Prof. Jane REICHEL – Creating legal framework for collaboration in Africa-the B3Africa experience

Biobanking in the spotlight ‐ International collaborations in Africa

Europe Biobank Week, 13-16 September 2016

Jane Reichel – Creating legal framework for collaboration in Africa-the B3Africa experience

One of the aims of B3Africa is to create a legal framework for data sharing between the EU and Africa. Since international biobanking area is situated complex legal landscape, the task is challenging. There are several human rights involved, which are traditionally upheld at the national or sometimes regional level, but with few global legal tools available. There are further great variations in development within the involved stated, with the EU taking a strong position in regards to data protection.

The B3Africa’s legal and ethical framework takes a dual approach to overcome these challenges; first, minimal, threshold requirements are developed for all users to apply and secondly, tools for sharing data and samples are developed. The minimum, threshold requirements demands that all processing of medical data within the B3Africa project should adhere to two basic principles, informed consent and ethical approval, both in regards to processing within a state and for cross-border sharing. The legal implementation of the principles are carried out within each national legal order, via ethical approvals from authorities or institutions enacting decisions or opinions applicable within the state. The B3Africa legal and ethical framework implements the national decisions/opinions via a IT-tools, a Model Data Management Policy. In order to share data and samples between two states, there is a need to find a model for connecting the ethical approval from the sending state to the receiving state. The legal and ethical framework will draft conflict of law-tools, such as Data Transfer Agreements and Material Transfer Agreements, taking into account the variety if legal requirements within the involved states and regions.

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