Denis Horgan BCL LLM MSc PhD
Executive Director, European Alliance for Personalised Medicine, Brussels, Belgium

It is well known that EU Member States have competency for their own healthcare systems under the Treaties, but it is equally true that, in today’s fast-moving health-related environment, there are disadvantages for European patients if Member States act in isolation.

Two obvious examples are frustrated attempts to improve EU-wide cooperation on health technology assessment and the much-reported current failings of the cross-border healthcare directive.1,2 More willingness to collaborate would not only improve the lot of patients and citizens, but also attract investment, allowing Europe to become a hub of innovation, able to provide services to its own economy for its continued prosperity.

Unfortunately, there are currently key gaps in stakeholder involvement, standardisation, interoperable infrastructure, European-level policy making, funding, data and research, and healthcare systems.3 On a scientific level, barriers exist since molecular data is complex to translate into information for clinical practice, for example, because of the heterogeneity of disease subtypes. And at the level of regulation, urgent policy actions are needed – backed by investment and relevant training – to remedy the research-to-market gap in the EU that threatens to condemn the bloc to trailing global competitors.4

The EU faces choices if it wants to pursue innovation and bridge the gap between research and the market place.

Areas of EU Influence

It is the EU that can encourage the constructive pooling of resources in research. It is the EU that can remove bottlenecks by creating an internal market for skills, patents, venture capital, innovation procurement and standard setting, to foster ideas which are quickly implemented on the market.

Within a strategic framework, it is the EU that can provide the coordination, via policy interventions and instruments, that permits more efficient and beneficial research activity to take place at an EU level, to make sure things dovetail well.

There have been some moves to take up the challenge with Member States and multi-stakeholder collaboration beginning to drive policy, regulatory, research and innovation activities. Subsequent moves are building on these leads.5

Smaller Member States to the Fore

Smaller Member States are starting to collaborate regionally in health-related areas, such as electronic health record and prescription exchange, cross-border agreements, and banding together in groups in an effort to lower medicine prices.6 Smaller states have been active in shaping health policy at European level and can now act as vital policy entrepreneurs pursuing normative policy agendas. This has been demonstrated by, for example, Slovenia and its major role in promoting cancer policy development at EU level.7

Due to the EU’s structure, more and more often smaller Member States are acting as rotating presidencies, and while they take the broader EU view given their six-month task, it has also become clear that Europe’s health policies need to recognise and tackle the inherent health system vulnerabilities faced, specifically, by smaller countries (by region) and in the regions of the larger ones.6 Many challenges remain for the EU’s smaller states, especially in the health arena, and these include – but are not exclusive to – a lack of interest by industry to place medical goods on such small markets due to high or inefficient unit costs of production, a lack of competition between providers which means high prices for medicines and medical supplies due to small volumes of consumption and, meanwhile, the administrative burden of regulation does little to help patient access and lower prices in these countries. In essence, European health policy needs to become better attuned to the specific challenges facing the health systems in smaller states and regions.8

EU next steps in healthcare

Let us be clear, Europe has attributes – including in smaller Member States and regions – that give it the chance of being highly competitive in a world fighting for leadership in this promising sector. It boasts cohesive and predominantly social health systems, working to a high standard with the same values in comparable structures and under similar pressures, adhering to similar legislation and other influences.9 Its scientific and technology capabilities in genomics and in many broader fields are globally respected and envied. Public funding support is available for health research, and major national and multinational programmes have demonstrably delivered successful results. And there is some health data infrastructure.10

With adequate investment and political will, the chances are good for successful cross-border collaboration, for enhancement of the data infrastructure, and even for that most elusive element of Europe’s skill-set – translating its knowledge capital into innovation. The merits of collaboration by Member States at EU level have been repeatedly extolled – now we need more of it. Closer collaboration on reference networks and data banks; wider access to information; institutionalised cross fertilisation between providers, payers, and regulators; and enhanced common understanding on health technology assessment are just some of the most obvious needs to integrate innovation into healthcare.11 Going forward, it will be important for everyone in the policymaking and regulatory frameworks to have a clear view of the impact they have on the development and introduction of innovation into healthcare.


1. Report on the implementation of the Cross-Border Healthcare Directive (2018/2108(INI)) A8-0046/2019. Available from:

2. European Commission. EU cooperation on Health Technology Assessment (2018). Available from:–51_en.

3. Horgan D, Jansen M, Leyens L, et al. An Index of Barriers for the Implementation of Personalised Medicine and Pharmacogenomics in Europe. Public Health Genomics 2014;17:287-298. doi:10.1159/000368034.

4. Siu Lillian L, Lawler M, Haussler D, et al. Facilitating a culture of responsible and effective sharing of cancer genome data. Nat Med 2016; 22(5):464-71. doi:10.1038/nm.4089.

5. Mazzucato M. Mission-oriented innovation policies: challenges and opportunities. Ind. Corp. Chang 2018; 27(5):803–815. doi:10.1093/icc/dty034.

6. OECD/EU (2018). Health at a Glance: Europe 2018: State of Health in the EU Cycle. OECD Publishing, Paris. doi:10.1787/health_glance_eur-2018-en.

7. Albreht T, Kiasuwa R, Van den Bulcke M. European Guide on Quality Improvement in Comprehensive Cancer Control. CanCon Cancer Control Joint Action, Slovenia National Institute of Public Health and Scientific Institute of Public Health Belgium, 2017. Available from:

8. OECD (2018), Pharmaceutical Innovation and Access to Medicines. OECD Health Policy Studies, OECD Publishing, Paris. Available from:

9. State of Health in the EU: Country Health Profiles. Available from:

10. Communication from the Commission to the European Parliament, The Council, The European Economic and Social Committee and the Committee of the Regions on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society. COM/2018/233 final. Available from:

11. Horgan D, Bernini C, Thomas P, et al. Cooperating on Data: The Missing Element in Bringing Real Innovation to Europe’s Healthcare Systems. Public Health Genomics 2019;22:77-101. doi: 10.1159/000503296