Council for Trade-Related Aspects of Intellectual Property Rights - Reviving discussions on the relationship between the TRIPS Agreement and Convention on Biological Diversity - Communication from Brazil, India and Peru

REVIVING DISCUSSIONS ON THE RELATIONSHIP BETWEEN THE TRIPS AGREEMENT
AND CONVENTION ON BIOLOGICAL DIVERSITY

COMMUNICATION FROM BRAZIL, INDIA and PERU

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1  INTRODUCTION

1.  Despite the explicit directive of the Doha and Hong Kong Ministerial Declarations, discussions on the mutual supportiveness of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and the Convention on Biological Diversity (CBD) have been dormant since 2011. The delegations of Brazil, India and Peru call on the Members of the World Trade Organization (WTO) to provide a clear mandate under the Ministerial Declaration of the 14th Ministerial Conference to revive discussions on this issue.

2  AN OVERVIEW OF THE CBD (1992) AND RELATED INSTRUMENTS

2.  A WTO-WIPO-WHO joint study of 2020 titled 'Promoting Access to Medical Technologies and Innovation' notes the profound influence of traditional medical knowledge on modern medicine. With 88% of WHO members acknowledging traditional and complementary medicine use, international trade in these products is growing rapidly. However, the study notes that this has come on the back of the rampant misappropriation of genetic resources (GR) and associated traditional knowledge  (TK). Some prominent examples of biopiracy include neem (India), turmeric (India), kava (Pacific Islands-Fiji and Vanuatu), ayahuasca (Brazil), quinoa (Peru), and hoodia (South Africa).[1] Assessing the economic loss to developing countries due to biopiracy is a complex task involving multiple factors, such as the loss of intellectual property (IP) rights, restricted access to genetic resources, negative impact on traditional industries, and discouragement of research and development in the country of origin.

3.  According to a recent WHO report, developing countries, especially those with rich biodiversity in Asia, Africa, and South America, supply approximately two-thirds of the plants used in western and global medical systems. This highlights the dependency of global health industries on the biodiversity of these regions.[2] While recent data is publicly unavailable, a 1999 report by the United Nations Development Program estimates that if a 2% royalty were charged on genetic resources developed by local innovators in the South, the North would owe over USD 300 million in unpaid royalties for farmers' crop seeds and more than USD 5 billion in unpaid royalties for medicinal plants.[3]  Another study notes that approximately 29,000 herbal substances used by more than 1000 companies have annual revenues exceeding USD 60 billion, with the bulk of the herbal products, or at least the raw material, sourced from biodiversity-rich countries in Asia, Africa, and South America.[4]

4.  The CBD (1992) marked the first step towards recognising the sovereign rights of states over their biological resources. It conditioned access to biological resources and associated traditional knowledge with prior informed consent (PIC) and access and benefit sharing (ABS) with local communities, who are the rightful holders of such knowledge. The Nagoya Protocol, which came into force in 2014, further developed the legal framework established under the CBD to operationalise the requirements of PIC and ABS. A significant shortcoming of the CBD and Nagoya Protocol is that it does not link these requirements with the patent system, resulting in the grant of erroneous patents to biopiracy-based inventions and lack of enforcement of the PIC and ABS commitments, particularly in a transboundary context.

3  THE ADOPTION OF THE WIPO TREATY (2024) ON GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE

5.  To address the above shortcomings, negotiations have been ongoing at the WIPO for over two decades to advance the conservation of genetic resources, traditional knowledge and traditional cultural expressions through the IP system. In 2000, the WIPO Intergovernmental Committee on IP and Genetic Resources, Traditional Knowledge and Folklore (hereinafter 'IGC') was tasked with concluding an international legal instrument to protect genetic resources, traditional knowledge and traditional cultural expression through the IP system. In May 2024, the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge ('the WIPO treaty') was adopted to increase the mutual supportiveness of the systems for the preservation of genetic resources and associated traditional knowledge and patent rights.

6.  The WIPO treaty requires patent applicants to disclose the source of the genetic resources and traditional knowledge on which their claimed invention is based. The disclosure requirement, if complied with by the applicant, would aid the patent office in conducting a prior art search. It would help prevent the patenting of inventions based on genetic resources and associated traditional knowledge that do not fulfil the requirements of novelty and inventiveness. Genetic resources and associated traditional knowledge obtained from one country are often used as a basis for seeking a patent in another. In such situations, the disclosure requirement would make the patent office the checkpoint to identify instances of transboundary utilisation of genetic resources and traditional knowledge.

7.  While a progressive instrument, the WIPO treaty could be further strengthened by integrating these commitments under the TRIPS Agreement. First, the WIPO treaty does not offer recourse to international dispute settlement if states fail to establish the disclosure requirement under their domestic patent systems. Second, the WIPO treaty does not address the requirements to obtain PIC under mutually agreed terms (MAT). Hence, even though the treaty introduces the disclosure requirement, it does not provide for compliance with the ABS requirements. The WIPO treaty shifts the burden to ensure compliance on the government agencies and local communities of the provider country, who must monitor published patent applications worldwide to ensure compliance and enforce ABS through PIC under MAT. Thus, amending the TRIPS Agreement to integrate the mandatory disclosure requirement could subject this commitment to the WTO's legal framework. Further, the TRIPS Agreement could build on the WIPO treaty to require evidence of PIC and benefitsharing arrangements as a prerequisite for patent grant or commercialization, thereby reinforcing the PIC and ABS commitments.

4  ESTABLISHING A LINKAGE BETWEEN THE CBD AND THE TRIPS AGREEMENT

8.  Given the close relationship between IP and international trade, the TRIPS Agreement integrated the minimum standards of IP protection provided under the various WIPO treaties into the trading regime, with the underlying objective of extending the WTO's binding dispute settlement, predicated on legally-supervised trade retaliation, to IP protection and enforcement. In 2001, paragraph 19 of the Doha Ministerial Declaration mandated WTO Members to discuss the relationship between TRIPS and CBD as part of the TRIPS review under Article 27.3(b) guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement. The Hong Kong Ministerial Declaration of 2005 reiterated the need to work towards a relationship between the TRIPS Agreement and CBD (paragraph 39).

9.  In 2008, a coalition of 109 WTO Members proposed an amendment to the TRIPS Agreement to implement the mandatory disclosure requirement and called for further negotiations linking the requirements of PIC and ABS with the patent system (document _TN/C/W/52).

10.  This was followed by another proposal in 2011 (document _TN/C/W/59), which garnered the support of 73 developing countries comprising India, Brazil, China, Colombia, Ecuador, Indonesia, Peru, Thailand, and the African and ACP Groups. Drafted as a textual proposal to amend the TRIPS Agreement through the introduction of Article 29bis, the submission spells out the provision for the mandatory disclosure of origin in patent applications, evidence of PIC and ABS as a prerequisite for patent grant or commercialization, and the legal implications of non-compliance, including patent revocation (see Annex I).

11.  The adoption of the WIPO treaty could provide a fresh impetus to resume these negotiations. A recent submission by Bangladesh, Colombia, Egypt and India (document _IP/C/W/708) has called for reviving WTO negotiations on this issue. Preserving genetic resources and associated traditional knowledge through the TRIPS Agreement will have two obvious advantages. First, the disciplines would be subject to the WTO's binding dispute settlement as compared to the WIPO treaty, which does not offer recourse to international dispute settlement. Second, it provides an opportunity to negotiate stronger disciplines and address the shortcomings of the WIPO treaty, in the context of achieving sustainability objectives. For instance, in contrast to the WIPO treaty, the proposed amendments to the TRIPS Agreement could require evidence of prior consent and a benefit-sharing arrangement as prerequisites for the grant of a patent or its commercialization. This would strengthen the enforcement of the PIC and ABS commitments, especially in a transboundary context.

5  WAY FORWARD

12.  In the context of protecting the legitimate rights of traditional communities and preventing misappropriation of genetic resources, the momentum gained from adopting the WIPO treaty must be channelled towards reviving negotiations on TRIPS-CBD linkage, thereby fostering greater harmony between the environmental, IP and trade regimes. This will ensure the flow of benefits to local and indigenous peoples of the developing countries as the providers and conservers of the genetic resources and the associated knowledge. This would also prevent the grant of erroneous patents and facilitate and ensure adequate and effective protection of Intellectual property rights.

13.  Given this background, the delegations of Brazil, India and Peru call on WTO Members to revitalise the discussions on the relationship between the TRIPS Agreement and CBD as part of the mandate of the 14th Ministerial Conference of 2026.


 

ANNEX 1

AMENDMENT TO ARTICLE 29bis, TRIPS, AS PROPOSED UNDER _TN/C/W/59

Presented below is the draft amendment to the TRIPS Agreement proposed by the delegations of Brazil, China, Colombia, Ecuador, India, Indonesia, Peru, Thailand, the ACP Group and the African Group under (document _TN/C/W/59) (2011).

Article 29bis

Disclosure of Origin of Genetic Resources and/or Associated Traditional Knowledge

1._    For the purposes of establishing a mutually supportive relationship between this Agreement and the Convention on Biological Diversity, Members shall have regard to the objectives, definitions and principles of this Agreement, the Convention on Biological Diversity, and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, in particular its provisions on prior informed consent for access and fair and equitable benefit sharing.

2._    Where the subject matter of a patent application involves utilization of genetic resources[5] and/or associated traditional knowledge, Members shall require applicants to disclose: (i) the country providing such resources, that is, the country of origin of such resources or a country that has acquired the genetic resources and/or associated traditional knowledge in accordance with the CBD; and, (ii) the source[6] in the country providing the genetic resources and/or associated traditional knowledge. Members shall also require that applicants provide a copy of an Internationally Recognized Certificate of Compliance[7] (IRCC). If an IRCC is not applicable in the providing country, the applicant should provide relevant information regarding compliance with prior informed consent and access and fair and equitable benefit sharing as required by the national legislation of the country providing the genetic resources and/or associated traditional knowledge, that is, the country of origin of such resources or a country that has acquired the genetic resources and/or associated traditional knowledge in accordance with the CBD.

3._    Members shall publish the information disclosed in accordance with paragraph 2 of this Article jointly with the publication of the application or the grant of patent, whichever is made first.

4._    Members shall put in place appropriate, effective and proportionate measures so as to permit effective action against the non-compliance with the obligations set out in paragraph 2 of this Article. Patent applications shall not be processed without completion of the disclosure obligations set out in paragraph 2 of this Article.

5._    If it is discovered after the grant of a patent that the applicant failed to disclose the information set out in paragraph 2 of this Article, or submitted false and fraudulent information, or it is demonstrated by the evidence that the access and utilization of genetic resources and/or associated traditional knowledge violated the relevant national legislation of the country providing genetic resources and/or associated traditional knowledge, that is, the country of origin of such resources or a country that has acquired the genetic resources and/or associated traditional knowledge in accordance with the CBD, Members shall impose sanctions, which may include administrative sanctions, criminal sanctions, fines and adequate compensation for damages. Members may take other measures and sanctions, including revocation, against the violation of the obligations set out in paragraph 2.

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[1] Victoria Tauli-Corpuz, 'Biodiversity, Traditional Knowledge and Rights of Indigenous Peoples' Third World Network (2003); Edward Hammond, 'Biopiracy Watch: A Compilation of Some Recent Cases', Third World Network (2013).

[2] WHO Global Report on Traditional and Complementary Medicine (2019) <https://www.who.int/publications/i/item/978924151536>.

[3] Human Development Report, United Nations Development Program (1999).

[4] Ramanujam Srirama et al., 'Species Adulteration in the Herbal Trade: Causes, Consequences and Mitigation' Drug Safety (2017).

[5] As mentioned in Article 2 of the CBD, "Genetic resources" means genetic material of actual or potential value and "Genetic material" means any material of plant, animal, microbial or other origin containing functional units of heredity.

[6] Including details of whom in the providing country such resources were obtained from.

[7] Article 17.3 of the Nagoya Protocol states that "An internationally recognized certificate of compliance shall serve as evidence that the genetic resource which it covers has been accessed in accordance with prior informed consent and that mutually agreed terms have been established, as required by the domestic access and benefit-sharing legislation or regulatory requirements of the Party providing prior informed consent". Article 17.4 states the minimum information that shall be contained in the IRCC when such information is not confidential.