Report of the mission "Financing and regulation of health products"

2023-08-29 14:40:26

THE issues of access to healthcare for our fellow citizens to guarantee patients the best treatments and an appropriate response to health needs, such as industrial and sovereignty issues of our health policy should lead us to a reflection on the evolution of the modes of regulation of the sector.

For several years, the Government has been deploying, in particular via the strategic committee for health industries and the plans France Recovery et France 2030strong measures to support our health industry, the dynamics of innovation and the relocation to France and Europe of the production of the most critical products, their active ingredients or their components.,

In a context of dynamic increase in expendituredriven in particular by the aging of the population and therapeutic progress, an unstable geopolitical environment and increased need to combat supply tensionsthe Prime Minister entrusted, at the end of January 2023, a mission to six qualified personalities.

This mission aimed toidentify possible ways to improve the health product financing and regulation system.

After more than six months of work during which the mission interviewed more than 170 personalities or organizations in a very broad manner and devoted a very significant amount of time to analysis and synthesis, the mission today submitted its report to the Minister of Health and Prevention Aurelien Rousseauto the Minister Delegate for Industry Roland Lescure as well as to the Minister Delegate for Public Accounts, Thomas Cazenave.

The ministers thanked all the members of the mission and underlined the quality of the work carried out. No report had previously studied the subject of health products from such a systemic and prospective angle by consulting the entire ecosystem.

This report, made public, contains a detailed diagnosis of the difficulties posed by the current regulatory system. It also makes a number of recommendations and of broad guidelines for reconciling access to care, industrial sovereignty issues and financial concerns for the sustainability of our social protection system, in a context where the growth momentum of the health products envelope remains strong, driven very strongly in particular by the arrival of innovative therapies. The mission thus emphasizes the necessary control of volumes through the commitment to proactive action, and calls for a new pact empowering all players in the health product value chain, in order to guarantee equal and sustainable access for patients to all health products.

The proposals formulated by the mission have already begun to serve as a basis for the preparation, by the Government, of the social security financing bill (PLFSS) for 2024, in particular in order to better control volumes, for example by increasing the use of rapid diagnostic orientation tests (TROD), to actively develop the use of biosimilars or even to facilitate applications for registration of innovative procedures by manufacturers with the High Authority for Health. In the coming weeks, specific proposals will thus be presented, which will complement the various actions already undertaken by France to support its health industry, improve patient access to innovations and encourage investment on our soil.

However, the extent of the structural changes proposed by the mission presupposes the commitment to a multi-year approach as well as the conduct of technical in-depth work on some of the orientations of the report. The ministers thus announced that the various State services concerned will be mobilized in the coming weeksin an interministerial approach, in order to take into account all the issues and work on the implementation of new policies, whether in terms of access to and support forinnovationof fight against shortagestaking into account environmental issuesof industry support and the strengthening of its investments in France, or even controlling the consumption of health products.

This work, which will be subject to regular monitoring under the aegis of the Prime Minister’s office, will make it possible to establish a new multi-annual and multi-party framework between the State and all stakeholders of the chain of production, supply and administration of health products.

The composition of the mission:

Agnes Audiermining engineer, France 2030 ambassador;
Claire BiotVice President of Healthcare Industry at Dassault Systèmes and Independent Director at Mauna Kea Technologies;
Frederic Colletpresident of the AI & cancer sector, France 2030 ambassador;
Anne-Aurélie Epis de Fleuriana company’s market access manager;
Magali TodayRenaloo Advocacy Officer, the voice of kidney patients;
Mathilde Lignot-Leloupadviser-master at the Court of Auditors.