As we move past the peak of coronavirus (COVID-19) infections in the UK, conversations are beginning to turn to how and when current restrictions to reduce the spread of COVID-19 will be eased. However, best estimates suggest that widespread availability of a vaccine won’t happen until 2021, so it’s likely that some social distancing measures may be here to stay for much of the year. Access to vaccines and medicines is therefore a top priority for public health and economic recovery.
Meanwhile, Brexit has had little attention in the headlines, but the end of the transition period looms large. Disruption from COVID-19 has reduced an already tight timeframe for completing UK-EU future relationship negotiations. Failure to do so runs the risk of further disruption when the transition period ends on 31 December.
This blog considers the potential impact of the end of the Brexit transition period on UK-EU coordination of vaccines and medicines to tackle COVID-19.
The regulation of medicines in the UK
Although healthcare is devolved, the licensing and authorisation of medicines in the UK is the responsibility of the Medicines and Health Regulatory Agency (MHRA) and its functions are reserved to Westminster. The MHRA is responsible for assessing the safety and efficacy of medicines, issuing marketing authorisations and monitoring safety.
The European Medicines Agency (EMA) performs an equivalent function for the EU to ensure consistency of approach to the regulation of medicines in EU Member States. It provides a centralised approval procedure for licensing to allow pharmaceutical companies to submit a single marketing authorisation to the EMA, which once granted is valid across the EU and the EEA (European Economic Area).
During the transition period, before any medicine can be used in the UK, it usually has to receive a marketing authorisation from either the MHRA, or the European Medicines Agency (EMA).
For more information on this process, see the SPICe briefing ‘Medicines in Scotland’
A co-ordinated response to COVID-19?
There have been mixed signals about the level of co-ordination and collaboration between the UK and the EU in this area. So far, the MHRA and EMA response appears to be aligned. Both have introduced a series of measures in response to COVID-19. These include:
- new guidance on clinical trials regarding participant safety
- expedited scientific advice and reviews of clinical trials for COVID-19 vaccines and treatments
- relaxing certain protocols such as postponing non-essential inspections
- fast-track approval for COVID-19 medical devices such as ventilators.
However, in other areas there has been confusion about why the UK has not chosen to participate in EU measures that it still has access to during the transition period. Media reporting has highlighted confusion over the UK Government’s decision not to participate in EU joint procurement of ventilators and protective equipment.
Access to vaccines and medicines during the transition period
During a global pandemic, being part of a large trading bloc like the EU may help to coordinate efforts to tackle the spread of infection. The EU’s Joint Procurement Agreement (JPA) was designed for this purpose, born out of weaknesses exposed during the 2009 H1N1 influenza (“swine flu”) pandemic.
A recent blog written by Dr Mark Flear at Queens University Belfast and published by The UK in a Changing Europe explains the advantages of the scheme:
“Joint procurement helps to optimise economies of scale and produce countermeasures as cheaply and quickly as possible. It offers a means to speed up access and enable targeting of the most vulnerable population groups, thus providing a key tool in efforts to limit the spread of COVID-19, relieve the strain on already overburdened healthcare systems, and reduce deaths.”
Additionally, the Commission has launched its ‘RescEU’ stockpiling scheme for medical equipment such as ventilators, personal protective equipment, reusable masks, vaccines and therapeutics and laboratory supplies.
These schemes are in their early stages, so it remains to be seen how this will improve the availability and cost of equipment available to Member States to tackle the pandemic and to what extent the UK participates in them.
Another factor that may affect UK-EU coordination and collaboration is the UK’s relationship with the European Medicines Agency.
Before leaving the EU, the EMA was based in London. This provided strong links between the EMA and the Medicines and Health Regulatory Agency. The BMA has stated that the location of the EMA in London bolstered the importance of the pharmaceutical industry in the UK and that the MHRA handled around 40% of the EMA’s decision making on medicines.
In March 2019 the EMA moved its headquarters from London to Amsterdam. The EMA says:
“One of the consequences of Brexit was that EMA relocated to Amsterdam, the Netherlands, in March 2019. This is line with Regulation (EU) 2018/1718, which covers EMA’s location and seat.
EMA continues to operate in accordance with the timelines set by its rules and regulations throughout the Brexit process.”
The EMA states the following on the transition period:
“During the transition period, EU pharmaceutical law as laid out in the ‘acquis communautaire’ will be applicable to the UK. This means that pharmaceutical companies can continue to carry out activities in the UK until the end of 2020.
However, the UK no longer participates in EU institutions after its withdrawal from the EU on 31 January 2020.
For EMA, this means that as of 1 February 2020, no one who represents the UK, or is appointed or nominated by the UK can participate in any EMA scientific committee meeting, working party meeting or in the Agency’s Management Board.”
Although the regulatory framework remains in place during the transition period, it is not clear whether the UK no longer participating in EMA decision-making processes includes collaboration on tackling COVID-19. This issue was raised in the House of Lords in March.
What role do the UK and Scottish Governments have in relation to the EMA’s response to COVID-19?
The Scottish Government has informed SPICe that it is not involved in any direct collaboration with the MHRA or EMA in relation to COVID-19. However, the UK Government Department of Health and Social Care (DHSC) has a weekly trilateral working level meeting with NHS England and Improvement (NHSE&I) and the MHRA during which they discuss issues such as the use of regulatory flexibilities, purchase of unlicensed medicines from around the world and other medicine related issues.
Scottish Government officials participate in weekly meetings with their DHSC counterparts and NHS National Procurement with their NHSE&I equivalents to ensure alignment with any devolved implications. Two MHRA Directors have also recently been added to the DHSC senior-level Medicines Supply Oversight Group.
After the transition period has ended, the extent to which the UK will collaborate with the EMA will depend on the outcome of the future relationship negotiations. The UK Government’s paper on its approach to the future relationship negotiations states its desire for “commitments to cooperate on pharmacovigilance and to develop a comprehensive confidentiality agreement between regulators, in line with agreements between the European Medicines Agency and Swiss, US and Canadian authorities” as part of a Comprehensive Free-Trade Agreement.
It also suggests this could include cooperation on “procedures relating to vaccines and other biological medicinal products, and clinical trials”.
However, it should be noted that, if the UK and EU fail to agree suitable measures as part of the future relationship, the end of the transition period in eight months could potentially affect the UK Government’s ability to coordinate on COVID-19 treatments and vaccines with the EU.
Damon Davies, Researcher, Brexit, Environment and Rural Affairs