The convention unique aims to simplify and accelerate the implementation of commercial clinical trials between private sponsors and French health care establishments by providing a simple and mandatory template reducing transaction costs. With this tool, the government hopes to increase France’s competitiveness in biomedical research.
While the convention unique had remained in the experimental stage for a few years, the 2016 National Heath Law enacted on January 6, 2016 compelled the set up of the convention unique for all new clinical trials started after November 17, 2016.
The convention unique is a mandatory template for agreements between health care establishments, care homes or health centres (“Health Care Institution”) and sponsors for the operation of commercial clinical trials involving humans.
The new convention unique system entered into force with the implementing decree of November 16, 2016. This mechanism derives from a former template created by an administrative instruction on June 17, 2014 that only applied to public Health Care Institutions.
While the new rules have clarified the scope and implementation mechanisms of the convention unique, certain aspects remain unclear, such as the notions of counterparties and eligible third parties and the convention unique’s interaction with public procurement rules.
The convention unique is entered into between the sponsor and the Health Care Institution. If the parties intend to compensate a third party (in the conditions described below), this third party must also sign the agreement.
If the research is conducted in multiple Health Care Institutions, each agreement must contain the same provisions relating to identification, billing and payment that the sponsor’s agreement contains.
The convention unique applies to all research involving therapeutic acts on human beings. It channels the financial flows related to the commercial clinical trials and is exclusive of any other agreement for pecuniary interest.
The sponsor must provide the products used for the clinical trial free of charge.
The sponsor must also bear the following costs:
- the defined costs incurred by the Health Care Institution generated by the implementation of the clinical trial which do not relate to the patient management (such as logistical, administrative or investigation costs, etc…); and
- the “extra costs” corresponding to all patient management costs entailed by the implementation of the clinical trial.
The ministerial order of November 16, 2016 provides the convention unique template and describes in detail how to calculate these costs.
In addition, the convention unique may provide for compensation related to the expected quality of the research data. This compensation may be either directly paid to the Health Care Institution or to a third party entity participating in the research that is not under the Health Care Institution’s legal representative’s authority provided that said third-party:
- is appointed by the Health Care Institution’s legal representative pursuant to public procurement law;
- has adequate governance to prevent from incurring any liability; and
- uses the compensation for research purposes.
This new mechanism permits the compensation of associations and supersedes the former inclusion incentive.
The convention unique shall be signed within 45 days after the Health Care Institution receives the sponsor's proposal. When the trial takes place in several sites, an additional 15 days period applies for any agreement with associated establishments. The target is ambitious but a recent survey shows that, despite the adoption of the convention unique, the implementation of clinical trials still takes too long.
Finally, it is important to bear in mind that the sponsor must transmit the convention unique after signature, for information purposes, to the National Council of Physicians (Conseil National de l'Ordre des Médecins, the “CNOM”).