The UK Government has set out proposed changes to the way in which medicines in the UK are authorised for use in a recent consultation paper, specifically referencing COVID-19 vaccines.
Government proposal to relax regulation of Covid vaccines
Unless exempt, in accordance with Regulation 46 of the Human Medicines Regulations 2012 (“HMRs”), medicinal products within the UK must have a marketing authorisation before being placed for sale or supply. Authorisation is granted by The Medicines and Healthcare Products Regulatory Agency (“MHRA”), which is the UK’s licensing authority. A medicinal product with a marketing authorisation is a ‘licensed’ medicinal product.
The MHRA is responsible for regulating medicines, medical devices and blood components for transfusion in the UK. During the UK’s membership of the EU, and the transition period ending on 31 December 2020, biotechnological medicines such as proposed COVID-19 vaccines are required to be authorised by the European Medicines Agency (“EMA”). From 1 January 2021, however, the MHRA will have increased powers to license all medicines, including vaccines.
Since the beginning of the COVID-19 crisis, governments around the world have funded research into possible vaccines. There was no knowing then how the crisis would pan out, but in view of the recent spike in COVID-19 cases, it would seem that a vaccine may be the only way to slow the spread sufficiently as to allow some normality to return to our lives. It is not surprising, therefore, that the Government is anxious to ensure that there is no delay in rolling out a suitable vaccine as soon as it is available.
The Government hopes to use current legislative provisions including Regulation 174 of the HMRs, to allow the MHRA to temporarily authorise the supply of a vaccine which has not gone through the full market authorisation process.
Regulation 174 provides an exemption to Regulation 46, and allows the MHRA to authorise the sale or supply of a medicinal product on a temporary basis in response to the suspected or confirmed spread of, amongst other things, pathogenic agents. The Marketing Authorisation process is lengthy, taking up to 210 days. In view of the COVID-19 pandemic, the Government anticipates it being necessary for the MHRA to use it powers under Regulation 174 to avoid any delay in administering vaccines to the UK population.
The Government is keen to emphasise that ‘unlicensed’ does not mean the vaccines will be untested. The MHRA will need to consider that the balance of risk and benefit to patients justifies the temporary supply of the vaccine, pending the issue of a product licence. The consultation paper does not seek to remove the requirement for strong supporting evidence of safety, quality and efficacy.
Further, any decision to authorise the supply of an unlicensed medicinal product could carry certain conditions as expressed by the MHRA. One of the proposed amendments makes it explicit that any temporary authorisation may be subject to conditions to enable the MHRA to define the safeguards that amount to a pre-requisite for the safe supply and use of the unlicensed medicinal product.
Since sufficient evidence of safety, quality and efficacy will still be required, the conditions imposed on any COVID-19 vaccine temporarily authorised using Regulation 174 are likely to be equivalent to the requirements of a marketing authorisation. It is only anticipated that the proposed amendments will allow for a flexible and pragmatic approach on how a national vaccine programme can be deployed.
It is worth noting that the government’s ‘preferred approach’ to enabling deployment of a vaccine for COVID-19, is utilising the MHRA’s usual Marketing Authorisation process. The proposed changes are to ensure that there is a legal basis for permitting temporary authorisation of an unlicensed vaccine, if there is a compelling case on public health grounds, given the nature of the threat we face as a nation. It is acknowledged that this is a very unusual situation. Only time will tell how compelling the case might be by the time an appropriate vaccine is available.
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