HC Deb 10 May 2002 vol 385 cc403-4W
Dr. Murrison

To ask the Secretary of State for Health (1) what assessment he has made of the health consequences of the sale of genetic testing kits to the public; [54203]

(2) what plans he has to regulate the sale of genetic testing kits; [54205]

(3) what assessment has been made of the voluntary system of regulation for commercially available genetic testing kits. [54204]

Yvette Cooper

Genetic testing kits that are placed on the market and fall within the definition of an in vitro diagnostic medical device (IVD) will be regulated by the IVD Regulations (SI2000 No 1315) which came into force on 7 June 2000 and has a transition period until 7 December 2003.

The Department has published two voluntary codes of practice and guidance for genetic tests being sold directly to the public. These set out broad requirements in areas such as: peer-reviewed evidence of value, accreditation and quality assurance in testing laboratories, consent, confidentiality, sample and information storage, and customer information.

Under the "Code of Practice and Guidance on Human Genetic Testing Services Supplied Direct to the Public" (September 1997) suppliers notify the human genetics commission (HGC) of their proposed service and HGC publishes a statement of conformance with the Code.

In addition, those supplying genetic paternity testing services are expected to comply with the "Code of Practice and Guidance on Genetic Paternity Testing Services" (March 2001). All Government and public bodies commissioning paternity testing services are expected, so far as is practical, to ensure that those supplying services comply with this Code.

The HGC is the Government's strategic advisory body on how new developments in human genetics will impact on people and on health care, with a particular focus on social and ethical aspects. We have asked the HGC to conduct a thorough review of the whole issue of genetic testing services offered directly to the public, including the voluntary system of regulation, and to report with their recommendations by the end of this year.