Post Brexit: Northern Ireland remains under EU regulations for prescription drugs – ‘GB’ medicines may not be dispensed
According to a Parliamentary briefing: “approximately 98% of the medicines used in Northern Ireland are imported either from or via Great Britain, often originating in the EU.”
From 1 January 2021, the EU laws and regulations regarding: ‘medicinal products’ – known as the ‘Falsified Medicines Directive’ will apply in Northern Ireland but not in Great Britain. The directive aims to prevent counterfeit medicines entering the supply chain – and applies to the majority of prescription-only medicines.
The requirement to conform to EU regulations for a province of the UK after the end of the Brexit ‘transition period’ is creating: “uncertainty and worry for pharmaceutical companies about what rules will apply to medicines that are imported to Northern Ireland having been supplied directly from – or delivered via – Great Britain.
EU Environment Sub-Committee wrote earlier in 2020 expressing their concerns to Edward Argar MP, Minister for Health. The Department of Health and Social care formally replied on 10 November – informing the Committee that the European Commission: “has agreed to a 12 month grace period before the regulations have to be complied with, providing businesses with more time to prepare.”
In the meantime, the pharmaceutical industry from research to manufacturing to retail – in GB and NI – have raised practical concerns about the issues that they now face. This has been widely reported elsewhere – some key links are included below.
For instance, at the time of writing, the EU has stated that will not recognise pharmaceuticals that carry only a ‘GB’ identification code. Further, medicines must carry EU identification codes – and without this authentication, the Pharmacist is required to ‘quarantine’ all such packs. Ultimately, this may mean new sources are required for drugs on the list of those presently dispensed in Northern Ireland.
Having considered the update concerning the grace period, Lord Teverson, Chair of the Committee, has written again on 25 November, saying that it welcomes the grace period, which relieves the immediate pressure and will allow businesses more time to prepare for any changes with regard to the supply of prescription medicines to NI consumers from 1 January.
However, the same uncertainties now apply from 2022, so the Committee urges progress in the coming months so that the grace period is not wasted – and has requested a response from the Minister within 10 days.
The European Union Environment Sub-Committee examines EU policy on agriculture, energy, climate change, the environment, food, fisheries, biosecurity and public health. It also considers the environmental aspects of the UK-EU level playing field. This Committee is a Sub-Committee of the European Union Select Committee
On 11 November 2020 the Northern Ireland Affairs Committee heard from witnesses: Colette Goldrick, Executive Director, Strategy and Partnerships, Association of the British Pharmaceutical Industry; Dr Richard Greville, Director, Distribution & Supply and ABPI Cymru Wales, Association of the British Pharmaceutical Industry
At the time of writing – 1 December 2020 – the detailed guideline on the Gov.UK website reads: “Rules for importing medicines to Northern Ireland are different because of the Northern Ireland Protocol. Further guidance will be published in due course.”
As part of the Brexit process, the European Medicines Agency – the licensing, approvals and regulatory authority for all medicines across the EU – was relocated with the loss of many specialist roles from London to Amsterdam in March 2019.
Supplying medicines to Northern Ireland from 1 January 2021 – GOV.UK (www.gov.uk)
Parliamentlive.tv – Northern Ireland Affairs Committee
‘Another year needed’ to amend Northern Ireland medicines distribution post-Brexit – BelfastTelegraph.co.uk
Brexit: the United Kingdom’s withdrawal from the European Union | European Medicines Agency (europa.eu)