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Report
on WHO - ICMR Post Launch Interactive Session on “ELSI of Genomics”
Held on 26th Ocotber, 2002 at
India International Centre, Lodi Road, New
Delhi
he most powerful revolution in medicine during the past decade has been in the field of genomic research that has completely transformed conventional medicine into molecular medicine. The remarkable unveiling of virtually complete Human Genome in June, 2000, and release of the genetic code in February, 2001, created jubilation amongst medical professionals across the globe, but at the same time, the intended applications raised several ethical, legal and issues social too (ELSI). Realizing these intricacies, WHO took the initiative to monitor how genome research could alleviate human sufferings from dreaded diseases while maintain and caution about the potential risks of such research in medical practice; particularly the potential risks of exacerbating global health inequalities. It also cautioned about the complex ethical and legal issues that might arise in diversified religious and cultural values across the globe. The first major initiative taken by WHO was in the form of a comprehensive document on “Genomics and World Health” released in Geneva on 30th April, 2002; which laid the foundation for building up a new discipline – “Ethical, legal and Social Issues of Genomics”. On behalf of the Government of India, ICMR took the lead in organizing a joint WHO ICMR Post Launch Interactive Session on ELSI of Genomics on 26th October, 2002 at New Delhi, where a large number of professionals from related integrated disciplines took part.
A total of 13 invited speakers deliberated during the four dedicated Sessions on various aspects of ELSI of Genomics which was attended by 45 participants (List of speakers / List of participants are annexed as Annexure I ) At the outset Dr. Padam Singh, Additional Director General, ICMR welcomed the invitees and acknowledged the initiatives taken by Dr. Tikki Pang, Director, RPC, WHO Geneva and Dr. Than Sein, Director EIP, WHO-SEARO, Delhi which enabled ICMR to organize this unique and solitary “Post Launch Interactive Session on ELSI of Genomics”. He also gratefully acknowledged the active interest taken by a number of prominent scientists, social activists, Human Rights experts including journalists related to this area. The invitation from Prof. N. K. Ganguly, Director General (DG), ICMR and Dr. Vasantha Muthuswamy, Senior Dy. Director General and In-charge of Bioethics programme at ICMR Headquarters in facilitating the organization of the meet was appreciated. Finally, Dr. Vasantha Muthuswamy, Sr.DDG, ICMR briefed about the programme and invited Dr. Tikki Pang, Director, RPC, WHO Geneva to initiate the first scientific talk.
Presentations by:
Tikki Pang, Director, RPC WHO/HQ, Geneva Dr. U. Thansein, Director, EIP/WHO, Delhi Dr. N. K. Ganguly, Director General ICMR, N.Delhi Mr. Hari Subramaniam, Attorney-at-Law, N.Delhi
During this session, following topics were covered:
The session was opened with a gracious deliberation by Dr. Tikki Pang on the overall global policy issues related to Genomics. He emphasized the need for universal guidelines on the usage of genomic research in improvisation of global health, while highlighting the cascade of developments leading to Declaration of Draft complete human genome in June, 2000 and the whole genesis of Human Genome Project. Equal sharing of benefit of human genome research between developed and the developing country was emphasized upon vehemently. Nevertheless, the potential risks, hazards and ethical issues, and the justice and resource allocation in the post genomic era were particularly discussed at length. Dr. Than Sein, Director EIP, WHO-SEARO, Delhi gave an overview of the regional and Indian perspectives on genomics. He briefed about the recent activities undertaken by WHO SEARO during the preceding years. The potentials of Genomics in diagnosing over five thousand inherited diseases, thalassemia, communicable diseases and non-communicable diseases, development of vaccines and drugs were highlighted. The implications of resolution against human cloning in 1997 were warranted. Similarly, the impact in genetic counseling and screening, pharmacogenomics, xeno-transplantation, population genetics, usage of stored DNA, gene therapy and eugenics in relation to IPR, legal and social issues were raised. Finally, he spoke on the WHO regional strategies for awareness, use of clinical genetic services and capacity strengthening on human genomics. A debate was also initiated on the controversies in banning human cloning, use/misuse and the control of international trade on human genetic material. At the outset, Prof. Ganguly, DG, ICMR opened his talk by defining ethics, particularly the code of ethics, research integrity, conflicts of interests, individual professional ethics, health care ethics, compliance and corporate ethics. He highlighted the commitment of ICMR in developing ethical guidelines ever since 1980, one of the earliest ethical guidelines in the world. Ethical implications of important genomic technologies, particularly the genetic engineering, human cloning, GM food, stem cell research and gene therapy were emphasized. Advances in genomic medicine research in India in the field of cancer genomics, vaccinology, microbial genomics, pharmacogenomics, vector genomics, neurogenetics and molecular basis of diseases were elaborated. While speaking on the role played by ICMR, universities and other government agencies in bringing the name of the country at with the developed world in the field of genomic research, Prof. Ganguly informed about the commitment of Government of India in apportioning appropriate funds for undertaking medical research on genomics through ICMR, DBT, DST, CSIR and other agencies. Issues related to stem cell research figured prominently. The institutional ethical and national apex committees focused ICMR as the nodal governmental body to operationalise the established protocol of ethical guidelines on issues for biomedical research on human subjects through clearances. Emphasis was laid on wider discussion on patent issues in terms of beneficiary vs. type of patent during commercialization. The impact of genetically modified food (GM Food) on human health and societal concerns were also expressed. At the same time, he cautioned over the possible impact of genomic data on human dignity, discrimination, benefit sharing with providers of genetic material and access to personal genetic data. Prof. Ganguly also gave an overview of the ICMR initiatives in identifying priority areas requiring development/implementation of ethical guidelines on issues such as the use of human tissues, xenotransplantation, fetal research, neurotransplantation, potential organ sources from an encephalic infants, gamete donation, prenatal screening and clinical trials on human subjects. Despite known priority areas, not possible to frame appropriate guidelines, excepting a few. At the end of his talk, he reminded global concerns on ELSI issues and stressed the need for greater public awareness. Finally, he called-upon the concerned professionals to introspect themselves for strict code of ethics by saying – “encourage respect for law and administration of justice; observe rules governing privileged communication and confidential information, promote/exemplify high standards of loyalty, cooperation and courtesy, perform all duties of the profession with integrity and competences and pursue high order of professional attainment. Mr. Hari Subramaniam, Attorney-at-Law, Delhi gave a detailed account of the IPR issues in health biotechnology and genomics and cited many examples of the use and abuse of genomic research in different parts of the world. He emphasized the need for developing appropriate guidelines and laws governing use of biotechnology products. He talked about the inventions, which are patentable. Usefulness of such patents should be noted as some may require human intervention. He also cited situations where the claimed innovations cannot be considered patentable – e.g. if it is mere modification, or against morality/law and so on. He further elaborated on Indian, EPO and US thinking and directives on the complex IPR issues by citing numerous examples of patent claims by the inventors in Biotechnology and genomics.
Presentations by: Prof. G. Padmanabhan, Former Director, IISc, Bangalore
Dr. C. M. Gupta, Director CDRI, LucknowDr. N. K. Mehra, AIIMS, New Delhi Dr. Shahid Jameel, ICGEB, New Delhi
During this session, following topics were covered:
· Genomics and Immune Response: Opportunities and Risk
Prof. Padmanabhan narrated the story of successes and failures of conventional and DNA vaccines by citing examples of recombinant hepatitis B Vaccine, Rabies DNA vaccine, rotavirus live vaccine, anthrax recombinant vaccine, JE live vaccine, leprosy live vaccine, HIV rDNA vaccine research and TB/Malaria recombinant vaccines. However, he cautioned that there is hardly 2% market for vaccines compared to pharmaceutical trade and there is likely to be a compromise on the quality and quantity of desired doses of vaccines across the globe. Therefore, instead of attempting to subsidize the costs, countries like India can take the leadership for global requirement of manufacture of DNA vaccine, particularly in view of the excellent technical skill with demonstrated viability in India. At the same time, he raised the complex legal issue of patents on genes, promoters, PCR and vectors, which would have their import on India after 2005? He opined that areas such as vaccines should attract minimal royalties and license fees, and be preferably given free in the name of humanity. He advised that relatively more developed ones amongst developing countries such as India should be entrusted with the task of manufacture of vaccine for global use and should be given all help for achieving this. Dr. C.M. Gupta, Director, CDRI gave a comprehensive account of pharmacogenomics and drug development in the Indian context. Pharmacogenomics has potential to improve productivity and increase the number and quality of new drugs by validating more genomically diverse and higher quality drug targets and speeding-up clinical development by designing better trials that clearly show better safety, efficacy and compliance. He predicted that by improvising medical outcomes by use of pharmacogenomics-enhanced drugs and diagnostics, pharmaceutical companies could benefit to the order of US$ 200-500 million in extra revenue for each drug. Apex scientific bodies in India e.g. CSIR, ICMR, DBT have launched country-wide programmes to identify and characterize new drug targets, especially in the area of tuberculosis, malaria, leishmania etc., besides new drug targets for diabetes, cardiovascular and neurological disorders. In addition, CSIR proposes to undertake single nucleotide polymorphism (SNP) mapping in over 500 genes to identify and characterize in Indian population, the genes linked to susceptibility to malaria, TB, diabetes and some cardiovascular and neurological disorders. Prof. N.K. Mehra cautioned about the possible risks while utilizing the benefits of immune responses derived through genomics, particularly the polymorphic immune response genes that regulate immune responsiveness. Major histocompactibility complex (MHC) genomics with its vast array of immune response genes provide an excellent minigenome model for genome-wide scans of disease genes. He cited several examples of the anticipated benefits of genomic developments in relation to MHC and immune outcome. He concluded by stating that “no longer affected by the ignorance of our genetic make-up, we now have within our grasp, the very essence and soul of our being”; surely, we will never be the same again. Talk of Dr. Shahid Jameel was addressed to psychological tussle between the human capabilities to play with nature vs ethics. Indeed, he raised a pertinent question whether a virus should (?) or should not be (?) synthesized in the laboratory and whether such extreme efforts are ethical. Because viruses have small genome, it is relatively very easy to chemically synthesize many viruses in the laboratory. He exemplified the chemical synthesis of the most common human pathogenic virus – the Poliovirus, in the absence of natural poliovirus template, reported recently in Science, Vol.297, 2002. He elaborated upon this by presenting a detailed protocol of the de-novo synthesis of poliovirus in a cell-free system, which would be misused by countries having technical might proving what the scientific might achieve against the laws of nature. However, the issue was raised whether such efforts are ethical and will benefit the masses, or else may be used as weapons of destruction? He felt that a global debate is needed to generate consensus on such advances in genomic research.
Presentations by:
Dr. Amar Jesani, SCTIMST, Thiruvananthapuram Dr. S. S. Agarwal, Director ACTREC, Mumbai Dr. Dipika Mohanty, Director IIH, Mumbai
Dr. V. Muthuswamy, Sr.DDG, ICMR,New DelhiDuring this session, following topics were covered:
The third session was particularly dedicated to the community-associated applications of the genetic/genomic developments and their impact on the issues of use versus misuse, and confidentiality and rights of the communities in the post genomic era. Dr Amar Jesani cautioned over the violation of rights of communities in the name of advocating benefit of genomic products to the masses. He covered three major areas: relation between ethics and rights; evolving implementation mechanism for ethics and law for empowering communities, and some specific issues related to rights in genomics. Consequent upon the suggestions made by the delegates, Dr Jesani made two major remarks-i) that legislating the implementation of ethics in research would be a major step forward in protecting the rights of researchers in India ii) that we should not be averse to laws, as often happens, and must support such regulations that empower people, but be vary of vested interests of new bureaucracy which may thus be created. Prof. S.S. Aggarwal, Director, ACTREC, Mumbai talked on the specific issues related to medical genetics and cited numerous examples of advantages and disadvantages that both the medical professionals and the consumers of such research have undergone through decades. He clearly defined how the genetic research is much different from other types of research because here an ethical issue involves the entire family or clan and not just an individual. He cited examples of Eugenics, Nazism, Chinese law and female foeticide, besides issues of discrimination leading to psychological effect; decisions regarding reproduction; commercial interests and the fear of the unknown through genetic manipulation. Discrimination due to leakage of genetic information of an individual may have far reaching consequences in terms of insurance claims, employment, school admissions or marriages. Therefore, he strongly suggested the need for waiver from informed consent for family history in specific situations. However, the person should give authorization for use or disclosure of genetic information for specific use which should be time limited. There should also be right to withdraw and accountability of requirement. He talked about various international legislations related to this area. In later part of his talk, he elaborated on pre-genetic test counseling and alternative options and emphasized the role of post-test counseling/follow-up. At the same time, he expressed concern over the extensive use of information technology (IT) that is likely to retrieve or leak information in medicine, particularly in view of the expanding commercial interests. Dr. D. Mohanty, Director, IIH, Mumbai spoke on the genetic diseases related to hematology, particularly thalassemia. While briefing on thalassemia prevention programme in India, she cited live examples of ethical complications in genetic screening of mothers and college students and prenatal diagnosis. She inferred that ignorance, indifference and misconceptions are major factors contributing to poor follow-up of prenatal screening. Dr. Vasantha Muthuswamy, Sr. DDG, ICMR spoke on the hardcore issues related to risks and misuse of genomic technologies in medical practice. She defined the principles of Biomedical ethics. Risk and cost benefit analysis of hi-tech research in medicine was critically presented. Her concern went further to the extent of “Designer children” and its wide implications in time to come. Options in use of embryos, cloning of animals and humans, stem cell gene therapy and abuse of biological warfare through genomic research were other important focal points of her talk. Finally, she highlighted the need of the hour and stressed-upon the need for public education, consensus amongst academicians, industry and regulatory agencies, development of appropriate guidelines, monitoring mechanism and continued dialogue.
Presentations by: Dr. Sandip Basu, Director, NII, New Delhi Dr. Deepak Pental, Delhi University, New Delhi Dr. Samir Brahmachari, Director CBT, Delhi
During this session, following topics were covered:
· Role of Developing Countries in Genomics Research for Future Health Care
The fourth session was the most crucial one and focused on maintaining balance between ‘Health for all’ versus ‘Genomic Research’ for the greater good of human beings. Dr Sandip Basu emphasized on the need for prioritizing use of genomic advancements for mass health care. He also emphasized the significance of ethics and animal experimentation. The issue of animal experimentation generates a great deal of moral heat and yet is rarely addressed in the systematic consideration of the ethics of biomedicine. No sober public debate on this crucial issue has so far been possible in India, given the tendency of the media to favor emotive or celebrity reportage. The controversy thus simmers without being understood. Biomedical research aims to work out how a human or animal body functions and looks for clues for interventions to correct dysfunction for ensuring better health. However, in the 20th century human society at large set the ethical norm that no human application is permitted until an intervention is shown to be safe. The safety of an intervention is universally extrapolated often from experimental studies involving animals, which becomes necessary out of respect and value to human life and dignity. Staunch animal-rights activists demand that animals, being living creatures, must be accorded the same dignity as human beings, or even more by virtue of being `innocent’. This could prove counter-productive if an intervention was to be ultimately used for health and welfare of humans. Some of the queries that he directed towards the audience were “Is such an anthropomorphic view of the animal world justified? Is there ethical coherence to it? A little thought will show that the animal-right activists’ concern for `animals’ is symbolic rather than substantive. Logically, `animal rights’ advocates should find keeping pets captive an equally abhorrent experimentation, which they do not. On the other hand, he advised that if their strident demands result in a virtual ban on using animals for any kind of research, the mechanism of pathogen city in human body would never be understood. Dr. Deepak Pental elaborated on the much talked topic of current times, the genetically modified food (GM food) though, GM food research has no direct linkage with ethics related to human genomics but it raises similar issues because of its implications on human consumption. Dr. Pental highlighted the impact of GM food and ethical concerns on consuming such genetically modified food by human beings. He cited numerous examples of GM food including that of potatoes and other crops that have revolutionized biotechnology; but he cautioned over sidetracking of ethico-legal concerns. Prof. Sameer Brahmachari gave a comprehensive account of the role of developing countries in genomic research for future health care. He raised issues that may go beyond the human genome sequence – particularly how do we harvest the first draft of human genome for benefit of people and how do we balance between IPR protection and private funding. He was vociferous in categorically citing the examples of sound strength of developing countries in genome research and how to use this ignored bulk of global mass to join hands with developed world in jointly contributing for the upliftment of human race. He spoke on the regulations pertaining to human Genome patentiblity adopted by various countries. He also asserted that the patents should not be granted to discoveries on human sequence derived from any natural sources, any gene sequence variation observed in SNPs and ESTs and also normal gene function of a gene sequence evolved through natural selection as these can not to be considered inventions. In relation to patenting diseased gene, benefit sharing need to be guaranteed. Taking cue from Chinese strength in the area he informed that through the combined efforts of an information technology expert and a scientist - the “web-lab” and “wet lab” combination - India could go for ahead in the area. Prof. Bramhachari also shared his experiences with HUGO - Ethics Committee recommendations and suggested steps against unethical exploitation of genetic material and finally concluded his talk by emphasizing the need for sharing and caring. The technical session was followed by a very interesting interactive session.
The meeting ended with a vote of thanks by Dr. Vasantha Muthuswamy.
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