What do you see as the biggest challenge facing Early Access Programmes in Europe today?
The biggest challenge facing Early Access Programmes in Europe is navigating the different regulatory requirements from country to country. While the objective of providing early patient access is consistent, each market has its own approval pathways, documentation requirements, timelines, and operational expectations. This lack of harmonization makes it challenging to build and scale programs across Europe, requiring companies to balance local compliance with a consistent global strategy.
What is one common mistake companies make when implementing or scaling an Early Access Programme?
A common mistake is waiting until an early access request is received before beginning EAP planning. Too often, EAPs are viewed as a response to demand rather than being proactively incorporated into Integrated Evidence Plans (IEPs). By embedding EAP strategy early, companies can better align evidence generation, supply planning, market access, and operational readiness, ultimately enabling more efficient execution and earlier patient access.
What emerging trend in the EAP landscape should industry leaders be paying attention to?
Industry leaders should be paying close attention to the growing role of Early Access Programmes as a source of real-world experience and strategic evidence generation. While patient access remains the primary objective, many organizations are increasingly exploring how EAPs can provide insights into treatment patterns, patient outcomes, and healthcare system needs that can help inform future access, reimbursement, and launch activities. At the same time, there is greater emphasis on integrating EAP planning earlier into product development strategies rather than treating it as a post-approval consideration.
What key insight or practical takeaway can attendees expect from your session at the summit?
One emerging trend is the shift from viewing EAPs solely as a patient access pathway to recognizing them as a strategic opportunity for both real-world evidence generation and launch readiness. Embedding EAPs into Integrated Evidence Plans early in development allows companies to generate meaningful insights, support future access and reimbursement decisions, and better prepare or commercialization while expanding access for patients with unmet needs.