In its decision no. 2021-832 DC of December 16, 2021, the Constitutional Council ruled on the conformity with the Constitution of the provisions of Law no. 2021-1754 of December 23, 2021 on the financing of social security for 2022 (LFSS 2022). Published in the Journal official on December 24, 2021, the law came into force on December 25, 2021, unless otherwise provided.
With respect to health products, most of the provisions are not immediately applicable. Indeed, many implementation measures are expected, making the entry into force of the LFSS a real headache.
In order to facilitate the operational implementation of the LFSS 2022 for companies, we publish a timeline of the main measures that concern medicinal products and medical devices (MD).
Table 1: Medical device measures
| Article | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
26 |
Extension of the “safeguard clause” applicable to MD to MD benefiting from early reimbursement by the health insurance | YES | / |
36 |
Entry into the common law of the coverage of remote monitoring MD | NO | Decree in Council of State determining the conditions for setting packages and prices Decree setting the content of the declaration of activity that remote medical monitoring operators must submit to the ARS Decree defining the conditions for removal from the “remote monitoring” list Decree setting the date of entry into force (by July 1, 2022 at the latest) |
58 |
Creation of a new method for advance payment of digital medical devices and remote monitoring activities by the health insurance system | NO |
Decree in the Council of State setting out the conditions for assessing the conditions of assumption of responsibility, the rules for setting the amount of financial compensation defined by the ministers and the procedures for its payment |
59 |
Registration of MD on the so-called “intra-GHS” list conditional on a favorable evaluation by the national commission for the evaluation of MD (CNEDiMTS) (with the possibility of taking into account opinions already issued by the high health authority (HAS) if they are sufficiently recent) Possibility of listing MD on the “en sus” list by indication |
YES YES |
/ / |
60 |
Implementation of a system allowing the National Agency for the Safety of Medicines and Health Products (ANSM) to be informed of MD stock-outs | Provision declared contrary to the Constitution by the Constitutional Council in its decision n°2021-832 DC | No applicable |
65 |
Possibility for the economic committee for health products (CEPS) to take into account the industrial criterion in setting the responsibility tariff for MD | YES |
/ |
Table 2: Medicinal product measures
| Article | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
5 |
Lowered the tax rate on the wholesale sale of pharmaceutical specialties from 1.75% to 1.5% (applied retroactively to 2021) | YES |
/ |
26 |
Extension of the “safeguard clause” for medicines to early access and direct access medicines[1] | YES |
/ |
| 58 |
Clarification of the regime applicable to continuity of treatment initiated in the context of early access Clarification of the regime applicable to the advertising of early access or compassionate medicines Clarification of the framework for compassionate prescribing when implementing a research involving the human person Revision of the procedure for setting the price of medicinal products on the retrocession list following the transfer to the ANSM of the management of the list Introduction of a specific reimbursement method for advanced therapy medicinal products prepared on an ad hoc basis (flat-rate annual basis per patient) |
NO YES YES NO NO |
Decree setting the minimum period during which the operating laboratory must ensure continuity of treatment initiated in the context of early access Decree in the Council of State setting out the procedures for recovery of the financial penalty imposed in the event of non-compliance with the obligation of continuity of treatment / / Decree in Council of State determining the procedures and deadlines for setting the prices of retroceded medicinal products Decree in the Council of State setting out the terms and conditions of coverage |
59 |
Regularization of the coverage of medicinal products dispensed in combination in a non-standard indication and creation of a rebate mechanism | NO |
Order setting the progressive scale of discount rates, by turnover bracket |
61 |
Authorization to the pharmacy for internal use (PUI) of health establishments to manufacture themselves medicinal products that laboratories would no longer be able to supply. | NO |
Decree in Council of State defining the special hospital preparations made in authorized establishments |
| 62 |
Creation of a new experimental reimbursement method – direct access – which will allow the reimbursement of certain medicinal products as soon as the HAS has given its opinion | NO |
Decree in Council of State defining the terms of application of the measure Decree setting the minimum SMR level for direct access Decree setting the minimum ASMR level for direct access Order setting the progressive scale of discount rates, by sales bracket Decree setting the start date of the experiment (no later than July 1, 2022) |
| 64 | Possibility for the pharmacist to dispense a biosimilar medicinal product, by substitution of the prescribed biological medicinal product, under certain conditions | NO |
Order listing similar biological groups authorized for substitution by pharmacists |
| 65 | Possibility for the CEPS to take into account the industrial criterion in setting the sale price of medicines | YES |
/ |
| 67 | Financial penalty implemented by the health insurance funds in the event of non-compliance with the serialisation obligation (verification of the authenticity of the information written on the boxes of medicines) by pharmacists | Provision declared contrary to the Constitution by the Constitutional Council in its decision n°2021-832 DC | No applicable |
[1] We only deal with the “safeguard clause” here. For your information, other contributions are also modified by article 26 of the LFSS for 2022.
