A senior executive from Alexion Pharmaceuticals Inc., the rare diseases unit of AstraZeneca PLC, has warned that the European Commission’s proposed reform of the EU orphan drug regulation could negatively impact innovation and access to therapies for 30 million patients in Europe if incentives such as market exclusivity periods are reduced for drugmakers.
Changes to the orphan medicinal products regulation form part of the commission’s efforts to modernize the general EU pharmaceutical legislation
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