GeneWatch UK is warning that today's data-sharing review report contains recommendations which will allow information in people's electronic medical records and genetic information from their DNA to be handed over to the pharmaceutical and biotech industries for research without people's consent.
Today's report, co-authored by the Information Commissioner and Dr Mark Walport, Director of the Wellcome Trust recommends that a new fast-track procedure should be established to allow the Secretary of State to approve data-sharing without needing primary legislation, and proposes a new system of 'safe havens' to allow 'approved researchers' access to data that is linked to individuals for research (1).
"Without clear controls on commercial use, genetic databases linked to electronic medical records will be open to abuse", said Dr Helen Wallace, Director of GeneWatch UK. "People deserve the opportunity to think about what kind of companies they want to have access to this information, and whether controversial practices such as gene patenting should be allowed".
Attempts to identify individuals who are 'genetically susceptible' to common diseases are controversial because this is likely to lead to the 'marketing of fear', where people are persuaded to buy unnecessary medicines and supplements to supposedly prevent a predicted future illness. Genes are generally poor predictors of most people's future health, because social, environmental and lifestyle factors are usually much more important. A database of DNA data linked to electronic medical records could also become a backdoor forensic database.
The data-sharing review was led by Mark Walport of the Wellcome Trust, a leading funder of the controversial UK Biobank research project, which aims to link the electronic medical records of 500,000 people with their DNA. A national database linking NHS medical records with DNA was first proposed by scientists from the pharmaceutical company SmithKline Beecham (now GlaxoSmithKline) in 1999, as part of a proposed public-private partnership. UK Biobank was a pilot study for this plan (2). However, the project - which does seek participants' consent - is four years behind schedule and is now thought to be too small to give reliable statistical results. The Wellcome Trust has been actively involved in lobbying to gain access to data contained in electronic medical records without people's consent, despite undertaking research last year which found that people want to make decisions about research participation for themselves. The Trust is also involved in plans to link biobanks across Europe (3).
Human genes can be patented by commercial companies if they discover a link between a gene and a disease: this practice is legal but highly controversial. International guidelines under the Declaration of Helsinki state that people should be informed of any conflicts-of-interest before they decide whether to take part in medical research, but this will not be possible if research is done without consent.
For further information contact:
Dr Helen Wallace: 01298-24300 (office); 07903-311584 (mobile).
Notes for Editors
(1) Recommendation 8 and Recommendation 15. Thomas R and Walport M, Data-sharing Review Report. Available on: http://www.justice.gov.uk/reviews/datasharing-intro.htm
(2) GeneWatch UK's history of UK Biobank is available on: http://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/History_of_UK_Biobank.doc
(3) More details are available in GeneWatch UK's submission to the data-sharing review, available on:
Plans to link biobanks across Europe are already underway: see
Manchester awarded Euros5m in biobank funding (7th July 2008):