1. S ocial scientists are interested in how different innovative medical technologies including human tissue engineered products (HTEPs) fit into the changing scene of international regulation and public policy development. European Union medical device regulations in principle are implemented nationally, but many tissue engineered technologies do not fit into existing formal regulatory organisational structures and definitions, creating, in effect, a regulatory vacuum. In this situation various informal and ‘proto-regulatory’ activity is taking place. The overall aim of this research is: To evaluate the implications of trends in regulation, governance, and evidential processes, in relation to the challenge posed by human tissue engineered products (HTEPs). The project investigates the implications of HTEPs for existing regulatory frameworks and healthcare ‘governance’, and vice versa. The aim is to develop analytic models for identifying factors which will shape the development of new forms of regulation in relation to innovation, market approval and clinical introduction of HTEPs, and to evaluate this regulatory activity in terms of implications for healthcare practice, public health and innovation/competitiveness. The broader governance environment is changing in response to diverse movements including consumer concerns, health technology assessment, risk-based regulation, international harmonisation of standards, and activity in cognate sectors such as biotechnology. The research focuses upon recent history of medical device and other regulation and current activity in the UK and other EU countries, and upon transnational European forums. This research project will: · Map the activity of groups contributing to the regulation of tissue engineering at the EU level and describe their interface with UK manufacturers, scientists, regulators, clinicians and patients/citizens · Elicit perceptions and values of these groups regarding the factors influencing the evolution of HTEP regulation · Survey differences in national regulatory approaches to HTEPs in the EU · Analyse and compare risk/benefit considerations of stakeholder groups as they relate to the 'assessment' of the safety, efficacy, effectiveness, ethical, legal and social aspects of HTEPs. Medical Device Governance: Regulation of Tissue Engineering in the UK and EU United Kingdom Economic and Social Research Council (ESRC) Research Programme on Innovative Health Technologies (IHT) in co-operation with the Medical Research Council (MRC) The research team Our research project team is multidisciplinary, covering medical sociology, bioengineering, health services research and science and technology policy. The team comprises Mr Alex Faulkner (University of Wales Cardiff, Wales), Dr Julie Kent (UWE Bristol, England), Dr David FitzPatrick (UCD Dublin, Ireland) and Ms Ingrid Geesink (University of Wales Cardiff, Wales). Contact To find out more about this project, please contact Ingrid Geesink or Alex Faulkner, Cardiff University School of Social Sciences - Phone: 029 2087 5184 / 4739. E-mail: Geesinki@cf.ac.uk or FaulknerAC@cf.ac.uk Regulation of Human Tissue Engineered Products at European level In the absence of agreed regulatory controls, populations in Europe may be denied the potential benefits of this new ‘regenerative medicine’ and industries will continue their innovation in other countries. Concerns have been expressed about the safety of these products and the adequacy of existing risk management approaches. Scientific and technical advice highlights issues relating to biological safety, cell sourcing and contamination, storage and tracking of tissues. The need for clarification of the regulatory position of HTEPs has promoted increased activity within the European Community, resulting in working documents that might change the existing regulations and guidelines. Currently different regulatory pathways are explored: both the Directorates-General SANCO and ENTERPRISE of the Commission are proposing drafts for new European legislation. European Commission DG SANCO The DG SANCO draft was issued in June 2002 under the title “Proposal for a Directive of the European Parliament and of the Council on Setting standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Storage, and Distribution of Human Tissues and Cells.” It covers all human tissue, from that procured as part of banking activities and whole tissues as well as commercial tissue engineering products. The proposed directive states how a tissue bank should operate, and that these should preferably be not-for-profit. European Commission DG ENTERPRISE While DG SANCO takes patient safety as its main approach, DG ENTERPRISE encourages free access of products across the European Union. Part of this DG is responsible for the pharmaceutical directives, and in May 2001 the CPMP Biological Working Party of EMEA published a document which introduced the possibility of a European-wide scheme for the regulation of human tissue. More recently DG Enterprise conducted a web based consultation exercise on the need for a community legal framework on ‘human tissue engineered products’. This consultation is intended to inform the drafting of a second Directive that is expected to address more specifically the manufacture, market approval and post-market surveillance for HTEPs. Possible Regulatory Pathways The relationship between DG SANCO and DG Enterprise and the responsibilities of both within the EU is central to future regulatory policy. While consumer protection legislation always applies to healthcare products it seems that the issues raised by tissue engineering products require a rethinking of current regulatory structures and policies. In the UK the Medical Devices Agency and the Medicines Control Agency merge on April 1st 2003 Schematic representations of possible regulatory pathways could be: Source: Thierry Chignon, senior consultant, Quintiles Consulting Europe (2002) “Initiatives to Harmonize Regulations of Human Tissues/Cell Products in the European Union.” http://www.raps.org/rainteractive/articlewinter2003.cfm?article_ID=97