NI could face medicine shortages, warns pharmaceutical body

A new requirement for the labelling of medicines is due to be implemented

A pharmaceutical body has warned of potential shortages of some medicines in Northern Ireland unless there is a delay to the implementation of the Windsor Framework.

The framework is the post-Brexit deal between the EU and UK which governs trade between Great Britain and Northern Ireland.

From 1 January, medicines sold here will need to be labelled 'UK Only'.

But the British Generic Manufacturers Association (BGMA) has said that not all suppliers will have their labelling ready.

Their chief executive said the changed rules could result in an "absurd situation" where NI customers faced shortages due to "bureaucracy".

'Serve the best interests of patients, not bureaucracy'

It is understood the UK government is confident that transitional measures will avoid disruption and it is not planning to ask the EU for an extension.

Mark Samuels, chief executive of the BGMA, said the industry "fully supports" the framework and the intent behind the labelling change.

However he added that the change was more complex and time consuming than anticipated.

"‘Medicines manufacturers are having to change packaging across all their lines in a very short space of time," he said.

"Many generic companies have hundreds if not thousands of lines and the regulatory adjustment to manufacturing runs at scale is a long and is a time-intensive process, typically taking six months.

"We are facing an absurd situation where patients in Northern Ireland will go without access to millions of packs of medicines due to a technical and artificial deadline when shortages are already at a record high. We need to serve the best interests of patients, not bureaucracy."

The supply of medicines from GB to NI has been one of the most complex post-Brexit issues and the original agreement reached in 2019 has been amended several times.

The Windsor Framework included an agreement that manufacturers could produce a single medicines pack for the whole of the UK, including Northern Ireland.

That means the relevant medicines must be labelled ‘UK only.’

That may sound relatively trivial but the BGMA said the operational work in factories to get the packaging ready would not all be complete by 1 January.

Mr Samuels said adding temporary labels manually would "in some cases" double cost of the medicine "as our industry is built on high volumes and razor-thin margins".

He said they were urging the government and the European Commission not to enforce the new rule from 1 January, "as the consequences could be severe for patients".

Other aspects of the Windsor Framework have already been delayed.

The BGMA’s concerns were first reported by the Financial Times.