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Open consultation

Consultation document: changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines

Published 28 August 2020

Introduction

COVID-19 is the biggest threat this country has faced in peacetime history, which is why the UK government is working to a scientifically led, step-by-step action plan for tackling the pandemic – taking the right measures at the right time.

Effective COVID-19 vaccines will be the best way to deal with the pandemic. Any vaccine must first go through the usual rigorous testing and development process and be shown to meet the expected high standards of safety, quality and efficacy before it can be deployed.

The independent Joint Committee on Vaccination and Immunisation (JCVI) will advise the UK government on which COVID-19 vaccine/s the UK should use, and on the priority groups to receive the vaccine based on the best available clinical, modelling and epidemiological data. This will depend on the properties of the vaccine, those most at need (including health and care workers) and the particular medical circumstances of individuals.

The preferred route to enable deployment of a new vaccine for COVID-19 is through the usual marketing authorisation (product licensing) process. If a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and efficacy, becomes available, we will seek to license that vaccine through the usual route. Until the end of December 2020, EU legislation requires biotechnological medicines (which would include candidate COVID-19 vaccines) to be authorised via the European Medicines Agency, and a marketing authorisation granted by them would automatically be valid in the UK. From January 2021, the UK’s licensing authority will have new powers to license all medicines, including vaccines. However, if there is a compelling case, on public health grounds, for using a vaccine before it is given a product licence, given the nature of the threat we face, the JCVI may take the very unusual step of advising the UK government to use a tested, unlicensed vaccine against COVID-19, and we need to make sure that the right legislative measures are in place to deal with that scenario.

A temporary authorisation of the supply of an unlicensed vaccine could be given by the UK’s licensing authority under regulation 174 of the Human Medicines Regulations (see below). A COVID-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine. ‘Unlicensed’ does not mean ‘untested’: this temporary authorisation process exists to address the possibility that, in certain situations of public health need, the licensing authority may consider that the balance of risk and benefit to patients justifies the temporary supply of the relevant vaccine pending the issue of a product licence. Regulation 345 of the Human Medicine Regulations transposes into UK law a requirement of EU law that key actors in the medicines supply chain cannot generally be sued in the civil courts for the consequences resulting from the use of an unlicensed product, or a new use of a licensed product, that a national licensing authority is recommending in order to deal with certain specific health threats.

The UK government is seeking views on proposals to make changes, in conjunction with the Minister of Health in Northern Ireland, to the Human Medicine Regulations 2012. These changes will support the effective rollout of a COVID-19 vaccine and the upscaling of influenza (flu) vaccination programme in the UK. It is important to emphasise, however, that although some of the measures specifically reference COVID-19 and flu vaccines, the proposed changes will also facilitate the efficient mass distribution of treatments for COVID-19, or for any other disease that poses a serious risk to public health.

Medicines regulation in the UK

The Human Medicine Regulations 2012 (HMRs), which the attached draft Regulations amend, set out a comprehensive regime for the authorisation of medicinal products; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance. They also provide for enforcement powers for the authorisation and supervision of medicinal products.

Medicines regulation is a devolved matter in relation to Northern Ireland and a reserved matter (to the UK Parliament) in relation to Scotland and Wales. This why changes to the UK-wide HMRs are made by the UK and Northern Ireland ministers, acting jointly. The Medicines and Healthcare products Regulatory Agency (MHRA), an Executive Agency of the Department of Health and Social Care, is the body that performs the functions of the UK’s ‘licensing authority’ under the HMRs across the whole of the UK, acting on the authority of the Minister of Health in Northern Ireland and the Secretary of State for Health and Social Care.

Policy objectives

The main policy objectives of these proposals are to:

In the interests of patient safety and providing clarity to the supply chain, clarify our approach to a pre-existing provision (regulation 174) in the HMRs, that enables the licensing authority to temporarily authorise the supply of an unlicensed medicinal product for use in response to certain specific types of public health threat, including the suspected spread of pathogens. We propose to clarify that this temporary authorisation can be permitted with specified conditions attached. That will allow, for example, the licensing authority to attach conditions to ensure product safety, quality and efficacy.
Clarify the scope of immunity from civil liability which regulation 345 of the HMRs puts in place for certain products whose unlicensed use is recommended by the licensing authority in response to certain specific types of public health threat, so that it clearly applies not just to manufacturers and healthcare professionals but also to the company placing an unlicensed medicine such as a vaccine on the market with the approval of the licensing authority – and to clarify the consequences on immunity, should there be a breach of the conditions imposed by the licensing authority.
Ensure that the UK has the available workforce to administer the COVID-19 vaccine and influenza vaccine.
Ensure that the vaccines and treatments used in response to certain specific types of public health threat, such as a COVID-19 vaccine, can be promoted as part of national vaccination or treatment campaigns.
Make short-term provisions for wholesale dealing of COVID-19 and flu vaccines, and treatments for pandemic diseases, in the case that the vaccine/treatment needs to be moved under NHS or armed services’ authorised arrangements between premises at the end of the supply chain by NHS and armed services’ providers of care that do not do not hold wholesale dealer’s licences.

Nature of the consultation

It is important to explain at the outset the relatively limited nature of this consultation exercise. Therefore, the following 3 limitations should be borne in mind: