Leaked documents reveal government and industry plans for NHS
A recent leak of documents from a Department of Health Advisory Panel on genetics has shown how Whitehall is working with industry to privatise genetic testing services and to turn the NHS into an 'R&D test bed for industry'.
The documents come from a panel advising the government on a forthcoming Green Paper on Genetics in the NHS. The panel is meeting in secret, in contrast to the Human Genetics Commission, the government's official advisors on human genetics policy, whose remit includes advising on NHS genetics services. In fact, the HGC is currently working on a report on the key ethical and social issues connected to personal genetic information, including its use in routine medical practice and research. It would thus appear that the government is attempting to marginalize the HGC from practical policy matters, because of the open way that it conducts its business. The HGC was also recently snubbed by the Human Fertilisation and Embryology Authority, over a decision involving genetic testing of embryos.
Some of the leaked documents, including papers by two biotechnology industry representatives, minutes of the panel's meeting, and a draft outline of the Green Paper have been posted on the website of the Genetic Engineering Network, at http://www.geneticsaction.org.uk/sellingUkDna/. The Network asked HGA to analyse the documents: our analysis is also posted at the same site. The main points of our analysis were:
Research in the NHS
There is increasing interest in human genetics in having access to thousands of samples, in order to compare genetic variations with medical history and lifestyle information. The aim is discover which genes cause predispositions to complex diseases such as asthma, heart disease, arthritis. The Medical Research Council and the Wellcome Trust have announced plans for a UK National Biobank, which will collect samples from 500,000 middle-aged people. According to the MRC, access by industry to the Biobank will be crucial to its success.
The Green Paper documents confirm suspicions that there are plans for a much larger enterprise, for which the Wellcome-MRC project may be just a pilot: the use of a national computerised system of NHS medical records by drug companies. The construction of such a national system, which has moved very slowly until now, partly because of fears about breaches of confidentiality, would be extremely expensive. Thus, for the government, one incentive for allowing industry access would be to recoup part of the cost by charging industry fees for access.
The paper by Crispin Kirkman of the BioIndustry Association (the trade association of biotechnology companies) envisages the large scale sale of NHS patient data and tissue samples to industry, and talks about competition between countries to be the preferred site for such research. According to Mr Kirkman, in order to succeed in this competition, and exploit the competitive advantage of the NHS record system, the UK should be talking to the drugs industry's working party on guidelines for genetics research, presumably in order to adapt its ethical guidelines to suit the convenience of industry.
Mr Kirkman is also concerned about the needs of UK companies versus foreign companies, and also to maximise benefit for 'UK plc', so that it does not become a 'third world genetics country'.
These proposals raise key issues about consent, confidentiality, regulation and compensation, which are especially sharp in the UK after the Alder Hey and related scandals.
On consent, it should be noted that if it becomes routine practice for hospital patients to be involved in research, it is difficult to believe they will be properly informed about the research they are giving consent to, or that their medical data and tissue samples will be sold to drugs companies, who may even patent genes based on the research.
The same confidentiality issues which have inhibited the development of an NHS electronic records system to date would seem heightened by the prospect of routine access by commercial companies and the special possibilities for discrimination that are raised by genetic information.
None of the papers mention the need for independent regulation or oversight of such research. In the UK, the only regulation that exists at present is the Research Ethics Committee system, which is under-resourced and not designed for studies on the scale envisaged. Mr Kirkman remarks that the system needs 'streamlining', a typical industry euphemism for de-regulation.
It is clear from many examples that genetics diagnostics companies tend to charge high prices for the use of genetic tests based on patented genes. There is no reason why the NHS should honour gene patents, since they are based on discoveries, rather than inventions. If the NHS does allow access to patients' samples, compensation should be based on fees for access, rather than royalty arrangements which depend on the uncertain commercial success of products derived from the research.
Privatisation and counselling
Another agenda that emerges from the papers is the privatisation of genetic testing services. Paul Debenham of University Diagnostics Ltd., a company which markets genetic tests envisages that the private sector will provide genetic testing for susceptibility to complex diseases, and pharmacogenetic tests (which determine which drugs will work best for a patient, and which will cause side effects), in some cases directly through pharmacies with no medical involvement at all. The direct marketing of genetic tests by biotechnology companies, is already well-advanced in the USA, with considerable harmful consequences, such as the marketing of unethical (eg. Sex selection) or unvalidated tests that may mislead patients and inadequate counselling.
The key issue is the provision of counselling. A massive expansion of genetic testing will be very expensive if the need for counselling to explain the results of tests is taken seriously. Those tests that the private sector is to supply are either to be given with little or no counselling, or the NHS may have to supply the counselling. In the latter case, the NHS will effectively subsidise the private sector, which will cream off the profits, without jeopardising the market for genetic tests by having to charge high prices for tests that include counselling.
In our view, counselling is an inherent part of genetic testing, which is an inherently public-service activity most suited to be done within the framework of the welfare state. Therefore, genetic testing should be done within the NHS. It should be properly funded: if the government seeks to expand genetic testing, it must not try to do so 'on the cheap' by minimising the provision of counselling. This will require extensive training of GPs and other non-geneticists, which will also be expensive. However, failure to do so will be disastrous for patients.
These leaked documents are very significant in revealing the shape of industry plans for restructuring the NHS, through genetic testing and research. Unfortunately, the lack of involvement of consumer and other public interest representatives has led to a predictable agenda, dominated by an emphasis on financial benefits for industry. It is vital that there is a vigorous response to this agenda, both before and after the publication of the Green Paper.