The UK government announced Thursday 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 Regulations of 2012, prohibits civil liability against Pfizer or healthcare professionals distributing the vaccine 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 U.K. 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.