§ Dr. GibsonTo ask the Secretary of State for Health (1) what the licensing and vetting procedures are for new genetic tests to be sold directly to the public; [44758]
(2) what mechanisms have been put into place to ensure that claims made by manufacturers of currently licensed genetic tests have scientific and medical validity; [44762]
(3) what the procedures are for approving and regulating genetic testing services. [44763]
§ Yvette CooperThe "in vitro" diagnostic medical device (IVD) regulations (SI2000 No. 1315) ensure that IVDs that have a specific medical purpose meet relevant essential safety, quality and performance requirements before being placed on the market with a CE mark. The regulations came into force on 7 June 2000 with a transition period until December 2003. During this time, manufacturers may choose on which basis to place their device on the market. The regulations require that manufacturers of IVDs bearing the CE mark must be able to demonstrate that the device will achieve the manufacturer's claimed performance.
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.
781WMinisters have asked HGC to conduct a review of the provision of genetic tests offered directly to the public, and to report by the end of the year.
Accreditation for UK laboratories providing diagnostic testing for patients is voluntary. It is mostly overseen by Clinical Pathology Accreditation (UK) Ltd. (CPA). CPA standards are compatible with international standards (ISO). Laboratories registered with CPA are subject to on-site peer inspection to ensure compliance with these standards.
Laboratory accreditation is now part of the quality standards compiled by the Genetics Commissioning Advisory Group (GenCAG) and endorsed by the Joint Medical Genetics Committee of the Royal Colleges of Physicians and Pathologists and the British Society for Human Genetics. Commissioners and NHS trusts purchasing genetic testing services are recommended to purchase from accredited laboratories.
NHS Commissioners may evaluate new service developments before agreeing to fund them. As part of the national NHS genetic testing network, consideration is being given to mechanisms to evaluate genetic tests before being considered for NHS funding. There is further scope for evaluation through the Health Technology Assessment programme which produces research information on the clinical and cost-effectiveness and broader impact of health technologies including diagnostic techniques.
§ Dr. GibsonTo ask the Secretary of State for Health what his policy is on(a) access to counselling and advice services, (b) procedures for gaining informed consent and (c) protection of personal genetic information where genetic testing is being undertaken. [44759]
§ Yvette CooperPatients may seek advice from their General Practitioner, other health care workers or NHS Direct. Specialist NHS services for genetics are concentrated in Regional Genetic Centres (RGCs), to which patients may be referred as appropriate. Those receiving genetic tests as part of NHS clinical genetic services normally receive counselling and advice before and, where appropriate, after testing.
The Government response to the 3rd Report of the House of Commons Select Committee on Science and Technology 1994–5, stated that: 'The Government agrees with the Committee.. that people who seek diagnosis of a genetic condition of late onset, i.e in adult life, should be given adequate information about the medical and social implications of the findings and offered sufficient counselling, in advance of any testing, and subsequently if the result of a test is positive'.
The Secretary of State announced in January 2002 how part of the £30 million investment in genetics would be used to pump-prime additional capacity within existing genetics services. This will enable more people concerned about familial disease to receive advice, testing and counselling.
Patients have a fundamental legal and ethical right to determine what happens to their own bodies. Valid consent to treatment is therefore central to all forms of healthcare, from providing personal care to undertaking major surgery. Patients may indicate consent non-verbally 782W (for example by presenting their arm for their pulse to be taken), orally, or in writing. For the consent to be valid, the patient must: be competent to take the particular decision; have received sufficient information to take it; and not be acting under duress.
The Department has issued guidance on consent, and this should be consulted for advice on the current law and good practice requirements in seeking consent. This includes what to do when a patient lacks the capacity to give consent to an intervention. The relevant documents are available at "www.doh.gov.uk/consent". Health professionals should also be aware of any guidance on consent issued by their own regulatory bodies.
Genetic information, like most other patient information, is held in confidence by health professionals and is also subject to the requirements of Data Protection legislation. This means that, unless exceptional circumstances apply, individuals should be informed about how the information will be used and that the information should only be disclosed to a third party with the consent of the person to whom it refers.
The Department published a national confidentiality strategy for the NHS "("Building the Information Core: Protecting & Using Patient Information: A Strategy for the NHS")" in December 2001. The development of systems and processes to record and respect patient preferences including objections to disclosures is a key element of the strategy. In addition, the Human Genetics Commission (HGC) has been considering issues associated with the storage, protection and use of personal genetic information and will be reporting to Ministers later this spring.
§ Dr. GibsonTo ask the Secretary of State for Health when he plans to publish the planned Green Paper on genetics. [44760]
§ Yvette CooperWe plan to publish our Green Paper on genetics later this year.