 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
The Potential for Discrimination in Health Insurance Based on Predictive Genetic Tests
Subcommittee on Commerce, Trade, and Consumer Protection
Dr. J. Craig Venter
Good afternoon. My name is Craig Venter. I am President and Chief Scientific Officer of Celera Genomics, headquartered in Rockville, MD with several additional locations in California. In June of 1998, the Applera Corporation and I launched Celera Genomics. Our goal was to build an information company to provide researchers in industry and academia with an integrated information and discovery system for genomic information available on a subscription basis. Today we are using that information and a massive effort to understand the products of our genes-proteins-to build a new kind of pharmaceutical company that will incorporate all this new information and new technologies for faster and cheaper drug-related discoveries. I am testifying on behalf of the Biotechnology Industry Organization (BIO). BIO represents almost 1000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products. Mr. Chairman and members of the Subcommittee, thank you for the opportunity to testify today about this critically important topic. We have all been dazzled over the past few years at the pace of scientific discovery. The mapping of the human genome and subsequent discoveries are just the beginning. Over the next several years, even more will become known about how our bodies develop, function, and change. This information will be enormously powerful. Armed with these data, scientists might soon be able to identify genetic causes of disease and learn about genetic factors affecting cellular development and function. Understanding the function of genes in key biological processes has become an important basis for creating new drugs and therapies. This information could, for example, tell us how and why certain diseases afflict certain people. It could also tell us why certain medications are safe and effective for some people, but cause adverse reactions or are ineffective for other people with the same diagnosis. This information could lead to the development of cures and treatments for diseases that affect tens of millions of Americans and their families. As you can see, Mr. Chairman, the future is indeed bright. Our nation is on the cusp of reaping the rewards from our significant investment in biomedical research. Using genetic information, biotech researchers will continue to learn about the causes and progression of disease and disability. Armed with this information, we can eventually conquer diseases and conditions that have plagued us for hundreds of years, indeed, for millennia. The results of this research is likely to be a more "personalized" or more "individualized" medical paradigm than exists today. Drugs and therapies are likely to be more targeted as we learn more about the impact and role of genes. BIO believes this paradigm will be extremely effective in improving the lives of millions of Americans and their families. Public fear and anxiety are obstacles to achieving this goal. Specifically, if the public believes that this system of individualized research and health care will lead to denial of health insurance or other benefits, they will not take advantage of what the new system could offer. The revolution that is at hand may not be realized because people are afraid to take part in it. That's why BIO supports federal legislation. The public must have confidence they can take advantage of technological developments without fear that the information gained from this technology will be used against them. For example, with the information individuals could get from genetic tests, they could take steps - such as improving their diet, avoiding certain drugs or foods, and getting preventive medical care - that are likely to improve their health. However, if individuals believe that this information will cost them their health insurance, they may not seek it. Mr. Chairman, we want to encourage people to get information about their health and take necessary steps to improve their lives. BIO supports national legislation to ensure that individuals' personal medical information, including genetic information, is safeguarded against misuse. That's why BIO strongly supported barring discrimination on the part of group health plans based on "genetic information" during congressional consideration of the Health Insurance Portability and Accountability Act (HIPAA). We view it as a moral duty - and good public policy - to assure the public that the great promise of biotechnology research will not be tarnished by abuses of this technology. We are proud of the fact that BIO worked effectively in 1996 to secure enactment of an amendment to HIPAA that provided these important protections against discrimination by health insurance companies based on "genetic information" about the individual. The protections against discrimination based on "genetic information" were not included in original House or Senate version of the legislation. The bills provided protections against discrimination based on "pre-existing conditions," but this was defined as a condition for which there had been a diagnosis and treatment. Adding "genetic discrimination" meant that individuals who take a predictive genetic test to determine if they will or are likely to manifest symptoms of a genetic-based disease are also protected. In fact, they have greater protections than individuals with pre-existing conditions (not being subjected to a waiting period for health benefits coverage). But HIPAA does not cover the individual insurance market. BIO would support expanding HIPAA's protections to this market. BIO has also consistently supported federal legislation - and now regulations - that create federal standards to protect the confidentiality of, and safeguard against misuse of, all personal medical information including genetic information. Genetic information is not different from other medical information. In fact, it is an integral part of medical information and cannot be separated from it. With the implementation of the HIPAA medical privacy regulations, individuals have much greater assurance that genetic information created and used in the health care context will not be disclosed to employers, insurance companies or other third parties without the specific authorization of the individual. This will go a long way toward helping individuals be confident that genetic information can be used and created within a confidential treatment relationship without fear that it can "leak" out into non-treatment settings. Protecting individuals from the misuse of this information-genetic discrimination-is complimentary to HIPAA regulations that make the information harder to get. As with most complex issues, however, as Congress debates protecting individuals from genetic discrimination, there are other critical issues to consider. Mr. Chairman, as you and your colleagues debate legislative proposals, BIO urges you to keep the following issues in mind: · Promote critical biomedical research· No price controls · Updated definitionsPromote Critical Biomedical ResearchAs noted, BIO believes that individuals' personal medical information must be safeguarded against misuse. While we must protect patients' rights, however, it is critical to allow important medical research to go forward. We are already beginning to see the results of biomedical research. As of today, 117 biotech products have helped a quarter billion people worldwide. Another 350 biotech medicines targeting more than 250 diseases are in late stage development. These products target unmet medical needs. Earlier in my testimony I highlighted the vast potential of genomic research to improve the lives of millions of Americans. This research will lead to medical breakthroughs in the years ahead resulting in many new drugs and therapies for citizens with serious illnesses. Mr. Chairman, BIO believes protecting patients and promoting critical research are mutually attainable goals. Federal policy must ensure the achievement of both. Health researchers often use and share health care information, including genetic information. Therefore, federal policy must not impose barriers to use of these data. Consequently, any federal proposal to prohibit genetic discrimination must be carefully written to ensure that research uses of information are not inhibited. No Price ControlsWhile it is important to prohibit insurers from denying access to individuals based on genetic tests, Congress should avoid regulating the price of insurance products. BIO would object to proposals that attempt to regulate the price of insurance by prohibiting the adjustment of premiums based on individuals'genetic information. BIO cannot support the bill's application to issues beyond access to insurance - the issue addressed by HIPAA. BIO opposes government intervention in pricing in this market as it does in the market for our companies' products. Update Definitions of Key TermsGenetics is a new and dynamic field. By legislating on genetic discrimination, Congress is charting new territory. Whatever action Congress takes will have large ramifications. Future regulations and legislation - at the federal and state levels - are likely to be based on this proposal. As Congress addresses this complex issue, therefore, it is essential that it draft legislation carefully define terms such as "genetic information." Unfortunately, many of the current proposals contain an overly broad definition of "genetic information." They typically define it as "information about genes, gene products, or inherited characteristics that may derive from an individual or a family member of the individual." According to this definition, virtually every piece of information on a hospital intake form or in a medical record -- from an individual's eye color to his or her cholesterol level -- would be considered "genetic information." Thus, legislating against the use of this information will impair virtually all research and treatment uses of medical information. While most of the proposals before Congress don't attach prohibitions to the use of "genetic information," they do contain this inappropriate definition. That is harmful because it has been used - and will likely continue to be used - by State legislatures as they act in this area. States have attempted to tie protections and regulations to this definition of genetic information. This could hurt research. Conclusion In sum, genetic information is extremely valuable. Armed with the information these technologies will provide, patients could make lifestyle and medical care choices that would have otherwise been unavailable. In addition, the knowledge gained by research used to develop new tests and the information gleaned from those tests will lead to new drugs and therapeutics to treat disease and maintain health. However, public anxiety could limit its potential. BIO has long supported federal legislation that will ensure that a person's individual medical information, including genetic information, cannot be misused. Consequently, BIO supports carefully drafted legislation prohibiting discrimination in health insurance based on genetic information. Thank you for the opportunity to testify today. I'll be happy to answer any questions you may have.
|
|||||||||||
|
