13 May 2005
A new report on intellectual property rights and genetics recommends that the Department of Health (DH) should recognise its pivotal position as both a provider and a recipient of intellectual property, and should adopt an active approach both to policy development in this area and to routine management of IPR issues. The report is the culmination of a two-year project commissioned by the DH through the Public Health Genetics Unit and undertaken by a project team from the University of Sheffield Institute for Biotechnological Law and Ethics, and Cambridge University's Intellectual Property Unit.
Specifically, the report recommends moving the argument on the patents issue away from what types of genetic material should be patentable, and towards implementing more robust criteria for granting patents, along the general lines suggested by a recent report from the Nuffield Council on Bioethics. The DH could influence this process by having mechanisms for making representations to the UK or European Patent Office to restrict the scope of particular patents, to challenge patent validity where it thinks this would be appropriate, and to prevent patent holders from abusing their monopoly rights. It should also encourage the negotiation of fair licensing agreements (both "licensing in" from other patent holders and "licensing out" its own inventions) and should work with other relevant Government departments, such as the Department of Trade and Industry, towards developing a shared policy framework for intellectual property rights in biotechnology and genetics. The DH should also support efforts to clarify the exemption from patent infringement that applies to research on patented inventions; this "research exception" is currently ill-defined and is particularly problematic in the area of clinical trials.
The report acknowledges issues of ethics and human rights that are raised by intellectual property rights, discusses these in outline and recommends that the DH supports initiatives by groups such as the Human Genetics Commission to tackle such issues as they arise.
Overall, the project team believes that, by taking a proactive stance on intellectual property rights issues and using its influence to ensure that policy is developed in a rational way, the DH can help to ensure that a balance is achieved between "just rewards for innovation and a fair price for health care".