Brexit: does the Windsor Framework help resolve challenges for health?
BMJ 2023 ; 381 doi: https://doi.org/10.1136/bmj.p825 (Published 11 April 2023) Cite this as: BMJ 2023;381:p825
Ever since the famous Northern Ireland Protocol was agreed to avoid a hard border on the island of Ireland, a shadow of doubt has hung over the health service in Northern Ireland (NI). The Protocol meant NI largely stayed within the EU single market for physical products, while Great Britain (GB) left. But NI receives 80% of its medicines from the other parts of the UK. 1
The Windsor Framework, which was announced on 27 February, passed its key vote in the House of Commons on Wednesday 22 March and has now been adopted by the UK government, includes a proposed EU Regulation specifically for medicines. 2 3 This largely removes the concerns of shortages resulting from these barriers, or medicines used elsewhere in the UK missing from shelves in Belfast. It cannot, however, fully resolve the challenges for health created by the dual regulatory status of NI.
Solving old problems
The EU already acted last year to remove one major immediate source of worry for suppliers and users of medicine in NI—the threat that medicines tested for compliance in GB would not be valid for use. 4
Article 3 of the proposed new Regulation will eliminate another: the threat that after a grace period ended, suppliers would need to start removing EU security tags and identifiers when a product entered GB, only to reapply new ones when it crossed the Irish Sea. 5 A House of Lords Committee recently described this as “the single biggest factor causing difficulties under the Protocol.” The Regulation simply removes this system for NI from 1 January 2025—or earlier if the UK provides the European Commission with written guarantees of compliance in areas such as labelling.
Even more radically, the new proposals would remove the main long term concern for medicines supply in NI: the prospect of not having access to products available in other parts of the UK. Driven by growing divergence in authorisations, which our recent report showed had slowly started to emerge, this was a source of concern among healthcare and medical officials we spoke to, both for cutting-edge drugs and for more inexpensive products where a wide range of suppliers helps guard against price rises and shortages. 1 6
This was the result of NI remaining subject to the approvals system for medicines within the EU’s single market. Under Article 4 of the Regulation, NI will in future simply use medicines approved by the UK. The UK has accepted rules that require monitoring, effective sanctions and reporting.
Creating new problems?
The shift to UK medicine authorisations means a prohibition on placing new medicines with EU authorisation on the Northern Irish market. Health and social care services do not get to “pick and choose.”
This may mean NI gets later access to cutting-edge products than people over the border. Recently, the European Medicines Agency (EMA) has been centrally approving new products faster than its UK equivalent, the Medicines and Healthcare products Regulatory Agency (MHRA). 7 This may be because the latter is understaffed or underfunded now that it no longer has access to paid work from the EMA—a regular industry complaint.
Transitional rules will apply to medicines already on the market, which can be sold in NI until their expiry date. But this does not apply to authorisations that took place after the UK left the single market on 31 December 2020. MHRA will need to catch up to EMA approvals to avoid a risk of available medicines being cut off. While in theory it already has a policy of generally accepting EU approvals, its capacity problems may make this difficult to achieve. 8 Moreover, new labelling rules apply, requiring medicines for NI to have a label that includes the words “UK only,” which will add a small but real cost.
NI now has a very complex status where EU medicines laws apply, but with huge exemptions and another jurisdiction, the UK, taking over the central role of authorisation. This does carry some risks. For example, what if in the future, the UK were to stop conducting batch testing to the standards still required for NI under EU law? Would there be confusing dual systems, or might the EU explore options to suspend bits of the agreement?
More than just medicines
The Protocol also subjects many products entering NI from GB to customs checks, designed to protect the EU system of tariffs and quotas against imports through the back door. A new decision as part of the Framework will expand an exemption for goods if they are used in NI for the sole purpose of providing health or care. Now, even if the importer sells products on to one “subsequent entity”—such as a hospital—to use the goods for care, they would not be subject to full customs formalities.
Meanwhile, a “trusted trader scheme,” will assist with the supply of products that are sold to or used by consumers in NI.
In respect of food law, the Framework effectively means EU legislation on, for example, food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control will no longer be applicable. 9 The UK could adopt lower standards for the whole UK if it wanted to—it always had the choice to adopt UK higher standards under the EU legislation that will no longer apply. However, such retail goods moving into NI from GB would become subject to specific rules to ensure they remain in NI—covering areas like certification and checks, consumer information and traceability.
Beyond medicines, many other crucial health products and services are unaffected. EU law on medical devices still applies in NI—likely less of an issue, because we heard during our research that most come from the EU, not GB. 1 But there is also no answer on the knotty issue of UK and EU professional qualifications no longer being recognised by the other side: a real issue for those clinicians who work across the border, splitting their time or in mobile services like ambulances.
Where next?
The Windsor Framework is not fully politically settled, with the Democratic Unionist Party having refused to vote for it, and holding out the continued threat of refusing to re-enter the devolved government at Stormont. Even though it has now been passed, it is designed for change, and even to manage conflict.
The new “Stormont brake,” the focus of the recent vote, would allow the UK on petition of the NI Assembly to block new EU rules on products, potentially increasing divergence. EU regulations will be subject to oversight by the Court of Justice of the EU which applies to the UK in perpetuity. The European Commission has monitoring powers, and there is a procedure for it to suspend the new provisions and take remedial action if the UK breaks its commitments, including where practices become too different.
If new rules on labelling and traceability were not required in GB, this would add a small but real regulatory burden and cost to supply of medicines in NI. But this could also set a course for cooperation. The complicated shared legal framework for medicines in NI could be a first step towards expanded mutual recognition between the whole UK and the EU. This would be beneficial for patients in both, offering global suppliers a larger, more appealing regulatory space.
Whether this is the latest stage in a twisting drama of health, Brexit and Northern Ireland, or the start of a more stable course for the whole UK, is still to be decided.
Footnotes
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Competing interests: none declared.
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Provenance and peer review: not commissioned, not externally peer reviewed.