The Netherlands
Patients with severe conditions who have no access to approved medicinal products can receive treatment through a Compassionate Use Program (CUP). The Medicines Evaluation Board (MEB) has published new policy guidelines for the implementation of these programs.
Key Updates in Policy
The procedure for requesting and granting a CUP is now detailed in policy document MEB 49.
Applications will be assessed based on three criteria:
- The medicinal product is intended for treatment of a severe, chronic, or life-threatening disease.
- There are no approved medicinal products available for this disease.
- A marketing authorisation application for the medicinal product has been submitted or supporting clinical trials are ongoing.
No More Temporary Approvals
Previously, CUPs received temporary approval for one year, requiring renewal after that year. Under the new policy, approvals are indefinite and valid until the medicinal product receives a marketing authorization or earlier, in case the benefit-risk balance turns out to be negative and requires termination of the program.
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