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Worsening Health Effect Of Climate Change In India: A Perspective

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At present, out of the top five most pressing global and local environmental challenges, ‘Climate Change’ features at the top.

It has been broadly defined as, “a change in global or regional climate patterns, in particular a change apparent from the mid to late 20th century onwards and attributed largely to the increased levels of atmospheric carbon dioxide produced by the use of fossil fuels.” 

The impact of Climate Change’ is so profound that, if not addressed immediately, it would most likely to cause extinction of human life from the planet Earth and that too in the most agonizing and painful way, lasting over a long period of time.

The Paris Summit and its objectives: 

To effectively address the ‘Climate Change’ issue, nearly 150 world leaders of 196 countries, including Prime Minister Modi, deliberated in the Paris summit earlier in December 2015. Their representatives and negotiators ultimately succeeded, at the fag end of the ‘Paris Summit’ to arrive at a global consensus for inking a new ‘Climate Change’ agreement.

Prior to this, a report titled, “Paris 2015: Getting a global agreement on climate change”, published in August, 2014 by the Green Alliance Trust, United Kingdom stated that the agreement, expected to be signed in this Paris summit should ensure a meaningful united global action on climate change, covering the following key points:

  • A strong legal framework and clear rules
  • A central role for equity
  • A long term approach
  • Public finance for adaptation and the low carbon transition
  • A framework for action on deforestation and land use

Experts opined that a strong deal will make a significant difference to the ability of individual countries to tackle climate change by ensuring the following:

  • Give a clear signal to business for desired environmental protection and pollution control
  • Guide investment toward low carbon outcomes
  • Create a simpler, more predictable framework for companies operating in different countries
  • Help meeting international development aims, which are at increasing risk from rising global temperatures.
  • Help reducing poverty
  • Help improving health and building security
  • Fetch huge benefits to the natural environment by helping to avoid biodiversity loss and the degradation of ecosystems upon which the existence of human life depends

India’s position on ‘Climate Change’:

India’s position on ‘Climate Change’ has been clear and is well captured in Prime Minister Modi’s reiteration in the Paris summit as follows:

“Climate change is not of our making. It is the result of global warming that came from an industrial age powered by fossil fuel. Yet, we face its consequences today, and that is why the outcome in Paris is so important and we are here today. We want the world to act with urgency. Agreement must lead us to restore balance between humanity and nature. We want a comprehensive equitable and durable agreement in Paris.”

Worsening health effect:

‘Climate Change’ could even drive the human race to extinction in its final outcome. Meanwhile, besides its devastated environmental impact on the planet Earth, it would gradually but surely worsen human health conditions.

In this article, I shall focus only on human health perspective on ‘Climate Change’. 

Direct and indirect health impact:

I would classify the adverse impact of ‘Climate Change’ on health basically into two categories:

- Indirect

- Direct

Indirect impact: 

Many of the indirect health impact events of ‘Climate Change’ either go unnoticed or are still considered as an ‘Act of God’. Although this issue relates to our ultimate survival, even today in India not many debates are taking place on the subject, mostly in the Television Channels. This amazing medium continues to remain obsessed with competitive high decibel shouting and slanging matches to strengthen the viewers’ appetite, even more, mostly on trivial sensationalism.

Fortunately, global awareness of the disastrous impact of ‘Climate Change’ is increasing, slowly but surely. 

I shall give below just a few examples of indirect health impact of this change:

- Extreme weather events, such as floods, droughts, tsunamis, heat-waves and other disasters would keep increasing the mortality rate. Many experts attribute the cause of the recent deluge in Chennai to ‘Climate Change’, though there are other view points too. 

- Extreme weather conditions have also started causing frequent crop failures, especially in the developing world like India. As a result, many people go hungry and children suffer from malnourishment, mostly in rural areas, precipitating adverse health consequences.

- The impact of all these on mental health is also at times devastating and should in no way be ignored. Frequent incidences of farmers’ suicide in India due to crop failures could possibly be due to their deteriorating mental health, which needs to be studied in detail.

Direct impact:

According to ‘Big Picture’ – a free and impartial educational resource that explores the innovations and implications of cutting-edge science, rising temperatures and pollution levels may act together to directly worsen various health conditions, a few examples are as follows:

- Researches say, air temperature is more likely to affect cardiovascular function, when ozone levels are high, including the heart’s electrical activity and airflow into the lungs.

- A recent review has established that air pollution sets off nearly as many heart attacks as physical exertion, alcohol or coffee. Belgian researchers examined 36 studies conducted in various countries between January 1960 and January 2010 to examine the percentage of heart attacks attributable to the common risk factors and found that air pollution increased a person’s heart attack risk by 5 percent.

- Higher temperatures may also make the body more sensitive to toxins, such as ozone.   

- Studies show allergies are on the rise in developed countries, including the United States, which could partly be rising carbon dioxide levels and warming temperatures. 

- A number of notorious diseases, such as, malaria and cholera, thrive with the increase in temperature and rainfall. To give an example, the mosquitos that carry the malaria parasites grow rapidly in hot and humid conditions. The increasing prevalence of such weather conditions in climate change is likely to spread these diseases in a much wider population.

Is there any upside for ‘Climate Change’? 

Available information also points out towards some possible, but limited benefits for ‘Climate Change’, as follows: 

- Reduced risk of dying of the elderly persons from extreme cold in the winters of the temperate countries.

- Longer summers in those countries are likely to improve agricultural yields of the farmers.

Let me hasten to add, all these upsides, if at all, may not help the developing and poorer nations of the planet Earth, as such climatic conditions are mostly prevalent in the developed nations of the world.

Need for further research:

A report titled, “A Human Health Perspective On Climate Change”, published on April 22, 2010 by ‘Environmental Health Perspectives’ and the ‘National Institute of Environmental Health Sciences’, identified the following major research areas that need to be further explored and understood in the ‘Climate Change’ perspective:

The above outcome of the study is exactly in the expected line, which was “to identify research needs for all aspects of the research-to-decision making pathway that will help us understand and mitigate the health effects of climate change, as well as ensure that we choose the healthiest and most efficient approaches to climate change adaptation.”

How can we all contribute individually?

On this subject, by a release on November 26, 2011, ‘The National Aeronautics and Space Administration (NASA)’ of the United States recommended some very easy to follow steps for all of us.

It said, each individual can help in this matter by using less energy and water. For example, one may consider turning off lights and TVs when one leaves a room. Turn off the water, when brushing teeth.

It suggests, another way to help is by learning about Earth and its climate. The more we know about how Earth’s climate works, the more we shall be able to help solve problems related to climate change and that is also the purpose of this article.

In addition, besides many others, we may consider lesser use of our private cars and more of available public transports. Smokers may consider to quit smoking. We can also help by planting trees, which absorb carbon dioxide from the atmosphere.

India’s high stake:

A December 9, 2015 article published in ‘The New York Times’, titled “For Indians, Smog and Poverty Are Higher Priorities Than Talks in Paris” reiterated as follows:

At the climate talks in Paris, “few countries have so much at stake as India. For the last month, the front pages of major newspapers have been dominated by one environmental crisis after another: City-dwellers are up in arms about hazardous levels of air pollution, which has already damaged the lungs of about half of Delhi’s schoolchildren. And last month brought torrential rains and flooding in the southern city of Chennai, evoking the erratic weather that climate experts warn about.”

India’s consistent stand in various ‘Climate Change’ talks is drawing a fine balance between rapid development of the nation, with commensurate new job creation and health safety & environment. However, the apprehension that is being expressed now by many, whether that is feasible on the ground at all, for holistic measures in the right direction, with the adequate funds flow for the same.

Thus, the key concern of the Indian negotiators was, signing of any global agreement to support a strong climate regime, without requisite funding, could seriously impede India’s economic growth and development agenda. The developing nations, such as India, therefore, expect adequate and committed funding from the developed nations for generation of clean energy to drive inclusive economic prosperity of the respective emerging economies.

Developed nations still not quite on the same page?

The developed nations, even in the final text of the deal, do not seem to be quite on the same page, with firm financial commitments. As a result, a ‘Tug of War’ of objectives, as it were, surfaced in the final negotiation process – mainly between sustained economic development and stringent global measures with fund commitment to contain possible extinction of the human race in the world.

The impact of an effective implementation of the agreement is expected to last almost in perpetuity.

Conclusion:                                                                              

Finally, on the last Saturday, December 12, 2015 a new global deal to address the pressing issue of ‘Climate Change’, was agreed in Paris. Unquestionably, this is a critical step forward for all countries to save the planet Earth.

Intriguingly, the deal still does not provide for a binding commitment towards adequate funding by the developed countries, which is so essential for the developing nations to adopt clean and renewable energy to contain the devastating impact of the ‘Climate Change’.

Although, the agreement does talk about funding of US$ 100 billion a year from 2020 to 2025, this is not the legally binding part of the deal, as many people had expected.

In my view, if there is just one statesman who could be singled out for taking exemplary initiative to make the deal come through, it would be President Barack Obama of the United States. He spoke several times to the heads of the several developing nations, including India, China and Brazil, many times to iron out the differences till the last moment, for this key global issue – indeed a statesman par excellence, at least to me.

Be that as it may, the deal has now been inked, Indian Government also has expressed its satisfaction and happiness with the final text of the agreement. Still, a key question haunts: Would it produce the desired results, as expected? Well, that depends on how effectively and time bound manner the global commitments get translated into reality, with required fund flowing smoothly, to contain environmental disasters, leading to natural calamities and jeopardizing human health-safety.

Let’s all keep our finger crossed, as the saying goes, “The proof of the pudding is in the eating.”

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

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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.

A Patient-Centric State Initiative To Revolutionize Disease Treatment

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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

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.

In VUCA World: Changing Dynamics of Prescription Generation Process

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The acronym VUCA is often being used to emphasize upon the Volatility, Uncertainty, Complexity and Ambiguity in various situations. The term has been derived from military vocabulary and is being used since 1990s in the business management parlance. VUCA is also considered as a practical code for awareness and readiness.

I find all the elements of VUCA playing an active role in the prescription demand generation space too, as it is based on various assumptions of what will work and what won’t in a fast changing pharmaceuticals business environment. 

The interplay:

Primary interplay in the sustainable prescription demand generation process of today’s digitally empowered VUCA environment, I reckon, could be as follows:

  • Volatility: Fast changing dynamics of medical communication with interfaces made of emerging modern technological tools carrying high risks of rapid obsolescence.
  • Uncertainty: Lack of predictability in assessing outcomes of increasingly expensive product detailing inputs, coupled with too many surprise elements popping-up in the environment almost from nowhere and more frequently.
  • Complexity: Multi-factorial Doctor-Medical Representative (MR) interactions, which get even more complicated with increasing time constraints for effective product detailing to take place.
  • Ambiguity: Difficult to fathom changing needs of the doctors/payors, leading to increasing cause-and-effect confusion by the pharma marketing strategy planners.

Keeping these in view, today I shall deliberate on the ‘Criticality of Optimal Mix of Human and State of Art Digital Interfaces’ for sustainable prescription demand generation in a VUCA environment.

The key influencer – a new study:

A research study published in June 2013, in the ‘American Heart Journal (AHJ)’ establishes that the interaction between physicians and MRs, though essential for  improvement of medical care, is indeed complex. This is mainly because of the apprehension that conflict of interests may affect the doctors’ prescription decision-making process. 

However, the fact comes out, the doctors tend to prescribe more of expensive medical products after interacting with MRs from the concerned manufacturing companies, which, in turn, raises the treatment costs for patients.

Study established MRs influence prescription decision:

This particular AHJ study compared the use of Bare-Metal Stents, Drug-Eluting Stents (DES), and Balloon Catheters according to company presence in the hospital. It concluded that MR presence was associated with increased use of the concerned company’s stents during percutaneous coronary interventions. The effect was more pronounced on the use of DES, and resulted in higher procedural cost of US$ 250 per patient.

In this particular study, it was found that DESs were used in about 56 percent of the cases, when the MRs concerned were at the hospital, against 51 percent when they weren’t there.

Interestingly on such interactions between the MRs and the drug/devices industry two opposite viewpoints emerge.

‘MR-Doctor interaction important‘ – Industry:

Quoting the Associate General Counsel and Director of Legal and Medical Affairs at the Advanced Medical Technology Association, a medical technology trade association, Reuters reported, “interactions between sales representatives and doctors benefit patients and are supported by professional medical organizations.”

‘MR interaction should not influence prescription decision’ – Doctors:

In the same report, the study’s lead author was quoted saying, “We need to evaluate carefully any interactions with medical industry to ensure that we minimize an effect on our decision making process.”

The bottom-line, though the debate continues:

This debate will keep continuing even in the years ahead. Be that as it may, the key fact that emerges out of the above study is, MRs do play a critical role in the prescription decision-making process of the doctors, especially for expensive medical products . Consequently, the pharmaceutical companies will prefer maintaining such ‘influencing’ roles of MRs to boost revenues of their respective brands.

This process assumes even greater importance in a VUCA world, as situation specific more frequent human interventions, strongly backed by state of art technological supports, would need to be effectively deployed for generation of sustainable prescription demand to excel in business.

The X-Factor:

However, one of the most challenging issues even in a VUCA situation is that pharma players continue and will continue to target the same sets of prolific prescribers for any given class of products in pursuit of success. As a result, time being so limited, very often even after waiting for hours MRs may not be able to meet the key prescribers.

Moreover, as and when the meeting takes place, it may well get restricted to just a very brief discussion due to the X Factor – paucity of the doctors’ time. Thus, delivering an effective product message in such a short time becomes increasingly challenging. Further, the difficulty in arresting un-interrupted attention of the busy practitioners due to X-Factor when they are with patients, compounds the problem.

Pivotal role of state of art technological tools:

The effectiveness of connection between respective brands of different drug makers and the doctors can be greatly facilitated with the application of state of art technology and modern internet based tools in varying proportions, as the sales and marketing communication strategy would dictate.

This area is emerging as a crafty game, which calls for wide-scale application of analytics.

Traditional strategies not enough:

In a VUCA world, while traditional face-to-face product detailing to doctors may continue to be the primary means for prescription demand generation, experimentation with a good number of new Internet based initiatives has already been started, as I discussed in my earlier article.

Hence, the concepts of digital marketing and e-detailing are gaining ground fast. Such initiatives of augmented digital communication of key marketing messages to doctors, would also help driving the key customers’ traffic to respective product Websites of the concerned companies for more detailed and convincing medical treatment solutions, as and when required by the busy doctors.

Types of digital interventions:

These digital interventions may include:

  • Highly targeted brand specific e-mailing responding to pre-identified needs of individual doctors
  • Sample ordering as per requirements of doctors
  • Live online product presentations at a time convenient to individual doctors
  • Quick and need-based problem solution centric online chats 24×7
  • Strategic usage of social media, backed by a robust pre-decided key output measuring matrix

However, the mix of each of these digital applications will need to be carefully worked out as robust supporting measures to key prescription demand generation activities, spearheaded by the MRs. 

MRs to remain as ‘Spearheads’:

In my view, MRs would still remain the frontline force in the emerging world (dis)order, may be lesser in number, for sustainable prescription demand generation process. Therefore, there is an urgent need to take them on board upfront and train suitably to make the modern digital interfaces successful as powerful differentiating support tools.

Technology based training on digital marketing and e-detailing as empowering initiatives, demonstrating tangible benefits that such high tech-interventions can offer in the overall sales performance of MRs, would play a critical role. Such efforts would, in turn, immensely help making digital augmentation strategies for pharma detailing successful, in the long run.

MR involvement is critical:

In my view, to be successful in a VUCA environment with all these endeavors, however tech-intensives those may be, there will be a critical need to make the MRs understand and learn the process. In tandem, it is equally important to actively engage them in the execution of the integrated medical communication strategy of the concerned companies.

Keeping this perspective in mind, I guess, it will be quite apt to quote Ben Franklyn, one of the Founding Fathers of the United States and a leading author, printer, political theorist, politician, scientist, musician, inventor and economist, all in one, who once wrote:

“Tell me and I forget, 

 Teach me and I remember,

 Involve me and I learn”

Thus, MRs would continue to have a critical role to play in the demand generation process for prescription medicines. However, they must be properly trained to be able to provide the types of knowledge and information that the doctors may not have ready access from elsewhere.

The entire process would, at the same time, require massive technological interventions, not incremental in nature but radical in scope and dimensions, and at a much wider scale than what we have been attempting today.

Challenges in India:

The very concept of VUCA in the changing dynamics of sustainable prescription demand generation, brings to the fore the issue of quality of MRs in India.

Currently there is a wide, both inter and intra company, variation in the educational qualifications, relevant product and disease area knowledge, professional conduct and ethical standards between MRs in our country.

Employability of MR in a VUCA world:

Just when we talk about augmented digital interfaces in medical communications, there exists a huge challenge in the country to strike a right balance between the level/quality of sales pitch generated by the MRs for a brand.

At times, many of them may not be properly armed with requisite scientific knowledge, and the basic norms of professional conduct/ ethical standards, while rendering their services.

They may not also be able to handle the sophisticated technological tools with quick application of minds. Hence, the subject of employability of MR in a VUCA world needs to be addressed afresh in India.

‘One size fits all’ strategies:

To make it happen, the pharmaceutical players would require to jettison, ‘one size fits all’ types of strategies in a VUCA world.

In tandem, pharma marketing strategists will need to be intimately conversant with a relatively difficult process of cerebral gymnastics to help formulating individual key prescriber-centric communication strategies, where MRs can play a key role with optimal digital interventions.

This is possible, if supported by the respective employers creating an environment of empowerment, backed by requisite product training, technological tools, modern behavioral inputs and above all by making investments to create of a large sustainable emotional capital for longer term  business excellence.

Conclusion:

All the elements of VUCA would keep playing very critical roles in sustainable prescription demand generation process in the years to come, more than ever before.

There is a critical need to understand the interplay between each of these dynamics on an ongoing basis to make strategic modifications quickly, whenever required. This is important, as the prowess to introduce right changes at right times will differentiate men from the boys in this ultimate ball game of the pharma industry. 

To succeed in a VUCA environment, pharmaceutical companies may choose to predominantly focus on harnessing their technological expertise. 

However, to face the waves of virtually unpredictable continuous change, only technology based efforts, I reckon, are less likely to fructify. Unless, these high- tech interventions are spearheaded by time-specific fast enough and intelligent skilled human responses in form of MRs. 

Having said that, it would be foolhardy to even think of completely taming VUCA with whatever human and technological wherewithal that any pharma player may be able to garner to achieve its goals. It is, in fact, a matter of relativity in managing VUCA in a given situation at a given time. 

Thus I believe, there is, on the contrary, a need to leverage a VUCA environment, for creation of an ‘Optimal Mix of Human and State of Art Digital Interfaces’ in the product detailing process with a high sense of urgency. This would be critical to gain cutting edge advantages for generation of increased prescription demand in a sustainable way.

For the pharmaceutical marketing strategists, this new ball game would obviously not be a piece of cake either, as the key success factors would involve the right mindset of first unlearning and then relearning the process on an ongoing basis, virtually in all time to come

With this perspective, I conclude by quoting the famous American writer and futurist Alvin Toffler, who once said,

“The illiterate of the 21st century will not be those who cannot read and write, but those who cannot learn, unlearn, and relearn.”

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.

 

Beyond ‘The Magic Moment’ of New Drug Marketing Approval

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“Uncontrolled clinical trials are causing havoc to human life. There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far.”

This is exactly what the Supreme Court of India observed while responding to a Public Interest Litigation (PIL) on the subject in January 2013.

While Indian regulators with the active intervention of the Supreme Court are trying to grapple with, besides others, the basic ‘human rights’ aspect of the Clinical Trial (CT), many countries in different parts of the world are moving much ahead at a brisker pace. They have started thinking and putting in place more patient centric newer drug approval systems and also, in tandem, hastening the process of bringing new drugs to the market.

Current general scenario in CT:

Currently, after pre-clinical studies and before applying for regulatory approval, a new drug has to be tested on volunteers in randomized studies to prove its efficacy and safety on patients. Relatively short duration of new drug trials can hardly establish long-term safety and efficacy, which are now arrived at through extrapolation of data collected during CT period.

It is worth noting, the overall situation changes dramatically after launch of these products, as their usage expands from a relatively smaller number of CT volunteers to millions of real-world patients.

In a situation like this, unrealistic expectation of patients’ safety in perpetuity based primarily on extrapolation of very limited CT data is being increasingly questioned today.

That is why, on going post-marketing surveillance, which is also known as a Phase IV CT, is considered as a much more effective process to gauge relative superiority of the drug against the existing ones in terms of both efficacy and safety on a longer term.

That said, today one reads and hears umpteen number of accusations for almost lack of any meaningful response on the part of the pharmaceutical companies, in general, towards revelations of post-marketing surveillance data. This could, in turn, expose the patients to various types of risks, including wasteful healthcare expenditure.

The ‘Magic Moment’ in the present regulatory process:

A recent paper highlights a single “Magic Moment” between pre and post-licensing processes in the current drug-approval model in many countries. In this system, the use of a drug is tightly controlled in a narrowly defined pre-licensing population. Thus, CTs are also conducted on such pre-defined and relatively homogeneous volunteers, who are generally free from complicating conditions.

However, after ‘The Magic Moment’ of marketing approval, a large number of heterogeneous patient population, with many of them on multiple therapy, also use these new products in uncontrolled settings. Situations as these had led to post-marketing major drug withdrawals like, Vioxx and Avandia due to patients’ safety.

These grave concerns have led to a strategic shift in the drug regulatory approval scenario throwing open new ideas in the drug approval process.

Adaptive Licensing:

To find the right answer to this vexing issue the drug regulators in many countries are  reportedly seriously contemplating to imbibe a process that will continuously help analyzing information through ongoing post-marketing surveillance data. Continuous medical data analysis like this will enable the regulators to modify their earlier decisions on marketing approval and also medical reimbursements related to pricing reasons.

This new process is called ‘Adaptive Licensing (AL)’, which is expected to benefit the overall healthcare system, by not allowing medical reimbursement of treatments with those drugs, which will provide negligible benefit over existing low cost therapies.

Difference between current mechanism and AL:

According to a ‘Health Canada’ paper titled, “The Path to Adaptive Drug Regulation”, the difference between the two is as follows:

Current system:

As explained above, post-licensing i.e. after ‘The Magic Moment’ of regulatory approval, treatment population grows rapidly and treatment experiences do not contribute to evidence generation.

Adaptive Licensing:

After initial license, treated patients grow more slowly due to regulatory restrictions. Patient experience is captured to contribute to real-world information. The marketing license is also modified accordingly from time to time.

Most desirable for many drugs:

Experts in this field opine that AL will help bringing in alignment of all required processes so important for a new drug seen from patients’ perspective like, R&D, regulatory approval and market access with the active involvement of all stakeholders like, the pharmaceutical companies, the drug regulator, payors/insurance companies and also the researchers.

In the AL system, a transparent drug development process will provide enough data on risk-benefit profile of the concerned drug to satisfy the drug regulator for its quick marketing authorization on pre-determined types of patients.

Such approval will follow real-life monitoring of efficacy and safety for modification of the drug license accordingly, wherever and whenever required.

Thus, AL is expected to strike a right balance balance between timely access to new drugs for the patients and the need to evaluate real time evolving information on safety and efficacy leading to a well-informed patient centric decisions by the drug regulators.

A continuous regulatory evaluation and decision-making process:

AL intends to evaluate a drug through its entire life span.  It has been reported that during this long period, clinical and other data will “Continue to be generated on the product through various modalities, including active surveillance and additional studies after initial and full licensing. The artificial dichotomy of pre vs. post licensing stages (‘The Magic Moment’) will be replaced by graded, more tightly managed, but more timely and potentially more cost-effective market entry and market stability.”

Not necessary for all drugs in the near term:

It is worth noting that AL system may not perhaps be required for all pharmaceutical or biologic products and will not totally replace the current system of drug licensing process, at least in the near term.

AL process may immediately be followed only for those products with a favorable risk-benefit drug profile as demonstrated in the initial data and there is a robust reason for early market entry of this drug to meet unmet needs, simultaneously with ongoing studies.

The ‘Magic Moment’ freezes in India…in perpetuity:

As per the Drugs and Cosmetics Act of India, after obtaining drug marketing approval from the regulators, concerned pharmaceutical companies are required to follow the pharmacovigilance system in the country to own the responsibility and liability of the drugs as enunciated in the Schedule Y of the Act. Unfortunately, this is hardly being followed in India, ignoring patients’ safety blatantly.

With the plea that most products launched in India are already being marketed in many developed markets of the world, the concerned companies prefer to depend on clinical experiences in those markets. This attitude totally bypasses the regulatory requirement to follow a robust pharmacovigilance system in India. Indian drug regulators also do not seem to be much concerned about this important patients’ safety related requirements, very surprisingly not even for biosimilar drugs.

However, the current ground realities are quite different. As we witness today, there does not seem to be much difference in time between international and India launch of innovative products. Thus, the argument of gaining medium to long-term experience on safety and efficacy from international data related to these drugs, does not seem to hold any water at all.

On the contrary, some drugs withdrawn from the international markets on safety grounds are still available in India, despite ire and severe indictment even from the Indian Parliamentary Standing Committee.

In a situation like this, AL process of Marketing approval for selected newer and innovative drugs may be considered by the Indian Drug Regulators, just not to be more patient centric, but also to help evaluating  pricing decisions of innovative drugs failing to demonstrate significantly better treatment outcomes as compared to the existing ones.

A recent example of AL:

One of the latest drugs, which reportedly will undergo such regulatory scrutiny of USFDA is Tacfidera (dimethyl fumarate) used for the treatment of multiple sclerosis, approved in April 2013 and costing US$ 54,900 per patient per year.  Interestingly, Tacfidera, before the drug can find itself on a formulary, will need to demonstrate its effectiveness in the real world.

The report indicates, “the first six months after a drug launch are always about educating payers about its benefits, and while most large payers are likely to make a decision to reimburse the drug in the next twelve months, data collection will continue and changes in policies might be made at a later date.”

Thus, in the years ahead, whether a new drug will become a blockbuster or not will very largely be decided by the ongoing real world data. If the promise of a drug diminishes at any point of time through clinical data, it will certainly going to have consequential financial and other adverse impacts.

Another interesting recent development:

Under new pharmacovigilance legislation in Europe, the European Medicines Agency has reportedly announced the list of over 100 drugs that soon will bear the “black triangle” logo. This initiative is directed to encourage both the doctors and patients to report side effects to enable close monitoring of drug safety.

Criteria to include drugs under additional monitoring are:

  • Medicines authorized after January 1, 2011 that contain a new active substance.
  • Biologics for which there is limited post-marketing experience.
  • Medicines with a conditional approval or approved under exceptional circumstances.
  • Medicines for which the marketing-authorization holder is required to carry out a post-authorization safety study (PASS).
  • Other medicines can also be placed under additional monitoring, based on a recommendation from the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC).

Conclusion:

Global regulatory experts do believe that in the concept of AL, there are still some loose knots to be tightened expeditiously to make it a fully implementable common drug marketing authorization process.  Appropriate pilot projects need to be undertaken in this area to establish beyond any doubt that AL will be decisively more preferable to the current regulatory process.

As and when AL will become the preferred drug-licensing pathway across the world, it is expected to offer greater real benefits of new drug development to the patients for their optimal use at an affordable price.

That said, some other experts do opine as follows:

“No matter how fast the authorization process operates, the merits of innovation will not be felt until they reach patients. And the barrier between authorization and patient access remains, in most of Europe, the issue of reimbursement.”

While all these are fast developing in the global CT scenario, in the jangle of Clinical Trials‘ in India, ‘Adaptive Licensing’ has still remained a critical missing ingredient even to encourage a wider debate.

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.

Health being a basic human right, the proposal for ‘Universal Health Coverage’ augurs well for India

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“The right to health is relevant to all States: every State has ratified at least one international human rights treaty recognizing the right to health. Moreover, States have committed themselves to protecting this right through international declarations, domestic legislation and policies, and at international conferences.”

-  The Factsheet, Office of the United Nations High Commissioner for Human Rights (OHCHR) and the WHO

Universal Health Coverage or Universal Healthcare:

In this context, “Universal Health Coverage (UHC)” is a healthcare system where all citizens of a country are covered for the basic healthcare services. In many countries UHC is also known as “Universal Healthcare” and may have different system types as follows:

Single Payer: The government provides insurance to all citizens.

Two-Tier: The government provides basic insurance coverage to citizens and allows purchase of additional voluntary insurance whenever a citizen wants to.

Insurance Mandate: The government mandates that insurance must be bought by all its citizens, like what happened in the USA in 2010.

Global scenario for UHC:

As per published reports, all 33 developed nations have UHC in place. The United States was the only exception until recently, till President Barack Obama administration implemented the ‘path breaking’ new healthcare reform policy in the country in 2010 against tough political opposition.

The new healthcare reform measures in the US had raised a storm within the local pharmaceutical industry, as well,  at that time for various reasons.

The countries providing UHC:

Based on an article titled, ‘ Analyzing our economy, government policy and society through the lens of cost-benefit’ published in  ‘True Cost’ following is the list of the countries where UHC is currently in place:

Country

Start Date of Universal Health Care

System Type

Norway

1912

Single Payer

New Zealand

1938

Two Tier

Japan

1938

Single Payer

Germany

1941

Insurance Mandate

Belgium

1945

Insurance Mandate

United Kingdom

1948

Single Payer

Kuwait

1950

Single Payer

Sweden

1955

Single Payer

Bahrain

1957

Single Payer

Brunei

1958

Single Payer

Canada

1966

Single Payer

Netherlands

1966

Two-Tier

Austria

1967

Insurance Mandate

United Arab Emirates

1971

Single Payer

Finland

1972

Single Payer

Slovenia

1972

Single Payer

Denmark

1973

Two-Tier

Luxembourg

1973

Insurance Mandate

France

1974

Two-Tier

Australia

1975

Two Tier

Ireland

1977

Two-Tier

Italy

1978

Single Payer

Portugal

1979

Single Payer

Cyprus

1980

Single Payer

Greece

1983

Insurance Mandate

Spain

1986

Single Payer

South Korea

1988

Insurance Mandate

Iceland

1990

Single Payer

Hong Kong

1993

Two-Tier

Singapore

1993

Two-Tier

Switzerland

1994

Insurance Mandate

Israel

1995

Two-Tier

United States

2010

Insurance Mandate

Highest per capita health spending has no relevance to the quality of health services/ outcome, but early implementation of UHC has:

The following table shows, although per capita spending on health is the highest in the US, the number of doctors, nurses and hospital beds per 10,000 population are highest in Cuba, UK and Japan, respectively. Japan also records the highest life expectancy at birth.Thus it appears, by and large, those countries which have an efficient UHC scheme running since quite some time from now are doing better in the health parameters as indicated below, especially, as compared to the US with the highest per capita health spending.

Country

Per capita spending on health (US $)

Doctors/ 10,000 pop

Nurses and midwives/ 10,000 pop

Hospital beds/10,000 pop

Life expectancy at birth
USA

    6719**

26

94

31

78
UK

2815

23

  128**

39

80
Russia

698

43

85

97

66
Japan

2581

21

95

  140**

   83**
Italy

2631

37

72

39

82
Germany

3465

34

80

83

80
France

3420

34

80

73

81
Cuba

674

     59**

74

49

78
China

216

14

10

22

74
Canada

3673

19

101

34

81

** Highest

Source: The Guardian, Data Blog, Facts are Sacred)

The current situation in India:

In October 2010, the Planning Commission of India constituted a ‘High Level Expert Group (HLEG)’ on Universal Health Coverage (UHC) under the chairmanship of the well-known medical professional 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 starts with:

“This report is dedicated to the people of India whose health is our most precious asset and whose care is our most sacred duty.”

The HLEG defined UHC for India 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”.

Ten principles for UHC in India:

Following are the ‘Ten Principles’, which guided the HLEG for the formulation of the recommendations for the UHC in India:

  1. Universality
  2. Equity
  3. Non-exclusion and non-discrimination
  4. Comprehensive care that is rational and of good quality
  5. Financial protection
  6. Protection of patients’ rights that guarantee appropriateness of care, patient choice, portability and continuity of care
  7. Consolidated and strengthened public health provisioning
  8. Accountability and transparency
  9. Community participation
  10. Putting health in people’s hands

UHC guarantees access to essential free health services for all:

Because of the uniqueness of India, HLEG proposed a hybrid system that draws on the lessons learned from within India as well as other developed and developing countries of the world.

UHC will ensure guaranteed access to essential health services for every citizen of India, including cashless in-patient and out-patient treatment for primary, secondary and tertiary care. All these services will be available to the patients absolutely free of any cost.

Under UHC all citizens of India will be free to choose between Public sector facilities and ‘contracted-in’ private providers for healthcare services.

It is envisaged that people would be free to supplement the free of cost healthcare services offered under UHC by opting to pay ‘out of pocket’ or going for private health insurance schemes

HLEG recommends ‘Price Control’ of ‘Essential Medicines’, just like draft NPPP 2011:

In its recommendation no. 3.5.1, HLEG postulated price controls and price regulation especially on essential drugs, which is quite in line with the draft National Pharmaceutical Pricing Policy 2011 (NPPP 2011). The HLEG report says:

“We recommend the use of ‘essentiality’ as a criterion and applying price controls on formulations rather than basic drugs. Direct price control applied to formulations, rather than basic drugs, is likely to minimize intra-industry distortion in transactions and prevent a substantial rise in drug prices. It may also be necessary to consider caps on trade margins to rein in drug prices while ensuring reasonable returns to manufacturers and distributors. All therapeutic products should be covered and producers should be prevented from circumventing controls by creating nonstandard combinations. This would also discourage producers from moving away from controlled to non-controlled drugs. At the same time, it is necessary to strengthen Central and State regulatory agencies to effectively perform quality and price control functions.”

Price control on essential medicines is also in force in China:

Chinese Government has put a cap on the prices of about 300 drugs featuring in their ‘National List of Essential Medicines (NLEM).’ Perhaps following the similar concept both the NLEG and NPPP 2011 have recommended price control of about 348 drugs falling under ‘The National List of Essential Medicines 2011 (NLEM 2011)’ of India.

Another recent report on ‘Free Medicines for All’:

Meanwhile,the working group of the Planning Commission on health, constituted for the 12th Five Year Plan (2012-2017) headed by the Secretary of Health and Family Welfare Mr. K. Chandramouli (now retired), has also submitted its report recently.

The Part II of the report titled, “Provisions of ’free medicines for all in public health facilities … recommends that health being a state subject, all the state governments of the country should adopt the successful and well proven Tamil Nadu model of healthcare procurement.

Tamil Nadu government through Tamil Nadu Medical Supplies Corporation (TNMSC) reportedly makes bulk purchases of drugs and pharmaceuticals directly from the manufacturers through a transparent bidding process, which reduces the cost of medicines to 1/10th and even to 1/15th of the Maximum Retail Price (MRP) of the respective product packs.

As per this report, the total running cost for the ‘Free Medicines for All’ project during the plan period would be Rs. 28,675 Crores and an additional allocation of Rs. 1293 Crores will be required as one‐time capital costs. The contribution of the Central Government at 85 % of the total cost would be around Rs 25667 crores for the entire Plan period.

Conclusion:

It was good to read that Ms. Nata Menabde, WHO country-head, India in her interview to ‘The Financial Express’ dated December 7, 2011 said, “We at WHO have been fortunate enough to be consulted on this (UHC). The meeting at planning commission was very productive and positive and we think the recommendations on the road map to Universal Health Coverage in the country is a step in the right direction.”

UHC, I reckon, will also be able to address simultaneously the critical issue of high ‘out of pocket’ healthcare expenses by the common man of the country. Implemented sooner ignoring the motivated stalling tactics, if any, by the vested interests, could usher in an era of a new healthcare reform process in the country.

That said, the proposal of the UHC in its current form does have some ‘loose knots’,which should be appropriately tightened-up through informed public discourse by the stakeholders in the healthcare space of India, sooner.

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.