Survivors of drug resistant tuberculosis, health organisations and the TB community in India and across the globe have appealed to the Prime Minister of India to issue a government use compulsory license for two of the essential drugs for Drug-Resistant Tuberculosis (DR-TB) treatment- Bedaquiline and Delamanid to encourage generic competition.
Bedaquiline and Delamanid adult formulations were added to the WHO Essential Medicines List (EML) for TB in 2015, and Delamanid was added to the WHO EML for children in 2017.
The Patents Act provides for a special provision that empowers the Central Government to notify a compulsory license for public non-commercial use. The government use license for Bedaquiline and Delamanid thus issued will encourage generic production and supply to India’s TB Control Program and reserving them for public health use.
Drug-resistant TB is a major public health problem across the globe. Out of the ten million people who fell ill with tuberculosis (TB) in 2016 alone, over half a million are estimated to have resistance to the most effective drugs used to treat TB, rifampicin and isoniazid. These new TB drugs offer fresh hope to those at high risk of treatment failure; notably, people living with HIV co-infected with DR-TB, children with DR-TB, extensively and pre-extensively drug resistant (XDR/pre-XDR) TB patients and those with drug intolerance.
With about 1.3 lakh annual incident of MDR-TB in India, the Indian TB Control Program is in the process of introducing these new drugs through donations and will have to pay INR 1 lakh for a six-month Delamanid course and bedaquiline INR 58,000 for a six-month course in the coming years. Prices of these drugs could be reduced 95% through generic competition.
Lawyers Collective along with 59 other civil society organisations (India and international) and 31 individuals have written to the Prime Minister of India seeking a government-use compulsory license on Multi-Drug Resistance TB drugs called Bedaquiline and Delamanid.
Read the full text of the letter below:
Mr. Narendra Modi,
Honourable Prime Minister of India,
Prime Minister’s Office,
South Block, Raisina Hill,
New Delhi 110011
March 12, 2018
SUBJECT: Appeal to issue ‘government use license for new TB medicines’ for securing access to affordable DR-TB treatments across the developing world
Dear Prime Minister Modi,
Representing people affected by DR-TB, various health organizations, people living with HIV and the TB community in India and across the world, we are writing to appeal to the Indian government to continue to play its crucial role in global health by addressing the urgent treatment needs for drug-resistant tuberculosis (DR-TB).
Although tuberculosis is gradually declining worldwide, nearly half a million people acquire DR-TB each year, which poses a serious public health challenge. In India alone, an estimated 1,30,000 multi-drug resistant TB patients emerge annually (Central TB Division, Annual Status Report, 2017).
After 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 improve the safety and efficacy 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 were added to the WHO Essential Medicines List (EML) for TB in 2015 while delamanid was added to the WHO EML for children in 2017.
These new TB drugs offer fresh hope to those at high risk of treatment failure; notably, people living with HIV co-infected with DR-TB, children with DR-TB, extensively and pre-extensively drug resistant (XDR/pre-XDR) TB patients and those with drug intolerance.
Subsequent to India’s adoption of the product patent regime for pharmaceuticals in 2005 (the WTO TRIPS deadline), bedaquiline and delamanid 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.
Currently, 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 programme in India. Not just in India, access to these critical drugs remains limited in other high burden countries 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 even higher in other middle-income countries. Additionally, the Japanese pharmaceutical corporation, Otsuka, charges an exorbitant USD 1700 for a six-month delamanid course, the price of which is not expected to decrease substantially.
According to a study published in the Journal of Antimicrobial Chemotherapy, the target generic price for a six-month course of bedaquiline and delamanid is between USD 48 to 102 and USD 36 to 96, respectively. Thus, prices could fall by up to 95% through the generic production of these life-saving medicines.[i]
However, in the absence of government support and awaiting patent expiries in 2023, a number of Indian manufacturers are hesitating to move forward with any plans for the production of these drugs.
Since it can take up to two years to develop and file a registration dossier with the Central Drugs Standard Control Organization (CDSCO) and the WHO prequalification programme, plans for the scale up and generic supply of these antibiotics to the TB programme needs to be put in place now.
As affirmed in the Doha Declaration on the TRIPS Agreement and Public Health and even more recently, by the United Nations High-Level Panel on Access to Medicines (UNHLP), international trade rules allow countries to issue licences when pharmaceutical companies fail to make patented medicines available and affordable to patients and governments.
Time and again, multiple countries have made use of this provision. Most recently, the Malaysian government affirmed its commitment to help the more than 400,000 people living with hepatitis C and scale up access to affordable treatment in the public health system throughout the country by issuing a ‘government use’ licence that enables its Ministry of Health to procure generic sofosbuvir at the lowest possible price.
India, too, supports the use of TRIPS flexibilities, the Doha Declaration and the UNHLP recommendations on access to medicines. Numerous health ministries rely on generic medicines from India, which have played a pivotal role in the scale up of HIV and HCV treatment across the developing world.
India’s role is thus critical and it needs to desist from endorsing secretive bilateral voluntary licensing deals between pharmaceutical companies for their own profits, and instead, operationalize generic supply through a government use license. The grant of a government use license on grounds of public non-commercial use (under section 92) would create competition, significantly reduce government expenditure, provide impetus to the scaling up of access to these new TB drugs globally and help kick start the generic supply of new TB drugs to the national TB programme by 2019.
So many lives depend on it.
Bazo Kire, Kekhrie Foundation, Nagaland
Bobby Khumanthem, Health Activist, India
Daisy Dharmaraj, M.D., Director TEST Foundation
Daisy David, Chennai
Dr Arne von Delft, living with presumed latent MDR-TB
Dr Ruvandhi Nathavitharana, Infectious diseases physician and TB researcher at Beth Israel Deaconess Medical Center and Harvard Medical School in Boston
Dr. Dalene von Delft, occupational MDR-TB survivor
Dr. Helene-Mari van der Westhuizen, TB Activist
Dr. Mira Shiva, MD
Dr. Zolelwa Sifumba, occupational MDR-TB survivor
Edwina Pereira, Child First Foundation
Eldred Tellis, Sankalp Rehabilitation Trust, Mumbai
Ganesh Acharya, TB Activist and Survivor, Mumbai
Henry Zohmingrhanga, ex-MPLAS Secretary, Aizawl, Mizoram
Ingrid Schoeman, occupational XDR-TB survivor
Jennifer Furin, MD., PhD., Harvard Medical School, Boston, MA, USA
Ketholelie Angami, Health Activist, India
Lorraine Misquith, Health Activist, India
Mutum Tilak Singh , TB survivor
Nandita Venkatesan, DT-TB survivor
Neil Jaitly Khongwir, Manbha Foundation
Paula Donovan, AIDS-Free World
Peter Angom, Health Activist, India
Prashant, TB Survivor
Raman Chawla, Independent Consultant, India
Anand Grover, Senior Advocate
Renbonthung Tongoe, ARK Foundation
Safiatou Simporé, Yolse, Santé Publique & Innovation, West Africa
Stephen Lewis, Director, AIDS-Free World
Suthirtha Dutta, Health Activist, India
AIDS Access Foundation, Bangkok
AIDS Access Foundation, Thailand
AIDS and Rights Alliance for Southern Africa (ARASA)
All India Drug Action Network
All-Ukrainian Network of People Living with HIV
ARK Foundation, Nagaland
Brazilian Interdisciplinary AIDS Association
Care and Support Society, Nagaland
Citizen News Service (CNS)
Delhi Drug Users Forum
Delhi Network of Positive People (DNP+)
Dimapur Network of Positive People
Drug Study Group, Thailand
Drug System Monitoring and Development Program, Thailand
Drug-Resistant TB Scale Up Treatment Action Team
European AIDS Treatment Group
Foundation for AIDS Rights, Thailand
Foundation for Consumers, Thailand
FTA Watch, Thailand
Global Coalition of TB Activists
Gramin Samaj Kalyan Vikas Manch, Jharkhand
Health GAP (Global Access Project)
Hepatitis AIDS and Tuberculosis (HeAT NE Region)
Hopers Foundation, Chennai
Initiative for Health & Equity in Society
International Human Rights Clinic, Northwestern Pritzker School of Law
ITPC, South Asia
Kalinga Network for People Living with HIV/AIDS (KNP+), Odisha
Knowledge Ecology International
Lakshita Foundation of India
Meghalaya Drug Users Network
Mizoram Drug Users Forum
Mizoram HCV Response Team (MiHReT)
Nirmaan Rehabilitation Facility
Northeast India TB Coalition
Pan-African Treatment Access Movement (PATAM)
People's Health Systems Movement, Thailand
Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)
Positive Women Network, India
Salud por Derecho – Spain
Section 27, Johannesburg
Social Awareness Service Organization
South Indian Harm Reduction Network
Thai Network of People Living with HIV/AIDS (TNP+)
The Global Network of People Living with HIV (GNP+), The Netherlands
The Sentinel Project on Pediatric Drug-Resistant Tuberculosis
Third World Network
Touched by TB- National Coalition of People affected by TB, India
Treatment Action Campaign
Treatment Action Group, USA
Western Harm Reduction Network, India
[i] Dzintars Gotham et al. “Estimated Generic Prices for Novel Treatments for Drug-resistant Tuberculosis,” Journal of Antimicrobial Chemotherapy 72, Issue 4 (2017): 1243–1252. Available: https://doi.org/10.1093/jac/dkw522, https://doi.org/10.1093/jac/dkw522
Shri Jagat Prakash Nadda, Minister of Health and Family Welfare (MOHFW)
Shri Suresh Prabhu, Minister of Commerce and Industry
Smt. Anupriya Patel, Minister of State, MOHFW
Dr Tedros Adhanom Ghebreyesus, Director-General, World Health Organisation
Ms. Preeti Sudan, Secretary, MOHFW
Ms. Rita A. Teaotia, Secretary, Department of Commerce
Shri Ramesh Abhishek, Secretary, Department Of Industrial Policy & Promotion
Dr. Vinod Paul, Member, NITI Aayog
Shri Manoj Jhalani, AS & MD, National Health Mission, MOHFW
Dr. R.K. Vats, AS & DG (CGHS), MOHFW