The distance we need to travel before cancer treatment is universally available is clear from the fact that cancer surveillance is in its infancy.

By Dr Amit Sengupta

Once discussed in hushed tones, cancer has entered normal drawing room conversations in India. This has to do, on one hand, with a rise in cancer incidence with a change in the country’s demographic profile. Cancer is primarily a disease that afflicts the later decades of life, though we do see a relatively small number of childhood cancers and cancers during adolescence and early adulthood. However, most cancers are clustered in the later decades of life and as people survive more, the incidence of cancer cases increase. The other shift in popular perception about cancer is that it is no more being considered as a death sentence in many cases as it attacks the victim when he or she is in the twilight zone. Cancer patients are surviving much longer, many are leading years or decades of fulfilling lives after diagnosis. Cancer therapies are more numerous, have less side effects than before because they are more targeted. New cancer drugs are being researched and developed every year.

Severely compromised access to diagnosis and treatment

Unfortunately the news is not all good for cancer patients in India. While new knowledge makes it possible to detect cancer early and to effectively treat a significant number, access to diagnosis and treatment is extremely limited. On an average there is a 16 percent chance of an average person in India being afflicted by cancer over a lifetime. While there are huge variations related to lifestyle, occupation, gender and conditions of living, this means that one in six people will be affected by cancer at some point in life. Clearly cancer is no more something that happens to someone else – it can conceivably happen to us or people close to us.

The Lancet reported in 2014 that the incidence of cancer in India (about a million cases in a population of 1.2 billion) is about a quarter of what one would see in Western Europe. This is easily explained by demographics – while the profile of India’s population is changing, India still has a relatively younger population compared to Europe. But the bad news is that, in spite of a relatively low incidence, the mortality from cancer in India is similar to what one sees in aging populations in the global North. Unlike in developed nations where cancer diagnosis and treatment are integral parts of the health system, in India most people with cancer will never receive effective treatment. Of those who develop cancer in India a large majority will never be diagnosed, of those who are diagnosed a majority will be diagnosed too late for treatment to take effect, and of those who are diagnosed in time, a significant number will not have access to the best treatment available.

Poor infrastructure for surveillance and treatment

The distance we need to travel before cancer treatment is universally available is clear from the fact that cancer surveillance is in its infancy. The National Cancer Registry Program (NCRP) of the Indian Council for Medical Research (ICMR) runs Cancer Registries in Mumbai, Bangalore, Chennai, Thiruvnanthapuram, Dibrugarh, Guwahati and Chandigarh, which cover just 7 percent of the population. Thus even basic data on cancer prevalence and trends is limited. Extrapolating the limited data available in these centres, the NCRP projects that there were 1,148,692 cancer affected people in India in 2015 and this number is projected to rise to 1,320,928 by 2020. Of these tobacco related cancers (mainly of the lungs, mouth, tongue and throat) are estimated to account for 28 percent, followed by 19 percent for gastrointestinal cancers, 13 percent for cancers of the female reproductive tract (cervix, ovary and uterus), 10 percent for cancers of blood and lymphatic systems and 9 percent for breast cancers. There are, of course, major gender differences – mouth and lung cancers are most common among males (in large measure related to higher tobacco use) while cancers of the breast and reproductive tract are commonest among females.

Like for all diseases, cancers take a higher toll on the poor. The 2014 Lancet report comments that in India “poorer people [are] more likely to die from cancer before the age of 70 years than those who are more affluent”. The poor are at a higher risk as many infections, unhygienic conditions of living and poor personal habits predispose to the development of cancers that would otherwise have been avoidable. Further they are less likely to be diagnosed or to receive treatment.

One doesn’t need to be prescient to conclude that long term survival of cancer patients is critically dependent on a functioning health system that promotes equitable access. There are only an estimated 300 cancer treatment centres for the entire county, largely clustered around metropolitan centres. Primary level facilities have little or no facilities for cancer detection, let alone treatment.

Where are the compulsory licenses for generic manufacturing?

Compounding this situation of poor access to facilities is the new challenge faced by India after it amended its Patent Act in 2005. Having become a signatory to the World Trade Organisation (WTO) agreement, Indian companies are not allowed to make generic version of newly discovered cancer drugs. Most new cancer drugs are prohibitively expensive as patent holders in the US and Europe charge monopoly prices. For example a month’s treatment for Renal Cell Carcinoma using Pfizer’s Sunitinib would cost about Rs 1,75,000 while treatment using BMS’s Dasatinib for leukemia would cost Rs 1,60,000 per month. The Indian Patent Act has a specific provision that allows the government to issue a license to a domestic company to produce a patented medicine – known as a ‘compulsory license’. This power can be exercised in situations where a needed medicine is not available at an affordable price in the domestic market. Unfortunately in over 10 years since India changed its Patent Act the provision has been used only once, when a license was issued to the Indian generic manufacturer NATCO to produce Bayer’s version of the anti liver cancer drug Sorafenib (sold by Bayer as Nexavar). The price drop was dramatic – from Rs 2,80,00 per month for Bayer’s drug to Rs 8,800 per month when substituted with NATCO’s generic version.

Towards the end of the UPA government’s second term the Ministry of Health had constituted a sub-committee to short list drugs which could be recommended for issuance of licenses to generic manufacturers, so that they could introduce low cost generic versions. Included in the list were several anti-cancer drugs, including dasatinib. The initiative was still born as other ministries, especially the Ministry of Commerce, posed objections to this move. The current government has signaled that it is willing to accommodate several objections raised by the US government regarding provisions of the Indian Patent Act, including those dealing with compulsory licenses. Political will is clearly lacking when faced with the might of the Multinational Pharmaceutical industry.

Concurrently Indian generic companies are working in a more hostile environment without the explicit support provided by the 1970 Patent Act. Neither do they feel secure that their interests would be safeguarded by public policies. In such a situation they would rather collaborate with MNCs (which they are doing as evidenced by the slew of collaborative marketing, research and manufacturing licenses they are entering into with MNCs) rather than annoy them with compulsory license applications. The net effect is that the Indian generic industry, the third largest in the world by volume and known as the ‘pharmacy of the South’ has been able to secure one measly compulsory license – worse than what even Zambia and Zimbabwe have approved!

The situation that Indian cancer patients find themselves in could have several remedies. Primarily solutions have to be located in a well resourced and affordable health system that scales up surveillance, diagnosis and treatment. Primary care services are as necessary as are tertiary facilities in such a system. Importantly the potential of India’s generic industry needs to be harnessed with clear intent and purpose so that the fruits of new knowledge are not denied forever to the growing number of cancer patients.