EU member state ambassadors have given their backing to a European Commission proposal which is intended to permit the continued free flow of regulated medicines from Great Britain to Northern Ireland, waiving the normal rules applying to medicines which enter the EU single market.
The planned changes would also safeguard supplies to Ireland, Malta and Cyprus for a transitional period of three years. All three states are currently heavily dependent on UK-regulated medicines.
The proposal now needs to be approved by the European Parliament before it becomes law.
The timing of the decision is also significant, coming as it does just eight weeks before crucial elections to the Northern Ireland assembly.
EU sees medicines regulation issue as priority for resolution
Wednesday’s (9 March) decision by Coreper – the EU’s committee of permanent representatives – makes good on a pledge made late last year by Commission vice-president Maroŝ Šefčovič, in charge of EU-UK relations, to prioritise resolution of the issue of movements of medicine into Northern Ireland.
In backing the specific proposal, EU governments have now also given their support to the Commission’s wider strategy of showing that the EU is focused on issues which really matter at local level in Northern Ireland.
Member states are not waiting for the arguments over customs checks at Northern Irish ports to be resolved first before providing safeguards on medicine supplies – a gesture which the EU hopes will reinforce the impression that Brussels is acting in good faith in the ongoing talks over the Northern Ireland protocol.
UK authorisations accepted for products used in Northern Ireland
The effect of the new measures is to allow any medicines which have been authorised by the medical licencing authorities in the UK to be allowed to be used in Northern Ireland, even if the relevant drug has yet to be licenced by the European Medical Agency.
In light of Northern Ireland’s status as effectively part of the EU single market, medicines used in Northern Ireland would otherwise have to be given separate authorisation at EU level – despite the fact that the region is fully integrated into the UK’s national health service.
The EU’s initiative has not been unequivocally welcomed by the British government, however, as the new rules will mean labelling requirements to ensure that UK-authorised medicines remain in Northern Ireland.
The EU has also said the UK should “comply substantively with EU law on quality, safety and efficacy of human medicines when issuing market authorisations for Northern Ireland”.
This is likely to be problematic for a government which is highly focused on issues of sovereignty, even though the real divergences between the UK and EU in this area are minimal.
The UK, for its part, has called for medicines to be removed from the scope of the Northern Ireland protocol entirely – something which the Commission has refused to countenance.
Wider Protocol negotiations remain deep-frozen for now
The wider negotiations on the Northern Ireland protocol remain deadlocked, meanwhile, and look set to remain so until after the assembly elections in May.
London and Brussels remain far apart on key questions over relating to checks on goods crossing the Irish Sea, and the levels of bureaucracy necessary to safeguard the integrity of the EU single market.