IN the United States, those who lived through the Depression of the 1930 and World War II are often referred to as ‘the greatest generation’ in recognition of their ability to survive great hardship, make do, and go on to build a rich and successful country. A similar view is shared in Britain, with the people of the 1940s admired for the wartime attitude summed up in the slogan ‘Keep calm and carry on’. Covid-19 has shown the country to be so unphlegmatic today that we’re more likely to be remembered as the panicked generation. The ridiculous, unscientific and unenforceable ban on groups of more than of six in social settings is the latest instance of the headless chicken mentality that has infected our rulers. There are other, less publicised instances of Covid-19 causing sensible thinking to be abandoned, such as proposals to change the use and application of vaccines.
The Government has put out a little-publicised consultation which would allow a Covid-19 vaccine to be used without the normal safeguards required for any medical product. Medicines are regulated under the Human Medicine Regulations 2012. These set out the long and detailed process required for any medicine to acquire a licence, without which it cannot be sold or used as a medical product. The regulations include a provision (Regulation 174) that allows a temporary authorisation for the supply of an unlicensed medical product for use in response to certain specific types of public health threat: the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation. As a ‘pathogenic agent’ can be anything that produces disease this, in practice, could mean any substance and thus allows for possible relaxation of licensing requirements to address Covid-19.
Medicines are currently licensed by the European Medicines Authority but from January 2021 – when Brexit might actually mean Brexit – a UK licensing authority will have powers to license all medicines, including vaccines. The government consultation envisages that, if there is a compelling case on public health grounds for using a vaccine before it is given a product licence, the new licensing authority may take the very unusual step of advising the Government to use an unlicensed vaccine against Covid-19. The decision to invoke Regulation 174 to allow use of an unlicensed medicine ‘will be dependent on the particular facts of the public health threat in question’. What facts the licensing authority will consider and how it will weigh them are not clear; one can only hope that they don’t ask Professor Neil Ferguson to write an algorithm to help make their decision.
Conditions may be imposed on the use of an unlicensed vaccine ‘whilst acknowledging that some flexibilities and pragmatic approaches may be required’. These weasel words – showing that Sir Humphrey Appleby is alive and well in the civil service – cannot disguise that the implementation of these proposals may result in the use of vaccine that will not have been fully tested before use. One does not need to be a convinced anti-vaxxer to be concerned by this.
The proposals suggest immunity from civil liability for vaccine manufacturers, distributors and health professionals for their involvement in the use of an unlicensed medicine, i.e. one will not be able to sue them should the vaccine have unforeseen side-effects. As with most things legal, there is some muddying of the waters, with circumstances set out where actors in the medical supply chain may still be liable. It’s understandable that those acting in line with government authorisation might be exempt from the legal consequences arising, but what is not made clear is where liability would sit; the silence may be an admission that this liability will rest with the UK licensing authority and thus with the government (and the taxpayer!)
More worrying are proposals to increase those who can deliver a vaccine shot to include, amongst others, ‘midwives, nursing associates, operating department practitioners, paramedics, physiotherapists and pharmacists’. This is somewhat misleading as many of these healthcare workers already administer vaccines e.g. pharmacists are often involved in delivering seasonal flu jabs, although only nurses are authorised to administer prescription-only medicines under written instruction of a doctor.
It’s not entirely clear who the new vaccinators would include. The proposals would allow those who are registered healthcare professionals who do not normally vaccinate, and people who are not registered healthcare professionals, to administer a licensed or temporarily authorised Covid-19 or influenza vaccine. There would also be ‘a new type of national protocol’ which will allow such people to administer a licensed or temporarily authorised Covid-19 or influenza vaccine. The changes to those authorised to administer vaccines would be time limited to April 1, 2022, ‘to allow fuller consideration of making a long-term change in this area’, or to put it more bluntly, this is a trial and those to be vaccinated would be the experimental lab animals.
So that’s clear then, isn’t it? You may be invited to take a vaccine that has not been fully tested, to be administered by someone who to date has not been considered suitable to give it and where the legal liability of those at every stage of the delivery process of the vaccine is somewhat murky. A poll found that 6 per cent of the UK population would definitely refuse to take a Covid vaccine, a further 10 per cent probably wouldn’t and another 15 per cent were not certain. These percentages would rise significantly if the normal processes for creating and delivering a vaccine were not followed. You have until 11.59pm on Friday to respond to this consultation (you can do so here).
Consultation document:
Consultation response:
