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Vaccine producers given immunity from civil liability

Zahra Nanji considers the latest announcement following the UK licensing of the Pfizer/BioNTech COVID-19 vaccine.

Posted on 04 December 2020

Positive news about the success rates of various COVID-19 vaccines has come in thick and fast over the past few weeks, with the announcement this week that the UK has become the first western country to license a vaccine against COVID and that  Pfizer/BioNTech vaccinations will be commencing next week. 

The speed at which the vaccine has been developed and licensed comes after the UK Government  elected not to follow the processes set out by the European Medicines Agency (EMA) for licensing.  

The EMA will decide on a licence for the Pfizer/BioNTech vaccine by 29 December.  The UK has adopted its own process, via amendments to the Human Medicine Regulations (HMR) 2012 after the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (SI 2020/1125) (HMCIR) came into force on 16 October 2020 following a three-week Government consultation. 

Amendments to the HMR has allowed a speedier licensing process, using the UK regulator the MHRA. The amendments to the HMR also include extending immunity from civil liability to companies producing the vaccine, rather than just protecting healthcare workers and manufacturers.
 
The development, approval and roll-out of the vaccine comes with the hope of a return to our pre-COVID world, however, there could be some resistance to the uptake of the vaccine due to the potential long term effects of the vaccine being unknown due to the lack of longitudinal studies. 

Given the extension of civil liability for those involved from development to distribution of the vaccine, if adverse effects were to manifest where would that leave the injured recipient of the vaccine? Who would be responsible for helping that injured person?

Currently, there will be no likely recourse to civil compensation, although the Vaccine Damages Act (VDA) would apply which will award up to £120,000 if someone suffers a very serious consequence.  However this sum may be insufficient to help an individual who suffers long-term harm, leaving their family, the NHS and the public purse to pick up the pieces.

There has been rapid implementation of protection from civil liability for all of those in the development, manufacture and supply of these vaccines when things go wrong, however, no counter-balance that if things do go wrong for an individual that they will also be financially protected. 

I consider that is unfair, unjust and it will undermine confidence in a vaccine where we ask an individual to take full unmitigated responsibility for the potentially serious effects of a vaccine where it has been arguably rushed out and is given under circumstances there is no recourse to remedy should things go wrong.  As is the case with all medicines, inevitably there will be those that do suffer potentially severe and life-changing adverse reactions. 

In these circumstances, in addition to immunity from civil liability for pharmaceutical companies amongst others, it would be pertinent to implement a fair and effective no-fault compensation scheme that is reassuring to the public, that there will be a safety net for them should things go wrong.

There will of course be the question of who funds any scheme. We have to remember that there will be very significant profits made as a result of the roll-out of the vaccine, these companies are not charities but businesses. With such significant profits being made, consideration should be given to a levy being charged on companies selling the vaccines to the market.

I consider that a no-fault scheme is one which should be considered very seriously, and given that it is clear that the Government can rapidly implement regulations when the need arises, rapid consideration and implementation of a no-fault compensation scheme which will properly financially protect individuals who may suffer adverse effects from vaccines should also be implemented. 

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Zahra Nanji
Medical devices Medicines

Zahra Nanji

Zahra Nanji is an associate solicitor in the consumer law team.