Switzerland

Stem cell research commenced in Switzerland in March 2000, when researchers Dr. Marisa Jaconi and Prof. Karl-Heinz Krause at the University of Geneva submitted the first-ever bid for research budget to the Swiss National Science Foundation, SNF, for a research project that would require imported human embryonic stem cells to work on.

The project was approved on its merits ad interim in Sept 2001 by the SNF and to act as a wake-up call to Swiss legislators. Lively public, political and professional debate followed. A proposed pragmatic, by international comparison middle-of-the-road Federal Stem Cell Research Act was challenged by national referendum in November 2004. But 66% of Swiss voters ratified the Federal Stem Cell Research Act and this came into force on 1 March 2005. In essence, the Swiss Act rejects unregulated research with human embryonic stem cells and bans therapeutic cloning, but it falls short of a general prohibition as is the case in several leading western nations.
The Swiss Stem Cell Research Act allows research with human embryonic stem cells and the production of new stem cell lines from supernumerary (or surplus) embryos while imposing strict conditions. Surplus embryos are generated by reproductive medicine centres (fertility clinics) for in vitro fertilisation but have no further direct use once pregnancy has been induced. Swiss law prior to passage of the Stem Cell Research Act called for surplus embryos to be disposed of. Contrary to the United States, Switzerland bans the donation of eggs and human embryos, and also bans surrogate motherhood.

The act forbids the creation of embryos for research purposes in order, amongst other things, to produce and use of stem cells. Only human embryos that are surplus from fertilisation may be used to derive human embryonic stem cell lines. The act expressly forbids therapeutic cloning, reproductive cloning and any other type of cloning. The additional restrictions are listed in our previous report N017/04 of 2004 (attached). A permit is required for the production of human embryonic stem cell lines and six conditions must be met to qualify (see report N017/04). The Federal Department of Health issues such permits after considering the opinions of independent external experts on any given research bid that is received. Concurrent with the act, Swiss patent law was amended to prohibit patenting unmodified human embryonic stem cells and stem cell lines.

In 1978, a small amount of federal funding was allocated for the first time by the Swiss National Science Foundation, SNF, to a research project on adult stems. Significant annual budget allocations for individual projects began from 1994, when SNF allocated some £ 0.3 million to five individual projects.

Over the past ten years, SNF allocated progressively increasing budgets to some 105 dedicated national research projects dealing with adult stem cells, totalling ~ £ 13 million (Appendix 1). Today, the annual allocation for individual projects averages £ 1-2 million and every such project has a life cycle of 2-3 years.

Part of this total included first-time allocation in 2001 of an estimated £ 0.4 million for two projects using one line of imported supernumerary human embryonic stem cells by Swiss pioneer Dr. Marisa Jaconi in the Laboratory of Ageing at the University Hospitals of Geneva. These projects research cell therapy of heart muscles subject to congestive heart failure. Human embryonic stem cells are differentiated in vitro toward cardiac myocytes and hematopoietic cells.

No other research projects with human embryonic stem cells have been approved by SNF since 2001. But given enactment of the new Swiss Stem Cell Research Act this March, several Swiss research groups that have thus far engaged in research on adult stem cells are expected to move into research with human embryonic stem cells. SNF has this year received 2-3 new applications by the University of Geneva and the Federal Institute of Technology Lausanne, EPFL, for funding such research. These proposals are under evaluation and some of them are expected to be approved and to receive new funding by September 2005.

With regard to funding, there are clear priorities for cell- and molecular biology including genetics. More specifically, priority areas are immunology, embryology and brain science. Cancer, clinical cardiovascular and pathophysiology are slightly less prevalent research areas.

National Research Programme (NRP) 46 is entitled 'Implants and transplants' and a large proportion of this programme is concerned with research on adult stem cells. It has a seven-year life-span (1999-2006) and a total SNF budget of £ 6.5 million. About one third of this budget (~ £ 2.2 million) is dedicated to adult stem cell research which is divided as follows:

According to the Swiss State Secretariat for Education and Research, SER, NRP 46 will be gradually wound down and its life span will not be extended.

National Centres of Competence in Research (NCCRs) were initiated in 2001. SNF inform us that some 10% of the total budget of the NCCR Neural Plasticity and Repair is devoted to neural stem cell research.

Contrary to possible expectations, none of the other three major Swiss biomedicine NCCRs (Molecular Oncology-Lausanne, Frontiers in Genetics-Geneva and Structural Biology-Zurich) are involved in stem cell research.

There is a clear regional geographic and institutional variation in the strength of stem cell research. The greatest research strength and intensity resides at the Universities of Geneva, Lausanne (in the institutions EPFL and ISREC) and Basel and their associated cantonal hospitals. These are followed by the Universities of Zurich, then Bern and finally by the Federal Institute of Technology in Zurich. Thus, a clear push for embryonic and adult stem cell research comes from the major centres in French-speaking Switzerland, and, interestingly, not Basel. Given Basel's strong global pharma industry base, Basel seems underrepresented from an industry lobby viewpoint.

Global ranking of Swiss stem cell research can be assessed on the basis of multiple criteria ranging from research budgets through to national regulatory regime, research literature quotations, industry activity, government support, public sentiment, quality of research infrastructure and output and size of national population. With its small population of 7.2 million, Switzerland does suffer from the problem of critical demographic mass and hence critical mass in stem cell research groups. In this global context, Switzerland finds itself in a similar position to progressive high tech European countries like Sweden, Israel and Denmark.

Statistics on Swiss reproductive medicine infrastructure relevant to human embryonic stem cell research potential.

• Switzerland has thirty reproductive medicine centres.
• Around 1000 surplus embryos were stored before the Swiss law on reproductive medicine was enacted in 2001. On 4 December 2003, both Swiss houses of parliament approved the law on stem cell research and this granted a period of grace from destruction of these embryos until 2005.
• In March 2003, then Swiss President Pascal Couchepin cited approximately 80 surplus embryos as having been available in 2002. He quoted data supplied by the Federal Office of Public Health. This after the commissioned Federal Statistical Office failed to keep a national record of surplus embryos since 2001 due to lack of resources.
• In 2004, Interior Minister Pascal Couchepin revealed that around 200 surplus embryos are created for artificial insemination each year in Switzerland.
• Compared to France with its 95 medical institutions and fertility clinics, the Swiss statistics are modest. A French survey estimated 120 000 frozen embryos in France accumulated over the past two decades, of which 55% could be used for research.
  

A significant regulatory challenge remains securing political approval for therapeutic cloning. But there is also new movement on this front, although any final outcome is expected to be some way off. In November 2004, the Free Radical Party launched a parliamentary motion in support of therapeutic cloning. However, Parliament will not debate the issue in the upcoming sessions, meaning that any possible approval on this issue will not be passed by Parliament until 2012 at the earliest.

For ethical and sociological aspects surrounding stem cell research, dedicated budget of £½ million has been allocated under the auspices of NRP 46 for seven research projects.

Ethical issues are handled by the Swiss National Ethics Commission for Human Medicine

Two Swiss government-funded agencies are charged with promoting public debate on human embryonic stem cell research. The first is the Swiss Centre for Technology Assessment, TA-Swiss in Berne. In its publication Human stem cells (2003), TA-Swiss sums up public debate on stem cells in Switzerland as having been

"a fairly quiet affair. Despite extensive activities by the Science and Society Foundation and others at national and local level, the debate remains largely restricted to specialist groups. One possible reason might be the pragmatic approach of the Swiss people to the issues involved. "

The second agency is the Foundation for Science and Society, Science et Cité. Focusing on one major issue of public debate every year, the Foundation dealt with stem cells during 2002.

Swiss National Science Foundation, SNF, is somewhat passive in its support for stem cell research given Swiss Federal Government imposed spending cuts on science and research. The official line is that they are waiting for indications of bottom-up demand for research funding from Swiss human embryonic stem cell researchers. SNF are probably also looking for direction from the higher Government agency, Swiss State Secretariat for Education and Research, SER.

The Swiss Federal Office for Health, BAG, drafted the Swiss Federal Stem Cell Research Act that came into force on 1 March 2005 and is charged with executing, administering and policing it. BAG also drafts and enforces similar laws governing basic and applied scientific research in biomedicine and on humans.

BAG can allocate two types of budget to stem cell research. Firstly, it can allocate project-specific budget. Secondly, it can allocate non-specific budget in order to bring in external experts to assess specific issues such as ethical considerations of research.

In terms of the new Swiss Stem Cell Research Act, supernumerary (spare) human embryos can now be collected for the first time in Switzerland for stem cell research. But administrative process of checks and balances is rigorous and long-winded. The collection process itself is expected to take at least 3 months, since the ethics commission has 30 days to check applications. Then applications pass to BAG who have another 60 days to screen applications.

BAG is currently working on a major new Swiss law - the Swiss Act Governing Research on Humans. But this law will not deal with human embryonic stem cell research which is considered to be covered adequately by the Swiss Stem Cell Research Act.

The State Secretariat for Education and Research, SER, is the highest government authority empowered to act on and finance human embryonic stem cell research below the Swiss Parliament. SER is working on a major push to encourage human embryonic stem cell research in Switzerland on two fronts in the wake of the recent political momentum on such research.

Firstly, SER have informed us that the only Swiss human embryonic stem cells researcher, Dr. Marisa Jaconi at Geneva University Hospital, will receive approval from the Federal Department of Health, BAG, to become the Swiss national reference laboratory for human embryonic stem cell lines. This paves the way for Switzerland to begin to source surplus human embryonic stem cells nationally and to generate own stem cell lines.

Secondly, SER very recently decided to initiate a new National Research Programme, NRP, dedicated specifically to human embryonic stem cell research. With the Swiss Federal Stem Cell Research Act in place, the new NRP will not require parliamentary approval. SER is currently working on a proposal which will be ready by year-end. Thereafter, this proposal will be subject to a brief feasibility study. Subject to favourable reactions, the new NRP could ideally be launched during 2006 (see 11. for more detail).

In its human embryonic stem cell research timeline, the Swiss Foundation for Science and Society states that Novartis, the major global pharma company based in Switzerland, started its research in this area in April 2002. This research is carried out at the Novartis Institute for Biomedical Research in Boston, USA, as one of four research areas under the Epigenetics Research Program. It is headed by NIBR's Professor En Li.

Novartis has drawn up its own 5-point corporate global ethical guidelines on human embryonic stem cells. One of the points rules out therapeutic cloning. Moreover, Novartis has established its own internal Ethics Committee with eight members. This met for the first time in July 2005 in Basel. We understand from SNF that Novartis are contributing some research funding towards the next phase of NCCR Neural Plasticity and Repair at the University of Zurich for the period 2005-08.

This suggests that Novartis may be in the process of allocating significant internal research resources to human embryonic stem cell research, however, outside Switzerland.

Throughout Switzerland, the general professional perception of the UK as partner of choice for human embryonic stem cell research is very high. We are aware of one teaching and research collaboration between Prof Yann Barrandon's Laboratory of Stem Cell Dynamics at the Federal Institute of Technology Lausanne, EPFL and the Institute for Stem Cell Research at the University of Edinburgh. Barrandon is an MD who has worked Harvard Medical School, Stanford University and the French Institut national de la santé.

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