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). Continue reading “Sponsored briefing: New consolidated regime of early access in France”

The Legal Business Awards, held at Grosvenor House on 30 September, provided the perfect backdrop to honour the leading lights of the in-house legal community from the last year. Taking the top prize of GC of the Year was easyJet’s legal chief Maaike de Bie (pictured), recognised for piloting the company successfully as the aviation sector was ravaged by the pandemic and responding robustly to a sophisticated cyber-attack. Highly commended in this category was Emily Reichwald, general counsel of Dr Martens.