Spotlight On MRNA ' Regulation Of MRNA Vaccines And Therapies

• Published date: 22 November 2021
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Coronavirus (COVID-19), Biotechnology & Nanotechnology, Government Measures, Operational Impacts and Strategy
• Law Firm: Bristows
• Author: Hugo Kent-Egan and Julian Hitchcock

Regulation of mRNA vaccines and therapies

Earlier in this series we considered some of the potential uses of synthetic mRNA to prevent or treat diseases. In this article, we take another look at these uses and set out how mRNA therapies are currently regulated, with a focus on the much publicised mRNA COVID-19 vaccinations. Finally, we consider the potential for regulatory flexibility in this exciting and rapidly developing area.

As set out in previous articles, mRNA technology can essentially be viewed as a consisting of two parts: (1) the delivery system and (2) the coded mRNA itself. The delivery system ensures the mRNA gets into the intended cells in the body effectively and safely. The mRNA component corresponds to the specific genetic sequence of the protein or antigen you want the cells to produce. This two component model is central to the current debate around the approval and regulation of mRNA therapies and how to apply the existing framework to these therapies.

Medicine authorisation routes

The regulatory starting point in the EU and UK for mRNA therapies is that they are regulated as human medicines. There are some specific considerations for each type of therapy but in general they are regulated by the same legislation that applies to most medicines, from over-the-counter household names such as paracetamol to ground breaking gene therapies such as Zolgensma.

There is specific additional legislation for therapies classed as advanced therapy medicinal products (ATMPs)¹. ATMPs include gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered products. At present, the only mRNA therapies to have received regulatory approval are the vaccines against COVID-19. Vaccines are specifically excluded from the definition of a gene therapy medicinal product and therefore these mRNA therapies are not classed as ATMPs. Future mRNA therapies may well be regulated by the ATMP legislation and therefore subject to the additional requirements this entails but this will depend on the scientific intricacies underpinning each therapy.

All medicines must be authorised by the relevant regulator, the MHRA in the UK and the European Medicines Agency (EMA) in the EU, before they can be put on the market. Usually this authorisation takes the form of a marketing authorisation (MA).

In the EU there are two main routes for authorising medicines, the centralised route and the national route. Prior to Brexit, medicines approved through a...