FAQs

An Early Access Programme enables eligible patients to access investigational, unlicensed, or pre-approval therapies before full commercial availability, typically when there are limited or no suitable treatment alternatives. At the summit, early access is explored as a strategic, regulatory, operational, and patient access priority across global markets.

These terms are often used differently across regions, regulators, and companies, but they generally describe routes that enable patient access to medicines before formal approval, reimbursement, or commercial launch. The summit explores how early access, expanded access, managed access, compassionate use, named patient programmes, and post-trial access are interpreted and operationalised across different markets.

Managed Access generally refers to structured routes that allow patients to access medicines outside standard commercial availability, often under defined eligibility, governance, data, safety, and supply conditions. The summit includes dedicated discussion around Managed Access Programmes, governance, physician responsibilities, programme transitions, and global access execution.

Post-Trial Access refers to continued access to treatment for patients after a clinical trial ends, where appropriate and feasible. The 2026 agenda includes sessions on planning post-trial access early, choosing between open-label extension, post-trial access, or early access, and managing the transition from clinical trial systems into post-trial access without disrupting treatment.

Early Access Programmes are becoming an increasingly critical part of development and launch strategy in Europe, especially as companies navigate fragmented regulatory frameworks, reimbursement gaps, pricing pressures, longer pre-commercial timelines, and rising patient access expectations.

Early Access Programmes are becoming more complex because teams must make earlier and higher-stakes decisions around programme type, country strategy, regulatory feasibility, data collection, supply, long-term treatment duration, governance, and transition into commercial access.

Common challenges include navigating fragmented regulatory frameworks, selecting the right access pathway, managing supply continuity, defining data collection requirements, supporting physician-led responsibilities, maintaining compliance, and sustaining patient access across crisis, acquisition, or organisational change.