Drug firms get six-month Brexit exemption to safeguard supplies
HPRA waives relabelling requirements as industry steps up no-deal preparations
No-deal Brexit: about 60 per cent of medicines used in the Republic of Ireland travel through or come from the United Kingdom. Photograph: Simon Dawson/Bloomberg
Drug manufacturers selling UK-licensed medicines in Ireland will not have to change their packaging under a six-month exemption that the medicines regulator hopes will avoid supplies being interrupted by Brexit. The Health Products Regulatory Authority said it could also offer longer exemptions on a case-by-case basis.
About 60 per cent of medicines used in the Republic travel through or come from the United Kingdom, according to the Irish Pharmaceutical Healthcare Association. The Irish industry is stepping up preparations for a no-deal Brexit, under which the UK would no longer be able to provide market authorisation for medicines sold in the State. As a result, any UK-held licences must be transferred to EU-based holders by the time the UK leaves the European Union, on March 29th, 2019. Companies are having to reorganise their supply chains and amend packaging and leaflets on medicines previously authorised from the UK.
“Normally, where the licence holder changes, all packaging must be updated to reflect this prior to any further batch of that medicine being certified for the Irish market; this can take some time,” a spokeswoman for the Health Products Regulatory Authority said. “However, for licence transfers directly related to Brexit, and to facilitate continuity of supply, the HPRA has agreed that stock bearing the details of the UK-based licence holder can continue to be batch-certified for six months post transfer of the licence.”
“Critical reliance on the UK”
Pharmaceutical companies are also preparing to minimise disruption caused by a disorderly Brexit by building up “bridging stocks” and devising transit routes that do not go through the UK. The UK land bridge has been a preferred choice for transporting valuable pharmaceuticals because it is quicker and cheaper than shipping products from the Continent directly by sea.
Some licence holders are also using an Irish subsidiary for medicines authorisation rather than a company in the UK.
“The overriding priority for the industry is to protect access to medicines to the public,” said Loretto Callaghan of Novartis, who chairs the Irish Pharmaceutical Healthcare Association’s Brexit project group.
The medicines regulator has been encouraging companies to find solutions to UK-based supply chains affected by Brexit and “supporting pragmatic or innovative solutions to potential regulatory barriers”. It is exploring opportunities for “dual-labelled packaging” with other European markets and with UK regulators to help maintain dual labelling for products sold both in the UK and in the Republic.
Ms Callaghan said the industry had been working with the regulator, customs authorities and other bodies as part of its planning. The State has a “critical reliance on the UK as a source of medicine”, and should the UK leave the European Union without a deal the industry would “do everything it possibly can within its control” to protect the supply of medicines.
The HSE said it was working on Brexit contingency plans, including measures to maintain patient services and the supply of medicines. It is liaising with the HPRA, the pharmaceutical industry and medicines distributors “to identify risk areas with regard to supply and to ensure that arrangements are in place in the event of disruption to supply chains”, a spokeswoman said.