Source: http://www.unsgaccessmeds.org/inbox/2016/2/26/patrick-juvet-lowe-gnintedemb-english-translation
Timestamp: 2019-04-20 06:39:20+00:00

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The success of intellectual property rights (IPR) in today’s global economy has opened doors to its expansion to include all types of goods that can bring capital gain to their holders. This upswing in the knowledge economy raises the issue of protecting traditional medicine (TM). In fact, TM takes on particular importance in exercising the right to health, since a large portion of the population resorts to TM, especially in developing countries. At the same time, TM sparks the interest of pharmaceutical industries, which rely on it for medical research that may result in inventions eligible for protection by IPR. Consequently, at issue is reconciling the protection of TM with the need for access to public health care and accommodating the interests of those who possess knowledge of traditional medicine, who are generally found in indigenous communities. Currently, mechanisms of protection vary between adoption of existing intellectual property rights (IPR) and the sui generis systems for protecting TM. However, none of these seem to offer sufficient guarantees of protection that would satisfy all the interests at play.
This paper contends that targeted modification of preexisting IPR could provide appropriate protection. This would mean introducing into these legislations a disclosure of origin requirement backed by sanctions. The principal lacuna in the current system is that it provided for this requirement without attaching sufficiently persuasive and effective sanctions. When it comes to implementation, the fact remains that such a measure would only be effective if recognized on an international level.
The success of intellectual property rights (IPR) in today’s global economy has opened doors to its expansion to all types of goods that may bring capital gain to their owners. In the wake of this upswing in the knowledge economy, protecting traditional medicine (TM) poses a serious problem.
Traditional medicine, like all traditional knowledge of which it forms a part, is a complex reality. It includes agricultural, scientific, technical, ecological and medical knowledge, knowledge linked to biodiversity, expressions of folklore, linguistic elements and cultural property (WIPO 2001), and the list goes on (WTO, Document IP/C/W/404 of June 26, 2003). It incorporates ancestral knowledge, belief systems and values of indigenous communities. It has no general definition widely accepted in the field. WHO has adopted a working definition of traditional medicine as “including diverse health practices, approaches, knowledge and beliefs incorporating plant, animal, and/or mineral based medicines, spiritual therapies, manual techniques and exercises applied singularly or in combination to maintain well-being, as well as to treat, diagnose or prevent illness” (WHO 2002). This set of knowledge and techniques is used to diagnose, prevent or eliminate an imbalance of physical, mental or social well-being.
The importance of TM in achieving the right to health has already been demonstrated. In African countries, 80% of the population resorts to TM to address their health care needs. In certain countries, the usage rate exceeds 90% of the population (WHO 2003). When traditional medicine is mentioned, the first thought is often that it refers to a specific practice of developing countries. But that is a mistaken notion. Systems of TM exist in numerous industrialized countries, where the term complementary and alternative medicine (CAM) is used to designate traditional medicine, and at times TM is better recognized and protected in those places than in certain developing countries. Such is the case in Australia and Canada. Furthermore, in most countries where a system of TM, whether formal or informal, subsists alongside conventional medicine, the problems that arise are nearly identical.
On the whole, the dynamic and potentially innovative nature of traditional medicine is universally recognized. The effectiveness of using traditional medicine against challenges posed by illnesses old and new is now largely recognized and continues to grow (UNAIDS 2002). According to WHO estimates, 25% of modern medications are prepared using plants originally used in traditional medicine (WHO 2003). Products of nature offer an invaluable opportunity to discover and isolate new modern medications. Therein lies the importance of protecting traditional medicine.
The principles that should govern the protection of traditional knowledge have been subject to reflections on an international scale. They revolve around several major objectives; namely: the fight against biopiracy and illicit appropriation of traditional knowledge, the pursuit of equity and shared benefits, the conservation and preservation of traditional practices, as well as promoting the usefulness and importance of biological medicinal resources for development. As a general rule, the main concern is satisfying the needs of local or indigenous communities and populations. Most systems of protection are inspired by texts such as: the TRIPS Agreement; the International Convention for the Protection of New Varieties of Plants (UPOV Convention, Act of 1978 and/or 1991); laws like those of UNESCO or WIPO for the protection of expressions of folklore; the Convention of Biological Diversity (CBD); the International Treaty on Plant Genetic Resources; the African Model Legislation for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources (AML) of 1998; or the United Nations Declaration on the Rights of Indigenous Peoples of 13 September 2007. Nevertheless, the logic that drives the protection of TM has failed to win unanimous support. At times, protection is understood to be a recourse to the instruments and principles of intellectual property, the main objective being to exclude unauthorized use of knowledge by third parties (WIPO 2012). At other times, it is perceived as a means of preserving traditional knowledge for all uses, likely to destroy or negatively affect the lifestyles of the populations that developed it (Correa 2001). Whatever the perception, it always contains the implicit idea of appropriation of traditional knowledge. Subsequently, effective protection of traditional medicine carries an association with recognition of a right to property. But what system should be used?
Current systems vary between adoption of existing intellectual property rights (IPR) and the sui generis systems for protecting traditional medicine. However, we feel that a better method for reconciling innovation with the need for lasting access to health care involves modifying current systems of intellectual property by integrating a disclosure of origin requirement backed by sanctions.
In practice, all types of intellectual property rights can, depending on the case, be invoked to ensure the protection of traditional knowledge. Recourse can also be found in the systems currently in place, such as patents, copyright and related rights, geographical indications, brands, industrial designs, plant breeders’ rights, as well as the law on unfair competition. Another possible example of protection is offered by the system of trade secrets, which would allow traditional communities to control the diffusion of their knowledge, innovations and practices. These laws can be used in and of themselves to protect traditional knowledge, or reinforced by combining them with other IPR (WTO, IP/C/W/310, IP/C/M/28, IP/C/W/257, IP/C/W/209, IP/C/M/37/Add.1, IP/C/M/29). In a broad sense, the two major sets of IPR—literary and artistic property rights on one hand; industrial property rights, of which patent rights are the most symbolic model, on the other—are considered to be applicable according to which set the traditional knowledge to be protected resembles most closely. Traditional cultural expressions or expressions of folklore are more generally associated with the protection offered by copyright on literary and artistic works. The goal of such inclusion in copyright law is to allow traditional communities or property holders to benefit from a set of moral rights and authors’ rights on their knowledge. Traditional knowledge linked to biological and genetic resources is itself often associated with a mechanism of protection organized in the systems of patents and plant breeders’ rights.
Still, the system is far from watertight. Certainly, in discussions on the protection of intellectual property, traditional cultural expressions and traditional knowledge are generally the subject of their own debate, in WIPO, for example. But even so, that does not mean these questions are separate in traditional communities. The distinction between traditional knowledge and traditional cultural expressions does not necessarily reflect the holistic perception of each holder when it comes to his or her own integrated property.
For many holders, traditional knowledge and their form of expression are considered an indivisible whole. Given the interactions and links that can exist between all kinds of traditional knowledge, including traditional medicine, a holder could, depending on the case and which opportunity seems most logical, move from one classic IPR system to another.
In any case, this highlights the unsuitability of the requirements imposed by classic IPR for ensuring the protection of traditional medicine. To this point, the patents system provides one of the most illustrative examples. Traditionally, three criteria are required in order to be granted protection by patent laws: novelty, inventive step and industrial applicability. Meeting these requirements constitutes a veritable Stations of the Cross, an insurmountable obstacle, even, for the patentability of TM (Dashaco Tambutoh 2001). For that matter, the international IPR system is considered to facilitate more than reduce biopiracy and illicit appropriation of traditional knowledge, which, incidentally, seems to corroborate recent news (Boury 2016). In response to these insufficiencies, numerous countries have adopted sui generis systems of protection.
In Africa, the two major regional intellectual property organizations, OAPI (Organisation africaine de la propriété intellectuelle, African Intellectual Property Organization) and ARIPO (African Regional Intellectual Property Association), now have sui generis legislation in place to protect traditional knowledge. In other countries around the world, such as Ecuador, the Philippines, Thailand and Venezuela, specific laws or constitutional provisions encompass special protection for traditional knowledge and TM. But on the whole, uncertainties remain.
The sui generis systems devised by OAPI and ARIPO legislators, for example, suffer from a significant lack of substance. By and large, the conditions as well as the effects of sui generis laws put into place by regional African legislators resemble classic models for IPR, such as copyright and patent laws. Moreover, these adopted texts provide neither mechanisms for carrying out and settling litigation, nor sanctions or means of recourse for the period of protection. Now, in the absence of such mechanisms, the established law’s relevance is uncertain; the text’s legal value, dubious. Because they can impose upon form, but impose virtually nothing on substance, the adopted texts seem to serve better as a frame of reference for passing laws to protect traditional knowledge and TM on a national level. Hence the idea that an appropriate modification of preexisting IPR systems would be more effective.
Serving as a compromise between acceptance and rejection of IPR in their current form, an intermediary approach consists of proposing to maintain the existing systems while including modifications that would curb their drawbacks. To that end, the prevailing idea is to introduce a disclosure of origin requirement for biological resources and traditional knowledge into the relevant patent texts. This would mean including, as an integral part of the IPR granting process, verification that biological resources and traditional knowledge were legitimately obtained and legal requirements in the country of origin were fulfilled. Essentially, defenders of this approach propose that the TRIPS Agreement be modified so that Members must require those seeking IPR on biological material or traditional (medical) knowledge to provide information on the source and country of origin of the traditional knowledge used in the invention, as well as proof that the national laws applicable to this knowledge have been respected. Failure to follow this provision should carry legal consequences (YOUSSFI née BRAHAM 2006; Correa 2003). Given the cross-border nature of research and development and business operations on biological resources and traditional knowledge, international recognition of the disclosure of origin requirement is necessary (Chouchena-Rojas and al. (eds.) 2005). In fact, a proposal from the African Group of WTO suggests that this requirement be introduced in article 29 of the TRIPS Agreement (Document IP/C/W/404, 26 June 2003), for provisions related to patent law.
One might consider, for example, that when the requirement is violated, and particularly when an inventor’s bad faith is established, the existing laws can be systematically retroceded to the profit of the indigenous communities concerned, without prejudice to any damages and interest.
By and large, the disclosure of origin requirement appears to be the key modification that would minimize the drawbacks of protecting traditional medical knowledge by IPR, especially by patent law. More than anything else, it is in the effects of such a requirement that its impact and ability to ensure this protection can be measured. But no consensus has been reached on the means of implementing the requirement, or on the most appropriate sanctions (de Werra 2009), although the need for an international regulatory instrument has been recognized. There is a particular worry that introducing a disclosure of origin requirement would have negative consequences on the patent system, discouraging applicants to respect the laws (WTO, document IP/C/M/49). But to that it may be argued that the principle of good faith is one of international trade in general, and that a true inventor should not have to doubt his creation. Furthermore, disclosure of the origin of his invention would not take away from the originality of his work.
Because of the eminently cross-border nature of the biological resources and medical knowledge of traditional communities, it must be recognized that substantial coordination on an international scale is an essential factor to making this mechanism work. This coordination could rely on a legal instrument to rule on traditional knowledge, or, more pragmatically, on an amendment to the TRIPS Agreement that would include both a disclosure of origin requirement and sanctions for violations from all players. In other words, nations must have the political will to advance these debates in order to achieve lasting rights to health while respecting the fundamental rights of both indigenous communities and holders of IPR.
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