Presented on Symposium at 22nd International conference of College of Medical Administrators of Sri Lanka, 13th March 2015 (Based on WHO/SEARO-Project Report of Study on Intellectual Property Rights (IPRs) and Trade in Traditional Medicines (TM) in Sri Lanka)

1. 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
Implementation of Global Strategy and Plan of Action
on Public Health, Innovation and Intellectual Property
– National Assessment Report – Sri Lanka

2. Learning outcomes
• Identify TM and trade issues
1.
• Analyze Legal Position of Sri
Lanka on IPRs2.
• Analyze ER issues in TM and
TK3.
• Develop IPRs model for TM &
TK4.
2

3. 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.
3

4. 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

5. 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.
5

6. 4. Identify trade and global
opportunities for TM
6

7. 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)
7

8. 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.
4.2 WHO Traditional Medicine Strategy
Key objectives:
8

9. 4.3 Populations using TM/CAM worldwide
Populations in developing
countries using traditional
medicine for primary health
care
60%
60%
70%
70%
70%
90%Ethiopia
Benin
India
Rwanda
Tanzania
Uganda
Populations in developed
countries who have used
complementary and
alternative medicine at least
once
42%
48%
75%
70%
80%
Canada
Australia
France
USA
Germany
9

10. Marketing of Herbal Products
(Thousand million US$)
0.86
1.6
3.05
4.4
5.4
0
1
2
3
4
5
6
1990 1994 1997 1999 2000
Annual sales of OTC herbal medicines in USA
4.4 Herbal medicines are rapidly
increasing in economic importance
10

11. 92
134
159
184
$0
$20
$40
$60
$80
$100
$120
$140
$160
$180
$200
1994 1998 2000 2002
4.5 Marketing of Herbal Products
in Great Britain (Million US$)
Source: House of Lords, 2000
11

12. 68%
30%
2%
4.6 % of Global Herbal Market Share
Other China India
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
12

13. 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 SDA-
imposed standards by 2007.
Source: Xinhua News Agency. Traditional Chinese medicine has broad
prospects in int′l market: experts. High Beam Research 2004
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
13

14. 14

15. Source: The World Medicines Situation –
WHO, 2004
15

16. 16
4.8 SWOT analysis of Sri Lankan TMS
Internal
factors
External
factors
Positive Negative
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. Hospitals 49, central dispensaries 159
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
Opportunities
1. World over natural and traditional
approaches being welcomed
2. Increased scope for innovation and change
in approach for therapies
3. Estimated global market size: US$ 75 bn
4. Nutraceuticals: Global market size is Rs.
12148 bn
5. Ayurveda coupled with medical and
experiential tourism
6. Exports of medicinal products
7. Resource for novel drug development by
reverse pharmacology
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)

17. 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.
Sri Lanka protected?
17

18. 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).
18

19. Percentage of General Practitioners with University Education
with the Traditional Medical System in Sri Lanka
Ayurveda
84%
Siddha
13%
Unani
3% 0%
19

20. 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

21. 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
21

22. 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
22

23. 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

24. 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

25. 25

26. 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.
• 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 know-
how, 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

27. 5.8 The traditional knowledge will be protected under the
proposed act against the following actions (Section 6 )
1. Access to traditional knowledge
2. Misappropriation of traditional knowledge
3. 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
4. unauthorized disclosure or use of traditional knowledge by any person or group of persons
corporate or unincorporated who legitimately had access to traditional knowledge
5. Use of traditional knowledge that violates the terms that was mutually agreed as a condition
of prior informed consent concerning access to that knowledge
6. False claims or assertions of ownership or control over traditional knowledge, including
acquiring, claiming or asserting intellectual property rights over traditional knowledge-
related 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
7. 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

28. 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

29. 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.
29

30. 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.
30

31. 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).
31

32. 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.
32

33. 6. Sri Lankan Experiences in IPRs issues
33
• 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.

34. 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

35. 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

36. 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

37. 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

38. 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

39. 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

40. -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.”
40

41. 8. Suggestions and Recommendations
1. Enforce and monitor the National and International Laws/Policies relating to the Import and Export
of Biodiversity related items.
2. 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.
3. 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.
4. Exchange information and develop intelligence with National and International institutions
concerned and develop especial network for IPRs and trade in South-East Asia region
5. 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.
6. 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.
7. Conduct unbiased investigations, prosecution and courts procedure on subjected detections.
8. Conduct educational, training, awareness programmes of IPRs and trade related matters for the
benefit of public, schools and University level.
9. Develop and maintain the database on IPRs related detections of TM and related knowledge.
10. Maintain the proper relationship with line Ministries, government departments etc and exchange
information with national and international organizations
11. Prepare & develop related publications and distribution
12. Establish of a TM and TK digital library and documentation of TK
13. Establish of TM &TK specific registration and innovation patent system 41

42. Figure 1: The way forward for develop IPRs rules for trade and
TM encouraging collaboration with responsible stakeholders in
Sri Lanka
42

43. 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..
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44. Acknowledgment
• World health organization, SEARO
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45. Thank you !
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