France

French government determined to sanction pharmaceutical companies for shortages of medicines

Jeanne Fabre

According to an article published by French newspaper, Les Echos, the French government has decided to impose financial penalties on companies in cases of negligence that result in shortages of medicines. Shortages of medicinal products are increasing in France (See our previous blog post: French regulator (ANSM) imposes major financial penalty on a pharmaceutical company Read More

France: Innovative medicines marketed too slowly

Laëtitia Bénard

The Montaigne Institute, an independent think tank dedicated to public policy in France and Europe, published a report on innovative medicines on 19 September 2019, strongly recommending acceleration in market access and the renewal of the medical and economic evaluation of medicines. In France, a reimbursed innovative medicine can only be marketed after the High Read More

France: Modification and simplification of the reimbursement evaluation procedure for certain medicinal products

Eveline Van Keymeulen

On 3 July 2019, a new Decree was published which modifies the evaluation procedure of generic and biosimilar medicines by the Transparency Commission of the High Health Authority (HAS). This Decree seeks to simplify the assessment procedures of such medicines in order to speed up their financing by French Social Security. The principle set out Read More

France: Enactment of new health law

Eveline Van Keymeulen

On 26 July 2019, France enacted Law No 2019-774 of 24 July 2019 on the organisation and transformation of the health system (New Health Law), which aims to establish a better organised health system in the French territories and strengthen access to care. Among other priorities, the New Health Law allows for the immediate initiation Read More

French “Pilot phase” for the clinical investigation on medical devices

Eveline Van Keymeulen

In light of the upcoming entry into force of the EU Medical Devices Regulation ((EU) 2017/745) on 26 May 2020, France is the first EU country to prepare for its application in practice by means of a pilot project. The Regulation, amongst other things, sets out a revised framework for Ethics Committees and competent authorities Read More