The supply of up to 9,000 medicines and medical devices into Northern Ireland could be at risk due to post-Brexit packaging and licensing rules, an industry group has warned.
Medicines for Ireland, the pharmaceutical trade association representing major medicine suppliers to the HSE and patients, has told the Seanad Brexit committee in a submission that imminent regulatory requirements threaten medicine supplies from Britain to Northern Ireland.
The Brexit agreement for Northern Ireland, designed to avoid a hard border on the island of Ireland, leaves Northern Ireland within the EU’s regulatory system for pharmaceuticals.
The Northern Ireland Protocol states that the “marketing authorisation holder” – the company or other legal entity authorised to market a product – for any medicines sold in Northern Ireland must be in the EU, the European Economic Area or Northern Ireland but not in Britain.
David Delaney, chairman of Medicines for Ireland, said that this requirement was forcing medicine makers to invest millions on reorganising regulatory filings, packaging and licences on bespoke boxes of medicines for Northern Ireland to service a market in European teams that would be like making special arrangements in the Republic for medicines being sold in Mayo.
The industry was at the “11th hour” in the search for a long-term solution as a grace period covering the movement of medicines from Britain to Northern Ireland was due to expire in January, he said.
“We urgently need post-Brexit solutions to ensure stable access for patients to medicines in Northern Ireland and across Ireland,” he said.
The British Generic Manufacturers Association said in July that it would have to withdraw more than 2,000 medicines from Northern Ireland because of the "impossible position" medicine suppliers found themselves meeting the new regulations to supply the Northern Ireland market.
Medicines for Europe, a sister organisation of the Irish group, now estimates that about 9,000 medicines and medical devices might be affected because small companies may decide not to proceed with a change in marketing authorisation holder and may simply decide not to supply products to Northern Ireland.
Mr Delaney, a board member of the group's sister organisation Medicines for Europe, said that a mutual recognition agreement between the EU and the UK, similar to the arrangement between the EU and Switzerland, would resolve the regulatory issues caused by the UK's exit from the EU.
Medicines for Europe has written to European Commission vice president Maros Sefcovic seeking a four-year derogation from the rules allowing companies or entities based in Britain to continue supplying medicines and medical devices into Northern Ireland.
The group said that enforcing the regulation would have “a very significant impact on pharmaceutical operators, with serious regulatory, fiscal, operational and financial consequences”.
Northern Ireland's chief pharmaceutical officer told a Stormont committee in July that there had been a "relatively small" number of products formally notified for withdrawal.
