Dear Minister,
The attractiveness of clinical research in France is under threat.
France Biotech, AFCROs, le Club Phase 1 and the collective on the mandatory single contract supporting the petition started by Professors Montalescot and Renard and all the signatories of this letter call on the Government once again to take notice of the alarming state of this highly-strategic sector and to bring together at last the real driving forces behind clinical research in our country.
France today is seen less and less as a strategic location for pharmaceutical clinical development. This state of affairs is currently made worse by the accumulation of several factors:
- Ever-lengthening evaluation time, especially for the early phases, by the ANSM,
- for some months now, the strike action by many ethics committees. These bodies are essential to the smooth operation of clinical research. Their strike could block any new clinical study,
- The terms and conditions for the introduction of the 'Single Contract', which radically changes the organisation and working practices of French clinician-investigators.
At the same time, the introduction of the mandatory "Single Contract", without prior consultation of the investigators, endangers the forms of organisation of French clinicians, which were both flexible and efficient. The signatories of this letter demand that hospital clinicians, who are central players in high-quality clinical research, really be listened to.
The French actors in clinical research also deplore the inconsistency of the latest legislative developments which have deteriorated and complicated a system of management of clinical studies making it less readable and more dissuasive still.
The signatories of this letter alert the authorities to the immediate impact of these serious malfunctions that are already making it impossible to implement a significant number of clinical trials in France.
Much damage is being done in the short run:
- innovative treatment from an early stage will be ever less available to French patients,
- France will become unattractive despite the substantial financial efforts French citizens have made over many years to support medical research,
- French private companies, associations and groups as well as academic research centres will be weakened and even go to the wall.
- Hundreds of jobs are threatened in the short term; thousands in the medium term.
We alert the Government once again to the strategic importance of clinical research and call for a Forum on Clinical Research to be held with all parties concerned.
Yours faithfully,
Pierre-Olivier Goineau, President, France Biotech,
Denis Comet, President, Afcros,
Dr Jean-Louis Pinquier, President, Club Phase 1,
Jean-Marc Gandon, President and CEO, Groupe Biotrial,
Prof. Gilles Montalescot, Head of Cardiology, Institute of Cardiology, groupe Hospitalier Pitié Salpetrière,
Prof. Eric Renard, Coordinator of the Endocrinology, Diabetes and Nutrition Department, CHU de Montpellier, Hôpital Lapeyronie,
Prof. Jean-Charles Soria, Head of the Therapeutics and Early Trials Department at Gustave Roussy, Director, SIRIC Socrate,
Prof. Luc Taillandier, President, ANOCEF,
Prof. Eric Pujade Lauraine, Founder President, ARCAGY GINECO,
Prof. Aimery de Gramont, President, GERCOR,
Prof. Jean-Paul Fermand, President, IFM,
Prof. Gilles Salles, President LYSA and LYSARC.
