Changing the Recipe: Food Security and Other Socio-Economic Considerations in Agricultural Biotechnology Regulation
Changing the Recipe: Food Security and Other Socio-Economic Considerations in Agricultural Biotechnology Regulation
Consumer demands, and the expectations of society more broadly, that socioeconomic considerations (SECs) be included in regulation of food are growing. The application of biotechnology to food plants, already a contested issue, is one area where an increasing role for SECs in regulation is being debated. There are growing calls for SECs, such as food security, to be included in biosafety assessment processes and IP protection of biotechnology. Similarly the sourcing of genetic resources, often used in agricultural biotechnology, is leading to calls for SECs to be dealt with by IP regimes.
In October 2012 the parties to the Cartagena Protocol on Biodiversity (CPB) met to address the issue of the inclusion of SECs in biosafety assessment processes.1 The meeting’s decision to establish an Ad Hoc Technical Expert Group (AHTEG) to develop conceptual clarity opens the way to developing guidelines on such processes and can be expected to inform governments of at least some countries on how their domestic policy should be shaped. These moves to include SECs, including the implications of IP, in biosafety assessments are occurring at a time when the cost and complexity of some existing regulatory systems for genetically modified (GM) crops, such as the European Union system, along with the lack of evidence of harm to people or the environment, ‘is generating pressure to make regulatory systems more risk-based and to take potential benefits into account’.2
After first examining SECs that may arise in the context of agricultural biotechnology, this chapter examines how SECs have been, or are proposed to be, included in international agricultural biotechnology regulation and the IP regimes that protect it. It then considers parallel moves in relation to Australian biotechnology regulation. Finally, it discusses the problems that need to be addressed for SECs to be usefully included in agricultural biotechnology regulation and makes some suggestions for future progress.
What are the Relevant SECs?
SECs in the context of agricultural biotechnology are a ‘broad spectrum of concerns about the actual and potential consequences of biotechnology’.3 Providing a taxonomy of SECs relevant to agricultural biotechnology though is a difficult task – although there has been much discussion and some work by certain jurisdictions,4 there is still a lack of information on the content or meaning of relevant SECs. Various bodies are beginning to compile possible lists of SECs such as the Third World Network,5 Chatham House, UK6 and the World Resources Institute.7 For example, the Netherlands Commission on Genetic Modification (COGEM) published a report in 2009 on the potential role of socio-economic assessments as part of biosafety approval processes.8 The COGEM report suggested that the criteria most relevant to Europe, but which have not yet been included in an assessment framework, could be summarized down to three themes – (1) benefit to society, (2) economics and prosperity, and (3) cultural heritage.9
A more detailed list was compiled through a 2009 survey for the CPB process.10 The survey was undertaken after the inclusion of SECs in biosafety assessments was discussed at the 2008 CPB’s Conference of the Parties/Meeting of the Parties (COP8/MOP8) and it was decided further technical guidance was needed. In 2009, a survey of countries’ experiences with SECs in biosafety decision making was conducted through the United Nations Environment Programme’s Division of Global Environment Facility Coordination (UNEP DGEF).11 The meeting of the CPB parties in October 2012 considered this information. The survey identified the five most important SECs as:
• food security;
• health-related impacts;
• coexistence of GM organisms (GMOs);
• impacts on market access;
• compliance with biosafety measures.
The next five SECs were variously drawn from:
• impacts on the conservation and sustainable use of biodiversity;
• economic impacts of changes in pest prevalence;
• macroeconomic impacts;
• farmers’ rights;
• consumer choice;
• economic impacts of changes in use of pesticides and herbicides;
• indigenous and local communities.13
Defining the content of any particular SEC is difficult and dependent on context. The SECs are tightly interwoven, and of course, different countries and groups within countries (such as consumers, producers and industry) interpret and are affected by any particular SEC in different ways. How a particular SEC is relevant to a specific country and what methodologies are appropriate in an assessment of that will also vary depending on, for example, whether the country is a developed, developing or least developed nation, because this determines the infrastructure and human resources available, and the usual governance patterns used in the nation. A SEC’s impact will also differ because of different cultural and religious values, political and economic capacity and forms of agriculture and biotechnology research undertaken in particular countries.
Food security, clearly an important SEC in the context of agricultural biotechnology, is an example of the difficulty of defining the content of a SEC. The United Nations Food and Agriculture Organization (FAO) defines food security as existing ‘when all people, at all times, have physical and economic access to sufficient, safe and nutritious food to meet their dietary needs and food preferences for an active and healthy life’.14 Some interpret food security then as simply meaning access to sufficient food. So, for example, Brookes understands the SEC of food security as part of the ability of households to afford to feed themselves.15 Others interpret food security as meaning access to the type of food that the consumer wants (preferences), and so for them food security includes choice. Yet others define it with wider dimensions as including conservation of biological diversity so that sufficient food can be ensured and yet others expand it to include the nature of agriculture itself insisting that at the least, the form of agriculture used must be sustainable. For example, Diblin et al. say:
in debating the prospective contribution of GMOs to food security, it is important to consider dimensions of the concept beyond basic food sufficiency: production must be sustainable, increases in production must be distributed equitably, and the food produced must be affordable and consistent with consumers’ perceived needs. Broader understandings of food security thus include questions about access and utilisation as well as simple availability.16
Further, for some the increasing use of GM crops to provide feedstock for alternative forms of energy, such as for biofuels, raises concerns that the use of agricultural land for that purpose puts increasing pressure on not using that land for food, and so poses a food security risk.17 The Third World Network sees this as a key concern within food security, for the purposes of developing countries, raising the issue of the impact of adoption of GM crops by subsistence farmers who may also supply domestic markets with food, for industrial use rather than use as food.18 A 2010 PMSEIC Report analysed food security as being composed of five pillars: availability, accessibility, acceptability, adequacy and stability, which cover all of the issues raised above and more.19
Some consider that agricultural biotechnology has much to offer in addressing both domestic and international food security problems. Others argue that GM technology undermines food security. Claims have been made that agricultural biotechnology is relevant to food security only because the commercialization of GM products is legitimatized ‘partly by the supposed necessity to “feed the world”’.20 One point is clear: ‘The contribution of agricultural biotechnology to food security, whether as benefactor or threat, thus remains as hotly contested as ever.’21
Compiling a list of SECs relevant to IP in agricultural biotechnology, particularly patents over GM traits and processes, is similarly difficult, with intertwining themes and issues. But in the context of food security, after describing the risk of contamination of non-GM crops by GM crops as one of the main threats to Australian food security posed by GM crops, Diblin et al. suggest a further threat is ‘the expansion in control of seeds by agricultural biotechnology corporations’.22 The same concern is raised in the context of developing countries by the Third World Network.23 Diblin et al. conclude that there is ‘increasing evidence of influence of giant seed and biotechnology corporations on agricultural and food policy. Corporate control of seeds has been widely viewed by critics as threatening food security and food sovereignty – i.e. control of domestic food production.’24 The diversion of public R&D funding into the technology, the loss of the opportunity to pursue other alternatives to the technology and the capture of the outcomes of public funding of biotechnology research by private companies are all also debated as SECs relevant to IP in agricultural biotechnology. The Third World Network raise the hampering of the free flow of information, knowledge and genetic materials that is needed for R&D in public universities as a further SEC relevant to IP in agricultural biotechnology.25
Regardless of the exact content of ‘food security’ as a SEC, agricultural biotechnology’s position on the boundary between agriculture (that is, living things) and food (commodities) is probably better described as being on a fault line in terms of the policy issues it raises. This is clearly demonstrated by the failure of the ambitious intergovernmental scientific panel announced in 2002 as a result of the World Summit on Sustainable Development. That panel, the International Assessment of Agricultural Knowledge, Science and Technology for Development (IAASTD), was launched in 2004 with a mandate to ‘forecast and propose responses to the agricultural and food security challenges facing the world, from  until 2050’.26 It was to assess the state of the field using established rules of scientific enquiry. The field was itself divided into eight themes, some of which are the SECs identified above as relevant to agricultural biotechnology (e.g. human health, trade and markets, traditional and local knowledge and community-based innovations, and women in agriculture), although biotechnology was itself treated as a separate theme.27 For reasons still in debate, the assessment failed. In relation to biotechnology itself, other than acknowledging the debates over the issue, the key document produced by the assessment made no progress on making an assessment or even explaining how to assess these issues. It only calls for ‘new kinds of support for the public to critically engage in assessments of the technical, social, political, cultural, gender, legal, environmental, and economic impacts of modern biotechnology’.28
Within the context of the Convention on Biological Diversity (CBD), the CPB is an implementing agreement addressing biosafety. The meaning of ‘biosafety’ is controversial, but for the purposes of this chapter is the safe use of biotechnology and its products, in particular those precautionary practices intended to ensure the safe transfer, handling, use and disposal of living modified organisms (LMOs) and their products.29 The CPB governs the transboundary movements of LMOs and establishes the rights of recipient countries to be notified of and to approve or reject domestic import or production of LMOs. The CPB uses the term ‘LMO’ to restrict its application to living organisms and thus excludes processed GM commodities from its scope. It is important to note here that GM food, one of the most controversial aspects of agricultural biotechnology, is therefore not included within the scope of the CPB. Conversely, for many countries, domestic regulation, such as Australian regulation of food and gene technology, applies to GM food or GMOs rather than only to LMOs.
Decisions under the CPB regarding import or production are to be on the basis of a biosafety assessment. Controversially, article 26.1 of the CPB provides that SECs may be included within the domestic measures implementing the Protocol:
1. The Parties, in reaching a decision on import under this Protocol or under its domestic measures implementing the Protocol, may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities.
2. The Parties are encouraged to cooperate on research and information exchange on any socio-economic impacts of living modified organisms, especially on indigenous and local communities.
There is debate about the proper interpretation of this article, such as whether an SEC must impact on indigenous and local communities to be relevant.30 Nevertheless, many developing countries in particular have expanded their interpretation of article 26 to include a broad range of SECs.31 Such countries include Indonesia,32 South Africa,33 The Philippines34 and (a developed country) Norway.35 Indonesia’s legislation, for example, provides: ‘This government regulation is based on the precautionary approach to contribute to ensuring environmental safety, food safety and or animal feed safety based on an accurate scientific method by considering religious, ethic, socio-cultural and esthetic [sic] norms.’36
The Philippines regulation says: ‘The socio-economic, ethical and cultural benefits and risks, of modern biotechnology to the Philippines and its citizens, and in particular on small farmers, indigenous peoples, women, small and medium enterprises and the domestic scientific community, shall be taken into account in implementing the [National Biosafety Framework].’37
In contrast the Norwegian Act says that: ‘In deciding whether or not to grant the application, significant emphasis shall also be placed on whether the deliberate release represents a benefit to the community and a contribution to sustainable development.’38
Other countries, particularly the agricultural export driven developed countries of Australia, the United States and Canada (which are not CPB parties), consider that biosafety assessments should be conducted on the basis of a science-based risk assessment only whereby scientific data is gathered and standard methodologies are used to determine whether the risk is one the jurisdiction is willing to take in allowing the deliberate release of LMOs into the environment. The considerations that are assessed in this manner are generally limited to risks to human health or safety or environmental risks. Any risks or benefits to SECs are excluded as is the use of social factors in risk evaluation.
In parallel with the developments under the CPB auspices, the European Union has also undertaken work on the SECs in GMO cultivation. The European Directive 2001/18/EC39 on the deliberate release of GMOs into the environment states that ‘Member States may take into consideration ethical aspects when GMOs are released’.40 This allows for different national standards on ethical judgment but there is no common definition or understanding of ‘ethical judgment’. This means different interpretations are being used in various European Union members. For example, Finnish law focuses only on ecological and health risks but Swedish law considers physical and societal effects, and the Swedish Office of the Auditor General reports that this is taken to include societal utility.41
The Directive also requires the European Commission to provide a report after three years of a GMO release on the Directive’s implementation, including an assessment of the socio-economic implications (defined to mean the advantages and disadvantages42) of deliberate releases and placing on the markets of GMOs. Although a report was submitted in 2004, the Commission raised the lack of experience with the issue as a hurdle in making an assessment. Therefore in 2008 the European Council invited further work on the issue by the European Commission and the Member States. The report was provided to the Council in 2011. This and its accompanying working paper43 provide a useful snapshot of what the Member Countries are doing in respect of the use and implications of GMOs but do not provide any detail on how SECs are or could be included in regulatory frameworks.
There is clearly the potential for conflict with a nation’s international obligations under the World Trade Organization (WTO) agreements. Article 26.1 of the CPB recognizes this when it states that the inclusion of SECs must be done consistently with the country’s international obligations. Two WTO Agreements are of particular importance to agricultural biotechnology generally, the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement), and a third, Trade-related Aspects of Intellectual Property Rights (TRIPS), is particularly relevant to IP.
Inevitably, different countries are variably susceptible to different SECs. Their ability to respond to those considerations though is constrained by their obligations to maintain international free trade. For example, the SPS Agreement concerns food safety and the regulation of animal and plant health. It recognizes that countries have the right to take sanitary and phytosanitary measures but requires that such measures be applied only to the extent necessary to protect human, animal or plant life or health so as to minimize trade barrier impacts and should not arbitrarily or unjustifiably discriminate between members of the WTO where identical or similar conditions prevail. Members of the WTO are also obliged to ensure that as far as possible their quarantine measures conform to international standards, guidelines and recommendations and are based on an assessment of the risk to human, animal and plant life or health, ‘taking into account’ risk assessment techniques developed by relevant international organizations.44
International IP Regulation and Agricultural Biotechnology
A second and more recent agreement under the CBD, the Nagoya Protocol,45 is further evidence of the growing creep of SECs into agricultural biotechnology regulation. Pursuant to the Nagoya Protocol, countries granting access to bioresources must, amongst other things, ensure domestic procedures require prior informed consent on mutually agreed terms by any indigenous and local groups that hold relevant genetic resources or traditional knowledge,46 ensure proper records are kept of the origin and use of genetic resources and benefits obtained from them and respect customs, traditions, values and customary practices of indigenous and local communities.47 Countries are also to consider the importance of genetic resources for food and agriculture for food security.48
An important ongoing debate arising out of these requirements is whether patent applicants should have to disclose the use of traditional knowledge or genetic resources in their invention49