Professor Tamara Hervey:

I thank the committee for inviting me to share some of my thoughts and research with the members. It is an honour to be here and I will try to help the members as best I can.

I am a professor of European Union law, and I have been researching and teaching the European Union’s health law and policy since the 1990s. I have been asked to focus on the legal implications of Brexit for the Irish health sector, particularly focusing on future EU-UK relationships.

Professor Maher has already outlined the uncertain elements of the current position. It is important to be clear that we will not have legal certainty until the terms of the UK's withdrawal from the EU and the terms of any future EU-UK relationships are legally defined.

I am envisaging more than one legal document that expresses the relationships between the EU and the UK going forward. People talk about the trade agreement but it is unlikely to be a single legal document.

Planning for Brexit in the health sector, like other sectors, is a question of contingency planning for unknown possible futures. Unlike other sectors, though, the health sector involves people’s bodily safety, dignity, and, ultimately, their lives. One thing that is certain is that the effects of Brexit on health will be significant, negative and will fall unevenly. They will fall most heavily in the UK but the effects of Brexit on health outside the UK will also fall unevenly, with Ireland one of the places outside the UK in which negative Brexit health effects will be most keenly felt. The other key point from our research so far is that the effects of Brexit on health will differ depending on the type of Brexit. In short, a no-deal Brexit is worse for health than a planned, organised Brexit.

I will not go over the current legal position. British politics is now waiting on the result of the general election. If the Johnson Government gets re-elected on 12 December 2019, the expectation is that the withdrawal agreement will pass through the British constitutional procedures. At that point, the negotiations will start for the next phase. As things stand, the EU and the UK have until the end of 2020 to negotiate one or more future agreements. As Professor Maher has outlined, that amount of time is insufficient to negotiate the relevant agreements, so further extensions will be required or we are facing another kind of no-deal scenario at the end of 2020. So far, no deal has meant no withdrawal agreement, but it may come to mean no, or insufficient, future agreements. There could be a partial no deal with some legal provisions in place but others not. I suggest the committee be mindful of the granular meaning of "no deal". A trade agreement may cover products or certain service sectors, but others relating to health policy may not be covered in a formal legal agreement between the EU and the UK.

If we have a no deal in December 2020, we are facing all the same kinds of problems for health as have already been flagged by this committee. Even if or when there is a free trade agreement, many aspects of the current arrangements will be on a totally different legal footing. I was thinking about how to conceptualise the committee's work on contingency planning for the Irish health sector. One way that the committee might wish to conceptualise the contingency planning needed in the Irish health policy sector is as follows. A hypothetical member state of the EU that is not reliant on the UK post Brexit for health products, substances of human origin, health services, health professionals or anything to do with health is a member state that has reduced the risks of Brexit for health to virtually zero. Of course, that is an entirely hypothetical situation, but it could be a useful way to understand Irish governmental planning for health post Brexit. Where can the Irish reliances on the UK, particularly on Great Britain, in the health sector, be reduced and how can steps be taken to reduce risks associated with it? Steps to reduce risks can involve either reducing reliance or securing a robust legal basis for continued reliance, or both these things.

The key issues here are about supply chains implicating the UK. In this area, the difference between supply chains implicating Northern Ireland and those implicating England, Scotland and Wales becomes really important because the withdrawal agreement's new arrangements mean different treatment between products from Great Britain and products from Northern Ireland. There are, as the committee is already aware, specific issues about products that cannot be stockpiled, like radioisotopes. It is important to remember that the political declaration is only a political statement and can be interpreted in many different ways. Different commentators read it as indicating different directions of travel. I am more inclined to read it as indicating something like the relationship the European Union has with Canada, while others read it as meaning a deeper relationship that is a bit closer to the relationship the EU has with Norway. The political language supports both interpretations so we do not have legal certainty.

I suggest that Ireland consider risks associated with regulatory divergence, such as in the area of health products. The political declaration states that the UK and EU would like to explore the possibility of inter-agency co-operation at the granular level of the European Medicines Agency, but this is very far from the current position where marketing authorisations for medicines are either granted at EU level or are mutually recognised across all EU member states. In the area of substances of human origin, one of the key things lost when the UK leaves the EU will be the alert system for unexpected adverse effects on patients, and there has been work to move that work from EU institutions to the World Health Organization and the Council of Europe. This might be a sufficient basis for sharing information between the UK and the EU.

The position relating to people was clearly summarised by Professor Maher. There are two groups of people who are important to the health sector, one of which is health professionals. The Commission has confirmed that UK qualifications that were recognised before Brexit will continue to be recognised. I note that the committee has already recommended that Ireland continues to recognise UK medical qualifications post Brexit. The practical position of health professionals and their families with UK qualifications within the Irish health sector will be affected by common travel area arrangements and the rights that UK nationals who are resident in Ireland have. For patients, it is a bit more complex and it is necessary to unpick the legal basis of current arrangements carefully to secure continuity of the current situation. The intention appears to be that the main change in terms of access to healthcare will be in legal form, rather than practice. In the formal legal position, I do not think that is the case.

That is because the legal form that the entitlements currently take for cross-border healthcare provisions are rights given to patients whereas the legal form in the future under the combination of service level agreements and common travel area measures will not be a right for patients, but an arrangement between the relevant health institutions in the different jurisdictions.

One group of patients not covered directly by the common travel area is EU 26 nationals who reside in Ireland and fall under the scope of the Irish health system because of their rights in EU law. Where provision is currently made for those people to be looked after in the Northern Irish healthcare institutions because of a memorandum of understanding or informal service level agreements, there is at least arguably an obligation in EU law to continue to treat them the same way as other Irish residents in terms of access to healthcare provided through those informal arrangements. Obviously, that obligation lies on Ireland but it will not be possible to hold the UK to account under an obligation in EU law for that care. This is a matter the committee might want to consider raising. I am not sure how Ireland's continuing obligations in EU law and the co-operation and working together arrangements can be clarified, but that is an area in respect of which some legal crystallisation might help.

The committee is right to identify regulatory alignment as a key legal question for planning going forward. Many of the challenges raised by Brexit for health are easier to meet if the UK and Ireland as an EU member state remain aligned in regulatory standards and approaches across the whole range of areas that affect healthcare and health policy. Many aspects of alignment are an EU competence and are outwith the unilateral control of Ireland as an EU member state. Of course, Ireland will exercise its influence within the EU institutions as a member state. Some aspects of health-related regulation and most aspects of health services provision remain within Irish competence. The committee will be mindful of this factor.