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Home > IP Topics Index > Bioprospecting, Traditional Knowledge, and Benefit Sharing > Access and Benefit Sharing: Illustrated Procedures for the Collection and Importation of Biological Materials CHAPTER NO. 16.3 Thornström CG and L Björk. 2007. Access and Benefit Sharing: Illustrated Procedures for the Collection and Importation of Biological Materials. In Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org. © 2007. CG Thornström and L Björk. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged. Access and Benefit Sharing: Illustrated Procedures for the Collection and Importation of Biological Materials
AbstractThe 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. 1. IntroductionAccording to the Convention on Biological Diversity (CBD), the rights to biological resources belong to the state in whose territory the resource is found. In order to prevent biopiracy and create a climate of mutual trust, the global community undertook to regulate the handling of genetic resources in the CBD, a binding international agreement. The goals of the CBD are to conserve biological diversity, promote its sustainable use, and ensure the fair and equitable sharing of benefits arising from its use. Responsibility for implementing the agreement is given to the state in whose territory the biological material is found. The CBD, however, contains rules that clarify the rights and responsibilities of all of the contracting parties. One relatively recent addition to the convention addresses the system governing access to genetic resources and the sharing of the benefits arising from their use: Access and Benefit Sharing (ABS). With this new legislation, a new world system for the use of biological matter now exists that has changed the nature of public and private sector R&D efforts. Anyone pursuing collection activities, whether of tangible materials or intangible information, may be subject to the 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. Such knowledge may, in national legislation, be considered intellectual property (IP) or trade secrets, and as such not in the public domain or available for unauthorized appropriation. Violation of the new access and benefit-sharing law, for example, by scientists conducting unauthorized collection activities, can result in fines, imprisonment, and the denial of future visits. Violation may also increase the transaction time needed to obtain a formal access permit. Therefore, it is essential not only to know the relevant policies, principles and laws, but also to have a practical understanding of the various potential ABS scenarios and the agreements, documents, applications, and other required procedural steps necessary for full compliance. 2. Four ABS ScenariosWe provide here the basics of ABS law, following four categories suggested in a recent publication by the Swiss Academy of Science,1 providing some examples of agreements currently or soon to be in effect. Please note that on the Internet you may find thousands of examples of letters of intent, research permits, prior informed consent/mutually agreed terms (PIC/MAT) agreements, material transfer agreements (MTAs), and confidentiality agreements. To find out which type of agreement fits your project best, please consult the legal department at your university or college. 2.1 No ABS situationFor some projects, research does not involve any access to genetic resources for which ABS contracts are necessary. However, other research permits may be required. A research permit request may ask for more details than necessary in this situation. Possible situations might include:
2.2 Simple ABS situationIn the simplest scenario in which access and benefit sharing are relevant to research involves the collection and transfer (including export) of samples for an inventory. A (standardized) MTA is normally sufficient. In some countries this could be done with a standard research permit application that includes the MTA (see section 3.2 dealing with the research permit). Other situations will require different actions:
2.3 ABS situationA third scenario involves a situation in which the export of samples is required for further analysis and study in a laboratory abroad. No further exploitation is planned. In this scenario, PIC, MAT, and MTA are all necessary. For the most part, completion of the documents mentioned in the simple ABS situations described in Section 2.2 is sufficient; however, each document will be more extensive. In the more-elaborate research permit applications, these additional documents are included. Confidentiality agreements also might be requested. 2.4 Complex ABS situationThe most complex scenario involving access and benefit sharing is a situation in which proposed research involves several steps, including research for commercial purposes and possible use of traditional knowledge. Initially, confidentiality agreements and letters of intent could be signed, followed by PIC, MAT, and MTA. In the MAT, issues concerning benefits have to be elucidated and agreed upon. Terms like interest, profit, and return, as well as payment times, have to be discussed and jointly interpreted by all stakeholders. 3. Illustrative Examples and Template AgreementsIn order to better assist the reader of this chapter in understanding the various ABS scenarios and the documents, letters, and agreements that might be applicable, we present examples of:
In addition, we also provide examples of ABS legal principles in various countries, along with useful online links where information can be obtained. It should be noted that the examples of template contracts or agreements presented below are for illustrative purposes only and in no way refer to specific existing agreements. The examples are meant to provide input for the development of real documents, which will need to be adapted to each specific circumstance. 3.1 Letter of intentThe letter of intent is a document in which the partners in the project describe their intentions. It is not legally binding as are the PIC and the MTA. It is mainly useful as a vehicle by which the parties can convey to one another their expectations and anticipated degree of involvement. A letter of intent could be used later as a basis for a PIC. A project could be financed through a planning grant, based on a letter of intent, and signed by all cooperating partners and stakeholders. The planning grant should finance the negotiations resulting in a PIC, MAT, and MTA. Planning grants have to be prepared three to four months before the deadline for submitting project proposals. The examples given here (Boxes 1A–1D; all Boxes are at the end of this chapter) are hypothetical but use features from the real world. It describes a study in a developing country where local scientists and indigenous people working together study herbs used for malaria and vector control. Stakeholders in the project could be the National Government (represented by the University of Vientiane and the Ministry of Environment and the Ministry of Health), local authorities in the province, national park officials where the study is performed, and indigenous people (represented by village representatives and individual healers). 3.2 Research permitTo be able to research in several foreign countries outside the E.U., you will need a research permit. In some countries, this is easy to obtain using a standard procedure with standard fees. In other cases, it can only be obtained in cooperation with a national partner or through prior informed consent contracts. For an example, see Box 2. 3.3 Prior informed consentPIC is a description of the project signed by all stakeholders and other concerned parties. It can be difficult to determine who exactly is affected by the project; another problem is financing the information and negotiations. It can also be problematic to have to devote all the work and generate expectations for a project that does not have any guaranteed financing. The prior informed consent is normally written to fit a commercial bioprospecting project. But how does it work with a basic noncommercial program? Near-term, medium-term, and long-term benefits should be considered, including up-front payments, milestone payments, and royalties. The benefit-sharing time frame should be definitively stipulated. Furthermore, the balance between near-term, medium-term, and long-term benefits should be considered on a case-by-case basis. The prior informed consent includes:
Prior informed consent means that everyone concerned has to be informed about the project and its terms before the project starts. If indigenous people are concerned, they must be informed so they understand the project. It may be necessary to translate the project into native languages or make a clear presentation with pictures. If the indigenous people do not give their consent, the project cannot start. A letter of intent could be used to introduce the project and start negotiations, even before the project is financed. When the project is financed, the letter of intent could be integrated into the PIC. Remember that most academic organizations are not familiar with using letters of intent. Also, it is also important to identify and understand the respective roles of the legal entities involved:
The above concerns and others are addressed and discussed in the following examples (Boxes 4A–4E) and their analysis. The PIC should always set a time schedule. The duration could be a couple of months, for a specific collection, to up to five years or so if the project includes a Ph.D. program. The PIC must also define what happens with material and results after the time schedule has ended (see Box 4C). Geographical area or areas shall also be defined realistically. This could be the whole nation or a local area. It is better to include any areas that could be of interest, rather than make it necessary to start new PIC negotiations, since these take a lot of time. An area could also be defined as a certain biotope in different geographical areas (see the examples in Box 4D). Scientists often specialize in collecting genetic resources within a certain family or selected genera. However, often material also is collected for colleagues interested in other species. If this is the case, it should be mentioned in the PIC, which should also state if the material will be given to a third party, how it will be used, and by whom. The genetic resources can be living or dead specimens, and also parts of specimens, such as genes, enzymes, or specified chemicals or extracts. Whole material from families or material from several genera can be included. The PIC can also include new derivatives made from the collected material. Questions to ask include: Why is the collection being made? How shall results be used? Is material to be taken out of the country? What information can be published? What species/samples can be transferred to a third party? What research methods may be involved? Have these provisions been set out in your project proposal for financing? Does publication of material obtained from indigenous people necessitate their consent? Is the project classified as commercial or as noncommercial? Box 4E offers several relevant examples. 3.4 Mutually agreed termsIn accordance with Article 15, Paragraph 7, of the Convention on Biological Diversity, each contracting party shall “take legislative, administrative or policy measures, as appropriate […] with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources. Such sharing shall be upon mutually agreed terms.” It is therefore important to assist parties and stakeholders in the development of mutually agreed terms to ensure the fair and equitable sharing of benefits. 3.4.1 Basic requirementsEveryone signing PICs and MTAs should understand the content, consequences, and meaning of certain terms. Mutually agreed terms take into account the different capacities and needs of those involved, including governments, indigenous and local communities, holders of ex situ collections, and the intended user organizations. This approach will contribute to fair negotiations and equitable shared benefits. Mutually agreed terms facilitate:
The following principles or basic requirements could be considered for the development of mutually agreed terms:
The following elements could be considered as guiding parameters in contractual agreements and as basic requirements for mutually agreed terms:
3.4.2 Typical termsA list of typical mutually agreed terms would include the following:
Mutually agreed terms for access to and specific uses of genetic resources (or derivatives), in accordance with Article 15, Paragraph 4 of the Convention on Biological Diversity, may also include conditions for transfer of such genetic resources to third parties, subject to national legislation of countries of origin. 3.4.3 The Bonn guidelines on MATThe development of mutually agreed terms should be based on the principles of legal certainty and minimization of cost. These principles were included in the Bonn Guidelines to respond to the concerns of scientific researchers and users of genetic resources that national procedures for obtaining access could be too complex and burdensome. The guidelines enumerate a detailed description of the type of provisions that could form part of a contractual arrangement. Some of the proposed provisions are quite innovative and include the specification of uses, the regulation of those uses in light of ethical concerns, the continuation of customary uses over genetic resources, the possibility of joint ownership of IP rights according to contributions, and the existence of confidentiality clauses and sharing of benefits from commercial and other utilization of genetic resources, including derivatives thereof. The principle subjects to be agreed upon as listed in the Bonn Guidelines are:
3.4.4 Convention on Biological Diversity: MAT guidelinesBox 5 provides the relevant sections on mutually agreed terms from Decision VIII/4 of the CBD. 3.5 Material transfer agreementsIf you need to transfer biological material from a foreign country, you must sign an MTA with the authorities of the foreign country. This could cover extracts for isolation of chemical compounds, as well as dried or otherwise preserved biological material. The material could be used in the national herbarium or for breeding purposes. The MTA should include:
See Box 6 (at the end of chapter) for a sample MTA that puts into place the above considerations. 3.6 Confidentiality agreementsBefore information of possible commercial value is given to another party, normally a confidentiality agreement is signed. The confidentiality agreement states what must be kept secret and stipulates a time frame for confidentiality. The agreement also includes paragraphs on how to proceed if confidentiality is broken. The Bonn Guidelines suggest that a confidentiality agreement be included in the PIC. Before signing any confidentiality agreement, a researcher should contact the legal affairs office at his or her university.2 See Box 7 for a sample confidentiality agreement. 5. Finding ABS InformationNow that you have an understanding of the basic steps to take to ensure ABS-compliance, how do you find out about the ABS rules of a given country? Which kind of legislation exists in the country you want to work in? Which conventions on biological material have they signed? In order to find answers to these questions, many countries have specific Web sites.3 5.1 EuropeThe E.U. and member states have signed CBD. The E.U. is now implementing ABS, but there is no common law. The E.U. Parliament and the Council directive have suggested introducing the country of origin in patent law (Directive 98/44/EG). The EC ABS portal covers: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom. Some specific country information follows:
5.2 AsiaThe ASEAN framework agreement on access to biological and genetic resources has been signed by Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. However, there is still great uncertainty in several countries about how to formulate contracts. Thailand, Malaysia, and Philippines are uncomplicated, while the situation in Laos and other countries is relatively complex.5 The Philippines was the first country to implement legislation to regulate access to biological resources. Executive Order No. 247, signed by the president of the Philippines in May 1995, was the product of discussions between government agencies, nongovernmental organizations, indigenous peoples, and academic consultants. The legislation established a framework to regulate biodiversity prospecting having four basic elements:
A material supply (or transfer) agreement is required for material leaving an institution. It should set out any relevant original terms of acquisition and state any additional terms of use, transfer, and benefit sharing. The Indigenous People’s Rights Act, 1997, includes a Code of Conduct for Academic Collector of Biological and Genetic Resources for collectors working in the Philippines.6 Other countries that passed such legislation include Bangladesh,7 Pakistan,8 and India.9 Some countries in Asia plan to regulate access to genetic resources to ensure PIC and benefit-sharing mechanisms. These include Fiji, Nepal, Pakistan, Papua New Guinea, Samoa, the Seychelles, the Solomon Islands, South Sri Lanka, and Vanuatu. 5.3 AfricaIn Africa, the OAU model law on the protection of the rights of local communities, farmers, and breeders and the regulation of access to biological resources (OAU, Addis Ababa, December 2001) has been used by some nations as a model for regulating access to biological material.10 So far, mainly Cameroon’s legislation follows the African Union principles. Case studies from Cameroon include contrasting benefit sharing in the pharmaceutical and phytomedical industries in relation to Ancistrocladus korupensis and sustainable harvesting of Prunus africana on Mount Cameroon.11 Nigeria12 and South Africa13 also recently passed legislations. 5.4 Latin AmericaCosta Rica has been one of the first countries globally to take a lead in biodiversity-related legislation. Information about regional groups, national governments, or state governments already regulating access to genetic resources to ensure prior informed consent and benefit-sharing can be found in the Ley de Biodiversidad No 7788, which has been in force since 1998.14 The rules on access to biodiversity (Presidential Decree No. 31-514) have been in force since 2003.15 The decree covers the following topics: access to genetic resources, equitable sharing of benefits arising out of the utilization of genetic resources, equitable sharing of benefits from the utilization of traditional knowledge, innovations and practices, intellectual property rights related to genetic resources and/or protection of traditional knowledge, innovations, and practices related to genetic resources. More broadly in Latin America, the Andean Pact decision 391/96 on the Common Regime on Genetic Resources is leading the tone of the discussions. Peru, under its National Strategy on Biological Diversity (Decreto Supremo No. 102-2001-PCM), recently added a regime on traditional knowledge (Law 27.811, August 2002). In Peru, a special national authority (INRENA) has been established to deal with access and benefit-sharing issues. The countries of the Andean region (Bolivia, Colombia, Ecuador, Peru, and Venezuela) decided to take a regional approach to regulating access to their genetic resources. The Andean Pact Decision 391 Agreement (1996) established a common rule on access to genetic resources for member countries, leaving implementation up to national regulation. The thinking behind this approach was that it made little sense for one country to regulate access strictly, when a neighboring country, with similar flora and fauna, had little or no regulation in place.16 Other countries where laws have been passed include Argentina,17 Bolivia,18 Brazil,19 Mexico,20 Panama,21 and Peru.22 5.5 Australia and the United StatesDespite the fact that the United States has never signed the Convention, most organizations and universities follow the CBD and the Bonn Guidelines.23 Several U.S. projects are financed with universities, together with NCI or NIH, and coordinated by the Fogarty International Center.24 Australia already regulates access to genetic resources to ensure prior informed consent and benefit sharing (the states of Western Australia and Queensland).25 6. ConclusionsDepending on the ABS situation (that is, no ABS situation, simple ABS situation, ABS situation, or complex ABS situation), a series of procedural steps will need to be taken pursuant to relevant national legislation. Accordingly, researchers must have a clear understanding of what documents need to be executed. These documents might include:
For each of these, it will be important to know who the authorized counterparts are in the country where collection activities are anticipated. In addition, it will be necessary to know where to find accurate and current information about the precise ABS legislation that prevails. Although this might initially seem daunting, full compliance is necessary. Careful planning and proactive management will pay off in the long term, by minimizing the possibility of misunderstandings and possible legal problems, including detainment or expulsion. Perhaps most importantly, these ABS regimes are in place to facilitate the building of equitable, sustainable, and solid networks for sharing biological resources for R&D programs. We all hope that the regimes ensure that any benefits that accrue will extend to all involved. Acknowledgements This chapter is based on a heavily edited synthesis of several documents prepared for a range of purposes. We are grateful to our colleagues and the publishers for having allowed us to edit and use extracts from these copyrighted materials.26
BOX 1A: SIMPLE LETTER AGREEMENT FOR THE TRANSFER OF MATERIALS Ministry of Environment, People’s Democratic Republic, represented by Mr./Mrs. __________; and the Department of Systematic Botany, Uppsala University, represented by Dr. Barbro Sundberg, hereby declare their intentions to develop a cooperative project in systematic botany and ethnobotany within the Nam-Nam National Biodiversity Conservation Area. Dr. Barbro Sundberg and her Ph.D. student, Hugo Brun, Uppsala University, and Ph.D. Mak Naeng, of the National University of the PDR, are given permission to collect plant material, in the form of herbarium vouchers, within the Nam-Nam NBCA in order to study the floristic biodiversity of the area and the documentation of the PDR genetic resources. All specimens are collected in triplicate and processed, and will be detained in the NU herbarium, in the Uppsala University (UPS), with one specimen going to the Stockholm Natural History Museum (S). All samples are marked with catalog number and the text: “The rights to this material belong to the PDR. Any distribution or DNA sampling of this material necessitates a specific permit from the Ministry of Environment of the PDR.” All publications deriving from the study of this material should acknowledge the Ministry of Environment of the PDR, and botanical publications should be published with consent of the curator of the NU Herbarium. All expenses for the above-mentioned project are planned to be financed by the Swedish International Development Cooperation Agency. The project is planned to take place from July 1, 2007, to June 30, 2010. This letter of intent covers that time period only. The Capital, February 10, 2007
BOX 1B: LETTERS OF INTENT—DERIVATIVES The Ministry of Health, the People’s Democratic Republic, represented by Mr./Mrs. _________; and the Department of Systematic Zoology, Uppsala University, represented by Dr. Åke Mattsson, hereby declare their intentions to conduct a cooperative project in biology within the Nam-Nam NBCA that concerns traditional techniques for malaria control and development of vector control. Dr. Åke Mattsson, Professor Dr. Thomas Lundberg, and Ph.D. students Nils Svensson, Uppsala University, and Mai Moeng, National University of the Capital, are given a permit to collect plant material and insect samples within the NBCA for documentation. All specimens are collected in triplicate and processed to be detained in the NU herbarium, in the Uppsala University (UPS), and at the Stockholm Museum of Natural History (S). All samples are marked with catalogue number and the text: “This material belongs to the PDR. Any distribution of this material to a third party requires a specific permit from the Ministry of Environment of PDR.” Prepared plant extracts are transferred to Uppsala University for analysis. All extracts are marked with catalog number and the text: “This sample belongs to the PDR. Any transfer of material to a third party necessitates a permit from the Ministry of Health, PDR.” All expenses for the project are to be financed by the Swedish International Development Agency. The project is planned to take place from April 1, 2007 to August 31, 2009, and this letter of intent covers that time period only. The Capital, March 3, 2007
BOX 1C: LETTERS OF INTENT—BIOPROSPECTING AND TRADITIONAL KNOWLEDGE The representative of the Council of Village Heads of Nam Rew and Nam Chaa Valleys, representing the people of the villages in the Nam Rew and Nam Chaa Valley, Nakay-Mai District, Nua Province, PDR and the Department of Systematic Botany, Uppsala University, Sweden, represented by Martin Stigberg, hereby declare their intention to cooperate on a project concerning plants used for traditional medicine and mosquito control. The project aim is to improve mosquito and health control for the people in the villages. All field equipment used for this control will be donated to the villages after the project time expires. All rights to findings, in the form of possible patents and marketable products, and profits from possible commercialization will be divided according to the following schema:
The project is planned to be financed by the Swedish International Development Cooperation Agency. Project time July 1, 2007, to June 30, 2011. Nam-Nam NBCA, February 28, 2007 Chief ………………. Martin Stigberg
BOX 1D: LETTERS OF INTENT—EDUCATION/TRAINING SITUATION The Faculty of Sciences, National University of the PDR (represented by Dr. Sue-Trong) and Department of Systematic Botany, Uppsala University, Sweden (represented by Dr Lisa Svensson), hereby declare their intention to cooperate on an ethnobotany project within the Nam-Nam NBCA, the People’s Democratic Republic. From the Faculty of Science, Mr. Mak Naeng MSc and Mr. Mai Moeng MSc will take part as Ph.D. students, with Dr. Lisa Svensson and Prof. Birgitta Eriksson from Uppsala University as supervisors. From Uppsala University, Hugo Brun is financed as a Ph.D. student. Financing for Mr. Naeng and Mr. Moeng is from the bilateral program of the Swedish International Development Cooperation Agency (Sida) and NUOL. Financing for Mr. Brun is from a grant from the Sida/SAREC to Dr. Lisa Svensson. Vientiane, February 25, 2007
BOX 2: RESEARCH PERMIT EXAMPLES FORM B-00127 ENVIRONMENTAL PROTECTION AGENCY/EPA APPLICATION FOR SCIENTIFIC AND/OR COMMERCIAL RESEARCH ON BIODIVERSITY IN THE COOPERATIVE REPUBLIC OF GUYANA NOTES TO THE APPLICANT
Please provide the information specified in the items below:
Signature of applicant Source: EPA, Republic of Guyana.28
BOX 4A: PRIOR INFORMED CONSENT—BIODIVERSITY AND ETHNOBOTANY: GARCINIA SENSU LATO (CLUSIACEAE) IN CUBA EXCHANGE CONTRACT FOR ACCESSING BIOLOGICAL RESOURCES BETWEEN THE NATIONAL BOTANICAL GARDEN OF CUBA (JBN) AND THE INSTITUTE OF EVOLUTION, GENOMICS AND SYSTEMATICS, UPPSALA UNIVERSITY, SWEDEN ON BEHALF OF THE FIRST PART: The National Botanical Garden under ownership of Havana University, Ministry of Education, JBN in advance, with legal address in Carretera El Rocio Km 3, Calabazar, Boyeros, 19230—Havana, Cuba, represented in this document by Dr. Angela T. Leiva Sánchez, as head director of the institution. ON BEHALF OF THE OTHER PART: The Department of Evolution, Genomics and Systematics, Uppsala University, Uppsala, Sweden, IEGSU in advance, with legal address in Norbyvägen 18D, SE-752 36 Uppsala, Sweden, represented in this document by Dr. Britta Ekholm as head of the Ethnobotany group of the Department of Systematic Botany at the Institute EGS, Uppsala University, Uppsala, Sweden. Both Parts Manifest:
BOTH PARTS: Acknowledging the person and legal entity which they sign on this document, agree to subscribe to the present contract following the next specifications, obligations and conditions: FIRST: The objective of the present bilateral contract is to access the Cuban alive biological resources for scientific purposes, for taxonomical studies, ethnobotanical studies, the investigation of chemical compounds and molecular studies on Cuban tropical plants of the genus Garcinia L. (Clusiaceae), in cooperation between JBN and EGS; the biological alive plant resources being accessed will be sent from Cuba to Sweden, as a sample big enough to achieve the above mentioned studies, from the wild harvest or donations of the Botanical Gardens in the National Network of Cuba. SECOND: The alive plant biological resources of Cuba from wild harvesting or donations of the Botanical Gardens in the National Network of Cuba will always have a herbarium sample that will be kept as part of the herbarium collections HAJB of the National Botanical Garden and UPS under ownership of the Uppsala University Museum of Evolution, and they will not be utilized for commercial purposes or exchange; if new species are described from this material, the holotypes must be deposited at the HAJB herbarium. THIRD: JBN will manage and pay the expenses for the official permits needed to access the natural areas, the biodiversity, exportation, and plant care. FOURTH: EGS will pay the expenses in Cuba of the Cuban partner for the supervisor, the driver that will take part in the expeditions and the plant care revision, the customs fee, and the transportation for the plant biological material. FIFTH: The live Cuban biological resources sent from JBN to EGS, collected from germination and cultivation will not be used for commercial purposes under any circumstances, if either the material’s origin is wild collected or is a donation from the Botanical Gardens in the Cuban National Network. SIXTH: The results derived from the chemical and molecular studies will be for mutual benefit and will be shared by JBN and IEGSU, in the way of scientific publications or otherwise, as agreed by the parts. SEVENTH: The transportation from JBN to IEGSU of the living plant biological resources will be done by EGS researchers directly from the International Airport José Martí, Havana, to Stockholm. EIGHTH: Possible modifications or additions to the present contract should be made through a formal agreement between the parties as included as an appendix to the present Agreement. NINTH: The present Contract of collaboration between JBN and EGS will be valid for two years from the signature date, extendable by equal periods, provided that no party terminates the agreement early. TENTH: Any difference or difficulty caused in relation with this Contract interpretation or execution, while in effect, will be resolved by means of friendly negotiations between the parties. In case an agreement cannot be reached, the conflict will be solved in the Arbitration Court of the Chamber of Commerce of the Cuban Republic. ELEVENTH: The applicable law is the portion of Cuban Law that agrees with the Convention on Biological Diversity, which both parties have signed. Two exact copies of the Contract will be signed, and both copies will be legally valid and will carry the approval of the Cuban Authority of the Centre for Inspection and Environmental Control. Each party will keep a copy in its possession. The present document is signed on 3 March of the year 2007. National Botanical Garden of Cuba Institute of Evolution, Genomics and Systematics _____________________________ _________________________________ _____________________________
BOX 4B: PRIOR INFORMED CONSENT—DESCRIPTION AND INVENTORY OF THE FLORA OF MALGONIA PROJECT 1: DESCRIPTION AND INVENTORY OF THE FLORA OF MALGONIA Parties: Institute of Systematic Botany, Uppsala University, Sweden, The prefect, Dr. Sven Berg, and the performing scientist, MSc Anna Skool, Institute of Applied Botany, University of Malgon, Malgonia, The director Dr. Marin Marais, the government of Malgonia represented by the director of the Malgonian Environment Protection Agency (MEPA). PROJECT 2. Inventory and use of the flora in Nam Noi valley, Lao People’s Democratic Republic (hereafter Laos or Lao PDR). Parties: - Institute of Systematic Botany, Uppsala University, Sweden, The prefect, Dr. Sven Berg and the performing scientists, Eva Lund, Dr. Mikael Engström, and MSc Birgitta Karlsson - National University of Laos, faculty of Science, the dean, Dr. Boukaone Nourinam, National University of Laos, faculty of Medicine, Dr. Bourisak Nam, NUOL represents the Government.
BOX 4C: TIME-FRAME EXAMPLES Project 1. Description and inventory of the Flora of Malgonia Project 2. Inventory and use of the flora in Nam Noi Valley, Laos
BOX 4D: EXAMPLES OF GEOGRAPHICAL DEFINITIONS Project 1. Description and inventory of the Flora of Malgonia. Project 2. Inventory and use of the flora in Nam Noi Valley, Laos
BOX 4E: DESCRIPTION OF MATERIAL Example 1: Description and inventory of the Flora of Malgonia Example 2. Inventory and use of the flora in Nam Noi Valley, Laos Example 3. Description and inventory of the flora of Malgonia Example 4: Inventory and use of the flora in Nam Noi Valley, Laos
Active compounds are identified using GC-MS and HPLC-MS. The project will serve technology transfer and technique training for Ph.D. students at NUOL. Blood sampling and analysis is performed by scientists of the medical faculty at NUOL. Ethical permits for blood sampling are obtained by the faculty. Expected outcome: improved malaria control among the population in the studied valleys and identification of possible products for malaria control. At least two PhD students will use the project to complete their exams.
BOX 5: CDB ON MAT
Source: CBD.29
BOX 6: SAMPLE MTA This overall Material Transfer Agreement (MTA) will govern the exchange of selected biological material between the University of Nangijala and the University of Uppsala, jointly referred to below as the Parties. This MTA is based on a collaborative research contract between the parties and may be amended where any national laws or regulations require it, or upon the mutual agreement of the contracting Parties. It is understood that all exchange of biological material will be done strictly in accordance with the principles set out in the Convention on Biological Diversity. The Parties therefore agree to the following terms and conditions: 1: Definitions Biological material means any material of a plant or animal, or microorganisms or other genetic resources or derivatives thereof. Provider means provider of biological material and may be the country providing a genetic resource collected from in situ or ex situ sources, including populations of both wild and domesticated species, according to the principles of the Convention of Biological Diversity. Provider may also be an institution providing part of a plant or animal, or microorganisms or other genetic resources or derivatives thereof. 2: Designation of Implementing Agency Depending on the situation in the countries of the respective Parties, several options for the designation of implementing agency are possible: 2.1 University X hereby designates an authorized representative from Faculty Y as the competent University X representative for the purposes of this MTA. Such a representative should be at the level of Director/Dean/Chairperson, or be an appropriate representative. For clarification, it is agreed that the Faculty Y shall be responsible for ensuring that all national laws and procedures in force in Country U, relating to the exchange of biological material, are respected. Faculty Y shall make reasonable efforts to inform individual researchers/investigators of the national laws and procedures relevant to this Agreement. 2.2 If the University has not designated an authorized representative, the University is represented by the Head of the Administration, and the Administration shall be responsible for ensuring that all national laws and procedures in force in Country U relating to the exchange of biological material are respected. The Administration shall make reasonable efforts to inform individual researchers/investigators of the national laws and procedures relevant to this Agreement. 3: Purpose The primary purpose of this Agreement is to provide a framework for the exchange of selected biological material for the purposes of research and education. 4: Ownership 4.1 Biological material exchanged in accordance with this Agreement, including any material contained or incorporated in modifications, wherever located, shall at all times be the property of the provider and shall not be used by, or transferred to, third parties without the knowledge, consent, and written authorization of the provider in accordance with the principles in the Convention on Biological Diversity. The ownership of any new intellectual property derived from material transferred under this Agreement shall be governed by the terms described in Article 7 of this Agreement. For the purpose of this MTA, the provider is defined as the Department or the University that has provided the biological material as defined in each Implementing Letter of Agreement and also defined in Article 5 of this Agreement. [Note: In the absence of specific legislation vesting ownership of biological material held by research institutions, it is prudent to have it vested in the Faculty or University. The Faculty in both Parties’ countries need to rigorously follow the developments in the emerging access legislation and respond to any legal developments accordingly.] 4.2 The Parties agree to refer to each other any requests for the use of material from third parties not defined under this MTA. 5: Implementing Letter of Agreement For all material to be exchanged or transferred under this Agreement, the Parties shall execute an Implementing Letter of Agreement (ILA), describing the nature of the material to be collected or transferred under this Agreement. Each ILA shall be concluded before any authorization for the transfer of material is granted. ILAs must contain the signatures of the relevant principal researchers that are providing and receiving the defined material in each ILA. The ILA must explicitly reference the rights and responsibilities of the Parties as defined by this MTA. [The purpose of this section is to avoid a situation in which an MTA would need to be concluded for every single exchange of material. The section will accurately define the nature of the material that is transferred under each MTA.] 6: Conditions relating to the use of biological material 6.1 The Parties agree that the material collected and transferred under this agreement is to be used for teaching and academic research purposes. 6.2 It is agreed that any other application or use of the material provided, including any modification thereof, for commercial purposes shall be allowed at the sole discretion of the provider. If either of the Parties wishes to use the material, or derivatives thereof, for purposes other than that described in Article 6.1 of this MTA, the authorization for such use shall be at the sole discretion of the providing institution as described in this MTA, and such authorization shall not be reasonably withheld. 6.3 Each of the Parties agrees to comply with the terms of this Agreement. This includes any scientists or any person(s) of either Party who may come to possess the material in the ordinary course of his/her business as an employee of the Parties. Such person(s) shall not make available the material or any part thereof, or related information to any person(s) or third parties other than those personnel under the Parties’ immediate and direct control. 7: Intellectual Property Rights Any inventions that are derived in whole or in part from the biological material transferred under this MTA shall be assigned in accordance with the relevant laws governing intellectual property. Each assignment shall (1) identify the provider of the material and (2) identify the country of origin of the material used in any commercialized product(s). The assignees of inventions of any commercialized product(s) shall negotiate a good faith, mutually acceptable agreement with the provider of the material, according to the principles set out in the Convention on Biological Diversity. 8: Publication Copyrighted publication generated from research exchanged under this agreement or extracted from biological material collected in the pursuance of this agreement shall not include any restrictions whatsoever regarding use of such publication by the Parties. 9: Duration of the Agreement This MTA shall be valid until the end of 2001, according to the BIO-EARN project contract. The agreement may be renewed for a new BIO-EARN Programme period (2002–2005) upon mutual agreement of the contracting Parties. 10: Termination 10.1 Unless otherwise agreed, this MTA will terminate at the expiration of the present cooperation program.
10.2 Nothing in this Agreement shall be interpreted as having the effect of preventing or delaying the publication of research findings resulting from the use of the material or modification thereof. 11: Settlement of disputes 11.1 In the event that a dispute arises regarding the interpretation or application of the provisions of the Agreement, the Parties shall initially resolve their disputes in an amicable manner through consultations. 11.2 If the Parties fail to resolve their disputes amicably within a period of six months, they shall resort to arbitration. 11.3 Each Party shall nominate two arbitrators, and a fifth arbitrator shall be nominated by the United Nations Legal Affairs Office. The latter shall be the Chair of the Arbitral Tribunal. The decision of the arbitrators shall be final. Decision shall be passed by consensus. If consensus cannot be achieved, the decision shall be made by vote. 12: Miscellaneous The Parties acknowledge that the biological material provided in pursuance of this Agreement may have characteristics that are unknown or difficult to determine and which may be potentially hazardous. Neither Party makes any warranties, express or implied, as to the safety, quality, viability, or purity of the material, or its merchantability or fitness for any particular purpose. University/Research Institute in the Nation concerned Name of University_____________________________________________ Full Address__________________________________________________ Authorized Officer_____________________________________________ Title________________________________________________________ Signature____________________________________________________ Date________________________________________________________ University in Sweden____________________________________________ Name of University_____________________________________________ Full Address__________________________________________________ Authorized Officer_____________________________________________ Title________________________________________________________ Signature____________________________________________________ Date_______________________________________________________
BOX 7: SAMPLE CONFIDENTIAL DISCLOSURE AGREEMENT This Confidential Disclosure Agreement (“Agreement”) is made and entered into as of the _____ day of ____________, 20__ (the “Effective Date”) by and between _______________________________________________________________________ (hereinafter referred to as “LENDER”) having its principle address at _______________________________________________________________________, and ___________________________________________________________________ (hereinafter referred to as “BORROWER”) having its principle office at _______________________________________________________________________. The LENDER and the BORROWER are each hereinafter sometimes referred to individually as a “Party” and collectively as the “Parties,” for the purpose of protecting the patent, trade secret, and other proprietary rights of the LENDER and the BORROWER in the following subject matter, which may be mutually beneficial to the Parties to disclose for evaluation: Subject Matter Description: The Parties agree as follows: Neither Party will directly or indirectly divulge to unauthorized persons any information received from the other Party that relates to the subject matter of this Agreement, except as otherwise required by law. As a condition to receiving such information, each Party to the Agreement hereby acknowledges that all information provided by either Party to the other in connection with the subject matter of this Agreement is confidential and proprietary with regard to the Party providing such information. Information to be subject to this Agreement shall be disclosed in writing or, if it is verbally or electronically disclosed as confidential at the time of disclosure, its confidentiality shall be confirmed in writing within twenty (20) days of disclosure by the Party making the disclosure. Each Party, as recipient of such proprietary information from the other Party, will disclose such information only to its employees, directors, agents, consultants, bankers, and advisors (“Representatives”) for the purpose of evaluation, and any Representatives to whom such information is disclosed shall be informed of the proprietary nature of the disclosure and of this Agreement and shall agree to hold such information in confidence and be bound by this Agreement in the same manner that each Party is bound. Each party shall be responsible for any breach of this Agreement by its Party Representatives. Neither Party will use such information received from the other Party for any purpose except evaluation, testing, research, and related activities and will not disclose such information to anyone except its Representatives, unless prior written consent is obtained from the Party providing such information or as required by law. This Agreement shall be binding on both Parties for a term of ______ () years from the effective Date of this Agreement, except under the following conditions:
This Agreement shall be governed by the laws of _______________________________. To evidence their Agreement to the foregoing, the Parties have, through duly authorized representatives, executed this Agreement. LENDER ________________________________________________________ By: ____________________________________________________________ Name: __________________________________________________________ Title: ____________________________________________________________ BORROWER _____________________________________________________ By: ____________________________________________________________ Name: ___________________________________________________________ Title: ____________________________________________________________ EndnotesAll referenced Web sites were last accessed between 1 and 10 October 2007. 1 Biber-Klemm S and S Martinez. 2006. Access and Benefit Sharing—Good Practice for Academic Research on Genetic Resources. 1st edition. Swiss Academy of Sciences: Bern. www.scnat.ch. 2 The Bonn Guidelines use the term secrecy agreement. Although there are different terms, including nondisclosure agreement, the editors of the Handbook prefer the term confidentiality agreement, which is more neutral and is used more widely. 3 For example, for Europe: http://biodiversity-chm.eea.europa.eu/. Worldwide: www.biodiv.org/programmes/socio-eco/benefit/. National focal points can be found at www.biodiv.org/doc/lists/nfp-abs.pdf. Case studies can be found at http://www.cbd.int/doc/case-studies/default.aspx. If you are unable to open a link here, use http://www.cbd.int/information/case-studies.shtml and click on case studies. 4 See http://www.nordgen.org/ngb/ and http://www.nordgen.org/ngb/. 5 The ASEAN Framework Agreement on Access to Biological and Genetic Resources (2000). www.grain.org/brl/?docid=785&lawid=1261. See also www.wipo.int/globalissues/databases/contracts/index.html and www.biodiv.org/programmes/socio-eco/benefit. 6 Further information: The Philippines Executive Order No 247 (May 1995) can be found at www.grain.org/brl/?docid=915&lawid=1482; www.chmbio.org.ph/eo247.html; www.chmbio.org.ph/dao20-96.html. 7 www.grain.org/brl/?docid=538&lawid=1274. 8 www.grain.org/brl/?docid=683&lawid=1456. 9 During 2001 India adopted a bill for the protection of plant varieties and the farmer’s rights (Bill. No.123 of 1999). A Biodiversity Bill (Bill. No.93 of 2000) has also been passed by the Parliament. www.grain.org/brl/?docid=322&lawid=1378 (in force beginning in 2002). 10 See www.grain.org/brl/?docid=798&lawid=2132. An explanatory booklet of the African Union Model Law, written by Professor J. A. Ekpere, can be found at www.grain.org/brl/?docid=798&lawid=2132. 11 www.biodiv.org/doc/case-studies/abs/cs-abs-aristo.pdf. 12 www.biodiv.org/doc/case-studies/abs/cs-abs-ng-a.pdf. 13 www.grain.org/brl/?docid=621&lawid=1222. 14 Both Spanish and English versions are at www.grain.org/brl/?docid=879&lawid=1859. 15 www.grain.org/brl/?docid=209&lawid=1872. 16 The Common Access Regime for Genetic Resources, Andean Pact Decision 391 (July 1996), can be found in Spanish at www.sice.oas.org/trade/JUNAC/decisiones/DEC391S.asp and in English at www.sice.oas.org/trade/JUNAC/decisiones/DEC391e.asp. These laws and others can also be found on the Web site of GRAIN (Genetic Resources Action International): www.grain.org/brl/index-en.cfm. 17 www.grain.org/brl/?docid=327&lawid=1677. 18 The Reglamento de la Decision 391 Regimen Comum de Acceso a los Recursos Genticos (in force beginning in 1997). www.lclark.edu/org/ielp/boliviaspanish.html; in English at www.lclark.edu/org/ielp/boliviaeng.html. 19 The Acre State Law (Accesso a recursos genéticos lei estadual) has been in force since 1997 and can be found at www.lclark.edu/org/ielp/acre.html. The Amapá State Law on Access to Genetic Resources, in force since 1997, can be found in Portuguese at www.lclark.edu/org/ielp/amapaportuguese.html and in English at www.lclark.edu/org/ielp/amapaenglish.html. This legislation can also be found on WIPO’s site: www.wipo.int/tk/en/laws/. The Medida Provisória No. 2.186-16 of 23 August 2001 regulates Access to Genetic Heritage, Protection of and Access to Associated Traditional Knowledge, Sharing of Benefits, and Access to and Transfer of Technology for their Conservation and Use and can be found at www.wipo.int/tk/en/documents/word/brazil-provisional-measure-por.doc in English. For Portuguese, visit www.planalto.gov.br/ccivil_03/MPV/2186-16.htm. 20 See Torres Nachon C and G Cantoe. Towards a Law on the Access and Use of Genetic Resources in Mexico. Center for Environmental Law and Economic Integration of the South. http://www.biodiv.org/doc/case-studies/abs/cs-abs-biodassur.pdf. 21 Law No. 20 (26 June 2000) on a Special Regime of Collective Rights of Intellectual Property of Indigenous People for Protection of their Cultural Identity and their Traditional Knowledge. www.grain.org/brl/?docid=461&lawid=2002. See also www.wipo.int/tk/en/documents/word/panama-executive-decree-12.doc. 22 The Propuesta de Regimen de Proteccion de los Conocimientos Colectivos de los Pueblos y Comunidades Indigenas Vinculados a los Recursos Biologicos (in force beginning in 2002), can be found in Spanish and English at www.grain.org/brl/?docid=175&lawid=2041. 23 www.state.gov/g/oes/rls/or/25962.htm. For Americans working in other nations, contact: Access and Benefit-Sharing Officer, U.S. Department of State’s Office of Ecology and Terrestrial Conservation, (202) 647-1804 or FAX (202) 736-7351. For research-permit applications, visit science.nature.nps.gov/research/. 24 More information about these can be found in Chemical Prospecting: An Overview of the International Cooperative Biodiversity Groups Program, Francesca T. Grifo Fogarty International Center. National Institutes of Health: Bethesda, MD www.fic.nih.gov/programs/research-grants/icbg/index.htm. 25 For information about performing research in national parks, see www.deh.gov.au/epbc/permits/parks/research. 26 Thornström CG and L Björk. 2006. Accessing Others’ Proprietary Biological Matter and Related Information–Towards a Handbook in Access and Benefit Sharing and Related Intellectual Property. Part three: Entering Into Agreements. Unpublished. Sennerby Forsse L. 2003. Inventory Regarding ABS Legislation in Selected Countries. Swedish Research Council/FORMAS: Stockholm. Thornström CG and Björk L. 2006. Accessing Others’ Proprietary Biological Matter and Related Information–Towards a Handbook in Access and Benefit Sharing and Related Intellectual Property. Part One: Chapeau. Unpublished. Also the publication in supra note 1. 27 Editors’ Note: This and other forms in this chapter have been lightly edited for English, consistency and clarity. 28 www.epaguyana.org/downloads/BiodiversityGuideLinesForResearch.pdf. 29 www.biodiv.org/decisions/default.aspx?m=COP-08&id=11016&lg=0. |
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Editor's Summary, Implications and Best Practices
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