To National Authority concerned with the European Directive 2001/20/EC - The implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Dear distinguished colleague,

I am a clinician involved in cancer treatment and research and I would like you to consider the implications of EU Directive 2001/20/EC and its incorporation into the national legislation and to act now to save the future of academic clinical research in Europe , before it is too late. Having experience of clinical trials in oncology and particularly of multi-centre international trials done by academic clinical research organizations, I believe that the EU Directive 2001/20/EC will seriously threat the academic research in Europe . This directive has been developed by the directorate general for enterprise of the European Commission which looks into competitiveness and free market in Europe . It should not have affected non commercial research but its impact into the real world has been largely underestimated.

The deadline for implementation and application of the directive is within few months, in May 2004. Many academic organizations will not be able to withstand with the impact of the Directive. Fortunately, the Directive leaves room for interpretation in some areas which gives the possibility for Member States to introduce clauses favourable to academic research.

The groundbreaking work of medical research organizations, such as the European Organization for Research and Treatment for Cancer (EORTC), is under grave threat due to dramatic changes in the rules and regulations governing clinical trial work that will come into effect following the implementation of the EU Directive. The EU Directive has made very little allowance for non-commercial, charitably funded clinical trials. It is clearly recognised that the clinical trial work undertaken by the non-commercial sector has led to significant public health benefits in the past. This has been particularly true for diseases such as cancer.

The guiding principle behind the Directive, to harmonise and increase the quality of clinical research across Europe , should be supported. But unfortunately, the EU Directive has been poorly thought through in key areas that will have a profound and damaging effect on non-commercial academic research which is vital to establish state of the art treatments for all patients with cancer . If the EU Directive is implemented in the way as laid out in the draft proposal then this will almost certainly derail a large number of high quality potentially life saving studies.

The national legislation should foresee special conditions for Academic non-commercial research to facilitate clinical research which aims at answering important public health questions. The legislation should foresee simplified procedures and conditions for using marketed drugs and the legislation should also ensure that clinical trials without medicinal products are not left apart.

I appeal to you to look carefully at this issue before it becomes irrevocably incorporated into national Law, and to do whatever you can to save our capacity of excellence for the benefit of all our patients.

Thank you for your cooperation

Yours sincerely