A vaccine against coronavirus could be rolled out as an unlicensed medicine under planned changes to the law which will also protect pharmaceutical companies from being sued if the vaccine causes side-effects.
Ministers have launched a short three-week consultation on plans to allow the medicines regulator to authorise any vaccine for use once clinical trials demonstrate it is safe.
Currently, during the Brexit transition period, the responsibility for licensing a vaccine rests with the European Medicines Agency but UK ministers want the ability to press a vaccine into service if they believe it is needed before a full license is granted.
The measures could come into force by October, ahead of the winter season but the Department of Health and Social Care said they would be used as a last resort.
As part of the rule changes pharmaceutical companies who create a vaccine that is used before it is fully licensed will be specifically protected from being sued.
The consultation document published today said: “This will help to give companies willing to cooperate in the sort of mass vaccination programme under consideration for Covid-19, or mass distribution of treatments in other situations, some assurance that they will not be exposed inappropriately to civil liability.”
Companies could still be liable under the Consumer Protection Act if a vaccine is found to be defective but only if it were possible to identify the problem before the vaccine was put on the market.
The government has not said whether the vaccine will be added to the Vaccine Damages Payment scheme, which pays £120,000 compensation to patients harmed or disabled by vaccinations.
During the swine flu pandemic in 2009 the UK rushed into use a vaccine created by GlaxoSmithKline (GSK) which had not gone through the normal testing process. It was linked to a small number of patients developing the debilitating condition narcolepsy.
The then Labour government indemnified GSK and subsequent legal action by more than a hundred people is believed to have cost taxpayers millions of pounds.
Peter Todd, a partner at Hodge Jones and Allen, which represented Pandemrix claimants said today’s announcement raised many questions.
He told The Independent: “Usually the protection to workforce is by a government indemnity, not through immunity.
“The DHSC [Department of Health and Social Care] statement does not mention if the government has indemnified the manufacturer of any Covid-19 vaccines – I think we should be told. I am sure they will have.
“The statement does not mention if Covid vaccines will be added to the Vaccine Damage Payment Act scheme, in the same way as the swine flu vaccines of 2009-10 were added. I think we should be told about that.”
He also questioned whether granting pharmaceutical companies immunity from civil claims complied with the Human Rights Act and the Article 6 right to a fair trial.
He added: “Claims against immunisers can arise due to circumstances such as vaccinating without informed and incorrect method of vaccination.”
From next year the Medicines and Healthcare products Regulatory Agency will have a new UK based licencing system in place and will be responsible for granting licenses for potential Covid-19 vaccines and treatments.
The government said the law changes were a “precautionary measure” if for some reason the EMA does not grant a license to a vaccine which is available this year.
Most experts say a vaccine is unlikely to be available until 2021.
Deputy chief medical officer Professor Jonathan Van-Tam said: “We are making progress in developing Covid-19 vaccines which we hope will be important in saving lives, protecting healthcare workers and returning to normal in future.
“If we develop effective vaccines, it’s important we make them available to patients as quickly as possible but only once strict safety standards have been met.
“The proposals consulted on today suggest ways to improve access and ensure as many people are protected from Covid-19 and flu as possible without sacrificing the absolute need to ensure that any vaccine used is both safe and effective.”
The consultation launched on Friday will amend the Human Medicine Regulations 2012 Act and also consider expanding the workforce who can deliver vaccine jabs.
In the event of an effective vaccine the government wants to train more doctors, nurses and other staff who are not currently involved in vaccination efforts to be drafted in. This could include giving the seasonal flu jab as well.
The regulations will extend indemnity protection to allow more staff to administer vaccines including unlicensed medicines, to make it easier and quicker to vaccinate large numbers of people.
The DHSC said the expanded workforce will undergo a robust training programme, and could include midwives, nursing associates, operating department practitioners, paramedics, physiotherapists, pharmacists and even student doctors and nurses.
It declined to say whether it had indemnified any pharmaceutical companies, citing commercial confidentiality. It also said officials were exploring adding the Covid-19 vaccine to the Vaccine Damages Payment Scheme.
A spokesperson added that the changes had been based on existing rules that had not previously been questioned from a human-rights perspective.
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