Key Implications for Successful Early Access Programmes in the French Market

August 28, 2023. 12:00PM EST/ 5.00PM GMT

Orphan Drug Consulting is hosted a webinar with Intsel Chimos titled “Navigating Recent ATU Changes in France: Key Implications for Organisations Entering the French Market.” 

Jason Cameron, COO of Orphan Drug Consulting, and Corinne Truffault, CEO of Intsel Chimos, lead the discussion. 

Early Access Programmes (EAPs), also known as Expanded Access Programs in the US, provide controlled access to pre-approved drugs for patients with life-threatening illnesses, especially rare diseases with no current treatment. In France, these programs are referred to as the ATU process, which involves exceptional regulations for therapeutic use of medicinal products without an MA, requiring the appointment of an exploitant. 

Recent changes in France’s ATU system, introduced in July 2021 as the AAC & AAP programmes, aim to optimise healthcare funds. However, questions arise about the impact on patient access to early treatments. Jason and Corinne delve into the role of Exploitants in accessing the French market and how these changes affect patient access, offering invaluable insights for companies navigating the French market. 

Jason Cameron is the Chief Operating Officer for Orphan Drug Consulting with over 25 years of experience in the pharmaceutical industry working across supply chain, distribution, manufacturing, and broader technical operations, with a particular focus on rare disease companies. Leading operational areas for multiple commercial product launches and global market expansions.

Corinne Truffault is a pharmaceutical professional with over 30 years of experience in the pharmaceutical industry. With a strong commercial background, she has held various positions throughout her career. Corinne currently holds the position of CEO at Intsel Chimos. Intsel Chimos specialises in helping biotechs, start-ups, and pharmaceutical companies gain early access to the French and European markets, ensuring that their products are made available to patients as soon as possible.

Orphan Drug Consulting Logo


Leave a reply