Supplies of crucial medicines including potential COVID-19 vaccines could be disrupted if the government fails to reach a Brexit deal for the pharmaceutical sector, industry leaders have told Sky News.
The Association of the British Pharmaceutical Industry (ABPI) warns that additional cost, red-tape and possible delays could follow a no-deal Brexit, or even a thin agreement that fails to address the complexity of medicine regulation.
“We are as prepared as we can possibly be, but we don’t need this extra red tape, extra complexity, extra cost and extra delay getting in the way of our supply chain at a time where we’re trying to deal with COVID,” said Dr Richard Torbett, chief executive of the ABPI.
“Clearly this is very frustrating and all of the time and effort and resource that has been put into the multiple levels of scenario planning around Brexit is time and effort and resource that could have been put to other better uses.”
Dr Torbett’s comments come as the pharmaceutical industry faces the challenge of delivering multiple COVID-19 vaccines while awaiting a Brexit outcome that remains uncertain just 36 days before the end of the transition period.
The UK exports around 45 million packets of medicine to the EU every month and imports a further 37 million, a huge volume of trade that, if significantly interrupted, could have profound consequences for patients.
The threat of disruption arising from new border controls was emphasised on Tuesday, when a trial of passport checks at French customs led to five-mile tailbacks on the M20 in Kent.
The industry has been preparing for potential disruption for more than four years, stockpiling at least six weeks’ supply of some medicines, but crucial issues of regulation and safety remain unresolved.
As an EU member, British companies enjoy mutual recognition of manufacturing standards including ‘batch testing and release’, the process by which every batch of medicines produced has to be checked and approved.
The ABPI has urged the government to ensure that current standards are rolled-over in a mutual recognition agreement, irrespective of whether the UK reaches a deal. With just 36 days until transition ends however, it’s unclear if it will happen and Dr Torbett warned of disruption if there is no agreement.
“It absolutely makes sense for those [batch] testing requirements to be mutually recognised between the EU and the UK, especially at this time where we’re trying to do with COVID.
“Immediately what would happen [with no deal] is that there would be duplication of all sorts of processes, whether that’s inspections in manufacturing facilities, whether it’s duplication and testing of medicines or vaccines.
“All of that introduces more cost and complexity, and ultimately potentially delay, into the supply chain. So we’ve been really clear with everybody what the risks are here. It’s very important they are listened to and prioritised by all parties that are negotiating this agreement.”
Dr Torbett’s comments come after British chemical company Croda International, which supplies a key component of the Pfizer COVID vaccine, warned of potential delays to supply chains in the event of a no-deal Brexit.
Three vaccines have reported high levels of efficacy against the virus in the last month, including one developed by Oxford University in collaboration with British pharmaceutical giant AstraZeneca.
Dr Torbett said it was evidence of the expertise in the UK industry, but distributing the vaccines at scale and speed will require an unprecedented effort.
“It will undoubtedly have to be a public-private collaboration to really deliver these vaccines to patients around the country and ultimately around the world,” he said.
“I know that there are very extensive conversations going on right now between individual companies and the government’s vaccines policymakers around exactly how that is going to work in this country. But I’m very confident that the right conversations are happening and the companies are as prepared as they can be in the circumstances.”
A Department of Health and Social Care spokesperson said: “The government has proposed to the EU an agreement on medicines and medical devices which would provide significant benefits to patients, industry and regulators in the EU and UK, including ensuring we have quick access to new treatments.
“Alongside these negotiations, we are working closely with partners across the health system to put in place robust measures for the end of the transition period, taking into account extra winter and COVID pressures.
“As part of these plans we have asked suppliers to stockpile, where possible, to a target level of six weeks’ total stock on UK soil, as part of a robust and flexible multi-layered approach which also includes re-routing supply chains and being ‘trader ready’.”
Labour’s shadow cabinet minister, Rachel Reeves, told Sky News: “It is disturbing that the government would contemplate a no deal disaster next month, especially in the middle of a pandemic and recession.
“It should go without saying that Tory ministers must listen to experts in the manufacturing of medicines, and put the public’s health and jobs first. It is damning that they feel the need to speak out in public.”
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