Welcome to the Business Engagement Programme

Business.2010 newsletter: Access and Benefit Sharing

Volume 3, Issue 1 - January 2008
The third objective of the Convention: Views on access and benefit-sharing from the plant science, biotechnology, pharmaceutical, horticultural and seed industries

Promoting more effective use of plant genetic resources

In spite of dramatic increases in world food productivity over the last 40 years, neither the status quo, nor ‘more of the same’ will be sufficient to accommodate future needs. Overall, food demand is expected to increase 2-3-fold by 2050. If productivity increases over the next 35 years rely solely on previously successful factors, then estimated future needs are: 3-fold increase in nitrogen use; 2.5-fold increase in phosphorous; doubling of cultivated land under irrigation; 18% increase in land area under cultivation (1). Therefore, meeting the estimated agricultural demands raises concerns of habitat loss, species extinction, release of CO2 from land clearing and tillage, and negative impacts on ecosystems worldwide. ‘More of the same’ is not a viable means to achieve sustainable gains in agricultural productivity. Among the remaining options are the more efficient use of fertilizer, water, and genetic resources.

Access
In the context of the CBD, access is discussed predominantly in a relatively narrow legalistic and procedural context. The CBD prescribes that “facilitated” access to genetic resources should be provided subject to “Prior Informed Consent” (PIC) of the owner with “fair and equitable” benefit sharing on “mutually agreed terms”. Industry is very familiar with these concepts for it is under the same parameters of PIC and benefit sharing under mutually agreed terms that companies, sometimes fierce competitors, secure contracts to license technologies or germplasm. The plant breeding industry in the industrially developed world has become accustomed to licensing. Indeed, in many countries, new varieties have only been developed and are therefore only available because of the successful negotiation of technology and germplasm licensing agreements. Successful negotiation of PIC and ABS among companies has resulted in higher performing products being delivered to farmers.

A major limitation to industry access to a broader array of genetic resources is the lack of knowledge of what is available and what might be potentially useful. Whole careers have already been spent in discussing ABS in the venue of the CBD with the focus, understandably, but unfortunately focused solely on the pretext that great economic value exists in those resources and that some might misappropriate those resources. Industry is a potential customer of those genetic resources. However, without knowledge of what is available, and without the availability to obtain sufficiently effective intellectual property rights (IPP), there will be little demand even by those organizations with the technological capabilities to perform the long term research. Greater evaluation of genetic resources is required.

It is worth reiterating that the CBD prescribes that nations should provide “facilitated access”. One example which demonstrates the huge scope and complexity of developing an effective access regime is provided by the National Biodiversity Institute of Costa Rica (INBio). This included the creation of a national biodiversity inventory which required training to classify one half million species; the development of databases and information management systems; business development and strategic planning; and the availability of efficient regulatory and legal structures sufficient to support contractual, regulatory and intellectual property protection laws.

Most countries have huge difficulties in living up to the national responsibilities that must be shouldered if national sovereignty is to be an effective component of a market-based system to encourage conservation through use and benefit sharing of genetic resources. Organizations situated outside of a biodiverse region are in no position to identify all of the indigenous and other interested parties who may have an interest in the PIC and benefit sharing provisions. This must be a sovereign country function, or the level of uncertainty may doom prospects for expedited access.

Benefit-sharing
Most, if not all of the discussion regarding benefit sharing in the context of the CBD revolves around the provision of benefits back to the providers of genetic resources. These benefits can take many forms, including non-monetary (e.g. joint research, capacity building, co-ownership of intellectual property) as well as monetary (e.g. bio-prospecting fees, milestone payments, percentage of royalties).

It may be beneficial to consider benefits in a broader context. Benefits must be created and allocated at every link in the chain from conservator and provider of genetic resources through the research and product development pipeline to the customer, the farmer or industrial processor; otherwise the chain breaks. A plant breeding company will, for instance, only survive when it generates benefits which can then be passed along to providers of genetic resources, to employees, to shareholders; and to customers. Customers (e.g. farmers) will only purchase products if they perceive that they will gain from making that purchase.

The FAO International Treaty
In contrast to the bi-lateral agreements conceived within the framework of the CBD, the FAO International Treaty for Plant Genetic Resources for Food and Agriculture (IT-PGRFA) provides a multi-lateral system. The International Treaty thus provides an important path forward to re-establish germplasm flows for ex situ genetic resource collections, largely for those collections that were previously considered to be, in the pre-CBD environment, part of the common heritage of humankind. Germplasm will be accessed according to the conditions of the standard Material Transfer Agreement (sMTA). The sMTA provides well for research only purposes. However, we believe its commercial provisions could be improved markedly. We advocate for ratification of the International Treaty by the US Senate so that the United States can participate in on-going sMTA discussion within the framework of the Treaty. Our hope is that the terms eventually found in a revised sMTA will be in line with commercial practice as promised by the International Treaty and will therefore help encourage more use of exotic germplasm by plant breeders concomitant with greater creation and sharing of benefits. We argue that standards need to be raised both in terms of the effective level of intellectual property protection needed to encourage increased investments in plant breeding, evaluation and pre-breeding and also with regard to obligations to return benefits for varieties that are dependent upon use of germplasm accessed via the International Treaty.

The current sMTA fails to adhere to usual business practice in that there is neither a threshold of time, nor of contribution by pedigree to trigger a requirement for benefit payment. In the current process, companies who would otherwise be willing to make the long term, risky investments in working with exotic genetic resources are at a disadvantage. They will either have to protect their invention with patents and then incur the undesirable sMTA consequences of royalty obligations that are unlimited. Or, as in most cases, they will only be able to utilize Plant Variety Protection (PVP). But, under current forms of PVP, and after making significant investments they would then provide the exotic germplasm in a well-adapted genetic background for free and immediate use by competitors. Consequently, in the current PVP environment competitors can free-ride on 10-20 years of the initial developer’s research programme and have no obligation whatsoever to contribute royalties. So, under current circumstances, neither IPP route provides a sufficient level of encouragement for risky and resource demanding exploration and development of exotic germplasm.

And, from the other perspective, nor are current standards for returning benefits to conservators and stewards of germplasm sufficiently high. We do not believe that “availability without restriction for further breeding” is either a sufficient or an appropriate form of benefit to meet the higher threshold and obligation of benefit sharing that should, in our minds, be required by the International Treaty. Royalties alone will likely be insufficient to sustain funding for the level of conservation or of evaluation of genetic resources that will be required to serve agriculture long-term. And, if royalties are paid only by those organizations patenting products, the royalty flow will be considerably lower. Optimally, royalties should be contributed by all who commercialise a variety that depends upon IT germplasm; the act of commercialisation, rather than type of IPP should be the trigger for contributing royalties. One approach could be a revised UPOV that provides immediate global access for further breeding through a deposit to commercialised PVP’d varieties that include IT germplasm in their pedigree; any inbred lines or varieties that contain IT germplasm that would not be freely available for further breeding would then be subject to a mandatory royalty payment.

How genetic resources for food and agriculture will be conserved and used is a major determinant of the future course of humankind. Usage of these resources will depend, not only upon technological capabilities of which humankind has demonstrated great ingenuity, but also upon wisdom and the political will to enact policies that encourage conservation and use. The historical record shows that the latter have proven more difficult to achieve. For despite taking millennia, technological progress in the plant sciences has occurred faster than has political progress to create mechanisms that will ensure the conservation and use of a comprehensive array of plant genetic resources for food and agriculture. Nevertheless, some progress has been made.

Swanson (2) notes that “the Biodiversity Convention represents a mere framework, only a beginning, not an ending”. Huge resources, covering the gamut from scientific to legal, are required to be invested in each country to facilitate access. Some valuable experiences have been gained, notably by Costa Rica. Successes are evident in the capacity building of biological research in source countries; critical prerequisites for conservation and sustainable use. The International Treaty is a work in progress that uses a multilateral approach. We believe that greater investments in public sector plant breeding coupled with greater private investments encouraged by more effective intellectual property protection on a global basis will be required to make this approach fully effective. However, it is also time to question whether a market-based system can ever provide the basis for conservation of genetic resources that will be of a sufficiently comprehensive scope.

In this respect, one of the most encouraging developments in recent years is the progress made by the Global Crop Diversity Trust (3) in establishing what is currently a USD 136m endowment to provide long-term funding to ensure a high quality, rational, global system of ex situ genebanks. Tangible evidence that consideration of ethics, aesthetics, common-sense, and the benefits that long-term, multigenerational, multinational, public goods provide has the power to cause corporations, foundations and governments to make substantial donations to support the genetic fibre of agriculture is perhaps the most encouraging development in the field of plant genetic resources in the past 50 years. Together, these developments suggest that humankind might now have progressed sufficiently across the second threshold of agriculture, a place where farmers use seeds bred by plant breeders, so that in the field of plant genetic resources, we are at least, to paraphrase the words of Winston Churchill, at “the end of the beginning”.

Dr. Stephen Smith is Research fellow and John Grace is Manager, Germplasm Licensing, Pioneer Hi-Bred International, Inc.
(1) This land area estimate, equivalent to adding the land area currently forested in the continental United States, is still an under-estimate, since most of the global land area best suited to agriculture is already cultivated. Furthermore, these estimates do not take into account additional demands made on agriculture to provide energy (biofuels).
(2) Swanson, T. 1997. Global Action for Biodiversity: An International Framework for Implementing the Convention on Biological Diversity. Earthscan Publications, London, UK.
(3) The Global Crop Diversity Trust