Bedaquiline donations threaten sustainable, affordable access for patients; letter to India’s Health Minister

More than 30 treatment activist organisations, public health organisation and patients have signed on to a letter to India’s Health Minister explaining the pitfalls of ad hoc donations from Pharmaceutical companies.
They call for the MOHFW to put in place clear guidelines in accepting donations from pharmaceutical companies, to safeguard against potential conflicts of interest that can undermine the role of the MOHFW and any of its agencies/committees, to regulate companies and take actions necessary for protecting patient safety.

As treatment activists, public health organizations, patients affected by TB and patients affected by Johnson & Johnson’s (J&J) faulty hip implants, we are writing in response to the recent announcement about a second round of donations of 10,000 courses of bedaquiline (BDQ) by J&J to the Indian Government [1]. J&J had previously donated 10,000 courses of BDQ to India’s TB programme in 2016, as part of a global donation programme operated in partnership with the U.S. Agency for International Development (USAID). The announcement of the new donation comes a full three years later in the backdrop of multiple regulatory actions and investigations by the MOHFW into harmful medical devices and cosmetic products marketed by J&J in India. Not only do these ad-hoc and piece-meal drug donations threaten the sustainability and predictability of the government’s MDR-TB treatment programme, the timing of the announcement certainly raises serious concerns that the donations are aimed at undermining strict regulatory action by the Ministry of Health and Family Welfare (MOHFW) and extracting concessions or leniency from the government.

Pitfalls of drug donations and threat to treatment access
BDQ is an important new drug in the treatment of MDR-TB. The “WHO consolidated guidelines on drug-resistant tuberculosis treatment”, 2019 [2] has recommended that BDQ be incorporated as a core drug in the MDR-TB regimen and that the drug replace and minimise the use of injectable aminoglycosides in the standard MDR-TB treatment regimen. Injectable aminoglycosides are associated with a number of serious side effects, including irreversible hearing loss [3]. As a result countries with a high burden of MDR-TB will be looking to buy BDQ at affordable prices. India plays an important role in supporting global health as a producer of affordable medicines not only for domestic purposes but also to serve the needs of other countries, especially in respect of epidemics such as HIV/AIDS and TB. The donations of BDQ to India not only create dependence on donations from a single supplier but also stifle the Government’s willingness to promote local production of BDQ by generic manufacturers to ensure affordable, sustainable and predictable supply to the Government programme. Donations are known to delay the entry of generic producers in the market which would increase affordability through competition. The 2010 edition of the World Health Organization (WHO)’s comprehensive guidelines on drug donation [4] sound the following note of caution: “The negative impact that donations may have on sustainable access to medicines is often not well appreciated, especially where it concerns expensive medicines with few alternatives. Donations of these products may influence the market and suppress competition. The donation may eliminate or greatly delay the import of cheaper alternatives, which will be necessary once the donation programme has ended and regular provision from public health budgets is necessary.”

Read complete letter here
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