Source: Kafila| March 16, 2016
Guest post by KALYANI MENON-SEN
The last few months have seen an unusual public engagement around questions of secularism, freedom of speech, sedition and the like, with furious debates everywhere from our campuses, streets and TV studios to the floor of Parliament. The budget session has been enlivened by scenes of high drama, with the leading lights of the Treasury benches bringing colour, sound and fury to their tutorials on patriotism and nationalism.
While these high-decibel histrionics have been appreciated and applauded by many, some unpatriotic elements are asking if they are designed to divert public attention away from behind-the-scenes negotiations and surreptitious deal-making that could undermine the rights and compromise the survival of millions of Indian citizens.
One such deal is now out in the open. In written submissions to the US Trade Representative, two US industry bodies (the US Chamber of Commerce and the US-India Business Council) have said that the Government of India has “privately reassured” them that it will not use the mechanism of compulsory licensing to allow commercial production of cheaper generic versions of patented medicines in India.
The note of gleeful triumph in this announcement is unmistakable. Ever since the present government came to power, US trade bodies and pharma industry bodies have stepped up their attack on India’s patent system and demanded the dismantling of safeguards that protect citizens’ rights from being sacrificed to commercial concerns. The provision for compulsory licensing, empowering the government to override patents and allow the marketing of generic medicines in the public interest, is a prime target for this attack. Also in the firing line are measures to prevent patent holders from dragging out their monopoly by “evergreening” (making changes that do not enhace the therapeutic value of a product and patenting it anew), and allowing third parties (such as consumer groups or generic manufacturers) to challenge and oppose patent applications before they are finally granted.
Provisions such as compulsory licensing are completely legal under WTO rules, and represent hard-won gains achieved through tough negotiation, benefiting not only India but also other developing countries who rely heavily on cheap Indian generics for meeting their public health needs. These provisions have been defended and protected by successive governments, and have won praise for India’s patent system from international bodies. They have been emulated by other developing countries such as Brazil, South Africa and the Philippines. That they can be so casually signed away by a government that is aggressively vocal on the issue of desh bhakti suggests that the decision-makers are either dangerously ignorant of the implications, or worse, are cynically promoting the interests of multinational companies over the rights of millions of Indians.
If what the USIBC and the US Chamber of Commerce are claiming is true (likely, since it has not been denied by the government) Indians with cancer are the group that will be most immediately and most lethally affected by this sell-out on compulsory licensing. According to the WHO’s World Cancer Report 2015, cancer is the second biggest killer after heart disease in India, with 3.5 lakh people succumbing to the disease every year. Of the 700,000 Indians who are diagnosed with cancer every year, more than half are women, with breast cancer being the most prevalent form of the disease.
Cancer treatment has moved ahead dramatically in the last decade, with the emergence of a new class of highly effective “biological drugs” that can target and destroy cancer cells without causing the debilitating side effects that come with conventional chemotherapy. Trastuzumab, patented in many countries including India by Swiss pharma major Roche under the brand-name Herceptin, is one such drug. Targeted at a particular variant of breast cancer called HER2+, trastuzumab has been hailed as a wonder drug that significantly reduces the risk of recurrence and increases the chances of a disease-free life. Researchers from UK have just announced preliminary results suggesting that early treatment with a combination of trastuzumab and another drug, lapatinib, can cause shrinkage and even complete disappearance of HER2+ tumours in a mere 11 days.
These new drugs can bring hope to Indian women, more than 150,000 of whom are diagnosed with HER2+ breast cancer every year, if not for one all-but-insurmountable barrier: the price. Provisions like compulsory licensing and the refusal to allow patent monopolies to be indefinitely extended through unethical practices like evergreening have been shown to be the most effective mechanism for bringing down prices of expensive patented drugs. The single compulsory licence issued by India – granted to generic manufacturer NATCO for Bayer’s kidney cancer drug Sorafenib – brought the price down from Rs 280,000 per dose to Rs.8000 per dose, a reduction of 3500%.
The emergence of cancer as a major public health challenge for the country and the rapacious pricing policies of patent holders were the considerations that prompted a move by the Ministry of Health for compulsory licensing of three cancer drugs. This proposal, made in 2013 after extensive groundwork by an expert panel, has disappeared into the black box of the Department of Industrial Policy & Promotion (DIPP), the entity within the Ministry of Commerce that holds sway over the patent system. Nevertheless, the threat of a compulsory licence was enough for Roche to back off from its attempts to get a secondary patent on trastuzumab, opening the door to competition from three domestic manufacturers and pushing down the price of the drug.
The backstage deal between the Government of India and Big Pharma on compulsory licensing provision is an addition to the growing body of evidence of the Modi sarkar‘s eagerness to give in to US pressure on patent issues. An early warning note was the assurance given to USIBC by the Prime Minister at the end of his first visit to the US, that a joint mechanism would be set up to resolve patent issues that are deterrents to the entry of US companies into the Indian market. The joint communique issued at the end of the visit included a commitment to “establish an annual high-level Intellectual Property (IP) Working Group with appropriate decision-making and technical-level meetings as part of the Trade Policy Forum.”
Almost immediately, the Ministry of Commerce announced that it had set up an IP think-tank to formulate a new IP policy for the country. Concerned civil society groups wrote to the PM cautioning against taking a narrow trade-focused view of IP and pointing out that there were issues of health, agriculture, food security and education that the policy would need to address. Pleas for a wider public discussion and debate on IP issues and a more consultative and transparent process of policy formulation have gone unheeded.
The fingerprints of Big Pharma are clearly visible in the draft of the National IPR Policy circulated by the think-tank in April 2015. Among the proposals is the setting up of an IP Task Force to enforce patent protection, in effect shutting out the competition posed to US companies by Indian generics. To add insult to injury, this Task Force is to be publicly funded – so Indian taxpayers will foot the bill for a mechanism that puts life-saving medicines out of reach of the majority of Indians. Experts have warned that the new policy will privilege multinational pharma companies at the cost of the national generic industry, undermining India’s status as the “pharmacy of the developing world”.
Ironically, even as the US seeks to impose its IP standards on India, its own IP regime is coming under increasing scrutiny. The spike in drug prices and treatment costs (as much as USD 1000 a pill for Gilead’s hepatitis C drug sofosbuvir and USD 137,000 for a year’s supply of Roche’s new breast cancer drug Kadcyla) is threatening the viability of public health programmes, fueling public anger and forcing candidates for the Presidency to take positions. Several recent rulings from the US Supreme Court have gone against pharma companies, including outlawing of gene patents and raising the bar on “inventive steps” to discourage evergreening, clearly aimed at restoring the balance between patent protection and citizen’s rights.
The supposedly clinching argument made by the US trade lobby (reiterated almost verbatim in the draft IPR Policy) is that stronger patent protection will result in more investments. In fact, the available economic and policy literature on the impact of stronger patents on development, foreign direct investment, technology transfer, and even innovation is highly contested. Experts point out that most economies that have surged in the past 50 years, including India, have done so by protecting key emerging economic sectors, and by reverse-engineering and adapting technologies to local needs.
The Indian Patents Act of 1970 placed limitations on the exclusive rights of patent holders in the food and pharmaceutical sectors. The government also invested strategically in developing domestic research capacities and in providing generic drug manufacturers with technical and policy support. This is the approach that enabled the generic pharma industry to grow to a level where it could claim for India the accolade of “pharmacy to the developing world”.
The final draft of the new IPR policy is awaiting Cabinet approval. It has not been shared with the public or with the hundreds of groups and individuals who gave detailed comments and critiques on the draft. Apart from weakening the provisions for compulsory licencing, the US has also been pressing for “patent linkage” (which would preventing Indian regulators from granting manufacturing licenses or processing the registration of generic versions of patented drugs), fast-tracking of patent examination (which would make it more difficult for civil society groups and generic manufacturers to challenge or oppose the patent) and special patent courts for adjudicating on disputes. Given the secrecy around the draft, we do not know if the cautions and arguments provided by activists and experts against yielding to these demands (which go well beyond the requirements set by the TRIPS agreement) have been taken on board. A leaked version of the final IPR document that has been circulating for some months gives little cause for optimism.
The government’s willingness to back off on compulsory licensing might well signal the beginning of the end for the progressive IP regime that India has struggled to build, defend and retain against enormous pressure from Big Pharma and its patrons over the last two decades. The fact that an assurance on an issue as serious as this has been given “privately” to a US industry body, without consulting or involving the Indian Parliament or the Indian public, is a disturbing signal that backroom deals and off-the-stage negotiations with Big Pharma will continue to set the parameters for access to medicines, whatever the new IPR policy might say.
In 2005, when India had to amend its patent regime to comply with the WTO’s Agreement on Trade- Related Intellectual Property Rights (TRIPS), the issue was debated in Parliament. MPs across party lines raised concerns about the impact this would have on the domestic generic industry, drug prices and access to medicines. The government of the day assured Parliament that it had built in enough safeguards to protect the interests of consumers by ensuring availability of medicines at affordable prices.
A decade later, a government that wears its patriotism proudly on its chhappan ki chhaati is quietly disposing of these safeguards while trying to keep Parliament and citizens otherwise engaged and entertained.
Kalyani Menon-Sen is a feminist activist and coordinator of the Campaign for Affordable Trastuzumab, a coalition of individuals and groups that is calling for making cancer drugs affordable and available through the public health system.
 World Health Organisation. World Cancer Report 2015.
 ‘ENOUGH SAFEGUARDS IN PATENTS ACT TO PREVENT PRICE RISE’, Press Release, Ministry of Commerce, 04 April 2005,http://commerce.nic.in/pressrelease/pressrelease_detail.asp?id=1610