On 2 December 2020, the majority of the UK population would have woken up to the news reporting that a COVID-19 vaccine has been authorised by the UK medicines regulatory body, the Medicines and Healthcare Regulatory products Agency ('MHRA').
This positive development has understandably been met with relief as well as keen anticipation of the vaccine roll-out. The media moved quickly in scrutinising the speed of regulatory approval and concerns around access to the vaccine. Clearly, these are issues of paramount importance but what is perhaps less widely reported is the regulatory mechanics through which the Pfizer and BioNTech vaccine has been authorised. Yesterday's approval by the MHRA falls under the legal mechanism referred to as a 'temporary use authorisation'. In this short blog, we explain the procedure under which a temporary use authorisation is granted and the liability exemptions that apply to this regulatory approval route.
What is a temporary use authorisation?
In the UK, the regulation of medicines is shaped by EU law and provides a framework for the robust regulatory scrutiny of medicinal products. The Human Medicine Regulations 2012 ("HMR 2012") is the core UK legislation governing the regulation of medicinal products.
Temporary use authorisations under HMR 2012 permit the supply of an unlicensed medicinal product for use in response to certain specific types of public health threat, including in response to the suspected or confirmed spread of pathogenic agents. The UK Government recently elaborated on this provision by specifying conditions of authorisation – specifically having in mind the roll-out of a Covid-19 vaccine programme. The implementation of the Human Medicines (Coronavirus) (Amendment) Regulations 2020 (the "2020 Regulations") now permits the grant of a temporary authorisation of an unlicensed product subject to specific conditions of safety, quality and efficacy, as may be prescribed by the MHRA.
The distinction between a marketing authorisation and a temporary use authorisation
Subject to narrowly defined exceptions, all medicines must obtain a marketing authorisation from the MHRA or European Medicines Agency (EMA) (depending upon the licensing approval route) before that medicine can be placed on the market. Prior to obtaining regulatory approval, sufficient evidence on the safety, quality and efficacy of the product must be demonstrated. There are similar requirements for applicants for temporary use authorisations. However, it is important to emphasise that a temporary use authorisation is not equivalent to a marketing authorisation approval. A standard marketing authorisation grants regulatory approval for a given indication for an initial period of 5 years (but can be renewed for unlimited validity) in the relevant territory. By contrast, for a temporary use authorisation, the product authorisation is valid for 1 year and the holder will be required to complete specific obligations (i.e. ongoing or new studies, and in some cases additional activities) with a view to providing comprehensive data confirming that the benefit-risk balance is positive. Once comprehensive data on the product have been obtained, the marketing authorisation may be converted into a standard marketing authorisation (not subject to specific obligations) which would mean that the 5 year initial validity period would apply (with the possibility of unlimited validity thereafter).
A product granted a temporary use authorisation is not a licensed product in regulatory terms. Its permitted use is authorised for a fixed period and the product remains subject to any conditions stipulated by the MHRA. However, it must also be stressed that in this context, ‘unlicensed’ does not mean ‘untested’. Indeed, citing the example of the Pfizer and BioNTech approval, the scale of that clinical trial was vast and involved in excess of 43,000 trial subjects with a reported efficacy of 95% in preventing mild to severe COVID-19 disease (based on the results from the phase III study).
Under EU law, Directive 2001/83/EC (the 'Medicines Code') contains rules that shield marketing authorisation holders, manufacturers and health professionals from civil liability arising from the use of an unauthorised medicinal product, or from the use of a product otherwise than in accordance with its authorisation, when such use is by the licensing authority in response to (among other things) the spread of pathogens.
The public policy rationale behind this principle is to provide a legal protection against exposure to litigation for companies who are willing to innovate into the development and manufacture of vaccinations to tackle global health threats such as COVID-19. The principle established under Article 5(3) of the Medicines Code was implemented into UK law by Regulation 345 of the HMRs. However, the exemption does not extend to the risks posed by defective products. In a UK context, a manufacturer would still hold liability for a defective product that meets the conditions under section 2 of the Consumer Protection Act 1987.
Why was the Pfizer – BioNTech vaccine approved by the MHRA (not the EMA)?
The UK formally withdrew from the EU on 31 January 2020 but EU law continues to apply to the UK during the Brexit transition period until 31 December 2020. Until the end of this period only the EMA can grant licences for COVID-19 vaccines. However, the above-mentioned 2020 Regulations create the mechanism through which the MHRA could grant the temporary use authorisation for the Pfizer and BioNTech vaccine.
It should also be noted that on 1 December 2020, Pfizer and BioNTech submitted their application for conditional marketing authorisation for their COVID-19 vaccine to the EMA. The assessment will proceed under an accelerated timeline and a marketing authorisation opinion could be issued within a matter of weeks. This expedited approval is possible because the EMA has operated a rolling review approach to expedite vaccine approval during the COVID-19 pandemic.