News & Analysis as of

France Pharmaceutical Industry

Hogan Lovells

Market Access in Europe: Navigating Pricing & Reimbursement Pathways

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In Europe, the regulation of pricing and reimbursement for medicinal products is primarily governed by national policies, as EU-level regulation is limited. Our latest brochure “Market Access in Europe: Navigating Pricing &...more

Hogan Lovells

French supreme Court, March 20, 2025, Alexion Pharma France: a historic turnaround for the financial regulation of French...

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In a decision of 20 March 2025 (Appeal No. N 22-23.927), the FR supreme Court ruled that the “product clawbacks” negotiated with the Economic Committee for Health Products (‘CEPS’) on the price of pharmaceutical products...more

Hogan Lovells

Le durcissement économique progressif de l'industrie pharmaceutique en France

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Au travers de diverses évolutions récentes, la situation économique des entreprises pharmaceutiques opérant en France devient progressivement plus contraignante. ...more

Hogan Lovells

Increasing financial regulation of the pharmaceutical sector by the French government

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Through various recent evolutions, the economic situation of the pharmaceutical companies operating in France become increasingly challenging. Various evolutions have recently occur in France: The Ministry of Health is...more

McDermott Will & Schulte

Bulletin Concurrence XII - Paris │Avril ● Mai ● Juin ● Juillet ● Aout 2024

McDermott Will & Schulte on

1. CONTENTIEUX - NOUVEAU RISQUE DE REMISE EN CAUSE À POSTERIORI D’OPÉRATIONS NON NOTIFIABLES - Par une décision du 2 mai 2024, l’Autorité de la concurrence (ci-après l’ « Autorité ») a fait pour la première fois...more

Hogan Lovells

New French template agreement for clinical trials: more standardization, less simplification

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Two updates to the French national clinical trial template agreements (Convention Unique) were published on August 5, 2024. They update the previous templates to take into account evolving practices in clinical trials. In...more

Morrison & Foerster LLP

Quarterly Cartel Catch-Up: 2024 Mid-Year Global Review

At the mid-year point, 2024 is shaping up to be an eventful year in cartel enforcement. In the United States, the U.S. Department of Justice (DOJ)’s Antitrust Division (Division) enjoyed two significant victories and finally...more

Hogan Lovells

La légalisation de plus en plus poussée des positions en matière d’accès au marché se confirme

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Les nouveaux avenants à l’accord cadre. La mise en pratique des préparations hospitalières spéciales et l'avenant à l'accord-cadre sur les hausses de prix à l'aune de la souveraineté sanitaire....more

Hogan Lovells

The increasing legalisation of French market access positions is confirmed

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The new amendments to the French framework agreement. The implementation of special hospital preparations and the amendment to the framework agreement concluded between the French professional organization of pharmaceutical...more

Hogan Lovells

Nouvelle contrainte à la charge de l’industrie pharmaceutique dans la lutte contre les pénuries de médicaments

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Un nouveau dispositif, porté par le projet de loi de financement de la sécurité sociale pour 2024, pourrait aboutir à imposer aux entreprises exploitant un médicament mature d’intérêt thérapeutique majeur qui souhaiterait en...more

Hogan Lovells

New offensive against the pharmaceutical industry in the fight against medicinal product shortages

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A new draft measure, included in the Social Security Financing Bill for 2024, aims to require companies operating a mature medicinal product of major therapeutic interest (MITM) that wishes to suspend or cease marketing it,...more

Hogan Lovells

Analyse du Rapport « Mission Borne » : Entre Espoirs et Déceptions pour le Secteur Pharmaceutique

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Le rapport Borne sur la régulation des produits de santé qui était très attendu est bien en deçà des attentes des acteurs du secteur. Très peu de propositions concrètes y figurent. La Première ministre Elisabeth Borne a lancé...more

Hogan Lovells

French decree regarding the “direct access”: a half-hearted step forward for pharmaceutical innovations

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Publication of the French decree regarding the experimentation of the "direct access" to pharmaceutical products with anticipated reimbursement: a half-hearted step forward for pharmaceutical innovations....more

Hogan Lovells

Décret relatif à l’accès direct : une avancée en demi-teinte pour les innovations pharmaceutiques

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Publication du décret relatif à l’expérimentation du dispositif d’accès direct des médicaments à un financement anticipé : une avancée en demi-teinte s’agissant de l’accès au marché des innovations pharmaceutiques en France....more

BCLP

Paris Litigation Gazette Issue 2 - March 2023

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Welcome to the Litigation Gazette. Each quarter, BCLP's Paris team will keep you informed of the main litigation news in competition law, commercial litigation, labor law, IP/IT/Data and compliance....more

Latham & Watkins LLP

Life Sciences Law Review - 11th Edition, France Chapter

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The eleventh edition of The Life Sciences Law Review covers a total of 24 jurisdictions, providing an overview of legal requirements of interest to pharmaceutical, biotechnology and medical device companies. The chapters are...more

Hogan Lovells

JPM2023 Trendspotting: successful early access in the EU

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As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more

BCLP

Differentiated general terms and conditions of sale

BCLP on

Distribution: In two rulings issued on 28 September 2022, the French Supreme Court clarified the conditions under which suppliers can be held liable for failure to comply with their duty to communicate - Article L.441-1...more

McDermott Will & Schulte

Intellectual Property & Health | News To Know – June 2022

RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more

Hogan Lovells

Long-awaited update of the French “Convention Unique” for clinical trials finally published

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A new French template agreement for clinical trials (Convention Unique) was published on April 9, 2022. This new version was much awaited since the initial version, dated back to 2016, was missing some key provisions...more

Hogan Lovells

Publicité et communication sur les dispositifs médicaux : la Charte française tant attendue enfin publiée !

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L'arrêté ministériel fixant la Charte relative à la qualité des pratiques professionnelles de présentation, d'information ou de publicité des dispositifs médicaux à usage individuel, des autres produits de santé et de tout...more

Hogan Lovells

Advertising and communication on medical devices: France’s long-awaited Charter finally published!

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The French ministerial order laying down the Charter on the quality of professional practices for the presentation, information or promotion of medical devices for individual use, other health products and any associated...more

King & Spalding

France - A Charter for the Promotion of Medical Devices (Including IVD)

King & Spalding on

An ordinance (« arrêté ») was published in the French Official Gazette of 8 March 2022 that sets out a quality charter overseeing the professional practices of individuals responsible for the presentation of educational...more

Latham & Watkins LLP

Life Sciences Law Review - 10th Edition, France Chapter

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France is generally known for its high quality and also highly regulated healthcare system. As an EU Member State, France has implemented the EU medicines and medical devices regimes. This chapter should therefore be read in...more

McDermott Will & Schulte

Intellectual Property & Health: Need to Know - France & Europe - February 2022

UNIFIED PATENT COURT - The Unified Patent Court (UPC) should become a reality in 2022 or in the first few months of 2023. The Protocol on Provisional Application (PPA) of the Agreement on a Unified Patent Court (AUPC)...more

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