The Northern Ireland Protocol Bill passed through its first parliamentary vote last week. It threatens to overturn central parts of the agreement signed just two-and-a-half years ago between the European Union and United Kingdom to avoid a hard border in Ireland. A dramatic break from international norms, it marks a new intensification of the UK’s struggle with the paradox of leaving the EU single market while seeking to avoid any sort of border in or around Northern Ireland. The EU has responded by reopening legal action against the UK, and shows little inclination to negotiate.
As part of our project on the impact of Brexit funded by the Health Foundation, we recently held a roundtable with leaders and health experts in Northern Ireland about how they are seeing the UK's departure from the EU, and the related political debates over the Ireland/Northern Ireland Protocol, play out for health.
What we heard is sobering. Despite the Protocol and subsequent EU unilateral actions addressing some emerging fears, there are several serious issues ahead that could lead to a further deterioration in relationships among stakeholders and government officials in Northern Ireland and across the UK – with important consequences for health.
The threat to supplies
The Ireland/Northern Ireland Protocol poses a number of ongoing problems for medicines. Many of these issues stem from retaining Northern Ireland as part of the European Single Market for these products, when 80% of medicines in Northern Ireland arrive from Great Britain (England, Scotland and Wales). Key issues identified by industry experts include:
- whether tests of batches of medicines in Great Britain are accepted in Northern Ireland
- whether Northern Ireland is able to access medicines approved by the UK regulator, MHRA, but not yet by the European Union
- The additional costs of deactivating and reactivating the new security tags that must be attached to medicines under the EU’s Falsified Medicines Directive (FMD) – new rules that were passed in 2011, but not fully implemented until the UK was leaving.
In the run up to last winter, when initial grace periods allowing batch testing and regulatory personnel to remain in Great Britain were about to run out, these caused a looming and threatening crisis in medicines supply.
Recent EU unilateral action, through a directive and a regulation, sought to address these frictions. These extend regulatory allowances, including on batch testing. They create a three-year FMD grace period, and allow the UK’s MHRA to approve products for Northern Ireland before the European Medicines Agency (EMA). Although not always formally discussed in public spaces, there is a sense among stakeholders that these actions marked not just legal progress, but progress in terms of the extent to which the UK government was willing to cooperate with the EU.
By early this year, pharmaceutical companies were feeling more secure about their future in Northern Ireland, as evidenced by a significant decline in the previously alarming rate at which firms had notified the government that they would withdraw from the Northern Irish market.
The immediate crisis for medicines supply in Northern Ireland has been averted – for now. However, a remaining issue is likely more permanent – authorisations of medicines at national level, where the EMA and MHRA make different decisions, or make decisions on a different timeline from each other. If the MHRA authorised a medicine the EMA did not, even under EU proposals, patients in Northern Ireland could not use it on an ongoing basis.
While that scenario in its extreme form seems unlikely from the point of view of the stakeholders from whom we heard, what does seem likely is that specifics of an authorisation will differ: the exact conditions and patient groups for which a medicine is authorised, the make-up, medicine delivery mechanism, or precise labelling requirements, for example. A medicine may even be available in Northern Ireland for a period, then withdrawn. This poses a real problem if Northern Ireland continues to use a UK product portfolio in general.
On the face of it, Clause 7 of the Northern Ireland Protocol Bill would address this by allowing firms in Northern Ireland to choose between the Great British and EU systems. However, the EU’s reaction to the UK unilaterally moving to break the treaty may mean that the overall effect is to prevent these issues from being addressed in the more cooperative, EU-led manner that was successful for other elements of medicines.
If unilateral imposition of the measures in the Bill lead to more regulatory checks at the border between Northern Ireland and the Republic of Ireland, as the EU tried to exclude products not meeting its standards from the single market, this could have serious effects. In particular, it might endanger the position of medical devices. We heard that these, unlike medicines, are being quite well served by continued adherence to EU regulations, with Northern Ireland in a better position than Great Britain.
Northern Ireland’s supply comes mainly from the EU: new frictions with the European single market at the expense of fewer frictions with Great Britain would likely be a net loss. In focusing on medicines, there is a danger of losing sight of the bigger picture of supply for the Northern Irish health and social care service.
Relationships and Northern Irish politics
Continued deterioration in UK-EU dialogue will also pose problems for the politics and governance of health in Northern Ireland.
We heard real concerns about cross-border relationships and cooperation, which are important for ensuring continuity in and improving the quality of health services and working together on shared public health threats. They are also important for tackling some of the other issues raised by Brexit across the island of Ireland, like the need for staff who work across the border to get themselves on two different professional registers to keep working.
As of yet, already existing and emerging programmes of care across the border have not been affected. But this would be a risk in a scenario where more barriers were present, and ongoing uncertainty is causing concern.
The Brexit process, and tensions over the Ireland/Northern Ireland Protocol in particular, have had a dampening effect on advocacy efforts among health care stakeholders. Representative bodies said they felt that it could at times be difficult to raise issues related to cross-border collaboration or health and social care workforce retention, in part because of the ways that regulatory issues related to medicines and other products can dominate the debate, and in part because in Northern Ireland’s already sensitive political environment, it had become difficult to question the outcomes of Brexit without being viewed as partisan.
Meanwhile, failure to form a government at Stormont directly due to tensions over the Protocol is preventing Northern Ireland from moving forward with the health and social care reforms broadly agreed by both unionist and nationalist ministers in previous governments since 2016. For patients and staff, this is probably the biggest impact Brexit is having on health care.
A problem for us all
Health in the rest of the UK also faces several risks. Although under the EU-UK Trade and Cooperation Agreement, in principle the UK may participate as an associate in Horizon Europe. This has become a bargaining chip. The UK government has said it is close to giving up on participation, and British researchers who had been awarded grants were forced in late June to give them up or move to the EU: 115 were stripped of their funding and will have lost the opportunity to lead research that this brought.
If the UK resists dispute settlement under the Withdrawal Agreement, the EU will have the right to retaliate through the UK-EU Trade and Cooperation Agreement. This could make customs and logistics barriers to imports for Great Britain even more difficult at a time of multiple shortages of medical supplies, from diamorphine to hormone replacement therapy.
With the UK government needing to first pass the Bill and then consider its implementation, while the EU responds with legal action and possible retaliation, the stability and predictability needed by suppliers, health services and ultimately patients seems a long way off. More than six years after the 2016 referendum, Brexit remains very far from ‘done’.