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Tripped: TRIPs and Access to Health, Food and Technology in Kenya
*Oduor Ong’wen

Introduction
Intellectual property is defined as information that has economic value when put to use in the marketplace . Many developed countries, on their path to industrialisation and economic development, used and adapted technological innovations and scientific breakthroughs from other countries. These policy options and flexibilities are no longer available to developing country members of the World Trade Organisation (WTO). Even before the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) was signed in 1994, there was widespread concern on the implications of intellectual property on critical issues affecting developing countries.

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- compliance. In Part I, the agreement spells such general provisions and basic principles, notably National Treatment and 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).

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 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.

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:

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:

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:               

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.

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.

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

Proposals on Intellectual Property Rights Going in the Wrong Direction
*Grain

The European Union is negotiating Economic Partnership Agreements (EPAs) with six regional blocs of African, Caribbean and Pacific Island states pursuant to the Cotonou Agreement of 2000. Negotiations on these EPAs are supposed to conclude before 31 December 2007, for entry into force on 1 January 2008.

The EPAs are free trade agreements (FTAs) aiming to liberalise the economies of former European colonies through a package of direct commitments to, and assistance from, Brussels.

A recent draft of the EPA between the EU and 16 Eastern and Southern Africa countries (Burundi, Comores, Democratic Republic of Congo, Djibouti, Eritrea, Ethiopia, Kenya, Madagascar, Malawi, Mauritius, Rwanda, Seychelles, Sudan, Uganda, Zambia and Zimbabwe) gives a taste of what these treaties might spell out in terms of rights to local biodiversity and traditional knowledge. The chapter on intellectual property rights (IPR) endorses the patenting of genetic material (including human genes) and indigenous knowledge from Africa by European companies through a consent-and-compensation procedure. This is meant to "protect" Africa from "biopiracy". If the 16 African governments sign onto this, patenting life would now be okay for them, after years of political struggle against this principle and despite their own African Union model law prohibiting it.

Worse, the draft EPA frames rights to African biodiversity and traditional knowledge as "intellectual property". In a briefing published by GRAIN earlier this year, we showed that all North-South FTAs dealing with traditional knowledge do this. The proposal even extends this interpretation, for the governments that sign it, to the concept of Farmers' Rights under the FAO International Treaty on Plant Genetic Resources for Food and Agriculture.

Farmers' rights a trade issue? Traditional knowledge to be bought and sold as IPR? Patents on life ok, as long as you pay? And all of this hammered out behind closed doors, far away from the rural communities who are the stewards of Africa's biodiversity and stand nothing to gain from it being sold off to European corporations as intellectual property.

ESA trade ministers meeting in Mombasa in September 2006 with EU negotiators said that they wanted an EPA that is "comprehensively pro-development and in our interest". If that is the case, these proposals on intellectual property rights would take them profoundly in the wrong direction.

* GRAIN is an international non-governmental organisation (NGO) which promotes the sustainable management and use of agricultural biodiversity based on people's control over genetic resources and local knowledge. http://www.grain.org

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Economic Partnership Agreement between Eastern and Southern Africa countries on one part and the European Community
This is the Intellectual Property Rights section in the 4th Draft EPA/8th RNF/24-8-2006/ The comment from Grain is based on this section of the ESA-EPA draft text

TITLE VI
INTELLECTUAL PROPERTY RIGHTS
Article 64Scope and Coverage
1. For the purpose of this Title, intellectual property covers copyright and related rights; industrial property rights; plant breeders rights; rights to traditional knowledge, folklore and genetic resources; and other rights recognised under the TRIPS Agreement and CBD and the International Agreement on Plant Genetic Resources

Article 65
Objectives
The objectives of cooperation in intellectual property rights shall be:
1. To ensure availability of legal, institutional and human resource capacities and policy frameworks for the protection of intellectual property rights whilst respecting and safeguarding public policies of ESA countries
2. Ensuring the economic development and social expansion of an ESA Country economy is not hampered by a restricted application of international and bilateral obligations in the area of intellectual property rights,
3. Ensuring the implementation of the flexibilities as are provided under the TRIPS Agreement and CBD and the International Agreement on Plant Genetic Resources
4. To facilitate technology transfer amongst the parties and especially to the ESA countries
5. To ensure adequate and effective protection of genetic resources, traditional knowledge and folklore of ESA countries and prevent bio-piracy
6. To ensure that the legitimate interests of the ESA countries are safeguarded
7. To provide for enhanced incentives for the development and research into new technologies especially in pharmaceutical products, including the production of generic medicine.
8. To ensure that claims of ownership of seeds and plant products cannot be transferred onto similar natural resources endemic to the ESA region
9. To provide support for the development and research to identify geographical indications on products of ESA countries. In the case of livestock this will include the Breed Characterisation Inventory
10. To grant legal protection to geographical indications identifying products of ESA countries in both the Community and among ESA countries
Article 66
Areas of Cooperation
1. The Parties shall strengthen their cooperation in all areas of intellectual property, including in the following areas:
a) the availability of legal, institutional and policy frameworks necessary for the implementation of the TRIPS Agreement whilst respecting the flexibilities therein, and the CBD and the International Agreement on Plant Genetic Resources
b) the establishment and reinforcement, including training of personnel, of national and regional intellectual property offices dealing in intellectual property matters
c) a fair compensation for the intellectual property holder while at the same time giving due consideration to the interest of the general in particular taking into account the needs and level of development of ESA countries.
d) effective protection of ESA countries genetic resources, folklore and traditional knowledge and bio piracy;
e) in granting patents utilising genetic resources from ESA countries, the EC and its Member States will require the disclosure of origin and proof of prior informed consent of the indigenous community concerned and equitable sharing of benefits; where a genetic resource is derived from a genetic material of an individual and the rights conferred by this paragraph are conferred on that individual
f) Exploitation of genetic resources from ESA countries by EU shall take due regard to the principle of prior-informed consent to ensure indigenous communities holding such genetic resources benefit from such exploitation.
g) prevention of abuse of intellectual property rights by their holders
h) Creation of awareness on IPR through an information exchange system with the aim to update each other on IPR development on time
2. EU shall support ESA countries to enable them benefit from the relevant provisions of the WTO Agreement on TRIPs and the in-built flexibilities especially with regard to public health, including access to pharmaceutical products at a reasonable price;
3. EU shall support ESA countries to enact appropriate laws, formulate policies and develop infrastructure for local production of pharmaceutical products, transfer of technology and the attraction of investment in their pharmaceutical sectors;
4. The EU shall provide incentives to enterprises and institutions in its territory for the purpose of promoting and encouraging technology transfer to ESA countries in order to enable them create a sound and viable technological base.
Article 67
Implementation
1. The implementation of this Title shall be reviewed after 5 years as from the date of signing this agreement. Such review may also include any relevant new developments that might warrant modification or amendment of this Title
2. In order to facilitate the implementation of this Title, EU shall provide, on request and mutually agreed terms and conditions, technical and financial assistance in favour of ESA countries.
Article 68
Institutional Arrangements
1. For the purpose of this Title the ESA-EU Committee on IPRs shall be established.

2. The IPR Committee shall be composed of technical representatives of all Parties and shall report to the joint ESA-EU Committee on Trade Cooperation.