The “Convention unique” is now an essential component of conducting commercial clinical research in France. Introduced by the Law on the Modernization of the French Healthcare System of January 26, 2016, to simplify contractual relationships between sponsors and healthcare facilities, it aims to accelerate the launch of studies while ensuring greater transparency regarding research-related costs.
What is a “Convention unique”?
The “Convention unique” is a contract entered into between the industrial sponsor of a research study and the healthcare facility where the study is conducted. The “Convention unique” serves as the reference document for all contractual and financial provisions related to a commercially oriented research study conducted in a healthcare facility, institution, or center.
In particular, its purpose is to define:
• the terms and conditions for conducting the research;
• the responsibilities of the various parties;
• the costs borne by the facility;
• the financial compensation paid by the sponsor;
• the terms for covering additional costs associated with the research.
When commercially oriented research involving human subjects takes place in a healthcare facility, institution, or center, it draws upon the expertise and resources of that facility or coordinated practice setting for its implementation. This generates costs and additional expenses for the facility, which bills them—as a service—to the industry sponsor of the research.
This agreement is unique because it brings together, for a single research site, the industry sponsor, the healthcare facility, home, or center, and, where applicable, a third-party entity receiving compensation. It is intended to be used identically by all French healthcare facilities, homes, and centers participating in the same research involving human subjects.
The principle is to establish a harmonized contractual framework that limits the need for specific negotiations at each research center, thereby enhancing France’s appeal for clinical research by reducing the time required to launch studies. The “Convention unique” thus replaces the multiple contracts that could previously be entered into among the various parties involved in conducting the study.
What types of research are covered?
The “Convention unique” must be used for commercial research falling under:
• Article L.1121-1(1) of the Public Health Code (RIPH 1);
• Article L.1121-1(2) of the Public Health Code (RIPH 2).
Clinical trials involving drugs, medical devices, or other health products may therefore be subject to this requirement provided they fall within these categories and are conducted in a healthcare facility.
Conversely, non-interventional research (RIPH 3) generally does not fall within the scope of the “Convention unique”. This distinction must be identified as early as the project design phase in order to establish the appropriate contractual framework.
What regulatory changes are expected in 2024?
The framework governing “Convention uniques” was updated in 2024; on August 1, 2024, the Ministry of Health published an information note regarding the use of the “Convention unique” for commercial research involving human subjects. In July 2025, a list of frequently asked questions (FAQ) regarding the use of the “Convention unique” was also published.
The information note details the use of the new agreement template provided for in the decree of July 29, 2024, and provides clarifications regarding:
• the scope of application of the “Convention unique”;
• the methods for calculating and billing costs;
• the management of research-related cost overruns;
• relationships between sponsors, investigators, and healthcare facilities.
These developments reflect the authorities’ commitment to further harmonize practices while addressing the challenges faced on the ground by healthcare facilities and sponsors.
What are the main challenges for pharmaceutical companies?
Anticipating implementation timelines
Even within a harmonized framework, contract negotiation remains a critical step in launching a study.
Early identification of research sites, cost assessment, and preparation of contractual documents are key factors in minimizing delays.
Managing financial aspects
Determining research costs is often one of the most sensitive points in negotiations. Sponsors must ensure that:
• the requested services are properly identified;
• additional costs are justified;
• the budget remains consistent with the overall clinical development strategy.
Ensuring regulatory compliance
Classifying the research and identifying the applicable contractual framework requires a rigorous regulatory analysis. A misinterpretation can have a significant impact on the project timeline and the sponsor’s obligations.
Ensuring effective coordination among stakeholders
Clinical research departments, healthcare institutions, investigators, CROs, and sponsors are all involved simultaneously throughout the process. Smooth communication and a clear understanding of each party’s responsibilities are often key to success.
Conclusion
The “Convention unique” is a central component of conducting commercial research in French healthcare facilities. While its purpose is to simplify relationships between sponsors and facilities, its implementation requires a thorough understanding of the applicable regulatory framework and associated operational constraints. For pharmaceutical companies, anticipating these challenges as early as the study preparation phase can help reduce start-up delays and ensure the project proceeds smoothly.
Atessia assists you in understanding the regulatory requirements associated with “Convention unique” and clinical trials.
Article written by Emilie BADET, Legal Consultant specializing in Health Law