PHARMACEUTICAL INDUSTRY IN EUROPE
7. Opposition of developing
7.3 THE IP DEMANDS OF DEVELOPING COUNTRIES AND LDCS DURING THE 1999 WTO MINISTERIAL
7.3.2 Demands Concerning TRIPs Pharmaceutical and Biotechnological IP Agenda
7.3.2 Demands Concerning TRIPs Pharmaceutical and
tended to leave aside a large sector of human creativity, namely the traditional knowledge possessed by local and indigenous communities.ʼ35
Second, developing countries and LDCs emphasized the issue of traditional medicinal knowledge, particularly with respect to the application of genetic, biological and natural resources and the management of such resources.36 Specifically, the patentability of pharmaceutical products based on substances and methods used by indigenous peoples posed a serious problem for developing countries and LDCs. In its statement to the Seattle ministerial meeting, Pakistan argued that developed countries have appropriated, without permission or compensation, traditionally owned medicines such as Neem and Haldee, as well as agricultural products, most notably Basmati rice.37
At WIPOʼs Round Table on IPRs and Indigenous Peoples of 1998, the Coordinating Body for the Indigenous Organizations of the Amazon Basin (COICA) presented various cases in which, according to its view, the medicinal know-how of indigenous people was appropriated and patented by Western pharmaceutical bodies.38 COICA argued that in 1996 a US-based organization, namely the International Plant Medicine Corporation, patented a variation of the medicinal plant Ayahusaca (known as ʻYageʼ).39 COICA explained that the plant Yage has been used and domesticated for centuries by the indigenous peoples of Amazonia and concluded that the patent was a ʻglaring case of biopiracyʼ.40 COICA also referred to a case in which a medicinal plant for the treatment of the tropical disease Leishmaniasis was patented by the French Institute of Scientific Research and Development Cooperation (ORSTOM).41
Third, and in view of the above, developing countries called for the establishment of an international legal framework, using either TRIPs or a sui generis system, that would allow legitimate holders of traditional knowledge to exercise effective control over the access, use, reproduction, imitation, exploitation and transmission of such knowledge for commercial purposes.42
Developing countries and LDCs outlined a two-stage programme for achieving the goal of establishing IPRs in traditional knowledge: (1) carry out studies in order to recommend the most appropriate means to protect traditional knowledge, including medicinal practices and expressions of folklore, and (2) on the basis of these studies, WTO members should negotiate the establishment of a multilateral system for the protection of traditional knowledge via IPRs.43 Separate communications from Honduras, Venezuela and India also laid down the demand for IP protection of indigenous and traditional knowledge.44 Prohibiting patents based on plants and animals (ʻlife-patentingʼ) and excluding the WHO list of essential drugs from patentability
Developing countries and LDCs had serious reservations about the patentability of pharmaceutical and biotechnological inventions based on plants and animals. In sharp contrast to the position of the R&D-based pharmaceutical
and biotechnological industries (see Chapter 8), developing countries sought to amend Art. 27.3b in order to prohibit the patentability of such inventions. As noted in the previous chapter, WTO members had to review Art. 27.3b – exclusion of plants and animals from patentability and the protection of plant varieties – by the end of 1999. Regarding the exclusion from patentability of plants and animals, developing countries and LDCs raised two major objections.
The first focused on the way in which the Art. 27.3b is formulated, that is, that according to this article the exclusion from patentability of plants and animals is optional rather than obligatory.45
The second objection concerned the distinction made in Art. 27.3b between plants and animals and ʻessentially biological processesʼ that can be excluded from patentability, and micro-organisms and microbiological processes for which a patent is compulsory. Developing countries and LDCs argued that such a distinction compromised a fundamental rule of the modern patent system:
that patents may be granted only to inventions and not to existing substances and processes (such as micro-organisms and microbiological processes) that are considered for all purposes a discovery.46 As argued by Kenya on behalf of the African Group:
By stipulating the compulsory patenting of microorganisms (which are natural living things) and microbiological processes (which are natural processes), the provisions of Article 27.3b contravene the basic tenets on which patent laws are based: that substances and processes that exist in nature are a discovery and not an invention and thus are not patentable.47
This argument was also supported by TIME magazine, which, using a rather controversial cover-page titled ʻWho Owns Nature?ʼ (30 November 1998) concluded that ʻcompanies often end up trying to pass off as invention what are, in fact, discoveries – glimpses, really – into the magical processes rolling into natureʼs crucible.48
Moreover, linked to the mapping of the human genome (Genomics), the issue of ʻlife-patentingʼ became subject to an intense global public debate.
Commencing in 1999, the race to publish the first blueprint of the human genome between the publicly-funded Human Genome Project and private biotechnologi- cal companies such as Celera, came close to the finishing line.49 So intense was the question of gene-patenting that in March 2000 US President Bill Clinton and British Prime Minister Tony Blair issued a joint statement calling for the free use of human raw data: ʻTo realise the full promise of this research, raw fundamental data on the human genome, including the human DNA sequencing and its variations, should be made freely available to scientists everywhere.ʼ50 However, in their statement, the leaders made a distinction between raw funda- mental data that should be made freely available to all and gene-based inventions
that should be entitled to IP protection, thus protecting the position of the phar- maceutical and biotechnological industries on that issue.51
With regard to the protection of plant varieties, Art. 27.3b requires that plant varieties be protected either by patents or by an effective sui generis system or by a combination of both. Given their reservations about life-patenting, developing countries proposed that plant varieties would be protected by a sui generis system that is based on the principles of the UN Convention on Biological Diversity (CBD), particularly Art. 15, and the International Undertaking on Plant Genetic Resources.52 Both conventions aim to protect the right of local farming communities and to publicly conserve biological resources as well as to promote biological diversity.53
Finally, several developing countries and LDCs also asked that Art. 27.3b – exceptions from patentability – should be expanded to included the WHOʼs list of essential drugs.54 The WHO model of essential drugs list (EDL), first published in 1977, identified individual drugs which together could provide safe and effective treatment for the majority of communicable and non- communicable diseases.55 The WHOʼs EDL programme seeks to increase the access and affordability of essential drugs for low-income populations, particularly in developing countries and in LDCs.56 In 1997, the WHO published its 10th model list of essential drugs, containing a list of 306 pharmaceutical drugs.57 Practically, the extent to which incorporating a list of ʻpatent-freeʼ drugs in the TRIPs agreement would damage the economic performance of pharmaceutical companies was not clear. However, the precedent of removing drugs from patentability was obviously controversial, as it negated the principle of non-discrimination in patented fields of technology.
In conclusion, as the Seattle ministerial meeting approached, developing countries and LDCs became highly resentful of the TRIPs agreement. Criticism of TRIPs became much more practical, seeking to modify the agreement in order to accommodate the needs of developing countries and LDCs. Demands by developing countries and LDCs concerning the structural capacity of TRIPs focused on three elements: (1) obliging developed countries to provide technical, technological and financial assistance to developing countries and LDCs in order to reduce the substantial costs, at least during the short term, that these countries may incur by implementing the TRIPs agreement; (2) extending the moratorium on the so-called non-violation disputes, and (3) granting longer periods to developing countries and LDCs for implementing the agreement.
Developing countries and LDCs also sought to limit the scope of protection granted by TRIPs in the field of pharmaceuticals. Here, demands focused on the grant of IP protection to traditional knowledge, particularly in practices involving the use of traditional medicine or those that are based on indigenous biological materials. Developing countries and LDCs also fiercely argued against life-patenting – the patenting of inventions that are based on plants
and animals. Indeed, from 1999 (when the Human Genome project was at a crucial phase) this issue became the subject of a world-wide debate. Finally, demands were also submitted with respect to the non-patenting of drugs that are included in the WHO list of essential drugs.