Models of Benefit-Sharing Policy: Opportunities ... - ACS Publications

Downloaded by RUTGERS UNIV on December 28, 2017 | http://pubs.acs.org Publication Date (Web): December 20, 2009 | doi: 10.1021/bk-2009-1021.ch029

Chapter 29

Models of Benefit-Sharing Policy: Opportunities and Challenges in Ensuring Equitable Natural Product Discovery in Africa Benjamin D. Neimark Department of Geography, Rutgers University, 54 Joyce Kilmer Avenue, Piscataway, New Jersey 08854

Since the latter half of the 20th century, there have been a number of international and national agreements created for the purposes of distributing benefits derived from the commercialization of natural products and the protection of intellectual property rights. However, in Africa, there exist many challenges to the adoption, implementation and enforcement of the agreement at the national level. In this paper, I highlight different models that have been implemented across Africa. By identifying both the shortcomings and opportunities in current models, one can better seek to build more equitable partnerships in practice.

© 2009 American Chemical Society

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Juliani et al.; African Natural Plant Products: New Discoveries and Challenges in Chemistry and Quality ACS Symposium Series; American Chemical Society: Washington, DC, 2010.


538 Historically, there have been vast array of interesting natural products developed from African plants. Once easily accessed and harvested the biogenetic resources and associated traditional knowledge from which many of these natural products derived are now subject to a host of international and national regulations governing their use. Since the latter half of the 20th century, there have been a number of international and national agreements created for the purposes of distributing benefits derived from the commercialization of natural products and the protection of intellectual property rights. These agreements were formalized under the Convention on Biological Diversity (CBD) and were signed at the 1993 Earth Summit in Rio de Janeiro by many African countries, and as of 2002, up to 52 African countries have signed and ratifed or agreed in principle to the terms of the treaty (1). The CBD came a long way in addressing many of the ethical issues concerning natural product discovery and commercialization. However, in Africa, there exist many challenges to the adoption, implementation, and enforcement of the convention. This has resulted in a number of ad hoc access and benefit-sharing agreements at the national level. These subsequent agreements because many challenges to ensuring that fair distribution of benefits are delivered and that effective intellectual property rights are implemented (1, 4) The primary purpose of this review is to provide an overview of the issues concerning access and benefit-sharing models that have been adopted across Africa. By identifying the shortcomings of the current models and highlighting opportunities that appear to exist, one may use that knowledge and experience to build more equitable partnerships among private and public institutions, hostgovernments and individuals involved in natural product discovery and commercialization.

Access and Benefit-Sharing and the CBD Bioprospecting is defined as the systematic search and commercial development of natural products used in novel pharmaceuticals, nutriceuticals and industrial applications (1). Given their prior success, the champions of bioprospecting argue that natural products in the form of plants, marine organisms and micro-organisms remain the preeminent source for bioactivity and drug discovery (2, 3). For example, a survey revealed that over $8 billion of U.S. prescription drugs in 1980 were plant-based, and found that out of the top one hundred and fifty brand names prescribed during a period of nine months in 1983, 57 percent of those drugs contained an active principle from a biological source (2). A more recent review concluded that from 1981 to 2002, over 60 percent of all new drugs introduced worldwide were based on a compound found in a natural product (3). The early 1990s marked a watershed moment for bioprospecting. A time when advances in drug discovery science and genomics coincided with growing concerns for the environment, including mass species extinction (4). With the advent of high-throughput screening, automation and new information



539 technology, thousands of extracts of biological resources could be now tested at rates commercially attractive to large-scale laboratories and pharmaceutical companies (5). Those living in areas which supplied the source material, and provided the medicinal knowledge leading to the discovery, would be monetarily rewarded in a pre-determined compensation deal or access and benefit-sharing agreement (ABS). These natural product discovery schemes where founded on the logic that the commercialization of valuable genetic resources will foster social and economic development in areas that have marginal economic opportunities. In June 1992, the CBD was open by the United Nations for signatures and was later entered into force on December 1993 (6). One of the preeminent protocols of the CBD, Article 15(1), describes the individual country’s rights over its natural resources. In return for its control, national governments must facilitate access to their biodiversity for scientists and in return for fair and equitable sharing of the scientific and monetary benefits that derive from commercialization (6). The CBD also provides an overarching blueprint for a number of related research protocols and guidelines for national policy, most noteworthy, including prior informed consent, mutually agreed upon terms, and a specific code of conduct for collaborating scientists and researchers. The three main objectives of the CBD include: • The conservation of biological diversity • The promotion of sustainable use of its components. • The equitable sharing of benefits that derives from the utilization of genetic resources (6). Intellectual Property Rights, TRIPS and Traditional Knowledge Internationally, the World Trade Organization’s (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights or TRIPS, in general, is the main force behind the implementation of intellectual property rights (IPRs). IPRs are goods that are derived from the mind or intellect, and are a feature of property that is reflected in copyrights, patents, trademarks, industrial design, trade secrets and domain names. In effect, they provide the “holder” the right to maintain exclusive control over the material (7). Overall, TRIPS, places emphasis on private property rights, especially concerning intellectual property to assist private companies and individuals the ability to patent discoveries made from nature based on scientific and/or traditional knowledge. One of the most contentions issues facing IPRs has to do with the placing of novelty found with discovery involving biogenetic resources under IPR protection. Many critics of TRIPS remark that “traditional” knowledge was never formally accounted under the agreement, making it easier to privatize traditional knowledge under the framework of international patent rights (8). For some critics, the patenting traditional knowledge was an act of “biopiracy,” or the misappropriation and downright theft of valuable biogenetic resources and associated traditional knowledge. The TRIPS agreement was however, not the only international framework that addressed intellectual property rights. One can point to a number of


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agreements that attempted to recognize traditional access rights and cultural knowledge in more formal means. One such agreement was the 1988 International Conference of Belem, Brazil, and in 1991 the second Code of Ethics of the International Society of Ethnobotany in Kunming, China (9). These two agreements were the first official recognition that traditional knowledge should be protected under formal property rights (10). Subsequently, both of these agreements were codified under the CBD in 1992. In the end, however, the use of both the CBD and TRIPPS as a framework for intellectual property rights only caused confusion about the correct way to move forward on the national level for many African nations (11).

Implementation of the CBD at the National Level in Africa African governments for a while have been concerned about the condition of their natural resources. This concern is highlighted by the African Convention on the Conservation of Nature and Natural Resources held in Algiers in 1968. The convention addressed critical environmental issues facing Africa and put in place protocols concerning conservation and natural resource management. This meeting ultimately set the stage for subsequent international agreements on the environment, such as the CBD. Developed in 2002, the Bonn Guidelines were created for the purposes of providing a framework for individual countries to implement the CBD at the national level. However, many African countries have been slow in adopting such measures. Examples of the different approaches selected African governments have taken to implement the CBD protocols at the national level are presented in Table I. Some African nations, such as Ethiopia, Kenya, Malawi and South Africa, have created new protocols for bioprospecting directly while others have adopted coverage that addresses access to genetic resources and protection of traditional knowledge within a country’s existing environmental laws. For example, a new comprehensive law developed in South Africa, requires anyone conducting any and all research and commercial trade involving medicinal plants to obtain research permits. This law, by far the most comprehensive in Africa may prove to be a new trend in the monitoring of natural product research and commercialization.


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Table I. African Countries that have Adopted National Access and BenefitSharing Agreement (ABS) Measures Country Cameroon


Central African Republic Ethiopia

The Gambia Kenya

Madagascar

Measure

ABS Coverage

Law No. 96/12 Relating to Environment Management Stratégie nationale et plan d'action en matière de diversité biologique (a) Proclamation No. 120/98 to Provide for the Establishment of the Institute of Biodiversity Conservation and Research (b) Proclamation No. 482/06 to Provide for Access to Genetic Resources and Community Knowledge and Community Rights National Environment Management Act 1994 (a) Environmental Management and Co-ordination Act, 1999 (b) Environmental Management and Co-ordination, 2006

AGR, NRM & Bio AGR, NRM & Bio, PIC

Law No 96-025 September 30, 1996

Year of adoption 1996 2000

(a) AGR, ESB

(a) 1998

(b) AGR, CTU, ESB, IPR,

(b) 2006

AGS, ESB

1994

(a)AGR,

(a) 2000

(b) AGR, ESB, IPR, NRM & Bio, PIC AGR, CTU

(b) 2006 1996


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Table I. Continued. Country Malawi


South Africa

Uganda

Zimbabwe

Measure

ABS Coverage

(a) Environment Management Act No. 23/96 (b) Procedures and Guidelines for Access and Collection of Genetic Resources in Malawi (a) National Environmental Management: Biodiversity Act (b) Regulations on BioProspecting and Access and Benefit-Sharing (a) National Environment Statute (b) National Environment Regulations, 2005

(a) AGR, ESB

Year of adoption (b) 1996

(b) AGR, ESB,

(b) 1996

(a) AGR, NRM & Bio. (b) AGR, CTU ESB, IPR, PIC

(a) 2004

Environmental Management Act, Chapter 20:27

(b) 2008

(a) AGR

(a) 1995

(b) AGR, CTU, ESB, IPR, AGR, ESB

(b) 2005 2002

SOURCE: Convention on Biological Diversity- Database on Access and Benefit Sharing Measures http://www.cbd.int/abs/measures.shtml: Accessed on: Dec. 5, 2008. NOTE: AGR - Access to Genetic Resources; ESB - Equitable Sharing of Benefits arising out of the utilization of genetic resources; CTU - Customary or Traditional Use of genetic resources; IPR - Intellectual Property Rights; NRM & Bio - Natural Resource Management and Biodiversity Conservation; PIC - Prior Informed Consent

Bioprospecting Models in Africa There are some commonly known examples of natural products derived from African plants. For example, the Devil’s claw (Harpagophytum procumbens), is a plant used in a phytomedicinal remedies as an antiinflammatory and analgesic (12). The southern African succulent Hoodia (Hoodia gordonii), which is commercially traded worldwide as an appetite suppressant (13). The bark of Pygeum (Prunus africana) is used as a phytomedicne for urinary complications and as an herbal remedy worldwide for benign prostatic hyperplasia and other urinary complications (12). There have also been a wide variety of African aloes have been used as a natural product in skin creams, shampoos and soaps. Furthermore, the fatty acids and oils form the fruits of a host of African plants have been harnessed to aid in cosmetic and fragrances, such as coconut oils, and jojoba, shea and almond butter (15). All of these products derive from advanced bioprospecting research and discovery. In general, there are three main types of bioprospecting observed in Africa, including collaborative contracts, mass bioprospecting collaborative agreements,



543 and private-public partnerships (Table II). Each of these is noted as having different methods of delivering benefits and protection of intellectual property rights. A collaborative contract, for example, is a project that involves agreements made between public research institutions each sharing similar goals of research and discovery of natural products. Institutions involved in this type of agreements usually see a mixture of short-term and long term benefits, including technology transfer, trainings and access to some monetary benefits in the form of milestone payments or payouts for significant breakthroughs in research leading to a discovery. The IPRs are scientific in scope and are determined through the national host-coordinating institution. One such example of a collaborative contract is the National Cancer Institutes’ acquisitions and collection programs (Phase I 1955-1982 and Phase II 1986-1997). The second type of bioprospecting in Africa is called a mass bioprospecting collaborative agreement (11). It is a collaborative arrangement between public and private research institutions and life science companies and environmental NGOs. A prime example of this type is the US federally funded International Collaborative Biodiveristy Groups (ICBG) (16). The ICBG is funded by the National Institutes of Health, the Foreign Agriculture Service of the USDA, and holds current projects in both Nigeria and Madagascar. As second example of mass bioprospecting is the Gibex, a multi-partner project centered out of Rutgers University in New Jersey, USA. Gibex was originally patterned on both the ICBG and NCI models in organizational structure and project goals and objectives. Organizations and institutions involved in mass bioprospecting usually see a number of benefits returned including technology transfer, trainings on hightech equipment, milestone payments and monetary payments of royalties derived from the commercialization of a natural product. Because of the structural capacity and wide scope of mass bioprospecting projects they are most likely to be involved in long term public benefits, such as biodiversity conservation projects in the countries they operate. Intellectual property rights, under the ICBG and Gibex, are determined by the host-country research institution; however, scientific discoveries are protected by U.S. patent laws. The third type of bioprospecting is that of the private-public agreement. Groups involved in this type of bioprospecting include public research institutions and private-for-profit companies. An example in Africa includes the agreement in South Africa between Phyto-pharm/ Unilever and the South African Council for Scientific and Industrial Research (CSIR). In this type of agreement, public institutions and individual groups are compensated in cash payments for their cooperation in supplying the natural product and associated traditional knowledge. Ideally, the terms of the intellectually property rights are determined by the agreement and signed by all parties prior to the research phase.


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Issues and Challenges to Effective Access and Benefit-Sharing Agreements Currently, there exist many challenges to the development and implementation of effective access and benefit-sharing in Africa. First, the majority of the biologically rich flora and fauna desired for natural products discovery reside in tropical and subtropical ecosystems, quite a distance from the research sites of Europe, Japan and the USA. This resource/research imbalance raises a number of issues concerning the proprietary use of natural resources and knowledge systems associated with their commercialization (17). Second, sometimes the natural resources collected for bioprospecting are found growing across national boundaries. Furthermore, resources can be collected in one country and transported to another by those looking to circumvent the scope of access and benefit-sharing laws. These geographic challenges may result in misidentifying who is the rightful receipts of benefits and how to adequately address ownership of intellectual property rights (18). Third, in some African countries there exist multiple documents that address access and benefits-sharing regulation. For example, a country may have a law regulating agricultural biogenetic resources while simultaneously have another separate law regulating biodiversity or research on animals or other mineral resources but not plants (see Table I) (19). These overlapping and sometimes conflicting laws may result particular delays for researchers and the return of benefits overall. Fourth, laws directed for research on bioprospecting are at time overrestrictive and may cause unintentional consequences for associated researchers and businesses. For example, sometimes laws may cause problems for commercial growers as well as home gardeners, nursery managers, educators, researchers, food scientists and many others for which the law may not have been intended, but now may need to apply for “user” permits.


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Table II. Examples of Different Types of Natural Products Discovery Partnerships Seen in Africa Structure of projects

Institutions involved

Collaborative contract

Public research institutions

Mass bioprospecting collaborative agreement

Public research institutions Private research institutions Life science companies Environme ntal NGOs

Private-public partnership

Public research institutions Life science companies

Example of project(s) in Africa National Cancer Institute (NCI) Natural products acquisitions and collection programs International Cooperative Biodiversity Groups (ICBG)

Example of countries involved Cameroon, the Central African Republic, Gabon, Ghana, Madagascar, and Tanzania, South Africa and Zimbabwe Nigeria, Madagascar

Global Institute for Bioexploratio n (Gibex)

17 countries across Africa

Phyto-pharm/ Unilever and the South African Council for Scientific and Industrial Research (CSIR)

South Africa

Potential benefits delivered Technology transfer Monetary payments

Biodiversity conservation Technology transfer Training Monetary payments

Monetary payments

Fifth, some countries in Africa lack the resources to adequately enforce access and benefit-sharing agreements. Although recent attempts have been made to ensure that research institutions adhere to the protocols set out in the access and benefit-sharing agreements, in many of these cases, governments lack the ability to ensure that benefits are being delivered to the rightful recipients, and moreover, if infractions are found, there is very little recourse for national governments to prosecute violators of the agreements. Finally, laws governing biodiversity programs and associated benefitsharing agreements are sometimes complex and difficult to understand. The potential for problems thus exists between parties who understand the terms of the agreements and those who do not. These misunderstandings may extend into


546 mistrust among institutions and governments and may development of over strict polices causing unnecessary restrictions even for host-country scientists to access material for basic research.


Conclusions: Opportunities for Benefit-sharing in the Landscape of Natural Products Discovery The purpose of the CBD, one of the premier documents in environmental governance, was to lay the framework for the development of national strategies to negotiate access to genetic and biological resources in return for adequate benefit-sharing. These benefits were to be returned in a number of different forms including, technology transfer and financial returns from subsequent commercialization. Advocates for the CBD maintain that in an ideal landscape, as long as consent is gained from host-country governments and agreements can be made so that participants receive sufficient benefits, then access should not only be granted, but facilitated (20). African countries that have since adopted access and benefit-sharing agreements at the national level seem to be receiving some beneficial returns (21). However, others note, that monetary benefits have been reportedly steady on the short-term; yet results of long-term benefits have been mixed (22). Beyond economic benefits, the transfer of technology, trainings on new scientific techniques and shared use of equipment among research institutions also may also be incorporated into a benefit sharing or collaborative agreement (4, 20). Furthermore, techniques on quality control and assurance, which is a main feature of this American Chemical Society book, have shown to have indirect benefits by linking small-scale producers with larger regional and international markets (15). In sum, the assurance of benefits back to host-countries must be in concert with the public and private research institutions and involved in the research and individuals who supplying both the natural product and associated traditional knowledge. Access and benefit-sharing agreements must be flexible enough to account for differences in social, political and cultural context of each research program and be comprehensive enough to cover the all interests of the groups participating. Property rights must be determined prior to research agreements and include prior consent by all parties active in the research. Overall, it is vital that agreements include information sessions of the research so that consent is granted and accountability between partnering institutions is transparent. At this point, the best way to ensure that benefits are to return to host countries, and property rights are respected, is by following the Bonn Guidelines to adopt suitable and comprehensive ABS laws and practices at the national level.


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Acknowledgments The researcher conducted the majority of this research on a Fulbright Institute for International Education (IIE) Award and a Rutgers University Graduate School Louis Bevier Fellowship. I want to thank both the Department of Geography and the New Use Agriculture Natural Plant Product Organization at Rutgers University for their support during the write-up phase of this chapter.

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Models of Benefit-Sharing Policy: Opportunities ... - ACS Publications

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