UNGA76 Science Summit

Agenda

10h00 Rita Lawlor Biobank Director, ARC-Net
10h15 Declan Kirrane Chair, Science Summit United Nations General Assembly 76 (SSUNGA76)
10h20 Kenneth Fleming Chairman, The Lancet Commission on Diagnostics,
10h35 Antonella Cardone Director of the European Cancer Patient Coalition (ECPC), Belgium
10h50 Giske Ursin Director of the Cancer Registry of Norway
11h00 Andrew Biankin Executive Director, International Cancer Genome Consortium, UK
11h10 Jean-Claude Burgelman Professor of Open Science Policies and Practices, Free University of Brussels
11h20 Lydia Kline Team Lead, Clinical Research Policy in the National Institutes of Health’s Office of Science Policy (OSP), USA
11h30 David Peloquin Partner, Ropes and Grey, USA
11h40 Kato Kazuto Osaka Universit, Japan
11h50 Brendan Burns Brendan Barnes, EFPIA, Director IP & Data Protection, EFPIA, 

This session will consider how regulations in data protection, medical devices and in-vitro diagnostics influence cooperation in medical science and health research to support the SDGs.

The session will initially focus on the European General Data Protection Regulation and its influence on the global stage. Given that its scope already extends beyond the borders of the European Union, it is arguably becoming the template for global legislation.

Therefore, the session is designed to impart up-to-date information on the European Union's GDPR; to look specifically at related research collaboration between South Africa and African and the European Union and the impact of the GDPR on those research activities, in particular in the area of health. The meeting will also raise awareness of the emergence globally of data protection regulations and related future developments in South Africa and more generally in the continent of Africa.

The GDPR also addresses the transfer of personal data outside the EU, including to African nations and developing nations more generally. The GDPR aims to give control to individuals over their personal data, to ensure the free flow of personal data between the Member States and to simplify the regulatory environment for international business by unifying the regulation within the EU.

Because research involving human health, drug safety and clinical trials requires the processing of personal data, the GDPR has posed particular challenges to the research sector both within the EU and elsewhere.
As the “Africa Initiative” is an integral part of the first Work Programme for 2021-2022 of the recently adopted “Horizon Europe”, it is important to consider how African Nations address should compliance and prepare for future data protection regulations in Africa.

The discussion will also consider the wider impact of how regulation can advance are otherwise innovation. It will look at The session will maintain a focus on the GDPR, but will look at this in the wider geographic context and in relation to other regulations including in-vitro diagnostics, medical devices and so forth. We also plan to visit the issue of biotechnology-related regulation and digital market regulations and the connection between them.

While conscious of the need to avoid a European bias in this discussion, it will be perhaps useful to look at the plans for the EU digital decade up to 2030, which coincides with the United Nations Agenda 2030 and of course the SDGs. Some of the issues to the fore, include:

• A digitally skilled population and highly skilled digital professionals;
• Secure and sustainable digital infrastructures;
• Digital transformation of businesses;
• Digitisation of public services.
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These priorities are also reflected in the United Nations roadmap for digital cooperation which prioritises the following five sets of recommendations on how the international community could work together to optimize the use of digital technologies and mitigate the risks:

• Build an inclusive digital economy and society;
• Develop human and institutional capacity;
• Protect human rights and human agency;
• Promote digital trust, security and stability;
• Foster global digital cooperation.

While the UN has put forward some very thorough recommendations, the UN cannot regulate. This is the preserve of nation-states. The meeting will look at how this fragmented and heterogeneous regulatory environment impacts the attainment of the SDGs.
The meeting will bring together policy and research leadership from around the world. The objective will be to create a much-needed forum for discussion on the broader implications of this regulation on transatlantic science cooperation, at a time when the regulation is arguably becoming a template for similar legislation globally.