The objective of this paper is to examine the viability and potential effects of different actions that Germany and the European Union (EU) can take to curb the growth of GHG emissions from the international transport sector. It analyzes different options that policy makers have available to reduce transport induced emissions. In doing so, this paper takes the impacts on trade, especially for developing countries, into account. The overarching question that is reverberates throughout this paper is: what are the advantages and disadvantages of different measures that Germany and the EU can take to limit emissions from trade-related transport?

Las negociaciones en curso para un Acuerdo de Asociación Económica entre Centroamérica (CA) y al Unión Europea (UE) han puesto el tema ensu punto más alto de la discusión desde que se iniciara en la región hace unos veinte años.

Agricultural biotechnology, and particularly as it involves genetic modification, promises a number of important benefits. These include improving agricultural yields by increasing the resistance of crops to pests and enabling them to flourish in harsh natural environments, improving the productivity of farmers, and reducing pesticide use. While these benefits have largely been confined to the agricultural sector, and the immediate physical environment surrounding it, future technological advances may yield additional benefits, including the
development of foods that improve the health of consumers.

At the same time, concerns have been raised about the potential negative impacts of genetic modification. From an environmental perspective, critics note the possibility of cross-pollination and gene flows to traditional varieties and the inability of regulatory systems to adequately manage the trade in genetically modified (GM) seeds in a way that ensures their segregation from traditional
varieties. With respect to development impacts, scepticism has been expressed about the ability of agricultural biotechnology to fulfill its promise, given the trends such as lack of focus on the development of crops and traits that would meet the needs of resource poor farmers, difficulty of poorer groups in accessing technologies protected by patents, and the potential for biotechnology innovations to displace traditional agriculture.
Agricultural biotechnology thus poses particular challenges and opportunities for regulators and policy-makers. In itself, however, it is neither good nor bad: agricultural biotechnology is merely a tool that, in order to serve sustainable development, should be oriented towards economic, social, environmental and other public policy objectives. Countries must define their broad agricultural and development policy objectives and only then determine whether, how or to what extent the development and adoption of GM technologies and products can facilitate them. In this regard, there is a range of needs and priorities that regulators and policy-makers may have to take into account and balance in their choices.

These needs and priorities include promoting food security, reducing agricultural poverty, increasing access to global markets, improving environmental quality and the welfare of agricultural workers, protecting biodiversity, improving public health through safer or healthier foods and encouraging the domestic development of research and development. Establishing an adequate approach to agricultural biotechnology - addressing and balancing the different needs, priorities, and objectives in national, regional, and international instruments and policies - is a complex task.
Developing countries have particularly struggled to develop policies and regulations that consider and respond to the specific challenges and opportunities posed by agricultural biotechnology. The need for such policies and regulations, however, is mounting. For the most part, developing countries do not produce GM crops, but the importation of such crops and derived products is increasingly widespread. Efforts are thus underway to evaluate the implications on their respective economies, environment, and societies, and to adopt the policies that will orient the use of agricultural  biotechnology towards national, regional, and international sustainable development goals.
The objective of this report is to identify the particular policy and regulatory considerations and options for developing countries in connection with the development and commercialization of GM technologies and products. In addition, this report aims to examine some of the policy-making processes that facilitate the review of these considerations and options. After this introduction, Section II explores the distinctive issues raised by agricultural biotechnology in developing countries, and describes the different options and considerations for relevant regulations and policies. Section III provides case studies on the way a number of countries, both developed and developing, have addressed the various promotional and regulatory issues posed by GM technologies and products. Section IV then elaborates a series of frameworks that should enable policy-makers to think through the various policy issues and options raised by agricultural biotechnology. Section V focuses on public participation, an important component in the design, implementation and monitoring of an agricultural biotechnology framework.
Section VI concludes the paper with some final analysis and remarks.

This study is made available as a working paper in order to facilitate broader understanding, consultation and inputs. It is intended to be a contribution towards the improvement of transparency and efficiency of patentability examination for pharmaceuticals inventions, particularly in developing countries. It proposes a set of general guidelines for the assessment of some of the common modalities of pharmaceutical patent claims, and suggests elements for the development of public health-sensitive guidelines for the evaluation and review of pharmaceutical patents at the national level. It examines the practices of some patent offices and suggests some mechanisms that may be adopted to incorporate public health perspectives in procedures for the granting of pharmaceutical patents.

This working paper is the result of an ongoing series of technical consultations and seminars organized by ICTSD, UNCTAD and WHO. Consultations held include the following: 1. Technical consultation, jointly sponsored by ICTSD, UNCTAD and WHO, on 14 September 2006 in Geneva. Participants in this consultation included Andre Escher, Swiss Patent Office; Caroline Ngome Eneme, South Centre; Cecilia Oh, WHO; Christophe Spennemann, UNCTAD; David Vivas, ICTSD; Gaule Patrick, Chairman of Economics and Management of Innovation Ecole Polytechnique; German Velasquez, WHO; Hans Bartels, WIPO; Jayashree Watal, WTO; Johanna Von Braun, ICTSD; Kiyoshi Adachi, UNCTAD; Milani Barbara, WHO; Octavio Espinosa, WIPO; Pascale Boulet, MSF; Preeti Ramdasi, ICTSD; Ricardo Melendez-Ortiz, ICTSD; Roya Ghafele, WIPO; Sangeeta Shashikant, TWN; Sisule Musungu, South Centre; Tony Taubman, WIPO; and Yuvan Beejadhur, UNCTAD.

2. Technical consultation, organized by the Food and Drug Administration (FDA) of Thailand in cooperation with WHO, in October 2005 (comprising representatives of drug regulatory authorities and patent offices of China, Indonesia, Malaysia and Thailand). During the event, comments were provided by Suradet Atsawintarangkun, Departament of Intellectual Property, Thailand; Achara Eksaengsri, Government Pharmaceutical Organization, Thailand; Narumol Dachanantawitaya, Departament of Intellectual Property Thailand; Jade Donavanik, Faculty of Laws, Siam University, Thailand; Farsai Chanjaruporn, FDA, Thailand; Suchart Chongpraesert, FDA, Thailand; Muhammad Farid Wong, Ministry of Health, Malaysia; Sasitorn Kittivoravikul, Thai Manufacturers Association; Nilsuwan Leelararamee, Thai Manufacturers Association; Jiraporn Limpananont, Faculty of Pharmaceutical Science, Chulalongkorn University, Thailand; Cecilia Oh, WHO, Geneva; Linda Sitanggang, FDA Indonesia; Yuwadee Patanawong, FDA, Thailand; Werawan Tangkeo, FDA, Thailand; Karin Timmermans, WHO Regional Office, South-East Asia Region; Frida Tri Hadiati, FDA, Indonesia; Vinit Utsavakitviree, FDA, Thailand; German Velásquez, WHO, Geneva; Krisantha Weerasuriya, WHO, Regional Office, South-East Asia Region; Farid Wong Abdullah, Ministry of Health, Malaysia; Wen Xikai, State Intellectual Property Office, China.

3. Review process held in June 2006, in which patent and public health experts from Australia, UK and WHO were asked for written comments and inputs on the draft guidelines. This review process benefited from comments by Tahir Amin, Solicitor of the Supreme Court of England and Wales, UK; Trevor Cook – former UK Patent Office; Susan Walters – former Australian FDA.

4. Expert consultation, organized by WHO in July 2006, with representatives of the Patent Offices of Argentina, Paraguay and Brazil. This event benefited from the comments made by Mabel Berardoni, Ministerio de Salud y Ambiente de la Nación, Argentina; Fabián Biali, consultor, Argentina; Monica Caetano, ANVISA, Brazil; José Cardillo, INPI, Argentina; Nora Donato, ANMAT, Argentina; Blanca García, MIC, Paraguay; Mirta Levis, CILFA, Argentina; Luís Carlos Lima, ANVISA, Brazil; Lilian Martínez, Ministerio de industria y Comercio, Dirección de la Propiedad Intelectual, Paraguay; Graciela Moltrasio, Facultad de Farmacia y Bioquímica de la UBA, Argentina; Susana Piatti, consultora de patentes, Argentina; Ana Paula Juca, ANVISA, Brazil; Alejandra Stoykowsky, INPI, Argentina; Juliana Vallini, ANVISA, Brazil; Germán Velásquez, WHO.

Note: This study is currently under a review process. If you would like to provide comments or inputs to this working paper, please send them to dvivas@ictsd.ch.

The study begins by examining the legal nature of Article 8(1) of TRIPs. It concludes that 8(1) provides a sound legal basis for national policy and legislative safeguard initiatives. This conclusion is supported by the international norms established by the Vienna Convention on the Law of Treaties and by other standard legal practices. The meaning and implications of the term ‘nutrition’ in Article 8(1) are then examined. Nutrition is a term whose definition has evolved over a period of years in various international forums, primarily those of the Food and Agriculture Organization of the United Nations (FAO). Its scope is extremely broad, including sanitation, health care and socio-economic factors as well as agriculture. This study focuses on smallholder agriculture for several reasons:

• agriculture plays the principal role in nutrition, it provides food

• approximately 75% of the world’s undernourished are smallholder farmers

• smallholder agriculture is of fundamental importance to the majority of the world’s developing economies

A large part of the districts of Kitui and Cusco are considered to be marginal in agricultural terms. This is considered to be representative of the general situation of smallholder farmers. The majority of the agricultural lands in Kenya and Peru fall in this category and smallholder farmers are largely restricted to the least productive areas in many developing countries.

Several key elements of the smallholder agricultural system are then examined:

• Seed. Farmers in Kitui make limited use of formal sector (commercially or institutionally developed) seed, which consists of imported hybrids in the case of the private sector and nationally developed composites and hybrids in the case of the public sector. No evidence was found of efforts to introduce new varieties specific to the conditions in Kitui. Farmers in Cusco make almost no use of formal sector seed, for any crop, as it is not perceived to provide any comparative advantage. There is no on the ground evidence of any significant private sector presence, or interest, in the region. In both Kitui and Cusco the informal (farmer developed) seed sector dominates the agricultural system. NGOs and the public sector, in the case of Kitui the FAO-Government of Kenya Farmer Field Schools project, are making valuable efforts to support this system but there is minimal funding for any research into seed to support these initiatives.

• Pesticides. Farmers in Kitui make limited use of commercial pesticides in food storage and vegetable production. There is a limited range of commercial pesticides available and there are serious problems regarding their effectiveness. There is some interest on the part of farmers in alternative approaches to pest management but no evidence of current initiatives to support this was found. Farmers in Cusco make virtually no use of commercial pesticides for any crop. However, they have developed a sophisticated system of pest management based on informally developed pesticides and a range of other practices commonly found in more formal integrated pest management (IPM) strategies. No evidence of significant formal research and development support for pest management solutions was found. The Peruvian public sector has made efforts in this area but has not had major impact.

• Fertiliser. Commercial fertiliser use is minimal to non-existent in both Kitui and Cusco. Farmers, with the support of the public sector and NGOs, are making efforts to develop composite manure fertilisers and other solutions.

• Livestock. This study did not focus on livestock, but this should not be considered as suggesting they are not critical elements of smallholder agricultural systems. The cost and availability of appropriate formal veterinary medicines is a problem. Ethnoveterinary medicines are widespread and largely effective. No evidence was found of formal research into ethno-veterinary medicines in Kitui or Cusco and there is concern over issues of the protection of traditional knowledge where they are examined. While not a current concern, the diversity of the genepool of cattle may be an issue for the future. The quality of forage crops has a fundamental impact on the productivity of cattle. The situation with forage crops is the same as that with seed. In Kitui forage crops fit the situation of minor food crops, there is no significant use of formally improved forage crops.

• Agricultural Research. The private sector, for market reasons, has little or no interest in developing products for smallholder farmers. Intellectual property rights, by focusing on an ability to capture benefits through monopolies, exacerbate this trend. The public sector traditionally focuses on the needs of smallholder farmers but its effectiveness is threatened by intellectual property rights in two ways: (i) private sector intellectual property rights may limit public sector access to innovations and germplasm that may be adaptable to smallholder needs and conditions while also limiting public sector research options due to concerns over the unhindered distribution of the products of its research, and (ii) failure of intellectual property systems to preserve the integrity of the public domain, and the consequent development of IPR strategies in public institutions, risks distorting research priorities to the detriment of smallholder farmers.

The evidence found in this study points to the fact that intellectual property rights have failed to create any significant benefit for smallholder farmers. It also suggests that they are contributing to a widening of the gap between commercial scale agriculture and smallholder farmers, thus further marginalising them. Finally there is a risk that as the use of IPRs spreads in developing countries its increased enforcement may threaten many key elements of the informal agricultural system, in particular as regards seed. This situation threatens developing country nutritional security on two levels. At the local level smallholder farming households are threatened by the undermining of their subsistence livelihoods while, at the national level, food systems are threatened by a collapse in the contribution of the smallholder sector. In policy terms, the impacts of intellectual property rights on nutritional security have the potential to affect the majority of the population in many developing countries and thus should be examined as a matter of urgency.

It is recognised that a number of initiatives could be undertaken to ameliorate this situation in the context of national cross-sectoral policy and legislative reviews. However, the recognition of three basic principles at the international level is suggested as a supportive framework for such national initiatives:

• The activities of smallholder farmers, in particular the saving, use, exchange and sale of farm-saved seed, should be explicitly stated as not subject to the rights of intellectual property rights holders.

• In accordance with the purpose and objectives of TRIPs, effort should be made to develop effective incentives for research targeted at smallholder farmers. This should include the possibility of intellectual property rights creating ‘space’ for alternative incentives. Measures to preserve the integrity of the public domain could be considered in this context.

• Limited exceptions to intellectual property rights should be permitted to promote the adaptation of protected products to the needs of smallholder farmers. These should apply to both research and development and to manufacturing and distribution.