Update on genetic non-discrimination legislation

10 August 2009

The Genetic Information Non-discrimination Act (GINA) was made a federal law across the US just over a year ago (see previous news). It prevents insurers from refusing to provide health insurance to healthy people on the sole basis of genetic predisposition to a disease, based on the results of a genetic test or a family history of a particular disease. It also prevents employers from requesting or using genetic information in the process of employment, promotion or dismissal of staff.
A recent commentary in the journal Nature Medicine highlights some of the gaps in this legislation [Wadman M. (2009) Nat Med 15(8):826]. Kathy Hudson, Director of the Genetics and Public Policy Center of Johns Hopkins University, said that "while GINA did lots of good things, there are other areas that have been left unattended." In particular, whilst health insurance is covered, long-term care insurance, disability insurance and life insurance are not addressed by GINA. As a result, numerous states are starting to adopt legislation to address this issue.
On a related note, Eurogentest has recently posted an unofficial English translation of the Human Genetic Examination Act (Genetic Diagnosis Act - GenDG), which was passed by the Bundesrat in Germany earlier this year (see previous news). This law, which has still to be enacted, relates to ‘genetic examinations’ and is much broader than GINA in the US. In addition to insurance and employment issues relating to discrimination, it also covers storage and destruction of both samples and data, provision for genetic counselling, and informed consent. It also states that genetic tests may only be conducted by medical doctors, thus essentially banning direct-to-consumer tests. Finally, it defines criminal penalties for anyone who violates the law, which range from fines of up to EURO 300,000 to prison time in certain circumstances.
Comment: At the core of both of these laws lies the concept that ‘genetic’ information is somehow importantly different from other information, and requires special protection. However, because nearly every human trait is in part determined by our genes, which interact with our external environment in a highly complex and unpredictable manner, the term ‘genetic’ is very difficult to adequately define. For example, GINA explicitly excludes sex from constituting genetic information, which is an almost entirely genetic trait that depends upon the inheritance of the X and Y chromosomes. Moreover, we all have some genetic predispositions – of varying magnitude and importance – to some diseases, and deriving the contribution of an individual’s genes versus their environment is near impossible for most diseases.
Since every individual is genetically distinct, it is always possible to discriminate between individuals based on genetic differences; the question, therefore, is when does such discrimination represent the unfair treatment of individuals? The principal of ‘actuarial fairness’ commonly used by insurance companies is based upon individual risk prediction specifically for the purpose of discriminating between people based on numerous risk factors, and offering premiums based on the predicted risk groupings. In the UK (and previously the US), insurers regularly use family history to inform their risk prediction, along with numerous other risk factors, which is a practice that has gone relatively uncontested for years. Similarly, the process by which employers select a future employee from a group of applicants explicitly involves discriminating between individuals based upon merit, which itself is not unrelated to either genetics or family history.
From this perspective, with respect to both the US and German laws, it is rather unclear why ‘genetic’ information has been singled out as requiring exceptional treatment versus other kinds of health-related information. In reality, the results from numerous other health-related tests may be much more predictive of disease than many genetic tests (e.g. blood glucose), and some are much more sensitive and have greater implications for family members (e.g. HIV status). Perhaps, instead of taking a blanket regulatory approach to preventing unfair discrimination based on the rather indistinct term ‘genetic’, criteria such as the clinical validity and utility of the test (be it diagnostic or predictive) and the personal sensitivity of the information would be more appropriate and effective.

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