Combined Effect Of EU Pediatrics And Orphan Drugs Legislation Under EU Commission Scrutiny
A joint evaluation of the EU pediatrics and orphan drugs legislation is due to commence next year in an effort to understand why the two legal instruments have failed to encourage companies to develop medicines targeting rare diseases in children. The initiative will help decide the possible need for future changes.
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Spring 2020 should see the publication of a working document by the European Commission on how to improve the operation of the EU legislation on orphan and pediatric medicines. The commission has asked for more input from member state experts.
The EU’s new health commissioner, Stella Kyriakides, has outlined the commission’s plans for dealing with medicines access issues in the EU member states. They include completing the review of the EU pediatric and orphan legislation and developing a new strategic plan to tackle shortages and affordability problems next year.
A new European Commission consultation marks the launch of an evaluation exercise to assess the joint impact of the EU pediatric and orphan drugs legislation in supporting the development of pediatric medicines for rare diseases.