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Collaboration For Sustainable Excellence – The Name of The Game in The New Normal

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The union minister of health and family welfare of India recently invited Japanese companies to collaborate with Indian companies on research and innovation in emerging therapies, like precision medicine, cell and gene therapy, biological products, and on the utilization of digital tools and technologies. This was reported on May 16, 2023.

Underscoring this objective, the minister articulated, “such collaboration on research and innovation would help enhance the domestic availability and affordability of these innovative therapeutic options.”

The area of research and drug innovation in emerging therapies and on the utilization of digital tools and technologies has emerged as one of the top focus areas of the country in the new normal. Currently, the Indian pharmaceutical industry is primarily focused on manufacturing generic medicines, exporting bulk drugs, and supplying active pharmaceutical ingredients.

Thus, this goal can be quickly achieved through global collaborations – at a time when India plays a pivotal role in improving health outcomes worldwide by serving as a dependable supplier of affordable and high-quality generic drugs. The country is currently providing approximately 60 per cent of the global vaccine supply, and 20-22 per cent of generic exports. Importantly, ‘In the battle against the Covid-19 pandemic, India has supplied essential drugs to around 185 countries,” he underscored.

Interestingly, after the Covid-19 pandemic, there has been a significant shift in the approach of both Indian and multinational drug companies towards business collaboration. This article will focus on this area with recent Indian examples, culled from available reports. However, before delving into this space, let me also point out that drug MNCs operating in India are also changing focus on their India operations, as reported in recent times.

Drug MNCs operating in India are also changing business focus: 

This was brought to the fore by several recent reports. For example, in February 2022, The Economic Times reported: 

  • In February, Novartis India passed on the sales and distribution rights of three of its established brands to Dr Reddy’s Labs and terminated the employment of 400 staffers.  
  • In October, US drugmaker Eli Lilly sold the marketing rights of its anti-diabetes drugs to Cipla and laid off 120 employees in India. 
  • Around the same time, Danish pharma company Lundbeck decided to exit India as part of its global strategy. 

However, their key goal remains - delivering new patient-perceived value – not just incremental, but in quantum measure for business growth.

The need for increased collaboration and shared resources:

Against the above backdrop, it appears to me that the pandemic has highlighted the need for accelerated cooperation and sharing resources to address global healthcare challenges, effectively. As a result of which, both Indian and MNC drug companies are recognizing the benefits of working together, and are actively seeking collaboration opportunities in the following areas. 
  • Access to Emerging Markets: Indian pharma companies have a strong presence in emerging markets due to their cost-effective generic drug manufacturing capabilities. Multinational companies recognize the potential of these markets and are looking to collaborate with Indian firms to gain access to these regions. By partnering with Indian companies, MNCs can tap into local expertise, distribution networks, and regulatory knowledge. 

- Example: In 2022, Cadila Healthcare entered into a collaboration with Novartis to develop and commercialize multiple oral solids and injectable generics for global markets, including emerging markets.

  • Research and Development: Collaboration in research and development (R&D) activities has become crucial for drug companies. MNCs bring advanced research capabilities, cutting-edge technologies, and substantial financial resources, while Indian companies offer a skilled workforce and a cost-effective environment for R&D. By joining forces, they can pool their strengths and accelerate the discovery and development of new drugs and therapies.

- Example: In 2021, Bharat Biotech collaborated with the Washington University School of Medicine in St. Louis and the International AIDS Vaccine Initiative (IAVI) to develop a novel vaccine candidate for HIV. This collaboration aims to combine the strengths of all three organizations to advance HIV vaccine research.

  • Manufacturing and Supply Chain: The pandemic exposed vulnerabilities in global supply chains, particularly in the pharmaceutical sector. Collaborations between Indian and MNC drug companies can help diversify manufacturing locations and strengthen supply chain resilience. Indian companies’ expertise in large-scale generic drug production can complement the specialized manufacturing capabilities of multinational firms.

- Example: In 2021, Hetero entered into a partnership with the Russian Direct Investment Fund (RDIF) to manufacture the Sputnik V Covid-19 vaccine in India. This collaboration aimed to increase the production capacity of the vaccine to meet global demand.

  • Regulatory Compliance: Regulatory compliance is a critical aspect of the pharmaceutical industry. Indian companies have been working closely with regulatory authorities to meet global standards and gain approvals for their products. Collaborating with Indian companies enables MNCs to leverage their understanding of regulatory processes, navigate local regulations efficiently, and ensure compliance with diverse international requirements.

- Example, in 2022, Biocon Biologics partnered with Adagio Therapeutics, a US-based biotechnology company, to develop and commercialize an antibody treatment for COVID-19. This collaboration involves regulatory support from both companies to navigate global regulatory processes.

  • Market Expansion: Collaborations provide an opportunity for both Indian and multinational companies to expand their market presence. Indian companies can benefit from the MNCs’ established marketing networks, while MNCs can leverage the Indian companies’ extensive distribution channels and market knowledge. Joint ventures and partnerships facilitate market entry, improve market penetration, and help companies capture a larger share of the global pharmaceutical market. 

- Example: In 2022, Torrent Pharmaceuticals collaborated with Swedish multinational company Handicare Group AB to distribute and market Handicare’s range of mobility solutions in India. This collaboration enables Torrent Pharmaceuticals to diversify its product portfolio and expand into the healthcare mobility market. 

  • Technology and Innovation Sharing: Collaborations foster knowledge exchange between Indian and multinational drug companies. MNCs can share their technological advancements and research findings, while Indian companies can contribute their insights and expertise in managing large-scale production. Such knowledge-sharing initiatives can drive innovation, improve manufacturing processes, and enhance overall operational efficiency. 

- Example: In 2022, Glenmark Pharmaceuticals entered into a collaboration with the Canadian multinational company SaNOtize Research and Development Corp. to develop a nitric oxide nasal spray for the treatment of COVID-19. This collaboration combines Glenmark’s expertise in drug development with SaNOtize’s innovative nitric oxide platform.

  • Intellectual Property and Licensing: Collaboration often involves the exchange of intellectual property (IP) rights and licensing agreements. Indian companies possess a vast pool of generic drug formulations and manufacturing capabilities. MNCs can license their patented drugs or technology to Indian partners for production and distribution in specific markets. These licensing arrangements benefit both parties by expanding the product portfolio and maximizing revenue potential. 

- Example: In 2021, Glenmark Pharmaceuticals signed a licensing agreement with Canadian biopharmaceutical company Xenon Pharmaceuticals to develop and commercialize a potential treatment for epilepsy. This collaboration involves the licensing of Xenon Pharmaceuticals’ proprietary technology for the development of a novel therapeutic product.

Conclusion:

Overall, as the recent trends indicate, the post-pandemic era has accelerated initiatives of strategic collaboration between Indian and multinational drug companies. By leveraging each other’s strengths and with shared value and resources, these collaborations aim to drive innovation, address global healthcare challenges, and deliver affordable and accessible healthcare solutions to patients worldwide. And thereby, will help deliver a unique patient experience.

Additionally, the examples, as available from published sources, highlight an increasing number of such recent collaborations, besides operational re-focusing by several MNC drug majors in India.  

These strategic steps clearly emphasize their joint efforts to drive innovation, expand their market presence, and address critical healthcare needs. From this angle, I believe, for sustainable business excellence and for staying relevant to customers in the new digital world, one of the top focus areas for Indian pharma players deserves to be strategic collaboration initiatives.

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 Marketing: The New Normal: Challenges of Change

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A lot has changed in healthcare marketing prompted by the Covid pandemic. Apace with these, lots of old problems continue to remain very much the same. The aforesaid was observed in a recent article, published by WARC, on May 21, 2021. Although, this analysis was done in the United States, it has a global footprint, as the disruptions are broadly similar, with a varying degree from country to country.

Healthcare marketing leadership, including the pharma industry in India, presumably, is taking notes of these critical changes, along with their degree of impact. These are the basics for required responses in India, while managing its snowballing effect, both global and local.

Today’s article will provide a bird’s eye view of this area, to encourage marketers continue with their ongoing deep-dive data gathering exercise. Then, comes sieving the ‘catch’ with cerebral power – before using modern analytics to draw meaningful inferences for strategy making.

Some macro-changes stand out:

Some of these widely visible changes, also captured in the above WARC article, include the following:

  • An emerging trend of re-orientation of the healthcare industry around patient outcomes.
  • Need to realize that health and safety are the currency that can be used to rebuild consumer trust across categories.
  • Increasing need to build deeper emotional connections with customers, going beyond product-oriented features, benefits, and intrinsic brand values.
  • Providing healthcare consumers more data and behavioral science-driven, personalized solutions to their problems – to drive better outcomes.

More people are realizing that: ‘Healthcare, after all, is about life and death, and those stakes have been tragically reaffirmed during the pandemic,’ as the above paper underscores. Thus, affordable “health and safety will continue to be a currency that brands can use to re-establish trust with anxious consumers,” the author reiterates. To steer a company in that direction the marketers need to create a pathway for success by joining several emerging dots in the new normal. Let give just a flavor of these emerging dots with three examples, as below.

‘The end point – the price point’ - re-emerging as a core value expectation: 

Interestingly, ‘The end point – the price point’ for quality treatment outcomes is re-emerging as one of the core values and expectations of the consumers, especially facing an uncertain future that everybody is witnessing today. The health system is also transitioning from ‘pay for healthcare product and services’ – to ‘pay for integrated value-based care offerings.’ In the changing environment, many pharma players seem to have realized that customers are no longer interested in paying for brand values that serve mostly self-serving interests of the respective companies.

More healthcare customers are digitally savvy now:

Today’s brand values need to be in sync with what the perceived value of the customers, enhancing their end-to-end experience of the disease treatment process, more than ever before. For example, increasing number of patients are now choosing between F2F – in-clinic consultations and remote or virtual consultations, for non-life-threatening ailments. Some often do data-driven online assessment for different treatment value offerings, against what these would cost to them.

Purpose driven corporate branding is making better impact:

Pharma industry’s purpose-driven branding initiatives, in tandem with creating robust corporate brands, are drawing much greater public attention amid the pandemic. The list includes both the original product developers and their contract manufacturers. Even in India, many held with esteem – Corporates, such as, AstraZeneca and Serum Institute of India (SII) for Covishield, or Bharat Biotech for Covaxin.

The same thing has happened world-wide with many other Covid vaccine and drug manufacturers, such as, Pfizer, Johnson &Johnson, Moderna, Eli-Lilly, Roche, and others. Interestingly, from the available data in the cyberspace or from word-of-mouth, several people have also inferred about comparative value offerings of each. At least 4 Covid vaccine manufacturers are showing-up in this year’s ‘Conscious Brands 100’ list of 2021. This is, apparently, unprecedented.

Demonstration of ‘patients’-problem solving skill’ with resilience pays: 

As we all know by now, the drug industry as such – across the world, instead getting overwhelmed by the problem, pulled up socks and rolled the sleeves to find out scientific means of saving as many lives as possible, soonest.

Almost overnight, repurposing old drugs for Covid treatment and development Covid vaccines, racing against time, were initiated. The entire healthcare industry including, Medical Diagnostic and Devices companies and others, did not fall behind to offer reliable tests for Covid diagnosis, and other life support systems and equipment.

Alongside, Omnichannel digital campaigns of many companies, and favorable news reports amid the pandemic, made people realize the stellar role of the industry in saving lives and livelihoods – from the Covid menace.

Such examples include Pfizer’s What to know About Coronavirus webpage; Merck Inc’s Podcast: How Merck is looking at past epidemics and science to respond to the coronavirus outbreak; and India’s Mankind Pharma’s Mask My India digital campaign. It captures the stories of heroes, who are setting examples and doing more than their call of duty during the COVID-19 pandemic in India. The campaign also spreads the message that ‘together we can all fight with deadly Coronavirus.’

Some pandemic-triggered India-specific challenges:

According to the April 2021 KPMG paper, Covid pandemic has brought to the fore some of the following challenges for the India pharma industry, some due to years of neglect:

  • Fragile public health care system and laboratory testing infrastructure and supplies of life support items. This primarily due to one of the lowest Government spend (1.56% of the GDP) on health. As a result, India currently ranks 155th out of 167 countries, in terms of hospital bed availability (Human Development Report 2020) with just 5 beds availability per 10, 000 Indians.
  • Changes in health care consumption pattern – especially with the increasing use of e-health or telehealth, besides, online ordering of medicines through e-pharmacies.

Apart from these, it’s also noteworthy – how pharma demonstrated its healthcare ‘problem solving’ skill to save billions of lives from deadly Covid-19 and its mutants, attracting unprecedented kudos from all corners. To keep this initiative going – meeting customers’ core expectations, in my view, could indeed be yet another challenge of change.

Conclusion:

There won’t be any ‘one size fits all’ sort of solution to address such challenges of change. Neither is all company’s challenges the same, in a relative yardstick. Each company would, therefore, need to understand what the pandemic triggered changes in market dynamics and customer expectations mean to them to pursue sustainable business excellence.

Thus, each player would require to elaborately make data-based assessment and analysis, to figure out where they currently stand, so far are the pandemic-triggered changes are concerned. With similar analysis, they should also try to fathom what are their customers’ specific value expectations, which may now go beyond the value that their brands can deliver, but critical for branding success.

Accordingly, a value delivery strategy to be worked out, taking all concerned on-board – with a carefully crafted employee and customer engagement blueprint – and mostly Omnichannel digital platforms.

To successfully navigate through the challenges of change, pharma marketers need to wear a different thinking cap. They would also need to realize that treating pharma marketing as an intrinsic product value delivery system, and by just doing digitally whatever traditionally used to be done manually, may not help generate an adequate return in the new normal. From this perspective, giving shape to a robust, comprehensive, integrated and Omnichannel digital strategic game plan for the organization, is the need of the hour.

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.

Taming Two Critical Covid Uncertainties For Pharma’s Sustainable Growth

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The reasons behind a great urgency of the Governments, besides high expectations of the general public, to have the ‘ultimate solution’ very soon, against the ongoing pandemic, are understandable. However, various media-hyped narratives on their clinical trials, and timeframe for expected launch – ranging from November this year to anytime in 2021, are making many experts to raise eyebrows on the scientific processes followed for Covid vaccine development.

Exact answers to the ultimate efficacy standard, safety profile and dates of their availability to the entire population, are still not clear – not even to many domain experts. Besides, two other critical and fundamental questions in India, are related to huge financial resources and other wherewithal, such as, countrywide stringent cold-chain logistics network, required to achieve this goal.

While effective, safe and high-quality vaccines, as and when these will come, will be pivotal to contain the alarming spread of Covid-19 – and that too in a wave after wave manner. Alongside, the intense search for effective anti-Covid medicines are also expected to come to fruition. Doctors will then have in their arsenals a number of highly effective alternatives, that can predictably cure individuals, when infected by this lethal virus.

It causes a great concern when someone asks, when will those days of great relief to all come? For, those days may or may not be very soon – could well be for an indefinite period. No one seems to know the answer, yet.

Until then, pharma companies can’t afford to remain in a ‘quick-fix mode’ to address the problems related to Covid related market and consumer mindset changes. Choosing this path could eventually prove to be very costly, especially for the lost time in leveraging some key opportunities. Moving in that direction, would entail rebuilding the organization by creating a new work-culture – a mindset to be all-time ready for any disruptive changes in business. Most importantly, if or as and when it comes, the organization should not get as overwhelmed, as is happening during the current global pandemic.

In this article, I shall deliberate the following two critical and interrelated Covid-19 issues:

  • The uncertainty in achieving what everybody is expecting to get right away – getting a preventive vaccine or a cure for the infected patients.
  • Inordinate delay in getting prompt medical care by many patients for non-Covid related serious ailments, leading to complexity of the disease. How long this situation will continue still remains uncertain.

As things stand today, these uncertainties could continue for an indefinite period, making some of the Covid related changes irreversible. Thus, my aim will be, first to recap where we are today with these niggles. And then, focusing on the crucial need to pave a balanced pathway – uncharted by anyone, for destination success – in the new world order. Let me begin with the first issue first.

The uncertainty in achieving what everybody is expecting:

Although, some Covid vaccines, reportedly, will be ready by early 2021, uncertainties and delays are still anticipated on the way. Some the reasons may include the following:

  • A critical challenge: About 5.6 billion people worldwide would need to be immune in order to end the pandemic (NEJM). Thus, vaccination process may take years to achieve the coverage necessary for everyone to be protected.
  • Huge investment required: India would need to invest between Rs 3,000 -5,000 crore to create additional facilities for making a huge number of vaccines, required for the Indian population. Currently no one has the capacity to manufacture it for 1.3 billion Indian populations. Moreover, vaccine alone is not the solution to the COVID-19 problem, according to experts.
  • High vaccine cost in India: As these vaccines come from a very difficult platform its cost is going to be significantly higher than many other vaccines, so there is going to be a requirement to think about how we are going to fund this.
  • Coronavirus mutating, potentially evolving: As reported on September 24, 2020, Covid’s continual mutation may make it increasingly contagious. The study says, it’s possible that when our population-level immunity gets high, this Coronavirus will find ways to get around our immunity.
  • The logistical challenge of a lifetime: Getting billions of doses of COVID-19 vaccines around the world quickly, would require 15,000 flights and 15 million cooling boxes. Stringent temperature control requirements for the vaccine supply chain must not be compromised at any point, not even in rural India. It’s worth noting, some of these vaccines may need to be kept at temperatures as low as -80 degrees Celsius. Currently, even in the developed world, the most efficient medical supply chain conventionally distributes vaccines at +2–8°C.
  • Vaccines may not provide complete protection: If COVID-19 re-infections are common, “vaccines might not completely protect against the virus” and would instead require a design similar to seasonal flu shots to protect from new variants. Interestingly. India may, reportedly, approve covid-19 vaccines that show 50 percent efficacy in clinical trials.

Converting problems into opportunities:

Such uncertainties may not only aggravate people’s overall health risks, but also their exposure to Covid infection. Drug companies, drug authorities and various Governments have been working hard on these issues. However, as flagged earlier, amid this health crisis, there is also another growing concern of a very serious nature. It pertains to many people delaying their non-Covid related medical care and medical interventions, for various reasons.

Pharmaceutical companies can convert this problem into a golden business opportunity with ‘patient-centric’ innovative strategies having a cutting-edge, and from a number of platforms. Let me illustrate this point with an interesting example of an initiative taken by a global pharma major, in this area.

A pace setting initiative:

On September 22, 2020, Fierce Pharma reported, ‘J&J wants everyone to know that taking care of their health can’t wait—even during a pandemic.’ This effort is based on the findings of a recent Harris Poll commissioned by them. This study revealed, the COVID-19 pandemic has caused many Americans (68 percent) to delay healthcare treatment. It ranges from standard routine exams to important elective surgeries to ER visits – with physicians sharing concerns about the long-term impact of patients delaying care. The situation is expected to be no different in other countries of the world, including India.

Based on this finding Johnson & Johnson (J&J) have recently launched a US-based online initiative, aimed at giving both patients and physicians information and resources about health care options. This unique campaign has been named – “My Health Can’t Wait”.

By a statement J&J announced: “As the largest healthcare company in the world, we are committed to helping people live their healthiest lives, which means getting the care they need, when they need it.” It added: “Through My Health Can’t Wait, we hope to provide patients and healthcare providers with resources to help stay connected and prioritize their health care, both during this pandemic and in the future.” The point, especially take note of is, ‘both during this pandemic and in the future.’ This part of the above sentence of J&J, echoes the well-known management dictum – converting problem into opportunities, I add, even during the Covid pandemic.

I hope, many pharma players may also wish to pursue similar direction, responding to their own specific needs. But, not just to keep the head above water, in combating this unprecedented health crisis, but with a long-term strategic perspective – to rebuild the organization – for business excellence the new normal.

The concept reverberates:

I find the concept of ‘rebuilding the organization now, for business excellence the new normal’, reverberating in several expert voices. For example, The McKinsey ‘Briefing Note’ of September 16, 2020 – ‘COVID-19 and the great reset.’ It said: ‘The world anxiously awaits an effective COVID-19 vaccine that can be readily distributed. Until then, the priority is to re-energize organizations—to act rather than react. Even as the uncertainties of the COVID-19 crisis multiply, the goal must be to rebuild for the longer term.’

The authors emphasized, ‘a crisis has a way of bringing things to a head.’ Many believe, the coming months might be the best opportunity in memory for healthcare companies to pursue exponential innovation. This, according to McKinsey, ‘could create an additional $400 billion in value by 2025. And now is the time to claim the hundreds of billions of dollars that could be saved through productivity gains.’

Thus, I reckon, apart from creating a great business compulsion of working harder to neutralize the short-term operational constraints, Covid pandemic also provides a unique opportunity to pharma leadership. It gives a space for them for thinking long-term, and from a strategic perspective. The aim is to rebuild the organization, placing it at a higher trajectory for success, in an uncharted frontier, thus far.

Conclusion:

Meanwhile, as on September 27, 2020 morning, India had recorded a staggering figure of 5,992,532 of Coronavirus cases with 94,534 deaths. The virus’s unprecedented onslaught on the country still continues, unabated. Be that as it may, coming back to where I started from, I reckon, pharma companies, in general, could play a stellar role in converting the dual problems of uncertainties into a number of opportunities. In that process, they can create a win-win situation for all, in the health care space.

The uncertainties related to scientifically proven, safe and effective Covid drugs and vaccines will, hopefully, be addressed – sometime, by the scientists and medical researchers. However, as the above McKinsey paper wrote: ‘Until then, the priority is to re-energize organizations – to act rather than react. Even as the uncertainties of the COVID-19 crisis multiply, the goal must be to rebuild for the longer term.’ Thus, the second issue, needs to be creatively leveraged mostly by individual drug players, starting from now.

From this perspective, pharma leadership, will need to commit quality time of thinking people, supported by adequate resources, for conceiving and effectively implementing a ‘patient-centric’ strategy, that patients will fall for in the new normal. That being done, the top honchos, will require to roll up their sleeves to prioritize primary, secondary and tertiary action areas.

Instead of trying to do a little bit of everything, in all possible areas of Covid related changes in the market dynamics, ‘primary action areas’ ought to be the starting point, deploying all resources. And then, expand to the ‘secondary’ and ‘tertiary’ ones, in a well-calibrated manner. Evaluation of results and tightening the strategic loose knots, if any, should be an ongoing process. If implementation of the process requires handholding, so be it. Because, taming these two critical Covid related uncertainties, is intimately related to a sustainable growth for the pharma companies.

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.

 

Gene Therapy Price: Commercial Viability And Moral Dilemma

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On May 24, 2019, Novartis announced the US-FDA approval of ‘the first and only gene therapy’ – Zolgensma, for a type of Spinal Muscular Atrophy (SMA), a lifesaving treatment for infants of less than 2 years of age. This unique drug halts disease progression with a single, one-time intravenous (IV) infusion.

On value offerings of Zolgensma,the Novartis CEO said: “The approval of Zolgensma is a testament to the transformational impact gene therapies can have in reimagining the treatment of life-threatening genetic diseases like spinal muscular atrophy. We believe Zolgensma could create a lifetime of possibilities for the children and families impacted by this devastating condition.”

Unquestionably, this development in medical science is indeed commendable. But, the jaw-dropping price tag – USD 2.125 millionattached to this product, has brought back gene therapy at the center stage of the incensed debate on access and affordability of such treatment for a vast majority of the population, across the world. Besides, two important issues related to gene therapy need to be effectively resolved – long-term commercial viability and the ‘moral dilemma’ that its market launch would prompt. And both are interconnected and also associated with the pricing rationale of such therapies.

I am terming  the second factor as a ‘moral dilemma’ rather than an ‘ethical dilemma’ because, “ethics is a more individual assessment of values as relatively good or bad, while morality is a more intersubjective community assessment of what is good, right or just for all.”In this article, I shall deliberate on these two interrelated issues. But, before delving into it, let me recapitulate in simple terms, what exactly is ‘Gene Therapy.’

What exactly is ‘Gene Therapy?’

According to US-FDA, human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.

Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms:

  • Replacing a disease-causing gene with a healthy copy of the gene
  • Inactivating a disease-causing gene that is not functioning properly
  • Introducing a new or modified gene into the body to help treat a disease

Gene therapy products are now being studied to treat diseases including cancer, genetic diseases, and also infectious diseases.

Gene therapy price has been going higher than highest, thus far:

‘At USD 2.1 million, newly approved Novartis gene therapy will be world’s most expensive drug,’ says another report of May 24, 2019.It is noteworthy that Zolgensma price has been kept higher than the highest priced drug before this product came. If his trend continues, the future gene therapy cost is likely to exceed even Zolgensma price, the implication of which for patients who will need such treatment to save life or manage the disease, will be huge.

Intriguingly, the high treatment cost for a rare ailment like, SMA - a degenerative disorder that usually kills an infant within two years, is not limited to just gene therapy.  According to the April 04, 2019 article titled, ‘Biogen SMA drug price, Novartis estimates for its treatment far too high – U.S. group’ of Reuters, the price of another drug for SMA – Biogen’s Spinraza, which is not a gene therapy, is also very high. Its list price is USD 750,000 for the initial year and USD 375,000 annually. As reported, ‘Spinraza, an important growth driver for Biogen, took in USD 1.7 billion in 2018 sales.’

What should have been the actual prices of these drugs?

Interestingly, to determine the value of these drugs, the nonprofit Institute for Clinical and Economic Review (ICER) ‘used a measure known as “quality-adjusted life year” (QALY), in which each year of healthy or near-healthy life resulting from the treatment is worth USD 100,000 to USD 150,000.

Using the QALY benchmark, ICER, reportedly, said Spinraza should cost between USD 72,000 and USD 130,000 for the first year of treatment, and cost USD 36,000 to USD 65,000 per year after that, for infants not yet showing symptoms of the disease.

Further, with an alternative benchmark, known as life-year gained (LYG) based on the additional number of years a person lives due to a treatment, Spinraza is, reportedly, worth USD 83,000 to USD 145,000 in year one, and USD 41,000 to USD 72,000 annually thereafter, as ICER determined.

Zolgensma, on the other hand, would, reportedly, be worth USD 310,000 to USD 900,000 for Type 1 SMA patients based on the QALY assessment, and USD 710,000 to USD 1.5 million using the LYG calculation, ICER said.

Notwithstanding, whether one takes the QALY assessment or LYG based price of Zolgensma and Spinraza, the treatment cost of rare diseases, such as SMA for infants, is beyond the affordability of most people – whenever these drugs become the only choice to save lives. Thus, the question comes: Is gene therapy commercially viable or sustainable?

Is gene therapy commercially sustainable?

Undoubtedly, the development of gene therapy signifies yet another milestone in medical science to save lives, which is highly commendable. Nevertheless, the question arises, who will be able to afford this treatment? Thus, is development of gene therapy commercially viable and could be a money churner for a company on a long-term basis? There doesn’t appear to be a clear answer to these questions, just as yet. There are several reasons for this apprehension. But, I am citing below just two examples – related to their humongous treatment cost.

According to the article, published in the Scientific American, in the past five years, two gene therapy drugs have been approved in Europe and one in the United States. The name of this article is ‘Gene Therapy Is Now Available, but Who Will Pay for It?’ Interestingly, only three patients have so far been treated commercially with gene therapy, in Europe.

UniQure’s Glybera, used for a very rare blood disorder, costing around USD 1 million per patient, has been used just once since approval in 2012. However, in 2017, due to commercial reason UniQure decided to withdraw Glybera from the market. Similarly, Strimvelisof Orchard Therapeutics – used for severe Combined Immunodeficiency, costing USD 700,000, ‘has seen two sales since its approval in May 2016, with two more patients due to be treated later this year.’ Interestingly, these apprehensions have not deterred many companies. The ball keeps rolling.

But the ball keeps rolling:

That the ball keeps rolling, and at a faster pace, is evident from what US-FDA envisages in this field. According to US-FDA, by 2025, they are likely to approve 10 to 20 cell and gene therapy products a year. This is based on an assessment of the current pipeline and the clinical success rates of these products.

Importantly, despite apprehension of many, even some of the top pharma players, are fast moving into this space – based on their own assessment of the market. But, to move meaningfully in this direction, there are many several critical success factors, most of which are quite challenging and cost-intensive. A few of these, for example, are – a right collaborative model, ability to develop a scalable manufacturing process and overcoming various technical and regulatory challenges on the way. Interested pharma players, apparently, have realized these needs.

Big Pharma players joining ‘Gene Therapy’ bandwagon:

Big Pharma players, such as, Pfizer and Johnson & Johnson (J&J) have started moving into this space. Let me illustrate the point with just a couple of examples.

On March 20, 2019, Pfizer announced: ‘Pfizer has acquired a 15 percent equity interest in Vivet Therapeutics and secured an exclusive option to acquire all outstanding shares.’ Both the companies will collaborate on the development of Vivet’s proprietary treatment for Wilson disease – a rare and progressive genetic disorder, if remains untreated may cause liver (hepatic) disease, central nervous system dysfunction, and death.

Just before this, on January 31, 2019, Janssen Pharmaceutical of Johnson & Johnson (J&J) announced a worldwide collaboration and license agreement with MeiraGTx Holdings plc – a clinical-stage gene therapy company, to develop, manufacture and commercialize its clinical stage inherited retinal disease portfolio, including leading product candidates for achromatopsia. Even prior to this, on January 05, 2018, J&J had announced that the company has established an exclusive research collaboration with the University of Pennsylvania’s ‘Gene Therapy Program’ for fighting Alzheimer’s disease with gene therapy. There are several such instances of gene therapy collaboration for Big Pharma.

With a slightly different collaborative model for gene therapy, on April 12, 2018, GlaxoSmithKline (GSK) signed a strategic agreement to transfer rare disease gene therapy portfolio to Orchard Therapeutics, taking a 19.9 percent stake in the company and a seat on the board. Simultaneously, this agreement strengthens Orchard’s position as a global leader in gene therapy for rare diseases.

What could be the moral dilemma in gene therapy pricing?

The dilemma with gene therapy is that they are frightfully expensive, but at the same time is ‘life-transforming’ for many, across the socioeconomic spectrum. This could be another ‘moral dilemma,’ as such exorbitant, if not seemingly ‘vulgar pricing’, as it were, would raise many questions on the company’s own principles regarding right and wrongin saving lives of patients with its gene therapy.

The reason for this moral dilemma in, especially gene therapy pricing is aptly elucidated in an article titled, ‘How to pay for gene therapies in developing nations,’ published in  Evaluate Vantage on March 22, 2019. Admitting that discrepancies in healthcare between rich and poor nations are nothing new, the article also raises a flag, indicating: ‘The potentially curative nature of many gene therapies heightens the moral conundrum that companies will face if and when these projects get to market.

Acknowledging that gene therapies are hot right now, with their developers taking aim at everything from hemophilia to rare eye diseases prevalent in rich nations,the author raises a pertinent question: ‘With rich countries like the US finding it hard to fund gene therapies, it is worth asking whether these projects will ever reach patients in developing countries. And if they do how will companies cope?’

Intriguingly, to create a larger market some are also targeting disorders, largely seen in poorer areas, such as sickle cell disease that could prove valuable also in the developing world. Expectedly, the pressure will mount from many corners to provide gene therapy at an affordable price. Big pharma players are likely to face this strong head wind, adding further fuel to fire of the moral dilemma of gene therapy pricing, especially for the developing world. As on date, no one knows what percentage of people in the developing world will have access to gene therapy. Even Novartis, reportedly, does not seem to have any plan to make its product available in the developing nations.

Conclusion:

Despite what has happened so far, as described above, looking around, we find a steady flow of gene therapy, some even promise remedial treatment outcomes. Big pharma companies, as well, have commenced a long-haul journey in this direction, with big stake investments.

Regarding, not achieving a huge commercial success with gene therapy, so far, one point is common for all, these are for the treatment of very rare diseases. Probably, because of this reason, some companies, having taken a cue from it, are moving away from ultra-rare diseases. Illustratively, GSK is still looking to use gene therapy in a collaborative platform, to develop treatments for more common diseases, including cancer and beta-thalassemia – another inherited blood disorder – as the above Scientific American article reported.

That said, the point to ponder now, if the effort to come out with a remedial gene therapy for these indications fructifies, would it ensure a long-term commercial viability, alongside giving rise to a moral dilemma on the rationale for gene therapy pricing? This seems to be akin to a ‘chicken and egg’ situation. It will be interesting to witness how it pans out, as we move on.

By: Tapan J. Ray   

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

Creating ‘Shared Value’ in Pharma – The Way Forward

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Many Pharmaceutical companies, both global and local, are struggling with a plethora of critical challenges. With the industry reputation diving south successful navigation through this headwind has become an onerous task, more than ever before.

Under this backdrop, the article, titled “Creating Shared Value” of Michael Porter and Mark Kramer, published in the Harvard Business Review (HBR) in its January – February 2011 issue, becomes very relevant to analyze the situation.

The paper says: “Companies are widely thought to be prospering at the expense of their communities. Trust in business has fallen to new lows, leading government officials to set policies that undermine competitiveness and sap economic growth. Business is caught in a vicious circle. A big part of the problem lies with companies themselves, which remain trapped in an outdated, narrow approach to value creation.”

The authors also articulated that pharma players, generally focus on optimizing short-term financial performance, overlooking the greatest unmet needs in the market as well as broader influences on their long-term success. They questioned: “Why else would companies ignore the well-being of their customers and the economic distress of the communities in which they produce and sell?”

Porter and Kramer advised the companies to bring business and society back together – redefining their purpose as creating “shared values”. It means generating economic value in a way that also produces value for society by addressing its challenges.In this article, I shall explore in this area.

Not CSR or Philanthropy, its engaging business as business, for social progress:

Creation of “Shared values” for a business is quite different from “Philanthropy” or “Corporate Social Responsivity (CSR)”. Philanthropy usually involves ‘donations to worthy social causes’ and CSR is primarily directed at compliance with community standards and good corporate citizenship. Whereas the creation of “shared value” means integrating societal improvement into economic value creation, making social improvement as an integral part of with a business model.

To create “shared values”, it is imperative for business organizations to create “social value” through active participation in addressing the social issues and needs related to the business. Or in other words, the creation of “shared values” would entail striking a right balance between “social value” and the “business value.”

An article titled “What Is the Social Value of Pharmaceuticals?”, published by FSG on February 13, 2014 dwells on the business relevance of creation of “social value” in the pharma industry. It writes,creation of “social value” corresponds to effecting positive change along the major societal challenges, such as affordable health care, by working more in collaboration with other stakeholders to address the needs of the underserved through commensurate value creation. This entails engagement of a business as a business, not as a charitable donor, nor through public relations, for social progress.

A resolution to create “shared value” in the pharma industry:

An interesting article, featured in SFGATE of the San Francisco Chronicle on July 11, 2018, elucidated that the reputations of drug makers have taken a hit over the past few years as the public and politicians have called out the companies for high prescription drug prices that even Americans are facing. Recently, President Donald Trump, reportedly, singled out the top pharma companies of the world  for raising the list prices on some of its prescriptions.

Possibly it’s a sheer coincidence, but on the same day, an intent of creating “shared values” with the society got reflected in the statement of the president of the Novartis Institutes for Biomedical Research. The officialexplained, why his company has a ‘contract with society’. He admitted that: The cost of health care, which has been rising has left many on the hook for a larger amount of their prescription drug cost that can place a big burden on patients in many countries, including the United States.

Consequently, the pressure from the people who need medications is now on the pharmaceutical companies for doing right, he added. Thus, Novartis feels:”We have a contract with society, and society is our shareholder. A company like ours exists to have a definitive impact on life threatening diseases, to keep people alive and healthy for a long, long time, full stop” – the official concluded.

A laudable intent, but is it credible?

The concept of pharma having a contract with the society ‘to keep people alive and healthy for a long, long time,’ is laudable, but is it credible? This question arises because, just before public articulation of this intent, the same company, reportedly, entered into USD 1.2-million contract with President Trump’s lawyer, Michael Cohen, allegedly, to provide access to the US President.

The exact reason for the same is being investigated by competent authorities, including the US Senators. However, another report highlighted, “Novartis is among the drug companies that has put through significant price increases for its products since Trump took office in 2017 – in some cases more than 20 percent.”

Another  repot of July 09, 2018, quoting a tweet of the US President, poured more cold water on the warm intent of pharma’s ‘contract with the society.’ According to this article President Trump tweeted: “Pfizer & others should be ashamed that they have raised drug prices for no reason. They are merely taking advantage of the poor & others unable to defend themselves, while at the same time giving bargain basement prices to other countries in Europe & elsewhere. We will respond!”

Consistently declining pharma’s image and public trust:

Many believe that due to such hyperbolic statements and conflicting actions of pharma, over a long period time, are driving down the public image and trust on the industry, in general, from deep to deeper level, which has not found its bottom, just yet.

The reality gets reflected in various well-recognized polls, conducted even in the top pharma market of the world, which is also one of the richest nations, globally. August 2017 Gallup Poll on ‘Business and Industry Sector Ratings,’ features pharma industry at the very bottom of the ranking, just above the Federal government.

The concern gets reverberated in the February 03, 2017 article titled, ‘How Pharma Can Fix Its Reputation and Its Business at the Same Time,’ published in the Harvard Business Review (HBR). The paper observes that the worrisome mix of little growth potential and low reputation prompts the pharma players, among other actions, developing new treatments for neglected populations, and pricing existing products at affordable levels – avoiding corruption and price collusion.

How will “shared value” creation help pharma?

The process of creating “shared values” will involve creating “social value” with all sincerity and a clearly defined purpose. Its outcome should be measurable, and the impact felt by the society. In tandem, striking a right balance between “social value” and the “business value” would call for a metamorphosis in the concept of doing business.

There aren’t too many examples of creation ‘shared values’ by pharma companies, yet. However, to illustrate this point, let me quote one such that was originated from India, which I had the privilege to observe closely. This initiative is ‘Arogya Parivar (healthy family) of Novartis in India.

‘Arogya Parivar’ is a ‘for-profit’ social initiative developed by Novartis to reach the under-served millions living at the bottom of the pyramid in rural India. As Novartis claims, since its launch in 2007, ‘Arogya Parivar’ is proving to be both a force for improving health in rural communities and a sustainable business. ‘Arogya Parivar’ is a commercially-viable program and began returning a profit after 30 months with sales increasing 25-fold, since launch. After successful implementation of this initiative in India, the company has created similar programs in Kenya, Indonesia and Vietnam, according to Novartis.

Conclusion:

The concept of ‘shared values’ emphasizes that business success of a company is closely related to the progress, development and wellbeing of the society where it transacts the business. This can be achieved by striking a right balance between the social need and the business need. In the pharma space too, the value creation in the business value chain may need to be redesigned to meet the ‘social value’. This happened as in the case of ‘Arogya Parivar’ initiative of Novartis in India.

Creating robust business models based on ‘shared values’, in sync with the business-specific needs of the society can help make more profit in areas where there is none, at present. It will also facilitate achieving additional growth of the organization and improve long-term competitiveness.

Consequently, pharma can earn recognition of the society as a powerful contributor for containing suffering and even death of many ailing patients, by increasing access to affordable medicines for those who need these most. This, in turn, would help pharma companies to improve their public image and reputation. Let me hasten to add that provided, of course, no countermeasures are taken by them, surreptitiously, as I have discussed above.

The good news is, some pharma players have already initiated action in this direction. Thus, I reckon, many of them would soon realize that creating ‘shared value – based’ business models are the way forward for sustainable business excellence.

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.

Organic and Inorganic Growth Strategy For Sustainable Business Excellence

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For an enthusiast, witnessing any organization growing consistently, is indeed exhilarating. This becomes even more interesting at a time when challenges and frequent surprises in the business environment become a new normal. A robust short, medium and long growth strategy turns out to be a necessity for sustaining the business excellence over a long period of time. This is applicable even to the pharma players in India.

The Chief Executive Officer (CEO) of an organization usually assumes the role of chief architect of this strategy, which needs to be subsequently approved by the Board of Directors of the company concerned, collectively. The Board holds the CEO, who ultimately carries the can, accountable to deliver the deliverables in creating the desired shareholder value.

Two basic types of growth strategies:

Based on the CEO’s own experience, and also considering the expectations of the Board of Directors, together with the investors, the CEO opts for either of these two following types of basic growth strategies, or a mix of these two in varying proportions:

  • Organic growth: Growing the business through company’s own pursued activities, or all growth strategies sans Mergers and Acquisitions (M&A) or by any other means not external to the organization.
  • Inorganic growth: Growing the business through M&A or takeovers.

There is nothing fundamentally wrong with either of these two types of basic growth strategies, or their mix in varying proportions. Nevertheless, it is generally believed that with the basic ‘Organic’ growth plan, the companies, or rather their CEOs have a greater degree of sustainable control in various critical areas. These often include, retaining senior management focus on the organizational core strength for sustainable excellence, or even maintaining the organizational culture and people management style, without any possible conflict in these areas.

In this article, I shall explore different aspects of these two basic growth strategies for sustainable business excellence. To illustrate the point better, I shall draw upon examples from two large but contrasting pharma companies. Let me begin this discussion with the following question:

When does a company choose predominantly inorganic growth path?

Its answer has been well articulated in an article of the Harvard Business Review (HBR). It says: “High-growth companies become low growth all the time. Many CEOs accept that as an inevitable sign that their businesses have matured, and so they stop looking internally for big growth. Instead, they become serial acquirers of smaller companies or seek a transformative acquisition of another large business, preferably a high-growth one.”

That said, none can deny that the short to medium term growth of a company following M&A is much faster and its market share and size become much larger than any comparable organizations pursuing the ‘Organic Growth’ path. Thus, more often than not, such initiatives create a ‘domino effect’, especially in the pharma industry, across the world.

Inorganic growth and key management challenges:

The short and medium-term boost in organizational performance post M&A, comes with its complexities in meeting similar expectations of the Company Board, shareholders and the investors, over a long period of time. This is besides all other accompanying issues, such as people related and more importantly in setting the future direction of the company. The cumulative impact of all this, propels the CEO to go all out for a similar buying spree. When it doesn’t materialize, as was expected, both the Board and the CEO are caught in a catch 22 situation. As mentioned earlier, I shall illustrate this point, with the following recent example covering some important areas.

The examples:

“Please don’t go, Ian Read. That’s the message Pfizer’s board of directors has made loud and clear to the almost-65-year-old CEO, who could very well retire with a $15.7 million pension package.” This is what appeared in an international media report on March 16, 2018.

Analyzing the current challenges faced by the company, the media report interpreted the indispensability of Ian Read in an interesting way. It reported: “The pharma giant considers Read the most qualified person to steer the company through a host of challenges, from oncology trial disappointments to investor pressure to make a big acquisition.” Investors are also, reportedly, sending clear signals to the CEO about the tough road ahead.

Thus, Ian Read “who turns 65 in May, also must remain CEO through at least next March and not work for a competitor for a minimum of two years after that to be eligible,” reported Bloomberg on March 16, 2018. It is interesting to note at this point that Mr. Read has been the Chief Executive Officer (CEO) of Pfizer – the world’s largest pharmaceutical company, since 2010.

A different CEO rated as ‘Top Performing’ pharma leader:

Pfizer CEO’s ‘exemplary leadership and vision’, has been captured in the Proxy Statement by the Independent Directors on the Board of the Company. However, Harvard Business Review (HBR) in its 2016 pan-industry ranking of the “best-performing” CEOs in the world, featured Lars Rebien Sorensen – the then outgoing CEO of Novo Nordisk. He topped the list for the second successive year. Sorensen achieved this distinction ‘Mostly, for his role overseeing astonishing returns for shareholders and market capitalization growth.’ All the CEOs were, reportedly, evaluated by HBR on a variety of financial, environmental, social, and governance metrics.

Interestingly, in the 2017 HBR list for the same, when the Novo Nordisk CEO was out of the race, no pharma CEO could achieve this distinction or even a place in the top 10. Pablo Isla of Inditex (Spanish clothing retailer), Martin Sorrell of WPP (PR major in the UK) and Jensen Huang of NVIDIA (American technology company occupied the number 1, 2 and 3 spots, respectively.

Two interesting leadership examples:

I shall not delve into any judgmental interpretations on any aspect of leadership by comparing the Pfizer CEO with his counterpart in Novo Nordisk. Nevertheless, one hard fact cannot be ignored. The accomplishments of Pfizer CEO were evaluated by its own Board and were rated outstanding. Whereas, in case of Novo Nordisk CEO, besides the company’s own Board, his performance evaluation was done by the outside independent experts on the HBR panel.

Was there any difference in their growth strategy?

Possibly yes. There seems to be, at least, one a key difference in the ‘growth strategy’ of these two large pharma players.

  • Novo Nordisk is primarily driven by ‘Organic growth’ with a focused product portfolio on predominantly diabetes disease area, besides hemophilia, growth disorders and obesity. This has been well captured in the company’s statement on February 6, 2017 where it says: “Organic growth enables steady cash returns to shareholders via dividends and share repurchase programs” and is driven by its Insulin portfolio.
  • Whereas, Pfizer, though in earlier days followed an ‘organic’ growth path, subsequently changed to ‘Inorganic Growth’ route. Pfizer’s mega acquisitions, in its quest for faster growth to be the world’s largest pharma player, include Warner Lambert (2000), Pharmacia (2002) and Wyeth (2009). The key purpose of these acquisitions appears to expand into a diversified product portfolio of blockbuster drugs.

Pfizer did contemplate changing course:

In 2010, barely two weeks on the job of CEO, Pfizer Inc., Ian Read indicated breaking up the company into two core businesses. However, after six years of meticulous planning, on September 26, 2016, the company announced: “After an extensive evaluation, the company’s Board of Directors and Executive Leadership Team have determined the company is best positioned to maximize future shareholder value creation in its current structure and will not pursue splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies at this time.”

Sustained value creation following the same path not easy:

After the decision to operate as one company and consolidate the business pursuing similar ‘Inorganic Growth’ strategy, Pfizer went ahead full throttle to acquire AstraZeneca for USD119 billion. But, on May 19, 2014, AstraZeneca Board rejected it. Again, on April 05, 2017, Reuters reported, “Pfizer Inc. agreed on Tuesday to terminate its $160 billion agreement to acquire Botox maker Allergan Plc, in a major victory to U.S. President Barack Obama’s drive to stop tax-dodging corporate mergers.”

Apparently, the current Pfizer CEO is now expected to finish his unfinished agenda, at least for the short to medium term, as the current blockbuster drugs continue losing the steam.

Conclusion:

It’s a common belief that slowing down of a company’s business performance is a compelling reason for its switch from the ‘Organic’ to ‘Inorganic’ growth strategy. The new CEO of Novo Nordisk – Lars Fruergaard Jorgensen also appears to subscribe to this view. While, reportedly, including negative growth at the low end in constant currencies in its guidance for 2017, Jorgensen apparently, confided that M&A will now be a part of the company’s growth search.

On facing a similar situation, the above HBR article suggested the CEOs to fight the short-term pressures of the business cycle of moving away from the ‘Organic’ growth path. This can be overcome by various means, as good ideas for organic growth can always attract required resources and support.

While choosing an appropriate basic growth strategy for the organization – ‘Organic’ or ‘Inorganic’, the CEO’s focus should be on what is best for sustainable and long-term business performance, without being trapped by the prevailing circumstances. Thus, addressing the internal causative factors, effectively, would likely to be a better idea in resolving the issue of a sustainable business performance. This is regardless of the underlying reasons, such as gradually drying up the new product pipeline while blockbuster drugs are going off patent, or due to several other different reasons.

Nevertheless, in the balance of probability, ‘Organic’ growth strategy appears to be less complex and is fraught with lower business risks and uncertainties. Consequently, it reflects a greater likelihood of sustainable achievements for the CEO, and in tandem, a long-term financial reward for the shareholders, investors, and finally the organization as a whole.

By: Tapan J. Ray   

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

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

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

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

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

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

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

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

The overall status in India:

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

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

MDGs and India’s achievements:

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

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

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

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

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

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

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

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

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

Health goals in SDG:

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

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

SDG 3 targets:

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

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

Is India poised for it now?

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

  • With the announcement of the National Health Policy 2017 (NHP 2017) and commitment to the same by none other than Prime Minister Modi himself, focusing on public health has now been recognized as one of the critical ingredients for the future economic prosperity of India. Hence, there is a fair chance now that the nation’s public health expenditure as a percentage of GDP would be gradually raised from around 1.2 percent to 2.5 percent – expectedly by 2020, bringing health in the core development agenda of both the Central and the State Governments.
  • The unfinished task of achieving MDGs needs to be completed faster, driven by its ongoing momentum. The national and the respective States-specific goals, along with a clear roadmap to achieve the targets within the specified time-frame, outlining the success indicators for each deliverable, assigning accountability to designated individuals with a periodic review system for the same, needs to be put in place, soon, actively encouraged by the current national development oriented Union Government, if not initiated already.
  • The process of implementation of the Universal Health Coverage (UHC), as enunciated in the NHP 2017 should be hastened. This is necessary to bring the entire population, without any discrimination whatsoever, as the beneficiary of this movement.
  • Scaling up the capacity building process at a much faster pace for the entire public health infrastructure and service delivery systems, along with skill development programs need to be placed at the center stage of the public health agenda of India, to bring SDG 3 to fruition.
  • Strategic involvement of private players and the credible NGOs to achieve SDG 3 targets would help move faster to ultimately experience the sense of a great public health related achievement for all concerned within, and probably outside the country, as well.

In conclusion:

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

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

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

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

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

By: Tapan J. Ray

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

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

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A thud!

Something fell from high above!

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

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

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

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

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

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

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

A recent study:

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

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

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

Greater concern in India:

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

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

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

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

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

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

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

Another recent study:

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

  • Very few population-representative data were found for mental disorders, with an average coverage of just 1 percent of the country’s population.
  • Major depressive disorder, anxiety disorder, and alcohol dependence were the most common mental, neurological, and substance abuse disorders, for men.
  • For women, anxiety disorder, major depressive disorder, and dysthymia were most common.
  • Human and financial resources for mental health are grossly inadequate with less than 1 percent of the national health care budget allocated to mental health in India.
  • Improvement of coverage will need to address both supply-side barriers and demand-side barriers related to stigma and varying explanatory models of mental disorders.

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

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

Role of traditional medicines:

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

Associated stigma:

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

Not a personal failure:

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

The Mental Health Care Bill:

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

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

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

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

Conclusion:

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

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

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

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

By: Tapan J. Ray

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.