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European Parliament Has Missed The Chance to Boost Orphan Drug Development

The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, say Baker McKenzie lawyers Els Janssens, Julia Gillert, Magda Tovar and Olha Sviatenka.

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The EU plans to change the market exclusivity periods for rare disease drugs • Source: Shutterstock

When the European Parliament adopted its position on the EU pharmaceutical package on 10 April 2024, it rejected most of its rapporteur's proposals to further reduce orphan medicine exclusivity (OME).

Instead, it aligned more closely with the European Commission's original proposal to keep baseline OME at nine years and provide one further year of market exclusivity for orphan medicines...

About The Authors

Els Janssens is a counsel specializing in healthcare life sciences regulatory matters, based in Baker McKenzie’s Brussels office.

Julia Gillert is of counsel at Baker...

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