Pandemic treaty zero draft wins NGO approval, compliance will be key

NGOs have long denounced lower-income countries’ inequitable access to COVID-19 vaccines and treatments. But the zero draft of the pandemic accord released Wednesday is giving them some hope that this may change in the next pandemic. Several of them were pleased to see support for intellectual property waivers, as well as transparency and access conditions over publicly funded medical products. “The several conditions on R&D and procurement contracts echo what many have been calling for, and really they hit on the core issues of concern,” James Love, director of Knowledge Ecology International, told Devex. In the draft, parties — meaning countries — are to make manufacturers disclose information on medical products that received public funding, including product pricing and contract terms for public procurement during a pandemic. While NGOs are aware that the text is far from final, some are also concerned the text is weak on enforcement. Devil in the details While the draft text mentions several measures to improve access to medical products in lower-income countries, particularly during a pandemic, some NGOs are concerned about the language used to enforce them. STOPAIDS points to the use of the terms “promoting” and “encouraging” manufacturers in the text, which it says is “too open ended,” and thus make it “difficult to monitor or enforce.” “[I]nstead of encouraging or promoting stakeholders to do something … the Treaty should be clear about what is mandated or required, or what steps (e.g. passage of national legislation) should be taken,” said Jake Atkinson, campaigns and media officer for STOPAIDS. He points to the language used in Articles 7 and 9 of the text, which specifically covers access and transparency provisions. Article 7 says parties shall “encourage entities, including manufacturers within their respective jurisdictions, that conduct research and development of pre-pandemic and pandemic-related products, in particular those that receive significant public financing for that purpose, to grant, on mutually agreed terms, licences to capable manufacturers, notably from developing countries.” “It completely punts on independent monitoring, which is key to compliance.” --— Nina Schwalbe, founder, Spark Street Advisors Parties are also asked to “encourage” patent holders to waive royalty payments by lower-income country manufacturers during a pandemic, although it adds that parties “shall require, as appropriate, those that have received public financing for the development of pandemic-related products to do so.” There’s also inconsistent language in Article 9 with regards to manufacturers disclosing information on product pricing and contract terms, he said. Under Section 3, the text makes it “compulsory” for manufacturers that receive public funding to do so, but manufacturers can only be encouraged to do this when they receive other external funding. “We believe this inconsistency does not go far enough in ensuring transparency from pharmaceutical companies,” he said. Atkinson said this was the case with the COVID-19 pandemic, wherein manufacturers that received external funding “refused to voluntarily share price information” as there was no mandate for them to do so — issues they highlighted in their recent report, Access Denied. Parties are also asked to “promote” several actions in the text, including in engaging community, civil society, and other nonstate groups such as the private sector, under Article 16 of the draft text. “Parties will have different understandings of what promoting this looks like and this language potentially allows for those with greater influence (like Big Pharma companies) to assert their interests to a greater extent than traditionally-marginalised voices like affected communities,” Atkinson said. Meanwhile, some are concerned about the lack of accountability mechanisms in the draft text. “It completely punts on independent monitoring, which is key to compliance,” said Nina Schwalbe, founder of public health think tank Spark Street Advisors. In a letter published in the Lancet, Schwalbe and others wrote about the importance of an accountability framework to ensure the accord’s success, noting how a review found that “enforcement mechanisms are the only treaty design feature that can improve the chances of state compliance.” Countries’ lack of compliance with the International Health Regulations, a legally binding agreement on how the world should respond to public health threats, “have contributed to several failures to contain outbreaks, including COVID-19,” they wrote. A ‘good start’ Nevertheless, NGOs describe the draft text as a “good start.” Love finds references to the TRIPS agreement in the draft text to be “quite strong.” But advocates still need to convince member states, he said, to include their proposals on a “share and share alike pooling mechanism” and an “open source dividend,” which are not in the draft. That pooling mechanism is for governments to share rights from government-funded research and development among a pool of WHO member states that share similar rights. The idea of an open source dividend meanwhile is for a portion of commercial rewards of a product to be apportioned with people or communities that openly shared their knowledge and other important information and materials “on a royalty-free and nondiscriminatory basis,” according to a KEI document. The draft also includes text pertaining to WHO having access to 20% of pandemic response products such as diagnostics, vaccines, personal protective equipment, and therapeutics “to enable equitable distribution.” Half of that should be in the form of donations and the other half given at an “affordable” price to WHO. But Love said that’s “inadequate.” “I'll be surprised if the 20 percent proposal makes it, but it looks reasonable, even inadequate, given that only 10 percent is a donation and the other 10 percent is a price regulated sale,” he said. Meanwhile, the draft outlines the needs of health workers during a pandemic response, but more can be done to improve it, says Polly Dunford, the president and CEO of IntraHealth International. She recommends that WHO emphasize the need for strong information systems with regard to health workforce planning and deployment. WHO should also specify how countries can protect their health workers from infection and violence during emergencies, and define who are emergency health workers, to ensure community health workers and nurse midwives, for example, are also seen as “integral to every country’s response to pandemics and other emergencies.” This is however just the zero draft of the pandemic accord, and the earliest it can be finalized is in mid-to-late 2024. States also need to ratify, accept, or approve the accord before it comes into effect. Negotiations on the zero draft will start on the last week of February 2023, As Lawrence Gostin, a university professor at Georgetown University and founding O'Neill chair in global health law, said in a tweet: “Now comes the hard work.”