Unlicensed vaccine manufacturers are immune from some, but not all, civil liability

4 September 2020
What was claimed

If an unlicensed COVID-19 vaccine is rushed into use by the British government, then the vaccine’s manufacturers would be exempt from civil liability.

Our verdict

This is generally correct. EU law, which has been adopted by the UK, protects manufacturers from liability if the government decides to supply their vaccines without licensing. However, they are not exempt from all liabilities.

A Facebook post has drawn attention to an extract from a Sun article, which states that manufacturers of a potential fast-tracked Covid-19 vaccine would be protected from civil liability if the vaccine is later found to cause harm.

This is mostly true. 

UK law does not usually allow the sale or supply of medicinal products, including vaccines, without marketing authorisation (product licensing). 

However, this doesn’t apply when the sale or supply of a medicinal product is temporarily authorised in response to “pathogenic agents” such as the virus which causes Covid-19. 

So the government could authorise the supply of an unlicensed Covid-19 vaccine, although, to be clear, unlicensed does not mean untested. Any Covid-19 vaccine rolled out to the public, unlicensed or not, will still go through clinical trials. Licensing usually takes place after a vaccine has undergone various trials and can typically take weeks or even months.

Any decision to fast track unlicensed vaccines would be a decision made nationally and not by individual suppliers. Manufacturers “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”, according to a government consultation document. 

This is a part of EU law which has been implemented into UK law.

However, the government consultation document also states that the law “does not provide complete immunity from civil liability.”

If the product is not found to meet safety standards or is defective, then there is a liability. 

One of the scientists working on a potential vaccine has stated that, while processes have been sped up, this doesn’t mean steps to ensure safety have been missed.

Further guidance around what a breach of these standards would mean, or how it would be assessed is currently being consulted on.  

It has also been recently reported that at least one potential Covid-19 vaccine manufacturer, AstraZeneca, has been exempted from future product liability claims with most of the countries it has supply agreements with. The article states it is not clear which specific countries this is, but it does have a supply agreement with Britain.

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