- Minakshi Bhardwaj (India/Japan) Institute of Biological Sciences, University of Tsukuba, Tsukuba Science City 305-8572, Japan Email: firstname.lastname@example.org
The internationally accepted definition of biotechnology is as defined in the convention of biological diversity that states "any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products and processes for specific use". This definition is agreed upon and signed by 168 member nations (CBD 2002). Biotechnology provides tools for development and it is thought as one of the solutions to meet the needs of the growing population internationally especially when the standards are becoming higher. Basically, there are three different areas in which biotechnology applications are used, that include food and agriculture, environmental applications, research in drugs, medicine and health care; and general technological developments of science.
Biotechnology is multidimensional so its governance also requires participation from many institutions. The governance of biotechnology has been particularly challenging given the scope and the parameters within which the technology can be applied, used and misused. Many international organizations are expanding their targets to include biotechnology into their immediate priority list to include it into their governing systems. Biotechnology requires good governing systems for the immense potential that has already made the technology havoc. This paper focuses on the role of developing countries in the international governance of biotechnology and the role of developing countries in the international governing systems.
Governance is described in different aspects, based on the institutional framework in which applied, like economics and corporate, environmental, developmental strategies, and ethical perspective. Governance is process of decision-making and the process by which the decisions are implemented. The governance system in general can be described as the framework of social and economic systems, legal and political structures within which humanity organizes itself (UNED 2002). UNDP describes governance as the exercise of political, economic, and administrative authority to manage a nation's affairs (UNDP 1999). It is the complex mechanisms, processes, relationships, and institutions through which citizens and groups articulate their interests, exercise their rights and obligations and mediate their differences. Governance embraces all methods, good or bad, that societies use to distribute power and manage public resources and problems. Since governance is the process of decision-making and the process by which decisions are implemented, an analysis of the governance focuses on the formal and the informal actors involved in decision-making and implementing the decisions made and the formal and informal structures that have been set in place to arrive at and implement the decisions.
The critical importance of democratic governance in the developing world was highlighted at the Millennium Summit, where the world's leaders resolved to "spare no effort to promote democracy and strengthen the rule of law, as well as respect for all internationally recognized human rights and fundamental freedoms, including the right to development." (UN 2000). Critical evaluation of the governance systems is needed for establishing the rules of law at both national and international level given that the decisions taken at the local level have a foreseeable impact on the global governance structures.
The ideals of good governance are based on ethical principles and the way we view ethics. Governance is also related to political philosophy, which has its roots in ethics. One of the ideals of good governance in modern society is participation, not only in the form of gender balance but also participation from all kinds of vulnerable groups in society and it needs to be informed and organized. This means freedom of association and expression on one hand and an organized society on the other hand (UNESCAP 2002). The ideal of participation is based on the ethical principle of respect for autonomy and recognizes the capacity of the participants that may be influenced in the decision making process. Recognizing the negative right to autonomy imposes on everyone the obligation not to coerce or otherwise interfere in other's actions (miller 1996). The ideal of transparency is based on the right to information, which is an extended version of right to education and right to know. It is also related to the utilitarian objective of impartiality that allows impartial consideration and equal consideration to all who could be affected the consequences. In that way transparency aligns with good and mature moral judgment for the choices to be made (Beauchamp and Walters 1994). Responsiveness is another ideal of good governance based on the deontological theories that institutions holding authority of decision-making should respond to the needs of people within a reasonable timeframe. It is also stems from Kantian theory of duties from rules of the reason, which commands that an act is morally praiseworthy only if neither for self interested reasons nor as the result of a natural disposition, but rather from duty. Equity and inclusiveness of governance is based on the ethical principle of justice that requires all groups particularly the most vulnerable, have opportunities to improve or maintain their well being (Tillich 1954).
Accountability is the key requirement for good governance. Accountability is necessary for all the social institutions and stakeholders involved in the governance. Who is accountable to whom varies depending on whether the decisions or actions are taken internal or external to an organization or institution. Accountability cannot be enforced without transparency and the rule of the law. Good governance also means that processes and institutions produce results that meet the needs of the society while making the best use of resources at their disposal. The concept of efficiency in the context of good governance also covers the sustainable use of natural resources and the protection of environment. It is based on mill's utilitarian philosophy, which claims that the good is characterized by seeking (i.e., attempting to bring about) the greatest amount of happiness for the greatest number of people. Accordingly, in the political realm, the utilitarian will support the establishment of those institutions, procedures and technologies whose purpose is to secure the greatest happiness for the greatest number. In contrast, an ethical deontologist, who claims that the highest good is served by our application of duties (to the right or to others), will acknowledge the justification of those institutions that best serve the employment of duties. Thus in governance the institutions that are not able to deliver the minimum goodness either in terms of fulfilling the duties or providing equitable justice and opportunities need to be reconsidered or changed. Since people are by nature sociable; there being few persons who turn from society to live alone - the question follows as to what kind of life is proper for a person amongst people. The philosophical discourses concerning politics and governance thus develop, broaden and flow from their ethical underpinnings.
Governance and bioethics are also related in the ways we view bioethics. As discussed earlier there are different ways to view bioethics. Descriptive bioethics -we can describe the "Bioethic" that people have through surveys, interviews and policy analysis (Macer 1994). People's views based on anthropocentric, ecocentric and biocentric thinking add to the overall projection and direction of the policies that are established later on. Prescriptive Bioethics forms the basis of governance, constitution and laws that governments of the world make for citizens to follow. Also expressed in the form of international guidelines, conventions, treaties and regulations. Interactive Bioethics is seen in debates to formulate the policies intended to build a consensus.
Many agencies associated with the United Nations system contribute to the global governance of biotechnology and also internationally the UN is considered the highest decision making body whose governance is abided by most nations. UN agencies like UNDP, UNEP, UNED, UNFCCC, UNIDO, are involved in the governance of biotechnology. Of them WHO and FAO are two specialized agencies directly involved in promoting biotechnology. These organizations are involved in establishing regulations and developing strategic frameworks for the future of global approaches in biotechnology in medicine and health care, food and agriculture biotechnology. Almost every UN organization works in collaboration with different national and international research institutes, government agencies, NGOs and private sector for effective, and coherent governance.
The United Nations provide a platform and equal opportunity for countries to provide their support in effective governance in the form of helping the agencies by investing in research and development and at the same time un provides a common table for the countries to discuss their national and international difficulties, priorities and finding solutions to the emerging problems. Since the agencies belonging to UN system are depended on the input given by the national governments, they play a critical role in the international decision making of the regulatory framework. The international decisions made at the UN platform have profound affects on the all the countries of the world. Although un is considered to be an equal platform of countries to participate, exercise their rights and put their priorities on the table; during policy formulation there is an apparent division seen in among the countries given their respective interests and choice of developments, which sometimes lead to sectarian groups of nations coming together with common interests. It is also evident in the international governance of biotechnology.
The four major participants in the international governance of biotechnology are the USA, the European union and other OECD countries, and the developing countries. The USA, the countries of the EU and other OECD countries also form the rich countries of the world, where there is a severe competition in terms of biotechnological advancements. However, since the interests of the countries are also depended on the national governing structures and the constitutional mandates, their priorities in the international arena are reflective of the developmental programs and the policies within their countries.
The regulatory procedures for biotechnology in Europe have become very stringent and have been criticized as being greatest barriers to trade. The regulatory procedure of biotechnology in Europe revolves around approaches toward horizontal and sector based legislations. The early regulatory framework for biotechnology was founded on a horizontal approach, which took account of the protection of the both human health and the environment across relevant sectors. Directive 90/220/EEC governed the deliberate release into the environment of genetically modified organisms (GMOs) and placing on the market of products for use as foods, feeds, and seeds as well as pharmaceuticals and directive 90/219/EEC governs work activities involving the contained use of genetically modified micro-organisms (GMMs). Both these are sector-based legislations and introduce provisions to specifically address risk and other issues relevant to the sector in question. The environmental elements still remain linked to the directive 90/220/EEC, which is one point of debate between US and Europe as it mandates a prior, affirmative regulatory approval before a GMO may be released into the environment. A manufacturer or the importer must submit a " notification" or application to the competent authority of the EU Member state where a GMO is marketed for the first time. The notification must provide the general information on the nature of the GMOs, the conditions for their release and an assessment of the possible hazards for human health and the environment. Then the competent authority evaluates within the timeframe of 90 days and, if found safer it could be released into the markets or disapproves it (EU 1990).
In February 2001, the EU adopted major revisions to directive 90/220, designed to improve public confidence in the process by which GMOs are approved. It is named as Directive 2001/18/EC and replaced directive 90/220 in October 2002. The new directive requires mandatory consultation with the public, mandatory labeling and traceability at all stages of the placing on the market, as well as the mandatory monitoring of the long-term effects. This is seen as a barrier to the products from the countries like US that are major exporters of GM food. It is also regarded as a barrier to imports from the other smaller countries, especially the poor developing countries that may not be able to comply with the standards set by the European Union (EU 2001).
Pursuant to policies adopted in early 1990s, the United States, in contrast to the EU does not regulate genetically engineered / modified products as such. In contrast to the EC, which uses a process-oriented approach, the responsible federal agencies in the United States prefer a product-oriented approach for the regulation of genetically engineered products. This latter system does not categorize genetically engineered products on the basis of the technique by which they were developed, but solely on the actual product characteristics. Same or similar standards are applied as to non-engineered products under existing regulatory authorities such as Toxic Substances Control Act, the Federal Insecticide, Fungicide, and Rodenticide Act, and the Federal Food, Drug and Cosmetic Act. Because these regulatory programs are administered by different federal agencies, so, too, a variety of agencies are responsible for regulating genetically modified products. So, for example, the U.S. Department of Agriculture (USDA) regulates plant pests, plants and veterinary biologics. The Animal and Plant Health Inspection Service (APHIS) of the US Department of Agriculture (USDA) authorizes experimental field releases by using field test permits. Since 1993, a simplified procedure has been applicable under certain conditions for the approval of releases such as previous field release experience. APHIS regulations under 7CFR Part 340 pertain to the import, interstate movement or release of certain genetically engineered plants. This includes deregulation for commercial release. The Environmental Protection Agency (EPA) controls microbial and plant pesticides, and novel micro-organisms, and transgenic plants that contain pesticidal components, such as genes or gene products that confer resistance against insects. These products are considered pesticides themselves. Regulation of such crops by the EPA is required only when field testing becomes large scale or the determination of a tolerance level or exemption from a tolerance is required. Aspects of plant health and environmental risks of such plants are assessed by the EPA. In addition, the EPA approves changes in the registration for herbicide use on transgenic crops but does not assess aspects of plant health or potential environmental risks of herbicide-tolerant crops.
The Food and Drug Administration (FDA) controls food, feed, food additives, veterinary drugs, human drugs and medical devices. The US Food and Drug Administration (US FDA) has authority under the Federal Food, Drug and Cosmetic Act to ensure the safety and wholesomeness of most food, except meat and poultry, which are regulated by the USDA, and agents with pesticidal characteristics falling under the jurisdiction of the EPA. Although pre-market approval of a product by the FDA is not formally required, all companies that applied for a new transgenic crop so far completed their consultations with FDA prior to the market introduction of the product. The FDA published in 1992 its statement of policy: foods derived from new plant varieties. The FDA relies on two section of the Act to ensure safety of foods and food ingredients. Whole foods, such as fruits, vegetables and grains are not subject to pre-market approval. The adulteration provisions of section 402(a)(1) place a legal duty on producers to ensure that the foods that they sell to consumers are safe and comply with legal requirements. The FDA has authority to remove a food from the market if it poses a risk to public health. Genetically engineered foods are regulated under this section as well (Maryanski 1997). The food additive provision, section 409, states that substances that are intentionally added to food must be generally recognized as safe (GRAS). Food additives are subject to review and approval by FDA before they are used in food. The FDA does not require labeling of food consisting of or derived from GMOs. Special labeling would be obligatory if the composition of a food developed through genetic engineering differed significantly from its conventional counterpart, for example, if a product contained substances that were not constituents in the human diet before (Rousu and Huffman 2001). The FDA regards the key factors in reviewing safety to be the characteristics of the food and its intended use, rather than the fact that new methods have been used in its production. This is a fundamental difference between the US regulations and those of the European Union, and lies at the root of much of the current controversy regarding GM foods.
Novel food products are not subject to special regulatory approval in the USA if the constituents of the food are the same or substantially similar to substances currently found in other foods (such as proteins, fats, oils and carbohydrates). For example, if a gene from a banana were transferred to a tomato, approval would not ordinarily be required before that food be placed on the market. However, if a sweetening agent that had never been an ingredient of any other food were added to a variety of grapefruit, then the novel food would need regulatory approval. The sweetener would be regarded as a 'food additive' and therefore be subject to other, more stringent, regulations (Madden 2001).
Many GM foods in the USA are not subject to special regulation and they may not be segregated from non-modified foods. For commodity crops (such as soybean and maize) imported into Europe, this can cause problems, since many such foods would have to be labeled under the EU novel foods regulation. For imports into Europe, this problem has been resolved for maize and soybean derived from GM plants by assuming that GM material will be present, unless the crop can be traced to a source which has been certified as free from GM material.
The US system is generally regarded as less burdensome for manufacturers than that of the EU, and many more GMOs have been approved. Critics of the U.S. approach say that regulatory efficiency has been achieved at the price of inadequate considerations of the risk, uncertainty and social values (Wirth 2001).
The situation of the governance of biotechnology in the developing countries in general is weak. Many countries in the developing world have considerable potential for biotechnology because of their wealth of biodiversity. However the divergent policies toward GM technologies have created a complicated policy choice in the developing countries (Serageldin and Persley 2000). Should the governments in the developing world follow the more permissive US approach towards GM technologies, or the more precautionary EU approach? Developing countries officials have come under growing pressure from various donor agencies, international organizations, philanthropic foundations, private business firms, and NGOs to adopt either one set of policies or the other, to fall in line behind Europe or the United States. The separate and distinct interests that some developing countries have in GM technologies risk being obscured in the process.
For example poor tropical countries face a stronger agriculture production imperative, suggesting that GM crops eventually be of higher value to them, compared with some rich countries. Yet at the same time, these developing countries tend to have weaker scientific, technical and regulatory capacity within their own borders, which could make the safe development and the use of GM crops more difficult to their scientists and farmers. The private industry driven US approach may not be well suited to the developing countries circumstances because of the natural tensions between the commercial interests and the property rights of the private international firms on one hand and the meager resources and distinct technological needs of farmers in developing countries on the other. Yet the European approach may equally be inappropriate, given that so many farmers and consumers in poor countries are not yet as wealthy and well fed as Europeans. In addition, farmers in most countries face rural environmental protection challenges quite distinct from those caused or faced by agriculture in Europe and other rich countries (Paalberg 1994).
For developing countries five areas of policy have been particularly discussed, which include intellectual property rights, biosafety, food safety and consumer choice, trade and public research investment. Some developing countries, like India, Kenya, Brazil and China have adopted national policies for the GM crops and in some respects theses policies are actually more cautious than those adopted in Europe. The degree of the caution is interesting, given the conspicuous unmet food production needs in some of these countries. The extreme caution is also surprising given the prevalence in some of these countries of precisely the crop-pest and crop-disease problems that GM crops have been designed to address. Governments of the developing countries have to decide whether to be promotional, permissive, precautionary or preventive towards GM crops in above mentioned several distinct policy venues (Paalberg 2000).
In most of the United Nations organizations, developing and the underdeveloped countries of the world form the majority of the member states. For example, UN FAO has 184 member states including 48 (Africa), 22 (Asia), 33 (Latin America and the Carribean, 21 (Near East), 2 (North America), 14 (South West Pacific). The UNESCO has 188 members and only32 rich countries, of which USA recently joined. The WHO has 192 member countries including 46 (Africa), 35 (Americas), 22 (Eastern Mediterranean), 51 (Europe), 11 (South East Asia), 27 (Western Pacific).
The figures above show that on paper there is a broad global representation of the developing countries and the underdeveloped member countries in the UN bodies, nevertheless when it comes to international debate for strengthening the direction of biotechnology and other general research, the voice of the developing countries is limited and sometimes even lost. There are several factors for such " non-participatory" or "narrow participation".
ØGeographical Imbalances: the issue of less participation of developing countries in the governance of biotechnology starts with representation of the experts as staff in the agencies associated with the UN system. There is not an even representation as staff of the secretariat of the governing bodies, nor on the expert committees. Attempts to balance them and give an equal opportunity for expertise development is also an ethical issue. There are several hindering issues present in the selection of the experts as staff that impede professionals of the developing countries to work at the UN agencies as staff. The lack of expertise in the form of international experience is one of them. The higher standards required in the eligibility criteria is a big challenge for the professionals of the developing countries who might be equally competent at international level, given a chance. It may also include publications as well as work experience in another UN agency or international research institutes. Their national experiences are sometimes not accountable as international criteria. It stems from the fundamental ethical issue of inequality in access to education both at national and at international level in particular in this context in order to become qualified.
ØReasons within developing nations: The obvious two fundamental problems that seem to be ever existing and still remain unresolved are poverty and overpopulation that are also root causes of many other issues that get magnified during policy making at national levels and are a cause of concern at international level also. According to World Bank, about 1.2 billion people live below poverty line and more than 3 billion people are poor. The greatest number of poor people live in South Asia but the proportion of the poor is highest in Sub Saharan Africa where millions of people are at the margins of survival. As mentioned above, shortage of available expertise within the countries, and their dependency on international experts is also a reason, which results in the lack of regulatory procedures that can be formulated for effectively controlled implementation of biotechnology in the developing countries. There is also an issue of instability in governing structures, which raises an ethical issue of public trust. In many developing countries, although political parties form a government through democratic selection still, in wake of clear majority they tend to have threat of losing the governments, which is reflected in policy making. There is also a conflict seen between the national and the local governing structures. Many times in spite of good scientific research within the nations, it does not reach the public because of the political problems. Science and politics need to be separated for common good and people.
Ø External reasons on the developing countries: globalisation especially in economic terms has had its own in depth consequences on the fragile economies of the poor countries. The international trade pressures have grown for developing countries. Liberal markets on one hand have opened international markets for the products of the developing countries, but it has also increased the pressure on the developing countries to meet the higher standards required for exports in the European and American markets. Local and national companies, small and big businesses within the nations have been affected as for some products the national standards of the rich countries may be higher from the international standards of the poor countries. There also exist regional competition within the poor countries to get access to the markets within their own region and also other regions. The delays in a consensus for international regulatory reforms in different arenas are another reason for developing countries to struggle for markets. Poor countries have large workforce, and rich human resources. However, lack of infrastructure facilities result in failure of even the best competent people to develop skills and experience, and keep parallel ingenuity with international developments. For experience, skills, and better professional development, sometimes best of the intellect go out to foreign countries, and nations lose their best of the human resources. The problem of "brain drain" is big and common ethical concern for the developing and underdeveloped nations.
Conflicting issues for developing countries in the regime of global governance of biotechnology
Globalization has proven both beneficial as well as harmful; especially it has a deep impact on the economies of the developing countries. Nevertheless, economic globalization has become unavoidable for global governance of biotechnology, which has resulted in many conflicting issues for majority of the Nations in the world. As discussed earlier developing countries face the issue of market liberalization for economic growth vs. protection of the communities, given that they have rich biodiversity that is usually being used as a trade off for foreign income. Should they allow open access to the genetic resources or try to protect the rights of their farmers who are burdened by hardship of environmental problem, and production of quality crops and other products and then issues of intellectual property even without ownership on their land and crops. At the governance level, national governments in the developing world are under immense pressure from international community to enforce stringent guidelines, on the other hand they have a struggle of streamlining domestic regulatory processes for biotechnology. Over that they have severe infrastructure shortage for even to gather the updated information and disseminate information to people. These are fundamental practical concerns that have a strong ethical basis.
International community has been engaged actively defining the ethical concerns of the developing countries at different fronts. There are several international efforts being taken at the UN level that reflect basis of fundamental ethical principles. Ethical principles are often implicit even if not explicit in proclamations. For example, Universal Declaration of Human Rights, FAO's mission of ensuring humanity's freedom from hunger, and World Bank's mission of world free of poverty and international concern for farmer's rights.
The need for better participation from the developing countries is well recognised and explicitly emphasized in many international declarations, conventions and guidelines, made in different biotechnology contexts. For example, the article 19 of the Convention on Biological Diversity states, "each contracting shall take legislative, administrative or policy measures, as appropriate, to provide for effective participation in the biotechnological research activities by those contracting parties, especially developing countries, which provide genetic resources for such research, and where feasible in such contracting parties". It emphasizes on equal participation by developing countries on handling of biotechnology and distribution of benefits. The FAO Code of Conduct on Plant Germplasm Collecting and Transfer of 1994 " aims to promote the rational collection and sustainable use of genetic resources, to prevent genetic erosion, and to protect the interests of both donors and collectors of germplasm". This need is also recognised and reiterated in medical use of biotechnology also. The Human Genome Organisation's ethics committee's declaration on benefit sharing (1996) states " the sharing of genes may call for strong solidarity within certain groups of people. Members of small group with rare genes who have helped research would be particularly deserving recipients of benefits. Moreover, research efforts should promote health universally and so include developing countries.
There is also a need for developing countries to recognise their potentialities and invest in the technologies that are environmentally friendly and help farmers and affordable to consumers without health risks. Research is also needed in the options for solutions of the basic problems like overpopulation and poverty. Better linkages are to be developed between governance of biotechnology and public understanding of science, given that public trust is crucial for effective implementation of policies and also for stable governing structures so that decisions taken can also be applied in practice at the level of common people. Also ethical standards need to be explicitly set in the governance systems to understand the needs and priorities of the nations for justice to all the nations and their people and benefit humankind with fruits of biotechnology that can help the world to have equity in all the spheres.
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