French Constitutional Council censors National Assembly’s ‘historic’ amendment on transparency

Eveline Van Keymeulen

On 20 December 2019, the French Constitutional Council issued a decision to censor, among other things, a historic amendment to the 2020 Social Security Financing Bill on transparency of medicinal product pricing and public contribution in research and development (R&D). Accordingly, the amendments requiring pharmaceutical companies to publicly disclose any public R&D contributions they have Read More

French Administrative Supreme Court annuls marketing authorisation for procedural reasons

Jeanne Fabre

Florida Palm Biogaran is a herbal medicinal product for the treatment of moderate urinary disorders associated with benign prostatic hyperplasia. On 31 December 2019, the French Administrative Supreme Court annulled the marketing authorisation (MA) for the medicinal product on procedural grounds. As a result, the medicine should no longer be prescribed or dispensed. The French Read More

The UK Food Standards Agency sets deadline for the CBD industry and provides safety advice to consumers

Eveline Van Keymeulen

On 13 February 2020, the UK Food Standards Agency (FSA) issued safety advice to users and set a deadline for businesses regarding cannabidiol (CBD) products under its supervision (i.e. mainly CBD oil, drops, foods and supplements). Noting the lack of information on the safety and contents of CBD products currently marketed in the UK, FSA Read More

Belgium – FAMHP issues updated guidance document for clinical trial sponsors

Kaat Van Delm

On 19 December 2019, the Belgian Federal Agency for Medicines and Health Products (FAMHP) issued updated guidance for clinical trials sponsors. This document (and each of its previous versions) was adopted in the context of a pilot project that aims to prescribe the procedures and rules for the collaboration between the FAMHP, the Belgian Clinical Read More

France – Impact of the 2020 Social Security Financing Bill for life sciences companies

Eveline Van Keymeulen

The French Social Security Financing Bill (LFSS) was enacted on 24 December 2019 and published in the French Official Journal on 27 December 2019. This year, the LFSS includes life sciences-related provisions:  Generic medicines reimbursement. Last year’s LFSS encouraged generic medicines substitution by capping the amount reimbursed for originator medicines to that of generic ones. Read More