How data protection legislation will impact health research within the context of the SDGs
As the United Nations meets to conclude its inauguration of the 75th anniversary General Assembly, the world feels a more challenging place than perhaps people have ever felt. Challenges come in many forms. The COVID 19 pandemic puts the need for a global research agenda and approach, including collaboration, into sharp relief. The United Nations SDGs seem to be the only reference framework for addressing future challenges. The SDG present an eloquent narrative on what the society needs to do, or at least should do.
Within the SDGs and in more direct response to COVID 19, health research is a vital priority. Despite the suffering associated with COVID 19, the pandemic has enabled a stronger dialogue on global research collaboration. This is evident in the range of measures supported in many countries around the world to respond to COVID through collaboration with partner nations. This does raise and will in future raise issues surrounding the protection of sensitive personal data for medical research purposes, including data transfers and data access.
While Europe has developed a very strong position and an extraterritorial approach to data protection in its General Data Protection Regulation (GDPR), other developed nations are moving in a similar direction or deciding to copy EU regulation through the equivalence process. Despite many years of preparation and planning, the GDPR still has a way to go defining measures and mechanisms to enable the transfer of data both within the European Union and with countries outside the European Union. However, very little has been done to recognise the impact of these measures developing countries and how developing nations and participate in and benefit from research initiatives at a global level. This session will prioritise the issues for developing nations.
Agenda
16h00 Declan Kirrane ScienceDigital@UNGA75, Belgium
16h05 Trish Scanlon Their Lives Matter, Tanzania
16h15 Michael Makanga European and Developing Countries Clinical Trials Partnership (EDCTP), South Africa
16h25 David Peloquin Ropes and Grey, Boston
16h35 Jasper Bovenberg Legal Pathways, Netherlands
16h50 Rita Lawlor ARC-Net Applied Research on Cancer Centre, University of Verona, Italy
17h05 Kurt Zatloukal Medical University Graz, Austria
17h20 Discussion
17h45 Conclusion
Speakers
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David PeloquinSenior Associate, Ropes and Grey, BostonDavid Peloquin is a member of the firm’s health care group. He focuses his
practice on advising academic medical centers, life sciences companies, and
information technology companies on issues related to human subjects and
animal research, data privacy, and Medicare/Medicaid and other third-party
payor reimbursement issues. He frequently writes and speaks on topics
related to each of these areas. In connection with the COVID-19 pandemic,
David has also been providing guidance on a variety of privacy and
regulatory issues related to development of diagnostic tests and mobile
applications, research studies, and general health care compliance.
In addition to his advisory practice, David regularly works with members of
the firm’s private equity group in conducting regulatory diligence of private
equity investments in the clinical research space. He also collaborates with
members of the firm’s litigation practice on government investigations
involving the clinical research enterprise. Prior to attending law school, David
worked as a project manager for a leading supplier of electronic medical
records. -
Declan KirraneDirector ISC Intelligence in Science and Coordinator EU Africa Radio Astronomy PlatformDeclan Kirrane is Managing Director of ISC Intelligence in Science, a specialized science, technology and R&D public affairs firm based in Brussels, Belgium. ISC develops and implements Strategic Research Agendas for science and technology-based organisations in the EU and US.
His practice areas cover IP, R&D consortia development, management and dissemination and is responsible for themes of ICT, health, security, defence, space and related policies, legislation, programmes and funding mechanisms. Declan Kirrane has a background in analysing the relationship between public and private R&D funding and the impact on R&D performance: he has worked extensively on science and technology policy evaluation methodologies and technology options for policy- and decision-makers. The EU’s Digital Agenda, emerging European space, security and defence policies are part of his remit. -
Kurt ZatloukalHead of EU Bio BankKurt Zatloukal, M.D., is Professor of Pathology and head of the Diagnostics and Research Center for Molecular Biomedicine at the Medical University Graz. His research work focuses on the molecular pathology of metabolic liver diseases and cancer as well as molecular diagnostics. He is working on the development of biobanking-related technologies and machine learning approaches for digital pathology. He coordinated the preparatory phase of the European biobanking and biomolecular research infrastructure (BBMRI) and is now director of its Austrian national node. In this context solutions have been developed for providing access to quality controlled human biological samples and medical data for research and innovation.
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Michael MakangaEDCTP Executive DirectorDr. Makanga is a clinician-scientist with 27 years of professional experience of working on health and poverty-related infectious diseases in Africa. This includes 23 years of work experience on medical product development and clinical regulatory activities. He holds a Medical Degree from Makerere University, Uganda; a Master’s Degree at the University of Liverpool, and a PhD Clinical Pharmacology at the Liverpool School of Tropical Medicine, United Kingdom. He is also a Fellow of the Royal College of Physicians of Edinburgh, Scotland.
Dr Makanga is EDCTP Executive Director. Before joining EDCTP, Dr Makanga was first in clinical practice and academia, and later clinical research and research management. Moreover, he has served in various scientific and policy advisory boards for international product development, philanthropic organisations, World Bank and pharmaceutical companies involved in developing medicinal products for poverty related and neglected diseases.
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Rita T. LawlorPh.D., CIPP/E, CIPM Fellow of Information Privacy (IAPP)Rita T. Lawlor is a Computer Science graduate of Trinity College Dublin with a doctorate in Oncological Pathology from the University of Verona where she is co-founder of the ARC-Net (www.arc-net.it) applied cancer research centre and is director of the ARC-Net biobank coordinating research activities. She is an IAPP Fellow of Information Privacy (International Association of Privacy Professionals) with CIPP/E and CIPM certifications for European data protection and is chair of the ISBER GDPR Task Force. She is a member of the management team of ICGC-ARGO, International Cancer Genome Consortium to accelerate research in genomic oncology and is a member of the board of the Italian Foundation on Pancreas Diseases (FIMP).
She is past president of ESBB, the European, Middle Eastern and African Society for Biopreservation and Biobanking (www.esbb.org) and a former director of ISBER, International Society for Biological and Environmental Repositories (www.isber.org). She is a member of the steering committee of BC-NET (Biobank Cohort Network of Low Middle Income Countries) of IARC (International Association for Research on Cancer). She co-authored the IARC Technical Publication on Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research.
Her current research interests are in molecular diagnostic markers and therapeutic targets and the role of cancer heterogeneity and molecular characterization of samples in the application of individualized medicine.