France: Recent developments on clinical trials agreement

17 November 2015

Anne-Charlotte Le Bihan, Jean Baptiste Thienot

In 2013, clinical research was declared a priority for the French economy by the Government.

To this end, it entered into an agreement with the healthcare industry, in which the latter committed to accelerate and simplify the procedures for the implementation of clinical trials. The aim was to have clinical trial agreements executed within 45-60 days.

To achieve this goal, the system relied on an industry-approved form of clinical trial agreement (“contrat unique”).

The existing position under this system is that the use of contrat unique has been very strongly encouraged, particularly in terms of financial incentives for hospitals, but has not been mandatory.

This is about to change, as a result of a new bill called the Modernization of the Health System bill, adopted by the French Parliament on April 14, 2015.

Article 37 of the Modernization Of The Health System bill provides that the research agreement should be "in accordance with a standard agreement defined by a decree of the Minister for Health", i.e. the “contrat unique” form.

On 29 September 2015, the Senate validated Article 37 after having made slight amendments. Article 37 of the bill now provides that research associations can be party to the contrat unique together with the hospital and the promoter. This amendment addresses a concern which had been raised by French practitioners. Research associations should now be allowed to receive directly remuneration from the promoter corresponding to services rendered, as was the case before the introduction of the contrat unique under French law.

The bill also provides that a copy of the agreement must be transmitted for information to the Board of the Medical Association.

The text of the bill is not yet final: the next step is for the bill to be adopted by the joint Commission (“commission mixte paritaire”).

To be continued…