in person I wanted Elizabeth of product.

I figured you would single yourself up a.

I've set a lot to the committee not just here, but to the broader committee on previous times to talk about it. I have several comments and I will try to get them before 3:00. First, and what to say how much respect the committee and the process we went through and particular Jim your leadership of your commitment and your persistence. We didn't often were always agree on things. But your attempts to ensure that I stayed with it, stayed with the committee and heard my comments, brines and occasionally others that had dissenting views is very much I need to say that to the whole committee acknowledged. What you say it was rammed down anyone's throat I would've been the throat there. There was not agreement but the process was well done and we took the extra time from two or three meetings ago where I felt very strongly that we needed more time as others to get public comment. I would like to publicly acknowledge that and think the leadership in doing that. Now, but, that was an important process and its great in a day like this to agree with Mark. First, I'm going to start with the charter issue. And I wasn't planning on going here but I think the, I have to make is on the comment [Indiscernible] about quality. First of all if we are going to debate the Charter, the charter was not axes and disparity, a have nothing to do with quality. You could argue that's a piece of it. And I won't go through with the single source labs do what they do on but proficiency and additional time with inspectors because of that exact sensitivity. That the labs themselves had but I have said that I'm extremely uncomfortable with the same by definition they are less good quality because there are plenty of great plans out there and I'm sure there are plenty of lousy labs out the. But by definition, I can't let that [Indiscernible] I have to comment on it. Secondly in the charter and you spoke today and in the past because I've spoken about the commentary between diagnostic and therapeutic, if indeed as you sit in the charter that it's only about diagnostics, I think one of the issues to summarize today should not compare the development cost and you called it sufficiently low for diagnostics versus therapeutic. If what we are talking about is diagnostics, the comparison of what it takes is not relevant. And even more relevant although I would say as a diagnostic developer, it's not particularly low. And it continues to increase regardless of the patent just because the burden of proof is and continues to increase is that we cannot look at it by the amount of dollars that goes and. Because the reimbursement rates as we've talked much in this committee, patents or not, unless you have an exception pricing you don't get any premium for patents as we talk about is about economic viability. It's not about that in constant dollars to create a test and $1,000 or $10,000. The SAA connector depiction of what the issues are regardless of either because of a comparison or not about up-front cost, it's about the full cost of educating running, and selling the test. Those are to comment on charter. Next, as we look at the summary comments, probably the thing I'm most disturbed about today and read all of the public comments and in detail I had my ten as the rest of the committee did. I don't think that we had adequately represented the comments from some of the largest academic institutions in the country. Who supported the idea of taxes, the need to deal with disparities, but the comment that the committee's recommendations go too far. And solve a problem that even if the academic centers and some of these were representing technology transfer offices and some of them were representing the university management and a broader sense, are saying that the committee's recommendations while there are pieces of it that makes sense go too far. I think in a summer, that needs to be represented and the comments you have in here accurate, but I think more commentary on what the other piece was not just from industry is important. Next composition of the committee, and as Mark said, the composition of the committee as a look at it now, I'm wondering why I didn't see that earlier. But in the -- Indeed come it's not fair for any one person to represent fully in industry because this is a diverse industry that is not minus a magic. I don't believe that all of industry feels one way and all of academia doesn't I think it's important to, I don't even know where Brian his institution is. But that to be fair we probably did need more representatives from non academic laboratories. And that's why I acknowledge again that it wasn't just an academic universities and others itself one way, they're not [Indiscernible] Industries [Indiscernible]. Next, right before my last point, I will go back to the reimbursement point and she live brought up a couple of issues today about it. I think the report its to also acknowledge the process. That needs to be eased, and did or not. But as we are talking about patents and one of the key findings as a group is that patents creates all access so Axa's creates access problems which is where I saw the three [Indiscernible] that one of the things that HH as and other agencies can do more readily than some of these other recommendations is to make a process for access when companies and laboratories want to be able to give the task to people who need it in can't afford it with a they have insurance or not. Make better transparencies process so we can regardless of the bigger issues in changing the world there, and may or may not happen, we can begin to get access to patients. Which to me is the broader issue that this committee is about. In summary, having those five points, I believe that the purpose of the patent system was done to create innovation and in a time limited way, it's the piece that provides the checks and balances the book allows innovation and allows others to come in at the appropriate time.

Thank you.

I believe that list and a comment and then Andrea and then we have to break. Liz, Rochelle and Andrea.

I work for 8 HS. I don't have an opinion on whether you are right or wrong but I wanted to bring up a couple points I didn't hear necessary addressed. Although some of them overlap with what they said. I didn't see any traditional an agnostic industry input on the committee. Did I miss that?

[Captioners transitioning]



I agree, but I think there maybe a distinct thing industry about whether it is reasonable to have sole source or not. I think it is somewhat regrettable for me. But I want to segue into is that I am in personalize medicine. As Mark brought up, they -- there are going to be tests. Those tests are going to be required you, before you use the job, a drug. FTE believes that those are tests that do not merit and enforced destruction and will probably require [ indiscernible ], which is a fairly high bar in regulatory world. So, I have heard from numerous companies that they don't like the risk involved. If they get in and put all the work into developing this diagnostic and the second they are out the door come everyone else can knock them off. They are not going to do it. I think you should --

They did not need to go through the PMA process.

But it is going through another company. Their commercial laboratories and --

I'm not saying it won't happen.

[ overlapping speakers ]

Laboratories are actually going through the process.

Right, right.

I understand that it didn't go through the PMA process.

I am just relaying what I have heard. I am not advocating one way or the other. I am just saying, consider the implications. But if this actually discourages companies from developing the test to get the drug on the market, it may have some unintended consequences. I don't know. You need to analyze that. The other thing is the size of the market I think actually drives how many labs will do this. If it is a relative with small market, then there are not going to be ten labs doing it. They can't all make money off of it. It is not all just about that stability.

But there was not a huge market either.

Right.

Rochelle and we will stop for a break.

A couple things. It is important anything about the university commons to realize that universities are the kind of -- they are kind of strange. They are not like companies. Individual researchers license and, so they are not seeing the entire picture. If they did, then it might have a very different view from the one we saw and the comments that we made. The other thing that we didn't have any antitrust people. We keep talking about this as a low these recommendations are making a huge change in the way that the world worked before. I like to point out that that is a very much not true. If you look at the sort of history of the world, patents are only one component of encouraging innovation. Competition is the other component. When you have a mother -- a lot of competitors, each competitor has to figure out ways to make the price lower, the quality better, to provide more information. So, competition has in the past been a huge motivator of innovation at least as much as the patents have been. Now, do we have as much competition as we have had before? I would submit that in the last ten years, 20 years, in fact, that is what has changed is level of competition. It has changed in a number of ways. First of all, in the last ten years, we got rid of research exemption. We are talking about asking for research exemption, that is the way the world was until a court decided that there were no research exemptions. It is not like there are high burdens that were dumped when the law became the law that it is now. It happened in a particular case in that case it looked one way. To the court had a very broad opinion. And the question now is whether that a very broad opinion is unpacking on health care in a way that was completely unforeseen by I the court. It is not a new idea. It is returning to an old idea that was part of the law for 200 what every years. In most cases, we had competition around patents. Jim started off by saying that they are a limited monopoly. I cringed when he said that, with all due respect. Patents are one way of accomplishing a particular problem, but there are almost always ways to invent around it. In this particular space with DNA we are trying to do diagnostic kits of people by looking at DNA, there is no invention around the patent. That is something completely different from anything we have ever seen in history. My third point, the last one, the breath of the patent system. It used to be put a lid -- it used to be pretty narrowly [ indiscernible ]. Has expanded so it covers business methods, including being a physician and treating the patients. But that is something new. The fact that this committee wants to think about that [ indiscernible ] where the court did not have any evidence, but by looking at evidence and thinking how these past decisions are affecting patient access seems to be not incredibly revolutionary thing that several of the speakers have made it out to be. So, on the burden of proof, I don't understand the burden of proof. I don't understand why it is any higher for us than it is the court. One more thing. The patent thing should encourage the market. It is not cherry picking the next easiest thing to do. You should encourage people to push science forward, because it is hard to get patent. In the last bunch of years, it is easier to get patents. You do not have to have invented step. The Supreme Court may pull back on that. Until now, you could not carry packs the things that were there, getting protections for it, things that were minor league is that simply were fairly easy to do might require some work. People did it because of competitive reasons.

I would just add, I was reminded that regarding the composition of the committee, Emily did represent the industry diagnostics. All right. Let's adjourned for 15 minutes and we will start back at 3:20.

[ Break until 3:20 EST. ]

[ 3:25 EST, Captioner standing by for event to resume. ]

All right, everyone. Time to regroup here. We've got to get down to the chat, because we've got to get these recommendations reviewed and moved on. Clearly, we are hearing lots of different perspectives. As I turn it back to Jim, what I think we will be doing is just going through them, limit the discussions to some of the issues around the recommendations. And then try to get a clear sense and vote on them as to where we stand, how close we are, since I know there are some people speaking a great deal and others who are quite. We need to know sort of, are we on track as a group? So, Jim, all right.

I am not going to threaten to cut any babies in half, I promise. All right. So, we do need to get through these, and we need to make some -- can you believe that? That is something from [ indiscernible ]. So, we need to get through these recommendations. We need to determine whether we are going to adopt them or not. This is, certainly -- these are open for work sniffing. They are open for judgment. If any of you have adjustments that make you feel like, I could go for it with this or that, by all means bring that up. We are going to try to move along relatively rapidly here. The first three are going to be the toughest. They are one to be the ones that you both the most contentious today, but we cannot debate forever. You have read the report. We have been through a lot of this before. So, let's discuss this first one for a moment. The Secretary of Health and Human Services should support and work with the secretary of commerce to promote the following statutory changes. One, the creation of an exemption from liability for infringement of patent claims on gene for anyone [ indiscernible ] for patient care purposes. Let me just go to remind you of the task force's rationale. This is meant to address patient access problems and quality concerns and to enable Laboratories. So, let's have ten minutes or so of discussion about this and then let's put it to a vote. Who wants to talk?

David.

Actually, Lauren is first.

Laura Rodriguez from NIH. I just wanted to ask. I guess first going back to Mark's, earlier about the technical members and contributions that were made during the task force committee. We were very much present, and I was not speaking during the earlier discussion because we have shared our thoughts in the process, and I thought that was a forum for the committee to have and also to thank Jim as well for the process that was there so opinions could be heard in their. I'd say that we do share many of the comments that came up before about action ability in some of the others cope questions. For this particular issue coming back to the recommendation, I will apologize, because I came on to the task force later in the development. I did have a question about why the task force put forward this language that really was so open in terms of it being this exemption being available to anyone verses' being more restrictive a round of the patient care issue.

Right. First off, in all funnel's in the patient care purposes, that is meant to be the overarching issue. The reason that we had it say, for example, not just applicable to a physician ordering the test or doing the test was primarily -- correct me if I am wrong -- driven by Emily who has an industry representative who develops kits, et cetera. She felt that it was unfairly privileging the academic university laboratory over others by allowing them the extension. So, we were trying to broaden it in the inclusive of industry as well, and it was really her advocacy that got us to add the making. Otherwise, using or ordering, or it may be offering for sale, that would have been sufficient.

Who is next?

David.

Well, I speak in favor of this statement of recommendation. The simplest way I could freeze it, I don't see why anyone could prevent me as an individual from asking a reliable source or laboratory to seek funds my whole genome and tell me what they found. I think that is my personal right, and I cannot see how the University of California could have sold that right to accompany to deny me that access of information pre or thinking about it as an access issue, I would say the same thing to my patients. I think they should have access to that information without obstacles as a part of General access to care. So, I would say that this is the high ground in terms of what we are doing in terms of principles. That sets aside the issues surrounding the use of patented materials for product development or therapeutics. But it does improve access. I think it is a modern thing to do. I know -- we started down this pathway of patenting and licensing of specific genes in an era when it was a very unique thing to do. Now we are certainly in a different era. To look ahead, I think to continue on the path we are on would be cumbersome and impair the health of the country.

Other comments?

Well, this is a process issue. Have we ever heard from PT zero? Don't have our representative from the P T zero?

Yeah, they joined us on every conference call.

Are they here today to talk about some of the issues we brought up and discussed to feasibility?

Again, PTO was on every single conference call we went to.

And their comments on some of the questions?

They informed us all along the way about the recommendations, et cetera.

But on the specific questions about feasibility and viability as we got close to the end --

I don't think that this -- for example, this recommendation, I don't think PTO is particularly relevant to this particular recommendation. This would kind of taken the PTO out of it.

I mean, I would think that by definition of taking it out, they would have a strong opinion about it.

They were there on every conference call.

Does the PTO only decide whether there should be a patent? They have nothing to do with infringement or exemption for liability. That is not something that PTO does.

They have come out in various statements over the years talking about what they believe on infringements. One of the things you talked about is the patent ability of new claims.

But this isn't -- [ overlapping speakers ]

I wanted to know if they represented --

Certainly, it doesn't look like at the table -- I mean, we will have one now. I assure you that PTO has intimately been involved.

We spent a lot of time talking about whether these patents would need to be infringed by the kinds of things that are being sold. We spent a lot of time talking to them about it. But that was just patent lawyers, not basically the PTO.

On this, in particular -- I don't remember, Deborah Leonard had some issues on, was this the one she had issues on?

She signed off on this.

I just wanted to clarify. This may not be what you are getting at, but the agency experts are part of the task force to provide technical information. It is important that we don't read anything one way or another into their participation of the task force. They are technical experts in providing information and technical corrections. And whether they support one thing or another. If you were getting at the feasibility, the question of feasibility, John may have some -- I don't know that we actually probed that with him, but as Jim said, he was very much involved.

I was moving it to the broader issue as opposed to on the committee on the technical expertise and that he and others gave us.

I think Paul was next.

I did have a question come a point of clarification about this. So, does this have implications for the next generation of patents on tests in the sense that it happened without an infringement capability -- a patent without an infringement capability is a different kind of tests done before?

Yeah, I think that what this does is it tries to dissect out specific claims. The claims that would be operative here would be claims that have to do with diagnosis. So, this wouldn't affect claims on therapeutic, et cetera. But it would, certainly -- yes, it would have an impact on diagnostics analysis of nucleic acids in the future.

This is just -- excuse me -- an exemption from liability.

No, that is not what it says.

The patent claims on the genes involved in the test. If you have invented some fabulous new test, you could get a patent on the test.

But that is not what it says.

A test developed under the patent. Under the patent. An exemption from liability for infringement of patent claims on genes. Patent claims on gene.

Let's say you invented some fabulous new tests so you could get a patent on the test, but someone else might have a patent on the genes. First of all, that is one of the problems this is trying to treat. If someone wants to develop a new test, you should be allowed to develop a new test. This part says that if somebody does develop the test, they would -- someone would still have to pay the loyalty to the test. It would not have to pay royalties to the person with the patent to the genes.

Does their need to be a modifier test that says diagnostic test? Is that necessary? Is that what you're advocating?

I want to understand the implications for patents on genes, patents on tests.

This as patent claims on genes.

So, you can develop a test --

Right.

It wouldn't interfere.

That is the difference in the whole report. You could come up with a new methodology to Detective to these genes and you could pass in the technology.

Gwen.

So, perhaps this is an I comment, but if the entire reason to develop these diagnostic tests is to improve patient care, how could there be an objection to this recommendation?

Well, you are probably asking the wrong guy.

[ laughter ]

I could tell you.

[ overlapping speakers ]

It is a general comment. The fact is that the entire basis of what we are looking at here is improving patient care. If you improve diagnostics and to improve its treatment, and that flows into [ inaudible ].

And that is what I think. Here is the fear. You are going to harm a patient care by doing this. That is the fear. I don't think that's justified. I have enumerated those reasons over and over. The fear though is that you are going to harm patient care. We're dismissing those people that are worried simply about profits, et cetera. But that would be the legitimate response.

And I think the fear is not necessarily today, because you could say that the genes tests are already out there. You are saying anyone can infringe on patents we have. We have the system for a reason. We might improve patient care if all health care was free. And we are debating that in a pretty broad way as to lowering the cost so there is pretty broad access to everybody all the time. We have a process, and this says the process of genes patents was nice, but we don't respect it and anyone can use the genes. I understand the issue about the task. Anyone can use of the genes in any way. For diagnostic purposes, I think it has broader implications than not, but I understand that is what it says. What happens in the next generation when you need to be able to create something that has some economic viability in the rest of the health-care system looks at it?

What I would propose -- let me ask a very specific question. As anybody have wording changes, specific wording changes that they feel would make this substantially better? And I am not talking about, yeah, erasing all. If that is the case, you just vote against it.

I just would insert the word diagnostic before test. I think it adds clarity.

Before, I would just put the clarifying for infringement of patent claims on genes but not methods or whatever it is that you mean to exclude. I am not sure I would have read this exactly right.

This was an issue that was brought in our conference call. We needed to be really clear.

That is a good point.

We may want to put that in the notes.

Hold on a second.

I don't want to pull the trigger on a change.

Somebody brought up during our discussion.

Okay. Is this what people suggest here? Andrea, is this a problem given the issue -- okay. Here is a potential monkey wrench by inserting diagnostic. Many of these tests will be used to determine predisposition. That is not a diagnostic issue. So, it makes me wonder whether diagnostic is --

I would take it out.

You are saying predisposition is not a diagnostic?

I think a lot of people would construe it that way.

Exactly.

When we do testing, it is not considered a diagnostic test. It is considered pre diagnostic.

I disagree with that, but I don't think that is the big issue here.

I agree to take it back out.

Okay.

Under FDA regulations, diagnostic doesn't just mean diagnose.

[ inaudible ] for metabolism.

Right.

[ overlapping speakers ]

What we mean by diagnostics, there needs to be a paragraph or so that provides a little elaboration of those kinds of details so people know.

But I don't think we can have a comprehensive to show some examples.

I think we should vote. Of the committee members vote -- of the committee members vote, and it should be -- oh, okay. All right. [ inaudible ] brings up an important issue.

Microphone.

I thought you were saying Mike. I was like, who the is Mike? Here is what I would propose. I think we can wait and ask that question I would propose at this point that we vote on this and then proceed. Any last-minute comments before we vote? All right. All in favor of this recommendation, raise your hand. Okay. So, we need to --

Four, five, six, seven, eight, nine, ten, 11.

All opposed?

Okay. All right. Oh, extension, good point. Any extensions?

I think we get it.

Okay. All right. A number two. This is designed -- and let me go to the wording on the next point. The second such rate changes would enable test developers to conduct research to design new tests. All right? It reads as follows. On the creation of an exemption from Pat and infringement liability for those who use patent protected jeans and the pursuit of research related health care and research entities also should be covered by this exemption. So, are there general comments and are there specific comments about how this can be improved if you in general favorite?

Can I ask a question on there? The term research isn't defined. I thought it would be helpful to better understand what the goal is by having a definition of that.

And I would add to that that related health care and research entities -- I mean, this one for me is problematic, because it is not adequately explicit about what we are really talking about.

Okay. There is a reason that we initially have to widen that with regard to research. We wanted to not, again, privilege clinical research, basic research, not only because we didn't want to [ indiscernible ], but it is often difficult to part those definitions. I am certainly -- I would certainly be in favor of any clarifying language that people want to suggest that we could discuss. Mark, did you have any ideas about how we might be able to gain more specificity without undercutting a research exemption?

Well, you know, I think -- I am not sure I could come up with a solution to it, but I do think if we could create the same sort of situation where we allow people to sort of self define what they are doing. You know, much the same way we will be talking about with DDC. They say we are not doing health-related tests. I think we need to -- if there are existing definitions of research or what a health care entity is that we are really talking about here, I think we are obligated to use those definitions and try to be as clean cut about this as we possibly can. I just would be uncomfortable that it is way too nebulous.

One of the things we discussed in the task force was whether they should be in -- we could gain tremendous specificity by saying in the pursuit of NIH funded research. That would be one option 3I am just throwing that out there. There are problems with that as well. The other issue is health care and research entities. There actually are very specific definitions for those. Do you remember? We talked about this on the task force called. I believe they were actually defined in [ indiscernible ]. There are specific recommendations or definitions of that. Let's tackle the research issue first. Do people feel that we should try to get more granular about what research is? Mark's point is a good one.

Andrea, you had some thoughts, I think, about -- for example, if worst to say NIH funded research, is that problematic?

There is more than NIH funded research.

What about health-related research? Glenn.

I think health-related research is better [ inaudible ]. We are the scientific partner for a major initiative on cancer. It is not NIH funded, but there are the whole point is that this project is they are only funding team signs. They are only funding people that are crossing institutions. If the IP issues aren't solved, they are going to be able to work with each other. I think it has to be health research. And I'll also like -- sorry. A second point was that I -- maybe I would like Rochelle to comment on the history of research redemption. You started saying something about that earlier.

Like in 1819 or something, there is an incentive for people doing research for their own curiosity. That has always been understood as meaning nonprofit research, basically. There was very few and [ indiscernible ] on it. In 1998I think there was this case in which a professor sued at do University and what had been his patented laser or something. He won and the court said, well, anybody doing research in the ordinary course is not entitled to the research exemption. And then I said, what is the University's Business? Their business is doing research and hiring researchers and encouraging fancy's students to come to their school. So, they decided that do didn't get the research exemption. By extension, nobody would. It is a strange case, because, first of all, the facts are really weird. Also, it was kind of a research --

But they should.

Don't tell my team.

[ laughter ]

It was a kind of research tool -- you know, it was something that you use to -- I cannot remember what you did with it. But it was a tool. And judges of the Federal Circuit have since said, we really only meant that for research tools. We really didn't mean it as a run-of-the-mill thing, but they never changed it. The Supreme Court kind of got a chance to look at it, but they argue that issue. They argue that the statutory Research defense, which is only for doing research for FDA approval, so it has been living in the last ten years with people kind of thinking that help with the Research contention does continue, but not really knowing, we just haven't had another case. In a way, this is clarified is what the law is and clarify it in a way that quite a few informally [ indiscernible ] of the Federal Circuit would agree with. Certainly, the Supreme Court case indicated the Supreme Court was kind of on the side of thinking we should read patents with having research exemption. Now, that research exemption would be for nonprofit research that would extend to universities and not to industries. In Europe, they have an exemption like that. They have actually had the kind of problems that you're talking about, a joint research project. Also, projects being done by for-profit companies that are very, very far up the stream. They said, if we are doing upstream research, what are we any different from the University doing upstream research? They is -- there is in a move in Europe to change this. It broadened in a way that other countries look like they are moving.

I also bring up another thing kind of interesting, and tickets to Mark's and Rochelle's points. I am skeptical to some extent of claims by some of these new companies, like that we are going to be doing research in a new way. But they might come up with new models that I don't think we should dismiss. I think that also would drive me to advocate for the broad term and not put limitations on the research. I think all those reasons to me [ indiscernible ].

I understand what you are saying. I am more comfortable with we can really be more definitional about the related health care and research entities. We have definitions that are from statutes that are applicable and I think it would be appropriate to reference it. I would say philosophically that this is really critically important because to assume that a patent holder is going to have all of the novel ideas around a certain entity, I think that is -- that has not been the case in history. By relief -- I can see this really impeding the important science, particularly given the areas that we really at the present time have no clue around, like regulation of genes. You cannot really look at the genes. How can you really answer those questions? I am philosophically it predisposes to being in favor of this, but I also recognize the fact that there is potential for harm.

So, what I would propose -- one more, and will take a look.

Well, I think it is part of what Mark said, but I believe it is not a marked case but around universities and the ability to do research. It to me this seems like a non-issue. When people have rights --

Now, it is very much an issue. For example, BRC one and two, clinical research was shut down.

Are there others? I have heard that and there have been some negotiations around one in particular, but if you look at a number of other cases --

[ overlapping speakers ]

Of the statutory -- the statutory research applies if you are doing research in order to generate data submitted to FDA. It is a very narrow research exemption. It was, basically -- it is a little broader. It was basically done so generic companies could do research. It is pretty narrow. The Supreme Court broadened it a little bit. You still have to have data. It still has to be generated data.

[ inaudible ] it is not relevant in the current diagnostic licenses you get.

Let me just say that I think it is well established that those doing research are not having any kind of established exemption except in narrow circumstances.

Some universities are following the nine points. That suggests that the Reserve research right either for themselves.

Many are doing that.

But they're not reserving Research rates in the kind of situations where there is a joint venture between university in a for-profit company. So coming in Europe you see these cases being brought by for-profit companies who say they think they should have the same rights to do upstream research like anyone else.

With the understanding that we will explicitly defined in health care and research entity using an established nomenclature, how many are in favor of this recommendation? Okay. And opposed? Okay. Okay.

[ speaker unclear due to low audio ]

Okay. The third issue is connected. We might have to have two of votes on the third issue. A there was some question in the task force as to whether in those first recommendations, Association patents should be full folding in -- folded in. The reason I did not address that at the time is that we have a separate recommendation that could stand on its own. This recommendation specifically addresses Association patent claims. The rationale behind this was not that there was some discreet statutory function that the secretary could advocates, not that there was some executive action that she could carry out, but the reason the task force felt that association patents should be addressed is that they are an extraordinarily active area of debate and interest now in the field. There are pending court cases that have hinges that revolve around Association patents in the courts pay attention to what bodies such as ours say. So, we thought we should weigh in on it. What this would do is say, the secretary should use her powers to discourage the seeking, granting, and invoking of the simple Association patent claims. It is the committee position that these claims represent basic laws of nature that cannot be a vented around. I would like two comments about this. One is that, again, as you can see, it is quite a general thing. It doesn't advocate some specific action. The words simple is one we spent a lot of time on. And the reason for the insertion of simple there is that there is, from my understanding, and Rochelle can speak, but there is question as to whether ones complex enough would say and out for some that associates two fins rise to the level of invention. That will ultimately be something that the courts will have to work out. What we are trying to advocate for here is that we did not feel, most of us on the task force, that simple associations, say [ indiscernible ] now flooding the medical literature, where we say that this will this is related to a relative risk for this disease. We didn't feel that that association should be patentable. We did not want to imply that there couldn't be such a in a complex algorithm that took [ indiscernible ] that we would want to preclude all options. I will be quiet now. Any comments? And I think we should have, basically, a discussion about whether -- if we want it, should stand on its own. Or should we fold into the first part?

I would have two comments. First of all, simple is just not adequately explicit. No one would know what a simple means. Everybody would define it differently.

But we do address it.

But it is not defined in an explicit way so that somebody reasonable could look at it. In some ways, that is when to be problematic. I think the more problematic thing here relates to the fact that opposed to the first thank you instances where I think we have all lot of challenges -- or a lot of not cleared, and there are cases that are going to provide clarity that are under adjudication. I'm not sure [ indiscernible ] is realistically true in the sense of how the court would know that this is what we are saying. It seems to me that if the court is actively considering this, this may be premature.

Okay. Other comments? Rochelle Kerry it's been a well, I don't think it is premature. The Federal Circuit is certainly struggling with that same question of whether all associations are patentable or not. They had that question a couple weeks ago. You inject a patient with somebody and you saw how it was metabolized. Although, somebody might say it is a law of nature. How you metabolize that is a lot of nature. Maybe we could do something like a direct association between genotype and phenotypes.

[ overlapping speakers ]



Yeah, because when you use the direct association between knows, when you have to use multiple genes to do a calculation, then you invented the form of compilation [ indiscernible ]. The thing that actually helps.

[ speaker unclear due to low audio ]

Yeah.

I want to make sure we all understand we know what we mean by direct.

Again, I think your point are well taken. We talked a lot about this. At some level, you read the U.S. Constitution. There are some things that are not completely clear, but you cannot be so specific that you've got the intent, right? You have to let the process kind of define what those are.

Well, the process will ultimately define what they are. I am saying that I think we have -- This is not something like life, liberty, and the pursuit of happiness. I think the direct -- when we talk about a genotype and phenotype, I think we can take a crack at that. I think we could have a reasonable definition of what we consider to be direct.

So, give me some possible wording here. Discourage seeking granting and invoking of association patent claims that -- I mean, how would you rephrase this to get that desired outcome?

[ speaker unclear due to low audio ]

Would it be enough to find direct in the comments?

That is fine, but we need to do that. If we are going to vote on this -- we could vote on it, but if we don't really understand or don't agree with what the definition of the comments are going to be, then it is still problematic.

Right.

You can finish your thought.

I was going to say, we could say that -- I mean, we could go so far as to say the association between a single olio. The problem with that I get to it is -- okay, look at the prostate cancer situation. We are now relief for well-established [ indiscernible ] that results in increased risk. It doesn't take a rocket scientist or a geneticist to figure out that, okay, I can use all four will side. It to me that is still a director association. I tend to want to not get so granular that we named the number of low side. I understand that Direct has some nebulous [ indiscernible ], but I am not sure we can do better.

I would just make my comments and recommendations. Back to the original point on the courts and what is happening. We get right back to it again. Our recommendation is for the secretary. We are not making recommendations on any particular case. At the end of the day, when she receives these recommendations, she will have to reconcile those with whatever the current case law is and whatever the future rulings are from those pending cases. She will have to get advice from OGC on doing that. I was going to actually recommend that some of these things be more copulative examples that might get us pass this definition question. I think it is 21 that something depends on where the lot is at that point. What we have under recommendations seven, licensing policies, [ indiscernible ]. At the end of the day, members two, four, I think six -- I look at the number of them, they could really be tucked under the secretary authority. Erastus with what she can and cannot do with federal funds. If we are going to be recommending that there be a more thorough legal review -- and that is some of the sticky point I have in this report. I don't feel like I have enough information on where the what is -- where the lot is.

Again, I don't think you were here when we went over how we were going to approach this session. I am in favor of going through these recommendations and deciding whether we want them or not. I think that I would like to C.S. decide whether we want to say something about association patent claims. If we don't, then I can talk about, do we want to talk it in as an example? I am not sure where that would go. In response to what the secretary can do with this, I think we on a task force are very cognizant of the fact that this is a nebulous recommendation, but I think that is important for the following reason. What we say, there is some attention paid to what we say. As a body that has spent five years looking at this, I think it is not unreasonable to take a stand on some certain things of that may be for purposes that go beyond simply that the secretary should do this. It is not unreasonable to say that this is what we would think and we would like the secretary to use her powers to discourage this. What I think we need to do is I think we need to decide whether we want to say this. If there are discrete changes to the wording of that could make it better, I think we should do that. At this point, I am trouble -- I have trouble getting around -- I have trouble finding a better modifier then direct. Any other ideas?

Jim, if I could help. It seems to me like at least I would suggest leading the second phrase as a committee [ indiscernible ] and moving back into the discussion. Then we are left with the position of whether we should encourage her to use her powers, discourage her from using her powers, or say nothing. I would favor leaving the phrase as it is but simply better defining Association patent claims. That is have a modifier just to say what that is. Thank you so, what kind of modifier?

I would say that is and put into plain English.

I just heard Rochelle say a direct correlation. What about something like this? The secretary should use her powers to discourage a seeking, granting, and invoking of association patent claims which --

[ speaker unclear due to low audio ]

Invoking a patent on a direct correlation.

You need anotherward then association. The simple word is a wink.

A direct link.

I don't know what the were direct means -- what the word direct means. We're talking about [ indiscernible ] correlation, I think it is whenever you want to use. If it is in direct, does it make it more patentable? Why complicate it?

But there are some -- sometimes you have multiple things that really will be discovered.

But this correlation at multiple [ indiscernible ], if you put five prostate cancers together, it is still a genotype phenotype association.

If we make a distinction [ indiscernible ] where you have to run [ indiscernible ] that you have come up with. You didn't have to come up with any computation. This and that maybe what we are talking about here -- or maybe I am completely missing the point -- but it is patenting an observation of an association as opposed to taking that observation and doing something.

It requires little in the way of sophisticated in France.

But don't you want to put single genes?

[ overlapping speakers ]

For example, diabetes.

[ overlapping speakers ]

Any first-year statistics clack, class student can do that. We certainly don't want to stay single. Again, what we originally had here was invoking Association patent claims between -- or we had simple in their. Again, my initial view was, can I define precisely what simple is? No, okay? But I think Pat or Stewart said, I know it when I see it. In other words, the courts will --

That is not our role. We are here as experts to be clear.

Well, as clear as we can.

But we can be clearer than this.

Okay. How can we be clear?

We have just had the suggestion of cutting out the second half of this, which I think makes it clear.

Right. So, we could put this in the report.

Of course. We are talking about clarity of language.

Okay. Just for the moment -- we can always back upon this. I am going to delete that. Now reads, secretary should use her powers to discourage the seeking [ indiscernible ] of direct association patent claims between do not type and phenotypes.

That is pretty clear.

That can apply to multiple genes. It could apply to one or whatever. Where things become a little bit more complicated is when people put genes together, the role of algorithms --

But people Pat the that. Of the whole argument you've just made about the patenting we are going to have a problem with algorithms put on those. Right? There may be an access issue.

The argument [ indiscernible ], and second there is an access issue. The problem with complicated algorithms is you might actually need a patent on it, because figuring it out is an going to be very easy. They're fine is currently very hard. Those kinds of things are things where I think maybe an updated [ indiscernible ] of what we are saying, and I don't think we have enough support to get rid of patents entirely.

As I said before, the report is silent as the quality of the data. There seems to be a glaring.

Again, bringing it back to this. The task force felt that we did not want to preclude the possibility that an association claimed that relied on a sophisticated algorithm that took tremendous inventiveness would be disallowed. We did want to take the stance that simple Association patents or direct association plus were an object and -- bore not legitimate. At some point we need to just go on this. To me, the remaining sticking point is the modifier. Should we have directed their? Should we have simple there? Or should we have no modifier?

And this is going to raise another sticking point, which is the other part of this is problematic. How can the Secretary use her powers to discourage that? Does the Secretary, in fact, have any ability to influence this at the present time? Is the answer is no, then we should get rid of this.



So, there is another option here that that raises. That is to not have this as a formal recommendation but to put into the report that the task force feels that association patents are illegitimate.

Maybe we should do something --

Somebody say that. What are you talking about?

Yeah, don't we address that elsewhere? I mean, I think -- I agree. I think I understand what simple is. I am not sure anyone else would agree. I think this is a problematic recommendations. I've been it would be good to highlight this in the report and say we are very concerned about this. There are some ongoing cases. We need to be aware. As appropriate for the Department of Health and Human Services to go on --

Okay.

And I think that it's to the legitimate issue that none of us are quite sure exactly what the secretary is supposed to do with this. I would move that we make a statement in the report that the committee feels, basically, this. And we could elaborate a little bit on what simple means. We do not have to have the necessity for gravity there that we would with a recommendation. So, I think that would be a very reasonable option.

I do not have a vote. I just wanted to express my support for going in that direction.

Other input before I took about as to this affect?

I might have predicted ridiculously basic question. These claims that we are having a hard time defining, representing the laws of nature that cannot be represented around, what is the basis of that?

If you look, for example, at briers this and [ indiscernible ] in the metabolite case, if I am mistaken -- if I am not mistaken, these are laws of nature. They should not be subject to patents. And we have taken that.

So we are taking the whole thing out.

That is what we are advocating.

[ overlapping speakers ]

I feel we spent five years dealing with this. Is not out of bounds for us to express some conclusions.

That is not my concern. My question is, I don't understand the basis for is it. Is just prior year's descent? Is.

It is the question of whether simple associations are patentable material. As we went through this morning in great detail, Association patents between G not tight end phenotype present his tremendous potential obstacles to the use of multiplex [ indiscernible ] sequencing, et cetera.

Are we certain that cannot invent around the is, that we are --

[ overlapping speakers ]

Technology fundamentally changes. The things we are calling simple associations now --

[ overlapping speakers ]

It has nothing to do with technology.

You go back 50 years and these are supposed to last over generations. Things that are simple now and that we describe --

No, no. Didn't you listen to what I said? Is an association --

[ overlapping speakers ]

Okay. I am going to make a proposal. I propose that we eliminate this recommendation and that we put in a report that the committee feels something, basically, along these lines. I know everybody doesn't agree, but that is why we have a vote.

Two separate votes.

No, no, no. I think is clear to me that there is a consensus -- does anybody want to have a vote on that? So, we are going to put it in the report -- what are you asking?

I guess I thought of reducing we were going to have a vote. A guess we're not having a vote.

Let's have a fault.

Once the recommendation? Who is in favor of having this as a recommendation? Who is against it? Okay. So, who sustains? Okay. So, what we have decided is that the report bash there is not one to be a recommendation. What I would move is that we at least address this in the report with wording that is substantially similar to this. Now, I would say we should have a vote on that. Who would vote for that option? Okay. Who is against? Okay. Okay. We initially had removed the issue of law of nature, all right, from the recommendation, which is in a recommendation anymore. My view is that in the report, we can be more expensive. I don't think there is an imperative to remove that when good at this point -- to remove that language at this point. In my recollection from reading the full report is that in the description about why this is a potential problem, we do have adequate detail there that does go into the issues relating to the law of nature. My recollection of this discussion was that it actually was fairly broad, not just [ indiscernible ]. There were a number of other examples. I think that stands on its own reasonably well. People can take from it what they will.

Okay. I think we have done most of the heavy lifting, though I might be surprised. The remainder of the recommendations are meant to -- There is going to be working that says -- and I think that was in the original wording this morning in the presentation. It says, okay, we recognize that revoking statutory changes is a complex, hard process. You may not even shoes come as a secretary, to do this. Because of the difficulties with that, we have come up with a number of other recommendations that we feel could address the issues that have been raised during the report. And that is what most of these really focus on. So, this one is concern in promoting adherence to designed to ensure access. Kind of long. Of the secretary should develop mechanisms [ indiscernible ] for the licensing of -- [ indiscernible ]. Articulating more specific conditions under which an exclusive licensing and nonexclusive licensing of the U.S. is relevant to neglect testing are appropriate. Professional societies should work properly -- [ indiscernible ] . continue their work to enable broad access to such technologies. As we discussed, one of the things that inevitably came up with this was the question, should these recommendations somehow had [ indiscernible ]? We are certainly all familiar with this litany of recommendations that a plain ice. Should there be more, and if so, how should we do that? Why don't we discuss those issues?

I think the issue there is to be clear. These were already out there and voluntary guidelines. The question is, what are we saying the sides --

Besides these are good guidelines.

If you think they are good issues and the report provides a narrative, the need to take out words like promote voluntary adherence. That is the question. But it worries me to reiterate what is already out there.

I no. I shared that.

I have a question. This has to do with payment in the Secretary [ indiscernible ]. If the Secretary were to say something like laboratories that don't licence broadly and that causes all the problems that the report suggests they might in terms of access and quality, the laboratories will not have access or entities doing business with them will not have access to federal dollars that are administered by HHS. Wouldn't that have a rather strong impact on the situation?

Actually, in a subsequent recommendation, we discussed that. There is also the issue of, for example, of whether [ indiscernible ] allows the Secretary and whether the what is such that that can be done say with funding dollars, et cetera. So, we one -- one way of trying to put more teeth in this if we chose to do this would be too, for example, get rid of a voluntary.

[ Captioner Transition ]

Exactly. Add to the other point they're definitely. And purse strings without a doubt in terms of prescriptions and limitations on [Indiscernible] secluded by other statutory restrictions which it is lowered into in terms of evaluation of the.

We can always go back. I don't mean to do REM anything through here. What happened there?

There are a variety of things.

The whole recommendation went away.

If they are going to seek--

It would be very interesting for someone to tell us this committee what options for influencing this kind of phenomena we have. So we can make recommendations that then would be relevant.

What if we were to said that the Secretary, that the committee supports these following things. Somebody helped write this down. And that the Secretary should investigate ways of promoting and parents that might include or that would include the use of funding as a deterrent or incentive to go something like that the estimate of more than investigate is the point.

I do not. I don't know that, I think again within the recommendation of the Secretary, I was standing on the same lines that Jim was saying. We think that these are good guys cropping should go. Their voluntary. We as a committee do not know what avenues would be available to promote adherence. If you want to use those words. So we would recommend that the Secretary investigate or explore what are the options to promote adherence to these guidelines. I think that that's a reasonable thing to do.

Again, I'm digging out loud. The committee support guidelines and then we could insert in their such as the OECD, nine points, etc. That encourage broad life -- By licensing and cement genetic test. Tommy out there. We would request that the Secretary.

Technically we recommend.

We recommend. That the Secretary.

Explore options that would promote adherence beyond the monetary. I would go further and say you've got to explore them, identify them and implement them.

To explore, identify and implement is what Steve said.

And implement such recommendations in ways that go beyond simply adherence.

Promote adherence to those recommendations.

Recommend a separate sport and identify and implement such recommendations. What were you saying?

That the Secretary exploit them identify and implement mechanisms that promote adherence. Beyond voluntary [Indiscernible]. My estimate that go beyond voluntary adherence.

And the second part of that would be I think whoever suggested that we recommend that the Secretary convene the group as opposed to just continue the way changed the verb to convene so there's an intense malady about bringing the people to the table to figure it out.

What ever the second part that you previously had.

Conveys stakeholders. Okay.

Its consistent with what we've done on previous reports.

Yes. Secretary should convene stakeholders we can worry about formatting letter. For example and the steering -- To continue the work of developing code of conduct. Yes to develop for them to develop a code of conduct will enable broad access to such technology.

Some of this comments I had changed that the language has been altered a little bit and we're exploring things and looking further at these issues. But some of the power that the guidelines have had is the fact there guidelines edit their voluntary and promote flexibility and by shifting to adherents I think again that as written, things would have to be looked at differently. There weren't originally developed with the intent of the regulations. Or anything that was mandatory. So that could change how some of it works and take away some of the power because the flexibility to look at the individual situation is helpful. And moving something forward and then, as written in terms of the main I think that is something that's well within the scope of the Secretary to do. And to bring stakeholders together and to have them go through these issues again and put something forward. I think that could be very constructive. Another question that I had again is all of this would only affect HHS [Indiscernible] research. There's a question of impact over all [Indiscernible].

That's an enologist limitation of all these types of things to the that's one of the reasons for recommendations one and two.

First of all, I think the guidelines internally have some flexibility in never go so making them making it more required [Indiscernible]. I thought Paul had ideas of a way to broaden the [Indiscernible] you could do things with funding of organizations that deal with these organizations?

Exactly. She has both direct and indirect influence on the environment in which these laboratories and a pat holders exist in nature. [Laughter].

Can you think it sounds to me like a possibility to include that would be to have a sub bullet that says something about the types of mechanisms.

GS authorities of the influences. We don't happen to know all of them. But she does. And we want her to [Indiscernible] departure is we wonder to marshal them for this and.

And employment mechanisms using her authority and influence and Resources?

Yes.

Using her authority and what was the other thing?

Resources, thank you.

In order to promote adherence to these guidelines. The way that -- In a way that goes beyond voluntary adherence. Other suggestions?

The one point is can give a rounded. It's only going to impact and I page funded research.

Eight action in some is day this is it interact with HHS funded research. Companies may [Overlapping speakers]

I don't know. I don't know, again talking about of the research that goes on in the private sector. For lots of private sector companies and the research and early developmental stage, NIH is a very big piece of it.

That actually is a good thing for the the Wednesday of this.

All right. So, we will do word smith in and find some time tomorrow or something to circulate.

I think from a [Indiscernible] if we can get a sense that things are not directionally correct, we should word smith and tonight in the back to the whole committee, not the ones we've already worked with, the ones so stiffly rewriting and get some final approval on those tomorrow. We will find some time.

That's right, I'm going to move this one. I think it was to take a vote on those as well.

Right.

Okay. And putting that at the end. Alll right. Let me go over again. This is for promoting adherence to norm is designed to ensure access to the Committee's sports fads and will fill an the let it go that encourages broad licensing and broad as think we should have a broad modifying of. Well, access agnostic and if we recommend is Secretary export and identify and implement madness and is under 30 and resources in order to promote, that will I guess that will promote adherence to these guidelines in a way that goes beyond voluntary adherence. The Secretary should convene stakeholders for example, to develop a code of conduct that will enable brought access to such technology. All those in favor?

Fourteen.

All right. Any opposed?

All right. Let me get rid of that. Okay. Enhancing transparency and licensing. And the reason for this was there was some dissent here. Imagine that. The Secretary should encourage holders of patents associated with genetic test and their licensees to make information about patents, licenses readily available either by making the sign licenses publicly available or by disseminating information about their technology and licensing conditions including any terms that pertain to the type of license field of use and the scope of the technology that is still available. And become the means to enhance public access to information about the licensing of patents related to team based diagnostics. The Secretary should direct NIH to amend its best practices to the licensing [Indiscernible] inventions to encourage licensers and licensees to include in their license contract a provision that allows each party to disclose information about its licenses. Including such factors as type of license filled of use and scope in order to encourage next-generation information.

Comments?

I guess I'd like to understand if there was dissent about this what the nature of it was. Probably better for someone the--

[Participant's audio is faint/unclear]

I think several of the universities also dissented to this and these letters and just say they did not want their financial information on good, bad or indifferent practices public information.

So this is, I want to make this a pejorative sense of the term, the issue is them less about the fact that there could be challenges relating to discovery of a IP or things is more related to public perception of what it is we are actually doing with--

Discloser on financial terms and the effort to not say yet negotiated a good deal or a bad deal with this type of company or other university and they did not want that information public.

Did we say anything about financial terms? My reading of this, maybe I missed the boat, my reading was really the idea was to know who is involved so that people that are looking to do actually begins with it would at least know the landscape looks like that is not necessarily disclosed in all financial information or anything else like that.

[Participant's audio is faint/unclear]

Right.

Now what money damages to others already license out their so [Participant's audio is faint/unclear] because it's already license.

I think you have to make that clear because builds of use to many food credit said that the term sheet that's all the conditions for which we are licensing.

I was certainly better clarify that because I nothing that and commission a study made public. And that's the case people are concerned that as we are send and we need to modify the language to make it clear we are tried to identify who is involved and if licenses are out there.

I thought that was the only information we were required but my impression was that some people consider that trade secrets. What deals they had, not the nature of the deal, the simple fact that had deals they wished to regard as trade secrets.

That was the second level that was voiced by industry as well as research and academia.

And a reading from a big, Bryant Stan was the center on this I think you is a major dissenter. What he says your is he doesn't believe the evidence supports the need for this. First patent information is readily available from USPTO the European that office, the Japan and, [Indiscernible] and others. I think for example, the individuals to pursue the case studies would argue that action this information is very hard to come by. And I think most of us would agree with that letter point. How could we change this I'm sorry. Of the. How could we changed this then to address the point that Maura and Mark or show a talking about.

And the crying was thinking of finding out whether there were patent you could Google principal. That isn't so easy either. But what Bob said was that was very hard to find out who you go to to even get a license. And that seems to me to be the kind of information that ought not be regarded as trade secrets. I agree about the financial information, that seems like really important information. That people might want to withhold. I would try to change it to as clear its non-financial information but that people could be able to find out who they need to get licenses from they won licenses because that's an abortive gain access.

The the point I'd make as we read the book of these is the operative word for the Secretary in both of those cases is encouraged go which implies a volunteer. So that would also then raised the question which brought a previously witches are we really looking just to enhance [Indiscernible] voluntary reporting or do we really want to--

Should sheet, reduce the same morning here. That the Secretary explore, identify and implement mechanisms using her 30 and resource. So that holders of patents associated with genetic test and then have a clause that for example excludes the financial aspects? Does that make sense?

And the way this doesn't go because limit go back to the full screen. What this says is about technology and licensing conditions including any terms but that pertain to the type of license filled of years and scope but that isn't financial.

Are we trying identify where licenses are does that necessarily Senate because the company that holds a patent has licensed that [Indiscernible] another entity that would naturally license it further?

Are we tried to draw a good pat holders are?

We are trying to do is find out who it's been licensed to for what feels abused ago because [Indiscernible] is going to be a big deal as multiplex testing becomes the norm. I want to setup a new test interactive it out [Participant's audio is faint/unclear] in on. To the first regional publication. And he tried to contact the office there or the university there or whoever. And sometimes it can find and you know where to go from there that might have already [Indiscernible] into that it's very hard to find that information.

If you identify the licensee, just that, [Overlapping speakers]

The terms of use. [Laughter]

And tried to delay the ground that people would be sensitive to however we [Overlapping speakers]

Then you can easily identify their contact information and then you that into the can seek to clarify [Overlapping speakers]

To debate test and maybe contact me to say [Indiscernible]

They may be required to disclose beyond [Indiscernible].

I don't agree with that but I think that's closer because when you put in any terms that pertain to the type of license, then it says you need to be able to do this much research at this time and keep it as as close of. There's all sorts of terms the relate to licenses and I did not believe it was some I was unsure what the full intention was. But I think when you have the way it's phrased initially its any terms and that goes these the Web technologies and the broad second sentence. And it's very easy to say I've got to give, make public all the information regarding this license. And I did not think that was the intention.

I'm trying to make this bigger so we can--

Is there a way to dissect is different terms and do research for the amount of time are do these [Participant's audio is faint/unclear] use the know what you're using the test for and why you're a license for diagnostic [Participant's audio is faint/unclear] clinical scenario and so forth.

Okay, what happened? Of by. July in to work our way towards this. Tried to put a little more teeth into a. One way of achieving that would be to use the same wording we did in the last one. We recommend a Secretary explored and identify and implement mechanisms is eager authority and resources that will make information about Pat licenses readily available. Of the? It by making the sign licenses public billable or by here's where we have to do word smith and go disseminating information about their technology and licensing conditions including Andy fell like any terms was too broad. What if we said including the type of license?

What I would probably do with this is to not be as, the first part of it is we are asking to explore and telling her exactly how to do it. And some ways. I would, say it's just the bare edge of my readability. That will make information about Pat licenses readily available. And then say the information that is necessary because of the concerns referenced in the report are around the field of would not constitute financial. And other words, you wouldn't have to RT click everything in the recommendation. You could basically say we're interested in this, not interested in that and expound on in the report.

Or indicate they should develop the elements in the following type.

Right.

Something like information needed for greater transparency due to concerns articulated in the report include -- Include and commission about -- Information about -- Would have been? To include information about their technology and license conditions. Terms that pertain to the type of license built of use and the scope of technology. How about that?

That phrase at the end that are still available doesn't make sense.

I took it out. Because it doesn't make sense. Okay. NB, as a means to enhance public access to information about the licensing of patents related to team based diagnostics the Secretary should direct NIH to amend its best practices for the licensing of genetic inventions to encourage licensers and [Indiscernible] to include in their license contracts a provision that allows each party to disclose information. Six we say here the Secretary should direct NIH to amend its best practices for the licensing of genetic intervention to require?

Would it be appropriate to ask the Secretary for the NIH to revisit it in its recommendation specifically addressed this point and bring those forward? As opposed to say this is exactly was begun. Are we certain that that's exactly what should be done? Or should we give NIH, let them use their expertise.

All we could say is say Secretary should consider directing NIH--

I was wondering SACGHS in the first part of this it's been changed to explore all of the authority and I would think that yes, this becomes a little bit new in terms of that would be done in the course of breathing the first part. Again, I think it needs to be explored and Eric DLN the questions that the N.I.H. would have about doing as a certainly changing it to consider if it's going to go beyond encouraged. I think there definitely--

So be would move to the port as part of the [Indiscernible] of paternities that could potentially book that. I agree, I it is redundant.

We're talking about then moving this sentiment and maybe what exactly are close to that wording to the report in the context or in the discussion this recommendation. Right?

Because I don't know that there is existing authority to do this.

Okay. So other comments about this?

So be is out?

The moves to the report. The boat then would be unless somebody, make it appear. We recommend that the Secretary explore, identify and implement mechanisms using her authority and resources that will make it commission about how my sense is readily available. The information needed for greater transparency due to concerns articulate it in the report include information about technology, and licensing conditions. Terms that pertain to the type of license to abuse and the scope of technology.

All those in favor?

Okay. All right. Movingg on. Advisory board. To assess the impact of the gene patenting and licensing practices. The Secretary should establish an advisory board. Which would be available to provide ongoing advice about the public health impact of gene patenting a licensing practices. This advisory board will also be available to receive in reports of problems condition at this genetic test from the public and medical community. The board then could review new data collected on patient access and assess the extent to which access problems are occurring. When of the board's missions would also be to recommend what information should be systematically collected through [Indiscernible] so that I Edison can be used to research questions about licensing including whether the licensing and and and the conventions has been conducted in accordance with NIH prospectuses for the licensing of a genetic invention. The advisory board could provide input on the implementation of the policy changes including the of the proposed recommendations in the report. Basically what this is saying is this arose because there seemed to be frustration that there was a vacuum there. That if people perceive problems they didn't know where to go, there wasn't any mechanism and this would take care of that.

Barbara?

I think I'd make it simple and keep the first sentence and that everything and go down to the lessons but the advisory board should also provide an have that be the recognition and the text [Indiscernible] about who should be at the table. [Participant's audio is faint/unclear] maybe specify a list of potential takeovers that would be part of that advisory board.

Mall for supplies in the is my eyes glaze over when is it a recommendation for this. Tell me get your specific.

The first and last.

Would be available some of public up and back of impending a licensing practices advisor Board could provide input is WS same?

Will we could do if this makes sense is with the tried to incorporate in the report these other things.

Making it explicit that the composition of the advisor Board would be reflective of of the [Participant's audio is faint/unclear] mention.

And report then insert a discussion along the following lines which also include suggestions about the composition of such a board. And then put--

Would this be an advisory committee in addition to [Indiscernible] pages?

I don't think this would be [Indiscernible]. Yes.

I was going to I think I'm going where you are which is advisory has a very specific meaning I think in the context of the Secretary. I had that question which was with that in fact be us. The second question is whether there would be expertise from would somehow be an intra-deparmental part of this report because we've already acknowledged there are different people that hold different pieces of this puzzle. And the third point is in our recommendation I've been was No. 3 may be, we do establish or recommend establishing and other group to explore best practices. In some sense could we look at building this into that? Would that be in because of? I don't think we should have recommendations for 50 new boards because.

That makes sense because the men I like your idea of intra-deparmental work group.

This now.

Your five-year tenure would end.

[Laughter]

That's right. Exactly. [Laughter]. In this war in which we will figure out that will go in the report that will be in the recommendation. Help me out here. You were saying we could discuss the need for intra-deparmental membership. We could also stem and I'd think it would be an advisory board then. Would be entered parliament -- Departmental, there are technical terms for those and we did find this out.

Are you suggesting that only?

Internal working group?

Are we suggesting Fed's only?

That's what I was thinking but I don't know.

This was outside.

[Participant's audio is faint/unclear] my mind went to Fed's own. Maybe so. Is there something between departmental group and adviser because chartering an advisory board looks like we're duplicating ourselves.

Can you just call it an advisory body and allow [Participant's audio is faint/unclear] do we should be constituted.

As long as we discussed we feel there should be intra-deparmental.

Advisory body which would be more intentionally vague and let her--

It could be inside or outside. Your not going to specify your wishes in that regard.

[Participant's audio is faint/unclear]

But if it's intra-deparmental than it may have more than one adviser.

[Participant's audio is faint/unclear] yes, my assumption with this would be that it was an advisory body that would report to her. And Do we need to say that?

I think you're focused on the public health impact here so perhaps you could have intra-deparmental but still reported to the Secretary.

Do we need to say that? Contract reportable to her? Or do we need? At this point I'm going to leave that offer a moment ago I was going to mention I was glad to put down here I'm sensitive to the idea that I will go ahead in gray and other board another advisory body when the about what our committee does its best to address issues of genetic health and society met talking about gene patents a. It does seem to me that my not be illogical to suggest that there could be a role for this committee. We've got intra-deparmental input etc. Does that make sense?

Sadly, it does.

It's still not fully representative.

We could discuss inter-departmental and even say others could be brought into a. Which could also suggest it might be a role.

Is it an advisory group that would be advising the [Indiscernible]?

My reason for bringing it up is the idea that is aimed at the rather natural function of this committee. Not a group that would advise this committee but a function--

Getting some like to enable broader membership in terms of this [Indiscernible] [Overlapping speakers] bring the recommendations on technologies and changes to the appropriate public or private bodies.

We've done that in some of the of the things when we talk about [Overlapping speakers]

I didn't want to necessary substitute one was word for another, but I think I think I'm envisioning that it needs to have representation from within the federal government and any step outside representation as well. And again, I'm going to reflect back to try and supply things that if we are recommending we call it whatever this body is that we tested to do several things. This will test it to look at the Best practices which was represented at think in recommendation did but that should be pulled into this and this and subsequent revelations about forming a group that they be given charge of all.

[Participant's audio is faint/unclear]

Right. Just bear with me because I'm trying to piece together these various ideas. The recommendation as we've got now is the very first. Per Barbaras recommendation. In the report we would then discuss those issues like I Edison and tried to get what we're talking about here. We could discuss the need for inter-departmental membership representation from a broad array of experts and stakeholders. And the nature of membership go because it just might be able [Indiscernible]. Does that get we are talking about?

And other structural way would be it would come over time is this bill involves standing subcommittees' of this committee.

That's a good point. We could discuss that in the report.

And we wouldn't spend so much time around this point talking about details.

Right.

And we could include an average and there might be a role for standing subcommittees'. [Indiscernible] [Participant's audio is faint/unclear]

Nothing is. I the guy have some kind of conflict of interest begum. Let me read the actual brief recommendation. Secretary, I'm sorry. The Secretary should is published an advisory body which would be about to provide ongoing advice about the public of the fact of gene patenting a license to practice as. The advisory board also provide input and implementation of any future policy changes including the of the proposed recommendations in this report and then within the report you talk about the composition, they need for inter-departmental membership and a broad array of experts. We could suggest the possibility that it's inappropriate role for [Indiscernible] with the Standing subcommittee.

Got it. Of changed the board to bodies. Alll right. I have to be there. This is body. All right. All in favor of this recommendation and did tendon in sessions and to the report?

Thirteen.

Okay. All right. Of federal efforts to. Brought licensing and patient access. The Secretary should encourage federal agencies within the Department of Health and Human Services to undertake the following actions. A, federal agencies should promote wider adoption of the principles reflected in the best practices. And OECD guidelines but the guards limited use, is this redundant?

And become a federal agencies should encourage wider use of the nine-point to consider licensing university technology point [Indiscernible] for example the explanatory text and appointed recognizes that licenses should not hinder the clinical research professional education and training. Is a public health authorities and the invalidation of the results or Quality verification. The question would be as I read these again, these are redundant.

Pulled into the previous one.

Yes. All right. So the motion is to fold this into the rhythmic condition or to fold into the discussion that refers to the recommendation?

Into the discussion.

Okay good. The consensus if people agree is pulled this verbiage into the report discussion of rec three. Bucket. All right, are people okay with that? I don't think we need an actual vote on that. Federal efforts, this is continued and that it's going to be the same thing. Federal agencies should explore whether approaches to address and bend [Indiscernible], this is a little different. This might be a separate recommendation. To explore patent tickets, and pools, clubhouses, and cross licensing agreements to facilitate the development of multiplex test our whole GM -- [Indiscernible]

Will recreate this group that's explain that this is a really important issue I think we need to explore in much greater detail so this would be one more thing I would pass that group to explicitly explore.

The suggestion that is to fold this into the report. Where we discuss the body, the advisory body, right? Okay. People okay with that? I like the fact we are making this simpler. All right. Licensing policies governing federally funded research to facilitate access. This is now a shift in a totally different issue. Because it is unclear whether the [Indiscernible] Act gives agencies authorities to influence how grantees license patented inventions, the Secretary should seek clarification about this legal question. If it is determined that such authority exists, the Secretary should promulgate regulations that enable the department's agencies to limit the ability of Christie's to exclusively license and vengeance resulting from government funding when they are licensed for the genetic diagnostic field of use. Exceptions to also be allowed if a grantee can show that an exclusive license is more appropriate in a particular case. For example, because of high cost of developing the test. The Secretary should also directed NIH to make compliance with NIH best practices that are licensing of economic events is an important consideration in future grants awards. The me see, there was something. And the question was should the below sentence from this recommendation be deleted, a modified form of this in? And that is that last sentence. Spent the last sentence relates to what will talk about in terms of its bond and options. That should go in to report relevant to I think that's recommendation three.

I agree. I did what Mark is saying that this should be inserted into the report. Where we discuss recommendation three. And this stands on its own as a recommendation that basically calls for a clarification of the legal questions. Does that make sense?

Okay.

I want to make sure I'm clear. And terms of clarification of legal questions, we have discussed earlier this is what you said Mark folding the rest of that into the earlier or are you still--

I was referring to the last sentence. I think as I was listening to this again, we are sort of prison main and [Audio interference] condition that we think we know there are defined and here are some things it could come I would basically limit the recommendation to say seek clarification on this and you could put a dent in the text of the report, here are some of the specific issues that are coming up that we need clarification about. I don't think we need to clutch of the recommendation person with all the rest of it.

You are saying take this and pulled into the report as well?

I would disagree because I don't think otherwise that language is premature before we have [Indiscernible].

That make sense. All right. Seven and I had a question on the last sentence. Because again that's directive in the sense that the committee stating that there should happen with regard to making the best practices and condition related to grant awarded. As it goes into other three would be something that's explored.--

I'm sorry, I was be occupied. Said that against the.

The sentence that Mark suggested be moved under recommendation three about with the Committee states that they should direct NIH to make the plans at the Best practices related to consideration for future credit which without having more conditional under recommendations three where there's the actual recommendation is to explore the authorities there possible. The strong statement would not be there.

As a condition of that. Discussion, right? In recommendation three. Of recommendation three. Is w are saying? The right, I think there's a question to be asked and answered whether or not that authority exists.

Man ask you cannot also put it under as part of what's left of the recommendation? Is one of the issues you whether and at age or Secretary has authority to?

I think is related to clarify.

It is. It would say here.

I'm not sure because this is really a Zionist and its related to the we're suggestion we explore whether this should be an element that would be part of the grant radio and scoring process in terms of, that's how I read this and if that's the case, that's not [Indiscernible]? ?

I think the question is as vital to allow her to use that information, right? And if so, we are saying is then she should direct the NIH to make compliance with it and condition of granting. I do think this probably belongs in the discussion of this recommendation.

Okay.

It's relevant to both recommendations. It will depend on the answers and one explanatory is under a recommendation three and the analysis of a vital.

Isn't this the first part of this of No. 7 by the most over a team thing for was No. 3?

That's the question I was wondering to. In some sense as with the ordering of the recommendations that this may precede because that may well define what is within purview and what isn't.

I think this comes after three because three had the as the possibility of affecting interact with Fundy's so they might affect more people than--

We could discuss this. And pointing you probably can't see that. We could discuss this in relation to this but we could also emphasize its relevance to three. And put them together. Put three and current seven adjacent. I don't want to make a mistake. All right. Are people okay with this? This then would be the recommendation because it is unclear whether they [Indiscernible] it is a disease [Indiscernible] pended in benches. [Indiscernible] and report, we would discuss this issue of using that authority to influence the funding decisions as we discussed this recommendation and then we would take this information where we discussed recommendation three about promulgating regulations that enable the Department agencies to limit the ability and grantees.

All right, all in favor?

All right. I know we have 60. Of by. Let's keep going and then we will go back. If think we are in the last leg but we are really not. We have to go back one more. Providing needed expertise [Indiscernible] this is something we asked the USPTO representative about. As I recall, the comment was we would take all the advice we can get. I don't want to put words in their mouth. But I don't want to overstep bounds is typical idea what to say, I don't want to force an advisory kind of board on USPTO if they don't want or need. But that was not my sense from the task force. To get that out there. This says the Secretary should recommend advise the USPTO as well the book is that this advisory committee to provide advice about scientific and technological the development and it to genetic test and technologies that may form its examination of that applications in the realm of human genes. The committee believes experts in the field should help USPTO and its development of guidelines on the terminations of non of business and subject matter of eligibility and the filled once pending courtesans says Boesky [Indiscernible] are decided.

It seems to me this would be able that could be defined under that previous group.

Yes.

I thought this group [Participant's audio is faint/unclear]. It's the scientific advice do we want to give the PTO rather than stakeholders kind of advice.

That's a good point.

Maybe we want to do that other thing.

Because we are talking about scientific and technological development.

Maybe a bigger role would make sense.

[Participant's audio is faint/unclear]. I'm confused. [Indiscernible] advise the USPTO.

I know.

At the technology office. I'm wondering if that already exists. I was at a National Academy given and we explored this commission who gives advice to the PTO. And Senate at that time they really would like more advise then they get. That they are left on their own quiet. But that was about seven is for finding out about more scientific information rather than information about the economic value of patents and things like that. If you think about a broader committee it would be about economic [Indiscernible] and spend the overall system of [Indiscernible]. That's not what I know the PTO wants this it wants more actual science who understand where the technology is right now. How much this new advanced really is different from something that fits mat could have done. How broad is the technology, how broad is the claim, [Participant's audio is faint/unclear]

It seems like the can certainly ask the White house for that kind of information and focus for the SPT. I'm wondering and terms of recommending to another Secretary do something. I'm thinking is there a possible way to alert to existing resources and suggest this be drawn upon or expand OS beauty is current in that.

It's smart science policy, right?

My initial reaction as we were discussing in the task force was to their really want to advise, as we queried the USPTO it didn't seem to be the case. This did same to my surprise as something that would be welcomed.

Do we want them to establish an advisory committee? Or do we want them to take heed of these issues that we've raised? And change that policy? This I think actually is not designed to change pending policy. This one. We have a once in there that are. But this 1 I think is saying look, it's a rapidly moving filled but technologically and legally, it would be who've the Secretary argued everybody of that office had some technical experts that --

We are not the only field that has this issue.

That's what I said when we were discussing this and to my surprise, it sounds like Rishel KISAM action, the USPTO is we will take that. The surprise me and I don't put words in the mouth, but I understand your reaction. I had the same reaction. It sounds like, what we can say we could use glans recommendation. We could leave the looser and say an advisory body.

Maybe this should be something where USPTO and the science advisers are all with this inter-departmental would ever we decided to call their earlier group and then everyone is talking to everyone. Creating a lot of independent bodies. Which is as active over the.

That's interesting. The only issue with that is as of Rishel points out, the intent of this was to try to really talk down on the technical issues in this rapidly changing field in light of things like, the [Indiscernible] technical issue. Is it obvious to a person burst in the art. So the only problem with pulling this into that previous body is that that has all the membership of policy people and we are talking here about science.

Part of the problem with the PTO is for each new signs they need new advisers. You can have a standing committee that's going to help the. Because the net science, the next new thing we have no net of technologist. Even though her nose when nanotechnology could do for genetics. So they really need an of people that will help point them to the right people to ask about new things. Because if they just choose somebody, they could choose the right person for the wrong person. Somebody is the caller tells them to choose somebody. You always wonder whether it's the right person. It's a neutral advisory committee to help them fear it out. It's more along the lines of what I was thinking about. The way I have listed with a one.

[Participant's audio is faint/unclear]

Advisory Committee to provide advice. [Laughter]. I think what we'd like to say is perhaps establish a body of a scientist or technical experts to provide advice about scientific [Participant's audio is faint/unclear].

You don't want a standing committee.

Of is going to suggest additional it, that this sector to explore a liaison relationship of this committee with the pattern office. On issues related to genetic technology. And then see where that goes.

I like to explore because I think there's enough uncertainty around the table here they will not sure we want to say you have to do this. Call me out here. Something like [Indiscernible] to explorer the establishment--

[Participant's audio is faint/unclear]

Now you're going to say may correspond.

We already have a representative, Michael [Indiscernible] is from the Department of Commerce. He sits on this committee.

Between this committee and [Overlapping speakers]

It could be more specific. We could leave that to the Secretary and Pat and office.

What if we say the Secretary and the Secretary of Commerce should explore, can we say that?

Torino out often -- Do we know how often?

[Participant's audio is faint/unclear]

Think about this, the USPTO is running these tenants on gene sequences long after sequencing was a really [Indiscernible]. There were still granted them up to last year when the Federal Circuit finally said maybe not. That's the kind of a problem. At the same time as our committee is doing this, there's also committee exploring how much the PTO should be [Indiscernible] by the Federal Circuit so that when the PTO something is obvious from the Federal Circuit with then pretty much have to say unless there's some clear reason to think it's wrong, we're going with the PTO decision. That kind of thing happens fairly often. Technology, nobody is saying, but a minute, everything in the field is changed. There's now 10,000 machines that do all of this automatically. The don't need that seeing any more. That's the advantage of the continuing relationship I like that liaison IDEA.

As the liaison right.

[Laughter]

What about this. During the that the. Let me get, the Secretary should explore with the Secretary of Commerce because that's necessary because of the USPTO liaison relationship between this committee and the USPTO. Which would provide advice about scientific and technological developments related to genetic test and technologies the main form its examination of that applications in the realm of human genes. The committee believes experts in the field to help USPTO and his development of guidelines and determinations lot of business and [Indiscernible] once pending court decisions.

We are not a scientific technical by.

[Participant's audio is faint/unclear] recommended advisers.

Okay. You are saying that this committee would recommend advisers?

Yes.

So forget the liaison?

No, that's the. Spent identify [Overlapping speakers]

Would provide advise and recommend [Overlapping speakers]

And recommend technical advisers -- I'm using it here. And recommend technical advisers who would provide -- Say what?

I think we are wondering year.

I know.

[Participant's audio is faint/unclear]

Would provide input about scientific and technical until the moment -- Okay.

You can take the second sentence out.

Yes.

And this might go in the report. Yes, okay. In the report discussion. Okay. What we've got at this point is Secretary should explore with the Secretary of Commerce and liaison relationship between this committee and USPTO which would provide advise and recommend technical advisers who provide input about scientific and technological developments related to genetic test and technologies that may inform its examination of pen applications. It could use a little tweeting. We could tweak this sort doesn't sound like William Faulkner on drugs. [Laughter]. In the report we would discuss some of those things.

Do we have approval for this?

Everybody is thinking they're never going to get dinner of the don't approve.

Sixty is the last one. We really are about the. Somehow I space this out. Okay. Are we done with that? Is just 6 D.

All right. Federal agencies should provide more detailed guidance regarding the licensing of patents associated with genetic test. In particular, this guidance should encourage the use of terms and licensing agreements particularly those with exquisite increasing the number of ventures the reverse the [Indiscernible] and sensitivity examples of milestones that a license could be required to meet or to earn to maintain license rep go with this is saying is that there should be more evidence about the kinds of milestones that need to be adhered to.

Does this rise to a level of recommendation?

What about the recommendation that Sheila started with about ways of getting funding for sole source [Participant's audio is faint/unclear]

I'm reading this the from link increasing the number of insurers the reimbursed to test, whose responsibility was that? Is that a mouse and for a company?

That came up with discussions that, but Mary had it was done. They been able to steadily increase the number of payers.

I think everyone but it would like to have more pairs.

[Indiscernible]

Related different on the other side.

We don't have a reimbursement recommendation and that seems to be to meet the biggest? Of this report.

I would say two things. One is that this specific recommendation isn't specific enough to with the Secretary can and can't do and includes things that I think the Secretary lily does not have. Federal agencies dealing federal agencies would be the ones that are actually under Department of Health and Human services.

Which would mean CMS.

[Overlapping speakers]

I think the other issue is the report week issued under reimbursement, there's no reason why we couldn't include language as we have done in other instances that says we have addressed a number of issues relating to reimbursement and genetic test. The pending issues that are outlined in this report are another impediment to this but an overall solution to reimbursement reflecting these previous recommendations and that is still needed.

Is it directed the whole patient access issue?

It seems like a lot of this report talks about reimbursement [Coughing] challenges reimbursement on patient access. I don't see that we--

Pares, is not fully read it. I think I'm a vaccinated against, I'm not sure. The issue from a the pair perspective as they would not equate reimbursement with axes but there was a patient always have the ability to access services if they're willing to pay out of pocket. And refers to issues of health and equity and then you say, yes we understand the health care system is inequitable in the way it's currently configured is it our job to solve all the problems of the health care system for other specific issues here that are very narrow that do in fact impact access and reimbursement. [Overlapping speakers]

I didn't bring is a because I didn't want to muddy the waters but the reality is with Medicaid is that each state defines its benefits but this did you talk the benefit package says we do not of a genetic test. It's not a contract in issue.

And many states it is.

I'm just saying we shouldn't delude ourselves into thinking that somehow the Secretary can do something in the Medicaid system that was glad to fix it but the at the point I'd make is while Marietta has in some ways solve the Medicare problem with a soft it was when a very unique way. They're located in your time and went to the Medicare carrier for the state of Utah and that carrier issued a local medical decision that cover that testing. And what they have told every other Medicare carrier is that because we are located in Utah, then this is covered by all Medicare.

I think also what was on their side was it became more and more clinically useful.

I'm not is a grain but I'm saying that the mechanism by which that reimbursement was accomplished was basically by playing some of day little funny issues about how Medicare is administered by the state level. So then, to presume that somehow this happen because of a national [Indiscernible] is delusional.

We have to get back to six the. The question is is there a role for a recommendation? That there is a need for more detailed guidance regarding licensing of patents. About terms and licensing agreements, etc. If so, does that rise to the level of a recommendation? Or should this be basically a part of the report?

It seems to me this is one more part of exploration of what can we do around this and it is the guidance needed. In some ways it does this reflect a general exploration of this that we reference to the other recommendation three or whatever? I'm not seeing anything necessarily unique or new year.

It's kind of my feeling. My feeling is that this is not too different from the previous recommendation. That it could be folded into the discussion of that recommendation.

Recommendation seven where you're asking for clarification around [Indiscernible] licensing terms it can do, so we don't even know yet whether or not the can before word [Overlapping speakers]

In fact, what that leads me to fill like is that perhaps this should be folded into the report where we discuss recommendations seven.

Right.

How do people feel about that?

All right. Right. Yes. [Laughter]

Exactly.

All right. First I will speak, Mark did a beautiful job in representing 80-point of publishers but I think there's a fundamental issue here that the needs to get dressed and that is that if these tests so source or other become very expensive and they're not covered as benefits, that it's important for us to recognize do we of and access issue. And while coverage decisions are based on science and on clinical results, I think it would be important somewhere to write in the review of what these tests are being offered to communities to citizens and I think you can do that without trying to mandate what insurers or Medicaid or Medicare would cover.

[Overlapping speakers]

Give me some morning. What would you say?

I think one would want to look in these genetic tests are proven of clinical merit. We would want to be sure that they are provided broadly and in the insurance policies and Medicaid and Medicare as payers. I think one of the debates can be that people can write out preventive services and they can ride out just as we talk about. And the glut to be sure that that's not occurring in the [Indiscernible] report ability.

[Indiscernible] to insure that they are included--

And Benedict coverages [Indiscernible] this could be reviewed--

Government appears.

The other thing which reference is an our letter to the Secretary regarding the reimbursement issues to update the report and highlight new issues but one of the things we did specifically talk about was the opening of the Medicare national coverage decision and a Medicare advisory committee to evidence based assessment and so some reference St. We've mentioned genetics in this context before. And this would be another place where this could be, again reinforcing what was said in numerous other situations.

Okay. Can we add a piece here that I had mentioned earlier which is streamlining the process for diagnostics to be able providers to be able provide free testing, but testing available -- Free testing for lack of a better word right now. And simplify and streamline the process because right now, as I've heard from physicians and all sorts of institutions, it is considered a kickback, can do it and as you described earlier, it's a very cumbersome process today that need to be streamlined so companies have the ability.

What we are advising the secretaries to do? Well with the recommendation the?

The recommendation in the same context of this on reimbursement is to consider to explore, understand and streamline the process.

[Overlapping speakers]

What if in this discussion in the report we put genetic test [Indiscernible] the important to entered the clinic manifested to provide government told [Indiscernible] and when not covered that the mechanisms for providing--

You can include in their their review the role of the mechanisms--

Examine the barriers, right? Met its not only one issue [Overlapping speakers]

It's something that has become more of an issue critically and this was to of the letters that came in to say there's been criticism directly your saying they're too expensive. One of the ways to deal with taxes is to allow this to happen. [Overlapping speakers]

Could you write something that did go in the report that -- I'm not sure how to do that.

[Overlapping speakers]

There's a number of different pieces that will add to this but it has to do with stark and start to and passed to do with some of the statutory things. Within Medicaid that say his or you cannot can do. And terms of discounting [Laughter]

It sounds like a lot -- The thing I wonder about is is it at all unique to genetic testing? It sounds like a very overarching thing and not sure--

Several of our recommendations are not unique because we talked about genetic [Indiscernible] three days ago.

[Overlapping speakers]

Its relevance to the reimbursement fees.

It's related to the sole sourcing issue?

I use it as is also an issue because it's often used as an example as was also suspended a but it's relevant more broadly and haven't indigent patient and have a test want it done.

[Overlapping speakers]

I would describe it more broadly and I know patient advocates would not call it charity care. It's for people for whom for what ever reason with their insured or not do not have access to the task. And for the companies and laboratories, academic, university and otherwise to have a streamlined process to do it. And to make people aware of what that process is because unanimously, the all complain about that.

Source test is one area but it's a test of $500 that everyone grabs and can afford. It doesn't have to be sole source.

[Indiscernible] streamlining the mechanism by which labs divided by companies can provide testing when not covered.

I think it's just Laboratories, as a matter where they are.

Paul from Stanford. The last two issues relate to a more generic equity issues. I've kept my mouth shipper demands of a because somebody focuses on disparity reduction, I was content with the conversation focusing specifically on that nation's. The fact we are bringing in more generic issues diminishes the equity arguments because it makes it a peripheral clause within a subcategory on one of the less exciting recommendations. [Laughter]. If we are going to include this, which I think it would be fine, then I would suggest that in the recommendation a preamble that says this is merely one component of this committee's concern was set of recommendations for ensuring equity in the provision of genetically related test and services in their piece. And we would remind the Secretary that earlier reports like the reimbursement Report and other components of equity issues have come up in prior things that have not been acted upon, are also relevant to this conversation begum and then an appendix or someplace list the recommendations that came through a relatively recent reports that address the issue of inequitable provisions. Because otherwise my concern is that we are really peripheral of raising the issue merely by putting it in this small type of a general suggestion would be to have an intro or preamble--

We need to go back and rework the wording of a recommendation.

Not the recommendation of the setup of the recommendation to ensure that the content for this report and its recommendations is really part of a much larger commitment and from this committee to a possible prison of relevant test and services. And preference if you will, the other relevant accommodations from prior reports speaks to this issue.

Okay. I think the hour is late. Thing [Indiscernible] has a busy evening. The want to say something?

Because of my newness to the committee and clearly this has been a five-year journey that you have led so many of our colleagues on and congratulations. I would have been building and largely with you, but having said that, at the very beginning there was some really substantive issues. It seems to me that a minority of the committee and what we heard from public comment are strong views and they are not want to abuse, 180-degree view points better different. I guess the question I have since these are complex legal issues that are going to be determined in many ways perhaps in court, is there room in past deliberations by this group for in the body facing it, the minority almost representation that say his concern is that it exists because I think what voices have been heard, referred a little bit about balanced. We've heard about the evidence, case studies but the evidence not as strong as we'd like to go I wonder if that's something that would happen.

This is probably a very long discussion. My feeling is this, we don't issue minority reports and is committed. We hash things out, or try to produce as balanced and if the report as possible that includes a freeze issues. I am not in favor of some kind of minority report that then dilutes what we have had a hard fought battle to achieve and is a son and I would say have done so with relatively decent proportion of the committee that endorses these things the vote no, I'm not.

[Overlapping speakers]

I think what we can do, the report can talk about some of the challenges and [Overlapping speakers]

I think we do. I've been told on numerous occasions that this especially has brought balance, etc., I think the place for trying to discuss the controversy is is the report.

There's been a report before we you've not had a unanimous agreement.

Yes.

Which one? I don't remember.

[Overlapping speakers]

Oversight was clearly not a unanimous report.

I thought in the and there were no notes.

-- No votes.

I understand that. Perhaps it's in writing the final document to include some of those issues in a more direct way. I'm very sensitive to that and we will do that.

All of the comments and all of the written public comments that they're all available in the public record and all associated with the report. We all recognize that not everybody--

That's the way it goes. I think we have accommodated bibbers viewpoints. We have had an extraordinarily open deliberation process. We have had abundant public comments. And we've had time for discussion. And I think that you can't make everybody happy. And I think you dilute the purpose of the report if you now start issuing alternate minority report.

I have to disagree with that. I don't think at least what I heard them say is not alt and minority reports. In any way, shape or form, because the vast majority of the information and the discussion is there. And I was part of many of the import of the team was [Indiscernible] it. I think there's a couple things. One is to acknowledge the dissenting views.

I think we do that in the report.

I don't see that in the report today. I didn't see in this summer's last April and made a comment earlier that I didn't see the summer is like today to the represent the breath of view from the public comment. In addition to some factual changes which are relatively small on the piece of it. I think we need to acknowledge that to ensure that that is represented because while all of this is public, it's not going to get out and people are not blind to read the 101st letter or even the first letter.

I certainly think we can look at the report to try to make sure again as we've done the whole process through to make sure that minority opinions are represented. But they are a minority opinion and I do not think that we should delay approval of this entire report--

I'm going to step in because I'm not hearing people say that we should delay approval of the report or recommendation but what I'm hearing is some people do not feel that some of the perspectives are represented as well as they might be. Not that they need to carry today we fat the discussion but as we go through and finalize the report, that we make sure that some of these [Indiscernible] are cleared and Inc. I would ask those of you who hold those minority reports to provide us the specific places where you think they don't come out so they can have it. Because at the end of the day, we do what people to collect their voice has been heard and are recognized. I would ask you to please help us with that. Because I know Jim to the best of visibility has listen to this committee to try and do that. But if it is not coming through clearly, please help us do that is specific way so we can move it.

I appreciate that.

[Overlapping speakers]

This also gives a very convoluted because the insertion of certain statements can and then change the entire thrust of the report which then makes the recommendation paradoxical. We have to be very careful.

That's what Colt is majority opinion. You see with the logic a given we think about it. [Indiscernible] this pages and pages.

Without making the report a disjointed and self contradictory entity, that's fine.

I think we can do that and I hope we can.

It's think therefore having a separate is a better way?

No. [Overlapping speakers]

In the notes at the bottom the committee to know of other opinions. There are ways we can do that.

Right, these were discussions we had a task force meetings over and over.

I recognize it was [Indiscernible], an acknowledged at the beginning it wasn't a discussion, the final report if anything is one of the public comments made had hardened in a position that had fewer broader issues to discuss because some is strikes me that critics and criticism will be needed if in fact the issues are shared.

I completely agree and I would maintain and I've had a lot of feedback, that it is balanced. If we can achieve greater balance, that's great. I'm all for a. But I just don't want to get the report or is essentially start over.

I read this with fresh supplies. Not the five years of intense [Indiscernible]. I think it's a it's extremely well done. This clearly, the the with the vote has come down on the recommendations. But I think from what I've heard from the public comment and what as I read it, I thought there could be [Indiscernible] case study method, not to signs there could be a reflection of other viewpoints in it not been getting at all the impact of the final discussion.

We are being told we must leave because they're using this room for another function tonight. It would? Those going to the dinner tonight it's at 62:00. We in the lobby as 16:00, we can give a revision we can look at my -- Look at tomorrow. We're going to come back and review the draft we had and finally take everything with the -- With you.

And we will meet everybody at 8:00 in the morning.

Thanks all.