Member states pleased with proposal on clinical trials
By Ophélie Spanneut | Thursday 26 July 2012
Member state representatives reacted positively to the proposal for reform of clinical trials, published on 17 July, presented to them at a working group, on 24 July. The 15 or so diplomats who expressed their views praised the European Commission’s text.
In fact, the Commission could hardly have done worse than the existing directive, dating from 2001, which has provoked universal opposition. Patient associations, pharmaceutical laboratories and researchers criticised it for imposing a very burdensome regulatory framework, especially in terms of administrative formalities. Clinical research has declined in Europe (a 25% decrease in trials between 2007 and 2011) and relocated to emerging countries.
The draft regulation simplifies and harmonises procedures, makes a distinction between trials in terms of risks and imposes greater transparency (see
Europolitics4467 and 4468). Stakeholders reacted positively at the time of its publication, but the pharmaceutical industry is concerned about the feasibility of its application given the complex division of competences between the EU and national levels. Under the proposal, member states will still be responsible for organising the consultation of ethics committees. During the negotiations, in 2000, for adoption of the existing directive, Parliament and the Commission had to address the argument of subsidiarity advanced by member states.
The very long text contains more than 90 articles and it would be “too ambitious to think that the technical review can be completed under the Cyprus EU Presidency,” said a diplomatic source. The working group will meet again on 4 September and then in early October and early November to continue the technical discussions.