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Covid-19 Vaccines – A Multifaceted Perspective

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Even after the destruction of millions of lives, livelihoods, social fabric and national economy of almost all countries – the mayhem of the Coronavirus pandemic continues, unabated.

Echoing what many other global experts, the United States National Institute of Allergy and Infectious Diseases Director has also reiterated ‘that the only “ultimate solution” for the Coronavirus would be a vaccine.’ He added, the social distancing measures and travel restrictions could help curb the outbreak but can’t last forever. Moreover, the virus might come back. Thus, only a vaccine could help in the long run.

That a speedy progress in achieving this goal, is the most critical remits for the global medical scientists and technologists, attract not many contrarian viewpoints. Nevertheless, some red flags are also visible in this critical area. Thus, to give a multifaceted perspective to the ‘Covid-19 vaccine story’, let me dwell on some of these contentious areas.

Vaccines may not be ‘silver bullets’ for all:

According to the news release of the World Health Organization (W.H.O) on July 15, 2020, 75 countries have submitted expressions of interest to protect their populations and those of other nations through joining the COVAX Facility. This is a mechanism designed to guarantee rapid, fair and equitable access to COVID-19 vaccines worldwide. These countries would finance the vaccines from their own public finance budgets and partner with up to 90 lower-income countries.

It further added, interest from governments representing more than 60 percent of the world’s population offers ‘tremendous vote of confidence’ in the effort to ensure truly global access to COVID-19 vaccines, once developed.

Expressing its optimism and also a concern at the same time, the W.H.O on August 03, 2020, informed – out of a number of vaccines, which are now in phase-3 clinical trials, it hopes to have a number of effective vaccines that can help prevent people from infection. Interestingly, in the same breath, it cautioned, “there’s no silver bullet at the moment and there might never be.” The question, that may arise, if a ‘silver bullet’ in the form of Covid-19 vaccines is not available and a vaccine doesn’t work for all, how complicated would then the situation be? Can one expect Covid-19 to end, at all?

When can one expect Covid-19 to end, if at all?

Closely following the above message – “there’s no silver bullet at the moment and there might never be,” another message, a bit intriguing, though, came from the W.H.O on August 22, 2020. This time the W.H.O said, “it hopes the planet will be rid of the Coronavirus pandemic in less than two years — faster than it took for the Spanish flu.” Elaborating the point, the W.H.O Chief underscored, by “utilizing the available tools to the maximum and hoping that we can have additional tools like vaccines, I think we can finish it in a shorter time than the 1918 flu.”

The impact of anti-vaccine movement to end Coronavirus pandemic: 

The question may sound crazy to many people, especially in India, but a similar concern has been expressed by many experts. The article – ‘Anti-vaccine movement could undermine efforts to end Coronavirus pandemic, researchers warn,’ published by the Nature on May 13, 2020, also raised this issue. The researchers of the study at the George Washington University, wrote - ‘studies of social networks show that opposition to vaccines is small but far-reaching — and growing.’

That anti-vaccine sentiments continue growing online, as medical scientists are flooring the gas pedal, has also been reported by ‘India Today’ on May 28, 2020 in an article titled, ‘Experimental Covid shots inject anti-vaccine sentiments.’ This belief was ‘prompted by theories that fast-tracked programs are profit-driven, loaded with health risks and will eventually lead to enforced immunization,’ it underscored. Notably, the W.H.O also has flagged the growing anti-vaccine feeling.

W.H.O flagged the growing anti-vaccine feeling:

The issue of growing anti-vaccine feeling has also been flagged by the W.H.O. It noted several reasons for fear of or opposition to vaccination, such as:

  • Some people have religious or philosophical objections,
  • Some see mandatory vaccination as interference by the government into what they believe should be a personal choice,
  • Others are concerned about the safety or efficacy of vaccines,
  • Or may believe that vaccine-preventable diseases do not pose a serious health risk.

Several of these could be significant in some geographical areas, within activist groups, community leaders, people with a different mindset, which may not be too difficult to overcome. Whereas, a few others may throw huge financial and logistical challenges to the nations. Interestingly, ‘one in three Americans is reluctant to take a COVID-19 vaccine.’

One in three Americans appears reluctant to be vaccinated:

According to a Gallup poll conducted between July 20, 2020 and August 02, 2020 ‘one in three Americans would not get a COVID-19 vaccine.’ This poll brought out the fact that ‘many Americans appear reluctant to be vaccinated, even if a vaccine were FDA-approved and available to them at no cost. Asked if they would get such a COVID-19 vaccine, 65 percent say they would, but 35 percent would not.’ Moreover, the percentage of Americans who feel strongly that parents should get their children vaccinated has also dropped by 10 percentage points, since 2001.

Other recent polls, reportedly, also found, whereas, around 50 percent of people in the United States are committed to receiving a vaccine, another quarter is still wavering. Some of the communities most at risk from the virus are also the “most leery.” ‘In France, 26 percent said they wouldn’t get a Coronavirus vaccine.’

Which is why, Covid-19 vaccines, which are expected to be available by early 2021, ‘won’t be mandated by the federal government’, according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “I don’t think you will ever see mandating of a vaccine, particularly for the general public. If someone refuses the vaccine in the general public you cannot force someone to take it,” he opined.  

But how broad is this ‘spectrum of doubt’?

As captured in the article, “The Coronavirus pandemic is the moment of truth for anti-vaccine movement,” published by the Financial Times on April 28, 2020, some of the emerging issues are worth pondering. It wrote, although, there is a small, highly organized group of people who are implacably against vaccinations, ‘there is a whole spectrum of people who are concerned, or are on the fence, about them.’ According to a poll it conducted in late March 2020, Covid-19 ‘outbreak has the potential to change their minds’ in different ways, such as:

  • Just 5 per cent of people in the UK say they would not take a Covid-19 vaccine if it were available, down from 7 per cent the week before.
  • Whereas, in Austria, 18 per cent said they would not take a Covid-19 jab, compared with 16 per cent three weeks previously.
  • The figure is similar in France, where 33 per cent – the highest proportion in the world — disagree with the statement “vaccines are safe”, according to another 2018 survey by the health research organization – the Wellcome Foundation.

Is there any anti-vaccination movement in India?

This issue has been well deliberated in many papers, one such is the article, “Theme – Ethical And Legal Challenges Of Vaccines And Vaccination, Public trust in vaccination: an analytical framework.” It was published in the Indian Journal of Medical Ethics (IJME), Vol 2, No 2 (NS) (2017). It makes some noteworthy points:

  • While vaccination is one of the most successful public health interventions, there has always been a parallel movement against vaccines.
  • Apart from scientific factors, the uptake of vaccinations is influenced by historical, political, socio-cultural and economic factors.
  • In India, the health system is struggling with logistical weaknesses in taking vaccination to the remotest corners; while on the other hand, some people in places where vaccination is available, resist it.
  • Unwillingness to be vaccinated is a growing problem in the developed world. This trend is gradually emerging in several parts of India as well.
  • Other factors, such as heightened awareness of the profit motives of the vaccine industry, conflicts of interest among policymakers, and social, cultural and religious considerations have eroded many people’s trust in vaccination.

The paper concludes by arguing that engaging with communities and having a dialogue about the vaccination policy is an ethical imperative. Be that as it may, the question still remains: With vaccines can people go back to the old normal?

Despite vaccines ‘We cannot go back to the way things were’:

It is for sure now that despite vaccination, people won’t be able to get back to the old normal. On August 21, 2020, the W.H.O further clarified ‘that a vaccine will be a “vital tool” in the global fight against the Coronavirus, but it won’t end the Covid-19 pandemic on its own and there’s no guarantee scientists will find one.’ One can find a clear meaning to this statement, if the same is read along with the W.H.O Chief’s earlier statement that “there’s no silver bullet at the moment and there might never be.”

Other challenges for mass vaccinations in India:

There are some research studies in this area. Let me quote one of those, published in the International Journal of Pharmaceutical Sciences and Research. The paper noted – although, immunization is the most cost-effective intervention for infectious diseases, there exists a scarcity of information on vaccination status of young adults and the role of socioeconomic conditions in India.

The study concluded – although Td/Tdap (97.3 percent) and MMR (66.4 percent) coverage was in line with the recommendations, for all the other vaccines the coverage was lower – varying from 5.5 percent to 35.4 percent. A number of factors were found responsible for limited growth and penetration of vaccines in India, such as:

  • Lack of adequate awareness among both physicians and patients.
  • Patients prefer treating rather than preventing diseases.
  • Vaccines are provided free under UIP program, but only for highly communicable and life-threatening diseases.
  • Obtaining vaccines through private system is expensive and medical insurance policies do not cover vaccines.
  • A lack of quality data on disease burdens and vaccine efficacy is the biggest obstacle in vaccine coverage in India.
  • Distribution is hampered by inadequate cold chains and constrains to last mile distribution. Storage in the clinics is limited due to frequent electricity blackouts in India.

The vaccination coverage was found better in respondents with higher educated and higher income parents. The researchers suggested patient education, planning by government for the implementation of policy for adult vaccination and involvement of physicians are must for better adult vaccination coverage.

Conclusion:

The United States, Brazil and India now account for more than half the total of over 22 million Coronavirus cases, globally. The number of fatalities had also gone past 782,000, as on August 20, 2020.  However, the Coronavirus cases in the country, as recorded in the morning of August 23, 2020, have also reached a staggering figure of 3,044,940 with 56,846 deaths, despite all measures that the country has been taking. No signs of any respite, just yet.

The Government of India has officially acknowledged that for protection from Covid-19 infection, ‘the herd immunity level is “far away” for the Indian population and it can only be achieved through immunization by vaccines.’ Hence, the country’s dependence and stake on this ‘silver bullet’ are very high. From this angle, the vaccine story needs to be viewed from a multifaceted perspective, including what the W.H.O has already cautioned:

  • ‘There’s no silver bullet at the moment and there might never be.”
  • ‘That a vaccine will be a “vital tool” in the global fight against the Coronavirus, but it won’t end the Covid-19 pandemic on its own and there’s no guarantee scientists will find one.’
  • The Coronavirus vaccines alone won’t end pandemic: ‘We cannot go back to the way things were’ in the old normal. In other words, people should try to adapt to the new normal to lead a normal life.

Besides, there could be other problems like, making vaccination mandatory. Or, distributing affordable Covid-19 vaccines through uninterrupted cold-chains in the remotest part of India, and appropriate storage there. Does India have a robust logistics support for the same, in place? Who will pay for all these? And more importantly, are there Plan B, C & D ready, to meet any unforeseen critical situation. Each of these warrants a deep-stick analysis – with a multifaceted perspective, as the devastating impact of Covid-19 pandemic is so real for all, especially for India.

By: Tapan J. Ray  

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

Shift from Disease Centered Care To Patient-Goals Directed Care In The New Normal

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In the initial days of the first quarter of 2020, no one could fathom that just within the next 4 months over two million fellow citizens will get infected by an unknown virus, recording over 45,500 deaths. Many authorities may wish to project or analyze these Covid-19 numbers in so many different ways. Nevertheless, the fact remains, currently, in passing each day India is recording the highest count of fresh Covid-19 cases in the world, alongside the most daily deaths from the virus.

In the early days of Covid19 in India, many expected a remedial pathway to emerge soon – conventional or unconventional. Accordingly, Indian citizens across the country responded to the call of some national leaders by observing some – even unconventional measures, such as:

  • On March 22, 2014, to “boost morale” of doctors and public workers, as urged by the Indian Prime Minister, many people banged pots and pans on balconies across India.
  • On April 05, 2020, again responding to the Prime Minister’s passionate call, a large number of Indians turned off lights, lighted candles and Diyas hoping to dispel COVID-19 darkness.
  • On May 02, 2020, as organized by the Government, the country’s armed forces engaged in a nationwide exercise to express gratitude to doctors, paramedics, sanitation staff and other front-line workers involved in fighting the Coronavirus pandemic.

Gradually, the stark reality sank in, as the old normal faded out in the horizon. Public expectations arguably started shifting from heavenly interventions, as it were, to science-based measures. It has now been generally accepted that there is no alternative to social distancing and wearing a mask at the public places. These should continue, till the ‘silver bullet’ – vaccines arrive. More so, when going for herd immunity “cannot be a strategic choice or option,” given the size of India’s population, as the Government said.

Billions of people have now started hoping for the ‘silver bullet’ to come soon. This sky-high expectation continues to be fueled by media hype – based primarily by the Press Releases of the concerned companies. In the midst of these, comes a word of caution from the apex health body of the world. As recent as August 03, 2020, the World Health Organization (W.H.O) announced, ‘despite strong hopes for a vaccine, there might never be a “silver bullet” for COVID-19, and the road to normality would be long.’

To add some degree of certainty in this humongous – primarily scientific and logistical challenge to save lives, – pharma and biotech industry, as usual, are coming to the forefront. Billions of eyeballs are now glued on to them – following every bit of what they are saying – as the devastating impact of this health catastrophe is profound. Besides individual health, the fall-out of the pandemic is intimately intertwined with livelihoods, nation’s economy, social fabric and adjusting to the new way of living, including new mechanisms for most transactions.

Obviously, this would create a new normal – quite different from the old one – and naturally would include pharma business, as well. In this scenario, patients will assume a much different status, especially in the disease treatment process. More patients would likely to prefer their individual health-goals directed holistic care, which calls for a holistic disease treatment solution. The process needs to be contactless as far as practicable, less time intensive and above all cost effective

In this article, let me focus on this area. I reckon, many pharma players are also evaluating the impact of this shift to achieve business excellence in the new normal.

The current treatment approach and the pharma focus:

A recent paper, published in the JAMA Cardiology on the April 2016, made some interesting observations in this area. Citing cardiology disease area as an example, the authors noted the following, among other points:

  • Physicians’ decision-making process generally ‘concentrates on disease-specific outcomes, following practice guidelines for specific conditions.’
  • Value-based purchasing also largely focus on individual diseases.
  • However, disease-centered framework is ill-suited for persons with multiple chronic conditions, including older adults and the majority of adult health care users of all ages.
  • Disease-centered decision-making results in treatment burden when patients must adhere to multiple guidelines and harm when guideline recommendations conflict.
  • Furthermore, disease-centered recommendations may not address what matters most to these patients – varying health priorities.

The shortcomings of this approach from the patients’ perspectives, besides adding greater value for patients, prompt a need for change. From the current disease-oriented treatment approach, and pharma’s business-related focus in sync with this system.

Habit of visiting specialists at the very beginning complicates the process:

The disease-oriented treatment approach, as it is today, isn’t a legacy issue. In the good old days, General Practitioners (GP) used to examine their patients thoroughly – covering the entire body. Thereafter, depending on the specific areas of need, expert interventions used to be recommended.

However, todays well-informed people, equipped with health information of all kinds, can possibly figure out the broad outline of their health problems. Accordingly, many of them directly arrange appointment with specialists. As most of them are generally not terribly wrong in figuring out the problem areas, specialists’ treatment progresses in the same direction. Other existing health issues, not being of high priority treatment areas for persons concerned, could remain ignored, till these also flare up.

Undoubtedly this approach, even if is made ‘patient-centric’, in a broader sense, by pharma players, would cost more time, more money to patients. Besides, loss of income and increase in morbidity. This is certainly an avoidable situation for all – patients, doctors and pharma companies.

Go beyond ‘patient-centricity’ encompassing ‘patient-goals directed care’:  

The new focus should be directed towards ‘patient-goals directed care.’ This approach, which flows from a very old and a classic concept of  Sir William Osler articulated in the 19th century. This remains as relevant today for any holistic - ‘patient-goals directed care.’ It goes way beyond much hyped ‘patient-centric’ approach.

Sir William Osler once said, “The good physician treats the disease; the great physician treats the patient who has the disease.” The great physician understands the patient and the context of that patient’s illness. Accordingly, I reckon, pharma players new focus needs to be in conformance to this concept. It fits in so well with changing patients’ expectations in the new normal.

As has been evaluated in many studies, although, patient-goals directed care may appear to be particularly useful for persons with multiple chronic conditions, ‘this approach works across the age and health span, making it a compelling path toward value-based care from the patient’s perspective.’

‘Each patient represents a story’ which needs to be carefully deciphered: 

The article – ‘To Be a Great Physician, You Must Understand the Whole Story,’ published in the Medscape General Medicine on March 26, 2007, elucidated the point nicely. It said, each patient represents a story, which includes their diseases, their new problem, their social situation, and their beliefs. A physician needs to understand this story. Accordingly, perform a targeted physical examination based on the historical clues, order the correct diagnostic tests, and interpret them in the context of the history and physical exam. Once the appropriate data are collected, the patient’s story needs to be revisited, based on scientific data.

Revisiting process of the patients’ story includes making the correct diagnosis or diagnoses. The story must reveal the patient’s context – Who is this patient? – What is the patient’s goal? – How might the patient’s personal situation impact the treatment options? And more – as the above article highlights.

Each patient’s story’ is important for pharma companies, as well:

Patients’ disease related stories are of crucial importance to the pharma players, as well, for strategic reasons. Not just to gain insights on the disease manifestation process, but more importantly to facilitate a company’s engagement with them.

Another interesting article has brought out some more important issues in this area. The paper is titled, ‘Patient Centricity and Pharmaceutical Companies: Is It Feasible?’ It was published by the SAGE Journals on March 28, 2017, where the authors underscored, engagement with patients can only be possible, if there is credibility. Elaborating this point, the paper cited two GSK examples aimed at building trust with patients and physicians, as follows:

  • Change in marketing practices: In 2011, GSK eliminated prescription sales targets in the US and introduced a new incentive model for sales and marketing practices based on value and feedback from prescribers; external speakers/ convention travel support was discontinued (2016).
  • Clinical transparency: Since 2013 GSK has committed to promote transparency of clinical research and is a leading example in the pharmaceutical industry—it was the first company to grant access to anonymized patient data. The ‘All trial campaign (2013)’ commits to publishing all trial data; the GSK patient-level data access site has become a multi-sponsored portal (2014).

Conclusion:

As of August 09, 2020 morning, the recorded Coronavirus cases in India have crossed a staggering 2 billion mark, reaching 2,153,10 with 43,452 deaths. The figure keeps climbing – faster than expected, unabated.

The business relevance for a shift from the conventional disease centered care to patient-goals directed care, require deep understanding of the top pharma leadership along with its very purpose, in the new normal. Patients deserve this now, more than ever before, as explained above.

In my view, a changing mindset to align pharma business strategy – from providing a disease-oriented care to patient-goals directed care, is expected to improve patient outcomes manifold. Nevertheless, like what the above SAGE article emphasized, the organization at its end would require defining collectively and with clarity – why is this change now? How it is to be done – step by step?  And what are the results the company aims to achieve?

Consequently, it would help create a large pool of delighted and company loyal customers having strong ‘word of mouth’ advantages. Top pharma leadership’s ‘buying in’ this concept, with an appropriate organizational structure in place, would herald a new dawn of ‘Patient Value-Based Care’ – Convid-19 pandemic notwithstanding.

By: Tapan J. Ray 

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

 

In Pharma’s Moment of Truth “What You Do is Who You Are”

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It’s a time when pharma industry will be tested, both by its external and internal customers – more than ever before. Looking back, in search of footprints on the sand is no answer either, as there isn’t any. But, a decision on moving ahead has to be made by each drug company in any case – charting a strategic pathway, in search of business excellence, if not for survival. A possibility looms large that the crisis may even overwhelm a company, if any, ill-conceived or ill-thought through steps are taken.

In that sense, the moment of truth has arrived for the industry – a time when ‘what different you do’ in the value delivery process of the business, will decide ‘who you are.’ One’s ability to lead the company or even follow the leadership, to navigate through this crisis, would determine the present and future success of the corporation. This isn’t an easy task. The evolving processes would be challenging to implement, and the traditional mindset may often act as a retarding force, as it were. In this article, I shall explore this critical area with recent examples, as far as possible.

Ability to fathom its most critical component is the bedrock for next steps:

The most critical component in this situation is the ability to make a careful and unbiased assessment of – how different would the ‘new normal’ be from the ‘old normal.’ The focus should not be on the barriers in making the necessary strategic changes, which I hear too often – but how to steer the business through this unprecedented crisis, regardless tough barriers on the way.

Covid-19 threat isn’t going to go away anytime soon:

However, one thing is for sure – no one knows, not just in India, but globally how big the crisis is, and will assume what form, when and how long. Let me give just three illustrations in this area that will be easily understood by all:

  • Initially, experts used to say, face masks are required only for those having symptoms and people close to them. “Masks are not required for those who doesn’t have symptoms. Whereas, the same experts are saying these days, “data now emerging about asymptomatic patients spreading the infection across the country, masks play an important role in containing the spread.” Thus, one is required to wear a face mask always while going outdoors.
  • Explaining the mode of disease spread, earlier, many experts, including the W.H.O, said that COVID-19 virus is primarily transmitted between people through respiratory droplets and contact routes. Thus, a mask is needed when one goes outdoors. Whereas, now the same experts, including the W.H.O, have confirmed that Coronavirus can be airborne indoors. In that case, one may need to wear a mask even indoors.
  • On April 23, 2020 the Director-General of Indian Council of Medical Research (ICMR), reportedly, claimed that the situation is stable, and the country has been able to ‘flatten the curve.’ But on May 09, 2020, Director, AIIMS, reportedly, said, “Currently, the cases are continuing to grow at a flat rate, sometimes even more. So, it is very difficult to predict when the peak will come; but it is likely to peak around June or July…” Whereas, an MIT study, which has also been reported in the press reveals, “India might see 2.87 lakh Covid cases per day by February 2021.”

These instances drive home the point – although a serious threat of Covid-19 infection will continue in the foreseeable future, but the way it will manifest itself, and the fresh precautionary measures that will deem necessary, may change with time. Let me give one more example of increasing threat of getting re-infected by Coronavirus by already infected individuals has heightened today than in the past.

The battle tactics need to be updated:

Strategy for war against Covid-19 onslaught may broadly remain similar. But the battle tactics in the multiple fronts need to be updated on an ongoing basis. This needs to be based on increasing or narrowing of the spectrum of threat and other critical factors, as scientific evidences will reveal from time to time.

For example, as is unfolding today, a large number of already infected people, particularly living in areas with high population density, may not necessarily develop any long-term immunity against the Coronavirus infection. Such a possibility will have a wide impact on any business strategy in the new normal that an organization may contemplate.

The rationale for constantly updating battle tactics:

Let me now focus on the rationale for constantly updating battle tactics based on scientific evidences with a few contemporary examples. The study, published in the Nature Medicine on June 18, 2020, found that individuals recovering from Covid-19 infection may have immunity only for 2-3 months. Although, it may not necessarily be construed that a recovered person can get re-infected, but any vaccine that may eventually come may need to address such issues, which seems to be a tough call.

Alongside, findings of another large research – Spain’s Coronavirus antibody study, published in The Lancet on July 06, 2020, has also cast doubt on the feasibility of herd immunity as a way of tackling the Coronavirus pandemic. As the BBC News reported on July 07, 2020 - based on these findings, Prof. Danny Altmann, British Society for Immunology spokesperson and Professor of Immunology at Imperial College London has made similar comments on effective vaccine development initiatives.

He said, the study would, “reinforce the idea that faced with a lethal infection that induces rather short-lived immunity, the challenge is to identify the best vaccine strategies able to overcome these problems and stimulate a large, sustained, optimal, immune response in the way the virus failed to do.”

“What You Do is Who You Are”: 

As the saying goes: “What You Do is Who You Are.” With this fast-evolving scenario, pharma leadership will need to effectively address a dual strategic game plan to outmaneuver the barriers of the Covid-19 pandemic:

  • Putting in place a robust operating strategy for customer value delivery process of the business.
  • Capturing the details of new Covid19 related ongoing developments to constantly hone the battle tactics in several different fronts.

Both the above processes will involve picking up all such validated research findings, mostly on the run. Mostly because, such issues may impact both internal and external customers of the organization, besides competition. Therefore, factoring-in each of those new developments, while constantly sharpening the war strategy and battle tactics in the fast-evolving scenario, will be of crucial. And, what you think or do in this situation will determine who you are – what type leadership traits you exhibit to face the challenges of the new normal, effectively.

Two types of leadership in the new normal:

Amid challenges of the present crisis, I reckon, top leadership will find two broad types of domain leaders – ‘pro-tradition’ and ‘pro-change’ – both will have successful past track records. They need to be identified for appropriate strategic tasks.

As is known to many, a good number of successful leaders are operating through decades around the concept of physical presence of patients while consulting a doctor or other health care providers. Several of them seem to be still unsure about the extent of organizational and operational changes required to face this unprecedented crisis, head-on. Even today, some of them keep trying to impress others by citing instances of what they did so well in the past.

There is nothing wrong in that. But, the business environment and requirements of those days were different – quite different from today’s demand. Curiously, many of such good leaders, with impeccable past success records, seem to be more bothered about seemingly insurmountable barriers on the way. They are afraid of migrating away or jettisoning the traditional pathway of success. Probably, the fear of failure – after achieving success for a long time, is the reason. I consider these successful professionals as ‘pro-tradition’ leaders.

There are also examples of another type of leaders. They are generally younger, looking forward with a contemporary mindset, nurture a can-do spirit with a resilience to bounce back, even in difficult times. Which is why, any transient fear of failure doesn’t usually overwhelm them. And, these leaders, I reckon, may be broadly termed as ‘pro-change’ leaders.

Keeping aside, past success records or future success potential of pharma leaders, in the current scenario – what they actually think or do in the changing environment to steer the organization out of this never-before crisis, will indeed determine ‘who they are.’

A contemporary initiative sets an example:

Top leadership of several drug companies, such as those at Novartis, is leading the way for a change management as the new situation will demand – by setting examples for others. These leaders seem to be taking note of all changes, as discussed above, while giving shape to a strategy, and reshaping the same based on data, as and when required. Interestingly, more technology professionals are getting attracted to pharma operations during Covid-19 pandemic than ever before, as a recent research report unfolds. This is a good omen for pharma and needs to be leveraged, effectively.

The findings of a new research report:

A new research report from Novartis -  A Powerful Pairing,  emphasizes: “The global COVID-19 pandemic sparked a seismic shift in the adoption and scaling of digital technologies across the healthcare sector at a pace never before seen. Almost overnight, organizations had to dial-up their efforts to develop, manufacture and ultimately bring medicines to patients in a socially distant world.” The survey brings out some interesting points, such as:

  • 86 percent of respondents believe the time has come for digital healthcare, and many of them are interested in taking part.
  • Regardless of the sector they currently work in, the two industries that technology professionals would consider switching to, are technology and healthcare and pharma (49 percent for each). This interest rises to 58 percent for workers based in India and 55 percent for those based in China. They feel, Covid-19 pandemic has made them more aware of medical causes around the world and how important they are. Through work in this sector, they can save countless human lives.
  • 52 percent of technology talent sees innovation potential in the healthcare and pharma sector, with the top reason to apply for a job being the opportunity to innovate through technology.
  • 89 percent technology professionals say that data science is important to the development and delivery of healthcare industry solutions and services.

Conclusion:

Surging ahead to reach a million mark, as on July 12, 2020 morning, the recorded Coronavirus cases in the country reached 850,358 with 22,687 deaths. With a record high of 27,755 daily cases yesterday, the pace of climb continues.

It’s now virtually a writing on the wall that India will have to sail through the unprecedented Covid-19 pandemic for quite some time, where unprecedented leadership interventions will be of critical importance – even in pharma. This endeavor will also call for selective induction of competent technology professionals in all pharma business domains, as required. The challenge involves not just carving out the ‘war strategy’, as it were, against Covid-19, but also continually honing the ‘battle tactics’ in multiple fronts – mostly on the run, for desired outcomes.

The situation calls for taking an in-depth inventory of an organization’s existing human resources, based on success ingredients required to turn the tide, which, I reckon, should also be the starting point in this venture. In this moment of truth – standing at the cross-roads of the drug industry, there is no further room for top pharma leadership to procrastinate the decision-making process. All competent professionals should be taken on board. In tandem, both – seemingly ‘pro-tradition’ and ‘pro-change’ leaders, should be encouraged to realize that in the new normal “What You Do is Who You Are” in the future pharma business.

By: Tapan J. Ray

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

The Stakeholder-Mix Has Changed, But Pharma Marketing Has Not

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“We try never to forget that medicine is for the people. It is not for profit. Profits follow, and if we have remembered that, they never fail to appear.”

In 1952, George Wilhelm Herman Emanuel Merck, the then President of Merck & Co of the United States said this. He was then aptly quoted on the front cover of the ‘Time Magazine’, epitomizing his clear vision for the company: “Medicine is for people, not for the profits”.

The globally acclaimed Management Guru – Peter F. Drucker had also clearly articulated in his management classics that, “Profit is not the purpose of business and the concept of profit maximization is not only meaningless, but dangerous.” He further said, “There is only one valid purpose of a business, and that is to create a customer” 

As this is an ongoing process, in the pharma perspective, it may be construed as ensuring access to new drugs for an increasing number of patients.

It really worked: 

In those days, driven by such visionary leadership, the pharma used to be one of the most respected industries and Merck topped the list of the most admired corporations in America. It is clear that pharma leadership at that time wanted to make ‘inclusive growth’, both in the letter and spirit, as an integral part of the organizational progress, moving with time.

Thus, it worked. The sales and marketing growth of the global drug industry at that time was not lackluster, either, in any way. The R&D pipeline of the drug companies used to be also rich, with regular flow of breakthrough new products too. 

Straying away from ‘inclusive’ to ‘self-serving’ strategies:

Much water has flown down the bridges, since then, so is the change in the public and other stakeholders’ perception about the pharma industry, in general. 

Sharply in contrast with George W. Merck’s (Merck & Co) vision in 1952 that “Medicine is for people, not for the profits”, in December 2013 the global CEO of Bayer reportedly proclaimed in public that: “Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India but for Western Patients that can afford it.” 

It appears that the focus of the pharma industry on ‘inclusive growth’ seems to have strayed away to ‘self-serving growth’, with the passage of time. As a result, a large majority of the new stakeholders started harboring a strong negative feeling about the same industry that continues its active engagement with the very same business of developing new drugs that save many precious lives. 

Granted that the business environment has changed since then, with increasing complexities. Nonetheless, there does not seem to be any justifiable reason for straying away from ‘inclusive growth’ strategies.                                         

As are regularly being reported, both in the global and local media, mindless arrogance on fixing exorbitant high new drug prices severely limiting their access, unabated malpractices in drug marketing and escaping with hefty fines, releasing only favorable clinical trial data, just to mention a few, are giving the industry image a strong tail spin.

Stakeholders changed, but pharma marketing did not:

Keeping the same strategic direction and pace, overall pharma brand marketing strategy also continued to be increasingly ‘self-serving’, and tradition bound. Success, and more success in building relationship with the doctors, whatever may be the means, is still considered as the magic wand for business excellence, with any pharma brand. Thus, since over decades, building and strengthening the relationship with doctors, continue to remain the primary fulcrum for conceptualizing pharma marketing strategies. 

It does not seem to have not dawned yet for the pharma marketers, that over a period of time, the market is undergoing a metamorphosis, with several key changes, and some of these would be quite disruptive in the traditional pharma marketing ball game. Consequently, the above key the fulcrum of pharma marketing is also gradually shifting, slowly but surely.

In this article, I shall deliberate only on this area.

A new marketing paradigm:

The key customer in the pharma business is no longer just the doctors. That was the bygone paradigm. The pharma stakeholders’ mix is no longer the same as what it used to be. 

The evolving new paradigm constitutes multitude of important stakeholders, requiring a comprehensive multi-stakeholder approach in modern day’s pharma marketing game plan.

Patients, governments, policy influencers, health insurance providers, hospital administrators, social media, and many others, have now started playing and increasing role in determining the consumption pattern of pharma brands, and their acceptability. More importantly, these not so influential stakeholders of the past, are gradually becoming instrumental in building overall pharma business environment too. This necessitates customized engagement strategy for each of these stakeholders, with high precision and relevance.

Changing mindset is critical: 

An effective response to this challenge of change, calls for a radical change in the marketing mindset of the top pharma marketers. The most basic of which, is a strong will to move away from the age old ‘one size fits all’ and ‘self-serving’ initiatives with some tweaking here or there, to a radically different ‘inclusive marketing’ approach.  In this game, both the types and the individual customer concerned, would occupy the center stage for any meaningful interactions on the brands and associated diseases, besides many other areas of relevance.

Multi-stakeholder – Multi-channel approach:

For a multi-stakeholder customized engagement, innovative use of multiple channels would play a crucial role, more than ever before.

Availability of state of the art digital tools, would facilitate crafting of comprehensive marketing strategies, accordingly. For example, for the doctors, some companies are moving towards e-detailing.

As I discussed in my article in this Blog titled, “e-detailing: The Future of Pharmaceutical Sales?” on September 13 2013, this modern way of interaction with the doctors is fast evolving. E-detailing is highly customized, very interactive, more effective, quite flexible, and at the same time cost-efficient too. Live analytics that e-detailing would provide instantly, could be of immense use while strategizing the game plans of pharmaceutical marketing.

A feel of the changing wind direction:

A relatively new book titled, “Good Pharma: How Marketing Creates Value in Pharma”, published in March 2014, and written by Marcel Corstjens, and Edouard Demeire, well captures some of the key changes in the pharma industry with a number interesting examples. 

The above book seems to somewhat respond to Ben Goldacre’s bestselling book ‘‘Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients’, which I discussed in this blog on October 15, 2012.  It made some important observations in many areas of pharma business. I am quoting below just a few of those incoming changes to give a feel on the urgent need of recasting the marketing models of the pharma industry:

On emerging markets’ like India:

“Emerging markets should not be seen as low-hanging fruits. Their prevalence of diseases may not be the same, the stakeholders may be very different. In addition, the healthcare infrastructure is often not very sophisticated, and these markets can be rather volatile and difficult to predict. It’s not a sure bet; you have to invest. … Companies need to commit seriously to building a heavily localized approach that is substantiated by a global reputation.” This is perhaps not happening in India, to a large extent, as I reckon.

On personalized Health Care (PHC): 

The new drugs brought to market by the pharma companies are not just expensive, but often work only for small segments of the patient population. In India this situation mostly leads to very high out of pocket expenditure, which often is wasted for the drug not working on the patient. Thus, the regulators and payers in the developing countries are setting the threshold for higher reimbursement. The authors observed that PHC is now being put forward as the industry’s best bet for satisfying stricter effectiveness criteria, not only by developing new drugs, but also by investing in the magical trio of the future: “drug-biomarker-diagnostic. In that case, pharma marketing would need to undergo a significant change, starting from now.

On ‘Category captains’:

The book also says, “The most financially successful companies in the past 20 years has been Novo-Nordisk. They have specialized in diabetes, they’re extremely good at that. Roche specializes in oncology. The larger the company, the more ‘captive’ areas they can have. The success of Novo-Nordisk, a relatively small company, proves firms of all sizes have a chance to compete, as long as they stick closely to their strengths. When this happens in a much larger scale, pharma marketing would also be quite different and more focused.

Many pharma companies are still avoiding to change, successfully. For example, as announced on May 31, 2016, Intercept Pharma of the United States announced its new liver disease drug with a hefty price tag of US$ 70,000 a year. According to the report, the company said, prices are justified by a drug’s level of innovation and cost savings for the healthcare system. This justification has now become very typical in the pharmaceutical world, which has been facing barrage of criticisms, including from Capitol Hill, about too-high drug prices.

However, as we move on, the writing on the wall seems to be very clear on the sustainability of health care business, the world over.

Conclusion:

Finally, the question arises, would the traditional approach still be good enough to achieve the desired sales and marketing objectives, any longer?

No, probably not, I reckon. With changed mindsets, ‘getting under the skin’ of each stakeholder, separately, would assume key importance. It would play a key role, while devising each component of any cutting-edge pharma sales and marketing strategy, tactic, and task.

The shift from the old paradigm, signals towards a total recast of pharma marketing to make it more ‘inclusive’, and not just ‘self-serving’. Newly crafted commensurate grand marketing plans and their effective implementation should satisfy the needs and wants of all stakeholders, simultaneously. Singular focus on building, or further strengthen the relationship with prescribing doctors, won’t be adequate enough, anymore.

Thus, the name of the new pharma ballgame would again be ‘inclusive marketing for inclusive growth’.

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.

‘Old is Always Not Gold’: The Saga of Uncertainty on the New Drug Policy Continues

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Along with the initiation of globalization process of India in 1991, many significant reform oriented steps are being taken by the Government for the pharmaceutical industry as its growth booster.

In tandem with gradual reduction in the span of price control, the government also ensured dereservation of specified drugs only for the public sector and opened it up to the private sector, as well.  During this period, foreign investments through automatic route was first raised from 49 to 74 percent and then to 100 percent.New product patent regime with the introduction of the Patents Act 2005 ushered in a paradigm shift in the pharmaceutical landscape of India, encouraging the domestic industry to invest in R&D. In line with these reforms, weighted deduction on in-house research and development  facility was increased to 200 percent to cover expenditure towards R&D, patent filing, regulatory approvals and clinical trials, over a period of time.

With creation of an enabling growth environment, the government helped the domestic industry catapult itself as a major global force to reckon with, in the generic pharmaceutical space of the world.

Unfortunately, in recent times, the policy makers of the country instead of flooring the gas pedal keeping public health interest in mind, seems to have decided to shift its foot on the brake, creating great uncertainty within the industry.

Recent developments: A cause of concern

As reported by the media the recommendations of the Group of Ministers (GoM) on the Draft National Pharmaceutical Pricing Policy 2011 (NPPP 2011) was scheduled for discussion in the Union Cabinet meeting on November 8, 2012.

Meanwhile, the Ministry of Finance (MoF) reportedly sent its views on the same to the Department of Pharmaceuticals (DoP) and also the Prime Minister’s Office (PMO) advocating continuation of the current cost plus pricing policy.

As a result, the media  reported that the NPPP 2011 was eventually removed from the Cabinet Meeting agenda of November 8, 2012, as the PMO referred the policy back to the GoM requesting the Cabinet Secretariat to mandate the Ministers to hold a fresh meeting (now scheduled on November 21, 2012), consider the view of MoF and get back to the Union Cabinet with a final proposal so that an appropriate decision may be taken by the Cabinet on the new Drug Policy before November 27, as stipulated by the Supreme court of India.

With this, the saga of uncertainty on the new Drug Policy continues unabated.

Finance Ministry views: Continue with cost plus formula:

The key recommendations of the Ministry of Finance as reported are as follows:

  1. The proposal to limit the NPPP to control prices of only formulations leaving aside bulk drugs is not ‘supported’.
  2. Top priced brands in many therapy areas are also the brand leaders. As a result, high prices of such drugs while calculating the ceiling prices would push up prices of many low priced drugs significantly.
  3. The current system which is a cost plus system is adequate to cover all legitimate costs for a manufacturer, particularly when the costing is being done annually and should be continued.
  4. The same cost plus system should also apply to other formulations where additional therapeutic elements will be added. Related incremental cost in those cases can be considered to determine the ceiling price of combination formulations.
  5. The Maximum Retail Prices (MRP) for all NLEM 2011 drugs may be fixed by the NPPA accordingly and the pharmaceutical companies would be free to price these NLEM products at any level below the MRP.
  6. Annual indexation of price with WPI is not supported. The cost analysis should determine the quantum of increase.
  7. Data related to prices and market shares should be collected from sources other than IMS even for drugs covered by them. The methodology to be followed by NPPA for evaluating IMS data and for collecting the data for medicines from other sources should be included in the NPPP.
  8. A phased movement towards 100 percent generic manufacturing, as recommended by the Ministry of Health (MoH), for all drugs under the NLEM should be considered.

The industry view: Have a Balanced Approach

As I understand, the industry feels that the Finance Ministry recommendations are continuation of the same old policy, which has failed to address the key issue of providing affordable and quality healthcare, including medicines, to all, since over last four decades.

However, the pharmaceutical industry has supported the recommendations of the GoM on NPPP 2011 as they reckon it will be a positive step to ensure affordability for the patients, ensure adequate availability and at the same time will not cripple the growth of the industry.

As recommended by the GoM, the draft NPPP 2011 would take the Weighted Average Price (WAP) of all brands with greater than 1% market share by volume as the ceiling price. This formula should improve patient affordability as Weighted Average Price (WAP) of all brands will be most representative of the Indian pharmaceutical market.

The GoM-recommended pricing policy, the industry feels, will certainly have an adverse impact on the pharmaceutical industry as price controls will be expanded and prices will now be based on roughly 91 percent of the pharmaceutical market by value. This will result in over 20 percent price reduction in 60 percent of the NLEM medicines. More importantly, the policy will also achieve the objectives of the Government in ensuring essential medicines are available to those who need these most, by managing prices in the retail market and balancing industry growth.

The existing cost-plus policy, industry leaders argue, has significant limitations and has adversely impacted industry and patients, for example, by shifting bulk drug production out of India (to countries like China), reducing innovation in cost control medicines, limiting new introductions and failing to help medicines reach patients located in rural India.

Many stakeholders have written about the negative implications of a cost-plus pricing methodology. Too stringent price control norms would stifle the pharmaceutical industry and may result in serious shortages of essential drugs in the country. An apt example in this case is that the existing price control regime under DPCO 1995 has caused manufacturing to shift away from the country about 27 notified bulk drugs under price control.  In fact, only 47 out 74 bulk drugs under DPCO 1995 are now produced in the country. Such a situation needs, the industry articulates, to be prevented from happening in the future.  It is quite likely the focus of the national pharma industry may shift then to export, defeating the primary purpose of the new policy.

Moreover, the WHO in its feedback on the draft NPPP 2011 welcomed the intent to move away from cost-plus pricing as it has been abandoned elsewhere. Even developing countries typically have no price control on private market (non-government, non-social insurance reimbursement) sales of pharmaceuticals.

Based on a survey of developing countries similar to India, it is seen that the countries that do have price control for private market drugs, employ market based methods e.g. in Brazil cost-based price regulations do not exist outside of government reimbursement, social insurance reimbursement schemes.  In short, essential medicines predominantly seem to be reimbursed either via government or social insurance or provided free by the government.

Since the Government has recognized that a pricing policy alone cannot ensure access to quality medicines, over the last few months, it has undertaken several steps in the right direction to improve access and affordability of medicines.

The Government has already announced that it will spend over US $5.4 billion to provide essential medicines free to patients in government-run hospitals and clinics. The Government is also in the process of putting in place a central procurement authority to purchase medicines for its use, which, if operated on a level playing field, can realize economies of scale and create the conditions necessary to drive down costs through competition. All such policies can enhance access to medicines and also promote healthy competition in the industry. Both the outcomes cannot be achieved with any price control regime alone.

Expanding access to quality medicines at affordable prices is in everyone’s best interest, and the industry seems to have expressed its willingness and keenness to engage in the development and implementation of policies that will make medicines in India more affordable and accessible to all. 

Pharmaceutical industry expressed its support to the key principles of the new pricing policy, essentiality of drugs and market based pricing so as to ensure greater patient sensitized pricing of medicines. As cited by the Economic Advisory Council (EAC) of the Prime Minister, the negligible increase in drug prices over the last 7 years illustrates the intense competition in the Indian Pharmaceutical Market. In comparison, prices of other essential items including food items have increased steeply. Between 2004 and 2012, price rise of drugs has only been 3/8th of all commodities and half of that of manufactured products.

However, in order to make the pricing formula more robust and to prevent prices of lower priced drugs from moving towards the ceiling price, a section of the industry recommended that this formula be combined with price increases limited to Weighted Price Index (WPI) or 10 percent p.a. (the present price increase cap for non-DPCO) whichever is higher, for individual brands. This measure is expected to make it a fool proof pricing mechanism.

New Drug Policy to focus on all-round inclusive growth:

The role and objectives of the NPPP should help accelerating all-round inclusive growth of the Indian pharmaceutical industry and try to make it a force to reckon with, in the global pharmaceutical industry.

The drug policy is surely not formulated just to implement rigorous price control of drugs. The policy includes other key objectives to contribute significantly towards achieving the healthcare objectives of the nation and also to boost the growth of the industry, working closely with other related ministries of the government.

As stated above by the industry, to correct the imbalance between availability and affordability of essential medicines, in 2005, the government constituted a special taskforce, which is widely known as ‘Dr. Pronab Sen Committee’. This committee was mandated to recommend options other than existing methodology of price control (DPCO 95) for achieving the objective of making available life-saving and essential drugs at reasonable prices.

In its report, the committee did suggest an alternative measure at that time, concluding that the present price control system (DPCO 95) is inappropriate, inadequate and complex, besides being time consuming in its implementation.

Conclusion:

Unfortunately, the views of the MoF point towards continuation of the same old regime, which has failed to deliver for so many decades.

I therefore reckon, it is about time to recognize that the ‘Old is not always Gold’, at least in this particular issue. The government should in no way allow the saga of uncertainty in the formulation of a vibrant and inclusive Drug Policy to continue. The policy makers should consciously shun away any possibility of taking retrograde steps on this critical matter for the sake of both patients and the pharmaceutical industry of India, alike.

By: Tapan 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.

Replication of ‘Old Paradigm’ of the developed pharmaceutical markets is unlikely to yield results in the evolving new paradigm of India

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“Health leaps out of science and draws nourishment from the society around it”

- Gunnar Myrdal (Swedish Nobel Laureate Economist)

The success concoction of the global pharmaceutical industry for India, by and large, still remains to be sustained attempts in various forms of replication of the ‘Old Paradigm’ of the developed world, even when a ‘Public Health Interest’ oriented new paradigm has started evolving in the country, faster than ever before.

Very interestingly, efforts to arrest this paradigm change still continue, even when healthcare related government policies are getting more and more ‘Public Health Interest’ oriented under increasingly assertive public opinion, together with healthcare cost containment initiatives of various governments also in the OECD (Organization for Economic Co-operation and Development) countries.

Commercial and public relations strategies for replication or recreation of more or less similar business excellence environment of the developed pharmaceutical markets of the world now in India, though some may say is possible and would work, but in my view is highly improbable, at least in the foreseeable future. To be equally successful in India, creation of India centric robust and differentiated business models, broadly aligning with the new evolving paradigm of the country, could probably make more commercial sense for all concerned.

“See things as they are, not way you want them to be”:

“Maintain and sharpen your intellectual honesty so that you’re always realistic. See things as they are, not way you want them to be”, wrote the Management Guru – Mr. Ram Charan in his book titled, ‘Execution: The Discipline of Getting Things Done’ co-authored by Larry Bossidy. In the same book the authors deliberated on ‘The 10 Greatest CEOs Ever’.

One of these 10 greatest CEOs ever, George Merck of the global pharmaceutical giant Merck & Co articulated his vision for the Company way back in 1952 as follows:

“Medicine is for people, not for the profits.”

George Merck believed, the purpose of a corporation is to do something useful, and to do it well, which also ensures decent profits.

I have personally witnessed the Merck (MSD) employees to start their business presentations quoting the above famous vision, even today. George Merck’s vision, I reckon, is more relevant today than any time in the past.

In the same context, another very senior official of a global pharmaceutical major was quoted in the Harvard Business Review in its April 28, 2010 edition saying:

“As western pharmaceutical companies consider how to be successful in emerging markets, they must address two key questions:

  • How will we bring high-quality health care to patients wherever in the world they may live?
  • How do we effectively manage the transformation of the traditional pharmaceutical business model to one that meets the diverse range of needs of the emerging markets?”

He further said, “Our approach to providing patients with access to our medicines is evolving. We have extended a flexible-pricing strategy for middle-income countries to improve the affordability of our medicines and increase access for patients with lower income levels, while remaining profitable.”

Though some companies have been able to carefully pick up this important signal and strategize accordingly, many others still prefer to follow ‘their own ways’.

Increasing healthcare consumption of India attracting global players:

Along with the economic progress of India, healthcare consumption of the population of the country is also increasing at a reasonably faster pace. According to McKinsey India Report, 2007, the share of average household healthcare consumption has increased from 4 per cent in 1995 to 7 per cent in 2005 and is expected to increase to 13 per cent in 2025 with a CAGR of 9 per cent, as follows:

Share of Average Household Consumption (AHC) (%)

Household Consumption 1995 2005 E 2015 F 2025 F

CAGR %

1.

 Healthcare

4

7

9

13

9

2.

 Education & Recreation

3

5

6

9

9

3.

 Communication

1

2

3

6

12

4.

 Transportation

11

17

19

20

7

5.

 Personal Products and Services

4

8

9

11

8

6.

 Household Products

2

3

3

3

5

7.

 Housing & Utilities

14

12

12

10

5

8.

 Apparel

5

6

5

5

5

9.

 Food, Beverages & Tobacco

56

42

34

25

3

(Source; McKinsey India Report 2007)

From this study, it appears that among all common household consumption, the CAGR of ‘healthcare’ at 9 percent will be the second highest along with ‘education’ and ‘communication’ topping the growth chart at 12 percent.

As per this McKinsey study, in 2025, in terms of AHC for ‘healthcare’ (13 percent) is expected to rank third after ‘Food & Beverages’ (25 percent) and ‘transportation’ (20 percent).

Thus, AHC for ‘healthcare’ shows a significant growth potential in India, over a period of time. Hence, this important area needs to attract as much attention of the policymakers, as it is attracting the pharmaceutical players from all over the world, to help translate the potential into actual performance with requisite policy, fiscal support and incentives.

Such a scenario in the pharmaceutical space is difficult to ignore by any player with an eye for the future.

Sectoral break-up of the Healthcare Industry:

Even while looking at the sectoral break-up of the healthcare industry, the significant share of the pharmaceutical industry should be quite enticing to many global companies.

According to IDFC Securities 2010, the sectoral break-up of the US$ 40 billion healthcare industry is as follows:

Industry

%
Hospitals

50
Pharma

25
Diagnostics

10
Insurance & Medical Equipment

15

(Source: IDFC Securities Hospital Sector, November 2010)

A promising market:

Pharmaceutical market of India holds an immense future promise already being globally recognized as one of the fastest growing healthcare markets of the world. All components in the healthcare space of the country including hospital and allied services are registering sustainable decent growth, riding mainly on private investments and now fueled by various government projects, such as:

  1. National Rural Health Mission (NRHM)
  2. National Urban Health Mission (NUHM)
  3. Rashtriya Swasthya Bima Yojana (RSBY)
  4. Universal Health Coverage (UHC)
  5. Free Medicine from the Government hospitals
  6. Centralized procurement by both the Central and the State Governments

Supported by newer, both public and private initiatives, like:

  • Increase in public spending on healthcare from 1.0 per cent to 2.5 per cent of GDP in the 12th Five Year Plan period
  • Increasing participation of the private players in smaller towns and hinterland of the country
  • Wider coverage of health insurance
  • Micro-financing
  • Greater spread of telemedicine
  • More number of mobile diagnosis and surgical centers

Need to strike a right balance:

The pharmaceutical companies need to strike a right balance between ‘Public Health Interest’ and their expectations for a high margin ‘free market-like’ business policies in India.

Pharmaceuticals come under the ‘Essential Commodities Act’ in India, where government administered pricing for all drugs featuring in the ‘National List of Essential Medicines 2011’ is expected and cannot be wished away, at least, for now.

Despite all these concerns, India still remains a promising market for the pharmaceutical players, both global and local. McKinsey & Company in its report titled, “India Pharma 2020: Propelling access and acceptance realizing true potential” estimated that the Indian Pharmaceutical Market (IPM) will grow to US$ 55 billion by 2020 and the market has the potential to record a turnover of US$ 70 billion with a CAGR of 17 per cent during the same period.

Domestic Pharmaceutical Industry has come a long way:

Domestic pharmaceutical companies have positioned themselves as formidable forces to reckon with, not just locally but in the global generics market too.

Currently India:

  • Ranks 3rd in the world in terms of pharmaceutical sales volume.
  • Caters to around a quarter of the global requirements for generic drugs.
  • Meets around 70 per cent of the domestic demand for Active Pharmaceutical Ingredients (API).
  • Has the largest number of US FDA approved plant outside USA
  • Files highest number of ANDAs and DMFs
  • One of most preferred global destinations for contract research and manufacturing services (CRAMS)

Patients are still being exploited:

Unfortunate and deplorable incidences of exploitation of patients, mainly by the private players, are critical impediments to foster growth in quality healthcare consumption within the country.

In this context, ‘The Lancet’, January 11, 2011 highlighted as follows:

“Reported problems (which patients face while getting treated at a private doctor’s clinic) include unnecessary tests and procedures, rewards for referrals, lack of quality standards and irrational use of injection and drugs. Since no national regulations exist for provider standards and treatment protocols for healthcare, over diagnosis, over treatment and maltreatment are common.” 

Prevailing situation like this calls for urgent national regulations for provider-standards and treatment-protocols, at least for the common diseases in India and more importantly their stricter implementation across the country by both the global and local players.

Pharmaceutical key business processes in India are almost a ‘free-for-all’ type:

Despite many challenges and damning reports of the Indian Parliamentary Standing Committees, overall key business processes in India are something like ‘free-for-all’ types, mainly because of the following reasons:

  • No pan-India voluntary or mandatory code exists for ethical Sales and Marketing practices
  • Many regulatory controls and standards are reportedly below par
  • Regulatory control on clinical trials done in India is reportedly sub-standard. In many cases even  adequate compensation towards trial related deaths is reportedly not paid to the victims families by the companies, mostly fixing responsibilities to the ‘Ethics Committees’.

Key factors to take note of in the changing paradigm:

While looking at the big picture, the global pharmaceutical players, I reckon, should take note of the following factors while formulating their India- specific game plan to be successful in the country without moaning much:

  • At least in the short to medium term, it will be unrealistic to expect that India will be a high margin / high volume market for the pharmaceutical sector in general, unlike many other markets, across the world.
  • India will continue to remain within the ‘modest-margin’ range with marketing excellence driven volume turnover.
  • The government focus on ‘reasonably affordable drug prices’ may get extended to patented products, medical devices / equipment and other related areas, as well.
  • Although innovation will continue to be encouraged in the country, the amended Patents Act of India is ‘Public Health Interest’ oriented and different from many other countries. This situation though very challenging for many innovator companies, is unlikely to change in the foreseeable future, even under pressure of various “Free Trade Agreements (FTA)”.

Government no longer accepts that medicine prices are cheapest in India:

Pharmaceutical companies in India will be constrained to live with the continuing focus of the government and also of the civil society on ‘reasonably affordable medicines’ irrespective of the fact whether they are generic or patented.

The Department of Pharmaceuticals has reportedly started comparing the Indian drug prices with international equivalents in terms of the ‘purchasing power parity’ and ‘per capita income’ and not just their prevailing prices in various developed markets converted to rupees.With such comparisons the government has already started voicing that prices of medicines in India are not the cheapest but on the contrary one of the costliest in the world.

The above argument though interesting, worth taking note of, by all concerned to successfully chart-out their respective game plans for India.

A recent media report highlighted that an inter-ministerial group constituted for regulating prices of patented medicines in India has recommended using a per capita income-linked reference pricing mechanism for such products.

The above news item also mentions that Tarceva, a Roche lung cancer drug, costs Rs 1.21 lakh in Australia and France while it costs Rs 35,450 in India. But when adjusted for per capita income, which is significantly more in these countries compared with India, the price falls to Rs 10,309 and Rs 11,643, respectively, for both countries as indicated below:

Country India France Australia
Per capita gross national income (PCGNI) (US$) 3260 33940 38510
Ratio of PCGNI of other countries to India 1 10.4 11.8
Eriotnib (Tarceva) 100 mg price in India (Rs.) 35450 121085 121650
Eriotinib (Tarceva) 100 mg Price in terms of weighted PCGNI (Rs) 35450 11643 10309
Sunatinib (Stutent) capsule 50 mg (Rs)       46925 363216 310384
Sunatinib (Stutent) 50 mg price in terms of weighted PCGNI (Rs)              46925 34925 26303

(Source: The Economic Times, August 16, 2012)

Government encouraging R&D Focus on the diseases of the poor:

Many in India, including ‘Council of Scientific & Industrial Research (CSIR)’ feel that the pharmaceutical R&D activities should also focus on the diseases of the poor, which constitute the majority of the global population.

However, global pharmaceutical companies argue that greater focus on the development of new drugs for the diseases of the poor should not be considered as the best way to address and eradicate such diseases in the developing countries. On the contrary, strengthening basic healthcare infrastructure along with education and the means of transportation from one place to the other could improve general health of the population of the developing world quite dramatically.

The counterpoint to the above argument articulates that health infrastructure projects are certainly very essential elements of achieving longer-term health objectives of these countries, but in the near term, millions of unnecessary deaths in the developing countries can be effectively prevented by offering more innovative drugs at affordable prices to this section of the society.

Recognition of India’s healthcare priorities is important:

Despite chaos in many areas, as mentioned above, a paradigm change in the way pharmaceutical business to be conducted in India, is slowly but surely taking place, where replication of any western business model could be counterproductive. The strategy has to be India specific, accepting the priorities of the countries, even with all its ‘warts and moles’

Participative strategies should yield better results:

To achieve excellence in the pharmaceutical market of India, there is a dire need for all stakeholders to join hands with the Government, without further delay, to contribute with their global knowledge, experience and expertise to help resolving the critical issues of the healthcare sector of the nation, like:

  • Creation and modernization of healthcare infrastructure leveraging IT
  • Universal Health Coverage
  • Win-Win regulatory policies
  • Creation of employable skilled manpower
  • Innovation friendly ecosystem
  • Reasonably affordable healthcare services and medicines for the common man through a robust government procurement and delivery system

Right attitude of all stakeholders to find a win-win solution for all such issues, instead of adhering to the age-old blame game in perpetuity, as it were, without conceding each others’ ground even by an inch, is of utmost importance at this hour. 

It is high time for the Government of India, I reckon, to reap a rich harvest from the emerging lucrative opportunities, coming both from within and the outside world in the healthcare space of the country. Effective utilization of this opportunity, in turn, will help India to align itself with the key global healthcare need of providing reasonably affordable healthcare to all.

Conclusion:

Thus in my view, just replication of the ‘Old Paradigm’ of the developed pharmaceutical markets is unlikely to yield results in the new evolving paradigm of India.

In this rapidly changing scenario, the name of the game for all players of the industry, both global and local, I believe, is recognition of the changing market dynamics of India, active engagement in the paradigm changing process of one of the most important emerging pharmaceutical markets of the world and finally adaptation to the countries changing aspirations and priorities to create a win-win situation for all.

By: Tapan J Ray

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

India – Young Today, Old Tomorrow: Emerging Issues of Aging, Health and Socioeconomic Profile of the Country

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‘World Health Day’ is celebrated every year on April 7, the day ‘World Health Organization (WHO)’ was founded in 1948.

Each year, on this day, people from all walks of life across the globe are invited by WHO to focus on a particular emerging health challenge of global relevance, which becomes the theme of the ‘World Health Day’ for the year.

In 2012, the theme for this day was, “Aging and health: Good health adds life to years”. It focuses on how good health throughout the life span can help the senior citizens to lead a full and productive life and in turn makes them valuable and experienced resources not just to their respective families, but also to the societies and communities they belong to.

Aging affects all:

The process of aging, without any exception, affects the entire population, young or old, male or female, rich or poor, alike, across the world and is considered as one of the key factors of social transformations through the passage of time.

With the advancement in medical science coupled with increasing social awareness for living a healthy life, the average life expectancy of the population in the 20th century reportedly increased by around 30 years in the developed world and is expected to maintain similar growth trend in the 21st century, as well.

Now, with an increasing life expectancy even in the developing world, the issue is assuming greater magnitude and at a much faster pace.

In the language of Steve Jobs:

Steve Jobs, the global icon and the former CEO of Apple Inc., during his commencement speech to Stanford in 2005, very aptly articulated as follows:

“No one wants to die. Even people who want to go to heaven don’t want to die to get there. And yet death is the destination we all share. No one has ever escaped it. And that is, as it should be, because Death is very likely the single best invention of Life. It is Life’s change agent. It clears out the old to make way for the new. Right now the new is you, but someday not too long from now, you will gradually become the old and be cleared away. Sorry to be so dramatic, but it is quite true.”

In a normal situation old age precedes death and just like the inevitability of death, everybody, even a baby born today will need to embrace the old age before being cleared away by death. Thus, as the population will age as a natural process, there will be growing need to make even the old age more meaningful. Sounds like a tall call, but quite pertinent indeed.

Although, an average elderly person of today is much healthier than of the past generations, they will still need appropriate health management and social security plans, especially for an emerging economy, like India.

World population aging faster:

Population Division of the Department of Economic and Social Affairs of the United Nations in its publication titled, “World Population Aging:  1950-2050”, described the trend of ageing of the global population and highlighted the following:

  • Population aging is unprecedented : This is unparallel in human history and the current century will witness even more rapid aging than the previous one.
  • Population aging is pervasive:  It is affecting every man, woman and child across the world, though currently it is at different stages of progress in different countries.
  • Population aging is enduring:  The world will not return to the young populations of our ancestors.
  • Population aging has profound implications:  It affects many facets of lives of human beings.

Increasing burden of disease:

The burden of some serious age related diseases increases by manifold as the life progresses towards its ‘twilight zone’. Even now, the treatment costs and overall burden of age related diseases, both in the developed and the developing countries, are escalating in an alarming proportion.

Age related diseases:

According WHO, in the industrialized countries over 75 percent of deaths in people of over 65 years of age are due to cancer, cardiovascular and cerebrovascular diseases, in addition to disabilities like, loss of bone density leading to osteoporosis.

As per published reports, the incidence of age related Alzheimer’s disease, which is now incurable, will almost double every 20 years to reach around 66 million in 2030 and over 115 million in 2050.

Research for delaying the onset:

Reuters in an article titled, “Is aging a disease?” published in May 20, 2010 reported that many scientists from various parts of the world are now studying the genetic mechanisms of the old persons to help delay, if not overcome, the onset of diseases like Alzheimer’s, cancers, diabetes, cardiovascular ailments and many other age-related illnesses to help leading a better quality of life during old age of the human population.

Elderly population and the impact:

As per an estimate of the United Nations (UN), there will be around 1200 million people over 65 years of age by 2025. Currently, from across the world millions of aging people are denied of proper health care for various reasons. The situation in India is much worse.

It is envisaged by many that failure, either on the part of the Government or society at large, to address this critical issue today, could have a snowballing effect tomorrow.

In Japan, currently half of the national health budget is spent on the elderly individuals, which constitute around a whopping 23 percent of the country’s population. According to another estimate of the Japanese Government, by 2055 half of their total population will constitute of retired senior citizens.

India:

With over 65 percent of the population of India being now below 30 years of age, the country is  well poised to have one of the largest numbers of young and productive population in the world, though 7 percent of country’s 1.13 billion people are now over 60 years of age and the number is growing.

The Median Age of the population will keep on increasing over a period of time as follows:

Aging Profile: India and other countries

Year 2000 2015 2025 2030 2035 2040 2050
Median Age–India 23.4 27.2 30.3 31.4 33.5 35.0 37.9
Median Age–World 26.4 29.5 31.9 33.0 34.0 34.9 36.8
Median Age–More Developed Regions 37.3 41.2 43.3 44.2 45.0 45.4 45.2
Median Age–Less Developed Regions 24.1 27.5 30.0 31.2 32.4 33.5 35.7
Median Age–Least Developed Regions 18.1 19.6 21.2 22.2 23.3 24.5 27.1

(Source: Population Division, Department of Economic and Social Affairs, United

Nations Secretariat)

Growth of elderly population is much faster than the population:

As as per the paper titled, “Implications of an Aging Population in India: Challenges and Opportunities” presented at ‘The Living to 100 and Beyond Symposium’ of the Society of Actuaries in Orlando on January 12–14, 2005, the Indian population has approximately tripled during the last 50 years, but the number of elderly Indians has increased more than fourfold.

Assuming continuation of this trend, the United Nations have predicted that the Indian population will again grow by 50 percent in the next 50 years, with the elderly population recording another fourfold growth.

Changing demographic profile:

The situation in India, therefore, by no means is a trivial one and needs to be addressed with a right earnest and sooner, mainly because of the changes in the demographic profile of the country, as follows:

Projected Changes in Indian Demography (in Million)

Age Group

2000

2015

2025

2030

2035

2040

2050
0-14 Years

347

345

337

327

313

300

285
15-59 Years

593

782

865

895

919

937

938
>60 Years

77

119

167

195

223

248

308
Total

1,017

1,246

1,369

1,417

1,455

1,485

1,531

(Source: Population Division, Department of Economic and Social Affairs, United Nations Secretariat)

Thus, over a period of time in India, increasing number of less productive elderly people and the declining trend of the younger population, could adversely impact the overall socioeconomic profile and and the disease burden of the nation.

Conclusion:

In India, there has been hardly any support in terms of social security, especially for a vast majority of people, who are unable to work after becoming senior citizens of the country.

In a situation like this, the Government of India, civil society and the private sector enterprises of the country should work in tandem to give shape to appropriate policy measures to effectively address the issues of the increasing number aging population of the country, over a period of time.

This is necessary not just for the socioeconomic reasons, but also to arrest any significant increase in the overall disease burden of the nation with its possible adverse impact on the growing economy of the country.

Continuing lack of interest to work out a long term social and policy measures to address the important issues related to population aging in India, in a holistic way, could significantly impede the pace of economic growth of the country, celebration of the ‘World Health Day’ on April 7, 2012 notwithstanding.

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.