5 December 2007
The Human Genetics Commission (HGC) has published More Genes Direct: A report on developments in the availability, marketing and regulation of genetic tests supplied direct to the public. This document builds upon the recommendations made in an earlier report Genes Direct which was published in 2003, the year after regulations implementing the In Vitro Diagnostic (IVD) Directive into UK law were enacted. These recommendations include developing an independent system of pre-market review to ensure that genetic tests offered direct to the public satisfy requirements for clinical validity and clinical utility, supported by a code of practice and appropriate educational initiatives.
At the time of the publication of Genes Direct, the HGC acknowledged that few genetic tests were being offered to the public. That situation has now changed. More Genes Direct (Appendix A) lists a range of tests that are currently offered ‘direct-to-public’ (via a non-medical intermediary) and ‘direct-to-consumer’ (without an intermediary between consumer and test provider). It also draws upon a meeting organised by the HGC in 2007 to make a series of consolidated recommendations. The HGC reiterates its call for a proportionate response, which falls short of an outright ban upon direct genetic tests (unlike other jurisdictions such as Switzerland and France, which have introduced statutory prohibition), concluding that most genetic tests that provide predictive health information should not be offered as direct genetic tests. However, it suggests that a pre-requisite for allowing such tests is to introduce a new offence of misuse of genetic information.
The HGC also presses for review of the classification system, which currently deems most genetic tests to be ‘low risk’, and for an alternative regulatory mechanism to be considered for lifestyle tests that currently fall outside the IVD directive. Because of the information that they are likely to yield, the HGC recommends that certain tests should only be made available via a health professional. For this category of tests, direct to public advertising should be restricted. Multiple stakeholders should be encouraged to develop a code of practice that takes account of guidance from the OECD and relevant international standards.
Comment: A proportionate regulatory approach, which takes account of both the seriousness and complexity of the information that a genetic test may yield, offers a pragmatic solution to the regulation of this complex area. However some commentators have questioned whether a methodology that builds upon genetic exceptionalism and additional regulation is the most effective strategy and that a better use of existing regulatory structures might suffice.