India's decision to grant a patent on a pneumonia vaccine to US pharma giant Pfizer will damage the country's generic drug industry, which saves thousands of lives across the developing world, medical groups have warned.
The Indian Patent Office last month granted Pfizer patent authorisation for Prevenar 13, which gives the company exclusive rights to distribute the vaccine within India until 2026 and blocks Indian manufacturers from making a generic version of the life-saving vaccine for export.
Prior to 2005, India did not grant patents on medicines — a situation that bolstered the generic drug manufacturing industry, which exports medicines to treat diseases like HIV/AIDS, malaria and tuberculosis around the world.
That put the South Asian nation in the sights of large pharmaceutical companies from the US and Europe, who say that patent protection and the profits it generates are crucial for funding further research.
After becoming a signatory to World Trade Organisation agreements, India began to recognise private ownership of intellectual property — including of pharmaceutical products.
"This current flash point is really a manifestation of larger battles over intellectual property, trade, and human rights," said Matthew Rimmer, a professor of intellectual property and innovation at the Queensland University of Technology.
According to a Medecins Sans Frontieres (MSF) report from 2005, generic Indian AIDS therapies can cost as little as $200, compared to more than $10,000 for their patented counterparts.
As the report put it: "Sick people around the world depend on Indian producers to manufacture affordable generic versions of new medicines."
"We knew back in 2005 that there would be some long-term pain associated with this system," said Leena Menghaney, the access campaign manager at MSF India.
"A large number of medicines and vaccines are now patented in India — so we're going to see, within the next decade or two, India not being able to produce a number of life-saving treatments."
Intense pressure from drug producers
Each year, the Office of the US Trade Representative releases a Priority Watch List of countries regarded as having harmful records on "protection, enforcement, or market access".
Despite the Pfizer decision, India remains on the Priority Watch List because of its intellectual property framework.
India is identified as one of the countries which will "be the subject of intense bilateral engagement during the coming year" — lobbying, in other words.
According to Ms Menghaney, the watch list is a "pressure tactic".
"The United States is very successfully using trade pressure on countries like India," she said.
"Their bilateral forums constantly reiterate the need to protect intellectual property, irrespective of the impact on human life."
Dr Rimmer believes the Trump administration has upped the ante when it comes to pressuring India about generic drug manufacturing.
"Increasingly, there are larger trade pressures being brought to bear on India," he said.
"The new Trump administration has very strong views about intellectual property and trade, and that's caused an amount of friction between the Trump administration and other superpowers like China and India."
What happens now?
MSF is seeking advice about the feasibility of legally challenging the patent that was granted to Pfizer — a process Ms Menghaney said could "take years".
"We are painfully aware of the dark reality. This is not just about an industry — this is about the life or death of patients."
In the meantime, she hopes Indian manufacturers can find a way to move past the challenges posed by pharmaceutical patents to ensure that people around the developing world have access to affordable health treatments.
Dr Rimmer said the global pharmaceutical industry needs to rethink the role of patent law in the way it operates.
"There's a need to recognise the right to health as a human right," he said.
"Patent law is also a very crude way of providing an incentive for research and development. So we need to think about alternative means of encouraging development."
Pfizer said in a statement to Saturday Extra that it delivers the pneumococcal conjugate vaccine to the world's poorest countries at a lower price than in higher income countries, through its partnership with GAVI, the Vaccine Alliance.
The company also said it is keen to work with the Indian government to "scale up deployment" of the Prevenar 13 vaccine in India.