A regenerative rallying cry

18 January 2013

With European stem cell research at a crossroads, ESF's Vanessa Campo-Ruiz and Maria Manuela Nogueira call for a concerted push for global support for regenerative medicine

Policy frameworks around the use of stem cells for research and therapeutic applications constitute a complex maze worldwide. In an age when nations strive to join the World Trade Organization to support business and become more competitive and prosperous, and where societies try to abide by common rules so as to stimulate the flow of ideas, people, capital and knowledge, the existence of a heterogeneous and nuanced picture in Europe does not benefit the economy nor the healthcare of millions of people. Europe shows a panoply of positions on stem cell research, ranging from conservative standpoints, to permissive governments, and even to environments where the issue is not tackled by legislation. Nevertheless, the complexity of the situation is not the result of any whim, but of diverse cultural traditions, political agendas and socioeconomic developments.

Alongside the impact of the financial crisis on many aspects of their daily lives, Europeans are facing great challenges that they expect healthcare systems to respond to. Increased global life expectancy, the prevalence of degenerative diseases and the changes in community healthcare induced by migratory flows are all issues that healthcare providers are seeking novel answers to.

The research community has offered some degree of hope to millions of people of all ages with its discoveries on the therapeutic potential of stem cells. Among these cells, it is those of human embryonic origin that have ignited the greatest controversy worldwide, because of the ethical ramifications of using cells from an ill-defined entity that has the potential of becoming a person. Financial interests and biased scientific stances have also spawned attacks on institutions willing to fund research on human embryonic stem cells like the US National Institutes of Health, fortunately to no avail for the time being. Current debates surrounding the public funding of research and commercialisation of therapies based on these cells are complex and intense, with no conciliatory solution on the horizon as things stand.

In Europe, national governments have designed their own individual legal frameworks and yet must also abide by the common rules that the European Union may set in matters that extend beyond national sovereignty. In addition to local cultural influences, the heterogeneity of the European landscape in terms of intellectual property rights and business legislations adds another layer of complexity. Researchers have tried to facilitate progress and contribute to this aspect of the global scientific enterprise by doing what they do best: providing the data and helping contextualise it, to better inform patients, policymakers and the rest of society. Europe has yielded some very promising results in fields such as ophthalmology, cardiology, oncology, hepatology, neurology, autoimmune disorders and wound healing. It is reasonable to assume that many more applications and beneficial spill-over effects will ensue in other fields of medicine – but this can only happen if research activity continues. 

Information pertaining to European legislation and recommendations is found in a vast array of reports, resolutions, directives and regulations that focus on topics such as tissue research, transplants, advanced therapies, biobanks and data protection. National positions also vary widely across countries, and the different bodies of the European Union are debating how best to integrate and update legislation that would apply to all member states, to ensure that the field is supervised by public bodies acting in the best interests of all citizens.

Yet binding legal decisions and their ramifications continue to ensue. The European Court of Justice ruled it illegal to patent discoveries on stem cells, and this ruling was taken into account by the European Parliament when recommending that research on human embryonic stem cells should not be funded in Horizon 2020, on the grounds that it makes little sense to sponsor what cannot be patented.

Scientists have debated and issued recommendations through platforms such as the Hinxton Group, the International Cellular Medicine Society and the International Society for Stem Cell Research. Yet research scenarios in Europe remain worryingly heterogeneous. The European Science Foundation (ESF) and the European Medical Research Councils (EMRC) issued authoritative policy reports on this issue in 2001, 2002¹ and 2010.² In an effort to map existing regulatory frameworks and issue recommendations, ESF and EMRC conducted a survey among member organisations in 30 countries.³ It was found that only four countries authorise research on stem cells not from embryos but from existing stem cell lines (Austria, Germany, Ireland and Italy). The UK, Belgium and Sweden appeared distinctively permissive, with national law authorising research on human embryos and permitting researchers to obtain cells from supernumerary embryos and from embryos created for research purposes, but banning reproductive cloning as such. Five countries allow human reproductive cloning (Croatia, Ireland, Lithuania, Luxembourg and Poland), with the remaining 25 featuring national legislation that prohibits it. Out of these 25, a great majority authorise research on human embryos, including the procurement of stem cells from supernumerary embryos and/or the creation of embryos for research purposes. The majority of countries surveyed do not authorise research on material from aborted foetuses.

Science knows no national boundaries, but intellectual property rights and other legal features do. The European Union still has no fully operable 'European patent' and is revising legislation impacting stem cell research from different angles. As mentioned above, apart from the 2004 Tissues and Cells Directive⁴ and the 2007 Medicinal Products Regulation,⁵ other legislative instruments focusing on personal data protection, clinical trials and data banks are further key pieces of the jigsaw that are being revisited at present.

The other integral component at stake is public funding, both at the pan-European and national levels. The European Union is now fine tuning the budget for Horizon 2020, its main framework programme for funding research and innovation. The research community in Europe is arguing the case for the added value of stem cell research and the necessity of keeping up funding on all fronts, whether cells come from human embryos or from adults – for each type bears a unique potential and at present cannot stand alone.⁶ Even if public opinion remains divided, there is a serious possibility that public funding from Brussels for research on human embryonic stem cells may disappear. The immediate impact of this will be detrimental for research projects and clinical trials already launched, and also for future investments and entrepreneurial ventures in Europe.

Eventually, such a restrictive environment will dissuade brilliant researchers from pursuing their work in Europe. The same is likely to be true among entrepreneurs, investors, healthcare professionals and patients. In the past, Europe experienced the devastating effects that these unidirectional 'brain drains' have had on its economy, universities and social welfare. Yet Europe prides itself on being a place where human rights and social equality are guaranteed. Thus, it is time for the continent to take an informed decision and a clear step forward, and ensure the rights of all those people who want to seek solutions for their healthcare conditions. Also, the time has come for Europe to stand up for its scientific and entrepreneurial community and become a place that welcomes progress and wellbeing.

¹ ESF-EMRC Science Policy Briefing 'Human Stem Cell Research: scientific uncertainties and ethical dilemmas', June 2001 (No. 14, first edition) and August 2002 (No. 18, second edition)
² ESF-EMRC Science Policy Briefing No 38 'Human Stem Cell Research and Regenerative Medicine – A European Perspective on Scientific, Ethical and Legal Issues', May 2010. ISBN: 978-2-918428-12-1
³  Ibid
⁴ Directive 2004/23/EC of the European Parliament and of the Council, of 31st March 2004, on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cell
⁵ Regulation (EC) No. 1394/2007 of the European Parliament and of the Council, of 13th November 2007, on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004
⁶ Robinton D A, Daley G Q, 'The promise of induced pluripotent stem cells in research and therapy', Nature (481) 295-305, 2012
Opinions in this article reflect solely the authors' personal views and not necessarily those of their employer.