A group of research funders and patient groups from across Europe have written to the EU urging all members to support stem cell research. There are worries that the recent European Court decision to ban patenting of technolgies involving embryonic stem cells and campaigning by groups opposed to embryo research will result in less money being spent on the field through Horizon 2020, the EU funding stream for science. The story has been covered in the Financial Times.
The EU funds scientific research through the €80bn Horizon 2020 programme. The Industry Research and Energy Committee (ITRE) and the Environment, Public Health and Food Safety (ENVI) Committee, both made up of MEPs in the European Parliament, are reviewing the programme and what it funds at their upcoming meetings next week.
Stem cells are an important tool for researchers looking at early human development, cell function and the underlying causes of disease. They are also used for in vitro toxicology testing which reduces the use of animals. Many researchers are currently looking at their potential use to treat a range of diseases as they can repair or replace tissue damaged by disease or injury; this is called regenerative medicine. The UK Stem Cell Foundation has a great list of current projects covering lots of diseases. According to the FT article, the total amount spent by the EU so far on projects involving human embryonic stem research is about €125m.
There are many different types of stem cells - embyonic stem cells (ESCs), adult stem cells (there’s lots of different kinds of these), fetal stem cells (from foetuses’ organs or umbilical cord) and induced pluripotent stem cells (iPSCs). All can differentiate into a range of other cell types – uniquely, ESCs and iPSCs can turn into any adult cell – but they all have slightly different properties and uses in biomedical research.
Embryonic stem cells are controversial because the embryo is destroyed in the harvesting process. The embryos come from those created for IVF but never implanted into the womb. However, once obtained, cell lines can be maintained indefinitely and used for lots of things.
European patent law prohibits patents for the industrial exploitation of the embryo, including those that require its destruction. This makes the patent law surrounding ESCs a bit iffy.
Last October, in the case of Brüstle v. Greenpeace, the European Court of Justice ruled that techniques that involve the destruction of an embryo are not patentable. This means you cannot patent any technologies that use embryonic stem cells as there are currently no ways of obtaining them without destroying the embryo. This decision is binding for Member States of the EU and has to be followed.
Last month the European parliament passed a resolution which included an amendment calling for the parliament to welcome the Brüstle v. Greenpeace and WARF decisions to restrict stem cell patents and “calls on the European Commission to draw the appropriate consequences from these decisions also in other relevant policy areas in order to bring EU policy in line with these decisions”. There are fears that this might have implications for funding for stem cell research through Horizon 2020.
Importantly though, none of these decisions ban the use of embryonic stem cells, which is still legal in the UK under regulated conditions.
What did we send to the EU?
It calls on the European Parliament, European Commission and Member States to maintain the funding already set out for stem cell research in Horizon 2020. Scientists must be able to continue research in all avenues of stem cell research using all the different cell types. This is necessary because research using different types of stem cells is complementary and knowledge gained in one area helps the other. It is too early to tell which route will be the most effective for ultimate clinical use, so it is essential to keep all avenues of research open. The statement says that a ban on funding specifically for embryonic stem cells would adversely affect the other areas of stem cell research.
The statement includes some good background and discussion of the impact of the court decision to ban patents on ESCs. It acknowledges that there is some fear this could discourage investment as companies would not be able to secure exclusive rights to any treatment they develop. However it also suggests this might not be too much of an issue because:
(a) it will be possible to obtain such patents in other jurisdictions (including the US);
(b) other aspects of any therapy (such as biomarkers or diagnostics or specific treatments) may still be patentable in Europe;
(c) inventors (and their advisers) will seek ways to obtain patents notwithstanding the decision;
(d) under the current regulatory framework, it will be virtually impossible for a regulator to approve a generic (technically a “biosimilar”), thus the regulatory protection for approved hESC medicines will be very high
Basically, they are saying there are ways around the ban so stem cell research is still a very important and viable field for treatment development. Notably, the UK has recently committed significant funding for stem cell research as part of the MRC Regenerative Medicine Strategy. And charities are investing in this research, the British Heart Foundation is raising money to establish one or two centres for Cardiovascular Regenerative Medicine in autumn 2013 with funding for four years.
So charities are concerned to see that valuable EU investment in this research continues. AMRC’s chief executive, Sharmila Nebhrajani has responded to the story today:
The UK is a world leader in stem cell science and charities are key funders of this research, investing alongside other public and private funders. The money they invest comes from patients, carers and their families, who donate in the hope of finding treatments for some of the most debilitating conditions. Patients want and need this vital stem cell research to continue and call upon the EU to continue to support this research.
The statement is well worth a read if you want more information on all these issues.
The Industry Research and Energy Committee (ITRE) and the Environment, Public Health and Food Safety (ENVI) Committee will be discussing the Europe 2020 programme next week. We will also send this statement more broadly to MEPs with an interest in health research and will continue to make the case for investment in stem cell research across Europe.