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Latest Life Sciences News

Could we…and would we..? UK CoA confirms that it is bound by previous precedent on second medical use SPCs

Life Sciences analysis: The UK Court of Appeal (CoA) handed down its decision in the much-awaited Merck Serono v Comptroller-General of Patents case on 28 January 2025. Not only did the three-judge bench of LJs Lewison, Arnold and Birss confirm that the court could not deviate from previous binding (UK) precedent on second medical use Supplementary Protection Certificates (SPCs), the court also noted that even if it could deviate from its own previous case law, it would not choose to do so in this case. Priyanka Madan, senior associate and specialist in SPC and pharmaceutical regulatory issues at Herbert Smith Freehills LLP, discusses the judgment.

HRA report confirms promising public engagement in health and social care research in the UK

The Health Research Authority (HRA) has published a report showing that 74% of health and social care studies received public involvement in 2023. The report reveals lower involvement rates in commercial research (53%) compared to non-commercial studies (89%). The HRA has reported that while the new Clinical Trials legislation, laid before parliament in late 2024, will not make public involvement a mandatory requirement, the government has expressed support for such involvement. The legislation follows a 2023 joint consultation with the Medicines and Healthcare products Regulatory Agency (MHRA) which showed strong backing for public involvement in trials. The HRA is now developing guidance for researchers based on the consultation feedback.

Court of Justice urged to uphold €60m Teva pay-for-delay fine

Law360, London: An adviser to the Court of Justice said on 27 March 2025 that it should uphold €60.5m in fines against Teva and its subsidiary Cephalon for an alleged conspiracy to keep a generic version of Provigil off the shelves.

Commission reviews Health Emergency Preparedness and Response Authority operations

The European Commission has published a review of the Health Emergency Preparedness and Response Authority (HERA) on 27 March 2025, examining its operations since establishment in September 2021. The review assesses HERA's effectiveness in strengthening EU health security through medical countermeasure development, production and distribution. With €6bn funding through 2027, HERA coordinates threat assessment, research, stockpiling and crisis response. The review identifies areas for improvement including clearer delineation of responsibilities with other EU bodies and more tailored funding mechanisms. The Commission maintains HERA should remain an internal service rather than becoming a separate agency.