Ambassador Alfredo Suescum (Panama)

India

4; 5; 6 REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B); RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION ON BIOLOGICAL DIVERSITY; PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE

India is one of the seventeen identified mega bio-diverse countries of the world. India is also rich in traditional knowledge associated with biological resources. This traditional knowledge is both coded, as in the texts of Indian systems of medicine such as Ayurveda, Unani and Siddha; and non-coded, which exists in the oral undocumented traditions. 58. India has been a major victim of bio-piracy. Pursuant to its ratification of the Convention on Biological Diversity (CBD), India developed a comprehensive legislation on biodiversity, including a Traditional Knowledge Digital Library (TKDL) database to prevent misappropriation of traditional knowledge at international patent offices so that cases of biopiracy can be prevented. India has signed a TKDL Access Agreement with nine International Patent Offices. While India has pioneered the TKDL to overcome language and format barriers, the results could only be limited. Improving prior art searches through the TKDL is only one part of the solution. Further, the TKDL represents a subset of the universe of available traditional knowledge. The realm of traditional knowledge in areas other than herbal cures and genetic resources is not covered by the TKDL. 59. While India is undertaking a number of measures at the national level in order to prevent misappropriation of genetic resources and/or associated traditional knowledge, the problem has an obvious international dimension and needs an international solution in order to be addressed effectively. The TRIPS Agreement continues to ignore the numerous IPR-related obligations in the CBD which are of interest to the developing countries. The disclosure proposal (IP/C/W/474) which was submitted in 2006 was followed up by the submission TN/C/W/52 in June 2008 with the support of 109 members. The latest submission on this issue TN/C/W/59 in April 2011, which is a draft decision to enhance mutual supportiveness between TRIPS Agreement and CBD, has been proposed by a vast majority of WTO Membership, including India. This proposal seeks an amendment of the TRIPS Agreement by inclusion of a new Article 29bis for disclosure of origin of genetic resources and/or associated traditional knowledge. A mandatory disclosure requirement in patent applications to include disclosure of origin and evidence of prior informed consent and access and benefit sharing, would, in addition to combating biopiracy, further strengthen the credibility of the patent system by facilitating assessment of the novelty and inventiveness criteria. 60. The Nagoya Protocol of the Convention on Biodiversity (CBD) entered into force on 12th October 2014. So far 96 Countries, including India, have ratified the Protocol. According to the CBD website, the Access and Benefit-sharing Clearing-House (ABS-CH), which is a platform for exchanging information on access and benefit-sharing established by Article 14 of the Protocol, is now fully operational. The ABS-CH is a key tool for facilitating the implementation of the Nagoya Protocol, by enhancing legal certainty and transparency on procedures for access, and for monitoring the utilization of genetic resources along the value chain, including through the internationally recognized certificate of compliance. So far, four countries (Guatemala, India, Mexico and South Africa) have published 50 internationally recognized certificate of compliance (IRCC) with details of prior informed consent for access to genetic resources and benefit sharing on mutually agreed terms. 61. In the 2030 Agenda for Sustainable Development, two targets (SDG 2.5 and 15.6) related to genetic diversity and the fair and equitable sharing of benefits have been included. This demonstrates that ABS and the Nagoya Protocol are making an important contribution to the conservation of biodiversity and sustainable economic development for all. Furthermore, the second meeting of the Conference of the Parties serving as the meeting of the Parties to the Nagoya Protocol on Access and Benefit-sharing was held in Cancun, Mexico from 4-17 December 2016. According to the CBD website, decisions that were adopted at this Meeting include progress made towards Aichi Biodiversity Target 16, the Access and Benefit-sharing Clearing-House, measures to assist in capacity-building and cooperation with other international organizations or initiatives. 62. It would be quite useful to the delegates of the TRIPS Council if the CBD Secretariat is requested to brief the TRIPS Council in the June session on the latest developments in the implementation of the Nagoya Protocol, including the decisions that were taken at the December Meeting at Cancun in Mexico. The briefing by the CBD Secretariat would be very important to understand the implications of the entry into force of the Nagoya Protocol on the TRIPS Agreement. We reiterate our demand for a formal briefing by the CBD Secretariat in the interest of the large majority of developing countries. We also support Ecuador's proposal for updating the three factual briefs by the Secretariat. 63. I conclude by stating that the TRIPS-CBD issue is one of the outstanding implementation issues and positive outcomes on outstanding implementation issues are one of the most important deliverables of the Doha Round for the developing countries.

IP/C/W/474; TN/C/W/52; TN/C/W/59

The Council took note of the statements made and agreed to revert to the matters at its next meeting.

31. The Chairman recalled that, at the Council's meeting in November 2016, Members had exchanged views under these agenda items. The discussions had covered substantive issues, such as the suggested inclusion of a mandatory disclosure requirement in TRIPS, as well as the patentability of life forms. Discussions had also covered two pending procedural proposals – whether the CBD Secretariat should be invited to debrief the Council on the Nagoya Protocol, and whether the WTO Secretariat should update the three factual notes that had been prepared and last updated ten years ago.

32. Since Members had remained divided both on the substantive and procedural issues, no progress could, however, be made. There had also been no unanimous support for a proposal made by some delegations that the CBD Secretariat be asked to debrief the Council when it was meeting in informal mode.

33. He recalled that there had been no more responses or updates to the Illustrative List of Questions on Article 27.3(b), and no notifications or reports of domestic mechanisms to protect genetic resources and traditional knowledge. Despite the importance attached to the Article 27.3(b) review, which had been on the Council's agenda since 1998, the last response or update on the questions had been submitted in 2003, some 14 years ago, and material had been received from fewer than one in six Members. He therefore reminded delegations that the Article 27.3(b) review was an integral part of the TRIPS Agreement. The information provided to the Council clearly did not cover the important developments that many WTO Members had seen in this area over the last decade. Regarding the CBD Secretariat briefing and the updating of the Secretariat notes, there was no substantive signs of evolution towards an outcome.

34. The representatives of Brazil; the Plurinational State of Bolivia; Bangladesh on behalf of the LDC Group; India, Ecuador; Egypt; Indonesia; China; Nigeria on behalf of the African Group; Australia; the United States; Switzerland; the Republic of Korea; Japan; Canada and the European Union and the Chairman took the floor.

35. The Council took note of the statements made and agreed to revert to the matters at its next meeting.

IP/C/M/85, IP/C/M/85/Add.1