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Britain’s pharmaceutical industry is appealing to Boris Johnson to strike a swift side-deal with Brussels to avoid delays and shortages of medicines if he crashes the UK out of the EU in a no-deal Brexit at the end of this year.
The prime minister’s announcement on Friday that he was preparing for no deal on 31 December has left the industry without the agreement on mutual recognition of standards needed to avoid hugely costly duplication of red tape and maintain the flow of trade in vital drugs.
With less than 75 days to go until the transition to post-Brexit relations with Europe, the Association of the British Pharmaceutical Industry (ABPI) says that failure to secure a sector-specific agreement would cost “many, many millions” of pounds and introduce delays of up to six weeks in supplies.
It comes as Mr Johnson and senior ministers prepare to launch an advertising drive warning businesses across the country that “time is running out” to prepare for the end of the transition period.
Meanwhile, the Patients’ Association said it was vital that patients do not see their care and treatment disrupted as a result of EU exit.
Speaking to The Independent, ABPI chief executive Richard Torbett said the industry had been working closely with government since the EU referendum of 2016 to ensure that the transition went as smoothly as possible, but still does not have details of the regulations it will be operating under after 1 January.
“There are 45 million packs of medicines going from the UK to the EU and 37 million going from the EU to the UK every month,” he said. “There are many thousands of medicines used by the NHS and other health systems and all of them require good flow of trade across borders, both within the EU and internationally, so it is very important.”
With 12,000 types of medicines supplied to the NHS alone, Mr Torbett said it was impossible to predict which drugs would be most likely to run short in the absence of an agreement, though he said patients with chronic conditions were most likely to be affected first, simply because they have more regular contact with the health system.
He welcomed this week’s announcement of a £78m government deal with ferry companies to provide additional services to eight ports on the south and east coasts of England, to ensure supplies of essential medicines in the case of gridlock at Dover.
This came on top of measures the companies had already taken – at “significant” cost – to reroute substantial amounts of their trade away from the Kent port, which previously handled the vast majority of medicine shipments but is thought the most likely location for queues and bottlenecks as new customs arrangements are introduced.
Drugs companies have also built up stockpiles to mitigate the possibility of shortages in the new year and avoid a “cliff edge” on 1 January, working with the NHS to better predict levels of demand, said Mr Torbett, though he stressed that this is not an option with some products with a short shelf life.
But he said that this did not resolve the problem that, without mutual recognition of standards, trade in medicines between the UK and EU would become “permanently more complicated”.
“Beyond the immediate supply issues, there are a number of very essential things that we need to get done in order to have supply security going forward,” he explained.
“For example, when a medicine is manufactured, every single batch of medicines has to get tested in a lab. Will those batch release tests in the EU be recognised in the UK and vice versa? We still don't know.”
Mr Corbett said the industry would ideally like a fully comprehensive free trade agreement.
But Mr Johnson’s announcement that he is walking away from talks on a deal unless the EU fundamentally changes its position has created a need for at least a bare-bones sectoral agreement.
“There’s a very bare minimum that we need for medicines desperately,” said Mr Torbett.
“Mutual recognition agreements are often signed outside of the free trade agreements, because it’s a real no-brainer that you don’t want to introduce any further complexity into the supply chain.
“We’ve been calling on the government and the European Commission to absolutely make sure that both sides prioritise patients. Let’s get a mutual recognition agreement done so we recognise each other’s standards.
“If you don’t do that, you can stockpile all you like and you can have all the ferries you like, you will introduce delays as more things have to get tested multiple times, which is obviously cost and complexity in the supply chain that we don’t want.”
Mr Torbett said resolving the issue was all the more urgent because of the coronavirus pandemic gripping countries on both sides of the English Channel, which is soaking up vast proportions of drugs companies’ time and resources.
“At a time of global pandemic, where we’re trying to keep medicine supplies going to the NHS and every other health system in the world, with half the global economy shut down, we really don’t need any more nonsense in the supply chain,” he said.
And he warned that the absence of an agreement would create uncertainty over the future development of one of the UK’s most important economic sectors, which is a major spender on research and development and exports products worth £30bn a year.
“Ultimately, it just ties us up in red tape more than we ever were,” he said. “And that will not be good news for investment and our ability to attract companies to put money here."
Mr Torbett insisted it is “perfectly possible” for London and Brussels to get the necessary agreement in the time remaining.
“They just need to prioritise it and get it done,” he said. “The fact that we haven’t got one ready is very frustrating. The last thing we want is to introduce any risk.
“We’re looking at the clock. We're well into October. And, you know, we need to get this clarity sooner rather than later. There’s an awful lot at stake.”
The chief executive of the Patients’ Association, Rachel Power, said: “Patients must not see their care and treatment disrupted after the Brexit transition period ends at the turn of the year.
“We know the Department of Health and Social Care (DHSC) and NHS have developed extensive plans to keep supplies coming into the NHS, and with the COVID-19 pandemic still certain to be a major factor in January, we very much hope they prove successful.”
A DHSC 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 rerouting supply chains and being ‘trader ready’.”