Feature

No patent, no cure?

Britain’s support for a draft European directive allowing genetic patents should cause concern, says Sarah Sexton

A draft directive now wending its way through the institutions of the European Union would explicitly allow industrial patents to be taken out on living biological material – genes, the proteins that genes express, cells, organs and whole organisms – ‘even if it already occurred in nature’. A group of British scientists has pointed out that ‘if this principle had been applied in chemistry, the elements would have been patented’. If the directive becomes law, there will be significant implications for health care.

A patent gives the holder monopoly rights for 20 years to use an ‘invention’ for commercial gain. The patent holder can charge others for using the patented product or process and can demand a royalty on any commercial applications derived from it.

Pharmaceutical research is moving away from the symptomatic relief of illness towards the diagnosis, prevention and cure of genetic conditions. European pharmaceutical companies argue that, without explicit patents on genes, investors would be unwilling to invest the hundreds of millions of dollars required to develop new genetic products. Potentially beneficial discoveries would either not be made, they contend, or would languish in the laboratory. In effect, they claim: ‘No patents, no cures’.

This view is rejected by numerous groups with long experience of working with or representing those with genetically-inherited disorders – those who should have the most to gain from the medical advances that biotechnology potentially offers. Such groups argue that, far from promoting research, patenting genes will hinder scientific inquiry and slow medical progress.

The Regional Genetic Service of Central Manchester Healthcare NHS Trust is unequivocal: ‘If it is possible to patent a gene… a single biomedical company could completely control all future research and medical development, leading from the isolation of a specific gene. This would not foster research, it would kill it.’

Other researchers warn that patents promote secrecy prior to the granting of a patent, hindering the free exchange of ideas and information necessary for co-operative scientific effort.

US biochemist Arthur Kornberg of Stanford University, who has been associated with a variety of biotech companies for 25 years, points out that ‘biotech companies are not in business primarily to do research and to acquire knowledge for its own sake; rather they are in research to do business and to turn a profit. They possess neither the mandate nor the tradition to advance scholarship… Profit-driven ventures are more likely to promote secrecy to subvert academic units with patent agreements and joint ventures that demand exclusive access to discoveries.’

Paul Martin of the science policy research unit at the University of Sussex confirms that ‘the granting of a gene patent to a firm interested in the treatment of one disease has forced others to abandon well-established programmes developing the same protein for other disease indicators.’

Meanwhile, the UK Clinical Genetics Society, the Clinical Molecular Genetics Society, the Association of Clinical Cytogeneticists and the Genetic Nurses and Social Workers Association warn that ‘most gene isolation to date has been done by public sector institutions using government and charity funds, and greatly helped by the free interchange of materials and information which has up to now been the norm in the non-commercial sector, but which is threatened by the rise of gene patenting.’

British charities which have spent millions of pounds on research into cystic fibrosis and breast cancer face the prospect of paying royalties to American or Canadian research groups – even though the successful genetic ‘discoveries’ of the latter are built on the work of the whole research community and the goodwill and co-operation of the public. The gene for inherited breast cancer, for example, was only found with the help of other doctors and researchers – and indeed the numerous families with hereditary breast cancer who took part in a worldwide research programme. The programme was largely publicly funded.

Wendy Watson, founder of the Hereditary Breast Cancer Foundation and one of several women who have had a preventative mastectomy, believes that ‘nobody has the right to patent this kind of information, which was only found with the help of the many families who have suffered a case of hereditary cancer. It is morally wrong that any company should benefit from that kind of information.’

The US company Myriad Genetics has applied for a European patent on the breast cancer gene, BRCA1, as well as on all therapeutic and diagnostic applications resulting from knowledge of the gene. If the patent is granted, Myriad Genetics will be able to charge patients or the NHS every time a screening test is carried out. It currently costs the NHS £600 to screen for the two breast cancer genes which have been discovered and £30-35 for each subsequent test: in the US, Myriad Genetics charges $2,400 (£1,500) to screen for the genes and $500 (£300) for each subsequent test.

Manchester’s Regional Genetic Service warns that patenting genes could make ‘the possibility of genetic testing for disorders such as heart disease or breast cancer so prohibitively expensive it would be beyond the scope of the NHS.’

While some regulation in the EU of intellectual property rights as they relate to biotechnological products is certainly needed, significant and far-reaching legislation should not be rushed through without informed public debate and scrutiny of the developments in biotechnology, nor without independent substantive assessments of the environmental, social and economic impacts of the legislation.

This is an edited version of a briefing published by The Corner House. For a copy, send an A4 SAE to: The Corner House, PO Box 3137, Station Road, Sturminster Newton, Dorset DT10 1YJ.