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​Unlicensed COVID-19 vaccine must be accompanied by redress scheme to protect public

Zahra Nanji argues that there must be a redress scheme in place to protect consumers in case of adverse reactions to a COVID-19 vaccine that could be marketed before it is licensed.

Posted on 22 September 2020

Leigh Day has flagged to the Department of Health and Social care (DOHSC)  that patients require the ability to seek redress should they find themselves injured by a vaccine.
The DOHSC carried out a consultation on proposed changes to the Human Medicine Regulations (HMR) which closed on 18 September 2020.  The amendments to the HMR are proposed in the event that a COVID-19 vaccine is found, so that it can be used in certain circumstances prior to it being given a product licence. 
The current legal framework under the HMR already recognises that, if manufacturers or healthcare professionals are asked to supply an unlicensed medicine in response to a public health threat, they should be immune from taking responsibility for the consequences of the use of that medicine in the way that they normally would.
The proposed amendments to the HMR are intended to give assurances to manufacturers that they will not be exposed to civil liability unless there are ‘serious breaches’ which would allow immunity to be removed. What a ‘serious breach’ is, is undefined except that it is to be judged objectively!
In our submission to the DOHSC, my colleague Bozena Michalowska, who heads the product safety and consumer law team at Leigh Day, has indicated that it not only unfair but also unjust to ask an individual to take full unmitigated responsibility for the potentially serious effects of a vaccine where it has been rushed out. 
This is because where a person has a vaccine, that person will be taking it not only to protect themselves individually, but also to protect the general public by preventing the spread of the disease. 
The COVID-19 vaccine will not have a track record for safety since the usual route of having 10 years of pre-market development and testing, will not have taken place.  This long term testing would ordinarily identify the risks and benefits of taking a vaccine so that they can be properly explained to a patient who in turn can choose to accept the risk of suffering potential side-effects. However, when the risks are unknown, weighing the risk is not possible.
As is the case with all medicines, inevitably there will be those that do suffer potentially severe and life changing adverse reactions to a vaccine.
It is for this reason we have strongly advocated that the proposals to extend civil immunity to manufacturers and big pharma, must be counter balanced with sufficient protections for those who may suffer an adverse reaction to a vaccine.
The only way in which patients will have confidence to take part in a vaccination programme is knowing they will be ‘protected’ by the vaccine or protected should they suffer an adverse outcome. Without the confidence of the public, any vaccination programme will fail.
The Vaccine Damages Payment Act 1979 (VDPA 1979), currently covers adverse reactions to vaccines. It was intended as a temporary measure, but unfortunately it has become permanent law.  Our experience shows us that payment under the VDPA does not meet the needs of people who suffer severe disablement as a result of taking a vaccine.  The Scheme requires the person harmed to prove that they have suffered ‘severe disablement’. However the VDPA does not make any provision for legal costs or support to be provided to establish the same, often leaving people not only injured but also without access to the scheme that was intended to help them.
Bozena Michalowska has commented:
“Payments under the current Vaccine Damages Scheme are derisory and totally inadequate for meeting the complex long term medical and financial needs of individuals who may suffer the, as yet unknown but potentially life changing, side-effects of the vaccine. The Scheme as it stands is already well known to be inadequate for those who have suffered previous adverse reactions.

"I do not believe that people will want to play Russian roulette with their health by taking a vaccine which they know nothing about, especially when they know that the risks they take are just taken by them and not a shared risk and they will not have sufficient protection, should things go wrong.”
Current consumer law under the Consumer Protection Act also fails to protect the consumer whilst it protects interests of the manufacturer. 
I believe that if steps are taken to extend immunity in respect of manufacturers and suppliers, then equal measures should be put in place to protect the interests of those who might suffer harm as a result of the vaccine. After all, the manufacturers and suppliers do make significant profits, the cost of them making a profit should not be at the expense of an injured person.
Leigh Day is particularly concerned about protecting large business and corporations without providing counterbalance protection for people in light of the recent report prepared by Baroness Cumberlege; ‘First Do No Harm'. 
The report was commissioned following multiple failures of the regulatory system, health care system, manufacturers and the courts to protect patients in respect of the avoidable harm caused by medical products including Sodium Valproate, vaginal mesh and Primados.
Baroness Cumberledge made nine recommendations in the report which are intended to prevent avoidable harm in the future and protect the interests of those who have been harmed in the past. 
Key among those recommendations is the establishment of a ‘no fault’ Redress Agency that mirrors the level of awards made by the courts in equivalent circumstances.
A significant step forward in implementing the recommendations of  the ‘First Do No Harm’ report would be amendments to the Human Medicine Regulations to ensure there is not only immunity to manufacturers but also recourse for injured persons to seek redress.
If this does not happen, then it is clear that the very strong messages conveyed by Baroness Cumberlege will have fallen once again on deaf ears.


Zahra Nanji
Medical devices Medicines

Zahra Nanji

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