The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based ...

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Laura Whiting and Alexandra Morgan of Freshfields Bruckhaus Deringer consider the reasons behind the adoption of the new SPC Manufacturing Waiver Regulation and reflect on whether the message sent out ...

Cristina Biggi of Bugnion examines the introduction of the new SPC manufacturing waiver, including the process that led to its creation and the amendments it makes to the SPC regulation Supplementary ...

Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are ...

A new European Union policy could increase the supply of legitimate pharmaceuticals in developing countries and thereby minimize the problem of counterfeit medicines, but many challenges remain. You ...