MEDIA RELEASE - 5 February 2003

 HGA criticises genetic testing decision 

Human Genetics Alert (HGA;1) today criticised the decision of the Human Genetics Commission (HGC) not to recommend strict regulatory control over genetic testing.  Instead, the HGC made weak recommendations to a newly-formed regulatory agency which will have insufficient legal powers to regulate genetic tests.  The decision ignores mounting evidence in Britain and the US of the harm that can arise from the exploitative marketing of scientifically-unvalidated and unethical tests (2).  This evidence clearly points to the need for statutory regulation.

The HGC is proposing that the new Medicines and Healthcare Products Regulatory Agency (MHPRA) should harmonise regulation of genetic tests with that of medicines.  Although the agency will be able to prevent the marketing of tests which do not work, it will have no powers to prevent companies marketing tests whose value in predicting disease is contested.  It will not be able to compel companies to provide proper genetic counselling.  Neither will the new agency, which is a technical regulator, be equipped to deal with broader ethical and social issues that result from particular genetic tests, eg. prenatal screening tests.
HGA stresses that there is no need for over-the-counter marketing of genetic tests. Such tests should always be taken under medical supervision and should be accompanied by genetic counselling from qualified personnel. Tests should not be given until their clinical usefulness, as is the case with drugs, has been validated by a statutory regulator.
HGA's director, Dr David King, said: "The new proposals are an advance on the HGC's previous plan for industry self-regulation.  But it has failed to bite the necessary bullet of statutory regulation, and has simply passed the buck.  Despite the marketing of extremely dubious tests, like so many Government advisers before them, the HGC prefers to wait until we have a major problem before it does anything.  It is failing in its duty as the Government's watchdog, which is to protect the public."
For more information contact Dr David King, 020 7704 6100.

Notes for Editors

1. Human Genetics Alert is a non-profit watchdog group funded by a leading British charity. 
2. In the USA, where genetic tests are currently not regulated we have already seen:
  • Testing without requirements for counselling or consent[i],[ii].
  • The marketing of tests whose predictive value and medical utility is uncertain[iii],[iv].
  • Manipulative advertising[v]
  • Testing that abuses children's rights[vi]
  • Widespread availability of unethical tests, such as prenatal sex selection[vii]


[i]  Giardiello, F.M. et al 1997 New England Journal of Medicine 336 823-827.
[ii]  McGovern, M. et al 1999 Journal of the American Medical Association 287 835-840.
[iii]  Relkin, N. et al 1996 Annals of the New York Academy of Sciences 802 149-171.
[iv] Enhancing the Oversight of Genetic Tests: Recommendations of the SACGT 2000 Secretary's Advisory Committee on Genetic Testing.
[v] Chandros Hull S. and Prasad K. 2001 Hastings Centre Report 31 33-35.
[vi] Saltus R. 2000 Knight-Ridder/ Tribune Business and Market News March 27 2000
[vii] Sachs, S 2001 New York Times August 15th.
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