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TWN
Info Service on Health Issues (Apr25/09) WHO: No Firm Commitments for Early Access or Production Rights in Pandemic Deal Geneva, 19 April (Sangeeta Shashikant & Nithin Ramakrishnan) – As World Health Organization negotiations on the main text of the Pandemic Agreement conclude, one of the most glaring shortcomings is the failure to secure binding commitments from manufacturers to make vaccines, therapeutics, and diagnostics (VTDs) available during a public health emergency of international concern (PHEIC) or to respond to early outbreaks. This undermines a core objective of the Agreement: the prevention of pandemics. Equally concerning is the absence of any clear obligation on manufacturers to license production of VTDs to developing country manufacturers, an essential measure for expanding global supply and addressing the recurring shortages observed during past PHEICs and pandemics. On the night of 10 April 2025, towards the end of the resumed negotiations on the Pandemic Agreement, general, vague, and non-binding language on the abovementioned elements in paragraphs 7 and 8 of Article 12 on the Pathogen Access and Benefit-Sharing System PABS) was “greened” effectively deferring these critical issues to future negotiations on the PABS system, which will be addressed in an annex after the Pandemic Agreement is adopted at the forthcoming World Health Assembly in May. [The Pandemic Agreement negotiation text that is highlighted in green indicates initial agreement.] The resumed 13th session of the Intergovernmental Negotiating Body (INB) for a Pandemic Agreement met in Geneva from 7 to 11 April 2025. Motivated by “greening” of most of Article 12 of the text, negotiations continued past midnight on Friday (11 April) into Saturday morning. However full agreement on the Pandemic Agreement remained elusive. Negotiations then continued again on Tuesday (15 April). The only concrete manufacturer commitment in the main body of the Agreement applies once a “pandemic emergency” is declared. Even then, the target of 20% of real-time production for WHO is weakly framed – only 10% is guaranteed as a donation, while the remaining 10% is to be provided to WHO at affordable prices but commitments will depend on the manufacturer’s nature and capacity. This leaves significant uncertainty as to whether the majority of manufacturers using the PABS system will commit to provide the targeted 20% of real-time production for WHO. [See New proposal guts certainty of vaccine and medicine supply commitments for pandemics] Since the start of the Pandemic Agreement negotiations, many developing countries have pushed for strong, binding obligations on manufacturers to ensure equitable access during PHEICs, including outbreaks that could lead to a PHEIC. They have also called for the provision of production licenses to expand supply options and address recurring shortages during such emergencies. However, as negotiations progressed, the European Union (EU) and other developed countries resisted these proposals, rejecting meaningful provisions advanced by the Africa Group and the Group of Equity. This resistance, combined with the INB Bureau and WHO Secretariat’s determination to conclude negotiations at all costs, led to the weakening and deferral of key, public health-driven proposals championed by developing countries. According to multiple sources involved in the talks, the Bureau had struck a deal with G7 countries on which parts of Article 12 would be adopted as a package, and which would be watered down and postponed for later negotiation. Paragraph 7 on Supply Commitments during PHEIC The final agreed paragraph 7 states: “The PABS Instrument shall also include benefit sharing provisions, in the event of a public health emergency of international concern as determined in accordance with Article 12 of the International Health Regulations, including options regarding access to safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the public health emergency of international concern, pursuant to legally binding contracts signed by participating manufacturers with WHO”. The current agreement falls far short of the original proposal by the Africa Group – also backed by the Group for Equity – which called for at least 20% of real-time production to be donated to the WHO. At one point, Namibia (on behalf of the Africa Group) and Egypt proposed a reduced figure of 15%, citing ongoing challenges in securing timely and affordable access during PHEICs, as seen in past outbreaks like Ebola and monkeypox. However specific percentages are not reflected in the agreed paragraph 7. Paragraph 7 merely states that the future PABS instrument will include benefit-sharing provisions for PHEICs and that these provisions may include options for access to VTDs during such emergencies. The specifics of these benefit-sharing commitments remain undefined – aside from the indication that multiple options may be considered and they will form part of legally binding contracts between participating manufacturers and the WHO. The paragraph is a step backwards even from more recent texts considered by the INB. The Bureau text at the end of the 13th session of the INB on 21 February states: “The PABS Instrument shall also include benefit sharing provisions, in the event of a public health emergency of international concern as determined in accordance with Article 12 of the International Health Regulations, including options regarding access to safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the public health emergency of international concern, pursuant to legally binding contracts signed by participating manufacturers with WHO. The PABS Instrument shall include a minimum percentage of vaccines, therapeutics and diagnostics to be pre-negotiated by WHO in the event of a public health emergency of international concern”. The final sentence was proposed by the Africa Group as a compromise for not mentioning specific percentages in the main part of the Pandemic Agreement, to facilitate conclusion of negotiations. However, prior to the April resumed session the reference to minimum percentage was unilaterally removed by the INB Bureau. According to diplomatic sources involved in the negotiations, the WHO Secretariat especially Dr. Michael Ryan, Executive Director of WHO's Health Emergencies Programme, repeatedly argued against manufacturers being asked to undertake commitments to provide a minimum fixed percentage of VTDs during PHEIC as such events vary from one PHEIC to another. Real-world experience demonstrates that this position is untenable. While the nature of PHEICs may vary, the imperative for timely access to medical countermeasures during such emergencies remains constant. Relying primarily on the goodwill of pharmaceutical companies has consistently proven inadequate. For example, in 2023, the MSF Access Campaign highlighted that access to Ebola treatments in affected countries remained at a “standstill” more than two years after their approval, despite five subsequent outbreaks of Ebola virus disease and the fact that these treatments were developed using materials shared by those same affected countries. [See MSF Access Campaign “Ensuring Access to New Treatments for Ebola Virus Disease”] Another case is that of monkeypox (mpox). As at 12 March 2025, Bavarian Nordic reportedly pledged 15,460 doses of MVA-BN (tradename Jynneos) vaccine while Emergent BioSolutions pledged 50,000 doses of ACAM2000 i.e. about 0.65% of the 10 million doses the Africa Centres for Diseases Control and Prevention (CDC) needs by the end of 2025 in the continent to control the spread of mpox. Further, of the 5.3 million pledged doses by governments and others, only 543,080 vaccines had arrived as of February 2025. On 17 April Africa CDC reported that just about over a million doses have been delivered to 10 countries i.e. only 10% of its needs, 8 months after the declaration of PHEIC. These facts make it clear that timely access for developing countries affected by PHEICs remains a serious challenge – one that WHO Member States must prioritize and urgently address. The WHO Secretariat’s position appears driven by a desire to conclude the Pandemic Agreement negotiations as quickly as possible. Pushing for strong equitable access provisions – opposed by powerful countries – would run counter to that goal and risk undermining consensus. Reflecting on the WHO Secretariat’s remarks, a developing country negotiator told TWN, “We do not want to complain about WHO staff, they are under tremendous pressure to save WHO from the impact of U.S. withdrawal and they want to see the WHO Pandemic Agreement done, no matter what the content is. But we can see that what they are saying is not a neutral opinion”. According to several diplomatic sources from Africa, there is still a desire to seek more concrete commitments on gaining timely access to VTDs during PHEICs, during the development of the PABS instrument. “The PABS system will be operational only after the development of the PABS instrument – by that time we can arrive at a percentage set aside for PHEICs”, said an African negotiator. Paragraph 8 on Additional Benefit-Sharing Sharing Provisions The agreed text on paragraph 8 states: “(8) The PABS Instrument shall also include additional benefit sharing provisions to be set out in legally binding contracts signed with WHO, including options for: (a) capacity building and technical assistance; (b) research and development cooperation; (c) facilitating rapid access to available vaccines, therapeutics and diagnostics with a view to responding to public health risks and events in the context of paragraph 3 of Article 13 of the International Health Regulations; (d) the granting of non-exclusive licenses to manufacturers in developing countries, for the effective production and delivery of vaccines, therapeutics and diagnostics; and (e) other forms of transfer of technology as mutually agreed (fn), and knowledge, skills and technical expertise. Footnote: As mutually agreed For the purposes of this agreement, “as mutually agreed” means willingly undertaken and on mutually agreed terms, without prejudice to the rights and obligations of the Parties under other international agreements.” This text is a construct of the INB Bureau, seemingly designed to dilute the impact of concrete proposals from developing countries – particularly those of the Africa Group and the Group of Equity – that were not fully acceptable to developed countries. It merges streamlined versions of developing country proposals with more general benefit-sharing language, weakening the original intent and specificity. The original proposal of the Africa Group (supported by Group of Equity) was (i) to get a firm commitment from the manufacturer with fixed percentages for advance release of VTDs at an outbreak stage as well as to replenish WHO stockpiles prior to an PHEIC; and (ii) to commit to granting non-exclusive royalty free licenses to WHO which can be sublicensed to developing country manufacturers during PHEICs and pandemics so that supply options can be rapidly expanded. Their detailed proposals were as follows: "(i) Prior to the declaration of a PHEIC, with the aim to prepare for an early response, at the recommendation of the Director-General, the Recipient Entity shall donate a part of its real-time production, not exceeding 20% of its real-time production, to address access needs in developing countries including for purposes of WHO stockpile. Any affected country may also request the Director-General to operationalize this paragraph. The Director-General shall make the recommendation to this effect, in consultation with the affected countries and the Emergency Committee. (ii) Grant to WHO royalty-free, non-exclusive licenses on standard terms and conditions to use its intellectual property, and other protected technology, know-how used in the process of product development and manufacturing, for the production and supply of pandemic-related products, needed in developing countries. WHO shall sublicense these licenses to manufacturers especially in developing countries, on standard terms and conditions in accordance with sound public health principles with the aim to diversify production and expand supply options to facilitate prompt equitable access in developing countries. For the purposes of this paragraph, the Recipient Entity shall on request by WHO share the complete regulatory dossier including the full technical know-how as well as any materials needed for the development and production such as cell-lines, hybridomas, plasmids, yeast, or mammalian cells, with the sublicensees of WHO.” These detailed proposals were steadily diluted. Each of the above elements were addressed in separate paragraphs in the draft text, until the April resumed session. The text following negotiations at INB 12, as of 6 December 2024 stated: “8bis [The WHO Director-General shall initiate advance release of real time vaccines, therapeutics and diagnostics especially to developing countries to prevent outbreaks from progressing into PHEICs and pandemics, in cases where affected developing countries lack equitable access and/ or for WHO stockpiles. Manufacturers shall comply with the Directors-General’s request for advance release.] 7. The PABS Instrument shall also include additional benefit sharing provisions [/ options] which may [/ shall] include granting [on a voluntary basis] [through WHO,] during a public health emergency of international concern and/or pandemic emergency, royalty free, non-exclusive manufacturing licenses [that may be sub-licensed] to manufacturers in developing countries for the production of vaccines, therapeutics and diagnostics for the pathogen causing the public health emergency of international concern and/or pandemic emergency.” As INB 13 approached, the draft text was unilaterally changed by the Bureau to read as follows: “8. The PABS Instrument shall also include arrangements for the rapid access to relevant vaccines, therapeutics and diagnostics, especially to developing countries, to prevent public health events from progressing into PHEICs and pandemic emergencies. 9. The PABS Instrument shall also include additional benefit sharing provisions which may include granting, as set out in legally binding contracts, through WHO, during a public health emergency of international concern and/or pandemic emergency, royalty free, non-exclusive manufacturing licenses [that may be sub-licensed] to manufacturers in developing countries for the production of vaccines, therapeutics and diagnostics for the pathogen causing the public health emergency of international concern and/or pandemic emergency.” The text for at the end of INB 13 as on 21 February was as follows: “8. The PABS Instrument shall also include arrangements for the rapid access to relevant vaccines, therapeutics and diagnostics, especially to developing countries, to prevent public health events of pathogens with pandemic potential from progressing into PHEICs and pandemic emergencies, pursuant to legally binding contracts signed by participating manufacturers with WHO. 9. The PABS Instrument shall also include additional benefit sharing provisions setting out options which may include granting, as set out in legally binding contracts, signed by participating manufacturers with WHO, coordinated by WHO, during a public health emergency of international concern and/or pandemic emergency, royalty free, non-exclusive manufacturing licenses [that may be sub-licensed] to manufacturers in developing countries for the production of vaccines, therapeutics and diagnostics for the pathogen causing the public health emergency of international concern and/or pandemic emergency.” Colombia added this text to paragraph 9: “These additional benefit sharing provisions shall also include transfer of technology, in line with Article 11”. On the last day of INB 13, Singapore proposed an alternative text to Paragraph 8 which appeared as ‘alternative text’ in the draft Pandemic Agreement circulated on 21 February. Singapore’s text did not create legally binding obligations on recipients of the pathogen samples and sequence information: “8 ALT. The PABS Instrument shall also include benefit sharing provisions to promote capacity building, technical assistance, research cooperation, particularly in developing countries, to prevent public health events from progressing into PHEICs and pandemic emergencies.” Several developing countries also opposed such open-ended voluntary ideas proposed by Singapore. Some negotiators strongly speculate that the late introduction of general benefit sharing proposals such as capacity building, technical assistance, research cooperation was a tactic aimed at diverting attention away from the two core demands of a large number of developing countries i.e. advance release of VTDs for outbreaks as well as the grant of licenses to developing country manufacturers through WHO. Developed countries were not keen to address these issues. Eventually this strategy prevailed. In advance of the resumed session, the Bureau merged all the proposals into a list crafted in more general but narrow language as benefit-sharing options to be considered during the development of the PABS instrument. The INB Bureau while circulating text for the resumed session negotiations, amalgamated all these paragraphs into one paragraph: “The PABS Instrument shall also include additional benefit sharing provisions to be set out in legally binding contracts signed with WHO, including options for: (a) capacity building and technical assistance; (b) research and development cooperation; (c) facilitating access to available vaccines, therapeutics and diagnostics with a view to preventing public health events from progressing into a public health emergency of international concern, upon request by the Director-General of the WHO; (d) the granting of non-exclusive licenses to manufacturers in developing countries, where necessary for the effective production and delivery of vaccines, therapeutics and diagnostics; and (e) other forms of transfer of relevant technology and knowledge, skills and technical expertise.” On the night of 10 April, the INB Vice-chair, Ambassador Tovar da Silva Nunes from Brazil, who also chaired negotiations on Article 12, was in a hurry to “green” the text, sources say, and unwilling to accept substantial changes to paragraph 8 especially from developing countries. The Africa Group attempted to replace “facilitating” in paragraph (c) with “enabling”, and this attempt failed, according to sources. The WHO Director-General Dr. Tedros Adhanom Ghebreyesus weighed in, pressuring the Africa Group to accept paragraph 8 as mostly proposed by the Bureau. The text put forward by the INB Bureau was however changed a bit in sub-paragraphs (c) and (d). In sub-paragraph 8(c) instead of saying “facilitating access to available VTDS with a view to preventing public health events from progressing into a PHEIC, upon request by the Director-General of the WHO”, the final agreed text states “facilitating rapid access to available VTDs with a view to responding to public health risks and events in the context of paragraph 3 of Article 13 of the International Health Regulations; …” The word “rapid” was added before access. This came as a replacement to “early” access which was sought by several developing countries, in particular the Africa Group who wanted stronger obligation than “facilitating access”. Further, instead of projecting the objective of preventing the outbreaks from becoming diseases, the paragraph now describes that rapid access will be facilitated to respond to the events, in which Parties have sought or accepted assistance from WHO under article 13.3 of the International Health Regulations 2005 as amended in 2024 (IHR). According to sources involved in the negotiations, developed countries were not willing to accept benefit sharing commitments for preventing PHEIC and pandemics from happening or upon request of the WHO Director-General. They argued that such commitment would not be “definite” and “limited” and could be used to harass pharmaceutical companies to force them to give free doses of vaccines and other medical products, at affordable prices every time there is an infectious disease outbreak. The WHO Secretariat then proposed a reference to the public health events as mentioned in Article 13 paragraph 3 of IHR 2005. This would mean the rapid access benefits would only be given to events where Parties to IHR 2005 requested or accepted assistance offered by WHO in responding to such events – most of which would have undergone an initial risk assessment according to IHR 2005 indicating a potential to cause or constitute PHEIC. [Article 13.3 of the IHR 2005 reads: “At the request of a State Party or following its acceptance of an offer by WHO, WHO shall collaborate in the response to public health risks and events by providing technical guidance and assistance and by assessing the effectiveness of the control measures in place, including the mobilization of international teams of experts for on-site assistance, when necessary”.] The final paragraph 8(c) text reflects a significantly narrower approach: on request by a State in responding to a public health risk and event. In contrast, the original proposal of developing countries was about manufacturers’ commitments to provide some supplies to replenish/create WHO stockpiles and for affected countries to prevent PHEIC, on request of the WHO Director-General (who has many responsibilities under the IHR). However, the final text leaves open the possibility to pursue a more practical approach, one more aligned with the objectives of the Pandemic Agreement. Paragraph 8(d) was also changed with the addition of “mutually agreed terms” attached to technology transfer, on the insistence of the EU that all references to technology transfer should be on mutually agreed terms. [See EU’s push to dilute technology transfer provisions delays conclusion of pandemic instrument negotiations]+
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