ISSUE: Europe needs to see breakthroughs in data access and sharing within and across its borders to enable opportunities of real world data, as well as changes to address territorialism, lack of data interoperability, need for common data models, privacy concerns and building of sustainable platforms. Without such initiatives Europe will see both a holding back of basic research and insights into health outcomes, as well as its competitiveness on the global arena of real world data utilisation. OVERVIEW: Europe/The EU is in a relatively unique position of increasing harmonisation of political, economic and social aspects of society, inclusive of healthcare, but fraught with challenges in all domains, in comparison to the United States, Asia Pacific and other regions worldwide. Despite moves to address fragmentation of both governance and application, such as the recent General Data Protection Regulation (GDPR), moves to a common digital market and greater collaboration on research and allied programmes, such as within the Innovative Medicines Initiative (IMI), we remain far from in an ideal position to see greater access, aggregation and utilisation of health data for research across the pharmaceutical industry and life sciences, and academia. Though two key drivers for use of real world data, pharmacovigilance and safety surveillance, and outcomes research for reimbursement, have been significant in their impact and focus for some key stakeholders, access to data and biological material to support Discovery and Development, as well as intra-disease area and inter-therapeutic area research remain very challenging. With a data tsunami from disparate sources and technologies, to a methods and outputs blizzard we also face an expertise drought that is not helping solve the issue of widespread data sharing in Europe, and to improving the efficiency of regulatory and HTA processes.