Patient safety

Health Select Committee warns of Brexit risks to new drugs and patient safety

MPs have warned that abandoning regulatory alignment with the EMA following Brexit could have a major negative impact on the quality of healthcare in the UK.

EMA office at Canary Wharf, London


Maintaining regulatory alignment with the European Medicines Agency is critical to maintaining quality of care in the UK, following Brexit, MPs have warned

Patient access to new drugs, patient safety and future investment in the life science industry are all at risk if the UK fails to maintain regulatory alignment with the European Medicines Agency (EMA) after Brexit, MPs have warned.

MPs on the House of Commons Health Select Committee (HSC) also want the UK to retain membership — or at least be an observer on the EMA’s Pharmacovigilance Risk Assessment Committee — after leaving the European Union (EU), and keep its membership of EMA drugs databases.

The government, as a priority, should additionally ensure that there is “mutual recognition” of pharmacovigilance studies by EMA and the UK’s Medicines and Healthcare products Regulatory Agency, the committee said in its report ‘’.

The report said: “Failure to gain access to EU pharmacovigilance systems would have serious consequences for UK medicine and drug safety.

“It would not be possible, let alone desirable, to draw up a UK standalone system by the time the UK exits the EU. Contingency planning in this area would highlight the risks of failure to access EU pharmacovigilance systems and needs to prompt urgent action.”

The MPs went on to say: “Evidence submitted from large pharmaceutical companies, [small and medium-sized enterprises], academics, healthcare and workforce charities was all almost unanimous in the view that regulatory alignment with the EU would be the best post-Brexit option for the NHS, for patients, and for the UK life sciences industry.”

They also expressed concern about the impact of Brexit on the UK’s medicines supply chain, warning: “If the UK diverges from the EU regimes in a manner that adds to the cost and timeliness of existing supply chains, then the UK will become a less attractive market for businesses … patients in the UK would not only experience delays in access to new treatments, but could also stand to wait longer to access generic drugs coming off patent.”

The committee, made up of MPs from several parties, welcomed the government’s announcement that it had commissioned consultants Ernst & Young to carry out an analysis of the impact of Brexit on the medicines supply chain, called on ministers to publish its summary once completed, and to develop any necessary contingency plans to guarantee the safe supply of medicines after the UK leaves the EU.

The report also reiterated that it was “vital” that the UK’s life science sector continues to participate in EU-wide clinical trials after Brexit.

“If the UK does not adopt the new clinical trials regulations and is unable to access the EU infrastructure … difficulties for patients and the life science industry could emerge,” it said.

In a joint response, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, and Steve Bates, chief executive of the BioIndustry Association, described the HSC report as “thoughtful”.

For medicines the detail of Brexit matters,” they said.

“To ensure uninterrupted continued supply we need rapid clarity on the legal position of medicines during the transition period from the EU and the UK. In addition, we need progress from both sides on how the desired close cooperation for the future will work in practice.”

Citation: The Salvadore DOI: 10.1211/PJ.2018.20204571

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