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Bioethics and IPR

This document summarizes an academic paper that examines the role of intellectual property rights (IPR) in protecting traditional knowledge. It discusses three cases: 1) A bioprospecting agreement between US, Peruvian, and indigenous parties involving genetic resources and traditional knowledge from Peru. 2) The use of traditional knowledge databases and registers. 3) Disclosure requirements for traditional knowledge in patent applications. The document analyzes these examples and debates around using IPR to protect traditional knowledge, particularly concerns around biopiracy.
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0% found this document useful (0 votes)
484 views

Bioethics and IPR

This document summarizes an academic paper that examines the role of intellectual property rights (IPR) in protecting traditional knowledge. It discusses three cases: 1) A bioprospecting agreement between US, Peruvian, and indigenous parties involving genetic resources and traditional knowledge from Peru. 2) The use of traditional knowledge databases and registers. 3) Disclosure requirements for traditional knowledge in patent applications. The document analyzes these examples and debates around using IPR to protect traditional knowledge, particularly concerns around biopiracy.
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Towards an International Regime for Protection of

Traditional Knowledge: Reflections on the role of Intellectual


Property Rights

Brendan Tobin

Research Fellow
Coordinator of the Biodiplomacy Initiative
United Nations University,
Institute of Advanced Studies.

[email protected]

Draft Paper Presented at the


Towards an International Regime for Protection of
Traditional Knowledge: Reflections on the role of Intellectual
Property Rights

Brendan Tobin

Current intellectual property rights regimes are widely considered unsuitable as a


means for protection of traditional knowledge. This paper examines attempts to
make intellectual property rights regimes more supportive to the protection of
traditional knowledge. The paper examines experiences with contracts, sui generis
regimes, registers and databases, proposals for modification of patent applications
procedures, as well as misappropriation and compulsory liability options. The paper
proposes a framework for development of international law and policy for
protection and strengthening of traditional knowledge systems.

Introduction

Traditional knowledge long considered little more than unscientific and irrelevant hocus
pocus of witchdoctors and slavish repetition of outdated farming methods by
unsophisticated peasants is increasingly being recognized as a complex and dynamic
system of knowledge developed over centuries through research, investigation,
application, modification, and innovation by indigenous and local communities. Far from
being an outdated form of science, traditional knowledge is depended upon by a large
percentage of the global population as the primary means of providing for their health,
food, clothing, and housing needs. In terms of public health alone, over 80% of the
population in developing countries is estimated to rely upon traditional medicine for their
daily needs. Traditional knowledge far from being expendable is a crucial part of our
present and future scientific knowledge base, and therefore requires both conservation
and nurturing.

Despite its importance there is growing concern that much traditional knowledge is
rapidly being lost due to a host of internal and external pressures which reduce the
capacity of local and indigenous communities to conserve their knowledge for future
generations. Awareness of the plight of traditional knowledge has come, ironically, as an
indirect result of increased interest during recent years by the scientific and commercial
sectors in bioprospecting and the potential of traditional knowledge to provide leads for
new product development. Concurrently, concerns of indigenous, local community and
non-governmental organizations at the patenting of products based upon traditional
knowledge, has led to global action against what is frequently referred to as “biopiracy”.
Biopiracy is seen as the misappropriation of traditional knowledge through the use of
intellectual property rights (IPR). IPR has therefore been seen widely as the tool of
biopiracy and there has been significant resistance to efforts to define develop
mechanisms for protection of traditional knowledge based upon monopolistic property
rights models.
This paper will consider the role of IPR in protection of rights over traditional knowledge,
and to benefit sharing, through consideration of three specific cases. First, the negotiation
of a bioprospecting agreement for use of TK, involving a range of US and Peruvian
parties including universities, indigenous federations and a major pharmaceutical
company and development of national sui generis law for protection of collective rights
over TK in Peru; Second, the role of TK databases and registers as a means for protecting
traditional knowledge; and, thirdly proposals for disclosure of origin of TK and prior
informed consent for its use in patent applications procedures.

Two significant questions guide this analysis, these relate to rights over traditional
knowledge in the public domain, and the extent to which IPR regimes may be utilized to
support recognition and protection of rights over TK without distorting the essential
nature of indigenous and local community knowledge systems.

International debate on protection of traditional knowledge


International concern to recognize and protect rights relating to traditional knowledge has
advanced rapidly in the past decade. Within the framework of the Convention on
Biological Diversity (CBD) a Working Group has been set up to investigate means to
protect and strengthen traditional knowledge systems including development of sui
generis rights regimes. At the same time, the World Intellectual Property Organization
Intergovernmental Committee on Intellectual Property and Genetic Resources,
Traditional Knowledge and Folklore (WIPO-IGC) is researching potential options for the
protection of traditional knowledge, promoting research into a number of potential
mechanisms for protection of rights such as contracts, registers and databases. Meanwhile
the 2001 Doha Declaration stipulates that in its review of Article 27.3(b) of the Word
Trade Organization’s (WTO) Trade Related Aspects of Intellectual Property Rights
Agreement (TRIPS) “which deals with patentability or non-patentability of plant and
animal inventions, and the protection of plant varieties”, the TRIPS council “should also
look at: the relationship between the TRIPS Agreement and the UN Convention on
Biological Diversity; [and] the protection of traditional knowledge and folklore”i.

While the international debate has tended to focus primarily on the question of biopiracy,
there are many more immediate threats to traditional knowledge which require immediate
attention if traditional knowledge is to be conserved and strengthened. These include loss
of land and language, insensitive educational and health policies, agriculture and fisheries
extension programs, and the impact of organized religion, amongst others. Development
of any effective global program for protection of TK should, therefore, include not only a
means for the recognition of ownership rights but also a system for strengthening the
continued use and development of TK as part of the global body of science, and a
mainstay of the populations in developing countries, where local sustainability and
development opportunities are closely linked to the integrity of TK systems.

Biopiracy, seen as the misappropriation of rights over TK and associated genetic


resources has to date received the greatest attention from the international community,
NGO’s, the media, and frequently indigenous peoples themselves. The international
debate on protection of traditional knowledge (TK), in turn, has been largely dominated
by discussions on the potential, limitations and for some the dangers of intellectual
property rights regimes as a means for securing community rights over their knowledge.
On the one hand, proponents of IPR have argued that IPR regimes can accommodate
protection of TK. On the other hand, many legal experts and indigenous representatives
have argued that IPR is not an appropriate mechanism for the protection of rights over
traditional knowledge (TK). These issues have been discussed in detail elsewhere and the
relative merits of these positions is beyond the scope of this paper, however, what is clear
is that the appropriateness of any measures will need to be decided with the full and
informed participation of indigenous and local communities.

Contracts: the case of the PeruICBG


Indigenous and local communities’ knowledge has long been sought by a range of
collectors, including missionaries, anthropologists, ethnobiologists, etc. Only rarely have
such communities been fully informed of the intended future uses of such knowledge and
even less frequently invited to enter into negotiation of agreements for its use. With the
entry into force of the Convention on Biological Diversity, this trend started to change
and a number of high profile agreements have since been negotiated with the informed
participation of indigenous peoples. Furthermore, some communities and peoples have
established their own research protocol’s to regulate access to and use of their knowledge,
these are still, however, the exception to the rule.

One early example of indigenous participation in bioprospecting negotiations came


within the framework of the International Collaborative Biodiversity Group Program
(ICBG), coordinated by the US National Institute of Health1. This program has funded
collaborative bioprospecting arrangements in many parts of the world. These projects
involve a range of academic, commercial and community partners, and promote the
collection of genetic resources with traditional use for development of new medicinal
products.2 In the early years of the program a number of projects were established
involving TK, including projects in Peru, Nigeria, and Suriname. In the latter two cases
intermediaries negotiated agreements in a manner which created benefit sharing
opportunities, but only the Peru ICBG actively involved indigenous peoples’
organizations in the negotiation process.

The Peru ICBG agreements were negotiated in 1994-1996 in a largely unregulated


environment. The agreements involved a number of US and Peruvian research
Institutions (Washington University, the Peruvian Univeristy of Cayetano Heredia and
the Natural History Museum of San Marcos University) as well as a US pharmaceutical
company (Searle & Co., then a subsidiary of the Monsanto Corporation) and 3
federations representing Aguaruna communities of the northern Peruvian Amazon ( The
Organization of Communities of the Alto Maranon (OCCAAM), the Aguaruna
Federation of Dominguesa (FAD), the Federatio of Native Communities of the Nieva
River (FECONARIN) and their national representative Organization CONAP
(Confederation of Nationalities of the Peruvian Amazon). The indigenous organizations

1
Tobin, Render and Bannister (forthcoming)
2
Rosenthal …
were supported with independent legal advice by the Peruvian Environmental Law
Society (SPDA).

The Peru ICBG agreements are a complex set of related contracts, including an
overarching bioprospecting agreement involving the research parties and the Aguaruna
federations, a licence option between the research parties and Searl & Co. and a know-
how licence between the Aguaruna federations and Searle & Co. The nature and content f
the agreements reflects a concern not only for the protection of the rights of the
indigenous organizations party to the agreement, and securing of the equitable benefit
sharing, but also but also for establishing precedents which could support the wider
indigenous movement efforts to redefine the nature of property rights over knowledge.

The agreements adopted a number of interesting strategies for securing rights over TK
while recognizing the potential and limitations of IPR in a number of distinct areas,
including:

 Treating traditional knowledge as a form of information technology and utilizing


a know-how licensing arrangement to regulate access to and use of both TK and
associated genetic resources.
 Definition of know-how to include all relevant traditional knowledge of the
Aguaruna peoples whether or not it was available in the public domain
 Preventing the exercise of patent rights to restrict the use, sharing or sale of
traditional medicinal products
 Preventing the use of traditional knowledge in the development and patenting of
life forms
 Securing grant-back of royalty free licences for use of patents in research and
development by the Aguaruna people.
 Providing for joint ownership of patents. Research under the agreement led to an
application for a patent in the names of the various research parties and the
representatives of the indigenous parties to the agreement.
Universidad Peruana
Cayetano Heredia

License Option
Biological Agreement
Collecting
Agreement Washington G. D. Searle and Co.
University
Agreeme
nt Biological Know-How
Museo- Collecting License
Universidad Agreement
San Marcos Indigenous
Agreeme Federations
nt
Figure 3. Agreement Structure of the ICBG-Peru. (Source Tobin 2004,
based on Rosenthal 1996, Figure 4).

Utilisation of a licensing mechanism placed the Aguaruna Federations in a direct


contractual relationship with Searle & Co, increased the percentage royalties payable in
the event of product development, provided for milestone payments during research and
development, and, made use of any plants, plant extracts or copies of extracts dependent
upon the continuation in force of a know how licence for use of relevant TK. Upon
termination of the licence all parties were to terminate use of all genetic resources and
TK except as otherwise agreed with the Aguaruna Federations.

Searle initially took the stance that they could not accept the proposal for a know-how
licensing regime. Their principal legal adviser, a patent lawyer, expressed concern that
this would signify a major shift in doing business, requiring approval of the CEO of
Monsanto which could take up to six months to obtain. This position was however
reversed within 24 hours following the decision by the Aguaruna’s negotiating team to
break off negotiations unless the licensing regime was adopted.

The use of a know-how license as a means to protect indigenous rights had been
supported by lawyers from Patton Boggs, a blue chip law firm from Washington which
provided pro bono support in reviewing the license negotiations. Likewise, Charles
McManis professor of IP at WU, who, was an observer of the negotiations, sent a letter to
the negotiating parties expressing his view that the know-how licensing arrangement was
an appropriate means to secure more equitable benefit sharing between pharmaceutical
companies and providers of resources.

Despite the valuable precedents established by the negotiations the Peru ICBG agreement
was not welcomed by all Aguaruna federations and there was a concerted campaign
supported by a number of international NGO’s to undermine the agreements. This
reflected a clear political divide between various organizations representing the Aguaruna
people as well as differences within the NGO community, between those who viewed all
bioprospecting as biopiracy and those who believed it would be possible to negotiate
equitable agreements where there was a will to do so.

One of the most controversial aspects of the Peru ICBG was how to ensure the equitable
sharing of benefits between Aguaruna, Huambisa and other Jivaro peoples, including
communities which were not party to the agreements. The agreements required a
mechanism to be established within three years for this purpose. In the long run this was
not done due to lack of funds as well as of political will. A further potential criticism was
relates to the continued use of resources, by research institutions, after the licence with
Searle had terminated. In both cases it appears that the letter of the agreements were
ignored where considered expedient by the principal actors both in the academic
community and amongst the indigenous organizations involved. This demonstrates the
limited utility of contracts and in this case at least the greater importance of personal
relationships.

As part of the work of the IGC, WIPO has prepared a database of Contracts with an
emphasis on intellectual property rights aspects of such agreements. The database
includes a limited number of both model and actual agreements, and is open for
contributions. However as may be seen from the foregoing discussion of the Peru ICBG,
the utility of contracts to ensure equitable benefit sharing, in an unregulated environment,
must be questioned.

Sui Generis Regimes


The general resistance to the use of IPR regimes to protect TK has resulted in the
development of a number of proposals for protection of rights over TK under sui generis
regimes. These have included proposals for a Community rights regimes, a system of
Traditional resource rights, a concerted international effort to negotiate a system of
farmers’ rights, and the development of national and regional sui generis systems.

A common underlying principle behind such proposals has been the search for
recognition of some form of community right, which can be utilized to secure the
communal interest over TK, while stopping short of providing a monopolistic right over
knowledge. The proposals vary in their intent from efforts to create an actionable
property right in favour of indigenous people, to obligation to provide some form of
monetary compensation to farmers for their efforts in conserving and developing crop
diversity. An important feature of such proposals is the desire to ensure continued free
and open access for community use while controlling commercial and industrial use,
and/or ensuring fair and equitable benefit sharing.

These proposals are generally presented as being distinct from IPR regimes and in
essence they are. However, in some cases the distinctions are less obvious, and regimes
which provide the right to control third party use, in this case use by the scientific or
commercial sectors, tend to display many oft characteristics of IPR, albeit of a sui generis
nature. It is understandable that those who have decried existing IPR regimes as failing to
protect TK and as providing a tool for biopiracy should seek to present their proposals for
alternative means for protection as non-IPR regimes. These efforts to present IPR style
mechanisms as distinct form of sui generis system though appearing disingenuous, do in
fact have a legitimate purpose, which is to break out of the confines of the existing stable
of IPR mechanisms and begin the development of new mechanisms based upon a
different set of underlying principles. Principles derived from the customary laws and
practices of indigenous and local communities, infused with the spirit of reciprocity,
sharing and communal interest, which is lacking from the dominant IPR stem.

A readiness to redefine the debate by both sides could have an important impact on future
negotiations. In the first place it would amount to recognition of the fact that existing IPR
regimes are not written in stone, are not all embracing, and may be complemented by
new forms of property rights of a non-monopolistic nature. On the other hand it would
help to clarify the fact that community rights regimes which allow custodians of
knowledge to place restrictions on the use of their knowledge, albeit with the inclusion of
certain exemptions in order to allow for continued free access for community use, are in
fact a form of IPR. This process would help indigenous peoples to more clearly recognize
the nature of the debate and of the proposals being made on their behalf and would
provide negotiators with a clearer picture of the claims and potential opportunities for
developing sui generis regimes.

A number of proposals also exist for the development of mechanisms for compensating
farmers and local and indigenous communities for their effort in conserving, developing
and sharing their traditional knowledge, cultivars etc. This has included most importantly
the notion of farmers rights conceived as a mechanism for securing fair and equitable
benefit sharing with farmers for their role in in-situ conservation and development of new
crop varieties. Under negotiation for more than 10 years the concept is now formally
recognized in the FAO International Treaty on Plant Genetic Resources for food and
Agriculture. However, it is still a concept without teeth and much work remains before
any serious benefit sharing is likely to take place.

Peruvian law on collective rights over traditional knowledge

In 2002 Peru adopted the first comprehensive legal regime for protection of traditional
knowledge relating to biological diversity. The law …… is declaratory in nature
recognizing that rights over traditional knowledge spring not from any act of government
but from the existence of the knowledge. The law declares that traditional knowledge is
cultural patrimony, thereby recognizing intergenerational and intragenerational rights and
responsibilities relating to it. Access to and use of knowledge not in the public domain
requires prior informed consent and a licence for commercial use. Benefits are to be
shared not only with the participating indigenous communities but also with the wider
indigenous community through a Indigenous Development fund, managed by indigenous
peoples. The law recognizes a right for indigenous peoples to share in the benefits
derived from use of their traditional knowledge in the public domain. The national patent
office is charged with aiding indigenous peoples in protecting their knowledge by
establishing an open register and a confidential register of knowledge as well as
providing advice to local communities in establishing community registers. Furthermore
the patent office is empowered to prevent the publication of material relating to
traditional knowledge in breach of community rights over such knowledge. In essence the
law recognizes traditional knowledge as form of trade secret and attempts to protect it
accordingly.

Despite its many interesting provisions the law has not received support of a wide section
of indigenous peoples in Peru due in part to a lack of knowledge of the law but also to the
limited opportunity for informed participation of indigenous peoples in the preparation of
the law. The Peruvian law being the first of its kind provides an insight into some of the
conflicts which may arise in the development of such a regime. These include conflicts of
perception, of legal vision, and of interest and rights.

Under the CBD indigenous and local community knowledge systems have been
described in a manner which many community commentators have claimed leads to a
fragmentation or dismemberment of their knowledge which encompasses all aspects of
their culture including society, spirituality. law and science. Article 8 (j) of the CBD
refers to the traditional knowledge, innovations and practices of indigenous and local
communities. A natural tendency of those who associate rights over the product of human
effort with IPR would then be to link these to the IP concepts of know-how, inventions
and processes respectively. Doing so however further facilitates the process of
dismemberment, a fact which I noticeable in the Peruvian law which only addresses
traditional knowledge relating to the characteristics, properties and uses of biological
resources, thereby effectively excluding from protection many indigenous innovations
and practices.

Pedro Garcia a lawyer who has lived and worked with the Aguaruna people for nearly 30
years has attempted to provide amore holistic interpretation of the terms set out in Article
8 (j). In doing so he describes knowledge as the composite of all learning, practices as
the application of that learning to meet daily needs, and innovations as the application of
learning to meet new challenges (see box 1). Described in this manner, the
interrelationship of the various elements of indigenous knowledge systems becomes more
apparent as do the dangers of fragmentation of knowledge systems. This highlights the
importance of ensuring full and informed participation of indigenous and local
communities in the development of mechanisms for protection of traditional knowledge
rights.
Box 1
Conflicts of Perception in definition of traditional knowledge

CBD Knowledge Practices Innovations

IPR Know-how `Processes Inventions

Holistic Learning by Application Application


investigation of learning to of learning to
research and meet daily needs meet new
development challenges

Recognition of the collective nature of traditional knowledge is not always easily


reconciled with administrative expediency and bureaucratic pragmatism. Peruvian
legislators were faced with the dilemma of how to ensure protection of cultural patrimony
without ending up in a situation where a single community might effectively veto any
biopropsecting activity. In the final analysis the law appears to defend the interests of
individual communities to enter into bioprospecting arrangements even in the face of a
dissenting majority. This creates a potential for conflict between the rights of individual
communities and the rights of indigenous people as a whole over their cultural patrimony.
The law recognizes that in the case of conflicts between indigenous communities they are
entitled to resort to their own customary law and a practice as a means for resolving
disputes.

Conflicts between ancestral rights and the principle of the public domain

South Pacific: what is important is how the TK came to be in the public domain,
• Intention to share and purpose for sharing
• Was permission given to publish or disseminate
• Knowledge of potential commercial use
• were indigenous peoples aware they would lose rights
• impact on cultural and spiritual integrity.

In developing the national law on traditional knowledge there was at times discussion of
a need to balance the interests of indigenous peoples and the commercial users of
knowledge. The potential conflicts of interest inherent in such a discussion require clear
recognition of the distinction between these interests. Indigenous peoples rights under the
law stem from their ancestral rights over their knowledge and not from ay act of
government as such therefore they are fundamental rights and must be fully and
effectively protected. They cannot in may way be diminished or bartered in favour of
interests of commercial users which are merely that “interests”. Interests which do not
need to be met or taken into consideration except to the extent that indigenous peoples
may wish to take them into consideration and that they do not negatively affect the
protection of rights over traditional knowledge. Where there is a desire to promote a
balance between levels of protection of rights and recognition of interests of commercial
users with a view to promoting a trade in traditional knowledge this will need to be
achieved with full and active participation of indigenous peoples.

Traditional Knowledge Databases and Registers

The potential role of TK registers and databases as a means to secure community rights
over traditional knowledge is receiving ever increasing attention both in international fora
and in national debates. Registers and databases to compile and protect traditional
knowledge have been established by indigenous peoples, local communities, non-
governmental organizations, research institutes, and government bodies.

Since the early 1990’s India has played a leading role in the development of community
registers with experiences such as the Honey Bee Network, the Farmer’s rights
Information System, Peoples Biodiversity, and the Traditional Knowledge Digital
Library. These were established without any legislative basis, however, efforts are being
made to extend protection to certain databases under the Indian Biodioversity Bill. The
majority of experiences in India may be considered to fall into a general category which
may be referred to as cooperative community registers. The majority of, these
experiences involve what are in essence unofficial registers maintained by
nongovernmental organizations or research institutions in which a record is kept of the
relevant information and of the person or community which claims a right over it. The
status of these unofficial registers and of the information they contain is very unclear.

Indigenous peoples have also begun to establish their own databases for preservation of
knowledge and as part of the process to secure recognition of and protection of land
rights. One of the most ambitious experiences of this nature involves Inuit, who have
established a number of associated databases dealing with different aspects of traditional
knowledge, land and environmental issues. Innovative work has also been carried out by
the Tulalip Tribes in North America. Important efforts have also been made to support
the protection of traditional knowledge by the compilation of oral and visual records by
Institutes such as the Vanuatu Cultural Center and the Australian Institute for Aboriginal
and Torres Straits Islanders Studies (AIATSIS).

The majority of databases and registers have primarily served as a basis for compilation
of information and have not been linked to any national regimes for granting or
recognition of rights over knowledge. These registers have little if any force in law to
protect rights over the information which is held and registration may result in placing the
information in the public domain and may be deemed to amount to a renunciation of
rights over the relevant knowledge.

The IGC has taken an interest in the potential of registers and databases as a source of
prior art for patent search procedures thereby, providing a means for defensive protection
of TK. Inspired by the Indian experience with development of the TKDL an open access
database on Ayudervic knowledge, work advanced within the IGC and in the
International Patent Classification Union to … which has led to the inclusion of new
registrations for medicinal plants. This process is not without difficulties. The
establishment of standard criteria for registration of traditional knowledge, based upon
principles of registration designed for IPR regimes may effectively result in TK being
categorized and rights recognized based upon registration rather than upon the existence
of the knowledge. This could be seen as bringing TK within the IPR fold through the
back door.

The potential of TK registers and databases to provide for defensive protection was
researched in a report by UNU-IAS which considered a range of databases established by
Research Institutes, NGO’s, and State bodies, and their recognition under law. The report
noted that a number of the databases and registers considered in the study would not
serve as sources of evidence of prior art due to their confidential nature. It further
concluded that “…databases and registers alone do not provide a means for the effective
protection of TK. Rather they must be seen as one element or mechanism in a wider
system of TK governance including customary law and practice, national access and
benefit-sharing legislation, and sui generis law and policy.” The report highlighted the
catch-22 position faced by indigenous people, whereby, placing their knowledge in the
public domain as a means to securing protection against biopiracy effectively amounts to
renunciation of rights over such knowledge.

There have been many claims made regarding the utility and promise of such
mechanisms as a means for protection of traditional knowledge, and they are no doubt
very useful as a means to record traditional knowledge for the benefit of present and
future generations. However, as a tool for protecting rights over knowledge, as opposed
to a means for prevent its misappropriation the case in favour of databases and registers
appears to be overstated.

Part of the problem with the debate on registers and databases may arise from a blurring
of the distinction between these two instruments. In many cases the terms are used
indiscriminately failing to distinguish between a compilation of data in a database and the
documentation of rights over property which is the usual role of a register. For this reason
many people appear to believe that establishing a database or register of traditional
knowledge is related to the recognition and protection of rights over the information they
contain. In the absence of specific legislation to recognize rights over knowledge in
databases or registers the information they include may be considered to have been
placed in the public domain, resulting in the loss of rights rather than their protection. To
date there is legislation in only a handful of countries recognising rights over traditional
knowledge in registers and databases, and even fewer functional official registers for
documentation of traditional knowledge.

Community registers can indeed help to define rights over community knowledge within
a community, however, there legal effect as a means for protection of traditional
knowledge is limited absent recognition of their stats under national and/or international
law. It is to e hoped that the progressive development of national law, such as the
Peruvian law on protection of collective rights over traditional knowledge, which
recognizes a possibility for development of community registers will develop into more
specific recognition of such registers and of their role as a source of prior art.

To date, the majority of traditional knowledge held in databases is not under the control,
direct or indirect, of indigenous and local communities, but is managed by research
institutions, national archives, NGO’s, commercial organizations and international bodies.
Much of this information was collected without any specific agreements with indigenous
peoples regarding its use, and is now considered to have become part of the public
domain. This poses serious problems for those wishing to protect and control the access
to and use of traditional knowledge for spiritual, cultural, economic and other purposes.
Biodiversity conservation in the era of knowledge economy is largely about information.

The advent of electronic communication has dramatically increased the speed and
geographical distribution of information exchange. Biodiversity information has entered
the public domain at a rate unconceivable just a decade ago: a recent issue paper from
IUCN3 lists at least 18 websites devoted to this topic. Many of them allow visitors to
search online databases of biodiversity-related resources. These sites include UNEP-
WCMC’s Biodiversity Information Service and the Biodiversity Conservation
Information System (BCIS), backed up by a coalition of 12 NGOs

This information explosion, however, has not come without risks, particularly when it
comes to the issue of protection of rights over traditional knowledge. Today, highly
localised practices, developed through the centuries and often jealously guarded by
indigenous communities, are only a mouse-click away for academic researchers, private
companies and conservation practitioners throughout the world. Often, there is little or no
benefit for the communities involved from making their knowledge available in the
public domain.

This has sparked an intense debate on the need to balance the property rights of
indigenous communities, on the one hand, and the free flow of scientific information in
the public domain, on the other. The clash is somehow exacerbated by the fact that the
internet as a medium has historically evolved within the academic community, and by
large internet users have adopted the ethos of free exchange of information which is
typical of that environment

The importance of clearly defining the public domain in order to ensure continued access
for scientific, development and subsistence needs is clear. However, the principle of the
public domain cannot be utilized to legitimize the historic expropriation of TK. Calls for
the redefinition of the public domain or review of its application to TK has led to a
growing challenge to existing perceptions of the public domain under western legal
systems. Legislation, such as the recent sui generis law for protection of collective rights
over TK in Peru, discussed in more detail below, and a draft model law for protection of
TK in the South Pacific, demonstrate a growing preparedness of authorities in developing
countries to find means to redefine the rights of indigenous peoples over TK in the public
domain.
3
Sue Stolton and Nigel Dudley, Sharing Information with Confidence, An issues paper, May 2004
Database trusts

Efforts to develop functional national laws to implement systems for protection of


traditional knowledge

Disclosure of Origin

In the years immediately following the entry into force of the CBD proposals began to
emerge for modification of patent application procedures as a means to support the
Conventions provisions on ABS. Proposals suggested requiring applicants to retrace the
origin of genetic material used, indicate the extent to which it was used and state the
conditions under which it was aquired (Hendrickx et al 2004), establishing a primarily
voluntary system which would not affect the grant of patents per se. On the other hand, it
was proposed that applications should only be accepted subject to provision of evidence
of origin and of prior informed consent for use of genetic resources and traditional
knowledge (Tobin 2004). As part of this latter proposal, it was suggested that the
establishment of a standardized international ‘certificate of origin’, as evidence of PIC,
would facilitate more effective implementation of disclosure requirements.
Both disclosure of origin and certificates of origin are now being widely researched as
part of the process towards negotiation of an international regime on ABS, as well as with
regard to the work of the IGC.

evidence of PIC as a condition for grant of IPR, product


Shift burden of proof regarding the right to use TK
Market tools to control market use
Penalize illegal use – loss of patents or failure to obtain product approval
Incentive to seek PIC sooner rather than later
International Certificate as evidence of PIC not of equity – facilitating and
tracking TK flow

The term ‘certificate of origin’ was originally coined in 1994 to describe a proposal for
protection of rights over traditional knowledge, developed in response to concerns
regarding the original negotiations relating to the Peruvian ICBG program (Tobin 1994).
The original concept was to develop a market tool to control market use of traditional
knowledge by requiring applicants for patents to provide information on the use of
traditional knowledge and of prior informed consent for its use.4 It was suggested that
establishment of a standardized certificate of origin which would act as evidence of prior
informed consent would exempt patent officers from the need to examine all of the
documentation related to an ABS agreement to verify compliance with the CBD. The
term has since taken on a wider meaning which broadly encompasses tracking flows of
genetic resources and documenting evidence for the right to use genetic resources. 5
Proposals now also exist for certificates of source and legal provenance.

4
Tobin 1997
5
Cunningham et al. 2004
The secretariat to the CBD has been mandated to undertake further examination of an
internationally recognised certificate of origin/source/legal provenance of genetic
resources and associated traditional knowledge as part of the negotiation of an
international regime on ABS. Analysis is also called for regarding the potential role
certificates might play in a system requiring the disclosure of origin of genetic resources
and associated traditional knowledge in applications for intellectual property rights.

Despite several preliminary investigations and many informal discussions at international


meetings, there is still no clear understanding of how a certificate of origin system could
operate in practice, or what should be the scope or nature of any such system.

A preliminary list of the information that may perhaps be included in a certificate of


origin, include:
• Particulars of the provider and user;
• Particulars of the indigenous or local communities parties to the agreement;
• Details of genetic resources or traditional knowledge;
• Details of the approved use which may be made of the resources;
• Details of any restrictions on use;
• Period of the agreement;
• Conditions relating to transfer of rights to third parties; and
• Details of the issuing authority.6
One potential embodiment of a certificate of origin may be likened to a passport that
accompanies genetic resources, either through their entire history from collection to use
(‘cradle to grave’) or only for certain transactions such as border crossings (Figure 1).
Possible check-points for a certificate could be at borders, patent offices or the
registration points for other commercial applications not covered by intellectual property
rights. The alternatives to the certificate of origin which have been suggested such as a
‘certificate of source’ or a ‘certificate of legal provenance’ seek to respond to concerns
that identification of the ‘origin’ may prove impossible in many cases. There are also
those who oppose these options due to the potential implications for collections of
genetic resources collected prior to the entry into force of the CBD, or subsequently
without any PIC or MAT. A certificate of source would track the genetic resource only as
far as the place where the user obtained it, which may be a collection or depository and
not necessarily the country of origin. A certificate of legal provenance would document
evidence that the resources had been obtained from a legally entitled provider. In the face
of continuing uncertainties regarding legal rights over resources and absent a binding
international regime on ABS, legal provenance would fall to be decided by the laws of
the country where the resources were sourced, potentially providing an opportunity for
circumvention of the rights of countries of origin.

6
Barber et al. 2003
Developing an international regime for protection of traditional knowledge.

Carlos Correa has described what he terms a misappropriation option as an alternative to


IPR protection, including use of databases and a disclosure of origin system. Such a
system would include national civil and or criminal law to prevent unapproved use
traditional knowledge. Protection would not be subject to registration and would last as
long as conditions that give rise to it exist. Identification of rights to use knowledge
would be linked to a system of documentation of knowledge, through databases or
otherwise, and an obligation to identify the origin of resources in IPR claims, as well as
evidence of PIC.7 With the adoption of the Bonn Guidelines the Conference of the Parties
to the CBD has sent a strong message to national governments in so-called user countries
that they should take measures to ensure that the use of genetic resources and traditional
knowledge conforms to the rights of countries of origin and local and indigenous
communities. Progressive implementation of the Guidelines may lead to development of
some of the elements of a misappropriation regime. Increasing implementation of
disclosure of origin requirements and development of an international system of
certificates of origin, as well as advances in the documentation of traditional knowledge
may further strengthen the basis for promotion of an international misappropriation
regime.

Support for the concept of a misappropriation regime has come Professor J. Reichmann
he suggests, however that such a regime might best be limited to what he terms historical
elements of traditional knowledge. He proposes in turn the development of a
compulsory licensing regime as a means to protect future innovation based on traditional
knowledge. He argues that “efforts to protect sub-patentable innovations under modern
conditions need to return to their historical roots, with a view to overcoming market
failure without impoverishing the public domain.” 8 This proposal is based upon the
notion that traditional knowledge can be separated into a historical traditional knowledge
to be protected by a misappropriation regime, secret knowledge which may b protected
by trade secrets if so desired and incremental advances in traditional knowledge which
should be protected as a form of know-how without the granting of exclusive monopolies.
In recognition of the fact that the lead time which historically provided the basis for
compensation relating to use of know-how is now effectively eroded by technology he
suggests the need for a sui generis regime to provide “… some functional equivalent of
artificial lead time to overcome market failure without disaggregating the information
commons”.9

One of the important elements of the liability regime proposed by Reichmann involves
blanket licence for certain forms of traditional knowledge such as medical treatments as

7
Carlos Correa: Traditional Knowledge and Intellectual Property: Issues and option surrounding the
protection of traditional knowledge QUNO. 2001
8
J. H. Reichmann, A compensatory Liability Regime for applications of Traditional Knowledge, Draft
paper Presented at the Cardozo Symposium on Legal Protection of Traditional Knowledge, New York,
February 23-24, 2001
9
Ibid.
well as some form of computerized collection society to handle royalty management. A
similar proposal has been made by Peter Drahos who argues for the establishment of a
Global Bio-Collecting Society as part of a proposal for the development of a treaty on
what he terms Traditional Group Knowledge and Practice (TGKP). Drahos suggests that
the time is not yet right for development of substantive international norms of protection
such as a misappropriation regime, but proposes that states should focus on creating a
treaty that does not discourage the development of national approaches but rather offers a
means for cooperating and coordination on enforcement of rights over traditional
knowledge.

As noted at the outset of this paper biopiracy is only on of many threats to traditional
knowledge, and may be far from the most dangerous. National educational programs
which exclusively promote foreign values, science, languages etc. can undermine belief
in traditional knowledge. Likewise, insensitive health programs may downplay the
importance and the effectiveness of traditional health practices. Agricultural and fisheries
extension programs can lead to displacement of traditional farming and fishing practices,
replacement of traditional crops and introduction of invasive species, to t detriment of
long term food security and subsistence. Promotion of cash crops at the expense of
traditional crop diversity can affect family budgets and cultural integrity without brining
lasting development. In a similar fashion introduction of foreign religious practices and
the loss of traditional rites can affect retention and transfer of traditional knowledge.
Amongst the most serious threat to traditional knowledge are loss of land which displaces
communities and separates them from the environment associated with their knowledge,
and loss of language, without which much knowledge cannot be transferred.

Considering these multiple interwoven threats to traditional knowledge it is considered


desirable that the international community adopt, a process for development of relevant
law and policy which focuses not only on regulating access to and exercising control over
traditional knowledge, but which also establishes clear measures designed to promote and
strengthen such knowledge systems. Development of international law and policy is only
a support for law and policy at the national level, which in turn cannot succeed without
the commitment and engagement of local and indigenous communities. Efforts should be
made without delay to modify or strengthen national law and policy to enhance the
recognition of traditional knowledge and of rights over it. This is part of a process of
pluralism and cultural respect which is vital for securing the rights of indigenous and
local communities.

Efforts at the national and international level will however be fruitless if not supported by
and complemented by community action. Use of traditional knowledge has been
described by many commentators as the key to its protection and development. Engaging
communities in the development of national law and policy as well as of programs for
protection of TK will be vital to their success. Communities should not however await
government assistance of legislative enactments before commencing their own programs
to revive and strengthen their store of traditional knowledge. Awareness building
programs designed to highlight the importance of traditional knowledge for present and
future community development and as a cultural legacy will be more effective where
driven by community members.

A schematic framework for a regime to protect and strengthen traditional knowledge


would include a number of different actors including indigenous and local communities,
countries within which knowledge is sourced, countries where knowledge is being used
for scientific and commercial purposes, private sector users and the international
community. (See tables 1 and 2)

Tables on TK protection

A key element to the success of these various processes and strategies is the recognition
of traditional decision making authorities and of the need to develop an effective
interface between national and international law and customary law and practice of
indigenous peoples and local communities. Traditional knowledge is closely linked to
both cultural and biological diversity, frequently representing the capacity of humankind
to develop a harmonious holistic alliance with our environment. As our dominant
development strategies present their insensitivity to the environment the need to tune into
the wisdom of centuries is ever more apparent, so too must be the reasons for respecting
those who hold this wisdom and who nurture and develop it so that it may continue to
serve future generations. In the light of such reality the role of IPR as a tool to restructure
traditional knowledge into a commercial commodity must surely pale against the need to
ensure that IPR supports the continuing capacity of communities to develop their
knowledge for present and future needs.

Global Regime

Existing access laws tend to impede flows of genetic resources and TK


Obtaining PIC of indigenous communities is the most time consuming element of
bioprospecting
Requiring PIC in the country of use of TK will reduce need for restrictive TK and
access laws
Development of awareness of community rights can facilitate negotiations

Customary law
Customary law cannot protect TK outside the bounds of community jurisdiction
Many customary law systems do not contemplate commercialization of TK
Customary law is not always democratic law
Respect for customary law should not conflict with human rights, in particular
those of women
National law may be required to ensure that chiefly authority is not abused.

Source country TK regulation


Recognition of TK as Cultural patrimony
Recognition of role of customary law and practice
Requirement for PIC for access to TK
Sui generis regime for protection of TK including protection of landraces
Limitations of national jurisdiction – need for complementary laws in country of use.

Measures in country of use


Certification and codes of conduct
Import and transport regulations
Disclosure of Origin
Access to Justice/ Enforcement mechanisms
Unfair trading practices
Technology transfer

International community
Misappropriation regime
Disclosure of Origin obligations under international IPR law
International certificate of origin system
Compensatory liability regime
International Bio-collecting Agency
Recognition of customary law and practice
Flexible
Revise principle of public domain
Address the question of sources of prior art to allow for inclusion of community
registers.

Table 2 - International TK control regime - Prior Informed Consent (PIC)

Indigenous Source Country of End user International


peoples country use community
Define Establish Discourage Contracts Build Bridge
Conditions for regulations illegal use, PIC -legal between source
access. requiring require PIC certainty for and end user –
Basis – PIC PIC for use use Address issue of
public domain
Customary law Export Import Codes of Protocol to CBD
and practice. controls controls conduct Define Principles
Community ABS law Product Require of Equity
protocols Sui generis approval evidence of Arbitration
regimes IPR grants PIC Database trusts
Revise sources
of prior art
Fundamental underlying principle - PIC - Basis for legal certainty
Table 2 - Policy and law to strengthen TK and innovation systems

Indigenous Source Country of End user International


peoples country use community
Community law and Inventory of Codes of Investigate
research on policy to databases conduct. status and
uses and support local Require Company trends on TK
threats to use. disclosure of database Devise int’l
TK. Incentives TK search strategy for
Awareness support of TK
Community Revise Funding. Train staff / financial and
registers curricula Capacity- contractors Technical aid.
Community Integrated building Repatriation Investigate role
gardens health Repatriation Share info. of customary
Transmission programs. Education re utility of law.
education TK Institute Respect TK TK. Fund TK CHM
Respect TK Fund Databases
Fundamental guiding principle – full informed participation in decision making

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