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TWN
Info Service on Biodiversity and Traditional Knowledge (Mar24/04) Geneva, 5 March (TWN) – In a dramatic turn of events on Wednesday morning (28 February), the International Negotiating Body Chair, Dr Viroj Tangcharoensathien of Thailand took the unprecedented step of suspending the pathogen access and benefit sharing (PABS) sub-group meeting, in response to mounting concerns voiced by developing countries regarding the proposed PABS text. The PABS text was circulated to Member States late evening on Tuesday, 27 February. Diplomatic sources revealed that the Africa Group deemed the proposal as a non-starter, signalling widespread dissatisfaction among developing countries. Another delegate noted that the Africa Group representative articulated sentiments shared by other developing nations regarding the inadequacies of the proposed PABS text. Following the suspension, there were separate discussions held among groups of developed and developing countries, indicating a stark division in perspectives. Approximately an hour later, the sub-group reconvened, albeit against a backdrop of lingering tensions and unresolved issues. The Africa Group and Group of Equity stressed that the Chair’s text had “not yet met our expectations” (of the 2 groups). The developing countries put forward 5 principles that they want to be reflected in the text before it would be acceptable to them. These are: 1. Equal footing between access and benefit sharing, as compulsory obligations for rapid and timely access to pathogens can only be accepted if there are equally strong compulsory obligations for sharing monetary and non-monetary benefits. 2. Genetic sequence data is an important resource and should not be treated separately from the biological material. 3. Access to pathogens and genetic sequence data should be through PABS system, minimizing the free riders outside the PABS system. 4. There have to be clear commitments on benefit sharing, especially during pandemic times. 5. Traceability and user registration with respect to accessing the PABS system. The Africa Group also categorically stated that the terms and conditions of the standard access and benefit-sharing contracts, data access or use contracts, as well as the contracts between WHO and laboratories and databases, should be determined by the States Parties to the PABS, and not by the WHO Secretariat. Gaps, Uncertainties and Flaws in the Chair Text on PABS The Chair’s text proposal mainly incorporates ideas introduced by developed countries into the negotiations while overlooking the comprehensive proposals made by developing countries for establishing an effective, accountable, and transparent PABS system. Consequently, numerous flaws and loopholes have emerged in the provisions addressing access to pathogens and genetic sequence data, intellectual property, benefit sharing, as well as in implementation and governance. The deliberate side-lining of PABS proposals from developing countries has unfortunately become the standard operating procedure of the sub-group Chair and Facilitators. These proposals were initially disregarded when the design elements of a PABS system were presented by the Chair and Facilitators on 12 February and reiterated on 14 February. [Note: See “Attempts to side-line Africa and Equity Group proposal on the PABS System” at https://www.twn.my/title2/health.info/2024/hi240205.htm” Responding to this blatant disregard for the interests of developing countries 70 civil society organizations, predominantly from the Global South, have issued a “Global Call for An Equitable Pathogens Access and Benefit-Sharing System in the Pandemic Instrument”. In a letter addressed to the Chair and Facilitators of the Sub-group on the PABS system, they expressed concerns over the side-lining of the proposal of Africa Group/Group of Equity. They call on the Chair and the Facilitators “to accept the PABS proposal by the Africa Group and Group of Equity and reflect them as key elements of the PABS system and ensure that the process is fair and not biased against the interests and proposals of developing countries and their call for the operationalization of equity.” Access to physical pathogen material and corresponding GSD The Chair’s text proposed that when a Party has access to a pathogen with pandemic potential within its territory, the Party shall share with WHO-coordinated laboratory networks (CLNs) the physical-biological material and with WHO-recommended databases (SDBs), the genetic sequence data (GSD). The text entrusts WHO with developing “key attributes and terms of reference for the CLNs and SDBs with arrangements to notify the users of biological materials and GSD of the benefit sharing provisions of the PABS system”. It further states that each Party may also share such biological materials and GSD outside the SDBs and entities outside CLNs. The approach taken by the Chair differs significantly from the proposals of developing countries, presented more than a year ago and reiterated in an earlier INB session. The Africa Group and Group of Equity have repeatedly underscored that access to physical biological materials has to be subject to standard legally binding terms and conditions agreed upon among WHO Members. Such a precedent exists in the context of the Pandemic Influenza Preparedness Framework (PIP Framework), whereby the sharing of biological materials with WHO-designated laboratories and outside the laboratories is subject to a standard material transfer agreement (SMTA) negotiated by WHO Members. In the case of GSD, developing countries have before and during the 8th meeting of the INB repeatedly stressed the importance of access to data being subject to user registration and acceptance of data user agreement (legally binding terms and conditions digitally accepted through a click-wrap agreement) as well as the establishment of a WHO sequence database accountable to WHO Member States. Unfortunately, the proposed text of the Chair disregarded these crucial concepts. The United States, the European Union, Germany, the United Kingdom, and France apparently opposed the idea of user registration, arguing that it would impact the current structure of GSD sharing. However, several developing countries emphasized the need for accountability in the system as a greater good. Norway, a co-facilitator of the sub-group, apparently echoed baseless ideas propagated by a European stakeholder, invited as an expert by the WHO Secretariat a few weeks ago. This stakeholder argued that the anonymity of users is imperative for open access, data interoperability, and automated machine interactions. Several data scientists, including bioinformaticians, confirmed with Third World Network that they consider this as a lame excuse. They pointed to the UNESCO Recommendation, which identifies accountability and vigilance as integral features of open science infrastructure. A developing country delegate said “it is Member States and not WHO that should discuss and decide on the terms and conditions of access and use of materials and GSD. Terms of reference suggest that the terms are not binding and do not have to be followed” adding that “It is unclear what are the ‘key attributes’ that will apply”, leaving significant uncertainty regarding the operational framework. In response to questions raised by developing countries, particularly on the nature of terms of reference and technical modalities, the WHO’s legal counsel stated that all arrangements with laboratories and databases would be contractually binding. This clarification was in sharp contrast with the explanation given by the Norwegian co-facilitator who stated that terms of reference would be merely the expectations of WHO and its Parties from the laboratories and databases. Many developing countries expressed doubts about the WHO Secretariat’s capacity to secure contracts with desirable levels of accountability to WHO States Parties, both with laboratories and databases. A delegate from a developing country spoke to Third World Network, saying, “With 11 years of experience, WHO has not secured a contract with GISAID and GenBank. How are we supposed to believe WHO will secure contracts with external databases for the PABS system under the pandemic instrument?” A particular concern of developing countries was the suggestion that GSD may be shared outside the WHO SDBs. “If Parties can share GSD with any database, then how will other Parties know if it has been shared?” a delegate involved in the discussions pointed out. There is also the concern that once physical material is shared by a developing country with a laboratory in a developed country, that laboratory may sequence the material and post such sequence outside the WHO SDBs, thereby undermining benefit sharing arising from the use of such sequences. The E.U. informed the sub-group that the current data sharing system cannot be altered because scientists should be guaranteed non-discriminatory and fair access, according to a diplomatic source. Additionally, it wanted to invite databases to hear what they can do and what they cannot do. The E.U. however did not respond to questions raised by Bangladesh, including: 1. How can WHO and Member States guarantee continued access to scientists if databases retain the unilateral right to suspend or terminate access? 2. How can an open system be secured in the face of rising biosecurity concerns about publicly publishing pathogen genetic data, as highlighted in the U.S. Congress? 3. How should situations be addressed when databases do not comply with the rules or conditions set by the Parties? 4. How do we address existing discriminatory practices in the current databases, such as varying user platforms and the unilateral suspension of access? Intellectual Property Intellectual property was another contentious point in the discussion on the PABS system. The text of the Chair/Facilitators text states that “Parties agree that intellectual property rights may not be sought on such materials and GSD”. Some delegations pointed out that this text “is inadequate as it does not capture the broad patent claims that are made encompassing pathogens and GSD”. A recent publication on “Intellectual Property Claims on Pathogens that Can Cause Public Health Emergency of International Concern” revealed that entities in developed countries, in particular in the U.S., appropriate shared material and GSD through the patent system. These claims can curtail further R&D as well as local production in developing nations, according to a developing country; the claimed “inventions”, once commercialized, can lead to monopolisation, impeding scientific progress and hindering efforts to combat public health threats. A developing country, aggrieved by such intellectual property claims, stressed that the Chair/Facilitators’ text should reflect the developing countries’ proposal that “[n]o IP claims shall be sought on WHO PABS biological material, including its GSD, or parts thereof, in any form including any modified form or for any use”, highlighting concern that data shared being patented by entities in developed countries without their knowledge. Another developing country questioned the value of open science if the scientists whose work contributed to the development of vaccines are denied access to those vaccines, highlighting the situation of scientists in the Global South. Benefit Sharing Many developing countries were especially irked by the lack of firm commitment to fair and equitable benefit sharing by all users of the PABS system including all manufacturers. The Chair’s/Facilitators’ text states that the Parties “shall facilitate the conclusion of legally binding standard PABS contracts to be agreed between manufacturers and WHO”, providing no guarantee that ALL manufacturers using the PABS system undertake a legally binding obligation to provide fair and equitable benefit sharing. The text proceeds to provide a list of benefits:
The vague and ambiguous list of benefits outlined in the Chair’s/Facilitators’ text fell short of the expectations of many developing countries. These countries had anticipated clear and tangible benefits to be provided during a Public Health Emergency of International Concern (PHEIC) or a pandemic. For instance, “arrangements for transfer of technology and know-how in line with Article 11” effectively means voluntary technology transfer on terms to be agreed with the technology holder. Such transfers failed to materialise during the COVID-19 pandemic. Moderna and Pfizer refused to transfer their mRNA technology and know-how to the WHO mRNA Hub. The multinational pharmaceutical industry also declined to participate in the WHO COVID-19 Technology Access Pool, a voluntary licensing arrangement hosted by WHO to diversify production and increase supply options. When developing countries sought clarity on the benefit-sharing obligation, the Chair alluded to the complexity of the issue, mentioning three categories of users: manufacturers of pandemic-related products, commercial users not manufacturing such products, and non-commercial users. He stated that arriving at terms and conditions corresponding to each user at this stage is challenging. Several developing countries reiterated that obligations related to access to pathogens and genetic sequence data can only be as robust as benefit-sharing obligations. If benefit-sharing obligations are weakened, then there can be no obligation or little obligation to ensure access to pathogens and GSD. Developed countries, especially the U.S. and the E.U. offered the excuse of wanting more users to join the PABS system, thus preferring to keep the benefit-sharing provisions broad and soft. A developing country delegation expressed its frustration in the corridors of the WHO: “At first, when it comes to access, developed countries want everyone to have access to pathogens and GSD everywhere they like, even anonymously. Then, when it comes to benefit sharing, they want every user to contribute to the WHO. It is like cutting at the root of the tree and waiting for fruits”. Implementation and Governance The Chair’s/Facilitators’ text proposes several elements on governance and implementation. First, it links access to pandemic-related products to prequalification and emergency use listing. Secondly, it seeks to establish a connection between the number and range of manufacturers signing PABS contracts and the operationalization of the PABS. Thirdly, it aims to declare the status of PABS as a specialized international ABS instrument under the Nagoya Protocol on access and benefit sharing. Finally, it entrusts the governance of PABS to the governing body of the pandemic instrument. Several developing countries opposed linking pre-qualification and emergency use listing to the PABS system, arguing that these subjects should be addressed elsewhere. Furthermore, developing countries highlighted loopholes in the idea of ensuring a minimum number and range of manufacturers to initiate the operationalization of the PABS system. A delegate from a developing country expressed concern that the current proposal could indefinitely prevent PABS from entering into force. Another developing country delegate mentioned that the clause on the threshold number of contracts is superfluous, as manufacturers can terminate contracts and continue to access pathogens from laboratories or GSD from databases, without accountability to the PABS system. Regarding the identification of PABS contracts as a specialised international instrument, developing countries raised concerns because the determinant features of such an instrument are yet to be established by the Parties to the Nagoya Protocol. Not all Member States of WHO are Parties to the Nagoya Protocol. Furthermore, the Parties to the Nagoya Protocol are still considering the question of whether a body outside the Protocol can recognize a multilateral access and benefit sharing instrument developed by it as a specialised international instrument under the Nagoya Protocol. Finally, with regard to entrusting governance to the governing body of the pandemic instrument, there was not much discussion on 28 February, according to sources. However, the concern here is that by only mentioning the governing body of the pandemic instrument, the PABS system will not be applicable to non-pandemic health emergencies falling under the International Health Regulations 2005 and governed by the World Health Assembly. The Parties to the Regulations will differ from Parties to the pandemic instrument if the latter is a treaty.+
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