Info Service on Health Issues (May19/03)
29th April, 2019
Dear Nadda ji,
Ad-hoc donations of bedaquiline threaten sustainable, affordable access for patients; Create conflict of interest for MOHFW in regulating Johnson & Johnson
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 IndianGovernment .
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  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 .
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  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.”
J&J’s attempts to extend its monopoly on BDQ in India are being challenged by people living with HIV and people with TB through patent oppositions of secondary patent claims; health groups have also called on the government to issue a government use license under Section 100 of the Patents Act to enable generic producers to make BDQ for India and for the rest of the developing world. It is therefore extremely disappointing to see the government’s continued reliance on donations from J&J for MDR-TB treatment.
This is an unsustainable approach to running India’s TB programme that is meant to serve and treat the world’s highest burden of TB and MDR-TB cases. This is also antithetical to the Government’s goal to eliminate TB in India by 2025.
The use of donations by India represents a larger threat to the global supply of affordable BDQ, particularly important for low- and middle-income countries which are grappling with high burdens of TB, and will contribute to keeping the price of BDQ high worldwide.
Conflict of Interest in respect of regulating J&J
On the one hand, J&J continues to control the supply of BDQ to the detriment of patients in India and the rest of the developing world. On the other, it is employing every tactic possible to avoid civil and criminal responsibility for harmful medical devices that it has sold to patients in India.
As you are aware, some time back a Committee appointed by the MOHFW had looked into the issue of J&J’s ASR hip implants. During the course of the enquiry into this matter, the company was found to have violated regulatory rules, concealed information that had bearing on patient safety and to have demonstrated negligence in informing patients about the recall of the ASR hip implant. As a result grievous harm was caused to patients.
To redress the injury and delay in justice to patients, a process was initiated under the MOHFW to compensate patients for the faulty hip implants. However, J&J launched a legal challenge against the compensation mechanism in the Delhi High Court and while flouting the Ministry’s instructions has refused to pay compensation to any patients, in spite of there being no stay on the relevant orders.
Recently concerns have emerged regarding the safety of other products marketed by J&J  and about unethical business practices .
Given the string of regulatory actions and investigations into J&J’s products recently, the announcement of the BDQ drug donations has led to apprehensions that the donations are an attempt to whitewash its image and induce leniency by the Government for the company’s transgressions, particularly in relation to refusal to compensate Indian patients of ASR hip implants, which the Government is pursuing actively both in and outside the Courts.
Therefore, we urge that there is a need 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. The Government and in particular the MOHFW should maintain an “arm’s length approach” from any such seemingly benevolent acts of welfare by J&J, as it continues to defend a position that smacks of corporate greed and apathy towards Indian patients in faulty hip implants and multiple such cases.
We therefore request the MoHFW to:
India Drug Action Network (AIDAN)
Ashwini Kumar Choubey, Minister of State, Ministry of Health &
For further information, contact: