[forthcoming in the July 1997 issue of nature biotechnology]
From May 22-25 the Indian National Academy of Sciences convened a bioethics symposium on the emerging ethical, legal, social and economic issues [ELSI] of genome research in Goa. The conference was organised by India's former Science and technology Minister and UNESCO Bioethics Committee member Professor M.G.K. Menon and Professor V.P. Sharma, director of India's large Malaria Research Centre. About 50 invited mostly high-ranking Indian and international participants attended a series of lectures pertaining to legal aspects (including the hotly debated issue of intellectual property rights, IPR), the organisation of bioethics education and implementation, the Indian human genome diversity project, ethical issues of behavioural genetics, gene therapy and DNA finger printing. Lively debates in two half-day interactive sessions debated ELSI of the human genome programme, genetic screening, testing, counselling and therapy, and last but not least bioethics education, awareness and dissemination.
One issues dominated the conference: the fear of many Indian participants that pharmaceutical companies would exploit the Indian biodiversity at great cost for the poorest of the peoples of this country. It cannot surprise that the issue of IPR legislation is hotly debated in India. Reportedly the UNDP estimates that biological resources worth approximately $5.4 billion are being stolen from developing countries every year. Dr Vananda Shiva of New Delhi's Research Foundation for Science Technology and Natural Resources Policy argued vehemently that India should retain sovereignty over its national resources and the creativity of its people. Patents would prevent the poor from accessing potentially life-saving drugs because their prices would be controlled by transnational companies. Shiva claims that patents would ultimately turn out to be a drain on public resources and not a fundraiser as other participants suggested. She contradicted Dr David Robert's, who represented Smith-Kline Beecham's views. Roberts essentially argued that India needs to change its IPR legislation or else it would continue to lose out in the international competition for investments by the pharmaceutical industry, because there would be no incentive for industry to invest in India. Most of his arguments, such as a slide demonstrating that new drugs can reduce hospital expenditure, were geared at a Western audience and failed to leave an impression on the conference participants in Goa. Some participants suggested that whether or not legislation changes would have no impact because of a lack of resources to enforce legislation in India. The continuing abuse of amniocentesis and ultrashall for sex selection in India was mentioned as a case in point. It is illegal for non-medical purposes yet it is widely used. The label 'genetic counselling' is abused by many service providers as a euphemism for sex selection.
The conference recommendations, as provided by Professor Sunil K. Pandya of Mumbai's KEM Hospital, suggest that the Indian Genome Initiative will focus on improving the means for genetic research in Indisa while working parallel on the ELSI of such research. Emphasis will be laid on location and population specific research. At present research should focus on studying India's biodiversity, identify loci of serious genetic disorders amenable to corrective intervention or therapy, to develop diagnostic tools, and recombinant molecules that can save lives and treat illnesses. It was suggested that DNA vaccine research would take an important place on India's research agenda. A closer interaction between genetic laboratories and departments in medical colleges, clinics and hospitals across India was recommended. These laboratories should offer diagnostic services available to all in need of them, conduct research on the genetic basis of unusual diseases encountered in India, and research the country's human genetic diversity. Emphasis was laid on the provision of pre- and post-test counselling, and on guarantees that the confidentiality of genetic materials provided to other Indian laboratories will be maintained. Particular concern was given to assure that the donors of such material's economic interests were safeguarded. Transfer of genetic material abroad should only take place in exceptional circumstances, and only to laboratories operating under similar legal constraints.
A great deal of time was spent discussing the issue how to increase public and professional awareness of bioethics. It has been suggested to start teaching the young in schools, and universities through special courses, textbooks, and journals. An interaction with teachers of law, philosophy, theology and the social sciences was seen as a necessary condition to assure success of this programme. National umbrella organisations such as the Indian Council of Medical research will be approached to support this ambitious undertaking. Of concern was the issue of obtaining voluntary first person informed consent given the educational situation of the majority of Indian people. It was suggested to introduce random tests to check whether the research subject actually understood what it was consenting to. Following CIOMS' research ethics guideline 8 it was argued that it should be guaranteed that material obtained from such subjects should only be used for the stated purpose, and that any material benefit derived from the study is shared with the subject and the community.
The necessity to create an adequate legal framework was emphasised, in particular given the realities of the international patent regime. Despite the worries about the role of industry, it was proposed to enlist industrial support for the setting up of the necessary facilities to manufacture anti-haemophilia factor, growth factor, etc. in India. Last but not least the creation of a coordinating advisory body was envisaged which would direct and monitor the overall aspects of research as well as the ELSI factors.
Udo Schüklenk, Ph.D.
Monash University
Centre for Human Bioethics
Clayton, Melbourne, VIC 3168
Australia
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