Scrutiny of medicines supply to Northern Ireland continues
The Protocol on Ireland/Northern Ireland Sub-Committee takes further evidence from healthcare experts as it continues a follow-up investigation into the impact of the Protocol on the provision of medicines to Northern Ireland.
In autumn 2021, against the backdrop of fears that some companies may decide no longer to supply medicines to Northern Ireland, the Committee undertook a short inquiry into the provision of medicines under the Protocol and wrote to the Government setting out its findings. The Committee is now undertaking this follow-up work to discuss how the situation has evolved since 2021, including following the adoption of legislative changes by the EU and the Northern Ireland MHRA Authorised Route (NIMAR) put in place by the UK. The Committee held its first evidence session for this follow-up work on 18 January.
- What are the main issues facing the pharmaceutical industry in terms of medicine supply to Northern Ireland under the Protocol as it is currently operating?
- How has industry adapted or changed its operating model as a result of the Protocol?
- Does the Protocol carry any current or potential beneficial effects from the point of view of medicine provision to Northern Ireland?
- What changes, if any, have taken place in relation to the scale of cross-border supply of medicines on the island of Ireland since the Protocol came into force?
- What has been the impact of the EU’s legislation on medicines, announced in December 2021 and in force since April 2022, including on the scale of product withdrawal from Northern Ireland?
- What are the main outstanding issues to be resolved relating to the supply of medicines, including i) the Centralised Procedure ii) the application of the Falsified Medicines Directive and iii) the supply of medical devices to Northern Ireland?
- Is the Northern Ireland MHRA Authorised Route (NIMAR) working effectively?
- What impact will the Northern Ireland Protocol Bill, including the proposed dual regulatory regime, have on the supply of medicines in Northern Ireland?
- What impact will future regulatory divergence between Great Britain and the EU have on medicine supply to Northern Ireland, and how can this be addressed?
- How are the UK and the EU engaging with industry regarding outstanding issues requiring resolution?
- What, in your view, is the best way forward to resolve the outstanding issues?