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Info Service on Health Issues (May24/05) WHO: INB Bureau Co-Chair attempts to shut down Africa Group’s benefit sharing proposals Geneva, 3 May (Sangeeta Shashikant) – Discussions on the pathogen access and benefit-sharing (PABS) system were often tense, on at least two occasions, when the Co-chair of the Bureau of the Intergovernmental Negotiating Body (INB) tried to shut down the Africa Group’s proposals on the matter. The resumed 9th session of the INB is meeting in Geneva from 29 April to 10 May to negotiate a legally binding instrument on pandemic prevention, preparedness and response. On the third day of the meeting (1st May), discussions began on Article 12 of the Bureau’s text on the PABS system. Most of the discussion was moderated by the Bureau Co-chair Roland Driece of Netherlands. According to sources, on two occasions, the Co-chair intervened as the Africa Group was making proposals on the PABS system, attempting to cut short the interventions. Discussions began with the European Union questioning language in the Bureau’s text stating that the WHO PABS system “is hereby established”, preferring instead language that such a system “shall be developed”, sources say. The Africa Group plus Egypt insisted that the text should establish the PABS system. Discussion on establishment of the PABS system triggered further debate on its legal nature as the PABS system is to be established under the Pandemic Agreement with the modalities and terms and conditions to be sorted out at a later date, after the Agreement has been adopted but before it enters into force. WHO’s legal office shared a white paper on Friday morning (3rd), on how the new instruments being considered, PABS and a One Health instrument proposed by the Bureau, will be established and how existing and future instruments (the International Health Regulations, the Pandemic Agreement, the PABS System and One Health Instrument (which is strongly opposed by many countries) will interact with each other given their different mandates, governance and financial structures. The paper does not provide clear options to WHO member States on how fragmentation of the health emergency can be avoided. Co-chair Driece also attempted to defer discussion on Article 12 by indicating that the rest of the day would be spent discussing other articles in the draft Pandemic Agreement. However, members of the Africa Group objected to the insufficient time allocated for this crucial aspect of the Pandemic Agreement. Egypt argued that Article 12 is the starting point for facilitating other articles stating that until Article 12 is cleared, progress cannot be achieved. In the afternoon of (1st May), discussions proceeded to the substantive aspects of Article 12 beginning with the foundations of the PABS system. Throughout the discussion, the EU insisted on replacing references to “PABS material and sequence information” with “relevant material” claiming that the biological material to be shared had yet to be defined. The EU ignored the definition proposed in the Bureau’s text i.e. “PABS material and information” means the biological material from a pathogen with pandemic potential, as well as sequencing information relevant to the development of pandemic-related health products. This move of the EU could be linked to the suggestion by Co-chair Driece that a One Health instrument be developed in the future, an agenda that the EU has been trying to push for a long time in the negotiations for a Pandemic Agreement. In the corridors, among developing countries there is significant opposition to such an instrument. Certain developed countries have also privately expressed concern about this new instrument. The scope and content of such an instrument is also unclear. The United States suggested replacing references to pandemic-related health products with “vaccines, diagnostics and therapeutics against covered pathogens”. Foundational Elements of the PABS System Many countries intervened suggesting changes as well as new elements to the Bureau’s text on elements that should form the foundation of a PABS system. The Africa Group proposed some key elements as the foundation of the PABS system including “transparency and accountability in all aspects of the operation of the PABS System” and that “users of the PABS system refrain from claiming intellectual property or other rights on PABS material and information that in any way limit access to or use of the PABS Materials and Information including parts thereof, shared through the PABS System”. India proposed that an element should be “not seeking to obtain intellectual property rights on PABS material and information or on any pandemic-related health product”. The Africa Group stressed that consideration of the PABS system as a specialized international access and benefit sharing instrument (SII] should be “following a 5-year review of the functioning of the PABS System and taking into account decisions of the CBD (Convention on Biological Diversity) and the Nagoya Protocol”. They made it clear that only Nagoya Protocol parties can decide which instrument is a SII. [The Nagoya Protocol on access and benefit sharing provides for SIIs following which the Protocol would not be applicable to the subject matter of the SII concerned.] Brazil and Malaysia also made clear that in the absence of a comprehensive PABS system that is operational, they are not in a position to accept the instrument as a SII. The US proposed adding: “national measures for prior informed consent and mutually agreed terms do not apply to PABS Material and Information accessed through the system”. Prior informed consent and mutually agreed terms are key elements for accessing biological materials under the CBD and the Nagoya Protocol. Most WHO Members are Parties to these 2 instruments. The US which is not Party to either instrument, is clearly seeking to undermine the core principles of the CBD and its Nagoya Protocol. Norway proposed that one of the foundational elements of the PABS system should be “consistent with open access to data” which was qualified by Malaysia with the addition “in a responsible, accountable and equitable manner”. The EU said an element should be: “The benefit sharing shall be implemented by legally binding contracts between the PABS system and private entities”. This proposal, however, is an attempt to sneak in its proposal on the development of the PABS system, an approach that is flawed and has been rejected by developing countries (see The European Union’s ABS Proposal for the pandemic instrument: Backwards in International Solidarity & Exacerbates Inequity). Bangladesh made it clear not only benefit sharing but also access should also be implemented through legally binding contracts which received support of several countries. Legally Binding Terms and Conditions On the components and elements of the PABS system, building on the Bureau’s text, the Africa Group proposed that the sharing of PABS material and information should be “as appropriate, based on national risk assessment in accordance with modalities, and subject to legally binding terms and conditions applicable to users of PABS material and information, WHO-coordinated laboratory network and sequence databases as to be determined and agreed to by WHO Members”. It added that there should be “the fair, equitable and timely sharing of benefits, both monetary and non-monetary from users of the PABS System, arising from access to PABS material and information, in accordance with modalities, legally binding terms and conditions to be determined and agreed by WHO Members”. Some developed countries proposed replacing “access to” with “commercial use”. Minimum Benefit-Sharing On benefit sharing, the Bureau proposed text with “minimum” monetary and non-monetary benefits that should be provided by users of the PABS system: “(i) in the event of a pandemic, real-time access by WHO to 20% (10% as a donation and 10% at affordable prices to WHO) of the production of safe, efficacious and effective pandemic-related health products”; and “(ii) annual monetary contributions from PABS System users shall be administered by WHO, based on modalities, terms and conditions to be defined, as per paragraph 6 of this Article”. Namibia on behalf of the Africa Group proposed the following “minimum” benefit sharing list, aimed at addressing different situations, amending some elements in the Bureau’s text: “(i) in the event of a public health emergency of international concern or a pandemic, provide to WHO at least 20% (10% free of charge and 10% at affordable to WHO) of real-time production of each safe, efficacious and effective pandemic-related health products”; “(ii) in the event of a public health emergency of international concern or a pandemic, supply pandemic-related health products at affordable prices to developing countries, and to comply with WHO’s allocation plan, if any”; “(iii) in the event of a public health emergency of international concern or a pandemic (PHEIC), to grant to WHO royalty-free, non-exclusive licenses on standard terms and conditions, which can be sub-licensed, for the production and supply of pandemic-related health products in order to meet the needs in developing countries”; “(iv) to make available pandemic-related health products according to paragraph (i), before declaration of a public health emergency of international concern, to address access needs in developing countries, including for purposes of WHO stockpiles, on the recommendation of the WHO Director-General in consultation with the Emergency Committee under the International Health Regulations”; “(v) annual monetary contributions from PABS System users administered by WHO, based on modalities, terms and conditions to be defined by WHO Members, as per paragraph 6 of this Article”. As Namibia was making its presentation on behalf of the Africa Group, Driece intervened, stating that the Group’s “wish-list” is not “helping us getting closer to compromise”. He argued in favour of the Bureau’s text, asking countries to refrain from making lengthy interventions, according to various sources. The UK made clear that it could not agree to any percentages and instead proposed text on “time bound contribution by relevant manufacturer of a portion”. It also proposed replacing “pandemic related health products” with “relevant vaccines, diagnostics and therapeutics on the basis of scientific evidence and public health needs”. The UK further said it could not accept the paragraph on sharing a percentage of pandemic-related health products during a PHEIC and wanted it limited to a pandemic. While the US agreed that the proposed contribution of products could also apply for PHEIC, it then proposed of “up to 20%” and that the monetary contributions should be “voluntary” and both the benefits should be presented as options. Japan supported the UK’s suggestion that there be no fixed percentages and the US proposal of the benefits being presented as “options”. According to various sources, Indonesia responded to these points arguing that paragraph 3 looks at minimum benefits, but if science and health needs point to a greater amount to be contributed, that can be added as additional benefits. Indonesia also highlighted the need for non-exclusive licensing agreements to be addressed differently, as part of the minimum list. Additional Benefit Sharing In another paragraph, the Bureau’s text speaks on additional benefits. Paragraph 4 of the Bureau’s text states: “The PABS System will also have additional benefit-sharing options, which may include: (a) voluntary non-monetary contributions, such as capacity-building activities, scientific and research collaborations, non-exclusive licensing agreements, arrangements for the transfer of technology and know-how of relevant diagnostics, therapeutics or vaccines in line with Article 11, tiered-pricing or other cost-related arrangements, such as no loss/no profit loss arrangements, for the purchase of pandemic-related health products during public health emergencies of international concern or pandemics; and (b) encouraging laboratories in the WHO-coordinated laboratory network to actively seek the participation of scientists from developing countries in scientific projects associated with research on PABS material and information”. The Africa Group, supported by a few other developing countries, sought to remove the word “voluntary” and to replace “encouraging” with “requiring”. Norway proposed merging additional benefit sharing options with minimum benefits, presumably to create a long list of benefit-sharing options for PABS users. However, this can also be seen as an attempt to dilute the benefit-sharing demands of developing countries. The US proposed that “will” be replaced with “shall” and paragraph 4 to apply to “commercial and non-commercial users of PABS Materials and Information”. Some other developed countries e.g. Switzerland also seem to agree that the list of minimum benefits should be only for commercial users while the additional list of benefits should apply to both commercial and non-commercial users. Other Operational Aspects The Bureau’s text proposed two other operational aspects as follows: “5. Each Party that has manufacturing facilities that produce pandemic-related health products in its jurisdiction shall take all necessary steps to facilitate the export of such products, in accordance with timetables to be agreed between WHO and the relevant manufacturers. “6. The modalities, terms and conditions, and operational dimensions of the PABS System shall be further defined in a legally binding instrument that will be operational no later than 31 May 2026.” Several WHO Members proposed amendments to the Bureau’s text as well as additional operational aspects. The Africa Group suggested that paragraph 5 should reflect that each Party shall support the effective operationalization of the PABS system. Another developing country added “fair, transparent, accountable” to that suggestion. The importance of paragraph 5 lies in the concern that during a health emergency, countries with manufacturing facilities will not allow the export of products to other countries, even though the products have been developed through shared PABS materials and sequence information. The Africa Group proposed the addition of “manufacture” before the word “export”, meaning a Party would have to facilitate the manufacture and export of the products. The UK proposed adding “located in its jurisdiction” after “manufacturing facilities” and proposed that export should be “consistent with WTO (World Trade Organizaition) rules”. Norway proposed deletion of “in accordance with timetables to be agreed between WHO and the relevant manufacturers”, although the text is practical from a public health perspective. The US proposed the following additional paragraphs: [5bis. During a pandemic emergency, each Party intends to include provisions in its procurement agreements for relevant diagnostics, therapeutics or vaccines that require manufacturers to reserve a portion of their production of those products and, in a timely manner, offer the reserved portion for donation or sale at an affordable price for use in countries facing challenges in meeting public health need and demand for relevant diagnostics, therapeutics, or vaccines.]
The US proposals are simply an attempt to lock in uncertain ad hoc product donations and contributions. They only expresses an intent, with no guarantee of access for developing countries, and if there is access, such access may be subject to further conditions imposed by the providing country, or after the needs of the providing country has been satisfied. During COVID-19, donations received had a very short shelf life, and had to be disposed by the developing countries that received them. The Africa Group proposed the following operational paragraphs: [6bis. All features of the PABS System shall become operational simultaneously. Any sharing of PABS material and information under any provision of the WHO Pandemic Agreement shall take place through the PABS system after its development pursuant to paragraph 6 and subsequent operationalization.]
[7. Production of vaccines, diagnostics and therapeutics relevant to the prevention, preparedness and response of public health emergency of international concern or a pandemic, irrespective of the technology, material or information used, implies use of PABS Materials and Information and all users including manufacturers shall immediately be subject to the terms and conditions of the PABS System including its benefit sharing requirements.] WHO Members are expected to take up discussion on the legal nature of the PABS system after receiving a White Paper that the legal office of WHO is preparing. This discussion will take place in the afternoon of 3 May.
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