The European Union has been accused of risking lives by insisting on slow checks on vital medicines and potential coronavirus vaccines produced in Britain after Brexit.
Michel Barnier, the EU’s chief negotiator, has rejected UK calls for mutual regulatory recognition on medicines and medical devices during negotiations on the post-Brexit free trade agreement, which continue next week in Brussels.
British proposals would prevent the need for medicines, devices and any UK produced coronavirus vaccine to be tested twice in the newly separated UK and EU jurisdictions. This could lead to delays in critical supplies and cost companies hundreds of millions of pounds every year.
Supply delays for medicines are estimated at up to four to six weeks on average but substantially longer, up to four months, for complicated products such as vaccines.
A UK Government official said: “The UK’s proposals on medicines and medical devices would provide significant benefits to patients, industry and regulators in the EU and UK, including by avoiding any new delays to access to medicines.
“We hope that the EU will engage with the proposal so that we can deliver these mutual benefits, which are particularly important in the current public health context.”
The EU has agreements on batch testing of medicines with the USA, Switzerland, Japan, Canada, Israel, Australia and New Zealand on public health grounds but has refused to grant the UK similar terms.
EU sources rejected the claim that “onshoring” testing to the EU would risk lives. They insisted that most testing labs had already transferred their credentials to EU jurisdictions and the industry was ready for the end of the transition period on December 31.
Sam Lowe, trade expert at the Centre for European Reform think tank, said, “After Brexit, the EU cannot ignore the UK’s role in its medical supply chains and the fact is the EU is still going to import a lot of medicine from the UK.”
Britain is the number one supplier of medicines to the EU by volume and the third in terms of value. UK-EU trade was worth €32bn in 2018 with Britain buying €20bn worth of medicines from the EU and selling €12 bn into the bloc.
Supply chains are highly integrated with UK supplies accounting for a third of EU demand and UK manufacturers importing 54 percent of their ingredients from the bloc.
Coronavirus exposed the EU’s dependence on imports for medical supplies, particularly from China. The EU, which faces long-standing medicines shortages, should diversify its suppliers to build up its resilience to future shocks, Mr Lowe said.
“Britain will compete with China to be the third-biggest supplier of medical products to the EU even if new trade frictions between the EU and UK reduce trade. It is in the EU’s interest to engage with the UK’s request,” he said.
Medicines are repeatedly tested in batches, which will have to be shipped under strict storage rules and can, for some rare diseases, be as small as one dose.
If labs in the EU and UK returned different results, the release of medicines in both jurisdictions would be stopped with potential delays of between four to six weeks.
Vaccines require stricter testing in specialist laboratories known as Official Medicines Control Laboratories, which are part of the Official Control Batch Release Network.
It includes the UK’s renowned National Institute for Biological Standards and Control (NIBSC), which was responsible for the scaling up of vaccines for Ebola and Meningitis C.
The EU has rejected a UK proposal for mutual recognition and that the NIBSC stays part of the Network after December 31, despite agreeing similar terms with Israel..
British researchers in London, Cambridge and Oxford are working on a coronavirus vaccine, which could now be delayed by the need for re-testing.
Six pharmaceutical and medical trade associations urged Mr Barnier to prioritise access to medicines over “larger political considerations”.
“Failing to agree key medicine provisions […] will only introduce unnecessary uncertainty and disruption and divert resources at a time when governments and industry need to fully focus on finding a solution to end this pandemic,” the lobby associations said in June.
The UK wants mutual recognition of Good Manufacturing Practice site inspections and batch testing certificates to prevent multiple inspections and testing of medicines. It wants “mutual recognition agreements for conformity assessments” for medical devices.
EU diplomats said that caving to the UK demands would not be accepted by the bloc’s member states.
“Testing and batch release sites will need to be located in the European Union,” a European Commission document published on Thursday said.