UK Vaccine Speedy Approval by Human Medicines Regulations Not Brexit

The UK became the first country in the world to approve the use of the Pfizer/BioNTech vaccine, which is set to begin the distribution process by next week. In the wake of the announcement, several conservative MPs attributed the success of the speedy approval by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to not being bound to EU laws as a result of Brexit, however, Misbar has found that this is not the case. The simple reason is that although the UK formally exited the EU on January 31st, 2020, the laws of the EU are still applicable to the UK until January 1st, 2021. This means that the UK has still been bound by the EU’s body of law that governs the approval of medication for public use.

Ordinarily, the MHRA works with the European Medicines Agency (EMA) acting in conjunction to approve medicines across the regional bloc, however, it would be the EMA, and not national regulators, that had jurisdiction to approve certain types of medicines, such as vaccines. In certain circumstances, this rule can be exempted under the EU’s Medicine’s directorate of 2001. Article 5 of the directorate, to which the UK is still bound, states the following “The Member States may temporarily authorize the distribution of an unauthorized medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.”

The MHRA was able to approve the Pfizer/BioNTech vaccine ahead of its European neighbors because Article 5 enables national regulators to bypass authorization from the EMA as the country is responding to “the confirmed spread of pathogenic agents.” As such, the expeditious approval in the UK was actually a direct result of following EU laws and regulations, and not because of Brexit, and that any EU member could have used Article 5 to expedite authorization. Furthermore, the head of the MHRA, Dr. June Raine, confirms this in a video, contradicting the Health Secretary Matt Handcock, stating “we have been able to authorize the supply of this vaccine using provisions under European law which exist until the first of January.”

Additionally, Prime Minister Boris Johnson on Wednesday, when asked to confirm Handcock’s statement, said that the nation’s authorization for the Pfizer/BioNTech’s COVID-19 vaccine as a result of international efforts and declined to credit the feat to Brexit for the quick pace of the regulatory procedure. As such, the Misbar team has found the claim to be false.