The Scientist

3 March 2004

Crunch-time for EU directive

Researchers still worried that implementing clinical trial law will harm academic research | By Stephen Pincock

Even before Europe's new clinical trials directive (2001/20/EC) was signed into EU law, some research bodies were warning that it would have a devastating impact on academic clinical trials. Now, with just 2 months to go until the law is supposed to be enacted by member countries on May 1, groups like the European Organization for Research and Treatment of Cancer (EORTC) are still lobbying hard in the hope that something can be done to avoid what they see as a disaster in the making.

The aim of the directive is to make the regulation of clinical trials across the European Union uniform while protecting participants. The problems, as some researchers see them, lie in increased legal and financial burdens that the law imposes on the organizers of a trial.

These include strict reporting and monitoring rules, drug manufacturing for marketed drugs, fees to ethics committees and authorities, and increased administrative work. Variations in applying the directive from country to country could also swamp international studies in paperwork, researchers warn.

All this may be borne by a drug company, researchers say, but is financially impossible and in some cases unnecessary for “patient-focused” or academic studies.

The directive “could be one of the really, really big own goals of the commission,” said Brian Moulton, organizer of the Save European Science campaign. The problems with the directive strike at the heart of the European Union's aim of creating a dynamic research environment, he told The Scientist. “They've bureaucratized this process out of existence.”

In January, more than 2000 European researchers signed the campaign's petition calling for the directive to be either scrapped or amended. But at this point, it seems there is little chance that either of those things will happen. Instead, most attention is focused on the detailed guidance that countries use when putting the directive into action in local law.

In recent weeks, 837 members of EORTC signed an open letter projecting dire consequences from the directive. A review of trials that were recently closed, currently open, or about to be activated showed that a strict implementation of the directive would mean approximately 60% of all EORTC's drug trials would have failed to take place.

In the letter, the organization asked member states to consider putting in place national rules that resemble a compromise worked out among scientists, lawyers, and parliamentarians in Belgium, where the national proposal makes special provision for noncommercial trials.

European research bodies are already working with their national governments to find their own solutions. In the United Kingdom, for example, the Medical Research Council is leading a task force that is providing advice on the needs of researchers to the country's Medicines and Healthcare Products Regulatory Agency.

A spokesman for the UK's Department of Health told The Scientist that the various partners in a publicly funded project may be able to distribute the responsibilities of “sponsorship” of a trial. This has been one area of major concern for research not conducted by pharmaceutical companies.

“The intention is to make this possible,” he said. “Representations have been made to the EU Commission. We are optimistic that they understand the concerns that have been voiced about academic research. There are indications the commission are moving towards a more flexible approach that recognizes the way groups collaborate in public funded trials.”

While national governments work out ways to implement the directive sensibly, state representatives are also meeting in Brussels to finalize detailed guidelines for implementing the directive. For example, meetings are currently taking place on the collection, verification, and presentation of adverse reaction reports from clinical trials. The European Commission told The Scientist it expects to have revisions out by around Easter.

Among other issues, the guidance deals with the type of information that needs to be submitted for approval of clinical trials. There are indications from the commission that this may be lighter for public researchers compared to trials carried out by pharmaceutical companies. Commission working groups developing guidelines have representatives from all EU member states and observers from the 10 countries due to join this year.

“This broad international representation allowed the group to take account of the different practices in conducting clinical trials and to look for ways to move towards a more harmonized system that would facilitate improved cooperation between groups in different countries,” according to a spokesman for Britain's Medicines and Healthcare Products Regulatory agency, which has been involved in the process.

The guidelines are based mainly on the International Conference on Harmonisation guidelines that form the basis for developing new medicines in Japan, the United States, and Europe, he said.