Underdiagnosis of tuberculosis is the most significant barrier to treatment access, said Johnson and Johnson, as public health voices call on the United States healthcare major to not pursue secondary patents on TB treatment drug bedaquiline.

The primary patent on bedaquiline had expired this week, in India and other countries, but treatment activists have been calling on the company to not enforce secondary patents that could jeopardise efforts to bring out less expensive versions of the drug.

“The most significant barrier to treatment access for patients today is underdiagnosis of the condition. In 2021, nearly 4,50,000 people became sick with MDR-TB while only 1,60,000 people were enrolled for treatment. This is a challenge for which we have invested significant resources to overcome and we must all get behind if we are to save lives and achieve the global goal of ending TB,” a J&J spokesperson said, responding to a businessline query on calls to not pursue secondary patents on the drug in high-burden countries.

“We have shipped more than 6,60,000 courses of bedaquiline across 159 countries since launch. Our access efforts include assisting countries to scale-up their use of our medicine responsibly and sustainably and we invest in multiple, critical anti-TB efforts,” J&J said, including its collaboration last month with the Stop TB Partnership’s Global Drug Facility. GDF is the largest procurer of TB medicines, which enables them to invite potential generic suppliers and purchase generic versions of SIRTURO (bedaquiline) 100mg”, it pointed out.

Vital drug

The reason why bedaquiline becomes critical is because it is the first drug for TB to be globally approved in over 40 years, and is less toxic and more effective than traditional TB treatments.

And at least three Indian companies, Lupin, Natco, MacLeod are preparing to bring out generic versions of the drug.

Humanitarian organisation Médecins Sans Frontières/Doctors Without Borders (MSF) have been vocal in urging J&J to not take legal action against any generic manufacturer that exported generic versions of bedaquiline in regions where secondary patents existed. According to MSF, J&J currently prices the drug at $1.50 a day for an adult treatment ($272/six months). With greater generic competition, the price of bedaquiline could drop, to an estimated $0.50 per day, it added.