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…
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…
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,…
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.…
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…
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…
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…
man reject gift
“Anti-gift” scheme: figures for the year 2021
The French National Medical Council has published its annual report for the year 2021, in which…
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…
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…
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…
“Transparency” scheme : what’s new ?
As a reminder, the "Transparency" scheme, provided for in Articles L. 1453-1 et seq. and R.…
Chambers Guide – Pharmaceutical Advertising
Under which conditions is medicinal product advertising authorized in France? Is the advertising of medicinal products…
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…
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 -…
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…
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…
Compassional access and early access : some new features
It will be recalled that one of the main contributions of the Social Security Financing Act…
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…
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…
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…
Paper desktop calendar 2022 schedule with tea cup on wooden desk
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…
Photo of blurred Pharmacy. Medical product shelves and entry doors.
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…
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…