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Union Budget 2017-18: ‘Modicare’ Remains A Pie In The Sky

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

Being enormously enthused with this development, in my article of April 06, 2015 in this blog, titled “Would Affordable ‘Modicare’ Remain Just A Pipe Dream In India?”, I also termed this new draft health policy as ‘Modicare’, just as a few others did. If implemented both in its letter and in spirit, NHP 2015 has the potential to overshadow even the ‘Obamacare’ of the United States, almost hands down. Although it’s an altogether different story that under the new President Donald Trump’s administration, this Act faces a real threat of extinction, at least, in its current Avatar.

Is health care also a serious political issue?

Prompted by what has been happening in the oldest democracy in the world, the above fundamental question does surface. Its answer could be both, ‘yes’ or ‘no’, depending on the voters’ awareness on the subject, and the importance attached to it for individual well-being, including work productivity.

However, in this article, to impress upon how important are the promises on health care to the common citizens in the oldest democracy, I shall draw two back to back examples of pre-election campaign promises related to universal health care in the Unites states, where the answer to the above question has been an emphatic ‘yes’. Thereafter, I would explore what is happening in India in this area to fathom what could its answer possibly be in the largest democracy of the world.

The United States:

On November 4, 2008, Senator Barack Obama of Illinois was elected as the president of the United States. Just in a year’s time ‘The Patient Protection and Affordable Care Act’ popularly known as ‘Obamacare’, was passed in the Senate on December 24, 2009, and passed in the house on March 21, 2010. It was signed into law by President Obama on March 23rd, 2010 and upheld in the supreme court on June 28, 2012.

By enacting this historic health care reform legislation, President Obama fulfilled his election campaign pledge to provide healthcare to all in the United States of America, almost immediately after coming to power.

Similarly, during his 2016 election campaign, Donald Trump pledged to repeal the ‘Affordable Care Act (Obamacare)’, if elected, calling it a “total disaster.” Accordingly, on January 20, 2017 – the same day of becoming the 45th president of the United States, in his first executive order, President Trump, told government agencies to scale back aspects of the Affordable Care Act – fulfilling his pledge to undo Barack Obama’s signature healthcare law that made medical services accessible to millions of Americans.

Whether, it is a good or bad decision may not be a point of discussion in this article, but so far as the pre-election pledge on health care reform is concerned, both the Presidents – Obama and Trump indeed ‘walked the talk’.

India:

Besides the above two examples, the general expectation of the stakeholders in India was that in the priority agenda of the new Government health care will feature much higher than ever before. This was because the main ruling party of the Government in power now had promised to deliver a robust healthcare reform in its Election Manifesto 2014, if it is voted to power. Let me just reproduce below some of those critical promises:

  • India needs a holistic health care system that is universally accessible, affordable, effective and drastically reduces the out of pocket spending on health.
  • The Party accords high priority to the health sector, which is crucial for securing the economy.
  • As NRHM has failed to meet the objectives, it will be radically reformed.
  • The overarching goal of health care would be to provide, ‘Health Assurance to all Indians and to reduce the out of pocket spending on health care’, with the help of state governments.
  • The current situation calls for radical reforms in the health care system with regards to national health care programs and delivery, medical education and training and financing of health care.

The manifesto then goes into the details of each reform areas, after stating, “the last health care policy dates back to 2002; India now needs a comprehensive health care policy to address the complex health care challenges, keeping in view the developments in the health care sector and the changing demographics. The party will initiate the New Health Policy.”

This expectation flickered yet again:

This expectation flickered yet again, when just on the eve of the 2017-18 Union Budget Session, no less than the President of India, honorable Pranab Mukherjee on the last Tuesday reportedly reiterated that his Government assures ‘Health care for all’.

It’s about three years since the new Government is firmly placed on the saddle, after being voted to power. Regrettably, much promised, the new and comprehensive health care policy of India is still not in place. Could it mean, unlike in the US, pre-election political pledges on health care is still not considered a top priority area for quick implementation either by the Indian voters or the winning political parties, post-election? Probably, it doesn’t also sound as vote catching as a plethora of other ‘developmental activities’, ‘Foreign Direct Investments (FDI)’ and ‘GDP growth’ do, for winning a national election in our soil.

In India, most of the population think or feel about medical treatment and prevention of diseases mostly when we ourselves, or our near and dear ones suffer from serious morbidity, or are almost in a dying condition from serious ailments. At that moment of truth, most of us face almost an insurmountable barrier to treatment access due to individual ‘affordability’ condition. In the absence of enough decent public health facilities, one is compelled to go for private medical services that cost a bomb, most of which being out of pocket. At other times, it does not seem to matter much to many, or becomes an integral part of a burning social, political or economic agenda. It has thus far remained a dormant need, which needs to be brought to open by creating greater awareness in ambitious India, even during and after bringing a Government to power.

The fastest growing nation incurs lowest public health expenditure:

Even post ‘Demonetization’ exercise in the country, India would continue to remain the fastest growing large country in the world. However, the Government allocates just around one percent of GDP on public healthcare expenditure, ranking among the lowest in the world, in this area. Regrettably, there does not seem to be an adequate realization both among the public, corporate head honchos, including a large section of the country’s highly partisan media that sans sharp focus on health care, this immaculate growth story can get adversely impacted, in the long run.

Incoherent union health budgets sans any report card on achievements:

Be that as it may, in this article, I shall present before you a snapshot of the health care budgetary measures announced by the Finance Minister in his Budget speech both in 2016-17 vis-a-vis in 2017-18. Thereafter, I would try to explore how incoherent these are, and without any comprehensive status report on time-bound set goals. This is important, as taxpayers hard earned money was spent on those ‘goodies’, probably to give an impression that health care has not been totally left out by the Government during its annual budgetary allocation.

To demonstrate how incoherent and ad hoc these health budgets are, let me place before you what were the key areas of Union Budgetary allocations in 2016-17. If I may refer to my article of March 07, 2016 in this Blog titled, “Healthcare: Unwrapping The Union Budget (2016-17)”, we shall find that the key features were as follows:

The previous Union Budget of 2016-17:

  • The Government will launch a new health protection scheme, which will provide health cover up to Rs. One lakh (Rs. 100,000) per family. For senior citizens, age 60 years and above, belonging to this category, an additional top-up package up to Rs. 30,000 will be provided.
  • To reinvigorate the supply of generic drugs 3,000 stores under Prime Minister’s Jan Aushadhi Yojana will be opened during 2016-17.
  • Starting a ‘National Dialysis Services Program’ to provide dialysis services in all district hospitals. The funds were to be made available through PPP mode under the National Health Mission. To reduce the cost, the budget proposed exemption of certain parts of dialysis equipment from basic customs duty, excise/CVD and SAD.

I am not sure how many stakeholders, if any, are aware of the exact status report on those proposals of the last year’s Union Budget allocation for health care. If that’s the prevailing situation, we now get another small bundle of different sets of ‘goodies’ in the Union Budget 2017-18, as follows:

Current Union Budget of 2017-18:

Even in the absence of a comprehensive National Health Policy, there are many other health related critical issues that may eventually impede the GDP growth rate of the country. A few examples of which are as follows:

  • The estimated premature deaths caused by cardiac ailments, stroke and diabetes, reportedly, will result in a loss of national income of over US$ 250 billion in the coming decade,
  • Mental health becoming a silent epidemic, affecting around 13 percent of the population and just 10 percent of them getting treatment,
  • Millions of families are unable to get access to secondary and tertiary care services for diagnosis and treatment of serious diseases, such as cancer, as they cannot afford private facilities, which gets compounded as India records one of the highest out-of-pocket health expenditure in the world, higher than even many lower income, lower-middle income, as well as the middle-income countries.

Nevertheless, the Union Finance Minister in his 2017-18 budget proposal announced a strong resolve for elimination of:

  • Kala-azar or Leishmaniasis and filaria by 2017
  • Leprosy by 2018
  • Measles by 2020
  • Tuberculosis by 2025

Unquestionably, these are grossly inadequate, especially, in young and ambitious India. Moreover, very people industry watchers would know whether the deadline set for each is achievable, and a periodic report card on the same will be made public or not.

Similarly, the government’s determination to reduce Infant Mortality Rate (IMR) to 28 by 2019 (39 in 2014) and Maternal Mortality Rate (MMR) to 100 in 2020 (167 in 2011-13) is also praiseworthy. However, both these, including tuberculosis prevention, diagnosis and treatment interventions, were a part of the Millennium Development Goals (MDGs) for India. These are an ongoing exercise set out in the Millennium Declaration in 2000. Moreover, why annual budgetary allocation only for those two now, out of 8 MDG goals?

A few other equally ad hoc health care measures, probably picked up at random, and announced by the Union Finance Minister in his February 01, 2017 budget speech were the following:

  • Rs 6,000 financial aid for pregnant women to cover hospital admission, vaccination and nutritional food.
  • Two new All India Institute of Medical Sciences (AIIMS) at Jharkhand and Gujarat.
  • 1.5 lakh health sub centers to be converted to Health Wellness Centers
  • Amendment of the Drugs and Cosmetics Rules to ensure availability of drugs at reasonable prices and promote the use of generic medicines
  • New rules for regulating medical devices to be formulated, which will be internationally harmonized and attract investment into this sector
  • Structural reforms in the medical practice and education.
  • For senior citizens, Aadhar based Smart Cards containing their health details. A beginning will be made through a pilot in 15 districts during 2017-18.

By all these, the government has proposed 27.7 percent increase in allocation for Ministry of Health and Family Welfare to Rs.47, 352.51 Crore in the latest budget from Rs 37,061.55 Crore in 2016-17, on the current abysmally low base of around 1 percent of GDP. A sizeable chunk of this budget is expected to go towards setting up of two new AIIMS and for conversion of 1.5 lakh health sub centers to Health Wellness Centers. The National Health Mission (NHM) for the entire nation, which the Government earlier said is not working, receives an increase of Rs. 3,000 Crore. According to media reports, the Public Health Foundation of India (PHFI) also considers this budget allocation as a frugal one.

Besides the general expectation for the beginning of a Universal Health Care (UHC) regime in India, pharma industry had generally expected the following immediate term relief, which also found no mention in the budget:

  • Corporate tax cut
  • Extension of time line for weighted deductions of R&D expenditure and adding filing fees and clinical trial expenses under the exemption.
  • Rationalization in excise duty for APIs to bring it on par with formulations.
  • Changes to excise duty due to impending implementation of goods and service tax (GST) Withdrawal of service tax on health insurance
  • Exemption of input service tax on support services

Conclusion:

The reason why I brought ‘Modicare’ in my budget discussion is that it needs well-articulated budgetary allocation, even for just the beginning of its implementation, besides having a robust policy in place. Even on the eve of the 2017-18 Union Budget Session, no less than the President of India had reiterated that his Government assures ‘health care for all’ – further rekindling this hope.

In the absence of a well-charted pathway for public health care in India, no wonder that this budget, in my opinion, demonstrates a clear lack of direction, incoherent and inconsistent, just as the previous ones.

I hasten to add that the Government’s focus on rural infrastructure and development, providing financial benefit to farmers, help building affordable houses, creating new jobs, ensuring ease of doing business, putting more disposable income in the hands of the people are well appreciated. However, none can possibly refute the dictum, especially in the young and highly ambitious India that: “It takes a healthy nation to build a wealthy nation”.

The bottom line, therefore, is, the fastest growing nation of the world continues to feel wise and smart with its lowest expenditure on public health. It also leaves a general impression that the Government has removed from its list of priority all the pledges made on health care, before, during and after having a firm grip on the leash of power. Consequently, this has made ‘Modicare’ no more than a pie in the sky, as it were, for many, even after years of sustenance of an indomitable hope of it coming to fruition.

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.

Drug Price Control in India: When A Local Media Goes Against, A Global CEO Doesn’t

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‘Variety is the spice of life’, as the good old saying goes. The week, just gone by, was indeed packed with a wide variety of surprises, well encompassing various important areas, some of which are as follows:

  • Effective November 08, 2016 midnight, Indian currency notes of ₹500 and ₹1000 denominations ceased to remain legal tenders. This demonetization followed extensive media coverage, both national and international, on unprecedented administrative and public chaos around this otherwise bold and good intent.
  • The same day witnessed much unexpected triumph of Trump as the 45th President-Elect and the Commander-in-Chief of the United States of America. It is entirely a different matter though, that post-election, millions of Americans reportedly took to streets across the United states to vent their fury over the billionaire’s election victory.
  • On November 07, 2016, a well-known Indian business daily, ‘The Economic Times’, in its editorial, apparently expressed its solidarity with the pharma industry, in general, to do away with drug price control in India. The key reason for this advocacy, as I could sense, is to encourage the drug players to grow by making more profits. I respect this view of the editor will all humility. However, the point that I am unable to ferret out though, what happens to especially the poor patients in such an eventuality. With hands-on experience in the pharma industry over several decades, it appears to me that the editorial suggestions, as well, grossly lack in requisite depth of understanding of the core issue.
  • On November 09, 2016, quite opposite to what the above editorial of ‘The Economic Times’, the current global CEO of GlaxoSmithKline – Sir Andrew Witty, in an interview, strongly argued in favor of the necessity of drug price control in India, that improves access to medicines for a vast majority of the country’s population. To substantiate this point Sir Andrew said in another interview on the same day, “We’ve seen demand of products jump 45 percent after the price is cut by 20 percent. The problem arises when we don’t have supply to cater to the demand, leaving patients frustrated. A bit more predictability (on the part of government) will help.”
  • As if this diametrically opposite views are not enough, on November 10, 2016, the well-known civil society organization – ‘All India Drug Action Network (AIDAN)’, reportedly sent legal notices to the CEO of Niti Aayog CEO and secretaries to the Health Ministry, Department of Pharmaceuticals and Department of Industrial Policy and Promotion over their talks to cut the powers of the National Pharmaceutical Pricing Authority (NPPA). AIDAN has termed this Government move “anti-national” and “anti-people”, further adding that it affects an ongoing case at the Supreme Court over various aspects of the drug price control.

In this article, I shall restrict myself to the pharma related issue of the past week, especially on the interesting advocacy through editorial, against the drug price control in India. Simultaneously, I shall also underscore its relevance in the country, primarily to improve access to medicines for millions of Indians, as articulated by one of the leading voices from the global pharma industry.

Is the yardstick of judging pharma industry different?

This particular question floats in my mind because of several reasons. One such is, almost regularly sponsoring fully paid trips for doctors, especially in an exotic foreign land, by many pharma companies. Such practices of the drug companies are generally inferred, more often than not spearheaded by a large section of the media, as dubious means of the organization to entice, or influence prescribing decisions of physicians in favor of their respective high priced brands, ignoring the health and economic interest of patients.

In similar context, just after having a quick glance over a not so important article, written on various operations at the headquarter of a global drug company situated in a beautiful locale of the world, when one focuses the fine print at the end as a disclaimer, which reads: “This reporter was in (name of the country) on an invitation by (name of the global company)…, do the readers arrive at the same conclusion on ‘gratification’, as above, and its consequent possible outcome on pharma related writings of these reporters?

Can the concerned members of the ‘Fourth Estate’ possibly claim desired intellectual independence in their analysis of a situation involving such companies or their trade associations, even after the above disclaimer? Or for that matter, related publications too, which allow acceptance of such avoidable ‘gratis’ by its reporters? Shouldn’t such incidences, whenever these happen, irrespective of who availed these, be perceived in the same light?

In the current scenario, this issue is something for us to seriously ponder. This is mainly because, for following similar practices, why should there be two different yardsticks to gauge the quality of professional independence of two different otherwise highly respectable professions?

This reminds me of a great pharma reporter, writing for an internationally acclaimed business daily, mainly on the drug industry and healthcare. I met him in India a few years back on his invitation. Although, I shall not take either his or his paper’s name. This is to show respect to our free and frank interaction. He flew down to India with his employer paying all the pharma reporting work related expenses. He met with all those in the Indian drug industry that he wanted to, primarily to capture the nuances of the thought pattern of large and small Indian pharma players. I was so impressed with his intellect, and independent professional outlook, like all those who met him during his that specific visit to India. Even now, I can feel his independent perspective, as I read his articles. It would be great to experience similar feelings, while reading pharma related articles and editorials, in various publications of my own country. At the same time, I shall be delighted to be proved wrong regarding any such possibilities in this area.

That said, I shall now move on to the relevance of drug price control in India.

Any relevance of drug price control in a ‘Free Market Economy’?

No doubt, this is a very pertinent question. Equally pertinent answers are also available in a 2014 paper titled, “Competition Issues in the Indian Pharmaceuticals Sector” of Delhi School Economics (DSE). The paper deals with issues related to failure of ‘Free Market Economy’, despite intense competition, especially for branded generic drugs in India.

Quoting a practicing surgeon, the DSE article states: “Sometimes it could be just plain ignorance about the availability of a cheaper alternative that makes doctors continue to prescribe costlier brands. But one cannot ignore the role of what is euphemistically called marketing “incentive”, which basically mean the inappropriate influence pharmaceutical companies exert on doctors. This runs deep. Hospitals choose to stock only certain drugs in their in-house pharmacies and insist that hospitalized patients buy drugs only from the hospital pharmacy. Drug companies sell drugs to hospitals at a price much lower than what the patient is charged, further incentivizing the hospital to stock their products. The cheaper brands often get left out in this game.”

Further, in an ideal free-market economic model, for all approved branded generics with exactly the same formulation, having the same claimable efficacy, safety and quality standards, though marketed by different pharma companies, competitive forces should prompt some parity in their pricing.

Any generic brand with exactly the same formulation as others and offering the same therapeutic value, but costing significantly more, should ideally attract a lesser number of customers, if and where purchase decisions are taken by the consumers directly. However, for prescription medicines it’s not so. The well proven process of consumers exercising their own choice to select a brand, mostly influenced by advertising or word of mouth, does not happen at all.

The Government attributes ‘Market Failure’ for pharmaceuticals:

In its price notification dated July 10, 2014, the NPPA has categorically stated the following:

  • There exist huge inter-brand price differences in branded-generics, which is indicative of a severe market failure, as different brands of the same drug formulation, which are identical to each other in terms of active ingredient(s), strength, dosage, route of administration, quality, product characteristics, and intended use, vary disproportionately in terms of price.
  • It is observed that, the different brands of the drug formulation may sometimes differ in terms of binders, fillers, dyes, preservatives, coating agents, and dissolution agents, but these differences are not significant in terms of therapeutic value.
  • In India the market failure for pharmaceuticals can be attributed to several factors, but the main reason is that the demand for medicines is largely prescription driven and the patient has very little choice in this regard.
  • Market failure alone may not constitute sufficient grounds for government intervention, but when such failure is considered in the context of the essential role of pharmaceuticals play in the area of public health, which is a social right, such intervention becomes necessary, especially when exploitative pricing makes medicines generally unaffordable and beyond the reach of most and also puts the huge financial burden in terms of out-of-pocket expenditure on health care.

Civil Society echoed the same sentiment:

In this context, it is important to note that seven large Civil Society Organizations in a letter of August 20, 2014 addressed to Mr. Ananth Kumar, the present Minister of Chemicals and Fertilizers with a copy to Prime Minister Modi, articulated similar views, as follows:

“Limiting all price regulation only to a list of 348 medicines and specified dosages and strengths in the DPCO 2013 goes against the policy objective of making medicines affordable to the public. The National List of Essential Medicines, a list of 348 rational and cost-effective medicines, is not the basis for production, promotion and prescription in India. In reality the most frequently prescribed and consumed medicines are not listed in the NLEM.”

Last week, AIDAN has also indicated that the reported Government move to curtail the power vested on the NPPA for drug price, affects an ongoing case at the Supreme Court over various aspects of the drug price control.

Are medicines cheapest in India…really?

It is often highlighted that medicines cost much cheaper, if not the cheapest, in India. This is too simplistic a view on this subject. It compares the prevailing Indian drug prices in Rupee, against the prices of similar drugs in other countries, just by simple conversion of the foreign currencies, such as, US$ and Euro into Rupee. To make the comparison realistic and credible, Indian drug prices should be compared against the same in other countries, only after applying the following two critical parameters:

  • Purchasing Power Parity and Per Capita Income
  • Quantum of per capita ‘Out of Pocket Expenditure’ on drugs

The Department of Pharmaceuticals (DoP) with the help of academia and other experts had earlier deliberated on this issue in one of its reports on patented drug pricing. The report established that post application of the above two parameters, medicines in India are virtually as expensive as in the developed world, causing great inconvenience to the majority of patients in the country.

Hence, common patients expectedly look for some kind of critical intervention by the Government, at least, on the prices of essential drugs in India.

‘Cannot do away with Drug Price Control’ – said the New Government:

On August 24, 2015 in an interview with a national business daily, V K Subburaj, the Secretary of the Department of Pharmaceuticals commented, “Price control on drugs a shot in the arm for health care” and “the Government cannot do away with it.”

He argued, “A large section of the population is poor. Suddenly, your system is disturbed if you have to spend more on drugs. Drugs are an important component of health care expenditure.”

Accepting the fact that in India, big and small companies investing in research would need more money, Mr. Subburaj said, “In India, we can’t afford to remove controls as the burden of disease is high.”

All stakeholders expect that there is some predictability in what the Government says. Can the stand taken by the policymakers change in just a year’s time, probably wilting under industry pressure?

Conclusion:

The drug price control in India is in vogue since 1970, uninterruptedly. The retail audit data continue to indicate that the growth of the Indian pharma industry, over the last four and half decade long price control regime, has been nothing less than spectacular. This would consequently mean, increasing consumption of drugs, leading to improved access to medicines in India, including its hinterland, though may still not be good enough. Sir Andrew Witty of GSK also articulated the same view, just the last week. It’s a different story altogether that some of the industry sponsored expensive market surveys attempt to wish it away.

Coincidentally, at the commencement of drug price control regime in India in 1970, almost all the players in the ‘Top 10’ pharma league table of the country, were multi-national drug companies. Today the situation has just reversed. Out of ‘Top 10’, about seven are home grown drug companies. Many of these companies were born post 1970. Without frequent M&As by the pharma MNCs, this number could have been probably higher today.

By the way, what’s the span of drug price control in India really – just about 18 percent of the total domestic pharma market now? Around 80 percent of the local drug market continues to remain in the ‘free-pricing’ and ‘high-profit’ zone.

When it comes to profitability, it is worth mentioning, the promoter of the so called ‘low margin’ generic pharma company – Sun Pharma, is the second-richest person in India. He created his initial wealth from India, despite ostensible ‘growth stunting’ price control.

Keeping this in perspective, is it not baffling to fathom the reason behind a local business publication’s apparently endorsing the advocacy initiatives of pharma industry against drug price control through an editorial, when a well-regarded global pharma CEO expresses a strong favorable view in this regard?

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.