A special edition of the XII Foresight Training Course “Innovative medicine and research: ethical, legal and regulatory issues” was held on 27th September 2019 in Toulouse (France), within the 7th European Association on Health Law (EAHL) Conference “Innovation & Healthcare – New challenges for Europe” in collaboration with the Council of Europe and Espace Ethique PACA-Corse/AP-HM.
Legal, ethical and regulatory issues of innovation in medicine and healthcare were analysed, focusing on emerging technologies in genetics, pharmacogenetics, advanced therapies as well as Information Communication Technology applications in medicine and research. Besides clinical benefits also economic and health outcome improvements were considered, as well as the respect of fundamental and patient rights.
The course, divided in 3 sessions, was very well attended; a wide selection of international representatives of academia and European organisations took part in the workshop and more than 50 participants registered for the event.
Professor Adriana Ceci and Annagrazia Altavilla, who closely collaborated in the realisation of the event, welcomed and introduced the course and its related topics.
All the speakers provided with a relevant and consistent contribution to the themes of interest of Fondazione Gianni Benzi, offering a complete and stimulating panorama of the ethical and regulatory aspects concerning innovation in the health sector.
An interesting point of view on the access to personal data and intellectual property for scientific research, both representing two significant issues, was provided in the perspective of innovative medicines.
Particular attention has to be payed to the paediatrics population taking into account the whole development process of innovative medicines. Legal and ethical aspects on the paediatric topic were highlighted and analysed.
In the last years Artificial Intelligence and Machine Learning are becoming increasingly fundamental in medicine. Several perspectives of these new applications in the medical and pharmacology field were presented along with potential ethical and regulatory challenges.
In the framework of innovation in health care, a key topic to be considered is the advanced therapy, that comprises gene therapies, tissue engineered products and somatic cell therapies. So far only 10 Advanced Therapy Medicinal Products (ATMPs) have been authorised in the Europe since Regulation 1397/2007 entered into force.
All the presentations illustrated during the workshop were widely appreciated, and they will be available on a dedicated section of the Gianni Benzi Foundation’s website.
This event represented an important opportunity to strengthen the close interaction between the medical innovation and legal-regulatory aspects thanks to the participation of exponents of different sectors.
Visit the event page to discover more about the agenda.
