- Medicine Access and Rational Use > Financing
- Traditional Medicine > Traditional, Complementary and Herbal Medicine
(2001; 88 pages)
8.2 Legal Protection of Traditional Medicine and Knowledge in Thailand
Thailand currently has five laws for the protection of IPR: the Patent Act 1979, the Copyright Act 1994, the Trademarks Act 1991, the Plant Variety Protection Act 1999, and the Protection of Layout-Designs of Integrated Circuits Act 2000. Legislation is being developed for protecting undisclosed information and geographical indications. In Thailand, since about 10 years, there is a socio-political movement to recognize community rights and to protect traditional knowledge. This has facilitated the enactment of an Act dedicated to the protection of traditional medicinal knowledge, since it was felt that 'mainstream' IPR legislation does not protect such knowledge sufficiently. In addition, the Thai Plant Variety Protection Act 1999 also contains provisions aimed at protecting traditional knowledge.
The Act on Protection and Promotion of Thai Traditional Medicinal Intelligence
Recently, Thailand has adopted a law to protect traditional knowledge in the field of medicines: the Thai Traditional Medicinal Intelligence Act 1999, which is under the supervision of the Ministry of Public Health. This Act is an example of sui generis legislation. Its main objectives are to reward traditional healers for their continuing contribution to health and health care, to create incentives for maintaining traditional medicinal knowledge, to set up a system for conservation and for regulation of access to biological resources and -traditional medicinal knowledge, and to undertake effective action to curb the destruction of species, habitats and ecosystems.
The Act establishes the rights of traditional healers to retain control over traditional medicinal knowledge through a public registry. To this end, the Act separates traditional medicines into medicinal herbs and traditional medicinal formula42. Traditional medicinal formula are further divided in three categories:
• General formula: formula which are already in the public domain and can be used freely by everyone. This includes formula which have been widely used and are widely available, as well as medicinal formula of which intellectual property protection has expired.
42 "Formula" can refer to knowledge about traditional Thai medicine as well as substances/ingredients.
• National formula: formulations providing significant benefits or having special medical value. The Act stipulates that the Ministry of Public Health has the authority to declare certain traditional medicine preparations as national formula. After the announcement, the rights over such a formula belong to the State43. Anyone who wants to use commercially a national formula for the production of drugs or for research and development must receive permission from the Government. Use of a national formula for commercial purposes without authorization is subject to criminal sanctions under the Act.
43 This provision in fact gives the State the right to 'nationalize' a private formula or a general formula, which offers substantial health benefits. Its main purpose is to prevent overly restricted access and/or the claiming of monopolistic rights over such formula.
• Personal or private formula: a private formula is established via registration. Applications for registration may be made by the inventor or developer of the formula or by the person who inherited the formula from the inventor or developer. The owner of a registered personal formula has the exclusive right to sell and distribute any product developed or manufactured by using the formula, as well as to use the formula for research. However, the exclusive rights are subject to certain limitations44. The rights over a registered personal formula subsist throughout the life of the applicant and continue for fifty years thereafter.
44 For example, the following are excepted from the exclusive rights: experimental use, private use by traditional Thai healers and production of drugs for household use or for use by State hospitals.
Applications for registration of a private formula should be filed with the Registrar, and will be examined as to whether they meet the criteria stipulated under the Act, notably regarding eligibility of the applicant. Registration takes place on first-to-file basis, and may be rejected if the application does not comply with the rules and procedures, or if the claimed formula is not registrable (notably in case the formula is a national formula or has already been registered as a private formula by another person). After examination, which focuses on establishing that the applicant really invented or inherited the formula45, the Registrar publishes the application. Third parties may oppose the registration within 60 days of its publication; if no such opposition is made, the registration of the private formula will be permitted.
45 The criteria for patent protection -novelty, inventive step and industrial application- do not apply to registrations under the Thai Traditional Medicinal Intelligence Act.
If a healer wants to commercialize his/her private formula, the product will also have to be registered at the Thai FDA, where evidence of quality, safety etc. will be required.
Foreign citizens may register their medicinal formula in Thailand on a basis of reciprocity (note: this means that the TRIPS principle of "national treatment" is not applied, since this Act is considered to be outside the scope of the TRIPS Agreement).
Salient points regarding the registration of private formula:
• The law only provides for registration of a formula by an individual (e.g. a healer); a community cannot register medicinal knowledge that is known within that community but not beyond. In that sense, the law does not recognize or establish communities' (collective) rights.
• The term of protection lasts until 50 years after the death of the inventor (which is similar to the duration of copyright protection). This is relatively long, and may provide the owners of the traditional knowledge with a possibility to earn exaggerated profits, thereby creating an unnecessary burden on society.
• Registration is granted on a first-to-file basis, as under the patent law. One could question whether it is appropriate to apply a first-to-file system in case of traditional medicine.
The Traditional Thai Medicinal Intelligence Act also provides for the protection of medicinal plants and herbs. The Ministry of Public Health has authority to put a plant or herb which has beneficial effects on health and which it considers at high risk of extinction on the Extinction List. Listed plants or herbs may not be used without authorization.
The Plant Variety Protection Act
The Plant Variety Protection Act was enacted in Thailand to comply with Art. 27.3(b) of the TRIPS Agreement. This Act is another example of sui generis legislation. Apart from new plant varieties, the Thai Plant Variety Protection Act also provides for the protection of traditional plant varieties and plant genetic resources. The Act recognizes the important role played by farmers and local communities as custodians and traditional crop cultivators. It acknowledges communities' contribution and compensates them by allowing local communities to register traditional plant varieties which are exclusively found within the community. After registration, the community becomes the right holder and has the exclusive right to use that traditional variety; their rights are comparable to the rights of breeders of new plant varieties46.
46 Criteria for a traditional plant variety are the same as for a new plant variety: distinctness, stability and due uniformity (this is in accordance with the UPOV 1978); in addition it has to be demonstrated that the variety cannot be found outside the community that wants to register it.
Apart from new and traditional plant varieties, the Act considers plant genetic resources. These belong to the State, and their use is subject to certain conditions, notably:
• prior informed consent from the community from which the plant originates;
• government approval (subject to community consent);
• conclusion of a benefit sharing agreement.
Material Transfer Agreement
A Model Material Transfer Agreement (MTA) has been developed for use in relation to both the Plant Variety Protection Act and the Traditional Medicinal Intelligence Act. A crucial issue is to establish clearly which agency or department has the authority to conclude a MTA. The MTA should specify:
• whether it concerns a transfer of biological material only, or whether traditional knowledge or know-how is included;
• the purpose and scope of the transfer, and the use of the knowledge or materials; notably, the details of the contract may differ in case use for commercial purposes is agreed to. Restrictions to potential use may be specified;
• who will have the right to apply for ensuing IPR protection, whether royalties would be paid, and if so, how they would be distributed among parties concerned (such as the local community and a traditional healer);
• a clause forbidding further disclosure of the transferred knowledge or know-how may be included;
• conditions with regard to technology transfer to the provider of the traditional knowledge can be included; for example, R&D can be performed in collaboration between the parties;
• termination of the contract and settlement of disputes will have to be addressed.
The Plant Variety Protection Act has established a scheme for benefit sharing in case of plant genetic resources, in which a negotiation will take place between the party seeking access (generally a researcher or company) and the appropriate Government Agency (in Thailand, this is the Ministry of Agriculture). However, the law has established a minimum rate of return to Thailand, equaling 5% of net sales. The law then specifies that these returns are to be shared as follows: 40% is for the State, 40% will be accorded to the local community, from where the resource originated, and 20% is for the individual farmer or breeder, provided he/she can prove to be the one who developed the traditional plant. In case no individual can prove this, the benefit will be shared 50-50 between the local community and the State.
The law also enables the establishment of a Plant Variety Protection Fund, which would tap a portion of the royalties paid by those who use plant genetic resources for commercial purposes. This Fund will be used to assist and subsidize activities related to plant varieties conservation, research and development.
It should be borne in mind that these laws have largely been developed 'from scratch' in a relatively short time. As a result, there are bound to be loopholes or other problems, some of which may only become obvious once the Acts have been in force for some time. But they are a starting point to address issues which, Thailand felt, are important.