18 March 2019
French Legal Framework for the exchange of health data by secured health messaging systems
www.twobirds.com/en/news/articles/2019/france/french-legal-framework-for-the-exchange-of-health-data-by-secured-health-messaging-systems

Before the entry into force of the GDPR on May 25th 2018, healthcare professionals and facilities and professionals in medico-social sectors empowered by law in France had to comply with the provisions stated in the ...

30 October 2019
The allocation of BSPCEs (Bons de Souscription de Parts de Créateurs d’Entreprise) to independent board directors: a small revolution for joint stock companies, a real breakthrough for the biotech world
www.twobirds.com/en/news/articles/2019/france/the-allocation-of-bspces

Biotech and medtech companies operate in an international environment where the composition of their governance bodies is a key criterion of credibility.

24 January 2020
Access to documents contained in a MA application file
www.twobirds.com/en/news/articles/2020/france/acces-aux-documents-contenus-dans-le-dossier-d-une-demande-amm

European Medicines Agency (EMA) had communicated to third parties (with some omissions), information contained in toxicological test reports and clinical trial reports obtained in a MA application file on the grounds ...

18 June 2020
Transfer of value in France: the long-awaited “anti-gift” decree has finally been published
www.twobirds.com/en/news/articles/2020/france/transfer-of-value-in-france-the-long-awaited-anti-gift-decree-has-finally-been-published

The French so-called “anti-gift” provisions strictly frame the conditions under which companies in the health sector are allowed to provide advantages, in cash or in kind, to healthcare professionals ("HCPs”).

26 August 2020
Transfer of value in France: publication of the regulatory provisions specifying the ceilings above which an authorization from the authorities is required
www.twobirds.com/en/news/articles/2020/france/transfer-of-value-in-france-publication-of-the-regulatory

An important change to the new regime governing transfer of value to HCPs, students and associations will enter into force on 1 October 2020.

02 November 2016
Bird & Bird Paris welcomes Emmanuelle Porte as a partner in the Life Sciences Corporate group
www.twobirds.com/en/news/press-releases/2016/france/bird-and-bird-paris-welcomes-emmanuelle-porte-as-a-partner-in-the-life-sciences-corporate-group

02 December 2019
The French Health Data Hub becomes reality
www.twobirds.com/en/news/articles/2019/france/the-french-health-data-hub-becomes-reality

The French Health Data Hub was born officially with the publication on 30 November 2019 of a ministerial decision (arrêté).

02 July 2019
Transfer of value: amendments to the French “anti-gift” provisions by the draft Health Act
www.twobirds.com/en/news/articles/2019/global/transfer-of-value-amendments-to-the-french-anti-gift-provisions-by-the-draft-health-act

The French so-called “anti-gift” provisions strictly frame the conditions under which companies in the health sector are allowed to provide advantages, in cash or in kind, to healthcare professionals ("HCPs”)

23 July 2019
New CNIL standard for all companies doing product vigilance activities
www.twobirds.com/en/news/articles/2019/global/new-cnil-standard-for-all-companies-doing-product-vigilance-activities

New CNIL standard for all companies doing product vigilance activities

29 October 2018
France: Measures in favor of generic and hybrid drugs under discussion in the French Parliament
www.twobirds.com/en/news/articles/2018/france/measures-in-favor-of-generic-and-hybrid-drugs-under-discussion-in-the-french-parliament

The draft bill for the financing of the social security scheme for 2019, under discussion in the Parliament, contains, in its Article 43, amendment proposals to the French Public Health and Social Security Codes in ...