H.E. Ambassador Dr. Walter Werner

India

5   PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE

33.   The WHO report on Traditional Medicine Strategy 2014-2023 notes that demand for traditional and complementing medicines has been growing at a fast pace. The extent of economic value contained in herbal medicines is evident from the fact that the output of Chinese medical material was estimated to amount to USD 83.1 billion in 2012, an increase of more than 20% from the previous year. 34.   The Trilateral Study (WHO-WIPO-WTO) on Promoting Access to Medical Technologies and Innovation (2013) acknowledges the fact that traditional medicines and medical knowledge provide leads for the development of new treatments. It goes on to mention that many existing modern medicines are originally based on herbal products. 35.   India is an ancient civilization with a rich body of 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. India is also one of the seventeen identified mega bio-diverse countries of the world, home to a vast and a rich diversity of biological resources. 36.   In more recent years, with the establishment of the Traditional Knowledge Digital Library in India, more than 1000 patent applications could be identified in a short period of time where a patent was being sought for knowledge that already existed in codified traditional knowledge systems such as Ayurveda, Unani, Siddha and Yoga. 37.   Countries have adopted various methods to protect traditional knowledge and associated genetic resources at the national level. However, it is important to note that what can never be addressed by the domestic/national regimes is misappropriation of existing knowledge in foreign patent offices. Absence of an international regime therefore is a major gap in addressing the problem of biopiracy. 38.   It has therefore been a long-standing demand that there should be an international regime that makes the patent office the check point to contain misappropriation. Patents should not be granted for existing traditional knowledge and associated genetic resources. Further where genetic resources and associated traditional knowledge form the basis of scientific development, it is important that patent applications must disclose source or origin of the resource and also disclose whether the access was on mutually agreed terms. Disclosure is important not only to address information asymmetry at the Patent Office but also to enable a better assessment of the inventive step. The TRIPS/CBD linkage is therefore important for developing countries because it seeks to address biopiracy. 39.   Pursuant to the Convention on Biological Diversity (CBD), India has been active in taking steps to implement its provisions leading to conservation of biodiversity, its sustainable use and equitable sharing of benefits. We enacted the Biological Diversity Act in 2002, notified the Biological Diversity Rules in 2004 and also established a three-tier institutional structure. 40.   The Nagoya Protocol of the Convention on Biodiversity (CBD) entered into force on 12 October 2014. 105 Countries, including India, have ratified the Protocol, till now. 41.   The Doha Ministerial Declaration in Paragraph 19 mandated that the TRIPS Council examine the relationship between the TRIPS Agreement and the CBD, and the protection of traditional knowledge and folklore. 42.   We also need to take note of the recent developments of the 2030 Agenda for Sustainable Development to which we are all committed. It specifically calls for promoting access to and fair and equitable sharing of benefits arising from the utilization of genetic resources and associated traditional knowledge, as internationally agreed, in targets 2.5 and 15.6. 43.   It would also be useful to the delegates of the TRIPS Council if the CBD Secretariat were requested to brief the TRIPS Council on the latest developments in the implementation of the Nagoya Protocol. The briefing by the CBD Secretariat would be very important to understand the implications of the entry into force of the Nagoya Protocol, to which 105 Members have acceded. We reiterate our demand for a formal briefing by the CBD Secretariat in the interest of the large majority of Members. We also support updating the three factual briefs by the Secretariat. 44.   I conclude by stating that we hope to continue our efforts in building momentum on the issue of the TRIPS/CBD linkage, taking into account the new developments, such as the finalization of the Sustainable Development Goals and the ratification of the Nagoya Protocol by more than 100 countries.

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

14.   The Chair proposed that, following past practice, the three agenda items would be addressed together. Members had seen important developments in these areas, over the last decade. However, information on those developments had not been shared with the TRIPS Council. For example, the Review of Article 27.3(b) was based on an Illustrative List of Questions agreed by the Council. To date, only 25 Members had submitted responses to that list and there had been no responses or updates since 2003. Similarly, there had been no notifications of domestic mechanisms to protect genetic resources and traditional knowledge under Article 63.2 TRIPS. He encouraged delegations to submit or update responses and to notify relevant laws and regulations to the TRIPS Council. This would definitively facilitate and enrich the discussions. He recalled that there had been no new developments on two long-standing procedural issues, namely:
a. The suggestion, first made in November 2012, that the Secretariat update the three factual notes on the Council's previous discussions on TRIPS/CBD and related items; and
b. The proposal, initially submitted in October 2010, that the CBD Secretariat be invited to brief the Council on the Nagoya Protocol to the CBD.
15.   The representatives of India, Egypt, China, Brazil, Bangladesh, the Plurinational State of Bolivia, Ecuador, Chinese Taipei, Chile, South Africa, Indonesia, Canada, Thailand, Australia, Japan, the United States of America, and Switzerland took the floor.
16.   The Council took note of the statements made and agreed to revert to the matters at its next meeting.

IP/C/M/90, IP/C/M/90/Add.1