management, development and application of traditional knowledge; discourage, .... Herbal Pharmaceuticals and Cosmeceutical Company â consultant and.
Study on Intellectual Property Rights (IPRs) and Trade in Traditional Medicines (TM) in Sri Lanka Dr. Pathirage Kamal Perera (PhD) Senior Lecturer/Head of the Department of Ayurveda Pharmacology and Pharmaceutics, Institute of Indigenous Medicine, University of Colombo, Sri Lanka Dr. Manisha Shridhar (PhD) South East Asia Regional Advisor, IPR & Trade & Health, Health Systems & Development (HSD), World Health Organization
Learning outcomes
1.
• Identify TM and trade issues
2.
• Analyze Legal Position of Sri Lanka on IPRs
3.
• Analyze ER issues in TM and TK
4.
• Develop IPRs model for TM & TK 2
1. Objective • To study the interface of intellectual property rights (IPRs) and trade in traditional medicine (TM) relating to Sri Lanka, including Access and Benefit Sharing in Public Health for research on traditional medicine systems and access to local biological resources.
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2. Rationale In the World Health Assembly Resolution, WHA61.21 Global strategy on public health, innovation and intellectual property, the Member states have focused on traditional medicine in a number of elements. Element (1.3): encouraging research and development in traditional medicine Element (3.4): supporting policies that will promote innovation based on traditional medicine Element(3.5): developing and implementing, where appropriate, possible incentive schemes for health-related innovation (a) encourage the establishment of award schemes for health-related innovation (b) encourage recognition of innovation for purposes of career advancement for health researchers Element(5.2): providing as appropriate, upon request, in collaboration with other competent international organizations technical support including the flexibilities recognized by the Doha Ministerial Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS), Agreement and Public Health and other WTO instruments related to the TRIPS agreement, in order to promote access to pharmaceutical products (e) encourage finding ways, in ongoing discussions, to prevent misappropriation of health-related traditional knowledge, and consider where appropriate legislative and other measures to help prevent misappropriation of such traditional knowledge. 4
3. Outcomes sought from the Study To explore and suggest possible course of actions most appropriate in the above rationale for Member States of SEARO with particular reference to Sri Lanka.
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4. Identify trade and global opportunities for TM
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4.1 Traditional Medicine “The sum total of the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illnesses” (WHO)
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4.2 WHO Traditional Medicine Strategy Key objectives: Policy — integrate TM within national health care systems, where feasible, by developing and implementing national TM policies and programmes.
Safety, efficacy and quality — promote the safety, efficacy and quality of TM by expanding the knowledge base, and providing guidance on regulatory and quality assurance standards.
Access — increase the availability and affordability of TM, with an emphasis on access for poor populations.
Rational use — promote therapeutically sound use of appropriate TM by practitioners and consumers. 8
4.3 Populations using TM/CAM worldwide Populations in developing countries using traditional medicine for primary health care
Populations in developed countries who have used complementary and alternative medicine at least once
90%
Ethiopia Benin
70%
India
70%
Rwanda
70%
Tanzania
60%
Uganda
60%
Germany
80% 70%
Canada
75%
France Australia USA
48% 42%
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4.4 Herbal medicines are rapidly increasing in economic importance Marketing of Herbal Products (Thousand million US$) 6
5.4
5
4.4
4 3.05 3 1.6
2 1
0.86
0 1990
1994
1997
1999
2000
Annual sales of OTC herbal medicines in USA 10
4.5 Marketing of Herbal Products in Great Britain (Million US$) $200 $180 $160 $140 $120 $100 $80 $60 $40 $20 $0
184 159 134 92
1994
1998
2000
2002
Source: House of Lords, 2000 11
4.6 % of Global Herbal Market Share Other
China
India
2% 30%
68%
Source: Aneesh T P, Hisham M, Sekhar M S, Madhu M, Deepa T V. International market scenario of traditional Indian herbal drugs - India declining... Int J Green Pharm 2009;3:184-90
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4.7 Case I: Lesson learnt from China •
Modernizing traditional medicine profession with government-sponsored GAPs , Good Manufacturing Practices (GMPs) and GCPs
•
GAPs stress selection of the correct germplasm with a high content of stable active components Offer SOPs for use of fertilizers, irrigation systems and disease management allied with insects and pest prevention and cure of herbs
•
GAPs also establish standards for noxious and harmful contaminants like heavy metals, pesticide residues and microbes in plants
All manufactures of TCM are mandated to comply with guidelines laid down by China's State Drug Administration (SDA) by 2004 and farms producing raw ingredients must comply with SDAimposed standards by 2007.
The pharmaceutical products can be patented in the field of traditional medicine, include traditional medical compositions, herbal preparations, extracts from herbal medicines or compositions, treated herbal materials and health foods with herbal medicines, etc. A new herbal medicine could be protected if first found to have curative effects Source: Xinhua News Agency. Traditional Chinese medicine has broad prospects in int′l market: experts. High Beam Research 2004
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Source: The World Medicines Situation – WHO, 2004
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4.8
SWOT analysis of Sri Lankan TMS
Strengths 1. Being practiced over ages with good manufacturing base 2. Sri Lanka is recognized world over as alternate medicine source including separate ministry. 3. Strong support system- 2 educational Institutions affiliated to 2 major Universities with teaching hospitals 4. Research Institute (BMARI) with drug corporation 5. Herbal gardens (Haldummulla, Pattipola, Ganewaththa etc.), biological hot spot 6. Opportunities Hospitals 49, central dispensaries 159 1. 2. 3. 4. 5. 6. 7.
World over natural and traditional approaches being welcomed Increased scope for innovation and change in approach for therapies Estimated global market size: US$ 75 bn Nutraceuticals: Global market size is Rs. 12148 bn Ayurveda coupled with medical and experiential tourism Exports of medicinal products Resource for novel drug development by reverse pharmacology
Weakness 1. Low scale of operations and Technology 2. Lack of globally accepted standards 3. Formulations don’t qualify for certifications 4. Not fully integrated with mainstrea markets 5. No efforts for new market access and branding 6. Low level of entrepreneurial aggressiveness 7. Irregular supply of inputs/ raw material 8. Low level of research integration with main stream medical sector Threats 1. Sector might become irrelevant to issues of health care for wont of innovation/ R&D 2. Brand recognition of alternate medicinal systems like Chinese, Latin & South American, African etc rising 3. Non documentation of traditional skills might lead to dissipation of knowledge. IPRs issues 4. Protecting the traditional knowledge from Multi-National Companies (MNCs)
Internal factors
External factors
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Positive
Negative
5. Analysis on existing legal framework in protecting TK and TM in Sri Lanka • With the development of new technology and development of world trade there is a threat for traditional knowledge on traditional medicine specially in the developing country who are yet unable to protect their own traditional knowledge. Do Sri Lanka protected?
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5.1 Sri Lanka Traditional Medicine and Traditional knowledge •
Number of Ayurveda physicians registered under the Sri Lanka Ayurveda Medical council is around 19,754 as at 31st December,2010 (Statistics from Ayurveda Medical council 2010).
•
Apart from the above registered physicians at the Ayurveda Medical Council, there are more than 8000 Traditional Medical Practitioners practicing medicines who are decedents of reputed families with secret formulae to cure deceases engaged in Public Health Care(Statistics from Ayurveda Medical council 2010).
•
About 60 to 70% of the rural population relies on traditional and natural medicine for their primary health care.
•
Herbal drugs are essential components of primary health care system in Sri Lanka (World Health Organization, 2001)
•
The Ayurveda and Deshiya Chikitsa systems use mainly plant and herbal preparations for the treatment of diseases, the former uses about 2000 species, the latter about 500. The plants are used singly or as mixtures (Weragoda , 1980).
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Siddha 13%
Unani 3%
Ayurveda 84%
Percentage of General Practitioners with University Education with the Traditional Medical System in Sri Lanka 19
5.2 TM and Traditional Knowledge (TK) •
Traditional Medicine related Traditional knowledge (TK) in Sri Lanka is mainly come with the formalized medicinal systems such as Ayurveda, Siddha, and Unani, which were basically mixed with traditional medical systems of Asian countries (Perera, 2012).
•
There is a large TK from Sri Lankan unique none formalized traditional medical system known as “Deshiya Chikitsa”(Perera, 2012). The community relies on this system for many treatments including for the treatment of eye diseases, fractures and dislocations, burns and scalds, boils and carbuncles and cancers.
•
Some of the practitioners specializing in fractures and dislocations are of such high reputation that they are often the first choice for treatment even by sections of the community accustomed to allopathic (western) medicine (Twarog S and Kapoor, 2004).
•
The TK involved has been protected in the form of family secrets transmitted from one generation to another due to IPR related issues.
•
There are more TK based on ola-leaf manuscripts and ancient books on traditional medical system. Still these texts TK are uncovered for public health development.
Note: Sri Lanka need to develop a national project for preserves these manuscripts and ancient books on traditional medical system for future research to develop health products. There is urgency for digitalized these knowledge for research and developments. It will become easily accessible for these TK for research and public health development. The Traditional Knowledge Digital Library launched by the Government of India, is an example of how ancient knowledge available in the ancient scriptures made digitally accessible . 20
5.3 TM and Pharmaceutics • Sri Lanka Ayurvedic Drugs Corporation which was incorporated in 1969 by the government extra ordinary gazette notification No. 14853/1 dated 11May 1969 under the provision of State Industrial Corporation Act. No. 49 of 1957 as the pioneer of manufacturing and marketing of Ayurvedic Drugs in Sri Lanka for more than 40 years. • The Department of Ayurveda, Sri Lanka has documented the national formalized medicinal system in the three volumes of Part I of the Ayurveda Pharmacopoeia . – The Pharmacopoeia identifies the raw materials used by physicians using the indigenous system, drugs that should be prescribed for various diseases, and methods of preparation for different drugs
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5.4 TM and Research •
Plants used in the local Ayurveda system have been botanically described, and many of these have been investigated for their biological activities by scientists in the universities and research institutes.
•
Bandaranayake Memorial Ayurvedic Research Institute (BMARI) was established for the development of Ayurveda and TM in Sri Lanka through research on related fields including clinical research, drug research, community based research and literary research .
•
There are three main University affiliated research and educational state Ayurveda Institutes in Sri Lanka. – The Institute of Indigenous Medicine is the premier Higher Educational Institute in Sri Lanka that provides instructions in Ayurveda, Unani and Indigenous system of medicine at undergraduate and postgraduate levels. The college of Ayurveda was first started in the Island (1929), subsequently upgraded and affiliated to the University of Colombo in the year 1977 as the Institute of Indigenous Medicine. – Gampaha Wickramarachchi Ayurveda Institute is affiliated to the University of Kelaniya – Siddha Section , University of Jaffna
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5.5 Intellectual Property Rights Act 2003 • The intellectual property rights act No: 36 of 2003 has replaced the code of Intellectual Property Act No: 52 of 1979. This act has introduced several types of property rights including copy rights, related rights, expression of folklore, industrial designs, marks, patents, unfair competition, undisclosed information, geographical indication etc. • Further with regards to the traditional knowledge the act states about expression of folklore. Section 24 of the Act offers a sui generis form of protection to the expression of Sri Lanka’s folklore. 23
5.6. Legal Position of Sri Lanka on IPRs on TM Sri Lanka implemented the Intellectual Property Act (Parliamentary act No: 36; 2003) to comply with the Trade Related Intellectual Property Rights (TRIPS) agreement.
Major drawback 1. Sri Lanka was unable to build an effective IPRs regime especially for the traditional medical system (TMS). 1. Article 62 of the 2003 Parliamentary Act, Plants, animals and other microorganism other than transgenic microorganisms used for essential biological processes for the production of plants cannot be patented. Natural materials are excessively used in health and pharmaceutical product development process in TMS. Threat : International trading Losing plant varieties especially medicinal plants along with the traditional medical knowledge 2. It only provides provisions for the folklores 24
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5.7
Legal Framework for the Protection of Traditional Knowledge in Sri Lanka - 2009
•
A Legal Framework for the Protection of Traditional Knowledge in Sri Lanka was prepared in 2009 to provide protection and proper management of traditional knowledge in Sri Lanka.
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However, this draft has not yet been approved .
Note:
•
According to the draft document “The Government of Sri Lanka recognizes: the importance and value of traditional knowledge in all the fields of human endeavor including scientific, technological, industrial, economic, cultural, educational, social and spiritual; and the necessity to promote the protection, development, conservation and preservation of traditional knowledge; meet the legitimate needs and expectations of the holders of traditional knowledge; secure the respect and recognition for the traditional knowledge and the holders thereof for their contribution to the knowledge and development; ensure fair and reasonable benefits to the holders of traditional knowledge for the use of traditional knowledge outside the traditional context; regulate use, disclosure, acquisition, preservation and conservation, management, development and application of traditional knowledge; discourage, control, counter and stop misuse of, misappropriation of an unauthorized access to, traditional knowledge; and enable the human race to duly benefit from the traditional knowledge of Sri Lanka(WIPO, 2009).
•
According to the draft Sri Lankan document "traditional knowledge" means the content or substance of knowledge that is result of intellectual activity and insight in a traditional context and includes the knowhow, skills, innovations, practices and learning that form part of traditional knowledge systems and knowledge that is embodied in the traditional lifestyle of a community or people, or is contained in written or codified knowledge systems passed between generations and “traditional knowledge” is not limited to any specific technical field, and may include agricultural , environmental, health care and medicinal knowledge, associated with genetic resources or other components. 26
5.8 The traditional knowledge will be protected under the proposed act against the following actions (Section 6 ) 1. 2. 3.
4.
5. 6.
7.
Access to traditional knowledge Misappropriation of traditional knowledge Acquisition of traditional knowledge by theft, bribery, coercion, fraud, trespass, breach of contract or inducement of breach of contract, breach of confidence or confidentiality or inducement of breach of confidence or confidentiality, breach of fiduciary obligations or other relations of trust, deception, misrepresentation, the provision of misleading information when obtaining prior informed consent for access to traditional knowledge unauthorized disclosure or use of traditional knowledge by any person or group of persons corporate or unincorporated who legitimately had access to traditional knowledge Use of traditional knowledge that violates the terms that was mutually agreed as a condition of prior informed consent concerning access to that knowledge False claims or assertions of ownership or control over traditional knowledge, including acquiring, claiming or asserting intellectual property rights over traditional knowledgerelated subject matter when those intellectual property rights are not validly held in the light of that traditional knowledge and any conditions relating to its access Willful offensive use of traditional knowledge of particular moral or spiritual value to its holders by third parties outside the customary context, when such use clearly constitutes a mutilation, distortion or derogatory modification of that knowledge or is contrary to public order or morality. 27
5.9 Registration of Traditional Knowledge • Section 9 (1) a of the proposed act stated that there shall be a Register for the registration of traditional knowledge maintained and kept by the Director General of Intellectual Property. The objectives of the Register will be; • collect and preserve the traditional knowledge • encourage and promote the use of traditional knowledge • prevent unlawful access to and patenting of traditional knowledge • ensure the equitable sharing of benefits arising from access to such traditional knowledge 28
5.10 Database of traditional knowledge • The Director General of Intellectual Property shall establish and maintain a database containing Traditional Knowledge in public domain (Proposed act). • Further article 15 (2) of the act stated that “The Commissioner for Ayurveda and other concerned government agencies shall identify, collect and transmit such knowledge to the Director General of Intellectual Property to be included in the database”. • Furthermore, the Director-General of Intellectual Property may also create digital libraries and other records of traditional knowledge as may be prescribed by the Minister.
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5.11 Prior Informed Consent • According to the proposed act any holder of traditional knowledge may grant prior informed consent to and conclude license contracts for access to such traditional knowledge in accordance with the provisions of the said Act. A license contract may contain the following: • Name, address and other details of the parties to the license contract as may be prescribed • A description of the traditional knowledge to which the license contract relates • The benefits that accrue to the holder of traditional knowledge • The amount to be paid to the Fund, where applicable • Restrictions relating to the use of the traditional knowledge, where applicable • The obligation of the parties receiving access to traditional knowledge to keep the holder of traditional knowledge informed of the status of the advances made in the activity for which access is requested.
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5.12 Traditional Knowledge Fund •
This proposed act will establish a fund named “Traditional Knowledge Fund” and will be maintained under this Act.
The following shall be credited to the Fund. • All such sums of money as may be voted from time to time by Parliament for the Fund; • All such sums of money that may be received as a result of a license contract entered into in pursuant to this Act • All such sums of money as may be received as royalties under this Act • All such sums of money as may be received as fees under this Act • All such sums of money as may be received as fines or damages awarded by Court under this Act; • All such sums of money as may be received for the Fund by way of loans, donations, gifts, or grants from any source whatsoever, whether in or outside Sri Lanka. • Most importantly in terms of traditional medicinal knowledge this draft act has provided provisions to establish a "Commissioner for Ayurveda" means the Commissioner for Ayurveda appointed under the Ayurveda Act No. 31 of 1961(WIPO, 2009).
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5.13 Traditional Knowledge Digital Library •
India extends protection of areas of traditional knowledge utilizing the established advantages of information technology through the setting up of a Traditional Knowledge Digital Library.
•
It also resolved to consider the possibility of creating a sui generis system for the protection of traditional knowledge, including expressions of folklore and genetic resources, where the existing intellectual property regime does not adequately address concerns relating to these areas.
•
It further resolved to protect and preserve traditional knowledge, encourage innovation and creativity and promote the sharing of benefits through the effective use of appropriate systems, including intellectual property systems.
•
Digital Library makes all documented information easily and comprehensively accessible to patent examiners with the objective of preventing the granting of patents for non-original inventions by making available what is already available in traditional system in published form. Once we have prepared such a database, WIPO would be able to make it available to others through their Intellectual Property Network.
•
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6. Sri Lankan Experiences in IPRs issues • Due to inability of implementing necessary rules and regulations to safeguard some of the medicinal plant varieties and traditional knowledge associated with those plants already have been lost. • The case of Kothalahibutu (Salacia reticulate), this clearly shows that the exploitation of wild varieties and the production of drugs based on our traditional knowledge to which patent rights have been granted to Japan and USA.
• The patent granted to the Japanese company prevents future generations in our country from using and producing similar drugs. • It was identified that by the year 1985, twelve plants of Sri Lanka were patented in Japan. • Patent licenses have also been obtained for Snake Gourd (Trichosanthis krilowii), Bitter Gourd (Momodica chatantia),Kekatiya (Aponnogeton crispus) etc. 33
6.2 Biodiversity Protection Unit (BPU) of Sri Lanka • In 2000, the Biodiversity Protection Unit (BPU) of Sri Lanka Customs was able to detect agricultural germ plasm of Cinnamon, Cinnamomum zeylanicum (Z.verum) during an attempted smuggling operation. There were two such attempts of smuggling under the declaration of ornamental plants. Sri Lanka has been reputed for its Cinnamon for thousands of years. • Detecting of longstanding massive smuggling rackets in plants such as Aponogeton crispus(Kekatiya) and Cryptocoryne spiralis (Athividayan) are well known in this country. • It was also detected that huge consignments of satin ebony and teak wood whose logging is detrimental to the environment, were allowed for export with the connivance of certain top Customs officials. 34
6.3 Case study: Salacia reticulata • There are about 19 patent licenses and two copyright reservations for salacia reticulata base products which have been registered. • The followings are some particulars of them: US patent no. 5691386 by Shaman Pharmaceuticals for diabetes; US patent No;5650167 by DAWA incorporated for Hepatitis B; US rights reservation for patent no 12859384 by Kyoto pharmaceuticals for Salacinol, US rights reservation No.46(8)133940 by Chem pharmaceuticals for Kotalanol; J apanees App. No.10074205 by Morishita Jinton for diabetes . All such investigations were carried out more or less recently and all research was conducted by local scientists. 35
6.4 Regaining traditional knowledge for economical development of traditional medical sector in Sri Lanka 1. While setting regulation for safe guard of further exploitation of these verities, Sri Lankan government can implement a cultivation programme of valued plants and develop herbal products from it. 2. Implement pharmaceutical drug development plant in Sri Lanka and develop medicine collaborate with those companies with setting regulation for safe guard of further exploitation. 36
6.5
What strategies that Sri Lanka could adopt to protect its medicinal traditional knowledge?
• Since conventional intellectual property rights regimes are ineffective in protecting traditional systems, sui generis systems would be most appropriate method which is proposed in the IPR act. • Some countries have adopted sui generis laws and measures, specifically to protect traditional medical knowledge.
Example: Thailand’s Act on Protection and Promotion of Traditional Thai Medicinal Intelligence protects “formulas” of traditional Thai drugs and “texts on traditional Thai medicine”. – Only those who have registered their IP rights can research, develop and produce drugs using traditional medical knowledge. At the international level, the international legal instrument on the protection of traditional knowledge negotiated by the WIPO (WIPO). 37
7. Case studies Based on face to face interviews conducted amongst selected stakeholders related to IPRs and trade in TM -Lawyer“Developed rules and regulations are difficult to implement due to improper coordination and lack of aware of public ”. -Policy maker – Department of Ayurveda “We have to be well armed with regulations and legal aspects first; herbal pharmaceutical developers and traditional healers should aware important of IPRs and encourage for achieve patents.” -Policy maker- Bandaranayke Ayurveda Research Institute (BMARI)“Need to develop and amends current rules and regulations for protect the IPRs and trade issues in TM and related TK. And also should digitalized these knowledge for achieve benefits for the sake of humanity.” -Traditional healer“We are not protected and not gain any benefits which we share from our familial health system to any researches or organization. If we share traditional knowledge benefits are not come to poorer after research. Some times after develop some formulas it goes to allopathic system and never can be use in TM system. Also research drugs are more expensive for use our country people.” 38
Ayurveda/ Herbal Pharmaceuticals and Cosmeceutical Entrepreneur “When we develop our product in ethical and standard manner our formulas should come under state Ayurveda pharmacopoeias and need to develop these pharmacopoeias with current standards. Government should interfere for develop IPRs and trade issues. Still we are not protected for achieve the benefits when compare to developed countries. “ Herbal Pharmaceuticals and Cosmeceutical Company – consultant and Ayurveda Practitioner “ Ayurveda/ traditional medicine pharmaceutical companies are the only innovative drug developers in Sri Lanka. Most of other health systems excessively depends the other countries for drugs. Government should encourage Ayurveda and herbal drug developers to achieve international standards and solve the IPRs issues in trade. It will lead to upgrade the export of herbal drug market and reduce health related cost especially importing drugs. Need to develop effective private public partnership with herbal drug development and developing other rules related to trade.” 39
-Herbal Pharmaceuticals and Cosmeceutical Entrepreneur “National Ayurveda pharmacopoeias formulations given to the nation which is crucial for human health; anyone wanting to use and develop these formulae must obtain a license from relevant authorities. Individual formulae are private formulations, the owner can use freely and develop these formulae according to drug development rules and regulations, anyone else must obtain permission from the owner to make further developments and a license. Other thing is it is essential for given petty or innovation patent for this kind of formulas or process for motivation and further development. Because petty or innovation model are less stringent than for patents. Patents need much involvement, time and money, and if it is failed ultimately lost their formula process secrets.” -Ayurveda/Herbal Pharmaceutical Consultant“Patent protection is a strong method to use, however for a country like Sri Lanka it is very difficult to implement patents considering the immense financial cost and technology that is required to implement patents.” -Ayurveda/ Herbal Pharmaceuticals and Cosmeceutical Entrepreneur “Even though Sri Lanka has passed the Intellectual Property Rights Act No: 36 in 2003, it does not cover the IPRs aspects in traditional medicine and related traditional knowledge for sufficient protection for share basis to the TM system.”
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8. Suggestions and Recommendations (Based on conducted workshops and plenary discussions with group of provincial Ayurveda practitioners at Bandaranayke Memorial Ayurveda Research Institute (BMARI), Sri Lanka) 1. 2.
3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.
Enforce and monitor the National and International Laws/Policies relating to the Import and Export of Biodiversity related items. Promotes the development programmes of the country through revenue collection, facilitation and enforcement in import and export of raw materials and herbal products and also in a manner, which will not harm the rich biological heritage of the country. Educate and create awareness among the Customs of the Biodiversity, Cultural and National Heritage Protection Division as well as the public on the IPRs subject matter. Exchange information and develop intelligence with National and International institutions concerned and develop especial network for IPRs and trade in South-East Asia region Attend and conduct meetings, seminars, workshops and contribution of expert opinions etc relating to policy matters and other matters held at governmental and non-governmental institutions related to IPRs. Develop strategic plans and renovate current Ayurveda act accordingly to safeguards, coordinate and sharing benefits of IPRs and trade related issues in TM and TK. Conduct unbiased investigations, prosecution and courts procedure on subjected detections. Conduct educational, training, awareness programmes of IPRs and trade related matters for the benefit of public, schools and University level. Develop and maintain the database on IPRs related detections of TM and related knowledge. Maintain the proper relationship with line Ministries, government departments etc and exchange information with national and international organizations Prepare & develop related publications and distribution Establish of a TM and TK digital library and documentation of TK Establish of TM &TK specific registration and innovation patent system 41
Figure 1: The way forward for develop IPRs rules for trade and TM encouraging collaboration with responsible stakeholders in Sri Lanka 42
References: 1. WORKING DOCUMENT-VERSION 01- JANUARY 2009 ,A LEGAL FRAMEWORK FOR THE PROTECTION OF TRADITIONAL KNOWLEDGE IN SRI LANKA (WIPO. (n.d.). Intellectual Property Rights and Medicinal Knowledge . Retrieved from www.wipo.int/pressroor0.unctad.org/trade_env/docs/srilanka.pdfm/en/briefs/tk_ip.html) 2. Annual Statistics Report 2010: Ministry of Indigenous Medicine Sri Lanka http://www.indigenousmedimini.gov.lk/Statistics.html and: http://www.indigenousmedimini.gov.lk/Downloads/Statistics%20Report%20Final%202011.%20November.pdf 3. De Silva, N. (2013). Sri Lanka's Traditional Knowledge and Traditional Cultural. Retrieved from http://saarcculture.org/images/stories/announcements/tk/full_papers/nirekha.pdf 4. Hirimuthugodage, D. (2009). TRIPs Agreement and the Agriculture Sector in Sri Lanka. Bangkok: Asia-Pacific Research and Training Network on Trade. 5. Maskus, K. (2000). Retrieved from Intellectual Property Rights and Economic Development: Intellectual Property Rights in the Global Economy: http://www.iie.com/ 6. Menaka, H. (n.d.). TRADITIONAL KNOWLEDGE (TK) OF COMMUNITIES: PROTECTION AND REDEVELOPMENT IN THE FACE OF EMERGING INTELLECTUAL PROPERTY RIGHTS REGIME. Retrieved from archive.cmb.ac.lk/research/.../TRADITIONAL%20(COPY)%5B1%5D.do.. 7. WIPO. (n.d.). Intellectual Property Rights and Medicinal Knowledge. Retrieved from www.wipo.int/pressroom/en/briefs/tk_ip.html 8. World Health Organization. (2001). Report of the Inter-Regional Workshop in the Context of Traditional Medicine. Retrieved from who.int/medicinedocs/pdf/h2944e/h2944e.pdf 9. Correa, C. (2000). Intellectual Property Rights, The WTO and Developing Countries, The TRIPsagreement. New York: Zed Books Ltd. London. 10. Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review, World Health Organization 2001Geneva, Switzerland 11. Perera P.K. Current scenario of herbal medicine in Sri Lanka. Conference proceeding, 2012, ASSOCHAM , 4th annual Herbal International Summit cum Exhibition on Medicinal & Aromatic Products, Spices and finished products(hi-MAPS) , NSIC, Okhla Industrial Estate, New Delhi, India. Yamamoto, Y., & Gay, B. (2007). Interllectual Propert Rights and Gender. Trade Insight, Vol:3, No: 2 43
Thank you !
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