France

France defines medical situations in which physicians can exclude generic substitution

Eveline Van Keymeulen

On 19 November 2019, pursuant to Article 66 of the 2019 Social Security Financing Act (LFSS), the implementing order that indicates the medical situations in which physicians may exclude substitution on prescriptions was published (Order of 12 November 2019). For background information, see our previous blog post French 2019 Social Security Financing Act introduces new Read More

France: Details of hybrid groups register published

Jeanne Fabre

In accordance with Article 66 of the 2019 Social Security Financing Bill (PLFSS), the details of the hybrid medicines register have been published through a decree on 20 November 2019 (see our previous blog post:  French 2019 Social Security Financing Act introduces new healthcare measures). Decree No 20169-1192 specifies the registration procedure and removal of Read More

French Administrative Supreme Court paves way for medical practitioner advertising

Eveline Van Keymeulen

On 6 November 2019, the French Council of State, the Administrative Supreme Court, granted the request to annul the implicit Minister of Health’s refusal to revoke the Articles of the Public Health Code (French language) that prohibited the use of any advertising by dentists and dental surgeons (Decision of 6 November 2019 docket 420225) (French Read More

France: Draft 2020 Social Security Financing Bill encourages price cuts and biosimilar uptake

Eveline Van Keymeulen

In order to ensure savings for the healthcare system in 2020, French legislators are encouraging biosimilar uptake and price cuts. The draft 2020 Social Security Financing Bill (2020 PLFSS) introduces new measures that tackle tactics developed by medicinal product originators, which consist of offering low prices for biological brands to healthcare institutions as a way Read More

French ANSM decides to maintain fast-track procedures for clinical trials

Eveline Van Keymeulen

After a successful test phase, the National Agency for Medicines and Health Products Safety (ANSM) announced in a press release dated 18 October 2019 that it would be maintaining the accelerated circuits for medicinal product clinical trial authorisations. The fast tracks were established on 15 October 2018 and then extended to Advanced Therapy Medicinal Products Read More