On 28 August 2020, the UK Department of Health & Social Care published a consultation on proposed changes to the Human Medicines Regulations 2012 ("HMRs") to support the rollout of COVID-19 vaccines.
The UK government states that although it is preferable that a new vaccine for COVID-19 is deployed through the usual marketing authorisation (product licensing) process, a compelling case may arise, on public health grounds, to deploy a tested, unlicensed vaccine against COVID-19. The proposed amendments to the HMRs amend existing legislative measures to clarify the regulatory framework applying in that scenario.
Regulation 174 of the HMRs already allows the licensing authority to permit a temporary authorisation for the supply of an unlicensed medicinal product for use in response to certain specific types of public health threat, including the suspected spread of pathogens. In the government's view it is implicit under Regulation 174, as currently drafted, that a decision to authorise the supply of an unlicensed medicinal product could carry certain conditions. However, this is not expressly articulated. Therefore, the government proposes amendments to clarify that specified conditions may be attached to the supply of a product temporarily authorised under Regulation 174, thus enabling the licensing authority to define the safeguards that would be a pre-requisite for the safe supply and use of the product. Such safeguards could range from specifying who the product is suitable for, setting batch testing and quality assurance standards, and ensuring that appropriate storage is in place throughout the supply chain.
The HMRs also already recognise, by way of Regulation 345, that manufacturers or healthcare professionals asked to supply an unlicensed medicine in response to a public health threat, should not be held responsible for the consequences of the use of that medicine in the way that they normally would for an authorised product. The amendments now proposed seek to extend the immunity to any company (and not only the manufacturer) placing such an unlicensed medicine on the market with the approval of the licensing authority, and persons who are not healthcare professionals but who may administer the product. The amendments also seek to clarify the consequences on immunity should there be a breach of the conditions imposed by the licensing authority under the new Regulation 174A. The consultation notes that, consistent with EU law, this immunity does not extend to barring strict liability claims made under the Consumer Protection Act 1987 that implements the Product Liability Directive and, therefore, the ultimate value of this immunity may be limited in practice.
The proposals also seek to: (i) ensure that the UK has the available workforce to administer a COVID-19 vaccine and influenza vaccine; (ii) allow vaccines and treatments used in response to certain specific types of public health threat to be promoted as part of national vaccination or treatment campaigns; and (iii) provide an exemption from the need for a wholesale dealer's licence for NHS organisations, NHS contracted service providers and the medical services of the armed forces to allow the swift and safe transfer of COVID-19 and flu vaccines, and other medicines for treatment of pandemic disease, in response to patient need.
The consultation period will run until the end of Friday 18 September 2020. However, it is acknowledged that the government is moving as quickly as possible to make the legislative amendments and, therefore, it welcomes comments after the consultation has finished and, even after amendments to the legislation have been made, as the government will remain open to the possibility of making further changes, very rapidly if need be.
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