In the European regulatory framework for medical technologies, the Internal Market competence is insulated from the Union limited powers in the field of public health and healthcare delivery. This compromise fitted the aspiration to turn the EU into «the most dynamic and competitive knowledge-based economy», without interfering in national health systems.
The SARS-CoV-2 pandemic upended this narrative. The disruption of supply chains caught both the Union and Member States unprepared, laying bare, and worsening, old and new discriminations. This has already pushed for a change of regulatory priorities on research and development (R&D): from catering to the market, to meeting the needs of patients and health systems (COM(2020) 761; EPRS, PE 697.197, 2021).
Against this backdrop, the proposed workshop should bring into focus the current models of R&D in the different but connected fields of medical devices and pharmaceuticals. We wish for an open, multi- disciplinary discussion on the market and government failures that prevent innovation towards unmet individual and collective medical needs.
We welcome papers on various issues related to the role of private and public law incentives in fostering innovation in areas of unmet medical needs, with a focus, in particular, on:
• free-movement of personal and non-personal health data for research
purposes between competition, intellectual property, and data protection
• medical knowledge as commons
• biobanks as research infrastructures
• role of liability rules in fostering R&D and access to healthcare
• access to medical products and services between competition law and prices
regulation
• role of private and public incentives in fostering innovation in areas of unmet
medical needs
• incentives and obligations in pharmaceutical e medical devices legislation and
IP rights
• impact of the revised “2022 RDI Framework”[C(2022) 7388] on medical
innovation
• role of Public-Private Partnerships
• public procurement and innovative medical solutions
• market failures preventing innovation towards unmet health needs
• role of HERA and other European agencies in promoting R&D on medical
devices and pharmaceuticals
• European support for medical R&D in developing countries
Prospective participants should send an abstract (min. 600, max. 1200 words) and a short cv to: elate@jus.unipi.it by the 31. March 2023. The results of the peer-review process will be made known by 20. April. The first draft should be sent by the end of June and the final version by the end of September.
The selected papers will be published in a special issue of a peer-reviewed indexed journal and the Authors of the best papers will be invited to present their work in an international workshop hosted by the University Pisa in October 2023.
The University will cover the costs for one night and travel costs (economy class).