White paper proposal for medicines registries

As part of its tranche of patent safety-related proposals, the white paper states that the government will allow the Medicines and Healthcare products Regulatory Agency (MHRA) to develop and maintain publicly funded medicines registries. The registries will be supported by a ‘comprehensive medicine information system’ which will collect data from both NHS and private providers, and are intended to provide patients, prescribers and regulators with evidence about use, safety and efficacy. The registries will be ‘…an important tool to support improving post-market surveillance of the use of medicines and help ensure consistent implementation of the highest standards of care’.

Pharmacovigilance has been a cornerstone of medicines regulation in the UK for many years. While the UK was part of the EU, the MHRA has played a leading role in the inspection of marketing authorisation holders with centrally authorised products that had located their pharmacovigilance system master files in the UK. In its role as supervisory authority, for certain pharmacovigilance systems in the EU, the MHRA conducted inspections of companies with centrally authorised products, in addition to inspections requested by the European Medicine Agency’s Committee for Medicinal Products for Human use.

Another key feature of the EU medicines regulatory framework is the EudraVigilance system for managing and analysing information about adverse drug reactions during the development and following the marketing authorisation of medicinal products in the Europe. EEA national medicines regulators have access to all data submitted to EudraVigilance, and receive spontaneous reports about new matters.

Following Brexit, the sharing of common systems, together with the exchange and recognition of data submitted for the purposes of medicines regulation between the UK and EU institutions has changed significantly. During the Brexit negotiations, the pharmaceutical and biotech industries made it repeatedly clear that regulatory harmonisation or alignment were preferable to divergence. The UK-EU Trade and Co-operation Agreement established a Working Group on Medicinal Products that will oversee the operation of a list of provisions set out in a dedicated medicinal products annex to the Agreement. The draft of this annex included a provision that the parties agree to ‘promote compatibility and convergence of regulations based on international standards’, but this does not appear in the final text, indicating that no agreement was reached in this regard.

At the time of writing, it appears that there is no agreement regarding information sharing between UK and EU regulatory authorities, including in relation to pharmacovigilance data sharing (‘pharmacovigilance’ does not appear in the final annex). The establishment of UK medicines registries may be intended to address this recent limitation to the MHRA’s pharmacovigilance capabilities, though it remains to be seen how the registries will be structured and operate in practice.