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A Rare Strategic Acrobatic Feat in Covid Time

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‘Keep nose to the grindstone while lifting eyes to the hills.’ Quite a while ago, all-time global management guru – Peter Drucker used this essential acrobatic feat as an example, for the business strategists. This illustration signifies the criticality of harmonizing decisions affecting both the short and the long-term goals of an organization, for a sustainable business excellence.

In most recent times, the pharma major AstraZeneca that has virtually become one of the household names, for developing a Covid-19 vaccine candidate with the University of Oxford, has performed the above acrobatic feat – with precision. During the prevailing unprecedented health crisis, the Company has unequivocally proven that it remains on course – in achieving its dual objectives, as Drucker had prescribed in his management classic – ‘The Practice of Management.’

It happened in tandem – without getting overwhelmed by the disruptive forced of Covid pandemic, unlike most others. Immediately, the Company focused on an urgent objective of saving the humanity – by developing, manufacturing and delivering a Covid vaccine to the world, in a record time. This was possibly a relatively short-term goal. And closely followed the other – a critical strategic decision for the organization’s long-term sustainable business excellence.

I have discussed before, the Company’s first initiative – developing a Covid vaccine candidate with the University of Oxford. Hence, in this article, I shall focus on two other related areas:

  • Deadly impact of rare diseases in some Covid infected young patients.
  • Why not some large Indian companies also explore similar strategies as demonstrated by AstraZeneca – and the reasons behind the same?

Before going into those areas up front, let me start with a brief description of AstraZeneca’s intent to expand its footprint in the of area of rare diseases, besides immunology area to help treat rare types of cancer.

The acquisition:

On December 12, 2020 AstraZeneca announced that to accelerate its strategic and financial development, the company will acquire Alexion valuing $39 billion. Subject to all statutory approvals, the deal is expected to close in the third quarter of 2021. Interestingly, Alexion’s top brand – Soliris, is the world’s one of the most expensive drugs in the world. It is prescribed to treat a rare – life-threatening blood disease paroxysmal nocturnal hemoglobinuria (PNH). Incidentally, rare diseases have also some significant relevance for Covid infected patients. Let me now recapitulate, some key aspects of rare diseases.

Some key aspects of rare diseases: 

Rare Diseases (RD) – also referred to as Orphan Disease (OD), are diseases affecting a small percentage of the population, and include genetic diseases, rare cancers, infectious tropical diseases and degenerative diseases. There is no universally accepted definition of a rare disease, yet. Different countries define these differently. However, the common considerations in the definitions are, primarily, disease prevalence and to a varying extent – severity and existence of alternative therapeutic options.

Impact of some rare diseases in Covid infected patients: 

Since the beginning of the Covid pandemic, people with underlying diseases, such as, hypertension, diabetes, cardiovascular and kidney disorders, are considered to fall in the high-risk group. They are more likely to have severe disease and complications and need to be extra cautious of the infection. Importantly, it has been recently reported that some rare diseases also increase risk of dying during Covid-19 pandemic at a younger age.

For example, as reported on December 07, 2020, recent studies indicate, rare autoimmune rheumatic diseases increase risk of dying during Covid-19 pandemic for younger patients. The researchers also found that women with rare autoimmune rheumatological diseases (RAIRD) had a greater increase in all-cause mortality rates during the pandemic when compared to men with RAIRD. However, there seems to be an India specific issue also in this situation, as well.

India specific issue for Covid infected patients with some rare diseases:

Some India specific issues on RD, could have a significant adverse impact on Covid infected patients in the country. One such critical issues is the ‘Baseline Knowledge of Rare Diseases in India.’ This fact was well captured in an important survey that was published with the same name, as an original article, in the ‘International Journal of Rare Diseases & Disorders,’ on November 06, 2019.

The study noted, among others:

  • Although, rare diseases have recently received worldwide attention, the developing countries are seriously behind in regard to awareness, drug development, diagnosis, and social services, in this area. India, which has one-third of the world’s rare disease population, has no accurate assessment of the problem.
  • The drugs for ‘Rare Diseases (RD), also called Orphan Drugs (OD)’, often cost exorbitant with difficulties in diagnosis and treatments.
  • Indian policymakers want to find out the number of RD and the extent of the population suffering from them and help provide treatment for them, which is a challenging task with 1.45% GDP health care budget for 1.3 billion people.
  • The health care professionals appear to have some awareness as compared with non-healthcare professionals, but even among health care professionals, only one third had a rudimentary understanding of RD and OD, whereas three-fourths have virtually no knowledge of RD.
  • Forty-three percent of health professionals had not seen rare disease patients, and a large percent of practicing physicians had not seen even one rare disease patient in their entire professional practice.

Thus, it is clear from this survey that the most important issues are awareness and diagnosis, as many rare diseases are not diagnosed or possibly misdiagnosed. Besides, the survey also observed, since 1983, many global companies started developing orphan drugs after the Orphan Drug Act implementation. There is none at this time in India, although in 2017, the Drugs & Cosmetic Act. 1945 has been amended to include “rare diseases and orphan drugs”.

The National Policy on Rare Diseases flagged some of these facts:

The ‘National Policy on Rare Diseases 2020,’ for India, released by the Union Ministry of Health on February 07, 2020, acknowledged many of these important facts. It also said, ‘Considering the limited data available on rare diseases, and in the light of competing health priorities, the focus of the draft policy is on prevention of rare diseases as a priority as identified by experts.’

Interestingly, the first of such policy was prepared by India in 2017 and a committee was appointed to review it in 2028. However, recently published the National Policy on Rare diseases, has also noted one more important point. It noted: ‘Paradoxically, though rare diseases are of low prevalence and individually rare, collectively they affect a considerable proportion of the population in any country, which according to generally accepted international research is – between 6% and 8%.’ Currently, India, reportedly, doesn’t have any registry of rare disease, which has now been entrusted to the Indian Council of Medical Research (ICMR) in the National policy.

Common symptoms can hide underlying rare diseases, leading to misdiagnosis:

The above policy has also noted, rare diseases are characterized by a wide diversity of signs and symptoms that not only, reportedly, vary from disease to disease, but also from patient-to-patient suffering from the same disease. Importantly, relatively common symptoms can hide underlying rare diseases, leading to misdiagnosis.

During Covid treatment, similar circumstances could lead to a serious life-threatening situation. The 2020 RD Policy also reiterates: “Early diagnosis of rare diseases is a challenge owing to multiple factors that include lack of awareness among primary care physicians, lack of adequate screening and diagnostic facilities etc.” That said, yet another key question arises – will developing and marketing such drugs be profitable for the pharma industry?

Will developing such drugs be profitable for the pharma industry?

It is worth noting that the National Policy on Rare Diseases 2020, aims more at lowering the incidence and prevalence of rare diseases based on an integrated and comprehensive prevention strategy, rather than ensuring patient access to affordable treatments. Nonetheless, it also says, within the constraints on resources and competing health care priorities, India will try to enable access to affordable health care to patients of rare diseases which are amenable to one-time treatment. In general, the policy suggests, ‘voluntary crowdfunding for treatment’ of rare diseases.

With this being the prevailing situation in India, even during Covid pandemic, an interesting article – ‘How Orphan Drugs Became a Highly Profitable Industry,’ published in The Scientist, noted some important facts in this area. It highlighted: ‘Government incentives, advances in technology, and an army of patient advocates have spun a successful market—but abuses of the system and exorbitant prices could cause a backlash.’

It also articulated, despite higher costs and less-certain returns, investments in drug development on the rare diseases side appear to ‘be bucking the trend.’ The result of the global focus on RD nowadays is: ‘Firms with marketing authorization for orphan products, are now more profitable than those without.’

This also partly explains the financial rationale behind AstraZeneca’s recent acquisition of Alexion Pharmaceuticals, valuing $39 billion.

Conclusion: 

As of December 20, 2020 morning, India recorded a staggering figure of 10,031,659 of new Coronavirus cases with 145,513 deaths. The country has already crossed 10 million in Covid cases as the vaccine approval remains pending. The threat of subsequent waves for further spread of Covid infection continues to loom large in many states. Meanwhile, many studies indicate that comorbidity should now include rare diseases, as well, especially to prevent deaths in younger patients. From this perspective effective diagnosis and treatment of RD are also coming under spotlights. Curiously, the National Policy on Rare Diseases 2020 focuses more on awareness and prevention of RD rather than access to affordable treatment, particularly in Covid infected patients to save precious younger lives. As I wrote previously and still believe, the ‘National Policy on Rare Diseases’ becomes more meaningful with ‘Orphan Drugs Act.’

Vaccines to prevent Covid infections are also expected to get emergency approval in India, shortly. At lease, some of these being available at affordable prices, including AstraZeneca-Oxford vaccine, according to reports. As recent reports indicate the same company, is also entering into RD therapy areas, through a key acquisition, yet another hope looms large. A hope for availability of relevant RD drugs at an affordable price for Covid infected patients, despite other apprehension, as I wrote before.

That apart, purely from the business management perspective, as well, this rare strategic acrobatic feat of AstraZeneca - ‘Keep nose to the grindstone while lifting eyes to the hills,’ during the Covid crisis, I reckon, is exemplary for the practicing managers.

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.

 

Enhancing Pharma Brand Experience In The New Normal

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In these days of unprecedented and all-pervasive disruptions – almost in every facet of life – caused by an unknown virus, scramble to find an effective solution for saving lives and livelihoods, still continue. The discomfiture seems to be omnipresent across the healthcare space.

On its upside, pharma witnessed an unparalleled surge in various collaborative activities both in the search for a cure and also in preventing the infection. The downside is, conclusive scientific evidences are still not available for these drugs – except one that was unraveled just on June 16, 2020. On the contrary, after granting emergency authorization on March 30,2020, for use of hydroxychloroquine and chloroquine in Covid-19 infection, the US-FDA on its own, revoked it on June 15, 2020 for lack of conclusive evidence.

Amid initiatives of saving lives, pharma industry – besides trying to be a part of saving livelihoods – alongside others, is also gearing up to restart its demand generation activities, and move ahead, as the looming crisis continues, unabated.

From the pharma industry perspective, this new beginning, as it were, in a scenario that was never envisaged in the past, would require two most critical ingredients, amongst several others, more than ever before. It is another major transformation, where pharma leadership would require encouraging:

  • A change in mindset with a fresh pair of eyes to find game-changing opportunities in the new normal.

This article will focus on the relevance of these two areas, for the drug companies to come out with flying colors, yet again, in a difficult situation.

Evolving changes in the pharma ecosystem:

That the evolving ecosystem is changing the life sciences value chain and creating new opportunities to capture future value by providing end-to-end solutions, was also highlighted in the EY report - “Today for tomorrow: realizing the potential of Life Sciences 4.0.” This was released in February 2020, as Covid-19 started changing the world and the way businesses operate.

To successfully navigate through such fast-changing healthcare landscape, ‘companies need to develop an exponential mindset that leverages technology for business model reinvention and empowering the workforce,’ the report emphasized.

As moving in this direction with agility is critical, drug companies will require a leadership team of a different mindset, who can ferret out path-breaking opportunities amid ‘never before’ problems. Mainly because, the strategy for success will be quite different from the traditional recent practices. Enhancing contemporary and personalized value of product and service offerings to healthcare consumers – with end-to-end solutions, won’t be everybody’s cup of tea in the shifting paradigm.

Let me explain some basic changes in the traditional sales and marketing domain to drive home this point. 

Some basic changes in the traditional sales and marketing practices:

Until Covid-19 battle is decisively won by a vast majority in the planet earth, by acquiring either a vaccine-induced or herd-immunity – maintaining social distancing and strict compliance with other health norms will remain in force. Besides, a palpable fear among a large population from getting infected by the Coronavirus, is unlikely to vanish soon. From this angle, many traditional pharma demand generation activities may not be as productive as they used to be, such as:

  • Meeting doctors the way one used to in the past for a face to face prescription demand generation activity, will be different. Moreover, per doctor call time may increase significantly – with a commensurate increase in cost, impacting average yield per call.
  • All marketing events, requiring the participation of many doctors under one-roof, namely – large symposia, Continuing Medical Education (CME) or even sending doctors by air for educational group-tours or even sponsoring any other medical events, may be challenging now.
  • Changing mindset of doctors, triggered during a long national ‘Lockdown’ period to remain updated from different sources in the cyberspace, may continue, prompting lesser interaction with drug company representatives.

There are many other areas, which different companies may consider a great commercial value, would also need to be identified – as the pharma companies restart their prescription demand generation activities. Nonetheless, equally important is to zero-in to alternative strategic approaches, soon.

Zeroing-in to alternative strategic approaches with a new mindset is critical:

There could be several strategic approaches for this area. One such is, mapping the end-to-end customer journey in the changing situation, to enhance their brand experience during this process. As the time is very limited now, being ‘right the first time’, will be crucial for pharma marketers. Otherwise, competition will prevail.

Any game-changing approach at this time, will call for a fresh pair of eyes, having a contemporary mindset. ‘I did it this way before’ approach will not work, as the situation is unprecedented, and there are no footsteps to follow. Thus, I reckon, the organization will require taking the following measures based on a predictive mindset and actionable insight:

  • Creating a ground swell of the need for the proposed changes – explaining the benefits of each.
  • Prompt mitigation of any resistance that may surface during this process.
  • Identifying the loose knots in the process of strategy implantation.
  • Choosing the implementation team with right competence, mindset and agility in achieving the set goals, across the business domains.
  • Providing continuous training, problem-solving support – ensuring an all-time learning mindset for all in the selected team.
  • Initiating an emotional omnichannel engagement to take all stakeholders on board – with aligned messages – for desired outcome.
  • Assigning accountability to each one, for achieving agreed results.

The biggest hurdle in the business transformation process:

In tandem, another key point also to be borne in mind. Because, with each passing day, some new finding in Covid-19 disease area – some good news for drug and a vaccine development, or could even be another crisis, may keep unfolding. The team should always remain on course, despite limited resources and other business challenges.

Many will know, the biggest hurdle for any transformation process is culture. Open minds of all concerned will make the process easier. With traditional business practices, it will be complex to navigate through the current situation. Therefore, a change in people’s mindset in the new situation, is a fundamental requirement to restart the pharma industry – in full steam.

The core objective needs to be understood by all:

The core objective during the entire process of such transformation, is to enhance a patient-centric brand experience – throughout its customers’ journey, seeking an end-to-end disease treatment solution. The process would, in turn, require a deep understanding of the emotions, requirements and related preferences of the customers. This is critical to establish a meaningful human connection, virtual or otherwise, with them.

Nevertheless, it will entail data-based and detail mapping the customers’ journey, while seeking an effective treatment solution for the disease that one is suffering from. Accordingly, creating a patient-centric content to build a brand persona, alongside crafty dissemination of the same for the target groups, through omnichannel platforms, will need to be diligently worked out. More important is its execution with military precision, by emotionally connecting the intended stakeholders to deliver a unique brand experience.

Conclusion:

Like many other countries, ‘unlock down’ process related to Covid-19 pandemic has already started in India, with varying degree at different places, though, depending on the nature of intensity and spread of the infection. However, the number of Coronavirus infected cases continues to maintain a steep ascending trend. As on June 21, 2020 morning, the recorded Coronavirus cases in the country reached 411,727 with 13,277 deaths.

The unlocking process of critical pharma industry activities has also started rolling. However, the new beginning has to be in sync with the fast-evolving changes in the pharma ecosystem. Many processes and deliverables, including formulation and implementation of an effective strategy for the same, will no longer be a replica of the traditional ones, as it were.

Similarly, to find game-changing opportunities in the pharma sales and marketing space, the marketers will need a change in their current mindset and having a fresh pair of eyes. This will be essential for an unbiased and effective mapping of end-to-end customer journey to enhance their unique brand experience. In tandem, it will help create key brand differentiators with cutting edges, for business excellence in the new normal.

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.

Multifaceted Coronavirus Narrative Raises Multiple Questions

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Last night, amid the national lockdown, many people followed Prime Minister Modi’s video message, broadcasted on April 03 at 9 am for all, ‘to challenge the darkness of Coronavirus together – with a Diya, candle, torch or flashlight, at 9 pm for 9 minutes, from their respective balconies.’ That was the 12th day of 21-day lockdown, when the deadly microbe – Covid19 infected, tested and detected cases climbed to 3,577 in the country, with the death toll rising to 83. This is against 564 - the total number of confirmed cases in India when the lockdown commenced on March 24, 2020.

With all this, a mind-boggling narrative is developing at an accelerating pace. It’s not just about the rogue microbe – rampaging the world hunting for its prey. But also pans over multiple dimensions of its fallout, impacting virtually everything, for all. People of all sections of the society are participating, deliberating or debating on this issue, as the invisible camera of destiny rolls on. Unprecedented!

That’s the real world where, despite fear of an unknown future, most people prefer freedom of expression while playing a constructive role in containing the menace, collectively. We are witnessing a similar scenario – the world over. But, more in the democratic nations. Relatively enlightened citizens will always want to participate in this emerging chronicle, shaping the overall narrative and help sharpening the nations Covid19 policy further – instead of being passive onlookers.

Meanwhile, the objective of maintaining physical distancing during 21-day national lockdown period and beyond must be achieved, regardless of any public discord on its mechanics. This has to happen, primarily because of the TINA factor. Likewise, it’s also a prerequisite that the lockdown is handled efficiently, with meticulous advance planning, deft and dignified handling of any situation, by all and for all. That said, the good news is, newer scientific, evidence-based data are revealing more actionable pathways, in this multifaceted narrative.

A multifaceted narrative raises multiple questions:

As I wrote above, Covid19 narrative is multifaceted and not just one dimensional. It’s true beyond doubt: ‘If there is life, there is the world.’ But, that has to be a life with dignity, a life that help protect families and facilitates contributing to the nation, in different ways – enabling a scope of fulfillment of all.

In this article, I shall, explore some important facets of the evolving narrative on the Covid19 outbreak to drive home this point. In that process some very valid questions, as raised by many, also deserve to be addressed. Some of these include:

  • Covid19 is a war like situation where no questions are asked about the strategic details of a warfare, why the same is not being followed today? In a war some collateral damages are inevitable, why so much of noises now?
  • Why has Covid19 created a general panic with stigma attached to it?  
  • Panic is avoidable, but is the threat real. If so, why?
  • Why people violating national lockdown by migrating from the job location to respective hometowns – increasing the risk of the disease spread, must be brought to their senses mostly through the harsh measures?
  • In the absence of any vaccine or an effective curative drug, why all decisions of policymakers must be blindly accepted by all, during national lockdown and maybe beyond, as if there is ‘not to reason why, but to do or die?’

Let me now explore each of these questions.

A war like situation?

No doubt Covid19 is a war like situation, but with some striking dissimilarities between a conventional war and this war. A conventional war is fought by a well-trained and well-armed defense forces with already developed a gamut, against a known and visible enemy nation.

Whereas, the war against Covid19 is against an invisible and unknown microbe’s sudden attack, being fought in India by a limited army of health care professionals and workers. They fight this war, mostly without adequate or no battle gear, like Personal Protective Equipment (PPE), testing kits and ventilators, supported by a fragile health care infrastructure.

Moreover, in the conventional warfare, the type of advance information and intelligence that the Governments usually possess against the enemy nations, can’t be matched by any private domain experts.

Whereas, Covid 19 still being a lesser known entity to medical scientists, as on date, the remedial measures are still evolving. Only scientific-evidence-based data can create actionable pathways for combat, spearheaded by the W.H.O. Thus, most people expect the nation to comply with, at least, the current W.H.O guidelines for health-safety of the population.

Further, in the cyberspace, several latest and highly credible research data are available for all. These are being well-covered by the global media as a part of the narrative. Thus, unlike conventional warfare, external experts may know as much, if not even more than the Government on Covid19.

Some avoidable show-stoppers:

There are several such avoidable show-stoppers. For example, when one reads news like, ‘Delhi Government Hospital Shut As Doctor Tests Positive For Coronavirus,’ or something like, ‘Indian doctors fight Coronavirus with raincoats, helmets amid lack of equipment,’ alongside a jaw-dropping one, ‘India Sends COVID-19 Protective Gear To Serbia Amid Huge Shortage At Home,’ chaos in the narrative takes place.

In the tough fight against Covid19 menace, these much avoidable fallout may be construed as show-stoppers, if not counterproductive. Many may advocate to pass a gag order against revelation of such difficult to understand developments, and keep those beyond any public discussion. Instead, why not order a transparent enquiry by independent experts to find facts – holding concerned people accountable?

Why has the disease created so much of panic with stigma attached to it?

This is intriguing because, according to the W.H.O – China Joint Mission report on COVID-19, around 80 percent of the 55924 patients with laboratory-confirmed COVID-19 in China, had mild-to-moderate disease. This includes both non- pneumonia and pneumonia cases. While 13·8 percent developed severe disease, and 6·1 percent developed to a critical stage requiring intensive care.

Moreover, The Lancet paper of March 30, 2020 also highlighted, in all laboratory confirmed and clinically diagnosed cases from mainland China estimated case fatality ratio was of 3·67 percent. However, after demographic adjustment and under-ascertainment, the best estimate of the case fatality ratio in China was found to be of 1·38 percent, with substantially higher ratios in older age groups – 0·32 percent in those aged below 60 years versus 6·4 percent in those aged 60 years or more, up to 13·4 percent in those aged 80 years or older. Estimates of the case fatality ratio from international cases stratified by age were consistent with those from China, the paper underscored.

Even the Health Minister of India has emphasized, ‘around 80-85 percent of cases are likely to be mild.’ He also acknowledged: “My biggest challenge is to ensure that affected people are treated with compassion, and not stigmatized. This is also applicable for the health care workforce, which is working hard to counter this epidemic. It is through concerted, community-owned efforts, supported by the policies put in place by the government that we can contain this disease.” This subject, surely, needs to be debated by all, and effectively resolved.

Panic is avoidable, but does a real threat exist with Covid19?

As The Lancet paper of March 30, 2020 cautions by saying - although the case fatality ratio for COVID-19 is lower than some of the crude estimates made so far, with its rapid geographical spread observed to date, ‘COVID-19 represents a major global health threat in the coming weeks and months. Our estimate of the proportion of infected individuals requiring hospitalization, when combined with likely infection attack rates (around 50–80 percent), show that even the most advanced healthcare systems are likely to be overwhelmed. These estimates are therefore crucial to enable countries around the world to best prepare as the global pandemic continues to unfold.’ This facet of Covid19 also requires to be a part of the evolving narrative to mitigate the threat, collectively, with a robust and well thought out Plan A, Plan B, Plan C….

Violation of lockdown increases the risk manifold, but… 

There isn’t a shade of doubt even on this count, in any responsible citizen. Besides individual violation, recently a huge exodus of migrant laborer’s ignoring the lockdown raised the level of risk for others. This exodus should have been stopped at the very start, by better planning and with empathy and dignity by the law enforcing authorities, as many believe. Curiously, even the current Chief Justice of India (CJI) commented, on March 30, 2020: “The fear and the panic over the Coronavirus pandemic is bigger that the virus itself,” during a hearing on the exodus of migrant laborers from workplace to their respective hometowns, due to Covid19 lockdown.

To mitigate the risk, the CJI advised the Government to ensure calming down ‘the fear of migrants about their future, after being abruptly left without jobs or homes because of the 21-day lockdown to prevent the spread of Coronavirus.’ The Court felt, ‘the panic will destroy more lives than the virus.’ Thus, the Government should “ensure trained counsellors and community leaders of all faiths visit relief camps and prevent panic.”

The CJI also directed the Government to take care of food, shelter, nourishment and medical aid of the migrants who have been stopped. This appears to be the desirable pathway of preventing the migrant exodus, causing greater risk to people, requiring better planning, deft situation management with empathy and dignity, by the law enforcing authorities. However, individual violations, if any, can be addressed by intimately involving the civil society, against any possibility of the disease spread.

Whatever decision the policy makers take, must be blindly accepted by all:

In this area, all must first follow what the Government expects us to do. Maintaining strict compliance with such requirements. But, some people do ask, is it in total conformance with the steps W.H.O recommends following? At the March 30, 2020 issue of the Financial Times reported, the W.H.O’s health emergency program has outlined four factors that might contribute to the differing mortality rates in Covid19 outbreak:

  • Who becomes infected?
  • What stage the epidemic has reached in a country?
  • How much testing a country is doing?
  • How well different health care systems are coping?

Many members of the civil society are also keen to know these facts, and may want to seek clarification, if a gap exists anywhere. After all, Covid19 outbreak has brought to the fore, an unprecedented future uncertainty of unknown duration, involving not just life, but a sustainable livelihood and a dignified living in the future, for a very large global population, including India.

Conclusion:

There seems to be a dose of chaos in an otherwise reasonably controlled scenario. One option of looking at it as a pure law and order issue, which needs to be brought to order only with a heavy hand. The second option is to accept it as a golden opportunity to take all on board, by clearly explaining what people want to know – with reasons, patience, persuasion, empathy and compassion, as is happening in many countries.  Of course, without compromising on the urgency of the situation. This is a challenging task, but a sustainable one. Overcoming it successfully, will possibly be the acid test of true leadership, at all levels. However, the slowly unfolding narrative on the ground, doesn’t appear to be quite in sync with the second option.

In the largest democracy of the world, people want to get involved in a meaningful discussion on Covid19 crisis, collectively – based on evidence-based scientific data. Then, it’s up to the policy makers to decide what is right for the country and in which way to go. In tandem, fast evolving, multifaceted Coronavirus narrative, I reckon, will keep raising multiple questions.

As the disease spreads, the pathways of combating it decisively, is being charted by different experts, led by the World Health Organization (WHO). This is being widely covered by the mainstream global media, even in the din of a cacophony. Nonetheless, it is generally believed that a true relief will come, only after a vaccine is developed and made available and accessible to all sections of the world. Till such time a ‘hide and seek’ game, as it were, is expected to continue.

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.

 

Cacophony Over Coronavirus Lockdown

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Currently, the entire India is trying hard to comply with the 21-day lockdown of the country, as communicated by Prime Minister Narendra Modi to the nation at 8 pm on March 24, 2020. The very next day,  while addressing his parliamentary constituency of Varanasi via video, he said, “the Mahabharata war was won in 18 days but this war against Coronavirus will take 21 days.”

After this announcement most people’s life, as I myself can feel it, has changed as never before in the past. Unlike the West, in India most of us are too much dependent on domestic help, for routine chores of the family. How difficult these are, at least, I never experienced in the past. Will life, in its entirety, ever be the same gain?

In addition, shortages of most of the essential items were felt everywhere, be these vegetables, grocery items or medicines. Leave aside, the non-essential necessities. But, the bottom-line is, the lockdown has to be followed. There isn’t any other effective alternative to protect ourselves, those working for us to make our lives easier and comfortable, our respective neighborhood and thereby our country. In its midst, a cacophony over this decision is palpable, whatever may be the reason. Many are from highly credible sources.

Exploring various facets of the cacophony, this article will dwell on the question that will arise at the moment of truth – on or after April 15, 2020: What happened after 21-day lockdown of the entire nation. I shall try to focus on this question with the most relevant facts.

The Government’s rationale behind 3 weeks lockdown:

As explained by the Prime Minister and later by several Indian experts, the rationale behind the 21-day lockdown will include primarily the following:

  • The incubation period of Covid19 is around 5 to 14 days. This is also the potential transmission period of the microbe. Effective social distancing of all, may contain or even stop its spread.
  • As all viruses can sustain or exist only by replicating, they are completely dependent on a host cell for survival and can’t reproduce outside a cell. Social distancing may help in this area, as well.
  • Since, the world doesn’t have any vaccine for Covid19, as yet, prevention alternatives are limited.

Cacophony includes: Is complete national lockdown the only answer?

Several highly credible voices are asking: Is the complete lockdown of the nation the only answer? For example, Professor Vikram Patel at Harvard Medical School, wondered about the relevance of national lockdown in his article of March 26, 2020. He wrote, without any widespread community transmission of the disease, the Government might have staved off the worst without a sledge-hammer approach of national lockdown, which no country at India’s stage of the epidemic has imposed.

Elaborating the alternative approach, he suggested to intensify case finding approach through testing and contact tracing, quarantining those who are infected, physical distancing by everyone, graded travel restrictions, preparing the health system to cater to those who may need intensive care and protect health care workers. Even locking-down limited populations with community transmission will be prudent. When properly implemented these steps ‘could have stopped the epidemic in its tracks.’ Citing examples, he wrote, many of our Asian neighbors have done it successfully. Even China, the original epicenter of the epidemic, did not lock down the entire country.

According to other reports, as well, the countries, such as, Singapore, Germany, Turkey, Taiwan and China, have so far handled Covid19 much better than other countries in containing the pandemic. They all ‘refrained from imposing a complete, nationwide curfew-like lockdown.’ China did bring only the Hubei province under complete lockdown, but not the whole country. Scientists expect that Covid19 will exist despite lockdown – till an effective vaccine is developed and made available for all.

Are our doctors adequately protected against Covid19?

Today, even the doctors and other health care workers remain extremely vulnerable to the disease.  Even in AIIMS doctors, reportedly, are using masks and sanitizers made by themselves or buying them. There is already a shortage of Personal Protective Equipment (PPE), which doctors are worried about. PPE includes face masks, eye shield, shoe cover, gown and gloves. These can be used for only five or six hours before having to discard them. Even N-95 face masks cannot be used for more than a day or two. And there is an elaborate protocol in place, as well, on how to dispose them. As the report said, doctors fighting Covid19 asked: ‘Not just claps, give us personal protective gear.’

Further, the Huffpost article of March 20, 2020 had emphasized with details: “Staying home can be hard, but it’s not even an option for the health care workers and scientists on the front lines of our global effort to thwart the COVID-19 pandemic. They have to arm themselves to face potentially infected patients and deadly viruses every day.” This gets vindicated by a March 26, 2020 report. It brought to our notice that 900 people have been quarantined after a Delhi Doctor unprotected by PPE tests COVID19 positive.

Another news article reported: “A day after the entire nation flocked to their balconies to clap for the heroes in the medical field, who are working relentlessly to arrest the Coronavirus pandemic, doctors in Telangana and Andhra Pradesh were greeted with humiliation and assault.”

Cacophony expands to religious solutions and explanations:

With the panic on Coronavirus spreading, the cacophony also includes religious solutions to the disease. For example, as reported by Reuters on March 14, 2020, ‘Hindu group offers cow urine in a bid to ward off Coronavirus.’ Another YouTube video also shows: ‘Hindu activists in India drink cow urine to ‘protect’ themselves from Coronavirus.’ According to many there are many takers of such concepts, whether one likes it or not.

Intriguingly, a top film star with 40.7 million twitter followers twitted on March 22, justifying public clapping at 5 pm during ‘Janata curfew’ and attributing a bizarre reason to it: ‘clapping vibrations destroy virus potency,’ which he later deleted against strong adverse comment from the scientific community. However, a number of, apparently responsible people, a few of whom are also known to me, often comment – such things can happen and do happen in a vast country like India. It isn’t a big deal. The cacophony goes on.

Be that as it may, regardless of enthusiastic public clapping and availability of cow-urine based solutions – fighting deadly Covid19 of potentially infected patients – without PPE, I reckon, is quite akin to asking a professional army to fight a tough battle without having adequate battle-gear.

Level of India’s preparedness just before national lockdown:

To ascertain this, leaving aside other critical areas, such as, quarantine and isolation facilities, let me cite a few examples related to PPE and testing kits. A news that came just a day before the national lockdown, reported a Government official commenting on a textile material used for masks and other PPEs: “Currently, demand is for 8 lakh bodysuits and N95 masks of the material. Orders for these have been placed.”

However, the Directorate General of Foreign Trade (DGFT), reportedly, banned the export of textile material for masks and coveralls, under the Foreign Trade (Development) and Regulation Act, just recently. Interestingly, as Reuters reported on March 28, 2020, ‘India needs at least 38 million masks and 6.2 million pieces of personal protective equipment as it confronts the spread of Coronavirus.”

Further, when testing is the only acid test to diagnose Covide19 infection – as on March 19, 2020, India, reportedly, had tested 14,175 people in 72 state-run labs, which is regarded as one of the lowest testing rates in the world. This is because: India has limited testing facilities. Thus, only those people who have been in touch with an infected person or those who have travelled to high-risk countries, or health workers managing patients with severe respiratory disease and developing Covid-19 symptoms are eligible for testing. Whereas, according to W.H.O, “All countries should be able to test all suspected cases, they cannot fight this pandemic blindfolded”.

However, after declaration of the national lockdown, the Indian Council of Medical Research (ICMR) on March 25, 2020, reportedly, invited quotations from manufacturers for supply of 1 million kits to test patients suspected of suffering from COVID-19. After getting a glimpse of the cacophony over the national lockdown for Coronavirus supported by a few examples, let us see what steps the W.H.O advises for all countries to follow in this pandemic. 

The steps W.H.O recommends following:

On March 16, 2020, the Director General (DG) of the World Health Organization (W.H.O) said: “We have a simple message to all countries – test, test, test.” On that day, observing that more cases and deaths have been reported in the rest of the world than in China, as compared to the past week, the DG elaborated the following:

  • Although, there has been a rapid escalation in social distancing measures, like closing schools and cancelling sporting events and other gatherings, but, not an urgent enough escalation in testing, isolation and contact tracing – which is the backbone of the response.
  • Social distancing measures can help reduce transmission and enable health systems to cope with. Handwashing and coughing into your elbow can also reduce the risk for yourself and others. But on their own, they are not enough to extinguish this pandemic. It’s the combination that makes the difference. Thus, all countries must take a comprehensive approach.
  • The most effective way to prevent infections and save lives is breaking the chains of transmission. And to do that, you must test and isolate. You cannot fight a fire blindfolded. And we cannot stop this pandemic if we don’t know who is infected. We have a simple message for all countries: test, test, test. Test every suspected case.
  • If they test positive, isolate them and find out who they have been in close contact with up to 2 days before they developed symptoms, and test those people too. Every day, more tests are being produced to meet the global demand.

Curiously, even three months after the massive outbreak of the Coronavirus epidemic in China, India doesn’t seem to have procured enough PPEs for the doctors and testing kits to diagnose the disease. Besides, lack of advance preparation to create adequate quarantine and isolation facilities in the country make the situation even more complex to effectively deal with.

Other challenges and frugal options:

With eight doctors per 10,000 people in India, compared to 41 in Italy and 71 in Korea and one state-run hospital for more than 55,000 people, the general population has developed a much avoidable habit, over a period of time. It is quite likely, even in the event of getting flu-like symptoms, the majority may not go to doctors. Instead, may try home remedies or go to a retail chemist for drugs. Some may even resort to self-medication, until a full-blown disease surfaces, complicating the situation further.

Hence, only two options are left. One – for each individual to take care of personal hygiene and physical distancing, and second – for the Government to announce a national lockdown, through its second sudden and late evening order, effective midnight of the same day. This took almost everybody by surprise and possibly creating a widespread panic – not so much about the disease – at least initially, but more for regular availability of essential daily necessities – food and for many people – medicines, besides means for daily living of scores of families. This was further fueled by the gross lack of empathy by the law enforcers.

Conclusion:

As reported, if Covid19 continues to spread at its current pace, India could face between around 100,000 and 1.3 million confirmed cases of the disease caused by the new Coronavirus by mid-May, according to a team of scientists based mainly in the United States. It’s important to note that with just 6.8 tests per million, one of the lowest rates in the world, India has been criticized for not testing enough.

Moreover, besides panic and economic fallout of the disease, the long-term impact that Covid19 may have on the mental health of different people, for various reasons, will also need to be ascertained. As Professor Vikram Patel of Harvard Medical School said in his above article, ‘the deliverable is not how many people clanged pots and pans’ or how many obediently followed the Prime Minister’s advice of staying indoors. “The deliverable is how many people got tested, how many doctors have protective gear, how many ventilators the government managed to manufacture or buy overnight.” Another deliverable is isolation centers, temporary hospitals in indoor stadia and quarantine facilities that are fit for human beings, he added.

On November 24, 2020 – when 21-day national lockdown commenced, the total number of confirmed cases in the country were reported as 564. Just at the beginning of the 5th day of the lockdown on March 29, 2020, as I write this piece, as many as 1032 people have been tested positive for Covid19 with 28 deaths. Against the above backdrop, some critical points that surfaced while exploring the cacophony over the national lockdown, can possibly be wished away only at one’s own peril.

Nevertheless, under the prevailing circumstances, there was no other alternative for the Government, but to announce immediate national lockdown, which all should abide by, religiously. However, whether Coronavirus will be won in India with 21-day of national lockdown – just three days more of what the Mahabharata war took, as the Prime Minister expects, will start revealing from April 15, 20120 – as the moment of truth arrives.

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.

 

Access To Comprehensive Healthcare Merits Multipronged Approach

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Since the turn of the new millennium, several high profile and flagship health schemes are being announced in India by the Union successive governments. Some of the important ones will include the National Health Mission, Rashtriya Swasthya Bima Yojana (RSBY) - a Health Insurance Scheme for the Below Poverty Line families and now Ayushman Bharat – National Health Protection Mission - expected to cover over 100 million poor and vulnerable families providing coverage up to 500,000 rupees per family per year for hospitalization related to secondary and tertiary care.

Besides, the Mental Health Care Act 2017 has been operational since last year. It was passed by the Rajya Sabha in August 2016, and the Lok Sabha on March 2017. The right to mental health care is the core of the Act.

Each of these announcements look good on paper and was accompanied with lofty government promises. Riding on the waves of hypes thus created, public expectations increased commensurately for getting easy access to a comprehensive and affordable health care, which now includes ‘Mental Health’ as well. Unfortunately, the Gordian knot in Indian public healthcare space continued to exist. As various reports  indicate, for example, one that appeared on November 27, 2018, – even Ayushman Bharat is apparently moving towards the same detection driven by some critical basic issues.

Consequently, scores of people still do not have adequate and affordable access to basic health care, including essential drugs – clamping price control notwithstanding. The government knows it well, as it increases vigil on drug pricing. Pharma industry also feels its scorching heat. Overall storyline remains mostly unchanged. The vicious cycle continues.

In this article, I shall dwell on a system-approach to delivering comprehensive public health care. The key objective is trying to figure out what is the core problem that most of these schemes are either not addressing or doing it with a ‘band-aid’ approach. One of the key requirements for improving access to health care significantly, I reckon, is a clear understanding on the characterizations of the critical stages of healthcare access and their dimensions, from the patients’ perspective.

However, before doing so, let me glance upon some health care related current and important facts, as uploaded in the government’s National Health Profile 2018.  

National Health Profile 2018:

As available in the National Health Profile (NHP) of India – 2018, following are some of the important facts, which are worth noting:

  • In the current budget year, public (government) spending on health is just 1.3 per cent of the GDP against the global average for the same at 6 percent.
  • Just one doctor serves a population of 11,000 people, which is way below W.H.O recommended a doctor to population ratio of 1:1,000. The scenario is even worse in many states, such asBihar with 1: 28,391, Uttar Pradesh records 1:19,962, Jharkhand with 1:18,518, Madhya Pradesh shows 1:16,996 and Chhattisgarh at 1:15,916.
  • Per capita public expenditure by the government on health, stands at Rs 1,112 that comes to Rs 3 per day. This puts India below other low-income nations like the Maldives (9.4), Bhutan (2.5), Sri Lanka (1.6) and Nepal (1.1).

These numbers provide just a flavor of the Indian healthcare space, as it stands today. Some may of course talk about legacy factor, but to move ahead more important for all is what is happening today in this regard. Yes, one more health mission, as mentioned above, has been launched on September 25, 2018 with similar hype as the past ones, if not more. Only the future will tell us what changed it brings to the ground. That said, I am not very upbeat about it either, as providing a comprehensive health care access has always been multi-factorial and will remain so. Let me now dwell on why I am saying so.

Understanding health care access:

The 2013 research paper on “Improving Healthcare Access in India” by erstwhile IMS Consulting group (now IQVIA), said that ‘health care access characterizes 3 stages,’ which from the patient’s perspective has 4 key dimensions. In the Indian context, these three stages are:

  • Accessing care: Physical reach and location
  • Receiving care: Availability/capacity, Quality/functionality
  • Paying for care: Affordability

Accordingly, healthcare access is a function of 4 key aspects:

  • Physical reaches to health care facility
  • Availability of doctors and medicines in those places
  • Quality of care provided by these centers
  • Affordability of treatment, if available there

Access to healthcare is slowly improving, but far from being enough:

All the above schemes of the government are primarily focused on ‘paying for care’ stage and ‘affordability’ of treatment, including drugs. To a limited extent it makes sense as the above study vindicates that ‘availability’ and ‘affordability’ have good impact on ‘access to health care’.

Since the inception of NHM, this approach, no doubt, has made some improvement in the overall access to health care in the country, as many studies indicate. The IMS Consulting study also observes that compared to 2004, more patients received free medicines in outpatient care in 2013 – over 50 percent of patients going to Government hospitals say that they get free medicines there. However, the outcomes of the same across the Indian states vary quite a lot.

Inadequate healthcare infrastructure and physical reach in rural areas:

Having noted that, grossly inadequate availability of public health care infrastructure – or when available physical access to many of those from remote villages, coupled with lack of availability of required doctors, paramedics, nurses and medicines in those dispensaries – often become major issues. Moreover, their capacity to providing quality care, besides longer waiting time, often pushes many – either to remain virtually untreated or to go to private care centers costing much more.

The study finds that such movement of people from public to private facilities leads to higher health care costs. Consequently, high usage of private channels drives up the out of pocket (oop) cost of treatment. Some of the details are as follows:

  • 74 percent of patients sought private consultation
  • 85 percent of ‘oop’ spending on health care was in the private sector
  • 81percent of patients incurred ‘oop’ expenditure for medicines

Curiously, 35 percent of patients in the study rated public health facilities as – good. Whereas an overwhelming 81 percent said so for private facilities. Nevertheless, associated high ‘oop’ expenditure for the same often becomes an economic burden. The large number of patients with chronic ailments, are the major sufferers.

Application of mobile-health could help improve access:

On improving access to health care in India, an interesting ‘Review Article’ titled, “Applications of m-Health and e-Health in Public Health Sector: The Challenges and Opportunities”, appeared in the International Journal of Medicine and Public Health, April-June, 2018 issue, makes some thought-provoking observations.

It says, while the use of mobile phone (MPs) has become commonplace in many industry sectors, such as banking, railways, airlines – the public health sector has been somewhat slow in adopting MP technologies into routine operations. Its innovative use can benefit patients and providers alike by enhancing access to health care.Smartphones’ usefulness in the treatment of chronic diseases – for example, monitoring of blood pressure, blood sugar, body weight, electro- cardiograph (ECG), has already been established.

The paper also suggests, mobile health (m-H) is more effective when tailored to specific social, ethnic, demographic group using colloquial language. If implemented craftily and systematically, m-H can revolutionize the scenario of the health care delivery system, in many ways. Optimal doctor-patient engagement policy for m-H needs to be formulated, outlining a legal framework and with multi-stakeholder collaboration.

Mental health still largely ignored:

Another important aspect of comprehensive health care is ‘Mental Health’, as more than 60 million Indians suffer from mental disorders, suicides being one of the major killers in India (Source: W.H.O, IndiaSpend). However, it is disturbing to note that awareness and access to mental health treatment, especially in the hinterland of the country, continue to remain ignored. Increasing incidences of farmers’ suicides, for example, notwithstanding.

This was further elaborated by the IndiaSpend report of January 30, 2018, which underscored:“Allocation to the National Program for Mental Health has been stagnant for the past three years. At Rs 350 million, the program received 0.07 percent of India’s 2017-18 health budget.This is despite the fact that an estimated 10-20 million Indians (1-2% of the population) suffer from severe mental disorders such as schizophrenia and bipolar disorder, and nearly 50 million (5 percent of the population) – almost equal to the population of South Africa–suffer from common mental disorders such as depression and anxiety.”

The report further highlights that, notwithstanding 15 suicides every hour and 133,623 suicides in 2015, India is short of 66,200 psychiatrists and 269,750 psychiatric nurses. It is also noteworthy, while a frugal sum of 0.06 percent of India’s health budget is for mental health care, the same for even Bangladesh stands at 0.44 percent (Source: W.H.O, IndiaSpend).

Conclusion:

From the above perspective, I reckon, although access to health care in India, except ‘mental health care’, is improving at a modest pace, it doesn’t seem to be anywhere near adequate, as on date. A holistic approach for a comprehensive health care access to all, through the public health system, seems to be the need of the hour.

That said, currently India is not meeting the minimum W.H.O recommendations for healthcare workforce and also in bed density. A large section of the population continues to lack affordable access to quality health care. Moreover, the importance of mental health is still unknown to many in the country.

Thus, in tandem with addressing all the three stages and four key dimensions of comprehensive health care access, it is imperative to leverage new technology-based       e-healthcare and digital devices like m-Health. Together, these will help provide and facilitate not just quality care to patients, but also complement the healthcare infrastructure, including doctors and paramedics – making quality and affordable health care accessible to all.

As I said in my article, titled ‘Mental Health Problem: A Growing Concern in The Healthcare Space of India, the ‘Mental Health Care Bill’, which is now an Act, redefines mental illness to better understand various conditions that are persistent among the Indian population.This is a good development, as it aims at protecting the rights of persons with mental illness and promote access to mental health care. Since, the current ground reality in this area is a cause of great concern, when will it be effectively implemented for all, is the all-important question.

It is imperative for all concerned to understand that improving access to comprehensive health care is multi-factorial issue. Therefore, it needs nothing less than a well-thought out multi-pronged approach for an effective solution.

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.

Pharma Policy Execution Gap Limits Access To Affordable Medicines?

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“The cost of new drugs is putting increasing pressure on people in both rich and poor countries”- was eloquently expressed in an article, titled “Why do new medicines cost so much, and what can we do about it?”. This was published by “The Guardian” on April 09, 2018.

Almost synchronically, expressing concern on this issue, the World Health Organization (W.H.O) advised the world leaders ‘to take bold new approaches’ for increasing access to medicines for all. A UN high-level panel on ‘access to medicines’ spent almost a year deliberating over related issues. The panel members were from pharma companies, as well as civil society and academics. The final report coming in September, backed de-linkage of the costs of R&D from the eventual price of the drug. Notably, the author who is also the health editor of the above publication, feels that any positive outcome in this direction is unlikely to materialize soon.

The majority of big pharma constituents, with the possible exception of GSK, whose then chief executive Sir Andrew Witty was unenthusiastic about the UN report. Probably because, it supported governments’ right to invoke ‘a get-out’ from the World Trade Organization’s TRIPS agreement. This is to bypass drug patents and make cheaper versions of the respective generic equivalents, in the interests of public health, in accordance with the 2001 Doha declaration. However, the author is hopeful that, “as happened with AIDS, each new crisis over access to medicines – whether concerning a common liver disease or a rare cancer, and particularly over the antibiotics that are under threat and vital to all our lives – is likely to put pressure on companies to find ways to bring the costs of medicines down.”

Stakeholder pressure for increasing access to medicines continues. Even in smaller developed countries, such as Switzerland, a section of the public demands that “Swiss authorities must act to make lifesaving drugs more affordable by introducing compulsory licensing.” Or, one can now see reports saying,“Irish patients are being denied access to nine drugs that are widely available across Europe, largely, on cost grounds.”

Nevertheless, regardless of mounting pressure for drawing a reasonable symmetry between cost of, especially new drugs and their improved access to patients, ongoing status-quo continues. In this article, I shall dwell on this concern from the Indian perspective, focusing on an agonizingly stark implementation-gap related to the current Indian pharma pricing policy.

Under pressure, pharma now recognizes the need for affordable drugs:

Coming under intense pressure of patients and other stakeholders, even the largest trade association of Big Pharma has recently changed its stance on this issue, though clearly sharking any responsibility for the same. It just recognized the need for affordable medicines for improved patient access to treatments by saying: “Too often patients have to fight to access breakthrough medicines that are revolutionizing how we fight disease.” It also accepted the fact that “many Americans are struggling to afford their medicines.”

“We can improve patient access and affordability by moving toward a system that prioritizes results for patients. Biopharmaceutical companies are working with insurers to develop innovative and flexible ways to pay for medicines that focus on results, lower out-of-pocket costs and enable patients to access the right treatments the first time” – it added.

What it really means: 

What it really means ‘treatment outcomes-based drug pricing’ or ‘value-based drug pricing (VBP)’. In other words, a situation where drug prices are set in line with their real and demonstrated clinical and economic value to patients, against other available products. This model will also ensure that patients’ money doesn’t get wasted from drugs that aren’t effective on them. The VBP model is, thus, significantly different from product pricing, based on ‘undisclosed’ cost of ongoing innovation for new drugs.

Is this Big Pharma’s new way to change optics?

The intent for imbibing VBP, as expressed by the above pharma association, throws open the door for discussion of its core intent. Is the intention real, or another Big Pharma way of changing general optics on the sensitive issue of new drug pricing? This doubt creeps in from the findings of some important studies on this issue. One such is an interesting paper, titled “Pricing for Survival” from KPMG. The analysis highlighted very limited application of VBP concept, and also why it is not yet viable – despite the hype being created around it.

According to KPMG, “there were 25 drugs engaged in various types of VBP with payers in the fragmented United States market as of September 2017. The problem is, these models appear to be limited in applicability to disease states with more standardized protocols and dominated by drug therapies with single indications – notably osteoporosis, diabetes and hepatitis C.” To date, VBP models seem to be facing several constraints, such as it is appealing mostly to payers that are fully integrated with healthcare delivery i.e., closed-loop payer-provider health systems or integrated delivery networks.

“The takeaway is, when it comes to specialty and orphan drugs, outcomes-based pricing simply faces too many barriers at present” – the article elaborated. Be that as it may, let me now explore the relevance of VBP in India.

Any relevance of VBP in India?

VBP has been tried in a health care environment where payers and drug companies are two critical players for access to affordable medicines, as we see in the KPMG study. Under any value-based pricing agreements for pharmaceuticals, both payers and pharma companies agree to link payment for a medicine to the value achieved, rather than volume.

Whereas, in the Indian healthcare scenario, as we are experiencing today, payers are mostly individuals.  Despite various well-publicized health schemes, expenditure on health, including drugs, remains by and large ‘out of pocket (OoP)’ – for a large Indian population. Hence, copying western framework for implementation VBP in India, would call for scores of ‘pharma – individual payer agreements.’ This would be a daunting task, if not impractical, to even try it out.

In this context, let me touch upon the Ayushman Bharat scheme that was launched by the Prime Minister on September 23, 2018, but just in one of the 29 states of India – Jharkhand. If, or as and when it will cover the entire country, the scheme is expected to bring 107.4 million families and more than 550 million people under health insurance coverage. However, the work seems to be still in progress.

There are three financing models for this scheme – insurance model, trust model and hybrid model – and the 19 states that have come on board for the scheme’s implementation in the country, have chosen a trust model, according to the Union Health Minister. The minister also reiterated: “Things are still unfolding. Only when the letters reach the beneficiaries will they understand and react.”

Nevertheless, the Union Health Minister himself, just like his counterparts in the previous governments, exhibited confidence that the country is “moving towards universal health cover with Ayushman Bharat scheme,” – as was the headline of the above media report.

Going by the past and current outcomes of several such government schemes in the country, and what the minister himself articulated on September 17, 2018, a large section of the Indian population still remains  apprehensive on the fast pan-India rollout and overall success of this ambitious health scheme. Hence, at this stage, I reckon, it may not be relevant to discuss the application of VBP model on Ayushman Bharat project. I wrote about such apprehensions in this Blog on June 18, 2018.

Having said that, VBP still remains relevant when we look at the government’s intent captured in the National Pharmaceutical Pricing Policy (NPPP) 2012,’ as I shall discuss below.

VBP and the policy implementation gap:

For making the point clearer, let me keep the Ayushman Bharat scheme aside because of its associated uncertainties. Even in the current health care environment of high OoP expenditure on drugs, especially on high priced new drugs, if one tries to make use of the VBP model, it is very much possible.

This is because, the National Pharmaceutical Pricing Policy 2012, under point 4 (XV) on ‘Patented Drugs, categorically states:  “There is a separate Committee constituted by the Government order dated February 01, 2007 for finalizing the pricing of Patented Drugs, and decisions on pricing of patented drugs would be taken based on the recommendations of the Committee.”

Curiously, even 6 years down the line, no meaningful decision has been taken on patented drug pricing in India by the successive governments. As I wrote in this Blog on December 12, 2016, Price Negotiation For Patented Drugs: Still A Policy Paralysis.

Parliamentary Standing Committee intervenes:

Six years after the constitution of the committee by the Department of Pharmaceutical (DoP), the long-awaited report was eventually submitted with a vague formula for pricing patented drugs in India. Intriguingly,the issue remained as such, until the Parliamentary Standing Committee’s August 2016 report was placed before the parliament. It strongly criticized the DoP’s efforts to recommend measures in regulating prices of life-saving patented drugs, despite government assurances for the same.

On September 23, 2016, media reported: “Upbraided by the parliamentary standing committee for its gross negligence and lackadaisical attitude, the department of pharmaceuticals has set about seeking suggestions from different ministries on price regulation of patented drugs.”

According to reports, a new inter-ministerial committee was formed thereafter, under the chairmanship of one of the Joint Secretaries of the DoP to suggest a new mechanism to fix prices of patented drugs in the country.
The other members of the committee are Joint Secretary – Department of Industrial Policy and Promotion (DIPP); Joint Secretary – Ministry of Health and Family Welfare; and Member Secretary – National Pharmaceutical Pricing Authority (NPPA). But, the saga continues – at the cost of patients’ health interest.

Conclusion:

As it appears, there still lies a clear opportunity for Indian drug pricing policy makers introduce VBP concept for patented drugs in the country. Following this model, the prices of new and innovative drugs under patents can be set in line with their real and demonstrated clinical and economic value to patients, over the available existing products. Health Technology Assessment (HTA), for example, could be an effective tool in this process.

Additionally, the VBP model could also minimize, if not eliminate the risk of patients paying a high a price for new drugs coming through incremental innovation, adding too little clinical and economic value over existing drugs. There may, of course, be some teething trouble or even important issues in arriving at consensus on value-metrics for VBP. But, this can be sorted out through meaningful engagement with concerned parties.

Strikingly, even after 6 years since the NPPP 2012 was announced, nothing tangible has been made known to stakeholders on the execution of ‘patented drug pricing policy’ in India. An avoidable policy execution gap continues, limiting access to affordable new medicines to a vast majority of the Indian population, even today.

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.

Will AB-NHPM Mitigate Indian Healthcare Crisis?

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Since long, hypes have created on several healthcare schemes in India, by the successive Governments of different political dispensation. These attracted mostly positive vibes at the time of announcements. Nevertheless, as we move on, a vast majority of Indians continues to live in the midst of a health care crisis, as it were.

The National Health Policy 2017 also acknowledges this crisis as it writes: ‘growing incidences of catastrophic expenditure due to health care costs, which are presently estimated to be one of the major contributors to poverty.’

More recently, the May 31, 2018 article, published in the British Medical Journal (BMJ) continued to echo the similar concern. It reiterated, since both government funding and social health insurance contributions are insufficient to meet health care needs of households, over three-fourth of all healthcare payments are paid Out of Pocket (OOP) at the point of service delivery while medicine purchase (approximately 63 percent) account for the single largest component of these payments.

A major cause of catastrophe and impoverishment at the household level is undoubtedly the OOP expenditure on health care, including medicines. According to the above BMJ paper, 29 million households, implying about 38 million persons were pushed into poverty in the year 2011–2012, only because of this reason. Although, this study was based on a cross- sectional analysis of ‘National Sample Survey data, 1994–2014’, the public health expenditure in India has not shown any significant increase since then, either. On the contrary, the public spending in some health-related areas has come down in the recent years.

Is a health care crisis primarily a ‘financial’ crisis?

The issue of budget allocation and adequate public expenditure on healthcare in India assumes significance to understand this point better. It is generally believed that ‘a health care crisis is primarily a ‘financial’ crisis in which countries cannot successfully meet people’s access to medicine due to the rising cost of health care services and, more importantly, pharmaceuticals.’ A sincere political will is absolutely necessary to resolve these issues, meaningfully – the paper points out.

But, there doesn’t seem to be any financial crisis in the country now, as the Government claims. India is the fastest growing nation in the world. Why is then the health care crisis continuing for the majority of Indian, if not worsening? Why isn’t public expenditure on health care increasing despite such spectacular financial achievements? Could it be due to lack of requisite political intent?

On paper all health care related schemes look good:

Yes, I reckon, on paper all health care related schemes look reasonably good, assuming these will be implemented well. These may include, National Health Missions (NHM) covering both rural and urban poor or even the likes of Rashtriya Swasthya Bima Yojana (RSBY). So is also the most recent one - Ayushman Bharat – National Health Protection Mission (AB-NHPM) announced by the Government during 2018-19 Union budget presentation and approved by the cabinet on May 21, 2018. However, its implementation on the ground seem to be wobbly, too. Thus, many wonders whether this new scheme on the block will help the nation tiding over the existing health care crisis.

I broadly discussed this subject on February 5, 2018, in this Blog. However, in this article, I shall try to ferret out the reasons of such apprehension on the AB-NHPM, against some critical parameters, just as illustrations:

Who contributes and how much to health expenditures: 

From the National Health Account Estimate (NHAE) of October 2017, one gets a broad idea of who contributes and roughly how much of the health expenditures in India, as follows:

Union Govt. State Govts. Local bodies Enterprises, including insurance NGOs External donors OOPE
8.2% 13.3% 0.7% 4.4% 1.6% 0.7% 67%

Where does the treatment take place?

Place Urban (%) Rural (%)
Public healthcare 21 28
Private healthcare 79 72

It is interesting to note, although private health care costs over 4 times more than the public healthcare, more patients are compelled to go for private health care. (Source: National Sample Survey 2014, Ministry of Statistics and Program Implementation.)

Reasons for not using public health care facilities:

Around55.1percent of households are not using public health facilities.The reasons for not using public health care facilities by the members of the household when they fall sick, as reflected in the National Family Health Survey (NHFS) data, are interesting. Following are the main reasons:

Poor quality of care No nearby facility Long waiting time Inconvenient facility timing Health Personnel absent
48.1% 44.6% 40.90% 26.4% 14.8%

Addressing these reasons would help significant reduction in OOPE:

The February 2018 report of the ‘Centre for Technology and Policy Department of Humanities and Social Sciences, IIT Madras,’ vindicates this important point. It provides unambiguous evidence that strengthening the basic infrastructure of Health Sub-Centers (HSC), along with trained personnel and adequate medicines, ensure diversion of patients from expensive private facilities – increasing patients’ access to affordable health care. Consequently, OOP expenditure by families in health care and particularly medicines, sharply comes down.The study reported that such reduction in outpatient care varied between 77 percent and 92 percent in a pilot project on ensuring universal health coverage.

Break-up of healthcare expenditure – primary care costing the most:  

One gets a broad understanding on the general break-up of health care expenditure in India from the (NHAE) of October 2017, as follows:

Primary care Secondary care Tertiary care Patient transportation Governance & supervision
45.1% 35.6% 15.6% 4.6% 2.6%

It is worth noting that transportation costs are significant for many patients, just for accessing the existing public or private health care facilities, besides getting important diagnostic tests done, or even to buy many medicines. This expenditure would continue to exist, even if NHPS is put in place. On the other hand, strengthening the low-cost Government HSCs, would help greater patient access to health care, bringing down the OOPE, remarkably.

Currently, a sizeable number of reasonably decent medical treatment points, are located quite far from many villages. Thus, availing any decent health care facility by a large number of rural folks, no longer remains a matter of choice, up until the disease turns into a life-threatening one, due to protracted negligence. One such example is a large number of child deaths occurred at the state-run BRD Medical College hospital in the Gorakhpur city of Uttar Pradesh, in 2017. Most of them were brought in a critical condition from far-off villages.

Highest OOPE expenditure incurred for outpatient treatment:

According to the December 2016 publication titled ‘Household Health Expenditure in India’  of the Union Ministry of Health, one will get an idea of top 3 key consumption areas, out of the total OOPE on health care services, which are as follows:

Outpatient care Inpatient care Preventive care
54.84% 31.96% 4.26%

However, of the total OOPE, 53.46 percent was spent on medicines and 9.95 percent was spent on diagnostics. More importantly, 82.29 percent of the total OOP medicines expenditure and 67 percent of total OOP diagnostic expenditure were in outpatient treatment, the report highlights.

New NHPM excludes two major components of OOPE: 

Based on the above facts, it is interesting to note, while the maximum expenditure for health is incurred towards Primary Care and Outpatient treatment, the brand new NHPM does not cover both. In that case, how will it address the health care crisis in India and significantly reduce OOPE on health?

Does the total cost for AB-NHPM reflect in any budget allocation?

In this context, let me touch upon the other aspect of AB-NHPM, which is giving shape to 150,000 ‘Health and Wellness Centre (HWC)’ in India.On April 14, 2018, the first HWC – under the AB scheme was launched by the Prime Minister of India at Bijapur in Chhattisgarh.But, the fund allocated in the Union Budget 2018-19 for HWCs is just Rs. 120 million, which realistically is expected to support just around 10,000 HWCs. Whereas, 150,000 HWC would cost around Rs. 3 billion. The same issue of abysmal budgetary allocation, both by most of the state governments and the center, has been raised for NHPM, as well.

As we have seen in the chart of ‘who contributes and how much to current health expenditures’, that OOPE stands out, it should in no way be allowed to remain around that number in India, because of continuing low public health expenditure on health care.

Conclusion:

Coming back to what I started from – the issue of ongoing health care crisis in India with incredibly high OOPE expenditure of the households on health. Many health care schemes have come, gone or about to be jettisoned – getting replaced by the tweaked versions of the old ones – of course in a new Avatar, supported by much expected media hypes, virtually terming it as a panacea. But, the key problem of sincere implementation of those schemes still lingers.

Sharp Government focus, backed by adequate budget allocation, on primary health care and bringing down outpatient treatment cost, which contribute to a high proportion of OOPE, remain as elusive as ever. Thus, I reckon, AB-NHPM is unlikely to mitigate the health care crisis in India, at least,in the short to medium term.

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.

 

Why MNC Pharma Still Moans Over Indian IP Ecosystem?

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Improving patient access to expensive drugs, paving the way for entry of their cheaper generic equivalents, post patent expiry, and avoiding evergreening, is assuming priority a priority focus area in many countries. The United States is no exception, in this area. The Keynote Address of Scott Gottlieb, Commissioner of Food and Drug at the 2018 Food and Drug Law Institute Annual Conference inWashington, DC by, on May 3, 2018, confirms this. Where, in sharp contrast with what the MNC Pharma players and their trade associations propagated, the US-FDA commissioner himself admitted by saying, “Let’s face it. Right now, we don’t have a truly free market when it comes to drug pricing, and in too many cases, that’s driving prices to unaffordable levels for some patients.”

Does US talk differently outside the country?

At least, it appears so to many. For example, in April 2018, the Office of the United States Trade Representative (USTR) released its 2018 Special 301 Report. In this exercise, the USPTO names the country’s trading partners for not adequately protecting and enforcing Intellectual Property (IP) rights or otherwise deny market access to U.S. innovators that rely on the protection of their IP rights.’ Accordingly, U.S. trading partners are asked to address IP-related challenges, with a special focus on the countries identified on the Watch List (WL) and Priority Watch List (PWL).

In 2018, just as the past years, India continues to feature, along with 11 other countries, on the PWL, for the so called longstanding challenges in its IP framework and lack of sufficient measurable improvements that have negatively affected U.S. right holders over the past year.

From Patient access to affordable drugs to Market access for Expensive Drugs: 

Curiously, the USTR Report highlights its concerns not just related to IP, but also on market access barriers for patented drugs and medical devices, irrespective of a country’s socioeconomic compulsion. Nevertheless, comparing it to what the US-FDA Commissioner articulated above, one gets an impression, while the US priority is improving patient access to affordable drugs for Americans, it changes to supporting MNC pharma to improve market access for expensive patented drugs, outside its shores.

Insisting others to improve global IP Index while the same for the US slides:

In the context of the 2018 report, the U.S. Trade Representative, reportedly said, “the ideas and creativity of American entrepreneurs’ fuel economic growth and employ millions of hardworking Americans.” However, on a closer look at the U.S. Chamber of Commerce’s annual Global IP Index for 2018, a contrasting fact surfaces, quite clearly. It shows, America, which once was at the very top of the overall IP Index score, is no longer so – in 2018, the world rank of the US in offering patent protection to innovators, dropped to 12thposition from its 10thglobal ranking in 2017. Does it mean, what the US is asking its trading partners to follow, it is unable to hold its own ground against similar parameters, any longer.

Should IP laws ignore country’s socioeconomic reality? 

MNC Pharma often articulated, it doesn’t generally fall within its areas of concern, and is the Government responsibility. However, an affirmative answer, echoes from many independent sources on this issue. No wonder, some astute and credible voices, such as an article titled “U.S. IP Policy Spins Out of Control in the 2018 Special 301 Report”, published by the Electronic Frontier Foundation on May 01, 2018, termed 2018 Special 301 Report – ‘A Tired, Repetitive Report.’ It reiterates in no ambiguous term: ‘The report maintains the line that there is only one adequate and effective level of IP protection and enforcement that every country should adhere to, regardless of its social and economic circumstances or its international legal obligations.

The ever-expanding MNC Pharma list of concerns on Indian IP laws:

The areas of MNC Pharma concern, related to Indian IP laws, continues to grow even in 2018. The letter dated February 8, 2018 of the Intellectual Property Owners Association, Washington, DC to the USTR, makes these areas rather clear. I shall quote below some major pharma related ones, from this ever-expanding list:

  • Additional Patentability Criteria – section 3 (d): The law makes it difficult for them to secure patent protection for certain types of pharma inventions.
  • TADF (Technology Acquisition and Development Fund)is empowered to request Compulsory Licensing (CL) from the Government:Section 4.4 of India’s National Manufacturing Policy discusses the use of CL to help domestic companies access the latest patented green technology.This helps in situations when a patent holder is unwilling to license, either at all or “at reasonable rates,” or when an invention is not being “worked” within India.
  • India’s National Competition Policyrequires IP owners to grant access to “essential facilities” on “agreed and nondiscriminatory terms” without reservation. They are not comfortable with it.
  • Regulatory Data Protection: The Indian Regulatory Authority relies on test data submitted by originators to another country when granting marketing approval to follow-on pharma products. It discourages them to develop new medicines that could meet unmet medical needs.
  • Requirement of local working of patents: The Controller of Patents is empowered to require patent holders and any licensees to provide details on how the invention is being worked in India. Statements of the Working, (Form 27),must be provided annually.Failure to provide the requested information is punishable by fine or imprisonment. It makes pharma patent holders facing the risk of CL, if they fail to “work” their inventions in India within three years of the respective patent grant.
  • Disclosure of Foreign Filings: Section 8 of India’s Patent Act requires disclosure and regular updates on foreign applications that are substantially “the same or substantially the same invention.” They feel it is irrelevant today.

Pharma MNCs’ self-serving tirade is insensitive to Indian patient interest:

Continuing its tirade against some developed and developing countries, such as India, the US drug manufacturers lobby group – Pharmaceutical Research and Manufacturers of America (PhRMA) has urged the office of the US Trade Representative (USTR) to take immediate action to address serious market access and intellectual property (IP) barriers in 19 overseas markets, including India, reports reported The Pharma Letter on February 28, 2018. It will be interesting to watch and note the level active and passive participation of India based stakeholders of this powerful US lobby group, as well.

Government of India holds its ground… but the saga continues:

India Government’s stand in this regard, including 2018 Special 301 Report, has been well articulated in its report released on January 24, 2018, titled “Intellectual Property Rights Regime in India – An Overview”, released by the Department of Industrial Policy and Promotion Ministry of Commerce and Industry (DIPP). The paper also includes asummary of some of the main recommendations, as captured in the September 2016 Report of the High-Level Panel on Access to Medicines, constituted by the Secretary-General Ban Ki-Moon of the United Nations in November 2015.  Some of these observations are as follows:

  • WTO members must make full use of the TRIPS flexibilities as confirmed by the Doha Declaration to promote access to health technologies when necessary.
  • WTO members should make full use of the policy space available in Article 27 of the TRIPS agreement by adopting and applying rigorous definitions of invention and patentability that are in the interests of public health of the country and its inhabitants. This includes amending laws to curtail the evergreening of patents and awarding patents only when genuine innovation has occurred.
  • Governments should adopt and implement legislation that facilitates the issuance of Compulsory Licenses (CL). The use of CL should be based on the provisions found in the Doha Declaration and the grounds for the issuance left to the discretion of the governments.
  • WTO members should revise the paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory license.
  • Governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO Members to use TRIPS flexibilities.
  • Governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfill the rights to health.

The DIPP report includes two important quotes, among several others, as follows:

Joseph Stiglitz, Nobel Prize for Economics (2001) – an American Citizen:

-       “If patent rights are too strong and maintained for too long, they prevent access to knowledge, the most important input in the innovation process. In the US, there is growing recognition that the balance has been too far tilted towards patent protection in general (not just in medicine).”

-       “Greater IP protection for medicines would, we fear, limit access to life-saving drugs and seriously undermine the very capable indigenous generics industry that has been critical for people’s well-being in not only India but other developing countries as well”.

Bernie Sanders, an American Citizen and Senior U.S. Senator:

-      “Access to health care is a human right, and that includes access to safe and affordable prescription drugs. It is time to enact prescription drug policies that work for everyone, not just the CEOs of the pharmaceutical industry.”

-      “Healthcare must be recognized as a right, not a privilege. Every man, woman and child in our country should be able to access the health care they need regardless of their income.”

Conclusion:

Why is then this orchestrated moaning and accompanying pressure for making Indian IP laws more stringent, which apparently continues under the façade of ‘innovation at risk’, which isn’t so – in any case. But, cleverly marketed high priced ‘me too’ drugs with molecular tweaking do impact patient access. So is the practice of delaying off-patent generic drugs entry, surreptitiously. Instead, why not encourage Voluntary Licensing (VL) of patented drugs against a mutually agreed fee, for achieving greater market access to the developing countries, like India?

Whatever intense advocacy is done by the vested interests to change Indian patent laws in favor of MNC pharma, the intense efforts so far, I reckon, have been akin to running on a treadmill – without moving an inch from where they were, since and even prior to 2005. The moaning of MNC Pharma on the Indian IP ecosystem, as I see it, will continue, as no Indian Government will wish to take any risk in this area. It appears irreversible and is likely to remain so, for a long time to come. The time demands from all concerned to be part of the solution, and not continue to be a part of the problem, especially by trying to tamper with the IP ecosystem of the country.

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.