European Science Foundation reports on the scientific, ethical and legal issues in human stem cell research

A new report from the European Science Foundation examines the key scientific questions for human stem cell research in the context of the rapidly emerging field of regenerative medicine. It explores the current ethical concerns, particularly with clinical application, and analyses how the legislative landscape has altered in Europe within the previous six years.

Regenerative medicine promises to be one of the most fascinating and controversial scientific developments of the 21st century. In this medical field, human embryonic stem cells could be applied in a variety of ways, for example to identify new compounds for drug development, or as cell-based therapies for treatments. The potential to use human stem cells to repair or replace tissue or organ functions lost through age, disease, damage or birth defects, raises strong ethical issues that must be considered integrally with any research. The different ethical or religious beliefs in individual countries in Europe means each has different policies for human stem cell research, and some are not willing to develop human stem cell-based therapies.

Stem cell research can be focused on clinical use, which specifically investigates potential therapies, or on basic research, which examines fundamental cell function and provides knowledge useful for therapies as well as providing a wider understanding of human development. Stem cells come from a variety of sources, embryos, foetal tissue and adults, and each has different characteristics.

The report observes there is a risk that embryonic stem cell lines may not be equally investigated for basic research because induced pluripotent stem cells (adult-derived reprogrammed stem cells) are similar in terms of several characteristics, easier to obtain and may present fewer ethical problems in some countries.  However, there are currently more safety issues reported with reprogrammed somatic cells than with embryonic stem cells. Their properties are not identical so research on both cell types is still necessary.

“Regenerative medicine is a promising area, but we need to understand the full picture of what stem cells could bring. We must be careful not to limit research on the different types of stem cells - both embryonic and non-embryonic stem cells offer complementary information,” said Professor Outi Hovatta from Sweden’s Karolinska Institute, who chaired the report. “More research will deepen our understanding about stem cells basic mechanisms, and the potential risks and benefits.”

The authors recommend public funding at the national and European level is needed to support human embryonic stem cell research. Given the variable situation in different European countries, progress toward therapies would be faster if researchers across Europe were given equitable research opportunities, provided that balanced facts about the risks and benefits of research were understood. If therapies become available, all patients across Europe should have equitable access to such therapies.

The report highlights a particular issue with the complexity of patenting human embryonic stem cell technologies in Europe. While innovations based on human embryonic stem cells can fulfil standard patentability requirements, the European Patent Convention is not clear about what falls within ethical guidelines. Under the convention patents cannot be issued for uses of human embryos for industrial or commercial purposes, but the convention does not state whether purely therapeutic use of stem cells would be defined ‘commercial’. The European Patent Office will not grant a patent if the invention relies exclusively on a method requiring the destruction of a human embryo. Yet this does not specify if ‘human embryo’ includes stem cells derived from a blastocyst, a very early stage embryo. Blastocysts that have lost the ability to develop into a human are a common source of stem cells for research.

Hovatta continues: “To make the most of potential innovations based on knowledge from stem cells it is important that we have a clearer picture of the patenting situation.”

The science policy briefing ‘Human Stem Cell Research and Regenerative Medicine: A European Perspective on Scientific, Ethical and Legal Issues’ is available online: www.esf.org/publications/science-policy-briefings