UK companies making non-branded drugs have already started to withdraw medicines from the Northern Ireland market because they cannot afford to meet the costs of new post-Brexit red tape, according to industry leaders.
The move threatens a sharp curtailment of the range of treatments available to patients in the region from the end of the year and may place further pressure on the UK and Brussels to find a solution to disruption in Northern Ireland since the post-Brexit trade deal came into force on January 1.
Under the Northern Ireland protocol, part of the 2019 Brexit treaty designed to avoid a hard border on the island of Ireland, medicines made in Great Britain will have to be licensed separately for use in the region as well as undergoing separate safety inspections and other checks before they can be released for patients.
Before the UK left the EU and European regulatory system, a medicine could be supplied to many European countries through the submission of just one regulatory dossier and a single set of standards and regulations.
Mark Samuels, chief executive of the British Generic Manufacturers Association, a body which represents UK-based drugs companies, said unless a solution was found immediately, some manufacturers were considering withdrawing up to 90 per cent of the medicines they currently supplied. Patients’ ability to access many current medicines would be in “serious jeopardy” he said, pointing out that generic drugs make up four out of every five medicines prescribed in the NHS.
Samuels said one of just two suppliers of potassium chloride — a vital ingredient in intravenous drips — had already pulled all eight of its products. “The resilience of that supply chain has now halved,” he added.
Patients in Northern Ireland also face losing access to cutting edge drugs. Samuels disclosed that a number of the association’s member companies had already taken “the difficult decision not to launch new products” in the region, including treatments for epilepsy, diabetes and cancer.
The alarm was also sounded by Martin Sawer, who runs the Healthcare Distribution Association, which represents businesses distributing more than 90 per cent of all NHS medicines. He warned against underestimating “how the extra regulatory and operational complications, associated with any segregation of medicine packs specifically for Northern Ireland, could affect the current distribution of medicines into Northern Ireland — the vast majority of which are currently supplied from Great Britain.”
One solution to the problem, Samuels said, would be a mutual recognition agreement under which medicines licensed for use in Great Britain would also be legal in Northern Ireland without the separate regulatory requirements.
But he ruled out the possibility medicines could easily be supplied from elsewhere in the EU as this would involve “changing Northern Ireland’s entire supply chain, from distribution to lab testing and so on, to be EU-based or based in Northern Ireland.”
Meanwhile, in an article for the Telegraph website, Lord Nigel Dodds, a Democratic Unionist party peer, warned that unless the protocol was reformed the “result would be restricted choice, higher prices, delays, supply shortages and reduced access to new and exciting trials and treatments”.
The UK government said it continued “to work intensively with the EU to address outstanding issues with the Northern Ireland protocol and minimise its impact on day-to-day-lives.”
It added: “We are also working closely with industry partners and the NI executive to help ensure continuity of medicines supply to Northern Ireland.”
On Thursday Lord David Frost, the minister in charge of overseeing the UK’s future relationship with the EU, and Maros Sefcovic, his Brussels counterpart, met and discussed the protocol, including medicine supply, and both sides agreed to intensify contacts in the coming weeks, officials said.
The department of health in Northern Ireland said: “There are already national and locally tried and tested mitigation arrangements in place for the surveillance of supply chains and for dealing with any supply disruptions to ensure that patients continue to get the medicines and medical supplies they need.”