pp. 112-114 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.

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3.4. Ethical Issues in the Generation and Utilization of Knowledge in Biotechnology

S. Visalakshi.

National Institute of Science Technology and Development Studies, New Delhi, India

It is an accepted fact that the next century is going to be one of biotechnology and information technology. The commercial prospects of and the ubiquitous use of biotechnology has made it an item in the priority list of both developed and developing countries. There is a lot of investment from both public and private parties in the generation of and utilisation of their results. This has brought traditionally isolated academia and the industry together, too closer at times to create new concerns relating to selection of projects, ownership of outcomes of the research etc.

In this paper an attempt is being made to look into the implications of the latest developments in the field of biotechnology or new biology from the points of view of new biology research as it is being performed, the research agenda, tools and techniques and information which would become available due to this activity, and to project their implications to creativity and social justice.

At the outset it is worthwhile looking into the process of generation and utilisation of knowledge in new biology which is of our concern.

KNOWLEDGE (NEW BIOLOGY)

GENERATION UTILIZATION

WHAT TO GENERATE WHAT TO USE

WHY - MOTIVE WHO USES

HOW GENERATED FOR WHAT?

CONSEQUENCE CONSEQUENCES

Inventions are driven by natural inquisity, take a long time to generate knowledge so are highly risky. Has implications for long time. Innovation is driven by commercial/application motive and takes a moderate time. Risk of being accepted in the market or not. Incremental development of knowledge is driven by market (continuous process and risk is less). From the existing literature on development of biotechnology in various countries, it could be observed that most of research which is going on in new biology/biotechnology could be grouped under the second and third category.

There are various motives to generate knowledge, including to enrich existing knowledge, to find answers to present questions, to reduce risk, to utilise existing capabilities, to own the generated knowledge, to control diffusion of knowledge. Of these the the last four have been observed to be the main motives behind generation of knowledge in new biology , contradicting prevalent notion that research should be driven by the logic of inquiry and not by the opportunity for profit.

Coming to mode of generation of knowledge in new biology, it has been observed from the exiting literature from different countries where Biotechnology has been well developed and put to commercial use, that it is done by setting up agenda for research by the interested parties with commercializability as a priority, create tools and mechanisms to establish ownership and control diffusion of knowledge. This is achieved by exploiting appropriate capabilities/facilities wherever exist through various contracts/appliances to reduce risk and costs.

Generation of knowledge in biotechnology or new biology as one observes is mostly in the hands of big companies of highly advanced countries and their perceptions of need form the agenda for research. The tendency in some countries to bias support towards gindustrially relevanth or applied research in the universities at the expense of fundamental research or to allow industrial research to supplant (gradually) the governmental support, could in the long run undermine the fundamental research base on which the future progress of biotechnology depends. This can also undermine the freedom of inquiry and dissemination of knowledge (evidence exists in various instances of a break down in communication amongst biotechnology in academic circle.)

To reduce risks on the cost of such research the capabilities and facilities in the public R&D and academic institutions are utilised. This at times extends beyond geographical boundaries (E.g. ASTRA Sweden setting up research group in India to work on tropical diseases using Indian Capabilities).

Natural resources - genetic resources in the form of microbes, plants, animals and certain human populations are utilised as basic materials for generating knowledge by manipulating the vulnerable and weak regulatory structures in the developing world. Thus only those lines of research which is profitable to the powerful few or perceived as need of the humanity are pursued.

This trend is encouraged advertantly or inadvertantly by different countries falling under both developed and developing countries alike whose policy is to gradually and consistently withdraw public support to S&T research.

This pattern of generation of knowledge in Biotechnology has led to a situation where in the results of the research are mostly in the form of private proprietary material like patents, protocols and processes, products and much less public output in the form of publications. Special contracts restrict free communication of the work and results for confidentiality reasons. gExpensive Sword - Wielding patent litigation by Gannett resulted in a diminished number of TPA R&D projects in other firms by the end of 1990. Wellcome in UK decided to end its TPA development agreement with Genetics Institute, citing the patent difficulties in prospect as one of the reasons. (Scrips Report on gWorld Health Care Biotech Industryh April 1991)

Mackenzie et al in their paper on gPatents Free Scientific Information and Changing International Regine in Intellectual Propery-the case of Elisa and Tandemh discuss the legal dispute between two US Biotechnology start up companies for a patent cover for a diagnostic kit using Monoclonal antibody, and illustrates the shift that has occurred in the boundaries between propritary information and free scientific information to the advantage of proprietary interests. Such transformation amounts to subtle but significant reallignment in the political economy of Science and Technology. Fox (1984) comments gpatents encroaching on Research freedomh in Science. It has been further substantiated by a study at NISTADS which involved analysis of the pattern of publication in Hybridoma from 1986-1995 wherein it was noticed that the proportion of patents over publications was increasing and a tendency of change in the location of the work i.e. from University departments to R&D groups in the industry. Further the subject matter of publication in the late 80fs are being shifted to form subject matter for patents. (Visalakshi et al 1996).

The tools and techniques which become available out of these efforts are diagnostic aids (in vitro, in vivo, prenatal diagnosis), therapeutic compounds, new seeds, new plants and microbes etc.

Utilising the fluid state of regulatory climate in different countries these products are introduced, data collected for validation purposes, through marketing pressures create new problems which include: unethical practices in health care in developing countries with less public awareness, and the enormous increase in the burden of health care expenditure in poor countries irrespective of the fact whoever pays for it.

Implications for the developing countries due to the above activities are and will in future be: they are being robbed off their genetic resources, become dependent permanently for their food needs on new seed companies, pay heavily for their health care needs and R&D set ups in these countries would become contract workers of MNCs.

The future possibilities of this trend of generation and utilisation of knowledge could lead to problems based on the genetic information of human beings through gene mapping techniques and prenatal diagnosis etc., both at individual and groups levels.

Increased usage of genetic material from identified groups for specific characteristics for research and commercial exploitation of information so generated by various authorities and third parties which could create new problems in making choices regarding very personal decisions like education, employment, marriage and child bearing etc.

Regarding sterilization - (neo-eugenic policies) one well known geneticist (Bentley Glass) wrote gThus in an over populated world it can no longer be affirmed that the right of a man and a woman to reproduce as they see fit is inviolate. The right that must become paramount is not the right to procreate but rather the right of every child to be born with a sound physical and mental constitution based on sound genotype.

The type of products which could create problems are the devices which could be used for genetic screening in workplace to detect specific heritable diseases, genetic susceptibility to certain diseases, special vulnerabilities of environmental risks, genes having no effect on health directly but statistically associated with future health outcomes and life expectancy, genetic and biochemical factors behind mental performance and ability, prenatal diagnosis which helps to detect defects at fetus level enhances reproductive options for eat riskf couple. (This state could change and the choice could shift from the couple to the State.)

The issues that arise out of the present patterns of utilisation of knowledge include biotechnology creates a need to reexamine the concepts of privacy, equality, autonomy (freedom to make choice), and confidentiality of personal information; and the identification and reduction of a human being to bare set of data on biological characteristics and mental capabilities. In a general sense a scientific basis for individual mental performances, ability, aptitudes and health could be easily distorted into justifications of politics that establish or preserve different standards of rights, liberties and different classes of citizenship. This would arouse concerns of gequality equity and equal opportunityh.This can create problems to classifications which till now have remained arbitrary by rendering a possible objective basis and a threat to continuance of precious but fragile fabric of social equality.

Thus one can see an emphasis on gnatureh than gnurtureh. Irrespective of origin and contribution basic material for generation of the present knowledge and it is put to use for betterment of life of the ghavesh and gthose who can affordh and is put to use on gthose who cant affordh only to exclude them and create new orders of classification. Do these appeal to us as issues related to Bioethics? If so, do we do something now or wait!

References

Scrips Report on gWorld Health Care Biotech Industryh April 1991

Mackenzie, M., Ketaing, P. and Cambrosio, A. (1992) Patents, free scientific information and the changing international regime in intellectual property pp. 123-6 in The case of ELISA and Tandem in Elisa as diagnostic tool - Prospects and Implications, Eds., Visalakshi, S. and Mohan, S., Wiley Eastern, New Delhi.

Visalakshi, S. and Soundarya, K. (1996) The shift towards privatisation of research results in hybridoma technology - evidence from bibliometric study. NISTADS Report.


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