Sunday, May 21, 2006

Public sector research and agricultural biotechnology

Over 20 research studies related to GM crops are ongoing in the public sector in India. It is important that public sector research be supported in order to facilitate a level playing field with resource-rich private sector companies

At the third meeting of parties to the Cartagena Protocol on Biosafety in Curitiba, Brazil, from March 13-17, the role of public sector research on genetically modified organisms (GMOs) received considerable attention. One of the concerns raised by public sector scientists is that under the Protocol the information requirements for small-scale confined field trials and risk assessments have to undergo a lengthy documentation process similar to that of bulk shipments meant for commercial use. Though the motive is not to undermine the objectives of the Protocol, the information requirement, the public sector scientists argue, should be commensurate with the lower level of risk involved in research activities. There is growing apprehension that in the long run this could hinder public sector research and instead increase the influence of the private sector as knowledge providers. It would hamper the attempts of civil society organisations to curtail private sector research and influence, which in a way defeats the purpose of the Protocol. Currently, the public sector in India has over 20 research activities related to the development of genetically modified crops. The government projects agricultural biotechnology as an important instrument in achieving food security in India. It is therefore important that public sector research gain necessary support in order to facilitate a level playing field with the resource-rich private sector companies, else the latter stand to gain.

Cartagena Protocol on Biosafety (MOP3)

The third meeting of parties to the Cartagena Protocol (MOP3) held in Curitiba, Brazil, reached a landmark decision on the documentation requirements for living modified organisms (LMOs). After hours of deliberation a consensus was reached: it was agreed that shipments that are identified and separated as containing transgenics will carry the label ‘Contains LMOs’. This landmark, as argued by some, will have a crucial impact on international trade in products derived from genetic engineering.

The Cartagena Protocol on Biosafety is a legally binding international treaty that governs the transboundary movement of genetically modified organisms. Adopted in 2003, the Protocol aims to ensure safe transfer, handling and use of living modified organisms that may have adverse effects on biodiversity and human health.

In 2005, two years after its adoption, the MOP2 at Montreal was to resolve issues on information requirements for documentation of LMOs for food, feed or processing (LMO-FFPs), but failed to do so, due to conflicting trade interests. It was apparent at MOP3 that countries were eager to reach a decision on the controversial issue of documentation. However, the article remained the bone of contention till the final hours when Mexico, supported by Paraguay, delayed the proceedings by resisting the clause on mandatory labeling of transboundary shipments containing LMOs, and instead suggested the insertion of brackets, implying that the topic was not completely resolved but open to future dialogue. After further negotiations, the signatories reached a consensus; they agreed to review country experiences on the implementation of documentation requirements in 2010 at MOP5, after which a final decision will be made at MOP6 in 2012. Mexico insisted on adding a clause which states that mandatory labeling does not apply to transboundary movement between parties and non-parties. Mexico is a major trading partner of LMO exporting countries such as Canada and the US, a non-party to the Protocol.

MOP3 also took decisions on other matters, including biosafety capacity-building activities, risk assessment for GMOs, and the operation of the Biosafety Clearing House, the web-based information exchange portal established by the Protocol.

Public sector research and the Protocol

The debate over LMOs at MOP3 was largely dominated by trade interests and therefore much of the implications of the Protocol are assessed in terms of its impact on trade in agricultural commodities. On the other hand, the “side events” were dominated by civil society organisations targeting their scepticism at big transnational companies that develop these genetically modified crops and also the socio-economic implications of such crops on small farmers. In hindsight, what seems to have emerged at the Protocol is the presence and importance of public sector research in agricultural biotechnology. Though public research was debated more informally at the side events than at the formal negotiation table, discussing its role in agricultural biotechnology itself underlines the fact that public sector research has wider policy ramifications. Particularly since the Cartagena Protocol is seen as a model on which countries formulate their biosafety policies. The larger picture that emerges from this debate is whether certain provisions in the Protocol can have a restrictive effect on public sector research -- a large number of which is carried out in developing countries -- as it requires lengthy information for small-scale confined field trial research and risk assessment where the level of risk is considered lower than shipments intended for commercial purposes. Is it possible to evolve a regulatory response that does not undermine the objectives of the Cartagena Protocol? At present, the Protocol does not accord separate treatment to LMO shipments for commercial purposes and for public research. Public sector researchers express concern about the implications of such decisions in the Protocol.

This lengthy documentation requirement can delay research and lead to increase in opportunity cost and utilisation of public funds. A study by the International Food and Agricultural Trade Policy Council (IPC) shows that for China, the cost involved in meeting strict documentation requirements for soybean imports amounted to US$ 13.98 million in 2005. Public sector scientists claim that the information required is so exhaustive that sometimes it is not available since research is ongoing or yet to be conducted. For instance, confined small-scale research on fruit and shoot borer resistant Bt brinjal in the Institute of Plant Breeding, University of the Philippines, Los Banos College, experienced a setback as the documentation process for importing the Bt gene from India took almost a year, instead of the expected three months. Scientists explain the need to define LMOs for confined field trials as public research could suffer serious setback worldwide.

The public sector initiative

Recognising the crucial role of the public sector in biotechnology and also the need to explain the implications of the Protocol on public research, several public research scientists from different parts of the world with similar concerns and objectives united to form the Public Research and Regulatory Initiative (PRRI). Most international negotiations such as the Biosafety Protocol are discussed and debated at length among country policymakers, many of whom may not be trained to handle complex scientific issues such as biotechnology. On the other hand, scientists work in isolation in laboratories knowing little about the implications of these negotiations on their research. It has been observed that the international negotiations of the Cartagena Protocol which began since 1995 have always been well represented by NGOs and the private sector. However, public sector researchers were conspicuous by their absence, despite the fact that the Protocol could have a direct impact on their research. The PRRI is an initiative to involve public researchers in international negotiations that have a direct impact on their work, such as the Cartagena Protocol.

One of the major reasons for participation in the Protocol is to make delegates aware of the substantial role played by the public sector on research in modern biotechnology worldwide. The team is represented by public research scientists from different parts of the world concerned about the importance of disseminating science-based information and to explain in layman’s terms, the science of agricultural biotechnology and to dispel certain misconceptions about crop biotechnology. The PRRI seeks to clarify that it does not align with private sector companies that develop GM crops, since both private and public sector are developers of GM crops, and are therefore considered to have similar profit motives.

Public sector research in developing countries

Since most public sector research is not profit driven, but more directed towards the needs of local farmers, the products derived from the sector have wider acceptance among farmers and sceptics, as no conditions are imposed on them. Besides, the products are distributed at costs that are lower than those of the private sector companies.

The role of the public sector in the research and development of crop biotechnology, particularly in developing countries, is often undermined. A study conducted by International Food Policy Research Institute (IFPRI), released in 2005, shows that there are more than 200 types of research conducted on genetically modified (GM) crops in 15 developing countries. The largest number of research studies was in Asia (109) of which 21 are in India. About 85% of the genetic resources used for developing these GM crops were sourced from locally available materials. Farmers seem to prefer the local variety as they adapt better and are also devoid of the intellectual property issues associated with the most of the private sector developed genetic materials. In most developing countries, examples of public-private partnerships in plant biotechnology are rare.

In many Asian countries the focus is on food crops and crops of high commercial value to increase food production in order to meet the demands of the burgeoning population and also to assist resource-poor farmers with marginal land holdings. These crops are developed to respond to local needs, in the form of drought and salinity resistance, insect, fungal and bacterial resistance, reduction in the use of agrochemicals, prolonged shelf-life, nutritional improvement, etc. In India where almost 70% of the population is still dependent on agriculture, these varieties can offer tremendous benefits.

Despite the large number of ongoing public sector research studies in developing countries, only seven have been commercially released. In India, crop biotechnology research in the public sector is at all various of development -- from the experimental to the pre-commercial stage, but none are approved for commercial cultivation. In China, public sector developed GM vegetables have been approved for cultivation. Currently, there are more than 44 ongoing confined field trials in developing countries and most of them have problems in moving on to the next phase, the pre-commercial trial stage. This is partly due to the confusion regarding the amount of information required for the confined and open field trials. One of the reasons for this delay, as cited by IFPRI research, is the implementation process of the Cartagena Protocol. This involves huge regulatory costs and can be carried out either by sharing these with government seed production facilities or seed companies. There is a need to expedite regulatory decisions and testing of public sector developed GM crops. Though it is widely accepted that public research can deliver GM crops in response to local needs, the regulatory procedure necessary to gain approval for commercial use can delay the process as these are novel crops that have not been tested earlier. The irony is that the GM crops in the West get speedier approval in developing countries as they have already been tested. As a result, crops developed by the public sector remain at the pre-commercial stages and farmers continue to wait.

Biotechnology is considered by many in the public and private sector to have enormous potential in achieving food security. At the same time, the scepticism of critics of agricultural biotechnology has been directed largely towards issues surrounding the technology, such as the transnational companies that develop it, the royalties involved, the socio-economic implications etc, but the focus has rarely been on the technology per se. Public sector scientists claim that genetically modified crops developed by public research can contribute to meeting the needs of the local farmers and that scientifically unfounded claims about the technology need to be dispelled. They emphasise that their role is to present the scientific facts of genetic engineering as they are, without any particular agenda. Transnational companies have the financial resources, but lack the trust of the general public. On the other hand, public research institutes have limited financial resources but are trusted to develop crops in response to specific local needs.

In India, the National Biotechnology Regulatory Authority suggested the speeding up of approval process for transgenic crops through a single window clearance mechanism. This is particularly significant for the public sector as it would minimise the public funds as well as the opportunity cost. At the same time, it would be important to examine the health and environmental safety aspects of the novel transgenic crops. Once the regulatory and safety aspects are in place, it is the farmers who would ultimately have the last word.

InfoChange News & Features, May 2006

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