ER Editor: The announcement of indemnity for Pfizer was made in the Independent last Thursday from the UK’s Department of Health and Social Care. And curiously, of all UK-based MSM outlets, only the Independent has carried it. Fred Porter of the University of Pittsburgh Law School provides his own account below.
Note that should anybody be damaged by this vaccine, they are only eligible to receive a one-time, tax-free payment of £120,000, which won’t get anybody very far, especially given that you must shell out so much in legal fees to prove your claim of vaccine damage.
The UK Govt document linked to below by Porter, and here (see Consultation document: changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines) deals with the topic of liability. Of note:
Regulation 345 of the Human Medicine Regulations 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.
And similarly under Section 2:
2. Civil liability and immunity
Any decision to roll out mass vaccination programmes for unlicensed COVID-19 vaccines, or indeed any pandemic disease treatments, will be taken nationally, not by the individual companies manufacturing or marketing the product.
The current legal framework already recognises that if manufacturers or healthcare professionals are asked to supply an unlicensed medicine in response to a public health threat, it is unfair also to ask them to take responsibility for the consequences of the use of that medicine in the way that they normally would.
The UK government wishes to clarify some important aspects of the legal regime relating to the civil liability of manufacturers and suppliers in this context.
Who is protected from liability
Article 5(3) of Directive 2001/83 requires that Member States lay down provisions so that marketing authorisation holders, manufacturers and health professionals are not subject to civil or administrative liability for any consequences resulting from the use of an unauthorised medicinal product, or from the use of a product otherwise than in accordance with its authorisation, when such use is by the licensing authority in response to (among other things) the spread of pathogens. This requirement is implemented into UK law by regulation 345.
What regulation 345 does, therefore, is transpose 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.
Since vaccines are apparently going to be administered on such a scale as to require a much larger workforce, staff additionally brought on, despite not being healthcare professionals in the usual sense, will also be exempt:
Vaccinators who are not registered healthcare professionals
It will also be apparent in what we say about workforce expansion that someone other than a registered healthcare professional may actually be administering unlicensed vaccines – and as a basic issue of fairness, we think they should benefit from the same immunity from civil liability as a registered healthcare professional who is performing the same role, if the person who is not a healthcare professional is following one of the proposed new protocols.
We also caution UK readers about this statement:
There is a possibility that both the flu vaccine and the COVID-19 vaccine will be delivered at the same time, and we need to make sure that in this scenario there is sufficient workforce to allow for this.
As we’ve already published, a Pentagon study has shown that flu vaccines can make recipients up to 36% more likely to get a NON-FLU viral respiratory infection. See here and here for that study. Other studies have shown the same thing, listed here. Intuition tells us that it’s probably not a good idea to mix vaccines, nor is there any safety data telling us if this is safe or not.
UK Government Grants Pfizer Civil Legal Indemnity for Covid-19 Vaccine
The UK government announced Thursday (Dec.3) that it had granted Pfizer legal indemnity protecting the American pharmaceutical company from civil lawsuits due to any unforeseen complications arising from problems with its COVID-19 vaccine.
The special legal indemnity was the result of an emergency government consultation in September, when the UK Department of Health & Social Care determined that changes to civil liability were necessary to better facilitate the widespread use of a COVID-19 vaccine in Britain.
The new regulation, Regulation 345 of the Human Medicines Regulation of 2012, prohibits civil liability against Pfizer or healthcare professionals distributing the vaccines for any damage that arises through use of the vaccine ‘in accordance’ with its recommended use. The Pfizer COVID-19 vaccine will, however, be scheduled alongside other vaccines subject to the Vaccine Damage Payments Scheme, which authorizes one-time payments of £120,000 for individuals who have been disabled in the rare case that a vaccine produces highly damaging side effects to patients. Such scheduling should allow claimants to still receive damages in the very unlikely event that they suffer serious side effects from the vaccine.
The UK is one of the first countries to grant emergency approval for the Pfizer vaccine, which it has done through powers granted in Regulation 174 of the Human Medicines Regulations. This Regulation sidesteps the usual licensing and authorization procedures that pharmaceuticals in the UK must pass before being approved for broad use.
Regulation 174 allows for emergency approval for medicinal products that may treat dangerous pathogenic agents, toxins, chemical agents, or nuclear radiation in Britain without needing lengthy periods of review. While Regulation 174 approval means that the vaccine will reach British patients quickly, the British Government has confirmed that Pfizer’s vaccine has still been subject to strict safety scrutiny and that the government is very confident in the vaccine’s safety for wide use.
Fred Porter is from the University of Pittsburgh School of Law
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