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Keep Pace with Pharma’s Even Nuanced Technology Driven Changes – For Success

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Since 2020, unprecedented global disruptions affecting lives, livelihoods, and business, have impacted India in equal measure, if not more – across various areas, including the pharma industry. If there is one change that is creating a snowballing effect, is the rate of progress and use of technology in its operations.

Consequently, finding properly trained people, to drive the new avatar of technology driven today’s business – right from R&D, supply chain, manufacturing, sales and marketing, customer behavior, market dynamics – poses a facet of ongoing challenges.

This is primarily because, some key business-success requirements have now significantly changed, but many are still nuanced that one may tend to possibly ignore. Thus, early identification of these and placing properly skilled – right people in the right job, who can floor the gas pedal in search of excellence, assume two key priorities for the pharma players, more than ever before.

Most companies, as I understand, are finding this task quite time consuming, if not arduous. The options are basically two. The first one – spot, search and hire the best talent from outside the organization. And the second – spot the internal talents, hone their skills, handhold them for some time on the job, before they take charge and assume accountability for achieving the set goals. In this article, I shall focus on the relevance, criticality, and associated intricacies that pharma leadership may encounter in this process.

Intense focus on the drug industry in last two years – blessings and burden:

A recent research study on Talent Trends For Life Sciences Organizations, published by Randstad Sourceright on July 22, 2022, came out with some interesting findings in this area. The key ones are as below:

  • In the past couple of years, the intense global focus on Life Sciences Industries brings both blessings and burden on the industry.
  • Key drug manufacturers received unprecedented levels of financial and regulatory support for the development of therapies and vaccines for the treatment and prevention of Covid-19 onslaught on the people across the world.
  • In tandem, the drug industry had to withstand tremendous pressures and intense scrutiny to achieve this task by re-prioritizing their R&D focus, which no drug manufacturer had experienced ever before.

Alongside, pharma customer characteristics and behavior also started changing fast in many areas, and consequently the market dynamics. Many of these changes are still nuanced and are driven by contemporary technology. Amid lesser concern for Covid-pandemic, the ongoing metamorphosis in the world of work – impacting almost all functional areas of a customer-driven organization, poses a fresh pharma leadership challenge.

Thus, for future business success, pharma companies now need to capture relevant real-time data, and analyze them to gain in-depth insight of these changes. Consequently, it is important to figure out how much the quality of talent requirement has changed for an organization, to continue to remain as patient centric. However, before doing that, it’s worth figuring out what kept the wheels of pharma businesses moving during the years of the recent pandemic.

What kept the wheels of business moving during the pandemic:

Several important studies have made dip-stick assessment in this space. One such recent study findings of Randstad Sourceright highlighted the following three, among others, as the key success factors for employee motivation in trying times, which kept the wheels of business moving:

  • Empathy of the leadership,
  • Flexibility in work life
  • Ingenuity of employees to quickly adapt to the new normal

Some of these, or all, may linger in the minds of many employees. They may still long for empathy at work and flexibility in the workplace, to unleash their full potential for organizational success. Otherwise, they may look outside, especially to those companies who can meet their expectations, in the new normal.

In this situation, fostering EQ within the organization to encourage employees committing to the corporate shared goal, is a key requirement for pharma’s performance excellence. The bottom-line is,how well an organization continues to nurture and retain or attract new talents, besides honing their skills in line with the changing customer value delivery process, would be critical.

Need to identify even nuanced changes in workplaces:

Thus, before making a dip-stick assessment to ascertain the changes in organizational talent requirements, it is worth getting a sense from the available studies what’s going on today in the industry.

Like many other countries, the pandemic is no longer an unsettling unease for most pharma organizations in India. At the same time, studies reiterate that it’s for sure that the pandemic related disruptions have ushered-in visible or nuanced transformations, especially in the operational areas of the life sciences business.

Some recent studies, such as, one done by McKinsey & Company on – Creating the workforce of the future, made a notable observation. It emphasized, “Pharma companies struggle to predict where they will see the talent gaps, these disruptions create, though a majority monitor key trends and track talent needs. Only a minority of companies (40 percent) believe that they really know which skills are needed now, let alone in ten years (less than 25 percent).”

Which is why, I reckon, it is now critical for the Indian pharma leadership to identify, analyze and address, both perceptible and nuanced transformation within their customers, employees, and other stakeholders. And then zero-in on changing talent requirements of employees in key operational areas, including sales and marketing – to gain a competitive edge in the marketplace.

However, it is worth remembering that the supply of quality talent remains limited, although it is essential to catapult the business in a higher growth trajectory. Besides, gradually changing employee expectations in the workplace culture – work-flexibility could emerge as another sought after factor to attract new talents from the millennials. 

The ways to move forward in this area:

Many companies may decide to hire new talents from outside the company, whereas some may look for developing people internally, through well-structured internal human development initiatives. However, the research study of Randstad Sourceright finds: ‘67% of life science and pharma leaders believe reskilling and upskilling employees for different roles is an effective way to address talent scarcity. Additionally, 63% say they already invest in internal mobility platforms to augment their recruiting efforts, while 53% plan to increase their investments in this area.’

Further McKinsey & Company in their above-mentioned article also suggested: ‘Reskilling employees to address talent gaps can help a company retain the bulk of its operations workers and empower them to take advantage of a new world.’ So did another article on building pharma talent of tomorrow, published in the Pharma Executive on October 05, 2022. It emphasized that training current employees who already know the business, and are familiar with the inner workings, would expectedly take much less time to deliver that is expected of them.

I also understand, a few large Indian pharma majors are also focusing on internal talent development as one of the key organizational development initiatives. They are identifying internal talents in an organized manner, up-skill them to shoulder new responsibilities – following a well-charted career path for each one of them. It’s important for the leadership to demonstrate and make these employees also feel that they are of great value to the organization.

From the above perspective, I reckon, in today’s environment when many employees are eager to search for a greener pasture that suits them better, the above approach also provides an opportunity for pharma employers. This opportunity is primarily to retain talents, by incentivizing them with learning, and development process, besides a chance for career progress in the company.

Conclusion:

One thing for sure is critical to ensure that right talents are always placed in the right job. This is crucial to keep pace with not just significant transformations. But even for emerging and nuanced technology driven changes in customer characteristics, behavior, and market dynamics. Thereafter, each organization will need to identify available in-house talents for upskilling, honing and development. Whereas some fresh new talents may necessarily be required to hire from outside or outsourced.

Several recent studies have also indicated that the best strategy in this regard, is the optimal combination of hiring from outside or outsourcing the new requirements, alongside internal talent development initiatives, and charting a career path for them. To chart on this emerging frontier calls for a mindset change. Thus, it is important for us to remember that only permanent factor in the pharma business is – change. Can one ignore it? Of course, but at one’s own peril, because in the long run “What You Do is Who You Are” in the future pharma business.

By: Tapan J. Ray      

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

 

Covid Prompts Pharma To Move Away From Competition Driven Business Model

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As deliberated in my just previous article in this blog, Covid has been a watershed in several areas of pharma business. One such key area is its competition driven strategic business model. It aims to deliver significant value for a longer time than the competition, protected by a patent thicket driven TINA factor – and only for those who can afford such patented drugs. It didn’t matter, if a vast majority of patients are denied access to these medicines, with a dangerous pricing trend acting as an insurmountable barrier. Flying solo has been the motto of most players in this ball game, to delight the stock markets.

Interestingly, Covid pandemic seems to be changing this model. Pharma industry, by and large, is now trying to demonstrate its core value for the society – moving away from displaying competition driven one-upmanship. In this article, I shall deliberate on this area.

Covid poses both – a humongous challenge and a great opportunity:

As the article, published in the MIT Sloan Management Review on April 16, 2020 highlights: ‘The COVID-19 pandemic may well prove to be the biggest challenge for humankind since World War II.’ The same holds good for the pharma industry, as well. The drug companies are now expected by all, to play a pivotal role in the fight against the pandemic ‘that is bringing health care systems to their knees and sending shock waves through economies across the globe.’

This is generally because, pharma industry possesses wherewithal to develop effective drugs and vaccines to combat this health crisis – if not alone, but certainly collectively. It also offers a great opportunity for pharma to ‘walk the talk,’ by demonstrating upfront that meeting all patients’ unmet needs lie at the core of the pharma business. As I quoted a global CEO in one of my articles articulating, this crisis also comes as ‘a Shot at Redemption in Pharma Industry.’

Thus, if the industry reacts quickly and responsibly, it may have the chance to also redeem a reputation that’s been tarnished for years. Some of these instances are, illegal marketing practices, corruption scandals, and obscene pricing of vital drugs, the MIT Sloan article underscored. Flying solo in this situation may not be just enough, if not foolhardy.

Flying solo in this situation may not be enough:

Taking this initiative won’t be a piece of cake, either, if pharma companies prefer to do it alone during this unprecedented health crisis.  The drug players will need to be willing and able to successfully collaborate with other players in the race to develop treatments and vaccines. Otherwise, their legitimacy will be fundamentally questioned, especially when the entire world is running against time.

The rationale of two top drug companies entering into collaborative arrangements is obvious – the realization that pooling of all resources together is the best way of delivering effective Covid related solutions to the society at the shortest possible time. The good news is, pharma has already taken the first step in this direction, even when some of them are competitors, in several areas – moving away from their competition driven business models, as of now.

Once strange bedfellows – now partners:

The article published in the Bloomberg Law on June 05, 2020 very aptly observed: ‘The race to address the pandemic has brought together strange bedfellows as big-name companies’ partner with their rivals.’ The Scientist also wrote on July 13, 2020: ‘The urgent need for tests and therapeutics has brought companies together and pushed researchers to work at breakneck speeds.’

One can find this happening on the  ground now, as some major pharma and biotech companies, including Eli Lilly, Novartis, Gilead, and AstraZeneca, formed a group called COVID R&D to share resources and expertise to try to accelerate the development of effective therapies and vaccines for COVID-19. Besides, Roche Holding AG and Gilead Sciences Inc. have teamed up on trials for a drug combination to treat Covid-19.

There are several instances of such collaboration also in the Covid vaccine area. For example, GlaxoSmithKline plc struck a deal with Sanofi to produce 1 billion doses of a coronavirus vaccine booster. Besides, Pfizer from the US and BioNTech from Germany are joining hands to co-develop and distribute a potential Coronavirus vaccine, aimed at preventing COVID-19 infection.

It’s a reality today that Covid-19 has brought not just the strange bedfellows within pharma and biotech companies together. Academia and governments have also moved on to the same collaborative platforms, to save people from a deadly and super contagious infection, in the shortest possible time. We have witnessed this

in India, as well. For example, the Council of Scientific and Industrial Research (CSIR) and Aurobindo Pharma Limited have also announced a collaboration to develop vaccines to protect against SARS-CoV-2 or COVID-19.

The rationale and some possible issues: 

Each of these players is bringing some expertise and intellectual property to the table. “As they work together, they’re going to create more, so you have the ‘yours,’ the ‘mine,’ and the ‘ours’ of collaboration,” as the Bloomberg Law points out. That said, any collaboration of such nature and scale will have its own share of legal issues, such as, patents, trademarks, trade secrets, revenue sharing models, and more.

The collaborators, in pursuit of saving mankind from Covid-19, are expected to find enough alternatives to resolve these glitches for a win-win outcome – not just for now, but much beyond – with the dawn of a new collaborative model. The rapid general acceptance of this collaborative model by more and more drug companies to meet unmet medical needs in many other areas – much faster, in all probability, will delight the health care consumers and also be appropriately rewarded.

Leveraging the collaborative business model beyond pandemic:

E that as it may, it still remains an open question to many, whether such collaborative model will be leveraged for an accelerated rate of drug, vaccine and diagnostics development beyond the pandemic.

The good news is, as The Scientist article reported, some pharma players are seriously pondering how to continue working in this new way – with the same sense of urgency and purpose, for other disease areas too. They believe, the lessons being learned with the collaborative models, may help expedite development of therapeutics in other serious conditions, such as, Alzheimer’s, intractable cancers and autoimmune diseases.

If and when it happens as a predominant business model, suffering patients and the society, in general, would lap it up and the innovators would be suitably rewarded. However, the paper also says, there are still some drug companies who prefer to continue working in a more insular fashion, as was happening in the old normal. But, experts also feel, that should not cause any worry, as long as majority prefers to continue following the collaborative models, in the new normal, as well.

Pharma would make a good profit from collaborative business models too:

For those who say that drug companies won’t make good profit from Covid drugs and vaccines, Pfizer CEO has an answer. Albert Bourla, Pfizer’s CEO, reportedly, has no patience for the argument that pharmaceutical companies should not be making a profit on the drugs and vaccines they introduce to fight Covid-19. This article highlights, at $19.50 per dose, the 1.3 billion doses of Pfizer BioNTech Covid vaccine that the Pfizer plans to make by the end of next year, could translate to nearly $13 billion in sales, after the company splits its revenue with its partner BioNTech. It is roughly the same as Pfizer’s all-time best-selling drug Lipitor sold in its best year.

Adding to it, another article on the same issue, published by Fierce Pharma on August 13, 2020, further reinforced the above expectation. It wrote, the longtime Evercore ISI pharma analyst haspredicted the total market for COVID-19 vaccines would be worth $100 billion in sales and $40 billion in post-tax profits. It assumed frontrunner Moderna would supply about 40 percent of the market, Novavax would take 20 percent and the other vaccine developers would split the rest. “One could look at the field under this base scenario and conclude it is reasonably valued in total,” the analyst concluded.

Nonetheless, there could still be several points that remained unanswered in this analysis. But the bottom line is, the collaborative model is not just profitable, it starts generating profit earlier and faster – virtually eliminating the cost of possible delays when a company flies solo.

Conclusion:

With a seemingly flattening curve, the Covid pandemic still continues, alarmingly. As of October 25, 2020 morning, India recorded a staggering figure of 7,864,811 of Coronavirus cases with 118,567 deaths.

With this backdrop, COVID-19 has provided the pharma industry a new opportunity to demonstrate its true value to the society – not the self-serving ones. It’s now clear that no one can rule out, there won’t be a similar unprecedented health catastrophe in the future too. It may come in various different forms, or may even be from a rapid and complex mutation of the same lethal virus.

Moreover, such crisis may not come and go in just a few months – may even linger for a long time. In any case, these may again be equally disruptive – or even more disruptive to lives, livelihoods and the economic growth engine. In such a scenario, putting the brightest scientific brains of the world together will be critical, and adding top speed to the process being the essence to come out of the crisis with least possible damages.

Covid pandemic has also demonstrated that the competition-based model of the drug could be a serious retarding force in that endeavor. What will matter, is a well-structured collaborative model that can create a win-win situation – both for patients and the business. I reckon, it’s about time to move into this model to find most effective drugs and treatment solutions for many other unmet needs related to a host of intractable diseases, much sooner.

There could, of course, be some business issues with this model. But those can be resolved amicably for an all-weather greater success in business, along with protecting the society – for all. From this overall perspective, it appears, Covid pandemic now sends a strong signal to pharma companies to move away from predominantly competition driven business models, expanding more into collaborative ones.

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.

 

Create Purpose-Driven-Brands To Win Marketing Warfare In The New Reality

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As we navigate through the Covid days, the hope of somehow getting back to the pre-pandemic normal still lingers – notwithstanding a host of uncertainties in its way. The longing is driven by the hype of availability of scientifically proven, safe and effective drugs and vaccines – unrealistically soon, despite top experts still keeping their fingers crossed. Some are even more forthright in their expression, as reflected in a September 30, 2020 report. It flashed a headline - “There is no getting ‘back to normal. The sooner we accept that, the better.”

Alongside, COVID-19 crisis has also triggered some disruptive changes in the business processes around the world. Amid this global health crisis, interestingly, several global pharma CEOs are sensing a number of game-changing opportunities – having business implications, even much beyond the pandemic.

One such example, as Bloomberg reported on September 29, 2020, the CEO of GlaxoSmithKline Plc feels: The Covid Pandemic is ‘a Shot at Redemption in Pharma Industry.’ Elaborating the point, she said: ‘the sector’s push to find vaccines and drugs to end the crisis, if successful, could change the perception of pharmaceutical companies in the future.’ Coincidentally, the researchers from The Harris Poll found:

  • As of May, 40 percent of the American public said pharma’s reputation had improved since the beginning of the COVID-19 outbreak
  • And 81percent recalled seeing or hearing something about the industry during that time.
  • This is a continuation of the former trend that The Harris Poll first noted on March 2020.

There shouldn’t much doubt, either, that similar general impression on the pharma industry, with a varying degree, may now be felt in most countries, across the globe.

Curiously, flowing from this ‘redemption of pharma reputation’ angle – with new drugs and vaccines, the scope for leveraging another opportunity is also surfacing. This is from pharma ‘branding’ perspective and pertains to creating ‘purpose-driven brands’ for success in the new reality – during the pandemic and much beyond. In this article, I shall focus on the second area, and would start with its relevance to increasingly more informed health care consumers of date.

‘Purpose driven brands’ – attained greater relevance in Covid time:

The concept of creating ‘purpose driven brands,’ is profound – it goes much beyond product features, benefits and intrinsic values. It is motivated by – why the brands exist not just for providing a solution to manage or cure a disease, but also to meet a crucial need in society.

Studies have unfolded, with better stakeholder connection – and greater share of their mind, ‘purpose driven brands’ help improve brand loyalty, resulting into increased revenue and profit. We will see below, why in Covid time, this trend has started gathering wind on its sail, and deserves to find its place at the very core of any pharma branding strategy.

The consulting arm of The Beautiful Truth, also echoed the same sentiment in the article – ‘How Pharma Can Navigate Change With Purpose.’ It reconfirmed, at times of external crisis, like the global pandemic, creation of ‘purpose-driven brands’ is vital. Not just ‘for saving and maintaining business, but also for boosting internal team morale, and reconciling public trust.’

The pandemic has redefined the core purpose of a brand:

Another recent article –‘Through COVID-19, Leading Brands Have Found Their Purpose,’ published in CMO by Adobe, among many others, vindicated this point. Acknowledging that the COVID-19 pandemic has redefined the meaning of brand purpose, the paper explained the reason for the same.

In pre-Covid days, many organizations used to build brands following traditional norms – curing or effectively managing a disease is the purpose of a brand. But, since last few years, a growing number of new generation health care customers expect a brand’s ‘purpose’ to expand beyond the product and the company. It has to be inclusive in nature – benefiting the macro-environment, including governments, health care professionals, and the public. With this expectation gathering momentum during Covid time, pharma players would also need to redefine the core ‘purpose’ of a brand. Incidentally, many pharma CEOs also believe, if this trend continues, the image of the industry would probably undergo a metamorphosis.

Surveys vindicate the rationale for redefinition:

Several top consulting organizations have published excellent articles covering a number of critical points in this area. One such paper - ‘Purpose is everything,’ was published in Deloitte Insights, on October 15, 2019. It wrote on how brands that authentically lead with ‘purpose’ are changing the nature of business today.

The rationale for redefinition of brand purpose, also gets reflected in a contemporary Deloitte survey, as quoted in the above article. It revealed the following top three issues that stakeholders identify with, while making decisions about brands: 

Top Issues

% of respondents
How the company treats its own people/employees

28
How the company treats the environment

20
How the company supports the community in which it operates

19

Aligning purpose to create deeper connections with stakeholders:

Especially at the Covid time, if companies try to align their purpose in doing good – for the society, they can build deeper connections with their stakeholders. And, in turn, amplify the company’s relevance in their stakeholders’ lives. From this perspective, it’s good to note in the above Bloomberg article, that one of the top pharma CEOs articulating the same in public. I reckon, increasingly, pharma businesses would endeavor harnessing the power and opportunity of aligning the ‘core purpose of brands’ with societal good, as came out in the above Deloitte article.

Mostly millennial generation favor ‘purpose-driven’ brands:

The initiation of this trend dates back to pre-Covid time with wider usage of internet. However, with the increasing democratization of health care - social media based instant information sharing, the ability to communicate with others as needed, have increased manifold. Consequently, stakeholders, particularly, the millennial generation with a different mindset, aspirations and expectations are expecting pharma players to act more on the pressing societal issues. This makes them lean towards a purpose driven brands and companies. The unprecedented Covid health crisis is acting as a force multiplier in this area.

Another study – ‘Why Customers Are Supporting ‘Purpose-Driven’ Brands,’ published in Link fluence epitomized this evolving customer preference succinctly. It reiterated, ‘It’s no longer enough for brands to deliver great products and experiences. Instead, consumers are demanding for brands to be more proactive and conscious in delivering value to society as a whole.’

‘Purpose-driven brands’ – the latest ‘marketing buzzword’?

This question was conclusively answered about two years ago -  from the 2018 Cone/Porter Novelli Purpose Study. Although, this survey was conducted in the United States, it has a global relevance amid Covid pandemic. Some of the key findings include: 

  • 78 percent believe companies must do more than just make money; they must positively impact society as well.
  • 77 percent feel a stronger emotional connection to Purpose-driven companies over traditional companies.
  • 66 percent would switch from a product they typically buy, for a new product from a purpose-driven company.
  • 68 percent is more willing to share content with their social networks over that of traditional companies. 

Examples of ‘purpose-driven’ pharma brands/companies:

Let me give just two examples each – from pre-Covid and Covid times. The article – ‘Mission-Drive Pharma Brands,’ published by Wonder on January 15, 2018, cited several examples of ‘purpose-driven’ pharma brands. This was based on a research of individual drug campaigns for top-selling drugs around that time. These include promotional campaigns on:

  • Humira: Highlighted the participation in a community food drive, and volunteering in a playground construction project.
  • Lyrica: Highlighted the engagement in a multi-generational interaction and helping others.

Encouragingly, while combating COVID-19, several pharma companies have also displayed a sense of ‘purpose’ to save the humanity from the pandemic, mainly through collaborative approaches. Let me quote below two such examples:

  • On April 14, 2020 GlaxoSmithKline and Sanofi announced a very unusual collaboration to develop a COVID-19 vaccine, expeditiously. This was done for a greater purpose, responding to the critical need of the society – saving millions of lives.
  • Roche called on and campaigned for the governments for focusing on testing and prevention, to maintain adequate medical supplies for health care professionals  around the world. It also urged the health authorities to work closely with the life sciences industry to tackle the Covid-19 pandemic through international collaboration to tackle Covid-19 pandemic.

Conclusion:

Meanwhile, as on October 04, 2020 morning, India recorded a staggering figure of 6,549,373 of Coronavirus cases with 101,812 deaths. Still there is no respite from Covid-19’s unprecedented onslaught on the country. Be that as it may,  coming back to the creation of ‘purpose-driven brands’ in the Covid time, let me quote again from the above CMO by Adobe article, where it underscored:“Never before have brands been asked to show their true purpose and leadership as they are today. It’s inspiring to see companies across industries and throughout the world come together to address some of the most pressing needs brought about by this crisis.”

As Accenture had articulated: ‘In an era of radical visibility, technology and media have given individuals the power to stand up for their opinions and beliefs on a grand scale.’ Keeping this in view, with gradually changing stakeholder mindset and expectations, the ‘purpose of a brand’ deserves to be a critical centerpiece in the pharma ‘branding’ process. Various studies have established – since pre-Covid time, and more during this pandemic – brands, reflecting a robust sense of ‘purpose’ on societal values, people and the environment, connect better with customers.

Consequently, as the stakeholders find these companies walk the talk, they develop a strong and sustainable brand preference, and reward the manufacturers commensurately, both directly and also through word of mouth. Alternatively, if the stated ‘brand purpose’ is not genuine – which customers can quickly find out through digital transparency, they shift their preferences to the deserving ones. Going by this growing trend, I reckon, creating ‘Purpose-Driven-Brands’ assumes a critical importance to win marketing warfare, in the new reality.

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.

 

Union Budget 2018: The ‘WOW’ Moment for Indian Healthcare?

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The 2018-19 Union Budget proposals, presented before the Parliament on February 01, 2018. Especially for those who take keen interest in the Indian healthcare environment, was there a ‘WOW’ moment in the budget? Some say, this long-awaited moment came with the Union Finance Minister’s (FM) announcement of the ‘Ayushman Bharat Program (ABP)’ – the “world’s largest healthcare program,” taking a major step towards the Universal Health Coverage (UHC) for all, in India.

Two other health care related major announcements made by the FM in his 2018 Union Budget proposal are:

  • 24 new government medical colleges by upgrading existing district hospitals.  This is to bridge the gap between doctor-patient ratio in the country.
  • An allocation of ₹60 million for nutritional support to all tuberculosis patients – ₹ 500 per month per patient for 10 months, during the duration of their treatment.

The ‘Ayushman Bharat Program (ABP)’:

In this article, I shall not touch upon what expectations of pharma and healthcare industries were not met with the budget, as that will no more than an academic deliberation, at this stage. I shall rather restrict my discussion to ABP, for obvious reasons. This potential game changer, covers two commendable initiatives, as follows:

1. The New Health Protection Scheme (HPS) offering health insurance coverage of ₹500,000 per family per annum, is expected to take under its wings 100 million vulnerable families, or around 500 million beneficiaries. The total budgetary allocation for this mega proposal, for which the detail contours, apparently, are yet to be fleshed out and made public.

Some Senior Government officials, though, have put across its sketchy outline during post-budget Television coverage, on last Thursday. However, many industry watchers construe HPS as an expanded version, with a different name, of the current ‘Rashtriya Swasthya Bima Yojana (RSBY)’, which provides annual coverage of just ₹30,000 for poor families.

A fund of just ₹20 billion has been earmarked for this mega project in the Union Budget 2018-19.

2. Creation of 150,000 health and wellness centers to provide ‘comprehensive health care’ – for prevention and treatment of both communicable and non-communicable diseases (NCDS), including maternal/child health services, and free essential drugs alongside diagnostic services. This will “bring healthcare closer to home”, as the FM articulated.

A sum of ₹1.2 billion (₹1200 crore) had been allocated for this project in the 2018 budget proposal. The FM also requested contributions from the private sectors through CSR, besides philanthropic entities, in adopting these centers.

The points to ponder before saying ‘WOW!’

So far so good. However, as the saying goes, the devil is in the detail. From that angle, sans any meaningful details, does it look merely as an expression of the Government’ intent? Or it is for real! This serious doubt emanates from some key considerations. Three of which, as I reckon, are as follows:

I. Is it the beginning of implementation of the much-awaited National Health Policy 2017 (NHP), where the Government had committed and expenditure for UHC around 2.5 percent of the India’s GDP? This number currently hovers around 1.4 percent –  reportedly, less than even Nepal (2.3 percent) and Sri Lanka (2 percent). There is no mention of this in the Union Budget Proposal 2018, either, how much it will now go up to. By the way, the same report, as above, of January 2018 also indicated that health costs push 39 million Indians back into poverty, every year.

  • Attaining the NHP 2017 objectives, prompts a rise of around 40 percent in the public health expenditure of the Government. Whereas, the allocated reported expenditure for health in 2018-19 at ₹52.8 billion over the revised estimate of ₹50.1 billion in 2017/18. This works out to an increase of just around 5.4 percent.
  • The allocated expenditure of ₹20 billion for ABP in 2018-19, over the last year’s (2017-18) very similar health budget for ‘National Health Mission (NRM)’, reportedly, of ₹26.70 billion, looks rather pale. The financial arithmetic doesn’t appear to add up, defying simple logic. Is the allocation enough to support the ABP for 2018-19, even if the ABP funding is shared in the ratio of 60:40 between the Central and the State Governments?
  • Diving slightly deeper, on February 02, 2018, quoting a Government official Reuters reported, the cost of providing health insurance to 100 million vulnerable families or close to about half the country’s population would require an estimated ₹110 billion (USD$ 1.72 billion) in central and state funding each year.
  • The government estimates the cost of insuring each family would be about ₹1,100 rupees (US$17.15), the above report says. Curiously, on the face of it, this huge amount appears as an ‘off balance sheet’ expenditure, as of now.
  • Intriguingly, when the ABP is still not in place, there has been, reportedly, a 2.1 percent decline in the allocation towards the NRM in 2018-19. Currently, NHM provides financial support to States to strengthen the public health system, including upgradation of existing or construction of new infrastructure. In addition, there is a 7 percent cut in the allocation for the ‘Swachh Bharat Mission’ Budget from 2017-18’s revised estimates.

II. The second question is equally critical. Just as the erstwhile State Sales Tax (now a part of GST), healthcare is also a state subject. Thus, a similar process of intensive consultation with all State Governments, as happened before the implementation of GST, to take them on board, has to be replicated for a consensus. This will include a commitment for 60:40 funding, alongside the mechanisms for effective implementation of ABP – step by step. Has that happened? Have all the States agreed to contribute 40 percent of total funding requirements in their respective states for ABP?

  • If the answer is yes – excellent! If not, when will the ABP be rolled out? Different senior government officials have indicated different dates on Television. Some said on the Independence Day this year – August 15, 2018. Some other official said on October 02, 2018 – Gandhi Jayanti of this year. Yet another responsible official said the actual implementation may, actually, take even more time. This could mean only one thing, the ABP has been announced without any fixed timeframe for its implementation.

III. The third question lies in the effectiveness of insurance-driven health care system, such as in the United States. The key question often is raised on this system: Do the health insurance companies derive more benefit out of this system rather than the patients?

  • Concurring with the experts of many other countries, India’s own – Dr. (Professor) K. Srinath Reddy, globally acclaimed cardiologist and the President, Public Health Foundation of India, reportedly is also of the opinion that “Government-funded social insurance schemes do increase access to advanced care. But they have not been shown to provide financial protection as they cover only part of the hospitalization cost and none of the expense of prolonged outpatient care which forms a higher percentage of out-of-pocket spending.”
  • Insurance-driven healthcare has been found wanting to properly balancing health insurance costs with access, quality of care and outcomes in several countries. The experience of most of those people in India who can avail the benefits of insurance-driven – the Rashtriya Swasthya Bima Yojana (RSBY) or Employee State Insurance Schemes (ESIS), are not very pleasant, either.
  • On the other hand, despite some peripheral issues, many prefer, the government run UHC, such as in Britain. These generally offer a broader health coverage to all, and most health and care related services are available free to the citizens. The UHC is fully funded by taxes there, though a private health care system exists along with it. Thus, serious apprehensions related to the depth of health care access, reach in the rural heartland, and the quality of product and services to be generally provided by the insurance-driven new HPS, continue to haunt.

Conclusion:

Considering all these aspects, renamed HPS, as it was announced by the FM on February 01, 2018, and subsequent incongruent and very tentative clarifications expressed through the media by some Senior Government officials, raises even more questions than answers.

Sans any transparent and well-laid out financial road map, detail mechanism of its operation, level of involvement and consensus reached with all the States on funding and implementation, specific timeframe for its rollout, besides addressing almost a collapsing public health-infrastructure framework in most States, the Government appears rather unprepared with HCP rollout in 2018.

Does this announcement for HCP, therefore, not reflect a bit of haste, if not an intent to achieve any other non-related objective? Thus, this edict didn’t fetch a WOW moment to me, at least for this year, or…did it?

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.

Drugs & Devices: Chasing Never-Enough Profit And Price Control

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On July 20, 2016, the Union Ministry of Health of India announced the addition of Coronary Stents to the National List of Essential Medicines (NLEM) 2015 with immediate effect, bringing them under the Drug Price Control Order.

Reacting sharply to this development, the medical device industry commented, with an undertone of threat, that this price cap could stop manufacturers from introducing technologically advanced stents in India.

However, without contributing to any further knee-jerk reaction, let me try to analyze in this article, whether the never-enough profit motive of the imported stent manufacturer prompted the Government to resort to price control for these life saving devices.

The use of stent:

In the treatment of coronary artery diseases, cardiac stents are now widely preferred in India, just as many other countries of the world. These are small expandable tubes, usually made of metal mesh, and are used to treat narrowed or weakened arteries in the body. 

One of its most extensive usages is in patients with Coronary Heart Disease (CHD), caused by the buildup of plaque, where stents are used to open narrowed arteries and help reduce the symptoms, such as, chest pain or angina, or to help treat a heart attack. This procedure of a percutaneous coronary intervention (PCI) is called angioplasty. 

According to the report of an experts’ sub-committee formed by the Government in October 2015, around 25 percent of deaths in India is attributed to Cardio Vascular Disease (CVD). Coronary Artery disease (CAD) is the commonest CVD accounting for 90-95 percent of all CVD cases and related deaths.

However, for a large majority of the Indian population, the cost of angioplasty is prohibitively high. A patient may have to shell out anywhere between around Rs. 60,000 and Rs. 150,000 for a stent coated with drugs, called Drug Eluting Stent (DES), to curb restenosis, according to published reports.

Even for most Government staff, the cost of angioplasty could well be several times more than their maximum reimbursable limit fixed for angioplasty. Thus, only around 3 out of 1000 needy coronary heart disease patients are treated with angioplasty in India, as compared to 32 in the United States.

An opportunity to shape up:

Despite DES being notified as drugs under the Drugs and Cosmetics Act, 1940, the coronary stents did not feature in the National List of Essential Medicines (NLEM) prior to the above notification, and therefore, were not covered by the Drug Price Control Order (DPCO), so far.

For a long time, this situation offered an important opportunity to the imported stent manufacturers to shape up with responsible pricing…but did they?

Why is angioplasty cost so high?

While trying to find out a credible answer to the above question, the following details on DES of Abbott Healthcare are worth looking at. This information was sourced from a Maharashtra FDA report, and referenced by Rema Nagarajan in her article published in the Times of India on September 25, 2014 to highlight why is DES so expensive for patients in India.

Although, pricing details are of 2014, nevertheless, it gives a flavor of the prevailing situation:

Cost Break-Up/Unit Cost per Unit (Rs.)
DES imported into India at 40,710
Sold to Distributor Sinocare at 73,440
Distributor Sold to Hinduja Hospital 1,10,000
Patient charged 1,20,000 (threefold increase of import price)

(Source: Maharashtra FDA report)

The saga of ‘Market driven pricing’:

Both the drug and the device companies apparently make valiant efforts to package such ‘arbitrary’ pricing as so called ‘Market Driven’ ones, though such price tags keep crippling many cardiac patients financially too. Ironically, the saga still continues.

Taking advantage of the free-pricing environment in India for Coronary Stents, to attain market dominance many global majors, possibly believe that they can print any Maximum Retail Price (MRP) on their import cost. It was happening even when the Government does not levy any customs duty on stents. Do these companies ignore its optics too? Who knows? 

Like most drugs, market forces do not play any significant role in the medical device pricing too, globally.

In June 2013, a research study published in the ‘American Heart Journal (AHJ)’, compared the use of Bare-Metal Stents (BMS), Drug-Eluting Stents (DES), and Balloon Catheters according to company presence in the hospital. It concluded that Medical Representative (MR) presence was associated with increased use of the concerned company’s stents during percutaneous coronary interventions. The effect was more pronounced with the use of DES, and resulted in the higher procedural cost of US$ 250 per patient.

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

The situation is not terribly different in India too, where also the medical choices are often influenced by the drugs and device makers through, much discussed, dubious means.

The market:

According to a market research report of ‘Future Market Insights (FMI)’ dated May 09, 2016, the coronary stent market of India was of US$ 481 million in 2015, and by the end of 2016 is expected to reach at US$ 531 growing at a CAGR of 14.0 percent over the forecast period of 2016 – 2026.

This study segmented the market on the basis of the following product types:

  • Drug Eluting Stent (DES)
  • Bare Metal Stent (BMS)
  • Bioresorbable stent (BVS) 

DES segment is expected to exhibit the highest growth and the BMS segment a stable growth, during the forecast period. This is mainly attributed to the emergence of new and more effective stents in the market, the report highlights. 

The market is dominated by the imported stents. Abbott, Medtronics, Meril Lifesciences and Boston Scientific, hold together around 60 percent share of the Indian market.

In India, nine of the 11 domestic stent manufacturers are located in Surat and Vapi of Gujarat. These stents are picking up the market share currently hovering around 30 percent, costing even less than half, as compared to the imported ones.

The Government stepped in:

When the industry did not seem to shape up, despite the regulatory opportunity available to keep the stents out of the NLEM, the media started writing about it, strongly and quite frequently. These were intended to bring some sanity into the imported and advanced Coronary Stent pricing system. Still nothing changed, and the Government had to step in.

Ultimately, in October 2015, the Union Ministry of Health constituted a sub-committee of expert cardiologists under the chairmanship of Prof. Y.K. Gupta, Head of the department of pharmacology, All India Institute of Medical Sciences (AIIMS). The mandate of this sub-committee was to examine the issues relating to the essentiality of coronary stents, and recommend whether the coronary stents should be included in the NLEM.

Accordingly, after a series of in-depth discussion with various stakeholders, which included stent manufacturers and the patient groups, the sub-committee recommended the inclusion of two categories of coronary stents, namely the DES and BMS in the NLEM. This suggestion was in response to “the enormous need of percutaneous coronary intervention, or angioplasty with stent.”

By a notification on July 20, 2016, the Ministry of Health announced that the sub-committee has submitted its report to the Government, and after thorough examination of the report, its recommendations have been accepted for implementation with immediate effect.

This decision of the Government is expected to set the stage for the National Pharmaceutical Pricing Authority (NPPA) to work out ceiling prices, which are expected to be 40 percent to 70 percent less than the current prices for these stents.

Conclusion:

For the last several years, many stakeholders, including the media and the Government, have been expressing grave concern over the exorbitant prices of the Coronary Stents.

Earlier in 2015, following a petition, even the Delhi High Court directed the Government to monitor the prices of stents in the market.

Indian drug price regulator, the NPPA, and some state FDAs too flagged the point that although locally manufactured stents are much cheaper, doctors and hospitals continue to use the imported ones, for various commercial and other reasons. As a result, the situation remained the same, adversely affecting the health of a large number of cardiovascular patients in India.

The last week’s decision of the Indian Government for inclusion of coronary stents in the NLEM, needs to be viewed under the backdrop of steep increase in the incidence of CHD in India. It clearly poses a significant public health hazard, where the cost of stents becomes a key treatment barrier for the majority of the patients incurring out-of-pocket health expenditure.

Price control of drugs and devices may not be the best way to improve their access to the most of the Indian population. Nevertheless, considering the high out-of-pocket expenditure for health care in the country, instead of behaving responsibly, doesn’t the drug and the device makers’ mindless chase after ‘never-enough profit’ objectives, often prompt the imposition of regulatory price control?

The fact that many global drug and device manufacturers, even after posting over 30 percent standalone net profit growth in India, continue cribbing incessantly about the stifling Regulatory and Intellectual Property Right (IPR) environment in the country, vindicates the above point well, possibly beyond any reasonable doubt.

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.