(2002; 131 pages)
Traditional medicine (hereinafter “TRM”)1 includes knowledge and practices either codified in writing or transmitted orally. Non-codified, orally transmitted knowledge is generally held and used only within a limited circle of people such as within specific indigenous or rural communities and falls within the sometimes used terms “indigenous” (or “tribal”), “farmers” (or “rural”), “popular” (or “folk”) knowledge (Koning, 1998, p. 263). Systems of TRM codified in writing are often sophisticated systems of medicine supported by theories and rich experience. Such TRM is often widely diffused on a national scale as well as beyond national borders, as in the case, for example, of Traditional Chinese Medicine (TCM), Ayurveda, Unani, Tibetan, Mongolian and Thai traditional medicine, Kampo and Korean traditional medicine (based on TCM).
1 For the purposes of the analysis in this study, the following definition of TRM has been adopted: “The sum total of all the knowledge and practices, whether explicable or not, used in diagnosis, prevention and elimination of physical, mental or social imbalance and relying exclusively on practical experience and observation handed down from generation to generation, whether verbally or in writing” (WHO Traditional Medicine Programme. SeeZhang, 1998).
In some cases, different TRM systems coexist within the same country. In India, for instance, the orally transmitted “folk” system practiced by village physicians/folk healers and tribal communities, coexists with “scientific” (Sasthreeya) systems such as Ayurveda, Sidha, Unani and Amchi that are based on organized, codified and synthesized medical wisdom with strong theoretical and conceptual foundations and philosophical explanations (Pushpangadan 2002, p. 5).
TRM serves the health needs of the vast majority of people in developing countries, where access to “modern” health care services and medicine is limited by economic and cultural factors. TRM is broadly used in such countries,2 often being the only affordable treatment available to poor people and those in remote communities. In a context of persisting poverty and marginalization3 and, in particular, in view of the high prices generally charged for patented medicines,4 the relevance of TRM in developing countries may, in the future, increase.
2 For instance, the per capita consumption of TRM products in Malaysia is more than double the consumption of modern pharmaceuticals. TRM is even significant in relatively advanced developing countries such as South Korea, where the per capita consumption of TRM products is about 36% more than modern drugs (Balasubramanian, 1997, p. iii).
3 See, e.g., UNDP, 2001;Hirst andThompson, 1996;Khor, 2000.
4 The TRIPS Agreement has imposed the obligation to recognize product patents for pharmaceuticals in all Members to the World Trade Organization. On the impact of patents on access to medicines in developing countries, see, e.g. Oxfam, 2000; Kettler, 2002.
TRM also plays an important role in developed countries. Many pharmaceutical products produced and used there are based on, or consist of, biological materials sourced through reference to traditional medicine. These include compounds extracted from plants and algae, as well as from microbial sources and animals. Plants, in particular, are an indispensable source of pharmaceuticals.5 The demand for “herbal medicines”6 has grown dramatically in recent years. The world market for such medicines has reached, according to one estimate, US$60 billion, with annual growth rates of between 5 and 15 per cent.7
5 See, e.g., Lambert, Srivastava and Vietmeyer, 1997, p. 1; ten Kate and Laird, 1999.
6 “Herbal medicines” are defined by WHO as “finished, labelled medicinal products that contain as active ingredients aerial or underground parts of plants or other plant material, or combinations thereof, whether in the crude state or as plant preparations. Plant material includes juices, gums, fatty oils, essential oils, and any other substances of this nature. Herbal medicines may contain excipients in addition to the active ingredients. Medicines containing plant material combined with chemically defined active substances, including chemically defined, isolated constitutes of plants, are not considered to be herbal medicines. Exceptionally, in some countries herbal medicines may also contain, by tradition, natural organic or inorganic active ingredients which are not of plant origin” (WHO, 1996, p. 178). For definitions in national laws, see Jayasuriya and Jayasuriya, 2002, p. 198.
7 Estimates by the Secretariat of the Convention on Biological Diversity, 2000. See also WHO, 2000a, p. vi.
Public policies with regard to TRM vary significantly between countries. Different policies exist, in particular, in relation to the integration8 of TRM in national health care systems. Some countries, such as China, the Republic of Korea and Vietnam, have adopted measures to promote integration9 aimed at exploiting the complementarities of TRM and modern medicine.10 Measures have included procedures for the registration of traditional healers or herbalists,11 the establishment of specialized hospitals, colleges and universities,12 the development of research programs,13 the validation and certification of TRM products,14 the introduction of ‘Good Manufacturing Practices’15 and the incorporation of medical doctors who have graduated from traditional medical universities, into the staff of hospitals of modern medicine to promote the use of TRM in combination with the practice of Western medicine.16 In some countries, such as Zimbabwe and South Africa, the responsible authorities accord substantial recognition to healers through national efforts designed to integrate traditional and Western medical systems. In others, healers are afforded no substantive recognition, their status existing purely within the custom of local communities (Lettington, 2000, p. 5).
8 The concept of ‘integration’ in the ethnomedical literature often implies the incorporation of aspects of TRM into national healthcare in a way acceptable to modern medicine. Many TRM associations prefer the term ‘partnership’ as suggesting a more equal relationship.
9 In China, for instance, the Constitution promulgated in 1982 and the present Constitution declared that the State should “develop both modern medicine and traditional medicine”. The Constitution establishes that “traditional Chinese Medicine and Western medicine should unite and learn from each other, mutually complement each other and improve together, in order to promote the integration of traditional Chinese and Western medicine”. See, Xie, 2002, p. 119..g.
10 It has been noted, for instance, that TRM has been more effective than modern medicine in addressing some diseases, such as certain viral diseases (Xie, 2002, p. 127)
11 In the case of Kenya, for instance, the herbalists have been required to register with the Ministry of Culture, and to obtain a recognition certificate. They have also been required to submit samples of all the herbal medicines they use to a scientific institution for testing (Kenya Medical Research Institute -KEMRI- or University of Nairobi), as well as to provide information on the names of the plants, the parts used, the methods of preparation, administration and dosages (Muchae, 2000, p. 12). See also Chandra, 2002, p. 152.
12 In China, in 1995 there were 2371 TCM hospitals and 30 TCM colleges, some of which have been promoted to university level. See Xie, 2002, p. 120-123. In India, there are 2.854 TRM hospitals and more than 387 colleges specializing in TRM (Chandra, 2002, p. 139).
13 See e.g., on China Xie, 2002, p. 129; on India, Chandra, 2002, p. 140. Several African countries, such as Burundi, Guinea, Tanzania, Cameroon and Mali, have established research institutions with statutory responsibility for undertaking research relating to TRM (Jayasuriya and Jayasuriya, 2002, p. 202).
14 In India, for instance, pharmacopoeial standards for 158 drugs are available and 634 formulations have been published in the Ayurvedic Formulary of India. Thousands of Ayurvedic and Unani formulations are licensed for sale over the counter by the national and local governments (Chandra, 2002, p. 143 and 138).
15 Such as in India and Indonesia (see Chandra, 2002, p. 139).
16 See, e.g. Xie, 2002, p. 119; Chandra, 2002, p. 143.
TRM has been recognized in western science as a valuable source of products and treatments for health care. It often provides leads for the development and commercialization of new pharmaceutical products. However, western intellectual property systems have regarded TRM, as well as other components of traditional knowledge (TK), as information in the “public domain”, 17 freely available for use by anybody. This has meant that TRM and other traditional knowledge has been exploited in Western contexts without any recognition, moral or economic, to those who originated or held the relevant knowledge. Further, diverse components of TRM have been appropriated under intellectual property rights (IPRs) by researchers and commercial enterprises, without any compensation to the knowledge’s creators or holders.
17 “Public domain” is generally understood in the IPRs field, as including any information that is not subject to IPRs or for which IPRs have expired. This means that, to the extent that some information is not covered under any of the IPRs modalities, it would belong to such domain and could be freely used. See, e.g., Fishman, 2000, p. 1/3.
Due to such cases of appropriation, growing attention has been paid in the last ten years to the issue of “protection” of traditional knowledge, including TRM. However, “protection” has been used in the literature and advocated by many interested groups, with quite different conceptions and goals in mind.
Some (e.g. Downes, 1997) understand “protection” in the context of IPRs, where it essentially means to exclude the unauthorized use by third parties of protected knowledge. Under this approach, IPRs may constitute either an offensive mechanism to support the commercialization of TK and to ensure benefit sharing,18, or a defensive tool to prevent the misappropriation of traditional knowledge.
18 “Benefit sharing” refers here to the fair an equitable participation of TK holders in the benefits arising from the commercial and other utilization of TK. See article 15 (7) of the Convention on Biological Diversity.
Others (e.g., Simpson, 1997) regard “protection” as a means to preserve traditional knowledge from uses that may erode it or negatively affect the life or culture of the communities that have developed and applied it. Protection here has a direct positive role in supporting TK based communities’ livelihoods and cultures, and requires the application of mechanisms - such as conservation projects - where IPRs have little or no part to play.
While all these forms of ‘protection’ are important, this paper focuses on issues relating to protection of TRM in the context of IPRs, both as a defensive and offensive strategy. Its main purpose is to try to clarify the extent to which IPRs may be used in relation to TRM, and what the implications of such use may be for public health.
Some aspects of TRM may be protected under existing IPRs, such as patents. There have also been proposals to develop sui generis systems of protection - that is, systems specially suited to the characteristics of traditional knowledge, including TRM.19 While such proposals in general fail to clearly set out the rationale for their adoption20, they are often, explicitly or implicitly, based on considerations of equity: if innovators in the “formal” system of innovation receive compensation through IPRs, justice requires that holders of traditional knowledge be similarly treated.
19 See, e.g., Ruiz Müller, 2002.
20 See, e.g. Girsberger, 2000, p. 1-3.
Though IPRs may, under some circumstances, help TRM holders to obtain a monetary compensation for their knowledge, by their very nature IPRs restrict the diffusion of the protected knowledge, thereby reducing static efficiency and imposing a cost on society. In the case of TRM in particular, the application of IPRs may benefit those who commercially exploit protected knowledge or who share in the benefits of such a commercialization, but at the cost of limiting access to TRM by those who need medicines and treatment. A tension, therefore, arises between different objectives: to compensate TRM holders and promote the commercialization of TMR, on the one hand, and to ensure the widest possible access to TRM, especially by the poor, on the other.
This study examines, first, some characteristics of TRM relevant to issues of IPRs protection. Second, it considers the rationale for the protection of TRM under IPRs, existing or to be created. Third, it discusses the extent to which existing modes of IPRs (patents, trade secrets, trademarks and geographical indications) may be applied to TRM. Particular emphasis is given to the discussion of patents, with the other forms of IPRs being touched on more briefly. Fourth, in the light of the analysis presented in the preceding sections, policy options available for the protection and promotion of TRM in the context of health policies are discussed, with consideration given to both IPRs and non-IPRs modalities. Finally, some considerations are raised relating to the issue of IPRs protection of TRM in the context of public health policy.