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Life Sciences France Pharmaceutical Industry

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

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

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

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

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)

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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

Hogan Lovells

Médicaments hybrides et inscription au répertoire des groupes génériques

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Le Conseil d’Etat confirme que seule la décision d’autorisation de mise sur le marché peut définir un médicament en tant que générique. Par deux décisions récentes du 7 juillet 2021 (Johnson & Johnson, req. n° 437803 et...more

Hogan Lovells

Hybrid products and registration in the generics register ("répertoire des groupes génériques")

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The French supreme administrative Court ("Conseil d'Etat") confirms that only the marketing authorisation may define a pharmaceutical product as generic. In two recent decisions of 7 July 2021 (Johnson & Johnson, req. no....more

Hogan Lovells

Haut-commissaire aux produits de santé, effort stratégique ou comité Théodule?

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Dans un rapport publié le 23 juin 2021, la mission d’information sur les médicaments de l’Assemblée préconise notamment la création d’un haut-commissaire aux produits de santé dont on peut légitimement se demander s’il sera...more

Hogan Lovells

Décrets et arrêtés accès précoce : si un doute demeurait sur la simplification, celui-ci est levé !

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Les textes réglementaires d’application du nouveau dispositif d’accès précoce au 1er juillet ont été publiés. Les dispositions se veulent précises sur le cadre juridique d’instruction des demandes et la HAS et l’ANSM...more

Hogan Lovells

First steps towards taking into account the organizational impacts of health care technologies

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On 31 December 2020, the French National Authority for Health (Haute Autorité de Santé - “HAS”), in charge of health technology assessment of health care products before access to reimbursement by the public health insurance...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 13

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In Washington: The Internal Revenue Service (IRS) is planning to extend the tax-filing deadline to mid-May, according to two top House Democrats. A news release Wednesday from House Ways and Means Committee Chairman Richard...more

Hogan Lovells

Orientations du CEPS et nouvel accord-cadre, une avancée de concert sur le prix des innovations ?

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Retour sur la lettre de mission que les Ministres de tutelle du Comité économique des produits de santé viennent d’adresser à son Président alors que le nouvel accord-cadre « médicaments » est en passe d’être publié....more

Hogan Lovells

Nouvelle doctrine de la Commission de la Transparence de la Haute Autorité de santé

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Dans la continuité de son Plan d’action pour les médicaments innovants exposé début 2020, la Haute Autorité de santé a mis à jour sa doctrine d’évaluation des médicaments. ...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter: Life Sciences: What's new in France? The new French anti-gift regulation is live since...

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Since October 1, 2020, healthcare companies have been required to implement the new French anti-gift legal framework, as substantially strengthened by the Ordinance No. 2017-49 dated January 19, 2017....more

Dechert LLP

UK Life Sciences and Healthcare Newsletter: Life Sciences: What's new in France? Avastin/Lucentis case: French Competition...

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On 9 September 2020, the French Competition Authority (“FCA”) issued an infringement decision sanctioning Novartis and Roche with record fines for the pharmaceutical sector in France, totaling 444 million euros, for having...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter: Life Sciences - What's new in France? Decree of 25 August 2020 on the harmonization of...

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In the context of the pandemic, Decree No. 2020-1090 of 25 August 2020 on various measures relating to the reimbursement of health products (the “Decree”) could have been overseen as merely being a technical document.  ...more

Hogan Lovells

Anti-benefits regulations: the last piece of the regulatory puzzle published

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Decree no. 2020-730 of 15 June 2020 and the ministerial orders of 7 August 2020 have completed and specified the new anti-benefits regulations which will come into force on 1 October 2020...more

Hogan Lovells

Combating COVID-19: Government powers for safeguarding supply of critical products and potential conversion of production – Italy,...

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The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more

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