What do you see as the biggest challenge facing Early Access Programmes in Europe today?
Too many and variable barriers : The lack of harmonisation across Europe – every country has different regulations , nearly all hospitals/regions have different platforms & access pathways, which can make it difficult to deliver equitable patient access.
What is one common mistake companies make when implementing or scaling an Early Access Programme?
Being reactive rather than proactive. It must be a strategic decision where all options and channel are assessed. The current commercial playbooks are too narrow and therefore too often companies wait until the first patient request arrives before thinking about how the programme will actually work operationally.
Bringing operational teams in early and designing the programme around both physicians and patients makes a huge difference once requests start coming in.
What emerging trend in the EAP landscape should industry leaders be paying attention to?
Knowledge is increasingly cheap with AI so Patients are becoming much more informed and feeling empowered to make request. The paternalistic model of medicine is well over even if the system was build on this model. The system will crack even more as patients are increasingly aware of Early Access options and working with their physicians /patients association to explore them. There's also a growing recognition that Early Access isn't just a regulatory exercise - it's a cross-functional effort that requires collaboration across Commercial, Access, Pricing, Medical, Regulatory, Supply Chain and Operations to make programmes successful. I also think we're seeing a greater willingness from companies to consider access strategies much earlier in clinical development.
What key insights or practical takeaways can attendees expect from your session at the summit?
- Waiting is not an option for many patients and their families. Behind every request is a real patient and family waiting for an answer.
- Practical examples of how good planning, collaboration, good will (non profit) can remove barriers and speed up access without compromising compliance.
- Hopefully attendees leave with a better understanding that successful Early Access programmes aren't just about regulations - they're about creating a pathway that genuinely works for patients, physicians and sponsors alike.