On 22 May 2024 partner Catherine Longeval, who co-heads VBB’s Life Sciences practice with partner Peter L’Ecluse, was a speaker at the EU Pharmaceutical Law Forum in Brussels. She teamed up with Jonas Lind Hansen of Novo Nordisk for a Dual Dialogue on the “Continuing rise of the use of unapproved products” in the EU. Catherine and Jonas highlighted the worrying growing use of compounding for purely economic reasons (so-called “replacement” or “economic compounding) as illustrated by the CDCA Leadiant case. They also addressed the issues caused by the routine use of hospital exemption ATMPs in some Member States. Catherine and Jonas then analysed the proposed changes to the current regulatory framework, more particularly in the draft Directive (version approved by the European Parliament on 10 April 2024), and concluded that these do very little to address the MAH’s concerns but rather may lead to a further undermining of the MAH’s rights.

You can access the slide deck of the Dual Dialogue via the below button link.