Eighteenth Report of Session 2019–21 Contents

3EU COVID-19: Vaccines Strategy6

This EU document is politically important because :

  • it concerns an EU public health procurement initiative in which the UK is eligible to participate during the Transition Period; and
  • it concerns regulatory flexibilities applicable to the whole of the UK during the Transition Period and which will continue to apply to Northern Ireland after the Transition Period.

Action

  • Report to the House.
  • Draw to the attention of the Health and Social Care Committee and the Future Relationship with the EU Committee.

Overview

3.1Recognising that conventional vaccine development can take many years, but that the search for a Covid-19 vaccine requires a much quicker response, the Commission has put forward this Vaccines Strategy. The UK was able to participate in the joint procurement element of the Strategy but has decided not to do so. It will nevertheless look to build strong collaboration with the EU and other international partners outside the framework of this initiative.

3.2The EU’s Strategy is based on two pillars:

3.3The Commission believes that “a common strategy allows better hedging of bets, sharing of risks and pooling investments to achieve economies of scale, scope and speed” and notes that its initiative builds on the inclusive vaccine Alliance by France, Germany, Italy, and the Netherlands. The Commission adds, though, that the identified benefits would be increased if more countries were to join the effort. To that end, says the Commission, it “is ready to support the development and operation of an inclusive international COVID-19 procurement mechanism that facilitates early and affordable access to vaccines and other tools for all who need it across the world”.

3.4On regulatory flexibilities, the Commission points to ways in which the authorisation of clinical trials might be accelerated. Further proposed flexibilities include shorter consultation requirements and allowing for the translation of documents into all EU languages after, rather than before, authorisation, along with the alleviation of language requirements on packaging and labelling. Promoting multi-dose presentation of vaccines is also set out in the Strategy, presented as a means of ensuring rapid and even deployment among Member States. Finally, a separate Regulation7 has been proposed to adjust and clarify certain legal requirements for the environmental risk assessment for Covid-19 vaccines that contain or consist of genetically modified organisms, aiming to ensure that clinical trials are not slowed down by these provisions. We have reported separately on that proposal.

3.5In his Explanatory Memorandum, the Secretary of State for Business, Energy and Industrial Strategy (Rt Hon. Alok Sharma MP) confirms in the following terms that the UK will not participate in the EU’s initiative:

The UK Government and the European Commission have had constructive discussions about possible UK participation in this joint procurement initiative. The European Commission has confirmed that the UK, in line with the terms of the Withdrawal Agreement, would not be able to take part in the governance of the scheme or the negotiating team. They have also confirmed that the UK would be bound to end our own negotiations with individual vaccine suppliers as soon as the EU decided to start such negotiations. lt is also difficult to see how we could pursue other commercial negotiations in good faith, since we could be required to abandon them at any moment. The UK Government has therefore decided not to join this scheme, since doing so would mean we would have no say in what vaccines to procure, at what price, in what quantity and for what delivery schedule. Therefore, we could not be confident that the scheme would meet UK needs. We will continue to take forward our own programme to support vaccine trials and manufacturing and secure vaccines for the UK public and the wider world. We will also look to build strong collaboration with the EU and other international partners outside the framework of this initiative.

3.6The Secretary of State adds that the UK will continue to consider on a case by case basis participation in all future EU schemes that may provide a route to support the public health response in the UK and in which the UK is eligible to take part until the end of the Transition Period.

3.7Concerning the second pillar of the Strategy — the regulatory flexibilities — the UK continues to follow EU law, including on the regulation of medicines, during the Transition Period. The UK will continue to work closely with the European Medicines Agencies on the use of any regulatory flexibilities needed to support the deployment of Covid-19 vaccines. Any future cooperation with the EU on medicines regulation is subject to the UK-EU Future Relationship negotiations.

3.8Regarding the Northern Ireland Protocol, notes the Secretary of State, Northern Ireland will continue to follow EU rules and regulations for medicines. Therefore, any regulatory flexibilities deployed by the EU after 1 January 2021 will need to apply to vaccines on the NI market.

3.9In the UK-EU Future Relationship negotiations, adds the Secretary of State, the UK is seeking a mutual recognition agreement on Good Manufacturing Practice inspections, batch testing and the Official Control Authority Batch Release, in order to reduce technical barriers to trade while also maintaining high levels of patient safety. Subject to securing such an agreement, any future Covid-19 vaccine placed on the UK market after 1 January 2021 will be subject to those arrangements.

Our assessment

3.10We note that the UK Government is keen to build strong collaboration with the EU and other international partners on COVID-19 vaccines development outside the framework of this initiative, and that the European Commission would also like to see “the development and operation of an inclusive international COVID-19 procurement mechanism”.

3.11As both the Government and the Commission recognise, this is certainly an area where global cooperation is desirable. While the UK and EU were unable to agree on a joint approach to this EU initiative, we are reassured that they both recognise the benefits of a multilateral approach and appear committed to that objective.

3.12We raise no issues with the Government but report this to the House as politically important. We draw the document to the attention of the Health and Social Care Committee and the Future Relationship with the EU Committee.


6 Commission Communication: EU Strategy for COVID-19 vaccines; 9021/20, COM(20) 245; Legal base: —; Department: Business, Energy and Industrial Strategy; Devolved Administrations: Consulted; ESC number: 41354.

7 COM (2020) 261 Proposal for a Regulation on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease.




Published: 29 July 2020