Implementation of Article 27.3(b) of The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
NATIONAL EXPERIENCES AND PLANS TO IMPLEMENT A SUI GENERIS SYSTEM OF PROTECTION IN ZAMBIA [1]
by Edward D. Zulu [2] Rosemary M. Makano [3] Anessie Banda [4]
May, 1999 - Lusaka, Zambia
TABLE OF CONTENTS
1.0INTRODUCTION
2.0TRADE AND PATENT LEGISLATION 2.1Patent Legislation and its Scope 2.2Revision of the Patent Act 2.3Protection of Plant Varieties under the Patents Laws 2.4The TRIPS Agreement on Article 27.3(b) 2.5Implications of Patenting Plant Varieties and Life Forms 2.6The Sui Generis System 2.7Africa Regional Initiatives in the Sui Generis System of Protection
3.0PLANT VARIETY PROTECTION THROUGH PLANT BREEDERS' RIGHTS ACT 3.1Status of the Plant Variety Protection in Zambia 3.2Membership to UPOV
4.0THE SEED SUPPLY SYSTEM 4.1The Informal and Formal Seed Sector 4.2Seed/Variety Quality Control and Certification 4.2.1Variety Release 4.2.2Seed Certification 4.2.3Crop Breeding 4.2.4Seed Production and Marketing 4.2.5Plant Genetic Resources Conservation
5.0PLANT GENETIC RESOURCES LEGISLATION
6.0ZAMBIA'S POSITION ON ARTICLE 27.3(b) OF TRIPS
7.0CONCLUSION
1.0 INTRODUCTION
Zambia is a member of the World Trade Organisation (WTO) and actively participates in its meetings as per WTO's membership requirements. Zambia is also party to various international conventions and agreements that promote sustainable management of biodiversity and their sustainable use. In particular, and to mention but a few, Zambia is party to the Convention on Biological Diversity (CBD), the Convention on International Trade in Endangered Species (CITES), and the International Undertaking on Plant Genetic (IU).
2.0 TRADE AND PATENT LEGISLATION.
2.1 Patent Legislation and its Scope
The Zambian Patent Law, Cap 400 of the laws of Zambia, shares a lot of things in common with the British Patent Act. The Act regulates the grant of protection for inventions in Zambia and does not exclude any field of technology. However, the Registrar is given powers under this Act to deny protection to inventions deemed to be contrary to public morality or law. Further, substances used as food or medicine which are mere mixtures of known ingredients, or a process for obtaining such mixture are excluded from patentability (Section 38 herein refers). Specifically, the Act excludes from patenting the following:
(i) any discovery, scientific theory or mathematical method; (ii) a literary, dramatic, musical or artistic work or any other aesthetic creation; (iii) A scheme, rule or method for performing a mental act, playing a game or for doing business or a computer programme; (iv) The presentation of information; (v) The patenting of any variety or animal or plant or any biological process for the production of animals or plants, not being a microbiological process or the product of such a process; (vi) Any invention whose exploitation may encourage offensive, immoral or anti-social behaviour.
The Zambian Patent Act further gives the Registrar of Patents discretionary powers to refuse to patent any invention which falls in the following categories:
* one which is frivolous as it claims as an invention a substance which is obviously contrary to well-established natural laws; * the use of which would be contrary to law or morality; * one which claims as an invention a substance capable of use as food or medicine which is a mixture of known ingredients possessing only the aggregate of those ingredients' properties, or claims as an invention a process for producing such a substance by mere mixture.
2.2 Revision of the Patent Act
Areas requiring amendments have been identified, but the actual process of amending this legislation has not resumed. Since the exercise is just at the stage of identifying sections requiring amendment, this task in being undertaken by the Patent Office. Naturally the process of this review will be co-ordinated by the Patent Office, under guidance from the Ministry of Commerce, Trade and Industry. As per national legislative review requirements, all the relevant stakeholders will be involved in this process. Amendment of the Patent Act would entail some substantial changes in its content and focus. At the moment it may appear that enforcement is not very strict and once the Trade-Related Intellectual Property Rights (TRIPS) Agreement is implemented in full it will require adjustment in the conduct of business activities.
2.3 Protection of Plant Varieties under the Patent Laws.
As indicated earlier, the Patents Act allows the Registrar, on a discretionary basis, to refuse certain classes of applications for a patent. However, the Act is not very clear on plant variety protection. Therefore, by interpretation, it is possible for the Registrar to grant a patent for a plant variety, but only if it can meet the criteria for an invention and if the complete specification "fully described the invention and the manner in which it is to be performed". Under such circumstances the question of obviousness and reproducibility would need to be resolved.
The difficulty with protecting plants under the patent laws is that they confer property rights which are private in nature. This means that under this law, once a patent is granted the owner enjoys exclusive rights to his or her invention. Therefore, the grant of a patent for a plant variety would mean "to grant to the patentee, subject to the provisions of the Act, full power, sole privilege and authority by himself or herself, their agents and licensees during the term of the patent, to make use, exercise and vend the invention within Zambia in a manner that would ensure that he/she enjoys the whole profit and advantage accruing by reason of the invention during the term of the Patent".
This would mean that the patentee would be empowered to control in total, the use of his/her plant varieties, including the saving of seed and its re-use on farms. The legislation does not, therefore, provide for "farmers privilege".
To date, there have been no applications for patents on biological material or biotechnological processes and as such no patents have been granted for such.
Equally, there has been no variety protection granted under this Act and presently the Plant Breeders' Rights Act is being formulated to address the issues of plant variety protection. See details in Section 3 of this paper.
2.4 The TRIPS Agreement on Article 27.3 (b)
Article 27.3(b) of TRIPS states that:
27.3 "Members may also exclude for patentability. (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement".
By interpretation, this article may be understood to provide inter alia that plants, animals and essentially biological processes for the production of plants or animals are patentable, but these may be excluded from patentability, depending on a country's preference. However, members are obliged to provide protection for plant varieties either by patents or by an effective sui-generis system or by a combination thereof.
2.5 Implications of Patenting Plant Varieties and Life Forms
Article 27.3 (b) has been viewed as one that will make developing countries lose control over their own biodiversity and the benefits they derive therefrom if patenting of plant varieties and life forms is permitted. Developing countries are endowed with rich biodiversity and allowing monopolies over these resources through patenting will curtail the enjoyment of these benefits by communities. Opting to extend the patent laws to plant varieties will be setting up a system of private rights for certain individuals and to prevent others from making, using or selling the protected variety or any product that might have patented genetic information. Consequently, farmers will not to be able to freely access or re-use their seed, nor will they be able to save and, or exchange seed.
Patenting of plant varieties does not provide for benefit sharing as this will be a private right of the patentee to the exclusion of anybody else. Major companies will have monopolies and secure ownership of plant varieties which contain genetic information obtained from the farmers' own fields in the developing countries, which would then be sold back to them with a royalty charge added thereto.
2.6 The Sui-Generis System
Article 27.3 (b) also provides for the protection of plant varieties through an "effective sui-generis system". This term has, however, not been defined sufficiently. It is difficult to determine what an effective sui generis system for plant varieties will entail.
It appears most likely that it might be on the lines of the International Union for the Protection of Plant Varieties (UPOV) inspired system. However, the sui generis system that allows developing countries like Zambia to provide for the protection of plant varieties should be developed and this should, in addition, accord recognition to innovations of indigenous peoples and local communities. In terms of definition, such a statute should define innovation to include any inventive input done collectively, accretionally, inter-generationally and over a period of time, in relation to genetic resources. The intellectual ownership rights of farmers and indigenous peoples over their plant varieties and seeds should be recognised and rewarded.
2.7 Africa Regional Initiative on the Sui Generis System of Protection
Delegates to the "Africa Regional Workshop on Understanding Biodiversity-Related International Instruments" that was held in Lusaka, Zambia from 11-15 January 1999 set up a Task Force to draft an African Model Sui Generis Protection System for biological resources, indigenous knowledge and innovations embodying the lifestyles of indigenous peoples and their local communities. The Draft African Model Sui Generis Protection System will be discussed at an African Regional Meeting later this year, under the auspices of the Organisation for African Unity (OAU), where it shall be adopted by the African countries.
3.0 PLANT VARIETY PROTECTION THROUGH PLANT BREEDERS' RIGHTS ACT.
The Zambian agricultural industry has in general undergone a remarkable transformation evolving from a highly centralized and government controlled to one that is liberalized. These liberalization policies have stimulated investment in the seed sector where the private sector and non-governmental organisations (NGOs) have taken an active role in seed production, marketing and distribution. These changes have significantly influenced the thinking and the direction of the seed industry in general and have in turn initiated policies related to Plant Variety Protection.
In Zambia, plant variety protection was not a common subject for discussion in agriculture until about 1991 when policies of economic liberalisation were introduced. As a result of these policies, many seed companies opened businesses in Zambia.
As these new investors started operating, they noticed that Zambia did not have mechanisms to protect their varieties from being 'stolen' by other companies. The Ministry of Agriculture, Food and Fisheries (MAFF) also became concerned that its varieties stood a high risk of bio-piracy from some seed companies, some of whom did not have superior materials at the time and were interested in gaining access to the Zambian public varieties.
Arising from these fears and the resulting pressure from industry, it was decided that a suitable piece of legislation be put in place to address the various concerns.
Currently, plant variety protection is formally recognised as an essential tool in the development of the agricultural sector, and the seed industry in particular, because the system provides the following benefits:
* Encouragement of investment in plant breeding. * Attraction of foreign varieties and technologies. * Multiplication of foreign varieties in the country. * Development of varieties adapted to specific conditions of each country. * Maintenance of varieties. * Protection of own varieties against appropriation by others. * Disclosure of technologies.
3.1 Status of the Plant Variety Protection in Zambia
Currently, Zambia is in the process of enacting law on plant breeders' rights to address issues related to the protection of plant varieties. To this effect, the MAFF has drafted a Plant Breeders Act which has yet to take legal effect. In line with government procedures on formulation of legislation, the Draft Act is receiving public input from all the relevant stakeholders.
The draft had a fair input from UPOV and the comments given were often timely and useful. The draft is mainly based on 1978 Acts of the UPOV Conventions on the protection of new plant varieties, published by UPOV in 1996. This model law was very useful and has still remained a useful reference material.
Some of the major concerns expressed by the public were that the Draft Act did not comprehensively protect community owned landraces (farmers' varieties) and other plants of various uses, which the communities have kept for generations. It was felt that the Act was also more biased towards cultivated plants and made little or no reference to other useful plants. It was further noted that the Draft Act seems to have narrowed its scope and placed more emphasis in protecting the rights of individuals, mainly breeders and seed companies, and remained silent on collective community knowledge and intellect. It was no wonder the Draft Act was called the "Plant Breeders' Rights Act". The Act does not seem to recognize the intellectual rights of communities and, with the current government policy on the promotion of the informal seed sector, clearly this was found not to be in harmony with government policy and, therefore, require to be re-visited.
As a result of the above concerns, the Draft Act on Plant Breeders Rights has briefly been put on hold in order to allow for wider consultations to take place. Furthermore, this delay also gives Zambia an opportunity to incorporate, into the Plant Breeders Act, the recommendations from the Lusaka Task Force and the OAU Draft Models on Sui Generis Protection Systems. It is expected that inputs from all these sources would assist to adequately take into account the aspirations of communities and their cultures so that their collective intellectual and ownership rights are protected.
3.2 Membership to UPOV
Zambia's understanding of the UPOV Convention of the 1991 provisions is that it introduces a somewhat patent system in a way which will give exclusive and private ownership rights on plant materials. This would, in turn, prohibit farmers from growing protected varieties and exchanging seeds on a non commercial basis. The system would, in addition, require that farmers pay royalty fees for every seed they purchase. Further, according to this Act, farmers using a protected variety without paying royalty fees could lose their produce as the breeder or originator could claim ownership.
Unless our interpretation of these provisions are wrong, Zambia fears that if the 1991 Acts are left in their present form, it might be difficult for Zambia to achieve the goals of integrating the formal and informal seed supply systems which is the current government direction. It is further feared that with this Act, government's commitment to the Convention on Bio-Diversity (CBD) might be compromised.
Another point requiring consideration is the cost of becoming a member of UPOV and the subsequent fulfillment of its obligations which Zambia, and perhaps many developing countries, might not easily afford. There is no doubt that the benefits of being a member of UPOV abound, but UPOV may wish to reconsider incorporating some of the provisions of 1978 Act into the 1991Act to make the conditions a bit more acceptable,
Given the above scenario, Zambia has no immediate plans to become a member of UPOV. The country is currently developing an informal seed supply system which places emphasis on the on-farm seed production and farmer to farmer seed exchange. There are fears that membership to UPOV might affect the efforts directed at promoting the informal seed production and rural seed entrepreneurship. The deadline of April, 1999 regarding closure to further accession to UPOV 1978 Acts in favour of the 1991 Acts needs a careful thought before making attempts to join.
Zambia will, at the moment, cautiously follow these developments and would decide to join UPOV at the appropriate time when her concerns are cleared.
4.0 THE SEED SUPPLY SYSTEM
Zambia's seed production and supply system essentially comprises the informal and formal sectors and it has been a matter of government policy to promote an integrated seed provision system. The informal seed sector is therefore being promoted following the failure by the formal seed sector to adequately supply seed to remote parts of the country.
A number of reasons have been advanced for the failure of the formal seed sector to supply seed to remote parts of the country. The formal sector prefers trading in hybrid seeds which have an in-built assurance for repeated sales. In addition, the formal sector has found it difficult to operate in the rural areas due to poor road infrastructure. Because of the high prices associated with hybrid seeds, small scale farmers are also unable to afford them.
In order to address this problem, government is now promoting on-farm seed production by the farmers themselves, either individually or through community groups. It is envisaged that on-farm seed production would ensure availability of seeds either through barter or cash transactions, or free exchange among the farmers themselves. The system is expected to evolve with the development of village seed entrepreneurs who would take the lead in seed marketing within their rural communities.
The government of Zambia recognizes, as a matter of policy, that it will recognize and support an integrated seed supply industry comprising the informal and formal sectors in complimenting each other to achieve crop diversification and household food security.
4.1 The Informal and Formal Seed Sectors
The informal sector is characterized by use of traditional varieties (farmers' varieties) and, to some extent, recycled improved seed which may have earlier been certified. This system accounts for well over 70% of national seed provision especially for non hybrid varieties. This sector is mainly driven by farmer communities and NGOs. Seed quality control in this sector is not as stringent as the one operative in a formal seed sector.
The seed classes moving in this sector are mainly those of Quality Declared (QD) which are generally lower than certified seed classes.
The formal sector has been dominated by the use of improved and certified varieties, especially hybrids. Supply systems under this sector accounts for about 30%. The major suppliers have been seed companies who have marketed the seed through a network of seed stockists, agencies and NGOs who are scattered throughout the country. The system is more organized than the informal seed sector and quality control is quite stringent than in the other case.
4.2 Seed / Variety Quality Control and Certification
Seed / Variety quality control and certification is controlled under the Seeds Act which provides regulations regarding the release of varieties, testing of seeds, inspections and imports of seeds. It also gives conditions for sale of seeds in the country. Under this act, only varieties that have been adequately tested under the Zambian conditions and are entered into the official variety list are eligible for marketing in the country.
Seed quality control and certification was until recently done by the government. The private sector was not allowed to participate. Following the liberalization of the economy, the Seeds Act was amended to allow for participation of seed companies in this activity by licence. The certification scheme recognizes voluntary and compulsory certification. Hybrid varieties fall in the compulsory category of certification and the implication is that seed can not be sold from such varieties unless it is certified.
4.2.1 Variety Release
According to the Act, only released varieties can enter seed production. A variety will normally require two seasons of independent testing before it can be released. There is a Variety Release Committee which decides on whether a variety can be released or not, The Committee also sets the release procedures and recommends varieties for removal from the list if found to be obsolete.
4.2.2 Seed Certification
Field inspections are done for all seed crops and the intensities will differ on whether the crop is hybrid or open pollinated. All the seed allowed to be traded on the Zambian market is tested for germination, physical purity, moisture, weed content and other parameters. The tests are done in compliance with the International Seed Testing Association (ISTA) rules.
4.2.3 Crop Breeding
Crop / plant breeding has mainly been in the hands of the public. The majority of crop varieties available on the Zambian seed market are all bred from government research institutions. These varieties are in turn forwarded to Zambia Seed Company (ZAMSEED) Limited which was given the sole right to commercialize the materials.
Foreign companies, except one private local Zambian company, have not established variety development and improvement programmes in Zambia. All their varieties are bred outside the country. Most foreign companies are merely trading in seeds and do not undertake research and development in Zambia.
4.2.4 Seed Production and Marketing
Seed production is mainly done by the private sector, financed by seed companies and to some extent NGOs. Government does not participate in seed production but has an interest in the strategic seed reserves which it finances through ZAMSEED Company. Similarly, marketing is done by seed companies through a network of seed stockists and agents.
4.2.5 Plant Genetic Resources Conservation
The National Plant Genetic Resources Centre (NPGRC) was established in 1989 charged with the following specific responsibilities:
* To gather, through exploration and collecting missions carried out in different ecological zones, information and materials of plant genetic resources of all indigenous and adapted exotic crops, their wild relatives as well as useful or potentially useful wild species. * Characterization and evaluation, rejuvenation, maintenance, multiplication and documentation of collected and stored material in collaboration with the Regional SADC Plant Genetic Resources Centre (SPGRC). * Preserve, through in situ conservation, other useful wild plant species. * Maintain active collections under short to medium term storage for indigenous and adapted plant genetic resources.
The in situ management of wild plant populations is spear-headed by other institutions such as the Forestry Department, National Parks and Wildlife, National Heritage Conservation Commission, and the National Institute for Scientific and Industrial Research (formerly NCSR - National Council for Scientific Research). The NPGRC collaborates closely with these institutions.
5.0 PLANT GENETIC RESOURCES LEGISLATION
Zambia has no specific legislation to regulate the collection, conservation and use of plant genetic resources. This is taken care of under the various pieces of legislation that regulate the management and use of Zambia's biological resources such as the Forests Act, the Natural Resources Conservation Act, the National Parks and Wildlife Act, to mention but a few.
With respect to international agreements, Zambia is party to the CBD and the IU pursued under FAO. Zambia also shares the intention and aspirations of the FAO Draft International Code of Conduct for plant germplasm collection and transfer, an administrative draft document which has been put in place. This document, although not legally binding, seeks to provide the following:
* To regulate the collection, conservation and use of plant genetic resources in ways that respect the environment, local traditions and cultures. * To avoid over harvesting of germplasm that may lead to permanent loss of genetic resources. * To promote safe exchange of plant genetic resources as well as related information. * To provide standards of conduct and define obligations of collectors and others handling plant genetic resources. * To bring recognition, incentives and respect of local communities who manage and make available plant genetic resources.
To ensure all collection activities and transfer of germplasm are officially sanctioned by the National Plant Genetic Committee.
Zambia is actively participating in the negotiations for the revision of the IU which is envisaged to become a protocol under the CBD. Zambia is, therefore, anxiously awaiting for the conclusions of the negotiations and the revised IU.
In the absence of the revised IU, Zambia will follow the provisions of the CBD in its handling of issues on genetic resources. In this regard, Zambia supports the African position on farmers' rights, access and benefit sharing issues being discussed under the IU.
6.0 ZAMBIA'S POSITION ON ARTICLE 27.3 (b) OF TRIPS
Zambia is not in favour, and does not support the use of patent laws to protect plants and animals, including patenting of all life forms. Instead, the country will remain committed to protecting plants and animals using a well designed and effective sui generis system which will be broad based as to recognize the rights of farmers and communities at large, who have over the years conserved various plants and animals.
Considering that Article 27 of the TRIPS Agreement hinges on matters that concern both the enhancement of trade on one hand, and conservation and preservation of the environment on the other, it is imperative that the review of Article 27.3(b) of the TRIPS Agreement takes into account the protection of the rights of the custodians of the knowledge base, who have worked consistently and sacrificed to conserve these biological resources.
As a country whose rural community depend solely on agriculture the following concerns are expressed as regards the TRIPS Agreement in its present state:
* lack of recognition of indigenous knowledge within the provisions of the TRIPS Agreement. * No clear explanation of the provisions of Articles 27.3(b) on the conservation and sustainable use of biological materials. * No clear definition of what constitutes the sui-generis system of protection.
In view of the above 'grey' areas, there is need to provide for a clear understanding of the coverage of the sui-generis system; whether indigenous knowledge and ecosystem protection fall within its coverage.
Since most least developed countries depend much on farming there is need to recognise the contribution of farming and indigenous communities to genetic resource conservation and enhancement. The right to compensation for the commercial use of their materials should be provided.
In view of the foregoing concerns, reviewing of Article 27.3(b) in favour of patenting will undermine the very existence of small-scale farmers who form the majority of the Zambian population.
7.0 CONCLUSION
As the world integrates and calls for equitable sharing of benefits derived from the global trading system, and as it calls for the conservation and sustainable use of the biological resources, countries world over are faced with a number of challenges to attain these objectives.
Considering that Article 27.3(b) of TRIPS hinges on matters that concern both the enhancement of trade and development on one hand, and the conservation and preservation of the environment on the other, it is imperative that the review of Article 27.3(b) takes into account these world concerns.
As a country whose population is solely dependent on agriculture, our concerns still hinge on:
* The double standards that Article 27.3(b) wishes to pursue in relation to conservation, equitable sharing and sustainable use of biological resources contrary to the spirit and aspirations of the CBD; * Lack of clarity on the content and provisions of Article 27.3(b) * Lack of recognition of indigenous knowledge with respect to the management of biological resources.
As rapid changes take place in plant varieties, much of the diversity contained in landraces and farmers' varieties are under threat of being replaced by new varieties. It should be noted that genetic engineering and its products in food has its own consequences whose full impact on the health of human beings is not yet fully assessed. These posses the danger of causing unrepairable damage of which many developing countries may not have the capacity to handle.
Zambia is looking forward to agreeing on a system that does not deprive farmers and communities of their rights over the biological resources. In this respect, Zambia is in favour of recognizing the contribution of farmers and local communities to genetic resources conservation and enhancement, and protecting their intellectual rights accordingly.
---------------------------------------- [1] A Country Status Paper presented at the UPOV-WIPO-WTO Joint Regional Workshop on The Protection of New Plant Varieties. 06-07 May 1999, Nairobi, Kenya. [2] Chief Seeds Officer, Ministry of Agriculture, Food and Fisheries. Seed Control and Certification Institute. PO Box 350199, Chilanga, Zambia. Telefax: (+260 1) 2781336; Cell 758836. [3] Principal Planning Officer, Ministry of Environment and Natural Resources. Planning and Information Department, PO Box 34011, Lusaka, Zambia. Tel: (+260 1) 229410; Fax: (+260 1) 229420 / 228595; Email: menr(at)zamnet.zm [4] Assistant Registrar, Patents and Companies Registration Office. PO Box 32020, Lusaka, Zambia. Tel. (+260 1) 225660; Cell: 704054; Fax: (+260 1) 227225