To attend the AERAP Science Summit please register here.

This session will consider how regulations in data protection, medical devices and in-vitro diagnostics influence cooperation in medical science and health research and EU-Africa research cooperation more generally.

The session will initially focus on the European General Data Protection Regulation and its influence globally. Given that its scope already extends beyond the borders of the European Union, it is arguably becoming the template for global data privacy legislation. What are the impacts in Africa?

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, particularly 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, ensure the free flow of personal data between the Member States, and 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 "Horizon Europe", it is essential to consider how African nations address compliance and prepare for future data protection regulation in Africa.

The discussion will also consider the broader 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 concerning 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 helpful to look at the plans for the EU digital decade up to 2030, which coincides with the United Nations Agenda 2030and, 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.

These priorities are also reflected in the United Nations Roadmap for Digital Cooperationwhich prioritises the following five sets of recommendations on how the international community could work together to optimise 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.