Bioprospecting
Bioprospecting (also known as biodiversity prospecting) is the exploration of natural sources for
Terrestrial
When a region's biological resources or
Other risks associated with bioprospecting are the overharvesting of individual species and environmental damage, but legislation has been developed to combat these also. Examples include national laws such as the US
Bioprospecting-derived resources and products
Agriculture
Bioprospecting-derived resources and products used in agriculture include
Bioremediation
Examples of bioprospecting products used in bioremediation include Coriolopsis gallica- and Phanerochaete chrysosporium-derived laccase enzymes, used for treating beer factory wastewater and for dechlorinating and decolorizing paper mill effluent.[9]
Cosmetics and personal care
Cosmetics and personal care products obtained from bioprospecting include
Nanotechnology and biosensors
Because
Pharmaceuticals
Many of the
Other examples of bioprospecting-derived anti-infective drugs include the
Bioprospecting-derived pharmaceuticals have been developed for the treatment of
Bioprospecting as a discovery strategy
Bioprospecting has both strengths and weaknesses as a strategy for discovering new genes, molecules, and organisms suitable for development and commercialization.
Strengths
Bioprospecting-derived
Natural products are also more amenable to membrane transport than synthetic compounds. This is advantageous when developing antibacterial drugs, which may need to traverse both an outer membrane and plasma membrane to reach their target.[10]
For some
With the Convention on Biological Diversity (CBD) now ratified by most countries, bioprospecting has the potential to bring biodiversity-rich and technologically advanced nations together, and benefit them both educationally and economically (eg. information sharing, technology transfer, new product development, royalty payment).[2][35]
For useful molecules identified through
Weaknesses
Although some potentially very useful microorganisms are known to exist in nature (eg.
Isolating and identifying the
Implementing and enforcing bioprospecting-related treaties and legislation is not always easy.
Whilst the structural complexity of natural products is generally advantageous in drug discovery, it can make the subsequent manufacture of drug candidates difficult. This problem is sometimes resolvable by identifying the part of the natural product structure responsible for activity and developing a simplified synthetic analogue. This was necessary with the natural product halichondrin B, its simplified analogue eribulin now approved and marketed as an anticancer drug.[40]
Bioprospecting pitfalls
Errors and oversights can occur at different steps in the bioprospecting process including collection of source material, screening source material for
Collection of source material
Prior to collecting biological material or traditional knowledge, the correct permissions must be obtained from the source country, land owner etc. Failure to do so can result in criminal proceedings and rejection of any subsequent patent applications. It is also important to collect biological material in adequate quantities, to have biological material formally identified, and to deposit a voucher specimen with a repository for long-term preservation and storage. This helps ensure any important discoveries are reproducible.[10][13]
Bioactivity and toxicity testing
When testing extracts and isolated compounds for bioactivity and toxicity, the use of standard protocols (eg. CLSI, ISO, NIH, EURL ECVAM, OECD) is desirable because this improves test result accuracy and reproducibility. Also, if the source material is likely to contain known (previously discovered) active compounds (eg. streptomycin in the case of actinomycetes), then dereplication is necessary to exclude these extracts and compounds from the discovery pipeline as early as possible. In addition, it is important to consider solvent effects on the cells or cell lines being tested, to include reference compounds (ie. pure chemical compounds for which accurate bioactivity and toxicity data are available), to set limits on cell line passage number (eg. 10–20 passages), to include all the necessary positive and negative controls, and to be aware of assay limitations. These steps help ensure assay results are accurate, reproducible and interpreted correctly.[10][13]
Identification of mechanism of action
When attempting to elucidate the mechanism of action of an extract or isolated compound, it is important to use multiple orthogonal assays. Using just a single assay, especially a single in vitro assay, gives a very incomplete picture of an extract or compound's effect on the human body.
Biopiracy
The term biopiracy was coined by Pat Mooney,[43] to describe a practice in which indigenous knowledge of nature, originating with indigenous peoples, is used by others for profit, without authorization or compensation to the indigenous people themselves.[44] For example, when bioprospectors draw on indigenous knowledge of medicinal plants which is later patented by medical companies without recognizing the fact that the knowledge is not new or invented by the patenter, this deprives the indigenous community of their potential rights to the commercial product derived from the technology that they themselves had developed.[45] Critics of this practice, such as Greenpeace,[46] claim these practices contribute to inequality between developing countries rich in biodiversity, and developed countries hosting biotech firms.[45]
In the 1990s many large pharmaceutical and drug discovery companies responded to charges of biopiracy by ceasing work on natural products, turning to combinatorial chemistry to develop novel compounds.[43]
Famous cases of biopiracy
The rosy periwinkle
The
The Maya ICBG controversy
The
The Maya ICBG case was among the first to draw attention to the problems of distinguishing between benign forms of bioprospecting and unethical biopiracy, and to the difficulties of securing community participation and prior informed consent for would-be bioprospectors.[52]
The neem tree
In 1994, the
Basmati rice
In 1997, the US corporation RiceTec (a subsidiary of RiceTec AG of Liechtenstein) attempted to patent certain hybrids of basmati rice and semidwarf long-grain rice.[57] The Indian government challenged this patent and, in 2002, fifteen of the patent's twenty claims were invalidated.[58]
The Enola bean
The Enola bean is a variety of Mexican yellow bean, so called after the wife of the man who patented it in 1999.[59] The allegedly distinguishing feature of the variety is seeds of a specific shade of yellow. The patent-holder subsequently sued a large number of importers of Mexican yellow beans with the following result: "...export sales immediately dropped over 90% among importers that had been selling these beans for years, causing economic damage to more than 22,000 farmers in northern Mexico who depended on sales of this bean."[60] A lawsuit was filed on behalf of the farmers and, in 2005, the US-PTO ruled in favor of the farmers. In 2008, the patent was revoked.[61]
Hoodia gordonii
In 2008 after having invested €20 million in R&D on Hoodia as a potential ingredient in
Further cases
The following is a selection of further recent cases of biopiracy. Most of them do not relate to traditional medicines.
- Thirty-six cases of biopiracy in Africa.[68]
- The case of the Maya people's pozol drink.[69][70]
- The case of the Maya and other people's use of Mimosa tenuiflora and many other cases.[71]
- The case of the Andean maca radish.[72]
- The cases of oubli berries (Gabon), and others.[74]
- The case of captopril (developed from a Brazilian tribe's arrowhead poison).[75]
Legal and political aspects
This section needs additional citations for verification. (August 2020) |
Patent law
One common misunderstanding is that pharmaceutical companies patent the plants they collect. While obtaining a patent on a naturally occurring organism as previously known or used is not possible, patents may be taken out on specific chemicals isolated or developed from plants. Often these patents are obtained with a stated and researched use of those chemicals.[citation needed] Generally the existence, structure and synthesis of those compounds is not a part of the indigenous medical knowledge that led researchers to analyze the plant in the first place. As a result, even if the indigenous medical knowledge is taken as prior art, that knowledge does not by itself make the active chemical compound "obvious," which is the standard applied under patent law.
In the
Also possible under US law is patenting a
Convention on Biological Diversity
The Convention on Biological Diversity (CBD) came into force in 1993. It secured rights to control access to genetic resources for the countries in which those resources are located. One objective of the CBD is to enable lesser-developed countries to better benefit from their resources and traditional knowledge. Under the rules of the CBD, bioprospectors are required to obtain informed consent to access such resources, and must share any benefits with the biodiversity-rich country.[80] However, some critics believe that the CBD has failed to establish appropriate regulations to prevent biopiracy.[81] Others claim that the main problem is the failure of national governments to pass appropriate laws implementing the provisions of the CBD.[82] The Nagoya Protocol to the CBD, which came into force in 2014, provides further regulations.[83] The CBD has been ratified, acceded or accepted by 196 countries and jurisdictions globally, with exceptions including the Holy See and United States.[79]
Bioprospecting contracts
The requirements for bioprospecting as set by CBD has created a new branch of international
An example of a bioprospecting contract is the agreement between
Traditional knowledge database
Due to previous cases of biopiracy and to prevent further cases, the Government of India has converted
See also
- Intellectual capital/Intellectual property
- Natural capital
- Biological patent
- Indigenous knowledge
- Pharmacognosy
- Plant breeders' rights
- Bioethics
- Maya ICBG bioprospecting controversy
- International Cooperative Biodiversity Group
- Biological Diversity Act, 2002
- Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)(1994)
- International Treaty on Plant Genetic Resources for Food and Agriculture (2001)
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Bibliography and resources
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External links
- Out of Africa: Mysteries of Access and Benefit-Sharing – a 2006 report on biopiracy in Africa by The Edmonds Institute
- Cape Town Declaration – Biowatch South Africa
- Genetic Resources Action International (GRAIN)
- Indian scientist denies accusation of biopiracy – SciDev.Net
- African 'biopiracy' debate heats up – SciDev.Net
- Bioprospecting: legitimate research or 'biopiracy'? – SciDev.Net
- ETC Group papers on Biopiracy : Topics include: Monsanto's species-wide patent on all genetically modified soybeans (EP0301749); Synthetic Biology Patents (artificial, unique life forms); Terminator Seed Technology; etc...
- Who Owns Biodiversity, and How Should the Owners Be Compensated?, Plant Physiology, April 2004, Vol. 134, pp. 1295–1307
- Heald PJ (2001). "'Your Friend in the Rain Forest': An Essay on the Rhetoric of Biopiracy". SSRN Electronic Journal. .