Personal genetics, the European regulations maze and the way out

Personal genetics and regulations have been the subject of active debate for at least the last 10 years, since the first direct-to-consumer tests were sold in the UK by Sciona Inc. (CO, USA). Opinions range from prohibition to free-for-all and all the shades in between. However, there has been very little progress in formulating regulations and the situation in Europe is particularly confusing, making it difficult for the provider and the consumer alike. The regulations maze is likely to be one major reason why the growth and public uptake has been slow: it is hard for companies to know how to operate and equally hard for consumers to understand what tests are useful versus those of dubious quality. This article gives a brief overview of the current situation regarding what regulations exist and looks closely at the areas where more clarity is needed. These include, exactly what should be regulated? What is health-related data? Who can and who should be able to have access to personal genetics? We conclud...