The Borne Mission[1] recommends reforming certain aspects of healthcare product pricing. It proposes, for example, that new factors be taken into account when setting prices, such as the environment, quality of life and organizational impact (see our article of August 30, 2023).
The Mission also suggests reshaping the framework and procedures for negotiations with the French Economic Committee for Healthcare Products (“CEPS”) (measures E.10, E.11 and E.12).
Conventional “preference”
The Mission considers that the conventional policy is a path to be preserved and favored.
It therefore recommends that a preference be established in principle for settling, by conventional means (i.e. agreements between industry unions and the CEPS), all issues that are likely to fall within the scope of the framework agreement (Accord-Cadre). In other words, legislative intervention would only be envisaged if negotiations failed.
In addition, it calls for more dynamic and regular ministerial orientations letters (LOMs), with a new LOM as early as January 2024. It should be remembered that the LOM of August 17, 2016 is still applicable[2], whereas the French Social Security Code stipulates that these ministerial orientations are in principle annual….
Finally, it urges the signature of the framework agreement on medical devices – under negotiation since 2019! – in September and proposes the creation of another framework agreement dedicated to homecare services.
Pooling rebates by medicines group
Starting in 2024, the Borne Mission recommends the development of mutualized rebates[3] for certain groups of medicines.
Mutualized rebates aim to regulate spending on a group of healthcare products, generally sharing the same indication. A global discount mechanism is contractually defined between CEPS and various companies. The rebate is then distributed among manufacturers in proportion to sales of each product.
According to the Borne Mission, the healthcare product groups concerned by this mechanism will have to be defined by agreement between the French National Union of the Pharmaceuticals industry (LEEM) and the French Economic Committee for Healthcare Products (CEPS). However, the Mission already proposes the application of mutualized rebates for:
- therapeutic combinations
- price reduction plans for certain therapeutic classes
- the gradual introduction of competition between products regulated by different mechanisms
Towards Europe-wide price negotiation
The Borne Mission recommends experimenting with a price negotiation mechanism common to several European countries – such as Germany, Spain and the members of the “Beneluxa” initiative[4] – to ensure competitive prices while guaranteeing uninterrupted market supply.
This experiment would involve:
- as a priority, certain key innovative molecules (particularly for rare diseases, with treatments costing more than €20,000 per patient);
- in a second phase, if appropriate, mature products in situations of supply tensions.
According to the Mission, the list of proposed medicines and partner countries for this experiment should be proposed by February 1, 2024.
[1] 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 healthcare products (medicines and medical devices). It is made up of six experts from the pharmaceutical industry, consulting firms, patient associations and public authorities.
[2] It was very slightly amended by the LOMs of February 4, 2019 and February 19, 2021.
[3] Manufacturers of reimbursed medicinal products or medical devices may undertake to grant the French National Health Insurance Fund (CNAM) a discount on all or part of their sales of these products in France. CEPS may also impose such discounts on manufacturers.
[4] The Netherlands, Belgium, Luxembourg, Austria and Ireland have introduced a joint mechanism since 2015.
