Draft Pandemic Accord: IP Waivers and Benefits for Sharing Pathogen Information Are In – For Now Pandemic treaty 17/10/2023 • Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) South Sudanese Minster of Health Elizabeth Chuei receiving a COVID-19 vaccine at Juba Hospital. Time-bound waivers of intellectual property (IP) rights and benefits for countries that share information about threatening pathogens are some of the key components of the draft pandemic accord sent to World Health Organization (WHO) member states by the Intergovernmental Negotiating Body (INB) on Monday. These two issues have been major bones of contention in negotiations and may well be watered down during the horse trading that will commence on the first official negotiating draft. (So far, there has been a “zero-draft” drawn up by the INB Bureau and a “zero draft +”.) The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), swiftly condemned the draft, describing it as “damaging” and “bad”, warning that it would have “a chilling effect on the innovation pipeline for medical countermeasures”. Earlier in the week, German Health Minister Karl Lauterbach stated unequivocally that his country would not countenance an IP waiver in the pandemic accord. “For countries like Germany and most European countries, it is clear that such an agreement will not fly if there is a major limitation on intellectual property rights,” Lauterbach told the World Health Summit. “That is a part of our DNA … we need intellectual property security in order to invest into vaccines, invest into therapeutics, diagnostics, and so forth.” However, Helen Clark, co-chair of the The Independent Panel for Pandemic Preparedness and Response, countered on social media that “maintaining pure adherence to intellectual property protection in a pandemic costs lives”. Comments from Germany’s Health Minister at #WorldHealthSummit indicate how hard it will be to get meaningful agreement around equity of access to #pandemic countermeasures. Maintaining pure adherence to intellectual property protection in a pandemic costs lives. @peoplesvaccine https://t.co/2kyi3GQ3C1 — Helen Clark (@HelenClarkNZ) October 16, 2023 Double-whammy for pharma Article 11 contains a double-whammy for big pharma. First, it calls on parties to commit to “time-bound waivers of intellectual property rights to accelerate or scale up the manufacturing of pandemic-related products during a pandemic, to the extent necessary to increase the availability and adequacy of affordable pandemic-related products”. Then it “encourages” patent-holders that are producing pandemic-related products “to waive or manage” royalties payment by developing country manufacturers during pandemics. Patent holders that have received “significant public financing” to develop their products shall be “required” to waive their royalties. “It is reassuring that, despite ferocious lobbying by pharmaceutical companies, the provision on the waiver of intellectual property is still in the text, but the current wording does not provide a significant change in the status quo,” said Mohga Kamal-Yanni, Policy Co-Lead for the People’s Vaccine Alliance. “Making the adoption of the waiver discretionary by using qualifiers such as ‘to extent necessary’ would make it difficult to apply this provision in practice.” Statement | Innovative pharmaceutical industry comments on release of WHO pandemic treaty: https://t.co/gsF46kePRH pic.twitter.com/98qui5nsXy — IFPMA (@IFPMA) October 17, 2023 R&D and transparency The draft tries to promote transparency by calling on member states to “encourage” manufacturers in their countries to “share undisclosed information” with qualified third-party manufacturers if withholding it “prevents or hinders urgent manufacture”. During the pandemic, for example, Moderna steadfastly refused to share its know-how with the WHO mRNA vaccine production hub in South Africa, which had found Moderna’s mRNA vaccine “recipe” online but was stymied by certain aspects of its production. In addition, countries “shall” publish the terms of government-funded research and development (R&D) agreements for pandemic-related products, including “pricing of end-products”. In the past, many countries have not imposed any conditions on pharma companies that have received government grants to develop medicines, leaving them to determine prices and access on their own. But the Drugs for Neglected Diseases initiative (DNDi), which develops treatments for neglected diseases, said it was “extremely disappointed” that a provision “to attach conditions to public R&D funding” that had been in the zero draft, had been excluded. “An obligation to publish contract terms, which we support as a separate obligation, does not ensure that public R&D funders use their leverage to attach pro-access conditions to their funding in the first place, nor ensure that recipients of funding enact pro-access activities,” explained Rachael Crockett, DNDi’s Senior Policy Advocacy Manager. “Both are needed – transparency and conditions – to not only ensure the fast and efficient development of health tools but also to ensure equitable access,” added Crockett. The draft also proposes “technology co-creation and joint venture initiatives” using an “open science” approach that encourages collaboration, particularly with scientists and research centres from developing countries. WHO Director-General Dr Tedros Adhanom Ghebreyesus and Professor Petro Terblanche, head of the WHO mRNA vaccine development hub in South Africa. Access and benefit-sharing One of the trickiest sections up for negotiation is Article 12, which deals with access to pandemic products and benefit-sharing arising from sharing information about pathogens. To address this, the draft proposes the establishment of the WHO Pathogen Access and Benefit-Sharing System (WHO PABS System) to “ensure rapid and timely risk assessment” and “facilitate rapid and timely development of, and equitable access to, pandemic-related products”. National laboratories and health authorities will be required to upload the genetic sequences of pathogen material to “one or more publicly accessible database(s)” of their choice in “a rapid, systematic and timely manner”. They will need to be part of a WHO-coordinated laboratory network to receive material from other bodies and won’t be able to seek IP rights on any of the material they receive. A standard material transfer agreement (a PABS SMTA) will govern the material transfer “Benefits, both monetary and non-monetary, arising from access to WHO PABS materials, shall be shared fairly and equitably,” the draft notes. WHO should get “a minimum of 20%” pandemic-related products” for distribution, with 10% being donated and 10% sold “at affordable prices”. Each country with manufacturing facilities to produce pandemic-related products “shall take all necessary steps to facilitate the export of such pandemic-related products,” the draft adds – no doubt, to circumvent a repeat of India’s refusal to allow the Serum Institute of India to export COVID vaccines during the pandemic. Manufacturers from developed countries should be “encouraged” to collaborate with manufacturers from developing countries “through WHO initiatives to transfer technology and know-how and strengthen capacities for the timely scale-up of production of pandemic-related products”. The draft also proposes options such as tiered pricing and “no loss/ no profit” arrangements for pandemic products that take into account the income level of countries. Even if a manufacturer does not opt for a PABS SMTA, if it produces pandemic-related products out of WHO PABS materials, it will be required “to ensure their fair and equitable allocation”. Civil society groups, with UNAIDS Executive Director Winnie Byanyima, for an IP waiver for COVID vaccines But Kamal-Yanni of People’s Vaccine Alliance said that while the language on PABS is improved, “we strongly disagree with the logic that allocating a percentage of production to WHO can ensure equitable access”. “Sharing technology, knowledge and intellectual property by manufacturers accessing pathogens and data should be mandatory to ensure equitable access to all medical countermeasures during a pandemic,” she added. Country obligations, The draft also sets out countries’ obligations to prevent, prepare and respond to pandemics – finally giving weight to the pandemic cliché that “no one is safe until everyone is safe”. All countries “shall”, for example, “detect, identify and characterise pathogens presenting significant risks” and “conduct risk assessment of such pathogens and vector-borne diseases to prevent spill-over in human and animal populations and cause serious diseases leading to pandemic situations”. Countries are also required to strengthen animal disease preventive measures to prevent zoonotic spillover, strengthen laboratory biosafety to curtail lab accidents and address antimicrobial resistance. To achieve this, developing countries will get “financial and technical support, assistance and cooperation” to strengthen and sustain a skilled and competent public health workforce. Tighter language – or belonging in the bin? Mohga Kamal-Yanni, Policy Co-Lead for the People’s Vaccine Alliance. “While it is positive that many equity provisions are included, their language is inadequate and unnecessarily vague to achieve their goals,” warns Kamal-Yanni. “The ability to apply transparency, technology transfer or intellectual property measures could be undermined by qualifiers and limiting language.” “Provisions calling only for the promotion and encouragement of measures necessary to ensure equitable access to medical countermeasures must be transformed into obligations and commitments,” she added. The Independent Panel’s Helen Clark welcomed the progress towards a pandemic agreement “which, together with reformed International Health Regulations, remains a unique opportunity to secure a world better protected from pandemic threats”. “A core principle and approach in the agreement should frame pandemic preparedness and response as a global common good. This would contribute to building the regional capacity, resilience and stated commitment to equitable access that is fundamental to a transformed international system,” Clark told Health Policy Watch. “I encourage member states to aim high on this aspect of the negotiations and on all others,” added Clark, the former Prime Minister of New Zealand. “We urgently need transparency on how the barriers to equity that were so evident in the global response to the COVID-19 pandemic will be addressed,” said Aggrey Aluso, the Pandemic Action Network’s Africa Director. “Key aspects to focus on right now are the inclusivity and transparency of the negotiating process, countries’ political engagement, as well as transparency on the pathway of transformation to address the barriers to equity,” added Aluso, who described the draft as “a good starting point for thinking about the key elements of a new pandemic accord”. He called for all countries, regardless of their size or wealth, to have an equal voice in the negotiations, and for the drafting group negotiations to be open to civil society, organisations and other stakeholders. But IFPMA Director General Thomas Cueni would prefer to bin the draft: “It would be better to have no pandemic treaty than a bad pandemic treaty, which the draft circulated to member states clearly represents,” said Cueni in a media statement on Tuesday. “The ability of the private sector to develop new vaccines and treatments in response to COVID-19 was driven by decades of R&D investment and the ability of scientists to rapidly access data on pathogens. If adopted, the draft treaty would undermine both and leave us weaker ahead of the next pandemic than we were in December 2019, and we urge governments to make significant revisions to the current text.” * Story updated to include comment on the draft from Helen Clark, co-chair of the Independent Panel. Image Credits: ULISES RUIZ / Getty Images Contributor, UNICEF, WHO, @FilesGeneva . Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.