After months of work and more than 170 hearings, the interministerial Borne Mission yesterday presented its conclusions to the Ministers of Health and Prevention, Industry and Public Accounts.
For the record, the Borne Mission was launched on January 25, 2023 at the initiative of the Prime Minister with the aim of formulating proposals to the Government concerning the regulation and financing of health products (medicines and medical devices)[1].
The 170-page report is divided into three parts: a diagnosis of the difficulties posed by the current regulatory system, the mission’s 12 convictions for building a “New Deal”, and finally some 60 proposals.
Many of these concerns the pricing of health products. Some – developed below – aim to systematize the consideration of factors linked to the environment (measure D.2), or to quality of life and organizational impact (measure E.6). Others – to which we will return in the next few days – aim to adapt the conventional methods used by the French Economic Committee for Health Products (CEPS) to set the price of health products to today’s challenges, and to combat shortages.
Taking environmental criteria into account
Following The Shift Project think tank’s 2023 report, which highlighted the contribution of health products and their industry to greenhouse gas emissions[2], the Borne Mission recommends “developing the use of environmental criteria in setting health product prices“.
More specifically, it is proposed to entrust CEPS with an envelope of “Green Credits”, which would constitute a “pocket” of CSIS Crédits[3]. The grids to be drawn up with all stakeholders should include packaging and logistics considerations.
On the environmental front, the Borne Mission also recommends:
- in public and private hospital contracts, to amplify the requirements relating to Corporate Social Responsibility (CSR) criteria, and the environment in particular;
- in general, to use existing regulations and labels (notably European directives) to encourage transparency and corporate environmental responsibility, rather than creating new ones.
Better consideration of quality of life and organizational impact
The Borne Mission notes that, despite the encouraging positions taken by the French National Authority for Health (HAS) in recent years, improvements in patient quality of life and organizational impact are not taken into account, if at all, in the clinical evaluation of health products by the Transparency Commission (CT) and French National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). By domino effect, these factors are also not taken into account by CEPS in price negotiations.
To ensure that these factors are systematically taken into account, the Borne Mission recommends, in particular:
- for medicines: make organizational impact one of the criteria for added medical benefit (“ASMR”), as the CNEDiMTS does for medical devices;
- for medical devices, and particularly digital medical devices:
- modify the criteria for expected benefit (“SA”) and added expected benefit (“ASA”) to include a genuine focus on organizational innovation, centered on the quality of life of the patient and/or caregiver;
- to introduce post-registration data collection on quality of life.
In order to make progress on these issues, the Borne Mission is proposing the creation of a working group with the administrations, concerned, companies (through the LEEM and the SNITEM) and patient representatives, which would submit its conclusions by February 1, 2024 at the latest.
More than sixty other measures are described in the report submitted to the ministers, including a particular focus on the safeguard clause and the determination of the M amount. The ministers have assured us that the proposals put forward by the Borne Mission have already begun to serve as a basis for the preparation of the SSFB for 2024, which will be unveiled in the coming weeks. To be continued…!
[1] It is made up of six experts from the pharmaceutical industry, consulting firms, patient associations and public authorities.
[2] This weight is estimated at over 8.1% according to the April 2023 report “Decarbonizing healthcare for sustainable care”.
[3] This “pocket” would be financed by PIA/France 2030 funds dedicated to “green industry” (~5% of the €4 billion announced, i.e. €200 million).
