By Ed Silverman
Last week, the Indian government moved closer to issuing compulsory licenses on three widely used cancer medications – including Roche’s Herceptin – in hopes of making these treatments more affordable to a wider swath of its population (back story). The effort comes a year after India issued its first compulsory license for a brand-name drug, Bayer’s Nexavar cancer treatment, a move that has multinational drugmakers concerned. The cost per dose for Herceptin is roughly $1,400 per month, although Roche maintains it has taken steps to widen access, such as lowering the price previously and arranging for local manufacturing. But Kalyani Menon-Sen, a feminist activist and researcher based in Delhi, who also coordinates the Campaign for Affordable Trastuzumab (the chemical name for Herceptin), says this is not enough…
Pharmalot: Why is the move by the government to issue a license for Herceptin such a big deal?
Menon: In India, breast cancer is the most prevalent form of cancer among urban women, and the second most prevalent for rural women. Data from the National Cancer Registry, which are likely to be underestimations, record 100,000 new cases a year, of which around 25 percent are the aggressive HER+ form. Younger women seem to be more vulnerable to HER2+ breast cancer – a very worrying trend. Predatory pricing by Roche is keeping Herceptin away from all but the most privileged women. It is shocking that women are dying when there is a medicine that can save them. And patent barriers keep Indian pharma companies from investing in the development and clinical trials needed to register biosimilars. A compulsory license and policy support from the government – for instance, through fast-tracking the approval process – would enable them to pose stiff competition to Roche and other pharma MNCs (multinational companies).
Pharmalot: What is the cost for treatment for one person? And how does that compare with incomes?
Menon: When Herceptin first became available in India, it was priced at around 110,000 rupees per vial (or about $2,050), making it unaffordable to all except the very wealthy. In March 2012, soon after the decision of the Indian Patent Controller to grant a compulsory license on Nexavar, Roche announced a cut in the price of Herceptin to 92,000 rupees (or about $1,700) per dose – a reduction of about 16 percent. Roche (RHHBY) also signed a commercial agreement with Emcure Pharma to market the drug under a new name.
As of August 2012, Emcure is offering a repacked and renamed version called Herclon to patients at a price of 72,000 rupees (or about $1,340) per dose – a reduction of about 33 percent from the 2011 price. But compare this with incomes in India – 72,000 rupees is about the monthly salary of a government servant after 25 years of work. Forget our Forbes billionaires – around half our population still lives on $2 a day. A Roche executive has been quoted as saying that, at one large hospital, which treats about 30,000 cancer patients a year, only 5 percent of those eligible for the breast-cancer treatment Herceptin currently receive the drug, and many take it for far less time than is recommended.
Pharmalot: So in other words, while the price drops may appear substantial in percentage terms, in real terms, the prices are still out of reach?
Menon: Roche’s price reductions are a joke, since they still keep the drug out of reach for all but the very rich. While Roche is using the deal with Emcure and its “voluntary” price reductions to claim that it is concerned about access issues, it is clear that the company’s pricing policy is motivated by greed for profits and the determination to retain control of the Indian market. The price cuts are defensive and pre-emptive measures to preserve its monopoly in India against the issuance of compulsory licensing and price control measures by the Indian government. Roche is hoping that marketing the cheaper version under a different name will prevent wholesalers from buying the Indian product and reselling it at a profit in other markets.
The price fixed by Roche has nothing to do with the cost of production of the drug. It is designed to milk the market to the maximum extent. Roche is not making any secret of this. According to their executive in charge of Middle East and Asian markets, Roche is aiming to win usage rates in India at least several-fold higher than today’s levels, and they are treating the Indian arrangement as a pilot deal while assessing a lot of possibilities regarding other emerging markets.
Pharmalot: Herceptin is a biologic, which is harder and more expensive to make. How does a compulsory license make this process easier for generic manufacturers?
Menon: Biologics are difficult to register. In the absence of any guidance on biosimilars from the WHO (World Health Organization), regulators in developing countries are simply following the developed country trend of asking for more and more comparative studies and data, thus raising the costs. Manufacturers are, therefore, faced with the dilemma of ‘how similar is similar enough?’ India certainly has the scientific and technical capacity to make drugs like (Herceptin). It is already producing other biologics like Pegylated Interferon 2b. The WHO must, therefore, start helping developing countries with setting up an appropriate regulatory pathway for registering biosimilars. This will make the whole process easier for manufacturers to negotiate.
Pharmalot: Are there any companies ready to make a version? If so, do you know which ones?
Menon: Well, there are indications that more than one Indian company has a biosimilar in the pipeline. But of course we can’t name any names at this point.
Pharmalot: What is the status of the Herceptin patent in India – when does it expire and has Roche filed extensions?
Menon: The basic molecule is believed to be without patent protection in India, but there is one key patent granted by the Kolkata Patent Office that expires around 2020, seven years from now. Apart from this, Roche has filed multiple applications, which are currently under prosecution.
Pharmalot: You wrote to the prime minister several months ago. What was the response?
Menon: Well, we think that our letter and the campaign have definitely played an important role in bringing Trastuzumab onto the short list of recommendations for compulsory licenses from the expert committee. This is the first biologic to make it to the list.
Pharmalot: Do you know which section of the law will be used to issue a license and what this will mean?
Menon: There are several sections that can be used. Section 92 can be used to issue a notification for issuance of a compulsory license on the grounds of public health emergency, extreme urgency or non-commercial use of the drug. After this notification, competitors can apply to the Patent Controller for a licence. Section 100, which deals with provisions for government use, can also be used in this case. Section 94 relates to termination of patent and is not applicable in the context of compulsory licenses.
Pharmalot: When is the government expected to make a final decision?
Menon: We understand that the recommendations of the expert committee have been forwarded to the Department of Industrial Policy and Promotion in the Ministry of Commerce. We are hoping that they will take a decision at the earliest.