Brexit: our asks to prioritise patient safety and public health

What does Brexit mean for patients? On 21 February 2018, a coalition of Brussels-based health stakeholders held a joint meeting to discuss how to prioritise patient safety and public health in the Article 50 negotiations on the future relationship between the UK and the EU.

The participants came from different organisations, including Member State representative and other policy-makers.

What does Brexit mean for the UK patients?

From a UK perspective, the “Brexit Health Alliance” was initiated, bringing together different stakeholders in the health sector (including the NHS, medical research, industry, patients and public health organisations). The focus of the Brexit Health Alliance is to safeguard the interests of patients and the healthcare and research during the Brexit negotiations.

Five areas have been selected, around which key “asks” have been formulated. In their collective statement, the participating organisations outline their main expectations when it comes to negotiations:

• (1) collaboration on research and innovation,
• (2) regulatory alignment,
• (3) reciprocal healthcare arrangements,
• (4) coordination of public health and wellbeing mechanisms, and
• (5) health funding.

What does Brexit mean for EU patients?

Though the importance of the implications of patients living in the UK should clearly not be undermined, the question is very often raised of what the implications will be for EU27 patients. Will the lives of patients residing in the EU27 countries be affected? And if yes in what way.

Feeling that this would indeed be the case, EPF joined an informal group of health stakeholders at EU level that had similar concerns. Five topics were identified as potentially having the biggest impact on EU27 patients in a common statement.

At the event, EPF Secretary-General, Nicola Bedlington, presented the five main “asks” of the informal coalition and concluded on the following three questions that still remain unanswered.

(1)          How will a trade agreement ensure sufficient and timely supply of medicines and medical devices for both EU and UK patients?

(2)          How will continued partnership on medical research be continued in order to enable innovative research to be conducted across the UK and the EU?

(3)          In the event of a ‘no deal’ Brexit, how would EU27 national governments avoid that public health be affected across the EU?”

A bit of background: Brexit in a nutshell

The UK joined the European Communities in 1973. 43 years later, on 23 June 2016, the UK voted leaving the European Union. Nine months later, Prime Minister Theresa May activated the official mechanism that will make Brexit a reality - Article 50 of the Lisbon Treaty. Following this, the European Council – made up of the heads of state or government of EU countries – adopted a set of political guidelines, which define the framework for the negotiations and set out the EU's overall positions and principles. During the negotiations, the EU is represented by Michel Barnier, as Chief Negotiator for the 27 EU countries. His taskforce at the European Commission coordinates the work on all strategic, operational, legal and financial issues related to the negotiations.

It was decided that the negotiations would be structured in two phases. In the first phase of negotiations, British and EU officials met each month for four days in Brussels to discuss three main issues: citizens’ rights, the Irish border, financial settlements. At the end of 2017, a join report setting out the commitments to be reflected in the Withdrawal Agreement, which set out that sufficient "agreement in principle" was reached on those areas. The second phase of the negotiation covers the arrangements for transition towards the UK's withdrawal, together with the framework for the future relationship.

Regulation of medicines and medical technologies

Every month, 45 million patient packs of medicine are supplied from the UK to the EU27/EEA and there are 2,900 individual medicine products produced in the UK that are supplied to EU27/EEA patients[1]. Even if we, at the moment, not yet know of the exact arrangement that will be made during the UK and EU governments, it is clear that if the UK leaves (or changes its position vis-à-vis) the internal market, there will be a disruption to this supply of medicines. EPFIA, the representation of the pharmaceutical industry operating at European level, has made an analysis of the situation and the possible implications. The role of the UK at the EMA is also of great importance, making a very valuable contribution to the centralised approval procedure.

A similar importance of the UK market can be seen in the medical technology side. In order for a medical technology to reach the market, approval is needed by “notified body”, an organisation assessing the conformity of the products before they are placed on the market. UK notified bodies are used to a very large extent and the loss of this capacity could have an impact on the availability of products. It is also unclear whether existing approvals given by UK bodies would be void or not following Brexit. MedTech Europe, the trade association representing the medical technology industries operating in Europe, outline their main concerns regarding Brexit negotiations in their position paper.

Brexit and research

The UK contributes a great part on healthcare research. Whether it is clinical trials, life-science research, European Reference Networks (ERNs), or Health Technology Assessment and Adaptive Pathways, the UK plays a vital role in participating in the EU research collaboration. A recent report gives an extensive overview of what the current UK contribution to EU research consist of. It is evident that all this expertise would be lost or compromised if a good agreement on future research collaboration is not reached.

Brexit and Public health

Although the “protection and improvement of human health” is a Member State where the Union can only support, coordinate or supplement actions (art. 6 TFEU), it is not stressed often enough that “common safety concerns in public health matters” are a shared competence (art. 4 TFEU). In two recent articles, the importance of public health actions at EU level is highlighted, drawing conclusions on the potential impact of Brexit. “With the public debate around Brexit focusing mainly on its economic and legal consequences, public health concerns are in danger of falling by the wayside”[2], writes Nina Renshaw, Secretary-General of the European Public Health Alliance (EPHA). In her essay, she explains how “health and safety protections – not only those in the workplace but also safety standards for consumer goods and standards for clean air and water – may be under threat”. In another recent article, parallels are drawn with the situation of Switzerland and the issues the country is facing with regards to public health cooperation with the EU. Similar or comparable issues will most likely be encountered by the UK following Brexit.

Brexit and Professional mobility

Professional mobility has a great impact on healthcare systems around Europe, with medical doctors and nurses being the two most mobile professions in the EU[3]. Highly trained healthcare professionals are the backbone of all European healthcare systems. Not being able to benefit from the expertise UK-based universities have to offer, would be a great loss for many members of the healthcare workforce. Next to that, patients are, at the moment, adequately protected by an alert mechanism established by the Directive on Professional Qualifications. This allows authorities of all Member States to warn each other if health professionals have been prohibited or restricted from practicing the profession in one country or have used falsified diplomas for their application for the recognition of their qualification. Even if mobility issues between the EU27 and the UK are solved, such mechanisms would potentially not be applicable to professionals moving between the two – a significant loss for patient safety.