Would Affordable ‘Modicare’ Remain Just A Pipe Dream In India?

When ‘Universal Health Care/Coverage (UHC)’, considering a critical socio-economic national responsibility’, has been implemented by the Governments in a large number of countries across the world, why has it still not been effectively addressed by the successive Governments in India, garnering adequate resources, at least, for its phased roll-out in the country?

According to published reports, not just all the developed countries of the world, a good number of developing nations too, including some in Africa, have various kinds of UHC mechanism already in place.

Even within the BRIC countries, India is still a laggard in this area.

Health related major national initiatives of this kind and scale, not only effectively addresses the issue of access to affordable healthcare for all, ensuring high quality of public health environment for a healthy society, but also helps improving economic productivity maintaining a healthy work force.

It goes without saying, UHC helps reducing ‘out of pocket expenses’ towards health, significantly.

OECD Health Statistics 2014: How does India compare?

Total health spending of India with only around 4.0 percent of GDP in 2012 was less than half the OECD average of 9.3 percent.

Public health spending usually tends to rise with the economic growth of a nation. However, despite high GDP growth in the past two decades, India ranks well below the OECD average in terms of per capita health expenditure, with spending of only US$ 157 in 2012 (calculated based on purchasing power parity), compared with an OECD average of US$ 3484.

It is indeed an irony that with highest billionaire wealth concentration, India still tops malnutrition chart in South Asia. (I discussed this subject in my blog post of January 26, 2015.)

Public sector usually becomes the main source of health funding:

In nearly all OECD countries, the public sector is the main source of health funding. However, in India, only 33 percent of health spending was funded by public sources in 2012, a much lower share than the average of 72 percent in OECD countries.

In India, health accounted for only 4.8 percent of total government spending in 2012, significantly lower than the 14.4 percent across OECD countries. Out-of pocket costs accounted for 60 percent of health spending in India in 2012, higher than in any other OECD country.

This trend has not improved much even today.

UHC deserves public funding:

In almost all OECD countries, including many developing nations, as well, UHC remains a key area of public health funding. 

Interestingly, very often UHC is projected as an idealistic social goal that is within reach of only the prosperous countries of the world. This is indeed a myth, as UHC is in place also in countries like, Bangladesh, Sri Lanka and even Rwanda in Africa, besides South-East Asian countries, such as, Japan, South Korea, Taiwan, Thailand, Singapore and China.

The strong relationship between health and economic performance of a country has now been well established globally.

Many case studies covering both the developed and developing nations, clearly point out that a country’s desirable focus on UHC does not just increase the life expectancy of its people, in general, but also facilitates economic growth in a sustainable way, which India is so keenly working towards.

Expectations for UHC received further boost from the new Government:

Just before the Union Budget Proposal 2015-16, in November 2014, national media reported: “ ‘Modicare’ to introduce free medicines, health insurance for citizens”.

It highlighted that in a major health sector reform, the new Government would ensure that every resident in India has access to affordable healthcare with provisions for free essential medicines while bringing over a dozen of diseases, including cancer and heart ailments, under the ambit of the proposed National Health Assurance Mission.

Another pre-budget media report on December 30, 2014, flashed: “The National Health Assurance Mission (NHAM) set to roll, once PM Modi gives go-ahead”.

It articulated, NHAM that has been in the works since 2011 when the erstwhile Planning Commission’s expert group submitted its report on UHC, is likely to take final shape in 2015. PM Narendra Modi is, however, still to see the presentation.

NHP 2015, bolstered hope for early adoption:

On December 31, 2014, when the present Government was in the midst of a series of major policy announcements for the country, The National Health Policy 2015 (Draft) was also released, further bolstering the hope for early adoption of UHC.

I discussed a related issue in my blog post of March 16, 2015 titled, “With Frugal Public Resource Allocation Quo Vadis Healthcare in India?

Affordable ‘Modicare’ overshadows even ‘Obamacare’?

Universal Health Care (UHC), as narrated in the National Health Policy (NHP) 2015 (NHP 2015 Draft) of Narendra Modi Government, making health a ‘Fundamental Right’ for Indian Citizens, is indeed profound in its both content and intent.

In this article, I would term the new health policy as ‘Modicare’, just as many others did. If implemented in letter and in spirit, as it has been proposed, NHP 2015 has the potential to overshadow even ‘Obamacare’ of the United States…hands down.

A change in the fundamental narrative:

UHC, as detailed in NHP 2015, changes the fundamental narrative of the country’s approach to extend healthcare services to all Indians, irrespective of caste, creed, income level, age or any other pre-determined and conceivable parameters.

However, for this purpose, Modi Government would need to double the public healthcare expenditure from its current level of less than 1 percent to 2.5 of the GDP. It was also indicated that the required fund would be raised by levying healthcare tax to citizens, directly or indirectly.

Government to assume a key role in healthcare:

Currently, private players are playing dominating role with around 70-80 percent share (around US$ 40 Billion) of total healthcare services domain in the country. In other words, public healthcare services cater to no more than 20 percent of the total market, and mostly are of dubious quality standards.

It is interesting to note, NHP 2015 places the Government as the major provider of quality healthcare services for all. However, an individual would have the right to opt for private facilities, of course by paying significantly more.

The business scenario could change dramatically for private sector:

In NHP 2015, the Government becomes the major provider of UHC services. The private sector healthcare players would then probably require going back to the drawing boards to reorganize their business models.

They may well choose to embrace Public Private Partnership (PP) initiatives related to UHC or decide to turn into to niche players in the high-price private healthcare space or something else, as they would deem appropriate. But surely, they would have to take a step or two back from the current dominant role, where there is virtually no competition from the public sector, even in the mass healthcare market.

NHP 2015, underscores the need for affordable drug prices. Thus, the private players could also face tough pricing pressure, as well, while negotiating for large Government procurement.

Both the above issues, when put together and in perspective, would probably not make the private healthcare players terribly enthused or feel at ease. In that scenario, the Government has its task well cut out, mainly for navigating through tough resistance coming from both the national and international lobby groups, in the process of implementation of ‘Modicare’ in India, of course, if it fructifies any time soon or at all.

No control on quality even in private healthcare services:

In India, besides medicines, there is no quality control on any healthcare services, be it public or private.

As public healthcare services are hardly available to a vast majority of Indian population, common people remain virtually at the mercy of pricing diktats of the private healthcare providers, while availing the same. They usually do not have any inkling for high cost of such services, which generally follow the simple ‘demand and supply’ market economy model.

With the implementation of NHP 2015, the Government being the single largest buyer and provider of both healthcare products and services, would presumably negotiate hard both on quality and prices with the respective suppliers, benefitting the patients immensely.

Moreover, since Indian citizens would be paying for healthcare on an ongoing basis through direct and indirect taxes, NHP 2015 proposes free medicines and diagnostics facilities to all, as and when UHC would roll out.

Quietly comes the dampener:

When the Union Budget 2015-16 raised the national allocation for health only by 2 percent over the previous year, it literally extinguished the hope for healthcare reform in India, any time soon, even in a phased manner.

Central budgetary allocation for this initiative is very important, as UHC has been planned to be funded both by the Union and State Governments in 75:25 ratio.

In this intriguing phase, Reuters came out with the ‘Breaking News’.

On March 27, 2015, it reported, though the health ministry developed NHP 2015 on UHC in coordination with the prime minister’s office last year, along with an expert panel, including an expert from the World Bank, Prime Minister Narendra Modi has asked for a drastic cutback of the ambitious healthcare plan after cost estimates came in at US$18.5 billion over five years. Consequently, this would delay a promise on healthcare made in his well-publicized election manifesto, indefinitely.

Prime minister Modi’s manifesto, ahead of 2014 parliamentary election that brought him to power, accorded “high priority” to the health sector and promised a ‘Universal Health Assurance’ plan. The manifesto also said, previous public health schemes that have been mired in payment delays, had failed to meet the growing healthcare needs of the public, the above report highlighted.

Initially, the new Union Health Ministry reportedly proposed rolling out the system from April 2015, and in October 2014 projected its cost as US$25.5 billion over four years.

By the time the project was presented to Modi in January 2015, the costs were already brought down to US$18.5 billion over five years. Even that revised estimate was considered too much and the program was not approved by the Prime Minister, without assigning any timeframe even for a relook.

The delay in ‘Modicare’ is intriguing:

Inordinate delay in the commencement of implementation process of ‘Modicare’ or UHC in India is rather intriguing, primarily due to the following two basic reasons, besides some others:

- NHP 2015 proposes to fund the scheme through indirect and direct taxation on people, who would be covered by this new health policy.

- Experts, such as, Nobel Laureate Dr. Amartya Sen, in scholarly writings, have established with strong evidences, both from the developed and developing nations, that the national focus on UHC goes well beyond just increase in the life expectancy of the population. Besides many other tangible benefits, UHC helps facilitate sustainable economic growth of a nation significantly, which India is now so keenly working on.

Conclusion:

Over the past couple of decades, despite impressive GDP growth of the country, successive Governments in India have not shown desirable inclination to invest in a comprehensive public healthcare project, like UHC.

As a result, the nation still suffers from public health maladies, such as, grossly inadequate number of doctors, nurses, other paramedics, number of hospital beds and other related infrastructure to cater to even the basic healthcare needs of all Indians.

Ironically, at the same time, either the government fails to spend the paltry budgeted amount because of poor governance, or even that small amount faces a year end drastic budgetary cut from the Ministry of Finance to manage the fiscal deficit target of the year, as happened even in 2014-15.

Considering the series of events that followed the announcement of the draft NHP 2015, it appears, the prospects for affordable ‘Modicare’ in India is rather bleak, as it stands today.

There is also a possibility that in the implementation process of ‘Modicare’ the Government may encounter tough resistance from interested lobby groups, purely for business considerations, as deliberated above.

The real reason for delay of ‘Modicare’ has not come from the horse’s mouth, just yet. Nonetheless, it is certainly one of those much hyped and publicized public promises of the Government that remained unfulfilled, at least in the financial year of 2015-16.

Although one should not try to see ghosts where there isn’t any, the moot question that still keeps haunting today: ‘Would much publicized and well sought-after ‘Modicare’ continue to remain just a ‘Pipe Dream’ in India?’

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

The Ghost Keeps Haunting: NCD Dogs Cancer in ‘Compulsory License’ Debate of India

In November 2012, as a part of the ‘Campaign for Affordable Trastuzumab’ for the treatment of breast cancer, a citizens’ collective, reportedly sent an ‘Open Letter’ signed by around 200 cancer survivors, women’s groups, human rights and health rights campaigns and treatment activists from across the world to the Indian Prime Minister, urging him to ensure that the breast-cancer drug Trastuzumab is made affordable for treating cancer patients in the country.

Trastuzumab was named because of the following reasons:

  • Breast-cancer affects around 28-35 per cent of all cancers among women in major cities of India.
  • No other drug against HER+2 cancer can reduce patients’ mortality as Trastuzumab and reduce the spread of malignancy to other parts of the body.
  • Majority of women with HER+2 breast cancer do not have access to a complete course of the drug, which reportedly costs anywhere between Rs 6 to 8 lakhs (US$ 11,000 to US$ 14,500).

Reaping reach harvest: 

According to a media report, three homegrown Indian companies are currently developing biosimilar drugs to this protein molecule to reap a reach harvest arising out of the emerging opportunities.

However, this is expected to be an arduous, expensive and challenging endeavor, as the concerned companies will require pursuing a complicated biotechnological route to create follow-on biologics for Trastuzumab.

The ‘Trigger Factor’: 

It is widely believed that the above ‘Open Letter’ to the Prime Minister had prompted the Ministry of Health to form an ‘Experts Committee’ to evaluate the situation and make recommendations accordingly.

Thereafter, within a short period of time, in January, 2013, in a move that is intended to benefit thousands of cancer patients, Ministry of Health forwarded the report of the above ‘Experts Committee’ to the Department of Industrial Policy and Promotion (DIPP) for its consideration to issue Compulsory Licenses (CL) for three commonly used anti-cancer drugs namely, Trastuzumab (used for breast cancer), Ixabepilone (used for chemotherapy) and Dasatinib (used to treat leukemia). Public Health Foundation of India (PHFI), among other experts, also reportedly had participated as a member of this ‘Experts Committee’,

For a month’s treatment drugs like Ixabepilone and Dasatinib reportedly cost on an average of US$ 3,000 – 4,500 or Rs 1.64 – 2.45 lakh for each patient in India.

 A ‘Technology Transfer’ discouraged: 

Such a rapid development in the CL landscape of India is indeed intriguing, especially after a voluntary announcement by Roche in 2012 that it will produce Trastuzumab and Rituximab in India through transfer of technology to an Indian contract manufacturer.

Consequently for a month’s treatment, the price of Trastuzumab will come down from around US$ 2,000 to US$ 1, 366, i.e. by 31 percent and Rituximab from around US$ 1,456 to US$ 682 i.e. by 53 percent. This was reportedly announced by none other than the Minister of State of Chemicals and Fertilizers of India Mr. Srikant Jena.

Despite this voluntary decision of technology transfer and price reduction of two life saving drugs in India by Roche, reported Government consideration for grant of CL for Trastuzumab, without getting engaged in any form of a win-win dialogue with the Company, could ultimately prove to be counter productive and may discourage further technology transfer of expensive patented drugs to India.

Increasing incidence of cancer in India: 

Cancer is just not a dreaded disease, but also making a devastating impact, financial and otherwise, on the lives and families of thousands of sufferers in India.

According to ‘The Lancet’, published on 28 March 2012, in India 556 400 people died of cancer only in 2010.

The paper also comments that only half of the estimated 9.8 million total deaths per year is captured by the CRS in India, fewer than 4 percent are medically certified, while more than 75 percent of deaths occur at home.

The Lancet study clearly highlights that most cancer patients in India die without medical attention and drugs. Cancer is, therefore, increasingly becoming a public sensitive disease area with high socioeconomic impact in the country. High treatment cost of this near terminal disease is beyond reach of majority of population in the country.

In a written reply to a question in the ‘Upper House’ of the Indian Parliament, the Minister of State for Health and Family Welfare on March 4, 2012 said that according to “Three Year Report on Population Based Cancer Registries 2006 – 08″ of the Indian Council of Medical Research (ICMR), the estimated numbers of cancer patients for 2015 and 2020 are 1.16 million and 1.27 million respectively. There is a gradual rise in the prevalence of cancer in India, though the government has initiated several measures in this area.

High incidence of breast cancer: 

As per a recent report, an estimated 1, 00,000 – 1, 25,000 new patients suffer from breast cancer every year in India and this number is expected to double by 2025.

Government is mulling CL for NCD: 

Currently the DIPP appears to be planning to extend the provision of Compulsory License  (CL) beyond cancer drugs to other Non-Communicable Diseases (NCD) in the country, like diabetes. 

Domestic Pharma Association supports the move: 

A major domestic pharmaceutical industry association, as per media reports, supports this move by clearly articulating, “Over the years, more deaths are taking place on account of Non-Communicable Diseases (NCDs) than communicable ones. It is, therefore, natural that this provision (CL) will be used for NCDs as well.”

UN declaration on NCD provides flexibilities in TRIPS Agreement: 

Experts believe that this new move on CL for drugs related to NCDs is a consequence of India’s signing the United Nation (UN) declaration on the prevention of NCDs in the country by, among others, using flexibilities in the TRIPS Agreement to increase availability of affordable drugs for such diseases.

The Government has already launched a “National Program for Prevention & Control of Cancer, Diabetes, Cardio Vascular Diseases and Stroke (NPCDCS)” as a pilot project covering 150 million people in 100 inaccessible and most backward districts during the financial year 2011-2012 at a cost of US$ 275 million.

Socio-economic impact of NCDs in India: 

Indian Journal of Community Medicine (IJCM) in an article titled, “Social and Economic Implications of Non-Communicable Diseases (NCDs) in India” has highlighted, among others as follows:

  • NCDs account for 62 percent of the total disease burden in India with a significant ascending trend both in terms of overall mortality and morbidity.
  • This burden is likely to increase in the years to come.
  • Due to chronic nature of the disease and technological advancements in care, costs of treatment are high leading to access barriers, or ‘catastrophic expenditures’ for those who undergo treatment.
  • There are evidences of greater financial implications for the poorer households suffering from NCDs.
  • Most estimates suggest that the NCDs in India account for a significant economic burden ranging from 5 to 10 percent of GDP.
  • An urgent multi-sectoral Government action is strongly warranted both on grounds of economic arguments and social justice.
  • Action needs focus on addressing the social determinants of NCDs for prevention and strengthening of health systems to meet the challenge.
  • A framework for monitoring, reporting, and accountability is essential to ensure that the returns on investments in NCDs meet the targets and expectations set in the national plans.

Innovator companies contemplating legal recourse: 

Reacting to all these developments, the global pharmaceutical companies have, once again, expressed strong commitment to protect and continue to defend their Intellectual Property Rights (IPR) within the legal framework of India.

They have also reiterated their belief that a robust IPR regime will encourage innovation in the country making available more and more innovative drugs for the patients in India.

An interesting WHO report on a ‘robust IPR regime’: 

In this regard a World Health Organization (WHO) research report titled “Patents, Price Controls and Access to New Drugs: How Policy Affects Global Market Entry” makes some interesting observations on a ‘robust IPR regime’.

The report highlights the following four important points:

1. Increasing the strength of a patent system to include long-term protection on pharmaceutical products appears to spur market entry mostly in the high-income countries.

For the low- and middle-income countries that are currently being encouraged to move to stronger protection through trade policies, the evidence that extending protection enhances access to new pharmaceuticals is mixed.

2. There is some evidence that high level of protection might encourage more frequent entry of innovative products in the short term. However, in the longer term the same domestic capacity could well be an alternative source of entry of such drugs.

3. Intellectual Property (IP) holders frequently assert that the poor quality of enforcement in developing countries undermines the value of their patent rights. However, it is quite evident now that patent laws in these countries are at least broadly meaningful commensurate to their respective domestic requirements.

4. The standard argument on price regulation that it will dissuade market entry for innovative drugs appears to have more relevance among the high-income countries and not so for the poorer countries.

The authors further indicate:

“There we find that while price regulation makes it less likely that new drugs will be available quickly, it does not appear to prevent new products from being launched eventually.”

Conclusion: 

Following all these recent developments and weighing pros and cons, one could well imagine that pressure on the Government from various stakeholders for CL on drugs for Cancer and NCDs will keep mounting, unless an alternative measure like, ‘Price Negotiation for Patented Drugs’ is put in place by the Department of Pharmaceuticals, sooner than later, in 2013.

The recent judgment of the ‘Intellectual Property Appellate Board (IPAB)’ on CL to Natco may further add fuel to this raging debate.

It is now quite clear from the Finance Minister’s speech on the ‘Union Budget Proposal’ for 2013-14 that eagerly awaited ‘Universal Health Coverage’ or ‘Free Distribution of Essential Medicines to all’ schemes will not be implemented, at least for now.

Thus in all probability, the ghost of CL will keep haunting the innovators in India unabated, unless an effective, scalable and sustainable model for improving access to patented drugs for majority of population in the country is put in place. This will call for demonstrative, innovative and constructive Public-Private-Partnership (PPP) initiatives, sooner. In this effort  all concerned should at first be aligned with the cause, in principle, and try to be a constructive partner to get it translated into reality together, rather than just playing the role of vociferous critics in perpetuity .

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.