Even as Drug-Resistant Tuberculosis (DR-TB) is turning into a major public health problem over the globe including India, a large number of Indian and international civil society groups have spoken to Prime Minister Narendra Modi to issue a government-use compulsory license for two of the drugs for DR-TB treatment- delamanid and bedaquiline – for obtain access to affordable DR-TB treatments over the developing world.
The Patents Act accommodates a special provision that empowers the Central Government to advise a compulsory license for public non-commercial use. The government use license for bedaquiline and delamanid thus issued will support generic production and supply to India’s TB Control Program and reserving them for public health use.
“These essential TB drugs give hope to people those at high risk; remarkably, individuals living with HIV co-tainted with DR-TB, children with DR-TB, widely and pre-extensively drug-resistant (XDR/pre-XDR) TB patients and those with drug intolerance “, the civil society associations said in its letter to the Prime Minister.
Following a gap of 50 years, the new antibiotics, bedaquiline, and delamanid, together with re-purposed drugs, now provide opportunities to countries with a high burden of TB to enhance the efficacy safety and safety of its DR-TB treatment regimens and thus, prevent further infections, resistance, and deaths.
As a response to the ‘high unmet medical need’ for new treatment options for multidrug-resistant tuberculosis, bedaquiline, and delamanid adult formulations in 2015 was added to the WHO Essential Medicines List (EML) while delamanid was added to the WHO EML for children in 2017, the letter further said.
Consequent to India’s adoption of the product patent regime for pharmaceuticals in 2005 (the WTO TRIPS deadline), delamanid and bedaquiline were two of the first TB drugs to be patented. The compound patents numbers for bedaquiline and delamanid are IN236811 and IN250365, which expire in July and October 2023, respectively.
At present, access to the new, patented TB drugs is solely dependent on ‘mere imports’ that Johnson and Johnson (J&J)/United States Agency For International Development (USAID) and Otsuka donate to the TB program in India.
Not only in India, access to these critical drugs remains limited in other high burden nations in the developing world. Once the USAID/J&J donation concludes in April 2019, the price for a six-month course of bedaquiline in India will be USD 900 and significantly higher in other middle-income countries.
Moreover, the Japanese pharmaceutical corporation, Otsuka, charges an exorbitant USD 1,700 for a six-month delamanid course, the price of which isn’t relied upon to decrease substantially.
India’s role is thus critical and it needs to desist from supporting secretive bilateral voluntary licensing deals between pharmaceutical organizations for their own benefits, and rather, operationalize generic supply through a government use license.
The grant of a government use license because of public non-commercial use would make competition, essentially reduce government expenditure, provide impetus to the scaling up of access to these new TB drugs all around and help kick to begin the generic supply of new TB drugs to the national TB program by 2019, the civil society organizations in their letter further said.