EU Gears Up For Compulsory Licensing Reform
The European Commission has laid out a number of possibilities for changing the EU framework on compulsory licensing to improve the availability of products in health emergencies. The options include extending the scope of compulsory licences beyond patents to other forms of protection such as data exclusivity.
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The first stage of the EU’s proposal to revamp the compulsory licensing system and prepare the bloc for future health crises is almost complete. The next steps are to publish an impact assessment, run a public consultation, and produce a draft regulation by the first quarter of 2023.
Industry representatives told a House of Lords committee about continuing Brexit-related problems such as the extra work involved in checking compliance with the EU Falsified Medicines Directive and the drawbacks of a proposed “dual regulatory regime.”
The Medicines and Healthcare products Regulatory Agency says that the fee increases to be introduced on 1 April, along with 18 new fees, are necessary for its long-term financial sustainability and its ability to provide a “responsive, innovative and efficient regulatory service.”