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The announcement that Europe’s drugs regulator will move to Amsterdam after Brexit provided long-sought clarity for its 900 staff currently in London’s Canary Wharf.
But to the pharmaceutical industry it was a reminder of how many critical issues remain unresolved just 16 months before cross-Channel collaboration over medicines regulation and patient safety looks set to end.
For pharmaceutical executives in the UK, the challenge will be to unpick decades of integration, throwing up issues not just for British patients but for those all over the continent.
The first problem is administrative. According to the European Federation of Pharmaceutical Industries and Associations, UK-based companies hold the marketing authorisations, or licences, for about 2,400 medicines across the EU.
After Brexit, and after the European Medicines Agency moves to Amsterdam, it will have to transfer these licences to another member state to allow the drugs to continue to be sold across the EU.
Guido Rasi, executive director of the EMA, on Tuesday insisted that the agency had already prepared plans to divide the workload currently undertaken by the UK’s national regulator, the Medicines and Healthcare products Regulatory Agency, among the other member states. The bill for relocation will amount to about €400m, since the EMA does not have a break clause on its London headquarters.
The MHRA, one of the most respected of all national regulators, currently undertakes about 30 per cent of the work to assess and inspect medicines across Europe
One in five EMA staff may not choose to move to Amsterdam, according to internal surveys, Mr Rasi acknowledged, signalling that the industry as a whole must prepare to duplicate infrastructure in the UK and EU.
“If we would like to avoid problems in terms of the supply of medicines and shortage of medicines they will have to do all the necessary steps in order to make sure we are not confronted with that situation,” he said.
For industry, this means planning for a no-deal Brexit even as it continues to hope that arrangements can be agreed that will allow for continuing mutual recognition on medicine approvals.
Then there is the wider problem of avoiding disruption to cross-EU drug supply chains.
Nathalie Moll, director-general of the European Federation of Pharmaceutical Industries and Associations, pointed to a recent survey of her members that revealed more than 2,600 products are partly manufactured in the UK.
Each month, the UK supplies 45m packs of medicine to the EU and European Economic Area countries and imports more than 37m packs in the other direction.
Should the UK wind up falling back on World Trade Organisation rules, 45 per cent of EFPIA members expect trade delays, according to the survey. WTO rules would also theoretically leave any medicine created after 2010 subject to tariffs.
Industry leaders, not just in the UK but the rest of Europe, have been spelling out the consequences to their own member governments, and national regulators, in an attempt to galvanise continuing future co-operation.
Steve Bates, chief executive of the BioIndustry Association, which represents biotech and smaller pharma companies, said that if a solution to maintain cross-Europe supply chains cannot be found “the problem is not BMW bumpers stuck in Harwich harbour; it is people not getting access to their medicines. Unpicking something as complex as this and putting it together again in less than two years is nigh on impossible,” he argues.
Emma Walmsley, chief executive of GlaxoSmithKline, warned last month that Britain’s departure from the EU was now involving “real costs”, as she said the company was now constructing new testing facilities across Europe.
Meanwhile, Pascal Soriot, chief executive of AstraZeneca, told journalists this month that “critical and specific” issues for his industry were quality control and the release of products after manufacturing. “What we are doing now is duplicating this process so products that have been manufactured in the UK can be tested and released . . . under European standards in case we have a so-called hard Brexit,” he added.
Pharma companies remain frustrated by the need to make this outlay, however. For large companies the price tag of putting duplicate facilities in place has been estimated at up to £115m in the first year alone.
David Jefferys, senior vice-president for Eisai, a Japanese pharmaceuticals company with a major presence in the UK, said: “Obviously, if there’s a mutual recognition agreement for and on behalf of EU27, or an extended transition, [this] problem goes away.”
But because of the need to find additional premises, and to transfer technology and expertise, “we have to press the button now if we’re to hit the deadline and have everything up and running for March 2019”.
Mr Jefferys, who also heads regulatory affairs for EFPIA and the Association of the British Pharmaceutical Industry, added: “We are in the countdown period now . . . and therefore effectively, we’re beyond the point of no return . . . We have to assume a hard Brexit.”