Article 51
Type of financing
Experimentation
Beneficiary
Medical device manufacturer
Context of use
Facility / City
Purpose of the program
Article 51, which stems from the 2018 Social Security Financing Act, aims to encourage, support, and accelerate the rollout of innovative experimental healthcare organizations based on novel financing models by waiving numerous general legal rules.
These experiments can be implemented in urban settings, hospitals, or the medical-social sector, and are designed to promote “care pathway-based pricing” approaches, thereby breaking down silos in the French healthcare system by encouraging cooperation among stakeholders.
Issue
A legal framework designed to pilot and fund innovative organizations that rely on innovative financing models promoting "pay-per-use" approaches.
Is this program right for my project?
Eligible projects must involve innovations related to the coordination of the healthcare pathway, the relevance and quality of health, social, or medical-social care, the organization of outpatient care, and access to care.
It does not allow for the testing of a technological device on its own and does not constitute early market access.
Type of funding
- Pricing, pay-as-you-go.
Source of funding
- National (funded through the FISS): Fund for Innovation in the Health System, managed by the CNAM and dedicated to funding exceptional services for regional and national projects, project engineering for national projects, and the evaluation of pilot programs (conducted by external service providers);
- Regional (funding via the FIR): Regional Intervention Fund, managed by the ARS, which covers seed funding and project engineering costs for regional projects under Article 51 (These are funds intended to cover non-recurring costs incurred during the “initial launch” of the pilot, which are not covered by exceptional services). Start-up funds are used to finance costs related to the project’s ramp-up phase, while engineering funds (CI) are used to finance additional costs related to the project’s setup and management).
Amount of funding
The amount of funding depends on each pilot project and must be detailed and justified in a funding plan (a financial table outlining all the project’s financial information). It is carefully reviewed by the Technical Committee on Health Innovation (CTIS).
Schedule / Frequency
Projects may be submitted on an ongoing basis via the relevant ARS platform or the Ministry of Solidarity and Health’s platform, depending on the geographical scope.
Type of carrier
- Collaborative project.
- The program is open to all stakeholders in the healthcare system:
- User associations, healthcare facilities (public or private), federations and unions, healthcare professionals, companies, home care professionals, supplementary organizations, or local governments may serve as project sponsors—there are no restrictions regarding the legal status of project sponsors.
Requirements
- Admissibility (purpose and necessity of deviating from general law)
- Innovative nature
- Feasibility
- Scalability for dissemination
- Value for money (efficiency)
How do I apply?
- Through the national submission platform for projects involving multiple regions.
- Via a regional submission platform for projects involving a single region.
See the list of regional contacts.
Find all the information you need to apply on the "You Have a Project" page.
Practical Guide
All the questions you need to ask yourself to properly address Article 51.
Who is the right person to contact?
- Regional Contacts
For regional projects, the ARS serve as the point of contact to help you develop your pilot program and support its implementation. The ARS approve regional projects.
The primary health insurance funds (CPAM) work closely with the ARS to support you in developing your project.
- National contacts
The Ministry of Solidarity and Health, and more specifically the National Support Team, oversees the "Article 51" program. Each project is assigned a liaison within the Ministry’s National Support Team, who serves as the primary point of contact for project leaders and is responsible for monitoring the review and implementation of the project. She serves as the liaison with the various ministry departments involved in the project.
An Article 51 team has been established within the National Health Insurance Fund (Cnam). It monitors the review and subsequent implementation of Article 51 projects.
I have an interregional project—who should I contact?
Interregional or national projects should be submitted to the national support team.
What are the steps to follow?
The first step is to submit a letter of intent (or preliminary terms of reference) to the relevant Regional Health Agency (ARS) (see the list of ARS email addresses) or to the Ministry of Solidarity and Health (RG-ART51@sante.gouv.fr), or via the dedicated submission platforms.
See the addresses of the platforms.
The letter of intent provides an initial description of the problem you have identified and the solution your project proposes. As discussions and work progress, it will evolve into a set of specifications.
The template for the letter of intent is available on the Ministry’s website.
Are you familiar with the Art 51 calls for proposals?
Calls for proposals (List of calls for proposals) and calls for expressions of interest (List of calls for expressions of interest) may be issued.
In response to calls for projects, stakeholders wishing to participate in the pilot program, based on defined specifications, complete the application form and submit it to the relevant authorities (most often, the Ministry and the relevant regional health agency—ARS).
The technical committee and the regional health agencies may issue a call for expressions of interest in order to collaboratively develop, with stakeholders on the ground, a draft set of specifications that best addresses concerns and takes existing constraints into account.
The draft specifications are then drafted by a working group comprising administrative staff and stakeholders from the health, medical-social, and social sectors, selected at the conclusion of the procedure.
How do I present my idea?
Check whether your idea is relevant:
- Feedback from healthcare professionals
- Analysis of practices in other regions or countries
- Review of available literature
- Patients’ healthcare journeys, particularly through better coordination among stakeholders
- The efficiency of the healthcare system
- Access to care—prevention, health, and medical-social services
Clearly define your issue
- What do you want to improve? What are the issues or bottlenecks that your pilot project addresses?
- Who are you targeting? Users, healthcare professionals?
- What value proposition do you want to implement?
How will you go about it?
- How does the current care system work? In what ways is it insufficient?
- Who can help you scale your solution?
- What kind of prototype can you offer?
- What are your next steps?
What are the key factors for success?
- Adopt a collaborative approach
- Propose a funding model that is as comprehensive and detailed as possible
- Anticipate the project evaluation and expected impacts
- Verify eligibility for an exemption