Covid-19 vaccine – It has been welcome and unwelcome news that the UK has become the first country to approve the Covid-19 vaccine which had been tested in a large clinical trial for Covid-19, by the UK’s Medicines and Healthcare products Regulatory Agency (MRHA). The MRHA is an executive agency responsible for ensuring the standards of safety and quality for biological medicines, promoting medical harmonisation and educating the public and healthcare professionals about the risks and benefits of medicines.
The Pfizer and BioNTech manufactured vaccine operates by injecting a small fragment of the Covid-19 virus’ genetic code into the body. When present in the body, the body recognises the fragment as foreign and the immune systems fights against it.
Brexit and the Authorisation of the Vaccine
Whilst there is divided opinion on the Covid-19 vaccine, coupled with questions surrounding its imperativeness, viability and possible side effects, Brexit has recently dominated the conversation.
In a recent interview on Times Radio, the Secretary of State for Health, Matt Hancock, linked Brexit to the vaccine’s speedy approval. Hot on the trail of the Covid-19 vaccine, Mr Hancock stated that the speed of the authorisation of the vaccine was due to the UK no longer being part of the European Union, as by leaving the European Union the process was faster and avoided delay.
The delay Mr Hancock refers to is the process of authorisation of the vaccine by the European Medicines Agency (EMA), an agency which facilitates development and access to medicines, monitors the safety of medicines and evaluates applications for marketing authorisation. The UK’s fast authorisation was a result of the ability of MHRA, the UK based regulator, to skip this stage and authorise the vaccine itself, an ability which Mr Hancock attributes to Brexit.
According to Mr Hancock, the UK was no longer obliged ‘to go at the pace of the Europeans, who are moving a little bit more slowly’, he stated, referring to the authorisation by the EMA. This statement had been praised by the Leader of the House of Commons, Jacob Rees-Mogg, who has tweeted in support of the Mr Hancock, although agreement from the Prime Minister was absent.
Covid-19 vaccine & The EU Law
Yet, the chief executive of the MRHA, Dr. June Raine states that it is in fact European Directive, 2001/83/EC, also known as the Community Code Relating to Medicinal Products for Human Use, that must be thanked for the approval of the vaccine. This Directive is implemented by Regulation 174 of the Human Medicines Regulations 2012, which incorporates the Directive into domestic legislation.
Article 5(2) of this Directive allowed the UK to ‘temporarily authorise the distribution of an unauthorised medicinal product’ in the event of a health emergency. Subsequently the UK could bypass the stage of getting the vaccine authorised by the European Medicines Agency and temporarily authorise the vaccine itself.
Although the UK has ‘left’ the European Union, Directive 2001/83/EC retains legal effect in the UK until the 1st January 2021. Moreover, as the Directive has been implemented, this law will remain part of domestic law after this date. Therefore, it is clear that contrary to Mr Hancock’s declaration, Brexit had no legal influence on the fast authorisation of the vaccine, rendering Mr Hancock’s claims baseless and incorrect.