摘要：Many potentially useful medicines arise from developing countries’ biodiverse environments and indigenous knowledge. However, global intellectual property rules have resulted in biopiracy, raising serious ethical concerns of environmental justice, exploitation, and health disparities in these populations. Furthermore, state-based approaches have not led to adequate biodiversity protection, management, or resource sharing, which affect access to lifesaving drugs. In response, country delegates adopted the Nagoya Protocol, which aims at promoting biodiversity management, combating biopiracy, and encouraging equitable benefits sharing with indigenous communities. However, the effectiveness of this framework in meeting these objectives remains in question. To address these challenges, we propose a policy building on the Nagoya Protocol that employs a World Health Organization–World Trade Organization Joint Committee on Bioprospecting and Biopiracy. BIOMEDICAL RESEARCH AND the discovery and development of medicines often focus on naturally occurring materials for products and applications. Searching for such compounds in diverse environments (e.g., rainforests, deserts, and hot springs) is deemed “bioprospecting.” 1,2 Bioprospecting has resulted in key advances (e.g., making polymerase chain reaction processes stable for medical application) and has led to life-saving advances in medicines and population health. 1 It has also established economic value for these resources and supported biodiversity conservation and indigenous communities. 2 However, biopiracy occurs when bioprospecting is used to appropriate knowledge and biodiversity resources to gain exclusive use through intellectual property rights (IPRs) without benefits for indigenous populations. 2,3 In addition to raising serious environmental justice issues, biopiracy adversely affects the health of local populations that fail to benefit from economic and medical gains derived from the biodiversity and indigenous knowledge that originated in their communities. The global health consequences of biopiracy include lack of access to medicines, failure to compensate for valuable traditional knowledge, and depletion of biodiversity resources that are needed by indigenous communities for their own ethnomedicine and health care. These impacts are particularly problematic because the health of these communities can be poor. 4 Because of the global nature of bioprospecting, biopiracy, and biodiversity, effective management—including environmental protection and sustainable development approaches—may be best performed through global governance. Global governance, however, has been ineffective in protecting biodiversity from biopiracy. Global IPR rules comprise domestic, multilateral, and supranational systems that establish minimum intellectual property standards. These global IPR systems focus on patent systems and private economic development under the World Trade Organization (WTO) TRIPS regime (Agreement on Trade-Related Aspects of Intellectual Property Rights) and on activities of the World Intellectual Property Organization. However, they have failed to protect indigenous rights, promote access to life-saving drugs, prevent biopiracy, or provide for responsible biodiversity development. 5–9 Governance relies on market forces and state entities of independent governments within a defined territory, which preclude the participation and protection of indigenous communities (both in developed and developing countries) that comprise groups of diverse social self-identification. This traditional state-focused governance model has not created incentives for developing countries to invest in adequate conservation, and thus, biodiversity resources in these countries are in danger of being depleted. 4,6 In response, in October 2010, the UN Convention on Biodiversity adopted the Nagoya Protocol, which attempts to protect biodiversity and sets rules on how nations access and share biodiversity benefits. 10 It successfully introduces key components of resource sharing of biodiversity benefits by establishing a framework for norms and rules that may be implemented by member states in the future. However, the protocol does not adequately address several concerns, including the following: a forum for indigenous peoples to adjudicate biopiracy claims, strong penalties to create disincentives for biopiracy, ensured indigenous access to developed drugs, promotion of the planning and implementation of sustainable biodiversity conservation and investment in public health infrastructures in developing countries, and adequate promotion of public–private partnerships (PPPs) that can leverage resources from both public and private stakeholders. We therefore propose a policy employing a joint health–economics committee, a World Health Organization (WHO)–WTO Joint Committee on Bioprospecting and Biopiracy, to address these equity issues and promote sustainable and responsible global governance in biodiversity management.
