May 6, 2021

The Honorable Amb. Katherine C. Tai
United States Trade Representative
Executive Office of the President of the United States
600 17th Street NW
Washington DC 20508


Re: Facilitate Generic Access to TB Medicines and Protect Public Health


Dear Ambassador Tai,

We welcome your new leadership as an opportunity to both restore and build global confidence in the U.S. and to respect multilateral trade rules that protect countries’ access to essential medicines and abilities to respond rapidly and equitably to matters concerning public health.

The COVID-19 pandemic sheds light on how stringent intellectual property and exclusive licensing (and the moral failures of high-income country governments) can obstruct the swift scale up of manufacturing capacity of treatments, diagnostics, and vaccines, and hinder affordable and timely access around the world. To overcome anti-competitive practices that limit access to life-saving medicines, particularly for drug-resistant tuberculosis (DR-TB), we represent TK civil society organizations that call upon the U.S. Trade Representatives (USTR) to stand down on India’s efforts to issue compulsory licenses for anti-tuberculosis medicines bedaquiline and delamanid.

With an annual incidence of 124,000 cases, India accounts for 27% of the global burden of DR-TB. Tuberculosis (TB) was declared a global emergency by the World Health Organization (WHO) in 1993 and a national emergency by Government of India in 2014. TB, the leading infectious disease killer in the world until COVID-19, continues to be a global driver of antimicrobial resistance (AMR). In 2019, just 45% of people with DR-TB in India were started on treatment. Impacts of the COVID-19 pandemic and related restrictions have had damaging effects on the TB response globally and especially in India. Research conducted by the Stop TB Partnership recently determined that TB outreach and services sidelined over the last year as countries battled COVID-19 resulted in a 20% drop in TB diagnosis and treatment worldwide, essentially erasing 12 years of progress in the global fight against TB. The Government of India reported a 70% drop in TB case notifications between the 10th and 15th weeks of 2020.

Between 2016 and 2017, bedaquiline and delamanid were initially made available by the Government of India in limited quantities and sites under the Revised National TB Control Program’s (RNTCP’s) conditional access program using 600 courses of bedaquiline and 400 courses of delamanid donated by Janssen and Otsuka, respectively. In 2019, and in line with the global standard of care determined by the WHO, the Guidelines on Programmatic Management of Drug Resistant Tuberculosis in India 2019 (PMDT 2019 Guidelines) recommended that bedaquiline be given to all DR-TB patients in India, as it is one of the core drugs with the least risk of side effects among all second-line drugs, and that delamanid be used as one of the preferred add-on drugs to complete regimens when other DR-TB drugs cannot be used. Yet by the end of March 2020, only 10,845 and 368 persons had received bedaquiline and delamanid, respectively. The continued extortionate prices charged for a six-month course of bedaquiline (US$360) and delamanid (US$1,237) and insufficient and unsustainable drug donation programs that are dependent on the “good will” of pharmaceutical companies have left the National TB Elimination Program (NTEP) in India to ration access to these life-saving medicines.

As has been rightly pointed out in the context of over 100 countries’ proposal before the World Trade Organization (WTO) to waive certain intellectual property provisions related to the “prevention, containment and treatment of COVID-19,” in authorizing compulsory licenses for medicines required to treat drug-resistant TB, the Indian government’s actions are legal and permissible under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and are in line with the Doha Declaration on TRIPS and Public Health.

India, like many low- and middle-income countries across the globe, is struggling to sustain critical TB, viral hepatitis, and HIV programs, particularly in middle of a concurrent public health crisis like COVID-19. In line with President Biden’s executive order for all federal agencies to fix systemic inequities in their operations (E.O. 13985 of Jan 20, 2021), the USTR could play a significant role in supporting countries which make use of legal public health safeguards which are consistent and align with international trade and intellectual property rules. The U.S. Government and USTR can maximize this opportunity to restore global diplomacy and confidence through increased collaboration necessary to facilitate generic competition and affordable access to the life-saving medicines, bedaquiline and delamanid, by resisting the deployment of its usual suite of intimidation tactics often used to do the bidding of pharmaceutical companies at the expense of public interest and a more equitable, just, and healthy world.

We urge your office to take the opportunity to “build back better” -- a central mantra of the Biden-Harris administration-- by respecting India’s sovereign right to invoke lifesaving legal tools enshrined in international law to restore the health and dignity of its citizens, whose lives have been wracked by concurrent public health crises.

Sincerely,

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