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National and regional laws to protect IK related to genetic resources

Summary

Indigenous knowledge (IK) is for many groups a valuable cultural, social and religious asset. More recently, it has come to be seen as an important economic asset as well, since elements of IK are being used to create new pharmaceutical or agricultural products. The direct or indirect use of IK in this way is now widespread. Generally, however, it is unauthorised, and it is almost always uncompensated.

One reason for this is that the tools created to protect formalised "modern scientific knowledge" when it is incorporated into new products — such as patents, plant breeder's rights (PBR) and copyright — offer only limited legal protection for IK. Recently, in an attempt to correct this situation, the Convention on Biological Diversity (CBD) and other global forums have made progress in defining approaches for protecting IK, especially as it relates to biological and genetic resources (see policy brief on global negotiations).

As a result of these efforts, some countries and regions have developed — and in some cases adopted — national laws, draft legislation and policies for the protection of IK. Examples can be found in the Philippines, the Andean nations of Latin America, Costa Rica, Brazil, Nepal, India, and Africa. In principle, these laws seek to give indigenous peoples some control over their knowledge — including a potential stake in any commercial applications — and at the very least, the right to reject its direct or indirect use.

But for a number of reasons, effective implementation of these laws and policies remains a challenge. One is the fact that some of the measures may not be practicable. A second is that some of the indigenous peoples concerned have limited awareness of key issues, such as how to assess the potential commercial value of their IK — which underlines the urgent need for capacity building in this area among national authorities and officials. Finally, such laws apply only to one country or region and do not offer global protection for IK. These problems reflect the need to build capacity building in, and raise awareness among, indigenous communities and, most importantly, the consideration of international measures to support the realisation of their rights.

Most of these laws have only recently been passed, so it would be premature to judge their impact at this point. Nor does this article attempt such a task. Rather, it seeks to pursue a more modest objective: namely, to identify and analyse the most relevant issues in the best-known IK protection laws and policies.

Recognition of rights over IK

Perhaps the best place to start is by reviewing existing approaches to the protection of IK. These can be divided into two broad categories: 'positive protection' and 'defensive protection'. The first of these usually implies special (or sui generis) laws that grant indigenous peoples exclusive rights over their knowledge, and thus the ability to control whether this knowledge is allowed to be exploited commercially, and if so on what terms. In contrast, 'defensive' measures are most relevant in relation to patents on IK being taken out in questionable circumstances.

The fundamental principle underlying national laws is the recognition that indigenous peoples have made an intellectual contribution to the conservation, maintenance and enhancement of biodiversity (and its components). Most of these laws, however, face two major practical problems. The first is the need to identify who, among a particular group or community of indigenous peoples, is legitimately entitled to provide consent for the use of its IK. The second is what should happen when IK is shared — as is usually the case — between neighbouring communities within a country, or even across national borders.

In Peru, for example, Law 27811 recognises the decision-making powers of indigenous peoples' representative organisations to provide the necessary prior informed consent (PIC), a principle enshrined in the CBD. If and when conflicts arise, the law stipulates that these should be solved according to the customary laws and practices of the communities and groups involved.

In other cases, such as the Organisation of African Unity (OAU) Model Law, the policy draft in Nepal and the Philippines Executive Order (and its implementing rules and regulations), it is left to the communities themselves to decide whether informed consent should be granted for activities involving the use of their resources or IK, without stipulating in detail what this refers to. Further national regulations will therefore be required to specify what this means in practical terms  — for example, whether informed consent needs to be obtained from just one community or several, from a community leader, or from a representative organisation.

Another problem raised by these laws is how they should be applied to IK that is already in the public domain and so freely available. Most of them only refer to IK in general terms. However, the Peruvian Law does distinguish between IK in the public domain and IK held by communities (which can be regarded as confidential). In the first instance, the law says that obtaining prior consent is optional, although interested parties are encouraged to obtain it. For confidential IK, however, the law specifies that the principles of trade secrets applies; if a non-indigenous party discloses it without the PIC of the community, compensation and civil sanctions can be sought.

Positive protection: registers and databases

A second element of 'positive protection' strategies is the use of registers and/or databases to protect indigenous knowledge. Such a step is proposed in the laws that have been drafted or already implemented in Nepal, Panama, Peru and the OAU, all of which refer to registers as an instrument for IK protection. Except for Panama, however, where registration in a database gives ownership rights to the individual or group taking this step, the register is primarily intended only to maintain and preserve IK, or as a means for defensive protection. In these circumstances, rights over IK exist whether or not such knowledge has been registered.

At present, only Panama has a fully operational register. It protects the rights of Kuna communities over their folklore expressions, in the form of traditional embroidery techniques. Registration has given Kuna communities exclusive commercialisation rights over their designs, textiles and garments. However, these rights can only be defended nationally. There is nothing to prevent third parties from using similar embroidery methods outside Panama.

India offers an interesting example of how registers can be used by non-governmental initiatives and grassroots organisations. The People's Biodiversity Registers and Honey Bee Network are projects that seek to document IK, and to recognise and compensate community innovators for their efforts. The mechanism has been successfully developed in a few Indian States, and in each case has enhanced awareness about 'ownership' of biodiversity and IK among local communities.

The Peruvian Law recognises the need for three types of registers: national, confidential and local. The national register, currently being compiled by the national intellectual property office, will serve to identify IK already in the public domain (so serving as a means of defensive protection against individuals or institutions who might try to make claims on such knowledge). The confidential register will be used for whatever purposes indigenous peoples decide. Finally, the local register will be developed and managed by indigenous peoples themselves, again primarily as a defensive instrument intended to prevent exploitation of this knowledge by others.

Positive protection: contracts and know-how licences

A third component of positive protection is the use of contracts and 'know-how licences' to regulate access to IK held by local communities, establish the terms under which such knowledge is transferred to universities and the private sector, and determine conditions for sharing benefits.

The Peruvian Law is based on an approach used by an International Cooperative Biodiversity Group (ICBG) project involving Aguaruna communities in Peru, Washington University in St Louis, United States, the Universidad Peruana Cayetano Heredia in Lima, the Natural History Museum in Peru and Searle Pharmaceuticals. Under an agreement between these parties, the Aguaruna communities, using traditional decision-making processes, have determined the conditions under which their IK related to medicinal plants can be used for research and development.

The fact that contracts are legally enforceable makes them the preferred tool within the academic and industrial realm. However, this is not necessarily true in indigenous communities for a number of reasons. These include the fact that the concept of a written contract — and the obligations that it embodies — are frequently unfamiliar, that the negotiations involved can be highly complex, and that the communities involved may lack sufficient information to be able to judge whether proposed contracts are fair and in their interest.

Some indigenous communities are also likely to be excluded from the contract negotiations and decision-making process, particularly where shared IK is at stake. In Peru, for example, although the ICBG was welcomed by some communities, others (from the same indigenous groups) that had been excluded from the decision-making process were wary of the outcome. However, such tensions are probably inevitable, and part of the challenge of ensuring the involvement of all interested communities in formulating contracts.

Positive protection: funds for IK

One important aspect of all strategies intended to provide positive protection for indigenous knowledge is the consideration of the potential use of funds generated by benefit sharing deals to support the preservation and maintenance of IK.

Peru's Law, for example, has established a Fund for the Development of Indigenous Peoples, under which a percentage of the monies generated from the use of IK will be placed in a fund deposited and managed by indigenous peoples. The OAU Model Law also establishes a Community Gene Fund (a trust fund) intended to receive money from national and international contributions interested in conserving genetic resources, as well as a fixed percentage from PBR protected varieties.

The idea behind such moves is to generate resources that benefit all indigenous peoples, regardless of whether they specifically provided IK or participated in an agreement. There is general recognition, however, that significant amounts of money are unlikely to be raised from an IK protection regime, and other sources of income are therefore needed in order to make a fund effective. Support from governments and the private sector, for example, could be used for projects that provide IK with appropriate levels of protection (perhaps in terms of documenting IK, developing informational tools, preserving IK and so on).

Past experience suggests the need for caution. The International Fund for Plant Genetic Resources, for example, which was set up by the Food and Agriculture Organisation in the 1980s, was never able to operate because countries and institutions failed to commit resources to it.

Positive protection: 'biodiversity rich areas'

A final aspect of positive protection is the designation of specific 'biodiversity rich areas'. Six indigenous communities in Cusco, Peru, for example, have created the Potato Park — an area extremely rich in potato genetic diversity and native Andean culture.

Although still awaiting formal governmental recognition, the park is an innovative response to the option to create "special agrobiodiversity areas" as provided for in a 1997 Peruvian law on the conservation and sustainable use of biodiversity. As part of this project, for example, a local register of has also been developed, for which local communities have used video cameras to document IK and local practices.

The Potato Park is an example of the way in which, by using the legal recognition and protection of livelihoods, land, customs, centres of agricultural genetic diversity and 'bottom up' initiatives, indigenous communities can enhance and use their knowledge of native crops and traditional agricultural practices.

Indeed, geographical areas and territories are all closely tied to IK, because cultures and indigenous livelihoods are based on land rights. Consideration of such issues is therefore widely recognised as underpinning any effort to preserve such knowledge.

Defensive protection: intellectual property legislation

Patents granted to inventions that, directly or indirectly, incorporate genetic resources and IK can be controversial, and regarded as unfair. One way of dealing with these is to require that the patent application documents whether prior informed consent (PIC) has been received from the communities providing the IK.

The laws in Brazil, Costa Rica and the Andean Community have pioneered the use of IK defensive protection. For instance, Decision 486 of the Andean Community on a Common Regime on Industrial Property has established as a general principle that a condition of granting a patent is that the biological inheritance (and related IK) of the region's indigenous communities is safeguarded. This principle was included in Peru's national regulation on PBR in early 1996.

Under the Andean law, patent applications for biotechnological inventions will need to offer the national IPR authority evidence that genetic resources and IK incorporated in the invention were legally accessed according to regional legislation. If the patent is granted, and information subsequently confirms that resources and IK were illegally obtained, the national authority may declare it invalid.

In the Andean regions, attempts are being made to forge effective links between national IPR authorities, improve access to genetic resources authorities, and enable IPR officials to more easily identify circumstances where genetic resources (or IK) may be involved. However, the handicap of localised jurisdiction remains: this condition is enforceable only to patents granted within the Andean Community.

Rather than reject claims for patents on IK for which the prior consent of communities has not been given, an alternative may be to allow them, but require patent holders to share out any future benefits from the commercialisation of the genetic resource and related IK. India, China and Indonesia have each considered adopting this approach. But such laws will only be effective when industrialised countries adopt them, since corporations based in these countries take out most of the patents concerned, and subsequently generate the largest revenue from them.

Some developed countries are moving in this direction. For example, Denmark already has a law requiring voluntary disclosure of geographical origin, while similar laws are under consideration in Belgium, Norway and Switzerland. There is however no specific reference to PIC. Furthermore, the best-known cases of 'biopiracy' have been identified in the United States and Japan. These countries have expressed continued opposition to including any such requirements in patent legislation in CBD, WIPO and other forums.

Defensive protection: disclosure through databases

As with positive protection, one potential defensive strategy is to set up databases and registers on which information about indigenous knowledge is actively documented and disclosed. Such databases are intended to prevent patents being taken out on the basis that the knowledge involved was already widely known — in other words, that "prior art" existed.

The Government of India, for instance, is developing a Traditional Knowledge Digital Library (TKDL). And the Nepal Draft Policy on Genetic Resources and Benefit Sharing and the country's Genetic Resources Act call for documentation and disclosure, through official and non-official databases and registers, of IK.

Such moves are themselves controversial. The directories may indeed prevent unauthorised access by informing patent authorities that a particular innovation is not new and does not merit a patent. However, they may also assist unauthorised use of IK by systematically documenting it in the public domain, sometimes with no informed consent from the communities involved.

Venezuela's Biozula Database, for example, was originally conceived as a purely scientific resource and created in the late 1990s by a public-private consortium of national scientific institutions. It has since been criticised by indigenous groups in the country for obtaining IK without PIC and then organising and incorporating it into a database that could become widely accessible (although it has not been made public so far).

Common issues and difficulties

Reality vs laws and concepts
It is sometimes difficult to imagine how laws to protect IK will be implemented in practice, given the social, cultural, economic and educational contexts in which indigenous people live and work. Barriers thrown up by isolation and language, along with scant understanding of 'Western' or external property concepts, together constitute the most critical issue of IK protection. Incorporating the customary law component and a universal recognition of its meaning will be critical to develop sound laws. Administrative procedures in some cases, and even the payment of fees, furthermore contribute to a disconnection between indigenous communities and formal law.

Time and patience
International IPR regimes have taken several centuries to develop. An IK regime, at the international level, could also take considerable time in the making and testing, using national experiences and protection efforts as guiding instruments.

Participation: tensions and frictions
Limited studies have been undertaken on the tensions that may arise among indigenous peoples 'competing' to protect shared IK. However, it appears that the position adopted by communities varies considerably. It is important that indigenous peoples' interests consistently engage with national IK policymaking processes, for example through active participation, lobbying of policymakers, and presenting in public proposal discussions.

Prior informed consent
All the laws and draft legislation considered in this brief address PIC as the foundation of IK protection. However, inevitable questions arise. Who provides PIC in cases where IK is shared between communities in a country or even across borders? How can benefits be equitably shared among communities? How should the interests of individuals within communities be handled?

Limitations of national jurisdiction  
National legislation per se is limited in guaranteeing effective protection of IK. Widely differing national laws and policy approaches may affect the possibility of ensuring universally recognised and effective legal protection. Many observers therefore believe that negotiating an international IK regime with standardised rules is of prime importance.

Public domain
Although there have been no attempts to make exhaustive quantitative assessments of how much IK is in the public domain, it is quite clear that much IK has been documented, systematised, and widely disseminated over the years. Information technologies are accelerating and streamlining this process. A considerable amount of IK has therefore become part of the public domain — sometimes with the consent of indigenous peoples, but most often not. This undermines possibilities of control over IK and realising benefits from its use and application.

Moving towards an integrated system

At times, the gap between law and reality might seem insurmountable. It has always been complicated for most indigenous peoples to have equal, equitable and timely access to the law and to mechanisms to defend their rights and interests. If an IK protection regime is to be effective, it must take these factors into consideration and discover the best policy and legal options for achieving protection goals. Though many of these laws and draft models look promising and seem conceptually sound, a number of practical questions must first be answered before they can be implemented.

For example, in many of the cases mentioned, indigenous peoples often justifiably claim they face difficulties in understanding and effectively making use of IK policies and laws. These are often too complex for effective use by indigenous peoples and involve high 'transaction costs', which act as an overall disincentive.

Given the massive diversity in indigenous cultures throughout the world, an international IK protection regime may first need to produce a broad set of principles. Countries could then base their own legal systems (adapted to national or regional needs) on these, while ensuring that there is reciprocity among countries and universal mutual recognition of rights. These principles should, however, not be so broad and general as to make the system unworkable or open to extreme interpretations.

Almost certainly, national laws and a future international regime will combine tools, instruments and laws (including modified IPR) in an interrelated, synergistic manner to ensure the protection of IK. Whether this is reflected in a single instrument (as in the case of Peru), a general policy, or adjustments to different legal instruments, it is the way in which these are interrelated that will ensure that indigenous peoples' interests are safeguarded. The Philippines provides a good example of different laws acting to protect IK (see below).

The Philippines: IK-related legislation

  • Executive Order 247 on access to biological resources (1995), and its implementing rules and regulations, establish PIC requirements when bioprospecting is to take place on indigenous lands or territories. There is no reference to the direct protection of IK, although there are restrictions on access to land where research activities are to be undertaken.
  • Republic Act 8423 (1997) established the Institute of Traditional and Alternative Health Care (PITAHC) to enhance traditional healthcare throughout the country by promoting and validating the use of traditional medicine and practices. A development fund has also been created to support the overall activities of the Institute. However, although clearly related to IK – a definition of traditional healers is provided – there is surprisingly no reference to benefit sharing and to the need to protect or maintain the IK of indigenous healers.
  • Philippines' Indigenous Peoples Rights Act (Republic Act 8371, 1997) recognises, protects and promotes indigenous cultural communities and peoples, creating an ad hoc commission for that purpose. This act determines that indigenous communities and peoples have a right to their traditions and customs and to the restitution of intellectual property taken without their consent. They are entitled to full ownership, control and protection of their cultural and intellectual rights (regarding genetic resources, seeds, medicinal plants, arts, designs and so on). Access to, and use of, their IK will be permitted only with their PIC.

  • Often countries seem to focus on a single strategy, based on a single, specific law. This may be the ideal. However, depending on circumstances, different laws and measures could be modified, revised, adapted and developed to offer an integrated system for IK protection where a series of instruments and tools (including contracts, PBR, IPR, funds and recognising land rights) serve the objective of protecting IK.

    The potential advantages of this approach need to be carefully assessed, however. Without land tenure and collective property rights of indigenous peoples, for instance, indigenous cultures and invaluable IK will gradually be overcome by powerful market forces or even disappear altogether. And without a parallel recognition of land and territorial rights, the discussions regarding protection of IK may, in the end, become completely irrelevant.

    Manuel Ruiz is director of the Programme on International Affairs and Biodiversity of the Peruvian Society for Environmental Law (SPDA), a non-profit organisation that aims to increase the capacity of societies to develop in an environmentally sustainable manner.

    References

    Commission on Intellectual Property Rights (2002). Integrating Intellectual Property Rights and Development Policy

    United Nations University (2003) User Measures: Options for Developing Measures in User Countries to Implement the Access and Benefit Sharing Provisions of the CBD 

    Tobin, B. (2002) Biodiversity Prospecting Contracts: The Search for Equitable Agreements. In Laird, S. (ed) Biodiversity and Traditional Knowledge: Equitable partnerships in practice. WWF, UNESCO, Royal Botanic Gardens Kew, Earthscan

    World Intellectual Property Organisation (2003). Draft Technical Study on Disclosure Requirements Related to Genetic Resources and Traditional Knowledge

    National legislation