July 1, 2022 – A new generic version of bedaquiline produced by Macleods Pharmaceuticals in India has cleared the Global Fund’s Expert Review Panel (ERP), an independent group of experts that reviews finished pharmaceutical products and makes recommendations on their use to the Global Fund. While ERP approval is a first step to unlocking access in Global Fund funding eligible countries and other countries with procurement agencies that recognise ERP quality standards, several barriers still stand between national programs and this potentially more affordable version of bedaquiline.
In recent years bedaquiline has become the cornerstone of treatment regimens for drug-resistant tuberculosis (DR-TB)– a tough-to-treat form of the disease that affects an estimated 500,000 people every year worldwide. Prior to the introduction of this transformational drug, DR-TB was treated using toxic regimens lasting up to two years, with rates of treatment success below 50 percent. With bedaquiline given in combination with other new and repurposed TB medicines, DR-TB can now be treated in as little as six months, with rates of treatment success ranging from 70–90 percent depending on the regimen.
And yet, despite the obvious desirability of treatment regimens anchored by bedaquiline, it still isn’t used as widely as it should be around the world. One major reason for this is the price. Johnson & Johnson sells a six-month course of bedaquiline for US$270 (US$1.50 per day), inflating the overall cost of shorter treatment regimens for DR-TB. In Russia and other countries that are part of the Commonwealth of Independent States (CIS), Johnson & Johnson’s commercial partner, Pharmstandard sells a six-month course of bedaquiline for up to US$2,000 (US$11 per day). Despite updates to World Health Organization (WHO) guidelines that have dramatically expanded the role of bedaquiline in the treatment of DR-TB, many country programs purchase only a limited amount of it each year and ration their constricted supply among a smaller pool of patients than should ultimately benefit. The unfortunate result is that communities affected by DR-TB around the world are still receiving outdated and lengthy regimens that can cause permanent disability (e.g., hearing loss) and are less likely to successfully cure them and prevent future antimicrobial resistance.
The new generic version of bedaquiline produced by Macleods has the potential to expand access to shorter, safer, and more effective regimens and make DR-TB treatment less traumatic for patients. In addition to Macleods, other manufacturers are developing generic bedaquiline and may have already filed their products with the ERP, meaning multiple bedaquiline generics could be available soon. Researchers from the University of Liverpool estimate that with adequate volumes, generic competition could bring the price of bedaquiline down to US$0.50 per day. Unfortunately, though, no one can experience the benefits of a potentially more affordable version of bedaquiline immediately (or even in the near future in many places) without government intervention.
Because Johnson & Johnson retains intellectual property protections on bedaquiline until at least 2027 in 64 low- and middle-income countries, generic versions of the drug cannot be sold or distributed until these patent protections expire. That is unless the Government of India, and other country governments where Johnson & Johnson has filed or been granted patent protections on bedaquiline, issue compulsory licenses.
The primary patent on bedaquiline expires in most places in 2023 but evergreening – the practice of excessively extending patent protections to limit competition – extends Johnson & Johnson’s monopoly out several years. Activists from communities around the world have been working to oppose such patents with limited success so far. As such, compulsory licenses in accordance with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and supported by the Doha Declaration on the TRIPS Agreement and Public Health are necessary in order for generic producers to be able to manufacture and sell generic bedaquiline domestically, as well as to export it to other countries where patent monopolies on bedaquiline exist, and for other country governments to be able to purchase and import generic bedaquiline.
In lieu of individual country governments issuing compulsory licenses, Johnson & Johnson and its commercial partners could commit to not enforcing its intellectual property rights on bedaquiline in India and other low- and middle-income countries. Activists have long argued that bedaquiline should be treated as a public good, especially considering the substantial public and philanthropic investments in the drug’s development, which have been estimated to exceed Johnson & Johnson’s by a factor of 1.6–5.1.
Communities affected by TB everywhere have a right to benefit from scientific progress, including access to short-course, bedaquiline-based treatment regimens for drug-resistant TB. To ensure that they do, we call on:
- The Government of India to respond to the petition filed before the High Court of Bombay (Meera Yadav & Anr. v Union of India & Ors. PIL (L) No. 495 of 2021) and issue a compulsory license to enable local developers to manufacture bedaquiline both for domestic use and for export to countries with insufficient manufacturing capacity to ensure access to generic versions of bedaquiline and the scale up of government procurement and implementation of the medicine;
- The Governments of Brazil, Belarus, Indonesia, Kazakhstan, Kenya, Kyrgyzstan, Moldova, Mozambique, Pakistan, Philippines, Russia, South Africa, Thailand, Ukraine, Vietnam, and other high TB burden countries where patents will block access to generic bedaquiline until 2027 and beyond, to issue compulsory licenses to enable local manufacturing or importation of generic bedaquiline for local use;
- The Governments of Bangladesh, Democratic Republic of Congo, Myanmar, Nigeria, and other high TB burden countries where patents have not been filed to ensure local manufacturing of generic versions of bedaquiline and/or the expedient and transparent procurement of generic bedaquiline and enrollment of all eligible patients onto bedaquiline-based treatment regimens;
- Macleods Pharmaceuticals and other generic manufacturers to begin filing with national regulatory authorities where necessary and commit to selling generic bedaquiline for no more than $0.50 per day; and
- Johnson & Johnson to commit to not enforce its intellectual property rights.
Finally, we encourage advocates working at the national level to take whatever steps possible to pressure their government officials to act in defense of communities affected by TB and in line with their right to benefit from scientific progress. Governments have “a duty to make available and accessible to all persons, without discrimination, especially to the most vulnerable, all the best available applications of scientific progress necessary to enjoy the highest attainable standard of heath.” — General Comment 25, Committee on Economic, Social and Cultural Rights. Bedaquiline is an essential medicine, and access to bedaquiline is essential to upholding the rights to health and life of people with TB.
