Brexit is shifting drug industry’s focus away from UK, MPs hearBMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j5668 (Published 06 December 2017) Cite this as: BMJ 2017;359:j5668
Drug companies seem to be looking to base future operations and processes outside the UK because of uncertainty caused by Brexit, MPs have been told.
During an evidence session of the parliamentary business, energy and industrial strategy committee’s inquiry into the implications for British business of leaving the EU, witnesses representing the drug industry said that changes in the sector were already evident.
Contingency plans were being drawn up in case the UK did not secure a Brexit deal that included “regulatory alignment” with Europe over medicines, they warned during the evidence session, held on 5 December. MPs asked whether any noticeable changes had occurred since the Brexit referendum in June 2016 regarding investment decisions and behaviour in the drug sector.
Paul Fleming, technical director for the British Generic Manufacturers Association—which represents UK based manufacturers and suppliers of generic medicines—said that the situation over quality control testing of batches of medicines had changed.
“At the moment that is done once and once only for the whole of Europe,” he said. “If there’s any risk of duplication on that, for example if the UK had to repeat that testing, that would have a very significant impact.”
Fleming added, “People are changing their behaviour and planning for that possibility by either thinking about building new facilities or moving to alternative facilities. Some companies are starting to do that already because of the time that that process takes.”
Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry and a fellow witness, said, “AstraZeneca have said they are having difficulty attracting some people to take up jobs in the UK. It’s understandable that if you’re coming from the continent, at this moment in time, it doesn’t seem like a good idea to move your family when there’s a period of uncertainty.”
Some drug companies had delayed making business decisions because of Brexit, he said, and some smaller companies were thought to have decided to move from the UK to Switzerland.
“GSK [GlaxoSmithKline] have announced that they are going to build some batch release sites on the continent because there is a requirement under EU law for batch release to be done in an EU state for those medicines that can only be distributed to the EU,” said Thompson.
Before the session the committee published written evidence submitted from 19 organisations. In its submission the BMA warned that, if the UK became a “second tier” market, the availability of new drugs and devices for patients in the UK could be delayed by as much as 24 months.
The BMA wrote, “Should the UK develop a significantly different regulatory process to the European Medicines Agency over time, there is a risk that the increased time and cost burden the pharmaceutical industry would incur through the duplication of processes, may lead to the industry prioritising the launch of new medicines sales in the significantly larger European market over the UK.”
During the evidence session witnesses also highlighted the dangers of having different systems in the UK and the EU for governing clinical trials.
Thompson said that companies doing clinical trials would be likely to choose EU sites to avoid having to go through two systems of approval after Brexit—the EU’s system and the UK’s. “It’s quite likely that the UK would miss out,” he argued.