Regulating Access and Protecting Traditional Health Knowledge through Intellectual Property Rights? Issues from a Holistic Health Systems Perspective

Abstract

Traditional Health Knowledge (THK) has been a resource for modern pharmacology and the pharma-ceutical industry since its inception. Until the 2000s, there was little obligation to acknowledge the use of THK by the pharmaceutical industry. Now, with the intellectual property regime becoming a prominent mode of regulating use of pharmaceutical inventions and innovations, and attempts by the pharmaceutical industry to patent products based on THK, rights of THK holders are being fore-grounded. The World Intellectual Property Organization (WIPO) is seeking to protect the rights of THK holders through international legal instruments under the Intellectual Property Rights (IPR) framework. This article discusses dilemmas arising from this attempt at bringing together two diverse knowledge frameworks. It draws upon existing literature on the nature of THK and upon the debates of the WIPO’s Inter-Governmental Committee on Genetic Resources, Traditional Knowledge and Traditional Cultural Expression (WIPO-IGC), and analyses them from the standpoint of a holistic health systems approach (HHSA) in an era of Sustainable Development Goals (SDGs). The approach leads to the conclusion that deliberations and promulgations of the WIPO-IGC will have long-lasting implications for the survival of diversity and context-specificity in healthcare. Therein lies the significance of thinking through the policy and legal measures to be adopted nationally and internationally.

Introduction

Bio-prospecting by the pharmaceutical industry has created the need for mechanisms of protection from commercial exploitation of the traditional knowledge (TK) of medicinal plants and herbs. This is linked to the protection of the plants as genetic resources (GRs), to the knowledge about their uses for human health, to their methods of collection from the wild and their cultivation, as well as the processes that enhance or allow their use as health technology. The current discussion at the World Intellectual Property Organization’s Inter-Governmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural Expression (WIPO-IGC) relates specifically to these issues. While it deals with TK in all domains, the healthcare and pharmaceutical industry are among the most organised potential ‘users’, hence its relevance for health systems. What need to be examined thus are the implications of applying the Intellectual Property Rights (IPR) regime to traditional health knowledge (THK)¹ and the forms of protection that can be built in to safeguard the rights of THK holders. However, little attention has been paid to these issues by health system analysts or policymakers.

In the current international policy discourse, many countries endorse the value of THK (WHO, 2008). The link between plant resources and TK, and their usefulness in healthcare, has already been recognised by the Convention on Biological Diversity (CBD) in 1992 (UN, 1992). It requires ‘access to use of TK by those other than its traditional holders’ to be allowed only when combined with ‘fair and equitable benefit sharing’ (UN, 2010). Sustainable Development Goals (SDGs), conceptualised on the three pillars of ecological sustainability, economic viability and social justice (UN, 2015), require a paradigm shift in how development is envisaged. In the case of health systems, reconfiguring the human-nature relationship with social justice leads one to see THK as a resource of the ex-colonised countries and the most marginalised communities, those most under-served by the dominant services. Thus, the legitimation and promotion of THK could strengthen all the three pillars of SDGs.

The primary healthcare (PHC) approach of the Alma Ata Declaration of 1978 had stated that the goal of Health for All could be achieved only by developing systems of efficacious, accessible, affordable and culturally acceptable services that were available closest to people’s homes. In this regard, it recognised the value of incorporating traditional healers wherever they exist (WHO, 1978). However, the reductionist nature of the dominant medical system’s paradigm and the doctor and institution-centred health service systems approach have only expanded since then. The vision of the CBD, the SDGs and the PHC approach, on the other hand, together provide the basis in policy discourse for a holistic health systems development. The principles of practice of THK can contribute significantly to this alternative thinking.

In this article, we define and employ the concept of holistic health systems approach (HHSA) to examine the implications of applying IPR regimes to THK. The article begins with (second section) the rationale for protecting THK in the present. It explicates the nature of THK in the third section, delineating the main pillars of the proposed holistic health systems approach. The fourth section contrasts the principles of THK with the conceptual construct of IPR regimes and briefly presents the WIPO-IGC draft instrument on Access and Benefit Sharing (ABS) and the related debates. The fifth section analyses cases across three continents to draw lessons from ABS arrangements. It then discusses the possible role and limitations of IPR mechanisms, ABS arrangements and legal instruments in protection of THK, summarising the systemic implications of the incompatibility of these frameworks for the marginalised communities, the primary holders of THK. The sixth section envisions an alternative framework in coherence with THK principles and suggests complementary policy measures in health systems development that would be necessary for implementing effective protection. The seventh section examines the challenges to implementation and makes concluding remarks.

Why Protect Traditional Health Knowledge?

Salience of THK in Serving the Health Needs of Populations

The significance of THK due to its increasing demand among lay populations and in the pharmaceutical industry has led to contestations over its rights of ownership, innovation and use in the present times. The current popularity and demand for traditional medicine (TM) internationally is spurred by the efficacious and safe remedies it offers for prevention and treatment of chronic diseases (WHO, 2013). In some contexts, it has been in continuous use as the primary source of care² and co-existed with conventional medicine due to historical cultural influences.³ In the recent decades there has been considerable expansion in the demand for complementary and alternative medicine among the middle classes across continents (Abdullahi, 2011; Emslie, Campbell & Walker, 2002; Harilal, 2009; Harris & Rees, 2000). For the modern scientific establishment and pharmaceutical companies the easy access to ready repositories of traditional plant medicinal knowledge helps shorten the otherwise long-drawn and expensive process of drug discovery (Jeffrey, 2002; Wakdikar, 2004).

Estimates of the volume of international trade in medicinal plants and their products vary by source from US$800 million in 2004 (Wakdikar, 2004) through US$60 billion (WHO, 2003) to US$80 billion (Mathur, 2003). BCC Research (2015) projections predict rapid growth in the global market for botanical and plant-derived drugs from US$24billion in 2014 to US$35 billion and US$7 trillion by 2020 and 2050, respectively.

The rising demand for TMs globally has led to the swelling of Indian exports in raw herbs, Ayurveda, Siddha and Unani (ASU) drugs and medicinal plant products (nutraceuticals and cosmoceuticals) (Harilal, 2009). Their value went up by 25 per cent, increasing from US$268 million to US$358 million between 2009 and 2012 (GoI, 2013). The value of exports to the European Union (EU) alone, (the largest importer of Indian herbs, ayurvedic and herbal medicines) grew by about 42 per cent between 2010–2011 and 2011–2012. India’s internal market for ayurvedic medicines was expanding at the rate of about 20 per cent annually in 1997 and the sales of medicinal plants grew by nearly 25 per cent between 1987 and 1996 (Masood, 1997).

The THKs’ long history of development and use in everyday life in several contexts of the Global South is now widely recognised. In most contexts the efficacy, accessibility and affordability of THKs underlie their popularity and usage. They are critical to survival in contexts of poverty and marginality. The very high traditional medicine practitioner (TMP) to allopathic doctor ratios in Malawi and Tanzania—17,000:35 and 30,000–40,000:600, respectively, are evidence of the high levels of reliance on the former’s services (WHO, 2003). In the African countries of Ghana, Mali, Nigeria and Zambia (where populations face very high risk of malaria), two-thirds of the children suffering from high temperature are first treated with herbal home remedies (WHO, 2003). The material resources and TK related to them have been maintained, developed, refined and handed from generation to generation and continue to meet everyday health needs of populations. A study conducted in 18 states of India in 2008–2009 revealed that in over 50 per cent of the surveyed households, home remedies and services of folk practitioners were being used to address pregnancy (in 14 of the 18 states), lactation-related problems (in 13 states) and to chronic illness (in 16 states) (Priya & Shweta, 2010). The study also showed a high demand for TM if the services were of ‘reasonable quality’ (Priya & Shweta, 2010, pp. 97–98). In Tamil Nadu, where both Allopathy and TM services in the public system were of high quality, over one-third of the total cases coming to the OPD chose to go to the TM clinic.

Given its wide utilisation and popularity, scholars have been advocating the incorporation of THK and its practitioners into the national healthcare systems through evaluation of effective remedies and training of healthcare providers (Cunningham, 1993; Priya, 2012, 2013b; Sadgopal & Sagar, 2007). A reconceptualisation and restructuring of primary health services proposes, that home remedies/self-care and traditional health practitioners form the first tier, community health workers and paramedics attached to the sub-centre at the second be supplemented with a TM doctor and a social worker at the primary health centre (Priya, 2011). At the global level, the World Health Organization (WHO) has time and again recognised the salience of THKs. The World Health Assembly (WHA) of 1977 and the Alma Ata declaration on PHC acknowledged TM as a legitimate choice in the planning of healthcare and advocated the integration of practitioners of TM in PHC (WHO, 1978). In its Beijing Declaration on Traditional Medicine in 2008 the WHO recognised TM ‘as one of the resources of primary healthcare services to increase availability and affordability and to contribute to improved health outcomes’ (WHO, 2009). The 62nd World Health Assembly (2009) and the WHO Strategy on Traditional Medicine (2014–2023) endorsed this. THKs can thus contribute to evolving a healthcare system that addresses issues of economic viability, social justice and strengthens a vision and practice of healthcare as a non-commercial service that is an integral part of people’s way of life and recognises human beings’ dependence on nature, thus addressing all three pillars of the SDGs.

Salience of THKs in Development of the Modern Allopathic Pharmaceutical Industry

THKs have been immensely valuable in the development of modern medical science and its technologies. The plant, animal and mineral base of TMs has contributed to development of the pharmacopoeia of ‘modern medicine’. All major medicinal alkaloids isolated through the nineteenth century from Morphine in 1806 to Aercoline (used to treat Alzheimer’s disease) in 1891 were obtained from plant sources in use among lay populations and traditional healers (Ravina, 2011; Sneader, 2005). Even though microbes and animals became the more important sources of antibiotics and hormones between the 1920s and 1950s, plant sources continued to persist as major prototypes for drug development.

In the production of modern pharmaceuticals the discovery of an effective molecule remains a prohibitively expensive and time-consuming process entailing the search, creation and testing of thousands of chemicals. Only 8 per cent of random samplings of chemicals suggested by formal scientists have confirmed therapeutic effects in laboratory tests as compared to three fourths of the plant species reported to have medicinal value by an indigenous group (Mgbeoji, 2006). Thus, obtaining information of natural plant sources in use in TM makes drug discovery a more economical endeavour. Mathur (2003) argued that the interest in THK could be attributed to the search for newer patentable formulations since a large number of pharmaceutical patents were set to be exhausted by 2006. Thereby the pharmaceutical industry is now using THK as a source of ready knowledge on which to build their R&D, catering to the demand for both modern and TMs (Ranjikar & Rajbhandary, 2008; van Andel & Carvalheiro, 2013).

Given its continuing relevance to health systems, THKs require protection in a macro context of IPR regimes. This calls for an understanding of their nature and distinctive characteristics.

The Nature of THK

Experiential and Situated Nature of THK

THK is a part of traditional ecological knowledge (TEK) that is produced due to direct dependence of communities on nature for their subsistence, necessitating an intimate interaction with the flora, fauna, soil, air and water in a particular place. They are rooted within collectively shared epistemologies of health and illness of communities and practitioners and draw their raw materials primarily from local natural resources (Shankar, 2007). TEK is produced through collective effort at a limited geographical scale, but also consolidated through interactions over generations and across larger geographical tracts. Its production through cycles of observation, experience, experimentation, application and reflection is similar to the steps in the scientific method but occurs in situ through interaction in a specific ecological, social and cultural context (Gadgil, Berkes & Folke, 1993). It is this pace and ‘situated-ness of experience’, coupled with its precedence in time, that characterises ‘traditional ecological or health related knowledge’ (Berkes & Folke, 1992).

Conceptions of Nature, ‘Ecological Conservation’ and Innovation in THK

Across indigenous societies, nature is seen as the repository of powerful supernatural entities that both nourish life and are sources of disease and misfortune, hence regarded with reverence and deemed worthy of protection against indiscriminate and disrespectful use (Gadgil et al., 1993; Mis’ra & Bondla, 2010; Snodgrass et al., 2008; Ulluwishewa, Roskruge, Harmsworth & Antaran, 2008). This perception of nature informs the classification of species, ecosystems and micro-systems which are based on their physical features, location, use, social and spiritual significance. Historically, gathering of medicinal plants and preparation of medicines was undertaken by practitioners and their apprentices or patients/families themselves. This specialised knowledge was generally held by a group of individuals with a ‘spiritual calling’, and formalised through ritual and religious controls governing rules of collection, timing and the permissible quantum of harvest of medicinal plants. Herbal knowledge and the dependence on forests inculcate ecological concern among gunis or herbalists (Snodgrass et al., 2008). Their belief in the supernatural powers of nature strengthened the impetus to protect forests and the animals. This approach integrating the subsistence, affective, religious, social, cultural and environmental aspects of human dependence on nature informs TKs of ecology and health and is what makes them holistic (Mis’ra & Bondla, 2010). Recent documentation shows that indigenous and rural communities are keenly tuned to the current changes in climate and their effects on the local flora, fauna and inorganic resources. The Koya and Konda Reddi tribes of the Eastern Ghats and the riverine communities in the Mekong basin have been found to adapt to changes in their ecosystems by innovating technology, social arrangements and other inherited wisdom governing the use of plants and animal resources (Mis’ra & Bondla, 2010; Santasombat, 2011). Hence TEK and THK are living traditions, actively preserved through inherited knowledge, labours and innovations of the knowledge holding communities.

Heterogeneity

THK comprises of a continuum of knowledges with informal or vernacular forms of health-related knowledges (traced in India as the praakrit traditions with a range of folk practitioners and specialists⁴) at one end, and the formal systems of textual, codified knowledge based on theoretical formulations of the body, health and disease causation at the other (the samskritic traditions⁵) (Ranjikar & Rajbhandary, 2008). Historically, the starting point of knowledge generation for both these streams was the collective experience of lay people some of which, through layers of use and refinement, has been systematised into codified expert-based textual systems of THK (Balasubramanian & Radhika, 1989).⁶ THKs heterogeneity, therefore, needs layered combinations of mechanisms for protection and promotion.

The Principles of THK: Contributions to Sustainability Thinking

Despite their heterogeneity, the spectrum of THKs is unified by the following principles:

a collective conception of knowledge generation and ‘custodianship’ (as against ownership that allows the right to dispose of or transfer),

universally applicable holistic conceptions of ecological-social-biological processes,

localisation of health measures linked to time and place,

individualisation of health measures based on spatio-temporal and individual characteristics and

an ethics of plant/natural resource use.

Thus, THKs, besides addressing critical links between the three pillars of SDGs, are valuable for creating knowledge conducive to sustainability transformations. The extensive presence and principles of THKs make them critical contributors in evolving a HHSA.⁷ The THKs are on the one hand components of the subject matter HHSA addresses and on the other are potential contributors in revisioning healthcare service systems and programmes.

HHSA links the micro, meso and macro levels of health systems incorporating the following:⁸

diverse world-views and health related perceptions,

technologies and practices of health promotion, disease prevention, diagnosis and treatment, palliation and rehabilitation, as well as,

the modes of utilisation of health-related knowledge from self-care within families to institutional services at a societal level,

ontologies, epistemologies and methodologies as well as institutional structures and regulatory mechanisms of health knowledge systems and

their political economy, social and cultural moorings.

While communities are attempting to preserve THK and its resources, with the simultaneous growing exposures to urban development, modern education, the aspirations to assimilate and the erosion of their habitats, THK is on the wane even among indigenous communities (Ulluwishewa et al., 2008; Wyndham, 2010). Thus, there is a need to protect this valuable knowledge from decline and possible extinction.

Bio-prospecting and IPR: For the Good of Humankind?

Historically TK holding populations were denied their fair share of the gains from the commerce that their resources and knowledges spurred. Colonial and commercial interests accumulated profits by appropriating food (potato, cocoa, coffee, sugar, maize, etc.), medicinal (cinchona and jalap root) and other (tobacco, rubber and sisal) plant resources and their knowledge from former colonies, even as TK systems were labeled as irrational, static and obsolete. Their contributions to the achievements of modern science were not credited by the scientific establishment, hardening the latter’s hegemony as the only valid and legitimate form of knowledge (Jeffrey, 2002).

It was only in the 1980s that the pillage of TK and natural resources by the scientific establishment and corporations of the North came to be acknowledged as ‘biopiracy’ by environmental activists working on development and aid issues (Mgbeoji, 2006).⁹ The pharmaceutical industry was now investing in bio-prospecting—defined as ‘the search for biodiversity, for valuable genetic and biochemical information found in wild animals, plants or microbial organisms’ for product development as a purely scientific and commercial endeavour (Jeffrey, 2002). Despite the increasing global recognition of the rights of indigenous peoples over their genetic and knowledge resources, the appropriation of their medicinal plant knowledge continued with little acknowledgement well into the 1990s. Official recognition of the TK holders’ rights and of ‘biopiracy’ as a violation of the same came only with the CBD, 1992.

IPR Regimes and Protection of THK

The vulnerability of rural and indigenous communities in the event of patent cases involving appropriation of their resources by powerful actors drew attention to the need for protection of rights of THK holders.

The CBD, 1992, had emphasised that the conservation of GRs and their TK are integrally bound. It advocated that the approval and involvement of TK holders be sought prior to the use of TK and innovations based on it. Under the CBD, the Nagoya Protocol on ‘Access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation’ bound the signatories to sharing the ensuing benefits, both commercial gains and new knowledge, equitably with the TK holders (UN, 2010). Simultaneously, concerns about protecting TK holders from exploitation by erroneous patents were raised and attempts to address the same were made in the domain of intellectual property regimes as well.

The WIPO Documents and Negotiations

In 1998–1999 the WIPO constituted fact finding missions across 28 countries to ascertain perspectives of TK holder communities in relation to IPR, and in the year 2000 set up the IGC on intellectual property (IP) and genetic resources (GRs), TK and traditional cultural expression (TCE). The IGC is in the process of preparing three separate international legal instruments, for protection of the GRs (WIPO, 2016a), TK (WIPO, 2016b) and TCE or folklore (WIPO, 2014). They provide the basis of continuing negotiations on the text of the instruments. As a UN agency, the WIPO views nation states as the mediating actors, respecting their sovereignty while expecting them to defend the rights of their communities and enforce protective mechanisms when commercial use is made of the TK by others. It has also created space for participation of representatives of indigenous peoples and civil society.

We examine the IGC draft on protection of TK for its implications for THK. The objectives of the legal instrument include:

To prevent the misappropriation/misuse/unauthorised use/unfair and inequitable uses of traditional knowledge; to control ways in which their traditional knowledge is used beyond the traditional and customary context; to promote the equitable sharing of benefits arising from their use with prior informed consent or approval and involvement for fair and equitable compensation; to encourage and protect tradition-based creation and innovation; and to prevent the grant of erroneous intellectual property/patent rights over traditional knowledge and its associated genetic resources.

Locating these objectives in the WIPO context, the document addresses issues regarding rights of TK holders and demands of those seeking access to TK for professional and commercial gains, their contestations and alternative statements put up for discussion (WIPO, 2016b). The WIPO draft document on Protection of TK, up for discussion since 2010, makes propositions on the provisions to protect rights of TK holders and demands of those seeking access to TK for professional and commercial gains, in the context of IPR (WIPO, 2016b). Interestingly, despite its democratic structure, taking the IPR perspective as the norm leads the document to invert the relationship that the competing actors have with TK. The TK holders whose communities and families have generated the knowledge are patronisingly converted into ‘beneficiaries’ as recipients of the monetary gains to be shared with them under the proposed legal instrument. Simultaneously, the bio-prospecting researchers and R&D wings of pharmaceutical companies get cast as the innovative ‘users’ of TK. The IPR discourse thus deepens the dominant perception of TK holders as passive custodians of a static knowledge while the modern commercial R&D establishment gets acknowledged and celebrated as the ‘innovator’.

Countries like the USA, Canada, Japan, Norway, the Republic of Korea and the Russian Federation are negotiating for terms in favour of the ‘users’ engaging in bio-prospecting. ‘Like Minded Countries’, Algeria, Angola, Bangladesh, Colombia, Egypt, India, Indonesia, Malaysia, Myanmar, Namibia, Pakistan, Peru, South Africa, Tanzania, Thailand and Zimbabwe, have been meeting since 2011 to further the interests of TK holders and associated GRs (WIPO, 2011).

Attempts to fulfil the objectives of the instrument have led to contestations over the following:

Defining what is to be protected and who the ‘beneficiaries’ should be: Which forms of TK should be included for protection under the law? In the case of THK, only that which is held secret by healers/communities or also that which is in texts or in the public domain as common knowledge? The northern countries are attempting to use as restrictive a definition as possible for what TK is to be protected. The ‘like-minded countries’ are arguing for the most inclusive definition for protection of all the three tiers of THK. Once outside protection, commonly used THK and its GR may, with minor ‘innovations’, become patentable and monopolised, given the extent of erroneous patents and international contestations to the existing protections under national laws.

‘Misappropriation’ is one of the contested terms. One option defines misappropriation as: ‘any access or use without prior informed consent or approval or involvement and, where applicable, without mutually agreed terms, for whatever purpose (commercial, research, academic and technology transfer)’. The second option creates loopholes for the ‘(mis)users’ to get through:

the use of protected traditional knowledge of another where it has been acquired by the user from the holder through improper means or a breach of confidence and which results in a violation of national law in the provider country, recognising that acquisition of traditional knowledge through lawful means such as independent discovery or creation, reading books, receiving from sources outside of intact traditional communities, reverse engineering and inadvertent disclosure resulting from the holder’s failure to take reasonable protection measures is not misappropriation. (WIPO, 2016b)

The scope of protection to be offered by the instrument would be based on a tiered approach, depending on the form of THK. Given the diversity of healers and forms of THK, defining each tier of THK and its holders will pose a challenge. Defining what is ‘public domain’ and ‘prior art’ will be essential. Beyond indigenous and local communities; should nations and national authorities be mandated as custodians of THK? Even if nations are recognised, should they have a fiduciary role? Or should communities retain decision making rights?

Four kinds of rights of the THK holders are visualised in the present text, which will require different mechanisms for application to the different forms of THK, hence the tiered approach. However, applicability of all the four rights (given below) to all forms of THK is also contested:

the exclusive and collective right to decide what use be made of the THK,

the use of their THK be disclosed to the knowledge holders and the user mandatorily disclose the source of THK on which the product is based,

use the knowledge in a manner that respects the cultural norms and practices of the ‘beneficiary’ as well as ‘the inalienable, indivisible and imprescriptible nature of the moral rights associated with the traditional knowledge’ (WIPO, 2016b, p. 9) and

a fair and equitable share of the economic benefits accruing to the user be given to the holders.

For the THK that is secret and/or uniquely attributable to a specific community, exclusive economic rights would apply. For what is in the public domain and widely known, a fees could be paid into a fund created at the national or international level.

The loopholes being suggested in the alternative text formulations put up for discussion relate to: ‘mutually agreed upon terms’ between the beneficiaries and users rather than clearly articulated norms of benefit sharing and putting knowledge widely known in the public domain as ‘outside the protection’. The very purpose of the instrument could also potentially be undermined by exceptions and limitations to the applicability of legal protection or placing rights under ‘national laws’ which are often non-existent or weakly written due to pressures from corporate interests and ruling elites.

Complementary measures are required of the member countries to operationalise the provisions. They can be divided into those that contribute to a defensive protection and others that provide positive protection. Creating a database of THK as ‘prior knowledge’ that can be made available to patent offices globally is a defensive measure against ‘erroneous patents’. The Traditional Knowledge Digital Library (TKDL) created by India is one of the best examples (Anonymous, 2011; Poorna, Mymoon & Hariharan, 2014). However, this measure is not applicable to knowledge that is widely known or is secret. The Regional Vernacular Manuscripts that could be part of the secret THK or that document widely known community knowledge can be similarly put into a database at state and national levels. For the widely known THK, the provision in the CBD’s Nagoya Protocol for compiling People’s Biodiversity Registers provides a similar approach at community level.

The Experience of Access and Benefit Sharing Arrangements

The attempts at operationalising ABS provisions as envisaged in the CBD and the Nagoya Protocol have revealed the complexities involved in arriving at fair agreements that meet the needs of both users and beneficiaries. Here we analyse three ABS arrangements from South America, Asia and Africa that showcase challenges in securing the beneficiaries’ rights to acknowledgement, decision-making, fair and equitable sharing of benefits and respect for their cultural frames. The producers and holders of THK in all three cases, were indigenous peoples—the Maya of Mexico, the Kanikar in South India and the San in South Africa who shared long histories of marginalisation and dispossession at the hands of the colonial state and later by the democratic governments in their free countries (Schuklenk & Kleinsmidt, 2006). Across all the three hunter-gatherer and agricultural societies the THK has been developed as a response to meet needs of food, health and survival.

Despite the geographical and linguistic diversity within the indigenous communities, prior consent and ABS negotiations were first undertaken with selected sections leading later to contestations by those left out. For instance ‘Maya’ is the collective name for several indigenous communities across Guatemala, Belize, El Salvador and Honduras; the International Cooperative Biodiversity Group (ICBG), however, was initiated only with the Mayas in the Highlands of Chiapas in southern Mexico (Nigh, 2002). The heterogeneity within THK holding communities adds to the complexity of issues of identity and representation when rightful ‘beneficiaries’ are to be identified for ABS arrangements.

Table 1 reveals the asymmetries of power that played a critical role in research and commercial establishments gaining access to THK that was sometimes considered sacred and governed by customary rules of secrecy among indigenous communities. Scientists located in publicly funded research institutions obtained THK through personal networks or from subordinate employees within indigenous communities, or from published colonial accounts while bypassing THK holding communities entirely or obtaining prior informed consent from selectively chosen sections among them.

Table 1

Accessing Plant-related THK in the Three Cases of ABS Arrangements: Actors and Events

	The Maya Indigenous People	The Kanikar Tribe	The San Indigenous People
Institution Accessing THK	International Cooperative Biodiversity Group (ICBG), USA	Tropical Botanical Garden and Research Institute (TBGRI), India	Council for Scientific and Industrial Research (CSIR), South Africa
Access seekers	Ethnobiologists from Georgia University, USA awarded a US$2.5 million grant, for ‘Drug Discovery and Biodiversity among the Maya of Mexico’ (1998–2004) by the US government’s National Institute of Health A consortium including: Georgia University, USA El Colegio de la Frontera Sur (ECOSUR)—a Chiapas research institution and Molecular Nature Ltd.—a British Biotech company formed to execute the project¹	TBGRI—public institution supported by the Government of India (GoI) and the government of Kerala state (GoK). The director of TBGRI initiated the development of ‘Jeevani’ the drug based on the Arogyapacha at the institution’s ethnopharmacological division The TBGRI licensed mass production of ‘Jeevani’ to private concern Arya Vaidya Pharmacy (AVP)^2,3	CSIR of the Government of South Africa isolated the appetite-suppressant molecule P57 in the Hoodia plant⁴ Collaboration with British Biotechnology firm—Phytopharm, granted sub-licences to pharmaceutical companies, Pfizer and then Unilever, to produce food products and supplements with appetite-suppressant properties to treat obesity⁴
Source of information about the medicinal plant and process of obtaining access to THK	Researchers documenting Mayan medicine in the Chiapas for 40 years; had developed political and social networks in the region¹	In 1987, both lead researchers encountered Arogyapacha in interaction with Kanikar guides in the All India Coordinated Research Project on Ethnobiology (AICRPE). This knowledge was secret and sacred to the Kanikar community With the promise of monetary gains and assurances against ‘misuse’ the Kanikar employees were persuaded to reveal the secret powers and use of the Arogyapacha fruit³	CSIR obtained information about Hoodia in 1963 in a project on wild edible plants for the South African Defence force. Colonial botanical accounts from 1796 and 1937 had already documented the use of Hoodia among the San⁴
Process of confirmation of its efficacy	Could not undertake lab-based verification of the herbal medicine; stalled due to the protests by COMPITCH (Chiapas Council of Traditional Indigenous Doctors and Midwives)¹	Lab based validation of anti-fatigue properties of the Arogyapacha^2,3	Identified and isolated non-toxic appetite suppressant active molecule in 1986, naming it P57⁴
Product development and mass production	Project stalled prior to the lab-based verification of the herbal medicine due to objections by COMPITCH¹	In 1994 scientists at TBGRI developed standardised polyherbal product—‘Jeevani’ with anti-fatigue, adaptogenic and immuno-enhancing properties^2,3 In 1996 TBGRI obtained licence for its production from the Kerala government, registering it in accordance with the Ayurvedic Formulary of India In 1995 TBGRI licensed the right to manufacture Jeevani to the private company—AVP, for 7 years, for a fee of `1 million and 2% royalty on ex-factory sales for 10 years from the date of commercial production³	Patented molecule P57 licensed to British biotechnology firm Phytopharm (1998) developing and commercialising Hoodia related products Phytopharm issued sub licences to Pfizer (1998) 2001 December clinical trials reported successful, making the drug closer to commercial availability⁴ 2002–2004, CSIR announced the development of Hoodia food supplements for weight-loss, but Pfizer withdrew in 2004 Sub-licensed then to Unilever in 2004; also withdrew in 2007⁴
Patenting	Did not get to this stage¹	TBGRI obtained an Indian process patent for product ‘Jeevani’, in 1996 but, invalid in the international market NutriScience Innovation LLC Ltd., Connecticut, USA, the US distributor for AVP, registered Jeevani as a trademark at the United States Patent and Trademark Office, AVP did not contest this infringement nor attempted to register Jeevani as a trademark in the US³ AVP did not renew the contract that expired in 2007³	CSIR patented the molecule P57 in 1996⁴

Sources: ¹Nigh (2002), ²Anuradha (1998), ³Bijoy (2007) and ⁴Wynberg and Chennells (2009).

However, in recent times indigenous communities have an increasing awareness of the tendency of corporations to monopolise products of THK-based research and the considerably large monetary gains they fetch. As a result representatives of THK-holding communities in some cases have taken issue with the unfair division of benefits and in some cases opted out of ABS contracts. There are also instances of pharmaceutical corporations retracting from the research and production venture on grounds of the non-viability of a safe and efficacious product.¹⁰ In either case, ABS arrangements are proving to be fragile entities. Of the three cases under consideration here it is only the one between the Kanikar and the Tropical Botanical Garden and Research Institute (TBGRI) that culminated in developing and manufacturing a health-enhancing product which made it to the market.

Two of the three cases (discussed in Table 2) underscore the critical role that vigilante organisations, NGOs, international civil society and the media played in informing THK holders of their rights, forcing research and commercial pharmaceutical establishments to the negotiating table and supporting THK holders in their negotiations for fair benefit.

Table 2

Involvement of THK Holders in the Three Cases of ABS Arrangements

	The Maya Indigenous People	The Kanikar Tribe	The San Indigenous People
a. Prior informed consent (PIC) from the THK holder	In 1998 PIC agreement in each of the 47 villages (46 agreed to participate) Mexico lacks a regulatory framework for bioprospecting, so PIC obtained from each individual landholder for the plants from privately owned land	No formal informed consent, but TBGRI interacted with the Kanikar informers’ panchayat but not with panchayats in other areas where Kanis were settled²	Predated the CBD. No PIC or benefit sharing agreement prior to the patenting CSIR had claimed that the San were extinct⁶; forced to negotiate by the Working Group of Indigenous Minorities of Southern Africa (WIMSA)⁴
b. Critical voices/vigilante groups	Poor representation of sections of local healers in PIC or negotiations. Supported by International non-governmental organisation—Rural Advancement Foundation International (INGO—RAFI), and others who campaigned against future bioprospecting by ICBG¹	Criticism of unilateral nature of ABS contract by the in 1995 by the Kerala Institute for Research, Training and Development of Scheduled Castes and Scheduled Tribes (KIRTADS) and Kanikar elders, healers and Kanikars from neighbouring panchayats for non-consultation and piracy²	WIMSA passed the resolution in 2001 that all benefits received from shared San heritage were to be divided among all the San Legal action against CSIR helped by bad publicity for Phytopharm and support of INGOs like Biowatch and Action Aid
c. Nature of involvement of THK holder representatives	• PROMAYA: NGO designed as part of the ICBG to represent the Maya COMPITCH was a government and NGO-supported collective of healers and midwives Refused ICBG collaboration due to the lack of government regulations for bioprospecting in Mexico	Kerala Kani Samudaya Kshema Trust formed in 1997 to share the researchers’ and 10% of the institution’s benefits initiated by the researchers in the presence of 40 Kanikar³ The Trust has nine members, all tribals including the original informers	In 2001 WIMSA informed the CSIR that they would stake a legal IPR claim⁴ March 2002 Memorandum of understanding (MoU) between CSIR and South African San Council (deputed by the WIMSA) recognising the San as the originators of knowledge and agree to principle of benefit sharing
	Later COMPITCH’s main objections were about: • the lack of satisfactory procedures of PIC and • exclusivity of the products of research¹		March 2003 CSIR and San Council sign benefit sharing agreement. San Council of South Africa discussed benefit sharing and allocations between San councils of Namibia, Botswana and South Africa and WIMSA San Hoodia Benefit Sharing Trust set up in 2005^4,6
Monetary gains	None¹	TBGRI voluntarily shared 50% of the license fee (`0.5 million) as well as half of the 2% royalty from ex-factory sales of the product for 10 years besides a compensation of `50,000 to the three Kanikar informers `650,000 was transferred to the Trust since 1999³	San were to receive 6% of CSIR royalties and 8% milestone payments that Phytopharm made to CSIR⁴
Co-ownership of the patent	None¹	None	None
Conditionalities set in the ABS contract	Did not reach this stage¹	None	In exchange for not contesting the patent the San Council demanded that compensation be provided to them Exclusive ownership of patents with CSIR⁴ San agreed to not enter any other third party agreements or have independent negotiations with the pharma companies for financial gains. In case of third party claimants the San would have to part with their share in the benefits⁴
Unintended developments of the bioprospecting and commercialisation exercises	No unanimity among the Maya about collaborating or withdrawing from the ICBG project¹ Maya now conscious of the motivations underlying research, the use of end products and impacts on their lives Greater concern and confidence to interrogate private appropriation of public goods	Illegal harvesting by traders of the Arogyapacha, plant now declared endangered³ Kanikar access to the plant now restricted; penalties for harvesting the wild plant Forest regulations stalled efforts by AVP to cultivate plant in the forest and supplement Kanikar livelihood^2,3	Illegal harvesting of the Hoodia, declared endangered Speculation in market prices, fake and illegal Hoodia derivatives in North America⁶ Hoodia Growers Association offered to share 6% of the benefits with the San (Mukuka, 2010)^4,5

Sources: ¹Nigh (2002), ²Anuradha (1998), ³Bijoy (2007), ⁴Mukuka (2010), ⁵Wynberg and Chennells (2009) and ⁶Wynberg (2010).

In sum, this analysis demonstrates that ABS mechanisms, however, favourable to original THK holder communities, are an insufficient means to protecting THK and ensuring continuing access and use of THK by its holders; thereby highlighting the need for an international instrument with more teeth than the CBD. Is the IPR regime adequate for this?

Incompatibility of IPR and THK Frameworks and the Systemic Logic of Commercial ABS

The basic premise of the IPR framework is that of individual creation of knowledge, giving rise to individual ownership of the knowledge and the right to exploit it for commercial gain for which the owner’s exclusive commercial rights are protected for a stipulated period of time. Given the collective nature of knowledge generation in systems of THK, tracing individual contributions to innovations may not always be possible and systems of THK do not fulfil the conditions of novelty given that the processes of medicinal preparation have long been well established. Hence individual patents, copyrights or joint inventorship are not viable options for protecting THK or the rights of its holders (WIPO, 2001), except for the hereditary secretly held THK. Given the local rootedness of knowledge and technologies of systems of THK, instruments of IPR regimes like geographical indicators or trademarks can at best help establish the contribution of THK holding communities or small enterprises by certifying the origin or quality of particular medicinal products. They do not however protect the knowledge per se (WIPO, 2001). In fact, the imposition of IPR regimes to THK is not only difficult because of its collective nature, but also undesirable if the characteristics and principles of THK are to be respected and considered worth promoting for sustainable development.

The commercial importance of THK-related to products leads to the selective fetishisation of this medicinal component of THK at the cost of the other non-medicinal elements, affecting the integrity of the knowledge system and its efficacy. Global commercialisation also violates the principles of THK since the concept of spatio-temporal locatedness in THK does not allow for its therapeutic regimens to be universally applicable, though its principles may be.

Folk medicine’s bottom-up knowledge generation process, personalised treatment regimens and the small scale of medicinal production based largely on locally available material has tended to keep it non-commercial. Even in the systems of codified THK, production of medicines has been more decentralised and small scale (with the role of the market limited to supply of locally unavailable raw materials), in sharp contrast to mass produced pharmaceuticals within biomedicine. Hence the notion of ‘healing as a service’ has held strong currency among practitioners, with a comparatively lower emphasis on its commercial aspect. Pharmaceuticalisation of THK over the last century, however, has promoted a commercial sector in TM as well.

In contrast, within modern biomedicine, expert knowledge produced in laboratories, removed from the natural and social context, is passed down to lay people by the experts. Practice of this top-down, reductionist knowledge now relies largely on chemical industry produced biomedical pharmaceutical products as profit generating entities. In such a system, when THK is used to extract an innovated product, the knowledge and product often lose connect with the social and ecological context and may begin to lose their holistic principles. The innovations based on the THK would complete the full cycle of knowledge–R&D–production–marketing and return to the lay community as top-down technological intervention, without incorporating the principles of THK. Besides the epistemic loss, the non-commercial healthcare returns as commercialised commodity. Further, unsustainable harvesting for mass production by industry may lead to communities even losing access to the plant resource and thereby access to practice of the THK.

Innovation of this kind also increasingly undermines the legitimacy of THK as a knowledge system. Not only is it left publicly unacknowledged as the original source, but it is also denounced by the dominant knowledge system even as the latter celebrates its own innovation. The extracted knowledge without its principles of practice and production, can even lead at times to harmful health effects, cited as evidence for further de-legitimisation. The de-legitimisation discourages the creativity and innovation of THK holders, reinforces the dominant stereotype of THK being static and obsolete, and thereby is detrimental to the THK system itself.

Now, with international recognition of the rights of TK holders, the IPR regime is being forced to offer ‘sharing’ of commercial gains with the TK holders. The dominant scientific and commercial establishment, through the IPR regime, is attempting to retain moral and cultural power by positing the THK holder as the ‘beneficiary’ while the bio-prospector becomes the innovative and enterprising ‘user’ of THK who is harnessing TK for the greater common good. This reflects a socio-political process very similar to the colonial experience of the nineteenth and twentieth centuries and is contrary to the expectations of the CBD.

Thus, the promise of minor monetary gains as ‘fair benefit sharing’ within IPR regimes is insufficient to compensate for undermining of the very essence of THK and further divesting it of its legitimacy.

Alternative Mechanisms of Access and Benefit Sharing: A Holistic Health Systems Perspective

While bio-prospecting and its use has the potential to create valuable new lines of medicinal products, access should not be allowed at the cost of acknowledgement of the original THK, of its legitimacy as valid knowledge and a decline in access to THK by the holder communities. Thus the challenge is to develop an approach that can effectively allow for such access and also supports continuity and innovation in the use of THK by its traditional holders.

Among the various forms of THK, IPR regimes can provide protection to the THK kept secret. However, with their customary rights as custodians who can use and promote the knowledge but not sell it to others, even this is questionable. If they do negotiate a transfer of knowledge, given the obvious power equation between the THK holders and the potential ‘users’, negotiated terms of exchange can rarely be fair and equitable (Sharma, 2002). Defensive protection of THK has been used for codified THK through evidence of ‘prior art’. For THK in the public domain, there is little assurance of protection against IP regimes that will be drawn upon by the pharmaceutical industry. On the other hand, entering into IP regimes, THK holders will only get drawn into the commercialised competitive world of ‘natural resources’ and their ‘exploitation’, losing their moral worldview vis-à-vis nature and THK. Since the THK worldview can potentially contribute to the evolving imagination of sustainable development, its loss will be an irreparable one to the world. So what mechanisms of its protection can be thought of in line with the cultural perspective of THK? Even when a culturally sensitive international legal instrument is adopted it will require to be supplemented with national laws and civil society vigilantism to ensure its provisions are implemented. Further, policy interventions are needed that enable and promote the continuing use and innovation by the traditional THK holders as indicatively suggested below.

Knowledge Sharing

Mutual and respectful sharing of knowledge should be the basis of designing ABS arrangements. This implies that the access be acknowledged and outcomes of ‘access and use’ of THK be shared back with the THK holders. National governments should also be required to introduce measures for legitimisation of the THK and conservation of natural resources with specific funds and mechanisms. Further, there could be a set of non-monetary benefit sharing mechanisms as suggested in the CBD and the Nagoya Protocol, where the innovations on THK by others are shared back into the community’s pool of knowledge using the concept of a ‘Knowledge Commons’ (Kothari, 2014; Scott, 2009).

Some questions that will then require resolution: Should this be at national or community level? If countries are seen as the relevant unit, then what should the national government be required to ensure as sharing knowledge back with the community? Should the THK holder community be given access to bio-technology and its use for enhancing their THK? This has been effectively demonstrated, for instance by employing spectrometry for calibrating the efficacy of medicinal plants in common use to develop standards for community practice (Birdi, 2012).

Ensuring Continuing Local Use

The continuing local use of THK will require policy inputs for ensuring local availability of medicinal plants and their inclusion in primary healthcare.

To ensure survival of plant material, industrial use of medicinal plants should be conditional on the industry employing measures that nurture and preserve them through cultivation and improving forest cover.

The databases required for defensive protection against ‘erroneous’ patents have necessarily to be in languages accessible to global patent offices. This can lead to a centralised resource of THK while local access to THK may dry up. Ensuring protection of THK at state/regional/local levels through creating publications and libraries in local languages, local dissemination through school education and mass media could provide important checks and promote continuing local use and innovation.

Policy measures to promote local health traditions in the health services through provisions such as cultivation of herbal gardens in health centre and school compounds and systemically linking them with folk healers and TM practitioners would provide access and contribute to their re-legitimsation of THK.¹¹ Institutional structures to document local THK, validate it, certify practices and practitioners as ‘prior art’, oversee conservation of the GR and oversee the operationalisation of ABS mechanisms could be set up at various levels from national to local.¹²

National law to be created as a necessary measure in the present context, such that it allows for all THKs, including the secret and diffuse, to be protected, creates grounds for judicial sanctions against misappropriation, and makes mandatory and judiciable essential measures to be taken by the state.

Vigilantism by civil society against erroneous patents is required at international level and for effective implementation of the various legal and policy mechanisms at the national, state and local levels. Official policy must promote such civil society action.

Challenges to Implementation

Any attempt to operationalise the defensive and positive protective measures will have to address some fundamental issues that remain unresolved.

Challenge of Operationalising the Clauses to Align IP with Cultural Frames and Ethics of THK

The clauses in all the three negotiating texts, for GR, TK and TCE that stipulate respecting the cultural norms and practices as well as moral rights associated with the TK will need to be elaborated in specifics (WIPO, 2014, 2016a, 2016b). This appears to be the most fundamental issue from the point of view of THK systems that remains unaddressed in the negotiations as of now. The report of WIPO’s fact-finding missions in 1998–1999 (WIPO, 2001) and a WIPO study on customary law and TK (WIPO, 2013) put together the perspectives of the TK holders. Yet there is still much work required to spell out its practical implications in full.

The WIPO study (2013) differentiates the possible contribution of customary law into procedural dimensions as in negotiation and conflict resolution, and substantive obligations. ‘…from a procedural point of view, customary law may govern how consultations should be undertaken, how disputes should be settled, how competing claims should be reconciled, and what penalties or remedies should be applied’(WIPO, 2016b, p. 17).

The substantive obligations relate to: ‘how knowledge and cultural expressions should be maintained and disseminated, as part of how the community conceives of itself’ (WIPO, 2016b, p. 12). When THK is used under an IP regime outside its traditional location merely for extraction of a product, it does not constitute a cultural diffusion, only a material appropriation. Any fair and equitable knowledge sharing must at least be related to respect for principles of the knowledge system from which the artefact is extracted. Just as a scientific temper is considered essential for good ‘science’, use of THK has to be coupled with a holistic ethos for its creativity and continuity.

Challenges of Establishing Boundaries in Raw Material and Knowledge on Wild Plants

Establishing clear and enduring boundaries of common property resources is important for the sustainability of sharing arrangements. However, medicinal plants growing in the wild and their associated local knowledges do not have such clear boundaries. Thus, negotiating with representatives across geographical diversities of THK owning communities is particularly salient in the context of obtaining prior informed consent and benefit sharing.

Challenges of Representation and Prevailing Social Hierarchies

How is representation of THK holder communities to be identified, given the heterogeneity within and between communities? When identifying a community for the purposes of informed consent for benefit sharing it is important to specify whether the ‘community’ in the specific instance is a legal entity, or a face-to-face social or residential unit or a formation constructed primarily to reap potential gains. The basis for its current solidarity must be identified to ensure representativeness and protection.

Second, can the nation state represent THK holder communities? Can the fiduciary role of the state be accepted as an adequate protection, given that in the three examples analysed, the research institutions were all public agencies?

Third, even if one manages to delineate the community that may share the benefits, there still remains the problem of representation of that community. What should be done in the case of undemocratic traditional leaderships, for instance in gender roles related to THK?

Challenge of Prevailing Political and Economic Policies

The biggest threat to any effective protection to THK, however, are the larger economic policy approaches of contemporary times that are displacing the indigenous and rural populations from their traditional geographies, destroying their ecosystems, their community and way of life. That the same international institutions and national governments are simultaneously working on both the economic policies and the protection of THK may seem paradoxical. However, it needs to be acknowledged that the serious consideration of an international legal instrument on protection of TK such as being proposed by the WIPO-IGC is an outcome of consistent assertion of the dignity, identity and rights of marginalised peoples and knowledge systems. The contestation is illustrative of the nature of democratic processes that challenge prevailing power equations, and underline the need for building democratic pressures in both the national and international spheres.

Conclusion

While the IPR regime is a reality that has to be contended with, it is unlikely to provide protection for THK in the comprehensive way that would be meaningful to its present holders and users. Therefore, the interface with the IPR regime should only be a defensive strategy to protect against exploitation by the modern patent system and biopiracy. Additionally, the international instrument should set out the responsibilities of any user of THK towards protection and augmentation of the associated plant resources and mandatory feedback of the innovations on THK into a ‘knowledge commons’.

Simultaneously, at the national level there is need to carefully design positive standalone (sui generis) mechanisms that would be able to protect the interests of the knowledge holders, including protection of all forms of THK and creation of mechanisms for a knowledge commons. Finally, strengthening the politics of democratisation of knowledge, including a holistic perspective for health systems development, will be critical.

Footnotes

Notes

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