SIGNPOSTS TO SUI GENERIS RIGHTS: 3 STRATEGY IDEAS FOR THE 1999 TRIPS REVIEW & BEYOND With the conclusion of the GATT Uruguay Round and its Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) at Marrakech in 1994, developing countries, from one day to the next, found themselves under the obligation to provide some form of intellectual property protection on plant varieties. TRIPS Article 27.3(b) requires that members of the World Trade Organisation (WTO, which replaced GATT) do this either through patents or some "effective sui generis system" at the national level (see box). This new reality is the antithesis of what many NGOs and other sectors have been fighting for over decades: space for local communities to assert their own options with regard to livelihoods, especially in terms of being able to retain and develop biodiversity within their own intimate surroundings. The TRIPS Agreement is really the first legal assault, at the global level, against people's rights to control biodiversity. The response to this should be no less assaulting, despite the tremendous power imbalances at hand. BOX 4: ARTICLE 27.3(b) OF THE TRIPS AGREEMENT Article 27 Patentable Subject Matter 3. Members may also exclude from patentability: (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement. Many NGOs who have been working to safeguard/open space in the policy arena for mechanisms of popular control over biodiversity are now starting to look seriously at whether and how to respond to TRIPS. The terms of that Agreement are not clear. The calendar for implementation is not clear either. By 1 January 2000, developing countries must have their legislation enacted in compliance with TRIPS Article 27.3(b). (For the least developed countries, the deadline is 1 January 2005). In that same year, 2000, the TRIPS Council will review the entire TRIPS Agreement, from Article 1 through 73. Just prior, however, in 1999, the TRIPS Council is scheduled to re-open the discussion on the very wording of Article 27.3(b) in order to "review" this sub-paragraph. Where that discussion leads is not predictable. The "review" that will take place in 1999 means "review to amend". Amendments may easily raise levels of protection of IPR, if such levels are in practice under other multilateral frameworks, by simple referral to the Ministerial Conference (Art 71). The TRIPS Agreement does not discuss procedures for lowering levels of IPR protection.  Thus, developing countries are in a situation whereby they have to implement an agreement by 2000 which will highly likely be modified in 1999. WTO officials concede that if the 1999 Review of Art. 27.3(b) results in substantial changes, the original implementation schedules are likely to be relaxed. Still, many developing countries are moving ahead toward implementation of TRIPS, despite the possibility that the sui generis option could very well be removed or other changes could occur. From our incomplete review of the situation at the national level in the South, we can summarise a few impressions: Many governments are interpreting the sui generis option in Art 27.3(b) to mean plant variety protection (PVP) along the lines of the UPOV Convention. A number of governments which are taking up the PVP route do not think such a system should deprive farmers of their own rights. They seem willing to include provisions to either protect the farmers' privilege (despite its absence from the 1991 treaty of UPOV) or provide wider space in the PVP law for farmers as breeders (their right to participate in the PVP system) and/or as conservers (the right to compensation for the commercial use of their materials). The pressure to legislate is heavy. Trade sanctions on countries which provide "weak" IPR is mounting from the US and the WTO (cf. Ecuador, India). And the first important WTO deadline of 1999/2000 is closing in fast. The space to be creative and engage in more socialised processes is not yet lost, however. In some countries, governments are willing to discuss alternatives with the NGO and indigenous sectors or allow media coverage of dissent against IPR. NGOs, POs and indigenous peoples' organisations are trying to articulate rights for communities in an array of legislative measures: access laws, PVP, amendments to their patent laws, comprehensive biodiversity laws and separate laws on community rights. Many are also directly involved in resisting IPRs on life forms all together. At the same time, national and local groups are not hedging their bets on their governments. Direct action in the form of documenting biodiversity and knowledge through community and national registers, independent lawsuits against offensive patents, technical trainings on improved biodiversity management and advocacy at the grassroots level, civil disobedience and so on are among numerous measures to assert community rights "come what may" of negotiations with the formal power system. A lot of NGOs which have been focusing on legislation regulating access to biodiversity are now beginning to look at the TRIPS framework of trade-related obligations. This includes international NGOs and movements which are starting to position themselves and draw up strategies toward the 1999 and 2000 WTO Reviews, as well as many local and national groups. Obviously, all these processes and targets would need to be well articulated in conjunction in order to create positive net effects. Of course, TRIPS is not the only issue. At the international level, there are a number of other fora and treaties that have something to say about who has what rights to plant and animal biodiversity. Ideally, the fights at FAO and the CBD for rights for farmers and local and indigenous communities over their biodiversity should not only impact the TRIPS Review. They should also help provide space for the development of real tools and mechanisms to protect and promote local rights. At the national and community levels, many important battles are being fought to improve peoples' control over their resources and livelihoods most of them not directly related to TRIPS but very important to influence the TRIPS scenario. Below, we present some options, possibilities and difficulties in relation to the sui generis rights discussion spawned by the TRIPS Agreement. We divide them into national and international frameworks, although the two are obviously interlinked. 3.1 SUI GENERIS OPTIONS AT THE NATIONAL LEVEL Identifying where the national manoeuvring space stops and starts under the grip of the WTO's new jurisdiction is a matter of debate, interpretation and a lot of other subjective factors. It has also much to do with sheer power dynamics. The WTO's legal and institutional setup, and the TRIPS Agreement itself, reflect how industrialised countries threaten and arm-twist developing countries into concessions draped as consensus. This is a sad reality that has to be taken into account when strategies and options for dealing with TRIPS are elaborated at the national or local level. The push to patent life goes back decades. So does the resistance against it. A number of developing countries have been discussing and drafting legislation that tries, despite the patent pressure, to somehow protect the rights of local communities who innovate with biodiversity, develop it and conserve it. It is important to stress that in many cases these initiatives were not born of or guided by the requirements of TRIPS. Many built their momentum under the Convention on Biodiversity or are simply the result of long standing pressure from civil society. A brief review of what has been proposed and developed so far as sui generis options follows. 3.1.1 Sui generis options under development Intellectual property rights for communities The idea here has been to vest IPR in communities given that communities are the source of many biodiversity-related innovations whose "origin" is negated by conventional IPRs. In more recent years, the word "property" has been deleted from such proposals because the sense of "property" was found to be inimical to community views (see below). However, Brazil's access law and the framework for Ethiopia's biodiversity rights legislation still refer to Community Intellectual Property Rights. Also, some countries are trying to evolve sui generis legislation explicitly for traditional knowledge related to biodiversity: the Andean Pact has such an agenda built in to its common regime on access and the Southern African Development Community may take up the same under the initiative of the new Southern African Regional Conference of Traditional Leaders.  Articulating the rights of local communities under any IPR umbrella clearly carries risks and drawbacks. While trying to "bring in" people who seem "left out" of the IPR system, it obviously reinforces the corporate sectors' justification for monopoly rights on life forms and inventions derived from traditional knowledge. As a means to achieve some kind of benefit-sharing toward communities, it commits them irrevocably to assign a market value to their resources, knowledge and culture and trade them as commodities in the commercial marketplace. Allowing the IPR system to further penetrate areas of knowledge and innovation still largely seen as "the commons" could simply be the next step in the destruction of those commons. Community Intellectual Rights & Collective Rights Community Intellectual Rights (CIR) have been tabled as legislation in India and the Philippines, among other countries. It aims to protect the rights of communities "formal or informal, organised or disorganised, monolithic or reticulate"  who have knowledge of biodiversity, maintain it, innovate with it and utilise it, to be able to continue doing so and to benefit more fully from it. This is construed as effective anti-biopiracy legislation. It aims to recognise the sovereignty of communities over the resources they live with, and assert their rights from being trampled by researchers and others claiming IPR on what belongs to the communities, even if slight modifications are made. In its various forms, CIR legislation does not interfere with community processes of exchange and development of materials and knowledge. It articulates community rights as collective and permanent, which the State has to abide by. In a draft made for India , it provides for co-ownership across communities and sets out the terms and mechanisms for commercial use of community resources and knowledge. In several countries in Latin America, NGOs have been pushing for Collective Rights developed along similar lines. "Polluted" PVP This is plant variety protection legislation based on UPOV but with "beyond UPOV" provisions for farmers. This often means the establishment of a Community or Farmers' Rights Fund whereby part of the royalties charged on protected seeds is channelled to communities (cf. Tanzania, India). In countries going further adrift from UPOV orthodoxy like Thailand, the Philippines and perhaps India still the PVP draft takes on a lot more complexity meant to safeguard community and biodiversity interests. This ranges from in- built links to national biosafety regulations, a grace period for filing applications on farmers' varieties, a narrowing of PVP's operating field to exclude certain categories of farmer- controlled plant materials, environmental impact assessments as requirement for protection, etc. No country working on PVP as a sui generis law under TRIPS has been found thus far to deviate from the UPOV criteria of distinction, uniformity and stability (DUS) for varietal protection -- except for Thailand.  The DUS criteria are considered one of the main reasons by plant variety protection erodes biodiversity at the farm level, as they encourage breeders to produce uniformity. Comprehensive biodiversity legislation This path is being approached by Costa Rica, perhaps Thailand, probably Ethiopia and South Africa, and is advocated in India as well. Here, the mechanisms affecting the rights of communities related to biodiversity are bundled together in an almost all-encompassing law. Following common precepts, the legislation tends to spell out mechanisms on access, biosafety, intellectual property, community rights, and national action for the conservation and sustainable use of biodiversity. For many legislators, this is an ideal approach as it can assure greater consistency. For the corporate sector it is something of nightmare as it creates too many cross-sectoral pressures. For NGOs and others advocating rights for local communities, it could carry an all-your-eggs-in-one-basket risk. Depending how it is developed, it could also end up too watery, thus not really providing specific mechanisms for local communities to protect and promote their interests. Sectoral community rights regimes Thailand and Laos, among others perhaps, are taking "pragmatic" approaches and tabling community rights legislation for different sectors. Both countries are evolving Community Forestry Acts with specific attention to the needs of communities who depend on forest resources and whose management rights have been decimated by both logging operations and nature conservation schemes.  Thailand is finalising separate legislation on traditional medicinal biodiversity and knowledge systems. One could imagine and many NGOs see the need for community rights legislation specifically for small scale fisherfolk living in coastal areas. Farmers dealing with crops and livestock are another group with specific dynamics and needs, while the particular situation of indigenous peoples should also be taken into account. The appeal of the sectoral approach is the amount of fine-tuning that can be achieved for different communities' specific needs and realities. It can also result in at least some groups achieving new powers at the local or national level should an all-your- eggs-in-one-basket approach fail. In principle, it also allows for more direct involvement of the relevant communities in the legislative process. The problem with the sectoral approach is that it cuts biodiversity and people into discrete categories, which can never fully reflect reality. Constitutional amendments This is not an objective in itself but lends more power to community rights legislation related to biodiversity. India has recently adopted amendment 73 to its Constitution recognising village-level authority over management of natural resources in conformity with local customs. Thailand has just adopted a new Constitution which explicitly identifies as the duty of the State "to promote and support people's participation in the conservation and use of natural resources and biodiversity in a balanced manner ... according to the principles of sustainable development" (Art. 79). Namibia has also highlighted biodiversity management as a constitutional concern. Brazil's Federal Constitution of 1988 calls on the State to "preserve the diversity and integrity of the national genetic heritage" in its environmental chapter.  Colombia's Constitution of 1991 also emphasises the protection of environmental and cultural diversity, and regulates the movement and use of genetic resources in accordance with national interests.  In fact, Colombia, Brazil and other Latin American countries have gone far to articulate the rights of indigenous peoples in their constitutions, which can lend force to collective or community sui generis rights systems. Grassroots action: community registers Peoples' action is ubiquitous in the shadow of the State and can never be supplanted by laws except by force. Community registers of local biodiversity and knowledge are spreading very fast, as are initiatives to upgrade conservation and innovation systems at the local level. Whether in Indonesia, India, Brazil, Chile, Ethiopia or elsewhere, documentation of local resources and knowledge by communities themselves is gaining ground. This options helps sensitise people to the problem of biopiracy. It establishes prior art (legal documentation to prove that the resource has long been known as useful for certain purposes) to ward off near-sighted patent examiners and their biased protocols. And it encourage local groups to take heed and enhanced responsibility for dwindling resources that are increasingly under threat. However, when it is institutionalised as part of formal legal systems (e.g. under PVP, CIR or even access laws) without sufficient protection against misappropriation, it carries an immense drawback of making local resources and knowledge even more accessible to global actors at the expense of local actors. 3.1.2 Traps under TRIPS The diversity of sui generis initiatives under way can be confusing. For most NGOs working on these issues, the patenting of life forms is unacceptable as it clashes head-on with many local cultures and value systems, and undermines the very conditions by which innovation and options thrive. Still, many groups which hold that position especially those working at the national level, faced with an onslaught of new legislative proposals resulting from outside pressures and agreements also have to work with or lobby their policy makers to avoid the worst within the IPR context. Continuous action is needed on both fronts: the frontal fight against the patenting of life needs to be broadened and strengthened, while the day to day struggle to keep spaces open for local communities in national legislation and international agreements also has to be vigourously pursued. But there are number of traps that are clear by now. Facilitating corporate control Any sui generis rights legislation which does not purposefully narrow or frustrate the operating field of the industrial IPR system, if not close off certain "territories", will do nothing to address the basic problem of biopiracy or the alienation of peoples' rights to control their local resources. Sui generis proposals that take a typical IPR system like patents or PVP and add a mechanism to redistribute royalties or put a farmer on the consultative committee do little more than justify the status quo. This is already happening with emerging access laws which provide for some prior informed consent and benefit-sharing procedures. The reason is that the very framework of access laws like TRIPS is to facilitate trade. Access regimes assume commercial relationships and cater to them. (They often do not deal with the access and exchange of biodiversity going on between communities, and sometimes they directly impinge on this.) Sui generis rights proposals can and should take a more fundamental approach by answering the question: "What rights have to be granted to whom to make community-based resource management work under truly popular control?" As with access, sui generis rights geared to simply "level off" the commercial monopoly playing field will probably only help justify corporate biopiracy and do nothing to enhance biodiversity-based livelihoods systems at the community level. Amending IPR legislation to make it more people-friendly, or politically correct, is not the same thing as vesting rights in communities. It will surely continue to serve its original intent, at the expense of community rights. Naming the nameless? Another problem apparent in most current legal approaches to sui generis rights is the dilemma of how to avoid that legislating rights in the race to please WTO or CBD, or just to fend off biopirates, leads to imposing an unwanted juridical personality on communities. "Indigenous and local communities" exist in international law states have committed themselves to take action with regard to their knowledge, innovations and practices in the CBD alone. How will states identify these people for the purpose of recognising their sui generis rights? One thing is devolving power as far down to the community level as possible in the administrative jigsaw puzzle of legal authority. Quite another thing is demanding that for the purpose of allocating jurisdiction over whichever biodiversity or whichever knowledge and practices, NGOs and the government collude in forcing a new identity on communities. Legalisation of the people themselves can be artificial and disastrous, especially if it is imposed from the outside. This dilemma is compounded by the fact that similar innovations - - e.g. medicinal plants or practices -- can span across different communities, and governments are feeling pressured to rework juridical boundaries to apportion the benefits. Privatising the commons If sui generis rights related to biodiversity are to legally protect the space that belongs to communities, then they will need to recognise the collective nature of the resources, the knowledge and the innovations in question. It is well acknowledged that farmers' seed systems, healers' health care systems, and indigenous and other peoples' livelihood systems based on biodiversity are collective. The collective nature of these systems cuts across both time and space and is the foundation of various rights and obligations already long in practice. Any sui generis rights legislation aiming to protect and promote these systems would have to recognise such principles and draw clear lines between them and private property same as it would have to draw clear lines between community rights and IPR. In many countries, industrialisation and privatisation of livelihood systems has reached such levels that it might seem impossible to question current tendencies and fight for communities, anonymity and commons as opposed to corporations, legal name tags and private property. Governments which have set their hopes on the route dubbed globalisation as the path to progress are often not willing to listen to anything else. If sui generis rights, in a legal form, are to make any dent in this trend, they have to be based on very clear principles. Any strategy which embraces the patenting of life will not make the dent. This does not mean that NGOs should not be involved in distorting PVP laws, introducing hurdles into patent legislation, or participating in debates on national legislative drafts where chances of implanting new precepts are often nil. But it does mean that these traps and numerous others have to be carefully avoided. 3.2 THE FIGHT AT WTO The battle at WTO during the 1999 TRIPS Review of Art 27.3(b), which relates so intimately to day-to-day struggles over the fate of people's life resources, is bound to capture the imagination more and more in the coming months. It should not detract from serious work that still needs to be pursued under other jurisdictions, such as CBD or FAO, or within other houses of intergovernmental cooperation like the EU. However, thoughtful plans have to be devised and strategically allied processes have to be developed if further space is not to be foreclosed and if new spaces are to be wrenched open within the multilateral trade regime. Ultimately, this regime must be subject to basic principles of social justice, human rights and ecological survival. Policy research and advocacy groups are just starting to devise possible strategies for the 1999 TRIPS Review and beyond. Little has been put on paper, much less discussed in collective NGO fora. Yet ideas are beginning to be articulated that can get the ball rolling on possible approaches, tactics, and specific goals for the Review process in relation to national realities. The following table highlights a few aspects of the situation for WTO members in relation to the sui generis option as it now stands (the Marrakech starting point) and in relation to the Review of Article 27.3(b) (the Geneva turning point). TABLE 3A: FROM MARRAKECH TO GENEVA TO.... The Marrakech starting point Countries availing of the sui generis option under Art 27.3(b) have two immediate choices: UPOV-style PVP and/or "other". Most observers are of the opinion that the sui generis "other" has to be some form of IPR, but it is not clear what that exactly means especially whether it necessarily implies exclusive rights.  For the purpose of TRIPS, whatever right is afforded must be "effective". What this means is open for debate. Some argue that it simply means that the right can be properly enacted and defended by the holder of the right. Others stress that a sui generis right on plant varieties is only effective if it provides equitable protection for all stakeholders involved including farmers and local communities. Most everyone is worried that it means "effectively serves US interests" and that the WTO dispute settlement mechanism entrenches this. The plants/animals clause will be renegotiated in 1999. The full TRIPS treaty will be renegotiated in 2000. Any "freeze" on the implementation of TRIPS that is called for in 1999 will reverberate on the rest of the TRIPS schedule. The Geneva turning point The United States wants to broaden IPR coverage on life forms at the 1999 TRIPS Review. This would mean a proposal to reword the Marrakech-agreed Article 27.3(b). At the very least, the US might want the sui generis option clarified to explicitly refer to PVP and perhaps name UPOV as the reference convention. Better for the biotechnology industry, but not necessarily breeders, the US might propose a deletion of the sui generis option altogether, leaving patents as the only means of required protection for plant varieties. At most, the United States could swing the axe and say, "Delete subparagraph (b) entirely." In this case, no exclusion from patentability for any form of life -- plant or animal -- would henceforth be permitted in any WTO members' patent law. The EU might try to play the broker between a hardline "No exclusions! Patents on everything!" US position and a more appropriate "Let us choose!" South position. After all, it was European patent law which justified the wording of 27.3(b) originally. By playing the broker, the EU might try to coax developing countries to make a trade-off and let the US radically amend or delete Art 27.3(b) in exchange for TRIPS-sanctioned coverage of traditional knowledge. Traditional knowledge might be swept under the "geographical indications" rug, tossed into a new WIPO register or promised a separate sui generis system of its own all with very dangerous implications. However, if the draft EU patent directive, which would legalise the patenting of plants and animals in the Union, is approved as might occur in 1998 many European countries will have little reason to fight hard on this issue. The risk that the broker keeps quiet, and South is alone during the 1999 Review, is high. The question is how hard the South is prepared to fight. Ideally, the main objective should be the opposite of the US intention: allow WTO members to exclude all life forms from patentability, with no "howevers" attached. But since Marrakech, a number of developing countries have been adjusting their IPR laws already in reaction to US pressure, while others are filling UPOV's ranks as a fast ticket to sui generis compliance. These countries may be less inclined to put up a fight for any form of community rights. Social advocacy groups will see nothing achieved in the 1999 TRIPS Review unless they specifically, and well in advance, prepare their governments to take certain positions. Some collective alignment within a South bloc, e.g. through the G-77 or regional groups, is always better. The baseline goal for most development-oriented NGOs concerned with biodiversity is to ensure that commitments to strengthen IPR do not spread further in 1999. If possible, they should retract. How to achieve this is no simple matter, especially since the US is already trying to build a fait accompli situation whereby developing countries will have stuck their necks out to reform their patent laws in the most "no exclusions" fashion already. This has happened in Indonesia, which often assumes a lighthouse role within the ASEAN. It is being empressed upon most Latin American countries and forms an integral part of the FTAA process. The fait accompli is a very strong power position to build, particularly under the terms and "spirit", depending on who you ask, of the TRIPS Agreement. Any enhancement of IPR obligations can be readily written into the multilateral trading rules by mere acknowledgement of higher standards being practised under another multilateral framework and simple acquiescence to that "given". South countries will have a hard time arguing for more biodiversity-related "space" under TRIPS, unless they have laws in place or under development which really honour broader rights which are free from IPR constraints. Credibility will not be won even from national constituencies unless the broader, non-IPR rights are the subject of state commitment. A few strategy ideas can be culled together from different organisations' thoughts and proposals so far. None of them are mutually exclusive, and of course, the possibilities listed here are only a starting point for discussion. 3.2.1 Introduce a full exclusion on life forms Many peoples' opposition to patents on life forms is so fundamental that it is strictly non negotiable. This position is held by people from the whole gamut of social classes, political parties, religions and other groupings across the geopolitical spectrum. Many governments try to uphold it in law and international relations as well. Until the Uruguay Round, which resulted in the creation of WTO, patent law was a matter of national sovereignty. That sovereignty has been ceded to WTO. But it should be regained. Given the overwhelming importance of biodiversity for food security, and ethical concerns about genetic manipulation and ownership of life, there is no reason for countries to shy away from reasserting their sovereignty over these issues by permitting a full exclusion for life forms under the TRIPS Agreement. There is clear legal basis for this option. The TRIPS Agreement does allow member states to exclude certain fields of technology, certain inventions, and open-ended groupings of things from their patent laws. This holds for inventions whose exploitation offends morality, for methods of treatment of humans or animals, for plants, for animals and for essentially biological processes. To argue that life forms should be kept out of the obligations TRIPS embodies is persuasive on moral, economic and socio-political grounds. Farmers cannot grow crops without the availability of seed and no one can eat if farmers do not grow crops. Plant varieties -- seeds -- should not be "in" TRIPS. They should be "out", along with all other forms of life. The only ones to gain by plant varieties being "in" are a few transnational companies from the US, Japan and Europe. The review of TRIPS Art. 27.3(b) is open territory to rework the Agreement. Developing countries have all of 1999 to change the Agreement and then change their laws in conformity with the Agreement in perfect consistency with WTO procedure. Therefore the legal opportunity is there. Life should be excluded from categories of inventions, from patentability, and from the jurisdiction of the WTO. This is achievable, although with great difficulty, if voices are strong enough. 3.2.2 Delete the entire "However" clause TRIPS Article 27.3(b) starts off by allowing countries to exclude plants and animals from patentability and continues with: "However, members shall provide for the protection of plant varieties either by patents or by an effective sui generis system of by any combination thereof". Short of regaining full control over the option of whether or not to allow patents on life at the national level, the second most desirable approach to the 1999 Review by those concerned about biodiversity and local communities would be to achieve the deletion of this entire "However" clause. The result would be that members may exclude from patentability plants and animals full stop. No ifs, buts, to-the-extent-possibles or other hidden agendas. The obvious advantage of this approach is its simplicity and directness. It is a logical position to advocate among people fighting against patents on life forms already, and it can build on existing coalitions and campaigns. It would also be a logical position for many developing countries to defend since a good number have legislation which does not allow for the patenting of plants and animals or may contain multiple safety nets. Even though the WTO members committed themselves to implement 27.3(b) as per its Marrakech wording, developing countries do have the option to recast that commitment in 1999 before their implementation deadline of 2000. If some countries can walk into the Geneva negotiating round in 1999 to raise the stakes, why can't other countries walk in and lower the stakes?  The obvious drawback is that it also will be difficult to achieve. The commercial biotech and seed trade sectors are acutely aware of biodiversity debates, and their interest in developing countries' markets is increasing by the day. As explained above, the US and to a lesser extent other OECD countries are geared towards the opposite objective, perhaps even the deletion of the whole subparagraph (b) of Article 27. The countries of the European Union might lose interest in the debate if the EU patent directive is adopted by the time of the 1999 Review, and might even align with the US on this matter. Yet another drawback is that recasting Article 27.3(b) to permit the exclusion of plants and animals from national laws does not, as such, put a halt on biopiracy of indigenous knowledge. Even if the deletion of the "However clause might look difficult from the start, it has important tactical value. If anything, it would help to balance off the intentions of those who want to delete every possibility to exclude certain subject matter from patent law. But perhaps most importantly, this campaign would clearly lay on the table what is non- negotiable for most NGOs involved in the management of biodiversity: "No patents on life!" 3.2.3 Raise the IPR entry barrier One fundamental way in which policy makers may wish to limit the damage incurred by TRIPS as it now stands is to broaden out the non IPR-protectable space called "public domain". Public domain refers to tangible and intangible goods or creations that are not appropriable under private law. In many countries marked by Roman legal traditions, the state is the ultimate owner of all natural resources on its territory. Centralised state jurisdiction is tempered by the state's agreement to recognise private rights to the same goods and resources, including physical property rights and IPR. As regards the evolution of laws concerning biodiversity, the border lines of public domain are being shifted around right now, refined, reconditioned and rediscussed. At the same time, the global tendency is that the public domain "the commons", in some cultures is increasingly eroded and privatised, be it through corporatisation of university research or through the biopirating of local resources and knowledge. NGOs may wish to examine how entrenching a new legal status for (parts of) biodiversity under the banner of public domain could add a layer of protection to community resources since protection from misappropriation is clearly needed. Within the context of the TRIPS negotiations, this can be done in various ways. One way would be to add a simple paragraph to Article 27.3 reading as follows: 3. Members may also exclude from patentability: (a.) (b.) (c.) inventions which are essentially derived from biological materials and associated knowledge in the public domain Another way would be to insert it as a conditioner to the requirement to provide protection on plant varieties: 3. Members may also exclude from patentability: a. (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants and animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. This provision shall not apply to plant varieties and associated knowledge which are essentially derived from materials and knowledge in the public domain. The first option has wider implications, as it allows countries to exclude all inventions based on biodiversity and related knowledge in the public domain from patentability. The second only offers that option with regard to the TRIPS requirement for IPR on plant varieties. Either way, no patent law would exclude inventions in the public domain as such. Technically, such inventions are not patentable since they are not novel. But by extending the non- patentability of materials and knowledge in the public domain to inventions clearly derived from them one level up one can try to diminish the space for biopirates to legally operate. It is a matter of raising the entry barrier for IPR, making the system more demanding of innovativeness for the corporate players. Thus it would broaden the unappropriable space called public domain. Further, it would use a concept of "essentially derived" innovation which is already accepted in international IPR law, namely the UPOV Convention of 1991. In the 1991-revised treaty, UPOV introduced the concept of "essentially derived" plant varieties. These cannot get independent titles of plant variety protection. They are too close to previously developed varieties. They are not new enough. But in the world of patent law, novelty comes a lot cheaper these days. If the measuring stick of novelty is going up for breeders in countries that subscribe to UPOV, then they can go up for inventors under patent law too. Rather than spending time trying to revoke patents on biopiracy things claimed "new" in the North but based on long-time realities in the South maybe governments should agree to raise the stakes for innovation and broaden the sphere of what is not patentable to incorporate inventions too close to the public domain for comfort. UPOV can lend a hand in showing how to do this. In the same spirit, India which has a lot of experience fighting against specific patents which have misappropriated Indian innovations is keen to revitalise and formalise the concept of "prior art" in patent law.  The point is essentially the same: to expand the borders surrounding what is recognised as lying in the public domain and hence being unappropriable by IPR. Prior art could include all forms of existing knowledge and raise the standards for when and where novelty is established in a patent application on an invention derived from biodiversity or indigenous knowledge developed in the South. 3.2.4 Impose the CBD context & criteria on TRIPS Proposals to introduce special considerations for biodiversity into the WTO TRIPS Agreement have been sprouting forth since some time. There is an increasing realisation that the promotion of grassroots strategies is central to the conservation and sustainable use of biodiversity. It is also becoming clear that local communities need special rights, incentives and protection, if they are to play any role in stewardship and development of biodiversity within economically viable systems. Both of these considerations are embedded in the legally-binding CBD. Current IPR laws, however, do little in this direction and in most cases undermine the rights of the local people managing biodiversity. Therefore, while some of the "community rights" momentum is being developed with a view to the CBD's need to further articulate and implement its Article 8(j), and in relation to the FAO negotiations on Farmers' Rights, the TRIPS Agreement does offer a direct link to those debates: its very own Article 27.2. TRIPS Article 27.2 allows WTO Members to exclude from patentability those inventions "the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality" (see Annex 3 of this report for the full text of the Article). It further specifies, among other things, that measures to avoid serious prejudice to the environment may form part of this exclusion. Given that genetic erosion and what is increasingly known as "bio-pollution" are direct prejudices to the environment, some link needs to be drawn between incentives to develop new technologies -- such as patents -- and the impact of the deployment of these technologies. Plant breeding and biotechnology (not only for agriculture: for aquatic and forestry systems, environmental management, animal and human health care, etc.) would clearly fall under scrutiny here. The relationship between TRIPS and CBD is gaining prominent attention: Over a range of meetings since 1995, the WTO's Committee on Trade and Environment (CTE) has tried to look at interfaces between the WTO agreements and the CBD, but has yet fallen short of making substantial recommendations. India the developing country most vocal in the TRIPS discussion has recently called on the CTE to reconsider the relation between TRIPS and the CBD, stating that TRIPS should be modified to remove inconsistencies with the CBD.  The WTO's first Ministerial Conference in December 1996 in Singapore already agreed to develop a common appreciation of how TRIPS relates to "the creation of incentives for conservation of biological diversity (...) including protection of knowledge, innovations and practices of indigenous and local communities embodying traditional life-styles relevant to the conservation and sustainable use of biodiversity."  In a meeting with NGOs called by the WTO Secretariat the following May, proposals were made to consider amending TRIPS to take account of the CBD provisions and specifically the needs of local communities who depend on biodiversity and related knowledge. As the report of this meeting states, "Different suggestions were made, including amending the TRIPs Agreement (...) to include precise references to biodiversity and environmental goals."  IUCN, a major player in biodiversity conservation work, launched in 1997 a four-year project aimed at achieving "coherence" and "harmonisation" between the two legal treaties, TRIPS and CBD. The project seeks "to ensure that TRIPS supports rather than limits countries' discretion to create sui generis systems for protecting traditional knowledge and genetic resources."  In this manner, IUCN seems to opt for the extension of IPR -- albeit sui generis -- over both knowledge and biological resource systems in developing countries. Many other NGOs have been calling for the assertion of CBD's precedence over TRIPS. As stated in CBD's Art 16, policies such as intellectual property are supposed to facilitate, not hinder, the achievement of CBD's objectives. Because IPR establishes private monopolies on the flow of genetic resources, TRIPS is seen as a contravention to the CBD. To rectify this, either TRIPS should not interfere with biodiversity or the CBD should have legal authority over TRIPS. The CBD Workshop on Traditional Knowledge and Biodiversity, held November 1997, recommended the establishment of a subsidiary body of the CBD to examine these questions more closely. The timeframe for any clarification or adjustment of the legal relation between CBD and TRIPS is, to some extent, affected by the 1999 Review of TRIPS. If during that year, the obligation to allow for the appropriation of biodiversity under TRIPS is unchanged or enhanced, it will be more difficult for CBD to assert conservation criteria over trade. 3.2.5 Impose human rights on TRIPS The TRIPS Agreement falls right through the human rights grill on at least one conspicuous account. It allows for the patenting of human beings by not excluding this field of "invention". This is not a far-fetched charge. Technologies to alter the genetic makeup of humans are being researched, developed and applied under the guise of medical research. These technologies are being patented -- in the form of DNA sequences, isolated cells, modified genetic constructs, techniques of gene transfer and so on. The world was recently rocked by aggressive statements from US scientist Dr. Richard Seed, who announced his intention to clone humans.  His purpose? To help infertile couples overcome reproductive barriers. Will he try to patent such a recipe? Of course, and TRIPS -- as US patent law -- is perfectly permissive of this. Could a patent on human cloning extend to the human being? Certainly. TRIPS violates not only human rights, by failing to exclude human beings from the field of patentable inventions, but ethics and morality. For many cultures, life and creation are sacred. This would mean they should not be subject to trade regimes and patent law. Some NGOs are arguing that Article 27.2 should be amended to expand the provision related to "ordre public or morality" to ensure that it can encompass whole groups of patents, such as patents on life forms as a class.  Currently, the TRIPS provision on ordre public and morality can only be invoked on a case-by-case basis, subject to "necessity" it is not the patent or the invention that must be afoul of morality for the TRIPS exclusion to be applicable, but its commercial exploitation. Although a lot depends on how this article will be interpreted, rewording this provision to exempt patents on life would probably require lifting the "necessity" clause as well. That might be as tough a battle as expanding the exemptions, or sui generis space, under 27.3(b). The TRIPS Agreement in full and hence Article 27.2 is not scheduled for review until the year 2000. Any blockage on the 1999 Review of Article 27.3(b) could reverberate negatively on this built-in schedule. One strategy could be to argue for the revision of both articles 27.2 and 27.3 together, as they are both clearly interconnected. Another approach would be to raise the issue of TRIPS and genetic technologies at the 50th anniversary of the Universal Declaration of Human Rights in December 1998. 3.3 THE FIGHT OUTSIDE WTO  Society's challenge to the TRIPS Agreement's provisions affecting food security and the rights of peasant and other communities will not be articulated within the confines of the WTO alone. TRIPS embodies a much more pervasive problem: the privatisation of genetic resources and knowledge systems by a small number of powerful economic actors. NGOs who are giving voice to social resistance and protest against this trend have singled out at least five avenues for action outside of WTO: The EU Directive Europe is still debating a draft directive on patenting of biotechnology inventions. Europe's law currently forbids patenting of plant and animal varieties. The directive, which was first drafted in 1988, would subvert this tradition. The European Parliament has been putting up a strong fight to stop (as in March 1995) or water down the directive, but pressure from the transnational corporations has been unprecedented. In May 1998, the Parliament will hold its perhaps final reading of the text. Government and non government forces have been trying to limit the negative impact of the directive, particularly through a so-called biopiracy clause. This would demand full disclosure of a country of origin's consent to transfer of genetic material in any application for a patent related to biological resources from developing countries. Whatever happens to the EU directive will have automatic bearing on the TRIPS Review. Sui generis rights under CBD? For many social groups, sui generis rights -- which are not IPR -- should best be developed in the context of the Convention on Biodiversity, not the international trade system. This is because the premises of the CBD lie on a recognition of the role of local communities and their contribution to sustainable development. The WTO's agenda, on the contrary, is secure maximum benefits to already strong commercial powers. The Conference of the Parties (COP) to CBD had to refine its understanding, and implementation, of Art 8j and 16.5 in particular. Also, governments are translating CBD into national programmes and policies. If these provisions are to be true to a sustainable development agenda, they should express community rights to share and nurture biodiversity under local terms, not entrench monopolies. On the other hand, those who favour IPR on biodiversity and local knowledge will certainly use a sui generis banner to introduce new systems of monopoly rights for local communities in both CBD and TRIPS. Will the CBD prevail over TRIPS or capitulate to trade agendas? The Fourth COP in May 1998 will be a next stage in these discussions. Strong Farmers' Rights? The negotiations on Farmers' Rights in the FAO confront the essence of TRIPS. While the FAO Undertaking on plant genetic resources (of which Farmers' Rights is a part) is not legally binding at the moment, most countries seem to agree that the current renegotiation of the text should, in the end, lead to a binding protocol to the Biodiversity Convention a sort of "agricultural charter" within the Convention. The negotiations on Farmers' Rights run the same risks as the ones on the CBD's Article 8(j). OECD countries do their best to cut any substance out of it, and leave it as a nice but empty declaration of principles. Most developing countries especially the African bloc are fighting hard to construct Farmers' Rights in a way that goes beyond the commitments in the Biodiversity Convention. In the negotiating draft of the FAO Undertaking, the bracketed text commits countries to promote and protect the collective knowledge and resources of farmers, and to set up sui generis systems at the national and international levels to do so. It also commits countries to let farming communities fully participate not only in the implementation but also in the definition of Farmers' Rights. A strong agreement on Farmers Rights within a legally binding IU is an important objective for many farmers organisations, as the position of Via Campesina attests (see Annex 6). Expose the bioprofiteers For many groups and agencies, including local governments, it is a priority to have a clear handle on the kind of activities that TRIPS serves as an incentive to. There is no better proof of the ill effects of TRIPS than the misdirected activities of research outfits, biotechnology companies and unscrupulous academics. Monitoring and exposing biopiracy is difficult but necessary to validate what is going on at the local level. State governments in Brazil are doing this  as are NGO coalitions there and elsewhere. Under scrutiny is a whole range of R&D initiatives from the Foundation on Ethnobiology to Shaman passing through UNCTAD's Biotrade Initiative, as local groups suspect them of deception and unjust profiteering from local biodiversity and knowledge. Even the Green Revolution research system is getting caught in the fray. The International Crops Research Institute for the Semi- Arid Tropics, an agency of the Consultative Group on International Agricultural Research based in Hyderabad, India, is siding with NGOs to act against Australians charged with biopiracy of chickpeas accessed through ICRISAT.  An Australian seed company claimed plant variety protection on the material, which originated in India and Iran, precisely as TRIPS allows. Documentation of these and other cases is essential to support community demands for counteraction. Direct protest A growing number of local communities and their support groups are expressing their opposition to biotechnology and intellectual property rights on biodiversity and indigenous knowledge through moratoria. The moratoria can mean that access to genetic resources, or bioprospecting, is physically prohibited. (They can also extend to physical protest against field trials of transgenic materials, as practised in Europe.) Moratoria on access to biodiversity is direct implementation of the CBD's underbelly, or what can be dubbed "prior informed dissent". Communities that see their rights to control biodiversity sold off through the Convention or through TRIPS will obviously stop cooperating with the scientific and business communities and they will find a lot of sympathy in the general public. The challenge imposed by TRIPS on social groups will obviously be taken up both inside and outside the WTO, and both inside and outside the contours of parliamentary debate. The legal cards are stacked against farmers and local communities. But spreading awareness about the biased terms of biodiversity trade and the immoral corner that TRIPS is driving our societies into could help turn that stack upside down. Notes:  According to Carlos Correa, "Once a country has increased its level of protection of IPRs during the transitional periods [built into TRIPS], it may be blocked to go back and diminish the protection by the 'freezing' clause contained in Article 65.5 of the TRIPs." Cited in SUNS #4068, Third World Network, 6 October 1997.  Resolution of the SADC Natural Resource Management Biennial Conference, Victoria Falls, Zimbabwe, 25-29 August 1997.  Third World Network, "Biodiversity Related Community Intellectual Rights", in Vandana Shiva et al., The Enclosure and Recovery of the Commons, Research Foundation for Science, Technology and Ecology, New Delhi, 1997, p. 164.  Ibid.  The current draft of Thailand's Plant Protection Bill -- not Plant Variety Protection Bill -- has four criteria for eligibility: novelty, originality, distinguishability and stability. UPOV's criterion of uniformity is not being used. See Supara Janchitfah, "Patenting Mother Nature Provokes Outrage" in The Bangkok Post, 4 January 1998.  "Thailand's Community Forest Bill completes public hearings" and Premrudee Daoroung, "Community forests in Lao PDR: the new era of participation?" both in Watershed, Vol. 3, No. 1, July- October 1997, Towards Ecological Recovery and Regional Alliance (TERRA), Bangkok. [7 ] ConstituiçÃ£o da República Federativa do Brasil, Título VIII, Capítulo VI, Art. 225.Â§1Âº.II.  Germán Sarmiento, "The New Constitution of Colombia: Environmental and Indigenous Peoples' Issues" in Widening Perspectives on Biodiversity, Anatole Krattinger et al. (eds), IUCN/IAE, Geneva, 1994.  See Carlos Correa, "TRIPS and the protection of community rights", further in this report, who argues that IPRs do not necessarily involve exclusive rights.  According to some lawyers, the non backsliding clause of TRIPS Art 65 does not apply to Art 27.3(b).  Bijoy Basant Patro, "India: Bio-Piracy Campaign Exposes Holes in U.S Patent Laws", IPS, New Delhi, 4 September 1997.  Chakravarty Raghavan, "Change TRIPS to reconcile with CBD, says India", SUNS 4064, Third World Network, 30 September 1997.  Cited in ibid.  WTO, Press/TE 019, WTO Symposium on Trade, Environment and Sustainable Development, July 1997.  "Harmonising the Biodiversity Convention and the WTO", in Bridges, Vol. 1, No. 6, ICTSD, Geneva, December 1997. For further information, contact IUCN at [email protected]  "US: Scientist announces plan to clone humans", IPR Bulletin, Vol. 7, No. 1, Institute for Agriculture and Trade Policy, 20 January 1998.  Rural Advancement Foundation International, "Proposal to Overturn GATT TRIPS", undated, circa September 1997.  This section tries to reflect ideas generated at the BIOTHAI / GRAIN international seminar on sui generis rights, Bangkok, 1-6 December 1997.  See the report of the Amazonian Biopiracy Commission, 18 November 1997.  "Recent Australian Claims to Indian and Iranian Chickpea Countered by NGOs and ICRISAT", RAFI Press Release, 6 January 1998.