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.
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