LAW RELATING
TO BIODIVERSITY: CHALLENGES FOR THE LAWYER
R.V.Anuradhaªª
Ashish Kothariª
Introduction
The exciting aspect of the legal profession is the
dynamic nature of its very essence: the law. At law school one of the first
questions that one is confronted with is whether law initiates the changes in a
social set-up, or does it merely follow it? Perhaps both are true, depending on
different circumstances. Then comes the role of the lawyer: does s/he merely
apply what the law states, or is there space for creative interpretations?
There are times when an intuitive response to a situation may make certain
things seem obvious, whereas the law may mandate something different. It is the
possibility for debate, discussion, differing views, differing perceptions that
makes the entire study of law some kind of a quest. And in a legal system like
ours where every law has to satisfy the basic tenets of, and can be tested time
and again against the touchstone of the Constitution, the role of the lawyer
becomes that much more challenging and interesting.
The purpose of this article is to highlight some
questions and aspects for resolution in the context of law relating to
biological diversity- a relatively nascent area of law. Environmental law,
rules and regulations are arguably a well-developed area of law in India. A new
entrant into this field of legislation is the proposed National Biological
Diversity Act. Like some of the other environmental laws[1],
the impetus and mandate for this law too springs up from an international
convention, namely the Convention on Biological Diversity (CBD)[2].
The stated objectives of the CBD are: biodiversity conservation, sustainable
use of biological resources, and equitable sharing of benefits arising from
such use[3].
One of the key aspects of the CBD is its policy and mandate with regard to
Access to Genetic Resources[4].
It has been argued that the agenda behind the CBD and its provisions on access
was simply to legitimise access to and control of the genetic resources of
gene-rich countries.[5]
However, it is also widely recognised that whatever may have been the politics
behind the evolution of the CBD, it does have certain strong provisions which
ensure that the genetic resources and knowledge associated with the same can no
longer be treated as a 'free good', and that there is scope for the framing of
regulations for controlling access to such resources in the national and local
community interest.[6] At the basis
of these developments however is the inescapable realisation that genetic
resources have tremendous economic potential which is being sought to be
harnessed. In the process, like any other economic activity, there would be
implications for rights- to property, over use of resources, to knowledge, the
possibilities of clashes between cultures, between different systems of
medicine and different agricultural
practices, and a whole plethora of basic definitional issues regarding:
'ownership', 'access', 'rights to knowledge and resources', 'conservation',
'sustainability', 'equity', 'informed consent' and 'benefits'[7].
How law and policy should respond to this is the challenge.
Whose
Resources?
Although the conceptual perception of genetic
materials as resources of quantifiable economic value is a rather recent
phenomenon, the knowledge and mastery of biological surroundings has been
critical to the survival of every human culture.[8]
It is estimated that more than half of the world's frequently prescribed drugs
are derived from plants or synthetic copies of plant chemicals, and this trend
is growing.[9] The other
aspect to be noted is that the debate on 'genetic resources' is not only about
the tangible physical resource alone, but about the intangible information base
associated with that resource. The originators and custodians of much of this
information are local and indigenous communities who through years of
consistent skill, observation and usage have developed a wealth of a knowledge
base regarding the use and properties of various biological resources.[10]
Again this is no new realisation. Access to resources and information, however,
was till now governed by the rules (or lack of them) of "spying, smuggling
and free access"[11].
What is new are the attempts in legal and political
discourse to address the imbalance from 'free access' to 'control over access'
to genetic resources and the associated knowledge. At the outset, however, it
is important to recognise the differing abilities to grapple with the legal
system of the 'players' involved in that the 'acquirers' of genetic resources
and information have the advantage over the 'creators' or 'originators', in
terms of technology, power and economic resources. In the absence of law and
policy at the national level, a number of bilateral "deals" have been
concluded in different parts of the world[12],
analysis of which raises the crucial issue of need for law as an instrument for
setting standards and mandating basic 'non-negotiables'.
Rights to the
resource
The CBD recognizes that the State has sovereign
rights over its biodiversity. For the purpose of law at the national level,
provisions relating to access and benefit sharing in the CBD raise issues
relating to property and use rights over land and things that grow on the land.
In the first instance, the question that arises is who has rights of ownership over biodiversity and over its constituent
genetic resources? Should this be the sovereign right of the state/ or the
property of the private owner of the land where such resource occurs/ or of the
community that lives amidst such resources, or of a combination of all of
these?
The law relating to property in India recognizes
that things attached or rooted to the earth constitute immovable property. It
also recognizes that 'benefits arising from land' is an interest in the land
and therefore immovable property.[13]
But would "benefits arising out of land" include the benefits arising
from use of genetic material components in the biological resources found in
the land? In cases of land belonging to a private owner, it would seem that
biological resources accessed from it are the property of such owner, and can
be taken only with the permission of such owner. What would be the law in cases when the land belongs to a person,
whereas another is responsible for the conservation and sustainable use of the
resource? What would be the law when land belongs to one person, and another
has knowledge and information regarding the resources on the land? These
aspects are yet to be answered. These questions become particularly more
critical when the reality of land ownership in India is examined.
In cases where the land from which access is sought
belongs to a village, the relevant law to be consulted would be the Panchayat
Acts. Most Panchayat Acts however do not vest 'ownership' over land with the
village, although matters such as 'land improvement', 'soil conservation',
'maintenance of community assets', 'development schemes for the village', are
matters frequently listed in Panchayat Acts. The Panchayat (Extension to
Scheduled Areas) Act, 1996[14]
has stronger provisions that state that the Gram
Sabha (village assembly) is empowered to safeguard the traditions and
customs of the people, their cultural identity and community resources and
further that tribals would have ownership over minor forest produce in such
areas.[15].
A substantial part of the biodiversity in India
exists in the "Protected Areas" declared under the Wild Life
(Protection) Act, 1972, or in the Reserved and Protected Forests under the
Indian Forests Act, 1927. The jurisdiction over these areas vests with the
State Forest Department. Neither of these laws addresses the issue of accessing
the genetic resources within their jurisdiction. In general however, the Indian
Forest Act, 1927 states that access to the forest resources can be had with the
written permission of the Forest Officer or by any rule made by the State
Government[16]. The Wild
Life Protection Act, 1972 states that plants may be removed from the area under
their jurisdiction only with the permission of the Chief Wildlife Warden under
the circumstances specified in the Act. Such circumstances are generally
collection of such plants for education and research purposes, or for management purposes such as
fire control.[17] Access to
and collection of the resources for commercial purposes is therefore not
contemplated under the Wild Life Protection Act, 1972.
Both the Indian Forest Act, 1927 and the Wild Life
Protection Act, 1972 also provide for the settlement and recognition of the
rights of the people dependent on the resources in areas within their
jurisdiction. Where such rights are recognised, should such people have a say
in access to such resources by 'outside' interests[18]?
Where such rights of communities to collect and use a resource were
traditionally and customarily recognised but are not so by existing provisions
of law, what would be the status of such rights[19]?
Who should decide on the access when the knowledge of the users of the
biological resource in a forest land is the basis on which physical access to
the resource is sought? The problem with regard to access to the resource in
all the scenarios contemplated above is complex because access to the physical
resource is more often than not, not sought at random. The reason and basis for
the access in the first place is the existing knowledge and information
regarding the resource. In the absence of any legal forms to protect that
knowledge, the question that really has to be addressed are on what basis
should access be regulated?
The proposed law relating to biodiversity[20]
drafted by the Ministry of Environment and Forests works on CBD's premise that
the State has the sovereign right over its genetic resources. The law proposes
to establish authorities at the national, state and local levels to deal with
the issues of access to genetic resources. However the issues with regard to
'ownership', jurisdiction, and inter-play with existing laws are yet to be
addressed and resolved. For instance, can the National Authority permit access
to resources within the jurisdiction of a national park or sanctuary, and can
it permit commercialisation of the same?
Access to
Knowledge and Resources: "Benefit Sharing", "Informed
Consent" and "IPRs"[21]
Benefit
sharing
The issue of rights, as discussed above, is
complicated by the fact that access is very often not sought to a biological
resource at random, but to one on which there is local community information
regarding its use and properties.[22]
The CBD's mandate in this regard is that where utilisation of the knowledge,
innovations and practices of local and indigenous communities leads to
benefits, such benefits shall be equitably shared with the holders of such
knowledge, innovations and practices[23].
The approach of the CBD in addressing the issue of iniquitous appropriation of
knowledge therefore is through the ‘solution’ of ‘benefit sharing’, a term that
has been qualified by two other terms in different provisions, viz., "equitable benefit sharing"[24]
and "fair and equitable benefit sharing"[25].
However these terms have not been defined, and this poses a further challenge
for law and policy.
The skepticism and consequent criticism of 'benefit
sharing', arises primarily in the context of the perspective of assessing the
commercial value and benefits derived from the use of ‘local knowledge’, and an
attempt to quantify the same as a percentage of the profits derived from the
final product. The basis for this skepticism is that this new tool of 'benefit
sharing' has little or no value when viewed against the series of historically
committed wrongs against such peoples. In the context of the gradual processes
of alienation of indigenous and local peoples from their land and resources,
displacement and the consequent disintegration of many of these communities- a
phenomenon primarily caused and being caused by the forces of the state or with
the active support of the state, the basic question that arises is the value of
'sharing' of a minor percentage of royalties with such peoples.
When viewed against the background of historically
committed 'wrongs' against such people, the continued appropriation of their
knowledge, and its legitimisation by the instrument of 'benefit sharing',
raises skepticism about the consequences of such an exercise[26].
Can 'benefit sharing', in an iniquitous situation of alienation from basic
rights to land and resources, ever achieve 'fairness' and 'equity'? Perhaps if,
as later discussed, benefit-sharing arrangements could include restitution of
rights and tenurial security over resources, it could reach towards 'equity',
but this is as yet in the realm of the theoretical.
The debate of percentages raises some more serious
questions. In some of the agreements that have been concluded between a private
corporation and a community, post-CBD, royalties promised range from 0.1% to
sometimes 3-4%[27]. It is
estimated that even if a low 2% royalty were charged on genetic resources that
had been developed by local innovators in the South, the North would owe more
than $300 million in unpaid royalties for farmers crop seeds, and more than $5
billion in unpaid royalties for medicinal plants[28].
The capacity to negotiate and 'bargaining power' therefore become critical
issues in achieving 'fairness'. Take for instance the case of a proposed access
that was sought by Diversa Corporation to the resources of the Yellowstone
National Park in the USA, in which case the royalty payments were to be of the
tune of 10%[29].
Linked to the issue of negotiating power is the
issue of 'perception'. For instance if the knowledge of the originator were to
be perceived not as 'raw material' for research, but as the know-how of another
corporate entity, the terms of negotiation would be very different. Then arises
a further issue: in a scenario where the rules of the game are framed by the
'acquirer' and imposed on the originator and the latter expected to take an
informed stand and negotiate- can fairness and equity really be achieved[30]?
Whatever may be the politics behind the evolution of
the concept of ‘benefit sharing’, it arose in a scenario wherein the knowledge
of local and indigenous communities was treated as ‘common heritage’ to which
all had access, and therefore it was regarded as free. Can the instrument of
'benefit sharing', in this light, be now used to achieve an equitable situation
wherein rights to land, resources and self-determination be advocated as
elements of an 'equitable benefit sharing' structure? In other words, can the
CBD mandate and the law implementing it be used as a tool to further strengthen
the debate regarding the rights of local and indigenous communities in other
forums?
Prior Informed
Consent
A further debate is with regard to how "Prior
Informed Consent" (PIC) may be achieved.: The CBD mandates PIC for access only in respect of the
"country of origin"; but it has been argued that it should also
operate at the level of the local community when its knowledge, innovations and
practices are to be accessed by outsiders.[31]
Indeed, this is mandated by Article 8j's phrase on requiring the 'approval' and
'involvement' of communities for such use. The relevant law in Philippines
recognises this, and has interesting provisions such as: basic elements in
consensus building in the community shall include information dissemination to
all members of the concerned peoples, assessment of the concerns and issues by
appropriate assemblies in accordance with customs and traditions and
discernment and initial decision by recognised council if elders, and
affirmation of such decision by all members of the community[32].
The procedure for achieving these elements is also elaborated in the law[33].
IPRs
From the 'prospecting' for genetic resources springs
the desire to retain control over one's use of such resources. And the tool of
Intellectual Property Rights (IPRs) to achieve this has created its share of
concerns. IPRs, arising in the context of rewarding and thereby encouraging
innovation during the industrial revolution, have been gradually expanded in
many industrialized countries to grant private ownership and monopoly over use
of genetic and biochemical products, the justification being that it is a
reward for the ingenuity involved in finding, identifying and developing such
products[34]. And with
the harmonization of IPR laws under the Agreement on Trade Related aspects of
Intellectual Property Rights[35],
the amendments to IPR laws in India to accommodate these developments is not a
distant possibility[36].
The choices range between: (a) complete prohibition of IPRs on 'inventions'
based on biological resources and/or reliance on knowledge of originators in
relation to the same, and (b) an IPR system which will be subject to strict
standards of scrutiny with regard to assessment of what would constitute
as an "invention". The former
option seems a distant possibility in the regime proposed by the TRIPS
Agreement, and also because many interest groups in India would not be in
favour of such an exclusion. The latter is being advocated and considered by
the Indian Government in its position paper at the TRIPS review. To effectuate
it, there have been suggestions that the norms of disclosure pertaining to an
IPR application should reveal the country of origin and the community which
provided the knowledge about the resources pertaining to the patentable subject
matter as well as proof of consent of such country and community of
origin.
One response to the access
debate at the local level, is the preparation of Community or People's
Biodiversity Registers. This exercise seeks to document the knowledge of
occurrence, practices of propagation, sustainable harvests and conservation, as
well as economic uses of biodiversity resources that reside with India’s local
communities.[37] On the
positive side, these registers are expected to function as tools to establish
claims of individuals and communities over knowledge and uses of biodiversity
resources, and to bring to them an equitable share of benefits flowing from the
use of such knowledge and such resources.[38]
However, the fear about biodiversity registers is that the process may have the
effect of placing knowledge hitherto regarded as “secret” by communities, in
the public domain, and that once this is done, it would be an open invitation
for corporate and research interests to freely use the knowledge available in
the same.[39] Adequate
safeguards in law relating to use of information in the registers, and in the
intellectual property regime as discussed earlier, will have to be urgently
brought in.
The draft law
on Biodiversity
As mentioned earlier a draft law on Biological
Diversity has been drafted and will in all probability be placed for
consideration before the next Parliament. In essence the law puts in place a
mechanism for regulating access to genetic resources. It addresses several of
the issues raised above. Some of its key features are:
·
The
Act states as its objectives the conservation of biological diversity,
sustainable use of its components, and equitable sharing of benefits arising
out of the use of biological resources.
The term biological resources is
defined as ‘plants, animals and micro-organisms and parts thereof, and their
genetic material and by-products, with
actual or potential use or value, but does not include human genetic material.
·
The
Act proposes to set up bodies at three levels, to carry out its functions. At
the national level, there will be a National Biodiversity Authority (NBA),
which will screen proposals for transfer of genetic resources abroad, advise
the central government of measures for conservation, sustainable use, and
benefit-sharing, suggest the use of the National Biodiversity Fund, and oppose,
where necessary, IPRs in India and abroad which violate the Act's provisions. A
proposed provision seeks to ensure that where patents are sought to be granted
on any 'invention' based on research and information on a biological resource
occurring in India, the Controller of Patents shall refer it to the NBA for its
permission and any other conditions that it may stipulate.
At the state level, there
will be State Biodiversity Boards (SBB), which will oversee use and conservation
of biodiversity within state jurisdiction. SBBs will also manage the State
Biodiversity Funds. At local levels, there will be Biodiversity Management
Committees, which will have a voice in regulating the transfer, use, and
conservation of resources and knowledge at community and individual level.
There is also provision for creation local biodiversity funds at the level of
institutions of local self-government. Rules are to be framed in respect of all the funds under the proposed law.
·
As
regards access to genetic resources, the law prohibits any person who is not a
citizen of India, any body corporate, association or organisation which is not
registered in India, or which is registered in India but has non-Indian citizen
participation in equity or management, from obtaining any biological resource
occurring in India and/or associated knowledge for research, commercial
utilization, or bio-survey or bio-utilization without the prior approval of the
National Authority. Approval of the National Authority is also required in the
context of transfer of material from
any citizen of India to a non-citizen or non-resident or body corporate having
non-Indian participation.
With regard to access by Indian citizens/ body corporate registered in India with Indian participation alone, the standards for approval are much lesser, and such entities are only required to give prior intimation to the concerned state Biodiversity Board before utilization for commercial or research purposes. Approval from either the State or the National Authority is, however, not mandated. The State Biodiversity Board may restrict the activity of the same is found violative of the objectives of conservation, sustainable use and benefit sharing.
The difference in treatment between Indian and non-Indian entities raises questions about the basis of this distinction, since Indians are not necessarily going to behave more responsibly towards the resource, or be more respectful of indigenous knowledge, when given easier access.
· While there is provision that Biodiversity Management Committees at the local level would have to be consulted by the National Authority and the State/Union Territory Biodiversity Boards in decisions relating to the use of biological resources and associated knowledge within their jurisdiction, there is no clear provision as regards how access to and use of information and knowledge of an identifiable community would be effectuated. For instance, if access is sought from a community whose representation at the local body is in minority, there is the possibility that its voice might get over-ridden. Further, there is no requirement for obtaining the informed consent of the affected community/ individual whose knowledge and information is being accessed. The law further provides that 'where necessary', the National Authority shall give information regarding approvals through public notice; however, there is no provision for 'public hearing' and addressing grievances through such hearings. The only remedy available would be through petitioning a court of relevant jurisdiction, after a notice of 60 days has been given to the Central Government in this regard. The State Biodiversity Board is not required to give notice of any kind for applications considered by it.
· The law mandates the National Biodiversity authority to challenge IPRs within India and abroad, which are found to be violative of India's and its communities' rights.
The provisions of the biodiversity law provide the basic framework for achieving control over access to genetic resources in the interests of achieving conservation, sustainable use and assuring benefit sharing from use of the resources. However, there are still certain aspects that need to be addressed, and it is hoped that this would be done in the Rules to be framed under the law. The basic problem, evident as it is, is that rules do not have the sanctity of the provisions of the statute. Rule making is an administrative act which does not need to conform to the rigorous standards of debate and discussion as a law. By that same logic, rules are far easier creatures to amend.
Some of the tasks for the Rules would be to achieve the following:
- Terms and conditions for access
The terms and conditions under which approval for access would be given for 'research purposes', and for purposes of 'commercialisation'. Monitoring and reporting requirements mandating the person seeking access to keep the community/country of origin informed of the developments from the research on the material.
- Ensuring Conservation:
The manner in which such approval would be given by the relevant authorities, and the terms and conditions that would be prescribed by them, keeping in view specific aspects such as the nature of the resource being accessed- an assessment of the ecological implications of its access, and pointers towards how its conservation and sustainable use can be achieved.
- Achieving Prior Informed Consent
In cases where access to resource and information is sought from an identifiable community/ group of persons within a community/ individual within a community (commonly referred to as the 'originator'), the rules would have to be more elaborate in terms of addressing concerns such as: a) the "informed consent" of the community- how such consent may be achieved- for instance prescription of requirements such as communication of the bio-prospecting activity in detail in the local vernacular language of the originator, interactive sessions and public hearings through which the originator understands the nature and implications of the access sought; (b) what would be the terms for continued involvement of the originator in the bio-prospecting activity and for achieving conservation of the resource; (c) what would be the terms of benefit sharing, and how would the involvement of the originator in such negotiation be achieved.[40] Model Material and Information Transfer Agreements would also have to be drafted to incorporate the basic elements for achieving the above.
- Achieving benefit sharing:
What kind of benefits are appropriate when a commercial product is derived from traditional knowledge: a 50:50 share of profits between the company and the originator which held the knowledge, the transfer of relevant technologies to this community, participation in R&D, exemption from the application of IPRs, revival of tenurial rights to land and resources, non-monetary awards, or others? By what mechanism would beneficiaries be identified, and benefits be transferred? What if more than one community holds the same knowledge, should benefits be shared with all? What in the case of innovations made by single individuals, or families, within a community: should they get the benefits, or the whole community?
Applicability
of General Principles of Law
Constitutional
Law
As mentioned earlier, one of the interesting aspects
of the practice of the law is the testing of any statute, rule or
administrative action against the basic tenets of the Constitution. The effort
in this section shall be to highlight some of the constitutional principles
that can be brought to come into play in the context of: (a) the rules and
regulations for access, and administrative action of the authorities
constituted under the proposed Biological Diversity Act; and (b) the legal
principles applicable to any private party seeking access.
The chapter on Fundamental Rights[41]
and Directive Principles[42]
in the Constitution elucidate the basic tenets of individual liberty, the
reasonable restrictions on the same in view of public interest, and the
principles that shall constitute the basis for governance by the State. Some of
the fundamental rights of relevance to the topic under discussion are:
-
Equality
before the law which has been interpreted as the right against unreasonableness
and arbitrariness[43]
-
Right
to life and personal liberty which has been interpreted as the right to
livelihood, life with human dignity[44]
-
Right
to conserve distinct language, script or culture[45]
-
Right
to enforcement of fundamental rights through writ proceedings at the Supreme
Court[46]
or any High Court[47]
The Constitution further provides that it shall be
duty of the State to apply the Directive Principles in the making of laws. Some
of these principles of interest to the present debate are:
-
The
State shall strive to promote the welfare of the people by securing and
protecting as effectively as it may a social order, in which justice, social,
economic and political shall inform all institutions of political life[48].
-
The
State shall, in particular, direct its policy towards securing that the ownership
and control of the material resources of the community are so distributed as
best to sub-serve the common good[49].
-
The
State shall promote with special care the educational and economic interests of
the weaker sections of the people, and in particular of the Scheduled Castes
and Scheduled Tribes and shall protect them from social injustice and all forms
of exploitation[50].
-
The
State shall ensure that opportunities for securing justice are not denied to
any citizen by reason of economic or other disabilities[51].
Some of the principles laid down by the judiciary in
interpreting the above are as follows:
·
Our
Constitution makes it imperative for the State to secure to all its citizens
the rights guaranteed by the Constitution and where the citizens are not in a
position to assert their rights. The State must come into the picture and fight
for the rights of the citizens. The Preamble to the Constitution, read with the
Directive Principles, Articles 38, 39 and 39A enjoin the State to take up these
responsibilities[52].
·
Economic
empowerment is a basic human right and a fundamental right as part of right to
live, equality and of status and dignity to the poor, weaker sections, dalits
and tribes. Justice is an attribute of human conduct and the rule of law is an
indispensable foundation to establish socio-economic justice[53].
·
Duty
to act fairly is part of fair procedure envisaged under Articles 14 and 21.
Every activity of a public authority or those
under public duty or obligation must be informed by reason and guided by the
public interest[54].
·
Another
interesting aspect is the willingness of the Judiciary to impose strictures on
a private entity if the activities of such entity infringe upon the fundamental
rights of the people. It may therefore be a possible argument that the activity
of a person seeking access to genetic resources, by its very nature has
implications for the rights of people. The obligations on such a person, for
instance to follow all the elements of the PIC procedure, achieve mutual
benefit sharing, etc., should therefore be enforceable not just on the basis of
a contractual obligation or a statutory obligation, but as a 'public duty',
enforceable by a writ of mandamus. It has been held by the Supreme Court that a
writ of mandamus may lie against a private entity depending on the nature of
duty imposed on that entity. The duty must be judged in the light of the
positive obligation owed by the person or authority to the affected party, no
matter by what means the duty is imposed.[55]
·
In
the absence of suitable laws, international conventions and norms, so far as
they are consistent with the constitutional principles, can be relied upon by
the judiciary[56].
·
In
view of the directive principles for securing social welfare and common good,
absolute freedom of contract and of laissez faire are no longer valid
principles[57].
Contract Law
A study of some of the principles of contract law
reveals how these could be used to address some of the concerns regarding
unequal bargaining positions addressed in this paper. For instance, the
definition and interpretation of "free consent" under the Indian
Contract Act, 1872, could provide valuable pointers to the development of PIC
under the legal regime for biodiversity:
·
Section
14, Indian Contract Act, 1872 defines "free consent" as:
"Consent is said to be free when it is not caused by coercion, undue influence, fraud misrepresentation, mistake."[58]
·
A
contract is said to be induced by "undue influence" where the
relations subsisting between the parties are such that one of the parties is in
a position to dominate the will of the other and uses that position to obtain
an unfair advantage over the other.[59]
·
Where
a contract appears on the face of it or on evidence adduced to be
unconscionable, the burden of proving that such contract was not induced by
undue influence shall lie upon the person in a position to dominate the will of
the other[60].
·
Fraud
is defined as acts committed by a party to a contract with intent to deceive
another party to enter into such contract.[61]
·
The
term 'misrepresentation' is defined as including causing, however innocently, a
party to an agreement to make a mistake as to the substance of the thing which
is the subject of the agreement[62].
Conclusion
The above issues are a small part of the larger
range of questions that arise in the 'access debate'. The so-called 'promises'
of genetic engineering and growth of the biotechnology industry are one of the
bases of the access debate. And while the promises are many, the problems are
equally bothersome. Biotechnology, as with any other technology, is a major
source of public power in modern society, and raises important concerns
regarding rights of use, control and participation in its use.
The recent controversy surrounding the field testing
of genetically modified cotton, and debates on implications of technologies
popularly called the 'terminator' and 'traitor' technologies raise further
challenges for our laws relating to the nature of standards to be adopted for
making an 'informed' choice about the environmental and health implications of
such technologies and use of its products. The growing use of genetically
modified crops raises more issues- about the safety of transferring organisms
into new environments, questions of liability for damage, and the need for
greater transparency in obtaining information[63].
Labeling of genetically modified products to enable the consumer to have a
choice, is another issue for the law. The applicability of the precautionary principle[64]
to the assessment of such technology does not have endorsement of all countries
as yet.
Some questions posed by the Human Development
Report, 1999, could be effective guides to the choices that law and policy
would have to make in this whole debate[65]:
"Does the control, direction and use of technology:
-
Promote
innovation and haring of knowledge?
-
Restore
social balance or concentrate power in the hands of a few?
-
Favour
profits or precaution?
-
Bring
benefits for the many or profits for the few?
-
Respect
diverse systems of property ownership?
-
Empower
or disempower people?
-
Make
technology accessible to those who need it?"
ªª R.V.Anuradha is an alumnus of NLSIU, and a lawyer based in New Delhi, India. She is also a member of Kalpavriksh- Environmental Action Group, New Delhi, and an associate with the Foundation of International Environmental Law and Development (FIELD), London. She can be contacted at A 119 Swasthya Vihar, Vikas Marg, New Delhi 110092; Tel: 91-205-8272/3198; Email: [email protected].
ª Ashish Kothari is a founding member of Kalpavriksh -Environmental Action Group, and formerly Lecturer at the Indian Institute of Public Administration, New Delhi. He can be contacted at Aptmt. 5, Shree Datta Krupa, 908 Deccan Gymkhana, Pune 411004; Tel/Fax: 91-20-5654239; Email: [email protected].
[1] The Air (Prevention and Control of Pollution) Act, 1981 and the Environment (Protection) Act, 1986 were enacted under Article 253 of the Constitution of India, 1950 as legislations to give effect to a decision adhered to at an international conference, namely the United Nations Conference on Human Environment held in Stockholm in June 1972.
[2] Convention on Biological Diversity, adopted June 5,1992, A/CONF.151/26, 31 ILM 818 (1992). Hereinafter referred to as CBD.
[3] Article 1, CBD. The term biological diversity is defined in the CBD and the draft Indian law as: "the variability among living organisms from all sources and ecological complexes of which they are part, and this includes diversity within species, between species and of eco-systems."
[4] The term genetic material is defined in the CBD and similarly in the draft Indian law as: "any material of plant, microbial or other origin containing functional units of heredity.” Article 15 of the CBD titled Access to Genetic Resources comprises of the following mandate:
§ Pursuant to the sovereign rights of states over their natural resources the authority to determine access to genetic resources rests with the national governments and is subject to national legislation. Each Contracting Party shall endeavour to create terms for facilitating such access for environmentally sound uses, and it shall not impose restrictions that run counter to the objectives of the CBD.
§ Access issues are to be determined on “mutually agreed terms”.
§ The principle of “prior informed consent” of the Contracting Party providing such resources is recognised, “unless otherwise determined by that Party”.
§ The Party taking the resources is obliged to carry on scientific research with the “full participation of, and where possible in” the Contracting Parties that provide the resources.
§ Each Contracting Party shall take measures with the aim of sharing in a fair and equitable way the results of the research and development and the benefits arising from the commercial and other utilisation of genetic resources with the Contracting Party providing such resources. Such sharing would have to be on mutually agreed terms.
[5]
See for example, Vandana Shiva,
"The Greening of the Global Reach", in Wolfgang Sachs (ed.), Global
Ecology, Zed Books, London, 1993. It is estimated that developing countries are
the source of 90% of the world's store of biological resources: UNDP, Human Development Report 1999, Oxford
University Press, New Delhi, p.70. This storehouse has tremendous potential for
pharmaceutical, agro-chemical and seed industries- popularly referred to as the
"Life Industry".
[6] See for example, Ashish Kothari, Understanding Biodiversity, Orient Longman, New Delhi, 1997; Vandana Shiva, An Activist's Handbook on Biodiversity, Research Foundation for Science, Technology and Ecology, New Delhi, 1999.
[7] It has been observed that the attempt to create a global market in property rights imposes one conception of ownership and innovation on a culturally diverse reality, benefiting private industrial research but not public institutes or farming communities: UNDP, Human Development Report 1999, Oxford University Press, New Delhi, p.70.
[8] J.R.Adair, "The bioprospecting question: Should the United States charge biotechnology companies for the commercial use of public wild genetic resources?" 24 Ecology Law Quarterly 131.
[9] UNDP, Human Development Report 1999, Oxford University Press, New Delhi, p.70.
[10] The contribution of indigenous knowledge is, at the basic level, towards the identification of the material in developing the drug, and often providing information of its precise uses in treating particular illnesses, its means of preparation and its dosages: Michael J. Huft, “Indigenous People and Drug Discovery Research: A Question of Intellectual Property Rights”, North Western University Law Review, Vol. 89, 1995, 1678 at 1723. See also for example, N.R.Farnsworth, 'Screening Plants For New Medicines' in E.O.Wilson(ed.), Biodiversity, (Washington D.C.: National Academy Press, 1988) where it is has been pointed out that of 111 commercially useful plant-based drugs, 74 percent were in prior use by indigenous communities; D.M.Lewis, Millennium: Tribal Wisdom And The Modern World, (New York: Viking Publ., 1992), illustrates numerous instances where the folk remedy of tribal people has lead to the pharmacopoeia of modern medicine; UNDP, Conserving Indigenous Knowledge, An independent study by the Rural Advancement Foundation International (Nairobi: UNDP, 1994), where it is explained that indigenous knowledge has made important contributions to agriculture, pharmaceuticals, DNA research and other industrial production. Pat Mooney, 'The Law Of The Seed', Development Dialogue (1983) where the use of genetic resources from crop plants of indigenous farmers by seed companies is discussed.
[11] Richard J.McNeil & Micahel J.McNeil, "Ownership of traditional medicine: Moral and Legal Obligations to Compensate for Taking", North-East Indian Quarterly, Fall 1989, 30-35.
[12] See for example, Environmental Policy Studies Workshop 1999, School of International and Public Affairs- Columbia University, Access to Genetic Resources: An Evaluation of the Development and Implementation of Recent Regulation and Access Agreements, The Tides Center- Biodiversity Action Network, 1999; Walter Reid et al., Biodiversity Prospecting, World Resources Institute, 1993.
[13] Section 3, Transfer of Property Act, 1872.
[14] The Panchayat (Extension to Scheduled Areas) Act, 1996 is a law enacted by the Union Parliament which has to be specifically enacted by all states. A couple of states having scheduled areas are however yet to translate the provisions of the Central law into State law. The Central Act however mandates that States are to enact laws implementing it within a year of its enactment, i.e., by December 1997. It can therefore be argued that in the absence of a State law, the provisions of the Central law would be applicable to the scheduled areas in the State. The law is to have jurisdiction over areas designated as Scheduled Areas under the Constitution of India: Article 244 read with the Fifth and the Sixth Schedules to the Constitution of India, 1950. However, a further concern is with regard to areas in which tribals live, but which, because of not having been designated as 'scheduled areas', cannot avail of the provisions of the Panchayat (Extension to Scheduled Areas) Act, 1996.
[15] The Panchayat (Extension to Scheduled Areas) Act, 1996 further provides that the Panchayats have the power to approve plans, programmes and projects for social and economic development, and are responsible for identification of beneficiaries under different programmes. It is also empowered to prevent alienation of land in the scheduled areas.
[16] Section 26, Indian Forest Act, 1927.
[17] In the case of plants specified under the Act, the requirements to be satisfied for such permission, o be given with the prior approval of the State Government, is that the access to and collection of the plant is for purposes of education or scientific research: Chapter IIIA, Wildlife Protection Act, 1972. In case of access to wildlife in Sanctuaries, permits may be granted for the purposes of study of wildlife and scientific research: section 28. The standard for permission is higher in case of National Parks declared under the Act, permission to remove wildlife can be given only upon specific satisfaction of the State Government that such removal is for the purposes of better management of the wildlife: section 35.
[18] This would be a difficult argument since rights recognised under the Indian Forest Act, 1927 and the Wildlife Protection Act, 1972, are in the nature of 'rights to use' granted by the Forest Department. However, this argument would have interesting implications for scheduled areas in view of the provisions of the Panchayat (Extension to Scheduled Areas) Act, 1996, discussed earlier, according to which the Gram Sabha in scheduled areas has ownership over minor forest produce: see, supra n.14 and 15 and accompanying text. In 'scheduled areas' that have been designated 'reserved' or 'protected' under the Indian Forest Act, 1927, or as 'protected areas' under the Wildlife Protection Act, 1972, what would be the status, is another teaser for lawyers. Maharashtra, interestingly, has neatly side-stepped this by notifying that this ownership will not apply to tribals inside protected areas that are located in scheduled areas!
[19] The manner of achieving 'conservation' through 'Protected Areas' and consequent alienation of peoples from nature has been severely criticised. It has been argued that some human activity and desired levels of biodiversity can co-exist, and that even where inviolate areas are needed, appropriate zonation should be done in full consultation with local communities: see, D. Western & R.M.Wright (eds.), Natural Connections: Perspectives in Community-based Conservation, Island Press, Washington D.C., 1994; Ashish Kothari et.al. (eds.), People and Protected Areas, Sage Publications, New Delhi, 1996; Ashish Kothari et.al. (eds.), Communities and Conservation, Sage Publications, New Delhi, 1998.
[20] The draft law will be discussed in greater length below.
[21] Many of the issues raised in this section have been analysed in the context of the benefit sharing arrangement between the Kani tribals of Kerala and the Tropical Botanic Garden and Research Institute: See, J.John, "Story of Mahabali Retold", Labour File, May-June 1997, pp.39-47; R.V.Anuradha, "Mainstreaming Indigenous Knowledge", Economic and Political Weekly, June 27, 1998, pp.1615-1620; R.V. Anuradha. 1999. Sharing the Benefits of Biodiversity: A Case Study from Kerala, India. Theme paper for South Asian Regional Review of Community Involvement in Conservation, sponsored by the International Institute of Environment and Development under its Evaluating Eden Project. Kalpavriksh, New Delhi and IIED, London.
[22] See supra n.10 and 11 and the accompanying text.
[23] Article 8(j) of the CBD states that Contracting Parties shall:
- respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity;
- promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices; and
- encourage the equitable sharing of the benefits arising from the utilisation of such knowledge, innovations and practices.
[24] Article 8j uses the clause: "encourage the equitable sharing of the benefits arising from the utilisation of such knowledge, innovations and practices". The Preamble to the CBD in para 12 uses the phrase: "the desirability of sharing equitably benefits arising from the use of traditional knowledge, innovations and practices relevant to the conservation of biological diversity and the sustainable use of its components".
[25] Article 15 dealing with 'Access to Genetic Resources' states as follows: "Each Contracting Party shall take measures with the aim of sharing in a fair and equitable way the results of the research and development and the benefits arising from the commercial and other utilisation of genetic resources with the Contracting Party providing such resources."
[26] At both the national and international levels, the struggle of indigenous and tribal peoples has been primarily for rights to land and self-determination. See, ILO Convention 169, Convention concerning indigenous and tribal peoples in independent countries, ILO Convention 169, 28 I.L.M 1382 (1989),and the UN Draft Declaration, Draft declaration as agreed upon by the members working group at its eleventh session, E/CN.4/Sub.2/1993/29.
[27] UNDP, Human Development Report 1999, Oxford University Press, New Delhi, p.71
[28] Ibid.
[29] Ibid.
[30] The applicability of principles of the law of contract are briefly discussed below in the section titled "Applicability of General Principles of Law".
[31] See supra n.22 and accompanying text.
[32] Rules framed in Philippines under the Indigenous Peoples' Rights Act, 1997 (Republic Act No. 8371).
[33] Ibid.
[34] Countries vary widely in the nature of protection for 'living material'. The United States grants patents on novel DNA sequences, genes, plant parts, plants or animal varieties, and biotechnological processes.
[35] Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs), Marrakesh Agreement Establishing the World Trade Organisation, Annex 1C, 33 I.L.M.81 (1994). Hereinafter TRIPS Agreement.
[36] India has already been directed by the decision of the Appellate Authority of the World Trade Organisation to establish mechanism for a 'mailbox facility' for considering for grant of "Exclusive Marketing Rights" application for patents for invention of substances that can be used, or are capable of being used as a medicine or drug. Such inventions were hitherto not considered patentable under The Patents Act, 1970. Subsequent to the WTO ruling, The Patents Act, 1970 was amended by Act 17 of 1999, to introduce Chapter IV A titled "Exclusive Marketing Rights". The TRIPs review process will begin at the end of this year, and is expected to address issues, inter alia, exceptions and alternatives to the IPR regime, especially the scope and content of sui generis rights for plant varieties contemplated under Article 27(3) of the TRIPS Agreement.
[37] Madhav Gadgil et. al., “People’s Biodiversity Register”, Amruth, Vol.1, Issue 5, October 1996, 2. See also, “Implementing Article 8(j) of the CBD through Peoples’ Biodiversity Registers”, Bulletin of the Working Group on Traditional Resource Rights, Winter 1997, No.4, 14-16.
[38] Madhav Gadgil, et. al., “Peoples’ Biodiversity Register,” Amruth, Vol. 1, Issue 5, October 5, 1996, 2.
[39] See, “Implementing Article 8(j) of the CBD through Peoples’ Biodiversity Registers”, Bulletin of the Working Group on Traditional Resource Rights, Winter 1997, No.4, 14-16.
[40] The rules framed under in Philippines under the Indigenous Peoples' Rights Act, 1997 (Republic Act No. 8371) for the purposes of achieving free and informed consent of these peoples and minimum requirements in the Memorandum of Agreement arrived at between the acquirer of the resource and the originator, provide valuable examples.
[41] Part III, Constitution of India, 1950.
[42] Part IV, Constitution of India, 1950.
[43] Article 14, Constitution of India, 1950.
[44] Article 21, Constitution of India, 1950.
[45] Article 29, Constitution of India, 1950.
[46] Article 32, Constitution of India, 1950.
[47] Article 226, Constitution of India, 1950.
[48] Article 38, Constitution of India, 1950.
[49] Article 39(b), Constitution of India, 1950.
[50] Article 46, Constitution of India, 1950.
[51] Article 39A, Constitution of India, 1950.
[52] Charan Lal Sahu v. Union of India (1990) 1 SCC 613.
[53] Muralidhar Dayandeo Kesekar v. Vishwanath Pandu Barde 1995 Supp (2) SCC 549.
[54] LIC of India v. Consumer Education and Research Centre (1995) 5 SCC 482.
[55] Andi Mukta Sadguru Shree Muktajee Vandas Swami Suvarna Jayanti Mahotsav Smarak Trust v. V.R.Rudani (1989) 2 SCC 691. Also see, K.Krishnamacharyalu v. Sri Venkatashewara Hindu College of Engineering (1997) 3 SCC 571.
[56] Visakha v. State of Rajasthan (1997) 6 SCC 241.
[57] Y.A.Mamarde v. Authority under the Minimum Wages Act (1972) 2 SCC 108.
[58] Section 14, Indian Contract Act, 1872.
[59] Section 16(1), Indian Contract Act, 1872. Taking unfair advantage of one's economic power has been held to be unconscionable under English law: Lloyds Bank Ltd. v. Bundy (1974) 3 All E.R. 757; Schroeder Music Publishing Co. v. Macaulay (1974) 3 All E.R. 616.
[60] Section 16(3), Indian Contract Act, 1872.
[61] Section 17 Indian Contract Act, 1872. 'Fraud' includes acts of: suggestion as a fact of that which is not true by one who does not believe it to be true; the active concealment of a fact; a promise made without intent to perform it; any act fitted to deceive.
[62] Section 18, Indian Contract Act, 1872.
[63] See, UN DP, Human Development Report 1999, Oxford University Press, New Delhi, pp-72-74. A biosafety protocol is being negotiated under the CBD, and a study of its meetings reflects starkly on how political positions affect decisions about the environment and the power of the biotechnology industry in influencing those positions. See issues of The Earth Negotiation Bulletin dealing with biosafety at http://www.iisd.ca/sd/.
[64]
The essence of the precautionary approach is embodied in Principle 15 of the
Rio Declaration as well as in the Preamble to the Convention on Biological
Diversity, both concluded at the Earth Summit in 1992 which, in essence
provides that where there are threats of serious or irreversible damage, or
threat of significant reduction or loss of biodiversity, lack of full
scientific certainty shall not be used as a reason for postponing cost
effective measures to prevent environment degradation and avoid or minimise
such threats. See, Kothari, A. and Anuradha,
R.V. 1997. Biodiversity, Intellectual
Property Rights, and the GATT Agreement: How to Address the Conflicts? Economic and Political Weekly, XXXII(43):
2814-2820, October 1997. Also in Biopolicy, Vol2, Paper 4, PY97004, 1997,
Online Journal, URL: http//www.bdt.org.br/bioline/py.
[65] UNDP, Human Development Report 1999, Oxford University Press, New Delhi, p.76.