Introduction

Introduction

The globalisation of regenerative medicine is gathering pace yet has not been examined with respect to its medium and long-term implications for European regulators, the corporate and clinical sectors or patients located within different member states.

Over the coming years it is hypothesised that the global pace of change in this field will be extensive, though uneven, and this needs to be both tracked and assessed to provide basic empirical and analytical research results to be made available to healthcare systems across Europe. It is a field that is characterized by complex dynamics across a range of scientific, clinical and industrial sectors, highly unstable, yet developing rapidly. Regenerative Medicine (RM) is also important to Europe given the emerging competition from Asia/Pacific and North America regions that are making health biotech development a priority and investing in what they perceive to be an industry of the future.

April 24th 2007 saw the EU Parliament adopt the ‘Advanced Therapies Regulation’ to harmonise guidelines that will, if approved by the Council, create a centralised process for approving new tissue and cell engineering therapies. This is an important basis for stabilising the RM market and research in Europe: this project examines the current and emerging socio-economic, political and bioethical issues that will need to be addressed in Europe as work in the RM field accelerates.

Objectives

Objectives of the Regenerative Medicine in Europe Project

This 3 year collaborative project will examine the socio-economic, political and bioethical implications for Europe of near-term and future global developments in the field of regenerative medicine. It will adopt an interdisciplinary approach which brings together social science and humanities researchers to understand the emerging needs, expectations and challenges that Europe faces. It is conceptually and methodologically innovative, empirically robust and policy relevant.

The objectives of the project are to provide:

• A detailed analysis of the competitive position of Europe within the globalisation of regenerative medicine, the requirements of successful innovation in this field and the EU policies that need to be developed to support Europe’s global advantage in the field.
• An integrated series of workpackages organised around three inter-related streams of research that constitute the platform for this analysis (the socio-economic, political and bioethical)
• An integrated quantitative relational database on the geo-economic pattern of activity within the field of regenerative medicine derived from a) ongoing review of secondary data sources and b) primary data derived from partner projects
• The use of novel methodological techniques to interrogate results using geometric mapping of data items secured by different projects in the three streams of work
• A continuing engagement with national and international policy makers and others to test and refine the implications of emergent findings for future European policy and regulation in particular

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