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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.

Covid 2.0 Rampages India As Top Echelon Policy Makers Ignore Science

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‘India is in the endgame of COVID,’ announced the union health minister of India, just in the last month – March 08, 2021. Although, it was then clearly known to medical fraternity that today’s Covid vaccines won’t be magic bullets against rapidly mutating new Coronavirus. Interestingly, a scientific-data based MIT study, published last year – on July 01, 2020 predicted that India might record the highest ever in the world – 287,000 new Coronavirus cases per day, by February 2021. At that juncture also Covid vaccines were expected to be available in India before that predicted time frame. The MIT study warning received a wide coverage even in India - by almost all news dailies, on that very month of the last year. The national Covid management team did not seem to have taken it seriously, along with others. These include, besides the top echelon of governance – a vast majority of Indians – across the social, political, religious and economic strata.

The fallout of such callousness – both at the individual Covid-appropriate behavior level, as well as Covid governance level, have been more disastrous than what was forecasted even in the above MIT study. The ferocity and scale of the second Covid-19 wave in India did not just overwhelm the nation, but raised grave concern across the world too. On April 22, 2021, India recorded the world’s biggest ever single-day rise with 314,835 new cases of Covid-19, causing death to 2,104 people. The very next day, this number increased to 332,730 new cases with 2263 deaths.

But, the peak of the Covid second wave hasn’t come, just yet. According to a mathematical model developed by a team of scientists from the IIT Kanpur and reported by news media on April 22, 2021, the number of active covid-19 cases in India during the second wave is expected to peak in May. The daily infection count is expected to exceed 350,000 cases. In this article, I shall dwell on three specific areas – acknowledging that the current scenario is the outcome of national misjudgment, if not a humongous misgovernance to prepare India for Covid 2.0:

  • Current struggle of India’s fragile and long-ignored health care infrastructure.
  • Need to neutralize some general misgivings on Covid vaccines and associated dilemmas.
  • Who is equipped to save people, if no external remedial measures remain unavailable for some more time?

India’s fragile and long-ignored health infrastructure can’t take anymore:

Amid this calamity, India has run short of oxygen, hospital beds, important Covid medicines, including Remdesivir. Curiously, reports keep coming incessantly confirm and reconfirm: ‘Ever since the second wave of the pandemic started, the healthcare systems in India have been teetering on the brink, with many hospitals unable to handle the relentless inflow of patients whilst also running short of beds, oxygen cylinders and other essentials.’

Doctors and many health care workers are overwhelmed by the massive scale of the human tragedy and in tears, as they articulate: ‘Many lives could have been saved had there been enough beds, oxygen supplies, ventilators and other resources – if the healthcare system had been better prepared for the second wave.’

The Supreme Court intervened, noting the ‘grim situation’ in the country:

Meanwhile, the Supreme Court of India, reportedly, ‘Suo motu’ (on its own) took note of the grim situation in the country and the havoc caused due to shortage of Oxygen cylinders in hospitals. Consequently, on April 22, 2021, the top court said, ‘it expected the Centre to come out with a “national plan” on the supply of oxygen and essential drugs for treatment of infected patients and method and manner of vaccination against the disease.’  The Delhi High Court also observed, “We all know that this country is being run by God,” coming down heavily on the Centre over the Covid-19 management.

Some Covid vaccine related misgivings and dilemmas:

Many people are raising questions of the efficacy of two currently available Covid vaccines in India – Covishield and Covaxin, especially against our probably ‘desi’ double mutant variety of Covid-19. The trepidation increased manifold when India’s former Prime Minister – Dr. Manmohan Singh got Covid infected after taking two doses of Covaxin. Or, reports, such as: ‘Sri Lanka reports six cases of blood clots in AstraZeneca vaccine recipients, 3 dead.’ Incidentally, these vaccines were made in India. Some may not possibly know that both the issues have been deliberated by the Indian scientists, who haven’t expressed any concern, as yet. This has to be shared with all by all concerned, soon. Let me explore some of these related issues, as follows:

Re-infection after taking Covid vaccines:

Regarding re-infection rate after taking two doses of Covid vaccines, the scientists have now released data establishing that only a very small fraction of those vaccinated with either Covaxin or Covishield, have tested positive. In any case, instances of a few “breakthrough” infections do not undermine the efficacy of the vaccines, they added.

The ICMR has also clarified, “These vaccines definitely protect against disease. However, the immune response begins to develop usually two weeks after every dose and there are variations within individuals, too. Even after the first dose, if exposure to the virus happens, one can test positive.”

Efficacy of Covishield and Covaxin against double mutant strains:

Notably, both – the Indian Council of Medical Research (ICMR) and the Centre for Cellular and Molecular Biology (CCMB) have announced last week that Covishield and Covaxin protect patients even from the ‘double mutant’, B.1.617, variety of Covid-19. Scientists believe that the “double mutant” is responsible for the sudden spike in the number of cases in Maharashtra and other parts of the country. They had earlier feared that this “double mutant” or B.1.617, may escape the immune system and thus vaccines may not offer protection from this strain of the novel coronavirus.

Reported risk of blood clotting with Oxford-AstraZeneca’s Covid-19 vaccine:

No cases of blood clotting have come to light in India. However, a government panel of experts is,reportedly, investigating for any domestic cases of blood clotting, even mild ones, as a side effect of the two COVID-19 vaccines being administered in India. According to India’s leading virologist Gagandeep Kang, “blood clots reportedly caused as a result of Oxford-AstraZeneca’s Covid-19 vaccine amount to a very small risk.”

As reported on April 24, 2021, the United States has also decided to immediately resume the use of Johnson & Johnson’s Covid-19 vaccine, ending a 10-day pause to investigate its link to extremely rare but potentially deadly blood clots. These details, I reckon, need also to be shared with all people, soon, in order to neutralize any doubt on administering Covid vaccines.

Covid vaccine availability and pricing:

Recent media reports highlight, at least six states of India – Andhra Pradesh, Chhattisgarh, Haryana, Maharashtra, Odisha and Telangana – are facing Covid vaccine shortage, as Covid 2.0 overwhelms India. Most of these states have already apprised the Centre of the situation, as the Supreme Court of India also seeks the details from the center about its current status.

As on April 22, 2021, India has administered over 135 million vaccine doses, where each individual will require two doses. Whereas, as published in Bloomberg on April 23, 2021, ‘1 billion Covid-19 vaccines have been administered around the world.’ The good news is, effective May 01, 2021, everyone above the age of 18 years will be eligible to get vaccinated. The Central Government will also lift its singular control on supply and delivery of Covid-19 vaccines in a bid to tackle the massive rise of cases that have crippled the country’s health infrastructure.

That said, the key question that follows – would Covid vaccine manufacturers be able to meet this increasing demand in India, when there already exists more demand than its supply? According to Niti Aayog Covid-19: Vaccine availability will improve by July 2021. The two major vaccine manufacturers in India are also indicating broadly similar time frame.

Meanwhile, amid a deadly second wave of Covid infections, a third Coronavirus vaccine - Russia’s Sputnik V, has been approved for emergency use in India. Incidentally, Sputnik V’s approval came not before India overtook Brazil to become the country with the second-highest number of cases globally. According to its local distributor – Dr. Reddy’s Laboratories, India will start receiving Russia’s Sputnik V vaccine by end May.

Be that as it may, it is still unclear whether enough Covid vaccine doses will be available right from May 1, 2021, to start inoculating all Indians above 18 years of age, across the length and breadth of the country. Besides, SSI’s decision to fix the rate of Covishield vaccine for private hospitals and state governments, has attracted sharp criticism from the Opposition, who argued that there was no logic in charging the state governments a higher price, when the Centre is getting the same vaccine at Rs 150 per dose.

This question surfaces, especially when SII Chief himself acknowledged that they are making profit even with Rs.150/per dose price as the pandemic ravages the nation. A news item of April 24, 2021 also underscores ‘Serum Institute’s Rs.600/dose for Covishield in private hospitals is its highest rate in the world.’ Nonetheless, price sensitivity to Covid vaccines during the pandemic is not specific to India.

Shareholders of Pfizer, J&J, reportedly, are also pushing for detailed COVID-19 pricing strategies of the respective companies, at their annual meetings. Curiously, at the same, yet another report highlights: ‘With the competition struggling, Pfizer’s COVID vaccine sales could hit $24B this year.’ Amazing!

India utterly overwhelmed, angry outbursts of concern beyond its shores:

Witnessing the nature of rampage caused by Covid 2.0 in India, global press blames the Indian top policy makers for utter failure to anticipate and tackle the devastating second wave. For example, The Guardian of the UK flashed a headline on April 21, 2021 – ‘The system has collapsed’: India’s descent into Covid hell.’ It further elaborated: ‘Many falsely believed that the country had defeated Covid. Now hospitals are running out of oxygen and bodies are stacking up in morgues.’ The Times, UK was harsher. It reported, ‘Modi flounders in India’s gigantic second wave.’ It further added: ‘Record levels of infection have put huge strain on the health service and highlighted the perils of complacency in the nationalist government.’

The New York Times reported on April 23, 2021: ‘India’s Health System Cracks Under the Strain as Coronavirus Cases Surge.’ The report also cited examples of ‘recent political rallies held by Mr. Modi that have drawn thousands, as well as the government’s decision to allow an enormous Hindu festival to continue despite signs that it has become a super spreader event.’

Conclusion:

Keeping aside the responsibility, or rather lack of it, of the National Covid governance team, individual Indians – like you and me – can’t in any way shy away from our own responsibility of compliance to Covid appropriate behavior, religiously. We are equally responsible, at least, for our own lives and fate. Even today, many of those who are wearing a face mask, are wearing in the chin – keeping the nose exposed – forget about double masking! Moreover, how many of us were or are eligible for Covid vaccination till date, but did not or could not take?

Curiously, Covid 2.0 is no longer striking mostly the poor urban population, living in slums or hutments, or the migrant laborer. Nor it is attacking mainly the senior citizens or people with co-morbidities. More young people, including children are getting infected in Covid 2.0. In Covid 2.0 – over 90 per cent of Covid new cases concentrate in in high rise and other buildings in major cities, like Mumbai. While urban slums account for just 10 per cent. On April 24, 2021, Bloomberg also reported, ‘India’s Urban Affluent Hit By New Virus Wave After Dodging First.’

Terming Covid 2.0 as concerning and scaring‘, Tata Sons Chairman also said, ‘India needs to get as many different Covid-19 vaccine licenses as possible. And replicate multiple factories on a war footing to ramp up production in order to meet the requirements as the country reels under the devastating second wave of the pandemic.’ It’s incredible, how a small country in the Indian subcontinent – Bhutan with limited resources, got its vaccination plan right and carried out, reportedly, the world’s fastest immunization drive.

Coming back to the last year’s above MIT study forecast for 2021 Covid situation in India. It goes without saying that this one, among several others, was based on credible data. It also brought to the fore the scientific reasons of consequences for not following the norms of Covid appropriate behavior. Looking back and coming back to real life scenario of date, one thing becomes crystal clear. When science is ignored, both at the highest echelon of national governance where the buck stops – or at the individual, social, religious or political level – it is virtually inevitable that a disaster would strike. And in most cases, it will strike hard – very hard. Much beyond what a human can withstand to survive. We have choice for survival – even in today’s frightening scenario. Let’s individually and collectively behave, as the science demands. Life and livelihood are important – for all of us.

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.

 

 

With Covid’s Second Wave ‘A Nation In Distress’ – Why?

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If someone tries to see a silver lining in the disruptive Covid-19 pandemic, besides its vaccine rollout in some countries, there will be at least one. As of April 17, 2021- over 119 million patients (India – over 12 million), reportedly, have recovered out of 141 million (India – over 15 million) of Covid infected patients.

But this can’t mask the grim reality of over 18 million patients remain still infected, with over 3 million deaths (India – 175,673), since the beginning of the Covid menace. In the Indian perspective, this is the highest ever incidence of death – in absolute numbers – for any reason, so far. Now comes the Covid second wave with its more devastation onslaught on human lives and other consequences for the nation.

In this article, I shall explore this area, as apparently a Tsunami-like the second Covid wave starts sweeping across the India states, posing a greater danger than the first one, to the lives and livelihoods of millions of Indians, yet again. Let me start with a perspective, leading to the current situation.

No clinically proven drugs, as yet:

There aren’t any definite or clinically proven drugs after completion of Phase III studies, as yet, for curing patients from Covid infection. Nor are there any such well proven vaccines with fully known efficacy, safety, time interval between two doses, duration of prevention from Covid infection, in the future. All drugs and vaccines are currently being used under ‘emergency use’ approval by country drug regulators, based on interim results.

At the very onset of Covid-19 first wave, other than some attempts of repurposing older drugs, the world did not have any proven drugs to fight against this deadly infection. The old antimalarial drug Hydroxychloroquine – was tried first, followed by other medications, such as, Lopinavir/Ritonavir. Both created a huge global demand and subsequent shortages, including in the pharmacy of the world– India. Subsequently, W.H.O discontinued hydroxychloroquine and lopinavir/ritonavir treatment arms for COVID-19 based on interim clinical trial data. These results showed, hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care.

At the beginning of the second wave of Covid-19, one of the latest repurposed drugs – remdesivir that is being widely used, especially for hospitalized patients, is also facing a shortage, even in the pharmacy of the world. Interestingly, even ‘Remdesivir has little or no impact on survival, WHO trial shows’.

Also – no clinically fully proven Covid-19 vaccines, as yet:

Possibly, the second-best antidote as of date, against rapidly mutating Covid-19 – after Covid-appropriate behavior by all, comes vaccines. All comes with ‘emergency use’ approval, based on interim results only, and with several challenges. These include efficacy against all mutating Covid-19 variants, exact safety profile, dosage interval and duration of protection. Interestingly, on April 16, 2021, Pfizer indicated that ‘Covid-19 vaccine recipients will “likely” need a third dose between six to 12 months after they’re fully vaccinated and suggested vaccinations for coronavirus could be needed every year.’ In this evolving scenario, Indian experts also acknowledge that - abidance to the defined health norms stays as a lifeguard, and will remain so for an indefinite period.

Several countries, including India, are making, and gradually expanding requisite arrangements to vaccinate their population. Whereas a large number of countries – mostly in the developing world, are still awaiting access to Covid vaccines. Meanwhile, another issue has started bothering many, which the April 10, 2021 issue of The Guardian had captured in its headline – ‘Global Covid vaccine rollout is threatened by a shortage of vital components,’ besides manufacturing capacity constraints compared to the current demand.

Global challenges with Covid vaccines in 2021:

As things have progressed with Covid vaccines, thus far, the year 2021 doesn’t seem to be a smooth run to vaccinate people across the world, deriving a significant outcome against the battle of this global menace. This gets vindicated by the following numbers, as published in the ‘Down to Earth’ magazine on April 13, 2021.

  • According to the Johns Hopkins University, United States, as of April 12, 2021, only 773 million Covid-19 vaccines had been administered across the world. This means, only a little more than 2 per cent of the world’s adult population, has been inoculated so far.
  • According to data analytics firm Airfinity, the world will manufacture 9.5 billion doses by the end 2021. Whereas immediate global need exceeds 14 billion doses to vaccinate the entire adult population.
  • According to Gavi – The Vaccine Alliance, this represents almost three times the number of vaccines the world was producing in the pre-pandemic period for other diseases.

In the midst of these, inoculation with, at least, two major Covid-19 vaccines – one from AstraZenecaand other from Johnson & Johnson, have raised safety concern in the United States and many European countries. These ongoing developments complicate Covid vaccine challenges further.

The Indian scenario – ‘a nation in distress?’

Despite building new and a workable emergency health infrastructure by several state governments to combat Covid-19 pandemic, the fierce attack of the second wave with mutating Covid-19 virus, has already made these bursting at the seams. The article - ‘A tsunami of cases’: desperation as Covid second wave batters India, appeared in ‘The Guardian’ on April 14, 2021, captures this desperate struggle of the nation. Another recent report depicted with grim pictures, how India is grappling with the second wave of Covid-19, terming it as ‘a nation in distress.’ There are enough indications that India’s fragile health infrastructure has already collapsed in some places.

According to another news item on April 14, 2021, more than 111 million people has been vaccinated in India, by that time. Notably, this number was achieved after fears of AstraZeneca’s Covishield vaccine shortages, which subsequently prompted the Indian Government to temporarily halt its exports by the Pune-based vaccine manufacturer – Serum Institute of India (SII).

Going by another estimate, if the current momentum continues, India would be able to vaccinate 40% of its population by December 2021, and 60% of the population by May 2022. The report cautions that ‘the non-availability of vaccines may scuttle the pace.’ As per the W.H.O release, three in five Indians need to be vaccinated, to reach herd immunity. For which, the country needs 145 crore doses of vaccine by May 2022. India currently has the capacity to manufacture 100 crore-130 crore doses per year, as per a Rajya Sabha committee report. Another report of April 10, 2021 also highlights, ‘at least 10 states in India have reported a vaccine shortage and many vaccine centers have been reported shut.’

My wife and I also experienced the Covishield vaccine shortage in Mumbai. Our scheduled online appointment for vaccination through Co-Win website of the Government at Sir HN Reliance Hospital,Girgaon, Mumbai, for April 17, 2021, was cancelled. At past 10 pm on April 16, 2021, the hospital rang us up to inform that they have closed their Covid vaccination center till fresh vaccine stocks reach them.

To combat the Covid pandemic – ‘Pharmacy of the World’ goes local:

Yes, to combat the Covid pandemic, the ‘Pharmacy of the World’ goes local for some critical Covid drugs and vaccines, several times in the past. This happened earlier with drugs, like Hydroxychloroquine, when India banned its export to cater to the domestic need for Covid treatment. It happened again now, as ‘Remdesivir, API and formulation were placed under Export ban on 11.04.2021.’

Similarly, India has now, reportedly, put a temporary hold on all major exports of the AstraZeneca’sCoronavirus vaccine (Covishield in India), made by the SII, amid an increase in domestic demand due to a surge in infection. As the news item highlights: ‘It will also affect supplies to Gavi, the W.H.O backed vaccine alliance, through which more than 190 participating economies – 98 higher-income and 92 low and middle-income, are expected to get vaccine doses.’ Such temporary measures are now necessary for India to effectively respond to India’s Covid fight – especially the vaccine crunch.

India’s current vaccine imbroglio, as Covid second wave strikes hard:

Besides the SII, a second Indian company — Hyderabad-based Bharat Biotech, was given permission in January for emergency use of its Covaxin, developed in collaboration with the ICMR. Although, Bharat Biotech can make 12.5 million doses each month, these will be a small proportion of the doses administered in the country, so far.

To effectively respond to the prevailing vaccine crunch, Indian Government already approved the ‘emergency use’ of Sputnik V vaccine, which will be imported till its domestic production commences. Further, the country’s health authorities have now decided to consider the grant of ‘emergency use’ approval of several other internationally developed vaccines, such as, Pfizer – BioNTech double-dose vaccine and Johnson & Johnson’s single-shot vaccine. At least, till then, India’s vaccine imbroglio to vaccinate all adult population in the country, irrespective of age – particularly when Covid second wave is not sparing the young adults, is expected to continue.

Conclusion:

The jaw-dropping pandemic situation, and the pathway to deal with this crisis, especially in India, is getting increasingly complicated in every passing day. As reported on April 16, 2021, Covid-19 is now fooling RT-PCR tests – the most reliable type of Covid test as on date. It is so alarming because: ‘A false negative report is bad for the patient as they might delay consulting a doctor. It’s also bad for others, as the patient might not isolate, and spread the virus around,’ as the report underscores. It has started happening because: ‘Multiple mutations in the coronavirus over 15 months are making parts of it unrecognizable to lab tests.’

Experts are trying to fathom, whether or not more people are dying in India’s Covid second wave, as compared to the equivalent time period of the first wave. This causes an added cause of great concern because, in the six months before the start of the second wave (from September 2020 to January 2021), India’s overall case fatality rate (CFR) was only around 1.1%. This means only 1.1% of cases resulted in deaths. Currently, at the very beginning of the second wave, CFR has already increased to 1.3% and remains below peak levels seen in the first wave – as of date.

Above all, many people – virtually from all social, political, religious and economic strata, are openly flouting the basic norms of Covid appropriate behavior, as daily seen on different TV news channels. Ironically, these are happening at a time, when Indian health care infrastructure is creaking against the enormous and devastating power of the second wave Covid pandemic.

‘Pharmacy of the world’ has also gone local for some critical Covid-19 drugs and vaccines, to save lives and livelihoods of the Indian population, having no other better alternative in sight, at this hour. Isn’t this a sign of ‘A Nation in Distress’ that makes a fervent appeal to all of us, at least, to behave properly – by religiously following the lifesaving Covid guidelines?

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.

 

Shape of Future Pharma Operations – Emerging A Pragmatic Outlook?

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Just as newer reports come almost every day on safety, efficacy, dosage interval or span of immunity of Covid vaccines, similar reports are also reaching us about the possible future shape of pharma sales and marketing operations. Some hardcore optimists, apparently more from India, still believe that current changes in pharma customer behavior are mostly transient. All business processes will eventually fall in their traditional grooves, as the Covid menace disappears from our lives soon.

No doubt, several studies are also bringing out a number of respondent doctors’ preferences on reverting to F2F engagements, programs and events. Nonetheless, most other experts, including several large global pharma majors, believe that the future shape of business operations won’t be quite the same as the past. There are better ways to be more effective, leveraging the changing environment. Accordingly, they have initiated actions, reimagining the pathway of new operational frontiers. In this article, I shall explore the evolving pragmatic outlook in just two of these action areas:

  • The new and unique role of medical representatives
  • Digital health care solutions as a new growth opportunity

New role of medical representatives:

A recent survey published by Reuters Events Pharma on December 18, 2020, revealed that 30% of the respondents still expect that Medical Reps’ (MR) face-to-face access to HCPs would return to the status quo ante of Covid pandemic restrictions. However, a majority of 70% felt that the old normal is unlikely return as such. The study also brought out that the size and disposition of sales teams are under review by many of pharma players and smaller field forces look likely, as the industry moves on.

My personal experience with the Indian Pharma Industry sources suggests, when a Covid pandemic wave starts finding its peak, the feeling of the above 70% prevails. However, when the same wave climbs down from its peak to a transient trough, a large number of Indian companies and experts tend to feel somewhat akin to what the above 30% expressed in the Reuters Events Pharma survey. The process gets repeated with the emergence of the next wave.

Alongside, as the above survey also finds out, most physicians are no longer expecting – brand-driven high sales pitches, during any MR-Doctor interaction or the engagement process. Instead, they are increasingly looking for insights – in an integrated, personalized and value-driven interactions with the Reps.

Considering this as a trend of over last one year or so, it is likely that MR-doctor interactions will now need to be on digital and omnichannel platforms to deliver a personalized and value driven an experience to the customers. In this environment, the field force may be smaller in size than what it used to be in early 2020 but will have a unique new role to play. This process will come with a new challenge, especially to those inbred companies, who are still undecided about the road ahead for business excellence, in the new normal.

Three new pharma leadership challenges:

Apparently, a large number of domestic drug companies, irrespective of size and scale of operations still feel comfortable to be in the old comfort zone that had propelled the business in a growth trajectory. Most pharma sales and marketing staff members, at several levels, have grown within the industry, consistently delivering high performance.

This situation by itself, as the above research paper revealed, poses three fresh challenges for many companies to make their field-staff ready to play a unique and fresh role in e-marketing. Thus, the three new knots to untie in the virtual world, are the following:

  • Currently, most MRs are not proficient in selling in virtually,
  • They are being led by people who have also never sold virtually,
  • They are being trained by people who also have never sold virtually.

MRs will continue to have a role to play even in the digital world:

To overcome the above challenges, today’s reality prompts new L&D needs of pharma’s new e-environment. And from this perspective, I think, they would need professional domain experts’ hand-holding, at least, in the transition phase of digital marketing. Some companies have initiated this process for greater sales force effectiveness, since 2019. A recent example in this area may be quoted from a report on October 01, 2019.

The article highlights, ‘AstraZeneca sales reps have some new help in the coaching department, resulting improved interactions and better development of sales reps’ strengths. While leaders still manage reps, artificial intelligence—in the form of data generated from thousands of field-coaching forms—now adds machine-learned analysis and advice.’

Thus, it is worth noting that MRs will continue to play an important role, alongside remote digital marketing using omnichannel or multi-channel engagement platforms. The same also came out clearly in the latest study from healthcare consultancy ZoomRx, reported on April 08, 2021, where its findings raised an important question - ‘Did pharma overshoot digital sales rep calls?’ This dilemma was prompted by the study charts reflecting a decline in its effectiveness, during this specific survey period.

Thus, in my opinion, a hybrid business model for better performance will be more effective in the new normal. However, ascertaining the right mix of digital and MR’s in-person interactions, may pose a challenge for many pharma marketers.

Entry into digital health solutions – an opportunity for growth: 

Before Covid pandemic, digital therapeutics or digital health solutions were not an unknown area for several pharma companies, as a growth booster in the modern world. But, it wasn’t explored so intensively as it is being discussed today, for the same. A recent paper titled, ‘Digital health during COVID-19: lessons from operationalizing new models of care in ophthalmology,’ published in The Lancet on February 01, 2021, vindicates this point.

The paper emphasized, due to Covid pandemic ‘the traditional face-to-face patient–physician care model has had to be re-examined in many countries, with digital technology and new models of care being rapidly deployed to meet the various challenges of the pandemic.’ It further highlighted, these new models incorporate digital health solutions such as telehealth, AI based decision support for triaging, besides clinical care, and home monitoring.

Global pharma majors, such as Novartis, have publicly acknowledged on January 21, 202 that ‘digital innovation looks set to dominate the 2021 healthcare agenda.’ The statement said, COVID-19 was a catalyst for change in healthcare during 2020 and an accelerator for digital health. Similarly, 2021 looks set to continue the revolution – exploiting ‘an explosion of interest, traction and scale’ in the potential for digital solutions. These would not only support remote working, but also keep the very fabric of business, healthcare, education, and essential services in operation.

Other important and recent examples of digital health care solutions: 

Witnessing the COVID-19 pandemic pushing more people toward virtual doctor visits over the last one year, AstraZeneca, as reported on April 06, 2021, is preparing for it in the new normal, through a novel project with Massachusetts General Hospital. The Company is now in the process of establishing and validating its ‘recently launched digital health platform, designed to help patients with chronic illnesses manage their conditions without stepping foot into the academic medical center’s clinic.’

Similarly, several other companies, are also investing to be early entrants with user friendly state of the art technology in this space. Interestingly, many of these ventures were reported during March and April 2021.

Conclusion:

Arthur Miller’s play ‘Death of a Salesman,’ broadly addressed the loss of identity and a man’s inability to accept change within himself and society. Although, the book depicts a larger philosophical perspective of life – many pointed out similar issues in the drug industry perspective, as well.

Nonetheless, many studies have established, pharma MRs have been effectively delivering, since long, the endpoint deliverables, as expected of them – sales. However, the question that still haunts many – can this core process be re-imagined for greater efficiency and effectiveness at a lesser cost, harnessing modern technology. An article, published in the Pharmaphorum on March 11, 2011, has also suggested – ‘in the wake of the COVID-19 pandemic, there is an even greater need to re-examine the rep’s role. How can a field force evolve to deal with current challenges and be future-fit for the way we will be working in the post-pandemic world?’ 

There is no confusion today that MRs’ will have a key role to play in pharma’s digital endeavor. However, the key purpose of having them has evolved during the pandemic. Such as, from being an efficient way to achieve personal communication objectives – to be an orchestrator for physicians to navigate the difficult landscape, providing them a differentiated service. For this purpose, I reckon, a hybrid business model for better performance, will be more effective in the new normal, while quickly adapting to digital transformation. However, arriving at the right mix of digital and MR’s in-person interactions, may pose a challenge for many pharma marketers, as it will be a company-specific need.

Similarly, the criticality of leveraging opportunities to provide remote delivery of digital health care solutions to patients, has also come onto the radar of many pharma players, during this difficult time. Several players have already added this area as a lucrative business expansion platform – many more are expected to follow. Thus, in my view, the fast-evolving data-based trends are now giving a pragmatic shape to future pharma operations – especially on the new and unique role of medical representatives and the relevance of digital health care solutions, as a growth opportunity.

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.

With Changing Customer Behavior Pharma To Leverage AI For Better Engagement

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More than 55 million doses of Coronavirus vaccines were administered in India, reportedly, at the beginning of the last week of March 2021, in what is the world’s biggest inoculation drive. Notably, amid this mega initiative, the news media simultaneously reported that ‘India is facing a second wave of coronavirus because it let its guard down too soon.’ I also reiterated in my article of November 16, 2020 that in the thick of ‘Covid Vaccine Challenges – Abidance To Defined Health Norms Stays As Lifeguard.’

From the pharmaceutical industry perspective – as I had written on July 06, 2020, in the midst of this pandemic, there appears to be a break in the clouds that pharma should effectively leverage. There isn’t an iota of doubt that Covid pandemic, for-all-practical-purposes, has propelled healthcare into a virtual world, primarily for survival of business, maintaining the continuity.

Most pharma players, especially in the sales and marketing domain, either were not or, were using e-marketing, in a selective way, as a key strategic tool in their brand prescription generation process. The pace of this shift in the digital space is now getting accelerated to more than neutralize the long-term impact of unprecedented business disruptions that overwhelmed the industry, last year.

Interestingly, a large number of pharma marketers weren’t focusing much beyond syndicated retail and prescription audit data, in the old normal. Whereas, to make digital strategies work effectively during rapidly changing customer behavior and business environment, ‘customer centricity’ is no longer an option today. It’s rather a key business success factor for effective customer engagement, in the prevailing environment. Thus, unlocking the ‘Herculean Power’ of targeted data of many types and genre, is a pre-requisite for acquiring deep insight in this area, while moving in this direction.

Alongside, comes the need to unleash the power of Artificial Intelligence (AI) to ensure pinpoint accuracy in targeted strategy formulation for the same. Well before Covid struck, I wrote on April 01, 2019 – ‘A New Pharma Marketing Combo That Places Patients At The Center of Business,’ flagging a slowly emerging need. Covid, unexpectedly, has provided a strong tailwind to it, increasing its urgency manifold in the new normal.

Consequently, pharma marketers should have, at least, a working knowledge in this area – such as ‘machine learning’ and other analytics-based processes of AI that can help them enormously. In this article I shall discuss, why it is so important for today’s astute pharma marketers to hone their knowledge in this area for making a strategic shift towards ‘real-life’ Patient-Centricity. No wonder, why top pharma leaders now consider this transformation so critical for pharma strategy formulators, to acquire a cutting-edge in the digital marketing warfare.

Patient needs aren’t really at the center of a business strategy, today:

Despite so much hype on patient-centricity – in a true sense, patient-expressed needs aren’t generally placed at the center of a business strategy, as on date, unlike most non-pharma companies. That pharma players, by and large, don’t have a robust online feedback mechanism in place to capture ‘patient-experience’ with medications – directly from patients, vindicates the point.

As I reiterated in my article of March 21, 2021: ‘Measuring patient-experience has always been an integral part, virtually of all types of sales and marketing using digital platforms. We experience it almost every day, such as, while buying a product through Amazon, buying grocery items through D-Mart, scheduling a doctor appointment through Practo, buying medicines through PharmEasy, or even for availing a service through Urban Company.’

Thus, patient-experience, in their own words, with prescribed medications, is generally expressed to the physician, if at all. The process, generally, doesn’t get extended to drug companies’ strategy formulators for taking a patient-centric amendment, wherever needed.

However, assuming that doctors would convey the same to concerned medical representatives, it becomes a third hand (patient-doctor-Rep-Company) feedback, with commensurate distortions in each verbal transfer of communications. The outcome of this strategic gap has been captured in several research studies.

Outcomes of absence of online direct ‘patient experience’ feedback system:

Let me elaborate this point by quoting an example from a contemporary research in this area. This study was conducted by DrugsDisclosed.com in August 2020 with a total of 3,346 patients all taking medicine on a daily basis – aged between 18 and 80. The key findings are as follows:

  • 72% of patients feel ignored by pharma companies.
  • 76% don’t trust advice from them.
  • 81% feel that drug players influence prescribing decisions.
  • 63% would like to give product feedback to directly to companies.
  • 69% find their medication effective.
  • 81% feel their medication is needed.
  • 77% feel confident with their medication.
  • 82% don’t feel bothered by side effects from their medicine.
  • 73% take the medicine as agreed with their doctor.
  • 74% feel that the benefits of their medication outweigh the disadvantages.

The study concluded – the above insights show the need for patients’ voices to be heard by the pharma companies. If medicines are to solve health problems for billions of people who need them, listening to real-life patient-experience with medication, is the key to unshackle the full potential of the world’s health systems. Thus, pharma companies need to directly listen to what patients experience and express with their medicines. It will help them earn customer-trust and greatness in business, while gaining new and important insights for performance excellence.

I hasten to add, although, this study was conducted among patients residing in the UK, Ireland and Denmark, the core issue, even in India, is unlikely to be much different from what appears above. This genre of pharma marketing approach would warrant extensive use of AI, much more in the coming days – than ever before.

The above genre of pharma marketing calls for extensive use of AI:

The above genre of pharma marketing calls for extensive use of AI, much more in the coming days than ever before. For example, as new generations of Covid vaccines will come – with some without the use of needles, like a nasal drop, machine learning tools may be necessary for pinpoint accuracy in market segmentation. I reckon, there will be many such areas, where those companies who would use AI to orchestrate a cohesive customer experience, will drive stronger differentiation, better customer access and higher sales impact.

In that process, creating opportunities and empowerment for deserving marketers to reap the benefits of AI based digital tools and systems, such as machine learning with human integration within sales and marketing, will be the need of the hour. Gaining actionable insights from this endeavor, marketers need to go whole hog to unleashing the power and value of AI for achieving business excellence. I wrote about it, even during pre-Covid days – on July 15, 2019. But, this approach has assumed much greater importance in the new normal, when innovative e-marketing is gaining momentum to gain a competitive edge. However, this would require more investment in AI than what it is today.

The process has accelerated during the Covid pandemic:

This has come out clearly in the results of McKinsey Global Survey 2020 on AI. The paper is titled – ‘The state of AI in 2020’ and was published on November 17, 2020. The findings of the study ‘suggest that organizations are using AI as a tool for generating value. Increasingly, that value is coming in the form of revenues.’

Although, the number of these companies is small, they are planning ‘to invest even more in AI in response to the COVID-19 pandemic and its acceleration of all things digital.’ The paper emphasizes that this could create a wider divide between AI leaders and the majority of companies who are still struggling to capitalize on the technology.

Pharma’s increasing use of AI during the pandemic:

The above trend gets reflected in the ‘AI In Pharma Global Market Report 2021: Covid-19 Growth And Change.’ The report underscores, the global AI in pharma market is expected to grow from $0.91 billion in 2020 to $5.94 billion in 2025 at a CAGR of 47%. The initial spurt in growth was mainly due to companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, the report underscores.

Although, the number of pharma entrants in this space isn’t yet very many, major players includePfizer, Novartis, IBM Watson, Merck, AstraZeneca and Bayer. Gradually, some Indian drug companies are also testing water in this area, as discussed in the article – ‘The Increasing Use Of AI In The Pharmaceutical Industry,’ published by Forbes on December 26, 2020.

Conclusion:

“Patient-Centricity” emerging as a hallmark, fueled by rapidly changing expectations and behavior of pharma customers, especially doctors and patients. To be effective with such changes in market dynamics – capturing ‘patient experience’ with medication – directly from them – to the respective companies online, is a necessity today.

Most other industries involved in digital marketing are already doing so. Pharma companies while embracing e-marketing can’t just wish it away, any longer. Today, when digital marketing has commenced in the pharma industry, with accelerated speed – machine learning alongside the creative application of AI powered analytics, can immensely help gaining actionable insights on customers. These include customer experience, their perception and pattern of usage of brands, besides channel preferences, preferred contents for effective engagement.

Thus, the consequences of not directly listening to patients’ voice on structured digital platforms – supported by analytics, can be ignored at pharma marketer’s own peril. Many of them may not yet be able to fathom the depth of its potential, opportunities and possible roadblocks, or simply unable to figure out where to begin with and – how. Experts’ hand-holding will be pivotal for them in the transition phase of this endeavor. From this perspective, I reckon, to keep pace with fast-changing customer behavior, pharma marketers need directly listen to patients’ voice online. And based on which, develop customized strategies by leveraging AI – for more productive engagement with them.

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.

How Pharma To Stay Relevant To Customers In The New Digital World

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Covid-19 vaccination has commenced in India on January 16, 2021, as in several other countries of the world. A few million Indians, across the country have already received their first shot, according to media reports. But, this isn’t the endgame of pandemic by any measure. Covid-19 will get over – only when it gets over.

Interestingly, on March 07, 2021, the Union Health Minister claimed, ‘the country is in the end game of the COVID-19 pandemic. Curiously, the very next day – the Indian Medical Association IMA termed it as: ‘Unauthorized political statements on Covid-19 pandemic invokes a false sense of security.’ Moreover, vindicating the IMA statement, the Coronavirus trend report, updated as on March 05, 2021 clearly demonstrated that ‘The pandemic is far from over.’

As a fallout of this pandemic, alongside many other nations of the world, most industries in India are going through a recovery process of disruptive changes in the business processes, after a harrowing time. Pharma industry is no exception in this area. Recreating contemporary operational processes to excel in the new normal, would call for not only jettisoning many practices from the old normal by the new ones, but also the creative deployment of the precious resources, by each pharma players.

Accordingly, the need for avant-garde digital-based customer engagement services, is gathering winds on the sails of the ships of pharma marketers, signaling a ‘never before’ urgency to move in this direction. It’s a new business imperative to survive, perform, and excel in pharma. At the same time, the industry also should examine other critical changes required in its primary interfaces with customers, in today’s fast evolving scenario.

This process would involve redefining the new roles of some critical positions in the organization. Today’s article will explore how pharma will stay relevant to its customers, increasingly getting more and more involved in the new digital practices.

Some key challenges in pharma digital strategy:

One of the key challenges for a productive ‘company – physician engagement’, in the new normal, is to be available at any preferred time of customers’ choice and the way they want. This may include, both virtual and in-person F2F engagements, along with customized contents for the same. This need is universal and, by and large, remains the same for key stakeholders of all drug companies.

This point was further reinforced, in the February 22, 2021 article on capacity building in the digital space, published in Reuters Events, Pharma. It focused on demands in new era of ‘digital-first customer engagement’, where content creation and omnichannel engagement also play equally vital roles.

Besides, the paper emphasized, today’s need is investing in the type of contents that add clinical value, as opposed to overtly commercial marketing type material. The primary task for marketers is now, therefore, to use updated, high-quality, neutral content on customer engagement platforms that will offer value – the customers are looking for – and not just values from a company’s self-serving perspective. From this angle, the new content model prompts greater customer involvement for meaningful outcomes.

In tandem, company staff members – including medical representatives, need to acquire multi-tasking expertise, being equipped with – required digital knowledge, skills on using digital platforms and ascertaining individual key customers’ engagement needs. Whereas a company’s digital strategist will work on “digital initiatives, solutions, products and how those will be integrated locally.” Thus, this is not about making everyone a digital expert, as the article underscores.

Need to redefine work processes and realigning the staff members:

As the above article from Reuters Events reconfirms, the digital approach that several pharma players were taking even a year or two ago is redundant in the new normal. Amid rapid transformation in the drug business, ‘pharmaceutical industry can no longer act like ostriches. Digital is no longer a fancy add-on, it’s an integral part of everything we do,’ the study highlighted.

Thus, to move in this direction effectively, pharma companies would require redefining many work processes and realign the staff members in sync with their new roles, accordingly. Further elaborating this point, the Accenture study – ‘A digital booster dose for health care,’ identified a few such roles that will undergo a metamorphosis to meet with post Covid challenges. Following are some, where urgent transformations required are, as follows:

 A.   ‘Intelligent representatives’ – not just ‘medical representatives’: 

In the current scenario, rep’s engagement process with the medical profession calls for leveraging specific intelligence based on behavioral preferences. This is fast emerging as a key requirement. Thus, the paper underscores: “Armed with a closed-looped CRM, representatives can effectively use data insights to plan, deliver and report calls.” I also indicated earlier – to succeed in this effort, individual skill sets, such as digital awareness and analytics will be of great use. The core objective is, looking through physicians’ eyes to understand their needs and solve problems by ‘serving customers as individuals, not as numbers in a call roster,’ the study emphasized.

B.  ‘Customer experience managers’ – not just ‘brand managers’: 

While using omnichannel digital platforms, doctor-patient interactions become more content dependent. Accordingly, brand managers’ role will be pivotal to facilitate a uniform interaction experience across all channels.

Therefore, for targeted communication, better understanding of doctors and patients and how they want to be engaged, is a key requirement. Which is why, brand managers will have to acquire skills, such as content management for continuous engagement across multiple channels. This is now absolutely necessary for effective branding in fostering a new genre of ‘customer-brand relationship’ model, across the company.

C. ‘Helping doctors manage their practice and patients better’ – not just ‘brand marketing’: 

‘Think beyond the patients’ – suggests the Accenture survey. This is because, virtualization of healthcare is all about doctors making further customizations into how they operate, both clinically (teleconsultation) and commercially (payments). This is, another important area where pharma companies can further differentiate themselves, by helping doctors manage their practice and patients better. The process entails acquiring critical skills in disease awareness, identifying key gaps that impact patient experience and clinical outcomes, alongside various digital engagement tools to perform these functions.

Conclusion:

The current year is expected to witness flooring of the gas pedal, as it were, in pharma’s digital transformation process, while navigating through humongous challenges on the way. The process includes, redefining work processes and realigning the staff members to establish a new customer-brand relationship’, based on Covid triggered changes in the customer behavior.

A quantum improvement in the usage of digital tools and platforms, alongside targeted content creation will be pivotal in pharma’s customer relationship management to excel in the changing business environment. Many doctors and patients have already signaled their acceptance for digital or virtual interactions, besides some well identified F2F engagements with relevant and personalized data-driven content as they expected from each drug company.

This need arises when one considers the findings of another Accenture Survey. It reported, while 39% of doctors want all medical representative meetings to be virtual, even post pandemic, ‘around 10% of key doctors still want to go back to pre-COVID-19 norms for in-person meetings.’ Thus, the point to ponder in this area is how to structure these F2F meetings for highly productive outcomes.

However, it’s also a reality that during Covid days, doctors wanted to interact with the Medical Reps more than what they used to do in the past. This offers a huge opportunity to drug companies in leveraging pharma rep’s interaction to accurately understand their customer-insight. Consequently, the new approach will help pharma companies, not only in staying relevant to its customers in the digital world, but also, to keep themselves prepared to face similar challenges in the future, proactively.

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.

 

Fostering EQ For Pharma’s Excellence In The New Normal

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On February 25, 2021, one of the top Indian business daily flashed a headline – “It will be working from home, post-pandemic too at many top companies.” It wrote, companies like, Tata Steel, Philips, Infosys and Maruti Suzuki are evaluating job roles to permanently enable employees working from home, or remotely – even after the pandemic. This is just one example, out of many unique outcomes of last year’s disruptive business turbulence, causing a potential mental or emotional impact on many employees.

Virtually across industries, many such significant changes have taken place in several facets of businesses including traditional operational processes. As has been widely witnessed, many desk-bound office jobs – temporarily, partly or fully – shifted to remote working – almost overnight, as it were. Such a shift is being contemplated in several work-areas by a number of drug companies, as well.

For understandable reasons, another concurrent and instant demand surfaced for a critical hard skill – involving applications digital tools and platforms. This was mostly to ensure that key business communications and customer engagements, at least, keep ticking during the crisis, despite unprecedented initial headwinds.

However, sans a catalytic soft skill that helps address several current-environment specific several organizational needs, even applications of digital skills are unlikely to be able to leverage the full potential of digitalization. While navigating through today’s uncharted frontiers, where there are no footsteps to follow, the organization will need flexibility and resilience among leadership, ensuring employee adaptability to change, and creating a new climate of fostering creativity with digital technology.

Interestingly, this soft skill – ‘Emotional Intelligence’ – often referred as ‘Emotional Quotient’ or EQ, wasn’t discussed, as much, for various reasons. In this article, I shall deliberate, why this much-known soft skill is indispensable for business excellence in the new normal – from the pharma industry perspective.

EI/EQ in business isn’t a new idea, but more important now than ever before:

Peter Salovey and John D. Mayer coined the term ‘Emotional Intelligence (EI)’ in 1990 describing it as “a form of social intelligence that involves the ability to monitor one’s own and others’ feelings and emotions, to discriminate among them, and to use this information to guide one’s thinking and action”.

In 1995, Daniel Goleman in his book ‘Emotional Intelligence’ defined EI as the ability to:

  • Recognize, understand and manage our own emotions and,
  • Recognize, understand and influence the emotions of others.

In other words, ‘this means being aware that emotions can drive our behavior and impact people (positively and negatively) and learning how to manage those emotions – both our own and others.’The ability to manage emotions is measured through Emotional Quotient (EQ).

EQ – a cutting edge of excellence, especially in the new normal:

Much before the pandemic, in 2018, McKinsey & Company had projected that between 2016 and 2030, demand for people with high EQ would grow across all industries. Again, in May 2021, the Company reiterated: ‘To meet this challenge, companies should craft a talent strategy that develops employees’ critical digital and cognitive capabilities, their social and emotional skills, and their adaptability and resilience.’

However, with unprecedented changes in pharma business dynamics, the process has been further accelerated. EQ is now expected to be a cutting edge for performance excellence – in any organization. Hence, digital savviness may not be just enough in the new order for organizational turnaround aspirants. Sans people with high EQ, among both – the leadership and staff members, digital transformation alone may not be enough for commercial success.

Long ago, Daniel Goleman epitomized it in his article - ‘What Makes a Leader?’ This was published in the Harvard Business Review (HBR) in January 2004, where he wrote: ‘IQ and technical skills are important, but emotional intelligence is the sine qua non of leadership.’ This old advice assumes even greater importance, in the new normal. 

With emotions prevailing in workplaces, high EQ improves performance:

COVID pandemic has demonstrated to all, including highly tradition bound and slow to change – the pharma industry that the name of the game of survival, particularly when a crisis strikes as a bolt from blue, is quickly adapting to changes. A time came as ‘national lockdown’ started – when a sense of losing control and confusion, virtually engulfed the work environment, which is so necessary for livelihood. A key example of these changes include, a sudden shift from remote working, related to remaining engaged with customers.

Alongside, home life and work life got merged for many. New ways of remaining in touch with customers, sometimes gave rise to a sense of seclusion or alienation, causing mental or emotional stress. Many employees’ keen desire and expectation of the return of the old normal – in the same form, are causing more emotional complications with them.

A study by EQ training provider TalentSmart also found that emotional intelligence is responsible for 58% of one’s job performance. Thus, any pharma company’s ability to be in sync with all employees, at the emotional level, is one the key requirements to boost performance. It will determine the effectiveness of digital tools given to employees to deliver the deliverables. Further, as other studies established, ‘the ability to connect with people on an emotional level – is crucial to maintaining strong and resilient teams.’

Some telltale signs of low EQ in an organization:

Some common telltale signs of low EQ in an organization, were well captured in an article with Covid pandemic in the backdrop. This was published in Inside HR on September 01, 2020. The manifestations of low EQ include, when employees:

  • Don’t want to take responsibility for their own feelings, but blame others for those,
  • Let things build up and then blow up,
  • Often overreact to life’s minor events while struggling to remain in emotional control.
  • Lack empathy and compassion,
  • Tend not to consider others’ feelings before acting,
  • Lack self-awareness of their own emotions and the emotions of others around them.

Such signals, if not addressed promptly, can lead to a number of adverse business outcomes. Especially when, quick adaptation to fundamental changes in the business environment, business operations and key customer behavior, is the name of the game. People’s EQ in an organization, could often stand between business success and failure – in the new normal, more than ever before.

Conclusion:

As pharma industry has started navigating through the new normal with wide-scale application of digital technology, employees also need to keep pace with these changes, and come on board. In such a ‘never before’ situation, emotional needs of both internal and external customers are to be properly understood, and effectively addressed, just as the need for digitalization within the organization.

Notably, low or high EQ are not genetic, neither are these pre-implanted in the brain by God. EQ comes as one learns through ongoing experience in life, and also from the advices of elderly, interaction with peers, superiors and training by professionals. This is a lifelong process of learning, which is continuously honed through practice in real life situations. It’s not bizarre, at all, if EQ of an individual has changed before, during and after the pandemic. What really matters is fathoming, how is the employee EQ today, monitor it continuously, and help the individual as and when required – to help the organization.

Several studies have established high employee EQ as a stronger predictor of success, that helps strengthen hard skills like digitalization by helping to think more creatively while using the tech tools and platforms. Thus, amid unparalleled changes in business operations, customer behavior and the need for quick adaptation to digital technology, fostering employee EQ to encourage them committing to the corporate shared goal, is an imperative for pharma’s performance excellence - more than ever before.

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.