Another goal that has been suggested as a rationale for the protection of TRM is based on its potential contribution to economic development, particularly development that would benefit local/indigenous communities.
The role of IPRs as instruments to promote and support commercialization - and thereby economic development - may be significantly different in the case of codified as compared to non-codified TRM systems. The commercial exploitation of herbal medicines, for instance, has opened up important business opportunities for Chinese77 and Indian78 companies, both domestically and internationally.
77 The total 1996 output of the finished TCM sector was U$S 3,7 billion. Thirteen out of the top fifty TCM producing companies were listed publicly on the domestic stock exchange (ten Kate and Laird, 1999, p. 80).
78 See, e.g. Agarwal, 2000; Rao, 2002.
Such exploitation, whether in regard to codified or non-codified TRM involves several steps - from procurement and authentication of raw materials to packaging and distribution. With increased demands for safety, efficacy and quality control, greater investments are required in research and development, plant capacity and compliance with good manufacturing practices.79 Such investments may in some cases, be significant, in particular, for the scientific validation of medicines through pre-clinical and clinical studies,80 as well as for the development of appropriate dosage forms. The size of these investments may pose an insurmountable barrier to poor local/indigenous communities willing to commercialize their knowledge.
79 In India, for instance, collaborative research programs have been established between industry and the Council for Scientific and Industrial Research (CSIR) in relation to raw materials, processing and formulation (see, e.g., Warrier, 1999, p. 14).
80 See, however, section IV.h below.
The granting of IPRs may stimulate the referred to investments, in that they may reduce the risk of free-riding by third parties. However, as discussed, in most cases the products, as well as their therapeutic uses, would be known and not patentable.81 Patents, if inventive, (as examined further in the following section) may be applied for and obtained for processes of extraction or manufacture, combinations and formulations. Some countries may also consider providing some form of exclusive protection over the test data developed in relation to a particular product, so as to allow for the recovery of investments made, but at the price of creating barriers to access.82
81 It is possible that trademarks and geographical indications rather than patents, prove in many cases to be the most useful tools for the commercialization of TRM. See section III.C below.
82 See also section IV.h below.
It may also be argued that the availability of IPRs protection could act as an incentive for local/indigenous communities to transmit to third parties knowledge kept under their control, thereby making commercial exploitation possible. IPRs may help to build the confidence necessary for that communication to take place.83 Though this is a plausible argument, it may overlook that IPRs are on the whole alien to local/indigenous cultures, and that it may be difficult to create trust on the basis of an instrument that is unfamiliar to them and based on values that are not shared. This argument may also overlook the difficulties that communities may face in acquiring and, particularly, licensing, any rights they obtain. As mentioned below, acquiring patent rights is generally complex and costly and enforcement costs through litigation are extremely high.
83 See, e.g, Drahos, 1997.
There may also be cases where local/indigenous communities desire to not only gain intellectual property rights, but to take on the commercialization of their TRM knowledge themselves, provided that they have the capital and managerial capacity to do so. IPRs may strengthen the communities’ market position in these cases.
The exercise of the right to development by indigenous peoples84 requires participatory and decision-making arrangements that are consistent with the concept of self-determination85 and specific rights in international law, and thus has implications for the appropriate development of policy in this area. For example, Article 7.1 of the ILO Convention 169 concerning Indigenous and Tribal Peoples in Independent Countries states that
“the peoples concerned shall have the right to decide their own priorities for the process of development as it affects their lives, beliefs, institutions and spiritual well-being and the lands they occupy or otherwise use, and to exercise control, to the extent possible, over their economic, social and cultural development. In addition, they shall participate in the formulation, implementation and evaluation of plans and programs for national and regional development which may affect them directly”.86
84See Declaration on the Right to Development, adopted by United Nations General Assembly resolution 41/128 of 4 December 1986. Article 1.1 states: “The right to development is an inalienable human right by virtue of which every human person and all peoples are entitled to participate in, contribute to, and enjoy economic, social, cultural and political development, in which all human rights and fundamental freedoms can be fully realized”.
85 As discussed previously, the right to self-determination applies only to indigenous peoples if they are ‘peoples’ for the meaning of the International Covenant on Civil and Political Rights and other such instruments. Instruments such as ILO Convention 169 that apply directly to indigenous peoples, are compatible with the right to self-determination and give form to many of its ramifications.
86 Article 7.2 goes on to require that “Governments shall ensure that, whenever appropriate, studies are carried out, in cooperation with the peoples concerned, to assess the social, spiritual, cultural and environmental impact on them of planned development activities. The results of these studies shall be considered as fundamental criteria for the implementation of these activities”. Thus, if States party to this Convention consider legislation or measures to protect TRM, or intend to support the development of international law on the matter, such a study should be undertaken and its results must be considered a ‘fundamental criteria’ for the implementation of that protection.
Where States wish to encourage the availability of protection for the purpose of economic development more generally, the benefits from such activities should be fairly distributed87. By common measures of fairness, some benefits should in some way be channeled back into the indigenous community/ies in which the TRM originated.
87 The preamble to the Declaration on the Right to Development recognizes the distribution of benefits as an essential component of development (note that the preamble does not have the legal force of the Declaration itself).