UK plans to boost pharmacovigilance and data collection on medicines

The UK Government has published draft legislation targeting a major restructuring of the National Health Service. This will see the abolition of CCGs (Clinical Commissioning Groups) and the creation of statutory Integrated Care Systems (ICSs).

Our specialist health team has produced initial thoughts on the structure and likely impact of the Bill: A new Health and Care Bill graces our shores.

The Bill builds on the proposals for reform made in NHS England’s Long Term Plan to make the NHS less bureaucratic, more accountable and more integrated, particularly in light of the Covid-19 pandemic.

New medicines information systems

Of interest to life sciences businesses will be the Medicine Information Systems proposals. The legislation will introduce powers to set up medicines information systems that combine existing pharmacovigilance information with bespoke data extracts from other systems. The Health and Social Care Information Centre, known as NHS Digital, would manage this work.

Medicines regulator, the MHRA, would be able to use the stored information to establish and maintain comprehensive UK-wide medicines registries for selected products. This would improve post-market surveillance on the use of medicines. The explanatory notes give the following example:

“where a safety issue has led to the introduction of measures to minimise risk to patients, registries would facilitate the early identification and investigation of potential non-compliance so that additional action can be taken by regulators in conjunction with health service providers at a national, local, or individual patient level.”

This plan tracks similar provision for medical devices information systems in the Medicines and Medical Devices Act 2021, and ties in with the recommendations of the 2020 Independent Medicines and Medical Devices Safety (IMMDS) Review under Baroness Cumberlege.

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