What are the potential implications of withdrawal from the EU for healthcare in Northern Ireland?

The Assembly Research and Information Service (RaISe) recently published a paper which provided an update on developments following the EU referendum on 23rd June. In this post, another in our series of articles examining some of the specific implications that a withdrawal from the EU may have for Northern Ireland, we examine what the implications might be for health and social care. This post follows a more detailed RaISe briefing paper on potential health and social care issues following Brexit.

Blue and yellow pills: There may have to be a change to the marketing authorisation of medicinal products for human use once the UK leaves the EU
Blue and yellow pills: There may have to be a change to the marketing authorisation of medicinal products for human use once the UK leaves the EU.

Health is not an area of significant EU competence and the role of the EU is largely to support Member States to effectively deliver related policy and services. Article 6 of the Treaty on the Functioning of the European Union lists ‘Public Health’ as amongst a range of policy areas where the EU can support Member States in this regard.

Article 168 further sets out the types of actions the EU can undertake within the field of public health to complement national policies, including to meet common safety concerns such as safety of organs, blood and blood products; provide early warning of, and measures to combat, serious cross-border threats to health (e.g. pandemics); and adoption of incentive measures to improve human health, such as EU alcohol and drugs strategies and the Tobacco Products Directive.

However, the impact of the referendum comes at a time of operational and financial pressures on health and social care systems across the UK, and for Northern Ireland during a period of significant reform of service delivery. There are a number of areas of significance to health and social care that will need to be resolved and a selected range of these is now considered. Some are of UK-wide relevance and some specific to Northern Ireland, for example, in the area of cross-border health care.

Reciprocal access to treatment – planned and unplanned health care

Under EU rules, people who come from elsewhere in the EU to live in the UK, or who leave the UK to live in another EU country, have access to health care on the same basis as nationals of that country. Arrangements will need to be negotiated with the EU as to how both ‘ordinarily resident’ UK citizens and citizens from elsewhere in the EU will access health care services in future. With regard to the treatment of visitors from the EU in the UK, and vice versa, new reciprocal agreements will need to be negotiated or the UK may seek to continue existing arrangements.

Unplanned care in another EU country

The European Heath Insurance Card (EHIC) is a free card that gives an individual access to medically necessary, state-provided healthcare during a temporary stay (including holidays) in any of the EU countries (and also Iceland, Lichtenstein, Norway and Switzerland), under the same conditions and at the same cost as people insured in that country. Residents of Northern Ireland apply to the NHS Business Services Authority to obtain an EHIC. There are currently over 660,000 valid EHICs in circulation in Northern Ireland

Access to healthcare in another EU country

EU Directive 2011/24/EU came into force in October 2013 and introduced scope for citizens across the UK to apply for reimbursement of cross-border healthcare treatment for planned and unplanned care. Under the Directive, once a patient has been assessed as needing treatment, and would be eligible to have that treatment in Northern Ireland, they have the right to obtain this treatment in another EU Member State, either privately or in the state sector.

Patients pay the treatment costs directly to the provider and in Northern Ireland the Health and Social Care Board (HSCB) will reimburse the patient for the actual cost of the treatment or the equivalent cost of treatment locally, whichever is the lesser. Except where legislation requires the seeking of prior authorisation, for example, where the treatment being sought requires an overnight stay in hospital or involves the use of highly specialised medical equipment or infrastructure, a patient may obtain healthcare in another Member State without authorisation from the HSCB.

Employment – Health and Social Care Staff

There is EU legislation in the field of employment which impacts on the delivery of health care services. This includes legislation concerning mutual recognition of professional qualifications – Directive 2005/36/EC (as amended by Directive 2013/55/EU) on the recognition of professional qualifications. This sets out UK obligations for recognising the relevant professional qualifications held by staff, from within the European Economic Area. The relevant UK regulations are the European Union (Recognition of Professional Qualifications) Regulations 2015.

Also relevant is the Working Time Directive (WTD). The European Commission is currently reviewing the WTD through a two-stage consultation of EU-level workers’ and employers’ representatives and a detailed impact assessment. One element is a health sector-specific study which covered a sample of Member States (including the UK) looking at the impact of suggested working time options on real-life healthcare scenarios.

If the UK Government decides to appeal or amend the regulations, which enacted the WTD, this would have implications for the employment contracts of health and social care staff and require negotiations with relevant unions.

Cross-border services and projects

Since 1992, Co-operation and Working Together (CAWT) has created and sustained a variety of EU funded cross-border projects and services between Northern Ireland and the Republic of Ireland, enhancing health service provision to many rurally isolated and peripheral areas. In the most recent tranche of projects CAWT managed 12 cross-border health and social care programmes funded by £24 million from the EU INTERREG IVA programme until 2014/2015, many of which are now mainstreamed into core services on both sides of the border.

In order to maintain the working relationships between the health services North and South, emphasis has been placed in the CAWT 2014-2019 Strategic Plan on particular strategic goals, such as embedding cross-border planning and implementation in core activities. An immediate priority for CAWT is to co-operate with the Special EU Programmes Body (SEUPB) and the respective Departments of Health to ensure a positive outcome to the implementation of the Health & Social Care Measure in INTERREG VA.

Development and licensing of medicines

The marketing authorisation for medicinal products for human use, as well as the rules for the constant supervision of products after they have been authorised, are laid down in Directive 2001/83/EC and in Regulation (EC) No 726/2004.

Each EU Member State has its own medical regulatory body, in the UK’s case the Medicines & Healthcare Products Regulatory Agency (MHRA). In the UK, companies wanting to sell new drugs or devices have to get them licensed by the MHRA. An alternative route for major pharmaceutical companies is to get approval from the European Medicines Agency (EMA), which is a decentralised agency of the EU.

If the UK negotiates to stay in the EEA there would not, in practice, be much difference to such regulation. If not, drug companies would need to go through a separate process with UK regulators for new products as the centralised European route would no longer be applicable to the UK.

Procurement of goods and services

Along with other public bodies and authorities in Northern Ireland EU rules on public procurement provide the legal framework for procuring goods, works and services related to the management and delivery of health and social care in Northern Ireland.

Medical and life sciences research

Research and innovation is another area of relevance as this includes participation by universities and research teams, through competitive bidding, in the EU research programme Horizon 2020. Key areas of relevant research that attract funding from Horizon 2020 are food and healthy diet; health; social sciences and humanities; and biotechnology.

The Innovative Medicines Initiative (IMI) is another area where the UK may be impacted. IMI is a partnership between the EU Commission and the European pharmaceutical industry. The IMI 2 programme has a €3.3 billion budget for the period 2014-2024, with half coming from Horizon 2020.