Here is an extract from the Executive Summary:

"The member states of the European Union are world leaders in the development of biobanking infrastructure to support research, making huge investments each year to support such initiatives. Biobanks collect biological samples and associated data for medical-scientific research and diagnostic purposes and organise these in a systematic way for use by others. The vision within Europe is to link biobanks together as part of a pan-European infrastructure to support medical research and health care. The long-term growth of the medical field of the life sciences within Europe will depend and be accelerated by this investment, which has the potential to lead to innovation in medical research, drug development and health care delivery. However, the governance framework for biobanking needs to be strengthened to adequately support this new infrastructure development.

A known challenge in this field is that the implementation of relevant ethical guidelines and legal instruments, such as the EU Data Protection Directive (Directive 95/46/EC), differs significantly from country to country, which impedes international collaboration and exchange of information. As an action under the 2011 Science in Society Work Programme of the Seventh Framework Programme (FP7), an interdisciplinary expert group was established to reflect on the ethical and regulatory challenges of international biobank research, and to identify options for addressing these challenges. This report presents the outcomes of the expert group’s reflection."