The COVID-19 virus is beatable, and the vaccine works. And now the Pfizer/BioNTech vaccine has been authorised by the Medicines and Healthcare products Regulation Agency (MHRA) for use in the UK. This follows changes to the law to allow for the safe production and distribution of the vaccine.
In an article in The Lancet on October 27, Kate Bingham, chair of the UK vaccine taskforce, summarised the position on the frontrunner vaccines at the time. She said: “The most advanced vaccines, such as those developed by AstraZeneca and the University of Oxford, BioNTech and Pfizer, and Janssen, are based on novel formats for which we have little experience of their use as vaccines, although the initial immunogenicity and safety data are encouraging.”
DH: Unlicensed - not untested
What legal steps have been taken in the UK to get to a position where a “novel format” of vaccine can be offered for mass immunisation? What do they mean for pharmacists? The legislative changes for the COVID-19 vaccine are largely to the Human Medicines Regulations 2012 in relation to licencing medicines.
There are tweaks to the all-important regulation 174 of the Human Medicines Regulations, which gives the MHRA scope to grant a temporary authorisation for the supply of an unlicensed medicinal product for use during pandemics. This means the product can be authorised by the MHRA despite not being licensed by the European Medicines Agency, which retains its powers over most UK medicines until January 2021. The MHRA still requires sufficient evidence of the safety, quality and efficacy of the medicinal product to approve unlicensed use.
In the consultation on the changes, the Department of Health and Social Care explains: “‘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.”
What do the legislative changes mean?
The new legislation means that conditions can be imposed on the authorisation of nationwide distribution and supply of an unlicensed product such as the Pfizer/BioNTech vaccine.
Additionally, the government has extended immunity from civil liability for some consequences resulting from the use of an unlicensed medicinal product, although there are still other liabilities and the exact scope of the immunity is complex.
There was already a degree of immunity from civil liability for products whose unlicensed use has been recommended by the state. Under the changes, those who are immune include companies placing an unlicensed medicine such as a vaccine on the market and the additional vaccinators for COVID-19 who are not registered healthcare professionals.
The limited immunity already applied to healthcare professionals, including pharmacists. But it is worth noting that if the conditions that the licencing authority has imposed on the vaccine are breached, the immunity may not apply.
However, if a breach was by a manufacturing company making the medicinal product, the pharmacist administering it should still be able to take advantage of the immunity from civil liability offered by the Human Medicines Regulations. The prime purpose of the change to indemnity was to provide reassurance to companies placing medicines on the market and the additional vaccinators that will be required.
The regulatory changes have helped get the COVID-19 vaccines over the line and closer to some pharmacies.
Susan Hunneyball is consultant solicitor at Gordons Partnership law firm
