"Today's announcement by the Stop TB Partnership/Global Drug Facility about a deal with pharmaceutical corporation Johnson & Johnson (J&J), for access to affordable generic versions of the lifesaving tuberculosis (TB) drug bedaquiline, offers a short-term solution for low- and middle-income countries -- but the deal remains just a stop-gap because bedaquiline will only be available to a limited number of countries that will be included in this agreement, procuring through the Global Drug Facility. The full terms of the agreement still need to be made public. While the included list of countries has yet to be made public, we have learned that the 9 countries in the Eastern Europe and Central Asia (EECA) region, which have some of the world’s highest burden of drug-resistant TB, are excluded from this deal. We remain concerned that J&J retains the global authority to determine access to lifesaving generic versions of bedaquiline in countries with a high burden of TB, even after the expiration of the main patent next week.
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We are heartened that this arrangement will likely reduce the cost of bedaquiline around the world. And we celebrate author John Green and his many followers for shining a light on this cause and campaigning with creativity and spirit to amplify the longstanding demands of TB survivors, communities, and civil society. Nonetheless, this deal falls short of the clearly articulated demands of communities affected by TB for patent non-enforcement or withdrawal. It is a creative procurement solution that will address the acute crisis in access to this lifesaving drug without solving the larger structural injustices that led to inequitable access to bedaquiline in the first place. Patent “evergreening” tactics like those deployed by J&J allow pharmaceutical companies to game an intellectual property regime in order to extend monopoly rights over publicly funded innovations.
Over the past year, the European Parliament’s Special Committee on the COVID-19 pandemic (COVI) analysed the impact of the crisis, evaluated the effectiveness of EU and national measures and made specific recommendations to address gaps and weaknesses in their actions. Parliament debated the report on Tuesday and adopted the text on Wednesday by 385 votes in favour, 193 against and 63 abstentions. MEPs outlined a clear roadmap for future action in four main areas: health, democracy and fundamental rights, social and economic aspects, and global response to the pandemic. Key proposals include enhancing the EU’s strategic autonomy for medicines, transparency for joint procurement activities, and stronger parliamentary oversight at both EU and national levels for emergency legislation.
As United Nations (UN) member states meet in New York on Monday and Tuesday to discuss the political declaration to be adopted at the General Assembly’s High-Level Meeting (HLM) on Pandemics in September, there are growing concerns that the current draft is weak and proposes an over-reliance on the World Health Organization (WHO) to manage future pandemics. The current draft – pared down from 58 to 15 pages – has dispensed with a number of critical concerns, particularly about how future pandemics will be governed, located almost entirely with the WHO. … Pointing out that the success of the WHO negotiations currently underway to develop a pandemic accord is not guaranteed, Sirleaf and Clark reiterate their view that “sustained highest-level political leadership on pandemic preparedness and response” is essential between and during health crises. … Describing the UN HLM as “a one-time and historic opportunity to commit to lasting and transformative change to pandemic preparedness and response”, they add that if member states “only tinker with the language” of the current draft, “the efforts to agree to the declaration will be wasted”.
The current draft of the political declaration, to be the focus of consultations on July 10 and 11, does not express the commitments required of Heads of State and Government to transform the international system of pandemic preparedness and response. Instead, it reads as a health resolution.
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The COVID-19 pandemic highlighted how current international laws and practices fail to ensure medical countermeasures (ie, vaccines, therapeutics, diagnostics and personal protective equipment) are equitably distributed in a global health crisis.
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In 2021, the 194 Member States of the World Health Organization agreed to begin negotiations towards an international instrument that would better position the world to prevent, respond and prepare for future pandemics (often called a ‘pandemic treaty’.)
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A pandemic treaty presents an opportunity to address these challenges in international law, and craft a better system, based on solidarity, for the global development and distribution of medical countermeasures.
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We recommend that a pandemic treaty ensures sufficient financing for biomedical research and development (R&D), creates conditions for licensing government-funded R&D, mandates technology transfer, shares intellectual property, data and knowledge needed for the production and supply of products, and streamlines regulatory standards and procedures to market medical countermeasures.
During the COVID-19 pandemic, the public sector provided significant funding to accelerate the research and development (R&D) of health products. Globally, however, unequal and inequitable access to such products has prompted questions on how placing strategic conditions on public funding could improve access to the fruits of R&D. An important aspect of this issue is how conditions on intellectual property (IP) can contribute to achieving public policy goals such as affordable pricing and reliable supply. To facilitate the discussion, the present report provides empirical evidence of conditions adopted by publicly funded international R&D projects directed at health emergencies, with a particular focus on IP management.
The Gates Foundation unveiled plans Wednesday to fund a long-awaited trial for what, if proven effective, would be the first new tuberculosis vaccine in over a century. … The Gates Foundation, which also funded early research on the shot, has committed $400 million to the trial, and the U.K.’s Wellcome Trust is committing up to an additional $150 million. The trial will take place across more than 50 sites in Africa and Asia and likely take four to six years to complete, Trevor Mundel, the Gates Foundation president of global health, told reporters. … Although the Gates Medical Research Institute is assuring manufacturing the vaccine, GSK will continue supplying an adjuvant, a molecule designed to amplify the vaccines’ signal to the immune system. A GSK spokesperson said that given the complexity of running a Phase 3 trial in lower-income countries, the company believed the institute was the best organization to move forward with the vaccine, and that GSK’s “most important contribution to global health is the science, investigating proof-of-concept through phase 2.” If the vaccine succeeds, the Gates Foundation’s work will be far from over.
As global health negotiations on addressing health emergencies in Geneva swiftly move into a decisive phase this summer, questions on accountability and governance will be crucial parts of the puzzle that countries must put together. These issues underpin not only a new Pandemic Accord but also amendments to the International Health Regulations. In today’s edition, we bring you a guest essay from the Panel for a Global Public Health Convention, that is suggesting an Independent Assessment Body and governance committees as defining features to improve accountability in the remaking of the governance of health emergencies. Also see the Bureau’s Text for a Pandemic Accord with suggestions on governance.
Three multilateral development banks and the World Health Organization (WHO) announced the launch of an investment platform on Thursday aimed at supporting low and middle-income countries to build their primary healthcare (PHC) services via grants and concessional loans.
PHC is widely recognised as the most effective way to improve health and well-being, and the recent World Health Assembly recognised it as the driver of universal health coverage, one of the United Nations Sustainable Development Goals (SDGs).
https://The Health Impact Investment Platform (HIIP), launched during the Summit for a New Global Financing Pact in Paris, will make an initial €1.5 billion available to LICs and LMICs in concessional loans and grants to expand the reach and scope of their PHC services.