Wide Gap Between Health Care Needs, And Delivery: Is The Bridge Still Too Far?

“Health inequities which abound in India must be corrected through investments in a robust primary health care system,” said Professor K Srinath Reddy, chairman, Public Health Foundation of India (PHFI), not too long ago.

The equity gap between health care needs and delivery for the general population of India continues to widen.

As the next Union Budget of India is coming nearer, the question in this regard that comes at the top of mind is:

Would adequate resources be allocated by the Union Finance Minister to bridge this gap effectively now or the elusive bridge continue to remain too Far?

The growing challenges: 

Up until now, despite making some progress in improving access to health care, India continues to face the growing challenges of:

  • Gross inequalities in this area by socioeconomic status, geography and gender. 
  • High out-of-pocket health expenditure pushes its ever increasing financial burden overwhelming on the private households, that accounts for over three-quarters of health spending in India.
  • Exorbitant out-of-pocket health spending is also responsible for mercilessly driving into poverty more than half of Indian households, or around 39 million Indians, each year.

The paper titled, “Health care and equity in India”, published by ‘The Lancet’ on February 05, 2011, well deliberated on this issue. 

The paper identifies 3 key challenges to equity in health care:

  • In service delivery
  • In financing
  • In financial risk protection

In the article titled, “My Expectations From The Union Budget (2016-17)”, written in this Blog on December 07, 2015, I also suggested that adequate resource deployment be made by the Government now in power, in all these three areas, while presenting the forthcoming Union Budget on February 28, 2016.

The root cause of inequity in healthcare:

I reckon, there are, at least, the following three key reasons that can be attributed to this failure, on the part of various Governments in power, till today:

  • Inability, primarily on the part of the central government, to effectively integrate healthcare with socioeconomic, social hygiene, education, nutrition and sanitation related issues of the nation. 
  • Health being a state subject, not much of coordinated and robust planning has so far been taken place in this area, between the Central and the State Governments, to effectively address the pressing health care related growing inequity across the country, in general.
  • Budgetary allocation and other fiscal measures towards health care, both by the central and most of the state governments, are grossly inadequate. 

As I said before, in another article published by this blog titled, “With Highest Billionaire Wealth Concentration, India Tops Malnutrition Chart in South Asia” on January 26, 2015, it is a well accepted fact that reduction of social inequalities ultimately helps to effectively resolve many important health care issues.

Otherwise, only a much smaller population of the country having adequate access to knowledge, social and monetary power, will continue to have the necessary resources to address their health care needs, appropriately.

UNICEF highlights stark inequalities in India:

According to UNICEF, every year, 1 million children below the age of five years die, due to malnutrition related causes in India. This number is worrisome as it is far higher than the emergency threshold, according to the World Health Organization (WHO) classification of the severity of malnutrition.

Highlighting stark inequality in India, the report says, “The net worth of a household that is among the top 10 per cent can support its consumption for more than 23 years, while the net worth of a household in the bottom 10 percent can support its consumption for less than three months.”

Are so called patient centric approaches” real?

Patients are also bearing a different kind of brunt altogether, from several other corners, on their health related issues.

Today, most of the important stakeholders of the health care industry, in general, seem to be using various facades of ‘patient centric approaches’, just for petty commercial gains, or for gaining some key strategic commercial advantages.

Such entities could well be pharmaceutical industry, doctors, hospitals, diagnostic centers, politicians or any other stakeholders.

It is unfortunate that most of them, at various different times, either pontificate about following ‘patient centric approaches’ or use the patients cleverly just to achieve their respective commercial or political goals, solely driven by vested interests. While on the ground, growing inequity in health care keeps marching north.

A recent paper of NITI Ayog:

In a discussion paper of July 18, 2015 titled, “Health System in India: Bridging the Gap Between Current Performance and Potential”, The National Institution for Transforming India Aayog (NITI Aayog), the policy think tank of the new Indian Government, has also accepted the following 3 critical realities, currently prevailing in the health care environment of India: 

  • India’s progress in health outcomes has been slower in comparison to other countries with comparable incomes and at similar stages of development. 
  • Impressive gains in per capita income should match with an increase in life expectancy or health status. 
  • Out of pocket expenditure in India is high (70 percent of total health expenditure). This is catastrophic for the poor and pushes an estimated 37 million into poverty every year. 

The NITI Ayog paper also emphasized, although health is a subject allotted to the State List, under the Seventh Schedule of the Indian Constitution, the Central Government is jointly responsible for items in the Concurrent List. 

Conclusion:

Currently, India is the global numero uno in the GDP growth rate. Thus, there cannot probably be any better time for the nation to leapfrog in the health care space, with a quantum increase in public financial commitments, to radically revamp the fragile public health system in the country. 

I repeat, incremental progress in the public health care system is just not enough for the country, extensive application of cutting edge Information Technology (IT) effectively, dovetailing with the creation of modern brick and mortar public health care infrastructure, top class human resource namely, doctors, nurses and related skill development process, on an ongoing basis.                                                                             

The Government should also ensure that the domestic health care industry comes forward to shoulder higher responsibility to enable the country in offering greater equity in health care, in tandem with the Union Ministry of Health and the State Governments.

This path, in my view, would help building a more equitable health system with a strong foundation of public health for more than 1.2 billion Indians. In that process the fast widening gap in equity, between health care needs and availability, could be bridged much sooner, and in a sustainable way.

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.

Just 16% Of Indian Population Has Access To Free Or Partially-Free Health Care?

Is health care currently a low priority area for the Government of India? Probably yes, and thus it is worth trying to fathom it out.

Besides planned frugal spending on overall public health in 2015-16, even as compared to the past trend, two other health related budgetary decisions of the Government are indeed baffling, at the very least.

As many of you, I too know that the incumbent Government in its first full-year budget of 2015-16 has sharply reduced the budgetary allocation on many important health related other projects, such as:

- Union budget allocation for the National Rural Drinking Water Program (NRDWP) that aims at providing safe drinking water to 20,000 villages and hamlets across India, has been drastically reduced this year. Curiously, this decision has been taken at a time, when India loses 200 million person days and Rs 36,600 crore every year due to water-related diseases.

- The Integrated Child Development Services (ICDS) scheme, which provides food, preschool education, and primary health care to children under 6 years of age and their mothers, has also been hit by a 54.19 percent budget cut this year. This decision too of cutting public expenditure on food, nutrition and health care for children to more than half, defies any logic, especially when 40 percent of growth stunted children in the world are reportedly from India, exceeding the number of even sub-Saharan Africa.

I hasten to add that the Union budget 2015-16 has indicated, as the states’ share in the net proceeds of the union tax revenues has increased, as per recommendations of the 14th Finance Commission, these central Government programs will now be run with a changed funding pattern between the Union and states. However, according to financial experts in these areas, regardless of devolution, the total money available to run these critical projects is sharply decreasing.

That said, on the other pages of the same Union Budget, public funding in the current fiscal year for bridges and roads has more than doubled. The budgetary allocation for these two areas now stands more than even education.

I deliberated on similar subject of access to health care in my blog of March 16, 2015, titled, “With Frugal Public Resource Allocation Quo Vadis Healthcare in India?

Health care sector is important for job creation too:

According to the World Health Organization (WHO), health care sector is one of the largest job creators, not just in India, but globally. Thus, Indian health care industry being one of the fastest growing industrial turf in the country with a reasonable base, deserves a sharper focus of the Government.

Additionally, the socio-economic benefits that this sector provides in creating a sustainable, healthy and highly productive work force, has been well documented and can’t just be wished away, in any case.

The neglect is intriguing:

Currently, total healthcare spend of India is no more than 4.2 percent of the GDP with public spending being just 1.2 percent of it. Other BRICS nations are way ahead of India, in this area too. To set a direction on country’s public healthcare spend, breaking the jinx of a long period of time, the draft National Health Policy 2015 of the Government aimed at initial increase in health expenditure to 2 percent of the GDP.

As a result of the legacy of neglect over a long period of time, which continues albeit more blatantly even today, only 16 percent of the Indian population declares today that they have access to free or partially-free health care. I shall dwell on this area subsequently in this article.

Keeping these in perspective, it was intriguing, when the union budgetary allocation for health care in 2015-16 was kept at Rs. 297 billion or U$4.81 billion for its main health department, almost the same outlay as in the previous budget.

When compared against public fund allocations, such as, US$ 93 billion for highway projects or US$ 7.53 billion for 100 smart cities in the country, one will get a realistic perspective of this meager health budget allocation, in terms of effectively addressing the health care needs of around 1.25 billion people of India. Over 70 percent of this population live in the hinterland.

Agreed that the Government focus on these ‘infrastructure projects’ are not unimportant by any means. Nevertheless, the above comparison only highlights how much priority the Government assigns to the health care sector of India and for the health of its citizens. This issue assumes even greater significance in combating several challenging health situations, such as, ongoing fight against increasing incidence of life-long chronic ailments and deadly life-threatening diseases like, cancer, fueling already high rate of morbidity and mortality in the high country.

A quick glimpse on a few outcomes of neglect:

The Working Paper No. 1184 dated January 8, 2015, titled “Improving Health Outcomes And Health Care In India” of the Organization for Economic Co-operation and Development (OECD), highlights some interesting points, as follows:

  • Chronic diseases are the biggest causes of death and disability accounting for 50 percent of deaths, with cardiovascular diseases and diabetes, respiratory conditions and cancers figuring most prominently.
  • Preventive interventions such as improving access to a clean water supply, reducing the spread of HIV/AIDS through better sexual education, and vaccination campaigns for other diseases will each deliver more significant returns in life years.
  • Vaccination rates for diphtheria, tetanus and pertussis, for measles and for hepatitis B are all much lower than in OECD and peer countries.
  • Minimal access to free or partially-free health care.

It is an irony that ‘life expectancy’ in India still remains well below the countries at a similar level of development.

Abysmal overall hygienic conditions:

The OECD survey brings to the fore  abysmal hygienic conditions still prevailing in India. It can only be improved through active intervention of the Government with necessary budgetary allocations, sans photo ops for some celebrities and most politicians. Sincere support and participation of the civil society and intelligentsia, in general, are also equally important.

The paper underscores, among others, the following extremely unhygienic conditions still prevailing both in urban and rural India:

  • Most households in rural India do not defecate in a toilet or latrine, which leads to infant and child diseases (such as diarrhea) and can account for much of the variation in average child height. Even today the sight of poor children defecating openly in the streets, that too in a city like Mumbai, is also not very uncommon.
  • The burning of solid fuels in particular (undertaken by more than 80 percent of the population in cooking) is a major risk factor behind ischemic heart disease, lower-respiratory tract infections and chronic obstructive pulmonary diseases and could also increase cataracts and stroke.
  • Exposure to air pollution is a significant problem.
  • Many of the poor continue to smoke heavily.
  • 11 of the lowest income quintile did not undertake sufficient physical activity, compared with 16 percent in the highest income quintile.

India provides minimal access to free or partially-free health care:

As I mentioned above, India provides minimal access to free or partially-free healthcare to its citizens, as compared to all the BRICS nations, many other countries in South East Asia and even in Africa.

The above OECD paper states that with poor health intertwined with poverty, the greatest gains lie with policies that address the social conditions which enable combating communicable and non-communicable diseases.

Among BRICS countries, India provides least access to ‘Free or Partially-Free Health Care’ Services to its general population. This is despite being the largest democracy in the world, which is now striving hard to emerge as an economic and military superpowers.

The following study shows that only 16 percent of the Indian population declares having access to free or partially-free health care from the government:

BRICS Countries % surveyed said ‘Yes’ to the question: “Does your household have access to free or partially free health care from the State”
India 16
Brazil 24
China 73
Russia 96
South Africa 62

Source: Credit Suisse Research Institute, Emerging Consumer Survey Databook 2014.

As the OECD paper states, in this study approximately 1500 respondents were surveyed in each country, with India and China both having larger sample size of 2500. The male-to-female split between respondents was roughly 50:50 in all cases with rural-to-urban split varying by country.

Poor satisfaction level with existing health care services:

This is very important; as public facilities are the predominant source of qualified health professionals in rural areas where much of the Indian poor reside. In addition, significant population growth is occurring in urban slums, where urban public health care facilities are struggling to provide basic services. In a situation like this, slum dwellers face challenging economic barriers to accessing expensive private health care services (MoHFW, 2012).

The OECD survey indicates that 41 percent of those in rural areas and 45 percent in urban areas were not satisfied with treatment by their doctors or facility.

The reason attributed to this dissatisfaction are as follows:

  • Distance was cited by 21 percent of people in rural areas and 14 percent in urban areas.
  • Public health care centers remain closed more than half the time and lack basic medical supplies, such as stethoscopes and blood pressure scales.
  • Non-availability of required services was cited by 30 percent of people in rural areas and 26 percent in urban areas.

This is quite credible, as according to the Government’s own estimates:

- 10 percent of primary health care centers are without a doctor

- 37 percent are without a laboratory technician

- 25 percent without a pharmacist (MoHFW, 2012)

The above picture is quite consistent with large scale surveys in poor communities of India, by OECD.

Health care business for up market is booming:

Growing inequitable distribution of healthcare products and services is now wide open and blatant, more than ever before. There is no signal yet that the Government would soon consider health care sector as its one of the key focus areas, along with education, just as infrastructure, such as, building roads, highways, e-highways, flyovers, bridges and smart cities.

For up-market patients, the private sector is creating world class facilities in India. We can see today a good number of ‘five-star’ hospitals, with more number of newer ones coming up offering jaw-dropping facilities, quite akin to, may be even surpassing what are being offered for patients’ luxurious comfort in the developed world. Although these facilities cost a fortune, one would usually need to be in a queue to get admitted there for any medical or surgical treatment.

Most of these hospitals are now in high demand for ‘medical tourism’. According to available reports India currently caters to health care needs of over 200,000 foreign patients. ‘Medical tourism’ business reportedly fetched around US$ 2 billion to India in 2012.

On the flip side of it, as we all read in the recent media reports, some of these hospitals in Delhi refused admission even to seriously ill dengue patients, as they can’t afford such facilities. A few of these patients ultimately succumbed to the disease and the parents of one such poor child, who died without any hospital treatment in that process, committed suicide unable to withstand the irreparable and tragic loss.

Giving ‘Infrastructure Status’ to health care sector:

When creating basic infrastructure is the priority area of the present Government for financial resource allocation, why not give ‘infrastructure status’ to the health care sector now? This is not just for the heck of it, but purely based on merit and earlier detail evaluation by a Government Committee of experts.

To address the critical health care needs for the vast Indian population with appropriate infrastructure, quality products, services and manpower, providing ‘infrastructure status’ to the health care sector could facilitate the whole process. Additionally, it can transform the Indian healthcare sector as one of the biggest job-generating industry too.

This has been a key demand of the industry until recently, though not so much being talked about it today. A few years back, the previous Government was reportedly mulling to assign full fledged infrastructure status to the healthcare sector, as it merits inclusion in the category of ‘infrastructure’, satisfying all the nine criteria set by the erstwhile Rangarajan Committee.

I find in my archive, the Confederation of Indian Industry (CII) also demanded ‘infrastructure status’ for the health care sector in its pre-union budget memorandum for 2010-11. In that proposal CII had estimated that health care industry in India requires an investment of around US$80 billion, whereas in the current fiscal year the public expenditure on health still languishes at U$4.81 billion.

This specific issue seems to have taken a back seat today, for reasons not known to me. However, it is interesting to note that not just the Government apathy, no such demand is being made today by the large multi-industry trade associations of India, as vociferously as we witness, for example, in the case of ‘The Goods and Service Tax (GST) Bill’.

Health care debate is not to the fore today:

Critical health care issues of the country don’t seem to be in the fore front today for comprehensive debates even for the Indian main stream media, to influence the government.

We have been experiencing for quite while that Indian media, including social media, in general, usually goes ballistic 24×7 mostly with selective sensational topics. These may include, among others…glitzy events on Government’s high profile advocacy initiatives to attract more Foreign Direct Investment (FDI) from large overseas companies…Or back home some unfortunate and tragic Dengue fever related deaths due to negligence just in Delhi, though the same and equally grave incidences taking place in the other states of India, are hardly getting any coverage…Or on some high profile alleged murder pot-boilers announcing media verdict conclusively, even before completion of police investigation and charge-sheet being filed in a court of law.

These are probably neither bad, nor unimportant, nor avoidable, nor can come within the ambit of any media criticism. I am also not trying to do that, either.

As the saying goes, variety is the spice of life. We, therefore, generally want to get a feel of it everyday early in the morning, mostly glancing through the newspaper headlines, or in the late evening watching impatient anchor with strong personal opinion trying hard to dominate over all other participants in high-decibel ‘TV debates’, as these are called by the respective channels.

In an era of sensationalized and eye-ball grabbing ‘Breaking News’ of all kinds, flashing everywhere almost every now and then, critical health care issues seem to have become a mundane subject to the newsmakers for any meaningful debate to influence the Government. Serious debates on critical health care issues presumably would not generate all important Television Rating Points (TRPs) to the TV channel owners. Though I have no idea, the TRP of such debates  probably has been estimated to be even lesser as compared to the cacophony aired by the TV channels on the cost to exchequer for the MPs subsidized meals in the Indian Parliament…with intermittent high pitch ‘war cry’ of the dominating anchor… ‘the nation wants to know this’.

Conclusion:

Be that as it may, health care environment impacts all of us, quite appreciably. There is not even an iota of doubt on it. However, we can feel it mostly when the reality hits us or our families hard…very hard, as serious and cruel ailments strike suddenly, or as we face avoidable disease related deaths of our near and dear ones, or when illness makes a loving one virtually incapacitated, even after facing financial bankruptcy.

Health care is a serious matter for all of us, just as it is a serious and critical business for every nation and every Government. This criticality factor is independent of whatever level of economic development the country is aspiring for. Thus, the indifference of the Indian Government, if I may say so, despite promising so much on health care earlier this year, is intriguing, and more so, when just 16 percent of the total population has access to free or partially-free health care in our India of the 21st century.

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.

India: Tops The GDP Growth, Remains At The Bottom On Health Care

On February 9, 2015, the Wall Street Journal (WSJ) reported, “India’s statistics ministry surprised economists when it unveiled the new numbers for the growth of India’s gross domestic product. It ratcheted up India’s GDP growth figures using a new methodology that pegs expansion in Asia’s third-largest economy at 7.5 percent last quarter and 8.2 percent the quarter before that. Economists and the ministry, using the old methodology, had originally said growth was closer to 5.5 percent during those quarters. This recalculation indicates that India has already dethroned China as the world’s fastest-growing big economy, though China’s economy is still four times the size of India’s.”

For Indians in particular, this has indeed been a significant ‘feel good factor’.

However, keeping this ascending GDP growth rate in perspective, when we study the current health care related data of India as compared to BRICS nations (Brazil, Russia, India, China, South Africa) or even OECD (Organization for Economic Co-operation and Development) countries, India features at the rock bottom.

In this article, I shall quickly compare some critical health care parameters of India, against the same for other BRICS countries.

At the rock-bottom on healthcare:

This becomes absolutely clear when we look at the recent data on ‘Health Status’ of BRICS Nations, as follows:

Health Status of BRICS Nations (2013*)

Life Expectancy at Birth  Infant Mortality per 1,000 Live Births Child Mortality under 5 per 1,000 Live Births  Maternal mortality ratio (per 100 000 live births) 
Russia Federation 71 9 10 24
Brazil 74 12 14 69
South Africa 59 33 44 140
China 75 11 13 32
India 66 41 53 190

* Life expectancy at birth data is of 2012; maternal mortality ratio is of 2010; all the others are of 2013. Source: Health and Health Care in BRICS Nations by Victor G. Rodwin, Wagner School of Public Service, New York University, 

The legacy factor:

This has not happened overnight, public health care has been getting neglected in India over a long period of time. However, the process of slowing down in this area has become more pronounced in the recent years, as we shall discuss below.

The following table based on relatively recent data on ‘Health Expenditure’ in BRICS Nations, well captures the abject lack of focus in this area, which is so vital for sustainable economic progress of India:

Health Expenditure in BRICS Nations (2012*)

GDP Per capita (PPP)  Public Expenses on Health        (% GDP)  Private Expenses on Health  (%GDP)  Total Expenses on Health (%GDP)  Out-of pocket Health Expenses (% of Total Healthcare Expenditure) 1
Russia Federation  24,805 3.8 2.4 6.3 33.52
Brazil 16,096 4.3 5.0 9.3 31.08
South Africa 13,046 4.2 4.6 8.8 7.21
China 12,880 3.0 2.4 5.4 34.67
India 5,855  1.3 2.7 4.0 58.05

* GDP per capita in PPP is of 2014; Human Development Index is of 2013; the rest of the data is of 2012. 1. Calculated based on private expenditure on health (% of GDP), total expenditure on health (% of GDP), out-of-pocket health expenditure (% of private health care expenditure). Source: Health and Health Care in BRICS Nations by Victor G. Rodwin, Wagner School of Public Service, New York University.

Lowest Human Development Index:

Human Development Index (HDI) is broadly defined as a composite statistic of life expectancy, education, and per capita income indicators, which is used to rank countries into four tiers of human development. Net outcomes of both education and health care play critical roles in the statistical calculations of HDI.

Among the BRICS nations, India registers the lowest HDI at 0.586, as compared to 0.658 of South Africa, 0.719 of China, 0.744 of Brazil and 0.778 of Russia.

Source: Health and Health Care in BRICS Nations by Victor G. Rodwin, Wagner School of Public Service, New York University.

High economic costs of neglect to health care:

An April 30, 2015 article of Reuters stated that over 60 percent of deaths in India are due to non-communicable diseases (NCDs) such as cancer, diabetes, chronic respiratory and cardiovascular diseases, which are responsible for about 70 percent of spending on healthcare. They also make serious adverse impact on the economic health of the country, with NCDs and mental illness expected to cost India US$ 4.58 trillion between 2012 and 2030.

This, by all means, creates a high priority situation, which needs to be addressed with commensurate well thought-out policy measures backed by adequate budgetary support.

The condition assumes even greater significance, as healthy and well-productive workforces contribute immensely to high and sustainable economic growth aspiration of a nation, always.

Healthcare budget gets further axed:

To meet the expectations of many, when the incumbent government is trying to floor the gas pedal for accelerated economic growth of the country, requisite budgetary allocation for quality and affordable healthcare in India, continues to lag behind.

On the contrary, in December 2014, just prior to the Union Budget Proposal 2015-16, the new Government reportedly ordered more than Rs 6,000 Crore or US$948 million cut (20 percent) from its own healthcare budget allocation of around US $5 billion for the financial year ending March 31, 2015, due to financial constraints.

In 2014-15, the finance ministry also ordered a spending cut of around 30 percent to US$ 205.4 million on India’s HIV/AIDS program.

Then came the Union Budget proposal 2015-16. Interestingly, even after several well publicized announcements by the Government on the ‘National Health Assurance Mission’, with generous promises on rejuvenation of public health care services sooner, the budget ignored all these – lock, stock, and barrel.

For 2015-16, the health care budget allocation was kept at Rs. 33,152 Crore, a tad more than Rs. 30,645 Crore of 2014-15. There has been no indication either for any comprehensive and integrated focus on healthcare, adequately backed by commensurate budgetary allocation, any time soon.

Could crimp efforts to control the spread of diseases:

Just around this time, a report from Reuters, quoting one of the health ministry officials, stated that this budget cut could crimp efforts to control the spread of diseases.

Interestingly, more newborns die in India than in poorer neighbors such as Bangladesh, and preventable illnesses such as diarrhea kill more than a million children every year.

This issue becomes even more glaring, when India contributing to 21 percent of the global disease burden, accounts for just a fraction of global spending on health.

What the Government promised, but did not deliver:

Before the Union Budget proposal of 2015-16, another article of Reuters dated October 30, 2014, quoting an Government announcement, reported that under the National Health Assurance Mission, Narendra Modi government would provide all citizens with free drugs and diagnostic treatment, in addition to insurance cover to treat serious ailments.

The proposed plan was to be rolled out in phases from April 2015 and was to cover the entire population by March 2019. The project would reportedly cost an estimated US$11.4 billion annually, when the entire population of the country comes under it.

National Health Assurance Mission was reportedly to focus, among others, on the following:

  • Improving preventive healthcare services by ensuring adequate availability of medical practitioners in rural areas.
  • Creating new infrastructure under existing welfare programs.
  • Providing tertiary care services through an insurance-based model with the government offering more than 50 drugs free to all the citizens.
  • Offering in the package, along with the drugs, about 12-15 diagnostic treatments.
  • Encouraging the State Governments to enter into outsourcing agreements for the provision of treatment.

All admirers of the new dispensation felt greatly obliged for this announcement. It was to some extent fulfillment of a long awaited expectation for a just and efficient healthcare system in India.

Adding strength to the Government’s promise, it was also reported that the World Bank along with UK’s health cost-effectiveness agency NICE are assisting India in this regard, providing technical assistance and advice on treatments the government should offer in its health care package.

However, at the end of the day nothing got translated into reality, at least not just yet.

Patients are compelled to turn to expensive private sector providers:

At around 1.3 percent of GDP, India’s public health expenditure is already among the lowest in the world, even as compared to 1.4 percent of Bangladesh, 1.6 percent of Sri Lanka and 2.9 percent of Thailand.

It is noteworthy that the public sector is the main source of health funding in nearly all OECD countries. 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.

Moreover, health accounted for only 4.8 percent of total government spending in 2012, significantly lower than the 14.4 percent across OECD countries.

A January 2015 paper titled, “Improving Health Outcomes And Health Care In India”, published by the OECD reconfirms that with India’s low life expectancy largely reflecting deaths from preventable diseases, the most significant gains in health would come from population-wide preventive measures.

The paper highlights that except a small number of states, overall access to public health care services in India is rather poor even today, resulting in many people turning to more expensive private-sector providers, who mainly serve those who can pay.

A quick comparison between public and private health care expenditure:

For a quick comparison between public and private health care expenditure, I shall refer to a very recent Government survey report.

This survey titled, “Key Indicators of Social Consumption in India Health” was conducted by the National Sample Survey Office (NSSO) under the Ministry of Statistics and Program Implementation of the Government of India from January to June 2014 period and was published in June 2015.

The following table prepared from the above NSSO survey, is an example that would highlight the extent of difference in the average medical expenditure per hospitalization between a public and a private sector hospital.

Average Medical Expenditure Per Hospitalization/Case in Public And Private Hospitals

Broad ailment category Public (Rs.) Private (Rs.)
Infections 3007  8134 
Cancers 24526  78050 
Cardio-vascular 11549  43262 
Respiratory 4811  18705 
Gastro-intestinal 5281 23933
Genito-urinary 9295 29608
Obstetric and neonatal 2651 21626
Psychiatric & neurological 7482 34561
Blood diseases (including anemia) 4752 17607
Endocrine, metabolic & nutrition 4625 19206

Need to garner resources to implement ‘National Health Assurance Mission’:

The High Level Expert Group (HLEG), constituted by the erstwhile Planning Commission in January 2011, under the chairmanship of Dr K. Srinath Reddy, produced a comprehensive report on ‘Universal Health Care (UHC) in India’ in November 2011.

On health financing, HLEG made 10 recommendations, where from I would quote just two as follows:

  • Government (Central government and states combined) should increase public expenditures on health from the current level of 1.3 percent of GDP to at least 2.5 percent in the first 5 years and to at least 3 percent of GDP by the next 5-year period.
  • Use general taxation as the principal source of health care financing – complemented by additional mandatory deductions for health care from salaried individuals and taxpayers, either as a proportion of taxable income or as a proportion of salary.

I reckon, to meet the budgetary needs for ‘National Health Assurance Mission’ both direct and indirect taxes require to be levied if possible, at least in the next budget, along with adequate incentives to the State Governments to do the same.

Conclusion:

Over a period of time, economic aspirations of India have grown by manifold and very rightly so. To achieve these aspirations, alongside, at least two critical social needs such as ‘Education’ and ‘Health Care’ must be focused on simultaneously. I underscore ‘simultaneously’. There does not seem to be any alternative either, if we want to ensure that Indian aspirations do not remain just a pipe dream, for long.

It does not give any pride to many when one witnesses India topping the league table of GDP Growth percentage, while continuing to remain at the rock bottom so far as the health care is concerned.

Education and health care are universally considered as the bulwark for sustainable progress and growth of any nation. Even all BRICS countries have realized and implemented that, being well ahead of India in those fronts, unquestionably.

Let’s believe and hope, India would not continue to neglect these two critical growth catalysts of any nation, for long, while trying to build a robust economy. Otherwise, pushing hard only for economic growth as a percentage of GDP, could well be akin to chasing a rainbow, if not creating an unsustainable bubble with disastrous consequences, in the long run.

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.

China Relaxes Drug Price Control: Is Pharma Euphoria In India Misplaced?

On May 5, 2015, the National Development and Reform Commission (NDRC) of China announced that price controls on most drugs sold there would be lifted from June 1, 2015. This move was believed to tackle issues of drug quality and to encourage innovation among domestic companies. Only narcotics and some listed psychotropic drugs would continue to be controlled by the government.

Quite like in India, Chinese price controls for most drugs were blamed by the industry for low quality and even adulterated medicines that seem to threaten public health.

Apprehension expressed:

Almost immediately after the announcement for ending price control on most drugs, many started expressing serious apprehensions that this decision of the Chinese Government would lead to higher drug prices for the consumers at the retail level.

Without taking any chances, the Chinese Government immediately switched to a high decibel communication process to allay such fear.

Chinese Government quickly acted on allaying the fear:

Xinhua reported, China’s top economic planner, almost simultaneously, asked the country’s price watchdogs to organize a six-month check on the movement of medicine prices, following the above decision.

The NDRC said the move is intended to detect any illegal practices disrupting market order, such as price fixing and artificial inflation of prices.

The agency also urged local authorities to create an online platform for better price monitoring. The NDRC also said the key intent is to curb illegal practices, such as price fixing and manipulative changes to increase drug costs.

Gigantic role of Chinese ‘Universal Health Care’ system highlighted:

The following explanations also came from the Chinese Government to highlight that this decision is not likely to have adverse impact on its citizens:

  • China has a function Universal Health Care (UHC) system in place
  • According to NDRC, 80 percent of drugs are sold through hospitals in China and not through retail channels. Thus, public hospitals are the places where most transactions take place and drugs are procured through a process that involves tough price negotiations with the pharma companies.
  • In addition to control of prices at the local procurement level, most of the freed drugs would still be controlled somewhat by various medical insurance plans even before they reach the Chinese hospitals, where 80 percent of drugs are dispensed.
  • With this announcement, the Chinese Government would lift controls on the price of about 2,700 medicines from June 1, 2015 that accounts for just about 23 percent of medications available in the country.
  • Experts also said they expected medicine prices to remain unchanged.

Has the pricing pressure in China increased, on the Contrary?

On May 26, 2015 in an article titled, “Foreign Drug makers Face Pressure to Lower Prices in China”, Bloomberg reported:

“Starting June 1, 2015 most drugs in China will be liberated from government-set price caps. For foreign drug makers, though pressure to cut prices is rising. Since late last year, many provincial governments have introduced new bidding systems to bring down the cost of medicines they procure, and they’re pushing multinationals to compete more directly with cheap local generics on price.”

Chinese healthcare scenario is different from India:

From the above scenario, it is abundantly clear that Chinese drug procurement, distribution and consumption scenario is quite different from India.

  • China’s UHC is well in place and over 80 percent of its population gets medicines from public hospitals. Whereas, UHC seems to have been virtually jettisoned in India by the incumbent Government, at least for now, and around 75 percent of the populations purchase medicines from the retail market, out of pocket.
  • Whereas, the National Health and Family Planning Commission (NHFPC) of China announced in May 2015 that it would increase healthcare subsidies this year by 19 percent, i.e. just over US$ 60 per person, India decided not to make any increase even on its abysmal low expenditure on health, in its Union Budget 2015.
  • According to the National Health Policy 2015 (Draft) of India, total per capita health expenditure of the country was at US$ 62 in 2011, against China’s US$ 274 for the same year. This gap is likely to increase significantly with China adding to it another US$ 60 per capita through increase in healthcare subsidies in 2015.
  • Chinese Government believes that this step would help improve economic growth and boost domestic consumption, whereas Indian Government obviously thinks differently.

‘Why not in India’ type of reaction is misplaced:

There are many other critical differentiating factors in the comparative healthcare scenario between India and China.

Be that as it may, keeping only the above differences in mind, when one comes across some weird reasoning in a section of the Indian media stating, no wonder that raises many other eyebrows simultaneously. More so, as pharma related Indian media is not just vibrant, a large section of it is mostly on the ball, with up to date domain knowledge, and presenting incisive analysis.

A bizarre report: “Comparing apples to oranges”?

That said, I recently noted, while flipping through some pharma related business reports, a bizarre and seemingly uninformed comment on this subject. The article recently published in a leading business daily questioned, why the drug pricing policies of India and China are different? Obviously the author does not seem to be aware of the differences in the overall healthcare scenario between India and China, as deliberated above.

If the above question is taken as benign and laced with a dash of ignorance, it certainly raises the good old and much often repeated question, “Are we comparing apples to oranges”?

This is because we are comparing medicine procurement, distribution, usages and consumption scenarios of those two different countries that cannot be practically compared at all, especially in this regard.

An equally bizarre comment?

To make such ‘off the cuff’ reports spicy, some news-unworthy masala is also usually sprinkled on it. If I remember correctly, I read somewhere in one such typical report, probably a head honcho of the Indian unit of a pharma MNCs making blissfully ignorant, equally bizarre, attention hungry, ‘shooting from the hip’ type of remarks. The person most probably commented something like; the decade long ‘draconian price control in China’ failed to improve access to medicines. Thus, Indian Government, he imagines, should strongly introspect on its drug price control and allow free pricing for all drugs. I am not very sure, whether this is the representative view of the pharma industry in India or probably not.

Domain experts’ eyes on the ball:

Fortunately and most likely in the same piece, the real domain experts made very pertinent and sensible comments on India China comparison on this critical issue.

I hasten to add, this is my personal view, and may be the author concerned meant something different, which I would accept with due respect and humility.

Conclusion:

Just because China has relaxed drug price control in the context of its own environment of a reasonably well-functioning ‘Universal Health Care’ system, India should not toe the line with its abysmally poor public healthcare products and services offerings. As a result of this, the country records one of the highest, if not the highest, out of pocket expenditure towards medicine in the world.

The bizarre reports and comments in this regard, as above, probably need to be taken, not with a pinch but loads of salt, and trashed for abject ignorance in the specific area.

Moreover, the Indian Government too does not seem to be in any mood just yet, to pay attention in the area of ‘Universal Health Care’ to ensure health for all in the country. The situation is not expected to improve in this year either, as the Government has not made requisite budgetary allocations for health, to play the ball as the time demands.

Does all these not mean that, going by the Chinese example, the ill-informed euphoria of a section of the Indian pharma industry is unrealistic, if not absolutely misplaced?

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.

 

With Frugal Public Resource Allocation Quo Vadis Healthcare in India?

The memory is still afresh in India. A new political dispensation took charge of the governance of the country, riding on the tidal waves of people’s hope and aspirations, with presumed credibility to ‘Walk the Talk’. The expectations were skyrocketing for a change…better days for all, sooner. This covered the public healthcare space, as well.

Responding to such genuine public expectations, when in May 2014, the then new Union Health Minister Dr. Harsh Vardhan reportedly announced that his ministry would soon start working on distribution of free medicines through public hospitals across the country, a hope for a long-awaited healthcare reform in India, sooner, was rekindled.

This happened despite the fact that similar promises were made by the immediate past Government too.

The Cost and the Span:

The erstwhile Planning Commission of India had estimated that a countrywide free generic drug program would cost Rs 28,560 Crore (roughly around US$ 5 Billion) during the 12th Five-Year Plan period. The Centre will bear 75 percent of the cost while the states would provide the rest.

Under the previous government plan, 348 drugs enlisted in the National List of Essential Medicines 2011 (NLEM 2011) were to be provided free at 160,000 sub-centers, 23,000 Primary Health Centers, 5,000 community health centers and 640 district hospitals of the country.

Previous action:

Late 2012, the previous Union Government made its first move in this regard by formally clearing Rs. 13,000 Crore  (around US$ 2.2 billion) towards providing free medicines for all through government hospitals and health centers.

To facilitate the process, in November 2013, the then Union Health Ministry by a notification reportedly made the public drug procurement system in the country through ‘Central Medical Services Society (CMSS)’ formally operational. For different flagship program of the Government such as, National Health Mission, the drug procurement was planned through the CMSS.

The notification said:

The CMSS will be responsible for procuring health sector goods in a transparent and cost-effective manner and distributing them to the States/UTs by setting up an IT enabled supply chain infrastructure including warehouses in 50 locations.

Unfortunately, due to resource constraint of the previous Union Government, the program of distribution of free medicines for all through public hospitals across the country could not be translated into reality.

The fresh hope scaled greater heights:

In the first Union Budget Proposal (2014-15) of the new Government, some high impact healthcare areas were addressed as follows:

A. Access improvement:

- “Health for All”: Free drugs and diagnostic services for all would help improving ‘Access’ to healthcare by manifold.

- Universal access to early quality diagnosis and treatment to TB patients would again help millions.

- Deeper penetration of health insurance and its innovative usage would also help a significant number of populations of the country having adequate ‘Access’ to healthcare.

B. Affordability:

- HIV AIDS drugs and diagnostic kits were made cheaper through duty rationalization.

- “Health for All” – Again, free drugs and diagnostic services for all would help answering the issue of ‘Affordability’, as well.

C. Capacity building:

- Two National Institutes of Aging (NIA) at AIIMS, New Delhi, and Madras Medical College, Chennai to come up.

- Four more AIIMS-like institutions in Andhra Pradesh, West Bengal, Vidarbha in Maharashtra and Purvanchal in UP, for which Rs 500 Crores were set aside.

- Additional 58 government medical colleges, including 12 colleges where dental facilities, were also proposed.

- The fund for 15 Model Rural Health Research Centers (MHRCs) in states for better healthcare facilities in rural India was provided.

- Central assistance to strengthen the States’ Drug Regulatory and Food Regulatory Systems by creating new drug testing laboratories and strengthening the 31 existing state laboratories was announced.

D. Innovation:

- Cluster-led biotech development was announced.

E. Ease of doing business:

- Number of common pan-industry initiatives enlisted in the Union Budget 2014-15 proposals, would improve overall ‘Ease of Doing Business’ in the healthcare sector too.

A concern remained…even at that time:

Despite all these, there was a concern. In the Union Budget proposals 2014-15, the health sector attracted a total outlay of Rs 35, 163 Crore, which was a very low increase from the previous year’s Rs 33, 278 Crore. I wondered at that time also, whether this increase would be sufficient enough to meet all healthcare commitments, as it does not even take inflation into account.

Draft ‘National Health Policy’ further boosted the expectations:

In the midst of growing expectations for healthcare reform in India, the Union Ministry of Health and Family Welfare through its draft National Health Policy, 2015 (NHP 2015) proposed making health a fundamental right.

The draft policy reiterates, “Many industrialized nations have laws that do so. Many of the developing nations that have made significant progress towards universal health coverage, such as Brazil and Thailand, have done so, and … such a law is a major contributory factor. A number of international covenants to which we [India] are joint signatories give us such a mandate – and this could be used to make a national law. Courts have also rulings that, in effect, see healthcare as a fundamental right — and a constitutional obligation flowing out of the right to life.”

The draft NHP 2015 even states, “The Centre shall enact, after due discussion and on the request of three or more states a National Health Rights Act, which will ensure health as a fundamental right, whose denial will be justiciable.”

The new draft policy acknowledges that primary healthcare of date covers not more than 20 per cent of the health needs and that a very high ‘Out of Pocket’ health expenditure (over 61 percent for of that is on medicines) is pushing nearly 63 million people into poverty every year.

One of the key features of the draft NHP 2015 is a universal medical insurance scheme that will be virtually free for the poor and affordable for the rest.

To translate all these good intents into reality, speedy implementation of a robust healthcare reform roadmap, backed by adequate budgetary support, is critical. Only such well coordinated and comprehensive action plan, when effectively put in place, would be able to send strong signals to the stakeholders about the seriousness of the Government to fulfill its much-hyped promises and obligations towards healthcare reform in India.

Required budgetary allocation:

The 12th Fiver Year Plan of the erstwhile Government of India, the fate of which is still not clearly known, acknowledged that the health sector expenditure by the central and state governments, both plan and non-plan will have to be substantially increased during the plan period. It also stated that the health expenditure was increased from 0.94 per cent of GDP in the 10th Plan to 1.04 per cent in 11th Plan and it should be increased to 2.5 per cent of GDP by the end of 12th Five Year Plan period.

That said, the bottom-line is, the current public spending on healthcare (excluding water and sanitation) is stagnating around 0.9 percent of the GDP.

Instead of increase, a steep cut in health budget of 2014-15:

Despite prevailing lackluster public healthcare scenario, in December 2014, just prior to the proposal of Union Budget 2015-16, the new Government reportedly ordered more than Rs 6,000 Crore or US$948 million cut (20 percent) from its own budget allocation of around US $5 billion for the financial year ending March 31, 2015, due to fiscal constraints.

The finance ministry reportedly also ordered a spending cut this year (2014-15) for India’s HIV/AIDS program by about 30 percent to US$ 205.4 million.

A report from Reuters, quoting one of the health ministry officials, stated that this budget cut could crimp efforts to control the spread of diseases. More newborns die in India than in poorer neighbors such as Bangladesh, and preventable illnesses such as diarrhea kill more than a million children every year.

India’s public healthcare expenditure one of the world’s lowest:

It is worth mentioning that at around 0.9 percent of GDP, India’s public health expenditure is already among the lowest in the world, as compared to 2.7 percent in China, 4.2 percent in Brazil, 1.4 percent in Bangladesh, 1.6 percent in Sri Lanka, 2.9 percent in Thailand and 8.5 percent in the United States.

It is noteworthy that the public sector is the main source of health funding in nearly all OECD countries. 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.

Moreover, health accounted for only 4.8 percent of total government spending in 2012, significantly lower than the 14.4 percent across OECD countries.

Similarly, ‘Out-of Pocket’ costs accounted for over 60 percent of health spending in India in 2012, higher than in any other OECD country.

Are the successive Governments ignoring healthcare in India:

Despite such worrisome scenario in the healthcare space, India’s healthcare budget has already witnessed a 29 percent decline over the past year, from Rs. 29,165 Crore in 2013-14 to Rs 20,431.4 Crore (post cut) in 2014-15.

This assumes even greater significance, when India, contributing 21 percent of the global disease burden, accounts for just a fraction of global spending on health.

The hope flickers:

As stated earlier, to meet its fiscal deficit target the Government has slashed the health budget by 20 percent for 2014-15.

Despite the above huge budgetary cut, the hope of the stakeholders continued to flicker, expecting some major announcement on healthcare related financial allocation in the Union Budget of 2015-16. The stakeholders expected, at least this time the new Government would ‘Walk the Talk’ to fulfill its own promises, made thus far, on healthcare.

Very surprisingly, even from the reform oriented new Government, the Union Budget 2015-16 came as a dampener for the healthcare space in the country. The budgetary allocation for healthcare has been proposed as Rs. 33,152 Crore, a tad more than Rs. 30,645 Crore of 2014-15, with no visible indication for any healthcare reform measure in the country, any time soon, adequately backed by commensurate budgetary allocation.

It is worth noting that in the first three years of the 12th Five-Year Plan, the total health spend has been round Rs 70,000 Crore. This is significantly less than Rs. 2,68,000 Crore allocated for 2012-17 period.

‘Health’ is a State subject:

In his Union Budget speech of 2015-16 , the Finance Minister has articulated clearly that health being a State subject, individual States would require to take appropriate measures in the healthcare area, especially after substantial devolution of resources to the States by the 14th Finance Commission.

That said, a well-coordinated national action plan for healthcare, championed by the Union Ministry of Health, is equally important. This would also require appropriate budgetary resource deployment at the center.

Conclusion:

As we have all witnessed, in the healthcare domain of India, various good intents have been announced with appropriate media attention in the recent months, as was done by the previous Government earlier. However, none of these seemingly ‘off the cuff’ announcements is supported by any clear strategic road map with clearly earmarked budgetary allocations. On the contrary, some retrograde steps have already been taken in this area, as mentioned above.

While the draft NHP 2015, emphasizing the need of its effective implementation, strongly encourages a framework that will “specify approved financial allocations and linked to this, measurable numerical output targets and time schedules”, there is no mention of it even on a long-term budgetary allocation perspective in the Finance Minister’s budget speech, not even the program on ‘free medicines’ and the National Health Assurance Mission, which the prime minister is expected to launch in April 2015.

All these assume high significance, as a quantum leap in budgetary allocation for health would be warranted in the years ahead to fulfill the promises that have been already made for healthcare reform in India.

With this backdrop, while looking through the kaleidoscope of Government slogans on development in various spheres of national interest, including individual life, society and business, I still find hope around, painted craftily with different hues and colors, albeit faded though.

In the midst of this ongoing semi mass euphoria, as it were, possibly due to long-awaited change in governance of the country, none seems to still bother too much on the healthcare needs of the common man, far from creating through an informed discourse a ground swell for public healthcare reform process in India, soonest.

As things stand today, I wonder, with continuing frugal public resource deployment, and that too for such a long time, ‘Quo Vadis’ healthcare in India?

By: Tapan J. Ray

DisclaimerThe 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.

 

Union Budget Proposal 2015-16 of India : Is Pharma Industry Now Out of Focus?

Budget Expectations:

Overall expectations of the Pharma Industry in India from the Union Budget perspective was very modest this year. The key areas were as follows:

- To encourage  innovation, in-house R&D exemption limit was expected to be raised from 200 percent to 250 percent

- Excise duty rationalization was expected on:

Formulations (5 percent)
API (10 percent)

- A reduction of MAT (20 percent) was expected on SEZ

Union Budget Proposals:

Status quo

Impact:

In view of this scenario, there has been virtually no sector-specific direct impact of the Union Budget 2015-16 on the Pharma Industry. This critical sector seems to be out of focus of the Government from the budget perspective, at least for now.

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.

A Patient-Centric State Initiative To Revolutionize Disease Treatment

In his State of the Union address, just before the recent visit to India in January 2015, President Barack Obama articulated the need to develop “Precision Medicine” in his country – a bold, giant and perhaps unprecedented State initiative to remarkably improve effectiveness of disease treatment.

To set the ball rolling, in his budget proposal for the year 2016, President Obama earmarked an amount of US$ 215 million for this purpose. This includes an allocation of US$130 million for the National Institutes of Health (NIH) to create a national research database of about a million American volunteers by studying their genetics together with other relevant factors, such as the environments they live in and the microbes that live in their bodies.

‘Precision Medicine’ initiative is similar to path breaking 13-year and US$3 billion Human Genome Project, that has formed the bedrock of modern genomics, President Obama said. He also expressed hope that the private healthcare sector too, including universities and foundations, will get involved to “lay the foundation” for this new initiative of the Government for the interest of patients.

Why is this approach so relevant in today’s healthcare?

In an article published in the ‘British Medical Journal (BMJ) in October 2012, Richard Smith - an editor of BMJ until 2004 and a Director of the United Health Group’s chronic disease initiative wrote:

“Doctors know that many of the patients they treat with drugs will not benefit. Many patients know that too.”

Dr. Smith also emphasized, for centuries medicine classified diseases by what could be seen, felt, and smelt. Thereafter, medical scientists in this area started defining diseases anatomically, physiologically, and biochemically. Even today, this is by and large the paradigm where most medicines fall.

Smith underscored, because of imprecise diagnosis the treatment also becomes haphazard. There is big variation in how individuals respond to drugs and yet that variation is not usually recorded. The regulators approve drugs based on their average performance even today.

The White House release also reiterates, most medical treatments have been designed for the “average patient.” This “one-size-fits-all-approach,” treatments can be very successful for some patients but not for others.

This calls for broadening the scope of disease treatment – from the conventional and error-prone ‘Disease Oriented’ approach, to relatively more unconventional and better targeted with greater value – ‘Patient-Centric’ ones, wherever needed.

Two current trends:

To address this key deficiency in the effective treatment of several dreaded diseases for many patients, following two are the current trends, as stated by William Pao, M.D., Ph.D., who led Roche’s Oncology Discovery & Translational Area research unit since May 2014:

  • We now know that on a molecular level every cancer is different – not only between different tumors, but even between different areas within a single tumor! This means that we need to match the right drug to the patient who we know will respond best to the drug, at the right time during the course of treatment.
  • Patients will have their tumors profiled not only for genetic drivers, but also for predictive immunotherapy markers at different time points in their course of treatment.

Personalized and Precision Medicine:

The above trends in the endeavor of making treatments more patient specific – thus more effective, have thrown open scientific discourse and intense research on ‘Personalized’ and ‘Precision’ medicines.

As Pfizer has described in its website:

Personalized Medicine is a unique approach to medical practice in which the individual aspects of a patient are directly considered to guide treatment planning, including his or her genetic make-up, key biomarkers, prior treatment history, environmental factors and behavioral preferences. This approach can be used to optimize pharmaceutical treatments and overall care.

Whereas, Precision Medicine is an approach to discovering and developing medicines and vaccines that deliver superior outcomes for patients, by integrating clinical and molecular information to understand the biological basis of disease. Precision medicine is the biopharmaceutical research and development paradigm that will help enable more patient-centered clinical practice, including treatment decision-making based on genetic information – an emerging standard now often described as “personalized medicine”.

As President Obama said while announcing the proposal on January 30, 2015, ‘Precision Medicine’ promises delivery of the right treatment at the right time, every time, to the right person.

He also said that the new effort will “bring us closer to curing diseases like cancer and diabetes…and give all of us access to the personalized information we need to keep ourselves and our families healthier.”

‘Precision Medicines’ Dominate Oncology segment: 

In the European Society for Medical Oncology (ESMO) 2014 Congress, pharma majors reported their latest advances on precision medicines in the cancer care. Bristol-Myers Squibb, Roche, AstraZeneca, GlaxoSmithKline (GSK), and Merck & Co. were among the companies presented updates of their most promising cancer drugs closer to this area.

According to a large pharma lobby group in the United States – The Pharmaceutical Research and Manufacturers of America (PhRMA):

“Recent advances in diseases such as cancer and cystic fibrosis are delivering on the promise of targeted treatments, and between 12 and 50 percent of all compounds currently being researched by the industry are potential personalized medicines. These advances hold great promise in improving patient outcomes and controlling costs by targeting the right medicines to the right patients.”

‘DCAT Connect’ Report of September 2014 also indicates significant increase in ‘Precision Medicines’ in the pipelines of the leading global pharma companies, which is a key change over the past decade.

In 2013, targeted therapies increased their share of the global oncology market, accounting for 46 percent of total sales, up from 11 percent a decade ago. According to IMS Institute for Healthcare Informatics, the global oncology drug market reached US$ 91 billion in 2013 with CAGR of 5.4 percent from 2008 to 2013.

Taking note of this trend, it appears that in the near future ‘Precision Medicines’ would possibly be the most promising class in the treatment of cancer, particularly in breast cancer, lung cancer and certain types of leukemia. This is mainly because medical scientists are already quite acquainted with the molecular signatures of different types of cancer related tumors.

Medical scientists and researchers are also working on ‘Precision Medicines’ to more effectively address many other diseases, such as, diabetes, cardiovascular and ailments related to several types of infections.

Increasing potential:

Realization of the potential of ‘Precision Medicines’ to improve care and speed the development of new treatments has just only begun to be tapped.

In recent times, scientists and researchers have accelerated efforts to understand more about biomarkers for this purpose. A study conducted by the German Association of Research-Based Pharmaceutical Companies (vfa) indicates that more than 20 percent of clinical trials carried out since 2005 focused not just on agents, but also on biomarkers. Before 1990, only one in twenty clinical trials addressed biomarkers.

According to another report, last year, 20 percent of all new drug approvals in the United States were for “Precision Medicine” treatments. This vindicates, yet again, the immense potential to turn genetic discoveries into innovative disease treatments for patients.

A bold state sponsored research initiative:

State funded, ‘Precision Medicine’ initiative is a bold new step of the American Government to revolutionize improvement in healthcare and treating disease. It is expected to pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

As the White House release reiterates, most medical treatments have been designed for the “average patient.” As a result of this, “one-size-fits-all-approach” treatments can be very successful for some patients but not for others. This is changing with the emergence of ‘Precision Medicine’, an innovative approach to disease prevention and treatment that takes into account individual differences in people’s genes, environments, and lifestyles.

In this process, ‘Precision Medicine’ gives clinicians tools to better understand the complex mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective.

Opposite view:

In an op-ed titled, ‘Moonshot’ Medicine Will Let Us Down, published recently in The New York Times, the author argued with his differing viewpoints.

I am quoting below three of those arguments:

  • “For most common diseases, hundreds of genetic risk variants with small effects have been identified, and it is hard to develop a clear picture of who is really at risk for what. This was actually one of the major and unexpected findings of the Human Genome Project. In the 1990s and early 2000s, it was thought that a few genetic variants would be found to account for a lot of disease risk. But for widespread diseases like diabetes, heart disease and most cancers, no clear genetic story has emerged for a vast majority of cases.”
  • “Another unexpected finding of the Human Genome Project was the problem of ‘missing heritability.’ While the statistics suggest that there is a genetic explanation for common conditions and diseases running in families or populations, it turns out that the information on genetic variants doesn’t explain that increased risk.”
  • “The idea behind the “war on cancer” was that a deep understanding of the basic biology of cancer would let us develop targeted therapies and cure the disease. Unfortunately, although we know far more today than we did 40-plus years ago, the statistics on cancer deaths have remained incredibly stubborn.”

I am sure, you will analyze the above points with the facts that you have at your disposal on this subject to arrive at a logical conclusion.

Current Applications:

Though these are still early days, initial benefits of ‘Precision Medicines’ have been reported in many areas, such as:

  • Genetic analysis of patients dealing with blood clots: Since 2007, the U.S. Food and Drug Administration has been recommending genotyping for all patients being assessed for therapy involving Warfarin.
  • Colorectal cancer: For colon cancer patients, the biomarker that predicts how a tumor will respond to certain drugs is a protein encoded by the KRAS gene, which can now be determined through a simple test.
  • Breast cancer: Women with breast tumors can now be effectively screened to determine which receptors their tumor cells contain.
  • Cystic fibrosis: In America, patients with a rare form of cystic fibrosis now can choose a drug designed specifically to target the genetic defect causing their illness. Specialized medical centers, such as “individualized medicine centers” at the Mayo Clinic, are also available to the patients for effective treatment.

Ethical issues:

While following this pursuit of excellence of the genetic scientists in the realm of disease treatment, some experts have reportedly raised flags of caution. They strongly feel that DNA code sequencing brings to light a “very real privacy concerns” of individuals.

GeneWatch UK is an organization that investigates how genetic science and technologies will impact on our food, health, agriculture, environment and society. They have been strongly arguing, if genome sequencing is extended to entire population, individuals and their relatives could then be identified and tracked by matching their DNA with the genome stored in the respective health records. This move, as contemplated by them, could “wipe out privacy” with an impact on the society.

Thus, the ethical and social issues in the development of ‘Precision Medicine’ primarily in the area of genetic testing need to be effectively addressed, sooner.

Conclusion:

The quest for moving away from conventional and error-prone ‘Disease Oriented Treatment’ paving the way for unconventional and value added individual patient-specific ones, may soon come to fruition.

Advances in ‘Precision Medicine’ have already led to powerful new discoveries and several new treatments that are tailored to specific characteristics of individuals, such as a person’s genetic makeup, or the genetic profile of an individual’s tumor.  This is leading to a transformation in the way the world can treat diseases such as cancer.

Patients with breast, lung, and colorectal cancers, melanomas and leukemia, for instance, should be provided with facilities in specialist hospitals to undergo molecular testing as a part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.

Although, the potential for precision medicine to improve care and speed the development of new treatments has only just begun to be tapped, some skeptics do say that tailoring medical treatments to individual characteristics of each patient is both overly optimistic and cost-prohibitive.

Be that as it may, in the balance of probability the benefits of prudent use of ‘Precision Medicine’ far outweigh the concerns expressed. This evolving new paradigm would help saving not just significant expenses, but also precious time that is usually spent on ‘trial-and-error treatments’, by enabling clinicians to determine quickly which therapies are most likely to succeed.

Though lot many grounds would still need to be covered in this area, the State sponsored ‘Precision Medicine’ initiative of America to revolutionize disease treatment, in my view, is indeed a laudable one, every way.

By: Tapan J. Ray

DisclaimerThe 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.

India’s ‘National Health Policy 2015′ Needs Wings To Fly

Ensuring ‘access to healthcare for all’ has remained a key well-articulated good intent of all the successive Governments in India, cutting across the political regimes, since 1983.

The Union Ministry of Health & Family Welfare published the first “National Health Policy (NHP)”, in 1983, which was endorsed by the Indian Parliament in the same year. The policy categorically enunciated the following:

“India is committed to attaining the goal of ‘Health for All by the Year 2000 A.D.’ through the universal provision of comprehensive primary healthcare services”.

For the first time after independence, this document captured the key directions and dimension of the national health policy such as, the creation of infrastructure for primary healthcare; close co-ordination with health-related services and activities (like nutrition, drinking water supply and sanitation); active involvement and participation of voluntary organizations; provision of essential drugs and vaccines; qualitative improvement in health and family planning services; provision of adequate training; and medical research aimed at the common health problems of the people. However, it did not elaborate much about the Universal Health Care (UHC).

Abysmal public expenditure to meet the key goal of NHP 1983:

The NHP 1983, which was revised in 2002, recommended an increase in public health expenditure to 2.0 percent of GDP in 2010.

The 12th Fiver Year Plan of the Government of India again acknowledged that the health sector expenditure by the central and state governments, both plan and non-plan will have to be substantially increased during the plan period. It also stated that the health expenditure was increased from 0.94 per cent of GDP in the 10th Plan to 1.04 per cent in 11th Plan and it should be increased to 2.5 per cent of GDP by the end of 12th Five Year Plan period.

That said, the bottom-line is, the current public spending on health is stagnating around 0.9 percent of the GDP. Leave aside implementation of the 1983 NHP goal of providing “Health for all by the year 2000 A.D”, even in 2015, India continues to grapple with the challenges for ensuring availability, accessibility, affordability and quality of comprehensive healthcare to all, though various governments have come and gone during this period. India’s rank in the Human Development Index (HDI) also remains at pitiful 136 out of 187 countries and despite improvements, India is likely to miss some key MDG targets in 2015.

Pockets of improvements – mostly grossly inadequate:

In the midst of gloom and doom in the health space of India, the 57 page draft NHP 2015 captures some of commendable improvements, as well, and very rightly so, which I am not going to repeat in this article.

A June 2013 report of IMS Institute also acknowledges that the extent of change and improvement in India’s healthcare system over the past decade is remarkable. The Government of India’s initiatives, as well as private sector actions and public-private-partnership programs, have contributed to this progress. Yet a lot more remains to be done.

The report highlights the following areas, which are worth taking note of:

  • The physical accessibility of public or private healthcare facilities is a challenge in rural areas. By contrast, in urban areas, accessibility is less of a challenge due to more facilities being available.
  • An increasing proportion of the population is using private healthcare 
facilities for both in-patient and out-patient treatments. Long waiting times and absence of diagnostic facilities are among the main reasons private healthcare facilities are chosen over public centers for in-patient treatment. For out-patient treatment, the availability or doctors and quality of care are cited as reasons for selecting a private healthcare facility. However, patients would readily switch to public healthcare centers if these issues were addressed, the research report states.
  • The cost of treatment at a public healthcare facility is much more affordable than at a private center. However, due to lack of physical reach, availability of quality treatment and other practices, patients are forced to use more expensive private facilities, thus exacerbating affordability challenges. The majority of Out of Pocket (OoP) expenses are due to medicines.
  • Overall, while there are pockets of improvements, significant healthcare access challenges continue to exist for the Indian population, especially in rural areas.

OoP expenses on health is one of the highest in India:

Out of Pocket (OoP) expenditure on health is one of the highest in India at 61.7 percent, as acknowledges by the draft NHP 2015, as well. This is against 35.3 of China, 30.6 of Brazil, 44.6 of Sri Lanka, 61.3 of Bangladesh, 14 of Thailand, 8.9 of United Kingdom and 11.8 of the United States. The reason being, due to lack of access to cheaper and quality public health facilities, a vast majority of the Indian population is forced to turn to expensive private healthcare providers, as confirmed by the IMS Institute in its above report..

Suggested framework for a comprehensive view of healthcare access:

The same June 2013 report of IMS Institute states that healthcare access has varying meaning in different countries, especially across developing and developed economies. In the developed economies, it is often equated to the access status of healthcare insurance, whereas in the developing economies, it is viewed primarily across two dimensions: the physical reach of a healthcare facility, and affordability to the patient.

Thus, it is important to build a framework that would provide a comprehensive view to healthcare access. The framework should be able to define healthcare access in the Indian context, aided by other parameters that are key in ensuring quality treatment to a patient.

The framework also allows understanding of each component of healthcare access separately, including inter-dependencies.

According to IMS Institute, healthcare access has 4 key dimensions as follows:

Physical Reach:

This component defines physical accessibility of a requisite healthcare facility, i.e. availability of a healthcare facility having an out-patient department (OPD) for common ailments, and an in-patient department (IPD) for hospitalization. These facilities may either be public or private in nature. Physical reach is defined as the ability to enter a healthcare facility within 5 kilometers (5km) from the place of residence or work.

Availability/Capacity:

This component defines availability of the requisite healthcare resources to provide patient treatment, i.e. doctors, nurses, in-patient beds, diagnostics, consumables, etc. The availability is governed by minimum specifications defined by the Government of India for public healthcare facilities, and international organizations such as W.H.O.

Quality/Functionality:

This component defines the quality of the healthcare resources available at the point of patient treatment.

Affordability:

This component defines the ability of a patient to afford complete treatment for the illness or disease.

Draft NHP 2015 – ‘Health is a fundamental right’:

Though the above parameters were not quite considered, as such, to define access to healthcare, the new government has done a good job with the draft NHP 2015, while updating NHP 2002. The new draft has evoked good interest among the stakeholders as healthcare has become very costly in India and continues to go north, steadily, as mentioned above.

The draft has covered lots of ground related to health, spanning across the change in the nature of the nation’s disease burden from communicable to non-communicable diseases, shortage of human resources in health sector and right up to the use of information and communication technology. It’s a hard fact that low investment in public health has been placing India consistently at the lower rungs of the development indices.

Against the backdrop of paltry public expenditure on health, the Union Ministry of Health and Family Welfare through its draft National Health Policy, 2015 (NHP 2015) has proposed making health a fundamental right, similar to denial of health an offence.

The draft policy reiterates, “Many industrialized nations have laws that do so. Many of the developing nations that have made significant progress towards universal health coverage, such as Brazil and Thailand, have done so, and … such a law is a major contributory factor. A number of international covenants to which we [India] are joint signatories give us such a mandate – and this could be used to make a national law. Courts have also rulings that, in effect, see health care as a fundamental right — and a constitutional obligation flowing out of the right to life.”

The draft NHP 2015 even states, “The Centre shall enact, after due discussion and on the request of three or more states a National Health Rights Act, which will ensure health as a fundamental right, whose denial will be justiciable.”

The new draft policy acknowledges that primary healthcare of date covers not more than 20 per cent of the health needs and that a very high OoP health expenditure (over 61 percent on medicines) is pushing nearly 63 million people into poverty every year.

One of the key features of the new draft policy is an universal medical insurance scheme that will be virtually free for the poor and affordable for the rest. The government expects the stakeholders to send their comments and suggestions on the draft policy by February 28, 2014.

However, the draft NHP 2015 does not deliberate on some other important areas, such as specific time-bound commitments on public investments, insurance cover on outpatient treatments & care and appropriate regulations for the private sector to contain healthcare costs.

Cut on current year health budget raises may eyebrows:

In the midst of the prevailing lackluster public healthcare scenario, just in the last month (December 2014), the government has reportedly ordered a US$ 948 million (20 percent) cut in its 2014-15 healthcare budget due to fiscal constraints.

It is worth mentioning that at 0.9 percent of GDP, India’s public health expenditure is already among the lowest in the world, as compared to compared to 2.7 percent in China, 4.2 percent in brazil, 1.4 percent in Bangladesh, 1.6 percent in Sri Lanka, 2.9 percent in Thailand and 8.5 percent in the United States.

In addition to the healthcare budget, the finance ministry has reportedly also ordered a spending cut this year for India’s HIV/AIDS program by about 30 percent to US$ 205.4 million.

A report from Reuters, quoting one of the health ministry officials, stated that this budget cut could crimp efforts to control the spread of diseases. More newborns die in India than in poorer neighbors such as Bangladesh, and preventable illnesses such as diarrhea kill more than a million children every year.

Needs wings to fly:

The draft NHP 2015 has come thirteen years after the previous NHP 2002 and following a 20 percent cut even on the paltry budgetary allocation on public health of this financial year. Thus, many skeptics ponder whether this well drafted NHP 2015, pregnant with many great promises, would ever see the light of the day.

The skepticism gets further reinforced, when the draft NHP 2015 says that to achieve its objectives the budgetary allocation on health would be increased to 2.5 percent of the GDP. The Government proposes to rely mostly on general taxation, besides creating a health cess similar to that of education cess, for effective implementation of this health policy. The draft indicates that 40 percent of this budget would come from central expenditure.

A quick reading of the following text from the Reuter’s report makes the scenario even more intriguing:

“The retrenchment (budget cut) could also derail an ambitious universal healthcare program that Modi wants to launch in April. The plan aims to provide all citizens with free drugs and diagnostic treatments, as well as insurance benefits.

The cost of that program over the next four years had been estimated at 1.6 trillion rupees (US$ 25 billion). The health ministry officials had been expecting a jump in their budget for the coming year, in part to pay for this extra cost.

‘Even next year we don’t think we’ll get a huge amount of money,’ said one official, adding that it was now unclear how the new program would be funded.”

Thus, the key point to ponder now: Would the NHP 2015 have wings to fly?

Is India just producing various documents on health without action?

Not too long ago, in October 2010, the Government of India constituted a ‘High Level Expert Group (HLEG)’ on Universal Health Coverage (UHC) under the chairmanship of the well-known international medical expert Prof. K. Srinath Reddy. The HLEG was mandated to develop a framework for providing easily accessible and affordable health care to all Indians.

The HLEG Report defined UHC as follows:

“Ensuring equitable access for all Indian citizens, resident in any part of the country, regardless of income level, social status, gender, caste or religion, to affordable, accountable, appropriate health services of assured quality (promotive, preventive, curative and rehabilitative) as well as public health services addressing the wider determinants of health delivered to individuals and populations, with the government being the guarantor and enabler, although not necessarily the only provider, of health and related services”.

I discussed this subject in my blog post of December 12, 2011, titled “Health being a basic human right, the proposal for Universal Health Coverage augurs well for India

Most probably, this excellent HLEG report on UHC has already become an archival material for the posterity to refer, if and when required.

Interestingly, despite governments of different political dispensation ruling the country since 1983, the key goal of the NHP 1983 to ‘provide healthcare to all by the year 2000’ continues to haunt us over the last three decades.

Public healthcare infrastructure, especially in rural India, still remains grossly inadequate.

In most of the villages in India, primary health facilities, if available, (except in some progressive states), continue to be shoddy, fragile and is gasping for breath, as it were. Recent examples of Bilaspur (Chhattisgarh) sterilization tragedy in November 2014, when 15 women died or the incident of last week in Chatra district of Jharkhand, where about 40 women allegedly underwent sterilization under torchlight, would vindicate this point.

Much hyped program of “free essential drugs for all, from the government hospitals” has not been universally implemented, just yet…again due to financial resource constraints and paucity of other wherewithal.

Conclusion:

Currently, none of the newer constitutional rights, such as right to food, education and employment, enacted by the lawmakers for the well being of the concerned people of the country, is functioning as desired for various financial and administrative reasons. Even making adequate budgetary provisions for all these projects continue to pose a great challenge, both for the central and the state Governments.

Overall, NHP 2015 is a well-drafted and comprehensive policy document. It analyses the successes and failures of the past quite well, with a proposal of making health as a fundamental right. However, the status and experience with the other fundamental right-based legislations in India, do not fuel much optimism in this critical area, at least, as of now.

Consequently, the draft NHP 2015 does not appear to be more than a lucid narration of good intents, just what the NHP 1983 and 2002 did. Next month’s Union budget allocation for the financial year 2015-16 for health, calculated as a percentage of India’s GDP, would hopefully bring more clarity in this area.

Additionally, other important areas such as, specific time-bound commitments on public investments for health; extensions of medical insurance cover to even outpatient treatments & care and appropriate regulations for the private sector to contain healthcare expenditure, are worth considering in the NHP 2015.

Shorn of all these, would the National Health Policy 2015 have its wings to fly?

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.