The WHO CA+ Discussions on Pathogen Access and Benefit Sharing: State of Play
By Nirmalya Syam
This brief explores the scope of a World Health Organization (WHO) pathogen access and benefit-sharing (PABS) mechanism as a possible outcome of the negotiations ongoing in the WHO Intergovernmental Negotiating Body (INB) for a WHO Convention, Agreement or other Instrument (WHO CA+) for pandemic prevention, preparedness, response and recovery (PPRR). After seven sessions of the INB, substantial differences remain between developed and developing countries on the PABS system. While the text contains specific obligations on rapid sharing of pathogen material and genetic sequence information reflective of the primary interest of developed countries to get such access outside the framework of the Nagoya Protocol to the Convention on Biological Diversity through a specialized WHO instrument such as the PABS system under the WHO CA+, the current text continues to be weak in terms of effectively operationalizing fair and equitable-benefit sharing. To that end, it is critical that detailed provisions on standard material transfer agreements, data access relating to their genomic sequence information and specific obligations on monetary and non-monetary benefit-sharing by recipients of pathogen material and sequence information are included in the provisions establishing the PABS system. Therefore, it is important that the proposals that have been made in this regard by developing countries are incorporated in the draft negotiating text.
Movement Forward on ABS for the Convention on Biological Diversity: Bounded Openness Over Natural Information
by Joseph Henry Vogel, Manuel Ruiz Muller, Klaus Angerer, and Christopher May
“Access to genetic resources” and “fair and equitable sharing of benefits arising [from their] utilization” is the third objective of the 1992 United Nations Convention on Biological Diversity (CBD). The expression is included in the full title of the 2010 Nagoya Protocol (NP). Neither agreement defined “material” in the phrase “genetic material” which resulted in misinterpretation that the object of access for R&D is tangible. Unfairness ensues: competition among provider Parties leads to the elimination of economic rents, which is desirable for tangibles but undesirable for intangibles. Once interpreted as natural information, the economics of information justifies a Global Multilateral Benefit-Sharing Mechanism (GMBSM) (Article 10 NP) which collects and distributes rents on value added to genetic resources. “Bounded openness over natural information” is the modality proposed for the GMBSM. The Executive Secretary of the United Nations Secretariat of the CBD recognized the argument in the 2021 Note “Digital Sequence Information on Genetic Resources”.
SOUTH CENTRE STATEMENT FOR CBD SBSTTA AGENDA ITEM ON BIODIVERSITY AND HEALTH
The draft Global Action Plan on Biodiversity and Health should support mainstreaming biodiversity and health linkages in national policies, strategies, programmes and accounts.
The South Centre suggests the following amendments to the draft Action Plan on Biodiversity and Health to ensure consistency with the objectives of the Convention and the Nagoya Protocol with regard to fair and equitable benefit-sharing…
Strengthening WHO for Future Health Emergencies while Battling COVID-19: Major Outcomes of the 2021 World Health Assembly
By Nirmalya Syam and Mirza Alas
The 74th World Health Assembly of the World Health Organization (WHO) took place in May 2021 in a time when developing countries had to confront a substantial surge in COVID-19 infections and fatalities, while continuing to face inadequate access to vaccines. Meanwhile, the majority of the global supplies were secured by a few rich countries, ignoring the pleas of the WHO Secretariat. However, even though discussions around the COVID-19 response and strengthening emergency preparedness and response dominated the Assembly, WHO Member States could not achieve any concrete outcome to addressing the question of equitable access to vaccines and other health technologies for COVID-19. In this context, this policy brief describes some of the major outcomes of the Assembly.
Statement by the South Centre to the Third meeting of the Open-Ended Working Group on the Post 2020 Global Biodiversity Framework (GBF)
The South Centre, the intergovernmental think tank of developing countries based in Geneva, is pleased to participate in the third meeting of the Open-Ended Working Group on the Post 2020 Global Biodiversity Framework (GBF). There is a lot of work to be done until COP-15. The new draft of the GBF improves on the previous version, yet several areas require significant improvements.
South Centre Statement to the formal meeting of SBSTTA 24
Agenda Item 3: Post 2020 GBF
Subsidiary bodies of the Convention on Biological Diversity (CBD) are formally meeting to advance the Post 2020 Biodiversity Framework. A dedicated funding mechanism for the CBD and mechanism for technology transfer and capacity building should be part of the framework. Read the SC statement.
The Proposed Pandemic Treaty and the Challenge of the South for a Robust Diplomacy
By Obijiofor Aginam
The motivation for a pandemic treaty is infallible because of the ‘globalization of public health’ in a rapidly evolving interdependence of nations, societies, and peoples. Notwithstanding the lofty purposes of the proposed pandemic treaty as a tool for effective cooperation by member-states of the WHO to address emerging and re-emerging disease pandemics in an inter-dependent world, the proposal nonetheless raises some structural and procedural conundrums for the Global South. The negotiation of a pandemic treaty should, as a matter of necessity, take into account the asymmetries of World Health Organization member-states and the interests of the Global South.
Misappropriation of Genetic Resources and Associated Traditional Knowledge: Challenges Posed by Intellectual Property and Genetic Sequence Information
By Nirmalya Syam and Thamara Romero
Improper acquisition of genetic resources (GRs) and associated traditional knowledge (TK) without prior informed consent and on mutually agreed terms, in accordance with national laws of the country providing the GR and associated TK, as well as without any fair and equitable sharing of the benefits derived from their utilization, has been a significant concern for developing countries. Intellectual property (IP) rights can serve as one of the means of such misappropriation. One of the mechanisms sought by developing countries to prevent it consists in the establishment of an effective multilateral legal mechanism for defensive protection against misappropriation, primarily through the introduction of a mandatory disclosure requirement about the source and country of origin of such resources in intellectual property right (IPR) applications. These negotiations have been taking place in different fora. However, there is an increased sense of frustration due to the lack of progress in achieving consensus during the last twenty years. Meanwhile, new modes of misappropriation of GRs are evolving through the use of genetic sequence information and data of GRs, and by applying technological developments in synthetic biology. This paper discusses the use of IP and genetic sequence information and data as modes of misappropriation of GRs and associated TK and the deficits of the current international legal framework in preventing such misappropriation. This paper also maps the state of play of the ongoing negotiations in the context of these issues in different fora, and, in conclusion, proposes possible alternative approaches for addressing these pressing issues at the multilateral level.
WIPO Negotiations for an International Legal Instrument on Intellectual Property and Genetic Resources
By Nirmalya Syam
Over the past few years, Member States of the World Intellectual Property Organization (WIPO) have engaged in negotiations for concluding an international legal instrument on intellectual property and genetic resources. While developing countries have a major interest in securing through this instrument a mandatory requirement for applicants of IP rights over innovations that utilize genetic resources or associated traditional knowledge to disclose their source or origin, certain developed countries that are major markets for such products are absolutely opposed to recognizing the disclosure requirement as an objective of the legal instrument under negotiation. Other developed countries are agreeable to a disclosure requirement with a narrow scope, broad exceptions, and weakened remedies against non-compliance. This Policy Brief analyses the current state of play in the negotiations considering the different positions as reflected in the draft negotiating text, as well as a proposal by the Chair of the WIPO intergovernmental committee where the negotiations are taking place, to bridge the difference and take the negotiations forward. This brief concludes that any meaningful international legal instrument on IP and GRs in WIPO must recognize the fundamental issue of misappropriation of GRs through the IP system that should be resolved through a mandatory disclosure requirement as the principal mechanism. It would also be critical to ensure that the WIPO instrument is coherent with other related international legal instruments such the Convention on Biological Diversity, the Nagoya Protocol on access and benefit-sharing; specialized instruments like the FAO Plant Treaty as well as related mechanisms or fora like the WHO (on use of pathogens as a genetic resource) and the United Nations Convention for the Law of the Sea (UNCLOS) negotiations on marine genetic resources beyond areas of national jurisdiction.
The Nagoya Protocol International Access and Benefit Sharing Regime
By Viviana Munoz Tellez
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity entered into force in October 2014. Ten years have now passed since the adoption of the Protocol by the Parties to the Convention on Biological Diversity, now with 129 Parties. The Protocol requires countries to set up access and benefit sharing rules and procedures for the Protocol’s implementation at the national level. This policy brief describes the main characteristics of the Protocol and makes recommendations for countries to advance in its implementation. Importantly, the Protocol’s language empowers countries with considerable policy space for the design of domestic access and benefit-sharing rules.
Today the judicial authority may be faced with balancing patent rights and patients’ rights or right to life. It shall use all the tools at its command and innovate if necessary, but shall rule in favour of life.
Digital Sequence Information (DSI) and national measures: approaches and perspectives
By Jorge Cabrera Medaglia
Digital sequence information (DSI, or genetic sequence data) is an emerging aspect of synthetic biology which involves certain functional genetic sequences being shared by different means. The genetic sequences from plants, animals or micro-organisms could be used to support conservation and sustainable use of biological diversity, to develop and commercialize new products and processes, or for other purposes. The regulation of the use of DSI for both commercial and non-commercial entities may have huge implications for the access and benefit-sharing (ABS) regimen established in the international instruments, ongoing processes and regional and national legislation that implement these conventions. International guidance is needed to promote a coordinated approach to secure fair and equitable sharing of benefits while avoiding a negative impact on the non-commercial benefits arising from the genetic data.