Some legal scholars argue that 'the predominant intellectual property rights regime-based on the Paris Convention (1967)29 is not adequate to protect traditional knowledge'.30 In fact, the regime of protection of traditional knowledge just became crystallised in 1992 with the United Nations Convention on Biological Diversity. The issue renting to the protection of traditional knowledge by the granting of patents in respect of traditional knowledge was discussed by the World Trade Organisation in the revision of the TRIPS Agreement article 27, 3(b) concerning traditional knowledge and biodiversity.31 The TRIPS Agreement, Article 27, 3(b) aimed to protect plant varieties either by patents or by the sui generis32 system:
Member may also exclude from patentability:
Plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological process. However, member shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.33
The United Nations Convention on Biological Diversity (hereafter referred to as
'CBD') was a product of the June 1992 United Nations Conference on Environment and Development (known as the 'Earth Summit') which was adopted in Rio de Janeiro. The CBD was entered into force on 29 December 1993, currently there are one hundred and ninety one parties as at 10 August 2009, the United States was one out of the five nations that did not ratify this Convention.34 The CBD was considered the first international agreement to clearly express the global importance of both traditional practices and future innovations in biodiversity conservation and sustainable development.35 The traditional knowledge related issues in the CBD are found in article 8(J).36 The recognition and protection under this article for traditional knowledge may be broken down into four elements: (a) respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity; (b) promote their wider application; (c) with the approval and involvement of the holders of such knowledge, innovations and practices; (d) encourage the equitable sharing of the benefits arising from the utilisation of such knowledge, innovations and practices.37
The importance of these elements related to the sustainable use of biological diversity and the equitable sharing of the benefits of its use. This model opens for all parties, access to biological resources located in their sovereignty. The CBD provisions relating to the protection of traditional knowledge also included article 10(c) which calls on parties to protect and encourage the customary use of biological resources in accordance with traditional cultural practices.38 In addition, article 18 concerning the technical and scientific cooperation
recognises and encourages the parties to exchange and develop indigenous and traditional knowledge.39
The models for protection of traditional knowledge and their relationship under the TRIPS Agreement and the CBD have engendered worldwide discussion among scholars. Both agreements came from different sources and different times. Presently, the issues concerning the relationship between the TRIPS Agreement and the CBD for the protection of traditional knowledge and folklore were discussed in the WTO-TRIPS Agreement review of Article 27, 3(b)40
The developed countries do not, in general, contest the right of developing countries to protect traditional knowledge.41 They generally hold the view that the TRIPS Agreement and the CBD are mutually supportive and object to the idea of disclosure requirement of genetic resources in the process of patent applications.42 At the TRIPS Council Meeting, 5-7 March 2002, these positions were repeated.43 Some developed countries, such as the USA, EU, Japan and Norway, said that the discussion in the TRIPS Council should wait for the results of work being one in the various international forums, such as the WIPO.44 In contrast, some developing countries, such as Brazil and India, underlined again the need to explore sui generis systems for the protection of traditional knowledge.45
In a survey conducted by the World Intellectual Property Organisation (WIPO) of forty seven countries and the European Community countries were asked if they had any specific law (sui generis) providing intellectual property protection for traditional knowledge. Only five countries; as Brazil, Costa Rica, Guatemala, Panama and the Philippines, answered that they had a specific law.46 As mentioned above, most of world's biodiversity is located in developing countries.47 This is especially true of herbal medicine or plant-based medicine. These resources are rich in rainforest and tropical countries. It is thus not surprising that the trend towards the protection of traditional knowledge has emerged from developing countries more than developed nations.
B Thailand and the Policy of Traditional Medicine Protection
Thailand48 is one of the richest countries of traditional medicine and genetic resources in the Southeast Asia region. As mentioned earlier, there are about 10,000 plant varieties containing medicinal properties in Thailand, about 2,000 terrestrial species of which are only found in Thailand49 and the density of medicinal plants rates are at 30 bio-species per one square kilometre.50 Thailand has also faced some experiences of biopiracy on Thai Jasmine rice (Thai Khao Horn Mari)51, Kwao Kruae (Pueraria mirifica)52, and Plao-noi (Croton sublyratus)53
Thai traditional medicine has long been used in Thai health care and is a sort of 'holistic and natural approach of health care' and related closely to the Buddhism religion.54 Moreover, some of them have been developed from India and China.55
In refer to the protection of consumer, Thai traditional medicine products have been controlled by the Drug Act B.E. 2510 (1967). There are both pre-marketing and post-marketing controls of traditional medicine. The pre-marketing control measures are: a) the manufacture, importation or selling of traditional medicine requires the license from Thai Food and Drug Administration (hereafter referred to as 'Thai FDA');56 b) traditional medicine needs to be registered with the Thai FDA in order to control the quality, safety and efficacy of the drug prior marketing;57 c) drug advertisements in all media have to get approval from the Thai FDA before distribution to die public. This is to control the 'truthfulness and non-exaggeration: of drug information.58 The post-marketing control is a general sampling check of traditional medicinal products from market places. These include the following:
a) Inspection of GMP [Good Manufacturing Practices] compliance at manufacturing sites;
b) Monitoring of manufacturing process changes to ensure no adverse effects on the safety or efficacy of the medicines; c) Monitoring of the use of marketed drugs for unexpected health risks, taking action if risks are detected by informing the public, investigating the cause and removing the drugs from the market; d) Receiving and handling of complaints; e) Safety monitoring program for new drugs; f) Re-evaluation of pharmaceutical products.59
29. The Paris Convention, an intellectual property agreement, became effective in 1967, specifically with patents, trademarks, and designs. See WIPO-IP Administered Treaties (2009) <http://www.wipo.int/treaties/en/> at 22 September 2010.
30. Carvalho, above n 28, 39.
31. World Trade Organisation, Council for Trade- Related Aspects of Intellectual Property Rights: The Protection of Traditional Knowledge and Folklore Summary of Issues Raised and Points Made, IP/C/W/370?Rev.1, 9 March 2006 <http://www.wto.org/> at 22 September 2010.
32. Sui generis is the Latin means 'of its own kind or class; unique or peculiar'. See Bryan A Garner, Black's Law Dictionary (9th Edition, 2009) 1572.
33. UNCTAD-ICTBD Project on IPRs and Sustainable Development, Resource Book on TRIPS and Development (2005) 388.
34. The United Nations Convention on Biological Diversity 1992, <http://www.cbd.int/convention/ parties/list.shtrnl at 22 September 2010.
35. Graham Dutfield, cited in Thomas J Krumenacher, 'Protection for Indigenous Peoples and Their Traditional Knowledge: Would a Registry System Reduce the Misappropriation of Traditional Knowledge?'(2004) 8 Marquette Intellectual Property Law Review 143, 153.
36. The United Nations Convention on Biological Diversity 1992, Article 8 (j) stating that'Each Contracting
Party shall, as far as possible and as appropriate: (j) Subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application With approval and involvement of the holders of such knowledge, innovations and practices, and encourage the equitable sharing of benefits arising from the utilization of such knowledge, innovations and practices'. See the United Nations Convention on Biological Diversity 1992, <http://www.cbd.int/convention/articles.shtmi?a=cbd-08> at 22 September 2010.
37. Carvalho, above n 28. 59.
38. The United Nations Convention on Biological Diversity 1992, Article 10(c), above n 36.
39. The United Nations Convention on Biological Diversity 1992, above n 36; see also Ruiz, Lapena and Clark, above n 19, 760-1.
40. See more details on the WTO Secretariat documents, Summarises of issues raised and points made on the TRIPS Agreement and the Convention on Biological Diversity. Paper IP/C/W/368/Rev.1, revised 8 February 2006, Review of Article 27, 3(b); Paper IP/c/w/369/ Rev.1, revised 9 March 2006; The protection of traditional knowledge and folklore. Paper IP/c/w/370/Rev.1, revised 9 March 2006; Review of the Provisions of Article 27, 3(b): Illustration List of Questions Prepared by the Secretariat- Revision. PaperlP/c/w/273/ Rev.1, 18 February 2003. The Seventh Session of the WTO Ministerial Conference held in Geneva, Switzerland, from 30 November to 2 December 2009. See the World Trade Organization, WTO: 2009 NEWS ITEMS <http://www.wto.org/english/news_e/news09_e/ gc_chair_stat_26mayO9_e.htm> at 22 September 2010. The general theme for discussion in this Conference shall be the 'WTO, Multilateral Trading System and the Current Global Economic Environment'.
41. The World Trade Organisation, Ministerial Conference Fourth Session, Doha, 9-14 November 2001, WT/MIN(01)/DEC/1 (Ministerial Declaration, Adopted on 14 November 2001) 4.
43. WTO news: 2002, News items TRIPS Council Regular Meeting 5-7 march 2002 <http://www.wto.org/english/news_e/news02_e/trips_reg_020307_e.htm> at 23 September 2010.
44. The WTO, Ministerial Conferences-Cancun 2003 'Briefing Notes on the Ministerial and the Main Issues' <http://www.wto.org/english/theWTO_e/minist_e/min03_e/brief_c/u,ief06_e.htm> at 22 September 2010; see also Graham Dutfield, intellectual Property, Biogenetic Resources and Traditional Knowledge (2004) 129-30.
Department of Commerce, Government of India, 'Protecting Traditional Knowledge: Why it is important' (2002) 4 No.4 india & The WTO, A Monthly Newsletter of the Ministry of Commerce and Industry 1, 17.
46. WIPO, Survey on Existing Forms of Intellectual Property for Traditional Knowledge, Document WiPO/GRTKF/iC/2/5 <http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_2/wipo_grtkf_ic_2_5.doc> at 22 September 2010; also cited in Carvalho, above n 28, 59.
47. Ruiz, Lapena and Clark, above n 19, 758.
48. The 'Kingdom of Thailand' known as 'Thailand' is the only country in the Southeast Asia region that has never been colonized. The Country consists of 513,115 sq. km or 198,114 sq. mi. as equivalent to the size of France or slightiy smaller than Texas. The total population in 2000 is about 62,056,000 (male: 30,885,000 and female: 31,171,000) and totally increased to 65,740,000 in 2007. The Country is surrounding by Myanmar, Laos, Cambodia and Malaysia. About 80% of the population is based on primary agricultural products. Thailand is one of me rice exporters among India, Bangladesh, Vietnam and the United States. Thai Khao Horn Mari known as Thai Jasmine rice has long been known among the rice consumers. In the past decades, Thailand began to shift the development into industrial manufacturing particularly for exportation. However, most of the people, particularly in rural areas, are still rely on agricultural sectors. See The U.S. Department of State, Diplomacy in Action, Thailand,
<http://www.state.gOv/r/pa/ei/bgn/2814.htm> at 22 September 2010; see also Narongsakdi Aungkasuvapala and Suvaj Siasiriwattana, 'Support to Vulnerable People in Welfare and Medical Services Collaboration of Social Welfare and Health Services, and Development of Human Resources: Country Report Thailand' (Paper presented,
at the 4lh ASEAN & Japan High Level Officials Meeting on Caring Society, Tokyo, Japan, 28-31 August 2006) 3.
Thai Traditional Medical Wisdom Protection Section, Thai Traditional Medicine institute, ‘CDB and Thai Constitutional Court' (2000) 4/1 Thai Traditional Medicine Journal 6, 8.
50. Thomas J Krumenacher, 'Protection for Indigenous Peoples and Their Traditional Knowledge: Would a Registry System Reduce the Misappropriation of Traditional Knowledge?' (2004) 8 Marquette Intellectual Property Law Review 143, 151.
51. 'Thai Khao Horn Mari' or 'Thai Jasmine rice' has generally been known and accepted by rice consumers for immemorial times. In 1995, Chris Deren, researcher the University of Florida's Everglades Research and Education Center in Belie Glade and Neil Rutger, project director of the United Stated Department of Agriculture was successfully develop the Jasmine rice line 'Khao Pathum Thani 1'. They planed to submit the new rice line of Thai Jasmine rice for patenting to the United Stated Patent and Trademark Office. This case was settled by the political discussion of the Thai Prime Mister Mr Taksin Shinawatra and the United States President Mr George W Bush on his visited the United States in December 2001. Finally Chris Deren and the United Stated Department of Agriculture declared not to seek for patenting on the new strain rice line of Thai Jasmine rice. See Woods, above n 9, 139-41. For whatever reasons, lastly, Thai Government policy has changed the name of 'Jasmine rice' to 'Khao-Hom-Ma-Li' (the meaning of Jasmine rice in Thai).
52. 'Kwao Kruae' or Pueraria mirifica is a kind of herb use for medicinal compounds, cosmetics and food additives. Thai Kwao Kruae (Pueraria mirifica) had been patent in various products in Japan, Korea, Australia, EU and the United States. It has been found as 'prior art' in Thailand. Kwao Kruae was documented in form of text by Laung Anusan Suanthorn published in Larn-na language (native northern language of Thailand) in B.E. 2472 (1929). The text was reprinted in Central Thai language in B.E. 2474 (1931). Kwao Kruae was first patented by Dr. Pope on behalf of National Research Development Corporation, London, England, it was submitted for patent on 14 April 1955 and granted on 6 November 1957. See Vichai Chokevivat, 'What should we do with the Patent of Kwao Kruae?1 (B.E. 2548 (2005)) 3 Thai Traditional and Alternative Medicine Journar 102, 102-113.
53. See GRAIN and Kalpavriksh, Traditional Knowledge of Biodiversity in Asia-Pacific: Problems of Piracy & Protection (2002) [27-8] GRAIN <http://www.grain.org/briefings/?type=5&l=1> at 22 September 2010.
54. Vichi Chockevivat and Anchalee Chuthaputti, 'The Role of Thai Traditional Medicine in Health Promotion' (Paper presented at the 6th Global Conference on Health Promotion, Bangkok, Thailand, 7-11 August 2005) 2.
The Drug Act B.E. 2510 (1967) Article 46 stating that 'No person shall produce or sell a traditional drug, or import of order a traditional drug into the Kingdom, unless he has obtained a licence from the licensing authority. The application for and the grant of a licence shall be in accordance with the rules, procedures and conditions prescribed in the Ministerial Regulation'. See Food and Druy Administration Thailand (Thai FDA), Drug Control Division, Ministry of Public Health, <http://www.fda.moph.go.th/eng/drug/pre.stm> at 22 September 2010.