Keynote speakers

Prof. dr. Anne-Marie Duguet

Anne-Marie Duguet is medical doctor and PhD in law. She is Emeritus Senior Lecturer at Paul Sabatier University where she taught medical law and bioethics. In the team « Bioethics » of the UMR/ INSERM 1295 CERPOP, she conducts her research on French and European health law, bioethics, law and ethics of research, digital technology, new technologies and genetics. She has participated in 15 European projects in charge of legal and ethics workpackages on topics such as ethics in neonatal intensive care, hematopoietic stemcell donation, violence against women, participation of elderly patients in medical research, and of patients with Alzheimer's disease, epidemic preparedness, access of Rainbow families to medically assisted reproduction, biobanking for research, end of life… She has been cooperating with Chinese universities for 15 years, leading Franco-Chinese projects and co-tutored theses. Within the UNESCO Chair "Ethics in Science and Society", she coordinates the working group on Digital Ethics, which includes an international panel. She has written more than 200 scientific articles and has published or contributed to about thirty books. In 2006, she organised the 16th World Congress of Medical Law in Toulouse and in 2019 the Conference of the EAHL. She is governor for France of the World Association for Medical Law and member of the advisory board of the European Journal of health law.

Influence of COVID on health law: a public health perspective


From the first waves, shortages of medical equipment and masks showed that no country could cope alone. An epidemiological surveillance (linked with the European Center for Disease prevention and Control)) had to be put in place. In each country, exceptional derogatory measures in health law were authorised to organise access to care.

The European Union, which has only a support competence for public health security, coordinated actions for repatriation assistance and transfer of patients between member states.

With exceptional speed, vaccines have been placed on the market in Europe thanks to the EMA's conditional marketing authorisation procedures. In June 2020, the European Commission adopted a European vaccine strategy and decided a group purchase.

Covid Pandemic has shown that states need to plan and coordinate for the emergence of future viruses, so the EU is considering setting up a dedicated authority : Health Emergency Response Authority (HERA).

Prof. dr. Herman Nys

The organisation and competences of the healthcare professions in the post COVID area. The opportunities and limits of EU Law.

 

In many EU Member States the emergence of COVID has challenged the way the practice of the different healthcare professions has been legally organised in the past decades or even centuries such as in Belgium. Especially the legal rules dealing with the competences and abilities of nurses, pharmacists and physicians with regard to the prescription, the delivery and the administration of the vaccine were at the centre of often emotional discussions. However, the COVID crisis has only brought to the surface that an integrated healthcare system adapted to the needs of chronic and self-determined patients also requires a much more flexible organisation and practice of the healthcare professions. The limits and opportunities of EU Law (directives; jurisprudence of the ECJ) in this regard will be the focus of my paper.


Herman Nys is emeritus at KU Leuven. He has been professor in medical law at KU Leuven from 1984 until 2016 and from 2000 and 2006 also professor of international health law at Maastricht University. He is co-founder of the European Association for Health Law, editor-in-chief of the European Journal of Health Law, editor of the International Encyclopaedia of Medical Law and member of the European Group on Ethics (2022-2025).

Prof. dr. Anniek de Ruijter

Anniek de Ruijter is Associate Professor Health Law and Policy at the University of Amsterdam and Director and initiator of the Law Centre for Health and Life. In her research she works on the question of how constitutional safeguards for health-specific rights and values can be ensured in the context of EU and global regulatory interactions. She has expertise in legal and theoretical legal analyses, which she combines with qualitative social science approaches. She works in interdisciplinary collaboration within biomedical, public health and social science consortia and is the co-lead on two interdisciplinary research consortia, on Global Health and on AI Decision-making in Health. Her research on improving the EU constitutional order for responding to human health disasters such as pandemics or bioterrorist attacks was awarded a personal grant of research excellence (2017) by the Dutch Scientific Research Organization, and she is currently working on a H2020 research on EU-India relations regarding access to pandemic vaccines.

 

She is Member of the Board of the Amsterdam Institute for Global Health and Development. She is also a member of the Steering Committee of the Section on Public Health and Law of the European Public Health Association and co-initiator of the European Health Union Manifesto initiative (with the Gastein Forum). Anniek de Ruijter is member of the editorial board of the European Journal Risk Regulation with Cambridge University Press and on the Editorial Advisory Board of The LANCET Regional Europe.

The Politics of Health in the EU: the Role of Law

 

 Quality of care has been a sensitive part of debates on a potential role for the EU in health. Should the EU be involved in the formulation of standards of care and quality when the conditions and organization of care is so vastly different across EU systems of health care? The answer of Member States to this question has been to attempt to limit a stronger role of the EU in the field of health. In consecutive Treaty changes, provisions were added to limit the possibility for adopting binding EU rules in the field of health. Paradoxically, this has not limited the inroads of the EU into human health law and policy, and along the way, the limited legal power in health has disempowered national health representation and its related professional communities, to influence the trajectory of the inroads of the EU in the field of health. At national level, it is these professional communities that play a central role in the formation of health law, policy and standards of quality and safety of care. Could a stronger legislative basis in Union Law also engage these national communities at EU level? And what difference could this engagement have for the policy content of EU health law and policy, and consequently for way the EU can play a role in the field of health?

Prof. dr. Markus Frischhut

Dr. iur. Markus Frischhut, LL.M. is Jean Monnet Professor, Chair ‘EU Values & DIGitalization for our CommuNITY (DIGNITY)’. He teaches and researches at MCI | The Entrepreneurial School®, where he is also Study Coordinator European Union Law. In his work, he focusses on EU law, EU health law, EU values, as well as the relationship of EU law and ethics. He has been working on cross-border healthcare (‘patient mobility’) within both the EU as well as the EEA, communicable diseases, as well as questions of ethics and values in the field of digitalization and medical ethics. Markus was guest lecturer at international universities (Bergen, Madrid, London, Seoul), as well as guest speaker at many international conferences. He recently also published a study commissioned by the European Parliament on “Strengthening transparency and integrity via the new ‘Independent Ethics Body’ (IEB)”. All his publications and other activities are documented and (as far as possible) available on the website of this Jean Monnet Chair: https://jeanmonnet.mci.edu/.

Quality of care and new technologies – the role of values and ethics


While ‘quality’ is value-neutral (degree to which certain requirements are met), quality in EU health law should not be value-neutral. ‘Access to good quality care’ is an EU health value. This soft-law statement has to be seen against the background of a ‘high level of human health’, as enshrined in EU primary law, as well as the principles of availability, accessibility, acceptability and quality (‘AAAQ’), as essential elements of the ‘right to health’. Obviously new technologies such as in the field of digitalization (AI, etc.) also have to comply with quality-related requirements of both ECJ case-law and existing or upcoming EU Secondary law (e.g., MDR, HTA, AI). Building on this, the EU additionally refers to ethics and values to offer suitable tools for these new challenges. Both ethical and legal principles shall lead to trust in new technologies and enable values-based, human-centric and inclusive quality, especially also for vulnerable persons.

Prof. dr. Dipak Kalra

Dipak Kalra, PhD, FRCGP, FBCS, British, is President of The European Institute for Innovation through Health Data (i~HD).  

He plays a leading international role in research and development of Electronic Health Records, including the requirements and models to ensure the robust long-term preservation of clinical meaning and protection of privacy. He leads the development of ISO standards on EHR interoperability, personal health records, EHR requirements, and has contributed to several EHR security and confidentiality standards.  

Dipak has led multiple European projects in these areas, including Horizon 2020 and the IMI programme alongside pharma companies, hospitals and ICT companies. He recently co-led a €16m project on the re-use of EHR information for clinical research, EHR4CR, alongside ten global pharma. He is a partner in another IMI project, EMIF, on the development of a European clinical research platform federating multiple population health and cohort studies. Dipak also led an EU Network of Excellence on semantic interoperability, and is a partner in other EU projects on the sustainability of interoperability assets, the transatlantic sharing of patient summaries and quality labelling.  

Dipak is Professor of Health Informatics at University College London and Visiting Professor of Health Informatics at the University of Gent. 

Pressure points between two Teutonic plates: GDPR and big health data research 

 

The GDPR demands the highest order safeguarding of the data protection rights of individuals, but this can be in tension with the collective rights of society to receive the best, safest and most advanced healthcare. Modern health research often requires large (=multi-controller) patient numbers and longitudinal (= linked), high fidelity (= difficult to anonymise), data for precision medicine, targeted therapies and AI development. Big (= not easy to minimise) data infrastructures (=no single purpose) proliferating across Europe (= multi-country) consistently face the same GDPR pressure points. i~HD’s mission is to engage with these big data initiatives. We find a strong desire to uphold the GDPR, to respect data subjects and to collaborate with us on finding the best governance approaches (the lava between the plates). This presentation will put the case for scaling up big data research and walk through these pressure points, strategies being piloted and the outstanding challenges.  

Prof. dr. Jean McHale

Jean McHale is Professor of Healthcare Law and Director of the Centre for Health Law, Science and Policy at the University of Birmingham. She is the author of a number of monographs, textbooks and edited collections. Her recent books include The Regulation of Cosmetic Procedures: Legal, Ethical and Practical Challenges with Melanie Latham (Routledge, 2020); Principles of Medical Law edited with Judy Laing (4th ed) (Oxford University Press: 2017); European Health Law: Themes and Implications, with Tamara Hervey (Cambridge University Press, 2015). 

Putting Patient Safety at the core of high quality  System in the EU : An unattainable EU Aspiration ?


In 2008 the European Commission in its Communication stated that its aim was that of “an integrated approach, placing patient safety at the core of high quality health care systems by bringing together all factors that have an impact on the safety of patients”. This was an ambitious statement- but was it too ambitious? Is patient safety something which the EU is itself effectively able to address holistically? This paper explores how the EU has addressed questions of patient safety in the fourteen years since that Communication. It argues that there are areas where there have been notable measures put in place to address patient safety concerns in this period. For example, there has been the major reform of the legal regulation of medical devices, there is also currently work to address the EU regulation of blood, tissue and cells. Other measures such as recent developments in whistleblowing law may impact on this area going forward. But there remain notable challenges. First, that some of the above reforms such as those of medical devices do not go far enough. Secondly, that of the diverse approach to health care delivery, professional regulation and funding available to health systems at member state level pose challenges for any attempt at a comprehensive coherent approach to patient safety. This is also something which also needs to be seen in relation to the broader impact of Austerity. Thirdly, in terms of policy development the Covid-19 Pandemic has affected both how safe patients regard health systems and demonstrated how fragile trust can be. Will the Pandemic leave a difficult legacy for patient safety going forward?