Kenya has participated in negotiations without any clear policy or negotiating strategy and with limited input from critical sections of the political economy. The negotiations have proceeded without sufficient parliamentary scrutiny. The signing of the TRIPs Agreement represented and manifested a major political failure for developing countries at three levels. First, failing to prevent this one-sided asymmetrical agreement from being brought into negotiations during the Uruguay Round (UR) of the General Agreement on Tariffs and Trade (GATT). Second, for failing to block when it was clear that TRIPs Agreement represented a bad deal. Third, for not getting anything substantive in return. For Kenya, this is a manifestation of constitutional, political and technical inadequacies.

GATT and TRIPs Agreement
The GATT had seven rounds since its inception. The last round of GATT negotiations(Uruguay Round) took eight years to complete and was the most comprehensive and  radical . In terms of intellectual property (IP) and technology transfer, one of the most important rounds was the 1964 Kennedy Round which established Non Tariff Barriers (NTBs) to trade as a GATT issue. It emphasised that tariffs were not the only trade-distorting instruments. The US, Japan the European Community (EC) states had emphasized the link between IP and international trade, arguing that weak or no protection of IP constitutes an NTB. These developments consolidated a policy shift instituted earlier by the International Monetary Fund (IMF), the World Bank as well as Kenya’s and Africa’s main bilateral “development partners” in the early and mid 1980s: trade would replace aid in a context of extensive economic restructuring under the now widely discredited Structural Adjustment Programmes (SAPs). IP would also have to be strengthened by all states receiving or expecting Bretton Woods support.

The Uruguay Round (1986-1994) dealt with many issues including intellectual property which,was covered by TRIPs. Of the agreements adopted under the World Trade Organization (WTO}, TRIPs was brought into the multilateral trading system (MTS) chiefly through the efforts of the United States government and its pharmaceutical and biotechnology  transnational corporations (TNCs).The motivation behind this move is the tough WTO Dispute Settlement regime that allows cross-retaliation for non- complianceIn Part I, the agreement spells such general provisions and basic principles, notably National Treatmentand Most Favoured Nation Clause. Part II addresses each separate IPR that is:  Copyright, Trade Marks, Geographical Indications, Industrial Design, Patents, Integrated Circuits Layout Designs,Trade Secrets and Undisclosed Information, Curbing Anti-Competitive Licensing Contracts. Part III of the agreement deals with TRIPS enforcement. The TRIPS agreement prescribes a dispute settlement mechanism based on articles XXII and XXXIII of the GATT 1994 and the Dispute Settlement Understanding (USD).

 Implications of TRIPs Agreement for Developing Countries
Intellectual property rights (IPRs) have acquired an importance that is unprecedented. In the 1980s, the United States’ government expanded the boundaries of the trade laws to include intellectual property and has since linked its bilateral investment treaties (BITs) as well as unilateral trade laws like the African Growth and Opportunities Act (AGOA) that defines trade with the countries of Sub Saharan Africa, to protection of intellectual property as an investment activity. Until the conclusion of the Uruguay Round of GATT negotiations, most developing countries as well as some developed ones had comparatively weak IPR regimes, meaning that IPR protection in these countries was limited – both in terms of coverage and duration of such protection. Knowledge is now considered as critical to development and an enhancement of a nation’s competitiveness, technological advancement and provision of goods and services needed by the society. But knowledge is constantly developed and improved through innovation and creativity. The TRIPs agreement, while purporting to contribute towards enhancement and improvement of knowledge by giving incentives to innovators through IPR protection, in the long run undermines access to knowledge and innovation. The TRIPs Agreement requires that WTO members apply intellectual property rights to all technologies. Although TRIPs allow members to exclude certain biological resources from patentability, there has been no tangible progress in the quest by developing countries to have the entire WTO membership agree explicitly that TRIPS excludes life forms from the patent regime. Another net transfer of resources from the South to the North takes place via the royalties and fees that the South must pay to acquire technologies from the North. In that respect it is the transnational corporations that benefit.

 The sui generis system has to be “effective” in order to be valid. It must be of commercial utility value. As communities do not have the massive financial outlays and technical capability of transforming their indigenous knowledge to industrial applicability, they have to either leave it open to some firms that can make commercial use of it – and patent under its own name – or enter into joint venture with transnational corporations (TNCs) that have the money and technology. In confrontation with developing countries, the TNCs have always had the upper hand since they have enough lobbying clout.

The TRIPS Agreement emphasises on more research and innovation and better access to new technology for all countries.  It enables all member countries to control anti-competitive practices in contractual licensing. However, special rules excluding the patentability of some specific processes do not always balance off the obligations undertaken by developing countries.

TRIPS and Human Rights
There is a principle that intellectual property are human rights that should be enjoyed by authors and innovators. It has often been said that authors have a right to the “moral and material interests” resulting from their scientific, literary and artistic productions as recognised in the Universal Declaration of Human Rights (1948). Authors – researchers, composers, and other innovators – are usually employed or are contracted, often on consultancy basis, by private corporations and often assign copyrights and patents to their employers or publishers; they should be adequately compensated for this. It is believed that there should not be any conflict between IPRs protection and human rights. However, a closer look at the TRIPS agreement and international and regional human rights’ instruments reveal major contradictions.  Policy makers believe that IPRs make tangible contribution to the scientific, cultural and economic enrichment of the society and benefit governments and companies. Research has shown that TRIPs undermine basic human rights like, the right to life, the right to food, the right to information and the right to development

Implementation of TRIPS agreement in Kenya
Domesticating the TRIPS agreement is more or less complete with the latest legislation being the new Copyright Act, 2001 which came into force on 1st February 2003. But what is the content of the TRIPs agreement, code and Kenya’s legislation and how do they affect major aspects of Kenya’s economy, agriculture, food security, health, and environmental conservation among others?

TRIPs and CBD biodiversity
Kenya, despite being a signatory to the Convention on Biological Diversity (CBD) of 1992, lacks national legislative instruments that exhibit a clear policy on access to genetic resources or access to relevant technologies. In Kenya and most other African States only microbes and microbiological processes can be patented. Yet under section 18(2) of the Seeds and Plant Varieties Act.37 Plant breeders rights may be granted to a person who has discovered or bred a plant variety. These are to be granted whether the plant variety is growing in the wild occurring as genetic variant, or whether artificially induced or not, as long as they are distinctive, uniform and stable.

In the run up to the Fourth WTO Ministerial Conference in Seattle, Kenya led African countries in arguing against some provisions of the TRIPs agreement, especially Art. 27. In light of this article Kenya and other developing countries are facing problems that:  developing countries, especially in Africa, have not yet developed policies or appreciated how biotechnology can benefit their economies. Thus they are in no position to design an IP system to promote welfare-enhancing biotechnology industries capable of competing with transnational corporations dealing with biotech products. It is not certain if such business will spring up just because life forms and micro and non-biological processes can be patented. It was observed that the debate on germplasm has concentrated on plant genetic resources and has yet to deal with other fields like animal and microbiological resources. African countries should therefore move into new biotechnology areas through participation in Microbiological Resources Centres (MIRCENs).

TRIPS and Prospects for Food and Food Sovereignty
Food security is defined as access by all people at all times to enough food for an active, healthy life. Its essential elements are the availability of food and the ability to acquire it.Consumer groups include the safety or hygiene of that food – it must be fit for human consumption. Innovation and intellectual property, including biotechnology and plant breeder’s rights are critical in ensuring food security.

Plant Breeder’s Rights
Internationally, plant breeders rights PBRs are governed by the International Convention for the Protection of New Varieties of Plants (UPOV).The only African countries that are members of UPOV are South Africa and Kenya. Kenya enacted legislation to protect plant breeders’ rights. Most of the new plant and seed varieties in Kenya are developed by government owned universities and public research institutes. These public sector organisations have shown little interest in seeking protection for their new varieties. It is feared that the introduction of PBR regulations will have the long-term effect of weakening research on crop varieties that are of less commercial value like traditional food crops. It is also feared that some of the food security crops will be displaced for cash crops. The anticipated shift of research priorities will bring a problem in technology development and transfer for resolving food shortage problems and hence may destabilise food security..

Biotechnology
Kenya and a number of developing countries are keen on developing biotechnology which is based on local agricultural technologies, including development of genetically engineered plants with pest resistance and other desirable characteristics. The impact of IP on local development of agricultural biotechnology is likely to be strongly negative because of the tight control maintained by firms from developed countries, resulting in restriction of the freedom of researchers in developing countries to develop these technologies or modify plant species. 

TRIPs and Access to Essential Medicines
Patents give their holders a monopoly, patent holders have an opportunity to charge too high prices at the disadvantage of poor developing countries. However developing countries should take advantage of Article 27 which permits exclusion from patentability of certain inventions where necessary to protect public order, morality, and health or to avoid serious prejudice to the environment. Compulsory licensing, parallel importation and generic medicines can be taken advantage of though there are complications involved.

Suggested measures
It has been suggested that developing countries take advantage of the three measures in TRIPs that would provide improved access to medicines:

1. Parallel imports, – the right to import brand name products when they are sold at lower prices in other countries is a viable option;
2. Compulsory licensing which is the right to grant a license, without permission from the license holder, on various grounds of general interest including public health; and,
3.  “Bolar exceptions” (early working), which is the right of a genetic producer to conduct tests and obtain approval from health authority before expiration of the patent, so that cheaper generic drugs are available immediately upon patent expiration.

It may also be useful for Kenya to consider introducing price controls on essential drugs to limit the huge mark-ups on drugs by distributors.

TRIPS and the Commercialisation of Indigenous Knowledge
Traditional communities are being cheated of their inventions and/or practices. Commercialisation of indigenous traditional knowledge has led to IP being granted to persons for knowledge of products or processes that have been known and used by traditional communities for centuries . Indigenous communities need legal protection so that they may benefit from their knowledge not through the current commercial exploitation. Modern intellectual property legislation in the form of copyrights, patents and trademarks does not fully protect indigenous knowledge. In few circumstances where attempts have been made to legally protect indigenous knowledge like in Nigeria, there are no provisions for communities to determine the use of and benefit from their own knowledge. There is also a risk of charging a community for the use of its own knowledge. There is however movement towards a sui generis system as developing countries are demanding that TRIPs agreement be amended to provide that any applicant for a patent relating to biological materials or to traditional knowledge shall be required by members to provide the following as a condition to acquiring patent rights:

1. Disclosure of the source and country of origin of the biological resource and of the traditional knowledge used in the invention.
2. Evidence of prior informed consent through approval of authorities under the relevant national regimes;
3. Evidence of fair and equitable benefit sharing under the relevant national regimes.

The countries recognised that these proposals would only provide “defensive protection for traditional communities from misappropriation of their knowledge – associated or not to genetic resources – through unauthorised patenting . They therefore proposed that an international framework to provide positive protection of traditional knowledge (TK) be established. Such a framework would involve:

1. Local protection through national level sui generic regimes including customary law.
2. Establishment of databases for traditional knowledge to prevent misappropriation .
3. A requirement for disclosure of the geographical source or traditional community from which traditional knowledge has been derived and sanctions for deliberate concealment or misrepresentation of the same.
4. A requirement for prior and informed consent and benefit sharing conditions given by the community or national/regional authority from which the knowledge is sourced.

3.7 TRIPs and Access to Technology
In technology, developing countries gain least and lose most from the strict IP policy, legislation and enforcement required under TRIPs. This is because they tend to pay the costs, in the form, for example, of higher prices for patented products and technologies, but gain little by way of technology transfer and development . The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovations and to the transfer and dissemination of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. The Agreement fails to address technology transfer sufficiently in its substantive provisions. It is argued that the agreement deals with issues in very general terms, but it is made more specific on the protection and regulation of abuse of IP.

For most developing countries with weak technological capacities, the evidence on trade, FDI and growth suggests that the cost of IP protection will far outweigh the benefits in the foreseeable future. In today’s liberalised and competitive environment, companies in developing countries can no longer compete on the basis of importing “mature” technologies from developed countries and producing them behind tariff barriers. And companies are more wary of transferring technology in ways that may increase the competition they face. The problem is less about obtaining mature technologies on fair and balanced terms. But more about accessing the sophisticated technologies that are required to be competitive in today’s global economy. TRIPs has strengthened the global protection offered to suppliers of technology, but without any counter balancing strengthening of competition policies globally. Therefore, it may be unwise to focus on TRIPs as a principal means of facilitating technology transfer. A wider agenda needs to give serious consideration to their policies for encouraging technology transfer. In addition, they should promote more effective research and cooperation with and among developing countries to strengthen their scientific and technological capabilities.”

Life Forms in the IP: Article 27(3)(b) of TRIPs
Article 27(3)(b)  provides for patenting of life forms. From the foregoing discussion on access to essential medicines, biodiversity and food security it is apparent that the problems are centered on ethical, moral, social, cultural, political and economic concerns related to the patenting of life forms. The potential effect of such patents on the way biological resources are controlled and exploited is highly crucial to developing countries because most of them have agro or biodiversity based economies. Further, it is recognised that biodiversity is one area in which they have a comparative economic development.

The TRIPs Agreement is grossly deficient. It focuses on the protection of the interests of the IPR-holders, without any significant balancing factors to protect the interests of the consumers of intellectual property products: There is nothing in the Agreement which will take care of the interest of new and small innovators who try to make innovations on the margin. The entire focus of the Agreement is to seek the maximum gain possible for the established patent-holders . The balance between these interests should be decided according to the socioeconomic background of the individual country.

Ethical Objections to Patenting of Life Forms
The possibility of living organisms constituting inventions has been questioned. It has been pointed out that there is a clear difference between ownership of individual plants and animals, which is recognised in most cultures and ownership of life forms as such, which is not. Some of the potential consequences of patents of life are also questioned from an ethnical point view, such as privatised research increasingly targeting products for the affluent. TRIPs leaves the definition of the three fundamental patent criteria (novelty, inventive step and industrial applicability) entirely to the discretion of national governments. No minimum standards are set. Implicitly, it can be argued, biopiracy is thus condoned by TRIPs.

The risk of biopiracy is one of the arguments for excluding living organisms entirely from patent protection, thus removing the potential for biopiracy altogether. Impact of seed patenting is not only viewed as an economic issue but a moral one given the common reality of mass starvation in Africa. Thus the commodification and marketing of life violates the cultural and moral values of African societies.

TRIPs and UPOV
UPOV is the commonly used acronym of the International Union for the Protection of New Varieties of Plants. Experts have pointed out certain problems with UPOV which the developing countries should take into account. This includes negative impact on produce by restricting the farmers’ rights to present more than one variety at a time, genetic erosion in the form of a bias towards the need of industrial agriculture and allowing companies to collect royalties on seed sale, and impact on research and development as evidenced in the decline in the sharing of scientific information and a decline in the rate of progress in plant breeding . Since Kenya is a signatory to the UPOV Convention, it is doubtful that there is sufficient room within its commitments for putting in place a sui generic system of protection for plant varieties as provided for under Article 27(3)(b). However, the provision does provide an opportunity for the protection of indigenous knowledge.

Proposed Reforms
Kenya needs to implement at least three reforms. First, Kenya countries should formulate specific, explicit and coherent IP, innovation and technology policies to cover all the critical sectors, including  Research and Development (R&D) in health, agriculture, and environmental governance as well as software, telecom and IT hardware and services as a matter of urgency. The policy should encourage or provide incentives for innovation, disclosure, and commercialisation of innovations by rewarding innovators and investors. It should bolster Kenya in exporting value added products. The policy should also foster non-IP modalities for regulating and promoting innovation these alternatives include social norms through measures intended to raise awareness and respect for innovation an IP, market and technology.

Second, Kenya should constitutionalise innovation, technology transfer and IP because these are core constitutions values and are basic instruments for national survival, development and competitiveness. This will bring innovation, IP and technology transfer into the public domain. In this way Kenya will be able to cultivate social norms within its citizens who will be able to develop and exploit innovations. It will also be able to make informed contributions to the TRIPs/transfer of technology discourse and secure national interests.

Third, Kenya should review ongoing legislation intended to make them TRIPs compliant by enacting legislation that implement Kenya’s core IP and innovation policies. Happily, the legislation can be TRIPs-compliant and at the same time deal with matters omitted by TRIPs or exploit the loopholes and ambiguity TRIPs. Kenya should undertake measures under which it can take full advantage of the exceptions provided in Article 31 and other TRIPs clauses. These exceptions can be used to model technology transfer transactions and regimes acceptable to Kenya without harming Western TNCs not comfortable with compulsory licensing measures.

Conclusion
“It is apparent from the foregoing that any gains achieved by developing countries and Kenya in particular under the TRIPs agreement will not be achieved without a  considerable degree of commitment to the issues mentioned in this paper. Our main finding is that the TRIPs Agreement, viewed independently of other factors provides leeway for developing country members to use the existing flexibility in TRIPs without interference and over-compliance preserves from developed countries.” It must be noted that even the existing flexibility under Article 27(3)(b) which allows for the protection of plant varieties by way of an sui generic system is under threat. Developed countries would like to have this limited exclusion removed in order to strengthen TRIPs scope in the area of patentable subject matters. For this reason, comprehension of and commitment to the issues is paramount.

Second, the flexibility must be exploited in as many ways as possible. For example with TRIPs ambiguity with regard to parallel imports, Kenya should adopt the doctrine of exhaustion of rights to allow for parallel importation of drugs. There are no rules in the TRIPs text on utility models or “petty patterns”. Any country would be therefore free to frame such a system in accordance with its own interests. There are no references either to matters which do not constitute “inventions’. This leaves considerable room for national legislation, particularly in the consideration of whether there is or is not an invention in the case of biological materials which already exists in nature but which are obtained by recombinant technology. In many countries, such materials may remain unpatentable as being “discoveries” and not “inventions.” However, it has emerged that for a lot of ethical issues solutions have to be combined from both within and outside TRIPs. For example, it may be necessary to introduce price controls with regard to essential drugs in addition to or as an alternative to allowing parallel imports.

* This is an abridged version of the 103 page report written by Oduor Ong’ wen. Oduor is the country director for the SEATINI office in Kenya. He can be contacted on: seatinike@sodnet.or.ke