France

France – Mediator scandal: Servier laboratories convicted of aggravated deception and manslaughter

Helene Laurent

On Monday 29 March, more than ten years after the opening of a criminal investigation and eighteen months after the start of an “out of the ordinary” trial, the Paris Criminal Court found Servier Laboratories guilty of “aggravated deception” and “manslaughter and involuntary injury” in the Mediator case. Servier laboratories marketed Mediator for years, an Read More

New pricing agreement in France includes provisions on biosimilars pricing for the first time.

Alexis Vaujany

On 5 March 2021, the President of the Economic Committee for Health Products (CEPS) and the President of the French pharmaceutical industry association (Leem) signed a new three-year framework agreement in the presence of the French Minister of Health. This framework agreement defines conventionally the rules for setting the price of medicinal products in compliance Read More

The French National Authority for Health proposes the first classification of digital solutions used in healthcare

Alexis Vaujany

Given the growing number of digital tools that can be used in healthcare, the French National Authority for Health (HAS) has recently developed a system for classifying digital healthcare solutions according to their purpose of use, their capacity to provide a personalised response and their autonomy, i.e. their ability to act with or without human Read More

French Interministerial Mission on Drugs (MILDECA) reacts to CJEU Kanavape judgment

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On 24 November 2020, following the decision of the European Court of Justice (CJEU) in the Kanavape case, the French Interministerial Mission for the Fight against Drugs and Addictive Behaviours (MILDECA) published an update on the legal status of cannabidiol (CBD) in France. The judgment, which was rendered on 19 November 2020, confirmed that CBD Read More

CJEU landmark ruling confirms that CBD is not a narcotic drug and that member states may not prohibit its marketing

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Today, the Court of Justice of the European Union (CJEU) delivered its long-awaited decision in Case C-663/18 (Kanavape) ruling that a member state may not ban the marketing of cannabidiol (CBD) extracted from the Cannabis sativa plant in its entirety. In today’s judgment, the Court finds that EU law, in particular the provisions on the Read More