Genetic advances will only be acceptable if their application is carried out ethically, with due regard to autonomy, justice, education and the beliefs and resources of each nation and community.” Patenting facilitates the process of product development in genetics as in other medical fields, but patent protection must balance the provision of necessary incentives for invention with protection of public health interests. Gene patenting could impede international collaboration, especially between developed and developing nations, to the detriment of health care and biomedical research. 2000

Authors Prof Heng-Leng Chee, Malaysia Prof Dan Brock, USA Prof. Sir David Weatherall, UK (Lead Author)

Table of contents Genomics & genome projects Genomics & genome projects Potential of genomics for health care Potential of genomics for health care Relevance & time scale of advances in genomics for global health Relevance & time scale of advances in genomics for global health Potential for health of developing countries Potential for health of developing countries Potential risks & hazards and their control Potential risks & hazards and their control Justice & resource allocation Justice & resource allocation Ethical issues in genetic research, screening & testing with particular reference to developing countries Ethical issues in genetic research, screening & testing with particular reference to developing countries Education & public policy Education & public policy Recommendations to WHO & member states Recommendations to WHO & member states

Genes and Environment: The characteristics of all living organisms reflect the complex interactions between their genetic make-up, their environment and the long history of the milieu in which they are raised Health and Biomedicine: It is likely that future research into disease- susceptibility genes will help us to understand the mechanisms…, it will allow treatment to be tailored to individual needs and, in the longer term- generate new approaches to preventive medicine based on genetic susceptibility to environmental hazards

Somatic gene therapy Currently the most promising results are being obtained for genetic diseases in which the inserted genes does not need tight regulation or a high level of expression As important diseases are expressed during early development ( Brain, ZNS ) the possibility of intrauterine gene therapy needs to be exploited Stem cell gene therapy Genetic engineering of cell populations to approach difficulties of immune rejection of cell products or use of patients nuclear DNA to create an embryo from which embryonic stem cells compatible with the patient could be derived

Germ line therapy It is important to distinguish whether germ line therapy is now sufficiently safe to be permitted from whether it could become so in the future. At present no correct removal and replacement of a gene is possible non-therapeutic genetic enhancements some consider human reproductive cloning a form of non- therapeutic enhancement... where at the present time its risks are far too great to permit.. the greatest ethical concern.. to use genetics to significantly enhance important normal human functions…. the unfairness of further widening already unjust inequalities of opportunity and well being between the rich and the poor

Patenting Summary: Because many of the medical benefits of genomics research may be expensive there is the danger that these new developments will increase the disparity in health care within and between countries. There are particular concerns that inequalities will be accentuated by the current trends in the management of intellectual property, particular the patenting of basic genomic information

Intellectual property, sharing benefits of research present situation is little less than chaotic…. Invention, natural occurrence: It is argued that a gene sequence is naturally occuring which therefore can not be patentable. The counter argument used by patent lawyers is that DNA sequence identification is a form of purification outside the body, such as patenting cDNA complementary to mRNA … but mRNA also exists in nature…,it is rather like saying that the same invention could be repeated if translated into a different language research The monopolies awarded by patents on genes are not in the public interest,.. It weakens the the contribution of the global research community. And may complicate the granting of concessional prices for the therapeutic agents. In addition patenting of proteins is becoming more chaotic than DNA patenting

WHO and patenting of genes : There is a need of a clear articulation and discussion of key questions: can patents on DNA sequences continue to be justified in the context of current technology ? What are real thresholds for novelty, inventiveness and utility ? Are such patents really necessary for successful innovation in health care ? what are the duty of patent holder in licensing their innovations ? Role for WHO for an international policy forum