Define And Adapt To Reality: Two Pivotal Pharma Leadership Skills For Sustainable Excellence

Posted on April 10, 2017 by Tapan Ray

Max DePree – a much quoted American businessman and author had once said: “The first responsibility of a leader is to define reality.”

While defining the reality within the drug industry today, it makes many industry leaders to ponder, despite so much of the good work done by the industry in various fields of pharma business, across the world, including India, why is the public perception on the overall leadership of this sector still so negative, and continue going south? Pharma leaders know the reasons too, but they seem to be still searching for the right set of answers without breaking the traditional mold of business.

Around end 2007, being concerned with this trend, the then Chairman of Eli Lilly reportedly expressed publicly what many industry observers have been saying privately for some time. He said: “I think the industry is doomed, if we don’t change”.

On the general apathy of breaking the traditional mold after having defined the business reality, an interesting article titled, “Healthcare Leadership Must Shift From A Cottage Industry To Big Business”, published on June 2, 2014 in Forbes, made some interesting observations, which are as relevant to India, just as many other countries of the world.

The article states that the ‘Healthcare Leadership’ has not kept up with the industry’s evolution to big business over the past 25-30 years – nor does it possess the required change management competencies to effectively lead and rapidly turn around an adaptive health care business model. Thus, unlike many other knowledge industries, pharma sector is still struggling hard to convert the tough environmental challenges into bright business opportunities. This leads to an important question: Being mostly inward looking, are these leaders failing to properly define reality around them, and therefore, not adapting to the critical external business environmental needs, soon enough?

Is current pharma leadership too inward looking?

From the available details, it appears that today, many inward-looking pharma leaders tend to ignore many serious voices demanding access to high quality medicines at affordable prices, especially for life threatening ailments, such as, cancer. Instead of engaging with the stakeholders in search of a win-win solution, global pharma leadership apparently tries to push the ball out its court with a barrage of mundane and arrogant arguments highlighting the importance of ‘drug innovation’ and hyping how expensive it is. Notwithstanding that by now, many people are aware of its frequent use, generally by the global pharma players, mostly as a veil, whenever required. Even then, many pharma leaders, instead of accepting the reality, continue to remain insensitive to the concerns not just of most patients, but other stakeholders and their respective governments also. This mindset further reinforces their inward-looking and self-serving image. This brings to the fore the key issue: Is this high time to pass the baton to a new breed of pharma leaders?

In the above backdrop, this article dwells on some intrinsic issues involved with the leadership puzzle of the industry, as it were. Thereafter, it deliberates on the importance of making some easy self-tests available to the young and especially the millennial pharma professionals, to facilitate them to self-discover themselves in this space, and that too at an early stage of their professional career, as they try to understand and define the business and environmental realities facing the industry.

Leadership skills are difficult to find:

Focusing on the pharma industry, I would say, especially in the pharma sector, leadership skill in all its functional areas though is considered as the most important one, but are equally challenging while identifying the right persons.

The 20^th Pharma CEO Survey, March 2017 of PwC, vindicates this point. The survey covered 89 pharma CEOs from 37 countries. Nearly all the Pharma CEOs participating in this survey picked out leadership as the most important for their organization, giving it the top spot, closely followed by problem-solving, creativity and innovation, all bracketed in the second, with collaboration and adaptability occupying the equal third rank, as follows:

Relative importance of skills in pharma industry	Skill sets	Respondents answering somewhat difficult or very difficult to get each one of these
1.	Leadership	79
2.	Creativity & Innovation	75
3.	Emotional intelligence	72
4.	Adaptability	63
5.	Problem-solving	55

Over two-thirds of the CEOs face difficulty in recruiting people with the requisite skills that they consider most important to their organization, such as, leadership, problem-solving, and creative skills, the report highlighted. For further deliberation hereunder, I shall pick up the top one – the leadership skill for the pharma industry, as I see it.

The age-old question – ‘Are leaders born or made?’

A critical question that is often asked even today – ‘Are leaders born or made?’ The question keeps coming as some enthusiasts continue to argue that successful leaders are born with visible or apparently invisible leadership traits.

Are leaders born?

To answer this question, let me quote an example. The Management Study Guide (MSG), well-articulated an approach to the study of leadership known as the ‘Great Man Theory’, giving examples of the great leaders of the past, such as, Alexander the Great, Julius Caesar, Napoleon, Queen Elizabeth I, Abraham Lincoln and Mahatma Gandhi. They all seem to differ from ordinary human beings in several aspects, possessing high levels of ambition coupled with clear visions of precisely where they want to go.

Added to these examples are many top business executives, sports personalities, and even contemporary politicians, who often seem to possess an aura that sets them apart from others. These persons are cited as naturally great leaders, born with a set of personal qualities that made them effective leaders. Thus, even today, the belief that truly great leaders are born, is not uncommon. Thus, according to the contemporary theorists, leaders are not like other people. They do not need to be intellectually genius or omniscient prophets to succeed, but they should certainly have the ‘right stuff’, which is not equally present in all people, MSG highlights.

Even today, some continue to believe in the ‘Great Man Theory’, regardless of many well carried out research studies of the behavioral scientists establishing that it is quite possible for individuals becoming leaders through various processes, such as, self-learning, keenly observing or working with some good leaders, following their advices, training, and practicing the experiences thus gained in one’s real life.

Are leaders made?

Just as above, to answer this question, as well, I would cite another important example.

A September 21, 2016 article titled, “What Science Tells Us About Leadership Potential”, published in the ‘Harvard Business Review (HBR)’, while answering the question ‘who becomes a leader’, stated as follows:

“Any observable pattern of human behaviors is the byproduct of genetic and environmental influences, so the answer to this question is ‘both’. Estimates suggest that leadership is 30%-60% heritable, largely because the character traits that shape leadership - personality and intelligence - are heritable. While this suggests strong biological influences on leadership, it does not imply that nurture is trivial. Even more-heritable traits, such as weight (80%) and height (90%), are affected by environmental factors. Although there is no clear recipe for manipulating the environment in order to boost leadership potential, well-crafted coaching interventions boost critical leadership competencies by about 20%–30%.”

What would a young pharma professional do in this situation?

The current breed of top leaders would continue grooming and promoting mostly those who fit their profile, while in the family owned businesses succession usually takes place from within the family. The situation is no different in the pharma industry. However, various studies indicate that millennial professionals with leadership traits will develop themselves.

Keeping this in mind and, at the same time, going by the above HBR article, I would tend to accept the dictum that, “Any observable pattern of human behaviors is the byproduct of genetic and environmental influences”. Thus, for identifying and then honing leadership skills in the pharma business, just as many other industries, I would prefer the process of dovetailing the heritable leadership traits with various environmental influences.

An ambitious pharma professional with high aspiration to make a difference in the organization that the individual represents, would obviously wonder what the way forward for him to achieve the goals. In my view, an honest self-test is the first and basic move in this direction.

The self-test:

Taking a cue from the article titled “Strategic Leadership: The Essential Skills”, published in the January-February 2013 issue of The Harvard Business Review (HBR), I would suggest that the young professionals may wish to ask themselves the following important questions:

Do I have the right networks to help myself see opportunities before competitors do?
Am I comfortable challenging my own and others’ assumptions?
Can I get a diverse group to buy into a common vision?
Do I learn from mistakes?

The answer to each of these ones should be clear and honest, as one doesn’t need to disclose those answers to anyone else. Nonetheless, by following this process, a young professional gets a clear view of where he or she stands in each of these important areas, which cover some of the basic traits of a leader.

The leadership package:

Irrespective of whether an individual has some heritable leadership traits or not, the above self-test would reveal a person’s strengths and weaknesses, help address the deficits and optimize the full portfolio of leadership skills, independently or otherwise.

Nevertheless, it is important to bear in mind, as several research studies have already established, though leadership skills are important and difficult to find, a few other salient skills such as, ability to apply in real life a creative and innovative mindset, supported by high emotional intelligence or emotional quotient (EQ) are also critical. This is because, together these offer the all-important leadership package for an all-round successful leader.

Should pharma leadership be eclectic?

I guess so, as there does not seem to be any better alternative either. Thus, I reckon, traditional pharma leadership needs to be eclectic. It has still got a lot to learn from other industries too. Let me give a relevant example here – to speed up development of electric cars by all manufacturers, the Cofounder and Chief Executive Officer Elon Musk of Tesla Motors has reportedly decided to share its patents under ‘Open Source’ sharing of technologies with all others. Elon Musk further reiterated: “If we clear a path to the creation of compelling electric vehicles, but then lay Intellectual property (IP) landmines behind us to inhibit others, we are acting in a manner contrary to that goal.”

In the important ‘green’ automobile space, this is indeed a radical, gutsy and an exemplary decision to underscore Tesla Motor’s concern about global warming.

Why such type of leadership is so rare in the global pharma world, even today? Besides sanctimonies, as these appear, why the global pharma leaders are not taking similar large scale initiatives for drug innovation, especially in the areas of difficult diseases, such as, Cancer, Alzheimer’s, Multiple Sclerosis and Metabolic disorders, just to name a few? For this purpose, pharma organizations would require mettlesome change agents who can break the traditional mold –new leaders of the millennial generation having a different business outlook altogether, could possibly do so.

Becoming a change agent:

Today, more than ever before, the ultimate goal of pharma leaders requires moving beyond making more money to satisfy the shareholders and stock markets. It also needs to include the requirements of society, in general, more than what mandatory CSR demands. This is palpable today, as many stakeholders vehemently questioning the business game plan of many pharma players. Would this situation change? I don’t know, but it should, which prompts a change in the overall quality of pharma leadership, at all levels. I have had reason to believe that a good number of bright, millennial pharma professionals look for empowerment to discover themselves early. Right at that stage, they also need to chart a road map for self-development, which would facilitate attaining their professional goals, quite in sync with the broad societal expectations, as they move on in life.

New pharma leadership would require greater focus on ethics and engagement:

While pharma industry leaders, in general, have been impressive articulators of all right things that need to happen, ‘Talking the Talk’ and ‘Walking the Walk’ in the frontiers of business ethics, values and shared goals are found wanting in many of them. These articulations are probably used to run expensive global ‘Public Relations (PR)’ campaigns, lobbying and advocacy initiatives in the corridors of power.

What else then could possibly be the reason for such perception gap that this great industry has allowed to increase, over a long period of time? Could it be that many pharma leaders have not been able to adequately adapt themselves to the demands of the changing healthcare environment and the needs of various stakeholders in this sector? Is the leadership, therefore, too archaic and it’s a time for a change?

Thus, unlike the current pharma leadership, the new age leadership needs to be ethically grounded, and engage all stakeholders effectively in a transparent manner with impeccable processes of governance involving all areas of business. Such leaders may not be know-all individuals in the pharma business, but must possess a clear vision of where they want to lead the company to, and don’t slip back, especially in terms of public image and meeting patients’ expectations.

In conclusion:

Pharma business in modern times faces rapidly changing stakeholder expectations, which are generally difficult to predict well in advance. Thus, today’s pharma leaders require to adapt their strategic approach and the tactical game plans accordingly for business excellence in an inclusive manner, and simultaneously try to shape the environment to the extent possible.

There is a growing expectation from the pharma leaders to do business by imbibing a caring outlook towards the society, where it operates. Spending time and money to transplant the past practices in the changed environment, or continuing with the traditional business approaches, I reckon, is a no-win game today.

Thus, there arises a need to help the young pharma professionals, from the early stages in their professional life, for shaping up as the chief change agent in the organization that they would lead. Even after reaching where they wanted to reach, these leaders should keep studying on a continuous basis, various other successful leadership styles, approaches and visions, to splice them into a more productive strategic approach for the business or functional areas that they lead.

This new breed of leaders would also require defining the reality prevailing in the industry on an ongoing basis, to pave the way for a glorious future for their respective organizations. This effort would call for regular and effective engagement with all the stakeholders through various digital and other platforms. The critical question that the new pharma leadership should never forget to continually ask themselves: “How can my organization provide better access to high quality and effective medicines to most patients along with achieving commercial excellence in business?”

Properly defining and quickly adapting to associated environmental realities with a creative mind, requisite emotional intelligence and ethical business practices, would call for coming out of the zone of comfort with promptness. These, I reckon, would be the two pivotal success factors for new pharma leaders for inclusive and sustainable success in business, as the industry moves on.

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.

MDGs Break Ground For SDGs: Is India Poised To Achieve The Health Goals?

Posted on April 3, 2017 by Tapan Ray

The Millennium Development Goals (MDGs) were placed in the pages of history amid several other remarkable global initiatives of the United Nations (UN), as the timeframe for achievement of these targets got over in 2015.

In 2000, the leaders of 189 countries signed this historic millennium declaration at the United Nations Millennium Summit for improving the lives of the world’s poorest people. Eight MDGs, were agreed upon by its members, each one supported by 21 specific, measurable targets and more than 60 indicators with clear deadlines, as a concerted global movement in this direction. The eight goals spanned across the areas of poverty alleviation, providing universal primary education, ensuring gender equality, preventing child mortality, meeting maternal health needs, protecting the environment and entering various global partnerships, with a target achievement date of 2015.

Did the glass remain ‘half-full’ or ‘half-empty’?

At the end of 2015 the UN reportedly called the MDGs ‘the most successful anti-poverty movement in history’. However, it could probably be a matter of looking at this glass either as ‘half-full’ or ‘half-empty’.

An interesting article published in the international daily ‘The Guardian’ on July 06, 2015, highlighted some hits and misses of MDGs from the global perspective.

Globally, several goals of the MDGs have not been made for various reasons. Focusing on health-related areas, I find, though the child mortality rate has reduced by more than half over the past two and a half decades from 90 to 43 deaths per 1,000 live births, its MDG target of an expected decline by two thirds could not be achieved. Similarly, the global maternal mortality ratio despite falling by nearly half, was far short of its aim of a two-thirds reduction. Likewise, despite the reduction of the number of new HIV infections by around 40 percent between 2000 and 2013, its MDG goal of halting and beginning to reverse the spread of HIV/Aids by 2015 has not been met.

The overall status in India:

According to the United Nations in India, in the above focus areas, the country has made some progress in reducing its under-five mortality rate, which declined from 125 per 1,000 live births in 1990 to 49 per 1,000 live births in 2013; maternal mortality rate also declined from 437 per 100,000 live births in 1990-91 to 167 in 2009.

India recorded significant progress in reducing the prevalence of HIV and AIDS across different types of high-risk categories, with adult prevalence reducing from 0.45 percent in 2002 to 0.27 percent in 2011. However, a quarter of global TB cases still occur in India with nearly 2.2 million people are diagnosed with the disease annually, and an estimated 220,000 die as a result.

MDGs and India’s achievements:

Coming now to target versus achievements, the Millennium Development Goals India Country Report 2015 released by the Ministry of Statistics & Program Implementation (MoSPI) in February 2015, states that India had put considerable emphasis on all the MDGs with significant progress. Although the nation could meet targets of some of these well ahead of the 2015 deadline, overall, only six of the 18 targets adopted as part of the eight goals in 2000 have been fully met. However, according to another report brought out by the U.N. Economic and Social Commission for Asia and the Pacific, India has met only four of the eight MDGs.

As per Sample Registration System 2013, though the overall reduction of Under 5 Child Mortality Rate (U5MR) was nearly 60 percent happened during 1990 to 2013, India had missed this target.

Similar were the performances for a reduction in the Infant Mortality Rate (IMR) and the proportion of one year old children immunized against measles and improving the Maternal Morality Ratio (MMR). However, the prevalence of HIV among pregnant women aged 15-24 years showed a declining trend and incidence of Malaria also came down. Thus, it appears that the progress made and the achievements recorded in India against MDG targets are indeed a mixed bag.

The same question, therefore, logically follows for India too: Has the glass become ‘half-full’, or remained half-empty post MDG efforts?

MDGs break ground for ‘Sustainable Development Goals (SDGs)’:

The MDGs comprising of eight goals to eradicate extreme poverty, were indeed a laudable concerted global initiative of the United Nations. It could reportedly bring over a billion people out of extreme poverty. According to ‘United Nations (2015): The Millennium Development Goals Report’, during the period of 1990 to 2015, extreme poverty fell in developing countries from 47 to 14 percent. Similarly, the proportion of undernourished people fell by almost half, with almost similar decline in the child and maternal mortality rate. Nevertheless, communicable diseases, gender/income inequalities and striking disparities between rural and urban areas continued to persist with the world’s poor remaining overwhelmingly concentrated in several areas.

Thus, learning valuable lessons and significantly benefitting from them, MDGs broke ground for the next logical global initiative in this genre. As the time-frame for implementation of MDGs got over in 2015, the global leaders on the same platform of the United Nations followed it through with the newly developed ‘Sustainable Development Goals (SDGs)’ in the same year.

While aiming to make the outcomes of the new drive more sustainable with a focus on the environmental goals, SDGs did not altogether jettison some of the unfinished agenda of MDGs – mainly for continuity. Unlike MDGs, SDGs are targeted primarily to the developing, least developed and poorest countries. Nevertheless, all member countries of the UN require participating, fund and actively contribute in achieving SDGs targets, no matter how developed they are.

While MDGs had only 8 goals, 21 targets and 63 indicators, SDGs are a set of 17 goals and 169 targets that all 193 UN Member States, including India have committed to achieve between 2016 and 2030. Importantly, though MDG targets were adopted in 2002 and got over in 2015, its effective time span for achievement was of 25 years, as the baseline data used were for the year 1990 with some subsequent revisions. Whereas the baseline for SDGs starts from 2015 estimates, which may be revised to actual figures as and when these are made available.

Health goals in SDG:

Health has a central place in SDG 3 to ‘ensure healthy lives and promote well-being for all, of all ages’. Briefly speaking, it commits itself to a global effort to eradicate epidemics of both communicable and non-communicable disease and strengthen health systems’ capacity, ensuring Universal Health Coverage (UHC), along with making medicines and vaccines affordable to all. In addition, SDG 3 clearly focuses on mental health issues with suicide being the second leading cause of death globally between the ages of 19 to 25. It also aims at reducing the numbers of deaths and illnesses caused by air, water, and soil pollution and contamination, significantly.

Towards further enhancing public policy efforts, SDG 3 emphasizes on strengthening the implementation of the WHO Framework Convention on Tobacco Control; supporting the research and development of vaccines and medicines; substantially increasing health financing; the recruitment, development, training, and retention of the health workforce; and strengthen early warning, risk reduction, and management of health risks. Besides, a few targets falling under other different goals are also linked to the health goal of SDG 3, in various ways.

SDG 3 targets:

According to the ‘Resolution adopted by the General Assembly on 25 September 2015’ on ‘Transforming our world: the 2030 Agenda for Sustainable Development’, SDG 3 lays down nine key targets, as follows, though a few of which overlap with the MDGs:

Reduce the global maternal mortality ratio to below 70/100,000.
Reduce neonatal mortality to below 12/1,000 and U5MR to below 25/1,000.
End the epidemics of AIDS, tuberculosis, malaria, and neglected tropical diseases and combat hepatitis, waterborne diseases, and other communicable diseases.
Reduce by one-third premature mortality from non-communicable diseases.
Strengthen the prevention and treatment of substance abuse.
Halve the number of global deaths and injuries from road traffic accidents (by 2020).
Ensure universal access to sexual and reproductive health care services.
Achieve universal health coverage.
Reduce the number of deaths and illnesses from hazardous chemicals and air, water, and soil pollution and contamination.

Is India poised for it now?

This is indeed a critical question. I guess, no one can just yet vouch, with a great degree of certainty, what exactly would India ultimately achieve against the SDG 3 targets. That said, I reckon, India has now all its success ingredients in place. Let me deliberate on just a few broad but very important ones out of all those, as hereunder:

With the announcement of the National Health Policy 2017 (NHP 2017) and commitment to the same by none other than Prime Minister Modi himself, focusing on public health has now been recognized as one of the critical ingredients for the future economic prosperity of India. Hence, there is a fair chance now that the nation’s public health expenditure as a percentage of GDP would be gradually raised from around 1.2 percent to 2.5 percent – expectedly by 2020, bringing health in the core development agenda of both the Central and the State Governments.

The unfinished task of achieving MDGs needs to be completed faster, driven by its ongoing momentum. The national and the respective States-specific goals, along with a clear roadmap to achieve the targets within the specified time-frame, outlining the success indicators for each deliverable, assigning accountability to designated individuals with a periodic review system for the same, needs to be put in place, soon, actively encouraged by the current national development oriented Union Government, if not initiated already.

The process of implementation of the Universal Health Coverage (UHC), as enunciated in the NHP 2017 should be hastened. This is necessary to bring the entire population, without any discrimination whatsoever, as the beneficiary of this movement.

Scaling up the capacity building process at a much faster pace for the entire public health infrastructure and service delivery systems, along with skill development programs need to be placed at the center stage of the public health agenda of India, to bring SDG 3 to fruition.

Strategic involvement of private players and the credible NGOs to achieve SDG 3 targets would help move faster to ultimately experience the sense of a great public health related achievement for all concerned within, and probably outside the country, as well.

In conclusion:

As MDGs break ground for SDGs, India seems to me quite poised to achieving its health goals.

Moving towards this direction will invite a sharp focus on addressing the non-communicable diseases, as well, while accelerating the ongoing efforts on maternal and child health, and nutrition.

It goes without saying that meeting SDG 3 targets will require adequate public investments for health, besides a well-crafted and time-bound public health policy, charting a clear roadmap for the same. The current Union Government now appears to have committed to both, putting its National Health Policy 2017 in place.

Once these goals are attained, it will enable India to clearly ‘Ensure healthy lives and promote well-being for all, at all ages’. In that process, a new India will be created where all essential public health related needs and demands of all, irrespective of their socioeconomic status, will be expeditiously taken care of, delivering with precision high quality of products and services.

Hopefully, the transformed India would then demonstrate to the world, as someone had said before, it’s just not a matter of ‘more money for health, but also more health for money’.

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.

National Health Policy 2017: Some Silver Linings, Some Trepidation

Posted on March 27, 2017 by Tapan Ray

In September 2016, the Supreme Court directed the Indian Government to finalize the ‘National Health Policy (NHP)’ guaranteeing ‘assured health services to all’, a draft version of which was already made available to the public on December 30, 2014.

In its order the Apex Court had said: “In case the Union of India thinks it worthwhile to have a National Health Policy, it should take steps to announce it at the earliest and keep issues of gender equity in mind.”

After a wait of over two years, on March 16, 2017, the Union Cabinet approved the final version of the National Health Policy 2017 (NHP 2017) for implementation. The tough socioeconomic distress of the general population related to health care, fueled by near collapsing public health care delivery system when private health care providers are becoming more and more expensive, prompted the current Government to initiate drafting yet another new ‘Health Policy’, with a gap of around 15 years.

NHP 2017 covers a gamut of subjects while articulating its primary aim, which is to inform, clarify, strengthen and prioritize the role of the Government in shaping health systems in all its dimensions. These are investments in health, organization of health care services, prevention of diseases and promotion of good health through cross sectoral actions, access to technologies, developing human resources, encouraging medical pluralism, building a knowledge base, developing better financial protection strategies, strengthening regulation and health assurance.

In this article, primarily for greater clarity in understanding by the readers, I shall start with the reasons of my trepidation and then focus on the silver linings of the NHP 2017.

Some trepidation:

While explaining the reasons for my trepidation, I shall go back to what I said even before. Over several decades, many of us have tried to ferret out the reasons of giving low national priority to provide access to reasonably affordable, quality public health care to all its citizens by the successive Governments in India but in vain. The quest to know its rationale becomes more intense, as we get to know, even some developing countries in Asia, Africa and Middle East are taking rapid strides to catch up with the health care standards of the developed countries of the world.

In the last few years, many such countries, such as, Thailand, Turkey, Rwanda and Ghana, besides China, have successfully ensured access to quality and affordable health care to their citizens through well-structured national initiatives. The Governments of economically poorer countries, such as, Sri Lanka and Bangladesh too are making rapid progress in this direction, protecting the most vulnerable populations in their respective countries from getting sucked into extreme poverty.

In this context, it will be worthwhile recapping that the NHP 1983, which was revised in 2002, also recommended an increase in public health expenditure to 2.0 percent of GDP in 2010. Not too long ago, in October 2010, the then Government in power constituted a ‘High Level Expert Group (HLEG)’ on Universal Health Coverage (UHC) under the chairmanship of the well-known international medical expert Prof. K. Srinath Reddy. The HLEG was mandated to develop a framework for providing easily accessible and affordable health care to all Indians. The HLEG Report defined UHC as follows:

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

That said, the reality is, even in the Union budget for 2017-18, the public spending on health keeps hovering around abysmal 1 percent of the GDP. The Union Budget Allocations for several critical health related programs have either remained just around the same as before, or have declined, in real terms. Almost similar trend is noticed in the States, as well. For example, according to the latest Maharashtra State Budget for 2017-18, the State has decided to spend much less on its medical and public health sector schemes in the forthcoming financial year.

Thus, leaving aside implementation of the most critical 1983 NHP goal of providing “Health for all by the year 2000 A.D”, even in 2017 India continues to grapple with the same sets of challenges for ensuring adequate availability, accessibility, affordability, and high quality of comprehensive health care for all.

Some silver linings:

Let bygones be bygones. Let me now focus on the silver linings of the NHP 2017.

Besides gradually raising public expenditure for health care from the current around 1.2 percent to 2.5 percent of GDP, following are examples of some silver linings as I see enshrined in several key objectives of the new health policy, besides several others:

Progressively achieve Universal Health Coverage: Assuring availability of free, comprehensive primary health care services; ensuring improved access and affordability, of quality secondary and tertiary care services through a combination of public hospitals and the strategic purchasing of services in health care deficit areas, from private care providers, especially the not-for profit providers; achieving a significant reduction in out of pocket expenditure due to health care costs with reduction in proportion of households experiencing catastrophic health expenditures and consequent impoverishment.

Reinforcing trust in Public Health Care System: Strengthening the trust of the common man in the public health care system by making it predictable, efficient, patient centric, affordable and effective, with a comprehensive package of services and products that meet immediate health care needs of most people.

Align the growth of the private health care sector with public health goals: Influence the operation and growth of the private health care sector and medical technologies to ensure alignment with public health goals.

Achieve specific quantitative goals and objectives: These are outlined under three broad components viz. (a) health status and program impact, (b) health systems’ performance and (c) health system strengthening. These goals and objectives are aligned to achieve sustainable development in the health sector in keeping with the policy thrust.

I was encouraged to note a few more silver linings, especially the following ones, from various different areas of the NHP 2017, which:

Intends to achieve the highest possible level of good health and well-being, through a preventive and promotive health care orientation, besides its emphasis on allocating up to two-thirds or more of resources to primary care followed by secondary and tertiary care.

Plans creation of Public Health Management Cadre in all States to optimize health outcomes and National Health Care Standards Organization to maintain adequate standards in public and private sector.

Advocates extensive use of digital tools for improving the efficiency and outcome of the health care system by creating a National Digital Health Authority (NDHA) to regulate, develop and deploy digital health covering the entire process of health care, besides encouraging the application of the ‘Health Card’ for access to a primary health care facility and services anytime, anywhere.

States that Health Technology Assessment (HTA) is an important tool to ensure that technology choice is not only participatory, but also guided by considerations of scientific evidence, safety, cost effectiveness, social values; and commits to the development of an institutional framework and required capacity for HTA’s quick adoption.

Assures timely revision of the National List of Essential Medicines along with the appropriate price control.

Promotes compliance to right of patients to access information on condition and treatment.

The high and low points in NHP 2017:

As I see it, following are - just one each - the most critical high and low points in NHP 2017:

A high point:

NHP 2017 making a categorical promise to increase public health spending to 2.5 percent of GDP in a time-bound manner, guaranteeing Universal Health Care (UHC), is indeed not just encouraging, but also a high point in its silver linings. This is because, without adequate Government spending in this area, it’s just not possible to give shape to UHC, however robust a national health policy is on paper.

A low point:

The draft version of the NHP 2017 had proposed making health a fundamental right for Indian citizens – quite like denial of health is an offence, and reiterated on enactment of this law as follows:

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

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

Thus, one of the lowest points or most disappointing aspects of the NHP 2017, as compared to its draft version, is the absence of the intent of having a National Health Rights Act. This change makes UHC yet another promise, just as before, without any strong legal backing. As many experts believe, when legal rights and mechanisms institutionalize collaborative goals, methods, and service delivery, they create legally binding duties. Government agencies, patient advocates, and the public can invoke such laws to urge collaboration and seek required public health care services, as promised, always.

The reason behind general expectations for the National Health Rights Act, is mainly because previous National Health Policies also assured ‘health for all’ within a given time-frame. The same promise was also carried through by various successive Governments in the past, but did not come to fruition. Nothing has changed significantly on the ground related to public health care, not just yet. Hence, exclusion of the proposed section of this Act in the final version of the NHP 2017 is a low point for me.

The trepidation lingers. Will it be or won’t it be, yet another repetition of the Government promises made through NHPs or otherwise, is the moot question now.

In conclusion:

Specific time frame for achieving most of these policy objectives and intents are still awaited.

Nonetheless, while a robust health policy for a new India, and a commensurate increase in Government spending on public health is much warranted, building a well integrate, comprehensive and accountable health infrastructure that will be sensitive to public health care needs of the country, should assume top priority today.

There exists an 83 percent shortage of specialist medical professionals in the Community Health Centers (CHCs) of India, according to the Rural Health Statistics 2015 released by the Ministry of Health & Family Welfare, which was reported by IndiaSpend on September 21, 2015. Again, on February 27, 2016, quoting similar Government Data, IndiaSpend reported that public-health centers across India’s rural areas – 25,308 in 29 states and seven union territories – are short of more than 3,000 doctors, the scarcity rose by 200 percent (or tripling) over 10 years.

Other sets of similar data on the grossly inadequate number of doctors, nurses, paramedics and hospital beds per thousand population in India, coupled with frugal rapid transportation facilities in the vast and remote areas of the country, send a clear signal that capacity building in these areas can’t wait any longer. It has been always essential, but did not feature in the ‘to-do’ list of the Government, until now. In that sense, silver linings in the NHP 2017 open the door of great expectations, especially for UHC, despite some trepidation.

Reasonably well-crafted and robust NHP 2017, needs to be integrated with similar initiatives of the States, soon. Effective implementation of a comprehensive, well-integrated and time-bound health care strategic plan, with requisite budgetary allocations having a periodic review process and assigning specific accountabilities to individuals, are the needs of the hour. Otherwise, the social and economic consequences of the status quo in the health care space of India, would impede the sustainable growth of the nation, seriously.

To progress in this direction, the prevailing status-quo must be disrupted, now – decisively and with a great sense of urgency. It is imperative for the Government to make each one of us not only to believe it, but also experience the same in our everyday life. It is important for all concerned to remember what none other than Prime Minister Modi tweeted on March 16, 2017: “National Health Policy marks a historic moment in our endeavor to create a healthy India where everyone has access to quality health care.”

The National Health Policy 2017 is in place now, this is the time to walk the talk!

By: Tapan J. Ray

Digital Divide And Indian Pharma Industry

Posted on March 13, 2017 by Tapan Ray

Over the last one and half decades of this new millennium, despite making significant headway in digital literacy, fueled by consistent progress in the penetration of broadband Internet and availability of more affordable smartphones, a large section of Indian population is still not digitally literate, not even in its importance and awareness, creating a sharp digital divide in the country.

This populace with inadequate or no digital literacy spans across a large section of our society, such as those who are generally poor, many living in rural areas, or lacking in adequate digital awareness, or exhibiting strong preferences in adhering to traditional approaches of doing things, or differently abled individuals, and many elderly persons.

In the health care arena, this citizenry constitutes one of the most vulnerable segments of the society often posing serious health risks, and mostly unable to make use of various digital tools while availing several social sector benefits of the government, as and when required.

However, more concerning is the fact that this gap is not just quite significant, there does not seem to be any near-term possibility of bridging it, either, as all accompanying responsibilities now lying on the government alone. Effective measures to bridging this gap do not depend on just technology, as the issue is multidimensional in nature, necessitating participation of all the stakeholders, pharma included – for a quantum leap in the business growth too.

This should not go unnoticed and unappreciated. Addressing this scenario effectively would call for a different strategic approach – not the usual run of the mill type ad hoc measures, both by the government, and in healthcare, also by the pharma marketers. In this article, I shall dwell in this area.

What it means?

In the modern era, the term ‘digital divide’ broadly refers to the gap between demographics and regions that have access to modern Information and Communications Technology (ICT), and those who don’t or have restricted access to it. Post late 1990s, this terminology is primarily used to describe the split between those with and without Internet access, particularly broadband.

In the global perspective, according to ‘Tech Target’ – the global network of technology-specific websites, the ‘digital divide’ typically exists between those in cities and those in rural areas; between the educated and the uneducated; between socioeconomic groups; and between the more and less industrially developed nations. Even among populations with some access to technology, the digital divide can be evident in the form of lower-performance computers, lower speed wireless connections, lower-priced connections, such as dial-up, and limited access to subscription-based content. The report also points out, while adoption of smartphones is growing, even among relatively lower-income groups, the cost of various data plans and the difficulty of performing tasks and transactions on smartphones continue to inhibit the closing of the gap.

To a large extent, this is applicable to India, as well.

It’s not just a technological issue:

Bridging the ‘digital divide’ in health care is not just a technological issue. It’s rather a complex one with many dimensions. It also depends on the health literacy of individuals, or a society, or the location where they live in. The World Health Organization (WHO) defines health literacy as: ‘The cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand, and use information in ways which promote and maintain good health.’

This is not just the ability of a person to understand the health messages, it also involves the individual’s ability to look for the required information, and taking further action accordingly. As a December 2016 study of Michigan State University Extension concludes, those who are more likely to experience low health literacy are, older adults, racial and ethnic minorities, people with less than a high school diploma, people with low income levels, facing language issue for communication and those with compromised health status, such as chronic health conditions. Culture and access to resources also affect people’s health literacy. Another October 2016 study published in the Journal of Medical Internet Research, establishes the connection between low health literacy and the skepticism on health technologies.

Effectively bridging ‘digital divide’ alone, may not resolve the issue of health literacy. Neither, just addressing the health literacy can bridge the gap of ‘digital divide’, effectively. Thus, there isn’t any ‘one size fits all’ type of solution, to address both these issues, for a synergistic outcome in improving affordable access to quality health care for all.

Bridging the ‘Digital Divide’:

That said, bridging the digital divide, especially in the healthcare segment, has immense relevance in the modern days. As PwC’s Global Digital IQ Survey report of May 2016 observes, health care is arguably one of the world’s most information-intensive sectors, and the opportunities to improve quality, encourage affordability and enhance the consumer experience are vast. Wider application of digital technology can help this sector tackle many of these pressing challenges, effectively. However, the sector is currently behind the curve, the report highlights.

According to another 2016 report by PwC on Indian healthcare, the digital connectivity of the country is expected to grow from 15 percent access in 2014 to 80 percent access in 2034, with rural Internet users increasing by 58 percent annually, which presents a great potential for telemedicine and remote diagnosis in the country. This is indeed encouraging.

Can pharma industry hasten the process?

As I said before, bridging the ‘digital divide’ and improving health literacy, may be construed by many as a primary responsibility of the Indian government, through various robust initiatives backed by allocated budgetary provisions. Nonetheless, in the realm of healthcare, I reckon, pharmaceutical and other related industries can significantly help hastening the process, not just as a social responsibility, but for significant growth in businesses, simultaneously creating a win-win situation for all.

Just to cite an example out of many, various pharma companies can set up ‘digital health information kiosks’ especially in those areas where awareness and participation of the local population related to healthcare issues are poor or suboptimal. These ‘digital health information kiosks’, providing various diseases or treatment related information that a pharma company may be interested in, can be set up at convenient locations, of course, with the approval of local authorities. Such information, should encourage people to seek more and more health information digitally, explaining the whole process, and at the same time persuading them to take available disease prevention measures. and advising them to visit doctors, to initiate early treatment, wherever necessary.

I repeat, this is just an illustration, there could several other ways of achieving the same result.

Increasing relevance:

For healthcare, the above trend would mean empowering most of the population to have unfettered access to knowledge in various health related fields, especially in prevention, management and available treatment options, for various diseases, encompassing both acute and chronic conditions. Thus, this process has the potential to create a significant snowballing effect, not just on

deeper penetration of telemedicine, but also on remote diagnosis in India. In tandem, leveraging this trend early enough and in innovative ways, is likely to enable the pharma players to provide a much-needed boost to their respective business ventures.

Advantage pharma:

Rapid transformation in the complex market dynamics, coupled with increasing challenges in making productive face to face interaction with important doctors for prescription generation and consequent fast decline in the economic outcome of traditional product detailing, is likely to hasten this metamorphosis. On the other hand, this change also brings a blessing in disguise for the pharma players, by opening many new doors of opportunity based on digital platforms, and thereby paving the way for reaping a rich harvest, for all those who will choose to be early adopters.

In the above context, intimate business involvement with the digital world in many areas, such as ‘digital sales and marketing’ assumes a high priority for Indian pharma players, just as it’s being imbibed by some global players, including many in other industries. The speed of its becoming the centerpiece in pharma sales and marketing strategy formulation process ought to be directly linked to the increasing speed of broadband Internet penetration, smart phone and other digital platform usages by people of all ages with enquiring mindsets. Thus, the destiny’s call is clearly ‘Advantage Pharma’.

Key benefits:

According to a paper of April 16, 2014, published by Salford Business School, Manchester, UK, the major benefits of ‘Digital Marketing’ are as follows:

It helps businesses to develop a wider customer base as it does not rely on physical presence or interaction.
It encourages customers to interact directly with businesses.
It is not limited by conventional opening times – customers can interact at a time and place convenient for them

Calibrated increase in usage of digital platforms:

It is worth noting, traditional methods of sales and marketing, barring a few exceptions, are currently prevailing in the Indian pharma industry. In this scenario, each pharma player, must carefully evaluate its current and future product-mix, along with customer types and base, as they would decide, first to initiate, and then to scale up their sales and marketing operations in the digital space in a well-calibrated manner.

In this new ball game, the fresh entrants would need to consider only the credible research-based data, on the rapidly changing aspirational mindset of young Indians, including doctors and patients, with smart phones being a key enabler, on the one hand. While on the other, these should provide optimal digital penetration in different geographical regions or areas, together with the usage of platforms and related demographic configurations.

For example, if a region shows high smartphone usage for community or group chat within the general population, a pharma company may explore the possibility of creatively designing a smart phone based ‘digital patient chat group’ as a part of its patient engagement initiative. In this ‘digital patient chat group’, the members suffering from chronic or even acute ailments can discuss with each other the issues for which one is seeking a solution, where even the pharma companies can intervene, wherever they can add value and is legally permissible.

The effectiveness in working out a game changing crafty blend of both brand and patient-centric communication package with digital tools would separate the men from the boys. It would demand top quality cerebral inputs from the pharma marketers – a requirement that is not so easily available in the current space of pharmaceutical marketing, dominated by a wide variety of freebies.

In conclusion:

Humongous digital divide in India is a fall out, predominantly of disparate availability and access to ICT, not just between those living in rural and urban areas, but spans across several other areas such as, between educated and uneducated people, demographic and economic classes, to name a few. Nonetheless, especially, since the last one and a half decades, the country has made significant headway in gradually reducing this gap, though a lot more ground is yet to be covered in this direction.

Today in India, we witness even various political parties, which used to be very traditional in their approaches have started using a wide variety of digital marketing tools successfully by deploying astute domain experts, to achieve their goals.

For the healthcare sector, including the pharma industry, this progress throws open many doors of opportunities, both for the public, as well as for the industry. Notwithstanding this digital divide and general prevalence of an overarching traditional behavior and response patterns, displaying visible apathy or inability to embrace the promises of the emerging cyber era, several doctors and patients have already started reaping the benefits offered by various digital platforms, tools and media. The regulators governing this sector, are also not lagging far behind, with their presence visible in the digital space too, including social media.

This challenge of change should be effectively leveraged by all stakeholders in healthcare, reaping a rich harvest. Like many other constituents in this intricate, yet interesting ball game, pharma industry too needs to assume an active, pragmatic and proactive role in several innovative ways.

Flooring the gas pedal to move into the digital space of healthcare, would provide significant competitive and commercial advantages to the early movers, more than ever before. When political narratives can be made more productive by embracing the digital platforms, why not the business narratives of the pharma industry in India?

By: Tapan J. Ray

How Cost-Effective Are New Cancer Drugs?

Posted on January 30, 2017 by Tapan Ray

The main reason why cancer is so serious a disease, is the ability of the malignant cells to spread in the body, both locally by moving into nearby normal tissue, and regionally to nearby lymph nodes, tissues, or organs, affecting even the distant parts of the body. When this happens, doctors term it as metastatic or stage IV (four) cancer.

Although most patients with metastatic tumors would eventually die of cancer, the treatment with various types of anticancer drugs, could help prolong life, in varying degree. No wonder, many new anticancer drugs now obtain regulatory approval based on their effectiveness on metastatic cancer patients. Consequently, it has now become almost a routine to administer newer anticancer drugs to patients with early stage of disease, after they have undergone surgery or radiotherapy.

But, these lifesaving drugs are expensive – very expensive! For example, a newer anticancer treatment is often priced at US$ 100,000 or more per patient, which, obviously, a large majority of the population can’t just afford.

Are these new drugs cost-effective?

To put in simple words, cost effectiveness of a drug is generally ‘expressed in terms of a ratio where the denominator is a gain in health from a measure (years of life, premature births averted, sight-years gained) and the numerator is the cost associated with the health gain.’

From this perspective, a January 2015 research study titled, “Pricing In The Market For Anticancer Drugs”, published by the National Bureau Of Economic Research of the United States observed that anticancer drugs like bevacizumab (US$ 50,000 per treatment episode) and ipilimumab (US$120,000 per episode) have fueled the perception that the launch prices of anticancer drugs are fast increasing over time.

To evaluate the pricing trend of these drugs, the researchers used an original dataset of 58 anticancer drugs, approved between 1995 and 2013, and found that launch-prices, adjusted for inflation and drugs’ survival benefits, increased by 10 percent, or about US$ 8,500, per year. This study was restricted to drugs administered with the primary intent of extending survival time for cancer patients and drugs for which survival benefits have been estimated in trials or modeling studies. The researchers did not consider drugs administered to treat pain or drugs that are administered to alleviate the side effects of cancer treatments.

The paper concluded, as compared to the older ones, newer anticancer treatments, generally, are less cost-effective. Despite this fact, the prices of these drugs are rising faster than their overall effectiveness.

How much do these drugs cost to prolong a year of life for cancer patients?

Another paper, titled “Cancer Drugs Aren’t As Cost-Effective As They Used To Be”, published in the Forbes magazine on September 30, 2015, expressed serious concern on the declining cost-effectiveness of new anticancer drugs. The author termed this trend as unacceptable, and more disturbing when providing just a year of life to cancer patients costs around US$ 350,000 to even US$ 800,000. High prices should reflect large benefits, and we need to demand value out of medical interventions – he recommended.

Do the claims of efficacy also reflect the real-world effectiveness?

Providing an answer to this question, a very recent article titled, “Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines”, published in the well reputed medical journal ‘JAMA Oncology’ on December 29, 2016, concluded as follows:

“Although innovation in the oncology drug market has contributed to improvements in therapy, the magnitude and dimension of clinical benefits vary widely, and there may be reasons to doubt that claims of efficacy reflect real-world effectiveness exactly.”

As stated above, this conclusion was drawn by the researchers after a detail study on the overall survival, quality of life, and safety benefits of recently licensed cancer medicines, as there was a dearth of evidence on the impact of newly licensed cancer medicines.

The authors analyzed in detail health technology assessment reports of 62 cancer drugs approved in the United States and Europe between 2003 and 2013, and found that these were associated with increased overall survival by an average of 3.43 months between 2003 and 2013. Following is a summary of the detail findings:

43 percent increased overall survival by 3 months or longer
11 percent by less than 3 months
30 percent was not associated with any increase in overall survival, which means almost one third of these drugs lacked evidence to suggest their increased survival rate when compared to alternative treatments
Most new cancer drugs, though improved quality of life, were associated with reduced patient safety

The researchers expect this study to support clinical practice, and promote value-based decision-making in the cancer drug treatment, besides assessing their cost-effectiveness.

Some overseas Cancer Institutes protested:

In 2012, doctors at the Memorial Sloan-Kettering Cancer Center reportedly announced through ‘The New York Times’ that their hospital would not be using Zaltrap, a newly patented colorectal cancer drug at that time, from Sanofi. This action of the Sloan-Kettering doctors compelled Sanofi to cut the price of Zaltrap by half.

Unlike India, where prices of even cancer drugs do not seem to be a great issue with the medical profession, just yet, the top cancer specialists of the American Society of Clinical Oncology are reportedly working out a framework for rating and selecting cancer drugs not only for their benefits and side effects, but prices as well.

In a 2015 paper, a group of cancer specialists from Mayo Clinic also articulated, that the oft-repeated arguments of price controls stifle innovation are not good enough to justify unusually high prices of these drugs. Their solution for this problem includes value-based pricing and NICE like body of the United Kingdom.

This Interesting Video from Mayo Clinic justifies the argument.

Was it a tongue-in-cheek action from India?

On March 9, 2012, India did send a signal to global pharma players on its apparent unhappiness of astronomical pricing of patented new cancer drugs in the country. The then Indian Patent Controller General, on that day, issued the first ever Compulsory License (CL) to a domestic drug manufacturer Natco, allowing it to sell a generic equivalent of a kidney cancer treatment drug from Bayer – Nexavar, at a small fraction of the originator’s price.

However, nothing has changed significantly since then on the ground for cancer drugs in the country. Hence, many construe the above action of the Government no more than mere tokenism.

In this context, it won’t be out of place recapitulating an article, published in a global business magazine on December 5, 2013 that quoted Marijn Dekkers, the then CEO of Bayer AG as follows:

“Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India, but for Western Patients that can afford it.”

Whether, CL is the right approach to resolve allegedly ‘profiteering mindset’ at the cost of human lives, is a different subject of discussion.

VBP concept is gaining ground:

The concept of ‘Value-Based Pricing (VBP)’, has started gaining ground in the developed markets of the world, prompting the pharmaceutical companies generate requisite ‘health outcome’ data using similar or equivalent products.

Cost of incremental value that a product delivers over the existing ones, is of key significance, and should always be the order of the day. Some independent organizations such as, the National Institute for Health and Clinical Excellence (NICE) in the UK have taken a leading role in this area.

Intriguingly, in India, public health related issues, however pressing these are, still do not seem to arrest much attention of the government to provide significant relief to a large majority of population in the country.

Conclusion:

Warren Buffet – the financial investor of global repute once said, “Price is what you pay. Value is what you get.” Unfortunately, this dictum is not applicable to the consumers of high priced life-saving drugs, such as, for cancer.

Prices of new drugs for the treatment of life-threatening ailments, such as cancer, are increasingly becoming unsustainable, across the world, and more in India. As articulated by the American Society of Clinical Oncology in 2014, this is mainly because their prices are disconnected from the actual therapeutic value of products.

Currently, a sizable number of poor and even middle-income patients, who spend their entire life’s saving for treatment of a disease like cancer, have been virtually priced out of the patented new cancer drugs market.

The plight of such patients is worse in India, and would continue to be so, especially when no trace of Universal Health Care/Coverage (UHC) is currently visible anywhere near the healthcare horizon of the country.

By: Tapan J. Ray

Mental Health Problem: A Growing Concern In The Healthcare Space Of India

Posted on January 16, 2017 by Tapan Ray

A thud!

Something fell from high above!

In no time, a bright young life of just a 32-year-old highly accomplished professional – a widely admired soul, vanished in the thin year, for good, mostly unnoticed in the quiet neighborhood, initially.

The news was more than a shock to my family. It engulfed me by the fire of impotent rage against this cruel play of destiny, where nothing can be undone, just nothing!

What prompted this so bright, successful, hugely promising and an ever-helpful-to-all guy doing what he did? No one could ferret out the answer, just yet, and possibly would never be.

Medical literatures have now established a close relationship between depression and its possible lethal outcome – suicide. Using literature data, one can estimate that 60 to 70 percent of the subjects attempting suicide were suffering from depression of various kinds. Was this young man too silently suffering from this undiagnosed and untreated mental illness?

In this article, I shall dwell on this important aspect of overall health care in India.

Depression ranks 4th in the 10 leading causes of the global burden of disease:

The World Health Organization (W.H.O) underlines: “Major depression is now the leading cause of disability globally and ranks fourth in the ten leading causes of the global burden of disease. If projections are correct, within the next 20 years, depression will have the dubious distinction of becoming the second cause of the global disease burden. Globally, 70 million people suffer from alcohol dependence. About 50 million have epilepsy; another 24 million have schizophrenia. A million people commit suicide every year. Between ten and 20 million people attempt it.”

A recent study:

Currently in India, millions of people with mental illnesses continue to remain untreated. This is vindicated by a chain of recent research studies titled, “China-India Mental Health Alliance Series”, published in ‘The Lancet’ on May 18, 2016.

The studies highlighted that: “China and India, which together contain 37 percent of the world’s population, are both undergoing rapid social changes. Because mental disorders account for a high proportion of morbidity, detailed knowledge of the mental health status of the populations in these two countries, and the evidence-base regarding the treatment of those disorders, are of paramount concern.”

“In China, mental, neurological and substance use disorders accounted for 7 percent of all (years of healthy life of the whole population) in 1990, rising to 11 percent by 2013. Similarly, in India, the proportion of all burden explained by mental, neurological, and substance use disorders rose from 3 percent in 1990 to 6 percent in 2013,” the researchers highlighted.

Greater concern in India:

In 2013, 36 million years of healthy life were lost to mental illness in China, and 31 million in India. The new research estimates that by 2025, though 36.9m years of healthy life will be lost to mental illness in China (10 percent increase), it will be 38.1m in India (23 percent increase). Anxiety and depression are the most common mental health problems among working age adults between 20 and 69 years.

Similarly, dementia is emerging as a growing mental health issue for both countries. However, from 2015 to 2025, it is estimated that the number of healthy years lost due to dementia will increase by 82 percent in India against 56 percent in China.

Interestingly, in August 2016, replying to a debate on the ‘Mental Health Care Bill’ in the Parliament, the Union Health Minister Mr. J. P. Nadda said, around 6-7 per cent of Indian population suffered from mental illnesses, while 1-2 per cent suffer from acute mental disease.

This means, over 70 million people are affected by mental illness in India, which has a close association with the rate of suicides, cardiovascular disorders, and loss of a significant number of productive days. It is estimated that around 50 percent of people with severe mental disease and around 90 percent of those with less severe symptoms, remain untreated in the country.

Depression, reportedly, the most prevalent form of mental illness that affects almost 3 to 5 percent of urban population living in cities, such as, Mumbai or Delhi. Around 30 percent of them are severely neurotic.

Alzheimer’s disease was reported to be the most common of severe disorders (54 percent) followed by vascular dementia (39 percent).

Another Government statistics indicate that 20 percent of Indians reportedly need counselling at some point of their lives. One per cent of the population suffers from serious mental health disorders, while 5-10 percent of Indians suffer from moderate disorders.

Another recent study:

Another recent report published in ‘The Lancet Psychiatry’ on 12 August 2016, captured the following details for India, in this area:

Very few population-representative data were found for mental disorders, with an average coverage of just 1 percent of the country’s population.

Major depressive disorder, anxiety disorder, and alcohol dependence were the most common mental, neurological, and substance abuse disorders, for men.

For women, anxiety disorder, major depressive disorder, and dysthymia were most common.

Human and financial resources for mental health are grossly inadequate with less than 1 percent of the national health care budget allocated to mental health in India.

Improvement of coverage will need to address both supply-side barriers and demand-side barriers related to stigma and varying explanatory models of mental disorders.

An associate professor of psychiatry at New Delhi’s All India Institute of Medical Sciences (AIIMS), reportedly said, there is just one psychiatrist for every 400,000 Indians. Apparently, he also said that there are only about 4,000 psychiatrists, 1,000 psychologists and 3,000 social workers in the entire country of over 1.2 billion people. Only 1,022 college seats for mental health professionals are set aside in India.

Or, in other words, a huge dearth of trained mental health professionals, coupled with low public investments, and fueled by high associated stigma, continue to compel many Indian populations lose many years of their lives to the illness.

Role of traditional medicines:

The study also suggests that traditional medicine practitioners, who are so common in India, “may be trained to recognize and refer patients who are at risk to themselves and others, or to advise patients against stopping their medication. Nevertheless, the authors do call for more research in this area to understand the effectiveness and potential risks of traditional medicines in the treatment and management of mental health.

Associated stigma:

It’s worth repeating, unlike many developed countries of the world, there is still a stigma associated with mental health problems in India. There are several instances of its adverse impact, not just on the social level, but also on the employment opportunities. These issues compound the treatment problem, making their public interaction too very weird at times, further increasing social polarization and inequalities.

Not a personal failure:

As the World Health Organization (W.H.O) articulates: “Mental illness is not a personal failure. It doesn’t happen only to other people. We all remember a time not too long ago when we couldn’t openly speak about cancer. That was a family secret. Today, many of us still do not want to talk about AIDS. These barriers are gradually being broken down.”

The Mental Health Care Bill:

The long-awaited ‘Mental Health Care Bill’, which after an extensive consultation process, is now awaiting the lawmakers’ formal approval for its enactment as law. The Bill, was passed by the Rajya Sabha on August 8, 2016, and is expected to be discussed in the Lok Sabha, probably in this budget session. It was first introduced on August 19, 2013, the Rajya Sabha Standing Committee report was submitted on November 20, 2013.

The bill reportedly redefines mental illness to better understand various conditions that are persistent among the population. It states that mental illness is a ‘substantial disorder of thinking, mood, perception, orientation or memory that grossly impairs judgement, behavior, capacity to recognize reality or ability to meet the ordinary demands of life’. Mental conditions related to alcohol or drug abuse are also included in the definition.

The Bill basically aims at protecting the rights of persons with mental illness and promote their access to mental health care.

One of the major highlights of the bill is decriminalization of attempt to suicide, as it states that the person attempting suicide will be presumed to be ‘under severe stress’ unless otherwise proven, and is not punishable. This move is commendable, ‘as it takes away the burden of implicating a mentally ill person in a crime that he or she had no sane control over.’ The W.H.O report on suicides (2000-2012) puts India right on top of the list in Southeast Asia. It says, the average suicide rate in India is 10.9 for every 100,00 people.

Conclusion:

Mental health has now been included in the United Nation’s ‘Sustainable Development Goals (SDG)’ at its General Assembly in September 2015. It is very likely that SDGs addressing mental health issues will become a part of country development plans and of bilateral and multilateral development assistance. This could well mean that millions of people will finally receive much needed help in this area.

Zeroing-in to India, mental health problems have since been a low priority area in the public health narrative of the country. The health information system of the country does not prioritize mental health, either.

To address this growing concern, besides forthcoming enactment of ‘Mental Health Care Bill’, the much-awaited healthcare reform of the nation, should include a transparent policy framework for mental health. A substantial number of community health workers, including traditional medicine practitioners need to be trained to deliver basic mental health hygiene and care. More serious cases, in that process, should be referred to the qualified professionals.

Mental health problems are growing at a rapid pace in India, being a cause of great concern in the healthcare space in India. It deserves to be treated like any other serious physical illness or disease, in a systematic way, backed by adequate budgetary support for affordable treatment and counselling measures, wherever required.

By: Tapan J. Ray

Awaiting The Two To Tango: Pharma Innovation And Public Health Interest

Posted on January 2, 2017 by Tapan Ray

“The rewards for the breakthrough drug discovery must be substantial, but if prices are the only mechanism through which returns on research flow, affordability will be compromised,” articulated an article titled, ‘Pharmaceutical Policy Reform – Balancing Affordability with Incentives for Innovation’, published in The New England Journal of Medicine (NEJM) on February 25, 2016.

The article arrived at this conclusion, on the backdrop of the high prices of prescription drugs becoming an issue of paramount concern, not just in the United States, but across the world. This concern is so acute that it found its way into policy proposals from both the prime candidates, in the American Presidential election held on November 8, 2016.

Through last several decades, healthcare sector in general and particularly the pharmaceutical industry, witnessed many innovations that cure and effectively manage ailments to improve the general quality of life. It enormously impacted the lives of many in the developed countries, and a few others which offer high quality Universal Health Care in a comprehensive format, for all.

A trickle-down impact:

Nevertheless, even no more than its just a trickle-down impact, helped increase overall life expectancy of the population in many developing and poor countries, mostly driven by the expanding number of cheaper generic drugs, fueled by more treatment and disease management options.

The paper titled, ‘World Population Prospects – The 2015 Revision’ of the Department of Economic and Social Affairs, Population Division of the United Nations’ reported that the life expectancy at birth rose by 3 years between 2000-2005 and 2010-2015, that is from 67 to 70 years. All major areas shared in the life expectancy gains over this period, but the greatest increases were in Africa, where life expectancy rose by 6 years in the 2000s, after rising by only 2 years in the previous decade.

Similarly, the global life expectancy at birth is projected to rise from 70 years in 2010-2015 to 77 years in 2045- 2050 and to 83 years in 2095-2100. Africa is projected to gain about 19 years of life expectancy by the end of the century, reaching 70 years in 2045-2050 and 78 years in 2095-2100. Such increases are contingent on further reductions in the spread of HIV, and combating successfully other infectious as well as non-communicable diseases.

The availability of cheaper generics gave some respite:

Out of a total population of 7.3 billion, as the above report says, the World Bank estimated that in 2013, 767 million people still lived on less than US$ 1.90 a day. Unfortunately, despite the greater availability of a large variety of cheaper generic drugs, the basic health care remains elusive to hundreds of millions of people in the world.

What causes more concern is the fact that 6 percent of people in low and middle-income countries are tipped into or pushed further into extreme poverty because of health spending, as the June 12, 2015 report of the World Health Organization (W.H.O) and the World Bank highlights. W.H.O has estimated that over a billion population of the world still suffer from neglected tropical diseases.

How many people benefitted from pricey patented drugs?

Nevertheless, despite so much innovation in the pharma industry, access to these new drugs remains elusive to a large section of even some the most developed nations, such as the United States, as they can’t afford these high-priced drugs. The overall situation, in this regard, is going from bad to worse. For example, the March 16, 2015 study published in the Mayo Clinic Proceedings reveals that the average annual cost of cancer drugs increased from roughly US$ 10,000 prior to 2000 to an astounding over US$ 100,000 by 2012.

Further, an August 31, 2015 article published in the ‘Health Affairs’ also gave examples of Biogen Idec’s multiple sclerosis drug, Tecfidera, which costs US$ 54,900 per patient per year; hepatitis C cures from Gilead Sciences, with a sticker price of $84,000 per patient; and Orkambi, a cystic fibrosis drug from Vertex Pharmaceuticals approved this month, priced at a whopping US$ 259,000 per year. A Kaiser Health Tracking Poll last July 2015 found that 73 percent of Americans find the cost of drugs to be unreasonable, and most blamed drug manufacturers for setting prices too high, the article stated.

The health care scenario in India is no better:

A study conducted by the ‘National Sample Survey Organization (NSSO)’ from January to June 2014, which was the 71st round of the ‘National Sample Survey’, and published in the ‘Health in India’ report, narrates a very gloomy picture for India, especially for a clear majority of those who incur ‘out of pocket’ expenses on medicines. The report states, out of all health expenditure, 72 percent in rural and 68 percent in urban areas was for buying medicines for non-hospitalized treatment.

Thus, many patients cannot afford health services, even when these are needed the most. As many as 68 percent of patients in urban India and 57 percent in rural areas attributed “financial constraints” as the main reason to take treatment without any medical advice, the report adds.

In this situation, the challenges that the Governments and the civil society are facing in many developing, and to some extent even in some developed countries, though for different reasons, are multi-factorial. It has been well established that the humongous global health care challenges are mostly of economic origin.

Pharma innovation benefitted the developed countries more:

A study titled, ‘Pharmaceutical innovation and the burden of disease in developing and developed countries’ of Columbia University and National Bureau of Economic Research, to ascertain the relationship across diseases between pharmaceutical innovation and the burden of disease both in the developed and developing countries, reported that pharmaceutical innovation is positively related to the burden of disease in the developed countries but not so in the developing countries.

Making the two to tango:

These facts prompt the need to make the pharma innovation and public health interest to tango. Several suggestions have been made and initiatives taken in this direction. Some of which are as follows:

Responding to this need, in 2006 W.H.O created the ‘Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG)’. The primary focus of IGWG is on promoting sustainable, needs-driven pharmaceutical R&D for the diseases that disproportionately affect developing countries. One positive effect of this global debate is that some global pharmaceutical companies have initiated their R&D activities for neglected tropical diseases, such as, Malaria and Tuberculosis. Many charitable organizations like, Bill & Melinda Gates Foundation and Clinton Foundation, are allocating significant funds for this purpose.

A paper titled, “Optional reward for new drugs for developing countries” published by the Department of Economics, University of Calgary, Institute of Health Economics, proposed an optional reward fund for pharmaceutical innovation aimed at the developing world to the pharmaceutical companies, which would develop new drugs while ensuring their adequate access to the poor. The paper suggests that innovations with very high market value will use the existing patent system, as usual. However, the medicines with high therapeutic value but low market potential would be encouraged to opt for the optional reward system. It was proposed that the optional reward fund should be created by the governments of the developed countries and charitable institutions to ensure a novel way for access to innovative medicines by the poor.

‘Open Innovation’ or the ‘Open Source Drug Discovery (OSDD)’ is another model of discovering a New Chemical Entity (NCE) or a New Molecular Entity (NME). Imbibing ‘Open Innovation’ for commercial results in pharmaceuticals, just has what has happened to android smartphones, would encourage drug discovery initiatives, especially for the dreaded disease like cancer, to make these drugs affordable for a very large section of people across the globe. In this model, all data generated related to the discovery research will be available in the open for collaborative inputs. In ‘Open Innovation’, the key component is the supportive pathway of its information network, which is driven by three key parameters of open development, open access and open source. This concept was successfully used in the ‘Human Genome Project’ where many scientists, and microbiologists participated from across the world to sequence and understand the human genes. Currently, pharmaceutical R&D is a well-protected in-house initiative of innovator global companies to maximize commercial benefits. For this reason, only a limited number of scientists working for the respective innovator companies will have access to these projects. In India, the Council of Scientific and Industrial Research (CSIR) is the champion of the OSDD movement, locally. CSIR believes that for a developing country like India, OSDD will help the common man to meet his or her unmet medical needs in the areas of mainly neglected tropical diseases.

Conclusion:

Thus, the ongoing heated debate on Innovation, Intellectual Property Rights (IPR) and Public Health Interest is gathering steam all over the globe.

Argumentative Indians are also participating in this raging debate. I reckon rightly so, as India is not only the largest democracy of the world contributing 16.7 percent of the global population, it is also afflicted with 21 percent of the global burden of disease. Considering this, the reason for similar heated debate in our country is indeed no-brainer to anyone.

Many would possibly not disagree, both encouraging innovation and safeguarding the public health interest are equally important to any society, be it in the developed nations or developing countries. Nevertheless, some constituents of ‘Big Pharma’ and their trade association still highlight that ensuring access to high price innovative drugs is the responsibility of the respective Governments. Any other regulatory mechanism to bring down such prices will be construed as a barrier to encouraging, protecting and rewarding innovation.

Be that as it may, most other stakeholders, across the world, especially the patients, are awaiting these two goals to tango. From that point, I reckon, giving a quick shape to commercially well-tested initiatives, such as, ‘Open Innovation’ model could well be an important step to ensure access to innovative new medicines for a larger number of patients of the world, meeting their unmet medical needs with greater care.

By: Tapan J Ray

Escalating Antibiotic Resistance, And Thwarting Ban Of Irrational FDCs

Posted on November 21, 2016 by Tapan Ray

September 2016 ‘Fact Sheet’ of the World Health Organization (W.H.O) raised a red flag on fast increasing incidence of Antimicrobial Resistance (AMR). It poses a serious threat to global public health, more than ever before. Consequently, effective prevention and treatment of an ever-increasing and complex range of infections caused by bacteria, parasites, viruses and fungi are becoming more and more challenging.

In this situation, various medical procedures, such as, organ transplantation, cancer chemotherapy, diabetes management and major surgery like, caesarean sections or hip replacements, invite much avoidable a very high element of risk.

Further, a July 2014 paper titled ‘Antibiotic resistance needs global solutions’, published in ‘The Lancet’ reports increase of incidences of drug-resistant bacteria at an alarming rate. In fact, antibiotic resistance is one of the most serious threats in the history of medicine, and new antibiotics and alternative strategies should be sought as soon as possible to tackle this complex problem.

Another more recent paper titled ‘Fixed-dose combination antibiotics in India: global perspectives’, published in ‘The Lancet’ on August, 2016 finds that nowhere in the world this problem is as stark as in India. It emphasizes that the crude infectious disease mortality rate in India today is 416.75 per 100,000 persons, which is twice the rate prevailing in the United States. Misuse, or rather abuse, of Antibiotics is a major driver of resistance. In 2010, India was the world’s largest consumer of antibiotics for human health, the paper says.

Thus, this critical issue calls for urgent action across all government sectors and the society, in general, as W.H.O cautions.

The Devil is also in irrational antimicrobial FDCs:

The reasons for the fast spread of antimicrobial resistance are many, and each one is well documented. One such factor is the use of irrational antimicrobial FDCs. Some of these have already been banned by the Union Government of India, though continue to be manufactured, promoted, prescribed, sold and consumed by the innocent patients unknowingly.

In this article, I shall focus on the banned FDCs of such kind, highlighting how the consequential serious threat to public health and safety is repeatedly getting lost in the cacophony of protracted court room arguments against these bans.

Irrational FDCs and antimicrobial resistance:

That ‘irrational’ FDCs of antibiotics very often hasten the spread of antimicrobial resistance, is now a well-documented fact.

The ‘National Policy for Containment of Antimicrobial Resistance in India 2011’ clearly recognizes that: “Antimicrobial resistance in pathogens causing important communicable diseases has become a matter of great public health concern globally including our country. Resistance has emerged even to newer, more potent antimicrobial agents like carbapenems.” The Policy also recommends removal of irrational antibiotic FDCs from the hospital drug list.

‘The Lancet’ article of August, 2016, as mentioned above, also reiterates, while citing examples, that “Studies of several antibiotic combinations, such as meropenem and sulbactam, have reported no additional advantage over their individual constituents, and have been reported to cause toxic reactions and promote resistance. Despite repeated investigations into the shortcomings of some FDCs, such drugs are still being manufactured and promoted on the Indian drug market.”

Why does it matter so much?

Corrective regulatory measures to contain the spread of antibiotic resistance are absolutely necessary in India, for the sake of the patients. According to a paper titled ‘Antibiotic Resistance in India: Drivers and Opportunities for Action’, published in the PLOS Medicine on March 2, 2016: “Out of around 118 antibiotic FDCs available in the Indian market, 80 (68 percent) are not registered with the Central Drugs Standard Control Organization (CDSCO). Moreover, 63 (19 percent) of around 330 banned FDCs are antibiotics.”

The global relevance:

Such regulatory bans of antimicrobials FDCs in India are important from a global perspective too, as ‘The Lancet’ article of August 2016 observes.

The article recapitulates that the ‘New Delhi metallo-β-lactamase’ – an enzyme that causes bacteria to be resistant to antibiotics, was first reported in India in 2008 and is now found worldwide. The growth of worldwide trade and travel has allowed resistant microorganisms to spread rapidly to distant countries and continents. In addition, some of these banned FDCs in India are reported to be exported to African and Asian countries too.

That said, each country will also need to play a significant role to curtail the abuse or misuse of antibiotics, locally. I find a glimpse of that in England, besides a few other countries.

A research paper of Antibiotic Research UK and EXASOL dated November 12, 2015, concluded that overall antibiotic prescriptions are coming down across England. However, the same paper also articulated that in the deprived areas of the country, such as Clacton-on-Sea, antibiotic prescribing rates are almost twice the national average.

Some big MNCs are no different:

In the Government’s ban list of irrational FDCs even some top brands of pharma MNCs feature, including antibiotic FDC of antibiotics. For example, on Mar 14, 2016, Reuters reported that one of the largest pharma MNCs operating in India – Abbott Laboratories, was selling a FDC of two powerful antibiotics Cefixime and Azithromycin, without approval of the DCGI. This could possibly be a legacy factor, arising out of its acquisition of a good number of branded generic drugs, together with their management, from a domestic pharma company. Abbott, otherwise is well regarded by many as a distinguished global institution, practicing high standards of business ethics and values, across the world.

Be that as it may, this powerful antibiotic cocktail that poses huge health risk to patients has reportedly not received marketing approval in the major global pharma markets, such as, the United States, the United Kingdom, Germany, France or Japan.

The Reuters report also elaborates that the drug ‘had been promoted and administered as a treatment for a broad array of illnesses, including colds, fevers, urinary tract infections, drug-resistant typhoid and sexually transmitted diseases.’ It also found chemists who were selling the drug to prevent post-operative infection and for respiratory problems. After the ban, the company has reportedly stopped manufacturing and sales of this antibiotic FDC.

Irrational FDC ban – a significant corrective measure:

Keeping all this in perspective, the regulatory ban on irrational FDCs of antibiotics on March 10, 2016, along with products falling in several different therapy areas, was a significant regulatory measure, among many others, to contain the menace of AMR in India.

Unfortunately, quite a lot of these formulations are still in the market, actively promoted by their manufacturers and widely prescribed by the doctors, till date. This is mainly because, to protect the revenue and profit generated from these brands, concerned pharma companies have obtained an injunction from various high courts against the ban, which was notified by the Government, earlier.

Thwarting FDC ban – a key issue:

Looking back, 294 FDCs were banned by the DCGI in 2007. At that time also, the same important issue of patients’ health, safety and economic interest got caught in an intriguing legal quagmire. As a result, implementation of the Government’s decision to ban of these irrational FDCs got delayed, indefinitely.

Added to this, irrational antimicrobial FDCs featuring in the ban list of March 10, 2016, got trapped in exactly the same legal battle, yet again. Thus, repeated stalling of Government ban on irrational FDCs, including antibiotics, continue to remain a key health and safety issue in India.

The latest development:

In September 2016, the Union Government has reportedly moved the Supreme Court of India in defense of its March 2016 ban on irrational FDCs.

In its petition, the Union Government has reportedly urged that all cases against the orders related to ban of ‘irrational’ FDCs, now being heard in various High Courts across the country, be transferred to the apex court and heard as a single case. The move is expected to cut any ambiguity that could arise from differing verdicts between high courts.

In case of a verdict favoring the ban of all the notified irrational FDCs, scores of patients will be benefited by not just falling victims to possible health menace arising out of such unjustifiable drugs, as the Government argues, but also due to expected containment of rapid spread of deadly antimicrobial resistance in the country.

Conclusion:

With the ban of irrational FDCs, the Union Ministry of Health has taken one of the much-needed steps to restrict antibiotic resistance in India, besides addressing other health and financial menace caused by such drugs.

The support of the Apex court of India to urgently resolve this legal jig-saw-puzzle, would also help control, though not in a holistic way, the scary antibiotic resistance challenge in India. In that process India would possibly be able to contribute its little bit towards the antibiotic resistance challenge, across the world, if we consider the ‘New Delhi metallo-β-lactamase’ case as a glaring example in this area.

It is, therefore, widely expected that for the greater public interest, the honorable Supreme Court may view this important health and safety issue accordingly, while pronouncing its final verdict. If and when it happens, hopefully soon, the prevailing industry practice in the country to make profits with dubious drug cocktails sans any robust medical rationale, basically at the cost of patients, can’t possibly be thwarted any longer, and will be effectively implemented on the ground.

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

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Escalating Antibiotic Resistance, And Thwarting Ban Of Irrational FDCs