European Association of Health Law's Interest Group on Supranational Biolaw
EAHL IG Supra Biolaw
The aim of the EAHL Interest Group on Supranational Biolaw is to promote European health law, especially in its European-level dimension.
ID: 355125643322-26
Lobbying Activity
Response to A New European Innovation Agenda
10 May 2022
Opinion from Dr Éloïse Gennet, Noémie Dubruel, Prof. Markus Frischhut and Dr Aurélie Mahalatchimy, on behalf of the EAHL Interest Group on Supranational Biolaw and the I-BioLex research project
The authors welcome this necessary and timely initiative and acknowledge the crucial importance of the five key issues identified by the Commission in regards to a new European Innovation Agenda: access to finance, pro-innovation regulation, strengthening and connecting of EU innovation ecosystems, better innovation policy making and development of entrepreneurial talent. In our response, we will tackle these elements with the specific perspective of innovation in the field of health, and more specifically of innovation in the field of pharmaceuticals.
Legal Basis: Art. 168.1 and Art. 9 TFEU on “health in all policies” should be added among the legal basis of this initiative.
Respect of fundamental rights:The future Commission communication on a New European Innovation Agenda should recall the importance of respecting fundamental rights and most importantly the Charter of Fundamental Rights of the EU.
The future communication should also recall the importance of the European Declaration on Digital Rights and Principles for the Digital Decade, especially given the strong link between this initiative and the digital transition.
Societal aspects of European innovation:We would like to stress the importance, when considering the need to increase innovation cohesion, to not only take into account economic and technological aspects of innovation but rather also take into account its societal aspects. The benefits of innovation should be directed to all, both individually and collectively, which entails the necessity to take positive action to direct innovation towards vulnerable groups and unmet health needs.
The Future Communication on the New European Innovation Agenda should include Responsible Research & Innovation as a key approach to align research and innovation with societal needs.
Health Innovation
Health Innovation as a strategic policy field to be acknowledged in the New European Innovation Agenda
To recognize the existence of a European innovation strategy in health would notably:
optimize the use of the range of competences of the EU, while respecting national competences, in the fields associated with health innovation
make clear the interest of a transversal European action already at work
ensure an overall coherence to concrete and scattered legal activities
take stock of the extent of past, current and future European action in the field and of its specificity by making it more understandable to European citizens and involving them
offer benchmarks reliable to players in the field while guaranteeing the flexibility necessary regarding the evolution of science and technology in the field of health innovation.
Human rights to be acknowledged regarding technologies and innovation in biomedicine and health: This initiative should also take into account the Convention on Human Rights and Biomedicine as well as the activities of the Council of Europe in regards to technologies and innovation in biomedicine and health.
Establishing a specific EU entity within DG-SANTE to support gene and cell therapy development: This entity, that could be similar to the Gene and Cell Therapy Catapult in the UK, would foster gene and cell therapy development in the EU, relying on the exceptional regulatory anticipation that have occurred in the field of Advanced Therapy Medicinal Products in the EU. It would particularly target the key bottleneck identified in this initiative for this area of health innovation.
Disruptive innovation in the field of health: Specific attention should be given to disruptive innovation in the field of health, taking into account the Expert Panel on Effective Ways of Investing in Health (EXPH) 2016 opinion entitled “Disruptive Innovation. for health and healthcare in Europe.
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