The call for compulsory licenses on two new tuberculosis (TB) drugs has got louder, with Geneva-based intergovernmental organisation, the South Centre urging countries like India to explore such action and expand access to these breakthrough medicines.
Johnson and Johnson’s Bedaquiline and Otsuka Pharmaceutical’s Delaminid are the two drugs holding out hope for people living with multi and extremely drug resistant TB (MDR and XDR TB). They are presently also at the heart of a Public Interest Litigation (PIL) in the Bombay High Court that urges the Centre to use CLs under the Patents Act (1970) to improve access.
A CL allows a third party to make a similar version of the innovative drug at a lower cost, on payment of royalty to the innovator.
In its statement on World Tuberculosis Day this week, South Centre said, it encouraged developing countries to “authorise production of essential TB drugs for government use or compulsory licenses if these are patent-protected in their territories to scale up treatment for and stall spread of drug-resistant TB, in line with the Sustainable Development Goal of ending the TB epidemic by 2030.”
Eight countries account for two thirds of the total TB cases, with India leading the count, followed by Indonesia, China, the Philippines, Pakistan, Nigeria, Bangladesh and South Africa, it said.
Leena Menghaney, with humanitarian organisation Medecins Sans Frontieres (MSF) Access Campaign, pointed out that the World Health Organization treatment guidelines provided for “salvage” regimens containing these two drugs for patients with limited treatment options due to extensive resistance.
Call for more producers
The petitioners in the PIL heard earlier this month were Meera Yadav, a TB survivor, and Jan Swasthya Abhiyan (Mumbai), through its co-convenor Brinelle D'Souza, also a TB survivor. The Centre has till April 28th to respond.
They called out the Centres reliance on donations from 'these companies for these medicines and pointed to international organisations that have advised against such a dependence, without alternatives.
Counsel for the petitioners, Anand Grover explained that a Government authorization or a CL would allow generic companies to make the drugs, paving the way for affordable drugs.
Support access
A J&J India spokesperson told BusinessLine , they were a “longstanding and committed partner” in the fight against TB.
To support India’s efforts “we provided the government with 22,000 courses of our medicine, free of charge, through our four-year global donation program. Today, bedaquiline is available to India and more than 135 low- and middle-income countries at a not-for-profit price through the Stop TB Partnership’s Global Drug Facility, and we have sufficient manufacturing capacity to meet current and future needs,” the spokesperson said.
Revenues from bedaquiline are reinvested in critical access-related activities, including quality-assured manufacturing, responsible distribution, etc, they added.
Ambitious goals of ending TB require innovation to develop new tools, and an ecosystem that encouraged “fair pricing and appropriate IP protections”, the spokesperson said. However, they added, the biggest barrier to treatment access in India and globally was that millions went undiagnosed. Otsuka sells Delaminid in India through multinational generic company Mylan. The company did not respond to an email seeking comment on the CL call on the drug.