The new European Union directive on clinical trials was scheduled to be implemented in all member states by May 1. However, many countries have not fully integrated the directive into clinical practice, and several noncommercial research organizations and patient groups throughout Europe are increasingly voicing their concern for the future of academic clinical trials.
The directive, which was adopted in 2001, is supposed to simplify and harmonize clinical trials work by creating a single legal framework for drug trials in member states (see News, March 19, 2003, Vol. 95, No. 6, p. 427). But even some members of the European Commissionthe body where European directives are draftedare now unhappy with how the legislation has turned out.
The heart of the problem lies in the increased obligations that the directive imposes on the sponsor of a trialan individual or organization who must now take total legal and financial responsibility for the clinical trial. This responsibility will include paying for all drug and device costs (even the cost of routine noninvestigational aspects of the treatment) while patients are on study. For example, an academic sponsor, rather than the health service, would have to pay for all the drugs that a patient receives, including fully licensed drugs, if even one component of the treatment is experimental.
Possibility for Amendment
In April the Environment, Health, and Consumer Affairs Committee of the European Parliament asked the Commission to amend the directivean unprecedented move for a body that had only recently voted to accept the change in the law. The change in attitude was largely the result of a major campaigning effort that was coordinated by the Irish Clinical Oncology Group, based in Dublin, and the Brussels-based Breast International Group.
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Campaigning against the directive has also had an effect in a number of EU member states. In Germany, for example, the Federal Council did not pass an amendment to their basic medicines law that would have transposed the directive into national law. Instead, it has referred the amendment to the conciliation committee because of concerns that it would put Germany into an uncompetitive position. The bill transposing the directive into Portuguese national law has also been held up because of worries about the effect of its provisions.
Campaigners have pointed out that charities and academic groups simply cannot afford the financial burden that the requirements of the new law place on trial sponsors. One of the most contentious provisions of the directive concerns the requirement for products to be provided free of charge to patients by investigators. Additionally, the product has to be specially labeled, packaged, stored, and handledeven if it is a drug that has been in common use for years. All of this would put a heavy financial and administrative burden on noncommercial sponsors, opponents say.
Increasing Trial Costs
Academic researchers estimate that the new regulations will increase the cost of clinical trials by at least 30%, with no evidence that trial quality or personal safety will be improved. "The end result will be that academic researchers will be unable to conduct independent evaluations of drugs, and the only clinical studies in existence will be those run by the pharmaceutical industry," said Martine Piccart, M.D., of the Institut Jules Bordet, in Brussels, Belgium, and chair of the Breast International Group.
This forecast may in fact be a little too optimistic. There are rumors that many large pharmaceutical companies have halted all new investigator-led research while they wait and see exactly what effect the directive will have. Other companies are believed to be moving research out of the EU. To date, these tales are largely anecdotal, but such moves could have a broad impact if more companies follow suit.
According to Brian Moulton, M.D., one of the leaders of the Save European Research campaign, which has been calling for the repeal of the directive, there are many difficulties yet to come. "We know that there are many potential problems out there, and some have yet to be identified as the clinical trial process seems to have engaged a `park' position around Europe at the moment," said Moulton, who is chief executive officer of the Irish Clinical Oncology Research Group. "We have been told that this is due to concerns about the effect of the directive and to a reluctance to be a guinea pig in the new process. It will therefore be a little longer before we can quote specific examples, but we continue to be worried about the situation."
According to a statement from the Save European Research campaign, "If this directive had been introduced 40 years ago, many of the most critical advances in cancer treatment would not have been made.... The directive represents a solution which is not needed to a problem which does not exist."
Among the organizations supporting Save European Research in their concerns are the European Organization for Research and Treatment of Cancer (EORTC), Cancer Research U.K., the German Breast Group (GBG), and the International Society for Geriatric Oncology (SIOG).
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