Monthly Archives: May 2021

Augment Pharma Customers’ New Value Expectations With Content Marketing

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‘COVID-19 is driving lasting changes in what HCPs need and value,’ found the Accenture Healthcare Provider Survey May 2020, named – ‘Reinventing Relevance.’ Several physicians from the US, Europe and Asia were found to have experienced a significant change taking place in many pharma companies’ communication with them – going much beyond just product information.

The study observed, right from the early days of Covid-19 pandemic, daily operations of many health care providers (HCPs) shifted to more virtual interactions with both patients and pharma companies. The participating doctors also felt, the services that pharma companies are now offering deliver higher value than the pre-pandemic period.

Accenture’s follow-up study in August 2020 reiterated, ‘pharma companies have improved how they engage with healthcare providers during Covid-19.’ It, therefore, appears that the new value expectations of many physicians are being met with a newer value delivery model, significantly deviating from pre-Covid practices.

For example, in the above August 2020 survey, most HCPs said pharma players are increasingly providing education on how to better treat patients remotely and help them manage their conditions in light of COVID-19. Besides, some of these companies are also helping patients understand various contemporary health and care related issues.

Against this backdrop, as the study underscored: ‘Now is the time for pharma companies to redefine their relevance.’ Picking up from here – in this article, I shall focus on the relevance of ‘Content Marketing’ in pharma to effectively deliver the new value expectations of physicians with a new value delivery model.

Pharma marketing can’t be ‘an outdated and uncoordinated analogue’ any longer:

Since quite some time, technological innovation has started opening new vistas of opportunities with new tools, multi-channels, and platforms for personalized and more effective customer engagement in pharma. But, majority of tradition-bound pharma players, unlike their counterparts in other industries, preferred to stick to the single channel marketing model, that has been offering golden eggs, till Covid-19 struck.

It’s not that no one in pharma knew at that time about the usefulness of content marketing. This is vindicated even in the article on the future of pharma marketing, published in the Pharmaphorum, on May 23, 2017. It wrote: ‘Where others have taken marketing innovation in their stride, pharma retains an outdated and uncoordinated analogue perspective of how to communicate its business.’

Citing examples of some pharma marketers, such as, Boehringer Ingelheim and Eli Lilly, it wrote, ‘while moves have been made to embrace new marketing methods, such as the integration of digital technologies for multichannel marketing (MCM) strategies, the way forward for pharma marketing is far from clear.’  It was – then.

It is different now; 

Covid-19 pandemic has encouraged many pharma marketers to expand marketing focus much beyond just product information to meet their customers new value expectations. These encompass some critical areas, as the May and August 2020 surveys of Accenture have brought out.

For many companies, content marketing strategy with an omnichannel presence will help build long-term relationships with customers. That said, for all to be on the same page, let me recap – what exactly is content marketing, and its difference from the traditional single channel marketing in the pharma industry.

Content marketing in pharma:

According to the Content Marketing Institute: ‘Content marketing is a strategic marketing approach focused on creating and distributing valuable, relevant, and consistent content to attract and retain a clearly defined audience – and, ultimately, to drive profitable customer action.’

Instead of pitching the products or services, content marketing provides contemporary, relevant, and useful content to customers to help them solve their contemporary issues in the given space. Since quite some time, content marketing is being practiced in many industries, including -by a selected few in pharma, as indicated above.

The key difference from traditional marketing:

The value of content marketing lies in the quality of personalized engagement between the customer and the company with personalized content through different channels. From this perspective, while traditional marketing is akin to ‘shouts’ at the customers – generally, for a brand prescription, whereas content marketing is akin to ‘talking’ with them for a solution. Content marketing in pharma is, therefore, about a grand strategy for effective participation in meaningful conversations for development stronger stakeholder relationships.

Content marketing usually includes educational articles – on the company website or in the form of e-books, videos, infographics, white papers, magazines, podcasts, or webinars. The content for all these need to be tailor made to credibly answer specific questions that customers have and provide them with something they can’t get elsewhere. This process of creating a deeper and a sustainable bond with stakeholders, often pays a rich commercial dividend, even in trying times.

Increasing use of content marketing, especially, in a fast-changing scenario, as we witness today, can help a pharma company to change and enhance its customer’s behavior toward the company, in a win-win manner.

Some recent examples of content marketing in pharma:

For more clarity, let me give below a few examples of good content marketing in the pharma industry, as available in the cyberspace – some of them capturing Covid related issues too:

  • Speak Your Migraine, developed by Novartis, was created to support people living with migraine. The website carries an impact assessment tool for the visitors to feel how migraine affects people’s lives, enabling them to openly share their experiences with doctors and family.
  • Lilly Pad is Eli Lilly’s official blog, consisting of articles on the company, its research to cure diseases and improve the quality of lives. The blog also provides details of the health and public policy, along with corporate social responsibility of the organization in various areas of the society.
  • Takeda Pharmaceutical launched its campaign IBD Unmasked to support and create increased awareness of inflammatory bowel disease (IBD). The campaign aims to help IBD sufferers find their inner super-strength and become superheroes like the characters featured in the graphic novels within the campaign.
  • Bayer’s content marketing initiatives span across print and digital media with a large following. The organization publishes two well-appreciated publications as a carrier of its content: The Bayer Scientific Magazine and the Bayer Magazine.

Conclusion:

Overall, pharma and biotech industries don’t seem to be doing as well in this area. According to ‘The State of Content Survey for Life Sciences’ by Accenture, only very few of them think that they are doing well. For example:

  • Just 13% of pharma and biotech marketers and 17% of med tech marketers think they leverage content well.
  • Only 4% in med tech and 11% in pharma/biotech report they have a clearly documented content strategy that meets their current and future needs (compared to 42% across all industries).
  • Only 6% of med tech marketers and 9% of pharma/biotech marketers feel objectives are clearly laid out (versus 19% across all industries).

It is quite possible that more than a year since Covid disruptions, this situation has somewhat improved for some companies. Nevertheless, amid this complex environment, most of the pharma and biotech players still require defining a robust ‘content marketing strategy’ for them. Establishing clear objectives of the content strategy based on well-researched data, along with its measurement criteria, will demand a quality thought process. Depending on the strategic requirements, the leadership will need to put in place an organizational structure for content marketing, including people, processes, technology, and tools that can deliver the stated content marketing goals – both during, as well as after the pandemic period.

Thus, I reckon, to effectively augment pharma customers’ new value expectations, content marketing needs to occupy an important place in today’s pharma marketing playbook.

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.

 

Rebalance KOL-Mix As Covid-19 Redefines Pharma Marketing

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‘It’s safe to say that 2020 was a year like no other and that 2021 will certainly not revert back to the old normal,’ reiterated the Harvard Business Review Article - ‘10 Truths About Marketing After the Pandemic,’ of March 10, 2021. Amid Covid 2.0, several astute pharma marketers, I reckon, have also realized the same by now. The recent Government announcement on the impending third wave of Covid-19, coupled with slow vaccination pace in the country, further strengthens this possibility.

That said, making all internalize that pharma marketing, and specifically the brand building process will no longer remain – as it traditionally was, may still be a tough task. Mere digitalization of the traditional marketing processes won’t be a magic wand, either, to excel in the rapidly transforming market situation. The task ahead is fundamentally cerebral – ahead of any Artificial Intelligence (AI) tools and applications.

With the market dynamics going through a metamorphosis, pharma marketing needs to be redefined. Capturing the nuances of this redefinition is essential also to ensure the right focus on the right Key Opinion Leaders (KOLs) – for successful branding with long-term image building. Today’s article will focus on this less charted area during the pandemic. Let me begin with a few examples of the redefined areas of marketing triggered by disruptive changes in the current pharma business environment.

Traditional pharma marketing axioms need to be redefined:

To give a flavor of this redefinition, I shall pick up the following two examples from the above Harvard Business Review Article and then zero-in on just one, to explore the recasting and rebalancing need of the KOLs, for business excellence in the new normal:

A.  Technology and human enablement:

Pre-pandemic belief: The right tech stack to drive modern marketing success.

Post-pandemic need: The right balance of factors (including tech stack) to drive modern marketing success.

In pre-pandemic days, focus on “tech stack” was emerging as an end-all game changer for marketing. But in the pandemic days there emerges a need to take a step back. The right approach to human enablement is becoming the key to properly understand the changes and their implications in the pharma business environment. Human enablement includes, making sure that people have the right skills to select and employ the most appropriate environment specific technology tools, effectively. The system should also ensure that the right measurement approaches are in place to motivate innovation and rewarding success.

B.  Relationship building to drive marketing success

Pre-pandemic belief: Relationships matter to drive marketing success

Post-pandemic need: Relationship building is everything to drive modern marketing success

Building relationship with customers rests on the bedrock of trust. Covid-19 has placed a new emphasis on relationships, faced with a near virtual sales environment. New findings indicate, the teams with existing relationships have been able to maintain revenue momentum, capitalizing on the strength of their prior bonds. In contrast, prospecting for new customers has required an evolved set of skills focused on selling solutions, not products, as the Harvard Business Review Article emphasized.

Trust, credibility, and integrity are fundamental to driving market momentum. These are foundational to the value exchange between a company and a consumer. As the Harvard paper writes, this has necessitated ‘a serious recasting of talent to identify people best suited to driving relationships in this new world of online interactions — a world that relies less on charm (and even an expense account) and more on insights and solutions. Trust will be built by and rewarded to those that listen to customer needs and then craft solutions to meet those needs.’

Thus, I believe, in the redefined pharma market, the marketers need to have a fresh look with fresh a pair of eyes to expand and select their KOLs to achieve their business goals – consistently, in the years ahead.

Pandemic impacted pharma’s KOL outreach:

Pharma marketers are well-aware how much they rely on their KOLs in several areas of a brand building strategy, including the creation of widely acknowledged brand reputation, winning key stakeholder trust on brands.  Thus, a robust strategy for engaging with stakeholders – based on KOL inputs, continue to remain an area of paramount importance for drug companies.

From this perspective, as I wrote before, during the early days of national lockdown triggered by Covid-19 pandemic, many marketers felt that in-person KOL outreach activities in physical events have only got disrupted temporarily. As the disruption prolonged, some companies hurriedly shifted online. Others hopefully kept waiting for some more time, and then tried to figure out how to catch up quickly by switching over to a more effective, interactive – and situation-specific contemporary communication channels and platforms, for them.

Marketers require recasting their KOL outreach strategy:

No doubt, KOL engagement remains a high priority area for pharma marketers - for guidance with fresh inputs while charting a new marketing pathway, mainly based on their:

  • Therapy area expertise where the company represents, and the sphere of influence
  • The span of influence to further business progress, gaining stakeholder trust and building brand reputation.

As the market environment and stakeholder expectations have altered significantly, in several marketing related areas, pharma marketers require quickly recasting their KOL outreach strategy, including virtual communication models and platforms. Many may consider, for valid reasons, though, that virtual events may not be as effective as effective as F2F physical events.

Notably, some well-researched digital outreach strategy for the KOLs – tailor-made according to their new expectations in the changing market dynamics, are trying to fetch the best out of them. The new initiative is also improving the effectiveness of virtual interactions manifold, steadily – with the ongoing honing of the processes. However, this would involve fresh mapping, and identification of a contemporary set of KOLs, soon, with in-depth understanding of their needs and interests.

Pharma KOL-mix need to include ‘influencers’ also:

Just to recap, KOLs are experts in their respective fields. Each one of them is also a well-regarded and influential voice, whose expert advice is respected and followed by many others – related to that field. These may include authorities in the same industry, whose opinion or decisions may have significant influence or impact on the business. In that sense, KOLs play the role of influencers, too.

Traditionally, in the drug industry KOLs are selected from accomplished and well-decorated medical experts who are often early adopters of new brands, playing a significant role in the prescription decision of other doctors.

Leveraging two other key roles of KOLs in the changing environment: 

The other two roles that need to be leveraged by pharma companies in the in the changing environment may include:

  • Making more people aware of the critical roles of pharma brands, e.g., what people have witnessed recently with Covid-19 drugs and vaccines.
  • Improving brand credibility and corporate reputation by gaining stakeholder trust. This is usually triggered a favorable word-of-mouth awareness of the role that the company is playing to save and improve the quality of human lives – and, in that process, the livelihoods.

This gets reflected in the most recent annual Axious Harris 100 survey, where two widely publicized Covid-19 vaccine makers – ‘Moderna and Pfizer leaped into the top 10 best-regarded companies in the U.S,’ among all other industries. This clearly highlights ‘Americans love their vaccine makers’. As reported, Moderna ranked third, while Pfizer featured at No. 7 on the strength of its product and innovation scores, nabbing high marks for vision and culture along the way.

‘They’re the first biopharma companies to crack the top 10 in the ranking’s 20-year history.’ Interestingly, Johnson & Johnson, which featured in the top 10 before; this year, it ranks 72 on the list with a reputation score roughly the same as 2020’s,’ the report adds.

KOL outreach needs to be more focused and well-targeted on even niches: 

This is an important need and has been vindicated by Deloitte focus group studies in the U.S., India, South Africa and the U.K and published on May 06, 2021. The studies found that the pandemic did improve overall pharma reputation score with a ‘reason to hope for more.’

However, still many respondents used phrases like, “profit-making” and “harmful”, as reasons of why they don’t trust pharma. Curiously, in the U.S., 29% of people cited “questionable moral integrity of biopharma executives” as a problem. Only about one-fourth (26%) of participants agreed that their trust in drug makers increased during the pandemic, even when Deloitte mentioned vaccine development.

Conclusion:

To mitigate such reputation, trust, and credibility related issues, besides transparency in drug pricing, besides efficacy and safety related research-data, pharma needs to work closely with a wider span of KOLs, who may help in explaining complex science in simpler words.

As the above Deloitte studies bring to the fore, the pandemic could be yet another fresh starting point for pharma to gain long-term trust of customers, and other stakeholders. In that endeavor, a fresh set of KOLs need to be identified through well-structured mapping. This initiative should ideally include, besides top medical and regulatory experts of high repute, globally acknowledged academics, top domain experts, and key members of the government.

Thus, in my view, as the pandemic redefines pharma marketing, there is an important need of rebalancing the KOL-mix of each company, based on their specific needs, especially in the virtual space, as the situation will unfold.

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.

 

To Allay Customers’ New Apprehensions Pharma Needs A New Conversation

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Since the beginning of 2020, witnessing the rapid spread of Covid pandemic with very high global fatality rate – virtually the entire global populations – directly or indirectly, have been looking up to the health care industry for help. This, of course, includes the drug industry – with high expectations of people on deliverables, blended with palpable apprehensions on what’s happening around.

Amid the wave after wave attack of Covid-19, many have realized that there will neither be any quick-fix or immediate solution to tame the virus. As India goes through the Covid 2.0 catastrophe, while waiting for Covid 3.0, a similar situation prevails in the country – with a sense of lurking fear for future uncertainties, slowly but steadily creeping in.

Thus, an unprecedented public expectation for speedy disentanglement of Covid-19 disruptions, confer a huge responsibility to all health care providers and entities, such as, the drug industry, which will be my key focus in this article. Just as any extraordinary situation calls for extraordinary initiatives, this national tragedy also demands from pharma professionals to start a new and proactive conversation, driven by ‘out of-box’ thinking.

I shall explore in this article, in which areas pharma needs to roll out a new conversation to meet with new expectations of its stakeholders, formed during the Covid Pandemic. This engagement needs to go beyond drugs and vaccines, spanning across key contemporary developments that are bothering pharma customers. The aim should be to help customers visualize a brighter horizon based on scientific reasons, in not-too-distant future, such as:

  • How several pharma companies are taking novel initiatives, as a part of their corporate objectives to save lives and livelihoods, faster.
  • How pharma players are thinking ‘out of the box’ to allay Covid related public apprehensions and neutralizing gross misinformation on Covid cure – based on scientific reasons, often selectively deploying their staff members.

In this regard, let me start with a recent advice of a top pharma veteran of global repute, especially on political and public expectations of ‘the endpoint’ for successful prevention and effective treatment of Covid-19 infections.

When focus is on ‘the end point – the price point’, it needs pharma’s attention:

Former CEO of Novartis Joe Jimenez – Ex-Novartis CEO and CEO & Cofounder of Aditum Bio, advised the same in an interview with Reuters Events, published on April 06, 2021. Although this was against the backdrop of the United States, the same is applicable to India, as well.

There, Jimenez said: “And I think the political focus in the United States is too often on the end point, the price point, which definitely needs attention, but not enough on the whole pipeline. And that absolutely needs attention and can bring down the price point at the end of the day.”

“It’s the pharmaceutical industry’s responsibility to show how their drug can lower total costs through the system, whether it’s reducing hospitalization or whether it is reducing other health care costs and comorbidities that lead to ever increasing budgets. If the industry focuses on that, I think I think that’s going to result in better launch success in the next few years,” he added.

However, there is another endpoint – of equal importance, especially in the Covid-19 prevention and the treatment process.

The other end point is equally important, as there may be an extended need for Covid vaccines: 

Wider access to Covid drugs and vaccines is another political and general public’s ‘end point’ of expectations, besides price. As I wrote in my previous article, on October 02, 2021, India and South Africa had proposed at the WTO about an IP waiver for Covid-19 drugs and vaccines to resolve the issues of access and affordability for these products.

Thereafter, on May 05, 2021, the United States also issued a statement supporting the IP waiver for Covid-19 vaccines at the WTO, in its ‘service of ending this pandemic.’ As reported on May 13, 2021, even China now backs the drugs and vaccine IP waiver at the WTO.

Patent waiver for Covid drugs and vaccines make sense for the coming years, especially, in view of the reports that ‘Pfizer, Regeneron CEOs see extended need for COVID-19 vaccines, treatments as pandemic enters the next phase.’ Adding that the data stressed a “need” for re-vaccinations, the Pfizer CEO said, while protection remains high for those six months, it does “go down by time.” Thus, the need for Covid vaccine may continue to remain as important as of date, to prevent the pandemic over, at least, a couple of years, if not beyond.

That apart, some interesting developments followed soon – coincidentally or otherwise.

Meanwhile, some pharma companies responded with laudable initiatives: 

Presumably, for wider availability and affordability of Covid drugs and vaccines, several pharma players alone or in association with governments, took some laudable initiatives. A few examples are, as follows:

  • On May 10, 2021, BioNTech, which has partnered with Pfizer to produce its COVID-19 vaccine, said it plans to set up a new manufacturing site in Singapore, with a capacity to produce several hundred million doses of mRNA-based vaccine.
  • As reported on the same day, as above, Eli Lilly promised to supply India with thousands of tablets of baricitinib for hospitalized COVID-19 patients. It also pledged to sign a royalty-free, non-exclusive voluntary licensing agreements with Cipla, Lupin and Sun Pharma—to expand baricitinib’s availability in the country. Notably, in this month itself, the DCGI has authorized baricitinib plus remdesivir combo for emergency use of ‘hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).’ Baricitinib has also faced a shortage of during the Covid 2.0 surge.
  • As per reports of May 12, 2021: ‘The US is looking at joint production of Johnson and Johnson’s Covid vaccine in India and ways to help manufacturers like Serum Institute of India (SII) to boost production,’

Pharma’s new role to allay public apprehensions in many Covid related areas:

In this complex scenario, various public apprehensions on Covid vaccines and drugs, need to be explained with scientific evidence – in a common man’s language. These include frequent changes in the dosage interval between two doses of some vaccines, whereas for other vaccines there isn’t any change in this area. Or why in India even within a group of fully vaccinated individuals, wearing masks or maintaining social distancing norms are necessary, when these requirements have been relaxed for fully vaccinated people in the United States. Or, when reports like: ‘Covid Cases Double In World’s Most-Vaccinated Nation, Raising Concerns,’ add fuel to the fire of public apprehensions in this regard.

Drug companies, especially those who are engaged in the global battle against Covid-19 – in their research lab, product development process, including clinical trials, can play an additional stellar role in this area, too. With ‘out of the box ideas’ for Covid related public engagement, they can scientifically respond to all public apprehensions with scientific reasons, in a simple language, on what is happening around most people, nowadays. Selective deployment of their own staff members can also make the initiative more meaningful.

This conversation may also include, science-based response to some bizarre claims of ‘Covid cure’ – from religious leaders having significant followers, and even by Union Ministers, without hurting their feelings or sentiments. These ‘advices’ were widely circulated by the mainstream global and local media, including the Wall Street Journal.

For example, one such report said: The president of a century-old religious organization declared that “consuming cow urine and cow dung will stop the effect of infectious coronavirus.” The swami added that a “person who chants ‘om namah shivay’ and applies cow dung” on his body “will be saved.” However, it was also reported that ‘Indian doctors warn against cow dung as Covid cure.’ Similar advice in different forms, even by elected politicians, keeps misguiding many unsuspected members of the public.

Conclusion:

A series of Covid related contemporary needs and apprehensions, besides the traditional ones are surfacing. These are to be mitigated, on an ongoing basis. Pharma players – individually and collectively, instead of being always reactive, may wish to volunteer to proactively address these issues to help people move in the right direction.

As Covid appears to be a medium to long-haul battle – unlike most other pandemics, pharma companies need to think ‘out of the box’ to create innovative – new – and proactive conversation models in this space. In turn, the initiatives will help them win long-term trust and loyalty of customers – that will always remain as invaluable assets, fueling sustainable growth in business.

By: Tapan J. Ray     

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

 

Impact of Covid Vaccines’ Possible IP Waiver In India

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Just when Covid 2.0 rages in India with almost 4,000 people died in just 24 hours, scientists warn that Covid 3.0, and further waves are now ‘inevitable, reported Reuters on May 06, 2021. With hospitals running short of beds and oxygen during the onslaught of Covid 2.0, the World Health Organization (WHO) highlighted, ‘India accounted for nearly half the coronavirus cases reported worldwide last week, and a quarter of the deaths.’

The report revealed some more heartrending details: ‘Many people have died in ambulances and car parks waiting for a bed or oxygen, while morgues and crematoriums struggle to deal with a seemingly unstoppable flow of bodies.’

No visible overall improvements with ‘here and now decisions’ or maybe the lack of it, of the National Covid Management Team, is perceptible, just yet. It’s also a matter of further concern that unlike what happened during Covid 1.0, the second wave of the virus, reportedly, ‘started hitting even young adults hard – leaving countless children to fend for themselves.’

Ironically, alongside a rapid surge in infections, India witnesses a sharp decline in Covid vaccination numbers though more people are eligible. The key reasons being supply chain related problems, despite India being one of the largest vaccine producers, globally. In my last article  published in this blog, I broached on finding a possible exit to this covid 2.0 maze in India. However, this article will explore some unprecedented developments of the last week in this area. To give a perspective, let me start by exploring whether the people responsible for Covid Governance in India, grossly misjudged the situation, claiming the ‘endgame’ of Covid-19, too soon.

‘India announced its triumph over Covid-19 early’:

A third Covid-19 wave is inevitable, but the timing could not be predicted, said India’s principal scientific advisor on May 05, 2021. Intriguingly, less than two months back, the national Government announced its triumph over Covid-19. On March 08, 2021, as Covid vaccination process for senior citizens and people above 45 years with comorbidities had just commenced, the Union Health Minister claimed, ‘India is in the endgame of the novel coronavirus pandemic.’ Just about a couple of months later, it sounded akin to a note of hubris for many, which prevailed, by and large, across the nation.

Acknowledging the same, on May 04, 2021, even Uday Kotak, MD&CEO Kotak Mahindra Bank and President CII commented, ‘India announced triumph over Covid-19 early’. He further urged: “We have to do whatever it takes to save lives first, even as we battle for livelihoods. And if our healthcare capacity is currently going through its challenges, we must be ready to curtail non-essential economic activities.” The latest editorial from ‘The Lancet’ also highlighted the same.

India’s Covid 2.0 – “A self-inflicted national catastrophe” – The Lancet 

Yes. The editorial of the latest – May 08, 2021 issue of The Lancet, also reiterated so. It emphasized, ignoring warnings about the risks of super spreader events, the government allowed congregations of millions of people from across India in religious festivals, along with huge political rallies with utter disregard to Covid appropriate behavior. ‘The message that COVID-19 was essentially over also slowed the start of India’s COVID-19 vaccination campaign, which has vaccinated less than 2% of the population.’ India’s national vaccination plan soon fell apart with the government abruptly expanded vaccination to all 18 years, draining supplies, ‘and creating mass confusion and a market for vaccine doses in which states and hospital systems competed.’

The IHME estimates a staggering 1 million deaths from COVID-19 in India by Aug 01, 2021. ‘If that outcome were to happen, Modi’s Government would be responsible for presiding over a self-inflicted national catastrophe. India squandered its early successes in controlling COVID-19. Until April, the government’s COVID-19 task force had not met in months,’ The Lancet editorial revealed.

Besides, India also misjudged the complexities involved in procurement, distribution and for speedy inoculation of affordable Covid vaccines, at least, to its entire adult population. But, before delving into that area, let me highlight an interesting mismatch.

India’s vaccine shortage when Pfizer logs a record vaccine turnover during pandemic:

Two contrasting scenario surfaces – as the world is reeling under unprecedented disruptions caused by successive waves of Covid-19. Witnessing India’s unparalleled healthcare tragedy in Covid 2.0, the W.H.O director general said: “The situation in India is beyond heartbreaking.” Outlining the reason for the same a separate report commented: A ‘complete collapse’ of preventive health: How India’s 2nd COVID wave exploded.

Concomitantly, one reads news items, which bring out, ‘Pfizer eyes $26B in COVID-19 vaccine sales for the year, with $3.5B already in the bag.’ Notably, most vaccine companies received huge public funding much before Covid vaccines were rolled out. For example, ‘The New York Times’ article of July 22, 2020 came with a headline: ‘Pfizer Gets $1.95 Billion to Produce Coronavirus Vaccine by Year’s End.’

The Scientific American also reported on November 18, 2020, ‘For Billion-Dollar COVID Vaccines, Basic Government-Funded Science Laid the Groundwork.’ It added: ‘Much of the pioneering work on mRNA vaccines was done with government money, though drugmakers could walk away with big profits.’ That’s exactly, I reckon, is the reality today.

Similarly, Moderna’s COVID-19 vaccine generated $1.73 billion in revenue during the first quarter, as compared to $3.5 billion of Pfizer’s Covid vaccine in the same quarter. Moderna now predicts its vaccine will generate $19.2 billion by year’s end. Interestingly, through its COVID-19 vaccine partnership with the U.S. government, Moderna also received nearly $1 billion in research aid. The Company is now joining a list of other vaccine players to take a supply order from the federal government.

By the same token, Serum Institute of India (SII) – the contract manufacturer of Covishield, developed and owned by Oxford University and AstraZeneca has also received initial advance funding from the governments, prior to its manufacturing.

Was India’s ‘Vaccine Maitri’ a pragmatic step?

Today, India is one such country facing the brunt of Covid vaccine shortage alongside arriving at an affordable price per dose of the same – a part of which is due to ‘unrealistic’ planning, as many experts believe.

For example, on January 20, the Indian government launched Vaccine Maitri – an ambitious program to export the two Indian-made shots – Covishield and Covaxin – to the world. On that exact date, India counted 14,112 fresh cases of Covid-19. Going by a report of May 01, 2021: ‘According to the government’s own submission before the Parliament, more shots were sent out of the country than administered to Indians as of mid-March.’ Many, therefore, wonder, whether this was a pragmatic decision that helped save lives of Indians during Covid pandemic.

An unprecedented development on vaccine IP waiver:

This is regarding IP waivers for Covid vaccines. In my last article, I wrote about it, stating, on October 02, 2021, India and South Africa had proposed at the WTO about an IP waiver for Covid-19 drugs and vaccines to resolve the issues of access and affordability for these products. It was also widely reported: ‘Richer members of the World Trade Organization (WTO) blocked a push by over 80 developing countries to waive patent rights in an effort to boost production of COVID-19 vaccines for poor nations.’

However, on May 05, 2021, a statement of the U.S. Trade Representative said, ‘as the extraordinary circumstances of the pandemic call for extraordinary measures, in its service of ending this pandemic the US also supports the IP waiver for Covid-19 vaccines, although the US administration supports IP protections generally. As expected, Big Pharma lobby groups, including PhRMA, reportedly, have strongly criticized the move.

Let me hasten to add, there is, at least, one exception in this area. Months ago, on October 8, 2020, Moderna said, ‘it won’t enforce its vaccine patents against other companies during the pandemic.’ Without specifying any names, the Company revealed, ‘other Covid-19 vaccines in development might already be using Moderna-patented technology.

The WTO process is expected to begin now, but how long will it take?

As the Reuters report dated May 06, 2021 indicated – with the U.S. backing a proposed waiver of Covid-19 vaccine IP rights, the next stop is for the World Trade Organization to hammer out a deal – a process that could take months. “At a minimum, it’s going to be a month or two,” said a former Trump White House trade official who previously worked at the U.S. trade mission to the WTO in Geneva. The waiver, if happens, could also be significantly narrower in scope and shorter in duration than the one initially proposed by India and South Africa.

The relevance of IP waiver:

Currently, only drug companies which own patents or their authorized manufacturers like SII can produce Covid vaccines. A global decision on patent waiver may encourage the patentees to share the formula and manufacturing technology, instead of reverse engineering, as is done for off-patent small molecules and some biotech drugs.  All companies with requisite resources may legally manufacture Covid vaccines, in that situation, leading to cheaper, and significantly more quantity of generic versions of Covid vaccines. This may help overcoming vaccine shortages, making the vaccines affordable, as well.

Some counter arguments and response:

As I wrote in my last article, the following three critical questions may arise in that scenario:

  • Will IP waiver help solve the immediate issues of vaccine shortages?
  • Can Covid vaccines be reverse engineered by domestic pharma industry without inventors sharing ‘Know-How’?
  • If yes, how long can it take?

The answer to the first question is – it may not help resolve the immediate crisis. But, for a medium to long term solution, there will be an emphatic yes, as Covid-19 fight is expected to be a long-haul one, as experts caution about subsequent waves of rapidly mutating new Coronavirus.

Moreover, Pfizer – BioNTech vaccine took less than a year from ‘mind to market,’ with support from all concerned. This is evident from Pfizer’s Press Release for the launch of Covid vaccine in the United States last year, on December 11, 2020. Thus, an efficient reverse engineering may also take that much time to respond to medium and long-term issues with Covid vaccines, especially in India.

Subsequent Covid-19 waves could be triggered by unpredictable compliance to Covid appropriate behavior of people. W.H.O has also warned: “When personal protective measures are being relaxed, when there are mass gatherings, when there are more contagious variants and the vaccination coverage is still low this can create a perfect storm in any country,”

Conclusion:

‘The pandemic is not a competition between companies and will not end without more-equal distribution of coronavirus vaccines,’ wrote Nature on March 30, 2021. It suggested: ‘It’s time to consider a patent reprieve for COVID vaccines.’

The world needs around 11 billion doses of Coronavirus vaccines to immunize 70% of the global population – assuming two doses per person. Interestingly, around 6 billion doses are meant for high- and upper-middle-income countries, against advance orders. Poorer nations, accounting for 80% of the global population, so far, have access to less than one-third of the available vaccines. ‘Unless manufacturing and supply can be distributed more evenly, researchers forecast that it will be at least another two years before a significant proportion of people in the lowest-income countries are vaccinated’, the paper concluded.

In this situation, I reckon, a temporary IP waiver would help in accelerating the end of the pandemic. It may not help immediately, but certainly in the foreseeable future, as discussed above. It may also call for an efficient and well thought out ‘Hub and Spoke’ distribution model. Simultaneously, of course, similar systems for raw and ancillary materials for vaccine production need to put in place to avoid intermittent shortages. 

As reported on May 08, 2021, India registered a record 4,187 Covid death with 4.01 Lakh new cases, in 24 hours. Capturing the depth of the Indian crisis, ‘India Today’ is coming out with a cover page article in its May 17 issue, with the headline – ‘Covid 2.0 – The Failed State.’ Another article terms India as the ‘Flailing state in Covid storm.’

As I reasoned above, if this unprecedented step of IP waiver for Covid vaccines is finally taken by the WTO, it will significantly help India – along with the world – may not be immediately, but certainly in the foreseeable future. Only adverse impact that the decision could possibly make, is curbing Big Pharma’s unprecedented profit on Covid vaccines, and that too, during a deadly global pandemic.

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.

 

Exploring An Exit To India’s Covid Management Maze

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‘India’s Covid-19 Crisis is Spiraling Out of Control. It Didn’t Have to Be This Way,’ was the headline of the lead article, published in The Time with the cover page ‘India in Crisis.’ All Indians also believe the same, as the current reality is shown virtually live in TV news channels daily, with experts commenting on the same.

Ironically, many in the country’s leadership still remain in a ‘denial mode’, even when the country records globally highest number, ever – over 402,110 daily new Covid-19 cases with 3,688 daily deaths, on April 30, 2021. One can also gauge how grim the situation is from the example of the US alert to its citizens in India. It says, ‘access to medical care is becoming severely limited because of a surge in Covid-19 infections and those wishing to leave the country should take advantage of available commercial transportation options.’

Notably, when most Indians, including the President of India, were taking pride in the country’s ‘Aatma-Nirbhar Bharat Abhiyan,’ especially in the Covid-19 vaccine area, during the pandemic, the stark reality appeared to be quite different. Pandemic demonstrated that each country is, in fact, interdependent. One may not acknowledge it in the days of hubris. However, when a crisis, like Covid 2.0 strikes the nation hard and interestingly – not unannounced, as many experts write, the reality dawns. This is also a reality that India as a nation could not adequately prepare itself for Covid 2.0 onslaught, even over a yearlong Covid 1.0 pandemic.

Nonetheless, India now needs global help, almost for everything – in the prevailing calamity – Oxygen, drugs like, Remdesivir – and vaccines, besides many others. Quite expectedly, witnessing the Covid 2.0 tragedy in India ‘Aid (also) pours in from the world to counter India’s Covid-19 second wave.’ Alongside, along with Indian media, even foreign media reports, ‘Bodies piling up at crematoriums: Record death toll may hide extent of India’s COVID-19 crisis.’

Amid Covid crisis, most countries in the world, including the United Kingdom, the United States,Israel and even India’s neighboring country - Bhutan focused on the mass Covid vaccination drive – at a blistering pace, to create a herd immunity. In this article, I shall explore the drivers and barriers for India to achieve a similar goal, soon.

Current developments with vaccine in India:

The latest development is – after a protracted hesitation, the Government of India opened ‘Covid-19 vaccination for all above 18 years of age,’ effective May 01, 2021. However, not so good news is, this happened at a time when the country is experiencing a Covid-19 vaccine shortage even for all adults above 45 years of age. Believing that government has taken this decision without enough advance preparation, experts warn, India is likely to face extreme Covid vaccine shortage from May 1.

They express concern: ‘India is running out of vaccines just as the new wave of Covid-19 infections batters the country, complicating Prime Minister Narendra Modi’s plan to inoculate the nation’s workforce while threatening to drag out the world’s worst healthcare crisis.’

India rejected ‘emergency use’ of imported Pfizer and other vaccines, unlike other countries:

Some decisions by Indian vaccine expert panel also delayed more vaccine availability in the country for ‘emergency use,’ sooner. For example, Reuters reported on February 05, 2021, ‘Pfizer drops India vaccine application after regulator seeks local trial.’ The Company had applied to the DCGI for a waiver of a local trial for importing its mRNA vaccine in India.

Similarly, as reported on February 25, 2021, ‘Expert panel seeks safety data for Russia’s Sputnik V Covid-19 vaccine before emergency use nod,’ in India. Ironically, it was again rejected on April 01, 2021. However, facing the fierce Covid.2.0 wave Sputnik V vaccine is now being imported from Russia. Similarly, as reported on April 30, 2021, ‘Pfizer begins exporting U.S.-made COVID-19 vaccine to Mexico.’ Pfizer has already exported 10 million doses to Mexico.

In the quagmire of indecision, late decision and other non-life saving priorities are omnipresent:

Many Indian and overseas experts opined that valuable time was lost to have more vaccines in India, by now. This is because, amid a wrenching surge in infections and deaths, on April 14, 2021 – ultimately, India agreed to fast-track vaccine approvals for ‘emergency use,’ without local trial. These are now applicable to all those Covid vaccines that have already been authorized by ‘drug regulators in the US, UK, European Union and Japan or cleared by the WHO, without having to conduct a local bridging trial.

The above developments, I reckon, gave rise to two core issues in vaccinating the Indian population of above 18 years of age – at a ‘blistering pace,’ as happened or is happening in countries, like the UK or the US.

Whereas, for speedy mass vaccination wealthy governments took a quick decision to stock up on COVID-19 shots from Pfizer and Moderna Inc, because of their extremely high efficacy. More so, when safety concerns and production problems temporarily sidelined vaccines from AstraZeneca Plc and Johnson & Johnson.

Two core issues for a speedy vaccination process in India:

No domain experts in the world doubt that mass vaccination is India’s Covid-19 escape route from the prevailing health care massacre. However, arising out of the above developments, successful implementation of Covid vaccination process  on the ground, making it available and affordable to all, poses a giant challenge. Thus, to effectively address the two core issues, with the quality of speed that it deserves, finding answers to the following questions are critical:

  1. How to add speed to the vaccination process?
  2. How to avoid different pricing for the same vaccine for the Central Government, the State Governments and the Private Hospitals? This will give a choice to the population for speedy vaccination, removing many personal apprehensions involving the entire process.  

Let me give an example, each of the most recent quagmire related to each one of the above issues.

All vaccination centers in Mumbai were shut for three days for shortages:

Reuters reported on April 30, 2021 carrying a headline, ‘Indian states run out of COVID-19 vaccines; nationwide inoculation delayed.’ It added, several Indian states have run out of COVID-19 vaccines a day before a planned widening of a nationwide inoculation drive. Interestingly, quoting Indian authorities it elaborated: ‘All vaccination centers in India’s financial capital Mumbai were shut for three days starting Friday due to a shortage of vaccines, as the country posted another record daily rise in coronavirus cases.’ The same saga can be witnessed in the national capital of India. ‘Don’t queue up outside Covid-19 vaccination centers tomorrow, the stock will arrive in 1-2 days,’ urged the Chief Minister of Delhi.

The Government allowed Covishield and Covaxin price increase amid pandemic:

Covishield and Covaxin were being purchased by the central government at a price of Rs. 150 per/dose. While announcing Covid vaccination eligibility to all Indians above 18 years of age – despite vaccine shortages, the government allowed the two Indian vaccine manufacturers to increase the same vaccine prices – for direct supply to the state governments and private hospitals.

The manufacturers lapped up this decision and increased the vaccine prices by several times, amid catastrophic Covid 2.0 pandemic. For example, for state governments the Covishield price was raised to Rs.400/per dose and Rs.600/per dose – for Covaxin. However, facing severe criticism from all quarters the prices were revised to Rs 300 (Covishield) and Rs.400 (Covaxin). Interestingly, still the price increases were double or even more from the initial prices of Rs.150/per dose.  Interestingly, one manufacturer even boasted  this so called ‘price reduction’ from their initial humongous price increases, as a ‘philanthropic gesture’. Interesting indeed!

A hidden solution within Supreme Court questions to the Center:

While hearing a Suo Moto case in connection with the ongoing Covid 2.0 calamity in the country, the Supreme Court of India also took note of the difference in Covid vaccine prices for the Centre and the state governments. It observed Covid vaccine manufacturing is publicly funded, hence are public goods – these are ultimately meant for the people of India. At the same time, the apex court asked some of the following profound questions to the central government on Covid 2.0 management in the country:

  • Why is the center not following the national immunization program policy in its Covid-19 vaccination drive where the Centre will buy all vaccines from the manufacturers?
  • How much investment has the Centre made into the vaccine companies and given advances in the last year?
  • What has been the financial contribution by the Union govt in research etc. in the development of vaccines?
  • How will the Centre ensure registration for vaccines for illiterate people and those without internet access as registration through Co-Win is mandatory in the third phase of vaccination?
  • Will one state get priority access over another in getting the vaccines?
  • How will the Centre ensure equity by private vaccine manufacturers when it is buying only 50 percent of the doses?
  • Has the center considered invoking Section 92 of the patents act and issue compulsory licenses so that drugs can be manufactured while the royalty is sorted?
  • Why are we paying so much for this vaccine for which AstraZeneca has set at a far lower price to the US citizens?

One may possibly find a hidden solution to the question of invoking Section 92 of the Indian Patent Act (IPA 2005) to address some critical Covid vaccine related issues in India.

Is invoking section of IPA 2005 a near-term solution?

As many would know, Section 92 of the Indian Patents Act is a special provision enabling the Central Government to issue Compulsory Licenses for the manufacture of patented drugs in a public health emergency. Section 100 of the IPA enables the Central Government to use patented inventions for government purposes. Curiously, the Supreme Court of India has, reportedly, also observed: “This is an exact case where we should go for compulsory licensing. This is a situation of Public Health Emergency.”

Just to recap, on October 02, 2021, India and South Africa had proposed at the WTO about an IP waiver for Covid-19 drugs and vaccines that could help resolve the urgent issues of access and affordability to these products. It has also been reported: ‘Richer members of the World Trade Organization (WTO) blocked a push by over 80 developing countries on Wednesday to waive patent rights in an effort to boost production of COVID-19 vaccines for poor nations.’

Although, U.S. Trade Representative has recently met with Pfizer and AstraZeneca to discuss this proposed IP waiver for Covid vaccines and drugs, what stops India to invoke Section 92 and 100 of its own Patent Act even during this seemingly uncontrollable Covid 2.0 pandemic?

The April 06, 2021 article of the Observer Research Foundation aptly epitomized the need of the hour. It articulated: ‘As the pandemic continues to rage, countries collectively have to find innovative ways to not just increase the production of vaccines, but also ensure their timely distribution at affordable prices.” Such an initiative may encourage more manufacturers in India to manufacture enough Covid vaccine, facilitating speedy inoculation to Indians and at the same time the government can make its price affordable for all concerned.

Conclusion:

The question, therefore, arises: Is India’s exit to the Covid 2.0 maze now visible? But, before arriving at any possible conclusion in this regard, one may try to address, at least, the following two critical questions:

  • Can Covid vaccines be reverse-engineered by domestic pharma industry without inventors sharing ‘Know-How’?
  • Can the IP waiver by the WTO or invocation of section 92 and 100 of IPA 2005 by India, legally mandate vaccine developers, like AstraZeneca, Pfizer-BioNTech or Johnson & Johnson, to share know-how with others, if they do not want to do so?

The resolution of the above issues won’t happen in a jiffy – at this stage. It may take more time. So, I reckon, will be the search for a permanent exit to India’s Covid 2.0 management maze, to avoid a similar strike by Covid 3.0, if or as and when it will come. Thus, till all adult Indians get vaccinated, each one of us must comply with Covid appropriate behavior responsibly, to save ourselves, our families, neighborhood, and above all our own nation.

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.