The authoritative source for independent research on UK-EU relations

16 Mar 2018


Any departure from the EU approach to regulating health and social care will have significant consequences given the complex arrangements that are in place in these sectors.

In biomedical research, for example, UK organisations are currently the largest beneficiaries of EU health research funds in Europe; EU research funding via the Horizon 2020 programme has benefitted the NHS; and EU collaboration in clinical research has generally been to the advantage of UK healthcare.

The EU’s common legal frameworks—for instance, on data protection, human tissue regulation and the safety of clinical trials—underpin that collaboration.

The Prime Minister in her Mansion House speech mentioned the prospect of a “far-reaching science and innovation pact with the EU, facilitating the exchange of ideas and researchers”, with payment for access.

Whether this will be welcomed by the EU is another matter. Its agreements with Switzerland over participation in such research programmes have been fraught, and it is questionable whether the EU would want to reciprocate the enthusiasm of the Prime Minister on this issue.

The EU has played an important role in the development of domestic public health law and policy.

For instance, while some aspects of tobacco control policy are matters for domestic law—such as the ban on smoking in public places—tobacco control in general is affected by EU Law.

The EU Tobacco Products Directive regulates a range of matters, including tobacco advertising and nicotine levels in tobacco. The Directive also addresses matters concerning trade in illicit tobacco, with measures directed at tracking and tracing tobacco products.

It is important that the UK’s commitment to tobacco control does not become weakened after it leaves the EU.

The safety and quality of donated blood, tissue, and cells and organs are also subject to EU regulation. The three main directives in this area, operating alongside a number of related directives, set out minimum quality and safety standards.

Establishments dealing with blood, organs or tissue need to be accredited, designated, authorised or licensed, and inspected by the relevant authorities of member states (such as the Human Tissue Authority in the UK) for the procurement, testing, processing, preservation, storage or distribution of human blood, tissues and cells.

Further provisions relate to the clinical selection of donors, information and consent. The Directives have also led to the introduction of standard operating procedures for the donation, procurement, packaging, labelling and transportation of human materials.

Some of these safeguards will remain in domestic law through the EU Withdrawal Bill, unless amended by ministerial action as the Bill will allow. A proposed amendment to the Bill seeks to secure that Brexit will ‘do no harm’ to health.

In other areas, however, reciprocity is required for the system to operate.

For example, certain safety issues are targeted through specific cross-EU rapid alert systems, such as the Rapid Alert System for Human Tissues and Cells (RATC) and the Rapid Alert System for Blood and Blood Components (RAB).

These enable information regarding adverse reactions to be shared quickly across member states.

The UK would not have access to these rapid alert and information systems unless there were specific sectoral agreements in place.

The Commission’s draft Withdrawal Agreement, published in February, indicates that the UK would not have access to such computerised databases post-Brexit.

The UK currently exports organs for transplant to other EU member states, with some organs being transferred across the border between Northern Ireland and the Republic of Ireland.

It is important that steps are taken to maintain such exchange systems after the UK leaves the EU. The EU is also strongly against commercial dealing in human materials and parts.

Provisions to this effect are contained in the EU Charter of Fundamental Rights and also in relation to the specific blood, organs and tissue directives.

While at domestic level, in relation to organ transplants, the UK has also been opposed to commodification, it is important to ensure that such commitments are not weakened once the UK leaves the EU.

On communicable diseases, the EU has its own agency, the European Centre for Disease Prevention and Control (ECDC), which is concerned with identification, assessment and communication of threats.

It undertakes a Health Security Initiative, which requires notification of health threats with the Health Security Committee, having a legal basis to act on such threats.

The EU’s role in this area is still evolving and the main instruments in relation to disease prevention derive from international law. Nonetheless, after Brexit the UK will not have access to such EU networks, which remains a major concern.

Data Protection is a further topic where the EU has been particularly influential.

In UK domestic law there have long been commitments to safeguard the confidentiality of patient information through the equitable remedy of breach of confidence, which is today also bolstered by protection through the Human Rights Act 1998.

However, data protection law also provides specific safeguards in relation to individual data access and control.

Currently, the law in this area is being reformed through the introduction of the General Data Protection Regulation and the Data Protection Bill 2017, implementing EU law. While initially the UK will therefore in many respects be aligned with EU law, the question is what happens longer term.

The structure of the legislation would enable comparatively straightforward amendments post-Brexit. In the Mansion House speech in March 2018, the Prime Minister emphasised the importance of Data Protection and the need for specific agreements and a role for the Information Commissioner.

It remains to be seen to what extent the EU is prepared to accept the UK’s proposals on this. It is important that commitment to patient autonomy and control of access to their own personal information is not put in jeopardy in the future.

By Jean McHale, Research Investigator at The UK in a Changing Europe and Professor of Health Care Law at the University of Birmingham. Read our Brexit and the NHS report in full here.


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