Regenerative medicine in Europe: New knowledge for the challenges ahead

Global advances in regenerative medicine have medium and long-term implications that have yet to be addressed in Europe, according to the REMEDiE (Regenerative Medicine in Europe) research project. The pace of change in this complex area of biotechnology affects stakeholders such as national and European regulators, scientific, corporate and clinical sectors, and patients in different Member States.

Regenerative medicine is the process of creating living tissues to repair or replace tissue or organ functions. It includes the regeneration of damaged tissues and organs in the body itself by stimulating previously irreparable organs to heal themselves, or the growing of tissues and organs by scientists in the laboratory for implant.

The project examines the socio-economic, political and bioethical issues that are emerging in this field, to provide a basis for stabilising its market and strengthening research activity in Europe. Regenerative medicine is an important sector for Europe, with the UK and Germany being the main centres of activity. However, it faces growing competition from Asia, notably China and India, and North American regions where health biotechnology development is a priority and where there are growing investments in what is perceived to be an industry of the future.

The three year research project (due to end in 2011) brings together social science and humanities researchers to provide new knowledge about the challenges that Europe is facing. It analyses Europe’s competitive position, the requirements that need to be in place for successful innovation and investment, and the EU policies needed to support Europe within this global biomedical field.

It is preparing a database on the geo-economic pattern of activity within the field which will be available to policy makers via the REMEDiE website in April 2011, and engages with national and international policy makers to test and refine the implications of findings for future European policy and regulations.

Among the key results so far are:

  • Stem cell and tissue transplant - there is a lack of an internationally unified regulatory framework for stem cell and tissue transplants. For example, there are inconsistent procedures for tissue banking, donor consent and maintaining donor anonymity. Regulation of stem cell ‘tourism’ to Spain, India and China needs to be supported by an analysis of direct-to-consumer web advertising, where much marketing is optimistic and unsupported by clinical evidence. Such tourism can complicate post-treatment monitoring and the protection of patient rights.
  • Innovation and investment - there is little or no commercial investment in embryonic stem cell technology in the EU. There are even difficulties in securing markers for more ‘traditional’ adult stem cell therapies: a crucial question relates to the reimbursement strategies in Europe which are multiple and often confusing – who decides on this and for what geographical region? Policy needs to provide a steer in the direction of a harmonisation of reimbursement practices across Europe. In addition, given the current reduced availability of Venture Capital and risk-averse orientation of investors, there is a strong argument that public policy support for the emergent European industry is needed to enable its ongoing financial viability.
  • Governance of regenerative medicine - EU governance of this field is highly fragmented because of differences across Member States and the multiple agencies involved. There is considerable variation in contexts for clinical trials and the social role they play beyond trials. As interaction between states, international bodies and networks become more complex, so new forms of multi-level governance, (transnational, public/private, global) become urgent.
  • Governance and ethics - recruitment of patients/tissue donors is an important route for accessing core material but issues of informed consent and the impact of cultural and religious differences are still being debated. There is no clear definition of ‘embryo’ (in terms of legal status as a person), and what is patentable varies by country. The moral issues that have emerged as a result of regenerative medicine challenge various dimensions of Intellectual Property (IP) law compared with earlier debates on the patenting of human genes: it is vital that a more detailed assessment of the moral exceptions under IP law is undertaken.

Although some similarities were found with the emergence of biotechnology in the 1980s, including regulatory uncertainties, ethical debates, the issue of securing intellectual property rights and the dominance of the US market, the study shows that there are important differences too. These differences include:

  • The need for new regulatory models and procedures, for example Advanced Therapy Medicinal Products (ATMP) in Europe, adopted in 2008 due to ignorance of longer term effects of RM.
  • The need for new structures for conventional Clinical Trial process.
  • Specific political and bioethical issues on property rights and usage of tissue, and women and their labour as biological resources.
  • The existence of diverse models of innovation/state/market relations in competitors such as in China and India.

The final REMEDiE conference is due to be held in April 2011 in Bilbao.

REMEDiE – Regenerative Medicine in Europe (duration: 1/5/2008 – 30/4/2011) is a Specific Targeted Research Project funded under the 7th Framework Programme for Research of the European Union, Thematic Priority 8 – Strategic activities.

See: http://www.york.ac.uk/res/remedie/

Contact: Andrew Webster, ajw25@york.ac.uk