Call for post-Brexit medicines regulation guidance

To get a single authorisation for selling new medicines across the whole of the EU, medicines manufacturers must apply to the EMA for marketing authorisation.

Catherine Drew of Pinsent Masons, the law firm behind Out-Law, said, though, that it is not clear what further steps manufacturers that submit their applications to the EMA during the Brexit transition period will be required to undertake in order to be authorised to sell those medicines in both EU27 countries and the UK once the transition period ends on 31 December this year.

The issue remains uncertain despite the publication of new Brexit 'Q&A' guidance earlier this week by the EMA, she said.

"What clients want to know and where guidance from the UK and EMA is currently lacking, is what happens after 31 December 2020 and what steps must be taken and timelines for the same, to ensure that applications currently pending before the EMA result in granted marketing authorisations valid in both Europe and the UK," Drew said.

In its new Brexit guidance, the EMA stated that there will be no "Brexit-related shortages of human or veterinary medicines" during the transition period. It outlined the actions being taken in the EU to avoid shortages arising after Brexit, which include encouraging UK-based pharmaceutical companies to transfer "essential operations" to within the EU or wider European Economic Area.

The EMA said: "If a company does not transfer relevant operations from the UK to one of the remaining EU/EEA member states in time before the 31 December 2020, the company may no longer be able to put the medicine on the market until it has made the necessary changes. These changes have to occur within a certain timeframe."

"EU/EEA authorities cannot force companies to act but it is in the companies’ interest to do so if they want to continue to serve the needs of patients and animals in the EU. EMA, the [European Commission] and EU/EEA member states have been monitoring the situation and advising companies on the necessary steps to take and urging them to make these changes in time in order to allow continued availability of medicines after the transition period. However, ultimately the responsibility to transfer relevant activities and to continue marketing a medicine in the EU/EEA lies with the company holding the medicine’s marketing authorisation," it said.

The EMA also urged pharmaceutical companies to take action in areas beyond the control of the EU authorities to "minimise the potential for supply disruptions after the transition period".

Catherine Drew of Pinsent Masons explained that the UK's exit from the EU on 31 January also has an immediate impact on the role the UK's The Medicines and Healthcare products Regulatory Agency (MHRA) can play in the decentralised procedure for medicine authorisations.

The decentralised procedure is another route by which companies can obtain marketing authorisation for medicinal products, currently for use in the UK and EU member states.  While the EMA procedure provides manufacturers with scope to obtain a single authorisation for marketing medicines across all of the EU and EEA, the decentralised procedure offers medicines manufacturers scope to obtain a bundle of national authorisations for marketing medicines via a system of mutual recognition that national medicines regulators in the EU and EEA participate in.

"Previously UK-based manufacturers seeking a bundle of national authorisations in certain EU states including the UK would be able to apply to the MHRA under the decentralised procedure," Drew said. "Within their application they could designate other EU member states in which they wished to obtain authorisation to sell their products. The MHRA would then lead the assessment of that application which would be discussed between the agencies of all those EU member states designated in the application."

"Now, however, as the UK has formally exited the EU, the MHRA can no longer lead these types of assessments. If a UK-based company wants an EU marketing authorisation they need to apply to the EMA, or apply under the decentralised procedure but using a different national agency based in an EU country as the reference agency. The UK can be listed as a concerned member state within that application during the Brexit transition period," she said.