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Report from the Sub-Committee on the Protocol on Ireland/Northern Ireland: Follow-up report Contents

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Chapter 3: The provision of medicines to Northern Ireland under the Protocol

205.In this chapter, we consider a discrete set of issues in relation to the provision of medicines to Northern Ireland, which have economic implications for the pharmaceutical industry and consumers, as well as healthcare implications for the people of Northern Ireland.

Previous scrutiny

206.In October 2021, the Committee held an evidence session with representatives of the pharmaceutical industry on the impact of the Protocol on the provision of medicines to Northern Ireland. Their evidence was summarised in a letter to Lord Frost in November 2021, which highlighted industry concerns over:

• The cost and operational impact of Brexit and the Protocol, including testing requirements, specific issues for provision of over-the-counter (OTC) medicines, the costly impact of application of the EU Falsified Medicines Directive, and the requirement for separate marketing authorisations for Northern Ireland.
• The scale and risk of product withdrawal in Northern Ireland. Witnesses told us that a wide range of medicines could be affected, albeit in terms of product choice rather than discontinuation of entire categories of medicine.
• The limited scope for cross-border provision on the island of Ireland (and therefore limited risk to the EU Single Market), due to the different models for medicines provision in Ireland and Northern Ireland.
• The positive impact of the Government’s unilateral extension of the grace period for medicines in September 2021, notwithstanding the need for long-term stability and a mutually agreed solution.
• Support for the Government’s proposal in its July 2021 Command Paper that medicines should be withdrawn from the scope of the Protocol entirely, so long as this was subject to mutual agreement between the UK and the EU.
• Concern that the Government’s proposal for a dual regulatory regime would not be viable in the context of medicines provision, given the practical challenges in such a highly regulated sector.
• Support for the Commission’s October 2021 ‘non-paper’ on medicines as a constructive step forward, but which left a number of technical issues outstanding, including in relation to wholesale dealers’ licenses, authorisation codes, centrally authorised products, a single medicine pack and single leaflet for patient information, the application of the Falsified Medicines Directive to Northern Ireland, and Mutual Recognition and Decentralised Procedures (DCP/MRP).
• The need for a mutually agreed solution, due to the uncertainty that would arise from unilateral action.
• The importance of continued industry engagement, in order for the UK and EU to understand the technical complexities of the issues at hand.193

207.The Committee sought further evidence from industry representatives after the EU’s publication of proposals for medicines in December 2021, resulting in a further letter to the Foreign Secretary in January 2022.194 This letter noted the views of stakeholders that the Commission proposals represented significant progress towards addressing the issues that had been identified, in particular regarding continued provision of OTC medicines, UK-wide licensing, the elimination of requirements for batch testing and import licenses for products moving from Great Britain to Northern Ireland, and the use of a single pack and leaflet across the whole of the UK.

208.Nevertheless, witnesses drew attention to a number of outstanding issues, including concerning UK-based qualifying persons, Wholesale Dealers Authorisation, DCP/MRP and combining UK and GB licences, the need to retain equivalent standards between the UK and the EU, concerns that Centralised Procedure licences are not covered by the EU proposals, changing ‘GB only’ product licences to UK-wide licences, and the continued application of the Falsified Medicines Directive to Northern Ireland.

209.In his reply of 25 March 2022,195 James Cleverly noted that industry had been broadly positive about the EU proposals, but that there were two remaining supply risks: EU authorised packs of novel medicines are still required for Northern Ireland, “which may lead to some companies discontinuing novel medicines in [Northern Ireland] or not launch them at all”, and concerns over the continued application of the EU Falsified Medicines Directive in Northern Ireland. Mr Cleverly highlighted that, by way of mitigation, the Northern Ireland MHRA Authorised Route (NIMAR) is being used to support the continuity of supply in Northern Ireland.

Further evidence received

210.The Commission proposals came into force in April, and several pharmaceutical witnesses submitted evidence to this inquiry on the current position.

211.Walgreens Boots Alliance (of which Boots UK is a division) said that the derogations to the full implementation of the Protocol had enabled them to maintain product availability in Northern Ireland. Nevertheless, continuing uncertainty had meant their wholesale partner was expecting to stop distributing some products in Northern Ireland. While they welcomed the EU’s proposals, they noted that:

• The proposals do not cover Centralised Procedure products, meaning that manufacturers will have to create separate packs for new centrally authorised products for Great Britain and Northern Ireland. This may affect supply to Northern Ireland given the small size of its market.
• Application of the Falsified Medicines Directive is a challenge as it implies that all products entering Northern Ireland from Great Britain need to be verified by wholesalers.
• The sale of medical devices in Northern Ireland has also been impacted by the Protocol, with new regulatory and labelling requirements amounting to £10,000 per product initially and £5,000 per annum thereafter.
• There are issues regarding labelling of own brand or proprietary medical devices sent to Northern Ireland in compliance with EU importer requirements, which, without a manageable solution, will lead to increased costs.

Their preference was to remove all medicines from the scope of the Protocol entirely “and build specific arrangements for this category of products”.196

212.The National Pharmacy Association (NPA) likewise welcomed the EU’s proposals, but also pointed out concerns around “residual issues” pertaining to the Falsified Medicines Directive and the application of EU law for centrally authorised products. They noted that a number of suppliers have already withdrawn from the Northern Ireland market, and reported shortages in OTC and pharmacy only medicines. They too called for the removal from the Protocol of medicines in their entirety.197

213.Teva UK, the leading supplier by volume of medicines to the NHS, also welcomed the progress made, which had enabled them to halt proposed discontinuation of medicines in Northern Ireland. They too highlighted the treatment of Centralised Procedure product licences as the “one very significant issue which remains outstanding”, as a requirement for separate marketing authorisations for Northern Ireland could make many medicines unviable there. There was also uncertainty as to how the contingency arrangements being planned by the MHRA would work in practice.198

214.The Ethical Medicines Industry Group (EMIG) stated that the EU proposals were “hugely welcome” and provided stability for the sector, as they removed checks on medicines moving from Great Britain to Northern Ireland, which in turn facilitated the uninterrupted supply of medicines. However, they acknowledged that many companies had already switched supply routes at great expense. They warned that the Government’s proposal unilaterally to bring forward legislation on the Protocol was “hugely worrying”, as it may lead to retaliatory action by the EU, with a “profound impact” on the pharmaceutical sector given the global nature of medicines supply.199

215.PAGB (the consumer healthcare association) stated that they were “enormously encouraged” by the steps taken by the UK and the EU to address the issue of medicines, including through the adoption of EU legislation and the contingency measures put in place by the UK. They acknowledged that the issues with centrally authorised products and the Falsified Medicines Directive need to be “ironed out”, but stated that the EU’s proposals had “helped ensure continuity in the supply of medicines to patients in Northern Ireland … the current arrangements are working well.” However, PAGB added that they had co-signed a letter from industry representatives to the Foreign Secretary, warning that:

“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.”200

216.The Northern Ireland Human Rights Commission (NIHRC) and Equality Commission for Northern Ireland (ECNI) stressed in particular the need to monitor and address any outstanding issues relating to the supply of medicines in order to allay fears relating to future availability, including for disabled people.201

Conclusion

217.Given the importance of these issues for the people of Northern Ireland, we welcome the steps that have been taken to alleviate problems with the supply of medicines to Northern Ireland through the EU’s legislation that came into force in April 2022. Nevertheless, we note that it would have been preferable for these solutions to have been taken forward on the basis of mutual agreement rather than unilateral action by the EU. In that context, we note the concerns of the Government and pharmaceutical industry representatives that a number of issues remain outstanding, notably in relation to centrally authorised products, the application of the Falsified Medicines Directive, and the supply of medical devices. We urge the UK and the EU to work together in constructive dialogue, and in full consultation with industry representatives, to identify sustainable solutions to these issues in the months ahead.

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