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RSNN Expert Meeting Report – Early Access Programmes in the Netherlands: Challenges and Opportunities Across the Patient Journey
Early access programmes play an important role in providing patients with unmet medical needs access to innovative treatments. On 19 May 2026, the Regulatory Science Network Netherlands (RSNN) brought together experts from different stakeholder groups to discuss challenges and opportunities for improving early access to medicines in the Netherlands.
The expert meeting brought together representatives from patient organisations, healthcare professionals, industry, regulatory authorities, and policymakers. Discussions focused on Compassionate Use Programmes (CUPs) and Named Patient Programmes (NPPs), examining challenges across the patient journey.
The expert meeting highlighted that early access programmes are an important contribution in providing timely access to innovative medicinal products for patients with an unmet medical need. At the same time, significant challenges remain with respect to harmonisation, coordination, and continuity of access.
The challenges described in this report primarily concern access to medicinal products before marketing authorisation. For certain patient groups, including children, additional access challenges may arise after initial marketing authorisation, as paediatric authorisation, reimbursement, indication extensions, and the availability of age-appropriate formulations often become available at a later stage. These issues were recognised but were outside the scope of the present expert meeting.
Participants expressed a shared commitment to continue working collaboratively on solutions that improve the alignment between regulation, marketing authorisation, reimbursement, and patient access. They emphasised that an integrated approach encompassing the entire patient journey is essential to fully realise the potential of early access programmes.