3.17 Patenting stem cells and genes
Patents are an important and imperative tool to promote research and development and are therefore an indirect incentive to conduct research in gene technology. For many enterprises performing such research and development it is crucial to obtain patenting in order to protect their research results from being utilised by others. At the same time, it constitutes the financial basis on which the enterprises build their continued research which, ultimately, will also benefit society. When it comes to patents on human genes and stem cells, some special ethical aspects must be considered apart from the purely practical ones. It concerns the dignity of each human being. In this connection it is important to have clear rules about what is patentable. It is in the borderland between patent expertise and ethics that misunderstandings arise. Among the various stakeholders there is today no clear and unambiguous understanding of the scope within the present patent system to patent human genes and stem cells. Thus, a consensus is required in order that the needs and concerns of the various stakeholders can be met. The pharmaceutical industry bears a large responsibility in the process of establishing balanced solutions. Stem cells Today stem cell research involving cell transplant options presents a promising opportunity to find the best treatment for patients. Human stem cell research is an important step towards developing new forms of treatment for such diseases as type 1 diabetes and Parkinson’s disease.
Lif believes:
- that human embryonic stem cells should only be used if the same scientific results cannot be reached by using human adult stem cells,
- that only human embryonic stem cells should be used which come from surplus embryos (fertilised eggs) from infertility treatment and which have been collected after voluntary informed consent,
- that multipotent/coherent stem cells from embryos should not be subject to patenting. Methods and processes for transformation of unmodified cells into modified cells for therapeutic use, adult cells and their precursors or tissues developed by using research protocols should be patentable.
Human genes Human genes (DNA sequences) are important tools for the development and manufacture of new medicines for the treatment of previously untreatable diseases or for the development of better medicines for existing treatments. An example would be that the insertion of the human growth hormone gene into a bacteria cell has made it safe to manufacture growth hormone without any risk of Creutzfeld-Jacob’s disease. Another example is the identification of variations of human genes which are important to the development of a disease and its treatment and which are expected to become a breakthrough in treatment adapted to the individual. Another promising, future medical treatment is gene therapy where healthy DNA from a human being is inserted into a patient’s body in order to repair the dysfunctional gene, for instance in a haemophilic patient who cannot produce coagulation factor VIII, or a patient with type 1 diabetes who is unable to produce insulin. Thus, the use of DNA from humans is important to treat patients. In this connection it is important to stress that the discovery of the gene cannot be patented, whereas the results achieved from the research based on the gene can. The gene is isolated outside the body – by for instance blood or tissue samples. It can then be manufactured synthetically so that it will be possible to mass produce the gene and develop a medicinal product. The patent as such does not give any rights whatsoever to the gene which is inside the individual human being.
Lif believes:
- that the human body as well as precusors to the human body should not be patented,
- that the simple discovery of parts of the human body, including genes (DNA sequences) and subsequences, should not be a patentable invention per se,
- that patents on isolated human genes (DNA sequences) should only be obtained, if the patentee has demonstrated a practical and commercial use of the invention,
- that patents on human genes should not be used to inhibit research and development and prevent free, non-commercial research. Gene patents should not be used to the detriment of the common good or stand in the way of using new diagnosis and treatment methods,
- that DNA sequences from humans should be available for non-commercial purposes in accordance with the development of biomedical research. In case of licence agreements for research purposes, the licence should be available on a non-exclusive and non-discriminatory basis and be based on fair conditions in accordance with biomedical research,
- that the regulation of gene technology should be effected by the scientific ethical committee system.
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