Each time Prime Minister Narendra Modi prepares to engage with the US, public health activists and observers in India get really anxious. And it’s happening yet again as Modi sets foot on American soil for a packed, three-day state visit.
The anxiety of public health specialists is not without reason and it’s not restricted to India alone, but also across the developing world. The fear is that if Modi capitulates to US pressure on India’s Intellectual Property Rights (IPR) regime, which it has been overtly and covertly exerting for years, it will make many lifesaving drugs unaffordable. Not just in India, but in most poor countries because India is the main pharmacy for the entire developing world.
The reason to peg this concern to a high level India-US diplomatic engagement is historic.
Although India’s trade and strategic conversations with the US are not all about pharmaceuticals, even a marginal mistake on the latter can be too costly for the country. Among a host of other negotiations, Big Pharma in the US, through several lobbying arms have been trying to water down India’s IP policy to suit their interests. They want India to freely issue patents for their drugs, even if they don’t qualify according to Indian IP laws or involve unfair practices such as ever-greening, so that they can sell them at whatever prices they choose and prevent Indians from making generics. They also don't want India to use its legitimate right to issue compulsory licenses to drugs that are critical to the health of the people of India as allowed by TRIPS.
Although the Government of India has clarified early this year that it hadn't promised the US that it wouldn’t issue compulsory licences, the Indian position is still not totally transparent for a number of reasons.
First, it is a strange India-US policy group. The Government of India had constituted an India-US “annual high-level Intellectual Property (IP) Working Group with appropriate decision-making and technical-level meetings” after Modi’s visit to the US in 2014. This decision allowed the US a role in influencing India’s sovereign rights. A real foot-in-the-door policy.
The details of the deliberations of this WG are unknown. But that the group came into existence in the wake of a joint letter by the US Senate and House Committees to the US International Trade Commission (USITC) which said that "India has not yet taken action to fully and effectively protect and enforce copyrights…, particularly against innovative US pharmaceutical companies, so as to advantage its domestic industries” has been disconcerting.
Then came the denial of patent to pharmaceutical giant Gilead for its Hepatitis C drug Sofosbuvir and its subsequent revocation. The application was originally rejected by the Indian patent office in 2015, but was accepted early this year. Media reports said there was intense pressure from the government on the patent office to grant a patent for this prohibitively expensive drug. Had the 2015 decision stayed, Indian companies could have manufactured the drug locally and made it available at a fraction of its original cost. In the US, the drug costs abut US $84,000 for a 12-week course. In a bid to probably avert further pressure from Indian activists and companies, Gilead subsequently made it available at a cheaper price in India through a voluntary licencing agreement with Indian companies.
In 2016, the patent office also rejected the application from a Hyderabad based company, Lee Pharma, for a compulsory license for an important diabetics drug Saxagliptin, originally manufactured by AstraZeneca. The grounds for compulsory licensing — that “the reasonable requirements of public with respect to the patented invention have not been satisfied, or that the patented invention is not available to the public at reasonably affordable price, or that the patented invention is not worked in the territory of India” as stipulated by the Indian patent law were not accepted, although the drug was not available widely at affordable prices. Activists saw this also as a bad sign of forfeiting the country’s IPR sovereignty.
Finally, the timing of the new IPR policy that the government had finalised recently also showed that India was yielding to pressure from the US. According to Commerce Minister Nirmala Sitharaman, the policy was finalised well in time for Modi’s visit. Intellectual property rights lawyer KM Gopakumar wrote about the new policy in Economic and Political Weekly: “Even though the policy contains certain measures to protect public interest, these measures can get undermined during implementation of the policy due to the overall thrust on IP generation and commercialisation without adequately recognising India’s socioeconomic imperatives. One of the unstated reasons for putting together the policy is to ease pressures from the US to deliver on IP awareness, service orientation of the Patent Office and IP generation. Thus the policy bears the danger of further increasing the pressure instead of minimising it.”
Leena Menghaney, South Asia head of MSF's Access Campaign minced no words when she said in a statement: “It’s outrageous that the US is trying to export its broken intellectual property system to India — a system that has caused medicine prices to skyrocket, leaving patients empty-handed, and patients and payers struggling to manage the cost of expensive patented medicines…These policies, which are increasingly not working for people in the US, should not be forced on people living in India or anywhere else in the world.”
India doesn’t realise that even a country such as Egypt fared better in resisting the US pressure. Egypt refused patent to Gilead’s Hepatitis C drug and will be in a position to manufacture and export the drug to other countries. Modi’s advisers and lobbyists of American pharmaceutical industry have likely misled him on India’s legitimate and legal rights and the importance of fair drug prices to keep Indians alive.