pp. 449-454 in Bioethics in Asia

Editors: Norio Fujiki and Darryl R. J. Macer, Ph.D.
Eubios Ethics Institute

Copyright 2000, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.

F33. Genetics and Biomedical Technology: The Emerging Milieu and the Indian Context

R.R. Kishore.

Chief Medical Officer, Ministry of Health & Family Welfare, India;

President, Indian Society for Health Laws and Ethics (ISHLE), New Delhi, India

Introduction

Fast advancing biotechnology, increasing quest for well-being, longer life-span, changing life styles, demographic transition, wider human interaction, growing commodification of human body, entry of corporate sector in the health delivery system, greater institutionalisation of services with higher dependence on managerial and bureaucratic setups, evolving moral concepts, lay adjudicators, judicial unpredictability, and a host of other factors have imparted unique plurality to the concept of human health and in today's milieu it carries far greater meaning and expectation than the earlier times when it was confined merely to somatic intervention. In this scenario medicine is not just a clinical science. It includes subtle appreciation of social, economic, cultural and religious aspects of individual and societal life. There have been many attempts at the national and international level to evolve an ideal legislative strategy in order to address the problems emerging out of advancing biotechnology but the conflicting perspectives and the multidimensionality of the issues involved continue to defy the solution. The biggest challenge emerges out of the respect granted to the living matter which being an end and the purpose per se is far beyond the discovery-invention, sale-purchase, and profit-loss notions. Inspite of its biology and the chemistry being clear the living material is never seen as a physical object. Life is the Absolute embodied. This is a universal perception, regardless of cultural or religious affiliations, and is the biggest challenge in the process of legislating the advancing biotechnology.

Global Developments

In one of his essays "The Impact of Science on Society", published more than forty years ago, Bertrand Russell observed, "Man has existed for around one million years, he has been able to write for about six thousand; he has farmed for longer, although not that much longer. Science, as a dominant factor in determining the beliefs of educated man, has existed for three hundred year, as a source of economic technique for around one hundred and fifty. During this brief time, it has proven to be an incredibly powerful revolutionary force. When we consider how recently science has achieved power, we can but believe that we are merely at the beginning of its action to transform human life. We can only hazard a guess as to what its effects will be."

The discovery of genes in 1953 by Crick and Watson and the subsequent events have concretized Russell's premonitions. A new cultural era has begun. Over 5000 different human diseases are known or suspected to have been caused from defects in single genes. The screening of single genes has become a practical possibility and the potentialities of genetic intervention extend to humanizing the animals and creation of new life forms. The transplantation technology holds the promise of producing persons out of unborn mothers, besides replacing the diseased organs. The humankind who have so far known only life and death are face to face with third eventuality namely, the PVS (Persistent Vegetative State). On top of this is the "Utility" with its vast potential of making the life worthless and misconceived, compelling one to search new meaning in the objects and the phenomena. Fiction is turning into reality and the discoverer has become the discovery. Erosion of individual's autonomy and the possibilities of biological exploitation of human species have created new ethical dilemmas contemplating highly evolved conceptual formulations. The biological link between past, present and future generations has always existed but in the contemporary milieu it has assumed new expression as a part of " Common Heritage of Humanity" which is no longer confined to material possessions like ocean wealth, uninhabited lands, space and heavenly bodies. On the economic front increasing globalization and privatization has disturbed the individual - community relationship and a new social order is fast emerging imparting enhanced vulnerability to the individual in the garb of accomplishing 'positive' social goals. The community perspective, founded on mutuality, reciprocity, complimentarity and optimization of resources, imparting freedom, security and orderly conduct to the people for ages is rapidly disappearing. In these emerging dimensions of life, biotechnology and human relationship the ancient and medieval doctrines are no longer able to hold the field and there is an urgent need to functionalise aptly conceived juridical principles, which throws a big challenge to the legal systems and the cultivators of law.

The patentability is no doubt a substantial legislative device to reconcile with the imperatives of social good with the dictates of individual interests. This must however be remembered that the concept originated to afford protection to the mechanical inventions and is based primarily on two preconditions namely, innovation, and utility. In the context of living materials it is difficult to meet these conditions because the products already exist in the nature as DNA molecules, proteins, antibodies or micro-organisms. and as such can not be held to be "new". The applicability too cannot be assured because, the living material keeps undergoing evolution and mutation which may alter its character and utility. Two more properties of the living material, i.e., its capacity to multiply of its own, and the respect granted to the living beings, further complicate the issue.

There have been different -- and changing -- legal strategies in the area of biotechnology. In the United States of America, beginning in 1889 the courts repeatedly held that living matter is a natural product and, as such, not patentable. Similarly, in 1973, the European Patent Convention ( the Munich Convention of 5 October, 1973) prohibited patenting of living material. But the attitude changed and in 1980, for the first time, in the United State legal history the Supreme Court of United States ruled in the case of Diamond against Chakrabarty that ,"living, genetically modified microorganisms are patentable". Subsequently, even the higher life forms were patented as in the case of Allen Oyster (1987) and the transgenic mouse or the Harvard mouse (1988). More recently, in 1990, the United States Supreme Court, in John Moore's case conceded property rights in one's tissues but excluded the possibilities of profits being made by third parties on a new product developed from such tissues. As against this frank and open approach in the United States the European strategy seems to be to rely on exclusionary clauses and liberal interpretations of Munich Convention in order to accommodate specific situations, as is evident by the decisions granting patents to biological products in a variety of cases like, Ciba-Geigy case (1983), Interferons Alfa-Biogen case (1989), Harvard OncoMouse case (1990), and more recently the Relaxina case.

The issue of biotechnological research and innovation is directly linked to economy. The research involves heavy investment which is possible only by industrial sector. The investors want adequate and timely returns which is not possible unless they are granted patency rights over their innovations i.e., the products and procedures developed by them. In the absence of such incentives necessary capital will not be available for the development of biotechnology. Already, the European countries have been facing fierce competition from the American biotechnology industry owing to liberal approach adopted in the USA in the matter of granting patents to biological materials. This is a major functional imperative and is in direct conflict with the inviolability of life.

Draft Proposed W.H.O. Guidelines

As per the Summary Statement on Ethical Issues in Medical Genetics issued by the World Health Organization on 20-22 February, 1995 the "Concluding summary guidelines" include following points...

1. Existing genetics services should be available equally to everyone regardless of ability to pay and be provided first to those whose need is greatest.

2. Genetic counseling should be as nondirective as possible.

3. All genetics services, including screening, counseling, and testing, should be voluntary, with the exception of screening newborns for conditions for which early and available treatment would benefit the newborn.

4. All clinically relevant information that may affect the health of an individual or fetus should be disclosed.

5. Confidentiality of genetic information should be maintained except when there is a high risk of serious harm to family members at genetic risk and the information could be used to avert this harm.

6. Individual privacy should be protected from institutional third parties, such as employers, insurers, schools, commercial entities, and government agencies.

7. Prenatal diagnosis should be performed only for reasons relevant to the health of the fetus and only to detect genetic conditions or fetal malformations.

8. Choices relevant to genetic services, including choices about counseling, testing, contraception, assisted procreation, and abortion following prenatal diagnosis, should be available on a voluntary basis and should be respected.

9. Adoptive children or children conceived from donor gametes should be treated equally with biological children under the guidelines.

10. Research protocols should follow established procedures for review and informed consent. Research on preimplantation genetic diagnosis should be permitted.

11. Protocols for experimental human gene therapy should receive national review, with attention to the potential benefits or risks from various approaches to therapy.

The Indian Context: What is in our national interest?

Consistency with the national interest is the primary requirement of any strategy in the field of biotechnology, particularly in the light of global legislations like TRIPS, under the GATT/WTO, which have brought life forms and bio-resources within the realm of Intellectual Property Rights. The national interest of a country as vast , and as heterogeneous and pluralistic, as India has manifold dimensions and includes:

1.Development of a stable and equitable social order and the emergence of a self-employed and economically independent rural population.

2. Promotion of community system of living and governance

3. Preservation of biodiversity as a source of continuing sustenance and livelihood of the people.

4. Recognition of community rights on the land and bio-resources on the strength of domicile, occupancy and use.

5. Promotion of biotechnological research in order to optimize the use of natural resources and to improve the quality of plant and animal life.

6. Treatment of traditional knowledge, skill and customs as national heritage.

8. Safeguarding of indigenous biological resources, processes, methods, innovations and expertise against smuggling and piracy

9. Preservation of the culture and values of the society

10.Keeping pace with the international advancements in biotechnology and to utilize the emerging knowledge to upgrade the national system, without encroaching on the public order and morality.

What is public morality?

Morality can be defined in many ways. To me it means conformity to the ideals of right human conduct. It is the manifestation of our concept of values, which basically emerge out of human virtues, but the concepts may differ to some extent according to religious and ethnic backgrounds. In a culture as affluent and as composite as Indian the morality plays dominant role in shaping the social order. It is a part of our daily life. The state's policies and legislative strategies, have to be compatible with the moral concepts of the nation otherwise they are liable to be rejected by the people. In the Indian context public morality includes,

1. Respect for Nature and all forms of life and life-styles

2. Respect for religion, religious practices and traditions

3. Special respect for certain sections of the society like , women, elderly, religious figures, saints and preachers, and objects and places of worship.

4. Obligation to protect the natural environment with particular attention to the places of utility to the commons, like rivers, lakes, forests, and wild life.

5. Non-commodification of the human body

6. Protection of the weak and needy

7.Respect for Nature and other forms of life

8. Noninterference in the life of others

9. Obligation to safeguard public property

10. Respect for the national and global heritage

11. Universal brotherhood

12. Respect for the dead

13. Concern for the future generations

14. Utilization of the emerging knowledge for ameliorating human suffering, ignorance and vulnerability, and for improving quality of life.

15. Prohibition of the negative consequences of economic growth like violation of individual's autonomy and creation of unequal social order.

Most of the above concepts have been recognized as "FUNDAMENTAL DUTIES" in our Constitution under Article 51A

Recent Developments

The perceptions in India are quite clear that the genetic knowledge has imparted new dimensions to disease prevention by foretelling the disease processes, and despite possibilities of misuse it holds a big promise in the preventive and curative medicine. The importance of genetic knowledge and skill as prized human attainments and the need to preserve the common heritage of humanity is also being fully realized. The approach is open and objective in order to ensure optimum utilization of this great tool, rather than imbuing it with unnecessary skepticism. A Special Task Force on Human Genetics was constituted in December, 1993 to initiate research and development in the area of biotechnology. The thrust of Indian effort is to utilize the emerging information for therapeutic purpose and also to understand the genome diversity of Indian population. As regards the genetic patentability, there is distinct concern to safeguard the country's rich biodiversity against possible attempts at its exploitation by foreign entrepreneurs and the need is being increasingly felt to enact suitable statutory provisions in this regard.

There has been positive legislative crystallization in several areas in order to address the issues relating to advancing biomedical technology and the changing milieu of health delivery system. Two important statutes deserve mention in this regard., namely, "The Transplantation of Human Organs Act, 1994" and "The Prenatal Diagnostic Techniques (REGULATION AND PREVENTION OF MISUSE) Act, 1994" The enactmentfs reflect the country's legislative wisdom and maturity by aptly reconciling the intrinsic sense of values as enshrined in the Indian cultural thought and the emerging imperatives of fast advancing biomedical technology and globalization.

The Indian Transplantation law effectively addresses all the major issues relating to organ transplantation, namely, prohibition of trade, protection of donor's rights, adequate availability of organs to the needy, optimization of transplantation costs, promotion of transplantation procedures, maintenance of their superior standards, and consistency with the country's socio-economic, cultural, and religious realities. Similarly, the law on Prenatal Diagnostic Techniques provides highly equitable and balanced provisions. It imposes complete ban on all kind of tests aimed at detecting the sex of the foetus, along with stringent penal provisions for violations, but allows freedom to undergo investigations to find out genetic abnormalities or disorders for therapeutic purposes.

Analysis of Article 27 (2)

Article 27 (2) allows exclusion of inventions from patentability only on the ground of:

i. Protection of public order or morality

ii. Protection of human, animal or plant life or health

iii. To avoid serious prejudice to the environment

The above provisions lead to the following significant consequences:

i No exclusion is possible on the ground of country's economic imperatives

ii. As regards the environment, exclusion is not permissible for its protection. It is operable only in the event of "serious prejudice" . This is not consistent with the country's ecological interests.

iii. Inspite of the restrictive nature of the exclusionary provisions the scope of exclusion, in practical terms, is substantial as the expressions, "public order" and "morality" are capable of wide import and, as we have seen above, can not be separated from the society's economic interests.

Analysis of Article 27 (3)

While Art. 27(2) uses a generic expression like "Invention" the Art. 27(3) seems to be more specific. It provides exclusion to:

i. Methods - diagnostic, therapeutic and surgical for the treatment of human or animals

ii. Essentially biological processes for the production of plants or animals (other than non-biological and microbiological)

iii. Plants and Animals (Other than micro-organisms)

The effect of Article 27 (3) is that we can not patent the micro-organisms, non-biological and micro-biological processes "for the production of plants or animals".

Let us first take the Non-biological and Micro-biological processes. They are used for preparation of beverages like tea, coffee, alcohol and many other indigenous drinks, foods , tobacco, drugs, vaccines, cosmetics, manure, insecticides and for many other purposes. They can be excluded from patentability for all these purposes and we can evolve our own legislative strategy for protecting and developing our national interests. The non-exclusion is applicable only for the production of plants and animals for which, at the present level of scientific knowledge, non-biological and micro-biological processes do not carry much scope. The production of plants and animals involves "essentially biological processes" which enjoy exclusion under TRIPS and as such our national interest is not affected. As regards the production of modified forms, or new species, of plants and animals by means of genetic intervention I will treat it as an "essentially biological" and non-"microbiological" process because genes are undoubtedly biological material and as such the process is covered under the exclusionary clause. There may be some controversy if one takes the view that during genetic intervention irradiation, drugs, cultures, and surgical procedures etc. are employed which are "non-biological' procedures. But in my view this argument does not hold water as these procedures are only the handling stages/steps and do not constitute the basis of formation of the modified or the new species which owes its existence to the biological changes at the level of DNA which is an " essentially biological process".

Coming to the micro-organisms it is clear that they can not escape patentability. But there are two important aspects of this issue namely,

I. It has not been stated in Article 27 (3) (b) whether the provisions are applicable only to the naturally occurring forms or also to the forms produced by artificial means. Since the entire connotation of these provisions pertains to the natural and existing forms I have a clear view that the expression "Microorganisms" does not include the future species which may be developed by genetic manipulation. This aspect is important because the genetically modified forms of micro-organisms carry substantial potential of utility.

ii. The main importance of micro-organisms lies in their utility to the plants and animals, including the human beings, by participating in the processes known as micro-biological processes. We have seen above that except for the production of plants and animals the use of micro-biological processes is not compulsorily patentable under TRIPS. As such, the patenting of micro-organisms does not affect our interests so long we are free to exploit the micro-organisms for micro-biological processes.

Conclusions

1. The export of all species of plants and animals endemic in India as well as the plant and animal materials capable of reproduction like seeds, roots, stems, eggs etc. should be prohibited.

2. The transmission of knowledge about the habitat, multiplication and uses of our plants and animal varieties to other countries should be strictly regulated and monitored.

3. The processes relating to the production of all the items from our bio-resources, as well as the items, (except plants and animals) should be patented for the purpose of international use.

4. All the rights relating to the production, conservation, use and knowledge of the bio-resources should vest with the community which has been caring, nurturing and using those resources.

5. The knowledge, skill and methodology inherited by the community as a tradition should not be alienable under IPR.

6. Privatization and globalization of the country's bio-resources should be confined only to the products and not to the biodiversity or the indigenous knowledge.

7. While safeguarding the national interest the approach should not be insular. The legislative provisions should be capable to accommodate global perspectives, and there should be adequate scope for free exchange of knowledge on scientific issues in order to keep pace with the latest technology.

Advancements in genetics and biomedical technology have imparted enormous potential of predictability, maneuverability, and curability to the humankind, contemplating matching intellectual skill to put it to the right use. Owing to non-evolution of appropriate conceptual formulations the emerging knowledge is not being adequately utilized. There is an immediate need to develop sound and objective ethico-legal paradigms, consistent with the medical, socio-economic, cultural and religious imperatives in order to liberate the candid advances in medical science from undue fears and apprehensions. The prevailing controversies are primarily the outcome of resource constraints, conflicting individual interests, dominance of individual's autonomy by common good, and the inconsistencies between the value concepts and material considerations, and as such, require to be resolved by a holistic and pragmatic approach, free from dogmatism and isolationism, with full appreciation of the promises held by advancing biotechnology.

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