Inclusion on the list “en sus”: the importance of the place in the therapeutic strategy
As a reminder, only products whose added expected benefit (ASA, for medical devices) or added medical benefit (ASMR, for pharmaceutical…
LFSS 2025: When will the pharmaceutical products new measures be applicable?
In its decision no. 2025-875 DC issued on Friday, the Constitutional Council ruled on the conformity with the Constitution of the…
LFSS 2025: When will the medical devices new measures be applicable?
In its decision no. 2025-875 DC issued on Friday, the Constitutional Council ruled on the conformity with the Constitution of the…
Does the failure to produce the studies requested by the HAS justify the withdrawal of reimbursement for the product?
When assessing the medical benefit (SMR) and the expected benefit (SA) of a healthcare product, the French Transparency Commission (CT)…
What can we learn from the 2025 expenses and income report?
Article L. 111-11 of the French Social Security Code stipulates that the Union nationale des caisses d'assurance maladie (French National Union…
Requesting a price that is “too high” may justify the refusal of reimbursement… without negotiation!
The French Social Security Code allows ministers to refuse the reimbursement of a healthcare product if it is likely to…
Pharma package: pharmaceutical companies soon to be required to apply for medicinal product reimbursement?
The European Parliament has just adopted in first reading the "pharmaceutical package" which includes a new directive and a new…
Product paybacks: pricing agreements must be strictly interpreted (annulment of a CEPS decision)
The French Economic Committee for Health Products (CEPS) can negotiate or set paybacks on products reimbursed by the French health…
CEPS report: what the 2022 report says about delays and disputes
On January 23, 2024, the French Economic Committee for Health Products (“CEPS”) published its activity report for 2022. It describes…
Price/volume paybacks and reimbursable indications: a review of the judge’s recent rulings
As a reminder, with the aim of regulating health insurance expenditures, paybacks may be negotiated between the French Economic Committee…
LFSS 2024: When will the medical devices new measures be applicable?
In its decision no. 2023-860 DC of December 21, 2023, the Constitutional Council ruled on the conformity with the Constitution of…
LFSS 2024: When will the pharmaceutical products new measures be applicable?
In its decision no. 2023-860 DC of December 21, 2023, the Constitutional Council ruled on the conformity with the Constitution of…
LFSS 2024: new paybacks to penalise medical devices with a negative environmental impact
On December 4, 2023, the French National Assembly definitively adopted the Social Security Financing Bill (PLFSS) on final reading without voting. Article…
PLFSS 2024: a new reimbursement regime post early access
Early access makes it possible to finance treatments that are presumed to be innovative and often expensive. However, once this…
Contradictory procedure: what’s at stake in terms of market access?
Many decisions concerning the reimbursement of healthcare products must be preceded by a contradictory procedure. The aim of this procedure…
Mission Borne: toward a redefinition of conventional policy?
The Borne Mission[1] recommends reforming certain aspects of healthcare product pricing. It proposes, for example, that new factors be taken into…
Mission Borne: new pricing factors for health products?
After months of work and more than 170 hearings, the interministerial Borne Mission yesterday presented its conclusions to the Ministers…
Vaccination: extension of prescription rights
Until now, the right to prescribe vaccines was reserved for physicians and, under certain conditions, midwives. However, the latter's competence…
What’s in the “Costs and Incomes” report for 2024?
Article L. 111-11 of the French Social Security Code stipulates that each year, before June 15, the National Union of…
Health products pricing : clarification of the “industrial criterion”
In a context of increasing supply tensions and stock-outs, the Social Security Financing Act ("LFSS") for 2022 added an "industrial…
PLFSS: medical devices soon to be substitutable by pharmacists
Article 31 bis of the Social Security Financing Bill (PLFSS) for 2023 provides for the possibility for pharmacists to substitute…
PLFSS: Creation of a specific financing method for advanced therapy medicinal products
The Social Security Financing Bill (PLFSS) for 2023, adopted today in first reading by the Senate, proposes to set up…
PLFSS: New rebates for manufacturers who apply for reimbursement in a limited number of indications
The examination of the Social Security Financing Bill (PLFSS) for 2023 by the deputies began today. Articles 30 (for medicinal…
Biosimilars: the Council of State clarifies the notion of prescription efficiency
Let us recall that an experimental incentive mechanism was introduced on the basis of Article 51 of the Social Security…
Real life studies: call for census from the HAS
The collection of real-life data[1] is a central issue for the evaluation of medicinal products and medical devices. On the one…
Reimbursement of innovative medicinal products : the new criterion of relative therapeutic value
Introduced in the Senate on November 25, 2021, the bill on health innovation aims to improve the conditions of access…
“Anti-gift” scheme: figures for the year 2021
The French National Medical Council has published its annual report for the year 2021, in which a section is devoted…
Can a medicinal product be required to be treated identically to other specialties?
The principle of equality requires the administration to settle identical situations in an identical manner[1]. In a decision dated April 6,…
Early access and compassionate access : how should industry compensate healthcare institutions for data collection?
It will be recalled that one of the main contributions of the LFSS for 2021 is the total overhaul of…
Medical devices, accessories, products for cosmetics use : what changes from now on ?
Ordinance No. 2022-582 of April 20, 2022 adapting French law to Regulation (EU) 2017/745 of the European Parliament and of…
“Transparency” scheme : what’s new ?
As a reminder, the "Transparency" scheme, provided for in Articles L. 1453-1 et seq. and R. 1453-4 of the French…
Chambers Guide – Pharmaceutical Advertising
Under which conditions is medicinal product advertising authorized in France? Is the advertising of medicinal products benefiting from derogatory access,…
Minimum safety stock increased to 4 months for 422 medicinal products of major therapeutic interest
The ANSM has just published the list of medicinal products of major therapeutic interest (MITM) that must be subject to…
The quality charter for the professional practices of persons responsible for the presentation, information or promotion of MD is published
Article L. 162-17-9 of the Social Security Code, created by the LFSS for 2018, provides - in the same spirit…
Security of supply : what we learn from the annual report of the court of auditors
The Court of Auditors[1]published yesterday its annual report for 2022, in which a chapter is devoted to the security of…
Assessement of the financial penalties imposed by ANSM in 2021
Six financial penalties were imposed by the ANSM in 2021 in relation to health products for an amount of €508,048,…
Compassional access and early access : some new features
It will be recalled that one of the main contributions of the Social Security Financing Act for 2021 (LFSS for…
A further step towards the dispensing of single medicinal products
Law no. 2020-105 of 10 February 2020 on the fight against waste and the circular economy (AGEC law) introduced, in…
Remote monitoring : HAS defines technical requirements for reimbursement of digital MD
Article 36 of the Social Security Financing Act for 2022 (LFSS 2022) provides for the entry into common law of…
Is the maximum sales price to health care institutions contrary to EU law?
This is essentially the question that the Council of State referred to the Court of Justice of the European Union…
LFSS 2022: When will the new measures be applicable?
In its decision no. 2021-832 DC of December 16, 2021, the Constitutional Council ruled on the conformity with the Constitution…
List « en sus » : all medicinal product providing an ASMR are now eligible
The long-awaited decree expanding the scope of medicinal products eligible for the list "en sus" has finally been published! It should…
The Constitutional council censures no less than 27 articles of the LFSS for 2022 !
In its decision no. 2021-832 DC of December 16, 2021, the Constitutional Council ruled on the conformity with the Constitution…