COVID-19: Government poised to amend regulations to allow use of unlicensed vaccine

Experts say robust legal protections are needed to inspire public confidence. The UK government has set out plans to amend drug regulations in case it decides that COVID-19 vaccines should be used before they are licensed, in a bid to roll them out more quickly.

In a consultation on the proposals that ran from 28 August to 18 September the Department of Health and Social Care for England explained that if a suitable vaccine emerged with strong evidence of safety, quality, and efficacy the government would seek to license it through the usual route but could supply it in the meantime.

The document added, “A COVID-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality, and efficacy of the vaccine. ‘Unlicensed’ does not mean ‘untested.”

The consultation, and the timeframe in which it was conducted, prompted some people to post their concerns on social media. 

However, the Human Medicine Regulations 2012 already allow the licensing authority to temporarily authorise the supply of an unlicensed product in response to certain public health threats, including the suspected spread of pathogens. The proposed change would allow conditions to be attached “to ensure product safety, quality, and efficacy”

The 2012 regulations also give healthcare professionals and manufacturers immunity from being sued in the civil courts for the use of some unlicensed products recommended by the licensing authority in response to a public health threat. The new regulations would extend the immunity to drug companies that have not manufactured the product but placed it on the market with the approval of the licensing authority, and they clarify the consequences for a breach of conditions imposed by the authority.

Social media posts play into existing concerns that many people might not accept the vaccine, as surveys indicate. Lawyers have told the Department for Health and Social Care that to inspire public confidence it must provide redress for the few people who might experience adverse effects.

Bozena Michalowska, a partner specialising in product liability at the law firm Leigh Day, said, “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.”

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Source: The BMJ, 28 September 2020