The European Commission and the European Medicines Agency issued a joint four-page document that set out how it saw operations working over Brexit.
The document stated that UK companies would have to set up some operations related to drug safety and approval with the EU to ensure their products comply with EU requirements.
It added that authorisation to sell a drug within the European Economic Area would have to be given by at least one member state’s regulatory body.
The EU could impose red tape and levies on British medicines imported into the EU
The Brussels paper illustrated the amount of disruption that could be caused to UK companies.
The Association of the British Pharmaceutical Industry (ABPI) said that setting up any such operation could take several years, which added pressure on the Government to negotiate a deal, or even a transitory agreement, before the expected date of the UK’s exit from the bloc.
ABPI Executive Director Dr Virginia Acha said: “The UK and European life sciences industry has regularly highlighted the importance of resolving the regulatory, supply and trading arrangements for medicines after the UK leaves the European Union, and the complexity involved in this process.
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“As such, we welcome the efforts of the EMA and others in helping companies to consider these issues and prepare for the future.
“However, the Brexit negotiations between the UK and EU have yet to start and their ultimate outcome is unknown, so it seems premature to advise companies to prepare only for an outcome where the UK is isolated from the European system.
“This Q&A refers to some of the many potential challenges ahead and further discussion and guidance will be needed as we seek to ensure that medicines continue to be developed and delivered to patients across Europe."
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ABPI Executive Director Dr Virginia Acha
Dr Acha added: “In an outcome where the UK is isolated from the European system for medicines regulation, companies in the UK will have to consider all options for the location of sites, systems and staff, to meet the requirements of the EMA and other regulatory bodies.”
Currently the EMA is based in Canary Wharf, east London, which is responsible for authorising medicines for sale across the EU.
However the European Union has stated that the body cannot remain in Britain once it has withdrawn from the bloc.
With that in mind the paper states that should the EU and UK not reach an agreement before the Brexit deadline then both substances used in the manufacture of the medicines, as well as the final product, would be considered imports and so impose a levy.
European Commission President Jean-Claude Juncker
The move could have a big impact on Britain’s lucrative generic industry which would be hit by such a tax.
The British Generic Manufacturers Association estimates that its medicines have saved the National Health Service about £13billion a year.
Health Secretary Jeremy Hunt told a Commons committee in January that the EMA is likely to move its office from London to elsewhere in Europe.
MPs were told the UK would seek a “relationship” with the EMA after Brexit, but the Health Secretary did not say if the Government would seek continued membership.