New York/New Delhi, June 26, 2017 - As U.S. President Donald Trump and Indian Prime Minister Narendra Modi meet at the White House today, Doctors Without Borders/Médecins Sans Frontières (MSF) warned that U.S. pressure on India to change its drug regulatory and patent system could result in millions of people in the U.S. and around the world losing their lifeline of affordable medicines. As an international medical humanitarian organisation that relies on affordable generic medicines produced in India to run its medical programs in more than 60 countries, MSF urged Modi to stand strong and protect India’s role as the “pharmacy of the developing world.”
The U.S government - backed strongly by the pharmaceutical lobby - is expected to step up pressure on several governments, including India and others in Asia and Latin America, to enforce and protect intellectual property (IP) of pharmaceutical corporations - an approach that has led to high drug prices in the U.S. and around the world by limiting competition. This has been revealed recently in several news reports based on the leaked draft of Executive Order on drug prices. [Read: Draft Order on Drug Prices Proposes Easing Regulations].
In the past, the U.S. government, influenced by pharmaceutical corporations, has successfully pressured India not to issue any compulsory licenses to make affordable versions of patented medicines available. There will now be renewed pressure by the U.S. government on India to make more and more concessions, such as extending the term of a patent beyond 20 years and lowering the standards for granting patents. India’s current law sets the bar higher than most countries, including the U.S., for which medicines deserve patents, allowing people to gain access to generic options sooner. India’s regulatory system, which has efficiently delivered a pipeline of affordable and adapted generic medicines such as those used in the treatment of HIV, hepatitis C, TB and cancer, is also now under the lens of the U.S. government.
“Aiming to boost the monopoly rights of pharma corporations overseas, the U.S. government is using several tactics to push India to make changes to its drug regulatory system that will restrict generic competition by linking the registration of medicines to their patent status, called patent linkage,” said Jessica Burry, Pharmacist for MSF’s Access Campaign.” “The U.S. is also pushing India to implement ‘data exclusivity,’ a mechanism that will prevent the Indian drug regulatory authority (DRA) from considering a generic applicant’s dossier for marketing approval for the exclusivity term, even when patents no longer apply or exist. People all over the world rely on affordable medicines from India, and we will not stand idly by if the U.S. continues to try to shut down the pharmacy of the developing world.”
India plays an important role in manufacturing and distributing life-saving medicines and vaccines to millions of people across the world. About 97 percent of the medicines MSF uses in caring for more than 300,000 people living with HIV are Indian generics. MSF also procures vaccines and essential medicines from India to treat other diseases, including tuberculosis and hepatitis C. The high prices pharmaceutical corporations charge for medicines are preventing people in both developing and developed countries from accessing the medicines they need. For example, in the U.S., some cancer medicines are priced at more than $100,000 per patient and one new hepatitis C medicine was introduced at $1,000 per pill.
“The United States has a history of pressuring India to change its pro-public health stance on intellectual property - a policy that has saved and improved millions of lives all over the world by making medicines more affordable. Ahead of his meeting at the White House, we’re urging Prime Minister Modi not to cave into any pressure from the U.S. and adopt pharma-backed policies that have caused medicine prices to skyrocket, leaving patients empty-handed and payers struggling to afford the expensive patented medicines,” said Leena Menghaney, South Asia Head for MSF’s Access Campaign. “At MSF, we have seen the enormous impact low-priced medicines can have one people’s lives. For example, by striking a balance between industrial production of drugs and public health, HIV regimens that were priced at $10,000 per person per year 15 years ago now cost $100 per year - that’s a 99-percent reduction in price, thanks to generic competition.”