Intellectual Property Rights and TRIPS

An overview of international instruments of relevance to plant genetic resources - Susan Bragdon
Shaping sui generis systems for the protection of plant varieties - Dan Leskien and Michael Flitner
The African experience in responding to Article 27.3(b) of the TRIPS agreement - J.A. Ekpere
The need for sui generis legislation on intellectual property rights and patents in the developing countries - J.M. Gopo
Options for a sui generis system for intellectual property rights and patents: the Zimbabwean initiative - L.T. Chitsike
Forms of intellectual property rights relevant for agriculture and plant genetic resources in Zimbabwe - S.S. Mlambo and A. Mafa
Options for a sui generis system for the protection of plant varieties - John Barton

Dan Leskien opened the session on IPR and TRIPS by reviewing the minimum requirements for the TRIPS sui generis system already presented in this report. The idea was to provide a framework for presentations on IPR focusing on sui generis options. Next came several specialists' presentations.

Ms Susan Bragdon's presentation was not a formal paper but a presentation from notes, which she made available for inclusion here. An IPGRI publication by Susan Bragdon and David R. Downes entitled "Recent policy trends and developments related to the conservation, use and development of genetic resources (Issues in Genetic Resources No. 7, June 1998) was distributed to participants.

In addition to the papers published here, Prof. John Barton addressed the workshop on "Options for a Sui generis System for the Protection of Plant Varieties." There being no formal paper, a complete version could not be included, but a summary of his presentation is given in this report.

An overview of international instruments of relevance to plant genetic resources - Susan Bragdon

Introduction

Some may wonder why IPGRI - traditionally a scientific and technical organization - would co-organize a workshop focusing on implementation of the TRIPS Agreement and the development of sui generis systems. It is because over the last ten years or so it has become increasingly clear that it is not possible for a scientific and technical institution concerned with genetic resources to pursue its mission in isolation from the policy developments affecting these resources.

Take the Convention on Biological Diversity as an example. Access legislation being developed by national governments under Article 15 of the CBD has the potential to have an enormous impact on the work and mission of the CGIAR, both on the work at the centres themselves and on our work with national programmes in developing countries. We are frequently asked about implications of legislation on access to agrobiodiversity, specifically its use, development and exchange, which are seen as vital components for food security.

The TRIPS Agreement and general patent trends are another example. Increasing privatization of agricultural research and the role of IPRs has direct implications for the role of the public sector and for the exchange, use and development of PGR.

IPGRI cannot carry out its work or be an effective partner to national programmes in developing countries in isolation from these developments. Over the next three days I look forward to exploring issues of common concern for Southern Africa; hearing the priority issues you identify; knowing what this means in terms of implementing Article 27.3(b) and the development of sui generis systems, and hearing how as a region you feel you might cooperate in addressing priority areas of concern.

Evolution of rights

A paper by IPGRI Board member Thomas Cottier noted that in the history of law there is a close relationship between the recognition of the economic and commercial value of a resource and the attribution and allocation of legal entitlements. As Cottier's paper notes, the classic example of resource allocation is, of course, of land and territory. Much of human political history - including wars fought - hinges upon this subject.

Many events of the second part of the 20th century centre around the allocation of oil, gas and mineral resources located at sea. Much of this process was triggered by scientific and technological innovation, such as the invention of the combustion engine and other uses of oil, gas and minerals.

Many believe that in the next century we will prominently be addressing the allocation of resources of which we have only recently recognized the value, because of their increasing scarcity and because scientific and technological innovations have increasingly allowed an economic value to be realized. I am talking here about water and, of course, our interest: genetic resources.

Humankind is facing questions of what kinds of rights should be created over these resources, in terms of both sovereign and private rights, such as intellectual property rights. It is in this context that basic questions of ethics and equity arise.

The role of international bodies

Developments in the last 5-10 years have significantly changed the policy environment relating to the management and control of genetic resources. The task of discerning all the issues of relevance to the conservation and management of genetic resources is extremely complex. Further complicating issues, laws and policies affecting genetic resources are being debated in the context of intergovernmental bodies with

· diverse objectives
· diverse actors and interests
· different power balances
· different cultures, where the types and tones of arguments vary depending on the particular forum.

Simultaneous with these international developments, national legislatures and courts are making rules about the ownership and control of plants, animals and their component parts. The situation is evolving so rapidly that a talk given one week requires updating the next.

Globalization and the policy environment

Decision-makers trying to devise good, coherent, consistent policy on genetic resources are faced with a myriad of related, rapidly evolving issues being discussed in multiple national and intergovernmental fora.

Most countries face an enormous challenge to overcome conflicts among economic, social and environmental interests and to create a coherent, consistent policy environment. One of the barriers to the transition to sustainable agriculture most often mentioned is weak government policies and institutions.

Most farmers - the ultimate managers of agrobiodiversity - face an unfriendly and even contradictory policy environment when it comes to the conservation of agrobiodiversity. For example, the policy goals of increasing productivity to meet short-term food security objectives, to increase export commodities and to enhance ecological soundness may result in conflicting pressures and incentive systems for the farmer.

With continuing globalization and increased understanding of the world's interdependence at all levels, few important issues can be meaningfully addressed without undertaking the complex process of unweaving and understanding relevant issues and then integrating a policy response. Developing a sui generis system therefore requires first of all an understanding of those processes currently functioning and having an impact on PGR.

Convention on Biological Diversity

The CBD entered into force at the end of 1993. Its objectives are threefold: conservation and sustainable use of biodiversity and benefit-sharing arising from its use.

The Conference of Parties to the CBD has met five times, the most recent being an extraordinary session held in February 1999, where the parties failed to adopt a protocol on biosafety in accordance with the internally created CBD deadline. In addition, there have been numerous regional meetings and meetings of the CBD's subsidiary bodies.

As already noted, the orientation and predominant influence in the creation and implementation of the CBD comes from an environmental perspective. Ambiguity, lack of understanding and the differing agendas of the parties have retarded a coherent and coordinated approach to that subset of biodiversity of particular concern to us at IPGRI: agrobiodiversity.

Indeed, many of the projects originally funded by the Global Environment Facility (GEF) on creating national biodiversity plans and strategies failed to include an agrobiodiversity component. A little less than two years ago, the GEF recognized this missing element and began working to incorporate it into previously funded projects.

Understanding the CBD and its implementation requires some understanding of its origins. The CBD's origins can be classified into categories corresponding to its three objectives. One major source was conservationists' concerns and the desire for an agreement that would embrace the broader concept of nature and protect the many elements of biodiversity not covered by existing laws.

Second, there was a move to incorporate the goal of sustainable use of biological diversity into conservation policy, recognizing in Article 8(j) the needs of local people living amid biodiversity for sustainable development, and conversely, recognizing the need to mobilize support for conservation by providing local benefits.

Third - and this is where the linkages become particularly sticky and critical for plant genetic resources for food and agriculture (PGRFA) - international debate on the terms for exchanging and sharing benefits from PGRFA created pressure to include in the treaty some obligations on these issues. Ironically, some of the key issues relating to agrobiodiversity - such as Farmers' Rights and the status of pre-CBD ex situ collections like those held by the CGIAR - were left outstanding with the request that they be resolved under the auspices of the FAO Commission.

To understand what is happening in the discussions revising the International Undertaking to bring it into harmony with the CBD, it is worthwhile exploring in more detail the approach taken by the CBD and what has flowed from that approach.

Access to genetic resources

In Article 15 on access to genetic resources, the Convention sets up a framework of general principles for structuring the international exchange of genetic resources, premised upon the national sovereignty of each country over genetic resources within its jurisdiction. The article keeps to the CBD focus on national action and, through reference to mutually agreed terms and prior informed consent, implies a negotiation - a bilateral approach - between source countries and recipients for access to genetic resources.

Under the CBD, several countries and some regions are developing or have already promulgated legislation regulating access to their genetic resources. The emphasis of these efforts has been on a bilateral approach. The Philippines, Thailand and the countries of the Andean Pact (Colombia, Ecuador, Peru, Bolivia and Venezuela) have adopted measures pursuant to Article 15, though I am unclear if all the legislation in all the Andean Pact countries has passed through their parliaments. I know Ecuador's has but that Peru's is still considered a draft. In addition, Brazil, Ethiopia with a draft entitled "Legislation on Access to Biological Resources and Community Rights," Fiji and India have draft legislation in various stages of consideration.

Impact of access legislation

It is difficult to assess the impact of such legislation when experience is so recent. Matters that remain unclear include:

· To what extent have benefits actually accrued from access transactions?

· What has been the effect of legislation on the number of requests for access? (e.g. are transaction costs reasonable and the procedures sufficiently clear and efficient or has the legislation caused parties to look elsewhere for access to genetic resources - has it put on chill on exchange?)

· To whom have benefits actually accrued? (e.g. have indigenous and local communities benefited from the transactions?)

· What effect, if any, has the legislation had on the exchange and use of PGRFA?

It is important to assess the current approach of access legislation and to think about how it may be structured to account for the particular nature of PGRFA. The exchange and use of agrobiodiversity is fundamental to agricultural production and food security. Indeed, agrobiodiversity is a critical component of environmental conservation. Impeded access to agrobiodiversity (either through its loss or through locking it up through access or IPR controls) raises the vulnerability of farmers by increasing risks and it undermines the stability of agriculture.

If systems are being put in place that inadvertently put a chill on the exchange of PGRFA, countries will likely be faced with making piecemeal exceptions or amending the legislation as they gain experience. If for some reason the multilateral system for PGRFA fails to get the political backing at the FAO Commission, the legislation may be more difficult to change and therefore may have the potential for more deleterious impacts.

The CBD has just begun an intersessional process on access and benefit-sharing under the CBD. This will include an expert panel, which will hold its first meeting in October 1999.

The issue of IPR and biodiversity was very controversial during the negotiations for the CBD. Some claim that Article 16 is too strong in its protection of IPRs; others find it too weak. The final paragraph of that article makes clear that the negotiators of the treaty were unable to reach consensus on the role of IPRs in the conservation and use of biodiversity. The gist of that provision is that parties are to make sure that IPRs are supportive of the treaty's objectives. Thus far the work of the Conference of the Parties and the treaty Secretariat has been confined to information gathering. There has been a call for case studies on the relationship but little empirical evidence is yet in.

International Undertaking

While the general principles on access in the CBD emphasize national action, they do not mandate bilateral transactions, nor do they preclude parties from establishing or entering into a multilateral system of regulating access. It should also be borne in mind that the genetic resources in ex situ collections acquired prior to the entry into force of the CBD fall outside its provisions.

The conclusion of the CBD had immediate ramifications for the FAO Commission, for the International Undertaking and for the operations of the CGIAR.

The International Undertaking is a non-binding intergovernmental agreement to promote the conservation, exchange and use of plant genetic resources. In the resolution by which the IU was adopted, member states recognized that "plant genetic resources are a heritage of mankind to be preserved and to be freely available for use, for the benefit of present and future generations" and that the IU was intended to facilitate the conservation and sustainable use of plant genetic resources. Signatories to the IU number 113 countries.

Prior to the IU, PGRFA were relatively freely exchanged. The IU was born out of demands from developing countries that the exchange of genetic resources be regulated to correct the growing asymmetry between the availability of the so-called "improved" varieties that were the products of formal breeding and the availability of farmers' landraces and other traditional varieties. The insertion of the concept of Farmers' Rights in the IU came about as a reaction to the established benefit-sharing mechanism available to plant breeders, namely Plant Breeders' Rights. But no comparable mechanism has been established for Farmers' Rights.

Since the mid-1990s, the commission has been engaged in a negotiating process to bring the IU into harmony with the CBD, perhaps eventually as a protocol to that treaty.

While it may not always seem that way, there has been headway and breakthroughs have occurred in the negotiations. Two years ago it was not at all clear that countries would agree that a multilateral system was the best approach for the exchange of PGRFA. As doubts grew about the strength of the market for agricultural genetic resources and the feasibility of identifying a country of origin, support for a multilateral system grew. While there are still major issues to resolve, there are also now general principles of agreement, including what is reportedly a rather weak agreement on Farmers' Rights. The next commission meeting is in April 1999 and it will be interesting to see what progress can be made on outstanding issues.

WTO/TRIPS

The TRIPS Agreement is one of the agreements of the World Trade Organization adopted in 1994 at the close of the Uruguay Round of Negotiations under the General Agreement on Tariffs and Trade. It entered into force in 1995, simultaneous with the inauguration of the WTO, the creation of which was also the outcome of the Uruguay Round. There are 131 countries that are members of the WTO and hence bound by TRIPS and other WTO agreements, and approximately 30 applications for membership.

The TRIPS Agreement embodies a rather counterintuitive notion that trade restrictions, such as an embargo on "counterfeit" goods that imitate copyrighted or trademarked products, are necessary to promote trade liberalization. The TRIPS agreement expands the scope of international trade into previously unaffected aspects of domestic production and marketing. Thus, for example, a WTO member is obligated under TRIPS to provide effective legal mechanisms by which a patent-holder from another WTO member state can prevent unlicensed persons from using or marketing the invention within the member's territory.

In reality, the TRIPS Agreement creates more pressure to adopt IP standards than past agreements because WTO membership requires assumption of the obligations of the TRIPS Agreement. In addition, there are strong incentives for compliance through the WTO's relatively strong dispute-settlement mechanism, which provides for the imposition of trade sanctions - including sanctions on unrelated products - against a member found to be in violation of the agreement.

But what does all this have to do with plant genetic resources? The connection is that the TRIPS Agreement requires that its members must provide for the protection of plant varieties either by patents or by an effective sui generis system or by a combination thereof. This requirement is contained in a provision dealing with what may be excluded from patentability. It is clear that this provision will require legislation or legislative changes in a great number of WTO member states.

TRIPS is not an international patent system but an international agreement that sets minimum requirements for IPR for its members. If a sui generis system is created for plant variety protection, it has to be established at the national level. Therefore, it has to satisfy various national interests, such as those of farmers, local communities and domestic seed and biotechnology industries, all of which are likely to have very different views on IPRs. In turn, these interests have to be balanced against other national policy objectives, relating, for example, to the areas such as trade, environment and development. Plant variety protection is just one piece of an overall policy package that will ultimately reflect a balancing of both narrower and larger objectives.

For example, decision-makers devising a sui generis system will necessarily face issues that will affect a wide range of biodiversity-related problems. Decision-makers need to be aware of the real and potential relationships between a plant variety protection system being devised and other relevant areas, including:

· national regulations on access to genetic resources (CBD Article 15)

· national legislation of relevance to the rights of indigenous and local communities, including the issue of Farmers' Rights in CBD Article 8(j)

· the International Undertaking on Plant Genetic Resources (IUPGR) currently under revision

· national seed legislation.

On the other hand, the TRIPS Agreement does not prevent the development of additional protection systems or the protection of additional subject matter. As long as it does not run afoul of TRIPS requirements, a country could, for example, include indigenous knowledge as subject matter to be covered by the sui generis system. Or it could set up a separate system for the protection of Farmers' Rights.

In any case, decision-makers must keep their national objectives and international obligations in mind to avoid any potential conflicts and to pursue synergies where possible.

UPOV

With Dan Leskien speaking later, I will not go into any detail on UPOV other than to discuss briefly why it is significant to this discussion.

UPOV encourages the adoption of sui generis laws for protecting new plant varieties by creating a distinct system outside of patent law. It requires that a plant variety be new, distinct, homogeneous and stable in order to be eligible for protection.

The Crucible Group in 1993 noted that the criterion of homogeneity reinforces the trend toward genetic uniformity and leads to a higher degree of vulnerability in farmers' fields. This criterion also excludes the possibility of protecting landraces and traditional varieties. This is not necessarily a bad thing, but as I mentioned under the TRIPS discussion, countries wanting to promote agrobiodiversity may wish to consider what mechanisms and tools exist to address agrobiodiversity concerns through promoting the conservation and use of traditional varieties and how these will interface with any PVP system the country may have in place.

CGIAR

Because the CGIAR is one of the largest and most important institutions in both the conservation and development of genetic resources, international policies and policy debates can and do have a profound impact on the CGIAR's programmes, priorities and day-to-day work. The autonomy of individual centres, with their different boards, mandates and constituencies, makes system-wide policy formulation and development extremely difficult.

Nobody disputes the fact that the vast majority of crop germplasm held by the CGIAR centres was collected from the fields and forests of the South's farming communities. But to whom that treasure ultimately belongs - to whom CGIAR is accountable and whether or not CGIAR's germplasm can be subject to intellectual property protection by any party - has been a topic of controversy and debate. As discussed earlier, the status of the collections of PGRFA made prior to the coming into force of the CBD was left as an outstanding matter in the negotiations. Negotiators adopted Resolution 3, which requested that this (and other) issues be addressed through the FAO Global System for the Conservation and Utilization of PGRFA. As most of the accessions held by CGIAR centres were collected prior to the entry into force of the CBD, the status of these collections is somewhat dependent on the outcome of the ongoing negotiations on the IU at FAO. Therefore, questions of ownership, terms of access and modes of benefit-sharing associated with these collections remain unanswered.

As an interim measure, the FAO Commission and the CGIAR decided to develop agreements that would keep material held at the centres in the public domain for the benefit of all humanity, in line with the mission of the CGIAR system. It is in this context that the 1994 FAO/CGIAR Agreements and their implementing measures, such as material transfer agreements, should be understood. The agreements were designed to ensure the relatively unrestricted flow of germplasm to all countries in the new bilaterally oriented context reflected by the entry into force of the CBD. Without these agreements, the role of the centres might well have been reduced to becoming brokers for individual countries in bilateral exchange transactions. It is understood that the FAO/CGIAR Agreements will be modified, if necessary, according to the outcome of the IU negotiations.

The need for international public-sector breeding is of increasing importance in a time of globalization and privatization of agricultural research. It is an important mechanism to provide choice and to focus on marginal and other areas that may not be attractive to the entities with a commercial focus.

Patent trends

Going back to where this presentation began, to the relationship between law and the ability to recognize commercial value, the application of modern biotechnologies to biomaterials has brought new economic opportunities and subsequent consolidation of industry concerned with biomaterials. It has also brought new challenges to IP regimes.

Driven by the private sector, the trend in industrialized countries has been toward the expansion of the scope and/or application of patents and plant breeders' rights to biomaterials. Yet there is a noticeable lack of empirical evidence about the potential impacts of IP regimes on biodiversity, food security and development.

The trend toward expansive plant-related patents is most advanced in the United States. Instead of providing an incentive for innovation, excessively broad patents controlled by a handful of life-industry corporations may actually deter the entry of new firms and discourage innovative research. Large corporations may be able to budget for the expenses associated with applying for and defending a patent, but the expense of licensing fees and the risk of costly litigation forecloses entry for smaller firms or public institutions.

An illustration of ethical concerns

There is much at stake here besides incentives for innovation. Strong ethical issues arise with the locking up of information, particularly in areas affecting food security and human health. In February 1999 the Los Angeles Times carried a report on the effect of private companies refusing to share the genetic code of a deadly staph bacterium. They say it cost them millions to discover, but officials say the data are needed to avert a public health crisis. A strain of Staphylococcus aureus, the most common source of life-threatening bacterial infections in hospitals, had arrived that was resistant to every antibiotic known to medicine.

But scientists working to divert a potential medical disaster have run into a significant roadblock from the most unexpected of places: their fellow scientists.

Biotechnology and drug companies have spent huge amounts of money decoding the genome - the genetic blueprint - of staph, with the hope of designing new drugs to challenge it. But they are unwilling to share that crucial knowledge with government and university scientists, a stance that many researchers believe is critically stalling the pace of scientific progress.

As a result of the private sector's refusal to collaborate, federal health officials have been forced to strike out on their own, duplicating the work at a cost of millions to taxpayers.

What might have been a triumph of modern science over a looming public health crisis has become a clash between the needs of companies to seek a return on their investments and the desires of academic scientists to put basic genetic information into the public domain.

But in the case of staph, public scientists argue that profit margins should be secondary to fighting a common public health enemy and that it is difficult to imagine a conflict where the stakes could be higher: fighting a possible outbreak of an untreatable infectious disease.

The delay in making the data public has "slowed research by four or five years," contends Dr Olaf Schneewind of UCLA, a leading staph investigator, who understands the industry's position but is unsympathetic to it. "From the perspective of industry, you can view this as a market," he says. "At the same time, there is a humanitarian issue."

"Not having this information is a big obstacle for the scientific community," says John La Montagne, deputy director of the National Institute of Allergy and Infectious Diseases. "Without this information, we don't have the insights we need... It's like keeping the map of the city of Washington secret."

The companies argue that they've spent all this money to get the data - why should they give it away for free? It will only remove their incentive to do research. "I believe science moves forward in unpredictable ways, and with something as basic as the instruction book of organisms, the more people who have a chance to look at it, the better the likelihood that a key insight will occur," says Dr Francis Collins, director of the National Human Genome Research Institute. "The question we ought to be asking is, 'What is good for the public?' I'm not sure that all this gold rush is going to serve the public's needs very well in the long run."

However, Collins also acknowledges that patent protection can serve as an incentive to get new antibiotics and vaccines to the market.

"My happy medium would be to get all the sequencing into the public domain, and if people want to claim intellectual property rights, [these have] to be based upon [discovering] the function or utility of a sequence, instead of claiming the sequence itself or hiding it," he says. "Then what we would reward would be a discovery of how it works."

While the law is not entirely settled, US patent officials say that scientists must indeed show the utility or usefulness of a discovery before they will be issued a patent. But some legal scholars observe that patents are being given for most basic discoveries, and they worry that this will hamper further research, as Collins fears.

Evidence that the law is not settled, and that this is causing jitters in the biotechnology industry, can be seen in a case brought recently by a farmer challenging the legality of a fundamental premise of the biotechnology industry - the patentability of modified plants. An Iowa seed merchant is arguing that the US Patent and Trademark Office erred in granting patents on modifications to plants such as corn, soyabean and cotton. A federal appeals court agreed to rule on the issue in October, and word has been quietly spreading since. The court's action indicates that the patentability of man-made plants remains legally untested. Oral arguments could begin as early as this spring. The American Intellectual Property Law Association, a trade group of patent attorneys, is preparing a friend-of-the-court brief in favour of keeping plant patents.

As this case shows, the expanded application of patents to plants may also affect farmers. Patents do not have a farmers' privilege or a breeders' exemption. Some US-based industry has rejected traditional farm practice by forbidding the saving of seed for replanting. In addition, consider what has been called the "terminator technology" by its opponents - what supporters call the technology protection system. This is a recently patented genetic technology that genetically alters seed so that it will not germinate if replanted. The technology is designed to prevent unauthorized seed saving by farmers.

The European situation is also moving toward expanded patent coverage. In an effort to harmonize the rules in the European Union, the European Parliament gave final approval to a controversial patent directive in May 1998. The new law came into force on 30 July 1998 but came under fire almost immediately. On 19 October 1998, the Dutch government filed a nullity suit at the European Court of Justice against the directive. I believe another government may now have joined the Dutch in that action. The German government has expressed concerns about the directive and has suggested that it may not be able to pass the legislation necessary to enact it.

The directive allows for the patenting of transgenic plants and animals provided they meet the standard criteria for patentability. The directive also says that plant and animal patent applications should specify the geographic origin of patented material. In the case of human material, the person from whom the genetic material was taken must have had the opportunity of giving free and informed consent "in accordance with national law." However, the directive provides no sanction for a breach of these requirements.

For those opposed to the patenting of life forms, the directive opens the floodgates to the industrial commodification of all life forms. For proponents in government and industry, the patent directive offers a much-needed compromise between the views of the biotech industry and the ethical concerns surrounding the direction of genetic research.

Conclusion: the challenge

As was noted at the beginning of this presentation, the objectives and interests of international and national institutions and actors with mandates affecting genetic resources are diverse and include, for example:

· Conservation and use
· Indigenous rights
· Maximizing profits
· Liberalizing trade
· Encouraging innovation
· Food security
· The creation of markets.

It is no wonder that understanding of the issues and their integration into a policy response is a formidable challenge to national governments, the CGIAR and other international institutions.

Shaping sui generis systems for the protection of plant varieties - Dan Leskien and Michael Flitner

Introduction

The purpose of this paper is to facilitate the shaping of a sui generis system for the protection of plant varieties as required under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). While IPGRI's "Recent policy trends and developments related to the conservation, use and development of genetic resources (Issues in Genetic Resources No. 7, June 1998) provides readers with information about the national conditions, obligations and potential objectives as well as about the key provisions of sui generis systems, this paper summarizes traditional and new objectives of sui generis systems and spells out their legal implications.

Article 27.3(b) of TRIPS allows members to exclude from patentability "plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes." However, in this case members "shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof."

Thus, the TRIPS Agreement offers three basis options:

· not to exclude plant varieties from patentability

· to exclude plant varieties from patentability and to grant a special sui generis right for the protection of plant varieties instead

· not to exclude plant varieties and to provide in addition for a sui generis right ("combination thereof").

Sui generis is Latin for "of its own kind," meaning in this context an intellectual property right designed specifically for the protection of plant varieties. The term is also used for many new or area-specific types of intellectual property rights (IPRs) and, in current debates over plant genetic resources, for intellectual property and alternative rights regimes (Farmers' Rights, Traditional Resource Rights), which may or may not fit in the conventional concept of intellectual property rights. In this paper, the term sui generis system is exclusively used in the sense of the TRIPS agreement.

However, the TRIPS Agreement does not define the term sui generis system or refer to any specific existing rights regime. One system that has been discussed as a possible sui generis system for the protection of plant varieties in accordance with TRIPS is the system of plant breeders' rights (PBR) as embodied in the UPOV Acts. Yet member states have a whole range of options for developing their own sui generis system for the protection of plant varieties, as long as this system conforms with some minimum requirements resulting directly from the TRIPS Agreement.

Minimum requirements of a sui generis system for the protection of plant varieties

WTO member states that exclude plant varieties or even plants in general from patentability have to provide for the protection of plant varieties by an "effective sui generis system." Although the TRIPS Agreement does not give any details on what elements this effective sui generis system would have to include, certain minimum requirements that such a system would have to fulfill may be drawn from the context of Article 27.3(b), the context of the agreement as an integral part of the WTO Agreement, and finally from the objectives of the TRIPS Agreement itself. Five such requirements can be discerned:

· The sui generis system has to be an intellectual property right, i.e. a legally enforceable right, either to exclude others from certain acts of commercial relevance in relation to the protected plant variety or to obtain remuneration in respect of at least certain uses of the plant variety by third parties.

· Since the TRIPS Agreement elaborates no further upon the term "plant variety" and does not specify any species or genera, member states might have to provide for the protection of plant varieties, whatever species or genus they belong to.

· The sui generis system needs to comply with the basic principle of "national treatment." This means that member states have to treat the nationals of other members no less favourably than their own nationals with regard to the protection of plant varieties.

· Any advantage, favour, privilege or immunity granted by a member to the nationals of any other country has to be accorded immediately and unconditionally to the nationals of all the other member states ("most-favoured nation treatment").

· Finally, in order to be effective, a sui generis system requires an enforcement procedure so as to permit action against any act of infringement of the sui generis right.

Time frame

The agreement establishing the World Trade Organization came into effect on 1 January 1995. Member states were obliged to apply all the provisions of the TRIPS Agreement from 1 January 1996. Developing country members and, under certain conditions, also members in the process of transformation from a centrally planned to a market, free-enterprise economy may delay the date of application of the TRIPS Agreement to 1 January 2000. A further grace period of six years has been accorded to least-developed countries. Under the TRIPS Agreement there has to be a review of article 27.3(b) in 1999. This review started only recently and its final outcome is unclear.

Elements of sui generis systems

Any sui generis system needs to address the following four key points:

· Protectable subject matter

The sui generis system has to define what is protectable. In practical terms this depends on the definition of "plant variety." Definitions vary, but they all refer to an assemblage of plants with enough similarity to be distinguished from other groups of plants. The main option available to countries is whether to restrict the term to bred or at least cultivated varieties, or whether to extend it to all varieties, including wild ones.

· Protection requirements

It must also be defined under which conditions sui generis protection is being granted. The main options include the traditional protection requirements under patent legislation, such as novelty or inventiveness; under PBR legislation, like distinctness, uniformity and stability (DUS); the possibility to modify these requirements to facilitate protection of more heterogeneous varieties, and also the inclusion of additional requirements like "Declaration of Origin" (DO) and "Value for Cultivation and Use" (VCU).

· Scope of protection

The sui generis system needs to define the rights conferred to the person whose plant variety fulfills all the protection requirements. The main points to be addressed here include (a) the list of acts that require the right-holder's authorization (e.g. reproducing, selling and importing), (b) the materials to which these acts refer (e.g. reproductive or harvested material), and (c) the exemptions from the right (e.g. exemptions for researchers and farmers).

· Duration of the right

Finally, the duration of the right conferred must be clarified. While the UPOV Act of 1978 provides a minimum protection period of 15 years, the TRIPS Agreement does not specify the duration of rights under a sui generis system.

The particular mix of these four points by any particular country should be arrived at in the light of the particular situation and objectives of the sui generis system for that country. Objectives may be grouped as follows:

· the traditional primary aim of plant variety protection, i.e. promoting research and formal plant breeding

· related aspects such as enhancing foreign investment, technology transfer and facilitating the import and/or export of plant varieties

· new objectives such as supporting the breeding of heterogenous varieties, promoting the conservation and use of genetic diversity and minimizing restrictions on the use of varieties

· related aspects such as preventing unauthorized access to genetic resources and facilitating the sharing of benefits

Finally, it will be useful to minimize administration and implementation costs whilst ensuring compatibility with TRIPS.

The relative importance of these objectives will vary between countries depending on characteristics such as:

· the state of development/capacity of domestic seed companies and formal plant breeding, especially in the private sector (may well vary crop by crop)

· balance between commercially and export-oriented agriculture and subsistence/local market oriented agriculture

· balance between public and private plant breeding

· importance of informal, farmer-to-farmer seed exchange, farmer and participatory crop development

· actual or aspired to political and economic groupings.

The traditional goals of plant variety protection

Promoting research and formal plant breeding

The historical rationale of IP protection for plant varieties is to provide private breeders with an opportunity to receive a reasonable return on past investments and thereby to provide an incentive for plant breeding beneficial to agriculture. Until today, there is no general agreement on the question of to what extent this mechanism works. But even though results from empirical studies are contradictory, there is wide agreement that IP protection for plant varieties can incite plant breeding activities provided that certain conditions with regard to breeding skills, agricultural technology, general infrastructure and market size are fulfilled. On the other hand, it is not possible to deduce the "right amount" of protection from such factors, as such a decision will have to be taken in the light of broader policy aims, which may vary substantially between countries.

The incentive effect of such a system mainly depends on the protection requirements and the scope of protection of the right conferred - that is, on the question of which exclusive rights breeders may obtain in relation to which kind of plant varieties.

It is obvious that for private formal breeders, it is most attractive to have strong protection for plant varieties resulting from their breeding activity. They will generally prefer protection as provided for in the UPOV Acts as their products will in most cases comply with the strict UPOV protection requirements. Yet while formal breeders are interested in as much protection as possible for their own products, they are equally interested in using genetic resources, including new varieties of other breeders, as an initial source of variation for creating further varieties and marketing them. This conflict of interests is reflected for example by the UPOV Act of 1978, which explicitly provides for the breeders' exemption (i.e. the right to use protected varieties freely as a source for further breeding). According to the Act of 1991, protected varieties may also be used freely; if, however, a variety has been essentially derived from a protected variety, it may only be marketed if the breeder of the original variety has given permission.

Patents as foreseen in the TRIPS Agreement provide by virtue of their scope the strongest incentive for private investment. However, there is no such thing as a breeders' exemption provided for in common patent law and it is clear that the research exemption does not cover the commercial use of protected subject matter. This lack of an exemption for breeders could hinder plant breeding activities, in particular for newcomers in the market, who are in a weak position when it comes to cross-licensing negotiations.

Related goals

· Attracting foreign investment and protected technology

One of the objectives of the TRIPS Agreement is to "contribute to the transfer and dissemination of technology." Even though it is hard to prove empirically, it is widely acknowledged that IP protection may attract transfer of technology protected abroad and also related direct foreign investment. On the other hand, IP protection will inevitably discourage foreign (and domestic) investment in imitative production. Furthermore it is clear that where other factors such as scientific infrastructure, economic environment and work force skills are not internationally competitive, this cannot be compensated by the highest standard of IP protection. By providing IP protection for technology, countries which lack competitiveness may actually deprive themselves of the possibility of freely using technology that is protected abroad.

By providing for the protection of plant varieties, countries may possibly attract foreign investment in domestic plant breeding and may thereby also benefit from an increased transfer of related technology. Still, in a highly competitive market, many countries are not in a position to provide an economic background that would incite foreign companies actually to perform plant breeding activities in that country. Countries lacking several features of competitiveness run the risk that the protection system, instead of attracting foreign investment and technology, is being used mainly to secure imports. Member states could limit the development of import monopolies by offering protection for only those varieties which have been bred and/or propagated domestically. It should be noted, however, that under the UPOV Acts, discrimination as to the place of breeding is not allowable.

· Facilitating import and export of plant varieties

In relation to the import of seeds countries may pursue two different goals, which, however, exclude each other. On the one hand a country may wish to incite foreign companies to import and market seeds in that country. In this case it might be necessary to foresee the same level of protection as the company enjoys in its home market. This is especially true if it is deemed illegal in the exporting country to export propagating material of protected varieties into countries that do not offer protection for varieties of the plant genus or species in question (see Article 14 of the 1991 UPOV Act).

On the other hand, without violating the TRIPS Agreement, a country may wish to allow domestic companies to import samples of materials protected abroad, to use and market them domestically at a considerably lower price than would be charged by the company that developed the variety. In this case the country might wish to set up sui generis legislation under which either only locally bred and propagated varieties are protectable or under which compulsory licences may be granted where propagating material of a variety is not produced domestically. Thus, a country may actually benefit from providing for less protection than other countries in order to allow its domestic companies to use foreign material without violating domestic laws.

In relation to export of plant materials, countries may wish to ensure a high degree of technical compatibility of their own protection and certification system with the protection and certification system of potential importing countries. This is especially true for high value export crops such as ornamental plants and vegetables, where the varietal material used is often subject to protection under the laws of the importing countries. The compatibility with the protection standards of importing countries is of growing importance as under the 1991 UPOV Act, the breeder's authorization is also required for the use of harvested material where this material has been obtained through unauthorized use.

Certainly, there is no need to apply the same strategy, whether it is import or export oriented, to all plant species or genera. Countries may provide different levels of protection for different species or even varieties. For example, in order to facilitate the export of ornamental plants, countries will have to avoid producing with varieties subject to variety protection in the importing countries. In order to attract foreign investors from UPOV member states and to have ready access to markets and materials, they will rather provide for protection similar to that available under UPOV. As far as food staple crops are concerned, countries may rather wish to benefit from using varieties protected abroad without having to pay licence fees and may therefore have an interest to grant rather weak protection in this field. They may adopt a protection system not based on exclusive rights with regard to material of the protected variety. Instead they could choose to grant the exclusive right to commercialize material of a variety in combination with a specific certificate or seal.

Taking new objectives into account

In recent years, a range of new goals with regard to plant breeding and agricultural biodiversity have appeared on the international agenda. While in the 1950s, when the first international convention for the legal protection of new plant varieties was discussed, the main emphasis was put on raising productivity in the agricultural sector, in the 1990s policymakers are confronted with new challenges. Some of the most important new objectives have been laid down in the legally binding Convention on Biological Diversity (CBD), which came into force in December 1993; others were internationally agreed upon in FAO's Global Plan of Action for the Conservation and Sustainable Utilization of Plant Genetic Resources for Food and Agriculture, which was adopted at the Fourth International Technical Conference on Plant Genetic Resources in 1996.

The CBD states that authority to determine access to genetic resources rests with national governments and that access, where granted, should be subject to the prior informed consent of the providing country unless otherwise determined by that country. The Convention thus provides an international legal framework for regulating access and encourages a sharing of benefits with countries providing genetic resources.

The FAO Global Plan of Action can be seen as a tool for implementing strategies from Agenda 21 and the CBD with regard to plant genetic resources in food and agriculture (PGRFA). Its main aims are to ensure the conservation and sustainable use of plant genetic resources as a basis for food security, to promote a fair and equitable sharing of the benefits arising from the use of plant genetic resources, and to assist countries and institutions responsible for conserving these resources in identifying priorities for action and building programmes to attain the mentioned purposes.

While both instruments are very careful in giving direct advice on how IP protection should be developed in the future, they clearly acknowledge the important role of related policy developments. The following section takes a closer look at the possible consequences of the more specifically relevant objectives of the two instruments.

Supporting on-farm management and improvement of plant genetic resources for food and agriculture

On-farm activities are an important complement to formal varietal development and seed supply systems. The FAO Global Plan of Action calls for "supporting on-farm management and improvement of plant genetic resources for food and agriculture." More specifically, governments should consider how production, creating economic incentives and other policies might facilitate and encourage on-farm management and improvement. It would appear that this consideration also touches upon the design of IPR systems for the protection of plant varieties as required under the TRIPS agreement.

There are two approaches that merit specific attention in this context. On the one hand, members may wish to minimize IPR-related restrictions with regard to on-farm management and improvement of PGRFA, either by setting up very strict protection requirements so as to exclude most of the varieties in question from any form of protection or by granting rather weak property rights in relation to those varieties.

On the other hand, members may consider including specific elements in their IPR system in order to create incentives for improving local varieties or enhancing genetic diversity among the different varieties of a given species.

Imposing minimum restrictions on the use of plant varieties, IPR are, by definition, rights to exclude others from certain commercially interesting acts in relation to the described subject matter and/or to obtain remuneration in respect of those acts. Likewise, plant breeders' rights may affect or even restrict agricultural practices, including those which are of particular importance for the on-farm management and improvement of plant genetic resources for food and agriculture as they shall be furthered under the Global Plan of Action. This is especially true if the IPR chosen restricts the planting back and/or the selling of seeds, which are important and common practices in large parts of the world. While under patent law any commercial use of an invention requires the right-holder's authorization, laws designed to protect plant varieties generally provide for exemptions from the scope of protection which are of particular relevance for some of these agricultural practices.

The goal to impose minimum restriction on the use of plant varieties can be pursued by setting up very strict protection requirements. Alternatively, members may design the scope of protection in a way that has minimum impact on the continued use of the protected varieties. The models available include the farmers' exemption as provided for by the UPOV Acts.

Under the 1978 UPOV Act and the PBR laws of most countries, the planting back of propagating material of the protected variety is allowable without authorization of the right-holder. This is the so-called farmers' exemption. It includes the saving and replanting of seeds. Some countries even allow for the selling of limited amounts of farm-saved seed ("brown-bagging").

The 1991 UPOV Act gives the farmers' exemption a markedly different meaning. First, the privilege has been put at the discretion of member states. Second, members may only allow farmers to propagate on their farm seed saved and retained on their farm "within reasonable limits and subject to the safeguarding of the legitimate interests of the breeder." Whether farmers planting saved seed have to remunerate the right-holders is the subject of some controversy. While some countries require farmers, except small farmers, to pay to the holder an equitable remuneration (which shall be sensibly lower than the amount charged for the licensed propagating material), others don't have comparable provisions.

The TRIPS Agreement leaves even more flexibility. It does not make it an obligation to require the right-holder's authorization for the planting back or selling of propagating material of protected varieties. It appears that a member state would even comply with the agreement, for instance, by granting breeders the exclusive right to sell propagating material of their variety in combination with a PVP (Plant Variety Protection) seal or certificate. In this case, the IPR would not affect or restrict any acts that may be regarded as important for on-farm management. Such a certificate may even incite farmers to improve local varieties and to make them widely available.

The continued improvement of plant varieties requires the use of protected plant varieties as initial sources of variation - in the formal and in the informal sector. This reality is reflected by the breeders' exemption in both UPOV Acts. In patent law, there is no such thing as a breeders' exemption and it is clear that the research exemption does not cover the commercial use of a patented invention, be it a gene or a plant variety.

Under the 1978 UPOV Act, protected varieties may freely be used for breeding purposes. According to the UPOV Act of 1991, protected varieties may also be used freely but if the new variety is deemed "essentially derived" from the original protected variety, it is subject to the right granted for the initial variety. Thus it may only be marketed if the breeder of the initial variety gives permission.

The purpose of the concept of "essential derivation" is to discourage breeders from superficially changing protected varieties and, by receiving a separate title of protection for their product, appropriating enhancement efforts of other breeders. This concept seems legitimate in an agricultural system with a clear division of labour between breeders and farmers. However, the concept of essential derivation may jeopardize the improvement of PGRFA by farmer-breeders insofar as they locally adapt protected varieties. These farmer varieties, most of which are obtained through continued mass selection or use of natural variants, would be deemed essentially derived and therefore subject to the plant breeders' right granted for the original variety.

Supporting the breeding of heterogeneous varieties

There is wide consensus today that in many situations, especially in risk-prone areas, it is an advantage to have a comparatively high degree of variability in the fields. The Global Plan of Action calls for promoting broader diversity in crops, increasing base-broadening efforts in breeding, and also reviewing policies that may affect the degree of uniformity. There can be little doubt that IPR legislation affects the degree of uniformity of plant varieties.

Most importantly, the protection requirements of uniformity and stability as currently applied by UPOV member states allow for very little heterogeneity. The levels of uniformity at present required by national authorities and international guidelines are often higher than is justified by the mere need to identify a plant variety. This is reflected by the definition of "plant variety" employed by the UPOV Act of 1991.

The need to describe plant varieties for the purpose of their protection clearly implies a tendency toward uniform varieties with a rather narrow genetic basis. Small-scale farmers with local varieties will often face difficulties in satisfying current demands in what concerns the uniformity requirement. In order to create incentives for the breeding of heterogeneous varieties better adapted to the needs of indigenous and small-scale farmers, member states may therefore consider either applying the UPOV requirements of uniformity and stability more flexibly or setting up a two-layered system providing for the protection of both homogeneous and more heterogeneous but still "identifiable" varieties. Since less strict protection requirements inevitably imply broader property claims, the rights conferred on the holders should be considerably less extensive than rights which are granted in relation to uniform varieties.

It also has been suggested that required uniformity should only refer to traits of relevance to the intended use and that such uniformity be balanced by maximizing diversity for other traits, perhaps requiring a minimum level of polymorphism for other traits. It should be recalled, however, that the subject matter for which protection shall be offered needs to be defined unambiguously.

Preventing unauthorized access and sharing the benefits equitably

In principle, access to PGR and the TRIPS obligation to provide for the protection of plant varieties are two separate issues. While the TRIPS Agreement requires establishment of a system for granting private rights, access legislation deals with genetic resources falling under the national sovereignty of a country.

However, both systems have in common that they aim at preventing unauthorized use of specific genetic materials. Intellectual property rights give a right to exclude others from the use of protectable subject matter. Access legislation typically addresses the question of under which conditions material covered by that legislation may be acceded to and finally be made use of for private, research or commercial purposes.

Regardless of the TRIPS Agreement, members are free to restrict access to genetic resources. The national authority to determine access to genetic resources is enshrined in the Convention on Biological Diversity. It has been suggested that by providing IP protection for plant genetic resources and plant varieties, a country could prevent the unauthorized access to, appropriation of and/or use of genetic resources by foreign entities, be they public or private. However, according to the TRIPS Agreement, member states shall accord to the nationals of other member states treatment no less favourable than they accord to their own nationals with regard to the availability, acquisition, scope, maintenance and enforcement of IPR. Therefore, WTO members are not allowed to discriminate against nationals of other WTO members as to the availability of the sui generis or other IPR. By providing strong IPR protection, a country with rather low technological and breeding capacity might therefore face a strong rise of foreign applications while the level of domestic applications might remain low. From this point of view it is not conceivable how an IPR system could contribute to curbing the unauthorized access to a country's genetic resources.

Still, members may consider linking IPR and access legislation, for example by making the grant of TRIPS sui generis rights dependent upon the legality of the use of the plant varietal material. Thus, a sui generis system can be used as a trigger point for the sharing of benefits gained from the use of those materials and/or knowledge. The instruments for implementing a benefit-sharing mechanism as part of a sui generis right include a declaration of the source where the genetic material used in the variety was obtained, or declaration of origin (DO) and the prior informed consent (PIC). By making PIC of the donors of genetic resources or associated knowledge a requirement for the granting of IPR, members could create a strong disincentive for companies to acquire and use material without authorization.

However, a system relying on IPR as the only facilitating mechanism for the implementation of benefit-sharing has three major shortcomings. First, without strong multilateral mechanisms, all benefit-sharing based on IPR can only be enforced on a national basis. Material taken from one country without approval can still be commercialized and protected in other countries unless they have specific legislation in place. The benefit-sharing mechanism based on DO and PIC as IPR protection requirements is thus not a mechanism to ensure that material is not exported and finally protected and commercialized outside the country of origin.

Secondly, the sui generis system as required by the TRIPS Agreement is hardly an adequate instrument to fulfill the CBD obligations as, by definition, such a system can cover only a few plant genetic resources. If the sui generis system shall be used for the purpose of financial benefit-sharing, it would seem logical to design the coverage of this system to be as broad as possible, the protection requirements as soft as possible and to grant strong exclusive rights in order to generate maximum monetary returns that could be shared. Such a system, however, would allow all plant genetic resources to be monopolized within a very short time. Plant breeding would thus be slowed down and would cease to create any returns. There are two extreme scenarios to deal with this problem. If the protection conferred by the sui generis rights is strong, it is necessary to set up rather strict requirements for protection in order to avoid the pitfall of complete monopolization of PGR. In this case the returns raised per application could be rather high; however, owing to the strict requirements, rather few PGR would fall into the scope of the system. If, on the other hand, the protection is rather weak, softer protection requirements may be acceptable. In this case the benefits per application would be rather low; the system would, however, cover quite a broad range of PGR. It is difficult to predict which of these models would raise more benefits.

Finally, the concept of the breeders' exemption and the concept of a case-by-case sharing of benefits obtained from the use of genetic resources may conflict with each other. If the use of plant genetic resources requires authorization of the country of origin, it can hardly be expected that plant varieties which are based on such resources can subsequently be used freely by other breeders.

Balancing the sui generis system with other IPR

Whatever form of sui generis system member states choose to establish, the interface of this system with other IPR is of utmost importance.

The need to regulate the interface of different forms of protection is demonstrated by the following example. If a patented gene is inserted into a plant which is protected under a UPOV-style breeders' right, the question arises whether the plant may be used freely under the breeders' exemption as an initial source for breeding a new variety, or whether such use would infringe the patent on the inserted gene.

The answer to this question is actually far from clear. While some argue that the plant should be freely usable for breeding purposes, others argue that any use of the plant would also make use of the patented gene and thus require the patent-holder's authorization. Between these two positions, one may also argue that the use of the plant is allowable without the patent-holder's authorization as long as the new variety does not contain the patented gene, or, if it contains the gene, does not express it. Whatever solution is chosen, it is obvious that the overlap of patents and weaker forms of protection tends to privilege the patent-holder and complicates considerably the legal situation of the holder of the weaker right.

Countries establishing a sui generis system for the protection of plant varieties should therefore consider carefully the interface between the sui generis rights and other forms of protection. To this end, they may consider excluding not only plants but also parts thereof from patentability and providing that the scope of protection of a gene patent does not extend to plants into which this gene has been inserted. More generally, they may wish to ensure that the scope of patents does not extend to subject matter that is excluded from patentability.

Minimizing administrative and implementation costs

The establishment of a sui generis system for the protection of plant varieties requires the setting up of a competent authority in order to examine legally and technically the applications for the protection of plant varieties. Under certain circumstances member states may choose to delegate the examination of applications and granting of IPR to regional or subregional offices.

As a general rule it can be assumed that the more sophisticated the protection requirements are, the more difficult and costly will be the examination of applications. If, for example, the variety to be protected must not belong to the state of the art, and that comprises everything made available to the public before the filing date, examiners have to be skilled in the art and need to have access to all the knowledge available to the public.

Whether the cost of such high-profile examination can be amortized strongly depends on the number of applications and the schedule of fees. Still, when determining the fees, members wishing to increase the number of domestic applications should also take the financial capacity of the domestic plant breeding and biotechnology industry into account.

Many countries already have some seed certification scheme in place that may be used for the purpose of implementing the TRIPS obligation to provide for the protection of plant varieties. Compared with the patent option, the adaptation of such certification schemes is certainly less demanding in administrative and implementation costs as well as in the level of technical skills required.

It should be noted that the costs for setting up a protection system vary from country to country and depend on numerous factors, such as the existing IPR system, seed regulation and the technical as well as the legal skills of personnel available. Any cost-benefit analysis therefore needs to be country specific.

Conclusion

There is a broad range of possible sui generis systems for the protection of plant varieties as required by Article 27.3(b) of TRIPS. Those systems should be explored and discussed before ready-made protection systems currently being used in many industrialized countries are adopted.

Sui generis systems for the protection of plant varieties should be tailored according to needs, conditions and political aims. While taking into account the traditional goals of plant variety protection, such as promoting plant breeding and attracting private investment in this sector, sui generis systems should also reflect widely agreed new goals, such as on-farm improvement of plant genetic resources and the equitable sharing of benefits resulting from the utilization of such resources and related knowledge. Furthermore, the sui generis system should duly acknowledge that the diversity of uses of varieties may warrant different legal responses.

As do all other IPR, sui generis systems need to be discussed and implemented in the context of general policy aims with regard to agriculture, food security and broader development issues. Article 27.3(b) of the TRIPS Agreement is up for review in 1999. If in the course of the implementation of their sui generis system members experience any shortcomings or problems with the existing provision, this is the right moment to bring them up in the review process.

The African experience in responding to Article 27.3(b) of the TRIPS agreement - J.A. Ekpere

Introduction

The Trade Related Intellectual Property Rights (TRIPS) Agreement is a component of the World Trade Organization, which was created in 1994. As a result of this agreement, the protection of intellectual property became an integral part of WTO.

The agreement covers each of the main areas of intellectual property. One of these areas is patents, including plant variety protection. Article 27.3(b) allows member states to exclude plants and animals from patent protection subject to the establishment of an "effective" sui generis system. No definition of effective sui generis system is given, yet developing countries - Africa included - must put a system in place by the end of 1999. Some countries are considering the sui generis option to compliance. The Union for Protection of New Varieties of plants (UPOV) is actively persuading governments that application of UPOV principles or membership in the Union will satisfy the demands of Article 27.3(b) of TRIPS.

For Africa, there are grave consequences associated with the intellectual property protection for plant varieties. It has been argued that protection of plant varieties will place undue restriction on farmers' practices, lead to genetic erosion and adversely impact research and development. There is also reference to the fundamental conflict between TRIPS and CBD. It is relevant to mention here that TRIPS was not negotiated by most countries as a discrete treaty. It was part of a take-it-or-leave-it compromise package decision by a few countries at the end of the GATT Uruguay Round. Therefore African countries were not able to say yes or no to TRIPS with due consideration to other existing conventions, for example CBD. This explains to a great extent the insertion of the review clause. Today, it is very clear that there are conflicts at the level of substantive provisions, not mere operational principles. Africa recognizes that TRIPS undermines the implementation of CBD.

The concern of the Organisation of African Unity and its member states is the consequence that patent protection on plants and animals could have no biodiversity and biological resources. The organization is fully aware of the damages that could be done to sustainable agriculture, food security, political stability and democratization as more and more crops (plants) become subject to monopolistic ownership of transnational corporations.

Protection of plant varieties in the classical sense is a new trade concept in Africa and hence few countries have actually put in place appropriate legislation and modalities for the implementation of the TRIPS Agreement in general and Article 27.3(b) in particular.

In this paper an attempt will be made to discuss the African experience in responding to Article 27.3(b) of the TRIPS Agreement. The review process will be advocated as necessarily the best alternative action toward the implementation of the agreement and options for a common position will be suggested.

TRIPS and obligation of member states

The TRIPS Agreement is part of the new World Trade Organization (WTO), which was adopted in 1994. The Trade-Related Aspects of Intellectual Property Rights details a comprehensive set of new rules and standards for intellectual property to which member states must adhere. Developing countries are given until 1 January 2000 to implement TRIPS-compatible intellectual property rights and national laws and least developed countries have until the same date in 2005. At these dates, these countries will have to implement and enforce Article 27.3(b) of the TRIPS Agreement patent provision. This subparagraph gives rights to biological resources, including patent rights for biotechnology processes and products, animals and microorganisms as well as plant varieties.

Specifically, Article 27.3(b) reads: "Members may also exclude from patentability plants and animals other than microorganisms and essentially 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 the WTO Agreement; that is, this year, 1999.

This subarticle attracted great criticism from developing countries during the TRIPS negotiations because of its negative consequences for food security, the environment and health. Of no less importance are recent abuses of intellectual property rights by transnational corporations and companies, which are patenting biological resources of developing countries without recognition of community rights and without benefit-sharing. Also, some sections of the subparagraph are open to multiple interpretation. Hence the review clause was inserted as a compromise.

The timetable and procedure for the review was established during the meeting of the Council of TRIPS held in Geneva, Switzerland, on 1-2 December 1998. The following programme was agreed to:

· Those members under an obligation to apply Article 27.3(b) are invited to provide information on how the matters addressed in this provision are presently treated in their national law. Others are invited to provide such information on a best endeavour basis (target date: 1 February 1999).

· The Secretariat was to provide an illustrative list of relevant questions to assist members to prepare their contributions.

· The Secretariat was to contact FAO, CBD and UPOV to request factual information on their activities of relevance. This information-gathering will be without prejudice to the nature of the review. The council will revert to the question if any further information might be requested from the Secretariat (Annual report, Council of TRIPS, 1998, p. 7).

By this decision and directive of the Council of TRIPS, the process for the review of the provisions of Article 27.3(b) of the TRIPS Agreement has become clear. The need for African countries to proceed with the review from a position of common knowledge and approach has become more urgent. To influence the review process, it is important to know not only who is taking decisions but also when decisions are being taken. There must be close synergy between national capitals in Africa and their trade missions in Geneva to present a common bargaining front. Africa must also collaborate and cooperate with countries of Asia and Latin America to present a coherent argument.

Africa's experience and response to Article 27.3(b) of the TRIPS agreement

Africa recognizes its obligation to a world driven by science and technology, international agreements and the principle of free trade based on free flow of information and knowledge. It has difficulty, however, accepting concepts and practices that are detrimental to its survival as a people and continent.

It is in recognition of this obligation that the Council of Ministers of the Organisation of African Unity meeting in Ouagadougou in June 1998 recommended that governments of member states should:

· Give due attention as a matter of priority to the need for regulating access to biological resources, community knowledge and technologists, and their implications for intellectual property rights as entrenched in the international trade regime of the TRIPS Agreement

· Adopt the draft Model Legislation on access to biological resources and call on member states to initiate the process at national level, involving all stakeholders in accordance with national interest and enacted into law

· Initiate a process of negotiation among African countries to formulate and adopt an African Convention on Biological Diversity, with emphasis on conditions for access to biological resources and protection of community rights

· Develop an African common position to safeguard the sovereign rights of member states and the vital interests of their local communities and to forge alliance with other countries of the South on the revision of TRIPS in 1999.

The countries may be classified into three groups on the basis of capacity to comply with the TRIPS Agreement or the proposed review of Article 27.3(b):

· Countries that have complied or can comply on the basis of existing legislation: This includes a small group of countries (South Africa, Zimbabwe?, Egypt) that have existing laws on protection of plant varieties and can almost immediately comply with the provisions of Article 27.3(b).

· Countries with legislation pending in parliament: There are a few countries (e.g. Kenya) that have legislation on protection of plant varieties pending in parliament. When this legislation will be enacted into law is anybody's guess.

· Countries without appropriate legislation: This category includes a large number of countries, ranging from those that have no patent laws to those with laws requiring amendments consistent with the provisions of the TRIPS Agreement and Article 27.3(b), and the review process has been mixed, indeterminate and uncoordinated.

The lead set by OAPI members may not necessarily be followed by ARIPO member states. This is because another six-day workshop (Kampala, Uganda, 4-9 March 1999) of over 40 senior trade policy officials from 21 East and Southern African countries criticized the TRIPS Agreement, calling attention to fundamental imbalances inimical to the development of Africa. They cited several adverse effects, which include constraint on domestic technological development, barriers to technology transfer and monopolistic high prices (including for medicinal products, seeds and software).

As far as Africa is concerned, they indicated that the most serious problem with TRIPS is that it fails to recognize the rights of local communities to their traditional and indigenous knowledge. This may lead to unjustified patenting of their knowledge and biological resources by foreign corporations. In the context of the review process, they suggest the exclusion of life forms and all biodiversity (biological materials) from patentability. They indicated that African countries should develop suitable sui generis systems of protection of plant varieties, indigenous knowledge and technologies, and community rights consistent with national priorities and should ensure that the TRIPS Agreement conforms with the Convention on Biodiversity.

Discussions at several other fora have suggested the development of an African common position on the TRIPS Agreement in general and the review of Article 27.3(b) in particular.

There is therefore reasonable disparity in the level of preparedness of African countries for review of or compliance with the obligations of Article 27.3(b) of the TRIPS Agreement. The need for coordination and cooperation is therefore self-evident. The Organisation of African Unity is currently poised to provide the desired coordination.

Future outlook

Africa's position on and response to the review of and/or compliance with Article 27.3(b) of the TRIPS Agreement is predicated on Africa's commitment to the spirit, principles and relevant provisions of the Convention on Biological Diversity, to the sovereign right of states over ownership of their biological and natural resources, and hence to their authority to determine access to genetic resources and to maintain knowledge, innovations and practices of indigenous people, subject to national legislation, as well as to ensure equitable sharing of benefits arising from the utilization of such knowledge, innovations and practices.

Africa remains a multi-ethnic continent with a deep sense of moral, religious and cultural values. Its population consists of a large army of indigenous people whose environment -comprising trees (sacred groves), crops, animals, birds, fish, other organisms, soils, etc. - is an integral component of their total lifestyle in fellowship with their fellowmen. Africa's long history, culture, and spiritual and political existence have survived centuries of careful growth and development consistent with the available benefits of western civilization. These values are currently being threatened by privatization, multinational corporations, unethical science and technical research outcomes through Intellectual Property Rights (IPRs) on life forms. Africa's response seems to suggest that these incursions are totally at variance with Africa's traditions and culture and are therefore unacceptable.

Africa is very much in favour of science, technology and innovations derivable therefrom. The development of new technologies and the dissemination of innovation are indeed a desirable ongoing process that must be supported by governments and nations with appropriate rewards and incentives. But the type of rights Africa needs are not IPRs, monopolized through privatization, but rights that support local communities, farmers, indigenous people, and their efforts over the past millennia to conserve and enhance biodiversity for the benefit of humankind.

Africa's preferred response would be to delay new legislation until the outcome of the review on the relationship between TRIPS and CBD is determined. In the alternative, Article 27.3(b) should be reviewed to provide full and unconditional exclusion of all forms of biodiversity, be they microorganisms, plants or animals, from IPR regimes.

The assistance of friendly nations of the international community at capacity-building and provision of resources to accomplish this objective will be highly appreciated.

The need for sui generis legislation on intellectual property rights and patents in the developing countries - J.M. Gopo

Abstract

The present Intellectual Property Rights (IPR) and patent systems do not have enough protective regimes to include issues on indigenous and traditional knowledge systems. The IPR systems and other forms of Intellectual Property Rights are based on disclosure of the innovation, the industrial application of the innovation, and in return, the inventor is given protection on the technology. Patents are therefore rights to stop anyone else from using an innovation without permission from the inventor. The fundamental problem for the developing world is the nature of the invention. How does one define invention? Is a discoverer of a new plant or animal species an inventor? Did David Livingstone invent the Victoria Falls? Can the Livingstone family patent the Victoria Falls? Can they claim ownership of the falls?

Laboratories, large corporations and pharmaceutical and drug-manufacturing companies developed in the West have pirated traditional knowledge systems about medical plants and in some cases medicinal plants themselves, and have used them in the manufacture of Pharmaceuticals. They have developed exclusive patents on the products based not only on the plants but also on the knowledge of traditional people about the medicinal values of the pirated plants. These companies have reaped windfall profits from the products without any equitable sharing of the benefits. Developing countries of Africa, Asia and Latin America need to guard against the patenting of life systems, the patenting of the world's food systems, the patenting of animals and human body parts, and the patenting of our health care systems. They must be aware that the present patent systems do not offer adequate protection to them but rather to the western multinational corporations. The developing countries need a new patent system that will ensure adequate protection. A sui generis patent system may be such a system for them.

Introduction

Developing countries of Africa, Asia and Latin America need to develop sui generis legislation on Intellectual Property Rights (IPR) and patents because they must guard against unfavourable patenting, piracy of resources and perverted promises by the western multinational companies. The patenting of life by the western multinational companies is the last assault on the peoples of the developing countries of Africa, Asia and Latin America. These countries must be aware that these companies are patenting the food systems of the world, patenting life forms, patenting animals, patenting heath care systems for the world, and more importantly, they are patenting people - humans, human organ systems, tissues and cells.

Developing countries are under pressure to establish patent laws that allow the patenting of life, of genes, the patenting of food crops, the patenting of livestock and of human tissue and cells. Pushing the development of IPR regimes that allow for the patenting of life systems are major transnational corporations, which want these patent rights in order to increase their profits from food, drugs and biotechnology products in the marketplace. At stake for them are the creation of new markets and legal control over the basic biotechnology products and resources of our food supply and health care systems. At stake for the developing countries are a wide range of ethical, economic and sociopolitical concerns, revolving around one central question: Is it right that corporations should own biological forms that are the underpinning to life?

The present patent system and other forms of intellectual property rights (IPRs) are supposed to get the disclosure of the innovation and protection of the technological progress in return. Patents are rights to stop anyone else from using an innovation without permission from the inventor. Any user who wishes to use the technology has to pay a price. The indigenous peoples of the developing countries of Africa, Asia and Latin America must ask whether they would want to see their body parts patented by multinational corporations, for whatever benefit to mankind. Should these multinational corporations and scientists from the United States, Europe and Japan get ownership rights over indigenous peoples' body parts, their indigenous and traditional knowledge? Should these multinationals own and control resources from the rural communities of the developing world? Should they own and control Africa's medicinal plants, plant and animal biodiversity, genetic resources and strategic food crops? Should the peoples of Africa, Asia and Latin America be forced to surrender such ownership of knowledge? Is it not preferable for the indigenous peoples and the rural communities to be able to patent their indigenous and traditional bodies of knowledge and protect the profitable use of these? The patenting of food systems of the world by the western multinationals raises a number of concerns.

Concerns

Patenting of our food systems by the western multinationals on a global scale and threats to food security

It is important for Africa and the rest of the developing world to know that 70% of the world's food supply comes from a few plants: wheat, maize, rice and potato. These crops are the backbone of crop production, plant breeding and food security. Biotechnology corporations and researchers in the West are trying to get and claim ownership on genes and plants because they claim inventions of the most important world food crops.

How can genes be new and invented? How can you invent a plant? What does this desired ownership mean to farmers and for local, national and global food security?

Potential harm for future agriculture and food security in developing countries

Developments in biotechnology involve potential harm for the developing countries that do not have the technology. Some seed companies have developed what is now code-named "terminator technology": cotton seed has been engineered so that it will not germinate when replanted. The seed industry in the world is controlled by a few multinationals, such as Dupont, AgrEVO, Monsanto, Norvatis, Delta and Pine-Land. The world's top ten seed companies, ranked by 1996 sales, are in the West. What sort of patent systems do you think these multinational corporations would like to see in Africa?

Is there food security for Zimbabwe and the rest of the developing countries of Africa, Asia and Latin America? The world's top ten food and beverage companies are the western multinational corporations. I submit to you that the current patent system does not promote innovation in Africa, but rather it fosters pirating of resources and unaffordable sale of western technologies to Africa and other developing countries.

Patenting animals

The European Patent Convention and subsequent national laws prohibit the patenting of animal breeds, animal races and animal species, and they also prohibit any innovations that are contrary to morality. However, European scientists, the multinational companies and the patent offices have been skirting around these rules and are obtaining patents on animals. These moves have aroused strong objections regarding technology applications on animals and humans.

The Dolly patents cover the use of the technology in all animals, including humans. The European patent convention and laws have not stifled the patenting of animals, as shown by the Dolly sheep affair. The Japanese have cloned and patented the cow. Humans are next.

Patenting health care systems

Health care systems often turn to biochemical compounds found in nature. This is as true for synthesized drugs as it is for natural medicine. Many of these compounds are derived from the biodiversity of the tropics and subtropics. The knowledge of and about their effectiveness comes from the indigenous people. Western scientists are often accused of biopiracy when they pinch not only the chemical cures derived from the rainforests but also take the traditional knowledge of the healer. This is both physical and intellectual theft, since foreigners patent this indigenous knowledge. The world's top pharmaceutical companies are in the West.

Patents and the human tissue trade

Developing countries of Africa, Asia and Latin America are the major sources of origin of tissue samples. The tissues, cells, genes and genetic materials (DNA, RNA, proteins) are sourced from developing countries and stored in developed countries without prior informed consent and in the absence of any protective mechanisms regarding the commercialization of their products. The market for human tissue and its products is enormous. According to the US consultant Frost and Sullivan, the worldwide market for cell lines and tissue cultures netted US$ 427.6 billion in corporate revenue in 1996. They predict that the market will grow at an annual average of 13.5% over the next seven years and will be worth US$ 914.1 billion by the year 2002 (Frost and Sullivan 1996)¹.

¹ Frost and Sullivan, in Businesswire 28, May 1996.

² RAFI, "The Human Tissue Trade." RAFI Communiqué, Feb. 1997.

The Biotechnology Research Institute (BRI) of the Scientific and Industrial Research and Development Centre (SIRDC) in collaboration with the Community Technology Trust (CTDT) held a national workshop aimed at developing sui generis legislation for Zimbabwe. The workshop showed that Zimbabwe needs to review the implications of signed and ratified international conventions such as the GATT/TRIPS agreements and the Convention on Biological Diversity (CBD). The country needs to develop sui generis legislation that is in conformity with GATT/WTO and the CBD articles.

To facilitate this process, there is a need to consult the relevant stakeholders, define what is needed, define what is patentable, define the regimes of protection required and identify the interfaces among the various players in Zimbabwe. It was shown that if Zimbabwe is to develop effective sui generis legislation, a number of issues need to be assessed and reviewed, including:

· A review of similar legislation from both developed and developing countries

· Defining the protectable subject matter of the sui generis system, taking into account the interests of the different stakeholders and their socioeconomic and cultural practices

· Defining the protection regimes required to protect traditional knowledge, innovations and technologies of both the formal and informal sectors, including the interface between the two systems

· Defining the scope of protection within such a sui generis system so that it provides attributes, privileges and benefits to the owner or holder of such innovation, technology or traditional knowledge, as is allowed under the TRIPS Agreement

· The aspect of traditional resource rights (TRR) should be viewed within the context of different types of rights relating to the traditional or customary use of resources through local (farming) communities. Traditional resource rights are widely recognized by different instruments, such as the CBD, the International Undertaking of the FAO and the International Labour Organisation Convention 169. This aspect needs to be addressed in the Zimbabwean context and appropriate legislative provisions need to be developed.

The overall objective of the workshop was to develop for Zimbabwe a model sui generis IPR-Patent legislation compatible with international conventions signed and ratified by government. Specific objectives were to:

· Review processes and forms of legislation from both developed and developing countries that have established sui generis legislation

· Discuss the three commissioned thematic papers and develop draft documents on such issues as forms of protection, patentable subject matter, national sovereignty and access to genetic resources, technology transfer, benefit-sharing and traditional knowledge and resource rights. The draft legislation proposals should be harmonized with international conventions and agreements signed and ratified by government, taking into account the socioeconomic and cultural realities.

· Draft and formulate model sui generis legislation for Zimbabwe to be submitted to the Research Council of Zimbabwe for onward submission to the Attorney General's Office, for consideration as a white paper for legislative purposes.

Article 15. Access to Genetic Resources

Recognizing the sovereign rights of states over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation.

Each Contracting Party shall endeavour to create conditions to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to the objectives of this Convention.

For the purpose of this Convention, the genetic resources being provided by a Contacting Party, as referred to in this Article and Articles 16 and 19, are only those that are provided by Contracting Parties that are countries of origin of such resources or by the Parties that have acquired the genetic resources in accordance with this Convention.

Access, where granted, shall be on mutually agreed terms and subject to the provisions of this Article.

Access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party.

Each Contracting Party shall endeavour to develop and carry out scientific research based on genetic resources provided by other Contracting Parties with full participation of and where possible in, such Contracting Parties.

Each Contracting Party shall take legislative, administrative or policy measures, as appropriate and in accordance with Articles 16 and 19 and, where necessary, through the financial mechanism established by Articles 20 and 21 with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from commercial and utilization of genetic resources with the Contracting Party providing such resources. Such sharing shall be upon mutually agreed terms.

The CBD and IPR

Article 16. Access to and Transfer of Technology

Access to and transfer of technology referred to in paragraph 1 above to developing countries shall be provided and/or facilitated under fair and most favourable terms, including on concessional and preferential terms where mutually agreed and, where necessary, in accordance with the financial mechanism established by Articles 20 and 21. In case of technology subject to patents and other intellectual property rights, such access and transfer shall be provided on terms which recognize and are consistent with the adequate and effective protection of intellectual property rights. The application of this paragraph shall be consistent with paragraphs 3, 4 and 5 below.

Each Contracting Party shall take legislative, administrative or policy measures, as appropriate, with the aim that Contracting Parties, in particular those that are developing countries, which provide genetic resources are provided access to and transfer of technology which makes use of those resources, on mutually agreed terms, including technology protected by patents and other intellectual property rights, where necessary, through the provisions of Articles 20 and 21 and in accordance with international law and consistent with paragraphs 4 and 5 below.

The Contracting Parties, recognizing that patents and other intellectual property rights may have an influence on the implementation of this Convention, shall cooperate in this regard subject to national legislation and international law in order to ensure that such rights are supportive of and do not run counter to its objectives.

Options for a sui generis system for intellectual property rights and patents: the Zimbabwean initiative - L.T. Chitsike

Introduction

Zimbabwe is one of the developing countries in Africa belonging to several international organizations and conventions on trade, development and environment. Among these are the World Trade Organization (WTO) and the Convention on Biological Diversity (CBD). In addition to these Zimbabwe is also a member of the Food and Agriculture Organization (FAO) and the International Labour Organization (ILO). These organizations have several agreements Zimbabwe has signed and committees of which Zimbabwe is a member, including the Trade-Related Intellectual Property Rights (TRIPS), Committee on Trade and Environment (CTE) and the International Undertaking on Plant Genetic Resources (IUPGR).

The objective of joining these organizations and their committees is to enhance Zimbabwe's development through trade, sustainable use of natural resources and capacity-building. While these objectives sound very appropriate and noble, the strategies and plans adopted at the global level through these institutions require that a detailed analysis be made to ensure that they are adequately balanced to promote development of both developed and developing countries. Very often a particular strategy is more beneficial to one of the two. With most of the more experienced governments, NGOs, academics and industrialists being in the Northern countries, experience has shown that key strategists for these organizations have largely been in favour of developed countries.

Among the institutions that have fallen into this situation is the Trade-Related Intellectual Property Rights (TRIPS) Agreement, which is a principal component of the WTO system today. Today's TRIPS originated from large multinational companies from the United States, EU and Japan who were interested in protecting their interests in trade, and then developed the existing conventions, such as the Paris, Berne and Rome conventions on property rights, into TRIPS as we know it today.

The short experience under WTO and its agencies since its establishment has already demonstrated that the United States is the biggest beneficiary of WTO, followed by the EU, whilst developing countries experience marginal development benefits, and least developed countries show negative trade growth (32%, 22%, 5%-0, respectively, Singapore Ministerial Conference, December 1996).

The current status of TRIPS and local communities

TRIPS in its present form is a WTO Agreement developed out of the Uruguay Round of negotiations and is based on the patent system of intellectual property rights. This system of rights denies property rights to local people and indigenous knowledge, practice and innovations. TRIPS only recognizes as worthy of protection inventions that conform to the Northern definition. Rights are recognized only when they generate profits and are capable of industrial application. This excludes all sectors of society who produce outside the industrial code of production and so for social good. Furthermore, to be accorded patent rights, the innovation must be trade-related.

In this connection, innovations in the public domain for local and domestic use are innovations that are denied recognition. This situation seriously affects the rights and opportunities for poverty relief and elimination in Third World countries including Zimbabwe. Local people end up being exploited and made even poorer by developed countries because their knowledge is accessed freely, then "treated" in laboratories in the North, and ownership rights to it are claimed through patents. Royalties are then paid to new owners by those who make use of the patented products.

However, there is a possibility of redressing this disadvantageous position facing local communities and Third World countries in general. This possibility arises from Article 27.3(b), presented as one of three exceptions in Article 27 itself. Article 27 says member countries can make patents available for any invention, whether product or process, in any field of technology without discrimination. The invention must meet the criteria of novelty, inventiveness (non-obvious) and industrial applicability (usefulness). It also requires that patent rights are available without discrimination as to where the invention was made and whether products are imported or locally produced (Article 27.1). This means that no invention should escape patent protection in any of the member states and that importing patented goods should be considered the same as exploiting or "working" the invention.

There are however, three exceptions:

· Article 27.2 says that countries may exclude from patentability inventions whose exploitation must be avoided to protect "ordre public" or morality. This covers inventions dangerous to human, animal or plant life/health or seriously prejudicial to the environment. Prevention of the exploitation of such an invention must be necessary for a country to be able to use this exception.

· Article 27.3(a) creates a second exception: that diagnostic, therapeutic and surgical methods for the treatment of humans or animals may be excluded from patenting.

· Article 27.3(b) creates the third exception: that members may exclude "plants and animals other than microorganisms and essentially biological processes for the production of plants and animals other than non-biological and microbiological processes. However, any country which does not provide patent protection for plant varieties must provide an effective sui generis system of protection."

Zimbabwe is a developing country with about 80% of its population dependent on natural resources for their sustenance in terms of food, shelter, income and health. Over the years, through indigenous knowledge, practice and innovations, indigenous and local communities have developed medicines, foods and industrial raw materials for the modern economy without getting benefits.

An example is Zinatha, the association of traditional healers in Zimbabwe, with 50 000 registered traditional healers, who use over 500 different types of plants for medical purposes. These have been developed through trial and error, experimentation and systematic observations over a long time. They have been tasted and are effective in curing many illnesses. The direct sources of these medicines are plant leaves, stems, roots, fruits, flowers and bark.

Besides plants, traditional health practitioners in Zimbabwe have discovered other forms of medicines, including parts of animals, birds, insects, snakes and fish. For example, hooves are used to treat backache. Some animals are more valuable than others; many parts of an elephant are used to treat a variety of ailments - the skin to treat epilepsy and the meat to treat pneumonia and several other infections.

A fairly large number of veterinary medicines have been discovered by traditional practitioners. These are medicines for cattle, pigs, goats, dogs and chickens. Examples of traditional veterinary drugs that are effective include those for the treatment of worms, constipation, snakebite and diarrhoea.

In the field of agrobiodiversity, Zimbabwe's indigenous knowledge, practice and innovation have developed landraces that have been modernized and commercialized. These include crops like okra (Abelmoschus esculeutus), pumpkins (Cucurbita spp.), tsunga (Brassica juncea) and sweet sorghum (Sorghum bicolor).

Despite developing these varieties of plants and livestock as medicines and foods, there have never been any benefits returned to indigenous and local communities. Many academics from universities interview both traditional health practitioners and farmers and proceed to publish the results of such interviews without acknowledging the source of much of the information. Many medical scientists have passed on the results of their investigations to established pharmaceutical companies that use the results without the permission of traditional healers.

Today, many scientists know that valuable chemical compounds derived from plants, animals and microorganisms are more easily identified and are of greatest commercial value when collected with the assistance of traditional healers. The scientists are aware that much of the basic research into traditional medicines has already been done by the traditional practitioners, though they do not formally acknowledge this. The incidence of cases of robbery of indigenous knowledge and medicines and landraces in agriculture has increased as a result of this awareness on the part of many scientists and pharmaceutical companies.

Zinatha has realized this and discouraged patent registration on an individual basis because one medicinal plant is often used by a whole community of healers, and therefore one individual should not benefit at the expense of the rest. In addition, the high cost of patent registration cannot easily be borne by individual healers, and in terms of negotiating some form of benefit-sharing, the grouping of healers - their association, like a farmers' community - should hold the rights of ownership. This shift from individual to community or association forms the basis for analyzing in more detail the case for a sui generis system for local communities. Local communities need a special protection system different from the established IPR systems, in a sui generis form.

Analysis of natural resources that demand patents or a sui generis system

In a more detailed analysis of Zimbabwe's natural and agricultural resources, it is important to draw up the following categories to determine whether or not the forms of varietal protection should be the same. The categories are open-pollinated food crops, inbred lines and horticultural crops and medicinal plants.

Open-pollinated food crops

Crops such as cereals and tubers represent the most complicated cases fuelling most discussions of plant variety protection issues. For the next season's production, the majority of peasant farmers like to reuse the grain of maize and finger millet or sorghum and the tuber-like sweet potatoes or madumbe that have been harvested. Moreover, within the context of informal seed systems in which farmers freely exchange, trade and save seeds, indigenous knowledge of landraces often contributes to the adaptation of varieties to specific farming systems. This approach fosters quick dissemination of newly developed varieties. In order to maintain this system and to guarantee food security at subsistence level, a form of sui generis protection would appear appropriate.

Inbred lines and horticultural crops

Zimbabwe has become an important horticultural crop country, with its production of ornamentals, fruit, vegetables and plantation crops. These are crops outside the focal interest of traditional farmers and such crops could do well with patent-like forms of protection, which would stimulate breeders' invention initiatives meaningfully.

The biological features of the protected material make its reuse unattractive for farmers. For horticultural crops, the harvested product generally cannot be used as a propagating material for the next generation, as can be done with grains from cereals. In addition, breeders from industrialized countries will export their best and most recent varieties more easily to countries in which an effective PVP system has been implemented. For these crops the extension of the protection to the harvested product and the concept of essential derivation are important provisions to safeguard breeders' inventions against plagiarism.

Medicinal plants

Property rights in medicinal plants are the object of debate. Some people feel that it is unjust for these valuable plants to be protected by intellectual property rights and wish to see them remain in the public domain. However it would be a useless exercise to attempt to retain medicinal plants in the public domain when their commercial value is increasing at a phenomenal rate, especially when there is a major shift from synthetic medicines to natural ones with few or no side effects. The real question, as already suggested, is: How can local communities benefit from a sustainable use or harvest of medicinal plants and their chemical products? It would appear that some form of sui generis system including benefit-sharing is worth considering, combined with copyright and trade secrets.

Zimbabwe's patents and plant protection legislation

Zimbabwe's intellectual property rights legislation has no provision for systems or consideration of community rights or interests. The existing legislation addresses patents, trademarks, industrial designs, plant breeders' rights, trade secrets and copyright. There is no legislation for farmers' rights, biodiversity, folklore or geographical indications.

Patent legislation

Zimbabwe is a signatory of the Paris Convention for the Protection of Industrial Property, 20 March 1883, (21 U.S.T. 1583,828 U.N.T.S. 305; last revised 14 July 1967) and its IPR legislation is largely derived from that convention. The Paris Convention involves two basic principles:

· The right of national treatment, which affords member states all the advantages nationals enjoy in regard to the protection of intellectual property. Accordingly, foreign inventors are treated in the same way as national inventors.

· The right to priority; under this right, any person who has applied for protection in one of the contracting states enjoys a right of priority for twelve months for claiming similar rights.

Plant Breeders Rights Act 1973

This legislation applies to new varieties of plants that have their origin in Zimbabwe. These are required to display novelty, uniformity, distinctiveness and stability. These criteria are compatible with UPOV 1978, although the Zimbabwe act makes no reference to any international convention or act.

Subject to the provision of Sections 34 and 48, plant breeders' rights are only granted in respect of new varieties of a prescribed kind. Presently there are 31 kinds of plants involved, including maize, millet, cotton, groundnuts, sorghum, tobacco, potatoes, coffee, protea, barley, wheat, apple, apricot, pea and bean. The number of plant varieties that are protected is incremental. They can be increased at the discretion of the registrar.

The legislation is not compatible with TRIPS because it does not provide for national treatment. There is a set of requirements specific to foreign applications. There is no coverage of landraces and farmers' varieties, as they do not conform to uniformity and stability criteria. Farmers' rights are not acknowledged. Medicinal plants are not covered, there is no reference to indigenous knowledge, practice and innovations and benefit-sharing issues are not considered in any way.

Similarity with the UPOV 1978 Act arises from the exemptions on saving farmers' own seed. In addition to that there is the breeders' exemption, under which anyone can use the protected variety for further breeding. There is, however, no mechanism to deal with parasitic breeding and essentially derived varieties.

The Zimbabwe Act imposes constraints on severa