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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EU Explains Plans For Use Of ‘Last Resort’ Compulsory Licensing
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.
WHO To Review Impact Of Mechanism For Tackling Substandard & Falsified Drugs
Recent incidents of illness and death caused by contaminated cough syrups show that there is a need to review the “member state mechanism” that is intended to coordinate efforts to tackle poor quality medical products, the World Health Organization says.
International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine
A workshop led by the European Medicines Agency and the US Food and Drug Administration sought to reach alignment on adapting COVID-19 vaccines to emerging virus variants.