No-Deal Guidance Outlines Brexit's Impacts on the Supply and Regulation of Medicines

The United Kingdom this week published a series on guidance documents on how to prepare for a scenario in which the United Kingdom exits the European Union with no deal struck, and several of those documents outlined serious impacts on the pharmaceutical industry.

In the event of a no-deal Brexit, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) says that, to ensure a continuous supply of necessary medicines, it will accept batch testing of medicines that are carried out in EU and European Economic Area (EEA) nations. For medicines manufactured in the European Union and EEA, the MHRA will accept the certification of a qualified person based in the country of manufacture without requiring additional certification.

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In a letter to the healthcare sector that accompanied release of the guidances, the Secretary of State for Health and Social Care, Matt Hancock, added that, to ensure that there is no disruption to the supply of medicine, the government is asking pharmaceutical companies to stockpile an additional 6-week supply of medicine, on top of their usual stock levels, in case normal supply routes through the European Union are disrupted. Hancock’s letter adds that the government is planning to bring medicines with short shelf-lives into the country by air freight. However, Hancock urged clinicians and community pharmacies not to stockpile drugs in their locations, nor to give patients longer supplies to keep at home.

Warwick Smith, director general of the British Generic Manufacturers Association and the British Biosimilars association, called these plans “Making the best of a bad job” in a statement. Smith added, “As we have consistently said, what is needed to ensure the supply of medicines to British patients is an agreement between the [United Kingdom] and the EU27 to allow the free flow of medicines and their components. Ideally, we want the [United Kingdom] to remain part of the European medicines regulatory environment, or more pragmatically a mutual recognition agreement to be agreed quickly.”

Additional information contained in the guidance documents noted that, post-Brexit, the MHRA would have to assume all functions currently handled by the European Medicines Agency for the regulation of drugs (an eventuality that would require changes to UK law), and pharmacovigilance efforts, currently conducted at an EU level, would become the sole responsibility of the MHRA.

The guidance also clarified that there will be no UK involvement in the new EU Clinical Trial Regulation, so there would be no UK access to the single portal for clinical trial data. UK—EU sharing of any type of data used for regulatory decisions on medicines would cease, and the United Kingdom would be required to develop a new system to receive regulatory submissions.