For immediate release Wednesday 5th February 2003
GeneWatch UK welcomed today's recognition by the Human Genetics Commission (HGC) that independent regulation of the genetic testing industry is needed. The HGC is planning to advise ministers that the new Medicines and Healthcare Products Agency develops a regulatory system for human genetic tests (1). The HGC today reversed its earlier proposals for industry 'self-regulation' of genetic tests following research it commissioned on the public's views.
"The HGC's proposals are a welcome step towards proper regulation of this industry," said Dr Helen Wallace, Deputy Director of GeneWatch. "Ministers must now act swiftly to put the necessary controls in place. Failure to regulate would be bad for health, bad for business, and potentially disastrous for public trust in human genetics."
Unregulated genetic tests are already being marketed in Britain via alternative healthcare practitioners. These tests claim to predict an individual's genetic risk of common diseases such as heart disease, asthma, osteoporosis and some cancers (2). Other genetic tests, marketed by UK company Sciona, claim to give genetically tailored dietary advice (3).
"We hope tough controls will follow this advice and stop the sale of these unethical and misleading tests," said Dr Wallace.
GeneWatch warned that as well as action by ministers, the next steps in implementing the regulations would be critical in determining the extent of the protection for the public.
GeneWatch is concerned about:
- the lack of an independent assessment of the claims made for genetic tests. Without such an assessment, many people will be misled about their health and conned into buying unnecessary medicines and supplements.
- the lack of a requirement for genetic tests to be administered by medical professionals. Without such a requirement, there is a danger that people will take genetic tests without understanding the implications of the tests or their results.
- the lack of an enforcement mechanism to prevent misleading or unethical genetic tests from being sold.
The new proposals address these concerns but will allow exceptions which have yet to be agreed.
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For further information contact:
Dr Helen Wallace: 07903 311584 (mobile)
GeneWatch UK Office: 01298-871898
Notes for editors:
- The report to ministers was discussed by the HGC today at their public meeting in London, 10.30am to 2pm, Wednesday 5th February. www.hgc.gov.uk. It is expected to be published in March.
- The tests, called "Genovations" are being marketed by the US company Great Smokies Diagnostics Laboratory (GSDL) via the UK company Health Interlink (See Observer article at www.observer.co.uk/uk_news/story/0,6903,877779,00.html and Genewatch briefing at www.genewatch.org/HumanGen/Tests/Genovations.rtf ).
- www.sciona.com. These tests were withdrawn from sale in the Body Shop after being criticised by leading scientists as meaningless and unethical.