The Genetic Alliance, a coalition of advocacy groups organized on behalf of individuals living with genetic disease, held a press conference on 1 April 2004 to call on the US House of Representatives to pass the Genetic Information Nondiscrimination Act (GINA). The bill, which would ban discrimination in health insurance and employment based on the results of genetic tests, passed in the Senate last year by a unanimous vote and has the support of the Bush administration, a key advisory committee and at least 230 members of the House.
Since that time, GINA has not been on the agendas of any House committees or on those of the offices of the Speaker and of the House Majority Leader. According to US Representative Louise M. Slaughter, who has led the campaign to pass legislation banning genetic discrimination since 1995, “Most people do not even realize that their employers and insurers can gather genetic information about them without their knowledge and then use it to fire them or deny coverage. Although there is a patchwork of federal and state laws that provide protection for some people, federal legislation is needed to provide strong protections for every American.”
In some ways, there is less than meets the eye in the debate over GINA. The Health Insurance Portability and Accountability Act already outlaws the use of genetic information to discriminate against individuals in group health insurance plans, which constitute a large majority of the insured in the US. As for those who have individual policies underwritten by insurers, there is no evidence of widespread denial of coverage or increases in premiums in response to genetic predisposition to disease. In fact, the health insurance industry's opposition to GINA stems largely from this point—that the bill is unnecessary and irrelevant. Convincing evidence of employment discrimination is also hard to come by.
The most compelling argument in favor of GINA is based on the credible evidence that large numbers of people are reluctant to undergo genetic testing, even to discover information that would help them more effectively manage their own health, because of concerns that insurance companies will use it to deny coverage. Public perception is by no means the best reason to enact federal legislation, but given the promise of genetic medicine, it would be painful indeed to squander the benefits of genetic diagnostics and treatment because of such fears.
Perhaps the best reason for passing GINA quickly is that it would prompt US policymakers to think about the much larger issues that confront us. Some of the proponents of GINA argue for one version or another of 'genetic exceptionalism', the idea that there is something fundamental that distinguishes genetic information from other medical information. They contend that because genetic data merely imply predisposition to disease in otherwise healthy people, it would be unjust to take it into account. But this description often fits nongenetic information as well. Indeed, the economic realities of the private health insurance industry in the US demand that insurance companies account for the greater risk of disease in some individuals, even if such a decision is based on factors, genetic or not, whose relevance to the likely onset of disease is by no means certain. As genetic information is integrated into medical practice, and the general public becomes accustomed to genetic technology, the weakness of genetic exceptionalism will become clear.
Therein lies the problem with a nondiscrimination law versus a moratorium (like the one restricting the use of predictive DNA-based tests in Germany until 2006). If the predictive power of genetic testing as it relates to common, complex disease is currently modest, that will not be the case forever. At some point each of us will no doubt be much better informed about our health risks. What then? Roberta M. Berry noted in a well-argued and prescient article titled “The Human Genome Project and the End of Insurance” that the viability of the health insurance industry depends on “a peculiarly delicate balance of knowledge and ignorance”. If individuals have more knowledge about their present and future health status than insurance companies do, they may succeed in getting 'bargain' coverage, with companies facing unpredicted claims that will drive up the price of premiums, resulting in lower-risk individuals taking their business elsewhere. On the other hand, Berry argues, if insurance companies require genetic test information, they will face the fact that, at the level of the whole genome, each of us is at risk for something. As a result, fewer people would be insurable. Either way, the industry would be forced to consolidate greatly, with uncertain consequences.
Eventually, of course, new treatments promise to make some of these concerns moot. Genetic testing has become an established clinical diagnostic tool that already has a measurable effect in improving health. One gauge of this progress is the fact that 26 US states currently mandate testing newborn babies for up to 35 inborn errors of metabolism by tandem mass spectrometry (MS/MS), a technology that readily allows many more tests to be added as they become clinically useful. But we find ourselves at a vulnerable moment. Genetic testing will reveal much of the potentially bad news encoded in our genomes, with the ability to intervene still on the horizon. It is therefore imperative that we do not allow genetic discrimination based on incomplete information to impede evaluation of the real risks and protections conferred by different genetic variants.
Some European countries are taking a promising 'fair limits' approach, which bans the use of genetic test information in insurance decisions up to a specified amount, but allows it beyond that threshold. Such an approach may preserve the necessary degree of risk discrimination in the system while maintaining a minimum level of coverage for everyone. But whether it would work without the safety net of a tax-funded state health and welfare provision is unclear. At the moment in the UK, there is just one test determined by the Genetics and Insurance Committee (GAIC) to be actuarially justified for rating purposes. The test, for Huntington disease, is used in applications for life insurance and voluntary private health insurance policies above £500,000 and £300,000, respectively.
The legislative language of GINA would establish a Genetic Nondiscrimination Study Commission in the US. Although it is unclear whether the commission will have a mandate similar to that of GAIC, it is to be hoped that the commission views the act that empowers it as merely the opening chapter in a complex and important debate.
We advocate medical treatment based on the best currently available genetic information. But we think there is a need to prevent discrimination by genotype in access to health care and in employment. Preventing even one attempt to deny coverage is a good aim, and the House should pass the bill.