Firms making non-branded drugs are already starting to withdraw them because of costly new red tape, ministers are being told – threatening to cut the treatments available.
The British Generic Manufacturers Association said planned new products being pulled before the rule changes come in next January included “treatments for epilepsy diabetes, and cancer”.
“We need an urgent solution today,” said Mark Samuels, the trade body’s chief executive, adding: “If we don’t have a solution immediately, they will feel it in January.”
The threat has blown up because, at the end of a 12-month ‘grace period’, medicines made in Great Britain will require separate licences for use in Northern Ireland, as well as different safety inspections and other checks.
The barrier is the latest to be put in the spotlight by the Northern Ireland Protocol, the 2019 treaty signed by Boris Johnson which has created a trade border in the Irish Sea.
The new red tape emptied supermarket shelves in January, leading to the UK unilaterally shelving further checks – and a legal action launched by Brussels.
Before the UK left the EU, a medicine could be supplied to most EU countries by submitting just one regulatory dossier and a single set of standards and regulations.
“Most medicines for Northern Ireland come from Great Britain and, according to the Brexit deal, from January, medicines that are licenced in Great Britain can no longer legally be supplied to Northern Ireland,” Mr Samuels said.
“At the moment we’re in a temporary grace period until the end of the year.
“However – because manufacturing of medicines is not something you can switch on overnight – the manufacturers have to make decisions now, about which medicines to supply from January onwards.”
Mr Samuels pointed out that 80 per cent of medicines in the UK are generic, pointing to potassium chloride – the solution commonly found in intravenous strips – as another under threat.
“It has been in particular demand during the Covid pandemic and has two main suppliers in Northern Ireland. One of those suppliers, has already pulled all eight of its products,” he told BBC Radio 4.
The government needed to ensure that “medicines for use in Great Britain can legally be used in Northern Ireland”, Mr Samuels said.
It would be very “complex” for companies “to change their entire supply chain” to bring in medicines from within the EU, he warned.
The 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”.