Overcoming epistemic injustices in the biomedical study of ayahuasca: Towards ethical and sustainable regulation

Epistemic Authority ◽

Double Blind

After decades of biomedical research on ayahuasca's molecular compounds and their physiological effects, recent clinical trials show evidence of therapeutic potential for depression. However, indigenous peoples have been using ayahuasca therapeutically for a very long time, and thus we question the epistemic authority attributed to scientific studies, proposing that epistemic injustices were committed with practical, cultural, social, and legal consequences. We question epistemic authority based on the double-blind design, the molecularization discourse, and contextual issues about safety. We propose a new approach to foster epistemically fair research, outlining how to enforce indigenous rights, considering the Brazilian, Peruvian, and Colombian cases. Indigenous peoples have the right to maintain, control, protect, and develop their biocultural heritage, traditional knowledge, and cultural expressions, including traditional medicine practices. New regulations about ayahuasca must respect the free, prior, and informed consent of indigenous peoples according to the International Labor Organization Indigenous and Tribal Peoples Convention no. 169. The declaration of the ayahuasca complex as a national cultural heritage may prevent patenting from third parties, fostering the development of traditional medicine. When involving isolated compounds derived from traditional knowledge, benefit-sharing agreements are mandatory according to the United Nations’ Convention on Biological Diversity. Considering the extremely high demand to treat millions of depressed patients, the medicalization of ayahuasca without adequate regulation respectful of indigenous rights can be detrimental to indigenous peoples and their management of local environments, potentially harming the sustainability of the plants and of the Amazon itself, which is approaching its dieback tipping point.

The Rooibos Benefit Sharing Agreement–Breaking New Ground with Respect, Honesty, Fairness, and Care

Cambridge Quarterly of Healthcare Ethics ◽

10.1017/s0963180119001075 ◽

2019 ◽

Vol 29 (2) ◽

pp. 285-301

Author(s):

DORIS SCHROEDER ◽

ROGER CHENNELLS ◽

COLLIN LOUW ◽

LEANA SNYDERS ◽

TIMOTHY HODGES

Keyword(s):

Traditional Knowledge ◽

Indigenous Peoples ◽

Biological Diversity ◽

Indigenous Communities ◽

Benefit Sharing ◽

Global Policy ◽

Nagoya Protocol ◽

Major Benefit ◽

Government Leadership

AbstractThe 1992 Convention on Biological Diversity (CBD) and its 2010 Nagoya Protocol brought about a breakthrough in global policy making. They combined a concern for the environment with a commitment to resolving longstanding human injustices regarding access to, and use of biological resources. In particular, the traditional knowledge of indigenous communities was no longer going to be exploited without fair benefit sharing. Yet, for 25 years after the adoption of the CBD, there were no major benefit sharing agreements that led to significant funding streams for indigenous communities. This changed with the signing of the Rooibos Benefit Sharing Agreement in South Africa, described in this paper. As the authors report, the Rooibos Agreement is a superlative in two respects. It is the biggest benefit sharing agreement between industry and indigenous peoples to date. It is also the first industry-wide agreement to be formed in accordance with biodiversity legislation. This article is a co-production between traditional knowledge holders, the lawyer who represented their interests, the Co-Chair of the Nagoya Protocol negotiations, and an ethicist who analyzed the major challenges of this historic agreement. With no precedent in the benefit sharing world, the agreement stands as a concrete example of the ‘art of the possible.’ Although the rooibos case is unique in a number of aspects, the experience offers many transferable insights, including: patience; incrementalism; honesty; trust; genuine dialogue; strong legal support; a shared recognition that a fair, win-win deal is possible; government leadership; and unity amongst indigenous peoples. Such ingredients of success can apply well beyond southern Africa.

Protecting Traditional Knowledge Holders' Interests and Preventing Misappropriation—Traditional Knowledge Commons and Biocultural Protocols: Necessary but Not Sufficient?

International Journal of Cultural Property ◽

10.1017/s0940739112000252 ◽

2012 ◽

Vol 19 (3) ◽

pp. 401-422 ◽

Cited By ~ 5

Author(s):

Krishna Ravi Srinivas

Keyword(s):

Informed Consent ◽

Traditional Knowledge ◽

Biological Diversity ◽

Indigenous Communities ◽

Benefit Sharing ◽

Nagoya Protocol ◽

Prior Informed Consent ◽

Knowledge Commons

AbstractThe experience of the indigenous communities regarding access and benefit sharing under the national regimes based on provisions of Convention on Biological Diversity and Bonn Guidelines has not been satisfactory. The communities expect that noncommercial values should be respected and misappropriation should be prevented. Some academics and civil society groups have suggested that traditional knowledge commons and biocultural protocols will be useful in ensuring that while noncommercial values are respected, access and benefit sharing takes place on conditions that are acceptable to the communities. This proposal is examined in this context in the larger context of access and benefit sharing under the Convention on Biological Diversity and implementing prior informed consent principles in access and benefit sharing. This article examines knowledge commons, provides examples from constructed commons in different sectors and situates traditional knowledge commons in the context of debates on commons and public domain. The major shortcomings of traditional commons and bicultural protocol are pointed out, and it is suggested that these are significant initiatives that can be combined with the Nagoya Protocol to fulfill the expectations of indigenous communities.

Beyond Unbridled Optimism and Fear: Indigenous Peoples, Intellectual Property, Human Rights and the Globalisation of Traditional Knowledge and Expressions of Folklore: Part II

International Community Law Review ◽

10.1163/18719732-12341269 ◽

2014 ◽

Vol 16 (1) ◽

pp. 3-37

Author(s):

Caroline Joan S. Picart ◽

Marlowe Fox

Keyword(s):

Human Rights ◽

Intellectual Property ◽

Traditional Knowledge ◽

Indigenous Peoples ◽

Biological Diversity ◽

Nagoya Protocol ◽

Trade Law ◽

International Trade Law ◽

Traditional Cultural Expressions

Abstract In Part I of this two-part article, we explained why western assumptions built into intellectual property law make this area of law a problematic tool, as a way of protecting traditional knowledge (tk) and expressions of folklore (EoF) or traditional cultural expressions (tce) of indigenous peoples. Part II of this article aims to: 1) provide a brief review of the Convention on Biological Diversity (cbd) and the Nagoya Protocol, and examine the evolution of the intellectual property rights of indigenous peoples from the Agreement on Trade Related Aspects of Intellectual Property (trips Agreement) to the cbd to the Nagoya Protocol; and 2) examine possible core principles, inducted (rather than deduced) from actual practices already in place in the areas of patents, copyrights, and trademarks in relation to protecting tk and EoF. These explorations could allow for discussions regarding indigenous peoples, human rights and international trade law to become less adversarial.

Power Relations in the Traditional Knowledge Debate: A Critical Analysis of Forums

International Journal of Cultural Property ◽

10.1017/s0940739111000130 ◽

2011 ◽

Vol 18 (2) ◽

pp. 143-178 ◽

Cited By ~ 2

Author(s):

Charles Kamau Maina

Keyword(s):

Traditional Knowledge ◽

Indigenous Peoples ◽

Biological Diversity ◽

Indigenous Communities ◽

World Intellectual Property Organization ◽

Policy Outcomes ◽

United Nations General ◽

The World ◽

International Decade

AbstractAn ongoing debate on the protection of traditional knowledge was prompted by the United Nations General Assembly declaration of the International Decade of the World's Indigenous Peoples in 1995 and the declaration of the Second International Decade in 2004. These two declarations challenged governments and the international community to address, nationally and internationally, issues that affect indigenous communities. One such issue is the protection of traditional knowledge. The three key international multilateral forums that are debating traditional knowledge issues are the World Intellectual Property Organization, the World Trade Organization, and the Convention on Biological Diversity. Using a political economy framework, this study analyzes the policymaking processes and mandates of the three multilateral forums in order to highlight stakeholders' levels of involvement in these processes. The study found that the multilateral forums' power structures, mandates, and decision-making processes disadvantage indigenous peoples and hinder their full participation in the forums' processes. The study recommends establishing a forum that would take into account indigenous peoples' worldviews; otherwise policy outcomes from these discussions will probably disadvantage indigenous peoples.

Positive Protection: Protecting Genetic Resources Related to Traditional Knowledge in Indonesia

FIAT JUSTISIA ◽

10.25041/fiatjustisia.v11no2.985 ◽

2018 ◽

Vol 11 (2) ◽

pp. 122

Author(s):

Rohaini Rohaini ◽

Nenny Dwi Ariani

Keyword(s):

Developing Countries ◽

Intellectual Property ◽

Genetic Resources ◽

Traditional Knowledge ◽

Biological Diversity ◽

Patent Law ◽

Intellectual Property Right ◽

Benefit Sharing ◽

International Pressure

Genetic Resources is a foundation of human life, as a source of food, industrial raw materials, pharmaceuticals, and medicines. From its utilization may provide a financial benefit to the provider and the user of it. Unfortunately, most of it obtained from developing countries through biopiracy, including Indonesia. Furthermore, in the early 1980s, access and benefit sharing (ABS) to genetic resources became an international issue. It leads to the adoption of the Convention on Biological Diversity (CBD) in 1992. However, since it was approved, the whole ideas of excellence of it could not be implemented, a problem on it still arises. Intellectual property right laws, in certain aspects, are possible for using to protect traditional knowledge from their utilization. However, at the same time, intellectual property regime also becomes “a tool” to legitimate of biopiracy practices. Due to massive international pressure, mostly in developing countries, it proposes two kinds of protections, which are positive protection and defensive protection. This paper will examine one of it, which is positive protection. By using the normative method and qualitative approach, this paper identified at least two kinds of positive protections that we can develop to protect genetic resources related to traditional knowledge, which are optimizing the patent law and developing the sui generis law. Furthermore, it can be done by some revision by adding new substances, an improvement on the articles, or even by doing the deletion on certain articles. Moreover, in order to develop the sui generis law, it identified several minimum elements that shall be contained on it, inter alia: the purposes of protection; scope of protection; criteria of protection; the beneficiaries of protection: the holder of traditional knowledge; the kind of rights to be granted; how the rights acquired; how to enforce it; how the rights lost or expired; and dispute resolution. Keywords: Positive Protection, Genetic Resources, Traditional Knowledge.

Awareness of the Convention on Biological Diversity and provisions regarding access and benefit sharing among multiple stakeholder groups in Bhutan

Oryx ◽

10.1017/s0030605318000819 ◽

2019 ◽

Vol 54 (5) ◽

pp. 735-742

Author(s):

Sonam Wangyel Wang ◽

Woo Kyun Lee ◽

Jeremy Brooks ◽

Chencho Dorji

Keyword(s):

Rural Communities ◽

Traditional Knowledge ◽

Biological Diversity ◽

National Level ◽

Benefit Sharing ◽

Structured Interviews ◽

Nagoya Protocol ◽

Stakeholder Groups

AbstractAs part of the Convention on Biological Diversity (CBD), the Nagoya Protocol on Access and Benefit Sharing calls for ‘fair and equitable sharing of benefits’ derived from the use of genetic resources and traditional knowledge. However, implementation of the Convention and the Nagoya Protocol has been challenged by the inadequacies of existing policies, lack of national-level frameworks, and inadequate knowledge among stakeholders. We used focus group meetings and structured interviews with rural communities, government representatives, researchers and Members of Parliament in Bhutan to collect data on awareness, knowledge and perceptions of components of the CBD related to access and benefit sharing. Our study indicated generally low levels of awareness about most components of the Convention, particularly among rural residents. Although local people in rural communities feel that benefits derived from local biological resources and traditional knowledge should be shared, there is uncertainty about who owns these resources. These results indicate that there is an urgent need to develop educational and awareness programmes, using a variety of media, to target particular stakeholder groups, with emphasis on residents in rural communities. This could empower local communities to participate meaningfully in decision-making processes to develop Bhutan's national access and benefit sharing framework, and to allow them to benefit from the conservation and sustainable use of local resources.

Chaper 7 Shaping the Convention on Biological Diversity: The Rising Importance of Indigenous Peoples within the Nagoya Protocol on Access and Benefit-Sharing

Non-State Actors and International Obligations ◽

10.1163/9789004340251_008 ◽

2018 ◽

pp. 126-139

Author(s):

Federica Cittadino

Keyword(s):

Indigenous Peoples ◽

Biological Diversity ◽

Benefit Sharing ◽

Nagoya Protocol

Tackling biopiracy in Southeast Asia: the need for a legally binding regional instrument

Asia Pacific Journal of Environmental Law ◽

10.4337/apjel.2020.01.03 ◽

2020 ◽

Vol 23 (1) ◽

pp. 74-98

Author(s):

Jinyup Kim

Keyword(s):

Southeast Asia ◽

Traditional Knowledge ◽

Biological Diversity ◽

Benefit Sharing ◽

Nagoya Protocol ◽

Biological Resources ◽

Knowledge Based ◽

Consistent Manner

Biopiracy, largely defined as misappropriation of biological resources and associated traditional knowledge, has occurred all around the world. Southeast Asia, one of the world's biodiversity hotspots, has been a victim of biopiracy in a number of cases across the region. Despite the high occurrence of the exploitation of resources, the region has not responded to the problem of biopiracy adequately. One of the most important reasons for this lack of response to biopiracy is the absence of a legally binding regional instrument(s). However, considering that (i) biopiracy does not respect national borders, (ii) most of the Southeast Asian states have ratified the Nagoya Protocol to the Convention on Biological Diversity, and (iii) soft law instruments adopted so far have failed to tackle biopiracy, this article argues that a legally binding regional regime should be established to tackle biopiracy in a consistent manner. Following an analysis of a number of biopiracy cases in the region, this article discusses why a legally binding instrument(s) is necessary. It suggests how to improve the current regional instruments pertaining to access and benefit sharing in relation to biological resources and associated traditional knowledge, based on the analysis of instruments adopted to tackle biopiracy in other regions.

The Patentability of Maori Traditional Medicine and the Morality Exclusion in the Patents Act 1953

Victoria University of Wellington Law Review ◽

10.26686/vuwlr.v32i1.5898 ◽

2001 ◽

Vol 32 (1) ◽

pp. 255 ◽

Cited By ~ 3

Author(s):

Susan Young

Keyword(s):

Intellectual Property ◽

Property Rights ◽

Traditional Medicine ◽

Traditional Knowledge ◽

Intellectual Property Rights ◽

Biological Diversity ◽

Patent Law ◽

International Obligations

Many indigenous peoples, including Maori, are offended by third parties 'appropriating' their traditional knowledge by means of intellectual property rights, such as patents. The author first surveys international debate about indigenous intellectual property rights in connection with the patenting of traditional indigenous medicine. The author examines the role of morality in New Zealand patent law and how this fits in with New Zealand's international obligations under the World Trade Organisation's TRIPs agreement and the Convention on Biological Diversity. The author examines whether the patenting of Maori traditional medicine can be prevented under the morality exclusion in the Patents Act 1953 and outlines five arguments which might be used to justify various levels of intervention in the patenting process in order to protect Maori control over their traditional knowledge.

JUSTICE, EQUITY AND BENEFIT-SHARING UNDER THE NAGOYA PROTOCOL TO THE CONVENTION ON BIOLOGICAL DIVERSITY

The Italian Yearbook of International Law Online ◽

10.1163/22116133-90000076a ◽

2015 ◽

Vol 24 (1) ◽

pp. 113-141

Author(s):

Elisa Morgera

Keyword(s):

Environmental Justice ◽

Genetic Resources ◽

International Law ◽

Traditional Knowledge ◽

Biological Diversity ◽

Benefit Sharing ◽

Legal Concept ◽

Nagoya Protocol ◽

Case Basis

This article attempts to bridge the multi-disciplinary debate on environmental justice and the traditional international legal debate on equity with a view to analysing the legal concept of benefit-sharing in international law. To that end, the article uses the Nagoya Protocol to the Convention on Biological Diversity as a testing ground for: (i) unpacking different notions of justice that may be pursued through fair and equitable benefit-sharing from access to genetic resources and the use of associated traditional knowledge; and (ii) relating different notions of justice to the different functions that equity plays in international law. The aim is to test the potential wider application of linking a pluralist notion of environmental justice to different functions of equity in other areas of international law that refer to benefit-sharing. It is argued that this helps systematically unveil implicit legal design choices in relation to the pursuit of justice through international lawmaking, and interpret international legal instruments in ways that can contribute to negotiate concrete understandings of justice on a case-by-case basis.