TRM has particular characteristics influencing the extent to which IPRs may be applied. TRM includes materials, processes and methods of treatment, individually or collectively held, constituted by old and recently developed knowledge, largely but not totally disclosed and capable of generating commercial value at different points of the value added chain. Most importantly, TRM has great value in many developing countries where it plays a crucial role in the health care systems.
Some governments, scholars and NGOs have voiced the need to protect TRM under existing or new forms of IPRs, in order to recognize and compensate the creators and possessors of such knowledge. Others object to that possibility for ethical, economic or other reasons, while demanding measures to prevent “biopiracy”, that is, the unauthorized appropriation of TRM under Western IPRs systems.
Discussions concerning the protection of TRM under IPRs, have generally focused on the injustice generated by third parties’ misappropriation, and on the benefits that some forms of IPRs (existing or to be created) may generate for TRM holders. Little attention has been paid to the costs associated to the establishment of IPRs, as they may limit access to medicines and treatment. This issue is particularly important, since TRM serves the health care needs of millions of people in developing countries.
Developing a policy on TRM and IPRs is a very complex matter and presents difficult dilemmas, for a variety of reasons.
First, the scope and content of such policy would logically depend on the pursued objectives. A great diversity of views exists on the objectives that IPRs may foster in the field of TRM. The analysis made above reveals that tensions exist between some possible objectives of IPRs protection, notably between conferring exclusive rights over TRM and ensuring access to health care, especially by the poor. Moreover, the role that IPRs may play in attaining some of the intended objectives (such as preservation) does not seem to have been carefully examined, and the potential of such protection is often overstated. Many of the objectives mentioned as justifying protection, such as benefit sharing, may be best attained by other, non-IPRs means.
Second, there are important differences among TRM systems in use, and any generalization about means for their protection is inappropriate. In particular, IPRs can play a quite different role with regard to codified and non codified TRM. In the case of codified TRM systems, the main problems to be addressed include the misappropriation by third parties and how to encourage investment for the validation of existing medicines. Misappropriation is also a concern in the case of non-codified systems, the main issues being in the context of IPRs the recognition of communities’ contributions and benefit sharing.
Third, the concept of TRM embraces different categories of knowledge that may be subject to existing forms of IPRs, if the conditions for protection are met in particular cases. Several components of TRM, including products and processes and, in some countries, uses and methods of treatment, can be validly covered by patent rights. In fact, a large number of patents have been granted in relation to natural products, combinations, extracts and preparations thereof, as well as processes of production. The use of patents to protect TRM, however, face important obstacles, due to the need to meet the patentability requirements and to the costs and complexity of procedures before patent offices and, most importantly, of enforcement in courts. Management capacity and investments are necessary to get value out of the use of such rights. Other modalities of IPRs, such as trademarks and geographical indications, may also be applied, but they do not protect the knowledge as such and similar obstacles are faced with regard to the acquisition and enforcement of rights.
Fourth, while developing sui generis regimes for the protection of TRM (or, more generally, traditional knowledge) is an open option, many conceptual and practical difficulties need to be addressed. By definition, such regimes should be adapted to the object to be protected and to the context where it would be applied. Suggesting one single model of sui generis regime may defeat the very concept that it purportedly promotes. In addition to difficulties in determining who owns and what kind of rights are to be conferred, in the absence of an international regime the establishment of a sui generis system at the national level would not solve the problems of misappropriation and lack of benefit sharing with regard to commercial exploitation of TRM made abroad.
Last, and perhaps most importantly, TRM plays a very important role in the health care systems of developing countries, particularly of the poor. The diffusion of TRM-based products is also significant in developed countries. The granting of IPRs-forms of protection on medicines used in TRM systems may have high social costs via a reduction in access to medicines and treatment essential to millions of people. It is unlikely that such costs be offset by the benefits that may possibly accrue from validation or the improvement on such medicines that IPRs protection would encourage. Therefore, when designing national policies on TRM, a careful assessment of the possible implications of IPRs protection of TRM on public health should be made.
As noted, misappropriation is one of the main problems perceived in this area. There are a number of changes in patent laws that may be introduced and actions that may be taken, nationally and internationally, in order to prevent misappropriation of TRM, namely: establishment of a universal standard of novelty for patent grants; disclosure of the origin of biological materials in patent applications; clarification and strict application of inventorship rules; and development of data bases to establish prior art.
Such changes and actions may help to address, if not completely solve, one of the most thorny issues in this field, and would constitute an important step towards a better legal treatment of this issue. Action may also be taken for a rational and effective implementation of the benefit sharing principles of the CBD which, paradoxically, very few developing countries have incorporated into national policies and regulations.
When identifying rationales and mechanisms for the protection of TRM held by local/indigenous communities, it is important that the perspectives, opinions and rights of indigenous peoples be considered, and that indigenous representatives participate in relevant decision-making processes. Such inclusion is not only a moral imperative but is, for some States, necessary for the satisfaction of their obligations under international law. A basic decision must be made as to whether any attempt to protect TRM will seek to impose Western standards and principles or face the more difficult task of accepting traditional concepts and finding ways to reconcile Western interests with them.
Some have suggested that the number of local/indigenous communities that would be likely to benefit from the availability of IPR protection may be small. Whether that is reason or not to go ahead with the creation of protection for TRM is a matter for local/indigenous peoples themselves to determine, in line with their own development and other priorities, including the effect of such measures, negative or positive, on their social and cultural development and rights.
While governments should recognize the contributions of local/indigenous communities and healers, and should condemn the misappropriation of their knowledge, they should not succumb, however, to the simplistic idea that the solution to the current problems of inequity and knowledge erosion can be solved by the adoption of existing or new forms of IPRs. Any solution to the problems associated to the protection of TRM requires a holistic approach.
Debates on IPRs protection have often overlooked that the existence of local/indigenous communities and, therefore, the preservation and further development of TRM, is indivisible from their cultural and natural environment. The principal threat to TRM knowledge is likely to originate not from the lack of legal recognition of IPRs, but from the continuous erosion of their cultures and the ecosystems in which local/indigenous communities live.
In light of public health priorities, governments may adopt several measures to promote the use of TRM for the affordable treatment of national and regional priority diseases, such as encouraging the validation, registration and quality control of TRM-based products.
IPRs should not run counter to but should support public health186. Developing countries may gain little and loose a lot if achieving the protection of TRM leads, in fact, to limiting access to TRM treatment and products. After the full implementation of the TRIPS Agreement, developing countries will be bound to pay more for needed medicines. TRM may become a critical component in the public health strategy of many of such countries. The benefits to society of safe and wide use of TRM may be substantial, while the granting of exclusionary IPRs may only benefit a few, if any.
186 See the “Doha Ministerial Declaration on the TRIPS Agreement and Public Health”, WT/MIN(01)/DEC/W/2, 14 November 2001.
Policies on TRM should aim at balancing considerations of equity and public health. While it is fair that TRM holders receive, when appropriate, a moral or economic reward for the knowledge they contribute, such reward should not be at the price of reducing access to TRM by people in need, particularly the poor.