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

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 https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-25-september-2020/jcvi-updated-interim-advice-on-priority-groups-for-covid-19-vaccination

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