Europe, a regulatory nightmare for direct-to-consumer genetic testing?

Lawyers seem to like direct-to-consumer (DCT) genetic testing. On the Genomics Law Report blog, which I highly recommend, there were no fewer than 23 entries that mentioned or were relevant to DTC in 2011.

Although my interests rarely overlap with those of lawyers, this is an exception.

DTC genetic testing comes in many forms, such as carrier tests for genetic disease, ancestry tests, and nutrigenomic tests. At first glance it appears that consumers should be able to purchase these tests and gain information about themselves and their genomes in any way they like.

However, many DTC tests have not been validated by medical professionals. This means that in the best case quality cannot be assured, and in the worst case, that they could be bogus. Wrong test results could have a large impact, and therefore most experts call for more regulatory oversight of how and by whom these tests can be provided.

In the United States, although the regulatory position of DTC genetic testing varies between states, there is also relevant federal legislation, such as the Genetic Information Nondiscrimination Act.

Regulation of genetic testing in Europe. Source: Borry et al. 2012, European Journal of Human Genetics

Less so in Europe. In a recent publication in the European Journal of Human Genetics, Pascal Borry and coworkers discuss the regulatory framework in seven European countries.

DTC genetic testing is not an area that is directly legislated by EU. Instead, each country draws up its own laws, and there is hardly any harmonisation between them. The result is that in some countries, such as Belgium or the United Kingdom, there is hardly any regulation of DTC genetic testing, whilst in others, it is strongly regulated - sometimes to the extent that non-medical and non-research genetic testing is explicitly banned.

The result is that European companies providing DTC genetic testing would have a hard time taking advantage of the EU's common market.

Could this be a reason why there are no large European DTC genetic testing companies that I am aware of?