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Medicines must not be forgotten as outcome of Protocol negotiations is awaited, urges Committee

24 February 2023

The House of Lords Sub-Committee on the Protocol on Ireland/Northern Ireland has written to the Foreign Secretary to urge the UK and the EU not to let the provision of medicines to Northern Ireland fall off the radar, following its consideration of evidence received as part of its recent follow-up investigation into the issue.


In January 2023, the Committee heard evidence from experts in the medical sector and pharmaceutical industry representatives on how the situation regarding medicine provision to Northern Ireland had changed since its initial inquiry in 2021.

The Committee was told that despite EU legislation coming into force in April 2022, which removed the immediate threat of large-scale withdrawal of medicines, the provision of medicines to Northern Ireland remains logistically complex, costly and inefficient. Notwithstanding a widespread assumption that the EU legislation had dealt with the problems, the Committee found that significant issues remained unresolved, notably the application to Northern Ireland of the EU Falsified Medicines Directive and the end-2023 deadline for replacement of EU Centralised Procedures in Great Britain, creating the risk of further cliff edges to come.

Key findings

In its letter, the Committee calls on the UK Government, in its dialogue with the EU, to address the remaining concerns expressed by the medical industry witnesses including:

  • Replacement of EU Centralised Procedure / Centrally Authorised Procedure with Great Britain-only licences: The deadline for changing existing licences to GB licences by the end of 2023 is “astonishingly tight”, and creates the risk of a new cliff edge in the supply of medicines to Northern Ireland, as it will not be possible to provide the same pack to Great Britain and Northern Ireland after this point. This may affect in particular prescription medicines, newer treatments, and those for more serious conditions including migraine, cancer pain and antipsychotic treatments.
  • Continued application of the EU Falsified Medicines Directive (FMD): Given the minuscule scale of the problem with counterfeit medication—0.005 per cent of medication (equivalent to one prescription per day) in the UK as a whole—the Committee heard that continued application of the FMD in Northern Ireland is the single biggest cause of logistical difficulties under the Protocol. Many witnesses called for the disapplication of the FMD in Northern Ireland.
  • Medical devices: Import requirements for medical devices moving from Great Britain to Northern Ireland is burdensome given the requirement for shops, petrol stations and pharmacies to provide information that they are the importer at the point of sale.
  • Regulatory divergence: There is serious concern regarding the practical impact for Northern Ireland of regulatory divergence between Great Britain and the EU, in particular the impact of divergent approaches to licensing by the MHRA and European Medicines Agency, and concerns that wholesalers may unwittingly be supplying unlicensed packs to Northern Ireland.
  • The need for enhanced engagement: The Committee was also concerned to hear that engagement with the pharmaceutical industry by both sides has diminished since the EU’s legislation was brought forward, leading to fears that the UK-EU talks were not addressing medicines. The Committee calls for both the UK Government and the EU to take urgent steps to address this and to re-engage with industry representatives.

Chair’s comments

The Chair of the Committee, Lord Jay of Ewelme, said:

“There is a widespread assumption that the EU legislation that came into force last April 2022 has resolved the problems with supply of medicines to Northern Ireland. This is clearly not so. While the legislation was welcome as far as it went, it is evident that significant issues remain unresolved. As the outcome of the UK-EU discussions over the future of the Protocol is awaited, the provision of medicines to Northern Ireland must not fall off the radar under a misapprehension that the problems have already been dealt with.

“Given the importance of a detailed technical understanding of the impact of the Protocol on medicine supply to Northern Ireland, the Committee were particularly concerned to note both the diminishing contact between the Government and the pharmaceutical industry and the paucity of direct engagement between UK industry representatives and the EU. Both the Government and the EU must urgently address this and re-engage with pharmaceutical industry representatives to ensure their concerns are addressed before rushing to get a deal done.

“Medicines matter to everyone, regardless of their political views. To echo the words of the medical industry representatives we heard from, the impact of disruptions to medicine supply on the health of citizens in Northern Ireland must remain of paramount importance. It would be morally indefensible for patients to be caught in the crossfire like this, to be treated as chess pieces in a much larger political game.”

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