Proposed changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines

On the 28 August 2020, the UK government published a consultation paper to consider changes to the Human Medicine Regulations 2012 (HMRs).

The paper seeks consultation under 5 headings: (1) temporary authorisation of the supply of unlicensed products; (2) civil liability and immunity; (3) proposed expansion to the workforce eligible to administer vaccinations; (4) vaccine promotion; and (5) provisions for the wholesale dealing of vaccines.

COVID-19 is the biggest threat the 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.  According to the paper, 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.  There are currently 6 programmes with investment by the UK government across 4 different vaccine types: adenoviral vaccines – Oxford/AZ (100 million doses) and Janssen (30md); mRNA vaccines – BioNTech/Pfizer & Imperial (30md); inactivated whole virus vaccines – Valneva (60md); protein adjuvant vaccines – GSK/Sanofi (60md) and Novavax (60md).

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.  In the event a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and efficacy, becomes available, the UK government 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.  In the event there is a compelling case, on public health grounds, for using a vaccine before it is given a product licence, however, given the nature of the threat, the JCVI may take the very unusual step of advising the UK government to use a tested, unlicensed vaccine against COVID-19, and there is a 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 HMRs.  A COVID-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied there was 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 HMRs 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 HMRs.  These changes will support the effective rollout of a COVID-19 vaccine and the upscaling of an influenza (flu) vaccination programme in the UK.  The paper 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.  The consultation period will run until the end of Friday 18 September 2020.