Immunity from civil liability


23rd October 2020

The Government anticipates that the Medicines and Healthcare Products Regulatory Agency (“MHRA”) will make use of its powers under reg.174 of the Human Medicines Regulations 2012 (“HMRs”), and temporarily authorise use of an unlicensed vaccine. This is in response to the specific health threat we face, in order to avoid any delay in rolling out a nationwide vaccination programme. The proposed changes are to ensure appropriate legislative measures are in place to support any such decision.

Unlicensed vaccines to prevent delay

The HMRs recognise that where manufacturers and healthcare professionals are asked by the MHRA to supply an unlicensed medicinal product, it would be unfair to ask them to accept responsibility for the consequences resulting from use of the product. Manufacturers and healthcare professionals are granted immunity from civil action in reg.345.

Regulation 345 transposes into UK law Article 5(3) of Directive 2001/83, which is a requirement that Member States set out provisions to protect manufacturers and healthcare professionals from civil liability arising from use of an unlicensed medicinal product in response to the spread of pathogens, such as COVID-19. The Directive does not, however, include pharmaceutical companies in the immunity from civil liability. The UK government proposes to amend the legislation to extend immunity to pharmaceutical companies also. In doing so, companies willing to cooperate in a national vaccination programme can be assured that they will not be exposed inappropriately to civil liability.

The consultation paper aims to clarify the scope of the immunity from civil liability contained in reg.345, so that it also applies to the company placing an unlicensed vaccine on the market; and to set out the consequences of breaching any of the conditions that the MHRA may place on the temporary authorisation.

Clarification about our future relationship with the EU is still required.

Our Brexit Virtual Conference on 24-26 November will give you clear guidance.

Sign up here

Enjoy That? You Might Like These:


articles

20 March -
The Anaesthesia Associates and Physician Associates Order 2024 (AAPAO) was made on 13 March 2024. The AAPAO is significant for two reasons: It brings anaesthesia associates and physician associates into... Read More

articles

19 March -
How do you grow a business? Not an easy question to answer as there are so many elements for start-ups to consider, but taking on board advice from those that... Read More

case-studies

21 February -
In an appeal against a Fitness to Practise panel decision, the High Court considered the issue of the correct basis for a case being remitted for re-hearing. This proved to... Read More