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IV. Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS)



TRIPS Review Negotiations

R. Silva Repetto and M. Cavalcanti
Legal Office



To review the nature of the foreseen 1999 "review of the provisions of Article 27.3(b)" of the TRIPS Agreement and the various options facing this review process as well as the process of review of the Agreement's implementation. This will ensure that countries will be prepared to actively participate in the multilateral negotiations leading to these reviews.


8.1 Introduction

8.2 1999 review of the provisions of Article 27.3(b)

8.3 Third Ministerial Conference of the WTO

8.4 Review of the implementation of the TRIPS Agreement

8.5 Amendments and reservations to the TRIPS Agreement

Annex 1: FAO work related to the implementation of Article 27.3(b) of the TRIPS Agreement



Four years after the adoption of the TRIPS Agreement, the obligations and options of developing countries to provide for protection of plant varieties remain undecided. In 1999, the sui generis option to comply with this obligation will be evaluated by the TRIPS Council. The shape of a TRIPS-compatible sui generis system will play a key role in establishing alternatives to patents on plant varieties1.

Developing countries have to prepare for the review of the provisions of Article 27.3(b) of the TRIPS Agreement. It remains to be seen to what extent developing countries can formulate a strategy to pursue their interests within the Agreement2.


The TRIPS Council is scheduled in 1999 to "review" Article 27.3(b) of the TRIPS Agreement. The text of the article states that "the provisions of [this] subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement". Within the TRIPS Council, countries are still discussing the nature of the review. On the one hand, most developed countries' delegations consider that the review should be a review of the implementation of the article. On the other hand, most developing countries' delegations interpret the provision as a mandate to re-open the discussion on the wording of the article, implying a revision of the text. Where that discussion will lead is not predictable.

Information gathering

In the meantime, Members who are already under an obligation to apply the Article have been requested to submit information on the way they have provided for plant variety protection in their national legislation. The TRIPS Secretariat was requested to provide an illustrative list of questions relevant to the matter in order to assist Members in their replying. The Secretariat was also requested to contact FAO, the Secretariat of the Convention on Biological Diversity (CBD) and the International Union for the Protection of New Varieties of Plants (UPOV) to request factual information on their activities of relevance in this regard, as the first step in the review process, without prejudice to the nature of the review provided for in Article 27.3(b). FAO, the CBD Secretariat and UPOV have already sent this information to the TRIPS Council and it has been published in the documents distributed in the February 1999 and the April 1999 meetings of the TRIPS Council3.

Many review options

If the review process turns into a revision of the vague wording of Article 27.3(b), the review negotiations will supply a unique opportunity to raise concerns and needs related to plant variety protection. The TRIPS review negotiations will furthermore supply the opportunity to develop a more pragmatic text bringing in the first experiences of implementation and interpretation in practice by the Parties. The review options are manifold.

Discussing every opinion and suggestion is neither feasible nor necessary within this framework. A number of suggestions, however, are worth mentioning as being productive contributions and practicable alternatives.

Avoid a textual review of wording

One, and probably the most simple suggestion, is doing nothing. Members would simply review progress in implementing the sub-paragraph and leave the wording as it is, retaining some ambiguity. This option, particularly supported by the United States of America and the European Community Governments, would provide countries with maximum flexibility within the existing Agreement, particularly because the exact meaning of most of the terms has yet to be agreed, or defined by international jurisprudence. By agreeing to do nothing the risk of having the alternative of "sui generis" systems eliminated is also reduced.

Exclude living organisms from patentability

Extending the exclusions from patentability to include all living organisms and the associated knowledge for their improvement, conservation and sustainable use gives another alternative. This is the option favoured by many developing countries whose genetic wealth and the food and livelihood security of their citizens could be threatened by ownership of biological resources through patents. It is a low cost option removing the need to defend their resources and know how through litigation. Benefit sharing arrangements should be agreed through the FAO negotiations for the revision of the International Undertaking on Plant Genetic Resources and through the CBD, which may prove a better arrangement for developing countries.

Remove the sui generis option

A further option lies in removing the sui generis option of plant variety protection. Most developing countries do not favour this.

Remove exclusions from the Article

Others suggest deletion of the whole Article 27.3(b), which would provide for no exclusions from patenting of living organisms and their accompanying intellectual property -an option favoured by some industrial countries. This would favour the biotechnology industry, which would be able to insist that all countries impose and recognize patents, and the right to patent living material irrespective of its origin. Nevertheless, this option would also remove the obligation to provide for plant variety protection.

Remove biodiversity from TRIPS

A radical suggestion was proposed by some developing country governments with support by non governmental organizations (NGOs). The suggestion is to remove biodiversity from TRIPS altogether. According to this suggestion, removing biodiversity is the only way to fully ensure a fair deal for communities and people in developing countries. Since achieving this ambitious goal may take more time than the 1999 review allows, a more practical fall-back option is to secure a five-year suspension of the implementation of Article 27.3(b) so that developing countries, which are facing enormous difficulties in the implementation of the TRIPS Agreement, may sort out the solutions more appropriately.

Incorporate reference to UPOV

Supported by several developed country governments, UPOV Member States suggested the TRIPS Agreement to be amended to include specific reference to the UPOV Convention. This would make membership in UPOV, and implementation of its specialized intellectual property rights (IPR) provisions, an obligation for all Parties to the WTO, subject to multilateral trade sanctions. Although facilitating the development of a sui generis system, this alternative would encounter resolute opposition from developing country governments. As previously mentioned, the UPOV system does not necessarily take into consideration some necessities and aspects of developing countries social and economic structures, nor biodiversity-related issues.

Enshrine "public domain" concept

A very specific proposal that has also emerged, and which could be regarded as a mere supplement to further changes, consists of adding a simple paragraph to enshrine the concept of "public domain", interpreting public domain as the property which belongs to the State. In many countries influenced by the Roman Law tradition, the State is the ultimate owner of all natural resources in its territory. Enhancing "public domain" could add a certain level of protection to community resources and even, to a certain extent, to the associated knowledge contained therein. According to its promoters, this alternative would word Article 27.3(b) as follows:

"Members may also exclude from patentability
(a) ...
(b) ...
(c) inventions which are essentially derived from biological materials and associated knowledge in public domain."

This would allow countries to exclude from patentability inventions based on biodiversity and related knowledge in the public domain. This would also make the level of the demand for novelty higher for patent applicants.

Negotiating strategies

Given the Agreement's commitment to start the review in 1999, while simultaneously enacting required legislation and negotiating a number of other related agreements, a further set of options arise, including:

What is clear is that the TRIPS Agreement review will provide for contentious discussions among Member States. About five years after coming into force, the negotiations have the great potential to recognize important issues. Particularly developing countries should consider the review as an opportunity to air their concerns related to the establishment of an international IPR system for plant varieties, and should stress the issues affecting these countries' peculiarities. Plant variety protection and Farmers' Rights should be regarded as connected principles within the global community. Biodiversity and genetic resources, and the agreements related thereto should be considered as background for the negotiations.

To achieve a most equitable solution for all Members, it is essential that all Parties participating in the review be equally trained in TRIPS and its implications. Only this could assure a fair negotiation among different countries and the potential for a fair and equitable conclusion.

The last 1999 meeting of the Council for TRIPS was held from 20 to 22 October. Inter alia, the agenda for the meeting included a review of the provisions of Article 27.3(b).

At the meeting, the United States of America and India each submitted a major paper concerning Article 27.3(b). The United States recommended its own patent-based model to other Members, arguing that an effective intellectual property protection system has been beneficial in stimulating research and development. The United States also warned Members that any sui generis system for the protection of plant varieties not modelled on UPOV-1991 would need to be looked at on a case-by-case basis.

India's paper focused on aspects of traditional knowledge and the problems associated with handling intellectual property in this area due to its strong oral tradition, as opposed to many developed countries' focus on text-based intellectual property. With respect to the forthcoming review of Article 27.3(b), India advised developing countries to wait before implementing sui generis systems, as the only model offered so far was that of the developed countries4. The Indian paper was supported by a Kenyan paper and by a group of developing countries that included Pakistan, Egypt, Brazil, Ecuador, Peru, and Paraguay.

Siding for the most part with the United States, the European Community argued that there is no conflict between TRIPS and Members' commitments under the Convention on Biological Diversity. The European Community disagreed with India that traditional knowledge was within the scope of Article 27.3(b), and pointed out that the World Intellectual Property Organization (WIPO) was currently working on this area5. The EC-US side was supported for the most part by developed countries, including Switzerland, Canada, Japan, Australia, and Korea.

Members reached agreement to continue the Article 27.3(b) review process in the year 2000, with the TRIPS Council Chair holding periodic informal meetings with delegates in an attempt to broker broad-based agreement.

With regard to the work being undertaken by WIPO on this issue, the Organization held a roundtable in Geneva on 1 and 2 November 1999 where the leaders of indigenous peoples' organizations attending the meeting on intellectual property and traditional knowledge criticized the WIPO approach in attempting to impose an intellectual property rights regime on traditional knowledge.

Indigenous peoples called on WIPO, governments and other multilateral organizations to explore other ways to protect and promote indigenous and traditional knowledge outside of the existent IPR regimes. Several indigenous peoples' representatives who participated in the WIPO roundtable were critical of many of the papers presented and of what they perceived to be WIPO's attempt to co-opt indigenous knowledge into the global patent and IPR system. They spoke up often at the meeting to voice their viewpoints6.

More than a hundred indigenous people's organizations separately issued a statement calling on governments to amend the TRIPS Agreement, Article 27.3(b), to mandatorily ban the patenting of all life-forms, all naturally occurring processes, and of traditional knowledge on the use of biological resources.

Near the end of the WIPO Roundtable, the Indigenous Peoples' Caucus, representing the indigenous peoples present at the meeting, issued a statement calling on WIPO to create a mechanism within its structures which would allow for more meaningful participation of indigenous peoples. It was furthermore mentioned that "since WIPO claims it is the body, which has a key role in traditional knowledge then it, should also formulate its own guidelines".


Before the Ministerial Conference took place in Seattle from 30 November to 3 December 1999, informal discussions were held at the Heads of Delegations level on a draft Ministerial Declaration for Seattle, which addressed the issues relating to TRIPS. These discussions showed some clear difference of views on how to deal with future work in this area. Several countries complained that the treatment of TRIPS in the draft Ministerial Text was very confusing.

Some of the proposals made by the developing countries included the need to review Article 27.3(b) to clarify artificial distinctions between life forms and to clarify that all living organisms and their parts cannot be patented; technology transfer obligations under Article 66.2 to be made mandatory, and an extension of the implementation deadline for Article 27.3(b). These proposals were rejected by the United States which said that it was against renegotiating the Uruguay Round Agreements and thus could not accept the implementation proposals of developing countries.

The Heads of Delegations also discussed two alternative texts under the future work programme. The first option had four points, stating that the TRIPS Council shall: (i) establish a system for notification and registration of wines and spirits eligible for protection and expanding the product coverage of Article 23; (ii) review Article 27.3(b) to clarify its provisions and consider action to have a supportive relation between TRIPS and biodiversity and the CBD; (iii) examining the scope of protection of traditional knowledge of indigenous and local communities; and (iv) in reviewing Article 71.1, enhance the TRIPS objectives in Articles 7 and 8.

The second option (which reflects the United States' view) contains only two points, that the TRIPS Council shall: (i) complete the mandated reviews and negotiations under TRIPS' built-in agenda aimed at the effective and timely implementation (including the establishment of a system to notify and register geographical indications) as well as the review of the Agreement's implementation; and (ii) consider in due course whether modifications to the Agreement are warranted, "it being understood that in any future negotiations no consideration will be given to lowering existing TRIPS standards".

As part of the Seattle Ministerial Conference Preparatory Process, some developed countries made a proposal to establish a Working Party in the WTO (or to consider additional disciplines in WTO) to deal with biotechnology. Such a Working Party would have a fact-finding mandate to consider the adequacy and effectiveness of existing rules as well as the capacity of WTO Members to implement these rules effectively. A Working Party on Biotechnology would provide a number of benefits to the WTO Members, according to the countries making the proposal, including: (i) providing a transparent process with a common focus and time-frame for preparatory, fact-finding work building on work already underway at the national level in several WTO Members; (ii) serving to inform those WTO Members not currently engaged in such exercises at the national level; and (iii) serving to identify constraints to full implementation by Members of WTO-consistent regulatory systems for biotechnology.

In the view of most developing countries these proposals could have serious effects on the efforts made by them within the framework of the CBD to establish a Biosafety Protocol which is aimed at preventing the indiscriminate export to developing countries of potentially hazardous genetically-modified organisms (GMOs) in products such as seeds, food and animal feed.

During the Seattle preparatory process the United States, Canada and Japan made proposals to consider trade in genetically modified organisms at the WTO. These proposals raised significant issues for WTO Members, in particular developing countries, who are concerned about: (i) the potential that possible new WTO disciplines on trade in GMO products would deregulate rather than regulate trade in biotechnology products at the national level, thereby limiting governments' ability to set national laws to test, and to control the import of, genetically modified food products on the basis of the precautionary principle; (ii) the proper relationship between possible new WTO disciplines and the need to regulate the transboundary movement of GMOs more effectively at the international level, including through an effective Biosafety Protocol; (iii) the potential for new WTO disciplines to constrain national labelling schemes designed to promote the consumer's right to know about GMOs; (iv) the proper role and limits of the multilateral trading system and whether the WTO should consider the "new issue" of trade in GMOs; and (v) broader questions about food security, agriculture, environmental protection, human and animal health, and equitable development.

Under the same preparatory process for the 1999 Ministerial Conference, on 4 October 1999, five Latin American countries (Bolivia, Colombia, Ecuador, Nicaragua and Peru) submitted a "Proposal on the Protection of Intellectual Property Rights Relating to the Traditional Knowledge of Local and Indigenous Communities". The signatory countries proposed that the Seattle Ministerial Conference established, within the framework of this Round, a mandate with the following purposes: "To carry out studies, in collaboration with other relevant international organizations, in order to make recommendations on the most appropriate means of recognizing and protecting traditional knowledge as the subject matter of intellectual property rights. [...]initiate negotiations with a view to establishing a multilateral legal framework that will grant effective protection to the expressions and manifestations of traditional knowledge"7.

At the Ministerial Conference there was no agreement regarding the inclusion of the above issues in a Seattle Declaration, which could not be adopted and remained just a "Draft Declaration".

The WTO General Council on 17 December 1999 decided to postpone until early 2000 a decision on how to proceed with issues outstanding from the Seattle Ministerial Conference.

One group of proposals on the table at the Seattle Conference sought delays in end-of year deadlines for applying obligations and other provisions of WTO agreements - for example, in intellectual property (TRIPS) and certain investment measures (TRIMS).

Members could not agree on whether to accept or reject the delays, or to consider them individually member by member.

These deadlines will be among the subjects discussed in consultations during 2000, and members agreed in the 17 December General Council meeting to exercise restraint and understanding in dealing with the deadlines while the consultations are underway.


Review of implementation begins in 2000

In the year 2000, the TRIPS Council will have the task to review the implementation of the entire TRIPS Agreement. According to Article 71.1 of the Agreement, the TRIPS Council shall review its implementation five years after the entry into force of the WTO Agreement, and shall "having regard to the experience gained in its implementation" review it two years after the year 2000, and at identical intervals thereafter.

It is to be noted that in this case the Agreement's provision explicitly states that the review is a "review of the implementation". This was not done in the case of the "review" mentioned in Article 27.3(b).


Other grounds for review

Reviews may be undertaken by the Council for TRIPS "in the light of any relevant new developments which might warrant modification or amendment" of the Agreement (Article 71.1).

Amendments merely serving the purpose of adjusting to higher levels of protection of intellectual property rights achieved, and in force, in other multilateral agreements and accepted under those agreements by all Members of the WTO may be referred to the Ministerial Conference for action in accordance with the established procedure (Article 71.2).

Reservations to the TRIPS Agreement are not possible without the consent of the other Members (Article 72).

Annex 1


FAO's technical expertise relevant to the TRIPS Agreement relates to intellectual property rights over plant varieties, animal breeds, related technologies and germplasm.

FAO's observer status on the TRIPS Council of WTO reflects the importance of its role in helping member countries meet their obligations under the Agreement.

FAO Commission on Genetic Resources for Food and Agriculture

The FAO Commission on Genetic Resources for Food and Agriculture (CGRFA) is the only permanent United Nations inter-governmental forum dealing specifically with matters related to the conservation and utilization of genetic resources for food and agriculture, and related technologies. It was established in 1983, as the Commission on Plant Genetic Resources. The 1995 FAO Conference broadened the Commission's mandate to cover all components of genetic resources of interest to food and agriculture.

In 1997, the Commission established working groups on plant genetic resources and on farm animal genetic resources. The working group on farm animal genetic resources was given the task of furthering the development of the Global Strategy for the Management of Farm Animal Genetic Resources, covering both technical and policy aspects of the conservation and sustainable use of farm animal genetic resources, which will include aspects of the regulation of access and exchange, intellectual property rights, and trade. The working group on plant genetic resources was to examine the implementation of the Global Plan of Action (described below) and related follow-up activities.

FAO has a specific interest in the implementation of Article 27.3(b) of the TRIPS Agreement. The obligation of WTO's developing country members to adopt protection to plant varieties, either by patents, or by an effective sui generis system, or by any combination thereof, has important implications for the development of their agricultural economies and trade. The process of review of the said article has generated both interest and concern about action to be taken, and many countries are seeking technical advice and assistance.

The Commission monitors the implementation of the International Undertaking on Plant Genetic Resources, the first international instrument governing the conservation and sustainable utilization of agricultural biodiversity, adopted by an FAO Conference Resolution in 1983. Currently, 159 countries and the European Community are members of the CGRFA and 113 countries have adhered to the International Undertaking.

Through the CGRFA, FAO members have been involved in negotiations concerning plant genetic resources for food and agriculture, and related technologies, particularly in the context of the refinement of the International Undertaking on Plant Genetic Resources, through a series of agreed interpretations, and complementary resolutions. In particular, FAO Conference Resolution 5/89, unanimously adopted, recognized Farmers' Rights as the "rights arising from the past, present and future contributions of farmers in conserving, improving and making available plant genetic resources, particularly those in the centres of diversity/origin".

The agreed interpretations are now part of the International Undertaking and seek to develop and maintain a balance between access to the new, commercial products of biotechnology on the one hand, and farmers' varieties and wild material on the other, as well as the interests of developed and developing countries, by balancing the rights of breeders (formal innovators) and farmers (informal innovators). It was endorsed in these resolutions, inter alia, that "Farmers' Rights" are to be implemented through an international fund for plant genetic resources; and that breeders' lines and farmers' breeding material should only be available at the discretion of their developers during the period of development.

United Nations Conference on Environment and Development (UNCED)'s Agenda 21, under Chapter 14, subsequently requested the realization of Farmers' Rights. Inter-governmental negotiations are currently underway in the CGRFA for the revision of the International Undertaking on Plant Genetic Resources (Conference Resolution 7/93), covering inter alia access to plant genetic resources for food and agriculture, and related technologies; the realization of Farmers' Rights; the integration of the three interpretative annexes into the Undertaking and its bringing into harmony with the Convention on Biological Diversity (CBD).

During these negotiations, countries are discussing possible systems of intellectual property rights (IPR), including patenting and "effective sui generis systems", that would be in line with, and fully compatible with the provisions of the TRIPS Agreement and with the Convention on Biological Diversity. A further issue is how to ensure that technologies developed on the basis of plant genetic resources are available on terms that are consistent with the protection of IPR, as required by Article 16.1 of the CBD. In addition, the CGRFA is also negotiating a Code of Conduct on Biotechnology, including a component on intellectual property rights.

In this context, during the round of negotiations at the Seventh Regular Session and the Fourth and the Fifth Extraordinary Sessions of the CGRFA in 1997 and 1998, many countries presented proposals for the realization of Farmer's Rights which included provisions for the development of national sui generis systems that would provide incentives for informal innovators, such as farmers and communities supplying plant genetic resources (and their countries), to have a right to a share of the benefits derived from their utilization. Many delegations recognized the connections with the provisions of the TRIPS Agreement. These proposals are reflected in the Report of the Commission and in the negotiating draft of the International Undertaking. FAO (in collaboration, as appropriate, with the International Plant Genetic Resources Institute (IPGRI) and other technical bodies) has provided the Commission with various technical studies and analyses of relevant topics, including this matter, to facilitate the negotiations for the revision of the International Undertaking. These studies could be made available to the TRIPS Council, if requested8.

In January 1999 an informal meeting of the CGRFA was held in Montreux (Switzerland) with the participation of experts representing the various regions and positions. The following inter-related issues were addressed: benefit-sharing, Farmers' Rights, the financial mechanism, the legal status of the revised International Undertaking, and others, including access to plant genetic resources for food and agriculture. The discussions that took place at the informal meeting enabled the Chairman of the Commission, with the help of all those present, to draw up a series of Chairman's Elements for consideration by the members of the CGRFA.

While the Consolidated Negotiating Text, revised through the deliberations of the Fifth Extraordinary Session of the Commission, remains valid, the informal meeting considered that it would be useful to prepare a simpler text, incorporating the Chairman's Elements. As a result, the Chairman drafted legal provisions that reflect the said "elements". In addition, and so that these legal provisions may feature in the full text of the International Undertaking, the Secretariat was asked to prepare a Draft Integrated Text for Revision of the International Undertaking which will incorporate, in the Consolidated Negotiating Text the legal provisions derived from the Chairman's Elements.

The negotiations for the revision of the International Undertaking will continue at the Eighth Regular Session of the Commission in April 1999 and, if necessary, at extraordinary sessions to be convened later in 1999 with the aim to finalize the negotiations in 1999.

The Fourth International Technical Conference on Plant Genetic Resources for Food and Agriculture: outcome and follow-up

The Fourth International Technical Conference on Plant Genetic Resources met in Leipzig, Germany, from 17 to 23 June 1996, and was attended by 150 countries and 54 intergovernmental and non governmental organizations. The Conference was convened at the request of the CGRFA, and was recommended in Agenda 21 of UNCED, and at the Nairobi Conference for the Adoption of the Agreed Text of the Convention on Biological Diversity. The Conference adopted The Global Plan of Action for the Conservation and Sustainable Utilization of Plant Genetic Resources and the Leipzig Declaration. It also considered the first Report on the State of the World's Plant Genetic Resources.

The Report on the State of the World's Plant Genetic Resources, was welcomed as "the first comprehensive worldwide assessment of the state of plant genetic resources conservation and use". The Report identified the urgent priorities that are addressed in the Plan. The Report and the Plan are two major elements of the FAO Global System for the Conservation and Utilization of Plant Genetic Resources9.

The Global Plan of Action was prepared through a participatory, country-driven process, involving a wide variety of stakeholders: Governments, non governmental and industry organizations, and individual scientists. A total of 158 governments prepared Country Reports, assessing the status of their plant genetic resources, as well as their capacity to care for and utilize these resources. Twelve regional and sub-regional meetings were held, where Governments considered regional problems and opportunities, and made recommendations for the Plan.

The Global Plan of Action recognizes that "certain policy, legal and institutional issues, inter alia, those related to ownership, intellectual property rights, exchange, transfer and trade in plant genetic resources, are confronting national programmes increasingly. Coordination is needed to provide national programmes with information on these issues and to assess the impact of international developments in these fields on the conservation and exchange of plant genetic resources, and to incorporate new research developments, as appropriate, into national systems and practices"10.

The Leipzig Declaration commits the Governments present to taking the necessary steps to implement the Global Plan of Action. Through the Declaration, the Conference stressed the need to enlist the widest possible participation in its implementation, and reaffirmed that "funds should be made available to finance the implementation, by developing countries and countries with economies in transition, of the Global Plan of Action". Accordingly, the Conference requested that the major multilateral and bilateral funding and development institutions be invited to examine ways and means of supporting the implementation of the Plan.

The Plan also recommends that Governments and their national agricultural research systems should "consider legislative measures which allow distribution and commercialization of landraces/farmers' varieties and obsolete varieties, if they meet the same distribution and commercialization criteria for disease, pests, health and the environment, as conventional or registered varieties"11.

FAO has reported the outcome of the Conference to major international, regional and national bodies dealing with food and agriculture, and invited their member constituencies to promote and take part, as appropriate, in the implementation of the Plan. Countries will monitor and oversee the implementation of the Global Plan of Action through the Commission on Genetic Resources for Food and Agriculture.

Technical and Legal Assistance to FAO Member States

FAO technical assistance to developing countries in relation to TRIPS is focused on assisting national authorities in analysing their needs and identifying appropriate policy options; strengthening the relevant capacities; formulating or revising national legislation; and advising on the structure and functions of the institutions involved.

The Plant Production and Protection Division and the Animal Production and Health Division of FAO have extensive experience in assisting member countries with those aspects of TRIPS associated with genetic resources conservation and utilization, seed policies and programmes and plant and animal breeding. The Development Law Service of the FAO Legal Office assists member countries with seed and propagating material legislation, plant variety protection legislation -including sui generis systems- and Farmers' Rights.

Specifically, in TRIPS-related matters FAO provides:

1. Technical assistance:

The Programme is coordinated by an Inter-Departmental Task Force on Follow-up to the Uruguay Round, which is in the process of identifying the trade-related technical assistance needs of the said countries in order to incorporate them in the national assistance programmes which will be further discussed and finalized by the competent authorities and organizations.

2. Legal assistance:

FAO's experience over many years has shown that justice cannot be done to the particular needs and circumstances of individual countries by theoretical studies or model laws. Sui generis systems are to be developed to suit the need of individual countries.

In an annex to this document, relevant examples are given of projects under which FAO provides technical assistance related to Article 27.3(b) of the TRIPS Agreement to developing countries.

3. Capacity building:

During the preparatory phase of the programme an Orientation Workshop for the regional and sub-regional FAO outposted policy staff, designated as focal officers of the Umbrella Programme was held in FAO headquarters from 30 November to 4 December 1998. The said staff is responsible for the organization and running of the specific regional/sub-regional courses and will design and implement region-specific training programmes.

Attachment to Annex 1

Examples of FAO Technical Assistance Projects

Under the Technical Cooperation Programme, TCP/BZE/6611: "Mandatory Health Certification Scheme for Citrus", the Government was assisted in the drafting of legislation to regulate the citrus certification scheme.

Caribbean Region
In 1995, the FAO Trust Fund project, GCP/RLA/108/ITA, "Improved Seed Production, CARICOM Countries and Suriname", contributed to the drafting of a model Seed Act for the region and of a draft Plant Breeder's Rights Act, which the Governments are now considering.

Assistance was furnished to the countries of the Communauté Economique des Grands Lacs (CEPGL) under a regional project, RAF/89/049: "Contrôle des échanges semenciers", with the objective of analysing the legal and administrative national frameworks related to seeds and formulating the necessary legal instruments. A Draft Convention on Seed and Planting Material Exchanges was drafted as a result of the project.

There is a project in the pipeline for support by FAO's Technical Cooperation Programme, with the objective of strengthening Chile's national programme for the conservation and sustainable use of plant genetic resources for food and agriculture. One specific objective covers the preparation of a draft instrument to regulate collection, conservation, exchange and utilization of plant genetic resources for food and agriculture.

In 1994, the FAO/World Bank Cooperative Programme prepared a project for World Bank Funding, based on the commercialization of a number of provincial seed companies, and the introduction of a supporting policy environment, including the establishment of a system of plant variety protection that conforms to the requirements of the GATT Uruguay Round. The US$185.5 million project was approved by the World Bank in June 1996, and includes a technical assistance component for advising on variety protection systems.

Democratic Republic of the Congo
Under a previous phase of the FAO/UNDP project, ZAI/92/002, "Assistance à la production semencière", a Seed Law was drafted, which is currently being considered by the Government.

Dominican Republic
Under its Technical Cooperation Programme, TCP/DOM/2352, FAO assisted the Government, inter alia, in the reorganization of the seed certification services and the drafting of a Seed Law and Regulations. The relevant authorities received also advice on matters related to plant variety protection.

In 1998 within the framework of the Technical Cooperation Programme, TCP/ECU/6712: "Apoyo a la Reestructuración del Sistema Nacional de Semillas", FAO assisted the Government in the formulation of a Draft Seed Law, which is now before Parliament, aimed at developing the national seed industry and meeting the standards for seed movement in national and international trade. In addition, national authorities received comments and advice on plant variety protection in relation to a comprehensive governmental Draft Law on Intellectual Property Rights.

El Salvador
In 1994, a project under the FAO's Technical Cooperation Programme, TCP/ELS/4452, "Apoyo a la Reestructuración del Organismo Certificador de Semillas", assisted the Government, inter alia, in drafting a Seed Law and Regulations. In addition, national authorities were advised on Plant Variety Protection matters.

Under the FAO Technical Cooperation Programme project, TCP/GEO/6711, an interdisciplinary mission assisted the authorities to build up a national seed industry development programme, including the relevant law and regulations.

In 1991 under its Technical Cooperation Programme FAO provided technical assistance to India on Plant Variety Protection, which was an input to the development of draft national legislation on the matter.

Under its Technical Cooperation Programme: TCP/JAM/6611: "Citrus Production and Certification Strategy", FAO assisted the Government in the formulation of draft legislation necessary for carrying out citrus certification.

Kyrgyz Republic
In late 1996 and 1997, under its Technical Cooperation Programme, TCP/KYR/6611: "Seed Legislation and Quality Control", FAO assisted the Government in the preparation of quality control schemes and assessed the seed related legislative framework in the Kyrgyz Republic. A Draft Seed Law was formulated as well as a Plant Variety Protection Law. Both drafts, with slight modifications were passed by Parliament.

Under FAO's Technical Cooperation Programme, project TCP/LIT/4553, an FAO mission assisted the authorities to prepare a seed master plan. On the basis of a Draft Seed Law prepared by the Government, FAO has submitted a revised version, which is now being reviewed by the authorities.

An official request from the Government has been received by the Technical Cooperation Programme with the objectives of strengthening the organizational and technical capacities of the National Seed Control Service and drafting the regulations necessary for the implementation of the Seed Law drafted with FAO assistance in 1994. The relevant legislation will be revised and updated as necessary in order to improve the seed certification and quality control schemes so as to allow the seed industry to compete on the regional and international markets.

At the request of the Economic Planning Unit of Malaysia, FAO approved project TCP/MAL/4553, under its Technical Cooperation Programme. The aim of the project was to strengthen seed and planting material production, and to develop a certification and marketing programme. FAO advised the Government on appropriate programme and policy measures for upgrading the national capability in variety registration, release and protection, and quality control and seed and planting material certification, by defining the respective role of various official agencies and the private sector. In addition, the project prepared a study analysing the implications of TRIPS Article 27.3(b), as well as the various options before the Government to give effect to this provision.

Under the FAO/UNDP project, MAU/92/007, "Appui à la vulgarisation de semences traditionnelles de qualité", a Draft Seed Law was prepared, which is currently awaiting submission to Parliament.

In 1997 a legal component was added to the Technical Cooperation Programme project TCP/NAM/4555: "Building Assistance to Improved Seed Production" with the objective of assisting the country in the formulation of a Draft Seed Act in order to enable it to implement the positive results of the project as far as the production of improved seed was concerned.

Project TCP/PAK/4557, under FAO's Technical Cooperation Programme, assisted the Government in the preparation of a seed sector development programme. Aware of the need to increase the involvement of the private sector, the Government intends to formulate a new comprehensive programme, including the adoption of specific legislation recognizing plant variety protection.

Under its Technical Cooperation Programme, project TCP/SLO/6711: "Planning of Strategy for Animal Breeding Development", FAO is assisting Slovakia develop the relevant legislative instruments.

The Government of Suriname is now considering the model Seed Act and draft Plant Breeder's Rights Act, which project GCP/RLA/108/ITA: "Improved Seed Production, CARICOM Countries and Suriname" (described above) contributed to drafting. Under project TCP/SUR/6711, FAO will now provide the national authorities with the necessary draft implementing regulations.

Tanzania was assisted by the FAO/UNDP project: URT/93/003, through the enhancement of the capacity to coordinate the national seed programme. The project assisted in the preparation of suitable draft legislation for a plant breeder's rights system.


1 Seiler, Achim. 1998. Sui generis systems: Obligations and options for developing countries. Biotechnology and Development Monitor, No. 34.

2 Editorial. 1998. TRIPS and the legal protection of plants. Biotechnology and Development Monitor, No. 34.

3 FAO's information is in the Attachment to Annex 1.

4 North-South Divide Splits TRIPS Council. International Centre for Trade and Sustainable Development (ICTSD). In BRIDGES Weekly Trade News Digest, Vol. 3, Number 42, 25 October 1999.

5 North-South Divide Splits TRIPS Council. International Centre for Trade and Sustainable Development (ICTSD). In BRIDGES Weekly Trade News Digest, Vol. 3, Number 42, 25 October 1999.

6 Martin Khor. Indigenous People Criticise WIPO Approach. In South-North Development Monitor (SUNS) #4545, 5 November 1999.

7 Opinions will, no doubt, differ regarding the advisability of requesting the WTO to tackle this issue, and the potential inappropriateness of referring to indigenous rights over the product of their collective intellectual effort in the terms of intellectual property. However, there is no real doubt that what is required is a regime to protect indigenous peoples' property rights over their intellectual effort, whatever the politically and culturally correct terminology for describing such a regime may be. Likewise, there is no doubt that the Peruvian proposal contemplates that any such mechanism would be of a sui generis nature, and not one based upon the principles of existing intellectual property rights (IPR) regimes per se.

Furthermore, calling for treatment of this issue within the framework of WTO is perhaps advisable, to avoid marginalization of the issue from debates on global trade which impact upon indigenous peoples human rights over their knowledge. (Brendan Tobin, Protecting Traditional Knowledge: The Challenge of Respecting Rights and the Danger of Vested Interests. Consideration of the Peruvian Draft Law on Protecting Indigenous Peoples' Collective Knowledge and a Latin American Communication to the Third Ministerial Conference of WTO. Draft paper submitted to BIO-IPR by the author (, 31 October 1999).

8 Background Study Paper No. 1: The appropriation of the benefits of plant genetic resources for agriculture: an economic analysis of the alternative mechanisms for biodiversity conservation (only in English).

Background Study Paper No. 2: Sovereign and property rights over plant genetic resources (available in English, Spanish and French).

Background Study Paper No. 3: Providing Farmers' Rights through in situ conservation of crop genetic resource (only in English).

Background Study Paper No. 4: Identifying genetic resources and their origin: The capabilities and limitations of modern biochemical and legal systems (only in English).

Background Study Paper No. 5: Información sobre las colecciones ex situ conservadas en jardines botánicos (only in Spanish and English).

Background Study Paper No. 6: Mejora genética para mantener la diversidad en los cultivos agrícolas (only in Spanish, but summaries in French and English are provided).

Background Study Paper No. 7: Contribución a la estimación de la interdependencia de los países en materia de recursos genéticos (available in Spanish, English and French).

Background Study Paper No. 8: Access to plant genetic resources and intellectual property rights (only in English).

Background Study Paper No. 9: Recent developments in biotechnology as they relate to plant genetic resources for food and agriculture (only in English).

Background Study Paper No. 10: Recent developments in biotechnology as they relate to animal genetic resources for food and agriculture (only in English).

9 As with other documents, the Report and the Plan could be made available to the TRIPS Council, if requested. They may also be accessed at Web site (, on the Internet.

10 Global Plan of Action, para. 237.

11 Global Plan of Action, para. 203 (e).

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