Home > Topics > Bioprospecting, Traditional Knowledge, and Benefit Sharing > Access and Benefit Sharing: Illustrated Procedures for the Collection and Importation of Biological Materials > Editor's Summary, Implications and Best Practices

There is an emerging new regime (or or a “world order” as the author of chapter 16.2 calls it) regarding biological matter: an international regime on access to genetic resources, as well as related materials and information, and the sharing of benefits arising out of their utilization. These chapters explain the what, why and how of these new regimes, providing the reader with a comprehensive roadmap for understanding the details, and then finding the correct path to compliance with the applicable laws, rules and regulations that may cover access in a given country.

This emerging new regime is driven by Access and Benefit-Sharing (ABS) regimes, which apply to research carried out for either scientific or commercial purposes. ABS has to do with accessing organisms or parts thereof (the “genetic resources”), and/or related traditional knowledge held by local and indigenous communities, that are obtained (“accessed”) from a country that is party to the Convention on Biological Diversity (CBD). In addition, other international treaties, accords and agreements have also added new legal ABS regimes legislation through the acquisition and use of biological material and related information.

Everyone (tourists, nature conservationists, scientists, photographers, journalists) is subject to these new ABS regime regulations. 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 impacted by the ABS system. Such knowledge may in national legislation be treated as intellectual property or confidential trade secrets, and is thus not in the domain for public use or subject to any form of unauthorized appropriation. As this chapter makes clear, violation by foreign parties (for example, scientists conducting unauthorized collection activities) of the new ABS regimes (for example under the CBD) may result in fines and/or imprisonment and denial of future visits. It may also increase the transaction time needed to obtain a formal access permit. A violation may also destroy possibilities for colleagues to work in the country. Thus, it’s important to know how to properly proceed, as these chapters instruct.

To understand the fundamental principles of ABS, one should know the relevant rules, regulations, laws, customs and conditions for benefit sharing of the country where one intends to conduct research and/or collect samples. It is important to carefully plan ahead for any such activities. This will involve contacting key organizations and people who can offer useful guidance and filing the proper documentation.

Basic issues to address for all biologists regarding access to biological material, and related information, from the territory of another sovereign state include the following questions, which should be asked before collection leading to R&D is initiated:

• Under which conditions may I, as a scientist, enter another sovereign state’s territory in my scientific capacity?
• Under which conditions may I, as a scientist, collect biological material and related information?
• Under which conditions may I, as a scientist, carry out or export biological material and related information from that sovereign state’s territory?
• Under which conditions may I, as a scientist, make further use of collected biological material and related information?

As a next step before initiating collection for the purposes of research, it is essential to identify and then contact an authorized counterpart in the country concerned to find out which rules apply. It is also useful to contact the country’s Embassy/Consulate/Legation in one’s own home country. In addition, it will be necessary to know where to find accurate and current information on the precise ABS regime that is in place in the country where collection activities are anticipated. Hence, as early as possible, it would be highly advantageous to receive information regarding the situation in the counterpart country pertaining to the following topics:

• What are the requirements for foreign parties seeking to access biological material and information?
• Which are the conditions of benefit sharing?
• What are the conditions regarding applying IP rights?
• What is the national focal point for ABS issues?
• Are written instructions on ABS conditions available to foreign parties?

These chapters present a practical overview of the principles and procedures underlying ABS regimes that will be useful to various types of research and access situations. Broadly viewed, ABS issues and access can be divided into four categories based on their complexity, in terms of the ABS system under consideration:

1. No ABS situation: The research does not involve any access situation or genetic resources. Thus no ABS contract is necessary. However, other research permits may be required.
2. Simple ABS situation: The research involves the collection and transfer (including export) of samples for an inventory. A (standardized) MTA is sufficient.
3. ABS situation: The export of samples is required for further analysis and study in a laboratory abroad. No further exploitation is planned. A simple ABS contract is sufficient.
4. Complex ABS situation: The proposed research involves various steps, including possible research for commercial purposes, or the use of traditional knowledge. A full ABS contract is required.

Whatever the ABS situation turns out to be, in the final analysis the most critical aspect will be to understand the ABS regime, thoroughly research the laws, rules, regulations and customs of the country where you intend to conduct research and plan ahead for all foreseeable contingencies. Knowing this well in advance, scientists can anticipate their obligations, and plan to make the proper contacts and file the correct documentation.

With this in mind, these chapters provide the reader with a series of template documents that are illustrative examples of what might be necessary, depending on the specific requirements of the collection activities. In 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 are presented as examples:

1. Letter of intent
2. Research permit
3. Prior informed consent/PIC
4. Mutually agreed terms/MAT
5. Model material transfer agreement, Material transfer agreement/MTA
6. Secrecy agreement

Although all of this might all seem daunting at the start, the documents are necessary and in a growing number of countries are required by law. Careful planning and proactive management will pay off in the long term, minimizing the possibility of subsequent misunderstandings and other problems, and can help minimize the spectre of legal problems such as detainment or expulsion. Perhaps most importantly, these ABS regimes are in place to facilitate the building of equitable, sustainable and solid networks for future partnerships in sharing biological resources for R&D programs, such that benefits accruing will be extended to all involved. As this chapter makes abundantly clear, the emerging new regime regarding biological matter is designed to foster long-term, equitable relationships in development.

Key Implications and Best Practices

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.

For Government Policymakers

• When a country joins the Convention on Biological Diversity (CBD), it is wise to implement an Access Benefit-Sharing (ABS) regime that carefully balances equitable access to biological resources, as well as related traditional knowledge, with the R&D expertise of potential foreign partners in development.
• Establish national policies concerning ABS, and make these, along with all pertinent laws, rules and regulations, readily transparent and easily available to any scientists who might be contemplating collection activities.
• Designate authorized governmental agencies and individuals who are key contact entities for foreign scientists contemplating collection activities in your country.

For Senior Management (university president, R&D manager, etc)

• Foreign scientists who wish to conduct collection activities in a given country are, by and large, seeking to build long-term partnerships, such that all parties involved will benefit.
• Cultivating relationships between an institution and foreign counterparts will encourage and foster R&D collaborations on biological resources from that country. This will be a dynamic way to tap the vast potential value of these natural resources and related traditional knowledge.
• Consistent with a country’s Access Benefit-Sharing (ABS) laws, rules, and regulations, it is important to establish policies and protocols in public sector institutions that foster and implement this national ABS regime. This, then, will facilitate equitable, sustainable and profitable relationships with foreign scientists and their organizations.

For Scientists

• When working with colleagues from foreign countries, remember that they will be authorized to make collections of biological materials only under specified circumstances. Thus, before proceeding with joint activities, check with your institution’s technology transfer office to make sure that all the necessary requirements have been properly attended to.
• Understand the fundamental principles of the Convention on Biological Diversity (CBD) and Access Benefit-Sharing (ABS) regimes. These are in place to both protect the resources of your country and also to build collaborative projects in R&D that will foster a broad and equitable distribution of benefits flowing from the biological resources of your country.

For Technology Transfer Officers

• Make certain that your office is up to date with the provisions of the Convention on Biological Diversity (CBD) and also any related Access Benefit-Sharing (ABS) regimes.
• Instruct your institution’s scientists and staff on the CBD and related ABS regimes.
• Provide your scientists and their foreign counterparts with an easily accessible resource for information on the CBD and your country’s ABS regime.
• Implement capacity in your institution for addressing the full spectrum of possible documentation that might be required for a foreign scientist to pursue collection activities in your country.
• Encourage your institution’s scientists to engage in collaborative R&D efforts with foreign colleagues, with the goal of realizing maximal value from your countries biological resources. When pursued according to your country’s ABS regime, this can be a win-win situation for all involved.