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About
MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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Why This Topic Is Important
It is anticipated that biodiversity and indigenous peoples’ traditional knowledge, as sources of discovery
similar in some ways to research, may be important sources of new technology for the future. While the
underlying dynamics are similar—involving documentation, protection, uncertainty, risk, rights,
investment, partnership, R&D, and marketing—there are legal issues that set these sources of new
knowledge apart. This section discusses approaches, policies, and mechanisms for managing
biodiversity as an input to R&D, within the context of the rapidly evolving international and national legal
frameworks for biodiversity resources and traditional knowledge.
Key Implications and Best Practices: Setcion 16
Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.
- The three guiding principles for a successful relationship in bioprospecting and related endeavors are a commitment to maintaining a fair, trusting, long-term relationship; efficient and reasonable authorization; and the equitable sharing of benefits between a company and its collaborators in the host country.
- The western system of IP rights, and particularly of patenting, is based on the premise that anything that is already known cannot be protected. Indigenous knowledge is often communal, has been disclosed, and has been passed on from previous generations. the very nature of indigenous knowledge, therefore, does not meet some of the criteria for intellectual property protection (such as novelty).
- A successful biodiversity access agreement includes a clear definition and assignment of legal rights to all genetic resources involved; prior informed consent from all domestic parties affected by the bioprospecting (including landowners and managers); a clear statement of rights to patent and commercialize products derived from discoveries made; and terms of confidentiality. The BAA also establishes a noncompetitive relationship between the parties; trust that no transfer of proprietary technologies or technical capacity involved under the agreement will occur with respect to third parties; and that no exclusivity requirements exist.
- Patent laws per se do not “create” biopiracy. Rather, biopiracy is a form of misappropriation, unfair acquisition, and inequitable sharing of benefits with respect to biological resources.
- Prior informed consent is an important principle in bioprospecting. This should include informed consent in the case of collection and use of plant/genetic materials, as well as informed consent of individuals and their communities regarding traditional medicinal use or uses of a plant.
- When dealing with foreign bioprospectors, your office will function as the gateway and regulator of their activities. As such, technology transfer officers will provide oversight to negotiating agreements for equitable sharing of rewards, defining access, discussing possible patentability, and protecting the rights of the indigenous peoples who are the stewards of these resources.
- Negotiating access to your country’s genetic resources, biodiversity, and TK will require a balanced, nuanced approach. equitable benefit sharing must simultaneously ensure fair returns to your country, yet not inhibit the R&D initiatives of foreign partners. Solid agreements will benefit all parties: your country, your partnering organization, and the country or community that provides the resource. Extreme situations, such as an expectation of immediate windfall returns or wanton biopiracy by outsiders, will freeze the resources and ultimately lead to their demise.
- Both monetary and nonmonetary benefits may be attractive to the university or institute; both, therefore, should be considered. Nonmonetary benefits could include training opportunities for scientists and donation of equipment.
 Abstract
Access and Benefit Sharing: Illustrated Procedures for the Collection and Importation of Biological Materials
by Carl-Gustaf Thornström, Lars Björk
Abstract:
The Convention on Biological Diversity (CBD) contains rules that clarify the rights and responsibilities of parties accessing biological resources from member nations. One aspect of the convention addresses the system that governs access to genetic resources and how the benefits arising from their use are shared. This legislation is commonly called the Access and Benefit-Sharing (ABS) program. Anyone pursuing collection activities, whether of tangible materials or intangible information, may be subject to these new regulations. Especially targeted are scientists and researchers who make significant use of proprietary genetic resources, biological matter, and related information, such as traditional knowledge and farming know-how. Therefore, it is important for all potential collectors to be familiar with the fundamental principles of ABS law as well as the procedures that must be followed in order to be fully compliant with the rules and regulations of the countries where collecting occurs. Well in advance of any collection activities, researchers should review the ABS situation, determine who could best answer questions about ABS, find authorized partners in the country of interest, locate relevant information on the specific ABS regime, and, most importantly, execute the documents, letters and agreements necessary to proceed with collection activities.
Abstract
Access and Benefit Sharing: Understanding the Rules for Collection and Use of Biological Materials
by Carl-Gustaf Thornström
Abstract:
The rules that govern the collection and use of biological matter have changed dramatically in the last 15 years. Arising out of the Convention on Biological Diversity (CBD), the Access and Benefit-Sharing (ABS) project applies to research carried out for either purely scientific or commercial reasons, for which organisms or parts thereof and/or related traditional knowledge are obtained from countries that are party to the CBD and their local and indigenous communities. Other agreements have added new ABS legislation to govern the acquisition and use of biological material and related information. Everyone—including tourists, nature conservationists, scientists, photographers, and journalists—is subject to these new regulations. But scientists and researchers who seek to access and use proprietary genetic resources, biological matter, and related information (such as traditional knowledge and farming know-how) are especially affected by the ABS project. It is essential for scientists and researchers to understand the fundamental principles of ABS. This includes knowing the relevant rules, regulations, laws, customs, and conditions for benefit sharing in the country where one intends to conduct research and/or collect samples. One must carefully plan ahead for any such activities by contacting key organizations and filing the proper documentation. Lack of planning may lead to unfortunate and undesired outcomes, including fines, imprisonment, deportation, and denied future access. Planning is critical.
Abstract
Bioprospecting Arrangements: Cooperation between the North and the South
by Djaja Djendoel Soejarto, C. Gyllenhaal, Jill A. Tarzian Sorensen, H.H.S. Fong, L.T. Xuan, L.T. Binh, N.T. Hiep, N.V. Hung, B.M. Vu, T.Q. Bich, B.H. Southavong, K. Sydara, J.M. Pezzuto, M.C. Riley
Abstract
Deal Making in Bioprospecting
by Charles Costanza, Leif Christoffersen, Carolyn Anderson, Jay M. Short
Abstract:
There is an upward trend in demand for intellectual property protection in agriculture. While international agreements exist to protect agricultural biodiversity, the specific rights, benefits, and responsibilities of parties entering into commercial agreements that involve the use of genetic resources still must be clarified. This chapter provides practical guidance for creating agreements around the use of biodiversity resources, as well as guidance that may provide valuable insights for creating similar agreements on the use of unique agricultural resources.
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