the traditional medicines predicament: a case study of thailand

The Traditional Medicines Predicament: A

Case Study of Thailand

Daniel RobinsonInstitute of Environmental Studies, the University of New South Wales; and Australian Mekong Resource

Centre, University of Sydney

Jakkrit KuanpothUniversity of Wollongong

The ongoing use and protection of traditional medicines presents unique challenges for

authorities, practitioners and stakeholders. With changes in the international intellectual property

environment and biodiversity regulation, the Thai government has responded to ensure that

traditional medicines, texts, traditional medical formulas, medicinal plants and herbs are protected

through the development of a sui generis law. Drafted in 1999, the Act on Protection and

Promotion of Thai Traditional Medicinal Intelligence is now being implemented in stages. Recent

incidents, including controversies surrounding local and foreign patents over a Thai medicinal

herb named kwao krua (Pueraria mirifica), have given impetus to traditional medicines protection,

but have also tested the utility and implementation of the act by the Thai Department of Public

Health. This article discusses the issues and implications in Thailand, while also reflecting on the

approaches for traditional medicines protection internationally and in other countries.

Keywords traditional medicine; sui generis rights; Thailand

International Context

With ongoing changes to both the international intellectual property regime and

also negotiations in the Convention on Biological Diversity (CBD) fora, a number

of developing countries have sought to develop unique systems for the protection of

traditional knowledge and biodiversity. Thailand has developed a particularly

unique approach with the creation of the Act on Protection and Promotion of

Traditional Thai Medicinal Intelligence (1999 [BE 2542]). This law has been

developed to protect the intangible assets of the Thai public, as well as the medicinal

biological resources of the country.

As a result of the expansion of the international intellectual property system to

all World Trade Organization (WTO) member countries from 1995, many

developing countries have sought to protect their traditional knowledge and

biological resources. The WTO Agreement on Trade-Related Aspects of Intellec-

tual Property Rights (the TRIPS Agreement) allows for patentability exemptions on

plants and plant varieties, animals and related products (but not micro-organisms);

yet if the exemption is applied it requires sui generis systems for the protection of

plant varieties (article 27.3(b)) (see United Nations Conference on Trade and

Development and International Centre for Trade and Sustainable Development

The Journal of World Intellectual Property (2009) Vol. 11, nos. 5/6, pp. 375–403

doi: 10.1111/j.1747-1796.2008.00347.x

r 2009 The Authors. Journal Compilation r 2009 Blackwell Publishing Ltd 375

[UNCTAD-ICTSD], 2005, for further background). This article of the TRIPS

Agreement is under an expanded review mandated by paragraph 19 of the 2001

Doha Declaration to consider the relationship between the TRIPS Agreement and

the CBD, the protection of traditional knowledge and folklore.

There have been continued submissions from developing countries to amend the

TRIPS Agreement. The most recent suggestions include demands for a ‘‘disclosure of

source and country of origin’’ patent requirement, in relation to biological materials

and/or traditional knowledge (proposed as article 29bis, Brazil, China, Colombia,

Cuba, India, Pakistan, Peru, Thailand and Tanzania, 2006). These submissions

represent important concerns about the misappropriation, improper patenting or

‘‘biopiracy’’ of biological materials and related traditional knowledge from developing

countries and indigenous or local groups (see Dutfield, 2004, p. 52, for a definition and

also more generally Shiva, 1997, 2001). The argument behind these submissions is that

a patent registration requirement for disclosure of origin of the source and country of

origin of genetic (or biological) resources and/or associated traditional knowledge

would limit the possibility for misappropriation of these subjects when used in

inventions. The ‘‘disclosure of origin’’ requirement has been raised by a number of

concerned and often bio-diverse developing countries, such as those above, and has

more recently been engaged with by countries such as Norway (June 2006), Switzer-

land (in the World Intellectual Property Organization [WIPO], in May 2003 and in the

WTO, November 2004) and the European Union (EU) (in WIPO, May 2005). The

different countries involved have not reached agreement over some of the terminology

involved, such as ‘‘genetic’’ or ‘‘biological’’ resources, and the inclusion of traditional

knowledge. They have sought different remedies for non-compliance with a disclosure

requirement, with the developing country submissions seeking patent revocation as a

punishment, while other countries such as Norway (June 2006) would prefer to see

‘‘effective sanctions outside the patent system, for example criminal and administrative

penalties’’. Lastly, the different parties involved have disagreed over the appropriate

forum for a disclosure of origin requirement, with a number of developing countries

seeking amendment to the TRIPS Agreement, while the EU and Switzerland have

sought to forum shift the discussions intoWIPO, in relation to the Patent Cooperation

Treaty.

Besides this, the WIPO Intergovernmental Committee on Intellectual Property

and Genetic Resources, Traditional Knowledge and Folklore (IGC) has been

meeting regularly in Geneva to discuss the protection of these resources and

subjects. At the twelfth meeting in 2008, the work of the IGC remained largely

inconclusive. A number of developing countries including India and Brazil have

been pushing for an internationally legally binding instrument to prevent the

misappropriation of traditional knowledge and folklore (preferably in the TRIPS

Agreement). On the other hand, the United States, Japan and other developed

countries have been seeking further clarification of the issues involved and the

relationship between intellectual property, traditional knowledge and folklore

(ICTSD, 2008a). As a result, discussions have made only incremental progress.

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The Traditional Medicines PredicamentDaniel Robinson and Jakkrit Kuanpoth

In relation to agricultural genetic resources and traditional knowledge, the

International Treaty on Plant Genetic Resources for Food and Agriculture

(ITPGRFA) was finalized in 2001 and came into force in 2004. The ITPGRFA

has a number of notable features such as a multilateral system of access and benefit

sharing over a range of listed plant genetic resources for food and agricultural

purposes. Parties that ratify the ITPGRFA agree to open up their plant genetic

resources to access via a Standard Material Transfer Agreement (article 12.4),

which also covers ex situ collections in gene banks of the International Agricultural

Research Centres. The Treaty also recognizes farmers’ rights, including the protec-

tion of traditional knowledge relevant to agriculture. Notably, some developing

countries have ratified the treaty, such as Bangladesh and India, but many

developing countries such as Thailand are adopting a ‘‘wait and see’’ attitude while

the parties to the ITPGRFA resolve any issues of implementation (Kuanpoth et al.,

2004; Robinson, 2007). Of relevance to this article, however, the ITPGRFA only

covers plant genetic resources for food and agriculture, meaning that only some

medicinal resources would also be covered by the agreement where they may also be

consumed as a listed food or crop. Thus, many medicinal herbs and plant resources

would fall outside the scope of this treaty.

At the same time, parties to the CBD have been negotiating an International

Regime on Access and Benefit Sharing relating to genetic resources in an Ad Hoc

Working Group. In addition to this regime, some parties have called for a

‘‘certification of origin’’ system for biological materials (Louafi and Tobin, 2005),

as well as for sui generis systems for the protection of traditional knowledge

(see UNCTAD, 2004). The push for this international regime and related systems

has been derived from concerns about international transfers of biological

resources and knowledge. Beyond the sovereign boundaries of countries, these

materials (and associated knowledge) cannot be protected under domestic laws,

or under local customary protocols. The Ad Hoc Working Group mapped

out the nature and scope of negotiations for the International Regime at its sixth

meeting in Geneva, January 2008. This momentum was continued at the ninth

Conference of the Parties to the CBD, where parties confirmed the modalities

and next steps for negotiation of the regime before the 2010 deadline (ICTSD,

2008b).

The promotion and protection of traditional medicines, and traditional knowl-

edge generally, fits rather awkwardly between these international legal regimes,

hence the title for this article. As Zhang (2004, p. 4), Coordinator of the Traditional

Medicines division of the World Health Organization (WHO), notes,

[a]t present, both the protection provided under international standards

for patent law and most national patent laws are inadequate to protect

TK and biodiversity. For example, traditional skills in manual and

spiritual therapies are different from those in modern practice, and

[often] there is no record of who invented them.

r 2009 The Authors. Journal Compilation r 2009 Blackwell Publishing LtdThe Journal of World Intellectual Property (2009) Vol. 11, nos. 5/6 377

The Traditional Medicines Predicament Daniel Robinson and Jakkrit Kuanpoth

There is no one system that has yet provided adequate legal mechanisms for

implementation nationally, although there have been various developments de-

scribed above for the regulation of access and benefit sharing pertaining to

biological resources and traditional knowledge. Despite this progress, traditional

medicines exist in a unique predicament that is being negotiated tangentially, but

not specifically addressed internationally.

In the context of this article, the development of the aforementioned interna-

tional systems has been informed by developments and policy-making innovations

within the domestic jurisdictions of concerned countries. Therefore, we feel that it is

important to examine national systems for the promotion and protection of

traditional medicines, and the potential implications they could have for inter-

national systems, or for application in other countries. Here, we focus largely on

developments in Thailand, while noting the approaches led by policy-makers in

other countries.

In response to the TRIPS Agreement, and due to public concerns about

biotechnological innovations and monopoly, Thailand has opted to exclude patent-

ability of plant and animal innovations under the Patents Act BE 2522 (1979, as

amended 1992 and 1999). Section 9(1) indicates that inventions that cannot be

patented include ‘‘naturally occurring micro-organisms and their components,

animals, plants or extracts from animals or plants’’. However, the extent to which

‘‘extracts’’ cannot be patented has been widely contested in Thailand and many

inventors have successfully registered chemical derivatives from plants, as well as

cruder extracts and pastes (as discussed in the kwao krua cases in this article). There

is also a ‘‘public ordre and morality’’ exclusion in the Thai Patents Act (section 9(5)),

which may ultimately prevent the patenting of some traditional medicines, as has

occurred in the Maori context in New Zealand (Young, 2001).

To comply with the TRIPS Agreement, the Thai government instead developed

the Plant Varieties Protection Act BE 2542 (1999), which is a sui generis plant

variety protection (PVP) law that draws on the 1978 version of the International

Treaty for the Protection of New Varieties of Plants (UPOV), while also adding

unique elements for the protection of general domestic varieties (including wild

varieties) and local plant varieties (Robinson, 2007). Additionally, and in collabora-

tion with this PVP law, the Department of Public Health developed the Act on

Protection and Promotion of Traditional Thai Medicinal Intelligence (1999 [BE

2542]), hereafter named the TTMI Act.

The development of these unique laws is largely a response to public and

government concerns about past incidents that have been variously labelled as

‘‘misappropriations’’, ‘‘bad patents’’ and ‘‘biopiracy’’ (see Blakeney, 2005 for

international examples; Dutfield, 2004). From Thailand, there are documented

cases relating to a trademark on jasmine rice (Kuanpoth, 2005; Tanasugarn, 1999),

expropriation of jasmine rice germplasm, the unauthorized retention of some

marine fungi samples by researchers at a UK University (Robinson, 2006), a

controversy surrounding the Thai medicinal herb plao noi (Croton sublyratus)



(Dhillion and La-aw, 2000; Robinson, 2006) and, most recently, a number of

incidents relating to the expropriation and patenting of a Thai medicinal herb

named kwao krua (Pureraria mirifica) (Robinson, 2006; Tanasugarn, 1999). Along

with international obligations under the WTO, and noting the talks related to

‘‘access and benefit sharing’’ and ‘‘traditional knowledge’’ in the CBD (which the

Thai government ratified on 31 October 2003), Thai government departments have

gradually developed these sui generis laws, and are now in the process of imple-

menting them.

The remainder of this article is divided into three main parts: an overview of

traditional medicine in Thailand, issues related to the protection of traditional

medicines (utilizing a case study of kwao krua) and a detailed overview of the TTMI

Act. The objective of the article is to outline the need for national systems such as

the TTMI Act, but also to note some shortcomings. As an overall outcome, we

argue that while further development of international patent system amendments

and progress on an International Regime in the CBD are warranted, additional

efforts need to be made at all scales of government towards the recognition of

cultural rights of local communities in relation to traditional knowledge.

Traditional Medicines in Thailand

Thai traditional medicine is a unique system of medicine based on the

assimilation of elements of a complex, almost mathematical theory

borrowed from Indian Ayurvedic medicine with a system which is in

all probability indigenous and derived empirically (Mulholland, 1988a,

p. 1).

The practice of Thai traditional medicine is widely prevalent throughout Thailand,

alongside Western medical practices. Dr Pennapa Subcharoen (2003), who was

instrumental in the development of the TTMI Act and the National Institute of

Thai Traditional and Alternative Medicine, notes that Thai traditional medicine is a

‘‘holistic approach, opposed to reductionism’’. Thai traditional medicine borrows

concepts primarily from Indian Ayurvedic medicine and also shares some influences

and links to Chinese traditional medicine. Subcharoen indicates that these have

been uniquely shaped through practices dating back to the Sukhothai period

(1238–1350) and especially the Ayutthaya period (1350–1767) (see also Mulholland,

1988a, p. 7). There is a considerable emphasis placed on overall well-being

(including spiritual aspects) for the prevention of illness. Many Thai herbal

medicines, teas, meals (most famously—tom yum soup), as well as treatments such

as traditional massage and sapaya (spa) are to be used for everyday health. In

addition, there are various treatments for the symptoms of illness.

Thai traditional medicine views humans as a part of nature and the universe,

and views health as a balance between a person and their environment (Saralamp

et al., 1996). This medical system relies upon finding a balance among bodily

elements of earth, water, wind and fire, each of which will relate to different organs



in a particular manner. Additionally, different tastes from herbs and foods will have

different properties affecting these bodily elements, and consequently a person’s

health (Salguero, 2003; Saralamp et al., 1996). These are fairly consistent principles

in Thai traditional medicines, but beyond this there are a huge range of different

therapies and remedies that can be identified, and these will vary depending on the

background context from which the knowledge is derived.

Knowledge is of course fluid and ever changing—it can be added to or

diminished and in some cases can be lost. Many have argued that some kinds of

knowledge are inalienable from place-based (local), cultural (including values),

spiritual (ritual, sacred and taboo) and environmental situations (in particular, see

Posey, 1999; and in Thailand see Chamarik and Santasombat, 1993; Santasombat,

2003). Certainly, in Thailand, there is some traditionalist resistance to the removal

of extracts of traditional medicinal knowledge, for example, from

embedded within holistic ayurvedic concepts and from Buddhism (Subcharoen,

2003).1 The embeddedness of Thai traditional medicines in cultural and religious

belief systems does not necessarily mean that it cannot be commercialized, and will

depend on other factors that define the knowledge and medicinal products. For

example, Chuakul et al. (1997) and Salguero (2003) note that there are two distinct

traditions in Thai traditional medicine, in which there is considerable overlap: the

royal tradition (public traditional knowledge domains) and the rural and ‘‘hill-

tribes’’ traditions (‘‘folk’’ knowledge domains). Official documents tend to depict

Thai traditional medicines in the ‘‘royal tradition’’ as complex and rationally

developed—generally distinguishing it from undocumented indigenous medicines,

as has also occurred in descriptions of traditional Chinese medicine (Hsiao, 2007;

Li and Li, 2007).

The royal Thai traditional medicine system is described as a systematically

derived system with knowledge and experience generated over long periods that is

well documented, usually in the form of enduring herbals, writings and parchments.

The system is epitomized by the Wat Pho School of Royal Medicine. During the

reign of King Rama III in 1836, during renovations of the Wat (temple), 60

inscribed stone tablets bearing acupressure charts, and 1,100 herbal recipes were

placed in the walls of the temple for future generations. Similarly, 80 statues

depicting massage techniques and yoga poses were erected throughout the temple

grounds (Salguero, 2003).2 With the publication of several manuals, traditional

Thai medicine came to be widely and publicly studied. Since this time, Wat Pho has

continued to be a widely reputed site of learning for scholars of traditional Thai

medicine.

Thai folk medicine is practised within local communities and is passed on from

generation to generation, usually verbally, and will vary widely depending on the

social and cultural system of the ethnic group or community in question (Chuakul

et al., 1997). Usually, folk medicines are not documented or recorded, although

there is now an increasing trend to do this. Although there are often closely guarded

secrets of different minority groups in the north of Thailand (such as the Karen,



Hmong, Lahu, Akha, Lua, Lisu and others—see Kampe, 1997), some authors have

documented various components of their knowledge. These include Anderson

(1993), Brun and Schumacher (1994) and Santasombat (2003). Because these folk

medicinal knowledge systems have not been systematically documented, there is

concern that an extensive array of knowledge could be lost over time through

modernization, introduction of modern medicines and because the knowledge may

not be passed down inter-generationally. In addition to these concerns, there is the

issue of unauthorized appropriation of resources and knowledge from local

communities and healers who may embody and internalize any wrongtgcqieang,

with the potential for detrimental spiritual and health effects for the healer.

Interviews with local community members revealed the physical internalization of

‘‘injury’’ according to their belief systems:

It is fine to be treated and to learn about the herbal medicines. But many

herbs require kha khruu [a ritual donation] to respect the spirits that

protect them. If someone steals the herbs I will get sick because a kha

khruu donation wasn’t paid—it is taboo (Mee-Leng, Hmong healer,

interview, Baan Khun Khlang, 13 February 2006).

The woman interviewed was a Hmong healer. In subsequent interviews with

local Thai and Karen healers, some similar sentiments were expressed, suggesting

that between different ethnic groups in the region there are linked beliefs drawn

particularly from Animism and Buddhism. Although this may be considered

superstition by some researchers, there are very strong cultural and spiritual views

about guardian spirits in many communities in Thailand (and adjoining countries)

that derive from rituals, beliefs and folklore (see Khanittanan, 1989; Kriengkrai-

petch, 1989; Laohavanich, 1989; Santasombat, 2003). Throughout the country,

farms also erect, maintain and tribute shrines dedicated to Phra-phuum (spirit lord

of the place/village) or Phii-baan (the spirit protector of the house) or to Mae

Phoesop (spirit of rice). The customary norms surrounding these rituals and shrines

are linked to beliefs such as karma and reincarnation, which cannot easily be

reconciled in legal terms. Thus, when a transaction of plants (or other biological

resources) and traditional knowledge occurs, a metaphysical transformation takes

place, which in turn may manifest in the spiritual or the physical (corporeal) injury

of a traditional healer.

Strathern (2004, pp. 99, 102) notes that biodiversity ‘‘transactions entail the

substitution of values . . .’’ and a ‘‘disembodiment’’, but such disembodiment may

be regarded as ‘‘a re-empowerment (the stripping away of extraneous identity) as

well as a moment of loss for one party and gain for another’’. Speaking of her

research with Papua New Guinean people, she highlights the dilemmas associated

with value substitution (in cultural and monetary terms) that arise from concepts

such as benefit sharing. Clearly, while not all local communities will have the same

spiritual connection to plants, there is a significant presence of these beliefs in

Thailand (where 95% of the population are declared Buddhists), and hence some



knowledge/plant domains are sacred. As Figure 1 illustrates, knowledge may be

held privately, and by specific communities, where it is managed through customary

regulations and social norms. Knowledge of the use of specific plants may also be

sacred, linked to spirituality and/or ritual, and thus misuse could be taboo as

discussed in the quote of the Hmong healer above. When knowledge is disclosed,

the prevailing Euro-American institutions surrounding knowledge, such as intellec-

tual property rights, generally imply that it is in the ‘‘public domain’’. But, as a

representative of the Indigenous Saami Council has indicated:

Indigenous peoples have rarely placed anything in the so called ‘‘public

domain,’’ a term without meaning to us . . . the public domain is a

construct of the IP system and does not take into account domains

established by customary indigenous laws (WIPO IGC, cited by

Taubman, 2005, p. 544).

Therefore, the point of knowledge transformation, where local or secret

knowledge enters the public domain, should be highlighted as a circumstance that

needs to be understood and protected through both formal and informal (custom-

ary) mechanisms. ‘‘Cultural rights’’ considerations such as these have been highly

problematic in international discussions on traditional knowledge and may ulti-

mately be better dealt with at national and local levels of governance.

Issues Related to the Protection of Traditional Medicines

The World Health Organization (WHO, 2002) 2002–5 strategy on traditional

medicines highlights a number of key challenges under four categories: national

Figure 1: Knowledge domains and knowledge flows under informal and formal regulatory

regimes



policy and regulatory frameworks; safety efficacy and quality; access; and rational

use. Similar to many other countries with prevalent traditional medicine systems,

Thailand has been working to improve their regulatory framework along the lines

of the recommendations of the WHO. Among other things, there are concerns

about the loss of traditional medicinal knowledge, access to traditional medicines

and equitable benefit sharing for local communities, unsustainable use of plant

resources and about medicinal herb misappropriation in Thailand.

Thai government representatives have particularly highlighted the importance

of intellectual property and genetic resources regulation in WHO meetings (WHO,

2001, pp. 17–9). The following section examines a number of controversial cases

whereby patents have been obtained by individuals who have raised broad public

concern about potential impacts on use of traditional medicines (for example about

exclusions from production, ethical implications, cultural and spiritual concerns).

The Thai Medicinal Herb Kwao Krua (Pueraria mirifica)

Considerable confusion has surrounded a number of attempts to patent composi-

tions containing white kwao krua (Pueraria mirifica). The herb kwao krua has been

known for its cosmetic and revitalizing qualities for more than 100 years by Thai

healers, communities and households. In more recent years, scientists have identi-

fied that the effects are related to the presence of phyto-oestrogens and phyto-

androgens, or plant-produced female and male hormones. Scientific claims have

since been made that the extracts may enlarge and firm breasts (white kwao krua)

and assist with male sexual performance and erection (red kwao krua or Butea

superba), similar to the Pfizer drug ViagraTM.

In 1998, a number of patents were filed with the Thailand Department of

Intellectual Property (DIP) on inventions based on the extracts of kwao krua. The

first patent granted was Thai patent application no. 8912 named ‘‘Medicinal herbal

Composition from Kwao krua’’ and listed as the invention of Mrs Mantana

Uawitaya, a Thai national. After the patent was granted, Matana Panich Chiang

Mai Co. Ltd, the filing company, put up advertisements and notices from a local

law firm in local newspapers informing the public and other producers that the

company now has exclusive rights to the production of white kwao krua and was

determined to enforce them (Tanasugarn, 1999). This patent was approved in May

1999, being considered to be based on an extract of a plant product as part of a

composition, and thus narrowly avoiding the scope of the patent exclusion on plant

and plant extracts under section 9(1) of the Patent Act of Thailand. The scope of

application of this exclusion is controversial in Thailand and raised questions on

why a patent was granted to such an extract when knowledge of it already existed in

the public domain. The kwao krua patent has met with similar concerns to those

expressed in CBD fora, with some parties indicating the need for broader coverage

of patent exclusions to ‘‘derivatives’’ of biological materials (see Chouchena-Rojas

et al., 2005).



Considerable public outcry was made over the claims by other local competing

pharmaceutical and cosmetic companies that they would be heavily restricted in

their use of products containing white kwao krua extracts. The Thai Drug Act BE

2510 has required traditional medicine manufacturers to register their formulas, and

current data show that there are more than 35 companies producing more than 50

formulas containing kwao krua. There are therefore concerns that patents on kwao

krua extracts may inhibit the use of others to continue their original business

practices (Subcharoen et al., 2001).

Thai scriptures collected since 1931 by Luang Anusarn-Sunthorn provide

evidence of the prior art of kwao krua in considerable detail. Clearly documented,

the knowledge of kwao krua is Thai traditional medicinal knowledge (national

public domain knowledge with a considerable history), but it is also traditional folk

medicinal knowledge (the herb is prevalent in the north-east or Issan region and is

often used by communities there). It appears that in the examination process, the

DIP did not know about the documents establishing prior art, which would make

the claimed invention fail a novelty and/or a non-obviousness test. Officials at DIP

now appear to be waiting for someone to bring the case to the Intellectual Property

and International Trade Court (Assawin-Tharangkun, 2005, 2006; Tanasugarn,

1999). So far, no one has challenged the patent and it is likely that the situation has

been resolved between competitors informally. Similarly, the advertized inflation of

the patent scope was criticized in the press. Eventually, it seems that the claims of

the lawyers have been ignored by other companies (Assawin-Tharangkun, 2006).

This case is important because it highlights that ‘‘local biopiracy’’ can occur, as

well as the more commonly reported foreign misappropriations and patents. This

contradicts the arguments of biopiracy contrarians that assume developing countries

are simply seeking to extract wealth from the pharmaceutical industry through the

discourse of biopiracy (see Chen, 2006, p. 26). Tanasugarn (1999) has suggested that

preventative measures for local biopiracy instances such as this could include further

training for patent examiners, access to traditional medical formulations in databases

or textbooks and social responsibility by private lawyers and intellectual property

counsellors such that they do not seek to inflate or obscure the scope of patents in the

public’s mind. Requiring disclosure of the source of origin of the materials and

knowledge used in the invention process could have potentially facilitated the patent

examiner’s rejection of the patent on grounds of prior art. If the inventor had

attempted to conceal the source of origin, however, the patent examiner still would

not have known. This indicates the importance of searchable databases or consulta-

tion with external expertise, as well as the deterrent of penalties for failure to disclose

the origin of materials and associated knowledge used in an invention.

Foreign Patents on Kwao Krua

A number of subsequent Thai patents and US patents have also emerged since. Dr

Wichai Cherdshewasart of Chulalongkorn University in Bangkok is the claimed

inventor of three different inventions under patent examination in DIP Thailand



relating to kwao krua. These apply to Thai patent numbers 046779, 048605 and

052443 (Industrial Property Information Center Thailand, 1998; 1999a; 1999b), of

which the latter has been the source of considerable controversy. According to the

head of the Patent Division of the DIP, the approval of these patents has been

challenged, having spent 2–3 years in the Intellectual Property and International

Trade Court, and then 3–4 years in the Supreme Court (Assawin-Tharangkun,

2006). Each of the patents refers to extracts of one or more of Pueraria mirifica

(white kwao krua), Butea superba (red kwao krua) and/or Mucuna collettii (black

kwao krua).

As intellectual property attorney and academic Dr Jade Donavanik (2004) has

highlighted, Thai Patent number 052443 appears to be the direct foundation of

USPTO patent number 6,673,377 (IPC, 1996; USPTO, 2004). The claims, in both

the Thai and the US patent applications, include an extract of kwao krua, a method

for extraction and a method for manufacture. While the patents on processes and

methods seem valid, the primary concern here is that the extract is not new, novel or

non-obvious. Cheil Jedang Corporation, a company based in Seoul, holds US

Patent number 6,673,377. The patent claim covers:

An extract derived from Pueraria mirifica having an effect on improving

breast firmness, breast enlargement and wrinkle removal from the

breast, wherein said extract is prepared by the steps of: drying tubers,

roots, stems, leaves and/or tissue-cultured calluses of Pueraria mirifica,

optionally by spray-drying, freeze-drying and/or vacuum-drying;

pulverising the dried tubers, roots, stems, leaves, and/or tissue

cultured calluses into pieces or powders and then immersing the plant

pieces or powders in a mixture of methanol and water; extracting the

mixture; and filtering the resulting extract and then concentrating it in a

vacuum to remove the solvent.

The extract does not appear to be particularly novel, and also fails to describe

the origins of the product. Because of the presence of patents already listed in the

Thai language at the DIP, there is already an established prior art for these

compositions in Thailand. Herbalists in Thailand are concerned that the patents

will affect exports of creams and cosmetic products already in the market

(Subcharoen et al., 2001).

Additionally, the non-governmental organizations BioThai and the ETC

Group have identified that a variety of kwao krua has become essential subject

matter in US Patent number 6,352,685, owned by Kose Corporation of Tokyo and

Shiratori Pharmaceutical Co. Ltd of China. The patent claim covers:

An external composition for skin comprising, as an essential ingredient,

a liquid extract of a dried root lump of Pueraria mirifica; wherein said

liquid extract comprises an extraction solvent which is at least one

selected from the group consisting of water, lower alcohol, liquid



polyhydric alcohol; and wherein said external composition for skin

contains 0.00001 to 5 wt% of said liquid extract of said dried root

lump of Pueraria mirifica as dried solid in the composition (USPTO,

2002).

Again, this claim merely relates to an extract of kwao krua for use in a cream or

a gel to be applied to the skin. Arguably, there is little real novelty, given the

documented prior uses of the plant and its extracts by Luang Anusarn-Sunthorn

and many other authors and herbalists. Therefore, it appears that the invention

under US Patent number 6,352,685 is not novel and should fail a non-obviousness

test, which would present a statutory argument for revocation of the patent in most

jurisdictions. However, US patent law does not recognize prior art in foreign

countries (Chen, 2006; Kadidal, 1998), raising a serious inter-jurisdictional problem

that is at the core of many biopiracy cases.

Dr Donavanik has made a persuasive argument that these claimed inventions

under patent have little innovative merit. This kwao krua case presents a strong

argument for a mandatory disclosure of source or origin patent requirement,3 as has

been sought internationally by Thai authorities, a number of developing countries

and other member states in the WTO TRIPS Council.4 Hypothetically, had there

been a ‘‘disclosure requirement’’ mandated internationally (hence also under US

patent law), and if patent examiners were required to check foreign traditional

knowledge databases,5 then the examiners would have likely been able to detect

prior art in Thailand and refused the patent on grounds of lack of novelty. If it was

found to be novel and was not refused, then a disclosure requirement would

stipulate that the origin of the material was Thailand. This would imply benefit

sharing flows back to providers (in this case, probably a Thai authority) under the

model currently sought in the TRIPS Council (see WTO doc IP/C/W/474).

Nevertheless, the documented public domain traditional medicinal knowledge

should have been detected for the patents on kwao krua in Thailand based on

standard patent criteria. This is something that DIP have expressed concerns about,

and the case has been one of the main bases for attempting to establish traditional

knowledge databases or registers for utilization by patent examiners (Assawin-

Tharangkun, 2006; Donavanik, 2006).

It should be noted that the plant is endemic to the region, not just Thailand.

The plant exists in Burma and Laos (and possibly also Cambodia) (Anon, 2005).6

Clearly, knowledge of the traditional uses of the plant, through documentation and

public use, has entered the public domain. Yet it has been claimed by some

traditional healers that the knowledge has origins in the Issan region, where the

plant is most prevalent (D. Pathi, 2006; T.Y. Pathi, 2006).

Bringing the discussion back to the CBD negotiations on a draft International

Regime on biological resources, the debatable origin of kwao krua and of its

therapeutic applications raises important questions about whose consent should be

sought in such a case and how fair and equitable benefits could be provided to



custodians of the plant and associated traditional knowledge. Legally, there are

two dimensions: use of the existing formulas and use of the herb. As a result of

these concerns, the TTMI Act specifically deals with protection of both these

dimensions.

In summary, the kwao krua patents cited by Dr Jade appear to fit within the

most typical definitions of ‘‘biopiracy’’. There is a strong case to suggest that the

patents should not have been granted in the first place, because they are not

sufficiently novel. This highlights problems with the patent examination process and

with prior art rules under US patent law. The cases also raise questions about

whether patents on phyto-chemical derivatives should be allowed considering

Thailand’s rules on the non-patentability of plants.7 There are also questions

regarding the potential scope for extension of benefit sharing to derivative-based

inventions sourced from traditional knowledge. Cases such as these were a trigger

for the development of the TTMI Act. The following sections discuss regulatory

systems for traditional knowledge protection, and the content and implementation

of the TTMI Act noting some of the positive mechanisms for protection of

traditional medicines, but also the limitations of the act.

Regulatory Frameworks for Protection of Traditional Medicines

The TTMI Act is one of only a few laws of its kind in the world designed for the

protection and promotion of traditional medicines. As Zhang (2004, p. 3) notes, in

many countries in Africa about 80% of the population depends on traditional

medicines for its healthcare needs. Throughout Asia, Latin America and the Pacific,

there is also a significant reliance on traditional medicines; for example in India

70% of the population is reported to use Indian traditional medicines (Zhang, 2004,

p. 3). Therefore, there are a range of social, ethical, economic and also cultural

reasons for the protection and promotion of traditional medicines. Attempting to

address this ‘‘gap’’ in legal coverage, a number of countries have taken it upon

themselves to develop national systems for the protection and promotion of

traditional knowledge, whether through alteration of existing patent rules or

through sui generis approaches. Laws from the Philippines and from China that

explicitly deal with traditional medicines warrant a mention here.

The Philippines has a Traditional and Alternative Medicines Act 1997 that

establishes an Institute of Traditional and Alternative Health Care, mandated with

a number of roles and responsibilities. The role of the institute focuses primarily on

assuring quality standards of traditional and alternative medicines manufacture, as

well as providing incentives (such as ‘‘tax breaks, exemptions and deductions’’) to

encourage their use and development. The act also mentions the local regulation of

access to traditional medicines, and compensation for access; however, no specific

mechanisms are described to assert these rights (Kuanpoth et al., 2003).

China allows the patenting of traditional medicines under their Patent Law

1992. Article 25 of the law allows patent protection under the subject matter of



products, usages and methods (Li and Li, 2007; WHO, 2001). However, the law

does not allow protection of medicinal herbs or non-specific products outside of

specific active chemical compounds. China also has a Regulation on Traditional

Chinese Medicine Prescription Protection 1993 (amended 2006) that was introduced

to protect traditional medicinal compositions that could not be protected under

their amended patent law. The regulation was particularly developed due to the

common circumstance where practitioners used multiple herbs for treatments and

did not know the precise therapeutically effective chemical compound, nor could

they prove the inventiveness of their claim. The regulation provides a 30-year

protection that has been the subject of considerable debate (Heping, 2007; Vadi,

2007). Reputedly, the regulation is protecting many very similar products, often for

similar treatments, making it difficult to identify effectively where infringements

have occurred. This sort of issue is exacerbated under circumstances where knowl-

edge of a treatment is shared among healer networks, but monopoly has been

granted to specific individuals or groups.

Notably, the Philippines (and Thailand, discussed below) have independently

developed unique national laws on traditional medicines systems because of the lack

of an adequate framework for protection available internationally. China, which

has utilized a patent rights approach, has struggled with the inflexibility of patent

rules. These circumstances suggest that in certain countries there is growing

recognition of the need to protect traditional medicines, and that more concerted

efforts also need to be made internationally.

TTMI Act

The TTMI Act was developed at the same time as the Thai Plant Variety Protection

(PVP) Act and there was reportedly considerable cross-department cooperation and

discussion.8 It has been claimed that the development of the act also saw consider-

able input from many groups and individuals within civil society (Santikarn, 2005;

Srethasirote, 2005). Table 1 provides a chronology of the development and

operation of the TTMI Act. The history of its development highlights the fact that

the development of sui generis laws involves considerable inputs of time, expendi-

ture and negotiations between stakeholders, and thus appears to be a risky prospect

for policy-makers in the early stages. However, the gradual implementation of the

act has been accruing some beneficial socio-cultural and economic outcomes

already, and it also provides a preliminary model for other countries that may

wish to protect and promote traditional medicines.

Notably, the PVP and TTMI Acts were designed to be complementary, with

each dealing with agricultural and medicinal plant genetic resources and traditional

knowledge, respectively. Briefly, the PVP Act quite uniquely provides different

kinds of protection for general domestic and wild varieties, as well as local plant

varieties. It was an objective of the law that all plant varieties within Thailand

would be subject to state sovereignty, and can be protected under one of the specific



Table 1: Development and Operation of the Act on Protection and Promotion of Thai

Traditional Medicinal Intelligence, and Plant Variety Protection Act

Date/

event

Description

Early

1990s

Alleged biopiracy episodes and misappropriations in other countries raise

concerns over the protection of genetic resources and traditional knowledge in

Thailand.

1992, 1993 The CBD is developed at Rio and discussions begin on potential ratification in

Thailand. Initially, many groups are concerned that there is not adequate

protection for genetic resources and traditional knowledge and thus advocate for

the government to develop new legislation before becoming a signatory.

1994 The CBD is signed by Thailand for gradual ratification and a process of drafting

the Plant Variety Protection Act and the TTMI Act begins.

1995 The TRIPS Agreement comes into effect requiring developing countries to

develop at least a sui generis system of plant variety protection by the year 2000.

1995–1998 The Department of Agriculture (DoA) develops a draft PVP Act focusing

primarily on new plant variety protection initially and concurrently the

Department of Intellectual Property develops their own draft PVP Act.

Assembly of the poor asserts concern over biopiracy and loss of traditional

knowledge. Pressure government to include elements of domestic, local and wild

variety protection.

The DoA includes elements of domestic, local and wild variety protection in the

draft PVP Act.

The Department of Public Health (DPH) develops a draft TTMI Act. There is

cross-department collaboration, particularly during the later stages of the

development of this Act.

Cases of ‘‘biopiracy’’ including the Jasmati case and the Marine Fungi/

University of Portsmouth case are reported in the media in Thailand.

Protests ensue and there is extensive public criticism, particularly of the Jasmati

trademark.

1999 Lower House of Parliament favours the DoA Act, but components of the DIP

Act as well as aspects of local and wild varieties protection are incorporated. The

PVP Act is passed by parliament to be administered by DoA.

The TTMI Act is approved by parliament at around the same time as the PVP Act.

Both acts are passed by the Council of State and come into effect.

2000–2004 The DoA and DPH begin establishing divisions to handle the affairs of each act.

Regulations and organic laws are quickly passed for the protection of new

varieties of plants under the PVP Act due to industry pressures.

Organic laws of the TTMI Act begin an open and participative, but long process

of development. Organic laws reach the Council of State and Cabinet

in 2004.

Ministerial Regulations are considered in parliament for the protection of local

and wild domestic varieties before being passed to the Council of State.

Thailand ratifies the CBD in 2003.



categories (new or local varieties) or under one of the general categories (domestic

or wild varieties). Rather than attempting to formalize exclusive protection for all

varieties, Thailand has sought to provide other forms of incentives to breeders of

domestic and farmers’ varieties (i.e. it is closer to a liability regime than a property

rights regime) (Robinson, 2007, 2008). For general domestic and wild varieties, the

Thai PVP Act (chapter 5) details access and benefit-sharing rules and does not

allocate exclusive protection. However, the Thai PVP Act does give more specific

protection rights for registered local community varieties (chapter 4). The commu-

nity would then receive exclusive rights to conserve, use, research, sell and

commercialize their registered plants, if so desired, in a manner similar to a new

plant variety right. The PVP Act also requires disclosure of the origin of the new

plant variety, or the genetic materials used in the breeding of the variety, as a

registration requirement (section 19(3)). The act also establishes a PVP Fund, that

accrues income from the collection, use, research or commercialization of general

domestic or wild varieties, registration fees and other sources (chapter 6). The fund

is used to assist in the conservation and development of plant varieties by

communities, as well as to cover other administrative expenses (Robinson, 2007).

Notably, there may be some cross-over between the acts, where plant genetic

resources are considered to be both a medicine and a food.

In addition to the development of the PVP and TTMI Acts, the Thai

Traditional and Alternative Medicines Institute was established as part of the

Department of Public Health. The Institute has since acted as a repository for

information on Thai traditional medicines including massage therapies, spa and

herbal remedies. The institute also acts as a clinic, where treatments can be sought,

and knowledge is shared with other clinics and healers’ networks throughout the

country. Thus, the institute has attempted to mitigate the potential loss of

traditional medicinal knowledge by documenting that which has been orally

exchanged in the past. Additionally, this documentation is seen as a way of

establishing prior art in the field, such that the traditional medicinal knowledge is

defensible from improper patents or ‘‘biopiracy’’. This sort of registration system

2005–2008 The local and wild varieties ministerial regulations are still being considered and

finalized by the Council of State. They have been continually delayed and are still

pending final approval. Similarly, some of the organic laws of the TTMI Act are

still being deliberated but are due to be released in the near future. However, a

Ministerial Regulation for Controlled Herbs has been passed in 2005.

Amendments to the TTMI Act were proposed in a draft bill by the government

and then subsequently withdrawn due to potential conflicts with the Ministerial

Regulations awaiting approval. Clearly, the implementation of the TTMI Act

has been hindered by the change of government and other political and

departmental conflicts.

Sources: Chokevivat, 2005; Setboonsarng et al., 1991; Srethasirote, 2005, 2008; Vanakrairoj,

2005; Tithiprasert, 2005.



has also been adopted by the DIP for other types of traditional knowledge since

2002, including folklore and designs.9

The remainder of this section reviews the TTMI Act with a discussion of

stakeholder perceptions and implementation issues encountered to date.

Administration of the TTMI Act

Chapter 1 of the act establishes the Committee on Protection and Promotion of

Thai Traditional Medicinal Intelligence. The committee is made up of ten Director-

Generals from a broad range of relevant government departments and, similar to

the Thai PVP Act, it balances these bureaucrats with selected practitioners who

have knowledge, capacity and experience in traditional Thai medicine, the produc-

tion or sales of traditional Thai medicine and plantation or development of herbs.

Chapter 6 establishes the Fund on Traditional Thai Medicinal Intelligence. The

fund receives its income primarily from state subsidies, and money from the private

sector relating to the operation of the act. The Fund is controlled by the Office of

the Permanent Secretary, from the Ministry of Public Health. No benefit-sharing

arrangement has been established for communities that reside in areas to be

designated as herb conservation areas (discussed below), and there are few limita-

tions on the expenditure of the Fund.

Commentators such as Jaroen Compeerapap, lecturer in intellectual property

law and traditional knowledge at Silpakorn University, have warned that careful

consideration needs to be made about implementation of certain aspects of the act.

Namely he has expressed concern that the mechanism for benefit sharing through

the fund is not clear or transparent. Furthermore, he notes that it is not clear how

the act will promote traditional knowledge of medicinal herbs, and that some

revision of the act may be necessary, or the organic law will have to clarify this

aspect (Compeerapap, 2001; Compeerapap, 2005). A Department of Public Health

official has indicated that traditional medicines promotion, although not explicit in

the act, is broadly pursued in the mandate of the department, and he noted the

recent promotion of traditional medicines fairs supported by the department

(Peetregaart, 2005).

Registration of Formulas, Texts and Patents

Chapter 2 of the TTMI Act outlines means for the protection and promotion of

intelligence on traditional Thai medicine. This section is devoted to protection of

formulas of traditional Thai drugs and similar texts on traditional Thai medicine.

Such formulas and text documents can be of three categories—national, general or

individual/personal. These reflect the differing knowledge claims and domains that

may surround traditional medicines. National and individual formulas and/or

documents can be registered and sui generis intellectual property rights can be

applied to them as discussed below.

The minister has the authority to announce formulas of traditional Thai drugs

or texts on traditional Thai medicines that have been widely used or whose

intellectual property protection has expired under section 33, as a ‘‘General



Formula of Traditional Thai Drugs or General Text on Traditional Thai Medi-

cine’’, depending on each case. General formulas and documents are not accorded

protection under the act, but rather are registered as a form of prior art to prevent

misappropriation (section 18).

Registered ‘‘National Traditional Medicinal Formulas and Documents’’ are

accorded a level of protection on the other hand (despite the discrepancy between

general and national formulas being vague in the text). Assumedly, the only

difference between general and national formulas and/or texts is that national

formulas are more specific and detailed, thus warranting specific protection. For

those wishing to use registered national medicinal formulas for research and

improvement for commercial benefit, they must make an application stipulating

benefit sharing with the Traditional Medicines Institute (section 19). The details of

such registrations have not been laid down yet under Ministerial Regulations and

thus the operation of this aspect of the law has been delayed.

The act also grants exclusive rights to a traditional healer who is eligible for

registration of an ‘‘individual or personal formula’’. The registered healer can be the

developer of the formula or an inheritor of such a formula, making it different from

a patent right (there is no ‘‘inventorship’’ requirement). The act provides for the

examination of the application as to substance. If the application does not comply

with conditions for registration, does not comply with the rules and procedures or if

it is found that the claimed formula is not registrable (e.g. when the formula is a

national formula or has been registered as a personal formula by another person),

the application must be rejected. Once registered, the owner of the registered

formula will have exclusive rights to use the formula for medical research, or to

sell and distribute any product developed by using the registered medicinal formula.

These exclusive rights should be valid for the life time of the bearer of the

registration and for another 50 years from the time of the registration owner’s

death. The exclusive rights are subject to certain exceptions and limitations,

including (1) use for academic and non-commercial research and experimentation,

(2) preparation of medicines by traditional healers and (3) production of drugs for

household use or for use in public hospitals.

Patents are also allowed on traditional medicines, meaning ‘‘medicines ob-

tained directly from herbs or derived from a mixture, blend or transformed herbs’’

(sections 3 and 34–43). Section 37 outlines public interest exceptions in which the

patent right may be revoked by the registrar and rights of appeal and reapplication

for a patent on traditional medicines (sections 38–43). However, much of the detail

surrounding patent registrations is not expanded and has been left to be dealt with

in the Ministerial Regulations and presumably the Patent Act, leaving us guessing

as to how such a system might operate in practice.

The registration system in chapter 2 has received some criticism from tradi-

tional practitioners and academics (Compeerapap, 2001). The main criticism

focuses on the individual-based rights system that does not conform to the

traditions and practices of most local communities in Thailand. Compeerapap



argues that the concept of personal rights is inappropriate and might lead to

conflicts among different individuals or communities that have inherited the same

or similar knowledge of a traditional formula. In addition, it would be difficult in

practice for authorities to identify precisely individuals or groups of individuals who

are the developer, the inheritor or the custodian of the traditional knowledge.

Currently, there are many individuals and organizations waiting to register drug

formulas; however, the approval of Ministerial Regulations has been delayed for

some time due to disagreements between Cabinet and Ministerial objectives.

Officials at the Department of Public Health have also had difficulty grappling

with some of the conflicting perspectives on protection, such as the criterion of

‘‘inventiveness’’ for patents, the demarcation of public and private domains, as well

as the practicalities of registration by the diverse range of traditional healers,

formula developers and inheritors (Peetregaart, 2006).

Another issue that is raised by the registration of formulas is with regard to

disclosure of secret information, particularly in cases where multiple parties have

knowledge of a formula. As illustrated in Figure 1 earlier, some individuals and

communities may view traditional medicines as sacred or may wish to keep them

secret. The secrecy of traditional medicinal knowledge has been discussed between

Thai authorities and stakeholders, with suggestions such as the use of systems

similar to trade secrets (Assawin-Tharangkun, 2005; see also Chen, 2006). However,

several local communities interviewed in Thailand were averse to the idea, due to

distrust and fear of disclosure, preferring to try and maintain customary and

informal modes of protection and secrecy (Assawin-Tharangkun, 2005, 2006).

The Protection of Medicinal Herbs

Chapters 3 and 4 of the TTMI Act detail the protection and conservation of herbs.

Under this chapter, the committee can specify the kind, characteristic, type and

names of herbs that are of study and research value, have important economic

significance or may become extinct, and designate them as ‘‘controlled herbs’’.

Controlled herbs are thus given special treatment designated by the minister, with

advice from the committee with regard to conservation, transport, use for medicinal

and study purposes, export and other matters. For controlled herbs, there is thus

certification required by individuals outside government bodies to undertake the

aforementioned activities on such herbs (Santikarn, 2005; Peetregaart, 2006).

For the benefits of conserving herbs and the areas from which the herbs

naturally originate in the ecological system, the minister, with advice from the

committee, can designate a ‘‘Plan for the Conservation of Herbs’’ that must then be

approved by cabinet. The plan designs powers to restrict access to conservation

areas to conserve natural resources with minimal human disturbance. The plan also

requires surveying and researching of the herbs to assist with conservation.

The act is quite strict in prohibiting ‘‘ownership of land, or plantation, or

construction, or cutting, or destruction, or burning, or destruction of trees, plants,

or biodiversity or the ecology system, or digging of minerals, stones and soil’’ in the



conservation area. It also restricts changes to waterways that might affect herbs in

very broad terms. If the owner or the possessor of the land registers the herbs on

their property, they are eligible for assistance or support under this act; however,

this assistance is not yet specified.

A potential conflict arises here where local communities following traditional

lifestyles have conserved or utilized protected herbs. In such cases, the medicinal

value of the herbs may not have been known were it not for those communities, and

there could have been unwanted disclosure that brought about such a discovery.

Thus, it is important to question whether such exclusion is necessary or justified,

and whether there has been prior informed consent about access to knowledge of

the herbs in the first place. Although there is a fairly balanced membership on the

committee, the final word rests with the minister and cabinet and it is conceivable

that custodian communities could be excluded from herbal use and conservation.

Such exclusion, however, could be construed as a breach of the ‘‘local community

rights’’ provisions of the Constitution of the Kingdom of Thailand. The newly

drafted constitution, which passed a referendum in 2007, contains a paragraph on

the protection of local knowledge:

Persons so assembling as to be a community, a local community or a

traditional community shall have the right to conserve or restore their

customs, local knowledge, good arts and culture of their community and

of the nation and participate in the management, maintenance, preser-

vation and exploitation of natural resources, the environment and the

biological diversity in a balanced and sustainable fashion (chapter 3,

part 12, section 66 of the Constitution of the Kingdom of Thailand).10

Notably, this section was included in this constitution, as well as the 1997 ‘‘People’s

Constitution’’, largely due to the influence and pressures of a number of academics and

public intellectuals (Zurcher, 2005). As a consequence of these constitutional protec-

tions, the cabinet and minister will have to be very cautious about how they handle

exclusion of local people from herb conservation areas. The previous Director of the

Traditional and Alternative Medicines Institute, Wichai Chokevivat, has indicated that

local communities are unlikely to be excluded—but rather, commercial-scale collectors

are the main target of these rules (Chokevivat, 2005).

It is worth noting here that in response to the increasing value of the different

varieties of the kwao krua plant, based on the emerging patents and therapeutic

claims, over-harvesting is emerging as a problem. Similar instances of medicinal

herb over-cultivation have been reported internationally, such as in China (Heping,

2004), South Africa (Mander, 1998) and elsewhere (Schippmann et al., 2002). While

it is not always a simple ‘‘cause–effect’’ linkage between patent claims and the over-

cultivation of medicinal plants, the expanded publicity surrounding the local Thai

and foreign kwao krua patents appears to have accelerated its collection. Thus,

protection of the intangible ‘‘intellectual property’’ aspects of traditional medicines

also needs to be considered alongside protection of the tangible product.11



The harvesting of the herb is already limited in national parks and restricted areas

by the laws governing them. However, in other areas the quantity allowed for

harvesting has been less clear. The Thai Traditional and Alternative Medicines

Institute of the Department of Public Health have since enacted a Ministerial

Regulation for Controlled Herbs under the TTMI Act. This regulation seeks to

enforce the protection of the plant from excessive collection (Sajirawatthanakul, 2005).

This does not yet exclude collection or cultivation by traditional medicinal practi-

tioners, but limits commercial quantities from being poached or harvested due to the

increasing rarity of the herbs. In one village, a traditional healer expressed concern

that they might be restricted from use of the plant (T.Y. Pathi, 2006), but this seems

unlikely and the head of the Thai Traditional and Alternative Medicines Institute has

stated that they will not restrict this kind of limited local use (Chokevivat, 2005).

During interviews, several officials from different government departments, such as

the Royal Forestry Department, noted that there may be conflicting jurisdictions

between authorities in relation to these conservation matters.

At an earlier date, Subcharoen (1999) had indicated that the Fund on Traditional

Thai Medicinal Intelligence would ultimately operate like an access- and benefit-

sharing mechanism. Santikarn (2005) suggests that ministerial regulations on the

fund will clarify this when they are passed from the Cabinet Committee and Council

of State where they have been deliberated for some time. The control of herbs will

often be placed under the authority of the government and there is no guarantee of

continued access, respect of customary protocols or of potential benefit flows to

custodian communities (Bai Mai, 2005). Furthermore, there is a question of whether

prior informed consent will be obtained of local custodian communities in disclosing

the value of such herbs and assuming state control over them. The continuing

traditional practice by village healers on such herbs could, in some cases, be

threatened by a classic Western version of conservation, that requires that humans

be separated from nature, despite a history of interaction. The former Director-

General of the Traditional and Alternative Medicines Institute (Chokevivat, 2005)

allays such concerns, saying that it is department policy to obtain prior informed

consent of these communities, and that the control of herbs should be conducive to

continued traditional medicinal practice. He notes that a pilot project will be needed

in the near future to test the implementation of these benefit-sharing policies and the

organic laws. Therefore, it remains to be seen whether the cultural and economic

rights of local communities (in terms of respect for customary norms and benefit

sharing) will be adequately respected.

Conclusions

The TTMI Act represents an advance in sui generis law making in its own right.

Despite this, the act is only partially implemented and there are only limited funds,

affecting administrative capacity. Gradually, after the initial costs of establishing

the institute, there is likely to be more time and resources available for effective



implementation of the TTMI Act, particularly towards the objective of recognizing

the economic rights of traditional medicines custodians or healer networks. With

pilot projects and the further development of Institute activities, we will see

registrations of traditional medicines, herb conservation projects and benefit-

sharing activities set to expand in the near future. This case study illustrates the

difficulties of achieving effective national sui generis laws for the protection of

traditional knowledge. Despite the significant investment of time, human resources

and political will, the technical and administrative burden of developing sui generis

rights in traditional medicines has delayed their implementation. In the meantime,

the TTMI Act and the institute that administers it have achieved successes including

the mitigation of over-harvesting of medicinal herbs such as kwao krua; the

promotion of traditional medicines through the institute, fairs, events and net-

works; and the storage of formulas, herb samples and transcripts of traditional

medicines at the Institute.

However, the institute administering the act also has a limited mandate that

may not protect domestic bio-resources from misappropriation and biopiracy on its

own. What may additionally be needed are registers and databases of traditional

medicinal knowledge and medicinal herbs. The Indian People’s Biodiversity Reg-

isters (PeBRs) present a good example of such a system, in which local communities

may still maintain control over who accesses their traditional knowledge, the

conditions of consent and whether or not the information is available to patent

examiners (Indian National Biodiversity Authority, 2006; Robinson, 2007).12 To

date, traditional knowledge registers in Thailand have only recently been developed

and remain small. In addition, international efforts such as the CBD International

Regime on Benefit Sharing pertaining to biological resources, when finalized, could

help resolve international biodiversity transfer and research issues as evidenced by

the foreign kwao krua cases.

Furthermore, the number of emerging biopiracy controversies indicates that

there is a current failure by patent examiners to explore adequately prior art in foreign

(and local) jurisdictions, or in the international patent system context. This provides

further support to developing country demands for an international disclosure of

source and/or origin patent requirement for biological resources and associated

traditional knowledge. Linked with searchable databases of traditional knowledge,

this could mitigate the granting of inappropriate patents by patent examiners.

Recognizing the cultural rights of local groups remains a challenge. The

existence of codified and non-codified ‘‘folk systems’’ in Thailand, and that are

likely in other countries with extensive traditional medicines systems (e.g. China and

India), raise additional complications for the protection and promotion of tradi-

tional medicinal knowledge. Clearly, it is important that researchers working with

these local healers and communities need to respect their customary norms, which

may include aspects of embodiment and personification of plants, linked to folklore

and spiritual beliefs. Legal approaches have been largely deficient at re-conceptua-

lizing knowledge in this respect and it remains important that further sensitive



anthropological research is conducted to allow appropriate respect of customary

norms of local communities, before the entry of knowledge into the public domain,

where it undergoes a metaphysical and disembodying transformation. Some model

laws such as the African Union Model Law on Rights of Local Communities,

Farmers, Breeders and Access, and the Draft Pacific Model Laws13 on traditional

knowledge respect cultural rights by explicitly requiring that researchers comply

with customary laws when seeking prior informed consent, as well as allowing some

customary forms of dispute resolution. If, when implemented nationally, these legal

approaches allow local communities to regulate the secrecy, customary use and

entry into the public domain of their traditional knowledge, then this is probably

one of the best forms of respect for the ‘‘cultural rights’’ of local communities.

This brings us to the final conclusion that there are a complex array of contexts

and issues surrounding traditional medicines and that they can only adequately be

addressed utilizing a number of approaches and systems (at local, national and

international scales).14 In this respect, suggestions towards the benefits of an

international legal regime, such as a Medical Research and Development Treaty

for example (see Vadi, 2007), may have merit for the achievement of economic and

administrative aims. Yet, recognition of cultural rights demands more complex and

diverse regulatory conceptualizations. As has been evident in discussions on

customary law in the CBD 8(j) working group on traditional knowledge, there is

an inherent paradox in seeking to ‘‘globalise jurisprudential diversity holistically’’

(Taubman, 2005). But only by working to assert their cultural rights at multiple

scales can indigenous and local communities truly achieve the respect they deserve

for their indigenous or traditional knowledge.

About the Authors

Dr Daniel Robinson is Lecturer at the Institute of Environmental Studies, the

University of New South Wales, and Research Associate at the Australian Mekong

Resource Centre, the University of Sydney, Sydney, NSW, Australia. On intellec-

tual property and traditional knowledge issues, Daniel has worked for, or consulted

to, several organizations including the UNCTAD–ICTSD joint project on intellec-

tual property, the Pacific Forum Secretariat and currently for the United Nations

Development Programme (UNDP). Daniel has a Ph.D. in Traditional Knowledge in

Thailand from the University of Sydney, as well as degrees in environmental law and

environmental science; e-mail: [email protected], [email protected]

Dr Jakkrit Kuanpoth is Senior Lecturer, Faculty of Law, the University of

Wollongong. Before coming to Wollongong, he taught at the School of Law,

Sukhothai Thammathirat Open University, Thailand. He holds an LL.B. (Hons)

(Ramkhamhaeng University); is a Barrister-at-Law (of Thai Bar); has an LL.M. in

International Economic Law (University of Warwick); and has a Ph.D. (University

of Aberdeen). He has published numerous articles on intellectual property law and



development, particularly focusing on pharmaceutical patents in Thailand and

south-east Asia; e-mail: [email protected]

Notes

The authors would like to thank the National Human Rights Commission of Thailand for all

their assistance, the Intellectual Property Research Institute of Australia (IPRIA) for their

support and all those who were interviewed or those who provided information to assist this

study. We would also like to acknowledge the work of the late Dr Pennapa Subcharoen, who

was a key figure in the development of protection systems for traditional medicines in

Thailand.

1 Although notably there is some suggestion that the links between Thai traditional

medicine and Indian ayurvedic techniques are actually something that has been

over-generalized in recent years, and that the links are actually a late addition or a

‘‘re-traditionalization’’ (see Brun and Schumacher, 1994, p. 32; Mulholland, 1988b,

p. 175; Salguero, 2003, p. 6).

2 The marble engravings of Wat Pho were recently included in UNESCO’s Asia-Pacific

regional Memory of the World listings, recognizing the importance of the traditional

knowledge in perpetuity.

3 Or alternatively, a ‘‘proof of legal acquisition requirement’’, as suggested by Dutfield

(2004), may have sufficed under these circumstances.

4 Mara and New (2008) report that now half of the WTO membership now backs a

disclosure of origin requirement as article 29bis. However, there has been ongoing

dispute over the inclusion of information concerning prior informed consent and

benefit-sharing arrangements, as well as conflicting opinions over sanctions for non-

compliance. The EU would like to see non-compliance resolved outside the patent

system, while many developing countries would like patent revocation as a penalty for

non-disclosure.

5 Under US patent law, patent examiners are required to examine prior art only from the

United States (see Chen, 2006, pp. 28–9; Kadidal, 1998).

6 This highlights the potential importance of the draft ASEAN Agreement on Access and

Benefit Sharing relating to the Utilisation of Biological Resources.

7 The law allows for patenting of plant extracts if they are purified and do not appear in a

pure form.

8 Although there were also other complaints by a number of individuals that the TTMI

Act was driven by personal ambitions of public health officials, that there was no

adequate consultation with other departments and that it could sometimes conflict with

the PVP Act or other forests or environment department laws.

9 Registrations in Thailand have been less successful than in countries such as India,

which has reputedly hundreds of thousands of registrations in several (government and

non-government) registers. In Thailand, where there are only a few thousand

registrations, there has been concern about traditional knowledge entering into the

public domain where it can be exploited inappropriately. Hence, many groups are

opposed to the idea of a traditional knowledge register.

10 An official version of the 2007 Constitution is available at the National Economic and

Social Advisory Council English pages [online]: hhttp://www2.nesac.go.th/english/i



[Accessed October 2008]. Under chapter 5, part 4, section 80(6), there is also mention of

the promotion of local knowledge, as well as section 86(2), which seeks to ‘‘preserve and

develop local knowledge and Thai wisdom and protect intellectual property’’.

11 In another Thai bioprospecting controversy, the extract of a Thai herb plao noi has been

patented by a Japanese company and is being cultivated and produced in Thailand

under the close vigil of the company involved. Local communities still use the plant; yet

there has not been the same mass-cultivation and commercialization of the product. In

the plao noi case, Thai officials and academics have been frustrated by a lack of benefit

sharing and technology transfer associated with the patent, which was granted before the

drafting of the CBD (see Dhillion and La-aw, 2000; Robinson, 2006).

12 Information on the PeBRs can be found online. Available at hhttp://www.nbaindia.org/pbr/pbr.htmi [Accessed October 2008].

13 The Pacific Forum Secretariat has developed a Draft Model Law on Traditional

Knowledge, Cultural Expressions and Folklore, and a Draft Model Law on

Traditional Biological Knowledge, Innovations and Practices.

14 As also noted by Timmermans (2003).

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