Patient safety must guide regulatory reforms

The IBMS notes with interest the recent publication of the UK Government’s Regulatory Action Plan, particularly the implications for the Medicines and Healthcare products Regulatory Agency (MHRA) and its role in the regulation of healthcare and medicines.

While we broadly support the commitment to enhancing innovation and streamlining regulation to encourage growth within the life sciences sector, the IBMS seeks clarity and assurance on how proposed reductions in the legal duties of regulators like the MHRA will be balanced against their crucial role in safeguarding patient safety and ensuring the efficacy and quality of healthcare products.

We welcome the government's commitment to facilitating the development and manufacture of highly personalised medicines, recognising this as a vital step towards innovative, patient-centred healthcare. The IBMS strongly supports closer collaboration between MHRA and National Institute for Health and Care Excellence (NICE), particularly the initiative for concurrent marketing authorisation and technology appraisal, as this could accelerate patient access to new therapies.

However, the IBMS expresses caution regarding the overall strategy of reducing regulators' duties. It is imperative that such streamlining does not undermine the robustness of the UK's regulatory framework, potentially compromising patient safety and public trust. Regulation must remain robust, evidence-driven, and fit for purpose, especially at a time when biomedical innovation is rapidly advancing and becoming increasingly complex.

The biomedical science workforce plays a critical role in safeguarding public safety. Their expertise and skills must be integral in shaping regulatory frameworks and ensuring clinical tools are both effective and safe. This involvement is especially crucial as technological innovations increasingly broaden access to healthcare.

We urge MHRA and other regulatory bodies to engage transparently with healthcare professionals, scientific experts, and patient groups as these regulatory reforms take shape. The IBMS is committed to collaborating constructively with the government and regulators, sharing the expertise of our members to ensure that regulatory changes truly serve patients' best interests and maintain the highest standards of biomedical science practice.