The report highlights 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, says Outi Hovatta of the Karolinska Institute, who chaired the report.
Under the Convention patents cannot be issued for uses of human embryos for industrial or commercial purposes, but the Convention does not state whether therapeutic use of stem cells would be defined as commercial.
At the same time, in a November 2008 ruling the European Patent Office said 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.
“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,” Horvatta said.
The report examines the key scientific questions for human stem cell research in the context of the rapidly emerging field of regenerative medicine, exploring ethical concerns, particularly with clinical application, and analysing how the legislative landscape in Europe has altered over the past six years.
In addition to the patenting issues, different ethical and/or religious beliefs in individual countries in Europe means each has different policies for human stem cell research, and some will not allow the development of human stem cell-based therapies.
The report says there is a risk that research using embryonic stem cell lines may be neglected following the discovery of induced pluripotent stem cells, which as reprogrammed adult cells raise far fewer ethical issues. But although they are similar to embryonic stem cells in some respects, 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,” the report says.
“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 Horvatta. “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 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, If, and when therapies become available, all patients across Europe should have equitable access to such therapies.
Stem cell legislation in Europe:
25 countries have adopted legislation which explicitly prohibits human reproductive cloning (excluding Poland, Lithuania and Ireland as well as Croatia and Luxembourg).
Seven countries allow human embryonic stem cell research and the derivation of new human embryonic stem cell lines from supernumerary in vitro fertilisation embryos (Belgium, Sweden, UK, Spain, Finland, the Czech Republic and Portugal). The same countries allow somatic cell nuclear transfer by law except Finland and the Czech Republic who neither prohibit nor allow it.
Three countries have adopted legislation to allow the creation of embryos for research purposes under strict conditions (Belgium, Sweden, UK).
17 countries allow the procurement of stem cells from supernumerary embryos.
Six countries have not adopted legislation regarding human stem cell research (Bulgaria, Croatia, Cyprus, Luxembourg, Romania and Turkey).
Human Stem Cell Research and Regenerative Medicine: A European Perspective on Scientific, Ethical and Legal Issues is available online: http://www.esf.org/publications/science-policy-briefings
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