UK will accept EU pharma testing even if no Brexit deal struck

But UK companies will not be able to sell medicines to the EU based on UK testing unless the EU changes its position on pharmaceuticals regulation.

The UK government confirmed the position in one of a series of technical notices published today on the implications of a 'no deal' Brexit for businesses and consumers.

The move ensures that the existing practice of accepting EU-based batch testing of medicines will continue in the UK even if the UK fails to reach an agreement with the remaining 27 EU member states on the terms of its withdrawal from the trading bloc by the scheduled date of Brexit, 29 March 2019.

The government's 'no deal' technical notice on batch testing medicines said: "The UK will continue to accept batch testing of human medicines carried out in countries named on a list set out by the MHRA (Medicines and Healthcare products Regulatory Agency). On exit day, this list would include EU countries, other EEA countries and those third countries with which the EU has an MRA (mutual recognition agreement)."

The same arrangements will apply to investigational medicinal products, which are substances being used in medical trials, where they are manufactured in EU and EEA states, the government said.

The government said the arrangements around batch testing in a no deal scenario that it has outlined would not be altered without industry consultation.

"These arrangements will continue until the government considers any further change is necessary," it said. "We are committed to working with industry ahead of any such changes to the arrangements outlined in this technical notice which might impact supply chains and manufacturing processes, and to giving at least two years notice of the introduction of any changes, in order to allow industry to fully prepare for their implementation."

The government said the position it has taken would "ensure continuity of supply in medicines" in a no deal scenario.

However, its approach is different to the one outlined earlier this summer by the European Commission and European Medicines Agency (EMA) regarding post-Brexit recognition of UK regulatory processes in the pharmaceuticals sector.

According to a 'question and answer' paper (10-page / 577KB PDF) the Commission and EMA issued, UK-based pharmaceutical companies will be unable to rely on marketing authorisations (MAs) issued by the MHRA to sell their products across the EU after Brexit in a no deal scenario.

"The approach advocated by the UK government would allow pharmaceutical companies based in and operating primarily in the EU to continue to supply products into the UK," said life sciences expert Catherine Drew of Pinsent Masons, the law firm behind Out-Law.com. "However, the same does not appear to be the case for UK companies seeking to import their products into the EU."

"The EMA has made it plain for some time that it is proceeding on the basis that the UK would become a third country post 30 March 2019 and as such companies must ensure that those obligations set out in the EU's directives on medicinal products which must be carried out in EU member states, continue to be done so post-Brexit. In effect this means that companies with test and release activities in the UK, hoping to sell their product in EU markets, will need to move those activities to another EU member state post 30 March 2019," she said.

The scenario highlighted by Drew was also identified by Dublin-based life sciences expert Karen Gallagher of Pinsent Masons at the time of the Commission and EMA announcement.

Gallagher said: "EU law requires that MA holders of centrally authorised medicinal products for human and veterinary use are established in the EEA, and that pharmacovigilance and batch release processes are carried out within the EEA by persons established in the EEA. Following Brexit, active substances manufactured in the UK will be treated as imported active substances, and will have to be manufactured in compliance with EU standards of good manufacturing practice. In addition, companies manufacturing finished products in the UK will need a site of batch control within the EEA."

"The EMA expects UK-based MA holders to take steps before 30 March to make any necessary changes to their existing marketing authorisations or applications and/or transfer them to holders located in the EU. In addition, UK based pharma companies without an alternative EU base will need to transfer some or all of their operations to an EU member state," she said.

In a statement announcing the publication of 25 of the government's new 'no deal' technical notices, the UK's secretary of state for exiting the EU, Dominic Raab, said the UK's position of accepting the testing and safety approvals of existing medicines was "pragmatic" and said he hoped the EU might change its mind and reciprocate.

"It is a sensible approach, for two reasons," Raab said. "First, it simplifies the planning for those businesses that are exporting from the EU, by avoiding the need, at short notice, to adapt to new regulations. Secondly, it minimises any potential disruption for UK businesses or consumers relying on that particular source of supply, in this case medicines from the EU."

"Of course, given that we start from a position of common rules, we would also hope and I think expect, in good faith between close partners that the EU would recognise medicines from this country with our regulatory approval. But in a no deal scenario, we can’t guarantee it," he said.