Malaysia, being one of the fast developing countries, has been showing keen interest in stem cell research and therapy. As the awareness in stem cell technology increases, issues like morals and ethics have been raised by various parties such as religious bodies and conservative organizations. These controversies do not only occur in Malaysia but also in other parts of the world where stem cell based work has long since been conducted.
On 10 March 2011, Yves Bot, one of the advocates general to the European Union’s Court of Justice (ECJ) in Luxembourg, recommended that the patenting of inventions which involve a use of embryonic stem cells should be prohibited.
The case arose from a patent granted in 1999 to Professor Oliver Bruestle of the University of Bonn, Germany, for a method of producing neural progenitor cells from so-called “embryonic stem cell lines”. Professor Bruestle’s patent was challenged by Greenpeace in 2004 for ethical reasons, with the argument that the stem cell research process patented by Professor Bruestle was invalid due to the use of cells which were derived from human embryos. Under the EU law, methods of research that involve human embryos for industrial or commercial purposes cannot be patented. The German Federal Court referred the dispute to the European Court of Justice in 2006 and sought their view on interpreting the term “human embryo”.
Although Yves Bot did clarify that embryonic stem cells are not equivalent to embryos in the eyes of the law, he maintains that embryonic cell lines are originally derived from fertilized human eggs and as such, patents cannot be granted for techniques that involve the use of embryonic stem cells. Most experts feel that he has taken a rather restrictive view on this issue.
While the opinion by Yves Bot is not legally binding, the ECJ, Europe’s highest court, will normally take into consideration opinions by the advocates general in most cases and is expected to decide in the coming months on whether a ban on stem cell research patents is necessary. Needless to say, this has sparked great concern among leading scientists in the stem cell research community as clinical trials using human embryonic stem cells have begun not only in Europe but in other countries around the world.
Europe has long gained a reputation in stem cell research due to their openness and fewer legal restrictions for investors to invest and to seek patent protection. However, with the possible ban on the patenting of stem cell discoveries looming in Europe, it has placed other countries which endorse stem cell research in a clear advantage. Take the US for example, which has been put in this position after the ban on US federal funding for human embryonic stem cell research was lifted.
Malaysia is not far behind as there has been rapid development and keen interest in the area of stem cell research and therapy. It was announced in April 2011 that Stempeutics Research Malaysia Sdn Bhd will begin their clinical trials on stem cell based drugs after receiving approval from the local authorities. The drug, which is derived from human bone marrow, is being used for orthopaedic and neurology-related illnesses. This is an encouraging step as Malaysia has now attained a level in stem cell research that few countries – led by the US – have achieved. This is also in line with the second phase of the National Biotechnology Policy to commercialize discoveries or products such as bio-generic drugs and health-related products.
Stem cell based research can be financially and technologically demanding on local researchers, but the possible ban in Europe and the steady progress of embryonic stem cell based research here in Malaysia could translate into increased funding by potential investors, in addition to the improvement of our research capabilities when foreign companies relocate and set up their companies locally.
As we all know, patent protection is one of the essential tools in raising funds especially for small start-ups. Researchers will need to protect their intellectual property to encourage pharmaceutical companies or other big corporations to part with huge amounts of money that is necessary to develop and commercialize their projects. Investors are not willing to invest in a good idea without patent protection or knowing that they will profit from their investments.
Although patents relating to embryonic stem cells have been granted in Malaysia, it still remains to be seen whether Malaysia will adopt similar policies in the near future if the ECJ revokes Professor Bruestle’s patent.
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