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Pharma Leadership Challenge In Post Covid Paradigm

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Bringing a long cherished relief to many, on September 15, 2022, the World Health Organization said, ‘we can see the Finish Line’ for the COVID-19 pandemic but it’s not over yet’. As I see today, several things are changing pretty fast in this scenario. Such as, not so long ago – on September 27, 2021, the same global health organization predicted differently: ‘World Will Live with COVID for Foreseeable Future.’ It further highlighted “It is dangerous to assume that omicron will be the last variant, or that we are in the endgame. On the contrary, globally the conditions are ideal for more variants to emerge.” The Wall Street Journal also reported on September 18, 2022 that the US President Joe Biden too  feels, ‘Covid-19 pandemic was over’ in the United States.

Be that as it may, I reckon, the world is not going to replicate to the pre-Covid mode of working, any longer. The Covid-19 pandemic has clearly made some impactful changes in the most work scenario, across the world. This has been revealed by several recent studies. With this perspective, in this article, I shall dwell on the challenges that the pharma leadership teams will face or are already facing, as the world shifts towards the post Covid paradigm.

Four critical areas for change:

To illustrate this point, I will focus on just three critical areas for pharma players, as follows:

  1. No going back to the pre-Covid mode of working
  2. Create a more employee focused organization for future success
  3. Determine the right size of digitally savvy field force in the new paradigm 
  4. Increase online share of voice in represented therapy areas and identify pharma’s digital world opinion leaders.

Why no going back to the pre-Covid mode of working:

With the onslaught of the Covid-19 pandemic on people’s lives and livelihoods fast receding, the need for some critical changes in several areas of pharma business, is now being felt by some forward looking astute pharma leadership teams. Recent studies, such as, the Gartner paper of June 16, 2022, among others, vindicate ushering-in some of the following changes in workplaces:

  • Ongoing changes in the way people work have transformed employees’ relationship, and their expectations of work.
  • Hybrid work could be a great opportunity, particularly for diverse talent..

Another article in this regard, published in the Harvard Business Review on January 13, 2022, capture 11 trends that will shape the work, in general, from 2022 and beyond. When I put some of these in the pharma space, it may include the following:

  • Employee turnover will continue to increase, as hybrid and remote work becomes the norm for knowledge workers in pharma companies.
  • Many repeated managerial tasks at various levels, will be automated, creating greater space for them to build more human relationships with their peer group and direct reports.
  • The tools used for working remotely are also being used to measure and improve employee performance on an ongoing basis.
  • The complexity of managing a hybrid workforce may drive some employers to evaluate a ‘return to the office’ with its pitfalls and benefits.

Thus, creating an employee focused organization becomes critical.

Creating an employee focused organization will be critical:

In the current scenario, the importance of being able to afford employees maximum flexibility, adapting and flexing to their individual circumstances and needs, is increasing manifold. This, has also come out very clearly in a number of studies, including one paper of the Healthcare Consulting Group (HCG), as reported on July 25, 2022.

Thus, nurturing employees’ desire for personal and professional growth, besides motivating them with a strong sense of purpose to their work, has become foundational to being an attractive workplace, more than ever before.

Is the pharma industry right-sizing the digitally savvy field force?

One can pick up several signals in this direction from what is happening, as the industry is opening-up with a rapidly declining onslaught of the Covid-19 pandemic. Various studies vindicate the intent of field staff reduction by the pharma industry. Today’s environment requires a digitally savvy field force of optimal size, which may vary from company to company.

For example, the article published in the Reuters Events Pharma on May 5, 2022, in this regard, elucidated “While Reuters Events Pharma’s own recent polling of the industry suggests a moderate reduction in numbers over the next couple of years, others see signs of more dramatic change.”

Many pharma players are now pondering – during Covid pandemic when companies were making so many less face-to-face calls, sales were OK. Now, when the intensity of the pandemic is receding, do they need the previous sales force numbers to make more such calls?

The general feeling appears to be that the old practices aren’t as productive as they were before, in the changing scenario. Thus, the paper underscored: ‘So with the largest players are already thinking about how to do more with fewer boots on the ground, how do they go about it?’ It concluded by saying: ‘No one is saying it is easy then, but the imperative for change is clear.”

Pharma customers’ online engagement is increasing with a low share of voice of companies:

This is yet another critical area of change where drug industry needs to strengthen its online voice. Several studies indicate that even a tiny part of most pharma companies’ online conversation about their represented disease and therapy areas doesn’t get captured in Google search. For example, yet another recent paper on this subject, published in the Reuters Events Pharma on July 05, 2022, confirms this point.

The article highlights: ‘Around 80% of patients Google for a recommended or newly prescribed medication. And doctors routinely use search engines too – to stay up to date, to verify assumptions and so on. Indeed, it may be no exaggeration to say that the answers found online are possibly the biggest influence on patients and HCPs today. Understanding their real-world digital information experience is, therefore, critical to identifying the content influencing their behavior.’

In today’s world, what these customers see and hear via search engines may shock many, the author emphasized. The study also reveals, despite many pharma companies’ investment in evidence-based, balanced, and accessible content designed for HCPs and patients, this is often buried far out of reach from the billion-plus health-related questions being asked of Google each day. ‘Pharma’s online voice often simply isn’t cutting through,’ it concluded.

What needs to be addressed soon in this area:

Each pharma marketer may wish to ascertain through data-based studies, which voices are dominating these conversations. And also, the nature and quality of the company’s own digital conversation and its share of voice. This is, besides getting to know who the digital opinion leaders are. Then, the task will be to find out ways to work with these people and share the company releases with them, requesting for their inputs, if any.

Conclusion:

The experience of the Covid pandemic and lockdowns has changed work patterns in many industries from what those were in the pre-Covid days. The drug industry is no exception. According to recent studies, two out of every five workers have either switched jobs or are actively looking for another that will fit into their working needs better, and with some remote work. This trend, being a common expectation, is gaining ground.

Thus, making an employee centric organization is now more important than ever before. Bringing together the best of remote working and office locations, as centers of excellence for team building, learning and innovation, is emerging as a central part of the pharma leadership challenge, as an HCG study, reportedly, also points out. It is generally believed that employees ‘who feel connected to purpose at work are more productive and more likely to stay.’ In tandem, pharma leadership teams also would require leaving a lasting impact on everyone’s work, which will be more tangible to them.

Alongside, as several contemporary studies indicate, and I also wrote in this blog on April 29, 2019 – ‘Adopt A Hybrid Business Model For Better Sales – Not A large Field Force,’ each company’s field force number also require a fresh look now with a focus on digitally savvy individuals. Another reason being pharma customers’ online engagement is increasing fast where most companies have a very low share of voice, as the search engine reveals. Consequently, identifying, partnering and in-depthunderstanding of key digital opinion leaders has become critical in creating a digital content that will influence the customer behavior. As reported on September 26, 2022, pharma major Sanofi, apparently has taken a major step in this direction.

From this perspective, it appears that the pharma leadership teams have a task cut out for them to effectively respond to the challenges of change in the post Covid paradigm – in search of pharma 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.

Physicians’ Increasing Digital Proficiency And Its Implication

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At a time, when an unexpected and unprecedented Covid-19 pandemic struck a catastrophic impact on human lives, livelihood, and the global economy the healthcare sector continued surging ahead. This is being fueled by exponential advances in medical science, and the pandemic-triggered explosion of digital technologies, data access, analytics – besides emergence of more informed and empowered consumers with new expectations and aspirations.

Echoing this, Deloitte’s paper - ‘2022 Global Health Care Outlook’ articulated: ‘The global health care sector continues to rise up to the new challenges presented by the ongoing pandemic, which continues to dominate health care systems’ attention and resources.’

No more than just a couple of years back, none could predict that a pandemic in these modern days, would have the power to initiate the unforeseen changes so quickly. This is especially applicable to – mostly tradition bound and slow to change – the pharmaceutical industry, even in India, which gets reflected in the growth of this sector. That too, amid sporadic disruptions in the operational areas of many companies.

As reported on December 29, 2021, Indian Pharma Industry registered a growth of 15% in 2021 led by growth of Covid-19 products, against a growth of 3% last year. The report emphasized that the challenges posed by the pandemic gave rise to new opportunities for the pharma sector to evolve quickly under changing circumstances.

Which is why, many players are being compelled to adapt newer digital processes and practices to survive and excel – while navigating through this uncharted frontier. These will call for growing investments for paving a high-tech digital pathway, primarily for an effective customer engagement, besides refinement of the product life cycle through digitization.

To give a sense of perspective on strategic implications of increasing digital proficiency of physicians, particularly in the context of an effective, patient-centric engagement by pharma companies, I shall focus on this development, in this article.

HCPs digital proficiency poses a fresh challenge – it’s real:

Increasing digital proficiency of HCPs during Covid-19 pandemic poses a fresh challenge to pharma marketers for several reasons. It’s so real, which will invite many fundamental strategic changes, as Covid-19 isn’t going anywhere, at least, anytime soon, contrary to what many people are expecting.

The emergence of Delta and Omicron like variants that infected a large number of fully vaccinated people, as well, is expected to continue. For example, as reported on January 27, 2022: ‘Just as the omicron surge starts to recede in parts of the U.S., scientists have their eye on another coronavirus variant spreading rapidly in parts of Asia and Europe.’

Increasing digital savviness of HCPs is now unstoppable. It is expected to keep rolling at faster a faster pace now than ever before. Endorsing this trend, an article published in the Pharmaceutical Executiveon January 20, 2022, made some interesting observations.

The author underscored that the trend of the digital shift of HCPs in their professional space, is an outcome of a catalytic effect of the pandemic. It poses a new challenge for the life sciences industry, requiring a complete revamp of the content strategy and customer engagement channels, for each specialty. It further said: ‘The wave of consumerism led by digital natives has impacted HCPs when it comes to engaging with content on various digital channels for personal consumption.’  

A recent research study vindicates the magnitude of the challenge:

A recently published Indegene study, revealed some thought-provoking areas in this space. The research surveyed 984 physicians from the United States, Europe, India, and China for this study. All participants have >10 years of experience and represent a broad spectrum of specialty areas. According to Indegene, the process of surveying HCPs had started since 2014, to identify how their digital habits manifest and how do they change. Some of the key findings of the study include:

  • More HCPs, in general, are increasingly adopting digital channels to consume content.
  • 77% of HCPs use digital channels primarily for personal learning and development.
  • 68% of HCPs prefer short webinars or webcasts over other virtual
    engagement channels, globally.
  • Only 47% of HCPs prefer receiving communication through the marketing e-mail channel, although, marketing emails are among the top 5 channels used by pharma companies to engage HCPs. 
  • 62% of HCPs are overwhelmed by product promotional content pushed by pharma companies on various digital channels.
  • 70% of HCPs said that pharma representatives do not understand their requirements completely. Further, 62% of HCPs said that the most significant area where pharma representatives can add value is, by understanding the needs of HCPs and sharing only relevant content with them to make the interactions more insightful. The one-size-fits-all approach will no longer work, and pharma companies will have to invest in greater personalization at scale and build better content development and operations capabilities.
  • Pharma to consider using digital channels to provide HCPs on demand access to reps and content.
  • Need to map and implement geographic variations in HCP preferences for content, channels, device, and time.

This evolving trend sends clear signals to pharma marketers that need for professional engagement with the HCPs has to be on their own terms in the new normal

‘Engaging HCPs on their own terms’ – the need of the new normal:

This emerging need also came out clearly in another recent Global Physician Specialty Survey by Medscape - with over 12,000 participants in key specialties across Europe, Latin America, Canada, Asia, and MENA.

It provided some actionable insights, highlighting online content consumption habits of HCPs across the globe, in the new normal. This study also found: ‘The pandemic has had an undeniable impact on the interactions between HCPs and the pharmaceutical industry, with the shift towards virtual engagement and online events likely to be long-lasting.’

Based on this finding, it flagged a critical issue. This is, while the consumption of online medical content is growing and traditional in-person meetings are still not completely back on the agenda, how can pharma players reimagine the way they reach their target audience? This is indeed a primary business requirement to maintain respective drug company’s share of voice and foster relationships with their key customers. The key takeaway from this study includes the following:

  • Being incredibly time poor even now, HCPs mostly prefer to engage with the pharma companies on their own terms.
  • Compared to traditional in-person interactions, most HCPs feel, digital engagement channels offer them greater flexibility that they desire.
  • Over half of the survey respondents rated their online consumption of digital content higher, or much higher now than before the pandemic.

Conclusion:

On the positive side, during a short span of the last couple of years, Covid-19 pandemic has also triggered unprecedented advances in various critical areas of medical science and related areas. These include, remote healthcare services, digital technologies, ease of access to required data by all, the application of sophisticated analytics and above all emergence of an increasing number of digitally empowered customers. Consequently, aided by greater disease awareness and the need for prevention, the ‘self-care’ space also witnessed exponential advances.

Besides, the pandemic has also offered a fresh opportunity to the pharma and biotech sectors – to leverage the break in the cloud for accelerating all-round innovation – charting new frontiers of the modern digital world to remodel their business models for a faster growth in a new paradigm. Although, pharma customers have remained mostly unchanged, their expectations, behavior, practices, and preferences have undergone a metamorphosis. Some of these changes may be stark, and more may be a bit nuanced. Marketers, need to map all the changes, which are specific to their organizations, to excel in the new paradigm.

That said and, as pointed out above, results of expert surveys and syndicated studies in this area, send a clear signal about the pandemic-triggered – increasing digital proficiency of HCPs, even in India. This trend needs to be leveraged for a thorough overhaul of pharma’s customer engagement models. This is a new ball game of the new normal – having a huge impact on the business performance of drug 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.

Covid Vaccine Challenges – Abidance To Defined Health Norms Stays As Lifeguard

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There isn’t even a shade of doubt today that Covid-vaccines are coming. However, some critical questions in this area continue to hang in the air, and are expected to remain so for some more time. Thus, every news on the development of Covid vaccines, particularly in their late stages of clinical trials, fuels billions of hopes and excitement, across the world.

The same thing happened, when Pfizer and BioNTech announced on November 09, 2020, some key details on their vaccine candidate. These include, ‘vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis’ from Phase 3 studies. The release also highlighted, ‘Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.’

Amid these new developments, it is also now beyond doubt that the pandemic will be brought under control, eventually. Interestingly, none possibly knows when it will happen. There doesn’t seem to be any clearly charted – time-bound pathway in place for the same, either – not just yet. That said, from the overall developments in this area for the past 10 months, especially in India, – two other crucial questions also remain elusive, as follows:

  • Has the country started preparing itself against any Covid-like future biological threats? If so, in what manner?
  • As India conducts the world’s largest  Universal Immunization Program (UIP), how robust is the country’s vaccine supply chain to effectively inoculate every Indian with Covid-vaccine?

I have already deliberated on several aspects of the former question in one of my previous articles, in this write-up. Therefore, this write-up will focus on the second query, with a specific reference to the continued relevance of abidance of the defined health norms for some more time, especially for my pharma industry readers. Accordingly, all astute pharma professionals in India, need to accept this new reality, and rewrite their brand demand generation strategies for the new normal. Let me start with how the cold-chain logistics for vaccines, in general, work in the country.

The cold-chain logistics for vaccines:

A paper published by the BBC News, on November 11, 2020, captured how the cold-chain logistics for vaccines, in general, work almost in all countries, including India. The article is titled, ‘Coronavirus: How soon can we expect a working vaccine?’ The steps involved in this exercise are as follows:

  1. Vaccines transported to destination countries (imported varieties).
  2. Refrigerated trucks for transportation to designated cold rooms.
  3. Distribution in portable and appropriate ice boxes to regional centers.
  4. Stored in electric fridges between 2 degree to 10 degree Celsius (for most of the existing vaccines.)
  5. Carried in portable and appropriate ice boxes to local venues for vaccination to individuals.

Associated challenges:

As the above paper highlighted, some important associated challenges in this space, which are mostly faced by the developing countries, like India, are as follows:

  • Adding a new vaccine to the existing mix could pose huge logistical problems for those already facing a difficult environment.
  • According to prescribed norms, all Vaccines in India requires a storage temperature in the range of +2 degree to +8 degree Celsius, except for Oral Polio Vaccine which need to be stored in the frozen state (-25 degree – 15 degree Celsius) at all stores except PHC/ CHC/Health post. The new vaccine ROTAVAC (116E rotavirus) by Bharat Biotech is being recommended to be stored at (-15 to -25 degree Celsius) till the intermediate stores and to be stored in the range of +2 degree to +8 degree Celsius at the last storage points like PHC/ CHC/Health posts. This has not posed much of a challenge. However, expanding it to cover the entire population of the country can be an “immense task.”
  • It is worth noting, although, AstraZeneca vaccine would need the regular cold chain between 2C and 8C, the Pfizer and BioNTech vaccine would need ultra-cold chain – storage at around minus 70C to 80C.
  • ‘Maintaining vaccines under cold chain is already one of the biggest challenges’ that countries face, and this will be exacerbated with the introduction of a new Covid vaccine.
  • Thus, more cold chain equipment will require to be added, making sure that fuel is always available (to run the freezer and refrigerators in absence of electricity) and repair/replace them when they break and transport them wherever you need them.

Curiously, India’s cold-chain logistics that cater to one of the world’s largest immunization programs for children and mothers, may not be enough for Covid-19 vaccination of the country’s 1.3 billion population.

Why India’s cold-chain logistics may not be enough for Covid vaccination:

Before coming to the above question, it is important to note that India is not just the pharmacy of the world, contributing over 20 per cent by value to the global generics market, and over 40 per cent (by volume) of US drugs. According to a recent report of Bernstein Research, Indian vaccine producers, such as, Serum Institute of India supply the bulk – over 40% of the global capacity of 5.7 billion doses annually. Home to some of the world’s biggest vaccine makers, India produces 2.3 billion doses of vaccines yearly, with 74% for export, said the report.

Regardless of this fact, India’s cold-chain logistics may not be enough for Covid vaccination of its entire population, primarily because it is currently geared for children. ‘India Spend’ report of October 13, 2020 titled, ‘India’s COVID-19 Dilemma: Adults Need Vaccines, Supply Chains Geared For Children,’ presents several such interesting facts to ponder over the following points:

  • Being the world’s largest in the Universal Immunization Program (UIP), India targets 26.7 million newborns and 29 million pregnant women every year (55 million people in total, or 4% of the total population). This requires 390 million doses of vaccines, over nine million sessions. But, can this infrastructure effectively handle Covid vaccination of 1.3 billion people?
  • The above question arises, because India has planned to administer 400 to 500 million doses of a COVID-19 vaccine, mostly to its adult population by the first two quarters of 2021. For this effort, the country will have to nearly double the total number of vaccinations given in the public sector program. Thus, one can well imagine, what a humongous task, it will be for vaccination of 1.3 billion population, at the shortest possible time.

Which is why – although, over the last decades, India has created a primary vaccination infrastructure, and gained enough experience in this area, these may not be enough for Covid mass vaccination program, as stated above.

What it would it entail:

As the above ‘India Spend’ report indicates, this effort will entail:

  • Ramping up capacity to administer vaccines,
  • Expanding and further strengthening cold-chain infrastructure and process of storing and transporting vaccines safely, besides logistics,
  • Ensuring adequate availability of ancillary items, such as syringes, glass vials, and intensive training of healthcare workers.

Without these, even if there is a life-saving vaccine available for COVID-19, people will not have access to effective vaccines, the report reiterates. From this perspective, let’s now have a glance to India’s current vaccine cold-chain logistics and infrastructure.

India’s current vaccine cold-chain logistics:

Currently, most vaccines in India are distributed by the Governments UIP mechanism. Accordingly, for the child immunization program, almost the entire vaccine cold chain is publicly funded and managed.

Going by the official statistics, at present there are in total – about 7,645 cold storages in the countrywith 68 per cent of the capacity being used for potato, while 30 per cent is a multi-commodity cold storage. ‘Most of these cater to farm produce in rural areas with ambient temperature storage and therefore are not pharmaceutical ready.’ As the industry sources indicate, ‘only a small part of the remaining 10 per cent of the industry is organized and capable of playing a key role in the distribution of the Covid vaccine.’

The comprehensive multi-year UIP plan for 2018-22 of India also specifies, while India’s UIP is currently supported by more than 27,000 functional cold chain points, only 750 (3 per cent) are located at or above the district level. The rest is located below the district level.

Nevertheless, the ongoing pandemic prompts India to administer Covid vaccines to its entire population of 1.3 billion population, over the shortest possible period of time. To achieve this goal, the cold chain industry of the country is warming up to handle this vaccine distribution challenge, maintaining the integrity of the cold chain.

The only organized pan-India cold chain player with 31 facilities is, reportedly, Snowman Logistics. Other companies, who are mostly the regional operators in this business, include Coldex, ColdStar, Western Refrigeration and JWL. Yet another report indicates, Maersk, is also poised inking a global logistics deal with US-based COVID-19 vaccine candidate COVAXX, including India. Be that as it may, the bottom-line remains, effective Covid vaccination program would not possibly commence until this gap is successfully bridged.

Conclusion:

Meantime, as on November 15, 2020 morning, India recorded a staggering figure of 8,814,902 of Coronavirus cases with 129,674 deaths. The average number of daily new cases appeared to have slowed down in the last few weeks, except Delhi. But, the threat of further spread of Covid infection, in waves, remains as it was before.

Robust and high-quality vaccine cold chain logistics in India assumes so much of importance, because of one critical factor – to preserve its effectiveness till administered to an individual. This is regardless of whether a person is located in cities, small towns or in the remote hinterlands of the country. The successful accomplishment of this task is crucial to combat Covid pandemic, until scientists find any predictable long-term solution.

The good news is, according to a new report: ‘Amid cold chain blues, Pfizer looks to powder vaccine formula in 2021.’ BBC News also reported: ‘A group of Indian scientists are working on such a vaccine. The “warm” or a heat-stable vaccine, they claim, can be stored at 100C for 90 minutes, at 70C for about 16 hours, and at 37C for more than a month and more.’

While the world awaits to witness this happening, we all should recognize a current reality. Tough challenges are still looming large on the way of effective Covid mass vaccination programs, especially for all adult population in India. Thus, the gravity for abidance to basic infection avoidance norms – wearing masks, social distancing and avoiding crowded places, stay unchanged. Accordingly, all astute pharma professionals in India, I reckon, need to accept the prevailing reality, and rewrite their brand demand generation strategies for the new normal.

By: Tapan J. Ray    

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

 

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.

 

Pharma’s Dual Challenge – To Save Lives And Livelihood

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“Jaan hai to jahan hai” (If you have life, you have the world). Prime Minister Modi - with a skillful tweak, used the couplet of the 18th century poet - Mir Taqi Mir, while announcing the criticality of 21-day national lockdown from March 24, 2020 due to Covid-19 global pandemic. Many Indians lapped up this concept, considering it as a short haul sacrifice to save lives. Possibly, because the Prime Minister had said at that time, ‘Mahabharata battle won in 18 days, war against Coronavirus will take 21 days.’

As the Covid-19 went on a rampage despite the national lockdown, the Prime Minister, on April 11, 2020, changed it to ‘jaan bhi and jahan bhi’ (life also, the world also). This slogan seems to be more relevant in the emerging scenario.

After over a couple of months stringent national lockdown, the necessity and urgency of restarting active life started assuming a priority status for all concerned. But, the restarting process won’t be a piece of cake either – for anybody. As it would not only involve saving lives, but also – ensuring proper means of livelihood, making the industries gradually return to normal, and thereby revival of the country’s economy.

Dr. Ashish Jha, Director of the Harvard Global Health Institute, has summarized the nature of this challenge concisely, as quoted by the article – ‘Five key questions about India’s rising Covid-19 infections.’ This was published by BBC News on June 15, 2020. Acknowledging that India is in a very difficult situation, Dr. Jha said, “We are still early in the pandemic and we have a good year or so to go before we turn the corner. The question is what is the plan to get India through the next 12 to 16 months?”

Like many other industries, this is an arduous task to accomplish even for the drug industry, and for that matter – by any country. From the pharma industry perspective, I reckon, the commencement of the ‘restarting’ process, would pose a tough and dual challenge for many players – for different reasons. The current expectations require them going much beyond developing and delivering effective drugs and vaccine to win the Covid-19 war, and include the following, as well:

  • The population needs to develop either a vaccine-induced or a herd immunity, for a long-term protection against Covid-19. Pharma companies can facilitate the former one.
  • The entire population should have access to scientific evidence-based Coronavirus drugs and vaccine – at a price that most people can afford, to achieve the goal of vaccine-induced immunity.

In this article, I shall explore the ground issues in this area while confronting this dual challenge by the pharmaceutical industry, in general.

Developing herd immunity not an option for India: 

As it is known to many, even without an effective vaccine, it is possible for the population to develop a herd immunity. However, in this situation, a very large population will need to get infected, with its consequent impact on healthcare infrastructure and people’s lives. But, it will possibly be foolhardy to even think about this option, particularly for any country, such as India.

Dr. Ashish Jha in the above article on the BBC News, has also captured this challenge, aptly. He articulated, ‘India cannot wait for 60% of its people to get infected to achieve herd immunity and stop the virus. ‘That would mean millions of people dead. And that is not an acceptable outcome.’ Moreover, India’s Covid-19 infection curve has not started flattening – there is no consistent and steady decline, just yet. Thus, a vaccine-induced immunity seems to be the only prudent choice for the country.

Other reasons why an early intervention is necessary:

A national lockdown in India was certainly necessary to save lives. However, its prolonged duration of over 3 months, has caused a widespread confusion, anxiety, and fear among the public regarding the disease. Consequently, it has created several unintended social consequences, such as disease related stigma, discrimination, besides triggering several serious health hazards. The World Health Organization (W.H.O) also recognizes this problem.

Instances of stigma and discrimination against medical personnel – doctors and health care workers are common and have already been reported. Similarly, those working in aviation, especially on flights that were sent to bring the Indians back from COVID-19 affected foreign land, also met the same fate. Interestingly, such instances are not uncommon even within various housing societies for high income groups and communities. The stigma associated with COVID-19 is real and here to stay, at least for some time.

Serious health hazards like, panic, depression and anxiety have also gone viral as the nation was observing lockdown. Experts, reportedly, have opined that the fear of contracting viruses, compulsorily going to institutional quarantine centers and rising number of deaths, among others, are big triggers for all. Many believe, various communications – formal and informal – to keep people indoors, have given rise to such unintended consequences involving average Indians.

These developments further reinforce the critical need for an early therapeutic intervention in the disease treatment and prevention areas, such as an effective vaccine, where pharma can deliver what it does the best, and sooner.

Green shoots of overcoming the first challenge are visible:

Although, the world has not reached there, just yet, some green shoots of overcoming the first challenge with scientific-evidence-based drugs and vaccine, are now in sight. Treating Covid-19 effectively with the old warhorse – dexamethasone at a very affordable price, is almost a reality today. W.H.O has also called to ramp up dexamethasone production for Covid-19 patients.

Meanwhile, a few other drugs, such as remdesivir and favipiravir have also received marketing authorization of DCGI for treatment of Coronavirus in India. Similarly, Oxford University and AstraZeneca’s experimental Covid-19 vaccine have, reportedly, entered the final stages of clinical trials. Scientists are now in the final assessment of how well the vaccine works in protecting people from becoming infected by the virus.

A shift in the most vulnerable population poses another tough challenge:

As the need to restart the economy of the country becomes paramount, alongside the urgency of saving lives and livelihood, a shift in the most vulnerable population for Covid-19 infection is clearly visible.

As many would know, Coronavirus pandemic started with the more affluent class of the society who mainly travel abroad for work or studies. However, it is now spreading fast in the lesser privileged social strata, including poor migrant labors and other marginalized population. The spread now spans across from affluent communities, right through densely populated slum areas. The trend keeps going north, as each day passes, as of now.

In such a situation, to contain the disease effectively, Covid-19 drugs and vaccine must be accessible and affordable to all. Making this requirement another tough challenge for the pharma industry – as and when the therapies receive marketing approval of drug regulators.

Recently available drugs are expensive, even in India:

From the recent trend it appears, unlike hydroxychloroquine or dexamethasone, most of these emergency use Covid-19 drugs, such as remdesivir or favipiravir may not be accessible and affordable to a vast majority of the population, as discussed below.

Like remdesivir, favipiravir is also, reportedly, the subject of at least 18 clinical trials involving more than 3,000 patients across India, USA, Canada, Italy, China, France, UK and other countries. Encouragingly, for the Oxford University developed Coronavirus vaccine, Serum Institute is expected to price it at Rs.1,000 per vaccine. Thus, for a family of 4 persons, it would cost around Rs. 4000. Be that as it may, lets have a look at the comparative clinical efficacy of cheaper and relatively expensive repurposed older drugs, against their respective costs.

Comparative efficacy and cost of a cheaper and expensive repurposed drugs: 

While comparing the relative clinical efficacy of cheaper and relatively expensive repurposed drugs – against their respective costs, some interesting facts surface, as follows:

According to the reported results, published by FiercePharma in an article on June 24, 2020, dexamethasone treatment led to a 35 percent reduction in death rate among patients on invasive mechanical ventilation and 20 percent for those receiving oxygen without invasive ventilation. The dose used was, 6 mg of dexamethasone in a single dose per day – either orally or via intravenous injection – for ten days at a stretch. Whereas, the cost of Dexamethasone (0.5mg) in India, for a strip of 30 Tablets, is around Rs.6.00.

Similarly, the same article reported, remdesivir has been found to reduce the death rate among severe patients to 7.7 percent from 13 percent for placebo, a difference that was not statistically significant.Whereas, remdesivir in India, will cost around Rs 5,000-6,000/dose. And its recommended dose for adults and pediatric patients weighing 40 kg and higher, is a single loading dose of 200 mg on Day 1 followed by once daily maintenance doses of 100 mg from day 2 up to 5 to 10 days.

Similarly, favipiravir will be available in India as a 200 mg tablet at a Maximum Retail Price (MRP) of Rs 3,500 for a strip of 34 tablets. Whereas, its recommended dose is 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14, according to its manufacturer.

An interesting fallout of Dexamethasone study:

An interesting fallout of the dexamethasone study on arriving at a fair price for remdesivir for treating Covid-19 patients, is worth noting. The Institute for Clinical and Economic Review (ICER) had earlier highlighted the “cost-effectiveness” benchmark price of remdesivir ranges from $4,580 to $5,080. However, ‘a new scenario analysis assuming the likely incorporation of dexamethasone as standard of care, produces a lower benchmark price range for remdesivir of $2,520 to $2,800.’

Conclusion:

As on June 28, 2020 morning, crossing half a million mark, the recorded Coronavirus cases in the country have reached 529,577 with 16,103 deaths. And the climb continues. In the context of the same disease, a publication of the London School of Economics and Political Science (LSE) had recently articulated: ‘In less than 3 months, COVID-19 has become a global pandemic of proportions we have not experienced this century. This has led to some of the largest economies in the world racing to develop a vaccine to combat the disease. However, in this time of urgency, patent laws may conflict with the equal provision of these future medicines worldwide.’

In sync with this sentiment, apprehensions of profiteering on drugs, tests, or vaccines used for the COVID-19 pandemic are mounting in almost all countries. Governments are now being encouraged to suspend and override patents and take other measures, such as price controls, to ensure availability, reduce prices and save more lives.

According to reports, Canada, Chile, Ecuador and Germany have already taken steps to make it easier to override patents by issuing ‘compulsory licenses’ for COVID-19 medicines, vaccines and other medical tools. Similarly, the government of Israel issued a compulsory license for patents on a medicine they were investigating for use for COVID-19.

From the industry, a strong demand for fiscal stimulus, such as the removal of the Health Cess and Customs Duty, to support patient access to critical medical products, is also gaining momentum, alongside the early release of Government payment to providers.

Thus, while exploring the dual challenge lying ahead for many pharma companies – to save both lives and livelihood – delivering effective drugs and vaccine may probably be an easier task than improving access to those – for all, in a meaningful way.

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.

Draft Pharma Policy 2017 Ticks The Right Boxes: A Challenge Still Remains

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Pharma policy is not a panacea to address all related issues, neither for the patients nor the industry, in general. As I see it, it’s no more than a critical cog in the wheel of the overall macro and the micro health care environment in India. Regardless of this fact, and notwithstanding virtually inept handling of previous pharma policies in many critical areas, each time a new policy surfaces, it generates enough heat for discussion.

Interestingly, that happens even without taking stock in detail of the success or failure of the previous one. A similar raging debate maintaining the same old tradition, has begun yet again with the Draft Pharma Policy 2017. This debate predominantly revolves around the direct or indirect interests of the industry, and its host of other associates of various hues and scale.

Having said that, the broad outline of the 18-page draft policy 2017 appears bolder than previous ones in several areas, and has ticked mostly the right boxes, deserving immediate attention of the Government. One such aspect I discussed in my previous article, titled “Draft Pharma Policy 2017 And Branded Generics,” published in this blog on August 28, 2017.

There are obviously some loose knots in this draft policy, a few are contentious too, such as the changing role of National Pharmaceutical Pricing Authority (NPPA), which apparently is doing a reasonably good job. I also find its link with several important national initiatives, especially ‘Make in India’, ‘Digital India’ and ‘Skill development’. Above all, the draft policy reflects an unambiguous intent to stop several widely-alleged business malpractices – deeply ingrained in various common, but important industry processes and practices that include, pharma sales and marketing, serious quality concern with many loan licensing manufacturers, and even in the issues related to ‘Product to Product (P2P) manufacturing.

The Department of Pharmaceuticals (DoP) reportedly commenced the preliminary rounds of discussion on August 30, 2017, where the Ministry of Health, the Ministry of Environment and the Department of Commerce also participated in the deliberation. In this article, I shall not go into the speculative areas of what ought to or ought not to come finally, instead focus on the key challenges in making the pharma policy meaningful, especially for the patients, besides the industry.

Policy implementation capability:

Whatever may be the net outcome of these discussions, and the final contours of the National Pharma Policy 2017, the implementation capability of the DoP calls for a thorough overhaul, being the primary challenge in its effective implementation. Since 2008, several illustrious bureaucrats have been at the helm of this important department, but nothing substantial seems to have changed in the comprehensive implementation of pharma policies, just yet. Concerned stakeholders continue to wait for a robust patented drug pricing policy, or for that matter even making the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) mandatory, which, going by what the DoP officials had reportedly hinted at many times, should have been in place by now.

The core reason for the same could well be due to a structural flaw in the constitution of DoP under the Ministry of Chemicals and Fertilizers, instead of making it a part of the Ministry of Health. The reason being to create a greater synergy in the implementation of both the Pharma and Health Policies, in a more meaningful way. But, that could be a topic of a separate discussion, altogether.

Initial adverse impact on the pharma industry:

Some of the following proposals, as articulated in the draft pharma policy 2017, are likely to cause initial adverse impact on the performance of the industry, especially considering the way the industry, in general, has been operating over a long time:

  • No brand names for single molecule drugs
  • Mandatory UCPMP with heavy penal provisions
  • e-prescriptions facilitating greater usage of less expensive high quality drugs with only generic names
  • Mandatory BE/BA studies for all generic drug approvals
  • GMP and GLP requirements in all manufacturing facilities
  • Restrictions on loan-licensing and P2P manufacturing.

Initial retarding impact, out of the above measures, may be felt on pharma revenue and profit growth, increase in overall manufacturing cost, and more importantly on the long term strategic game plans of most pharma players, in one way or the other.

The Government is aware of it:

Nevertheless, to make a significant course correction through policy interventions, in curbing widely reported alleged marketing and other malpractices, dubious quality standards of many drugs, and sufferings of many patients with high out of pocket drug expenditure, the Government apparently firmly believes that such an outcome is unavoidable, although need to be minimized. The following paragraph detailed in the Annual Report 2016-17 of the Department of Pharmaceuticals, vindicates the point:

“The domestic Pharma market witnessed a slowdown in the ongoing financial year owing to the Government’s efforts to make medicines affordable. The impact of this can be seen in the industry’s financials as well. The drugs & pharmaceuticals industry reported poor sales performance for two consecutive quarters ended September 2016. Sales grew by a mere 2.9 per cent in the September 2016 quarter, after a sluggish 2.5 per cent growth registered in the June 2016 quarter. The industry’s operating expenses rose by 5.4 per cent during the September 2016 quarter, much faster than the growth in sales. As a result, the industry’s operating profit declined by 5.4 per cent. Operating margin contracted by 185 basis points to 21.1 per cent. A 3.4 per cent decline in the industry’s post-operating expenses restricted the decline in its net profit to 0.8 percent. The industry’s net profit margin contracted by 160 basis points to 13.7 per cent during the quarter.”

Just the pharma policy won’t increase access to health care or drugs:  

Just a pharma policy, irrespective of its robustness, is unlikely to increase access to health care or even medicines, significantly, despite one of the key objectives of the draft pharma policy 2017 being: “Making essential drugs accessible at affordable prices to the common masses.” This articulation is nothing new, either. It has been there in all pharma policies, since the last four decades, but has not been able to give the desired relief to patients, till date.

Pharma and Health Policies need to work in tandem:

To be successful in this direction, both the Pharma and the Health Policies should be made to work in unison – for a synergistic outcome. This is like an individual musician creating his or her own soothing music, following the exact notations as scripted by the conductor of a grand symphony orchestra. The orchestrated music, thus created is something that is much more than what a solo musical player will be able to create.

This is exactly what is not happening in the health care ecosystem of India, over decades, and continues even today. Each of the Pharma and Health policies are implemented, if at all, separately, apparently in isolation to each other, while the holistic picture of health care remains scary, still progressing at a snail’s speed in the country!

The predicament of the same gets well reflected in a World Bank article that states:

“In India, where most people have dug deep into their pockets to pay doctors, pharmacies and diagnostic centers (or ‘out-of-pocket spending’) as the norm for a long time, vulnerability to impoverishment caused by medical expenses remains high. Though government health spending is estimated to have steadily risen to 30% of the country’s total health expenditure – up from about 20% in 2005 – and out-of-pocket payments have fallen to about 58%, dropping from 69% a decade ago, these levels are still high and not commensurate with India’s level of socioeconomic development. In fact, the average for public spending on health in other lower middle-income countries is more than 38%, while in China, government spending accounts for 56% of total health expenditure.”

Affordable drug – just one parameter to improve its access :

While ‘making essential drugs accessible at affordable prices to the common masses’ is one of the top objectives of the draft pharma policy. The degree of its success is intimately linked with what the National Health Policy 2017 wants to achieve. It promises ‘improved access and affordability, of quality secondary and tertiary care services through a combination of public hospitals and well measured strategic purchasing of services in health care deficit areas, from private care providers, especially the not-for profit providers.’

The Health Policy 2017 also states: ‘Achieving a significant reduction in out of pocket expenditure due to health care costs and achieving reduction in proportion of households experiencing catastrophic health expenditures and consequent impoverishment.’ It is no-brainer to make out that reducing out of expenses on drugs is just one element of reducing overall out of pocket expenditure on overall health care. When there is no, or very poor access to health care for many people in India, improving access to affordable drugs may mean little to them.

A major reason of the ongoing ‘Gorakhpur Hospital’ tragedy, is not related to access to affordable drugs, but access to affordable and a functioning public health care system nearby. In the absence of any adjacent and functioning Government health facilities, the villagers had to commute even 150 to 200 kilometers, carrying their sick children in critical conditions to Gorakhpur. The question of access to affordable drugs could have arisen, at least, for them, if the country would not have lost those innocent children due to gross negligence of all those who are responsible for such frequent tragedies.

Thus, improving access to affordable essential drugs, as enunciated in the pharma policy, depends largely on improving access to affordable and quality public health care services. Both are intertwined, and require to be implemented in unison. Without the availability of affordable health care services, the question of affordable essential drugs would possibly be akin to putting the cart before the horse.

Conclusion:

The degree of resistance, presumably from the industry and its associates, to have a new and robust National Pharma Policy that meets the related needs and aspirations of the nation, in an inclusive manner, is generally much more than any National Health Policy, for obvious reasons.

As several proposed changes in the draft pharma policy 2017 appear radical in nature, its grand finale, I reckon, will be more interesting. At the same time, navigating through the waves of tough resistance, coming both from within and outside, will possibly not be a piece of cake, either, for the policy makers achieve the stated goals. Nevertheless, in that process, one will get to watch where the final decision makers give-in or dilute the proposals, and where they hold the ground, supported by a solid rationale for each.

Thus, the bottom line is: Where exactly does the challenge lie? In my view, both the National Health Policy 2017, and the Draft Pharma Policy 2017 mostly tick all the right boxes, especially in ‘making essential drugs accessible at affordable prices to the common masses’.

However, the fundamental challenge that still lies ahead, is to effectively translate this noble intent into reality. It would call for making both these policies work in tandem, creating a synergy in pursuit of meeting the nation’s health and socioeconomic needs on access to affordable health care for all, including medicines.

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.

 

Gilead: Caught Between A Rock And A Hard Place In India

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I had mentioned in my blog post of August 4, 2014, titled “Hepatitis C: A Silent, Deadly Disease: Treatment beyond reach of Most Indians” that in line with Gilead’s past approach to its HIV medicines, the company would offer to license production of sofosbuvir (brand name Sovaldi) to a number of rival low-cost Indian generic drug companies. They will be offered manufacturing knowhow, allowed to source and competitively price the product at whatever level they choose.

Sovaldi (sofosbuvir) is a once-a-day patented drug of Gilead for cure of chronic hepatitis C infection in most patients. Sovaldi has been priced at Rs 60,000 (US$ 1,000) per tablet in the developed markets with a three-month course costing Rs1.8 Crore (US$ 84,000), when it reportedly costs around U$130 to manufacture a tablet. This treatment cost is being considered very high even for many Americans and Europeans.

Gilead has also announced that it has set a minimum threshold price for Sovaldi of US$ 300 (Rs.18,000) a bottle, enough for a month. With three months typically required for a full course and taking into account the currently approved combination with interferon, the total cost of Sovaldi per patient would be about US$ 900 (Rs.54,000) for a complete treatment against its usual price of US$ 84,000 (Rs1.8 Crore). The company would offer this price to at least 80 countries.

Breaking-news in India:

On September 15, 2014, International media reported that Cipla, Ranbaxy, Strides Arcolab, Mylan, Cadila Healthcare, Hetero labs and Sequent Scientific are likely to sign in-licensing agreements with Gilead to sell low cost versions of Sovaldi in India.

It was also reported that these Indian generic manufacturers would be free to decide their own prices for sofosbuvir, ‘without any mandated floor price’.

Indian companies would require paying 7 per cent of their revenues as royalty to Gilead, which, in turn would ensure full technology transfer to them to produce both the Active Pharmaceutical Ingredients (API) and finished formulations. The generic version of Sovaldi is likely to be available in India in the second or third quarter of 2015, at the earliest.

Another reason of Gilead’s selecting the Indian generic manufacturers could possibly be, that of much of the global supply of generic finished formulations is manufactured in India, especially for the developing countries of the world.

Patent status, broad strategy and the possibility:

It is worth noting here that the Indian Patent Office (IPO) has not recognized Sovaldi’s (sofosbuvir) patent for the domestic market, just yet. This patent application has been opposed on the ground that it is an “old science, known compound.”

It is interesting that the Indian Pharmaceutical Association (IPA) and others, such as, Delhi Network of Positive People and Natco have reportedly opposed Sovaldi’s (sofosbuvir) patent application. If the patent for this drug does not come through, low priced generic versions of Sovaldi, without any licensing agreement with Gilead, would possibly capture the Indian market.

Conversely, due to unaffordable price of Sovaldi for most of the Hepatitis C patients, even if a patent is granted for this drug in India, the sword of Compulsory License (CL) on the ground of ‘reasonably affordable price’ looms large on this product.

To negate the possibility of any CL, in the best-case scenario of a patent grant, Gilead seems to have decided to enter into licensing agreement with seven other Indian generic manufacturers to create a sense of adequate competition in the market, as many believe.

However, if the IPO considers sofosbuvir not patentable in India, it would indeed be a double whammy for Gilead. Without any patent protection, all these in licensing agreements may also fall flat on the face, paving the way of greater access of much lesser priced generic sofosbuvir to patients, as indicated above.

The action replay:

If we flash back to the year 2006, we shall see that Gilead had followed exactly the same strategy for another of its patented product tenofovir, used in the treatment of HIV/AIDS.

1. Voluntary license:

At that time also Gilead announced that it is offering non-exclusive, voluntary licenses to generic manufacturers in India for the local Indian market, along with provision for those manufacturers to export tenofovir formulations to 97 other developing countries, as identified by Gilead.

Gilead did sign a voluntary licensing agreement with Ranbaxy for tenofovir in 2006.

The arrangement was somewhat like this. Gilead would charge a royalty of 5 percent on the access price of US$ 200 a year for the drug. Any company that signs a manufacturing agreement with Gilead to manufacture API of tenofovir would be able to sell them only to those generic manufacturers that have voluntary license agreements with Gilead.

Interestingly, by that time Cipla had started selling one of the two versions of tenofovir, not licensed by Gilead. Cipla’s generic version was named Tenvir, available at a price of US$ 700 per person per year in India, against Gilead’s tenofovir (Viread) price of US$ 5,718 per patient per year in the developed Markets. Gilead’s target price for tenofovir in India was US$ 200 per month, as stated above.

2. Patent challenge:

Like sofosbuvir (Sovaldi), Gilead had filed a patent application for tenofovir (Viread) in India at that time. However, the ‘Indian Network for People Living with HIV/AIDs’ challenged this patent application on similar grounds.

3. Patent grant refused:

In September 2009, IPO refused the grant of patent for tenofovir to Gilead, citing specific reasons  for its non-conformance to the Indian Patents Act 2005. As a result, the voluntary license agreements that Gilead had already signed with the Indian generic manufacturers were in jeopardy.

Current status:

In 2014, while planning the launch strategy of sofosbuvir (Sovaldi) for India, Gilead seems to have mimicked the ‘Action Replay’ of 2006 involving tenofovir, at least, in the first two stages, as detailed above. Only the patent status of sofosbuvir from the IPO is now awaited. If IPO refuses patent grant for sofosbuvir, Gilead’s fate in India with sofosbuvir could exactly be the same as tenofovir, almost frame by frame.

Gilead and the two top players in India:

Very briefly, I would deliberate below the strategic stance taken by two top generic players in india, from 2006 to 2014, in entering into voluntary licensing agreements with Gilead  for two of its big products, as I understand.

Ranbaxy:

In my view, the stand of Ranbaxy in Gilead’s India strategy of voluntary licensing in the last eight years has remained unchanged. It involves both sofosbuvir and tenofovir.Thus, there has been a clear consistency in approach on the part of Ranbaxy on this issue.

Cipla:

Conversely, an apparent shift in Cipla’s strategic position during this period has become a bone of contention to many. For tenofovir, Cipla did not sign any voluntary license agreement with Gilead. On the contrary, it came out with its own version of this product, that too much before IPO refused to grant patent for this drug.

However, unlike 2006, Cipla decided to sign a voluntary license agreement with Gilead for sofosbuvir (Sovaldi) in 2014, though no patent has yet been granted for this product in India.

Has Cipla changed its position on drug patent?

I find in various reports that this contentious issue keeps coming up every now and then today. Some die-hards have expressed disappointments. Others articulated that the new dispensation in Cipla management, has decided to take a different stance in such matter altogether.

In my view, no tectonic shift has taken place in Cipla’s position on the drug patent issue, just yet.

The owner of Cipla, the legendary Dr.Yusuf Hamied has always been saying: ‘I Am Not Against Patents … I Am Against Monopolies’

He has also reportedly been quoted saying: “About 70 per cent of the patented drugs sold worldwide are not invented by the owning companies”.

He had urged the government, instead of having to fight for CL for expensive lifesaving medicines by the generic drug makers, where voluntary licenses are not forthcoming, the government needs to pass a law giving the generic players “automatic license of rights” for such drugs, making these medicines affordable and thereby improving access to patients. In return, the local generic manufacturers would pay 4 percent royalty on net sales to patent holders. He was also very candid in articulating, if Big Pharma would come into the developing markets, like India, with reasonable prices, Cipla would not come out against it.

According to Dr. Hamied, “When you are in healthcare, you are saving lives. You have to have a humanitarian approach. You have to take into account what it costs to make and what people can pay.”

Considering all these, I reckon, the core value of Cipla and its stand on patents have not changed much, if at all, for the following reasons:

  • The voluntary license agreement of Cipla with Gilead for sofosbuvir (Sovaldi) along with six other generic manufacturers of India, unlike tenofovir, still vindicates its strong opposition to drug monopoly, respecting product patents.
  • Cipla along with manufacturing of sofosbuvir, maintains its right to market the product at a price that it considers affordable for the patients in India.

Conclusion:

Indian Patents Act 2005 has the requisite teeth to tame the most aggressive and ruthless players in drug pricing even for the most feared diseases of the world, such as, HIV/AIDS, cancer, Hepatitis C and others.

Many global drug companies, resourceful international pharma lobby groups and governments in the developed world are opposing this commendable Act, tooth and nail, generating enormous international political pressure and even chasing it in the highest court of law in India, but in vain. Glivec case is just one example.

Some pharma majors of the world seem to be attempting to overcome this Act, which serves as the legal gatekeeper for the patients’ interest in India. Their strategy includes not just voluntary licenses, but also not so transparent, though well hyped, ‘Patient Access Programs’ and the so called ‘flexible pricing’, mostly when the concerned companies are able to sense that the product patents could fail to pass the scrutiny of the Indian Patents Act 2005.

It has happened once with even Gilead in 2006. The drug was tenofovir. Following the same old strategy of voluntary licenses and relatively lower pricing, especially when its drug patent is pending with IPO post patent challenges, Gilead intends to launch Sovaldi in India now.

Carrying the baggage of its past in India, Gilead seems to have been caught between a rock and the hard place with sofosbuvir (Sovaldi) launch in the country. On the one hand, the risk of uncertain outcome of its patent application and on the other, the risk of CL for exorbitant high price of the drug, if the patent is granted by the IPO. Probably considering all these, the company decided to repeat its 2006 tenofovir strategy of voluntary licenses, yet again in 2014, for Sovaldi in India.

As of today, Sovaldi strategy of Gilead in India appears to be progressing in the same direction as tenofovir, the way I see it. However, the final decision of IPO on the grant of its patent holds the key to future success of similar high-voltage, seemingly benign, marketing warfare of pharma majors of the world.

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.