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UK plans to bypass EU regulator on Covid-19 vaccine rollout


Measures would allow MHRA to grant temporary authorisation for vaccine before full licence is granted

The government has announced a raft of measures to enable the mass rollout of a Covid-19 vaccine, including a change of regulation of the Medicines and Healthcare products Regulatory Agency that would allow it to bypass EU rules if a vaccine is found before 2021.

The new measures, now out for public consultation, would allow the MHRA to grant temporary authorisation for the use of a new Covid-19 vaccine before a full product license is granted.

According to the government, the measures are “precautionary” and will be used as a “last resort” if there is a strong public health justification for widespread use of a vaccine before it has been granted a product licence by the European Medicines Agency during the Brexit transition period.

When the Brexit transition period ends in 2021, the MHRA will be responsible for granting licences for potential Covid-19 vaccines and treatments.

The government has now launched a three-week consultation on the measures, which are set to come into force in October.

The proposals under consultation will also allow more healthcare professionals to administer a potential vaccine.

The consultation also seeks to clarify the scope of the protection from civil liability so it applies to companies that order the medicines and the additional workforce that could be allowed to administer the vaccines.

The changes will see the government “empower the Medicines and Healthcare products Regulatory Agency as it prepares to transition to a role where it gains new authorisation and licensing powers after Brexit”, said Doug Brown, chief executive of the British Society for Immunology.

“These steps will help to ensure that the UK can benefit from a Covid-19 vaccine should one become available in the near future that is proven to be safe and effective.”

Ohid Yaqub, a senior lecturer at the Science Policy Research Unit at the University of Sussex, said the consultation “shows some of the thought and preparation going into the deployment of a possible Covid-19 vaccine”.

“Its main purpose is to give the government the option to authorise a vaccine before it is licensed by the European regulator and laying down some of the legal groundwork to do so.

“If the government chooses to exercise this option, it would help public confidence if the government commits to fully disclosing its reasons for regulatory divergence from the EMA’s decision-making, especially in its interpretation of safety and efficacy.”

Steve Bates, chief executive of the UK Bioindustry Association, said this “may well become a crucial regulation at a crucial time”.

“As the development of Covid-19 vaccines and the end of the transition period are now happening at the same time, we urgently need the government to publish the detail of how medicines regulation will work [post Brexit],” he said.

“Agreement of an EU-UK deal covering medicine regulation would further enhance certainty for medicine supply chains underpinning vaccine development for the UK and the EU.”