- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Public Health, Innovation, Intellectual Property and Trade > Intellectual Property (IP) and Trade
(2002; 131 pages)
E. Designing a sui generis Regime
Given the difficulties in applying existing modes of IPRs protection, even if modified, to address some of the problems raised by traditional knowledge, several proposals have been made to develop sui generis regimes for the protection of such knowledge through international or national sui generis regimes.151 Little progress has been made, however, in actually designing them.
151 For a review of literature on the matter, see Dutfield, 2000a.
Proposals for the recognition of “tribal”, “communal” or “community intellectual rights”,152 and “traditional resource rights”,153 among others, essentially advocate such a sui generis approach. In many cases, however, the rationale for the proposed protection is unclear in terms of the specific objectives to be reached (Correa, 2000a).
152 See, e.g., Berhan and Egziabher, 1996, p. 38.
153 See, e.g., Posey and Dutfield, 1996; Koon, 1999.
A few countries have started to address the complex conceptual and operational problems involved in the recognition of communities’ rights over traditional knowledge. For instance, “collective” intellectual property rights have been recognized by the Constitution of Ecuador (1998). The Biodiversity law of Costa Rica (1998) protects “ sui generis community rights” (article 82). The Provisional Measure No. 2.052 of Brazil (21.12.00) recognizes the rights of local communities to benefit from their knowledge and to be compensated for its economic exploitation. They can prevent third parties from disclosing or transferring such knowledge without their authorization. In the Philippines, the “Act to Recognize, Protect and Promote the Rights of Indigenous Cultural Communities/Indigenous Peoples” (No. 837, of 28 July, 1997), stipulates that:
“Indigenous Cultural Communities/Indigenous Peoples are entitled to the recognition of the full ownership and control and protection of their cultural and intellectual rights. They shall have the right to special measures to control, develop and protect their sciences, technologies and cultural manifestations, including human and other genetic resources, seeds, including derivatives of these resources, traditional medicines and health practices, vital medicinal plants, animals and minerals, indigenous knowledge systems and practices, knowledge of the properties of fauna and flora, oral traditions, literature, designs, and visual and performing arts” (Section 34).
At the international level, the Council for TRIPS has under its consideration the review of article 27.3(b) of the TRIPS Agreement. The Doha WTO Ministerial Declaration also highlighted the need for further work in this area154. The review of article 27.3 (b) has been regarded by many developing countries as an opportunity to harmonize the TRIPS Agreement with the Convention on Biological Diversity (the CBD),155 and to develop rules for the protection of traditional knowledge.156 The approaches proposed by different countries however, differ.
154 See paragraph 19 of the Doha WTO Ministerial Declaration (WT/MIN(01)/DEC/1) adopted on 14 November 2001, which calls for the Council for TRIPS to examine the issue of protection of traditional knowledge and folklore.
155 See, e.g., the submission by Egypt, WT/GC/W/136.
156 See, in particular, the submissions by India (WT/GC/W/147)and by the African Group (WT/GC/W/302).
For the African Group, such a review should preserve the room existing at the national level to develop specific modalities of protection for traditional knowledge. Venezuela157 has gone a step further and proposed the development of binding international rules on the matter. It has suggested
“to establish on a mandatory basis within the TRIPS Agreement a system for the protection of intellectual property, with an ethical and economic content, applicable to the traditional knowledge of local and indigenous communities, together with recognition of the need to define the rights of collective holders” (WT/GC/W/282).
157 Under Decision 391 of the Andean Pact, the Member countries thereof are bound to develop legal regimes for the protection of communities’ knowledge. A constitutional provision to that effect has been adopted in Ecuador. None of the Andean countries, however, have so far developed such regimes.
Though the viability of this latter proposal in the framework of the TRIPS Agreement is still uncertain, it addresses one of the problems that countries opting for the protection of traditional knowledge under a sui generis regime would face: due to the principle of territoriality, protection at home would neither prevent the misappropriation of the protected knowledge in other countries, nor allow the TK holders to obtain any type of protection abroad. Hence, an international agreement would be necessary in order to obtain legal recognition of such holders’ rights on an international scale.
Some developing countries (notably from Latin American and the Caribbean) have also actively promoted the increased involvement of the World Intellectual Property Organization (WIPO) in the discussion and development of a sui generis regime for traditional knowledge.158
158 As mentioned, an Inter-Governmental Committee to deal with these issues was established by WIPO in September 2000.
The establishment of sui generis regimes pose many complex conceptual and practical issues (Correa, 2000a; Correa, 2000c). Such problems include the determination of:
• who the title-holders are and how are they represented;
• the subject matter of protection;
• the eligibility requirements and modes of acquisition, possibly including registration;
• the kind of rights to be granted (exclusive rights, or merely remuneration or moral rights);
• the duration of protection and its possible retroactive application;
• sanctions in case of infringement; and
• enforcement mechanisms.
There are two important additional problems to be faced. First, as mentioned, there is a great variety of codified TRM systems, while local/indigenous communities utilize various forms of TRM knowledge (which in many cases may be shared by more than one community). In order to be consistent with the very concept of sui generis, such systems should be tailored to the diverse cultures and environments in which they would be applied. In fact, certain communities could be said to have developed their own sui generis systems under their own customary laws. The idea (quite popular in certain circles) that a single sui generis regime may fit all, and that Western experts (including this author) are better equipped than the communities themselves to design systems suitable to their conceptions and needs is thus highly debatable.
Second, should a sui generis regime be established in a particular country, the territoriality principle deems that such a regime would not get recognition in other countries, unless bilateral, regional or international agreements were adopted. While it may take some time to develop an acceptable international regime, bilateral or regional agreements may be more rapidly agreed upon and implemented. In any case, unless an international standard is developed, the value of new forms of IPRs protection will be limited to within national borders. In this sense at least, the use of established IPRs forms, if possible at all, and if consistent with a clearly articulated and appropriate rationale for protection (and especially if actually enforceable by their holders) present more advantages than newly established, but territoriality limited, sui generis forms of protection.
It has been suggested that the mutual recognition, on an international basis, of sui generis regimes established on the national level should be promoted (Department of Commerce, Government of India, 2002). This approach essentially advocates for an extraterritorial application of national laws on the matter, something that many countries may be very reluctant to accept. An alternative approach could be based on the global enforcement of private judgments and injunctive relief in commercial litigation as proposed in the draft “Hague Convention on Jurisdiction and Foreign Judgments in Civil and Commercial Matters” (which is being negotiated under the Hague Conference on Private International Law).159
159 See Love, 2001.
Thailand is possibly the only country that has so far developed a comprehensive sui generis regime for TRM medicine (see Box 1). One important feature of the Thai law is that all three types of formulae can continue to be freely used domestically by traditional healers or Thai communities in limited quantities. The law also provides for measures aimed at the conservation and sustainable utilization of the medicinal plants, especially those at high risk of extinction. In addition, the Institute of Thai Traditional Medicine160 was formally established (after having been in operation for seven years), and a Thai Traditional Knowledge Development Fund was created.
160 The Institute is governed by a committee composed of equal numbers of NGO’s and governmental officials. Registration and other activities are distributed among 75 provincial offices throughout Thailand.
The Thai regulations have permitted the registration of over 700 licensed local manufacturers producing traditional medicine. In 1998, there were already 4,300 formulations registered with Thai FDA. These numbers are still increasing. The total value of production in 1999-2000 was around 320 million bahts161, without including traditional medicines produced individually by healers (Subcharoen et al, 2000).
161 Approx. U$S 7,5 million.
The Thai Act provides a model of a special regime for the “protection” and the “promotion” of TRM which does not prevent the traditional healers from continuing to produce preparations for individual use. It contains, however, some questionable elements. In particular, the very long period of protection may create an “unnecessary burden on society” and provide “unreasonable profits to the owners of the traditional knowledge” (Kuanpoth, 2001, p. 6-7). In addition, there have been implementation problems, since no “national formulae” have been announced, and it has been difficult to establish title to “private formulae”.
The Thai sui generis TRM regime
The “Thai Traditional Medicinal Intelligence Act” distinguishes different categories of “Traditional Formulations”:
The commercial use of a national formula, for the production of drugs or for research and development, is subject to permission from the government (criminal sanctions are provided for in the case of infringement).
“Private Formulae” can be freely used by the owner. Third parties must obtain permission from the owner to use the formula. The request for the registration of a “private formula” can be submitted by an inventor or developer of the formula, or an inheritor of the inventor or developer of such a formula.
The Act grants exclusive rights by allowing the owner of the registered personal formula to use the formula for research and to sell and distribute any product developed or manufactured by using the formula. However, there are certain limitations to the exclusive rights. The rights over a registered personal formula remain in force throughout the life of the owner and subsist for a further period of fifty years from the date the applicant dies. One of the main objectives of the sui generis protection is that the exclusive monopoly granted by the State should enable the owners of traditional knowledge to be adequately compensated for their contribution.
“General formulae”, finally, are well known traditional formula that may be used freely by anybody.
Source: Kuanpoth, 2001, p. 6-7.
In addition, the patent-like rights conferred under this system may allow title-holders to charge high prices, thereby reducing affordability to medicines essential to a large part of the population. Though it is arguable that the sui generis regime, as described, is necessary to promote investment in testing and validating TRM-based products, there is no analysis supporting this hypothesis, or examining other possible, less restrictive, options. The establishment of a sui generis regime of this kind would only seem to be justified if it were proven that benefits to society outweigh the deleterious effects on public health that such regimes may create.