In a report published by the House of Commons, experts in the field of prescription medication described a dire situation for medicine safety in the United Kingdom (UK) if a “no-deal” departure from the European Union (EU) happens. Prescription medication verification and testing will have to be recreated by the Medicines Health and Regulatory Agency (MHRA) and the EU’s Falsified Medicines Directive (FMD), which is the EU’s version of track-and-trace, will no longer be applicable to prescription medication sold in the UK. The report noted, “Witnesses told us that, without provisions with the EU to continue to exchange data, the UK would be shut out of critical EU data exchanges on pharmacovigilance, falsified medicines and clinical trials.”
Remarks from the BioSciences Association (BIA) described a “real threat of counterfeit medicines entering the UK supply chain” and suggested that the Government should reconsider the decision to revoke legislation implementing the FMD. BIA representatives reminded the House of Commons of how important the FMD was to prescription medication safety, citing recent MHRA recalls that were a direct result of information received from their EU counterparts.
As the report noted in its summation of the dangers posed to the prescription drug supply by Brexit, “If the UK leaves the EU without a deal, it will become a third country for the purposes of service provision in the EU, meaning that mutual recognition of regulatory regimes will end, and UK service providers will have to abide by the host state rules of each Member State as opposed to a single set of EU rules.”
Regulatory Affairs Professionals Society recorded the MHRA’s response to concerns brought up last January about the FMD, "In the event that the UK leaves the EU in March 2019 with no deal in place, and as stated in the agency's broader consultation… we expect that the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK."
The House of Commons report also describes how unpredictable the medication supply will become under a no-deal Brexit. Martin Sawer, Executive Director of the Healthcare Distribution Association testified that among other problems, “expect some critical shortage probably in the lower volume medicines, not the everyday ones, which are stockpiled very high. Unless prices go up, the medicine might not come to the UK. The manufacturer will sometimes not provide it to the UK if the prices are too low.” The report noted that in general, “witnesses said that it was difficult to measure the extent of medicine shortages that would result from such disruption,” but a no-deal Brexit would only compound any shortages that the country already faces on a daily basis.
If a no-deal Brexit does happen, the safeguards that protect the medicine available to British citizens will be completely stripped away. Drug counterfeiters will easily exploit any holes available to them, and poorer health outcomes will be a result.