Patients vs patents

In these divisive times, if there is one thing that unites Indians, apart from cricket and Bollywood, it is the fear of falling ill. It is not just the disease or death that we are afraid of. There is the gnawing fear of medical expenses. The vast majority of Indians — nearly 80 per cent — have to pay for medical treatment out of their own pockets.

If someone in the family falls seriously ill, it means having to take a loan or mortgage whatever assets one has. Millions have suffered in the process. Even today, despite all the health insurance advertisements that one sees, less than a quarter of the population is insured, and typically such schemes do not reimburse the cost of medicines.
But 2013 could usher in major changes. Amid the avalanche of gloomy news, there have been important developments that offer some hope. The campaign to make medicines affordable is gathering momentum within the country and the government appears responsive, at least in this area. Recently, the health ministry recommended three anti-cancer drugs for “compulsory licensing”. Compulsory licensing, or CL, is a tool which a government can use to allow a domestic company to manufacture and sell a generic version of a patented drug without the consent of the patent-holder, who receives compensation. This is permitted under the World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights (Trips). The health ministry’s decision stemmed from an expert committee’s brainstorming sessions. Now the matter is with the department of industrial policy and promotion (DIPP), ministry of commerce. It is not known how long it will take to notify the CL for the three cancer drugs — trastuzumab (or Herceptin, used for breast cancer), ixabepilone (used for chemotherapy), and dasatinib (used to treat leukemia). But the important thing is that the process has started.
As expected, the news has been wildly cheered by patients’ groups and public health advocates. Activists are delighted that the government is finally showing some daring and is willing to face the wrath of Big Pharma. “The response from government indicates that we have been able to make a strong case for prioritising constitutional rights of citizens over markets and profits. Now that the expert committee has made its recommendation, we look forward to a notification under Section 92 of the India’s patent act, inviting manufacturers to come forward to manufacture a biosimilar of trastuzumab,” says Kalyani Menon Sen, campaign coordinator, Campaign for Affordable Trastuzumab.
Cancer drugs are prohibitively expensive and the prospect of cheaper cancer drugs is indeed a big deal in a country where cancer is on the rise. A month’s treatment for a patient, drugs like trastuzumab, ixabepilone and dasatinib can cost anywhere between `1.64 to `2.45 lakh. The prospect of a sharp dip in the prices is therefore something which most people would celebrate. The reactions of multinational companies, who hold most of the patents, are obviously adverse. Lobby groups for multinational drug firms in India argue that the country’s Intellectual Property Rights ecosystem is getting muddied, that foreign investment can be affected and that patients’ rights must be balanced against the rights of inventors. The health ministry’s decision comes on the heels of another recent development involving CL. In January this year, in Chennai, India’s Intellectual Property Appellate Board (IPAB) heard the final arguments in the Bayer versus Natco case, India’s first-ever instance of compulsory licensing. This case involves the German pharma company Bayer, and its drug for liver cancer, Nexavar (sorafenib tosylate). Bayer has a patent on this drug since 2008. Indian generic major Natco applied for a CL on the drug in 2011, and it was granted last year. The CL has pushed down the price of the drug by more than 95 per cent. Bayer gets six per cent royalty on the sales that Natco makes under the terms of the CL but is intensely unhappy. It has appealed against this decision. Both sides have concluded their arguments and IPAB’s verdict is now keenly awaited.
The MNCs say that the grant of compulsory licence for Bayer’s Nexavar to Natco raises serious concerns about the robustness of India’s IPR system, and the latest decision by the government to grant CL to three more cancer drugs, only compounds those fears. To add to the gathering storm, the final verdict from India’s Supreme Court on a patent on Swiss drug major Novartis’ cancer drug, Glivec, is also expected soon.
Why should the prospect of affordable drugs raise hackles? The reason is simple. Because it is not just a case of one, two or three cancer drugs, nor is it about company A or company B. Compulsory licensing is one of the “flexibilities” allowed by India’s patent law under Trips. Many other countries such as Thailand and Brazil have used CL in public interest. Now, even China is going the CL route. But compulsory licence remains one of the thorniest issues in the global debate on patents versus patients.
India, as a manufacturer of low-cost generic drugs that save millions of lives across the developing world, is at the epicentre of this debate. What India does or does not do can potentially impact the affordability of not only cancer drugs but a whole range of life-saving medicines.
India has made some bold announcements: It says it will push through universal healthcare and that it will step up public procurement of generic medicines. There are great initiatives within the country that support this drive to make medicines more affordable. Among the best-known is the Tamil Nadu model of bulk procurement of drugs which other states want to replicate.
The recent developments on CL, along with some of these initiatives, can be a game-changer. As a pharmacy to the developing world, India has a right and the responsibility to show that it can successfully deal with seemingly antagonistic worldviews, and that it can protect public interest while not tearing up the patent regime. Will it step up to the plate? Will it allay our acute fear of falling ill? The world is watching.

The writer focuses on development issues in India and emerging economies.