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Patients and the European Parliament
Lobbying and the Biotechnology Directive
Scientific progress in biotechnology has resulted in existing intellectual property laws being asked to cope with situations that were only ideas in the fertile brains of science fiction writers when they were first enacted. As a consequence significant differences in interpretation of the criteria for patentability have emerged in the different Member States of the EU, making strategic planning difficult and impeding the development of bio-pharmaceuticals for the treatment of currently intractable or incurable diseases.
Nearly a decade ago the European Commission introduced the first attempt at harmonisation. This fell at the final hurdle when the European Parliament rejected the recommendation of the final conciliation process set up by the Maastricht Treaty. The need for harmonisation did not go away, so the Commission introduced a second, revised version, which sought to recognise the Parliament s concerns.
When the first version of the Directive was under consideration the debate over the 'pros' and 'cons' of biotechnology and the need for creation of a standard interpretation of intellectual property rights was, crudely, portrayed as a clash between industry interested in profits and the exploitation of science, and non-profit groups who wanted to claim the moral high ground by highlighting the dangers associated with exploiting scientific advance because of the incomplete nature of our current knowledge, and a heightened sensibility to the possible risks. This led to a polarisation of the debate and a lack of clarity about the potential that biotechnology has to benefit people, and to change our perceptions about health and disease.
In this debate, the voice of patient support groups was absent. It is not surprising that the significance of the issue passed many patient groups by. Most voluntary groups are concerned with rare disorders about which little is known. Most of their efforts (and their sparse resources) are devoted to supporting their member families, obtain the services and support for everyday needs, and to fund specific research, if they can, into their disease. The ramifications of European intellectual property law are, understandably, not often of immediate concern. Yet the hope for a cure is universal.
If scientific progress is to be developed into effective treatments, it will be necessary for patient groups to engage in the debate over patenting and appreciate the commercial incentive necessary to carry potentially interesting phenomenon through the process of clinical trials and product registration. Equally, it was important to protect possibly vulnerable groups from overweening blandishments of possibly unscrupulous interests. The inclusion in this second debate amongst MEPs of the patients' point of view provided a means whereby the focus of the debate could be shifted. Patients are a group who are, broadly, pro-biotech, realising its potential to lift the threat that currently incurable genetic diseases represent. The realisation that the ethical option might well be to use this new technology, rather than to do nothing, with the chance to alleviate potentially avoidable suffering, gave the Parliament the impetus to consider biotechnology in a positive light which was important for those who, hitherto, had perhaps been unhappy at the prospect of seeming to offer a 'carte blanche' to commercial interests.
Yet patient groups did not simply accept the Commission's proposals. Nor did they unquestioningly accept the arguments of the commercial sector. Instead they sought to introduce safeguards that would both promote investment and prohibit exploitation. Patient groups lobbied for a more explicit definition of the circumstances under which gene sequences could be patentable; with tighter specifications of the industrial and commercial applications in the patent applications. They also lobbied for the creation of an ethical committee and for enhanced protection for embryos and for animals used in research.
The Parliament was subject to intense lobbying from all quarters during the period leading up to the first plenary vote, both for and against the proposals and the amendments agreed by the Legal Affairs committee. Fortunately, the views and opinions of patients, and their desire to see biotechnology fulfill its potential, seems to strike a chord with MEPs and they voted overwhelmingly for amendments which will help to bring this about. Of course, there is still a long way to go before the legislative process is complete, and we must maintain the pressure if the legitimate hopes of families are to be met