The European Union Directive on clinical trials, will enter into force on 1 May 2004, however scientists from the public sector and medical charities have raised concerns about the future of publicly funded clinical trials in Europe.
The EU Directive 2001/20/EC, adopted on 4 April 2001, concerns "the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use".
However, there are concerns that it will actually impede and inhibit publicly funded clinical trials.
The directive defines a sponsor as "an individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial" and sets out the legal obligations of the sponsor. This applies to the industry context, but the non-commercial trials operate on a different basis.
For more information on this issue, you can read BMJ’s article ’Implementing the European clinical trials directive’.
