Review of EU SPC regime makes case for manufacturing waiver reform

A study published by Medicines for Europe (MfE) suggests that the SPC manufacturing waiver, implemented in July 2022 to reduce the impact of supplementary protection certificates on the manufacture of generic medicines in Europe, is having mixed results. While some manufacturers have relocated and invested in Europe, others have not due to legal uncertainty, concerns over disclosure of confidential information and practical issues. Respondents have also expressed concerns about the publication of notification letters by patent offices and the limitations of the waiver, such as the six-month grace period for biosimilars and complex products. MfE has proposed reforms to address these issues in the upcoming 2024 review of the waiver regime.

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