… Critics have pointed out gaps in the deal. For one thing, 17 countries including Russia and other former Soviet republics with high burdens of MDR TB are excluded from generic access by a license that J&J signed in 2018 with the Russian pharmaceutical company Pharmastandard. The company has exclusive commercial rights to supply bedaquiline in those countries. There, it already charges significantly more for the drug than the current GDF pricing, which is $272 for a 6-month course, or $45 per month. (Researchers estimated in 2017 that the price of the generic medicine would range from $8 to $17 per month, based on the price of ingredients, regulatory requirements, and other variables.) These 17 countries can already procure the branded drug from J&J through GDF—and its price in some countries may drop as a result of the competitive bidding process this month, Waning notes. Other countries with high MDR TB burdens, such as South Africa and Indonesia, don’t procure drugs through GDF and are similarly excluded.
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The WHO and other stakeholders, including CSOs, are developing a medical countermeasures platform (MCP) for future pandemics. Many are concerned that this will repeat key mistakes in the global COVID-19 response. The global COVID-19 response was coordinated through the Access to COVID-19 Tools Accelerator (ACTA), which demonstrated some success, but also missteps and failures. Given the likelihood of a pandemic as serious as COVID-19 occurring in the 25 years, we unpack several reforms that are needed to increase equity in the next pandemic.
Following lengthy negotiations, Johnson & Johnson has granted Stop TB Partnership's Global Drug Facility’s licenses that enable Global Drug Facility (GDF) to tender, procure, and supply generic versions of SIRTURO® (bedaquiline) for the majority of low-and middle-income countries, including countries where patents remain in effect. GDF has shared with the TB community important updates on plans to launch a global, competitive tender for bedaquiline by end July 2023. All bedaquiline suppliers that meet GDF`s quality criteria are eligible to participate in the GDF bedaquiline tender and have been briefed on the tender goals, processes, and timelines.
"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.
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.