The regulation debate is very much polarised at the moment. At one end of the spectrum, some think there is no need for any specific regulation and, at the other end, some see strict regulation as the only option. CA feels that there are too many gaps in the current patchwork of regulation to ensure the proper consumer protection needed in this new and developing area. The current gaps increase the risk that these loopholes will be exploited.
Public interest should come above commercial gain in the supply of genetic tests direct to the public. All potential avenues for the provision of genetic testing services that fall outside of conventional medical systems of referral should be considered as direct-to-consumer and should be subject to the same kind of monitoring and control. We accept there are differences between the spectrum of tests that may be made available and the type of controls needed to safeguard consumer interest. However, there is currently no specific regulatory mechanism in place to assess the efficacy or reliability of genetic tests (whether for predictive, diagnostic or lifestyle purposes). Some form of oversight is a necessary first step. The situation might change in the future if, for example, less problematic tests with fewer implications are developed and made available to the public, but a means of identifying such tests should be put together in a transparent and open way.
CA recognises the civil liberties argument that an individual should have the right to know personal genetic information about themselves without restriction from the state. We do not want to impose needless restrictions on an individual's access to this information. Rather, it is important to ensure that proper safeguards are put in place. Failure to implement such safeguards could mean that companies alarm people with meaningless results or offer false reassurance at no small expense to the consumer's pocket.
It is important that strict rules governing genetic technologies keep up with developments. There is a need for an independent agency to monitor such developments. Specifically, the emergence of the over-the-counter sale of genetic tests needs to be closely monitored and controlled. There are a huge number of consumer issues that need to be addressed before such tests come on to the market. Implications for consent, confidentiality, protection, storage and use of personal genetic information all need to be considered. Consumers need protection from misleading claims and from the potential misuse of their genetic information. Methods of assessing the technical validity and clinical usefulness of the tests being marketed are needed.
Consumers must be properly informed of the risks and implications of taking a test to ensure that they are able to make informed decisions about whether to go through with it. This inevitably means that more work will be needed to determine the level of information required to enable an individual to make informed choices about testing. This is especially pertinent where many of the consequences or implications may be unknown at the time of testing. Providers must have arrangements in place to ensure that people who undergo testing have access to pre- and post-test counselling and advice services. Furthermore, full consent must be obtained for all uses of personal genetic information.
Nikki Ratcliff, Consumers' Association