|
||
|
TWN
Info Service on Health Issues
By Sangeeta Shashikant & Rajnia de Vito (Third World Network) A group of prominent public health lawyers and civil society leaders warned that the positions taken by several developed countries in the ongoing negotiations on the establishment of a Pathogen Access and Benefit-Sharing (PABS) system in the context of the Pandemic Agreement, are inconsistent with their binding obligations under international human rights law, in particular the right to health and the right to benefit from scientific progress. The warning was delivered at a webinar held on 10 September by AIDS Healthcare Foundation (AHF), the Geneva Global Health Hub (G2H2) and Third World Network (TWN) to discuss a formal complaint that 16 civil society organisations (CSO) submitted to the UN Special Rapporteur on the Right to Health on 2 July, ahead of the last session of the Intergovernmental Working Group (IGWG) negotiating the PABS instrument. The complaint targets the negotiating positions of the European Union, Norway, Japan and Switzerland. Speakers for the webinar were K.M. Gopakumar of TWN; Sharifah Sekalala, Professor of Global Health Law and Director of the Global Health Law Centre at the University of Warwick; Jorge Saavedra, Executive Director of the AHF’s Public Health Institute; Susana van der Ploeg, Coordinator of the Brazilian Interdisciplinary AIDS Association (ABIA); and Allan Maleche, Executive Director of the Kenya Legal and Ethical Issues Network on HIV and AIDS (KELIN). The CSO complaint argues that the EU, Norway, Japan and Switzerland support mandatory sharing of pathogen materials and sequence data but oppose enforceable measures requiring users and manufacturers to share the resulting benefits. These countries have resisted standardised contracts, user registration, traceability, guaranteed WHO access to vaccines, therapeutics and diagnostics, production licensing, revenue contributions and public-domain research outputs. These positions risk creating an extractive system in which developing countries provide pathogen resources while corporations retain intellectual property monopolies and commercial gains. The complaint asserts that such an approach undermines the Pandemic Agreement’s objectives and the Right to Health. The CSO complaint is signed by 16 movements and organizations, including the TWN, Oxfam, AHF, the People’s Health Movement (PHM), Health Justice Initiative (HJI), ABIA, the Working Group on Intellectual Property (GTPI), Pan African Treatment Access Movement (PATAM), KELIN, Medicus Mundi International (MMI), the Brazilian Working Group on Access to Medicines (GTPI) Brazil, Proyecto sobre Organización, Desarrollo, Educación e Investigación (PODER), Asociación Internacional para la Salud (AIS), Society for International Development (SID), Global Fundación Grupo Efecto Positivo (GEP), iFARMA and Geneva Global Health Hub. The 8th round of PABS negotiations resumed on Monday, 14 September, as Member States returned to the negotiating table to resolve the outstanding issues in the Annex to the Pandemic Agreement. A System Born of Inequality Moderating the discussion, Sangeeta Shashikant of TWN recalled that the PABS negotiations arose from the “staggering inequalities” exposed during COVID-19 and other health emergencies. She highlighted the Pandemic Agreement’s Article 12 requirements that access and benefit-sharing be treated “on an equal footing” with terms and conditions on access and benefit sharing that provide legal certainty, traceability, consistency with the Convention on Biological Diversity (CBD) and its Nagoya Protocol, and an overall system that is transparent and accountable. She noted, however, sharp divergences in the negotiations: the EU, Norway, Japan and Switzerland, supported by other industrialised countries, have resisted measures that would make the system accountable, benefit-sharing predictable, effective and enforceable, while advocating rapid and largely unconditional access to pathogen materials and genomic sequence data. She highlighted that while the differences in positions may seem technical, actually at the core of these are issues about equity, accountability and the distribution of benefits from global scientific cooperation and in particular the realization of the right to health obligations in the context of preparing for, preventing and responding to a health emergency. The Legal Basis of the Complaint Gopakumar set out the legal reasoning behind the civil society complaint. Under Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), State obligations on the Right to Health apply not only within the borders of a Party but also in other countries. He cited paragraph 39 of General Comment No. 14 of the Committee on Economic, Social and Cultural Rights, which states, “To comply with their international obligations in relation to Article 12, States parties have to respect the enjoyment of the right to health in other countries, and to prevent third parties from violating the right in other countries”. Paragraph 39 also states that “States parties should ensure that the right to health is given due attention in international agreements” and “should take steps to ensure that these instruments do not adversely impact upon the right to health”, he added. He also emphasized that paragraph 39 further clarifies that under the Right to Health, “States parties have an obligation to ensure that their actions as members of international organizations take due account of the right to health”. “Everyone of us knows that WHO is an international organization and they [referring to EU and allies] do have an obligation to conduct themselves and their positions, especially the negotiation positions, should not undermine the right to health”, Gopakumar explained. Gopakumar gave concrete examples of how the positions of the EU, Norway, Japan and Switzerland depart from this standard. In particular they were opposing a binding requirement that a share of vaccines, therapeutics and diagnostics be earmarked for WHO distribution during a Public Health Emergency of International Concern (PHEIC) and early-stage outbreaks before it escalates into a declared pandemic; and resisting even a basic user-registration requirement for accessing pathogen sequence data – a safeguard, he noted, far less onerous than the sign-up requirements routine on ordinary email or social media accounts. He also invoked the right to benefit from scientific progress and its applications under ICESCR Article 15.1(b). This human right, elaborated in General Comment No.25, has as it core obligations the following: · Ensure access to those applications of scientific progress that are critical to the enjoyment of the right to health and other economic, social and cultural rights; · States parties have a duty to prevent unreasonably high costs for access to essential medicines; · Access to research results and their applications should be regulated in a form that allows developing countries and their citizens adequate access to these products in an affordable manner, such as access to essential medicines; · International cooperation: If a pandemic develops, sharing the best scientific knowledge and its applications, especially in the medical field, becomes crucial to mitigate the impact of the disease and to expedite the discovery of effective treatments and vaccines. Gopakumar explained that geographically diversified production under PABS is intended to prevent supply bottlenecks during health emergencies by enabling WHO-licensed production in multiple regions. However, the proposal for recipients (developers/manufacturers) to provide production licenses as a mandatory benefit has been opposed by those four countries. He argued that their positions risk undermining existing international access and benefit-sharing norms under the CBD and Nagoya Protocol, as well as the rights to health and to science. Human Rights Matters: PABS Must Transform the Structural Conditions of Global Health Inequality Sekalala stressed that “human rights matter because at the heart of this are humans”, ultimately it is about protecting “the most dispossessed” and “the most vulnerable.” A human-rights approach requires States to assess whether international cooperation will actually deliver equitable outcomes. She warned that “if States create rules that will globalize rapid access to pathogens and sequence data while leaving access to vaccines and know-how in the concentration of a very few hands of people whom we now know we cannot trust when push comes to shove, because they will not do the right thing, then we haven't created a system that is human rights compliant by its very nature, because we know from experience that we cannot just rely on people without any obligation to do the right thing.” She emphasised that States’ human rights obligations do not disappear when negotiating international agreements. Therefore, she stressed human rights should inform and guide the negotiations. She said “it's really important in light of their existing obligations under Article 12 of the International Covenant on Economic and Social and Cultural Rights to really take to heart this obligation and the right to health within their existing negotiation strategy, so that it's not an abstract right, it's something that they're using fundamentally every day”. Under Article 12 of the ICESCR, States must consider the right to health not only domestically but also through “international assistance and cooperation.” General Comment 14 reinforces this obligation by requiring States to take the right to health into account when concluding international agreements. Against this broader framing, Sekalala argued that the question for Member States is not simply whether having an agreement is marginally better than having no agreement at all, but whether it will make a “tangible difference” to the right to health. In Sekalala’s assessment, many of the limitations and caveats being proposed by developed countries will mean there is no tangible difference for the Global South. The objective should instead be to “create a status quo [...] (in which) access is non-discriminatory, is globally distributed across the world for the countries in most need. [...] The test is not whether PABS will create some redistribution during the next pandemic, but whether the system changes the material conditions through which scientific progress enables resources to circulate globally[...] If this system doesn't change, then actually we have failed.” This means moving beyond “tinkering at the edge of the percentages” and addressing more structural questions, including manufacturing capacity, intellectual property and access to technology. She further stressed the importance of international cooperation, noting that States must consider how their actions affect people in other countries. Referring to the UN Committee on Economic, Social and Cultural Rights' COVID-19 observations, she highlighted the call for States to use their influence in international organisations to advance “universal equitable, affordable access to vaccines and medicines.” On PABS specifically, Sekalala argued that “pathogen and benefit sharing [must be] on an equal footing”, clarifying that real reciprocity should ensure that countries with weaker manufacturing capacity can access the resulting medical products when they need them. She also linked PABS to the right to science under Article 15 of ICESCR, emphasising that international cooperation is essential to ensuring that the benefits of scientific progress are shared broadly. She cautioned against allowing corporate interests to take precedence over human rights, urging States to return to the principle that human rights are “fundamentally about people.” Sekalala concluded by saying that “PABS gives us an opportunity to create something where we acknowledge that health systems have been deeply colonial, deeply extractive. And we have an opportunity here to re-address this structural inequity.” But she warned that PABS will fail if it focuses narrowly on pathogen access while leaving the broader structures of inequality untouched. “A PABS system will fail its purpose if it allows access to pathogens while leaving the benefits to science untouched”. A human-rights approach therefore requires attention to “the distribution of capabilities as well as… the distribution to medicines in a crisis.” Global Health Cannot Be “Europe First”, ‘Switzerland First’ Jorge Saavedra, Executive Director of AHF’s Global Public Health Institute, brought the perspective of an organization providing health services across 50 countries, primarily in the developing world. He said that during COVID-19, AHF watched as face masks, ventilators, vaccines and medicines were hoarded by wealthy countries. When WHO members agreed in 2021 – in the aftermath of the Omicron variant's identification in Botswana and South Africa – to negotiate a pandemic treaty, AHF welcomed it as a chance to secure health equity. Instead, he said, countries that had long championed global solidarity, including EU member states, Norway, Japan and Switzerland, began blocking measures favouring equity. He said, “To our surprise, countries that had previously championed health equity and global solidarity and global cooperation […] began to push back against or block decisions favoring health equity.” This reversal, he said, was precisely why AHF decided to support the civil society complaint. He pointed out Switzerland’s host-country dynamics in Geneva: "It is clearly taking positions against developing nations and in favour of Big Pharma, an industry that is also based in Switzerland... rather than neutrality; the priority in these negotiations is Switzerland first, or, just as the European Union, it is Europe first." He added, “Perhaps what these wealthy nations should remember is something that they themselves stated a few years ago, that communicable diseases recognize neither political nor geographical borders. Consequently, an outbreak in Honduras or Congo or Bangladesh could eventually reach Europe, Japan or North America. It is in the interest of all humanity and to everyone's benefit to ensure health equity and equal access to medicines and vaccines needed to control outbreaks”, stressing further that “they should at least believe in the right to public health, something that will eventually affect them, even if they build walls around European countries.” Saavedra also recounted a conversation with a former president of Botswana, who described how the country's early, transparent sharing of Omicron sequence data was met with flight bans and trade restrictions – while the resulting vaccine formulations were patented and later sold back to Botswana at exorbitant prices. “So he (former president of Bostwana) told me, I'm not against patents, but patent rights should not belong solely to those with the technology to develop the product, 50% [...] of the benefits of the patent, should actually belong to the people who provided the blood, the blood samples from which the information for developing that new technology was derived [...]. And that came from the pathogen information provided in most of the cases by developing countries”. Saavedra argued that it is for governments to set the rules governing both patents and access to their benefits. A colonial and racialised pattern, ABIA warns Susana van der Ploeg of ABIA, a Brazilian civil society organisation with decades of experience addressing HIV/AIDS and public health, situated the PABS negotiations within a broader struggle for human rights, social justice and equitable access to health technologies. Drawing on the experience of HIV/AIDS and COVID-19, she stressed that scientific innovation alone cannot guarantee access to medicines and other health technologies. She stressed that “A medicine can exist and still remain out of reach for the people who need it.”. She highlighted that the central lesson is that patents, high prices and corporate control can determine who benefits from scientific progress and who is left behind. This makes it essential that access to pathogen samples and genetic data is directly connected to benefit-sharing. “Pathogen samples and the genetic data must be linked to fair and equitable sharing of benefits. So this is not a choice. It is an ethical duty to protect human rights.”, she said. She emphasised that PABS is not being negotiated in a legal vacuum. The Convention on Biological Diversity and Nagoya Protocol have already established the principle that access to genetic resources should be linked to fair and equitable benefit-sharing. The Pandemic Agreement similarly recognises the relationship between pathogen access and benefit-sharing. van der Ploeg connected PABS to the right to participate in scientific progress and enjoy its benefits. She argued that this right cannot be understood simply as a right to contribute to or access scientific knowledge. It must also address how the economic and technological value generated through scientific collaboration is owned and distributed. She warned that intellectual property is not a secondary issue and that patents, trade secrets, exclusive licences and other forms of intellectual property protection can concentrate ownership and financial benefits in the hands of companies and countries that control those rights. She stressed that IP is a ‘central barrier’ to production and access. She recalled that during COVID-19, more than 100 countries supported the TRIPS waiver to temporarily remove intellectual property barriers, but several developed countries and the European Union blocked the proposal. “And today we see the same contradiction in the PABS system. The European Union and countries such as Norway, Japan, Switzerland, support legal duties for countries to share pathogen samples and genetic data, but they resist equally strong duties to share the benefits. They resist guaranteeing access to vaccines, medicines and tests. They also resist technology transfers, license to expand production, transparency and the sharing of financial benefits. At the same time, they want to protect intellectual property monopolies over technologies developed from shared samples and data.”, she said. She placed this asymmetry within a longer history: "This position reproduces a colonial and racist logic as well." Citing the UN Committee on the Elimination of Racial Discrimination's recognition that racial discrimination need not be intentional to be unlawful, she argued that a PABS system requiring the Global South to supply biological resources and data while ownership, technology and profit remain concentrated in wealthy states and corporations "is reproducing colonialist exploitation," even without explicit discriminatory intent. "There can be no global health security without equity, and there can be no equity without access and benefit-sharing," she concluded. Charity & Goodwill is Not Good Enough Allan Maleche, speaking from an African public-health perspective, stressed that the fundamental bargain of PABS must be reciprocal: “If sharing pathogens is compulsory, sharing the benefits that come from them cannot be voluntary.” He argued that benefit-sharing is not merely a technical issue concerning samples, sequence information or contracts, but determines whether people can actually access vaccines, diagnostics and treatments during health emergencies. Drawing on the experience of COVID-19, Maleche recalled that African countries shared information, participated in research and contributed to global disease surveillance, including the early identification of Omicron by scientists in South Africa and Botswana. Yet this openness was met with travel restrictions, while African countries were later “at the back of the queue” for vaccines. He warned that similar patterns were emerging with mpox, demonstrating that “goodwill is not enough.” For Maleche, benefit-sharing must have concrete meaning. It requires sufficient supplies of vaccines, treatments and diagnostics “wherever that emergency is happening,” as well as affordability and timely delivery. Products must reach affected populations while they can still save lives, not months after the peak of an emergency”. It should also include “sharing technology, knowledge and production opportunity” so that African and other developing countries can expand their own manufacturing capacity. He argued that the PABS bargain must therefore be legally balanced: countries provide pathogen materials and sequence information quickly, while the resulting benefits are shared “quickly and fairly.” It would be unacceptable for Africa to have a legal obligation to share pathogens while receiving vaccines and treatments merely as “an act of charity.” Both sides of the bargain, he stressed, must be “clear and legally binding.” Maleche proposed several practical elements for an enforceable PABS system: standard agreements; registration and traceability; guaranteed allocation of vaccines, treatments and diagnostics; affordable access and production licences; technology transfer; and clear reporting and accountability mechanisms. He particularly stressed that anonymous access to sequence information would make accountability impossible: “A system that cannot identify its users cannot hold them accountable.” Addressing developed countries directly, Maleche acknowledged concerns about scientific openness, speed, administrative burdens and incentives for innovation, but argued that these cannot justify placing certainty on pathogen access while leaving benefit-sharing uncertain. “We are not asking developed countries to choose between innovation and equity. We need both.” He concluded that equitable benefit-sharing is also essential to global health security. Outbreaks that begin in Africa can quickly threaten other regions, while fairness can build the trust needed for countries and scientists to share information rapidly. The objective, he said, should be a system in which the success of PABS is measured not only by “how quickly pathogen materials and information move” but also by how quickly the resulting vaccines, diagnostics and treatments reach communities in need. “We are asking them to move from promises to guarantees, from charity to fairness, and from voluntary goodwill to enforceable obligations.” Beyond percentages: a structural challenge Responding to audience questions about whether PABS alone can address inequities rooted in the wider global economic system, and about bilateral government-to-government data-sharing deals that leave the terms of reciprocity undefined, the panellists agreed that legal accountability – not the goodwill of companies or donor states – must anchor the system. Sekalala argued that states retain decisive regulatory power over corporations, including licensing authority, and should not abandon that leverage. Maleche, addressing a question on bilateral agreements, insisted that any sharing of health data must specify from the outset who may use it, for what purpose, and what must be returned – whether through affordable products, technology transfer, local manufacturing or research access. Shashikant, closing the discussion, said the negotiations cannot be judged a success if they produce only marginal shifts from the status quo. "It's not just about your population," she said of States' obligations. "It's your obligation to also support, through international cooperation, the realisation of the rights of people in other countries." The panel's shared conclusion was unambiguous: without enforceable, reciprocal obligations linking access to pathogens with access to the benefits including resulting vaccines, treatments and diagnostics, the WHO's new pathogen-sharing system risks becoming, in Susana van der Ploeg’s words, another chapter in which "the Global South shares everything while companies in wealthy countries control the technologies and the profits."
|
||
