Robert Lettington and Mita Manek

In 1999 WTO Member States will convene to open the mandated review of Article 27(3)(b) of the Uruguay Round Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs). This sub-clause controls what is currently one of the most controversial areas of both the environmental/international trade and North/South debates--the patenting of life forms. The most popular images of this field are those such as the Rosslyn Institute’s "Dolly the Sheep" and the deep ethical questions that such innovations raise about the practice of cloning. Occasionally hitting the headlines are other stories involving remote indigenous communities whose ethno-botanical knowledge, and sometimes even their actual genetic material, are being taken and commercialized by large, demonized, trans-national corporations (TNCs). These are all critical issues but behind them are the less media friendly questions that are of far greater immediate importance to the Developing World, those of basic food security, medicine, and a straightforward fair return for a resource that is provided. Just as with the Industrial Revolution the magical leap that has been made in the Developed World, and that may prove to be the "Genetic Revolution", owes much of it’s existence to the raw materials, and to some degree the markets, of the Developing World. This seemingly cyclical turn of events has led to the coining of the term "Bio-Colonialism".

In 1992, in an attempt to maximize the benefits of the emerging Genetic Revolution for all mankind, the World queued up to sign the Convention on Biological Diversity (CBD). Its aim was to encourage the development of innovations relating to biodiversity, but in a manner that would ensure their availability to all and that would preserve biological resources for posterity. The CBD has been often criticized for its ambiguities, "‘impressively opaque’ in the words of The Economist".¹ In many other legal documents this is considered to be a fundamental asset that allows for organic development in implementation, the United States Constitution being the classic example. TRIPs, on the other hand, is generally a very specific document. It claims to be a set of minimum standards but while it states that "(m)embers may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement"² it also states "provided that such protection does not contravene the provisions of this Agreement".³ This prevents the use of more than minimal alterations to the protections afforded by TRIPs, e.g. the much debated concept of communally held patents is almost ⁴ definitely precluded by Articles 27 to 38 of TRIPs which consistently only allow for individuals as the holders of patent rights.⁵ Certainly attempts to expand on the interpretations of patent rights would be tempting the fate of the WTO Dispute Settlement Board. The one exception to this rule in TRIPs is Article 27(3)(b). It has become famous, naturally through controversy, due to its ambiguities and when one combines this fact with its subject matter it would appear to be the logical link to the CBD. As one sub-clause out of seventy-three articles it may seem insignificant but for the Developing World’s concerns over food security and medicine it could well be Pandora’s one spirit of hope in a world of troubles.

This paper is intended to provide a framework for the environmental issues enmeshed within TRIPS Article 27(3)(b), to facilitate debate, assist in the identification of problems and stimulate the formulation of ideas and policies to address such. It is not intended to provide the definitive analysis of each issue approached but to lay out the basic facts and debates that will hopefully chart a course for researchers and policy makers to pursue. Accordingly the paper will first proceed to examine issues related to pharmaceuticals. This will be followed by a discussion of the debates over agriculture, in particular as it relates to food security in the Developing World and finally will turn to indigenous and traditional knowledge. In conclusion there will be an emphasis on why it is imperative to be prepared for all the implications that the renegotiation of Article 27(3)(b) encompasses.

The pharmaceutical industry is considered to be one of the U.S.’ most internationally competitive industries, where the sale of pharmaceuticals based on traditional medicines alone have been estimated to amount to more than $32 billion annually.⁶ Health is obviously a fundamental human need. Pharmaceuticals to improve, or often maintain, this health are an extremely expensive, and time-consuming, product to develop but generally very cheap to imitate and/or replicate. Those who operate in this area expect to recoup these investments from a premium on the sale of the commercial product. The difficulty here is obvious in that the majority of the World cannot afford these premiums and thus must wait for the expiry of a patent’s twenty-year monopoly before they can be cured.

Article 27 (2) of TRIPs allows the exclusion from "patentability inventions, the prevention of which is necessary to protect ordre public ... including to protect human, animal or plant life or health. ..." The clause could feasibly be used to prevent the patenting of pharmaceuticals by any state that decides to enact such a law. The difficulty is with how far one can go to preserve life or health, as the Argentineans found to their cost when they refused to grant patents for pharmaceuticals.⁷

India has also been forced into dropping its exclusion of pharmaceuticals from patenting and the result both there, and in Argentina, is a dramatic raising of prices along with an equally dramatic squeezing of domestic pharmaceutical firms. Often quoted in opposition to these phenomena is the fact that the bulk, and arguably all, of the World Health Organization’s list of essential drugs are no longer covered by patent protection and can thus be produced generically. This is certainly true but as the World constantly experiences with diseases such as Ebola and AIDS ⁸ it is the new diseases that can often prove the most devastating and these require state of the art drugs. Malaria is another interesting example in that its long history of adaptability to any drug that is created means that by the time a patent expires the drug is only of limited utility. From the TRIPs perspective the fundamental question is one that is also fundamental to intellectual property protection as a whole. This revolves around two basic points. The first is made by the industry lobby and says that without intellectual property protection industry will not provide the investments required to develop new drugs and thus human health will, overall, suffer. The opposite argument is that there is no evidence for this and that investment and protection are not tied. By seeking extended protection industry is simply seeking to maximize its profits in a manner that distorts the market and limits its size. This is an area that needs much clarification, currently it seems to be something of a chicken and the egg situation. Is it intellectual property protection that stimulates the industry or is it the industry that pushes for intellectual property protection. Historically it is clear that the latter is the case, Switzerland in the nineteenth century being the classic example. However, in this globalized, highly competitive, world it is no longer so obvious.

The CBD enters the arena principally through the questions of benefit sharing and local adaptability since the bulk of the raw materials for the pharmaceutical industry are derived from the Developing World but tend to be processed and developed in the Developed World. The resolution of these questions is largely in the hands of the developing countries. To take advantage of the CBD’s mechanisms a state must put legislation in place that enacts these mechanisms. For a state to invoke the CBD in claiming that it has been unfairly treated is a sham unless it has taken the initiative to develop its regime. Adaptability is the issue that many feel the pharmaceutical industry is unduly oriented towards the interests of the Developed World and that the Developing World simply makes use of what happens, by coincidence, to be applicable and affordable. This is again something that is largely in the hands of the developing countries. There is a need to use the CBD to tie the provision of raw materials to research that is of use to the country of origin. The legislation that can achieve such objectives must be produced in the developing world. When the debate begins over whether it can be fitted into the World Trade Organization regime, which it surely will, the developing world must coordinate and ensure that its views are represented, rather than being manipulated by the carrot and the stick of aid and trade sanctions.

The area of crop variety development should not be underestimated, its significance to all economies is enormous and it shows great promise for growth. It is estimated that foreign genetic resources have added $3.2 billion to the $11 billion annual U.S. soybean crop and about $7 billion to the $18 billion annual corn crop.⁹ This is quite apart from the fact that all of the top 15 crops in the U.S., with annual sales of $50 billion, originally come from foreign sources.¹⁰ The other point that is conclusive is that the bulk of the genetic inputs that create these dramatic advances originate in Developing Countries.¹¹ However, the countries of origin have traditionally derived little benefit from the richness of their biodiversity. There have been isolated instances of countries treating genetic resources as protected interests,¹² but in general the rule has been that they should be an "unregulated and freely accessible good".¹³ The CBD introduces the concept of national sovereignty over genetic resources ¹⁴ and thus constitutes a marked break with custom and practice in the field.¹⁵ National sovereignty, and thus the heart of the CBD’s access regime, is embodied in Article 15.¹⁶ The regime itself is not laid out, rather there are a set of guidelines and a requirement for the enactment of national legislation that fits them. The surprise fact is that a mere handful of countries have taken advantage of this change of canons and thus begun to realize the value of the assets they possess. This handful includes the Philippines, the Andean Pact countries, India and Malaysia and most of this action has only occurred within the last few years. Countries such as Eritrea have also included skeletal provisions in general biodiversity legislation. The final stage of negotiations for the CBD took place in Nairobi in 1992 ¹⁷ but to date the Kenyan government has not enacted any form of implementing legislation, although initiatives are underway.¹⁸

The development of an international framework for access to genetic resource regimes directly addresses the debate over the question of agricultural resources and food security. The main element of this, however, is not the question of reasonable compensation for the use of the Developing World’s resources but rather the more immediate question of making sure that everyone has their nutritional needs met.¹⁹ The two basic points are as follows. On the one side is what might be described as the "pro-biotechnology" camp. Their position is that since there is widespread malnutrition in many areas of the globe then ipso facto there is not enough food to go around. With the rapid growth of the World’s population not likely to slow down in the near future and a seemingly equally inevitable degradation of suitable arable land ²⁰ we must therefore look to maximize the output of the arable land that is currently in use. This camp is not, however, united. There are those who advocate the pioneering of genetically engineered crops as the hope for the future, those who support the more traditional green revolution practices such as hybridization and finally those who see a blend of the two. The other camp, which could be thought of as "pro-governance", looks to the fact that when one considers the World’s total output of food in comparison to its total population there should not actually be problem. On top of this is the fact that much arable land is underutilized or needlessly degraded. Their arguments vary in extremes, much as with the pro-biotechnology camp. Some advocate the severe limitation of things such as livestock production due to its inefficient use of resources ²¹ while others suggest that states should be more actively encouraged to act responsibly in regard to the resources at their disposal. This could be the facilitation of transporting over-production from the developed countries or more effective management and logistical practices in the developing countries. As with most things in life it would seem to be that a judicious mix of the two camps is the most likely way forward, one cannot ‘un-invent’ the wheel but one can make sure that it turns safely.

The involvement of TRIPs and the CBD in this debate is quite deep. TRIPs is seen as the tool of the pro-biotechnology camp while the CBD is seen to be that of the pro-governance camp. However, such points of view fail to take account of the fact that while the CBD pushes benefit sharing,²² technology transfer ²³ and community rights ²⁴ it also specifically advocates the sustainable use of biological resources ²⁵ and the development of related technologies.²⁶ On the other hand TRIPs, while very strictly protecting innovations in certain areas, does allow for the exclusion of life forms from patenting ²⁷ and for compulsory licensing.²⁸ Every one of these has proven to be a highly contentious issue, often creating deep north-south divides. Despite this synergies can easily be found between the CBD and TRIPs in the area of food security and agricultural production generally.

The "authority to determine access to genetic resources rests with national governments and is subject to national legislation".²⁹ Article 15 (1) of the CBD is arguably the most significant element of the access to genetic resources regime. As has been noted earlier this constitutes a major shift in international policy regarding biological resources. However, there is no reference to questions of property rights.³⁰ The effect is that a state now explicitly has the right to regulate the regimes which govern its biological resources but must further iterate its policies regarding individual rights, or the lack thereof. On the other hand TRIPs regulates the ownership of resources at the individual level. While TRIPs’ approach undoubtedly has implications for national policies it does not necessarily directly impinge upon them. The only way in which it could be construed to have such an effect, at least for Developing Countries and Least Developed Countries,³¹ is if a country fails to take any initiative under the options contained within Article 27(3)(b). Plant varieties are explicitly dealt with in Article 27(3)(b) where a country has the option to either provide patent protection or an "effective sui generis" system. This is not defined and thus provides wide latitude. Failure to make use of its sui generis option under Article 27(3)(b), almost by default, forces a state to sign up to the UPOV Convention, much as Kenya and Zimbabwe are having to consider doing at the present time,³² when it nears its TRIPs compliance deadline. A country may decide that UPOV is not a bad option but the loss of independence implicit in the whole idea of being forced to make the decision in a hurry and take the consequences as they come should be enough to worry any policy maker.

The areas of potential conflict between TRIPs and the CBD as regards agriculture are seen to exist in both a broad and narrow nature. The largest concern is that of the promotion of genetic uniformity among the World’s principal food crops. This arises whether one is looking at plant varieties being patented or protected by the most commonly referred to sui generis system, UPOV. The theory is that the UPOV system, and possibly any other ‘effective’ system, must, in order to function have a clear method for defining what is protected. Thus UPOV has its distinct, uniform and stable (DUS) criteria.³³ The difficulty with these criteria is that they are seen to favour the production and use of genetically uniform crops. If one must produce a variety that conforms to the DSU standard to have it protected then logically one is not going to invest in the development of a variety that is highly adaptable and variable as this will preclude one’s monopoly which will in turn lessen one’s investment return. The range of varieties is also limited in that the restriction of use of ‘essentially derived’ varieties ³⁴ means that investment is not worthwhile on any variety that will not clearly escape this label. To produce a variety that fits such a requirement will take great investment and thus one will focus on a few easily distinguishable, profitable, varieties. The result of this is an excessive dependence upon a few basic types unless a very reliable return can be identified. It is not hard to see the disadvantage in such practice. Dependence upon a narrowed genetic base creates an innate vulnerability to any new, or previously harmless, disease or pest. This vulnerability has been proven not to be a myth in places such as the American mid-west and South East Asia with dramatic losses in wheat and rice crops respectively. These cases are the extreme examples of why the preservation of biological diversity is so fundamental among the canons of the CBD.

One of the more widely, and hotly, debated clauses of the CBD is Article 8(j) which recognizes the value of indigenous and local knowledge and the rights of its holders. The principal difficulty with this is that such knowledge is not something that falls within the parameters of existing intellectual property protection. TRIPs was largely built upon the existing needs and practices of the Developed World and thus it consistently considers the rights of individuals, whether natural or legal, and nowhere does it recognize the customs and needs of traditional and indigenous communities for whom ownership of knowledge is either a more complex, or a more abstract, concept. There are range of issues within this field but chief among them is the question of communal rights. This must be clearly delineated from the concept of ‘common’ rights which is the idea of ‘common heritage of mankind’. Communal rights are rights that exist within a particular group allowing them to exclude others from those rights. The CBD does little more than recognize these rights and thus discussion here will focus upon the issues within TRIPs.

As has been mentioned earlier TRIPs allows for more extensive protection than that provided for in the agreement ³⁵ but the implementation of such protections could be an extremely contentious move. Further, TRIPs exclusively considers the patent rights of individuals and not those that might be communally held, whether by local communities or a nation as a whole. This is the origin of difficulties such as the W.R. Grace patent issued for Neem derivatives. As long as one can produce a sufficiently novel step to take a product away from its traditional origins, which can often simply consist of processing and purification for commercialization, one can protect the product against all. This includes the providers of the knowledge that created the product in the first place. In some instances it has even been claimed that the imposition of protection could restrict the traditional and indigenous communities’ customary practice. However, TRIPs favours large-scale commercial concerns over the rights of indigenous and local communities in more ways than this.

In Article 29 (1) it is required that a patent applicant reveal sufficient information regarding the invention that a person "skilled in the art" would be able to produce the product or complete the process. Such a clause is standard throughout Developed World intellectual property legislation. This requirement creates problems in that many elements of traditional knowledge are bound up with ceremonial events or are held in sacred trust and thus protection cannot be sought without violating some basic principle of the peoples involved. This choice between protection of one’s rights and maintenance of one’s principles would seem to be a case of being "stuck between the devil and the deep blue sea".

Article 27 provides both further restrictions on patentability in various areas and the one clause that could be used to create greater flexibility. Article 27 (1) of TRIPs states that:

patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.

The "inventive step" and "capable of industrial application" requirements are deemed "to be synonymous with the terms ‘non-obvious’ and ‘useful’ respectively." These terms are once again standard in Developed World intellectual property legislation. The effect of this is that the developed countries have already extensively litigated a large range of questions related to these terms and thus very specifically defined them. On the other hand most developing countries have barely, if at all, written their intellectual property legislation ³⁶ and have certainly not advanced far with defining the exact meaning of many terms. The tendency in such a situation is for the definitions provided by the Developed World to remain dominant for want of any alternative. This kind of situation means that LDC conditions are not adequately catered for. Traditional knowledge once again provides a good example, it will probably be declared unpatentable on one, or all, of the "new", "inventive step" and "industrial application" standards.

It is Article 27 (3) of TRIPs that contains the best options for creating a more flexible, Developing World friendly, system of IPRs. However, due to the fact sub-paragraph (b) is due for review in mid 1999 it also constitutes the greatest potential area of conflict. Sub-paragraph (a) is the simpler of the two sub-paragraphs in that it allows for the exclusion of "diagnostic, therapeutic and surgical methods for the treatment of humans or animals". This derives from the humanitarian idea that it is unethical to restrict such fundamental aids to health and survival. However, what is often overlooked is what is not covered here. It is methods that may be excluded and any hard technology ³⁷ is still required to be subject to protection. This effectively guts the value of Article 27(3) (a) as regards many methods since knowledge of the method is useless without knowledge of the accompanying hard technology. This is a particularly controversial area with many developing countries traditionally allowing the exclusion of things such as pharmaceuticals from intellectual property protection, as mentioned earlier under Article 27 (2). Despite being a much debated area the countries concerned are not likely to be able to continue with this tradition, particularly after the recent success of the United States in forcing India, among others, to adopt intellectual property protection for pharmaceuticals. This affects things such as traditional knowledge as while a state may exclude the method that is used to employ something such as a traditional medicine, thus preventing its privatization, they cannot do the same for the actual medicine. Once the relationship between a particular compound and an ailment is known, which will be easy to do since if excluded the method will be in the public domain, a research-oriented company could protect a derivative product against the world. The result of this somewhat paradoxical situation is that a state is unlikely to want to exclude traditional methodology from protection since by doing so it will simply be providing signposts to compounds that may be subsequently protected against the people who facilitated their discovery in the first place. The same sort of risks are also going to be involved with agricultural products. Ultimately all such information is likely to become more restricted and thus less available to those with limited means.

Sub-paragraph (b) of Article 27 (3) represents a compromise between the interests of the Developed and Developing worlds. Its main function is to allow for the prevention of the patenting of life, whether plant or animal. The Developed World has predictably declined to make use of this exception and, led by Europe and the United States, has made moves to explicitly allow for the protection of life forms. On the other hand the Developing World, with it’s limited or non-existent research capacity in the area of cutting edge biotechnology, has generally preferred not to provide any protection for life-forms. This means that both methods and products can be kept freely, and more importantly cheaply, available. Like most compromises Article 27(3)(b) is also at the heart of the controversy surrounding TRIPs. It has been argued that the sub-clause’s requirement for the protection of plant varieties by either patent, a sui generis system or a combination of the two simply allows for legal monopolies of what were traditionally common resources. While this may not be a beneficial change it seems that it is one the world must learn to live with. If taken in this light Article 27(3)(b) potentially provides a useful avenue for the defence of much knowledge. The sub-clause does not expand upon the nature of a sui generis system and thus, so long as some form of protection is provided, one could shape a system in almost any way that one wished. For instance there is no reason why one could not allow for the protection of community resources and knowledge that do not fulfill the requirements of the patent system. There is also no real reason why one could not provide protection through negative rights such as a blanket prohibition on the patenting of endemic resources. The argument for this would simply be that one is protecting the rights of a wider group of people. There would, however, be a fight over this as the Developed World will surely argue that it does not constitute an effective sui generis system. While such a broad approach to Article 27(3)(b) seems to be quite permissible the difficulties are twofold. First is the fact that states interested in pursuing such an approach will have to resist tremendous pressure not to. The second is that the sub-clause is due for review in mid-1999. Tension is already building over the polar positions of wanting to abandon Article 27(3)(b) altogether or dramatically expanding it’s scope. Neither of these positions is widely held but what is being put forward is that the sub-clause must be maintained to allow states to take advantage of options such as those discussed above.

Within TRIPs itself there is a section that deserves examination as a possible foundation for a sui generis regime: Section 7 Article 39, Protection of Undisclosed Information. In common parlance this is known as trade secrets protection. A trade secret is not a precisely definable asset. It could be information that does not meet the requirements for patent protection or it could be that the holder of such information simply does not want to publicly reveal his knowledge. It is in this flexibility that the potential use of trade secret law to protect biotechnological knowledge lies. Article 39 (1) lays down the requirement that a trade secret be protected but it is in clause (2) that the real protection is specified:

2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices [(NB)] so long as such information:

• is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;
• has commercial value because it is secret; and
• has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.

[(NB)] For the purpose of this provision "a manner contrary to honest commercial practices" shall mean at least practices such as breach of contract, breach of confidence and inducement to breach, and includes the acquisition of undisclosed information by third parties who knew, or were grossly negligent in failing to know, that such practices were involved in the acquisition.

This area has great potential. A major feature is that the secret is protected for an indefinite term thus allowing it to be kept as part of a community’s heritage, a benefit that cannot be afforded by mechanisms such as patent protection. The main benefit of trade secret protection, however, is that no explicit effort is needed to protect the knowledge beyond "reasonable steps under the circumstances ... to keep it secret." Thus the burden of registration and it’s associated requirements for the proving of a process or product are removed. However, there are problems with this. One is that there is some dispute over whether "the person lawfully in control of the information" could be construed as consisting of a group rather than an individual. This is obviously not difficult if a shaman or similar individual is in sole possession of the information but if the information is held community wide, or nationally, it could become a little more awkward. It may be possible to avoid this by claiming that a chief, medicine man, government official or similar individual is the holder of the trade secret and has chosen to reveal it to those members of his immediate community on the understanding that it is a secret. Trade secret law does not preclude the revealing of information, merely its general dissemination. Of course this means that any community must not publicly disseminate the information it possesses. This could be hard to achieve in communities whose tradition is to allow free access to their knowledge. Some redefinition of ‘dissemination’ is clearly required but since one is advocating the use of trade secret law as a base to build upon, rather than as a wholesale transplant, this should not be difficult.

Another difficulty is that one must establish that the secret protected has commercial value and that such value exists because it is kept protected. This has been put forward as constituting a major stumbling block but if one approaches it from the view of the community concerned, the logical view, it should not be problematic. Even if the knowledge and/or resource is not charged for one could argue that it has commercial value for its users in the sense that it removes the necessity to purchase a replacement from outside. Also if it is used in any form of barter system within the community, or in relations with outsiders, then it is clearly part of a traditional commercial system. The value could be said to exist due to secrecy very easily if it is part of a barter system. However, even within the community it could be said to exist as if it was not secret it could be commercialized to the detriment of the community by outsiders thus resulting in a net loss to the community.

The final problem with trade secret protection is its limited nature. The secret itself is not protected, the law actually constitutes a prohibition on discovering the secret from the holder or someone he has passed it to on the basis that it is a secret. Once the secret is in the public domain or is discovered independently the protection ceases. This leaves a large hole for "bio-piracy" or even genuine revealing of the secret. It also means that a community could be vulnerable due to its lack of detailed knowledge of the situation. They may reveal the information in all innocence and thus destroy their own rights or they may be taken advantage of by a more sophisticated outsider.

What is clear is that trade secret law definitely provides an opportunity for effective protection of knowledge regarding particular resources and it’s inclusion in TRIPs means that WTO member states cannot afford to ignore it. At the same time for trade secret law to be truly effective in this role it must be adapted in areas such as what is actually protected. If it could be expanded to protect the actual secret rather than constituting a prohibition on unfair discovery, basically moved away from unfair competition law towards a variety of human rights based patent law, it could provide the ideal solution.

The main reason that Africa needs to be aware of the issues involved with TRIPS Article 27(3)(b) and its renegotiation is the consequences that await should it not develop a strong position to defend its interests. If TRIPS is altered in a manner that does not serve African interests and countries then cease to observe it rigorously they will open themselves to the possibility of a dispute settlement action under the WTO Understanding On Rules And Procedures Governing The Settlement Of Disputes. India, for example has already been found to be in breach of TRIPs by a panel established under that Understanding.³⁸ There is every reason to think that the US especially will make the enforcement of TRIPs obligations a priority. The history of the U.S. 1988 "Special Section 301" provision ³⁹ of the 1974 Trade Act ⁴⁰ (Special 301) is instructive in this regard.

The United States is quite famous for its various attempts, often successful, to impose its jurisdiction extra-territorially and Special 301 is a classic example. The aim is to provide added protection for U.S. IPR owners in foreign markets.⁴¹ The U.S. Trade Representative (USTR) is required to identify those countries which fail to maintain and enforce adequate IPR protection or that do not provide ‘adequate and equitable market access for U.S. IPR owners’.⁴² The most extreme offenders are then listed as "priority foreign countries."⁴³ The definitions are quite broad, and thus extremely powerful:

• if the foreign country denied adequate and effective means under the laws of the foreign country for persons who are not citizens or nationals of such foreign country to secure, exercise, and enforce rights relating to patents, process patents, registered trademarks, copyrights and mask works.⁴⁴

Much the same holds true for the definition of denial of fair and equitable market access:

• if the foreign country effectively denies access to a market for a product protected by a copyright or related right, patent, trademark, mask work, trade secret, or plant breeder’s right, through the use of laws, procedures, practices, or regulations which:
1. violate provisions of international law or international agreements to which both the United States and the foreign country are parties, or
2. constitute discriminatory nontariff trade barriers.⁴⁵

The implications do not stop here though. Developing countries generally have an exemption from TRIPS compliance until the year 2000 but this is not enough to protect them from listing as a Special 301 Priority Country.⁴⁶ In one of the most extreme amendments to Special 301 the USTR has the power to list a country as Priority even if it is in compliance with its obligations under TRIPS.⁴⁷

The actual process of a Special 301 investigation is initiated by any interested party ⁴⁸ by filing a petition with the USTR in response to a foreign country’s act, policy or practice that adversely affects the petitioner. The USTR then has a maximum of forty-five days within which to commence an investigation, the exception being if the USTR believes that an investigation would be detrimental to U.S. economic interests and reports such to Congress.⁴⁹ Thus proceedings very quickly reach the highest levels of authority in the U.S. Government. Along with this rapid initiation process there is a short time limit for action, the USTR must complete investigations within six months, nine if the case is a complex one.⁵⁰ Upon the completion of an investigation that results in unsatisfactory findings negotiations will be undertaken by the USTR to resolve the dispute. If there is no settlement at this point sanctions may be imposed ranging from withdrawal of benefits under existing trade agreements to imposition of punitive duties or import restrictions.⁵¹

This is clearly an extreme piece of legislation but it should not be underestimated because of that fact, the U.S. has been happy to use Special 301, or the threat of it, on a number of occasions. In three cases sanctions have actually been imposed while there are a variety of other cases that have either been settled or are under negotiation.⁵² The most famous of the cases involving sanctions was that of 1997 where Argentina lost fifty percent of its benefits under the Generalized System of Preferences because of its failure to provide patent protection for pharmaceutical products.⁵³

There are a variety of designations at a less extreme point than priority foreign country and the 1997 listings serve as an example of how wide ranging the USTR’s interest is:⁵⁴

Africa is conspicuously absent from this list but that should not provide much reassurance when one examines just how wide ranging the list is.

Special Section 301 is a very good example but is not the only punitive measure provided for in U.S. law and the U.S. is not the only state capable of considering such measures. The lesson is that if Africa does not keep up with the pace of international intellectual property law, and push its common interests forward in that realm, it risks slipping even further behind in the technological race while also exposing itself to extremely damaging trade disputes.

1 ‘The Earth Conference: Biodivisive’, The Economist, June 13, 1992, at 93. Quoted in Gerald J. Mossinghoff, ‘The Biodiversity Convention and Intellectual Property Rights: Conflict or Harmony?’, Patent World #106, October, 1998, at 2.

2 Uruguay Round Agreement on Trade-Related Aspects of Intellectual Property Rights (1994), Article I(1).

3 Id.

4 I say "almost" as one could try to make use of concepts such as corporate identity in this area.

5 Uruguay Round Agreement on Trade-Related Aspects of Intellectual Property Rights (1994), Section 5, Articles 27 - 38.

6 RAFI, 1994; Mugabe et al., 1996.

7 Bhala and Kennedy, 1998 at 1175.

8 How many Developing Countries can afford the USD16,000 - 20,000 per annum connected with the current treatments for AIDS?

9 CR-140 Cong. Rec. s14046-01. (Westlaw) Letter from Archer Daniels Midland Co. to Congress urging ratification of the CBD.

10 UNEP, 1992 - quoted in: BIOPOLICY INTERNATIONAL 17- MANAGING ACCESS TO GENETIC RESOURCES at 1 (John Mugabe et al., 1996).

11 GLOBAL BIODIVERSITY ASSESSMENT (V.H. Heywood ed., 1995)

12 The case of the 19^th century Chines prohibition of the export of silkworm larvae is a classic example. ACCESS TO GENETIC RESOURCES - STRATEGIES FOR SHARING BENEFITS, 7 (John Mugabe et al. eds., 1997). There is also Thomas Jefferson’s rather famous smuggling of protected rice samples from Italy to America in the 18^th century.

13 BIOPOLICY INTERNATIONAL 17 - MANAGING ACCESS TO GENETIC RESOURCES (John Mugabe et al., 1996)

14 United Nations Convention on Biological Diversity, Article 15, June 1992.

15 A GUIDE TO THE CONVENTION ON BIOLOGICAL DIVERSITY, IUCN Environmental Policy and Law Paper No. 30 at 76 (Glowka et al. 1994)

16 United Nations Convention on Biological Diversity, Article 15, June 1992.

17 United Nations Convention on Biological Diversity, June 1992.

18 The Kenyan Government has created an inter-agency committee, which has in turn created an expert working group, with the mandate to draft legislation on access and benefit sharing issues. There is also a working group, within the inter-agency committee structure, to produce interim guidelines regulating access to plant germplasm.

19 The FAO estimates that currently there are 800 million undernourished people in the world, 200 million of whom live in Sub-Saharan Africa - about 40% of the region’s total population. By 2010 forecasts predict that there will be 302 million undernourished people in Sub-Saharan Africa, 35% of a total population of 874 million. These forecasts might seem to suggest an improvement, however, in the context of global figures it would seem that Sub-Saharan Africa is going to fall further behind the rest of the World. The World total of undernourished people is predicted to fall to 680 million - undernourished Sub-Saharan Africans will thus constitute almost 45% of the World’s undernourished. FAO Food, Agriculture and Food Security: The Global Dimension. (Document WFS 96/Tech 1). Rome 1996, p. 27. Quoted in Food Security for a Growing World Population: 200 Years After Malthus, Still an Unsolved Problem. (Professor Dr. Klaus M. Leisinger, The Novartis Foundation for Sustainable Development) 1996.

20 25 billion tons of topsoil lost per year. Monsanto, 1997 Report on Sustainable Development including Environmental, safety and Health Performance. (March, 1998).

21 It is an accepted fact that the inputs of cereals, land etc. that are required for commercial livestock production would provide greater nutritional value if used directly.

22 CBD Article 15(7).

23 Id. Articles 15, 16, 17, 18 & 19.

24 Id. Article 8(j).

25 Id. Articles 6 & 10.

26 Id. Article 19.

27 Trade Related Aspects of Intellectual Property Rights, Article 27(3)(b).

28 Id. Articles 30 & 31.

29 Convention on Biological Diversity, Article 15 (1), June 1992.

30 Glowka et al. supra note 9.

31 This is due to the exemption from all but National Treatment, Article 3, Most-Favoured-Nation Treatment, Article 4, and Multilateral Agreements on Acquisition or Maintenance of Protection, Article 5, which is embodied in Article 65(2) & Article 66(1).

32 UPOV’s position on this is that does not wish to force states into membership but if that is the direction things are going it is understandably not averse to widening it’s membership. Conversation with Barry Greengrass, Vice-Secretary General of UPOV (17/1/99). The principal driving force behind this phenomenon has been seen to be the United States, which has been pushing UPOV upon the world. "Preparations for the 1999 Ministerial Conference: General Council Discussion on Mandated Negotiations and the Built-In Agenda. Communication from the United States", World Trade Organization Document Dissemination Facility, document WT/GC/W/115 (19/11/98). The evidence for this is not hard to find if one looks at the large increase in UPOV’s membership in recent years, which now stands at thirty seven, and at the number of countries which are UPOV compliant without being members, somewhere in the nineties.

33 International Convention for the Protection of New Varieties of Plants (UPOV), Article 5, December 2, 1961, as revised November 10, 1972, on October 23, 1978, and on March 19, 1991.

34 Id. Article 14(5).

35 TRIPs Article 1(1).

36 For instance Kenya’s industrial property legislation was hastily drafted in 1989 when it was believed that Kemron would be the wonder drug for HIV/AIDS and it is only now being reviewed and amendments proposed.

37 "Hard technology" being taken as consisting of things such as machinery, computers, pharmaceuticals etc. This is as opposed to "soft technology" that consists of things such as know how.

38 See India-Patent Protection for Pharmaceutical and Agricultural Chemical Products, Report of the Panel, 5 September 1997, WT/DS50/R. See also Appellate Body Report, 19 December 1997, WT/DS50/AB/R.

39 Section 1303 of the Omnibus Trade and Competitiveness Act of 1988, Pub. L. No. 100-418, 102 Stat. 1179 (1988), codified at 19 U.S.C. § 2442.

40 19 U.S.C. §§ 2411-20.

41 Bhala and Kennedy supra note 42 at 1172.

42 Id. at 1173.

43 19 U.S.C. § 2242(b).

44 Id. § 2242 (d) (2).

45 Id. § 2242(d) (3).

46 Article 23(1) of the Understanding on Dispute Settlement requires Members seeking a redress of a violation of a WTO Agreement to have recourse to the rules and procedures of the Understanding.

47 Id. § 2242(d)(4). See also Bhala and Kennedy supra note 42 at 1174.

48 15 C.F.R. § 2006.0 (b) Anybody who has a significant interest affected by a foreign act, policy or practice, e.g. a producer, importer, exporter, trade association or union.

49 19 U.S.C. § 2412(a)(2); 15 C.F.R. § 2006.3

50 19 U.S.C. § 2414(a)(3)(A)-(B).

51 Id. § 2411(c).

52 Bhala and Kennedy supra note 42 at 1175.

53 See U.S. to cut Argentine GSP Benefits for Failure to Provide Patent Protection, 14 Int’l Trade Rep. (BNA) 106 (1997).

54 See Office of the USTR, Fact Sheet: Special 301 Annual Review (April 30, 1997). USTR Fact Sheets are available from the USTR’s website at http://www.ustr.gov. From Bhala and Kennedy supra note 42 at 1175-6.