From ... in Health — May 6, 2021

COVAX: Enhance Transparency, Share Intellectual Property

(New York) – The COVAX vaccine initiative should publish its contracts with vaccine developers and facilitate sharing of intellectual property to make vaccines swiftly available and affordable for all, Human Rights Watch, Amnesty International, and Public Citizen said today. COVAX, which was created in April 2020 to procure and distribute vaccines to low- and middle-income countries, should incorporate human rights standards and principles of transparency and accountability. The groups wrote to the leadership of COVAX on December 14 with questions related to COVAX human rights policies and practices, and recommendations related to transparency and vaccine availability and affordability, among others. COVAX responded in detail in a March 25, 2021 letter, following a preliminary response on January 6. “COVAX should be stronger on human rights and transparency so it can deliver critical, lifesaving vaccines swiftly to the dozens of countries relying on them,” said Arvind Ganesan, business and human rights director at Human Rights Watch. “Publishing contracts and prices while sharing intellectual property is a good way to start ensuring that vaccines are affordable and available for billions of people who desperately need them.” COVAX has the responsibility to undertake robust human rights due diligence in accordance with the UN Guiding Principles on Business and Human Rights and the 2008 Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines that were issued by the UN special rapporteur on the right to health. As part of its human rights due diligence, COVAX should respond to concerns related to supply, manufacturing capacity, the intellectual property landscape, and pricing, and regularly publish results and impacts, the groups said. What is COVAX? COVAX is led by three organizations: the Coalition for Epidemic Preparedness Innovations (CEPI), which funds vaccine development and manufacturing; Gavi, the Vaccine Alliance, which works on pooled procurement and delivery; and the World Health Organization (WHO), which coordinates vaccine allocation. COVAX was created to help low- and middle-income countries access vaccines by sharing risk and pooling procurement and is largely funded by governments. It also plans to reserve 5 percent of those vaccines to allocate as a “last resort” through a humanitarian buffer to cover high-risk groups where there are gaps in vaccination coverage, including areas controlled by non-state armed groups that are inaccessible to governments. The facility began delivering vaccine doses in late February. It had only been able to deliver 49 million doses to over 100 countries as of April 30. It aims to provide vaccines for at least 20 percent of participants’ populations. It also faces a significant funding shortfall. On April 8, COVAX announced it needed to raise an additional US$2 billion to reach its goal of supplying 2 billion doses this year. For countries significantly dependent on COVAX for their vaccines, even achieving this goal is far from the vaccination coverage needed to reach herd immunity. For example, the Africa Centers for Disease Control and Prevention has identified a goal of vaccinating at least 60 percent of Africa’s population by 2022. Urgent Need for Transparency COVAX has said it aims to maintain transparency around its plans and operations except when disclosure would violate confidentiality obligations. Since mid-December, COVAX has increased public disclosures of information related to its work, including vaccine distribution, provided summaries of CEPI’s funding, and committed to publishing a summary of Gavi’s deals for COVAX. The groups urged COVAX to publish all contracts surrounding vaccine research and development, and procurement, and to publicly disclose additional details related to country and industry participation, and pricing. However, COVAX responded that its contracts “contain commercially sensitive and proprietary information protected under confidentiality obligations” that cannot be disclosed. Instead of relying on confidentiality clauses, COVAX should ensure that its work is fully aligned with UNICEF’s longstanding practice of price transparency, and publish all its contracts to facilitate accountability over public expenditure, the groups said. While COVAX said it was “working with manufacturers committed to minimal profit pricing,” it has not yet published details about procurement pricing and profits in its agreements with vaccine developers and manufacturers. COVAX also has yet to publicly commit to verifying such pricing through a third-party audit. Governments and other donors funding COVAX should demand maximum transparency and accountability, including to verify all commitments by companies to supply COVAX at nonprofit prices or minimal profit pricing through third-party audits whose results are publicly shared. This is especially important as governments purchase vaccines through COVAX with public money and financing. Publishing contracts and procurement prices is key to providing the public a way to monitor government spending and is a bulwark against conflicts of interest and corruption. “COVAX should lead in transparency, not lag,” said Peter Maybarduk, access to medicines director at Public Citizen. “It should show the way forward in sharing technology and know-how, so the world can build a pandemic resilient future, rather than allowing pharmaceutical corporations to dictate terms.

The World Health Organization must push its COVAX partners, Gavi and CEPI, to expect more of the pharmaceutical giants benefiting from their resources.” Recommendations to Expand Global Supply Global vaccine distribution has been highly skewed toward higher-income countries. Though nearly 200 countries have started vaccination, more than 87 percent of vaccines have gone to high-income or upper middle-income countries, while only 0.2 percent has gone to low-income countries, according to a World Health Organization statement on April 9. Vaccine supply shortages have severely hampered and delayed COVAX work. Factors causing the problem include shortages and supply disruptions in raw materials for vaccines needed to bring production to a global scale, the practice by high-income governments of pre-booking a major surplus of vaccines, exclusive licensing, and ever-shifting export policies. Expanding and diversifying manufacturing through sharing of intellectual property and open, non-exclusive licensing are key to the success of COVAX in the short- and long-term, the groups said. The groups specifically urged COVAX to publicly endorse and align its work with the WHO’s Covid-19 Technology Access Pool (C-TAP), a platform for sharing knowledge, intellectual property, and data necessary for the Covid-19 response. COVAX responded that aligning and co-operating with C-TAP “is not an immediate priority,” given the pressure it faces to meet its vaccine delivery goals this year. “COVAX should recognize that the sharing of knowledge and intellectual property is essential to fulfilling its own mission of guaranteeing fair and equitable access for every country in the world,” said Tamaryn Nelson, health adviser at Amnesty International. “By refusing to engage with initiatives that have the potential to significantly boost global vaccine supply, COVAX seems to be shooting itself in the foot and hampering its very own work.” Additionally, India and South Africa introduced a proposal at the World Trade Organization in October 2020 to temporarily waive some intellectual property rules under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) until widespread vaccination is in place worldwide. Approval would help expand global manufacturing. The proposal has the support of more than 100 countries and hundreds of civil society organizations, but has been stalled for over six months by a handful of high-income governments, including the US, the European Union (represented by the European Commission), the United Kingdom, Canada, Australia, Switzerland, Japan, and Brazil. Some governments have cited their funding commitments to COVAX while continuing to block the waiver proposal, even though the two efforts are completely different and complementary in nature. The WHO has publicly supported the waiver. CEPI and Gavi should also publicly support the waiver and urge governments to do the same, the groups said. However, COVAX said it does not believe that intellectual property barriers are a key constraint to vaccine distribution and production. Instead, it believes that high start-up costs and complicated production processes are the major impediments. CEPI funds vaccine developers and requests information about patents and legal disputes from its potential awardees but does not publish this information. CEPI could require awardees to share intellectual property as a condition for receiving funding, and enforce compliance with its equitable access policy more firmly, including by issuing public health licenses, but it has not yet done so. Intellectual property rights experts have publicly highlighted how exclusive licensing, in which a company decides to whom and on what terms to grant a license to produce their technology, often with restrictive conditions and control over price and volumes, has exacerbated Covid-19 vaccine shortages, especially in the short-term. COVAX should do its due diligence around the concerns raised and take action to remedy any potential risks, in line with international human rights norms, the groups said.

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