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Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020

Volume 682: debated on Friday 16 October 2020

The primary objective of our policy is to support the expansion of the annual seasonal flu vaccination campaign and to support the successful roll-out of a safe and effective covid-19 vaccine. Throughout the coronavirus outbreak, the Government have brought in the right measures at the right time, based on the most relevant and up-to-date scientific advancements and advice. As the UK enters the “flu season” where domestic transmission is rising, it is important that the Government can respond swiftly and effectively to the current situation.

The independent Commission on Human Medicines (CHM) will advise the UK Government on the safety, quality and efficacy of any vaccine; no vaccine will be deployed unless stringent standards have been met through a comprehensive clinical trial programme. The preferred route to enable deployment of any vaccine, including new vaccines for covid-19, remains through the usual marketing authorisation (product licensing) processes.

In the interests of patient safety and bringing the pandemic to an end, which will allow life to restore to normality, the Human Medicines (Coronavirus and Influenza) (Amendment) (England) Regulations 2020 will come into force, for the most part, on 3 November 2020, although some provisions need to be brought into force on the day after they are laid before Parliament. Our plan is to bolster the safeguards to product authorisation and to improve access to necessary vaccines in order to protect the public ahead of the winter and beyond, and ultimately reduce mortality.

The regulations introduce measures to support the safe future mass roll-out of a covid-19 vaccine, and the expansion of the annual seasonal flu vaccination programme, and include bringing the five main changes into effect:

Reinforcing temporary authorisation measures to provide for the attaching of conditions, a technical change in order to make sure that any unlicensed products that the Government recommends for deployment in response to certain public health threats must meet required safety and quality standards;

Expanding the workforce able to administer covid-19 and flu vaccines to improve access and protect the public, including by new immunisation protocols for covid-19 and flu vaccines;

Rationalising the scope of the pre-existing partial immunity from civil liability for the pharmaceutical companies whose unlicensed products are recommended for use by the Government in response to certain public health threats, and also extending that partial immunity to all members of the additional workforce that could be allowed to administer temporarily authorised vaccinations under the new immunisation protocols;

Ensuring that treatments used in response to certain specific types of public health threat can be promoted by advertisements to the public as part of national campaigns;

The provision of an exemption from the need for a wholesale dealer’s licence to allow the swift and safe transfer of covid-19 and flu vaccines, and other medicines for treatment of pandemic disease, in response to patient need, by NHS and armed services providers at the end of the supply chain.

If a covid-19 vaccine is ready for deployment prior to 1 January 2021, these measures will bolster existing temporary authorisation powers that allow the Medicines and Healthcare Products Regulatory Agency to consider approving its use, before a full product licence is granted, provided it is proven to be safe and effective during the extensive clinical trials. The measures are especially necessary in the context of the transition period because until its end any full product licence for a potential covid-19 vaccine must be granted by the European Medicines Agency (EMA).

The UK Government have sought views on proposals to make changes, in conjunction with the Minister of Health in Northern Ireland, to the Human Medicine Regulations 2012. The Department has further welcomed views from any interested individual or organisation through a public consultation which ran from 28 August and closed on 18 September, also holding discussions about the proposals with specialists and key stakeholders in tandem. We welcome the participation of all individuals and organisations who contributed to the consultation and received over 188,000 responses. We analysed these responses and based on feedback made three key changes to the content of the legislation, which are explained in the explanatory memorandum published alongside the instrument.

The explanatory memorandum published with the instrument also explains why some of the provisions of this instrument breach the rule that provisions of statutory instruments subject to the negative procedure should normally be laid 21 days before the instrument comes into force. The measures that are being brought into force in breach of the 21-day rule are essentially permissive and enabling. The priority action is to support the annual flu vaccination roll-out; delaying their implementation could increase the incidence of influenza in the UK. Currently a safe effective vaccine for covid-19 to deploy is subject to the outcome of clinical trials. However, any delay to the annual vaccination roll-out would hamper an important aspect of the covid-19 fightback.

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 “frontline” workers—and the medical circumstances of individuals. Updated JCVI advice can be found at