Many of our member companies (1) are small- and mid-sized enterprises and have often found it difficult to translate the Bonn Guidelines into practical advice that was relevant to their operations. With this in mind, we have developed our own Guidelines for BIO Members Engaging in Bioprospecting. (2).
The guidelines BIO members work, in general, with materials obtained ex situ, such as genebanks, depositories, and internal sources. In the event members wish to access in situ resources, the BIO guidelines provide a set of general principles and examples of best practice.
Since bioprospecting is not regulated in a consistent or comprehensive manner within countries or at the international level, companies have extensive discretion to shape their conduct to meet whatever requirements countries impose with respect to bioprospecting activities. The guidelines direct companies to identify applicable requirements to follow in any specific jurisdiction in which they engage in bioprospecting. The guidelines are designed to supplement, not supplant, national bioprospecting requirements imposed by countries.
The guidelines attempt to overcome what I think are some of the shortcomings of the Bonn Guidelines, including problems with definitions pertaining to the scope of genetic resources, and what types of information are required for obtaining permission to access materials. Our guidelines, for example, only apply to materials of non-human animal, plant or microbial origin that contain functional units of heredity and that are subject to the requirements of prior informed consent. This is clearly set forth under the Convention on Biological Diversity. Clarity on this point is very important to BIO members because fundamental biotechnology discoveries are biological and gene-based in nature.
The Model Material Transfer Agreement Our members also expressed a need for a model ‘material transfer agreement’ (MMTA) that they could use for transferring possession and authorizing use of samples of genetic resources found ex situ and in situ.
The MMTA comports with our long-standing position that contracts provide the most effective means for fulfilling the objectives of the CBD because they allow the parties the most flexibility in structuring the successful conditions for transfer, allocating benefits arising from the transfer, and administering the transfer. As a result, the MMTA provides a structure that facilitates compliance with the CBD while allowing the parties flexibility to maximize their gains under the contract. It is not a standard or one-size-fits-all contract such as the Standard Material Transfer Agreement developed under the International Treaty on Plant Genetic Resources for a very specific type of low-cost, limited purpose. The MMTA can be a ‘stand-alone’ agreement for use for the transfer of a small number of samples of a single genetic resource from an ex situ collection. The MMTA is also designed to be used as part of a bioprospecting agreement or could be supplemented to cover the transfer of associated technological information such as traditional knowledge.
As in the BIO Guidelines, the MMTA will apply only to genetic materials of non-human animal, plant or microbial origin. In addition, the MMTA contains routine provisions such as the identification of the party transferring the material (the owner of the genetic resource) and the transferee (the party interested in research and/or development of the resource, e.g. a university or a company). The MMTA includes details related to the transfer itself as well, e.g. identification of the physical samples that will be transferred; the location where the samples were obtained; and any requirement for depositing samples with international depositary institutions.
The MMTA also requires incorporation of a list of the proposed uses of the genetic materials and explicitly prohibits the transferee from obtaining patents on the genetic resources in the form transferred. This prohibition does not prohibit the patenting of improvements made using the samples. Furthermore, while the MMTA includes a requirement to include terms for distribution of benefits, such distribution would be expected to differ widely from contract to contract depending on the needs of the transferor, the needs of designated beneficiaries such as indigenous or local communities, the commercial value of the transferred physical samples, the intended use of the samples, the likelihood of using the samples to create a commercially viable product, and other factors. As a consequence, BIO member companies believe that it is inappropriate to suggest a model formulation for the nature of benefits, or the manner in which benefits should be shared, as no single definition would be appropriate in all circumstances.
Opening a transparent dialogue While biotechnology has provided us with many tools and products in healthcare, agriculture and the environment, we have yet to scratch the surface. Research and collaboration in this area holds much promise for owners of genetic resources as well as users of those resources. As such, we encourage an open and transparent dialogue between owners and users as the biotechnology community plays an ever-increasing role globally.
James C. Greenwood is President and CEO of the
Biotechnology Industry Organization (BIO).
For more information, contact Lila Feisee, Managing Director for Intellectual Property,
contact.
(1) The Biotechnology Industry Organization (BIO) represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other countries. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. BIO produces the annual BIO International Convention, a global event for biotechnology (
Bio.org).
(2)
Guidelines for BIO Members Engaging in Bioprospecting.
