Early last year, when the Union government allowed the production of Nexavar, a liver and kidney cancer drug, by an Indian company against the wishes of multinational pharma major Bayer, the prices of several indigenously made cancer drugs tumbled.
It was a complete game-changer in affordable healthcare in India, which not only reduced the price of Nexavar from a prohibitive Rs. 2.8 lakh a month to Rs. 6,600, but also led to the reduction of prices of a few other cancer drugs as well.
The step that led to this dramatic fall of prices was by an intervention of the Union government called “compulsory licensing” (CL), by which a national government can allow somebody to produce a patented drug without the consent of the patent owner.
After Nexavar, the government of India has begun steps to issue compulsory license for three more cancer drugs - Trastuzumab, Dasatinib and Ixabepilone.
Compared to Nexavar, the impact of this move is going to be unprecedented because Trastuzumab is a wonder drug against a certain type of breast-cancer that affects about 100,000 women in India. Breast cancer tops the cancer burden in urban India, and an aggressive HER+2 type of cancer is increasingly more prevalent among young women.
About 28-35 per cent of all cancers among women in major cities is breast-cancer. Trastuzumab not only reduces the mortality of patients with HER+2 cancer, but also is effective against the spread of malignancy to other parts of the body.
So far, there is no other drug against HER+2 cancer with such efficacy. It can be administered alone, along with chemotherapy and after surgery. In many cases, it even helps avoid surgery, which many find disfiguring.
However, majority of women with HER+2 breast cancer do not benefit from the wonder-effect of the drug because of the prohibitive prices by its manufacturer and patent-holder, Roche, the multinational drug company. A full course of the drug costs anywhere between Rs six to eight lakhs. A generic version - in this case a bio-similar product - should not cost more than a tenth of this price.
Unlike Nexavar (chemical name Sorafenib), no Indian company has yet started making generic versions of Trastuzumab. According to available information , three Indian companies are currently involved in creating this molecule, but it is a difficult process because they have to take the biotechnological route to replicate it.
Commonly, generic versions of patented drugs are chemical copies made by reverse engineering of the final molecule through chemical processes. In simple terms, what it entails is taking the final molecule (of the drug) and working backward to create the same molecule through an alternative process.
Technical expertise, research facilities, appropriate investment and availability of high quality human resources are important for such processes. Endowed with all the four, India is a leader in generic production of drugs. What it requires, however, is an enabling environment, most of which is legal and patent-related.
In the case of Trastuzumbad, the generic version will be a biological equivalent and not a chemical copy because this drug cannot be replicated chemically. A biological process is trickier and more expensive.
The government decision on Trastuzumbad and the other two cancer drugs will be significant because Indian companies are reluctant to invest on developing a bio-equivalent, if the drug is still under patent. The patent on this wonder drug is due to expire in 2014, but Roche has filed several patent applications to Indian patent offices to block any such development even beyond 2014.
Under such uncertain patent regimes, no company would risk its investment. If the government issues a CL, the Indian drug companies can safely invest and fast track the process. Apparently, one of the Indian companies developing the drug is in the third stage of the process and hence if a compulsory license comes through, the Indian version will be out in the market sooner than later.
The latest development is yet another example of informed civil society pressure leading to concrete results as seen in countries such as Brazil and Thailand. In November 2012, the Campaign for Affordable Trastuzumab, a citizens’ collective, wrote an open letter to the Prime Minister, signed by around 200 cancer survivors, women's groups, human rights and health rights campaigns and treatment activists from around the world, urging the government to make the drug affordable and freely available to patients.
“Drug companies are holding our health hostage to their greed for profits” said Kalyani Menon-Sen, coordinator of the Campaign. “Roche should not be allowed to get away with such predatory prices. Courts and other authorities like the Competition Commission must take suo moto action against Roche for abusing its dominant position in the market.”
She also called on Indian manufacturers to expedite the production of bio-similars of Trastuzumab.
Compulsory licensing is one of the two flexibilities provided under the TRIPS (Trade Related Intellectual Property Rights) to allow member countries of WTO (World Trade Organisation) to prevent the abuse of patents. Contrary to the general belief, compulsory licenses are issued not only by developing countries, but also by countries such as Canada, USA, UK, France and Australia, whenever it suits them.
India joined TRIPS and complied with its rules in 2005 by amending the patent act of 1970, which also meant giving up a lot. However, it does have flexibilities such as CL to ensure that its citizens have access to affordable care and multinational companies don’t get away with predatory pricing. All that it takes for such a move is immunity from vested interests and political will.
“Such a move will not only make healthcare more affordable, but will also lead to domestic competition among generic manufacturers, which in turn will lead to further fall in prices” said KM Gopa Kumar, legal advisor and senior IPR researcher at Third World Network, a global think tank on development issues.
The other TRIPS flexibility that WTO allows its members to protect its citizens’s health is parallel importing, under which countries without technical capability to produce the generics can import from other countries. India may not be a beneficiary of this provision, but it can help other countries. Indian generic drugs are imported by several countries in the world.
Generic manufacture of potent MNC drugs against HIV and multi-drug resistant TB and their dramatic price falls are the inspiring success stories of the last decade. Cancer seems to be the new frontier. There are also illnesses such as hepatitis-C, the treatment of which can become affordable if a generic version of the MNC drug is available. The MNC drug at present costs about Rs. 6 lakhs and the country has a huge hepatitis -C burden.
In the coming years, the generic intervention and similar price cuts will have considerable impact on treatment of cancers and other non-communicable illnesses as well as infections such as hepatitis-C.
Without being apologetic to anybody - the MNCs and their parent countries - the government just has to take proactive steps that are vital for its citizens.