LEGAL ASPECT OF GM TECHNOLOGY AND BIOSAFETY IN TANZANIA

Biosafety Training Workshop 3 -12 January 2007 Arusha, Tanzania

Project : Capacity Building of Regulatory Agencies for Safe Handling of Modified Plants and Plant Materials in Tanzania. (TCP/URT/3102)

Genetically

Food and Agriculture Organization of the United Nations Developed by George Mandepo, International FAO Consultant Legal Officer Ministry of Agriculture Food Security & Cooperatives United Republic of Tanzania

January 2007

Table of contents

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OBJECTIVE OF THE MODULE: ................................................................................................. 41.0 Section 1 - Introduction to GM technology and Biosafety ...................................................................................... 4 1.1 What is biotechnology and biosafety in the context of international treaties .......................................................... 5 1.2 What is Biosafety? .................................................................................................................................... 5 2.0 Section 2 - International Instruments relevant to GM technology/biosafety ................................................... 6

2.1 International Instruments that aim to ensure development/ promotion and transfer of technology (IPR regime) 7

A) CONVENTION ESTABLISHING WORLD INTELLECTUAL PROTECTION ORGANIZATION (WIPO) .............................................................................................................. 8 B) UNION FOR THE PROTECTION OF PLANT VARIETIES (UPOV) ................................ 9

C) TRADE RELATED ASPECT OF INTELLECTUAL PROPERTY RIGHTS (TRIPS) AGREEMENT ............................................................................................................................... 112.1.2 Instruments that provide for environmental protection and ensuring rational utilization and sustainable development of technology. ........................................................................................................................................ 12 (a) (b) (c) 2.1.3 (a) (b) (c) (d) (e) Convention on Biological Diversity (CBD) 1992 .............................................................................................. 12 Cartagena Protocol on Biosafety. .................................................................................................................. 14 International Treaty on Plant Genetic Resources for Food and Agriculture 2001 ............................................. 19 Instruments that facilitate trade and ensuring safety of products of modern biotechnology. ........................ 21 Sanitary and Phytosanitary Standard Agreement (SPS) .................................................................................... 21 Technical Barriers to Trade (TBT) Agreements ........................................................................................... 23 The Codex Alimentarius Commission ............................................................................................................... 23 The International Office of Epizooties (OIE)................................................................................................ 23 International Plant Protection (IPPC) ................................................................................................................ 24

3.0 Section 3 - International Trade regimes Versus Modern Biotechnology in the Developing countries .................. 24 4.0 4.1 4.2 Section 4 National Policies and legislation related to Biotechnology/ Biosafety in Tanzania ................... 27 Implementation of International Agreement in Tanzania ............................................................................. 28 Relevant Policies for regulation GM technology and biosafety .................................................................... 30

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4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.3 4.4 4.5 4.6 4.6.1 4.6.2 4.6.3 4.6.4 4.6.5 4.6.6 4.6.7 4.6.8 4.6.9 4.6.9.1 4.6.9.2

Draft Tanzanian Biotechnology Policy ......................................................................................................... 30 National Trade Policy 2003 .......................................................................................................................... 30 The National Environmental Policy (1997) .................................................................................................. 30 National Science and Technology Policy for Tanzania (1996) ..................................................................... 31 The National Forest Policy 1998................................................................................................................... 31 National Agriculture and Livestock Policy ................................................................................................... 31 National Biosafety framework ...................................................................................................................... 31 National Biosafety Forum ............................................................................................................................. 32 Weakness of the existing biotechnology and biosafety framework .............................................................. 33 Legal Instruments relevant for GM technology and Biosafety regulation in Tanzania ............................... 34 Constitution of the United Republic of Tanzania .......................................................................................... 34 Tanzania Food, Drugs and Cosmetics Act No.1 of 2003 .............................................................................. 34 The Industrial and Consumer Chemicals (Management and Control) Act No 3 of 2003 ............................. 35 The Environmental Management Act, NO. 20 0f 2004 ................................................................................ 35 Forestry Act No 10 0f 2002 .......................................................................................................................... 39 The Plant Protection Act No. 13 of 1997 ...................................................................................................... 39 The Seed Act No.18 of 2003 ......................................................................................................................... 39 Animal Diseases Act No. 17 of 2003 ............................................................................................................ 40 Intellectual Property Rights legislation. ........................................................................................................ 40 Patents (Registration) Act No. 1 of 1987 ................................................................................................. 40 The Plant Breeders Act No.22 of 2002 .................................................................................................... 41

5.0 Conclusion and way forward ................................................................................................................................. 42

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Objective of the Module:This Module covers legal and trade aspect of GM technology/ biosafety in Tanzania. The general objective of the module is to show how international law and national legislation address concerns of impacts of modern GM technology. It should be noted that Law is one of the enabling mechanisms through which society can realize the potential and avoid the risks of modern biotechnologies, and therefore, this training will help participants to understand how international and national law may assist in realization of modern biotechnology's potential and avoid its possible risks. Among international and national Instruments covered in the module include: International instruments that support technological transfer (Intellectual Property Rights). Biosafety instruments which address the risks posed to the environment and human health when Genetically Modified Organisms (GMOs) are released into the environment either for research or for commercial purposes. Food safety instruments which address the risks posed to humans by genetically modified foods. Consumer protection instruments that designed to protect the consumers' right over the products of modern biotechnology.

1.0 Section 1 - Introduction to GM technology and Biosafety

What this Section is about The objective of this Section is to just to give in a nutshell an introduction to GM technology and Biosafety. Aims of this Section To provide some background information for the GM technology and Biosafety in the legal context.

What you will learn Background for GM technology and biosafety in the context of the existing international agreements . Rationale for international, regional and national biotechnology/ biosafety legal framework.

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The potentials of modern biotechnology in improving agricultural, industrial, and health sectors as well as environmental conservation cannot be overemphasized. For the developing countries like Tanzania, advances in the GM technology hold great promise for addressing key challenges in agriculture, human health and the environment. However, there are concerns over the potential adverse effects of modern biotechnology to human health and the environment. In view of this reality, various international and national institutional and legal frameworks have been developed in order to facilitate adaptation of new technology as safe form as possible. In the collective term, measures, policies and procedures for minimizing potential risks that GM technology may pose to the environment and human health are technically referred to as biosafety. Biosafety is concerned with regulatory aspects of GM technology. It embraces the safe introduction, handling and use of Genetically Modified Organisms.

1.1 What is biotechnology and biosafety in the context of international treatiesThe Convention on Biological Diversity (CBD), 1992 defines biotechnology as any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use1. At international level, CBD is as first international legal instruments to adopt a scientific definition of biotechnology. In its broader context, the definition of biotechnology covers many of the tools and techniques that are commonplace in agriculture and food production. On the other hand, the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, 2000 (CPB), defines modern biotechnology to mean application of: (a) in vitro nucleic acid techniques, including recombination deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or (b) fusion of cells beyond the taxonomic family, that overcome natural physical reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.

1.2 What is Biosafety?The introduction of GM products has had a profound effect on international trade, which primarily influenced by consumer choices. However, due to lack of effective regulatory systems on food and other products, in many parts of the world, there have been fears over the introduction of modern biotechnology especially after the start of commercialization of Genetically Modified products. Concerns have been raised on number of angles ranging from safety, potential abuses to protection through IPR system, ethical and social aspects etc.

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Article 1 of the Convention on Biological diversity, as concluded in Rio de Janeiro on 5 th June 1992

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The need to ensure food security for present and future generations, to conserve and sustainable use natural resources, to respect human rights, and to share the benefits of technology in an equitable manner, has resulted to the changes in policies and legislation in various part of the world. The term Biosafety is not expressly defined in reviewed international instruments. However, by impliedly construction of Cartagena Protocol to CBD, the terminology may means all policies and regulatory measures that intend to ensure that safely use of modern biotechnology.

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Section 2 - International Instruments relevant to GM technology/biosafety

What this Section is about The objective of this Section is to examine how various international instruments attempt to regulate modern biotechnology. It discusses interaction between international trade and modern biotechnology in the developing countries. Aims of this Section To show how International Agreements/ Treaties impacting on modern biotechnology. To show what are the obligations of member countries to such international agreements. To identify challenges which developing countries have to comply with international agreements. To create awareness to the participants on the existing international instruments impacting on GM technology.

What you will learn Role of international Treaties in the GM technology and Biosafety regulation.

At the international level, there are number of international agreements that impacting on regulation of modern biotechnology. Some are primarily trade agreements whilst others are primarily concerned with protection of the environment and sustainability. The International legal instruments for GM technology can be categorized into three groups, namely: (a) Instruments that aim to ensure development/ promotion and transfer of technology by providing protection of innovations (Intellectual Property Rights); 6

(b) Instruments that provide for environmental protection and ensuring rational utilization and sustainable development of technology; (c) Instruments that facilitate trade and ensuring safety of products of modern biotechnology.

2.1 International Instruments that aim to ensure development/ promotion and transfer of technology (IPR regime)The international instrument that aim to ensure development/ promotion and transfer of technology are the instruments which facility technological transfer by provided sort of incentive to the innovator, discovers or developers of a particular technology with view to compensate their material and mental efforts incurred in discovering such technology. The system referred to as Intellectual Property Protection (IPR).

How does the IPR legal regime work?The Intellectual property Rights (IPR) is a legal regime that provided for an exclusive right to an innovator of a new technology. It confers the holder of a right that excludes others from prescribed period of time from using, producing or exploiting in any manner, the benefits or fruits of intellect without securing authorization from the right holder. IPR allow the holder of the rights to recoup the investment in research required to develop the new invention, which can be quite substantial for high technology inventions and, in exchange, society receives the benefit of the disclosure of the new invention. Different forms of IPR exist such as patents, trademarks, industrial designs or copyrights and Plant Variety rights/plant breeders rights. Each form of IPR has different requirements and grants different rights. In general, inventions eligible for patenting must be new, involve an inventive step (or be nonobvious) and be capable of industrial application (or be useful). Patents are granted for a limited time period, usually 20 years and are only valid in the country where they have been granted. As the patents is the strongest form of intellectual property protection in the sense that they normally exact the greatest control over the patented genetic material. Patent protection is also frequently obtained through broad patent claims, (for example, on genes, the vector or carrier for effecting the transformation, which may cover a number of potential varieties or crops incorporating the gene), any far reaching exceptions for research and farmers right may be difficult to create, which will be possible through a PVP law. Plant variety protection (PVP) is considered as an incentive for commercial breeders of plant varieties to invest in Research and Development (R&D).It provides for protection to new plant varieties that have previously not been commercialized, are distinct from existing varieties, and are uniform in their main characteristics and stable over the years for those characteristics. Unlike patented material, protected varieties can be used for the development of new varieties without the authorization of the rights holder.

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Trade Marks have a small role, though important, as far as agricultural biotechnology is concerned. Trade Marks are relevant in identification of plant products such as seeds of a particular enterprise. They can convey to customers an indication of the quality of the products. Traders of new variety may want to use trademarks of a particular enterprise because of that enterprise known attributes or qualities. The IPR system in agriculture provides a way of ensuring the financial revenues required to make the technology profitable. In the modern biotechnology, IPR law has the following main objectives: (i) It provides legal rights to creators and innovators as a reward for investing time and energy in research and for their consequential achievements; (ii) By protecting rights of originators, it provides incentives for creativity and innovation and for economic, social and cultural progress; and, (iii)It is a legalized mechanism for the transfer of technology.

What are international IPR instruments relevant to GM technology?At the international level, there about three major IPR instruments relevant to GM technology i.e. Convention establishing World Intellectual Protection Organization (WIPO), Union for the Protection of Plant Varieties (UPOV), and WTO- Trade Related Aspect of Intellectual Property Rights (TRIPS) Agreement.

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Convention establishing World Intellectual Protection Organization (WIPO)

World Intellectual Protection Organization (WIPO2) was established to encourage creativity through protection of intellectual property throughout the world through cooperation among States and, where appropriate, in collaboration with any other international organization. WIPO works to harmonise intellectual property rights, standards and legal provisions internationally. WIPO administers 23 international IP treaties. However it is not obligatory for member states of WIPO to be parties to these treaties. The treaties administered by WIPO fall into three categories: Intellectual Property Protection (defining internationally agreed basic standards); Global Protection System, including PCT; and Classification, systematising IP information. In the area of IPR relevant to biotechnology (patents), the most significant treaties are the The Patent Cooperation Treaty (PCT), 1970 (providing for a unified procedure for filing patent applications to protect inventions internationally) and The Patent Law Treaty (PLT) of 2000 (a multilateral treaty aims to harmonize formal procedures for a patent application). Under the2

Signed at Stockholm on July 14, 1967 and amended on September 28, 1979

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referred Treaties, WIPO classifies the PCT as a global protection system treaty and it allows patents to be applied for through a single international route as an alternative to the submission of separate applications to each state in which the patent is desired. Through patent rights recognized under WIPO, in some countries, (for instance USA) a patent legislation is used to protect plant verities where by protection is for sexually reproduced plants (and genes, tools, methods to produce varieties). Another WIPO treaty relevant to the area of biotechnology is the 1977 Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedure. Under this Treaty, states that require deposit of the microorganism for which a patent is being applied must accept its deposit in an International Depositary rather than on a national basis.

How does WIPO interact with other International Organization/agreement? Previously, IPR under WIPO did not involve agriculture biotechnology, the influence of UPOV and TRIPs did bring the issue into WIPO consideration. Recognising new issues for intellectual property rights emerging from the biotechnology revolution WIPO established an Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore in 2000. This Committee among other things was mandated to consider options for continuing discussions or further work in the interface between the patent system and genetic resources and the intellectual property aspects of access and benefit-sharing regimes. The outcome of the Committee is expected after July 2007 3 WIPO now works alongside the World Trade Organisation and its Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).

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Union for the Protection of Plant Varieties (UPOV) 4

The objective of UPOV Convention is the protection of new varieties of plants by an intellectual property right by granting plant breeder rights to the innovators of new plant varieties. Under the Convention, the plant breeders right is granted where a variety is new (novel) and meets condition of Distinctness, Uniformity and Stability (DUS test). Under UPOV system of sui generis, any variety that fulfills the DUS criteria and that is new (in the market) is eligible for protection, and there is no need to demonstrate an inventive step or industrial application, as required under a patent regime. A DUS examination involves growing the candidate variety together with the most similar varieties of common knowledge, usually for at least two seasons, and recording a comprehensive set of morphological (and in some cases agronomic) descriptors.

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see http://www.wipo.int/edocs/prdocs/ en/2006/wipo_pr_2006_470.html The Convention was adopted in Paris in 1961 and it was revised in 1972, 1978 and 1991

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The purpose of the UPOV Convention is to ensure that the member States of the Union acknowledge the achievements of breeders of new plant varieties, by making available to them exclusive property right, on the basis of a set of uniform and clearly defined principles.

Interface between UPOV and other international TreatiesAmong important features of UPOV 1991 is inclusion of farmers rights and permission to countries to provide in their national laws for the concept of farmer saved seed. However, farmers privilege recognized in UPOV Convention is limited in scope. In particular, each member state may enact a provision in its national plant variety protection laws permitting farmers to use for propagating purposes on their own holdings the product of the harvest, which they obtained by planting a protected variety on their own holdings. In addition, this privilege must be exercised within reasonable limits and subject to the safeguarding of the legitimate interests of the breeder (Article 15(2)). Unlike the 1978 Act, the 1991 version of the farmers privilege does not authorize farmers to sell or exchange seeds with other farmers for propagating purposes, a limitation that commentators have criticized as inconsistent with the practices of farmers in many developing nations, where seeds are exchanged for purposes of crop and variety rotation. Also the word reasonable limits provided in Article 15(2) of the Convention has been interpreted differently, some countries have applied restriction to the acreage, others on quantity of seed and species subject to the farmers privilege. On the other hand, the requirement to safeguard breeders legitimate interests has been applied to require farmers to pay some form of remuneration to the breeder for their privileged acts. In some cases, Article 15 of UPOV Convention have been interpreted to provide for promotion of new technology of plant breeding by protecting rights of a breeder while on the other hand ensuring benefit sharing between the breeder and the conserver of the original genetic material (a farmer). This Article may embody the objectives of the International treaty on Plant genetic resources for Food and Agriculture of 2001 in relation to Farmers rights which will be discussed later in this Module. The Convention intends to facilitate transfer of technology and ensuring agricultural development through new and improved varieties, this is done by motivating breeders through granting plant breeders rights and allowing the use of material of protected variety for non- commercial purposes. However, there is no any provision in the UPOV Convention relating to preservation of genetic resources. This makes sense, since it is not the purpose of intellectual property law to protect the environment but to protect works of human genius. As result of this, some developing countries are trying to draft their own Plant Variety Protection laws, which incorporate pro-biodiversity agendas in the spirit of CBD.

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c)

Trade Related Aspect of Intellectual Property Rights (TRIPS) Agreement5

The TRIPs Agreement is the first and only IPR treaty that seeks to establish universal, minimum standards of protection across the major fields of intellectual property. TRIPS set minimum standards which individual members may supplement. It covers the areas of copyright, patents, trademarks, geographical indications, industrial designs, integrated circuit designs and trade secrets. Particularly relevant to the field of biotechnology are the patent rules.Article 27.1 of TRIPs provides 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 [...]. Under this Article, the terms "inventive step" and "capable

of industrial application" may be deemed by a Member to be synonymous with the terms "non-obvious" and "useful" respectively.Article 27.2 on the other hand envisages that certain inventions can be excluded by Members (of WTO) from patentability in order to protect [...] ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment [...]. In this regard, article 27.3. b permits Members to exclude from patentability [...] plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non biological or microbiological processes. However, this provision also stipulates that Members [...] shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.

It should be noted that TRIPS sets out minimum standards and does not prevent Members from increasing the rights and by implication introducing new intellectual property rights so long as these are consistent with the general TRIPS provisions. Through Article 27.3(b), countries could enact a plant varieties protection law based on patent, sui generis or any combination of those two regimes. Many countries members to WTO opted to enact their IPR law on PVP based on sui generis. Article 7 of TRIPs requires protection under IPR should contribute to the soci-economic development of a member country. It provides that the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

Is the TRIPS effective for IPR protection to its members?Since its operationalisation, the meaning of Article 27.3(b) of TRIPS on IPR has been the subject of significant debate for some years with differing views over the propriety of IPR protection for plant varieties. It have been argued that TRIPs provisions on plant varieties5

Adopted in 1994 as a treaty administered by the World Trade Organization (WTO).

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do not refer to or incorporate any preexisting intellectual property agreements, including the 1978 and 1991 UPOV Conventions. This is opposed to other fields of intellectual property, such as patents, copyrights and trademarks, for which TRIPs expressly requires its members to comply with the standards of protection contained in preexisting IPR agreements some administered under World Intellectual Property Organization (WIPO), such as the Berne Convention for the Protection of Literary and Artistic Works and the Paris Convention for the Protection of Industrial Property. As a result of such omission on IPR on plant varieties, TRIPS members are neither required neither to become members of UPOV nor to enact national laws consistent with either UPOV Convention. Other members to WTO agreements still concerned that different national standards of protection would be an obstacle to free trade. There have been various trade discussions to review the provision of TRIPs Agreement, the TRIPS Council Meeting held in Doha Qatar in 2001 agreed upon the framework for a new round of trade negotiations. The Doha Ministerial Council suggested for the broadening the discussion on TRIPs to cover biodiversity and traditional knowledge. The topics raised in the TRIPs Councils discussions include: the pros and cons of various types of protection for new plant varieties (patents, UPOV,etc); how to handle moral and ethical issues and harmonization of TRIPs Agreement and the Biological Diversity (CBD).

2.1.2 Instruments that provide for environmental protection and ensuring rational utilization and sustainable development of technology.The International that protect environment and ensuring rational utilization and sustainable development of technology are Convention on Biological Diversity (CBD), its Cartagena Protocol on Biosafety and FAO - International Treaty for Plant Genetic Resources for Food and Agriculture, 2001.

(a) Convention on Biological Diversity (CBD) 1992The Convention on Biological Diversity was created at the 1992 United Nations Conference on Environment and Development at Rio de Janeiro (also known as Rio 92) and entered into force on 29 December 1993.The CBD is one of the international legal instruments that have effect on innovation in agriculture.

What is the scope and applicability of CBD?The main objectives of CBD are the conservation of biological diversity, the sustainable use of its components, the fair and equitable sharing of benefits arising out of the utilization of genetic resources6. The CBD also recognizes that nation states have the sovereign right to exploit their own resources and the authority to determine the conditions of access to them.

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Article 1

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CBD defines genetic resources to mean any genetic material of actual or potential value. On the other hand, term genetic material is defined as any material of plant, animal, microbial or other origin containing functional units of heredity. The CBD provided for in situ conversation of plant genetic resources. Conservation in situ involves the preservation of ecosystems and natural habitats and the maintenance of viable populations of species in those settings. Conservation of resources occurs where farmers and indigenous communities safeguard traditional plant varieties in the locations where they grow naturally or are cultivated. The CBD provides guiding principles for the preservation of biodiversity and it requires that states carry out national biodiversity assessments and have conservation strategies. It has a 'clearing house' for exchange of information, which aims to give universal access to its database, country reports and scientific case studies. A Conference of Parties (COP) was established under CBD to deal with themed biodiversity programmes such as agricultural biodiversity and marine biodiversity and also with 'crosscutting' issues that include biosafety, access to genetic resources and intellectual property rights.

How is CBD relevant to GM technology/biosafety?Article 8(g) of CBD requires each Contracting Party as far as possible and as appropriate to establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from GM technology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health. The CBD has general provisions to promote notification, information exchange and consultation regarding activities under a party's jurisdiction or control which are likely to significantly affect adversely the biodiversity of other States or areas beyond the limits of national jurisdiction (Article 14(1) (c)). These provisions can be interpreted to apply to GMOs. Article 19 (3) of CBD addresses the handling of biotechnology and distribution of its benefits arising from conservation and use of biological diversity. By interpretation, this Article covers modalities of setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity. In addition, where it does not ratify or accede to the Biosafety Protocol, a CBD party still needs to implement article 19(4), Article 19(4) of CBD creating a bilateral obligation for a CBD party to provide information on an LMO prior to providing it to another CBD party. This information includes any available information on the regulatory measures taken by the exporting CBD Party and any available information on the potential adverse impact of a particular LMO.

Does CBD have any relationship with the IPR regime?13

Although the CBD does not expressly deal with IPR agreements, it contains numerous provisions relating to IPRs. In particular, Articles 16(2)-(4) state that the transfer of technology and measures taken to gain access to such technology shall be consistent with the adequate and effective protection of IPRs recognized in international law. Thus, for example, where a government encourages foreign direct investment of industrial technologies (such as a biotechnological process used to insert new genetic sequences into existing plant varieties) it must respect any patent rights that the owner of that technology has acquired to protect it. Article 16(5) of CBD recognizes that patent and other IPRs may have an influence on the implementation of the CBD. Through this Article, member states are obliged to cooperate in order to ensure that IPRs are supportive of and do not run counter to the objectives of CBD. Furthermore, Article 11 of CBD calls on each contracting party to adopt economically and socially sound measures that act as incentives for conservation and sustainable use. This provision constitutes the very core of the relationship between IPRs and genetic resources, raising the question whether IPRs act as a positive or negative incentive for the conservation of genetic resources. It should be noted that indirect or direct appropriation of genetic resources (or products containing genetic resources or biologically derived materials, including synthesized products), especially through patents and plant breeders rights - PBRs, is, one of the main reason why Access and Benefit Sharing principles and rules were incorporated in the CBD as part of the great political bargain between developed and developing countries. CBD as one of the ABS instruments, seeks to ensure that access to biological and genetic resources is subject to certain conditions (sovereignty, mutually agreed terms, prior informed consent), which guarantee that benefits derived from the use of these resources are fairly and equitably shared among the user and the country providing them.

(b) Cartagena Protocol on Biosafety.The Cartagena Protocol on Biosafety, often referred to as the Biosafety Protocol or BSP, is the first international treaty regulating transboundary trade of genetically engineered organisms. The Protocol concluded and adopted in Montreal on January 29, 20007 in order to implement the Convention on Biological Diversity8. The Protocol was created to try to minimise the risks to genetic diversity posed by living modified organisms (LMOs), i.e. "organisms resulting from the use of modern biological techniques" The main objective of the Cartagena is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from7 8

The Protocol entered into force on 11th September 2003. The Protocol was called the Cartagena Protocol on Biosafety after the city of Colombia where it was originally scheduled to be concluded and adopted.

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modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary9. The Protocol applies to all parties who are members to the Convention on Biological Diversity (CBD). The Protocol does not change the rights and obligations of parties under any existing international agreements and does not restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than that called for under the Protocol, provided that such action is consistent with the objective and the provisions of the Cartagena Protocol (CPB).

Important terminologies used in the CPBSome of important terminologies used in the CPB are: Transboundary movement" means which has been defined to mean the movement of a living modified organism from one Party to another Party, save that for the purposes of Articles 17 and 24 transboundary movement extends to movement between Parties and nonParties; and "Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology; Living organism means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids.

Scope and applicability of CPBThe CPB is both a Trade and Environment treaty. It regulates modern biotechnology and LMOs in particular by establishing practical rules and procedures for safe transfer, handling and use of Living Modified Organisms (LMOs) that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health10. The Protocol has a specific focus on regulating transboundary movement of LMOs (i.e. movement of LMOs across borders, from one territory to another).

What are exceptions to CPB? The CPB Protocol does not apply to the transboundary movement of LMOs which are pharmaceuticals for humans that are addressed by other relevant international agreements or organizations11. Also according to Article 6, the CPB does not to apply on LMOs that are in transit and destined for contained use from the Advanced Informed Agreement (AIA) procedure which may be regulated within the territorial jurisdiction of a member to the CPB Such

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Article 1 of the Cartagena Protocol of Biosafety According to Article 4 11 Article 510

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regulation may be done by placing the information on such regulation in the Biosafety Clearing-House (BCH).

Advanced Informed Agreement (AIA)In order to protect an importing Party from taking a decision without being fully informed on the intended use and risks from an LMO intended for release into the environment, the CPB provided for the requirement of Advanced Informed Agreement (AIA). The procedure for AIA is similar to a Prior Informed Consent Procedure (PIC) which has been used in several environmental treaties. The AIA constitutes the central part of the procedure regarding transboundary movements of LMOs and it applies to the first transboundary movement of LMOs for intentional introduction into the environment of another Party12. The AIA procedure ensures that before a LMO is imported into a county for the first time for the intentional introduction in environmental, the party of import is notified about proposed import; receives full information about LMO and is intended use; afforded an opportunity to assess the risks associated with LMO in order to decide whether or not to allow such importation. Under AIA, Party of export or exporter is required to ensure notification to, in writing to the competent national authority (CAN) of the party of import prior to intentional transboundary movement of LMO. The Protocol imposes a legal obligation upon Party of export to ensure the accuracy of the information about the LMO 13. Within 90 days of receipt of notification, the Competent National Authority shall be entitled to acknowledge receipt of notification to the notifier14 The Competent National Authority of the importing country is required to notify its decision to both the notifier and the BCH within 270 days of the date of receipt of notification15. Failure by the country of import to communicate its decision within stipulated time shall not imply permission for the importation of LMOs. The Competent National Authority of the country of import may also require additional information before make nay decision.

Are there any exceptions to AIA?The AIA under CPB does not apply to: - LMOs in transit - LMOs destined for contained use in the Party of import and - LMOs intended for direct use as food or feed or processing

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The aim of AIA is to promote a shared responsibility between exporting and importing Countries in protecting human health and the environment from the effects of the LMOs.13 14

Article 8 (1) and (2) Article 9.1 15 Article 10.3.

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Under the CPB, LMOs intended for direct use as food, feed or for processing are subject to a simplified form of the AIA procedure. The simplified procedure does not require information on the intended date or dates of transboundary movement, the quantity or volume of the LMO to be transferred, the regulatory status of the LMO in the Party of export, and previous notification about the LMO made to other Parties. It is assumed that this information may be made available through the BCH, where can be accessed by any Party who requires it.

Information exchange of between partiesThe Cartagena Protocol also called for the establishment of a Biosafety Clearing House to facilitate exchange of information between parties, collate national laws and regulations and assist in implementation of the agreement. The Protocol established BCH under Article 20. BCH may be used to assist Parties to implement the Protocol taking into account special need of developing countries.

Risk assessment and managementThe CPB provides also for risk assessment and management. Under the Protocol, the assessed risks should be those risks likely to pose to biological diversity and to human health. The assessment of risks based on the information received in the notification16 and other relevant scientific evidence. The cost of risk assessment shall be borne by the notifier (exporter) if the Party of import so requires. Article 16.4 of CPB requires that risk management includes the continued observation of an LMO after its release (deliberate or accidental) into the environment be undertaken .

Institutions for implementation and public awarenessUnder the Protocol each member must appoint a 'competent national authority' and a 'national focal point' to be responsible for administering the Protocol and reporting back to the Intergovernmental Committee for the Cartagena Protocol (Article 19). Parties are encouraged to advance public awareness of "safe transfer, handling and use"(Article 23, and to help developing countries to fulfill their obligations through financial aid and the transfer of technology (Articles 22 and 28).

Socio-economic considerationsArticle 26 of the Protocol is on socio-economic considerations when making decisions on import of LMOs. Although it gives special regard to impacts on the value of biological diversity to

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Article 15

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indigenous and local communities, it allows these considerations only so long as they are consistent with their international obligations, mostly meaning the WTO trade agreements. Dispute and Settlement The Protocol does not contain provisions related to dispute settlement, but refers to those of the Convention on Biological Diversity, which provides for optional recourse to judicial settlement, arbitration, or conciliation (Articles 27 and 32 of the Convention CBD). .

The Precautionary PrincipleIn a departure from the World Trade Organisation's regulations on trade which must be based on sound scientific knowledge", the Cartagena Protocol incorporates the precautionary approach of the 1992 Rio Declaration allowing parties to act, even when there is scientific uncertainty, to avoid potential risks. The CPB endorses the precautionary approach. The precautionary principle applies to imports, placing on the market of LMOs. The Protocol contains references to the concept of precaution in some of its provisions: - The Preamble and Article 1 of the Protocol, which makes reference of the precautionary approach, contained in the Principle 15 of the Rio Declaration on Environmental and Development. - Provisions regarding in the decision-making process in articles 10(6) and 11(8), which remarks import decisions for LMOs and LMO- for food or feeds or processes (LMOsFFPs) and in Annex III which concerns to risk assessment. In the lack of scientific certainty due to insufficiently relevant scientific information and knowledge regarding extent of the potential adverse effect of LMOs on the conservation and sustainable use of biological diversity in the party of import, the precaution principle 10(6), 11(8) and Annex III allow a Party to take decision as appropriate, with regard to the import of LMO and LMOs- FFPs. Unintentional transboundary movements of LMOs The Parties to the Protocol shall notify immediately or potentially affected States and BCH when an unintentional transboundary movement of LMOs has occurred that is likely that may have adverse effects on the environment and risks to human health. Furthermore, the Parties to the Protocol have to make available to BCH information on points of contact for receiving the notification, in the event of unintentional transboundary movement ( Article 17 of Cartagena Protocol). . Illegal Transboundary Movement of LMOs The CPB requires each Party to adopt appropriate domestic measures in order to prevent and penalize transboundary movements; i.e. movements carried out in contravention to domestic measures implementing the Protocol. Moreover, it establishes that in the event of an illegal

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transboundary movement, the affected Party may require the Party of origin to dispose at its own expense of the illegal LMO. The Parties have to notify the BCH each time there is an illegal transboundary movement of LMO into its country (Article 25).

Capacity building and Financial resourcesThe CPB is also provides for a need to build capacity for the national implementation agencies. Article 22 requires Parties to co-operate in the development and strengthening of human resources and institutional capacities in biosafety in developing countries, small islands States and countries with economies in transition. Moreover, the Protocol supports the transfer and access to technology from developed countries to less developed ones. Capacity building includes also provision of the necessary scientific equipment and supplies for biotechnological tests and related investigations to identify LMOs and their products in order to enable a meaningful implementation of the provisions of the Protocol. .

What is liability and redress under the CPB?In the legal sense, the term "liability" is normally associated with the obligation to provide for compensation for damage caused to persons, property and the environment. Liability and redress in the context of the Protocol concern the question of what would happen should the transboundary movement of LMOs results in damage. Liability and redress are addressed in Article 27 of the Protocol, which provides: "the Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms, analyzing and taking due account of ongoing processes in international law on these matters, and shall endeavor to complete this process within four years". The issue of liability and redress is still in the negotiations.

How CPB interact with other international Treaties?The recitals of CPB stress that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements. In the circumstance, the protocol does not affect countries existing obligations to the other international agreements. Also Article 14 of the Protocol allows parties to enter into bilateral, regional and multilateral arrangements regarding international transboundary movement of LMOs. However, such agreements or arrangements should be consistent with the CPO or should not provide lower level of protection as opposed to that provided under the protocol

(c) International Treaty on Plant Genetic Resources for Food and Agriculture 2001

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The objectives of FAO- International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) are the conservation and sustainable use of plant genetic resources for food and agriculture (PGRFA) and the fair and equitable sharing of the benefits arising out of their use17. This Treaty entered into force in April 2004.

How the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) operates?ITPGR applies to all Plant genetic resources for food and agriculture. It refers to the modern biotechnologies in the preamble and acknowledges that PGRFA are indispensable as raw material for crop genetic improvement including that through modern biotechnologies. The PGRFA Treaty mainly incorporates the philosophy of the CBD but adopts the multilateral approach on access and benefit sharing (ABS) in contrast to the bilateral approach under the CBD. The Treaty provides for the conservation, exploration, collection, characterization, evaluation and documentation of plant genetic resources for food and agriculture18. The Treaty also requires cooperation in development and transfer of appropriate technologies leading to an efficient and sustainable system of ex situ conservation. 19 The technology may include the modern biotechnologies. Under Article 5.2, the ITPGRFA requires contracting parties to take steps to minimize or, if possible, eliminate threats to PGRFA. By interpretation of Article 5.2, the threat to PGRFA may include threats posed by modern biotechnology such as GMOs. Article 9 provides for the farmers rights. However, it leaves it upon member countries to determine mode of legislation of farmers rights.

How the ITPGRFA interact with other International Agreements?

In its context, ITPGRFA addresses both issues of IPR and protection of genetic diversity that used in the formal breeding process. It seeks to modify existing IPR legal regime so as to permit farmers themselves to claim exclusive rights in the plant varieties they cultivate informally and it recognizing farmers rights not through IPRs but through benefit sharing mechanisms, such as payments and technology transfers, that compensate farmers for their contributions to plant genetic diversity.

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Article 1.1. Article 4 19 Article 5.(1)(e)

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The access and control provided under the Treaty is consistent with the CBD, which grants states the sovereign right to control their plant genetic resources. Further the CBDs benefit sharing objectives is covered under ITPGRFA by conditioning access upon the current or future payment of compensation or the transfer of technology to the authority providing access. The specific conditions of access will be specified in Material Transfer Agreements (MTAs) entered into between the entity (whether governmental or private) that owns or controls the germplasm and the entity (usually private) that seeks access to it. The right of farmers to participate in decision-making at the national level on matters related to the conservation and sustainable use of PGRFA is among the measures to protect and promote Farmers Rights20. This could be interpreted to include the right of farmers to participate in biosafety decision-making processes and to have access to information which is provided under CPB. Though under IPR regime (WIPO, TRIPs and UPOV) it envisaged that innovator of new technology would depend on the genetic materials from either in situ or ex situ conservation, the regime is not concerned much with the mechanisms for protecting Traditional Knowledge (TK) or sources of breeding materials for sustainable breeding process as provided for in CBD or CPB. On the other hand, the ITPRFA may be considered as the only instrument providing a compromise for implementation of IPR and benefit sharing instruments that are impacting on modern biotechnology. The current negotiations are going on including the Doha negotiation which intend to bring

2.1.3 Instruments that facilitate trade and ensuring safety of products of modern biotechnology.The international instruments deals with standards and safety adoption and use of products of modern biotechnology include WTO- Sanitary and Phytosanitary Standard Agreement, Technical Barrier to Trade, Codex Allimentarius, OIE, IPPC etc. the full discussion of such instruments is as given here below:

(a) Sanitary and Phytosanitary Standard Agreement (SPS) What does SPS agreement provides and how is it relevant to GM technology/biosafety?

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Sometimes, Farmers Rights are mistaken for the Farmers Privilege under PBR UPOV regimes. The Farmers Privilege is basically the right of farmers to use and consume the seeds from protected varieties after these has been sown. UPOV 91 leaves countries the option on whether to implement this exceptional right.

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The SPS is a WTO agreement which provides for a multi-lateral framework of rules to guide development, adoption and enforcement of sanitary and phytosanitary measures to minimize their negative impacts on trade. The SPS applies to all sanitary and phytosanitary measures that may directly or indirectly effect on international trade21. The SPS sets out a code of good practice for the preparation, adoption and application of standards to be enforced by the member countries. The agreement requires countries to use standard or harmonized measures measure necessary for the protection of human, animal or plant life or health based on scientific principles provided under the SPS and other relevant international organization22. The agreement provides for the sovereignty of countries to apply precautionary measures when relevant scientific evidence is insufficient but such measures should not be arbitrary, unjustifiable or restrictive to the international trade23 The SPS Agreement recognizes the standards and guideline developed by three relevant organizations: the FAO/WHO Codex Alimentarius Commission (for food and food safety), the International Office of Epizooties (for Animal Health), and the International Plant Protection Convention (IPPC) (for plant health)24. Those standard-setting bodies all have their working groups on safety aspects of GMOs and GM foods. Though SPS agreement does not explicitly mention biotechnology or GMOs, when GMOs are in international trade, and may pose a threat to human, animal or plant life or health in an importing country, the SPS Agreement would apply to national sanitary or phytosanitary measures (SPMs) designed to address the threats prior to import. Under SPS, WTO member States must ensure that sanitary and phytosanitary measures are based on an assessment of risks to human, animal or plant life or health (Article 5(1)). Risk assessment techniques developed by relevant international organizations must be taken into account. Risks are to be assessed taking into account a number of enumerated factors including available scientific evidence (Article 5(2)). Pursuant to Article 5 (3) of the SPS Agreement, Member States can also take "relevant economic factors" into account when assessing the risk, and establishing risk management measures (i.e. establishing the appropriate level of protection as manifested by a sanitary or phytosanitary measure). Economic measures include (1) the potential damage to production or lost sales; (2) costs of control or eradication; and (3) relative cost effectiveness of alternative approaches to limit risks.

21 The SPS defines of Sanitary to mean any measures that applied to protect animal or plant health from risks arising from entry, establishment or spread of pests, diseases and other organisms; additive, contaminants, toxins or diseases organisms in foods, beverages or food stuffs; diseases carried by animals, plant or plant products, and any other damages within the territory .

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Article 2.1 Article 2.3 read together with Article 3.3 24 Article 3.4 and Clause 3 in Annexure A

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(b) Technical Barriers to Trade (TBT) AgreementsLike SPS agreement, Technical Barriers to Trade (TBT) was negotiated prior to the commercialization of any GM products. The TBT Agreement intended to ensure that WTO members do not use technical regulations and standards as disguised measures to that are restrictive to trade. In international trade law, health and environmental standards and regulations, labeling, symbols, and packaging marking can be considered as technical barriers to trade.

How is TBT Agreement relevant to GM technology/biosafety?The TBT Agreement applies to all products. It does not apply to sanitary and phytosanitary measures. Therefore, the SPS Agreement would apply where a biotechnological product may be a risk to human, plant or animal health. The TBT Agreement would apply where, for example, a product is merely labeled as containing GMOs. The TBT Agreement is relevant to GM products because it generally applies to technical regulations and standards, including packaging, marking and labeling requirements. It also applies to conformity assessment procedures. For example, GM crop commodities that have been assessed and found to be "substantially equivalent" to their conventional counterparts would be considered "like products" and thus would not require specific labeling.

(c) The Codex Alimentarius CommissionThe Codex Alimentarius ensures that consumers receive products that meet internationally accepted minimum acceptable quality levels, are safe and do not present a health hazard. In addition to specific standards, the Codex also includes related texts. Related texts include advisory instruments: statements of principle, codes of practice, guidelines and codes of technological practice. Some of these instruments apply to food and food products that have been derived from GM technology (genetically modified). The Codex has been working on food safety issues surrounding GE organisms and their food products for a number of years and has generated consensus documents that discuss how to conduct food safety risk assessments for GE organisms and their food products. Those documents include Principles for the Risk Analysis of Foods Derived from Modern Biotechnology, and Guideline for the Conduct of Food Safety Assessment of Food Produced Using Recombinant-DNA Microorganisms.

(d) The International Office of Epizooties (OIE)The OIE, the World Organisation for Animal Health was established in 1924. It sets out standards for movement of animals and animal products. The main objectives are to prevent the spread and introduction of animal diseases and harmonise regulations for trade in animals and

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animal products. In regards, to GMOs the OIE has conducted work on scientific evaluation of GMOs that are pharmaceuticals for animals.

(e) International Plant Protection (IPPC)25The IPPC regulates plant pests, it also regulates any organism, object or material capable of harbouring pests or spreading pests that affect plants or plant products26 the purpose of such regulation is to prevent the spread and introduction of these pests and promoting measures for their control. IPPC provides a framework to develop and apply harmonized phytosanitary measures through the elaboration of international standards, the creation or management of national plant protection organizations. IPPC defines term Pest as any form of plant or animal life, or pathogenic agent, injurious or potentially injurious to plants or plant products27. Therefore, the IPPCs scope of application is broad enough to cover products of modern biotechnology and genetically modified organisms that may directly or indirectly injury or damage plants. Under the IPPC, the Commission on Phytosanitary Measures was established. The Commission recommended for the development and adaptation of the international standards on phytosanitary measures (ISPMs). ISPMs are the standards, guidelines and recommendations recognized as the basis for phytosanitary measures applied by Members of the World Trade Organization under the Agreement on the Application of Sanitary and Phytosanitary Measures. Also under IPPC there are detailed Standard Specification on the Plant Pest Risks Associated with LMOs/Products of Modern Biotechnology and Code of Conduct for the Import and Release of Exotic Biological Control Agents which provides for the handling and release into the environment of strains of organisms created artificially by genetic engineering techniques In general, the code applies to exotic biological control agents (i) imported for research; (ii) imported and released for biocontrol; and (iii) imported and released for use as biological pesticides.

3.0 Section 3 - International Trade regimes Versus Modern Biotechnology in the Developing countries

What this Section is about The objective of this Section is ;

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The International Plant Protection is an FAO agreement which was originally adopted in 1951. It has been subsequently revised with the latest revision adopted in 1997. 26 (Article .I (4)). 27 Article II(2)

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To discuss in brief how international instruments affect policies and legislative frameworks of developing countries. To examine challenges that developing countries such as Tanzania may face in deciding for an appropriate policy and legal framework for regulating issues of modern biotechnology technology.

Aims of this Section To show what should be an appropriate GM technology/biosafety regulatory regime for the developing countries. What you will learn How international instruments can be of assistance to developing countries in establishing appropriate national regulatory structures for GM technology and biosafety. As we have seen from discussion on international instruments, developments in GM technology are compelling for revising the approach towards the policy and legal regimes for members of WTO. In that regards, various national governments are bringing in changes in the national laws in order to protect and encourage investments in GM technology. These policy changes have further widened the scope of the ongoing debate28. Along with this, the negotiations are taking place in other international organizations such as the WTO, which may have impact on international trade. They include Technical Barriers to Trade (TBT), the Sanitary and Phytosanitary Measures (SPS), Trade-related Aspects of Intellectual Property Rights (TRIPs) and Agreement on Agriculture. Biotechnology issues also become relevant in the overarching trade issues such as market access and competitiveness. While developed countries have established their national frameworks to deal with GM technology and biosafety focusing primarily on domestic priorities and strategies, most developing countries are doing so under less flexible circumstances. They increasingly seem to be expected to set up their national regulatory schemes based on the requests and expectations of their main trade partners. For example, some developing countries like India, Egypt etc have embarked on the GM adoption for some years, this includes development of regulatory mechanisms for handling GM. However, in most of those countries, no agricultural biotechnology product has yet been approved. The regulatory regime in different countries has emerged at different pace and has taken all different directions. The national responses have largely been driven by specific national situations. In other countries such as Tanzania, specific policies for GM technology or regulatory framework to accommodate the safe handling of GMOs are yet to be approved despite being members to CBD and CPO for more than three years.

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Sachin Chaturvedi S. R. Rao: Biotechnology and International Trade Regime: Options before Developing Countries, at http://scholar.google.com/scholar%3Fq%3Dauthor:%22Chaturvedi%22+intitle:%22Biotechnology+and+I ternational+Trade+Regime:+Options+...%22+%26hl%3Den%26lr%3D%26oi%3Dscholarr

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On the other side, implementation of International agreement relating to IPR has brought a lot of debates in the trade regime of the world. Though patents were designed for industrial application, with biotechnology, in some countries, patent are now granted on micro-organisms. In context of developing countries patents for plants seems to be a recent phenomenon, though it has been there for sometimes. Impact of IPR on biodiversity has been the subject of intense debates among countries and commentators. Although reliable data and information has been produced regarding the social and economic impacts and importance of IPRs in developing countries, limited information actually exists regarding impacts of IPRs on conservation and sustainable use of biodiversity per se. For the developing countries, it is argued that one verified impact of IPRs (specifically patents) is interference on the principle of sovereign rights of countries over their genetic resources and to some degree on sustainable use. The regime allows direct and indirect misappropriation of biological and genetic resources and traditional knowledge (biopiracy). It is also argued that IPRs has negative impacts on developing countries agriculture by enhancing the concentration of research and development capacities in hands of private sector conglomerates (usually involving biotechnology companies, universities, research institutions) or dependent on private sector funds, promote widening of the technology gaps between North and South, limit availability of research materials, etc. As we have seen from discussion in the International Agreements, the CBD has specifically recognized the complex and controversial relationship between IPRs an biodiversity (articles 15, 16, 19) Article 16(5) is particularly relevant in the sense that it take cognizance of the impacts of IPR (patents and other intellectual property rights) on conservation, sustainable use and benefit sharing of biodiversity. It is expected also that through on going negotiation on implementation of various international agreements, developing countries will have proper option to choose in drafting their IPR and ABS legislation. We have also seen that through option provided under the WTO- TRIPs, many developing countries decided to legislate their own national PVP laws based on sui generis system. However, within the regional trading blocks, countries are indirectly compelled to adopt a new legal and policy approaches. For example, recently, Southern Africa Development Community (SADC) has started to prepare a Regional Protocol on Plant Breeders Rights which is compatible with UPOV. However, within the region, only two countries (South Africa and Zimbabwe are members of UPOV. These two countries and Tanzania are only countries having PVP legislation. As far as adaptation of modern biotechnology on aspect of GMOs, there remains a degree of unpredictability of outcome with regard to the application of regulatory measures governing GMOs, and with regard to potential challenges to such measures. Policy ambiguities and uncertainties, as well as gaps, exist. On the other hand, while many developing countries are members to various binding and non- binding International instruments relating to safety and standards, the ability of those countries to participate in standard setting bodies, and to implement international standards, has been lacking. It seems also that WTO agreements are increasingly being replicated or reflected in other fora, For example, CPB provided expressly not

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to limit its members obligations to other international commitments, while other WTO or FAO agreements gives rooms for members to participated in other international or regional agreements which in one way or another may apply inconsistent with WTO or FAO agreements29. What should be done by developing countries? Most of the international legal regimes are worded in a manner that can accommodate member countries divergences. What shape will a policy or regulatory framework of a particular country take, will depend on the available options to that particular country for furtherance of its developmental goal. The options will have to be well though out, taking into consideration various factors including the countrys natural resources, its capacity to exploit and protect them, its economic development goals and other social factors such as culture and customary norms of its communities and people.

4.0Section 4 National Policies and legislation related to Biotechnology/ Biosafety in Tanzania

What this Section is about This Section examines policies and national legislation related to biotechnology and biosafety in Tanzania. It covers also existing national biotechnology and biosafety forum and international agreement which Tanzania is a party. Aims of this Section To identify exiting national policies and legislation impacting on GM technology/biosafety. To show extent of compliance by Tanzania to the International Agreements. To show the existing strength and gaps in policies and legal framework that may hinder friendly adoption of modern biotechnology.

What you will learn International agreements which Tanzania is obliged to implement. Existing policy, national regulatory framework for GM technology and biosafety regulation. Existing strength and gaps in GM technology/biosafety regulation.

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For example Draft OAU Model for Biosafety is criticized for having some provisions which are inconsistent with the Cartagena Protocol on Biosafety

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4.1

Implementation of International Agreement in Tanzania

Tanzania is a member to the following international agreements which it is obliged to implement: (i) Cartagena Protocol on Biosafety (acceded on 16th March 2003) (ii) International Treaty for Plant Genetic Resources for food and Agriculture (ratified in February 2004). (iii) WTO Agreements (TRIPs, SPS, TBT, etc) - (since 1995) (iv) International Plant Protection Convention - acceded in February 2005. (v) WIPO since 1983 (vi) CBD ratified on 8th March 1996. Apart from being a member to the above referred international instruments that are impacting on GM technology and biosafety, Tanzania has also shown commitment to join UPOV in a near future.

4.1.1 What obligations does Tanzania has under the International agreements(d) Among obligations that are provided to the contracting Cartagena Protocol on Biosafety and IT-PGRFA include: parties under the CBD,

To build capacities for research, assessment identification, evaluation and monitoring of biodiversity and develop strategies for conservation and sustainable utilization of her biological resources. To designate of the national Focal Point (NPF) to be responsible for its behalf to liaison with the Protocol Secretariat. To designate of the one or more competent national authorities (CAN) to be responsible for performing administrative functions required under the protocol. Provide the Biosafety Cleaning House (BCH) with detail of national contact points and other information etc. Make some information available through the BCH as provided for under Article 20 of the Cartagena Protocol (Information on the competent national authority(ies); through the BCH information on existing laws, regulations or guidelines relevant to LMOs and all other information resulting form implementation of Cartagena Protocol) Formulate relevant legislation that comply with CBD, CPO and IT-PGRFA

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(e) Under IPPC, Tanzania is required to have a National law that provides for among other thing (National Organization mandated for Plant Protection issues (National Plant Protection Organization); Procedures for Pests risk analysis etc.

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(f) Under TRIPs Tanzania is obliged to ensure protection of IPR through it own national legislation be in the form of patent, sui generis or combination of the two.

4.1.2 What Tanzania have done to comply with international agreementIn order to comply with various International Instruments, Tanzania has made some policies and legal reforms. This includes: Formulation of National Biotechnology Policy (not yet completed); Enactment of the Environmental Management Act 2004 to implement CBD. Adoption of National Biosafety Framework in 2006. Designation of National Biotechnology and Biosafety Focal Points/Competent Authorities.

Apart from policy and legal reform, Tanzania participated in the following programs for capacity building: UNEP/GEF project aimed at supporting capacity building for on Biosafety regulation. USAID funded Association to Strengthen Agricultural Research in East and Central Africa (ASARECA). ASARECA facilitates collaborative research between those countries linked to ASARECA (e.g. Uganda, Kenya, Ethiopia, Eritrea), East African Regional Programme and Research Network for Biotechnology, Biosafety and Biotechnology Development (BIO-EARN). BIO-EARN is a programme designed to build policy and research capacity in agricultural biotechnology.

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At regional level (SADC and East African Community): Tanzania is participating in the SADC programme for harmonization of policies and regulatory framework for seed Industry in order facilitates regional Trade. Harminsation covers Seed certification, phytosanitary and quarantine issues). Also at SADC, Tanzania is involved in the development of regional common protocol for the Plant Breeders Rights which is compatible with UPOV.

At East African Community, Tanzania is or may be bound to implement the following documents that may have legal implications in the modern biotechnology (a) East African Community, Environmental Assessment Guidelines (this guidelines requires projects that occur on one country but that may impact one or more countries to have a single EIA); and (b) Harmonized Sanitary and Phytosanitary Standard Measures (these documents are in the process of adaptation for use in the form of Protocol). (c) Harmonized procedures for regulation of GMOs ( in the negotiation process)

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4.2Relevant Policies for regulation GM technology and biosafetyA national biotechnology policy serves to integrate political, social, ethical, health, economic and environmental considerations into decisions regarding the safe and appropriate use of GM technology and GM products. Currently, Tanzania does not yet have a biotechnology or biosafety policy in place. However, there are various policies and strategies that are impacting on Biotechnology which are implemented by different sectoral Ministries (e.g. Ministries responsible for science and technology, health, Agriculture, environment, trade etc). These Policies are:

4.2.1 Draft Tanzanian Biotechnology PolicyThe Tanzanian Biotechnology Policy is still in formulation stages, it was drafted by the Ministry responsible for Science and Technology and is still going through the government processes for adoption. The draft policies recognizes the importance of GM technology in national development, and among issues addressed in the Policy include the need to have skills to meet development objectives that require biotechnology applications. It provides for biotechnology development strategies funding, institutional framework and capacity building in order to support biosafety regulatory system. The draft policy recognizes also that establishment of appropriate mechanisms for risk assessment, risk management, risk communication and mitigation requires human resource environment that has scientific knowledge and skills to implement functional biosafety regulatory system. It is important to point out that in its broader context, the policy does not specifically address GMOs. It deals with it in the general context of biotechnology development. It is however clear that in Tanzania, adaptation of modern biotechnology and GMOs experiments have not been hindered by the absence of an official policy.

4.2.2 National Trade Policy 2003The National Trade Policy aims at promotion of trade. It addresses international agreements relevant to biotechnology i.e. TBTs and SPS. Under the Trade policy, it is expressly provided that TBTs and SPS will not be used as unnecessary trade restrictive measures on imports and that the Government will continue to observe and enforce international standards rigorously in order to protect economic activities, particularly in the agricultural and livestock sectors from the dangers of exotic pests through SPS measures and ensure consumers protection against substandard and harmful products through application of suitable measures under the SPS and TBT agreements.

4.2.3 The National Environmental Policy (1997)The National Environmental Policy recognizes the importance of conservation and sustainable utilization of the national biological resources. It stipulates the need for undertaking programmes and actions for the conservation and sustainable utilization of biological resources to prevent and control the causes of significant reduction or loss of biological diversity (Paragraph 32). It

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further states, Strategic measures shall be put in place for the development of biotechnology, especially to ensure fair and equitable sharing of the results and benefits arising out of utilization by foreign recipients, of genetic resources originating from Tanzania, and biosafety. The Policy puts emphasis on environmental impact assessment (Paragraphs 63-67) as an important policy instrument that would facilitate the integration of environmental concerns in the decision-making process. It further states that one of the cornerstones of the environmental impact assessment process will be the institution of public consultations and public hearings in the EIA procedures. It further acknowledges the need to have an environmental management legislation to implement it (Paragraphs 68-72).

4.2.4 National Science and Technology Policy for Tanzania (1996)The Policy focuses on, inter alia, biotechnology, genetics and genetic engineering, and exploitation of medicinal, agrochemicals and industrial chemicals.

4.2.5 The National Forest Policy 1998This Policy provides for the forest biological conservation and advocates for the environmental impact assessment. However, due to the recent nature of modern biotechnology, the Policy is not explicit on GM technology/ biosafety matters.

4.2.6 National Agriculture and Livestock PolicyThe overall objective of the policy on Food and Agriculture is to achieve self-sufficiency in food and food security through increased food and livestock production as well as increased production of commodities for export. The policy places emphasis on food production and underscores the need to utilize science and technology in order to develop the agriculture sector.

4.3National Biosafety frameworkA national biosafety framework is a combination of policy, legal, administrative and technical instruments that is set in place to address safety for the environment and human health in the context of modern biotechnology. They are intended to serve as mechanisms for ensuring the safe use of GM products without imposing unacceptable risk to human health or the environment, or unintended constraints to technology transfer. Within the international context, establishing such a system has many dimensions and associated challenges and will require investments to build institutional and human capacity for implementing and managing the developed framework. There is neither a single best approach nor standard that reflects national environmental, cultural, political, financial and scientific capacity to build a National Biosafety Framework.

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In Tanzania National Biosafety Framework was approved in the last year 2006 and contains the following main objectives: (i) To establish science-based, holistic and integrated, efficient, transparent and participatory administrative and decision making system so that Tanzania can benefit from modern biotechnology while avoiding or minimizing the inherent environmental, health and socio-economic risks; and To Ensure that the research, development, handling, transboundary movement, transit, use, release and management of GMOs are undertaken in a manner that prevents or reduces risks to human and animal health, biological diversity.

(ii)

The approved NBF appears to have an objective of encouraging and assisting the establishment of an appropriate national regulatory framework. In its face, the Framework is neither a policy nor a binding legal document for biosafety regulation.

4.4National Biosafety ForumThe National Biosafety Forum for Tanzania comprises of the following institutions in the rank of hierarch: National Biotechnology Advisory Committee (NBAC). (Established in April 2002 under the Ministry of Science, Technology and Higher Education). NBAC is National Biotechnology Focal Point and is responsible for advising the Government on all matters concerning biotechnology, policy, and institution framework and biosafety regulation. Ministry responsible for Environment (National Focal Point for Biosafety) NBF is responsible for review and approve biosafety applications for research, confined release, precommercial release or placing on the market; and to oversee the implementation of biosafety issues. National Biotechnology Advisory Committee (Ministry of Science) and National Biosafety Committee (within Ministry of Environment). National Biosafety Sub-committees (Monitoring, Assessment and Scientific Advisory Committee). Competent Authorities/ Relevant Ministries (to be designated by NPFP)

Institutional Biosafety Committee. According to National Biosafety Framework, role of the National Biosafety Committee include: (i) (ii) (iii)Review of relevant applications; Advise on policies, legislation and other policy instruments; Undertake study and evaluation of biotechnology research and control and minimize the concomitant risks and hazards associated with the deliberate release of GMOs in the environment.

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(iv) (v)

Undertake study and evaluation of biotechnology research and control and minimize the concomitant risks and hazards associated with the deliberate release of GMOs in the environment; and Advise the NBFP and Competent Authorities.

Competent Authorities which will be responsible for following up, supervising and controlling the implementation of the biosafety regulations are designated NBFP. The roles and responsibilities of the Competent Authorities include: (i) (ii) (iii) (iv) (v) To review relevant applications or proposals for development, introduction, import, export, transit, contained use, release or placing on the market; To review, make or have made risk assessments of GMOs or products thereof. To advise the NBFP; Designate inspectors and undertake inspection as well as other control measures to ensure compliance with the Biosafety Regulations; and To undertake assessment of socio-economic impacts as well as ethical and cultural impacts.

Institutional Biosafety Committee (IBC) are designated by Institutions which are involved in the import, export, handling, contained use, release or placing on the market of GMOs or products of GMOs. The Roles of IBC are:(i) (ii) (iii) To review the containment and confinement levels required by the Guidelines for the proposed research; To hold discussions on the comparative ecological, economic and social impacts of alternative approaches to attain the purpose/objectives of the proposed GMO and other services; To report immediately to the relevant Ministries/Competent Authorities and appropriate official in the concerned organization, any significant GMO activities, problems with or violations of the regulations and any significant research related accidents and illness.

4.5Weakness of the existing biotechnology and biosafety framework The existing structure of biotechnology and Biosafety framework does not provided for effective coordination of relevant organs/ institutions. While issues of biotechnology are handled by MSTHE, on the other hand issues of biosafety are handled by the Division responsible for environment and . Though the National Biosafety Framework and EMA 2004 require establishment of institutions to deal with environmental/biotechnology issues within sectoral ministries, it is still not clear on responsibilities and structure of accountability of such sectoral institutions to the National Bodies that are referred to as Focal Points. Under the CPB, it requires that a country to establish NFP and CNA for implements the Protocol including receiving notification and communicating decisions under the AIA 33

procedures. In the context of the Protocol, a single entity may be designated to fulfill the purposes. However, a CNA is required to have capacity in terms of financial and human resources to handle issues of LMOs. One of the major challenges for the designated NFP for Tanzania is lack of resources. It is not clearly provided in the existing framework, how the institution for implementing biotechnology and biosafety will be funded and capacitated. The existing policies are implemented in parallel, without harmony. Some of these policies, which are very important to biotechnology, for example National Agriculture and Livestock policy (a Policy that could have assisted in agricultural biotechnology) is outdated and need to be reviewed.

4.6Legal Instruments relevant for GM technology and Biosafety regulation in TanzaniaAs we have seen from previous sections, Tanzania is a member to various international and regional instruments respecting biotechnology and biosafety. Apart from preparing policy framework for biotechnology, at that national level there are some legal instruments that are impacting on modern biotechnology.

4.6.1 Constitution of the United Republic of TanzaniaThe Constitution of the United Republic of Tanzania is a mother law of the land. It takes precedence over any other law enacted by the Parliament. In its Article 14, the Constitution states, that Every person has the right to live and to the protection of his life by the society in accordance with the law. Article 18 Section 2, provides that every citizen has the right to be informed at all times of various events in the country and the world at large, which are important to the lives and activities of the people and also of issues of importance to the society. In view of the above referred provision, the Constitution is very fundamental law providing for basic rights for the people of Tanzania i.e. to have the right to information; to participate in public debate; and to protect their environment, which are important elements of Biosafety regulation as enshrined in Cartagena Protocol.

4.6.2 Tanzania Food, Drugs and Cosmetics Act No.1 of 2003The TFDA legislation sets out the procedure for controlling the importation, manufacture, labeling, marking or identification, storage, selling and distribution of these products or any material or substances used in their manufacture. The TFDA has inspectors who could be used to enforce biosafety requirements under its mandate, particularly in respect of Articles 5 and 11 of 34

the Biosafety Protocol, on pharmaceuticals an