PRESS RELEASE - May 23rd, 2016
Biotrial strongly contests Marisol Touraine’s statement and is astonished at the behavior of the IGAS
The medical research center in Rennes, Biotrial, was shocked to discover the Health Minister, Marisol Touraine’s, statements this morning.
Biotrial only received the General Inspectorate of Social Affairs’ (IGAS) final report at 10:30 am, this Monday, May 23rd, at the same time the press conference – which Biotrial was not invited to attend – was ending. This report had, however, been previously provided to the media on Sunday evening.
Regarding the plan of action required by the Social Affairs and Health Minister:
- The clinical research center, Biotrial, did not wait for the IGAS report and the Health Minister recommendations to make volunteer care improvement its utmost priority.
- A plan of action has already been put into place following exchanges with the French National Agency for the Safety of Medicines and Health Products (ANSM) and this for several months. In addition, the ANSM and the Regional Health Agency’s (ARS) recommendations were immediately put into place after the accident in January 2016.
Regarding the General Inspectorate of Social Affairs’ report:
- The clinical research center Biotrial, once again, contests the conclusions from the IGAS final report which, in order to stay consistent with the report that was hastily published in February, would not allow itself to include the input provided by Biotrial. The center deplores the methods, contrary to legal procedures, that were used to put together the report and that therefore remove all of its credibility:
o Non respect of the adversarial principle
o Non respect of the rights of the people interviewed
o Non mention of any possible conflicts of interest
- Biotrial will submit to the Health and Social Affairs Minister its plan of action, which is already in place, and for which it is surprising that she did not seek it out, nor even ask if it existed.
Biotrial deplores this situation, especially since it has always strictly respected the test protocol validated by the ANSM, and that it has been shown that it is the Portuguese Laboratory Bial’s compound, by it unexpected and unpredictable toxicity, which is at fault for the accident.
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BIOTRIAL is a private center for medical research licensed by the Ministry of Health (based in Rennes, with an International presence). It conducts Phase I clinical trials, i.e. for a first administration to humans, on behalf of laboratories and biotechnology companies.