The European Commission made clear this week how it intends to treat API makers from the U.K. after that country gives up its EU membership: just like it treats those from China and India.
The EU this week posted a Q&A that it sent to drug companies that says upon U.K.’s so-called Brexit from the union, currently slated for the stroke of midnight on March 30, 2019: “The United Kingdom will then become a 'third country.'"
And third countries, like China and India, must jump through special hoops when they export active ingredients to EU members. That means APIs have to be manufactured according to all of the EU cGMP guidelines, of course, but in addition, they must be shipped with a written confirmation from the “competent authority of the exporting third country” that verifies a plant has been inspected and its processes are up to European Medicine Authority standards.
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The rules were put in place in 2013 when concerns about poorly manufactured drugs and counterfeits were running high in the U.S. and Europe. That was the year that India's Ranbaxy Laboratories, now owned by Sun Pharma, pleaded guilty in the U.S. to charges of shipping adulterated drugs and agreed to pay $500 million in penalties.
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At the time the rules were implemented in the EU, drugmakers were concerned that they would be cut off from needed API supplies because China and India, their largest API suppliers, might be unable to meet the deadline to inspect and approve API makers. Many started buying from API makers in the EU, including the U.K., to avoid disruptions.
There is an out for U.K. API makers. Countries that are deemed to have “equivalent” standards to those of the EU, like the U.S., do not have to include the confirmations. Of course, as a member, the U.K. was on equal footing, but it would now have to get that designation and that requires an audit by the European Commission, which can be a lengthy process.
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Finished products manufactured in the U.K. also will have new rules to meet, including having a site in the EU where each batch can be tested and certified, including a quantitative analysis of the APIs in the drugs.