Pharma industry seeks early EU-UK drugs agreement

  • Pharma looks to ease cross-border movement of medicines
  • Demand for MRA in meeting with ministers
  • Drugs companies frustrated by pace of Brexit talks

Pharma industry leaders are calling for an interim deal to ease the passage of medicines between the UK and Europe, as fears grow of post-Brexit shortages of drugs and medical devices.

The demand for a “mutual recognition agreement” (MRA), under which safety inspections and certification of individual batches of medicine in the UK would continue to apply in Europe, and vice versa, came at a meeting between senior industry representatives and ministers last month, according to two people familiar with the discussions.

Without an MRA, duplicate inspections of manufacturing sites will need to be carried out in the UK and in a European member state. Each batch of finished products will also need to be tested in the UK and again in the EU before it can be released for sale or export in both jurisdictions.

Global drugmakers have become increasingly frustrated over the pace of Brexit negotiations as the deadline for the UK’s departure from the EU approaches. Companies are now going ahead with contingency plans as fears grow that patients will struggle to access life-saving medicines in the event of a hard Brexit.

Deal contingent on larger trade pact

The industry has been lobbying the UK government and the EU for an early agreement that would allow them to move prescription drugs across the border easily while ensuring that the approval of new medicines is not delayed.

However, both the EU and the UK say that any deal will have to form part of a larger agreement on trade.

© Chris Ratcliffe/Bloomberg

UK officials say Britain will seek to maintain “exactly the same regime” for medicines after Brexit as now, as part of a free trade deal to be negotiated after March 2019.

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, underscoring the significance for patients of securing a deal.

One person with knowledge of the situation said that, while the industry’s “maximalist” demand was still for regulatory alignment and frictionless trade with the EU, “with 296 days to go we are going to need some very basic things to keep an integrated supply chain going.

Downing St hears of concern for patient safety

“The benefit is that this [MRA] could be done speedily as a first step”, added the insider, pointing to similar arrangements already in place with “third countries” such as Canada and Australia.

Attendees at the Downing Street meeting — the inaugural gathering of the Life Sciences Council, a government-industry group — highlighted the potential impact of failure to agree continued membership of the European customs union.

One business described flying in 500 vital “trauma packs” from Belgium to surgeons working on terror victims at the Ariana Grande concert bombing in Manchester last year, which took just hours without the need for customs checks, but which could be in jeopardy after Brexit.

“Unless there is clarity about the customs union or what you do in this unforeseen trauma setting, there is a real concern about patient safety,” said one of the company’s executives who spoke on condition of anonymity.

Pressing the case for mutual recognition of medicines approvals, Pascal Soriot, chief executive of the Anglo-Swedish drugmaker AstraZeneca and co-chair of the Life Sciences Council, said: “What value is there in building a bureaucracy to do your own assessment of a medicine when, basically, you could say it’s approved in Europe, so we will accept it, and vice versa?”

© Chris Ratcliffe/Bloomberg

Mr Soriot added that Astra was already duplicating all its quality control processes in Sweden “so we can release medicines in Europe, under European standards”.

But he warned that drugs also had to be moved across borders and without “a fluid border” there might not even be “enough customs officers to handle the customs movements”.

Sanofi and Merck make preparations

A spokesperson for French drugmaker Sanofi said it was “making increases to warehouse capacity and recruiting additional support to manage any changes to customs arrangements”.

Merck is also preparing to stockpile up to six months worth of medicines in some jurisdictions, although a spokesperson pointed out these were “contingency plans” that might not be implemented.

Meanwhile, Swiss pharmaceutical group Novartis said this week that any regulatory divergence between the UK and EU “may mean new medicines’ licenses would be delayed in the UK due to the need for a separate UK regulatory submissions, which would likely be prioritised only after that for the much larger EU population”.

Phil Thomson, head of global affairs at GlaxoSmithKline, told the health select committee of MPs last year that his company, which has announced plans to set up additional drug testing facilities in Europe, had allocated up to £70m to prepare for the impact of Brexit. He pointed out that this money would otherwise have been spent on developing life-saving medicines.

The health department said: “The UK’s position on medicines regulation remains clear: we want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical innovation.”

Additional reporting by George Parker in London

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