ties, the Agency is charged with implementing the European Union’s IVDD, which encompasses genetic testing. Advisory bodies include the Genetic Testing Network and the Human Genetics Commission, which is the UK government’s main advisory body on genetics. In addition, the National Institute for Health and Clinical Excellence advises on the clinical utility and effectiveness of new medical products, including genetic tests.

The Genetic Testing Network evaluates tests for Mendelian diseases, according to the well-established gene dossier protocol. There currently is no analogous formal body for common diseases.

The Human Genetics Commission (HGC) began considering DTC genetic tests in the 2003 report Genes Direct. Among other recommendations, the report advised that genetic testing for Mendelian diseases should not be offered direct-to-consumer, but only in the traditional clinical setting and with adequate pre- and post-test counseling. The HGC produced an updated report More Genes Direct in 2007.⁴ The report determined that most genetic tests fall into the lowest of four risk categories and therefore do not require pre-market assessment of clinical validity or utility; self-certification is sufficient. The Commission has recently revisited its assessment and has now recommended that genetic testing should be classified as medium-risk. The European Union’s IVDD still considers genetic testing to be low-risk, however, and the UK’s official position reflects the EU’s assessment.

The HGC held a seminar in 2008 with a wide range of stakeholders, including some DTC genetic testing companies. One of the conclusions, strongly supported by the companies, was to develop a common international code of practice. In September 2009, the HGC released for comment a draft document, A Common Framework of Principles for Direct to Consumer Genetic Testing Services.⁵ The framework, which could form the basis of an international code of practice, included the principles: