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21 Feb 2023


UK-EU Relations

Mark Samuels, Chief Executive, British Generic Manufacturers Association (BGMA), explains the impact of the Northern Ireland Protocol on medicine supplies to Northern Ireland, suggesting that any UK-EU deal should offer a solution to the issue.

The potential ills of the Northern Ireland Protocol and its impact on the supply of medicines to the region have been diagnosed for some time. Over the past two years, short-term treatments have been prescribed to keep the system in relative health, but time is running out to find a much-needed permanent cure.

Generic and biosimilar medicines – the everyday drugs on which the health service relies – are critical to the NHS. Four out of every five UK prescription drugs are generic (i.e. off-patent) medicines. When a drug’s patent ends, generic manufacturers can enter the market, creating competition that drives down prices by 80-90%. Generic medicines save the NHS around £15bn/year across the UK, whether you are a patient in Sunderland, Swansea, Stirling or Strabane – the health service’s finances would be terminally ill without this saving.

In Northern Ireland, the use of generic and biosimilar medicines is essential to the financial sustainability of the health service and has an impact on almost all patients. The vast majority of medicines used within the region are sourced and supplied through Great Britain; this is where the Protocol comes in.

The generic medicines industry is based on high volumes, efficiency and typically low margins. Supply chains are long and must be managed effectively to ensure the right medicine gets to the right patient at the right time. Anything that adds duplication or is a barrier to efficient supply chains can risk massive disruption and make supply unviable. Not only logistical headaches but regulatory problems can also hurt supply.

As Northern Ireland accounts for just 2% of all United Kingdom medicines supplies, the existing pre-Brexit system of a single medicinal product must be maintained for the entirety of the UK. Manufacturers cannot afford to supply Northern Ireland with its own separate pack for every medicine because it would make many products loss-making.

In the protracted on-and-off negotiations over the Protocol, some progress has been made that has halted the initial and potentially catastrophic wholesale withdrawal of products – forecast to be 2,100-3,400 medicines withdrawn as a direct consequence of the Protocol. EU willingness to amend EU law has nursed supply to Northern Ireland from Great Britain. Though an improvement of what the Northern Ireland Protocol initially allowed, these amendments rely upon UK and EU medicines regulations staying aligned. However, this alignment is coming under strain over time.

The so-called ‘derogations’ from EU requirements were only temporary treatments. This year will see a large number of EU-issued medicine licenses converting to GB licenses (adding to the GB-only licences that have been approved by the UK regulator MHRA in the last couple of years). This change is significant. It creates the necessity for products to meet both GB and Northern Ireland / EU regulatory standards to be available in both regions. Here, increasing complexity starts to become a barrier.

One potential solution already being discussed is joint GB/NI packs that comply with both systems. But this is a theoretical cure. It has rarely worked practically in the past – even neighbouring EU member states have found it incredibly difficult to agree patient information wording for medicines.

Without a lasting solution, the medicines industry may be forced to stop supplying products to Northern Ireland. It would mean patients losing access to thousands of medicines covering numerous conditions. Future launches would also be drastically curtailed. In the short term, it would be a care crisis for patients in Northern Ireland.

Time is running out, and there needs to be a solution blue-lighted to Northern Ireland. Any deal agreed between the UK and EU on the Protocol must make sure it offers a permanent solution on medicines. To maintain equality of access across the whole of the UK, we suggest the government’s Green Lane plan should be expanded to include medicines supply across the UK, allowing GB-licensed medicines to be supplied to Northern Ireland. This solution would future-proof the system from disruption arising from any potential divergence between UK and EU medicines regulatory systems. It would be a simple, elegant, one-step solution.

However, the ‘golden hour’ for treatment is closing for Northern Ireland’s medicines supply. Manufacturers put patients first and complied with the sticking plaster approach and workarounds that have come from the negotiations to date. But this cannot continue, and a permanent solution needs to be agreed upon quickly, or future supply to Northern Ireland will become unsustainable. Manufacturers have sounded the alarm for over two years; now, the UK government and EU must put on their scrubs and cure the Protocol before it’s too late.

By Mark Samuels, Chief Executive, British Generic Manufacturers Association (BGMA).


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