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With the sixth meeting of the Intergovernmental Negotiating Body (INB) meeting to develop a  pandemic accord currently underway in Geneva, the World Health Organization (WHO) chief minced no words when he slammed “groups with vested interests” for trying to sabotage the negotiations. “Twenty years ago, the tobacco industry tried to undermine negotiations on the WHO Framework Convention on Tobacco Control. The same thing is happening now,” Dr Tedros Adhanom Ghebreyesus told a media briefing at the WHO headquarters in Geneva on Wednesday. “Groups with vested interests are claiming falsely that the accord is a power grab by WHO, and that it will stymie innovation and research. Both claims are completely false,” said Tedros.

This Policy Brief discusses the state of play of the negotiations of the pandemic instrument at the World Health Organization. The Intergovernmental Negotiating Body (INB) is increasing its meetings as the target deadline for completion in the first half of 2024 draws closer. To advance, the political will needs to be scaled up in the next months. The expectations should not be lowered to focus on the lowest common denominator. Real progress needs to be made in priority areas of concern for developing countries to keep momentum.

As Johnson & Johnson’s (J&J) 20-year primary patent on the critical, lifesaving drug-resistant tuberculosis (DR-TB) drug bedaquiline expires in India today, Médecins Sans Frontières/Doctors Without Borders (MSF) called on the US pharmaceutical corporation to publicly announce it will not enforce any ‘secondary’ patents for the drug in any country with a high burden of TB, and withdraw and abandon all pending secondary patent applications for this critical drug everywhere. MSF also called for a commitment from J&J to not take any legal action against any generic manufacturer that exports generic versions of bedaquiline to or from countries where secondary patents on the drug exist. The corporation should make this announcement public by the UN TB Summit taking place in New York this September. 

As the primary patent on Tuberculosis drug Bedaquiline expires in India and other countries on Tuesday, at least three Indian companies — Lupin, Natco and Macleods — are poised to bring out their generic versions of the drug. A precise timeline on when the companies would launch bedaquiline is not defined, given the evolving global scenario on the drug, but industry sources told businessline that some of them were in the local regulatory process. Last week, J&J granted the Stop TB Partnership’s Global Drug Facility licences that would enable them “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.

Roland Driece, co-chair of the Bureau of the Intergovernmental Negotiating Body (INB), told the body’s sixth formal meeting that while he understood member states’ eagerness for a first draft on which to start text-based negotiations, discussions on Chapter Two of the compilation text (referred to as WHO CA+), focusing on equity, should be completed first. “I would rather have a first draft that has substance which we all feel is strong enough to have real line-to-line discussions on, than having something in between which is not good enough yet,” said Driece. “So I would rather have a good first draft than a quick first draft, but we will come back with a proposal on how to get there.” 

Once it became clear that wealthy nations would help themselves to coronavirus vaccines long before poorer nations had access, researchers across Africa, Asia and South America banded together with the World Health Organization. Never again, they vowed, would they allow themselves to be at the mercy of the Western world while a deadly pathogen tore through their regions. They launched a sprawling initiative that included companies and institutes in 15 middle-income countries in the global south, the half of the world longing for coronavirus vaccines in 2021 even as wealthy countries stockpiled doses. The groups aimed to develop their ability to produce messenger RNA vaccines. … Called the mRNA vaccine technology transfer hub, a mouthful meant to reflect their intention to share mRNA technology, the initiative is distinct from the typical, competitive mode of drug development in which companies keep discoveries secret. … The United States has not funded the initiative thus far. The bulk of the program’s funds are from Canada, France and the European Commission.

The move will allow Stop TB Partnership to offer licences to tender, procure, and supply generic versions of SIRTURO, otherwise known as bedaquiline, in 44 new countries, including those where J&J’s patent remains in effect, nearly doubling the reach of the company tuberculosis treatment. “In my knowledge, I can’t recall a similar deal to this,” Brenda Waning, chief of Global Drug Facility, a partner in distributing the drugs, told Forbes. She said she hopes the project can “set a model” for other companies. … Mr Green’s followers briefly made #PatientsNotPatents a trending topic on Twitter. In April, Doctors Without Borders also called on the drug company to make the treatment more available.

… 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.

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.