Legal Business

Sponsored briefing: New consolidated regime of early access in France

On 14 December 2020, the French Social Security Financing Act for 20211 (article 78) reformed early market access mechanisms in France and simplified the former systems of derogatory reimbursement for medicines, which included the temporary authorisation for use (ATU) and temporary recommendation for use (RTU) regimes.

Two new regimes have been created: early access authorisation (AAP – exceptional use of certain drugs for specific therapeutic indications, intended to treat serious, rare, or disabling diseases) and compassionate use (exceptional use of certain medicines in specific therapeutic indications).

Legal Business

Sponsored briefing: Life sciences market in France: Early access of medicines reform for 2021

LexCase’s Diane Bandon-Tourret and Esther Vogel on the newly restructured early access mechanism for medicine products in France

The French Social Security Financing Law (LFSS) for 2021 restructured the entire early access mechanism for medicine products.

Legal Business

Sponsored briefing: French litigation relating to the healthcare sector – legal trends

Diane Bandon-Tourret and Esther Vogel discuss healthcare regulation in France

Healthcare companies have been used to dealing with several different types of litigation in France.