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Executive Summary

The UK pharmaceutical industry is concerned about potential barriers to trade that might arise with the EU post-Brexit, especially if co-operation mechanisms such as mutual recognition agreements are not in place by the time the UK leaves. API manufacturers have specific worries, but there won’t be answers for some time.






Active pharmaceutical ingredient (API) manufacturers in the UK seeking to export to the EU post-Brexit could in theory be required in advance to have written confirmation from the country’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), that they comply with EU good manufacturing practices (GMP).


Getting on the EU’s so-called “white list” of accredited countries whose GMP framework is considered equivalent to that of the EU would solve the problem, according to Peter Gough, executive director of the pharma-biotech division of NSF Health Sciences.


Gough referred to barriers to trade that might exist in the pharma sector post-Brexit at a seminar in London on March 1 at which MHRA chief executive Ian Hudson spoke. The UK will be a “third country” once it leaves the EU; in addition to the potential import restriction regarding APIs, Gough pointed out, finished and semi-finished pharmaceuticals destined for importation to EU member states will be subject to retesting before entry. Unless, that is, a mutual recognition agreement between the UK and the EU – such as exists between Switzerland and the EU in this area – is in place.


In a Q&A session at the seminar, Gough suggested from the floor that the barriers to trade that he mentioned would be negated “if we got a mutual recognition agreement with the EU and the UK went on to the European Commission’s ‘white list’ for APIs”. “How long do you think it would take to get those mechanisms in place and can that be accomplished in two years?,” he asked the presenting panel.


[There is a two-year period during which the Brexit negotiations will take place. The UK government’s Brexit bill suffered a setback on March 1, but Prime Minister Theresa May seemingly still hopes to notify the EU officially of the country’s plan to leave by the end of this month and so trigger the start of official talks. March 15 is being mentioned as the date this will happen.]


Hudson was diplomatic in his answer to Gough, whose company provides auditing, consulting and education services to life science companies. “The final model of what is mutually recognised, what is co-operation and what is stand-alone will really depend on all the negotiations,” Hudson said. There will be some elements where the UK would want to have mutual recognition, some elements where it would want co-operation and some elements where it would want to do things itself, he added.


“None of us know where we will end up in all of this,” Hudson said. It was, though, “right that we get all the issues on the table” and work out what issues need to be considered or addressed “from day one”.


With regard to APIs, Gough was referring specifically to EU rules under which compliance with EU GMP must be confirmed in writing by the relevant authorities in the exporting country for each API manufacturing plant. This requirement is waived for exporting countries that are on the Commission’s “white list”, a list of accredited countries whose GMP framework is considered equivalent to that of the EU. The rules, which came into force in July 2013, are part of the EU Falsified Medicines Directive and apply to all APIs imported into the European Economic Area (the EU plus Iceland, Liechtenstein and Norway). (Also see "Ruffled feathers and interim measures: API rules applied" - Scrip, 20 Sep, 2013.)


*Ian Hudson was speaking at seminar in London on March 1 entitled “The future of the life sciences sector in the UK – funding, regulation and the impact of Brexit”. The seminar was organized by the Westminster Health Forum, whose core sponsors are drug company Boehringer Ingelheim and Optimity Advisors, an advisory firm that focuses on strategy, operations and IT.


From the editors of Scrip Regulatory Affairs.

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