Policy paper on biodiversity

2nd draft version (March 2014)

Authors: Drs Stefano Golinelli, Dr Karina Vega-Villa, Drs Juan Fernando VillaRomero Research Coordinator: Dr George DAFERMOS (FLOK Stream #2)

= Executive summary = With world records for the number of amphibian, reptile, bat and tree species, and more than 20 dialects spoken within an area of about 100,000 km2, Ecuador is one of the most biologically and culturally diverse countries in the world. We propose a broader definition of biodiversity for the Ecuadorian context, to include not only biological elements but also indigenous culture and knowledge. In the face of a changing climate, Ecuador has the potential to sustain this biological and cultural diversity in the long term due to its geographical location. We present a scenario that harnesses open and collaborative synergisms between government, academia, citizen scientists, and the private sector seeking to develop long-term economic activity from the rational exploration of Ecuador’s vast and unique biodiversity. A fundamental precedent is the significant investment of the Government of Ecuador in scientific development, education, and infrastructure, specifically in the areas of energy diversification, transport and telecommunications (more than US$21 billion between 2007 and 2013). Couple this investment to the densest collection of life forms in the planet, and with a global trend towards economies based on applied life sciences, and it is clear Ecuador is strategically placed to become a regional powerhouse. Through a robust network of collaborators inside and outside Ecuador, we are currently capable of implementing scientific work focused on biodiversity conservation, ethnobotanical and ethnomedical development, production in biological platforms, and environmental quality protection. Our goal is to contribute to the realization of Ecuador’s concept of knowledge-based local bioeconomies, and to export knowledge regarding the unique biological and cultural resources from Ecuador to global communities through novel international markets.

= Introduction = In the context of the emerging bioeconomy, i.e. any economic activity derived from applied life sciences, the value of available biological resources is likely to increase worldwide in the near future. Humans rely on variability in biological systems for survival: from the domestication of crops to an innate immunity to particular diseases, variability in biological systems enables selection and diversification within groups. We select elements that perform better in a particular context, and further diversify selected elements. However, during the last decade new technologies – most notably the revolution of “omics” disciplines in biology – have added new value to the study and application of biological resources, especially considering that less than 1% of the estimated number of biological species are described and available to human technology: e.g. 100,000 species of fungi have been described to date, but there is an estimated 1.4 million species yet to be discovered. The monetary value of this biological diversity, the result of 3.8 billion years of evolution, is truly incalculable. A 1995 study by Vogel et al. on the economics of plant diversity in Ecuador suggests that royalties derived from the commoditization of endemic plants range between US$256 million and US$429 billion, cautioning about the economical and political implications that such values, calculated on the basis of different assumptions, can have. Current technologies open the door to the development of innovations derived not only from plants but from all life kingdoms. The vast majority of Ecuador’s biodiversity, however, remains unexplored but its significant potential to generate and sustain economic activity in the long term is evident from previous experiences. To improve environmental health and to assist the diagnosis and treatment of ailments and disease, the rainforest has yielded organisms capable of degrading polyurethane under landfill conditions, as well as information regarding significant differences between microbiomes inhabiting indigenous communities or citizens in developed Western countries. This wealth of knowledge is translated into industrial applications in environmental restoration, energy diversification, and healthcare. By the end of the decade, products and services derived from biological systems will complement an economy today fully dependent in non-renewable mineral resources. On the other hand, Ecuador’s cultural diversity has resulted in numerous traditional pharmacopeias, i.e. the medicinal practices of local and indigenous communities. The information that is known for the majority of indigenous groups in Ecuador is to a great extent fragmented, and the quality of information about biodiversity is poorly understood. Global interest in ethnomedicine, i.e., the application of traditional knowledge in the area of human health, has increased significantly in the last years. China is the leader in ethnomedical research and is continuously expanding the application of modern technologies in the evaluation and development of their pharmacopeia. For example, recently developed computational approaches that can describe drug action in the context of the whole system (i.e., cell, organ, or body) have been successfully applied to the evaluation of traditional Chinese medicine. This continuous combination of modern technology and ancient medicinal knowledge has considerably expanded China’s manufacturing and healthcare industries.

Southern nations are usually in technological disadvantage but rich in biological resources. Biopiracy, i.e. the unauthorized access and commercialization of biological resources in a specific country, thrives on ignorance. Ecuador has significantly increased its investment in science and education: from ~US$1 to ~US$3 billion between 2006 and 2012, to a total investment of ~US$8 billion to date, and thus is steadily accruing the capacity to fully develop resources associated with its vast biodiversity. By developing economic activity from knowledge derived from the exploration and application of Ecuador’s biological and cultural diversity, the country can materialize a proper model of local knowledge-based bioeconomy attuned to the Ecuadorian context. To implement an economy based on knowledge derived from its vast natural capital, Ecuador must review, if available, any concepts and tools associated with the generation of economic activity from the protection, exploration, and application of cultural, biological, and ecosystemic diversity.

Through technology, information can be developed into commercial products, thus, an economy based on biological and cultural information adds value to Ecuador’s biodiversity. Today, Ecuador relies on the export of its biological diversity mainly in the form of material resources. In this context, it is necessary to compare the outcome of policies that consider biological diversity a source of materials, versus the outcome of policies that consider biological diversity a source of information applicable through biotechnology and bioinformatics to the generation of products and services. Currently, these products and services are relevant to the diversification of energy sources and the improvement of human and environmental health. Ecuador’s unique ecological, biological and cultural diversity can inform the development of the technologies required to navigate climate change, and the challenges associated with our increasing population. One hectare of rainforest in Ecuador, for example, can provide a quick revenue from the extraction of material resources above (plant and animal products), and below (minerals), in the short term. The same hectare of rainforest, however, can inform scientific work articulating biology, industry, and economy in the long term future. For example, highly optimized custom microorganisms can be designed as platforms for industrial production, and Europe currently develops the legal and technical infrastructure required for a broad and global exchange of microorganisms and genetic elements.

Here, we present policy proposals that rely on a scientific approach to identify and develop tangible and intangible value from of biological and cultural resources that make Ecuador unique. We also propose a broader definition of biodiversity for the Ecuadorian context to include all variables related to the diversity of life forms in the country, from the molecular sequences of nucleic acids to ecosystems, habitats and niches as well as traditional knowledge, the result of an historical mix of Western and indigenous culture.

= Critique of capitalist models = Life sciences raise concerns among those actors who perceive biotechnology as taking humanity to the “realms of God” and against the “Law of Nature” (Vroom, 2009). Bioprospecting, i.e., the commercialization of useful biological phenomena, has been particularly criticized by scholars and activists in that it is an evident illustration of the commodification of life occurring under the contemporary neoliberal regime, in which everything is reduced to its financial or technological dimension. Whereas this perspective touches important issues, especially for what concerns indigenous communities with their alternative cosmologies and value systems, in our opinion, previous experiences should not lead to an a priori refusal of the exploration of Ecuador’s biological diversity, even with the explicit objective of generating economic activity.

Our critique to contemporary capitalist models is not “metaphysical” but departs from the acknowledgement that present legal configurations in Ecuador are unsuitable for reaching appropriate goals, i.e. knowledge and technology exchange, scientific and economic innovation, and an appropriate system of incentives for applied biodiversity research. Briefly, the fiasco of contemporary bioprospecting models derives from a corrosive interplay between international and domestic norms directly conflicting with the open collaborative atmosphere required during scientific research. Scientific development requires openness and collaboration, but today we witness a “hyperownsership” regime (Safrin, 2004) based on private and public enclosures that do not serve any interest in the long-term (Kloppenburg, 2013).

The private enclosure
For what concerns the Intellectual Property (IP) dimension, in the last decades US and EU regulations have increasingly broadened the scope and the reach of IP protection, while the World Trade Organization has simultaneously imposed these norms to its members. Patents, for example, are envisaged as necessary conditions for stimulating private investments in basic research. However, an increasing number of actors warn that in the long term, proprietary configurations hinder rather than promote innovation. This is particularly true within the biotechnological domain, where:

a) A vast majority of biological resources at the molecular and ecosystemic levels is unknown and remains unexplored; and

b) Innovation processes require a flexible combination of disciplines, technologies and areas of expertise with dynamic economic properties (Van Overwalle, 2008).

Therefore, mirroring the concept of the “tragedy of the commons”, in which numerous rights-holders' combined use quickly depletes a resource (Hardin, 1968, 2008), it has been widely argued that excessive levels of IP protection are resulting in the “tragedy of the anti-commons”, i.e. a fracture between stakeholders whose collaboration is crucial in solving problems. This type of coordination breakdown arises when a single resource has numerous rights-holders who prevent others from using it, frustrating what would be the socially desirable outcome of development through scientific research (Heller, 1997, 2008).

The public enclosure
Obstacles to rational and timely evaluation of biological resources, nevertheless, are not only a matter of IP. Significant influence is also exercised by national and regional regulations that implement the Convention of Biological Diversity (CBD) – ratified by 168 countries during the Río Earth Summit in 1992 – to grant sovereign rights over biogenetic resources to national States thus overturning their traditional status of common heritage of the mankind. As we will explain in more detail in Section 5 by looking at the Ecuadorian framework, this empowerment of national States to design their own regulations has generated a paradoxical situation that is severely hampering basic research, the prospects science offers for technological progress, and the realization of an appropriate system of economic incentives for applied biodiversity research.

The “mercantilist” approach implicit in the CBD principles envisage genetic resources as material commodities, and developing countries may implement regulations that restrict access only to those actors wishing to commit themselves to share the benefits of their Research & Development (R&D) efforts. Biodiversity, however, is different from traditional commodities in that:


 * 1) Its full commercial value is usually unknown, non-obvious, and requires several years to be verified. A large-scale scientific exploration of potential applications is what adds value to Ecuador’s biodiversity, and therefore, restricting access or investigation is likely to decrease the value of these resources since no commercial development can be formulated.
 * 2) Unlike material resources, what is perhaps more valuable in regards to biological diversity, genetic material in particular, is its information content. (Genetic) information is a very valuable asset and can be obtained, copied, modified, and distributed through digital means. Genes, for example, can be expressed in digital format and synthesized without needing to access their parent physical material (Soplin & Muller, 2009).

Therefore, physically restricting access to biological resources discourages exploration and basic research, reduces the value of biodiversity, and in no way protects Ecuador resources from biopiracy. It may be possible to control the trade of traditional commodities operating within well defined pricing systems, but easy access to biological resources in Ecuador is rampant and can very well avoid any benefit-sharing requirement. After more than 20 years from the entry into force of the CBD, the financial returns from biodiversity have not materialized: as suggested by Filoche & Foyer (2011), they are a “green eldorado”, which everybody dreams of but nobody has ever seen.

= Alternative models = The last section concluded that the private and public enclosure of information derived from biodiversity resources is limiting the benefits that research in life sciences can bring, with particular reference to developing countries lacking the resources required to cope with technological, financial, and legal issues involved in biotechnological R&D and global markets. This section, instead, will present practices, discussions, and initiatives to illustrate the possibility of creating more open, efficient, and just techno-scientific models for the emerging bioeconomy in Ecuador. Sub-section 3.1 will review some recent developments in biotechnological R&D, emphasizing, for example, how a combination of “material” and “socio-legal” transformations might smooth the way to more participatory forms of research and application of life sciences’ knowledge. Sub-section 3.2 will review the latest evolution of multilateral and national regulations in the field of access to genetic resources, and on the distribution of benefits deriving from their utilization. It will show that the Nagoya Protocol may provide greater legal certainty for biodiversity rich countries to stimulate the scientific exploration and responsible administration of biodiversity.

“Openness” and “democratization” within the biotechnological domain
During the last decades, the “information feudalism” (Drahos, 2002) of present IP settings and the capital-intensiveness of life sciences deterred developing countries or “small private” actors to engage in biotech R&D. Although this configuration oriented research toward responding needs of large corporations and industrial countries, recent trends suggest that this situation could quickly change. Clear possibilities for more diffused, decentralized, and participatory forms of biotechnological development exist and continue to improve.

Diversified biotech R&D: developing countries, start-ups, and grassroots life scientists
For what concerns the capital-, knowledge-, and technological-intensiveness related to the development of economic value from research in life sciences, the costs of some important technologies are falling exponentially (e.g. DNA sequencing and synthesis), while information and communication technologies (ICT) enhance access to relevant information and reduce the technical mediation of research practices. Small scale and relatively “cheap” bio-informatics tools, for example, are freely available and open to modification in order to succeed in different contexts. Several developing countries took advantage of this situation to increase their engagement in R&D with the goal of shaping it in accordance to their own priorities. Brazil, Malaysia, and South Africa are large countries with significant financial, economic, and academic resources recently invested in R&D. However, also less equipped states, e.g. Costa Rica and Cuba, also invest significantly in these areas.

At the other end of the spectrum, small life sciences’ start-ups backed by pools of private investment are flourishing in North America and in BRICS countries. Furthermore, low-cost, de-institutionalized, and distributed forms of citizen biotechnology are a reality and can be adapted to the Ecuadorian context in different areas (See Kera, 2011, 2012, 2013). For instance, the Do-It-Yourself biology (DIYbio) movement has made biotechnology a worthwhile pursuit for ordinary citizens since it is designed to translate laboratory practices into everyday language and solutions to ordinary problems. Using a small home laboratory, for example, it is easy to identify edible species and specific organisms. Through open workshops and intense collaboration, citizen scientists can develop creative workarounds including open hardware for biotechnology R&D. Through open collaboration, thus, the cost of setting up a community research laboratory decreases by one or two orders of magnitude (Landrain et al, 2013). Important scientific and commercial breakthroughs have been already made using open, collaborative approaches, while DIYbio practices rapidly grow in sophistication and continue to attract private and public funding. Furthermore, Ecuador offers the opportunity of merging indigenous knowledge with cutting-edge research methods to develop biotechnology grounded on neo-traditional social and economic relationships. For example, citizen scientists in Indonesia use contemporary scientific knowledge according to their own values and social, ecological, and financial situations, which are inscribed in and influence technological developments. (Kera, 2013).

Alternatives to proprietary approaches and “open source biotechnology”
For what concerns the IP landscape, attempts at modifying the present scenario are evident from information activists, developing countries, scientists, entrepreneurs, and corporations increasingly aware of the “tragedy of the anti-commons”. Currently proposed and/or implemented collaborative licensing models are suited to respond to the specific interests of extremely diverse actors. “Ideal model types” are described briefly below (for a comprehensive review, see van Overwalle, 2007).

Patent pools are consortia of at least two companies that agree tocross-license patents relating to a particulartechnology. Patent pools can raise concerns of oligopolistic practices in which corporations exclude other players from innovation processes, but in the present context they are crucial to deal with the patent thickets distinguishing the biotechnological domain. States and public research institutions can be part of these consortia''. Clearinghouses'' are mechanisms whereby “providers” and “users” of patents and technologies are matched. They can merely provide (protected) information or cater for both access and use of inventions. In the field of agricultural biotechnologies, Cambia Patent Lens and PIPRA are well-known examples of the former type of clearinghouse. Liability regimes are conscription mechanisms that permit a participant in the system to use intellectual property (IP) without a direct negotiation with the IP owner. Users of an asset are required to pay for the use of the asset and cannot be refused use of that asset; they control the decision of whether to take the asset or not. In other words, owners of the asset have a right to payment, but not a right to exclude. This avoids anti-competitive strategic behaviors by patent owners, but excludes the possibility on their part to determine the ways in which a resource can be used by third parties. Open source models, on the other hand, present the possibility of translating the free software principles (copy-left, horizontal peer production) to the life sciences’ industry with the overreaching goal of enabling research diversification and innovation in terms of objectives (neglected diseases, and other context-specific technologies), and of stakeholders and R&D institutions (from private citizens to public institutions). According to Janet Hope, 2008, biotechnological R&D satisfies the three basic conditions – i.e modularity, granularity, and low cost integration – that make horizontal peer production more efficient than traditional configurations (Benkler, 2006). In our opinion, this latter concept of open source biotechnology is extremely promising for the Ecuadorian context in at least three dimensions:


 * 1) It examines the creation of open, but protected, commons: such as within the software arena, “free seeds”, “free knowledge” and “free technologies” are a matter of liberty, not price. Roughly, “free” means that users have the freedom to distribute study, change, and improve biological or cultural material including knowledge, information or technologies according to the principles established by the provider of the resource. An “open and protected commons” model differs from traditional “public science” models in that “public science” models allow knowledge to be appropriated and enclosed but requires significant financial, technical, and legal resources.
 * 2) From the standpoint of information economics, genetic information, and indigenous knowledge show features associated with goods that are non-rivalrous, i.e. whose consumption does not exclude others from consuming the same resource, non-excludable, in the sense that if it is known, it is difficult to exclude others from its use; and non-transparent, since to evaluate information, the information must be known.
 * 3) While greatly facilitating circulation of knowledge and resources during early evaluation stages, the “open source” does not automatically preclude commercial involvement of private actors. In the software industry “open source” led to a great diversification of products and stakeholders including new actors (public, private, and “civil”) that relied not solely on their financial power, but also on their expertise and inventive capacities when developing, maintaining, and exchanging proprietary rights (see Hope, 2008; Kloppenburg, 2013).

The model of “open-protected commons” should be considered. It might be the most adequate management strategy to promote innovation and collaboration during initial R&D steps, while leaving legal precedents for the reclamation of property rights. An “open-protected” model encourages curiosity, facilitates discovery, and strengthens the most critical resource in a knowledge-based economy: the intellectual capital. The exploration of Ecuador’s biodiversity, for example, can contextualize education in “Escuelas del Milenio” by coupling the academic emphasis on scientific thinking, biology, and ecology, with to hands-on experience documenting local biodiversity at various levels and without overwhelming regulatory bodies. Through open academic study in anthropology, bioinformatics, biochemistry, engineering and architecture, among many other disciplines, an “open-protection” model leads to knowledge generation at higher education levels. In 5 years, Ecuador can capitalize on the economic activity generated by properly trained professionals interested in exploring and applying Ecuador’s collection of natural laboratories. This cultivated knowledge derived from the study of nature and culture can sustain long term economic activity. Ecuador can export this experience and knowledge to the world. For example, Ecuador can export bioinformatic software, policy frameworks, engineering, and healthcare. Education can be articulated to ongoing scientific work in genomic and phenotypic diversity, evolution, climate-change adaptation, bioenergy, applied indigenous knowledge, ethnomedicine, industrial symbiosis, and resource discovery. During the active exchange of knowledge and technology, public, private or public-private partnerships can explore trading and reciprocal learning at local, regional and international levels. '''Sub-section 3.1.3. '''presents a initiative to emphasize how proprietary rights could be re-mastered to serve goals that are radically different from the ones they serve in the contemporary neoliberal regime (more information on other open source initiatives is available in Annex III).

In short, an “open-protected access” model enables stakeholders to access and explore Ecuador’s biological and cultural diversity, but provides fundamental precedents for the reclamation of property rights. In Section 4.b. we emphasize the fundamental difference between scientific and commercial research. In the long term, Ecuador can export these resources, solutions, and experiences to the world.

The merits and financial, legal, and technical feasibilities of “open source biotechnology” – an analogy of “free software” practices – have been tested in the context of citizen-science driven research in life sciences. From a small gathering of genetic engineers and bioinformaticians, the potential of citizen involvement in biotechnology has required a myriad of “open source” licenses, repositories, material transfer agreements (MTAs), software, and peer production platforms. Today, biotechnology is becoming even more open and accessible.

The Democratization of science
The BiOS (Biological Open Source/Biological Innovation for Open Society) Initiative is an international initiative to fosterinnovation andfreedom to operate in thebiological sciences. BiOS was officially launched in 2005 byCAMBIA, an independent, international,non-profit organization dedicated to democratizing innovation. Its intention is to initiate new norms and practices for creating tools for biological innovation, and use binding covenants to protect and preserve their usefulness while promoting diverse business models for the commercial development of these tools.undefinedBiOS aspires to democratize, diversify, and decentralize agricultural life sciences. In “practical” terms, it works on the design, development, and dissemination of legal and technological tools to re-orient R&D towards specific development goals. To date the activities of CAMBIA have generated four important outcomes:


 * 1) Standard cost-free BiOS licenses to create “freedom to innovate”. In lieu of royalties and other restrictions often imposed by legal agreements, licensees are required to comply with three conditions: a) to share with all BiOS licensees any improvements in defined technologies for which they seek any IP protection, b) to not assert over other BiOS licensees their own or third-party rights related to the defined technologies, and c) to share with the public any and all information about thebiosafety of the defined technologies. CAMBIA provides two “open source” biological technologies: TransBacter and GUSPlus, which are available to all non-profit researchers and institutes upon signing a BiOS MTA. For-profit companies sign a BiOS license and make a contribution to CAMBIA calculated on the company’s financial means;
 * 2) A series of “open source” MTAs, a common form ofbailment used to provide materials for life sciences research, such as bacterial strains, plant lines, cell cultures, or DNA. The BiOS website provides MTAs for biological materials;
 * 3) The Patent Lens, an online patent search facility and knowledge resource, or in “technical terms” a patent clearinghouse for life sciences. Launched in 2000 and renewed in 2013, it allows searching over 10 million full-text patent documents. It is the only not-for-profit facility of its kind, with international coverage and links to non-patent literature and tutorials;
 * 4) The Bioforge project, an on-line platform explicitly modeled on SourceForge which bills itself as "the world's largest Open Source software development website” promoted peer-production endeavors acting as a discussion commons, information resource, repository of data, code and software tools for the world of open biology. The project stopped in 2013.

The revival of bio-prospecting: multilateral negotiations and proactive national strategies
As seen in Section 2, the CBD envisaged bioprospecting as a way to provide biodiversity-rich countries with financial compensation for environmental preservation. Nevertheless, for almost 20 years this principle has been implemented only through vague and voluntary guidelines for the sharing of benefits emerging mostly from the utilization of genetic resources (see Bonn Guidelines). This climate of distrust and uncertainty, together with excessive expectations about short-term financial benefits, led biodiversity-rich countries to enforce restrictive regulations, which hampered basic research while most likely commercially-oriented endeavors simply ignored them (Tvedt, 2007).

In 2010, however, CBD parties finally agreed on the Nagoya Protocol, which will entry into force after the fiftieth instrument of ratification. Although “open source” (Oldham, 2009), “cartel-based” (Vogel, 2000) or “commons-based” (Dedeurwaerdere et al., 2012) multilateral solutions would have probably dealt better with the trans-boundary and informational essence of biological and cultural resources, the adoption of the Protocol surely represents a positive step towards a fairer international system (Kamau, 2010). Beyond its binding nature, the Protocol constitutes an ambitious attempt to develop an international instrument complementing critical aspects of previous Access-Benefit Sharing (ABS) instruments, such as:


 * 1) A clear definition of “utilization of genetic resources”, which includes the use of genetic and biochemical material, or their derivatives (Art. 3);
 * 2) The acknowledgment of user countries’ obligation to ensure compliance to the “benefit-sharing” principle within their national legislation (Art. 15) and the creation of monitoring instruments (Art. 17) that offer providers increased legal certainty;
 * 3) The envisioning of a multilateral mechanism to manage genetic resources (Art. 10), such as the one already in place for a wide range of food and agricultural genetic resources under the IT-PGRFA treaty.

This multilateral advancements, together with the increasing awareness about the inadequacy of the restrictive models implemented since the 90’s, have pushed several biodiversity rich countries to review their norms on access to genetic resources in order to create a regulatory environment that stimulates basic research and the development of domestic capacities, and that also protects the rights of the wider public and of the indigenous communities. In this section, we will present first some insights on how recent years saw the emergence of “commons” systems, both in terms of accessing biodiversity and in terms of protecting innovations; and secondly, some options to protect indigenous rights over their traditional knowledge when developing solutions for local problems.

Brazil beyond biodiversity fetishism
The Brazilian experience provides a valuable example of the evolution of norms for the management and valorization of biological resources. Indeed, since the entry into force of the CBD, Brazilian legal policies pertaining both ABS and IPR have been dictated to avoid losing control of genetic resources and natural substances during the course of R&D. Brazil affirms its sovereignty over biodiversity with regards to third countries and the prominence of state authorities with respect to its own citizens. The result may be termed “biodiversity fetishism”: biodiversity has become an object of economic fantasizing, a mirror of the national identity, and a political taboo embodied in an ABS regime that prevents either access to or use of the resources (Filoche, 2012). However, Brazilian policy-makers are becoming increasingly aware of this situation and have supported reformative efforts in the last few years.

With reference to access to genetic resources, the Brazilian ABS regime has been sharply criticized by researchers and private companies as too exclusive, and such a criticism has been taken into account in later regulatory revisions. Whereas a comprehensive analysis of this process exceeds the scope of this Section, in our opinion two developments are important to highlight:


 * 1) The rules relating to benefit-sharing in the event of access for commercial purposes have been relaxed. As originally designed, the system required an ABS agreement to be signed even before research commenced. Since 2007, regulations recognize that researchers and companies do not know exactly what or where innovations are found. Thus, unless access is requested with the explicit goal of developing commercial products, it is possible to postpone benefit distribution agreements until scientific evidence permits the formulation of appropriate development strategies. In the event of requests for commercial use, projects are qualified as bioprospecting after industrial or commercial production is proved viable.
 * 2) The access system has become a hybrid of public heritage, private property, and common property and the relative powers of the scientific community in the management of resources have gradually increased. Research scientists through council representation increasingly enjoy preferential rights and may have easier access to a given resource, especially in the case of non-commercial research, even if important private rights and public hold remain.

Regarding the issue of how rights to these innovations and natural substances are allocated, Brazilian regulations have demonstrated the possibility of promoting domestic biotechnological development without relying on neo-liberal models.


 * 1) The economy of the patent has been secured by exploiting the provisions of the CBD and the Nagoya Protocol. Control at the national level is maintained through access regulations and at the international level through the involvement of public research institutions or Brazilian companies acting as intermediaries between suppliers and users. These companies benefit from an exchange of expertise, technology, and resources with foreign partners. In addition, patents registered with the National Institute of Intellectual Property (INPI) abide by the legal requirements of ABS and obtain a “certificate of legal origin” since 2010. With the entry into force of the Nagoya Protocol, this certificate will become necessary in patent systems worldwide.
 * 2) In terms of patentability, domestic regulations are more restrictive than regulations in Northern countries. Natural substances are treated as commons: researchers and companies have fewer rights to natural elements but can access a larger and more open “common-pool”, and are equally allowed to patent the final product. Furthermore, anyone – including foreign researchers and firms – has access to the local biodiversity, and can develop novel products suitable to patent protection especially in jurisdictions where naturally occurring life forms can be appropriated. Even though this situation does not suit the interests of scientists and companies interested in protecting their innovation, it responds to concerns by the State, NGOs, and scientists concerned with the tragedy of the anti-commons and about private appropriation of resources by foreign and domestic parties.

Traditional Knowledge Commons and Biocultural Protocols
Article 8(j) of the CBD asserts the rights of indigenous and local communities (ILC) over their traditional knowledge (TK) and the need for recognition of their sovereignty. So far, however, the implementation of these principles has proven difficult in spite of the legal arrangements included in national and regional legislations. In particular, a constraint has been posed by the apparent incompatibility between the customary law of indigenous culture and concepts of private property and market commodification sponsored in the Western system. In Ecuador, collaboration between industry and indigenous communities usually seeks two-party agreements and reciprocal benefits. This scheme has generated significant economic activity, particularly in tourism and value-added agriculture.

The idea of a commons-oriented approach enters the heart of the TK debate in the context of Article 8(j). A TK Commons does not preclude ILCs to enter into commercial ABS agreements to use their TK in exchange for financial compensation. However, the TK Commons offers the possibility to move beyond the dominant interpretations of Article 8(j) according to which the sale of TK leads to conservation. A TK Commons allows communities to share their TK with other ILCs and non-traditional actors whilst equally defining and controlling its use and any benefits derived from that use. In the Ecuador context, this idea highlights the sui generis systems of customary laws that are integral to the ILCs ways of life, and the challenge of articulating customary law with local, national, and international policy. In Ecuador, ILCs are sometimes incapable of obtaining and executing judicial sentences, so it remains to be seen to what extent ILCs can use the current Ecuadorian legal system to protect their TK. A TK Commons, nevertheless, ensures the ILC’s knowledge is not disembodied by widening the understanding of “community” to include all non-commercial users who agree to abide by the customary laws that underlie the use of TK.

Unifying values shared by the majority of ILCs include reciprocity, equilibrium, and duality. Reciprocity means equal exchange in society and in nature, which, if adopted into a rule for use, would suggest that access should be reciprocal so that communities receive knowledge and resources in equal measure in return for the access provided. Equilibrium means balance in nature and society, which suggests that respect for nature and social equity plays a significant role in the articulation of terms and conditions for use. Finally, duality refers to the idea that everything has a complementary opposite, which supports openness to complementary systems and offers a certain degree of compatibility between traditional and western systems as necessary for TK Commons with non-traditional members to operate. Therefore, biocultural community protocols offer both access to ILC’s TK and transfer of valuable technology from non-traditional members, and could be envisaged as veritable and binding forms of contracts and/or IP protection.

Accordingly, the following elements are the foundations of the TK commons licenses, in both the digital and physical forms: a) the use of TK takes place only under the terms of the license. Any person using TK is therefore taken to have agreed to be bound by the license, which sets out how TK can be used and what obligations users incur to respect the spiritual and cultural values and customary laws of the knowledge-bearing community . The licensee will not appropriate or profit from any new development based on the TK by restricting further access to such new development or requiring payment for it but will instead place these new developments back into the TK Commons, usually by placing it under the same license; b) Using TK in a manner that is inconsistent with the stated terms and conditions in the license is forbidden; c) Any subsequent users of the TK or developments based on it who access it from the licensee will also have to comply with the terms of the license; d) All licensees must provide enduring recognition of the source of the TK; e) Any change in licensed use of the TK would require explicit permission from the holders of the TK; f) The licensee will not use the TK in any manner that would cause harm to the environment; g) The licensee will ensure the confidentiality of all research material so as to prevent unauthorized access to TK or developments based on it by third parties who are not part of the license.

An interesting example of TK Commons has been proposed by ILCs of the Bushbuckridge area in the Mpumalanga province of South Africa. These ILCs established a biocultural community protocol: A charter developed as a result of a consultative process within their communities that outlines the community's core cultural and spiritual values and customary laws relating to their TK and resources. This biocultural community protocol provides clear terms and conditions for access to their collectively held TK and resources (Abrell et al., 2010).

= Preliminary general principles for policy making = Biology has become the key technology of the 21st century and applications of life sciences play a crucial role in current social, economic, environmental, and cultural developments. Ecuador needs to satisfy at least the three following conditions to take advantage of the these technologies in order to build a rational polycentric bioeconomic model where knowledge is treated as a protected commons that promotes innovation while pursuing socially-sound goals.


 * The increased participation of indigenous communities in bioeconomic processes

Indigenous communities of the American continent maintain a relationship with their natural environment alien to the commoditization of material resources common in Western societies. This relationship is shaped by an appreciation of the indivisible relation between nature and man, and by a keen understanding of the cycles that enable the healthy functioning of an ecosystem. This more intimate relationship has placed indigenous communities at the forefront of a clash between development through extractivism, and the right to life and a peaceful existence. Relocation efforts when indigenous and financial interests collide usually result in etnocide and/or cultural extinction. Because natural resources constitute not only material but many times sacred instruments, indigenous communities see themselves as guardians of their local biodiversity. The rights of indigenous communities over their knowledge and resources associated with its conservation and experimentation are expressly recognized in global, regional, and national legislations.

In Ecuador, the involvement of indigenous communities is crucial to rationally develop biotechnology while faithfully protecting resources for future generations. In the ethnobotanical field, for example, traditional knowledge often exceeds formal scientific knowledge, and the involvement of local healers in R&D project maximizes the possibility of developing products. As an example, technical and scientific cooperation agreements between the Universidad Tecnica Particular de Loja, the Direccion Provincial de Salud de Loja, and the Saraguro Healers Coucil have permitted ethnobotanical studies that promote the Saraguro culture and the sustainable development of Saraguro medicinal and biological resources. This experience must inform future collaborations inside and outside Ecuador.


 * The distinction between commercial and non-commercial research, and information currency

The vast majority of biological and cultural resources in Ecuador remain unexplored. Therefore, a basic understanding of the magnitude of Ecuador’s resources should be promoted to generate knowledge and engage citizens, perhaps under an “open-protected commons” model. Economic activity, on the other hand, explicitly seeks marketable products. In this sense, there should be a distinction between research aimed at generating knowledge, and research aimed at generating revenue. Policy-making should understand this difference to encourage collaboration and open research at early stages, and an active exchange of knowledge, technology and materials, at later. Current bioprospecting regulation in Ecuador fails to protect resources because it ignores differences between research types, and expects financial compensation from every granted access. This expectation is not compatible with investment in science, and thus research and collaboration are discouraged, while commercial research institutions opt for development approaches that do not require continuous access. Furthermore, considering biological resources a material, and not information, is questionable when whole genomes can be exchanged digitally. Another distinction between for-profit and for-benefit downstream research may be considered in order to preferentially contract to entities whose goals are consistent with the commons perspective.


 * A physical and digital repository for the collection and administration of natural and cultural resources

In the context of an active exchange of knowledge and materials, efforts to establish a physical and digital repository for the collection and administration of Ecuador resources is justified and strongly recommended. This common pool of resources would fulfill four crucial tasks: Firstly, the creation of this repository would facilitate access to researchers. The goal is to stimulate innovation at a local level and to recruit collaboration to facilitate knowledge and technology exchange before moving to the global scenario. Biological repositories may be designed as commons through “open source” standard licensing schemes and non-profit preferential procedures resembling the ones adopted by CAMBIA BiOS or by the Open Source Seed Initiative. Secondly, repositories would provide a legal precedent to certify the origin and amendments to Ecuadorian resources. Frauds and unethical access or appropriation would be prosecuted. To access the collection, parties would agree to respect Ecuadorian sovereignty as mandated by the CBD. This agreement would constitute a sui generis legal protection under the Nagoya Protocol should conflicts arise among commercial researchers, the State, and indigenous communities. In addition, establishing property rights Ecuador may litigate parties not bound to the CBD. Thirdly, the creation of these repositories would constitute a strong stimulus for the gradual development of domestic capacity in the domain of biotechnology. Database management and scientific research can inform local developments in bioinformatics, a goal perfectly attuned to the existing technological and financial capacities of Ecuador. Finally, well-managed databases would maximize transparency about the origin and the uses of biological and cultural resources thus increasing mutual confidence between stake-holders. This database should be managed by a committee of independent scientists and representatives from Ministerio de Ambiente, and Instituto Ecuatoriano de Propiedad Intelectual.


 * Openness, alternative IP protection systems, open source approaches, and an emphasis on education, knowledge, discovery, and citizen biology

As we have seen in Section 2, contemporary hyperownership approaches hinder both innovation in the life sciences, and the delivery of products with tangible, positive impacts on socio-economic development. Thus, access to knowledge and resources should not be promoted only in the bioprospecting domain, which is the initial step of research projects, but rather throughout strateig phases of the R&D chain.

We presented several collective licensing schemes in section 3.1.2 that respond to shortcomings of the “private” model. The open-source model can deliver scientific activity while strengthening Ecuador’s intellectual capital. The open-source model promotes knowledge circulation, prevents private or public appropriation, preserves the rights of participation for local people and communities, and encourages private actors to explore and evaluate potential commercial endeavors. Borrowing from the legal framework pertinent to information resources, an open-source model is particularly well-suited to cope with the challenges associated with biological elements as a source of information, particularly in the emerging field of applied (meta)genomics. Information economics has emphasized the advantages of “open source” approaches in managing large sets of data with different applications.

The synchronization of education, knowledge, and discovery to fit the new educational system should encourage the appreciation of Ecuador’s biological and cultural resources. From “Escuelas del Milenio” to “Ministerio Coordinador de Sectores Estratégicos”, the (re)discovery of Ecuador’s vast collection of life forms could engage young students in becoming the scientists of the future by providing a context and justification to build upon their natural curiosity. A multicultural educational system should be expanded nationally to encourage the revitalization of the diverse cultures and ethnicities in Ecuador. In the short term, engaged students can move within a culturally sensitive education framework towards formal training and jobs in applied biological sciences. In the long-term, scientists and citizen biologists can eventually become the backbone of a innovation spiral focused on the delivery of small-scale solutions strongly adapted to the contextual environmental, social, and cultural conditions in which Ecuadorians live.

= The Ecuadorian policy framework = In this section, we examine the Ecuadorian framework for bioprospecting in order to emphasize the shortcomings of the present system and to set the context for our proposal, introduced in Section 6. The number one difference between Ecuador and other megadiverse countries is the extreme density of biological diversity that exists in Ecuador’s relatively small territory. The second difference is a privileged location with access to Asian and North American markets. The third is Ecuador’s mature infrastructure for global commerce. With proper incentives, clear regulations, and flexible frameworks that accommodate extremely rapid developments in science and technology, Ecuador may constitute a regional experiment for the institution of an economy based on knowledge derived from the exploration of local natural and cultural capital. Cataloguing and management, for example, may be more efficient in a small country. While the Ecuadorian framework is strongly influenced by regional regulations – especially CAN Decisions 391 and 481 enacted in the 1990s to implement the CBD, we will focus on Presidential Decree #905, which states domestic procedures to access biological resources.

As far as indigenous involvement is concerned, Art. 8.8 recognizes the rights of indigenous and local communities as authors of the intangible component associated with genetic resources. Art. 20 establishes the actors involved in the approval of access to resources with an intangible component, i.e. Ministerio de Ambiente, Secretaria Nacional de los Pueblos, Movimientos Sociales y Participación Ciudadana, and Instituto Ecuatoriano de Propiedad Intelectual. No guidelines, however, are provided to facilitate resource protection by local communities while simultaneously enabling scientific research and economic development. For instance, Ministerio de Ambiente is the major player in decisions related to the intangible component of biological resources (Art. 34-38), thus minimizing decision-making capacities from indigenous communities. Similarly, Art. 43 and 44 establish the formation of repositories for biological resources in research institutions; however, they do not acknowledge the values of indigenous communities in terms of their cultural resources.

Even more problematic is the lack of understanding of the mechanisms of contemporary scientific R&D. Firstly, Art. 26.1 and 26.5 require financial compensation and the signing of an ABS agreement for every access. The distribution of benefits, as proposed, seems unrealistic because the outcome of R&D efforts is unpredictable. thus not all species have the same potential value. Secondly, Art. 2.4 inadequately addresses the fundamental distinction between non-commercial and commercial research. Although certain types of “non-commercial” research are excluded from the scope of Decree #905, a Contrato Marco outlining research details is always required and exceptions do not cover all the research activities that can be classified as “basic” or “not-commercially oriented”.

Regulations placed in the name of avoiding biopiracy, in fact, do not prevent natural resources from fleeing Ecuador and do not guarantee revenue from any potential utilization. To illustrate this, we will describe an Ecuadorian case-study in which o the above-mentioned conditions were not addressed. We will also present a hypothetical scenario in which one or more of the recommendations here made would have facilitated activities contributing to an economy based on knowledge derived from the exploration of Ecuador’s biological resources.

Epibatidine
The discovery of epibatidine illustrates the essentiality of indigenous involvement, potential timelines, the need for resource repositories and distinctions between basic and commercial research. Aware of indigenous groups using amphibian secretions for hunting, more than a decade of scientific work led to the discovery of epibatidine. Although epibatidine was of little use for human therapy, industry quickly aimed R&D efforts to the development of epibatidine analogs. This resulted in the successful development of Tebanicicline almost 20 years after epibatidine was first described.

Epibatidine was identified as the component in the skin of poison-dart frogs (Epipedobates anthonyi) responsible for the potent analgesic effect observed in animal studies. It was considered a promising therapeutic agent with a novel mechanism of action that did not cause dependence. In 1974, scientists from the National Institutes of Health (NIH) in the US collected hundreds of specimens of this frog, a species endemic to Southern Ecuador and Northern Peru. Specimen collections by NIH scientists continued without difficulty until 1987, when the family of frogs Dendrobatidae was included in the endangered species list of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). Scientists at the NIH did not have enough extract to confirm preliminary studies, and the technology at the time was inadequate to elucidate chemical structures with small amounts of sample. This haltered further research on the pharmacology of the compound(s) responsible for the analgesic effect, and ultimately prevented synthetic production of the compound(s). The emergence of new technologies years later allowed the use of minimal amounts of sample for analysis, and the chemical structure of epibatidine was elucidated. This opened the door for industrial synthesis and further development. The publication of the chemical structure of epibatidine in 1992 propelled Abbott Laboratories to focus their ongoing research in compounds that had chemical structures similar to epibatidine. Further studies showed that epibatidine would not be an adequate candidate for use in humans because the effective dose and the toxic dose were in close range. A number of synthetic derivatives showed fewer side effects, and one derivative in particular – Tebanicline or ABT-594 – has been studied for pain management in humans since 2009.

In the epibatidine case, 35 years passed between the first recorded collection of frog samples and the first in-human studies with the synthetic derivative. Scientific and technological developments enabled the discovery of epibatidine with a very limited access to its source specimens. Even though it is still too early to predict whatever success Tebanicline may have, discussions of benefit sharing may be already relevant. This case exemplifies the long term potential value of biological resources and the limitations that blocking access to them puts on the advancement of basic research. These limitations may very well be due to the lack of policies that integrate indigenous communities in the process of discovery.

In an ideal scenario, Ecuador has a repository of indigenous knowledge and decides under which conditions access by NIH scientists to Ecuadorian resources is granted. Reciprocal research agreements between institutions inside and outside Ecuador include indigenous representatives capable of assessing and communicating the process that leads to a calculation of value. Unreported collections by third parties, especially for endangered species, are illegal. Indigenous communities have the authority to investigate and limit collections. Active exchange and collaboration leads to product development and commercialization, parallel to environmental protection and the strengthening of Ecuador’s scientific capacities.

= Ecuadorian policy recommendations with institutional participation = Our proposal is geared towards the generation of knowledge, technology, and solutions derived from Ecuador’s vast biological and cultural resources. In this context, we propose that Ecuador’s ongoing industrialization efforts revolve around the long-term exploration of its unique natural and cultural capital. Ecuador’s resources can inform R&D driven by local priorities in the areas of sustainable agriculture, food security, energy diversification, ethnomedicine, and environmental quality. In the long term, Ecuador can export these experiences to fulfill the promise of a knowledge-based economy.

Let us emphasize that:

a) No other country has a natural capital as dense as Ecuador’s b) No other country has invested so recently and so broadly in infrastructure and education

Technology and economy converge today intimately and globally. In this context, Ecuador’s natural and cultural capital can generate knowledge to inform industrial development and economic policy. This in turn should promote the rational exploration, development, and conservation of Ecuador’s biological resources. Reciprocal collaborations at the community, institutional, national, and international levels are vital. The rich and dynamic knowledge of indigenous communities at the local and national levels, for example, adds incalculable value to scientific discovery. Inter-institutional collaborations and proper incentive mechanisms that enhance the participation of academia and the private sector can connect rapidly evolving technologies with dynamic local knowledge and the global economy to crystallize the promise of a knowledge-economy based on research on applied biodiversity. Here we propose a set of mutually supportive measures and amendments to expedite scientific discovery, manage commercial development, and strengthen Ecuador’s research capacities.

In short, our amendments include:

Their participation would involve establishment and management of local repositories, decision-making authority on resources related to traditional knowledge, and recognition as authors/innovators in reciprocal collaborations. Such involvement is not only mandated by international agreements, but is also included in Decree #905. Thus, no particular legislative measure is required to attain this goal, but rather the scaling-up and the implementation of existing institutional arrangements foreseen by Art. 20 and the clarification of stakeholders, their rights and their responsibilities during the exchange of materials and information are needed. An improved definition of the competences of the Ministerio de Ambiente, the Instituto Ecuatoriano de Propiedad Intelectual, and the Secretaria Nacional de los Pueblos, Movimientos Sociales y Participación Ciudadana is needed as to guarantee the respect for indigenous rights. In addition, the development and implementation of protocols pertaining cultural resources, possibly but not necessarily anchored on the TK commons model presented in 3.2.2, could further strengthen indigenous decision-making rights while simultaneously reducing transaction costs for researchers'''. '''
 * Modification of Decree #905 to establish a pivotal role for indigenous communities during the release and development of traditional knowledge 

The active participation of scientific bodies that have relevant experience in R&D, i.e., scientific societies, academic institutions, and private research organizations in Ecuador, should be part of the governance of bioprospecting. In order to achieve this goal, Decree #905 can be modified to broaden the scope of research exemptions (Art. 2.4), to establish a scientific committee to evaluate access requirements together with public authorities and to allow the postponement of benefit-sharing agreements until appropriate requests can be formulated. The Brazilian model constitutes a valuable source of inspiration, and these modifications would be consistent with the spirit and the legal structures set up by CAN decisions 391 and 486 as well as with Decree #905.
 * Modification of Decree #905 to better distinguish basic and commercial research

Biological and cultural repositories would be monitored nationally by the pertaining authorities as established in Decree #905 (Art. 20) in addition to SENESCYT, and Comisión de Biodiversidad de la Asamblea Nacional. However, a distinction for resources associated with traditional knowledge, i.e., cultural resources, would expedite research when the participation of indigenous communities is not mandatory. In order to achieve this goal, Art. 43 and 44 should establish the management of cultural repositories locally by indigenous experts.
 * Modification of Decree #905 to establish the collection and administration of biological and cultural resources 

A National Bioprospecting Company would facilitate the rational evaluation of the economic and scientific potential of Ecuador’s biodiversity and the creation of a commons-oriented bioindustry. The NBC would be endowed with the required scientific and legal expertise to ensure the involvement of national researchers, which is already obligatory under Decree #905, and to guarantee smooth relations between external parties, the government, and the indigenous communities. In addition, the NBC could be designed to become the most relevant commercially-driven body not only for public-funded scientific research but also for bioprospecting regulation activities. It could be run by a multi-stakeholder Steering Committee integrated by all relevant parties. Once in place, collaborations with the NBC could be made mandatory for foreign parties demanding access.
 * The establishment of a National Bioprospecting Company (NBC)

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