PAGB – Written evidence (FUI0004)


PAGB submission to House of Lords Sub-Committee on the Protocol on Ireland/Northern Ireland’s further call for evidence




  1. PAGB, the consumer healthcare association, welcomes the opportunity to provide evidence to this follow-up inquiry on the impact of the Protocol on Ireland/Northern Ireland. This submission builds on the written and oral evidence PAGB provided for the Committee’s introductory inquiry into the operation of the Protocol on Ireland/Northern Ireland.


  1. PAGB is the UK trade association representing the manufacturers of branded over-the-counter (OTC) medicines, self care medical devices and food supplements. These products can be bought from a pharmacy or other retail outlets without a prescription and help people to stay healthy and self care for self-treatable conditions.


  1. In light of the statement, delivered to Parliament on 17 May, regarding the Government’s plans to legislate for wider changes to the Northern Ireland Protocol, PAGB has co-signed a letter to the Secretary of State for Foreign, Commonwealth and Development Affairs, seeking assurance that there will be no comprehensive changes to the current scenario as it pertains to the movement of medicines between GB and NI. PAGB co-signed the letter alongside other associations representing the pharmaceutical and life science industry, innovators, manufacturers and wholesale distributors of prescription and OTC medicines. This submission draws out the key points made in that letter.


Key points:


  1. PAGB was one of the first organisations to identify the serious challenges with how the Northern Ireland Protocol affects medicines. We have been enormously encouraged by how the Government and the European Union have taken steps to address these issues – both through the adoption of the EU’s legislative changes and the Northern Ireland MHRA Authorised Route (NIMAR) put in place by the UK.


  1. The solutions may not be perfect – for example, there are still issues that need to be ironed out for prescription medicines relating to Centrally Authorised Products (CAPs) and the Falsified Medicines Directive (FMD). Nonetheless, the solutions have helped ensure continuity in the supply of medicines to patients in Northern Ireland. Ultimately, in the view of our members, the current arrangements are now working well.


  1. We recognise that it is for the Government to seek changes to the Protocol in the way it determines is most effective; it must respond to the sensitive political situation in Northern Ireland. However, it would take our members significant time to adjust to widespread changes that could unintentionally impact the supply of medicines for patients in Northern Ireland. In that vein, it is the view of our members that, aside from changes relating specifically to CAPs and the FMD, the current arrangements for medicines should be protected.


  1. We hope that a resolution to the remaining issues relating to CAPs and the FMD can be reached via negotiations and by building on what has been achieved to date. This resolution should include proper transition arrangements that allow companies to plan and implement to appropriate timelines.


  1. In summary, agreements for the supply of medicines have already been achieved and applied by the UK and EU. These agreements are paramount to ensuring the continued secure supply of medicines to Northern Ireland and are working well. Wholesale changes to these agreements would cause significant disruption and uncertainty, both for our members and patients in Northern Ireland. As a result, they must be avoided, and outstanding issues should be resolved via negotiations – building on what has been achieved to date – rather than unilateral action by the UK.



Michelle Riddalls

Chief Executive, PAGB

30 May 2022