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Opioid Crisis: A Looming Threat To India?

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A serious, but a typical health crisis that has shaken America, is now, apparently, in search of its prey in India – a soft target to ignite a raging fire of misuse or abuse of prescription drugs of addictive in nature. That India could probably be the next victim of this menace, is now being widely discussed and reported in the international media, though not so much in India, itself.

The January 2019 communique of the National Institute of Drug Abuse spotlights: ‘Every day more than 130 people in the United States die after overdosing on opioids.’ Whereas, in 2017, more than 47,000 Americans, among 1.7 million suffering people, died as a result of an Opioid overdose. Snowballing effect of Opioids addiction commenced over a couple of decades ago and includes – both prescription pain relievers and synthetic Opioids, such as fentanyl, among others.

The health menace of this humongous dimension is not only jeopardizing public health, but also impacting the social and economic welfare, work productivity, besides drug addiction related criminal behavior of an increasing number of addicts.

In this article, exploring the factors – that not just ignited, but fueled this fire, I shall try to explain why India could be a fertile ground for another opioid epidemic. The key intent is to thwart this menace without further delay, learning from the ‘Opioid crisis’ in the United States. Moving towards that direction, I begin with a brief description of the genesis of this crisis, primarily to ensure that all my readers are on the same page to feel the gravity of the situation.

The genesis of Opioid crisis:

The terms – ‘Opioid epidemic’ or ‘Opioid crisis’are generally referred to rapid increase in consumption of prescription and nonprescription Opioid drugs in America that began in the late 1990s. It is noteworthy, until the mid-1980s and early 1990s, physicians seldom prescribed opiates because of the fear of addicting patients. This was established in several studies, such as, the July-August 2016 Article, titled ‘Drug Company Compensated Physicians Role in Causing America’s Deadly Opioid Epidemic: When Will We Learn?’

In the ninety’s, as the above paper indicates, some “medical experts and thought leaders led by the neurologist and pain specialist Russell Portenoy, MD, proclaimed that the risks of addiction to Opioids were minimal and that not treating pain was cruel and even amounted to medical negligence.” Incidentally, Russell Portenoy was at that time known as the “King of Pain” and was the Chairman of Pain Medicine and Palliative Care at Beth Israel Hospital in New York.

The paper also articulated, “Portenoy and his acolytes wrote articles and gave lectures to physicians about the safety of narcotics. They repeatedly cited a study by Porter and Jick in ‘The New England Journal of Medicine’ that stated that only one percent of patients treated with narcotics became addicted.” It is a different matter, as the authors indicated, the above trial was ‘not a controlled study at all. It consisted of a short 101-word one paragraph letter to the editor.’

Understandably, the rapid spread of Opioid use in America commenced on the following years. As The author highlighted: “To this day in most American hospitals, nurses on their daily rounds, ask patients to rate their pain on a scale of one to ten and then may administer a narcotic accordingly.”

HHS corroborates the fact:

In line with the finding of the above paper, the U.S. Department of Health and Human Services (HHS) traces the origin of the U.S. Opioid Epidemic in the late 1990s. When, asHHS also reiterated, ‘pharmaceutical companies reassured the medical community that patients would not become addicted to opioid pain relievers.’ Presumably, the general image of the pharma industry not being as questionable as today, ‘health care providers began to prescribe them at greater rates,’ – HHS further noted.

Thereafter, all hell broke loose, as it were.With increased prescriptions of Opioid medications, the widespread misuse of both prescription and non-prescription Opioids started taking its toll. Obviously, it happened as the prescribers were not as cautious and restrictive and concerned about prescribing Opioids because of their addictive nature, as they were before 1990s. It seems unlikely that astute medical practitioners won’t be able to fathom the devastating health impact of such highly addictive medications on the users.

America had to declare the Opioid crisis as public health emergency: 

In 2017 HHS declared Opioid crisis as a public health emergency, announcing a strategy to combat this epidemic. Separately, in October 2017, President Trump also declared the same as the ‘worst drug crisis in U.S. history’.One can sense this Presidential level urgency from the recent report of The Washington Post. It emphasized - ‘America’s largest drug companies saturated the country with 76 billion oxycodone and hydrocodone pain pills from 2006 through 2012, as the nation’s deadliest drug epidemic spun out of control.’

The above information comes from a database maintained by the Drug Enforcement Administration that tracks the path of every single pain pill sold in the United States – from manufacturers and distributors to pharmacies in every town and city. The data would provide an unprecedented look at the surge of legal pain pills that fueled the Opioid epidemic, resulting in nearly 100,000 deaths from 2006 through 2012, as the article highlighted.

In view of this, and also looking at the chronology of the genesis of this crisis, it is worth exploring the role of pharma companies in triggering this health hazard in America.

The role of pharma companies in the crisis: 

That there is, apparently, a role of some big pharma players in the Opioid crisis was widely reported by the international media. One such article titled, ‘Big Pharma Is Starting to Pay for the Opioid Crisis. Make Those Payments Count,’ was publishesby The New York Times, on August 28, 2019.

It said: ‘As innumerable court documents and investigations have shown, Opioid makers, including Purdue and Johnson & Johnson, routinely and knowingly misled the public about their products. They played down the risks of addiction, insisting that their drugs were safe and, if anything, underutilized. And they combated growing concerns with aggressive lobbying and public relations campaigns.’

The September 01, 2019 article titled – ‘America’s Opioid catastrophe has lessons for us all, about greed and racial division’, published in The Guardian went a step forward. Explaining the reason for the situation to attain a ‘crisis’ stage, it said, ‘big pharma saw huge profits in medicalizing the social stress of the white working class.’ Thus, the question that comes up, is there any strong and credible evidence to associate Opioid crisis with pharma marketing?

Association of Opioid crisis with pharma marketing:

Several reports point towards a possible pharma-doctor nexus for the Opioid crisis. One such evidence is provided by the same  July-August 2016 Article, as quoted above. The paper said:‘Recently and belatedly, Portenoy has backtracked and admitted he was wrong about the addictive properties of Opioids.’ He was quoted in the article saying: “I gave innumerable lectures in the late 1980s and ‘90s about addiction that weren’t true.”

Another original investigation report in this regard, titled ‘‘Association of Pharmaceutical Industry Marketing of Opioid Products With Mortality From Opioid-Related Overdoses’, was published in JAMAon January 18, 2019. The paper concluded:‘In this study, across US counties, marketing of Opioid products to physicians was associated with increased Opioid prescribing and, subsequently, with elevated mortality from overdoses. Amid a national Opioid overdose crisis, reexamining the influence of the pharmaceutical industry may be warranted.’

The article also indicated: ‘Recent data suggest that when physicians receive Opioid marketing, they subsequently prescribe more Opioids.’ The researchers pointed out:‘Amid a worsening Opioid crisis, our results suggest that industry marketing to physicians may run counter to current efforts to curb excessive Opioid prescribing.’

Again, the same September 01, 2019 article, published in The Guardian, also stresses– ‘The relationship between big pharma and US doctors can only be described as corrupt.’ Quoting the official figures, it highlighted: ‘The total paid to doctors and hospitals by drug companies was more than $9bn. Unsurprisingly, the greater the payments, the more willing doctors were to prescribe Opioids.’

The India’s tryst with Opioid drugs:

As many would know, India has remained for a long time one of the largest Opioid medicine producers in the world. However, most of the country’s population had a restricted access to Opioid pain relief drugs.

This was because, the International Narcotics Control Board, established in 1968, and the Narcotic Drugs and Psychotropic Substances Act of 1985 ‘codified the bureaucratic thicket for any doctor who wanted to prescribe opioid painkillers. Physicians feared fines, jail sentences and losing their medical license if they skirted regulations.’

The amendment came in 2014:

According to reports, the need for pain relief being “an important obligation of the government,” the Narcotic Drugs and Psychotropic Substances Act, was amended in 2014, creating a class of medicines called the “essential narcotic drugs.” The list of which includes, morphine, fentanyl, methadone, oxycodone, codeine and hydrocodone. Alongside, the conditions for bail in drug offenses will be relaxed and the mandatory death penalty for those previously convicted of certain offenses will be revoked.This is expected to create a better balance between narcotic drug control and the availability of Opioid drugs, for beneficial use of patients.

The flip side – a looming threat?

So far so good. Nevertheless, another article – ‘How big pharma is targeting India’s booming Opioid market,’ appeared in The Guardian on August 27, 2019, shows the flip side of this development. It says, as India loosens its stringent narcotics laws, ‘American pharmaceutical companies – architects of the Opioid crisis in the United States and avid hunters of new markets – stand at the ready to fuel that demand.’

Many are truly concerned about it, especially in a country like India, where any medicine can be procured over the counter, hoodwinking robust drug laws. Thus, as the above article adds, ‘a looming deluge of addictive painkillers terrifies some Indian medical professionals, who are keenly aware that despite government regulations most drugs are available for petty cash at local chemist shops.’

Providers of pain management are increasing, so also self-medication:

Today, ‘pain management’ as a specialty treatment, can be seen in many hospitals of the country. In tandem – apparently, ‘at the insistence of the professional societies that accredit hospitals in India, nurses and doctors are now encouraged to assess pain as a “fifth vital sign“, along with pulse, temperature, breathing and blood pressure.’ Besides, as The Guardian article of August 27, 2019 also noted, ‘General practitioners have started prescribing these drugs.’

Yet another important point to note, according to studies, one of the most common reasons for self-medication is for pain – 18.34 percent, where self-medication is done with nonsteroidal anti-inflammatory drugs in 49.4 percent of cases. Keeping pace with this trend, most generic pharma companies are having pain management product in their brand portfolio, unlike a couple of decades ago.

Early signs of drug companies’ special marketing activities:

There are many examples. But I shall quote The Guardian article again to drive home this point. The paper talks about hints of ‘American pharma’s fingerprints’ in a glass cabinet in the waiting room of a famous clinic in Delhi. Some of these include ‘awards from Johnson & Johnson honoring the doctor for symposia on pain management; a plaque for “his valuable contribution as a speaker” about tapentadol, an Opioid marketed by Johnson & Johnson in 2009. The dispensing counter does a brisk business in Ultracet, branded tramadol tablets made by a Johnson & Johnson subsidiary.’

Alongside, another interesting point is peeps in – the drugs, which are now commonly prescribed for chronic pain were first approved for use by cancer patients. ‘One of the first formulations of fentanyl, for example, was a lollipop because chemotherapy left cancer patients too nauseated to eat. In India, pain physicians now prescribe fentanyl patches to patients with chronic muscular pain.’

Every year, more of such drugs are coming to market. Many chemists, hospitals and medical shops are also acquiring requisite licenses for keeping these drugs. Curiously, Opioids are available in not just oral, but injectable, patches and syrups – the article noted.

Conclusion:

There are many striking similarities between the developments that preceded the American Opioid crisis and the emerging scenario of the same in India. One such is, its onset in America was in the late 1990s, with the regulatory relaxation in introducing Opioid drugs. However, the first announcement of the full-blown crisis on the same, took a couple of decades to come.

In India, the regulatory relaxation for some Opioid drugs came in 2014, and now its 2019. Thus, it’s possibly too early to even track, in which direction it is moving. However, given the prevailing overall healthcare scenario in India, the concern remains palpable. The decision makers, hopefully, would consider putting in place effective checks and balances, taking a leaf from the American Opioid epidemic. The measures should include, among others, effective implementation of legal and regulatory provisions; making health care delivery systems robust and transparent; protecting vulnerable patients from rampant and irresponsible self-medication, besides promptly addressing general concerns with pharma marketing practices.

The whole process should be aimed at benefitting the deserving patients, suffering from excruciating pain, while minimizing Opioid drug misuse or abuse. There should not be any repetition of human sufferings on this score, like what people are now witnessing in America. Effective action from all concerned – right from now, will decide whether or not Opioid crisis is a looming threat that India can successfully neutralize.

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.

Spirit Behind Drug Patent Grant: Secondary Patents: Impact on Drug Access

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For more effective treatment against existing diseases, besides combating new or a more complicated form of existing ailments with precision, drug innovation is absolutely necessary and on an ongoing basis. This makes innovative drugs so important for the population, globally.

Besides academia, the pharma industry has remained in the forefront of the search for new drugs, for so long. What makes this process so crucial is, cheaper generic drugs flow from the innovative drugs, post market exclusivity period, which together form the bedrock of the pharma industry’s business model. Consequently, a robust patent protection for the new molecular entities, not only enable the drug innovators to make a reasonably good profit, but also encourage them to keep this virtuous circle moving, faster.

Although, the drug patents are granted for 20 years, after obtaining marketing approval from the respective drug regulators, a time period - ranging between 7 and 12 years, is available to the company to realize its maximum commercial benefits. Thereafter, the patent expires, paving the way of market entry of cheaper generic equivalents to make the drug accessible to a larger population. This is the playbook, which deserves to be accepted and respected by all, both in the letter and spirit.

Currently, the narrative has started changing, apparently, repudiating the spirit behind the grant of new drug patents, especially with the entry of a number of expensive, large molecule biopharmaceutical drugs. After obtaining a fixed-term market exclusivity, more intricate legal measures are being taken to extend the fixed-term market monopoly for an unknown period, delaying market entry of cheaper biosimilar equivalents, post patent expiry, as long as possible.

In this milieu, India appears to be the only country in the world, where the country’s ‘Patents Act’ provides enough safeguard to blunt those legal tools, effectively, to protect patients’ health interest. Quite expectedly, this new narrative of the drug innovators is yielding the best return in the Eldorado of the pharma world – the Unites States. It is also no secret that US vehemently opposes several provisions of the Indian Patents Act 2005, under pressure from the most powerful pharma lobby group, as many believe.

Using the spirit behind drug patent protection as the backdrop, I shall dwell in this article, how this so precious spirit is gradually losing its basic purpose, especially for blockbuster biopharma drugs. Is the key intent behind sacrificing the spirit behind drug patent grant to keep their brands money spinners and big – even after expiry of original patent – as long as possible – at the cost of patients’ health interest?

Despite the original patent expiry, biggest biologic drugs remain big:

The fact that original patent expiries have done little to halt sales of some of the industry’s biggest products – mostly biologic drugs, was clearly elucidated in an  Evaluate Pharma article – “Biopharma’s biggest sellers – the oldies that just keep giving,” published on August 14, 2019. This gets vindicated, as we look at the ‘top ten pharma brands with biggest lifetime sales – from launch to 2018’, in the following Table I:

Product Company Launch year USD Billion
1. Lipitor Pfizer 1997 164.43
2 Humira AbbVie 2003 136.55
3. Rituxan Genentech/Biogen 1997 111.50
4. Enbrel Amgen 1998 108.16
5. Epogen Amgen 1988 107.90
6. Advair GSK 1998 104.20
7. Remicade Janssen 1998   98.00
8. Zantac GSK 1981   97.42
9. Plavix Sanofi/BMS 1998   90.63
10. Herceptin Genentech/Roche 1998   87.97

(Adapted from Evaluate Pharma data of August 14, 2019)

The point to take note of:

The point worth noting here, with the exception of Advair, Zantac, Lipitor and Plavix, all others – among the top ten brands, are biologic drugs. Moreover, what is most striking in the Table I, despite the expiry of the original patents, a large number of biologic brands were able to expand their sales, pretty impressively, for well over two decades. As we shall see later, this situation is expected to continue, at least, till 2024.  As the Evaluate Pharma article states, for various reasons, these multibillion dollar brands have been able to avoid the expected post patent expiry ‘onslaught from biosimilars in the key US market’, which is incidentally the most valuable pharma market in the world.

One of the key reasons that helps delaying cheaper biosimilar drug entry expanding patient access, is a crafty strategic measure adopted by these companies through the creation of a Patent Thicket with secondary patents. As I discussed in this Blog on April 22, 2019, this is a crafty way of ‘evergreening’ patent term beyond 20 years, legally. Whether such measures conform to the spirit of granting 20 years product patent, becomes a moral question, or an issue of probity for the concerned companies, at the most. Be that as it may, a concern over this situation has been raised in many countries, including the United States.

Barrier of secondary patents: 

Biosimilar drug developers continue facing multiple non-financial challenges, such as, scientific, regulatory, pricing. I have already discussed some of these barriers in this blog on July 31, 2017. Instead, I shall focus in this article, with greater detail, on the intricate and a well-woven net of secondary patents. However,before delving into this area, it will be worthwhile to have a quick recap on the basic differences between original patents and secondary patents.

According to WIPO, “Patents on active ingredients are referred to as primary patents. In later phases of the drug development, patents are filed on other aspects of active ingredients such as different dosage forms, formulations, production methods etc. These types of patents are referred to as secondary patents.”

Another excellent paper, authored by two distinguished researchers from Columbia University and LSE, makes some important points on this subject. It says, secondary patents have become increasingly important to the pharma industry, especially in the U.S. and Europe over the past three decades. The basic purpose of ‘taking out multiple patents on different aspects of a drug in order to cordon off competitors is now standard practice in the pharmaceutical industry.’ As the authors further said, this is primarily because: ‘Secondary patents can protect market shares by extending periods of exclusivity beyond the dates in which patent protection would otherwise lapse.’

Interestingly. devising patent strategies to extend periods of market exclusivity is generally considered in the industry, as a key component of ‘product life cycle management,’ – not by the marketing whiz kids, but by astute patent attorneys. Nevertheless, as the paper articulates, critics of this practice often use the more pejorative – evergreening, to describe it.

Examples of impact of secondary patents:

Many research papers suggest, besides scientific complexity in biosimilar drug development being a key reason for their delayed market entry, secondary patents are even tougher barriers for the same. This was brought to light a few years ago in a ‘Review Article’ – ‘The Economics of Biosimilars’, published in the September/October 2013 issue of American Health & Drug Benefits.

Some of the key points made on this issue include,AbbVie plan to defend Humira (adalimumab) with more than 200 secondary patents, Merck’s giving up its biosimilar project on Enbrel when Amgen got its expanded patent life. There are many other such instances.

Its effect would last longer: 

Experts believe, the effect of creating a strong secondary patent shield around blockbuster biologic would last much longer. As the above Evaluate Pharma article underscores: ‘This ability to fend off biosimilar competition is one of the reasons Humira is set to snatch Lipitor’s crown next year as the industry’s most successful drug.’

The Table II below that lists ‘top 10 pharma brands from their respective launch date, including estimated forecast till 2024’, vindicates its long-lasting impact:

Product Company Launch year USD Billion
1. Humira AbbVie 2003 240.05
2 Lipitor Pfizer 1997 180.19
3. Enbrel Amgen 1998 139.83
4. Rituxan Genentech/Biogen 1997 136.07
5. Revlimid Celgene 2008 123.64
6. Remicade Janssen 1998 117.20
7. Epogen Amgen 1988 115.87
8. Herceptin Genentech/Roche 1998 114.89
9. Avastin Genentech/Roche 2004 114.27
10. Advair GSK 1998 113.61

(Adapted from Evaluate Pharma data of August 14, 2019)

Although, Zantac and Plavix no longer feature in this table, one drug that leapfrogged much of the competition to become one of the industry’s biggest future bestsellers is Revlimid. The projected sales of the drug over the next six years will actually outstrip its sales to date. However, much of this is dependent on whether generic competition will arrive ahead of Revlimid’s 2022 patent expiry, the paper indicated.

Concern expressed even in the US for the delay in biosimilar market entry:

Many big spending countries on health care, such as the United States expected that timely biosimilar drug entry will help contain health expenditure significantly. However, the article published in the Fierce Pharma on August 29, 2019, raises an alarm, but with a hope for the future. It says: “It’s no secret biosimilars haven’t made a big dent in U.S. drug spending. Some experts have even said it’s time to give up on copycat biologic.”

This hope gets resonated with what, ‘the former US-FDA commissioner Scott Gottlieb argues’. He feels, ‘It’s too soon for that’, while ‘calling on Congress to bolster the budding market.’ However, in my personal view, this will remain a difficult proposition to implement, as biologic drug players will continue using their relatively new, but powerful weapon of filing a number of complex ‘secondary patents.’ These will help extend the market exclusivity period of their respective brands, much beyond the original patent grant period, unless a counter legal measures are taken by the lawmakers of various countries, including the United States. But, India is an exception in this regard.

Indian patent law doesn’t encourage ‘secondary patents’:

The good news is, Indian Patent Act 2005, doesn’t encourage ‘secondary patent.’ This is because, section 3 (d) of the Indian Patent Act 2005 limits grant of ‘secondary pharmaceutical patents.’ An interesting study reported on February 08, 2018, discussed about 1,700 rejections for pharma patents at the IPO spanning over the last decade. But, there is a huge scope for improvement in this area.

Which is why, the not so good news is under-utilization of the same section 3.d by the Indian Patent Office (IPO), as are being voiced in many reports. One such paper of April 25, 2018 highlighted,72 per cent of pharma patent grants are secondary patents. These were granted for marginal improvements over previously known drugs for which primary patents exist. That said, despite such reported lapses, blocking of some crucial secondary patent grant has benefited a large number of patient population of India.

Blocking secondary patent grant has helped India immensely:

While US recognizes secondary patents, blocking secondary patent grant, especially for biologic drugs has helped Indian patients immensely, with expanded access to those medicines. This was also captured in the above study. Besides the classic case of Novartis losing its secondary patent challenge for Glivec in the Supreme Court of India in 2013, several other examples of secondary patent rejection are also available. This includes, among others, Glivec of Novartis and the world’s top selling drug for several years – Humira of AbbVie.Against a month’s therapy cost of ₹1,6o, ooo for Glivec in the US, its Indian biosimilar version costs for the same period ₹11,100. Similarly, while the treatment cost with Humira in the US is ₹85,000, the same with its biosimilar version in India is ₹ 13,500, as the above study finds.

Conclusion:

The core purpose of drug innovation, as widely touted by the R&D-based drug companies, is meeting the unmet needs of patients in the battles against diseases. Thus, drug innovation of this genre must not just be encouraged, but also be adequately protected and rewarded by granting product monopoly for a 20-year period from the date of the original patent grant. Curiously, piggybacking on this basic spirit behind the drug patent grant, pharma lobby groups are now vocal on their demand for giving similar treatment to secondary patents on various molecules. The tone of demand gets shriller when it comes to section 3. d of the Indian Patents Act, which doesn’t allow such ‘evergreening’ through secondary patents.

Thus, the key question that surfaces, while the original patent grant for innovative drugs help meeting unmet needs of some patients, whose unmet needs would a secondary patent grant meet, except making the concerned company richer? Further, for highly expensive biologic drugs, delayed market entry of cheaper biosimilars in that process, would deny their expanded access – failing to meet the unmet needs of scores of others.

Hopefully, India won’t give in to pressure of multinational pharma lobby groups, channeled through various powerful overseas government entities. At the same time, I hope, the government in power at the Eldorado of the pharma industry, will consider giving a fair chance of market entry to cheaper biosimilars, including those from India, to also grow their business globally, but in a win-win way.

The key objective of all stakeholders involved in this process, should be to uphold the basic spirit behind drug patent grant. It may even call for challenging the core intent behind secondary patent applications, the world over, that deny quicker market entry for cheaper biosimilars, sans heavy litigation expenses. This will help expand access to cheaper biologic medicines to all those who can’t afford those, otherwise.

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.

 

 

 

 

OTC Drugs in India: ‘Where Art Thou?’

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It is now a widely accepted fact that responsible self-medication plays an important role in health care, facilitating greater access to medicines and reducing overall health care cost. With continued improvement in people’s education, general knowledge and socioeconomic conditions, self-medication has been successfully integrated into many health care systems, throughout the world.This was emphasized in the paper “The benefits and risks of self-medication,” published by the World Health Organization (WHO) based on a presentation of the WHO Coordinator, Quality Assurance and Safety: Medicines, way back in March 2000.

Which is why, calibrated deregulation of prescription drugs for ‘Over the Counter (OTC)’ sale, are helping many countries to expand drug access in a cost-effective manner, facilitating overall health care, through responsible self-medication.

In this article, I shall try to explore the OTC drug issue in India, against the backdrop of the veracity of dangerous and virtually uncontrolled self-medication in the country. It will be interesting to recap where India stands in this area, despite the enactment of so many relevant laws and rules to eliminate this menace. In tandem, it will be worthwhile to fathom why is India still keeping away from promoting responsible self-medication through OTC drugs? Even when this is widely considered as one of the effective ways to improve access to drugs for specified common ailments at a reduced treatment cost for patients.

OTC Drug in India: ‘Where Art Thou?’ – becomes a relevant question in this context. Let me pick up the thread of this discussion from the general belief among a large number of domain experts that OTC drugs facilitate responsible self-medication.

OTC drugs facilitate responsible self-medication:

For greater clarity in this area, it will be worthwhile to first recapitulate the definition of self-medication. The W.H.O has defined itas, ‘the practice whereby, individuals treat their ailments and conditions with medicines which are approved and available without prescription, and which are safe and effective when used as directed.’

Whereas, self-medication with prescription drugs is not only an irresponsible act, it can often be dangerous to health for the users. On the other hand, OTC drugs facilitate responsible self-medication, as the drug regulators of respective countries have included under this category, with clear guidelines, only those medicines, which:

  • Are of proven safety, efficacy and quality standard.
  • And indicated only for conditions that are self-recognizable, and some common chronic or recurrent disorders.
  • Should be specifically designed for the purpose, will require appropriate dose and dosage forms and necessarily supported by information, which describes: how to take or use the medicines; effects and possible side-effects; how the effects of the medicine should be monitored; possible interactions; precautions and warnings; duration of use; and when to seek professional advice.

Since, OTC drugs facilitate responsible self-medication, it will be interesting to know how the constituents of Big Pharma, such as Pfizer, view the social impact of legally recognized OTC drugs.

Social impact of self-medication with OTC drugs:

Like many other large global pharma players, Pfizer also believes: “OTC medicines provide easier access to treatment options for common conditions, offering not only convenience, but also timely treatment and relief for sudden symptoms or minor ailments.” The company also acknowledges, OTC medicines, as classified so by the drug regulators of a country, “provide consumers safe and effective treatments for commonly occurring conditions, saving them time and money that might otherwise be invested in other, more expensive health services.”

To substantiate the point, Pfizer communique referred to the U.S. study, which by analyzing the seven most common acute and chronic, self-treatable conditions found that 92 percent of those who use OTC medicines in a given year are likely to seek more expensive treatment elsewhere, if OTCs were not available.

The above may be construed as a generally accepted view of both, the drug regulators and a large number of drug companies, globally. Thus, it won’t be a bad idea to quickly have a glance at the process followed by the drug regulators of the major countries, such as US-FDA, for OTC classification of medicines.

US-FDA classification of OTC medicines:

In most countries of the world, as many of us would know, those who are permitted to sell drugs under a license, can sell two types of drugs, namely: prescription drugs and nonprescription drugs. OTC medicines, obviously, fall under the nonprescription category.

Briefly speaking, US-FDA defines OTC drugs as “drugs that are safe and effective for use by the general public without seeking treatment by a health professional.”The Agency reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example, analgesics or antacids, instead of individual drug products. For each category, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of ‘recipe book’ covering acceptable ingredients, doses, formulations and labeling.

Many of these monographs are found in section 300 of the Code of Federal Regulations. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness and labeling of all marketing OTC active ingredients. While this is the scenario in the United States and a large number of other countries, let’s have also a glimpse of this aspect in India.

‘OTC drugs’ in India:

As on date, legally approved as OTC drugs along with the guidelines, for responsible self-medication during pre-defined common illnesses, doesn’t exist in India. Accordingly, neither drugs & Cosmetics Act, 1940 nor the Drugs & Cosmetics Rules, find any mention of OTC drugs, as yet. While even responsible self-medication is not legally allowed or encouraged in the country, ‘self-medication’ of all kinds and of all nature are rampant in India, possibly due to gross operational inefficiency on the ground.

Several research papers vindicate this point. One such study that was done with 500 participants, reported 93.8 percent self-medication with no gender difference. The most common reasons for self-medication were found to be – 45.84 percent for fever, 18.34 percent for pain, and 10.87 percent of headache, among others. While the common medications used were listed as nonsteroidal anti-inflammatory drugs 49.4 percent, followed by antibiotics 11.6 percent, besides other drugs.

Among those participants who took self-medication were of the opinion that self-medication resulted in quick cure of illness – 50.75 percent, saved their time – 17.46 percent, and gave them a sense of independence – 17.06 percent. The most common source of information was found to be a local chemist/pharmacy – 39 percent.

Raising a flag of concern that indiscriminate self-medication is dangerous for the population, the study suggested that public health policies need to find a way of reducing unnecessary burden on healthcare services by decreasing the visits for minor ailments. One such way is a well-defined OTC category of medicines, as are being created in many countries, including the United States. However, it appears, the Indian drug regulators are still apprehensive about giving a formal recognition of OTC drugs in the country, to prevent self-medication that is, unfortunately, rampant in the country, even otherwise.

Self-medication rampant, although illegal in India:

Regardless of all drugs laws and rules being in place to prevent self-medication with prescription drugs, these seem to be just on paper, the ground reality is just the opposite in India. In the absence of a clearly defined category of OTC drugs with guidelines, most medicines falling under the drug act, are prescription drugs, except a few drugs on the Schedule K of the Drugs & Cosmetics Act. Currently, non-pharmacy stores can sell a few Schedule K drugs classified as ‘household remedies’ onlyin villages with less than 1,000 populations, and where there is no licensed dealer under the Drugs and Cosmetics Act.

Primarily to prevent self-medication and also to ensure maintenance of specified storage conditions, among others, the D&C Act requires all other drugs to be sold by a retail drug license holder and sold only against the prescriptions of registered medical practitioners. Such drugs are labeled with a symbol ‘Rx’ on the left-hand corner of the pack and the symbol ‘NRx’, if drugs fall under Narcotic Drugs and Psychotropic Substance Act.

Additionally, these are also labeled with a warning – ‘To be sold on the prescription of a registered medical practitioner only.’ All retailers, pharmacy/medical store are supposed to strictly abide by this directive. But in reality, who cares? One can possibly get most prescription drugs that one wants, without a doctor’s prescription.

The same holds good for virtually unregulated advertising of some self-categorized ‘OTC drugs’, many of which fall under the prescription drug category. I re-emphasize, the terminology of OTC drugs does not exist, at all, in the D&C Act of India, not as yet.

Virtually uncontrolled advertisements of some so called ‘OTC’ drugs: 

Media reports indicate, widespread complaints received in the drug controller general of India (DCGI)’s office that vitamin tablets and capsule formulations are being marketed in the country as dietary/food supplements to circumvent the Drugs Price Control Order (DPCO).

Curiously, to resolve this issue – way back on July 24, 2012, the Drugs Technical Advisory Board (DTAB), the highest authority in the union health ministry on technical matters, deliberated on the OTC drug issue in India. After detailed discussion, the DTAB has given its green signal to amend Schedule K of the Drugs and Cosmetics Rules in this regard.

But Food safety watchdog Food Safety and Standards Association of India (FSSAI) did act promptly on this matter. On September 24, 2016, FSSAI), reportedly, issued new guidelines clearly specifying that health supplements should not be sold as medicines and also fixed the permissible limits of various ingredients used in the products. It further said: “Every package of health supplement should carry the words health supplement as well as an advisory warning not for medicinal use prominently written.

“The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, the standards laid down by the international food standards body namely the Codex Alimentarius Commission shall apply,” FSSAI added.

The juggernaut moves on:

The point worth noting here that all laws, rules and regulations are in place to discourage both, self-medication and surreptitious way to sell products sans medicinal values, as medicines. Despite the enacted laws and rules being reasonably robust to achieve the intended objective, inefficient implementation of the same keeps the juggernaut moving, perhaps gaining a momentum.

Is OTC Drug Category coming now or just another good intent?

The good news is: On September 18, 2017, the Drug Consultative Committee (DCC), in principle approved to amend rules on Drugs and Cosmetics Act to include a separate schedule for OTC drugs for minor illnesses like fevers, colds and certain types of allergies. However, in the meeting of February 20, 2019, the DCC constituted another subcommittee under the chairmanship of Drugs Controller, Haryana to examine the report on OTC drugs. The final decision is still awaited without any prescribed timeframe for the same.

Conclusion:

Creation of separate schedule for OTC drugs in India, is still a contentious issue for some. Nonetheless, such a long overdue amendment in the D&C Act, along with well-regulated OTC guideline as and when it comes,I reckon,will expand drug access to patients. Alongside, the drug makers must ensure that these OTC medicines are safe, effective and offering good value for money.

As the author of the above W.H.O articled emphasized: ‘High ethical standards should be applied to the provision of information, promotional practices and advertising. The content and quality of such information and its mode of communication remains a key element in educating consumers in responsible self-medication.’ Thus, in the Indian context, it will be equally essential for drug companies to make sure that OTC medicinesare always accompanied by complete and relevant information that consumers can understand without any ambiguity.

Be that as it may, I agree, even responsible self-medication is not totally risk-free – not even with OTC drugs, just as many other things that we choose to do in life. The risks associated with the use of OTC medicines may include, risks of misdiagnosis, excessive drug consumption and for a prolonged duration, precipitating drug interactions, side-effects and polypharmacy.

This discussion will remain theoretical until the D&C law and rules are appropriately amended to accommodate much awaited OTC category of medicines. Till then one can possibly ask in India: ‘OTC drugs, where art thou?’

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.

 

Is India in The Eye of The AMR Storm?

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‘With 700,000 people losing battle to antimicrobial resistance (AMR) per year and another 10 million projected to die from it by 2050, AMR alone is killing more people than cancer and road traffic accidents combined together.’ This was highlighted in the Review Article, ‘Antimicrobial resistance in the environment: The Indian scenario,’ published in the Indian Journal of Medical Research (IJMR), on June 03, 2019.

The article further noted, ‘AMR engendered from the environment has largely remained neglected so far,’ which has a snowballing effect. Illustrating the enormity of its impact, the researchers recorded: ‘Economic projections suggest that by 2050, AMR would decrease gross domestic product (GDP) by 2-3.5 percent with a fall in livestock by 3-8 percent, costing USD100 trillion to the world.’

Besides International media, fearsome consequences of AMR are also being highlighted by the Indian media from time to time. For example, on November 21, 2018, a leading national business daily carried an apt headline: ‘India in the firing line of antimicrobial resistance.’ More intensive coverage of such nature for this public menace, would hopefully appeal to the conscience of all those who can meaningfully address this situation, especially the government.

Against this backdrop, I shall explore in this article, whether India is really in the eye of this AMR storm, which is posing an unprecedented threat to many lives, perhaps more in India. 

India is being called the AMR capital of the world: 

Analyzing the emerging research data in this area, India was referred to as ‘the AMR capital of the world,’ in the 2017 Review Article, title ‘Antimicrobial resistance: the next BIG pandemic.’ Curiously, besides umpteen number of published papers documenting this scary development, very few enlightened individuals would dare to push an argument to the contrary. Whereas, besides framing a policy document on AMR,nothing much is changing in India on this score. This is happening, even when it is evidenced that a gamut of the most powerful antibiotics, are not working against many deadly bacteria. Added to it, India still doesn’t have a public database that provides death due to AMR.

Are adequate resources being deployed to fight the menace:

Today one would witness with pride that India’s ‘Chandrayaan 2’ lunar mission is moving towards the Moon’s south polar region, where no country has ever gone before. At the same time, despite AMR threat, India’s budgetary allocation for health in 2018-2019, reportedly, shows a 2.1 percent decrease of the total Union Budget from the 2.4 percent in 2017-2018.

It is interesting to note that India: ‘Despite being the world’s sixth largest economy, public health spending has languished at under 1.5 percent of GDP, one of the lowest rates in the world. For comparison, the United Kingdom shelled out 9.6 percent of its GDP in 2017 on health. The United States’ health expenditure is 18 percent of GDP.’

‘Ayushman Bharat’ and health care infrastructure:

Recently lunched public health program - Ayushman Bharat, although is not a Universal Health Care (UHC) program, it has targeted to cover ‘less than half the population and excluding 700 million people’. While giving a thumbs-up to this initiative, if one looks at the overall health infrastructure in India to make it possible as intended, it may not encourage many.

To illustrate this point, let me quote only the salient points, as captured in a 2018 study, published in the British Medical Journal, as follows:

  • The total size of health workforce estimated from the National Sample Survey (NSS) data was 3.8 million as of January 2016, which is about 1.2 million less than the total number of health professionals registered with different councils and associations.
  • The density of doctors and nurses and midwives per 10,000 population is 20.6 according to the NSS and 26.7 based on the registry data.
  • Health workforce density in rural India and states in eastern India is lower than the WHO minimum threshold of 22.8 per 10,000 population.
  • More than 80 percent of doctors and 70 percent of nurses and midwives are employed in the private sector.
  • Approximately 25 percent of the current working health professionals do not have the required qualifications as laid down by professional councils, while 20 percent of adequately qualified doctors are not in the current workforce.

The intent to deliver health care as announced by various governments from time to time is good. But, the available health infrastructure to deliver these meaningfully are grossly inadequate, creating a huge apprehension among many. This is not just because of the grossly inadequate number of hospitals, doctors, nurses and paramedics, but also their even uneven spread in the country. The cumulative impact of these, fueled by corruption, ‘missing doctors, ill-equipped health professionals, and paucity of required funds’ continue creating a humongous problem for the public, at large, to get affordable health care.

At the same time, there is ‘a serious lack of new antibiotics under development to combat the growing threat of antimicrobial resistance.’ Imagine, a situation when India gets caught in the eye of the AMR storm and imagine the consequences of that, as you deem appropriate.

Lack of new antibiotics under development to combat AMR:

The World Health Organization (WHO) report - ‘Antibacterial agents in clinical development – an analysis of the antibacterial clinical development pipeline, including tuberculosis’, launched on September 20, 2017 shows ‘a serious lack of new antibiotics under development to combat the growing threat of antimicrobial resistance.’

It further reported: ‘Most of the drugs currently in the clinical pipeline are modifications of existing classes of antibiotics and are only short-term solutions.’ The report also found, very few potential treatment options for those antibiotic-resistant infections identified by WHO as posing the greatest threat to health, including drug-resistant tuberculosis which kills around 250 000 people each year.

Thus, the point to ponder simultaneously is, whether there is any decline in global investments for antibiotic research, both by the drug industry and the public funders.

Declining investment on new antibiotic R&D: 

As stated in the May 2016 paper, titled ‘Tackling Drug-Resistant Infections Globally. As the report indicates: ‘The UK Prime Minister commissioned the Review on Antimicrobial Resistance to address the growing global problem of drug-resistant infections. It is chaired by Jim O’Neill and supported by the Wellcome Trust and UK Government, but operates and speaks with full independence from both.’

The report acknowledges that new antibiotic research and development has been suffering from decades of under-investment by companies and governments. The reason being, antibiotic discovery and development are no longer an attractive proposition for commercial drug developers, for a key fundamental reason:

And this is, lack of a dependable, commercially-attractive market for antibiotics that meet large unmet medical needs. As a result, the volume of sales of a such new antibiotics will be low, and restricted only to multi-drug resistant bacteria. Otherwise, older and cheaper antibiotics will still work against most other infections. In that scenario, patented new antibiotics will have to compete with generics, keeping the price low. This combination of price pressure and low volumes makes antibiotics unattractive as a commercial proposition for many drug developers.

Which is why, as the report says: ‘Less than 5 percent of venture capital investment in pharmaceutical R&D between 2003 and 2013 was for antimicrobial development.’ Against total venture capital investment of USD 38 billion in pharmaceutical R&D, antimicrobial venture capital investment was mere USD 1.8 billion, during the same period. Coming back to India specific concerns, let’s have a look at the sociocultural issues in the country, associated with AMR.

Sociocultural issues are fueling the fire:

Understandably, the AMR problem remains intricately intertwined with a number of sociocultural issues of India. It has been established in several studies that social level, socioeconomic and socio-cultural status can play a significant role in the health status of people. Most research done on this subject indicates that higher level of socioeconomic classes reflects at a higher level of health and longevity. Much of this comes from the fact that there is a higher level of education and health care that is available for ‘this class level’.

Sociocultural issues in India also includes, poor hygienic practices, inadequate clean water and good sanitation facilities across the country, besides improper implementation and lack of good governance of health policies, rules and regulations. These factors are also aggravating the AMR problems in the country, as stated in the article, titled ‘‘Public Health Challenges in India,’ published in the Indian Journal of Community Medicine, in its April-June 2016 issue. Which is why, just addressing the indiscriminate use of antibiotics and restricting its wide consumption, aren’t not enough, any longer.

Is India in the eye of the AMR storm?

‘Antimicrobial resistance (AMR) has emerged as a major threat to public health estimated to cause 10 million deaths annually by 2050. India carries one of the largest burdens of drug-resistant pathogens worldwide.’ This was highlighted in the research paper, titled ‘Antimicrobial resistance: Progress in the decade since the emergence of New Delhi metallo-β-lactamase in India’, published in the Indian Journal of Community Medicine, on March 12, 2019.

The article noted, ‘AMR has been identified as a global health threat with serious health, political, and economic implications.’ The paper concluded with a serious note, which is worth taking note of. It found, the full throttle efforts to tackle the AMR challenge in India still requires significant efforts from all stakeholders. It underscored, ‘Despite the adoption of a national policy and significant activities already underway, progress is limited by a lack of clear implementation strategy and research gaps.’ 

Suggested areas of focus in India:

As ‘the Sword of Damocles’, in the form of AMR, hangs over the head of Indian population, there are certain important measures that the country can definitely take to contain AMR, whereas some other critical ones will be challenging to roll out, immediately.

It is unlikely, during this period India will have the requisite wherewithal to focus on discovery and development of new antibiotics to tackle AMR. Similarly, only framing rules and regulations for doctors, patients, dispensing chemists or hospitals to prevent antibiotic misuse, which are not persuasively yet strongly implemented, won’t also yield desired results. Nevertheless, efforts must continue for their effective compliance.

That said, what the country can seriously focus on, sans much constraints, is on taking collective measures in resolving some of the crucial but intimately associated sociocultural issues, with all sincerity and precision. A few of these important areas include, intense public awareness campaigns on the growing threat to life due to AMR, clubbing the benefits of availing good sanitation facilities, hygienic lifestyle and everyday practices.

Moreover, misuse of antibiotics in poultry, animal farming and agriculture should be curbed. Alongside, mass vaccination program for prevention of bacterial and viral infections, should be made available all over the country. Monitoring of the incidence of death due to AMR, on an ongoing basis, is another practice should also feature in the must-do list, providing access to this database to public. Responding meaningfully to International coalition for country-specific action, is also very important. To attain this goal a healthy socioeconomic environment needs to be encouraged, with corruption free efficient governance.

Conclusion:

That India is in the eye of the AMR storm, can’t be wished away any longer. Thus, the fight against AMR will need to be a well-orchestrated one, engaging all stakeholders as partners. The private sector should also actively participate in the AMR awareness programs under public–private partnership (PPP) or through Corporate Social Responsibility (CSR) initiatives.

The whole process should be backed by a creative strategy, having buying-in from all concerned, but spearheaded by the government. That’s the minimum that, I reckon, should happen when the country is in the eye of the impending AMR storm.

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.

 

The Challenge of Holistic Value Creation With Pharma M&A

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Two mega deals, right at the dawn of 2019 gave a flying start to Merger & Acquisition (M&A) activities, in search of inorganic growth, by some large pharma companies. The two biggest ones are Bristol-Myers Squibb’s (BMS) USD 74 billion buyout of Celgene, and AbbVie’s USD 63 billion purchase of Allergan, as announced on January 03, 2019 and June 25, 2019, respectively. However, overall in the second quarter of 2019, there were, reportedly, only 22 deals – ‘the smallest quarterly deal count for at least a decade.’

As a strategic option for greater value creation to drive growth, M&A is being actively considered over a long period of time. The key focus of such value creation for the company remains primarily on enriching the pipeline of New Chemical or Molecular Entities (NCE/NME) for revenue synergy, besides cost synergy. This is understandable. But, for various reasons, alongside, a key question also comes up for debate – is the core purpose of such value creation to drive companies’ growth, primarily with more number new drugs, sustainable? The query assumes greater relevance in the evolving new paradigm. This is because, a basic shift is taking place in the core organizational purpose of value creation.

Thus, it appears, the nature of value creation through M&A would also matter as much. Can it still remain a drug company’s financial health centric, any longer? Should the M&A initiatives also not take under their wings, the value-offerings expected by patients from a drug company – beyond innovative pills? Would a holistic value creation through M&A would now be the name of the game? If so, how?  The discussion of my today’s article will revolve around these questions. Let me initiate the deliberation by recapitulating the key motivation behind M&A initiatives of the drug industry.

A key motivation behind the M&A initiatives in the drug industry:

While recapitulating one of the key motivations behind pharma M&As, let me refer to some interesting and recent studies, such as, the 2019 paper of McKinsey titled, ‘What’s behind the pharmaceutical sector’s M&A push.’ It also acknowledges, the use of M&A to bolster drug innovation is unlikely to change any time soon.

That many drug companies actively pursue the M&A option as a game changer for inorganic growth, is vindicated by the recent big deals, as quoted above. Since early 2000 and before, the companies that made the biggest deals to create new value synergies with, have been paying heavy deal premium to enrich their new product pipelines. Quite often it includes several new and emerging classes of drugs, as acquisition targets.

This also gets corroborated in the Press Release of the 2019 BMS deal, which says: ‘The transaction will create a leading focused specialty biopharma company well positioned to address the needs of patients with cancer, inflammatory and immunologic disease and cardiovascular disease through high-value innovative medicines and leading scientific capabilities.’

Lesser yield of traditional pharma M&A than the broader market:

This was emphasized in the June 06, 2019 article, published in The Washington Post, titled ‘Big Pharma Has to Bet Big on M&A. Investors Don’t.’ The analysis found, the returns from the big pharma deals ‘don’t look as good compared to the broader market’, although for very patient investors many of these have resulted in longer-term gains. To illustrate this point, the paper pointed out: ‘Of the eight biopharma deals worth more than USD 40 billion that closed in the last 20 years, only one delivered better returns than the S&P 500 five years after it closed.’

Naming Merck & Co..’s USD 47 billion acquisition of Schering-Plough Corp. in 2009, the researcher justified: ‘That deal is arguably something of an accidental winner. Long-term success didn’t come from any of the products that Merck targeted in the merger; instead, an afterthought of an antibody that was initially set to be sold off became Keytruda, a cancer drug that’s projected to generate USD 15 billion in sales in 2021.’

Innovative product launches no longer a holistic value-creation for patients: 

Thus, unlike yesteryears, enriching new and innovative product pipeline through M&A won’t serve the key purpose of value-creation for patients to treat deadly diseases in a holistic way. The primary reason for the same was articulated in the Deloitte Paper titled, ‘Disruptive M&A: Are you ready to define your future?’ The article emphasized: ‘The confluence of technological change, shifting customer preferences, and convergence across sectors is redesigning how products and services are developed, delivered, and consumed.’

Thus, mere acquisitions of innovative product portfolios, intended to provide better treatment choices for patients, may not meet the holistic needs of consumers’ while going through the disease treatment process. In depth understanding of such preferences with all associated nuances, is absolutely essential in today’s complex business scenario. Which is why, it calls for avant-garde type or ‘disruptive M&As’, that can help alter the business growth trajectories, making the disrupted company disrupt the competitive space, being game changers of the industry.

Calls for avant-garde type or disruptive pharma M&As:

Today, it’s crucial for any drug company to create a unique treatment experience for patients. This is emerging as a pivotal factor for the success of a brand.

Even most innovative products will need to be supported by disruptive back-office technology for market success. Thus, acquisition of disruptive technology to effectively augment the brand value delivery process is equally important, in tandem with enrichment of new product pipeline. This is expected to emerge as a critical driver in pharma M&A. Such takeovers, I reckon, may be termed as avant-garde type or disruptive M&As – for holistic value creation for patients.

‘Disruptive M&A’ creates a much broader range of possibilities and targets:

For a holistic value creation through disruptive M&A focus for target selection needs to be significantly different from the standard models of M&As – and not just about the quality of NCE and NME pipeline. The above paper also highlighted: ‘Disruptive M&A opportunities requires evaluating and assessing a much broader range of possibilities and targets than traditional M&A.’

With the right kind of target selection after a thorough analysis of the business model, disruptive M&A may help the acquiring drug companies to go beyond achieving revenue and cost synergies. It can also provide cutting-edge business capabilities, alongside enriching and expanding the talent pool, key business processes, and, of course, the state-of-the-art technology –inorganically.

Initiatives and focus of drug companies of this genre, are expected to be more in the coming years, primarily driven by a new type of value creation to offer a unique disease treatment experience for patients with their respective brands.

A new type of value creation for patients in healthcare space:

It has already started happening in the recent years. For example, Amazon, on January 30, 2018 , announced, it is collaborating with Warren Buffet’s Berkshire Hathaway, and the bank JP Morgan Chase to create an independent, nonprofit health care company ‘with the goal of increasing user satisfaction and reducing costs.’ They also announced the organizational focus on two of the following areas, which are interesting and unconventional:

  • Technology solutions that will provide U.S. employees and their families simplified, high-quality and transparent healthcare at a reasonable cost.
  • Draw on their combined capabilities and resources to take a fresh approach.

As the New York Time (NYT) reported: ‘The alliance was a sign of just how frustrated American businesses are with the state of the nation’s health care system and the rapidly spiraling cost of medical treatment.’ The report further added: ‘It also caused further turmoil in an industry reeling from attempts by new players to attack a notoriously inefficient, intractable web of doctors, hospitals, insurers and pharmaceutical companies.’

Although, this has happened in the United States, it sends a strong signal to the state of things to come sooner than expected in the health care space, dominated, so far, by pure pharma and biotech players, across the world.  New types of value creation for patients of similar nature, especially by tech greenhorns in the pharma space, can be wished away at one’s own peril.

Consumer-focused digital companies redefining healthcare value creation:

‘2019 EY M&A Firepower’ report also highlights the innovative efforts of consumer-focused, digital companies to carve out a solid niche for themselves in the pharma dominated health care space. With ‘effective deployment of their ‘connected devices, data analytics skills and deep consumer relationships, these new entrants are positioned to have access to important real-world data that could, in part or in full, determine future product utilization and payment,’ as the report emphasized.

Such fast-evolving development also prompt pharma players to act fast. And the most practical way of doing so, with a high possibility of success, is through disruptive M&A. Ongoing entry of consumer-focused, digital companies in health care increase the urgency for life sciences companies to act, now.

Conclusion:

Thus far, pharma and biotech companies have been engaged in a massive wealth creation for themselves by using their biological and chemical know-how for novel drugs and devices. This ballgame has to change now, ‘as the lines between health and technology continue to blur’, according to the EY Firepower report.

Capabilities of big data and analytics will increasingly be more essential for success, regardless of having a rich pipeline of NCEs and NMEs, even with the potential to achieve blockbuster status in the market. Thus, the ballgame has to change.

Against this backdrop, the key challenge of pharma players for a brighter tomorrow would undoubtedly be ‘holistic value creation.’ Its core purpose should be to deliver a unique patient experience, encompassing the entire disease treatment process – going beyond innovative drugs. One of the quickest routes to create this virtuous cycle, I reckon, is through ‘disruptive M&As – moving away from the traditional model for the same.

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.

Deadly Climate Change Impact On Human Health: How Prepared Is India?

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It’s not uncommon to find many people, including heads of countries, expressing their serious apprehensions in public, about the scary impact of climate change. Just the last year, on November 26, 2018, BBC News captured one of such incidences with the astonishing headline: “Trump on climate change report: I don’t believe it.” The findings of this report have underscored, ‘unchecked global warming would wreak havoc on the US economy.’

Similarly, a few years ago, on September 05, 2014,CNN News 18 quoted Prime Minister Narendra Modi as saying: “Climate has not changed. We have changed. Our habits have changed,’ while answering to a question on climate change. Regardless of the outcome of any split-hair analysis of the rationale behind such statements from the world leaders, such public discourse could trivialize the possible catastrophic impact of climate change on the planet earth.

Be that as it may, that climate change is taking place, carrying all its ill-effects, is real now, without any ambiguity. There is also widespread consensus among the members of the United Nations that ‘the Earth is warming at a rate unprecedented during post hunter-gatherer human existence.’

It is worth noting that way back in 2001, the ‘Third Assessment Report of the Intergovernmental Panel on Climate Change’, further recorded: “There is new and stronger evidence that most of the warming observed over the last 50 years is likely to be attributable to human activities”, most importantly the release of greenhouse gases from fossil fuels.

Several ‘International Agreements’, including the Paris Agreement on Climate Change - all supported by hard scientific data, have called for immediate, quantifiable measures in each country to address the ‘wide-ranging environmental threats, such as ozone depletion and long-range transboundary air pollution.’ Against this backdrop, in this article, I shall focus on the dreadful effect of climate change in the proliferation of a wide-variety of ailments, especially infectious diseases, within a few decades. While doing so, let me first have a quick recap on what is ‘Climate Change’, in a simple language.

Climate Change – a quick recap:

According to the United Nations, ‘Climate Change is the defining issue of our time and we are at a defining moment. From shifting weather patterns that threaten food production, to rising sea levels that increase the risk of catastrophic flooding, the impacts of climate change are global in scope and unprecedented in scale. Without drastic action today, adapting to these impacts in the future will be more difficult and costly.’

It’s important to note, although, the planet Earth’s climate is constantly changing over geological time, the current period of warming is occurring more rapidly than many past events. Scientists are concerned that the natural fluctuation or variance, is being overtaken by a rapid human-induced warming, as they emit more greenhouse gases. As these gases get trapped in the atmosphere, more heat is retained that has serious implications for the stability of the planet’s climate, even impacting human health with grave consequences. The World Health Organization (W.H.O) has also warned that the health of millions could be threatened by increases in malaria, waterborne disease and malnutrition.

Its impact human health:

The direct and indirect impact of climate change on human health is profound. Before I go into the specifics, let me indicate some of the direct ones, as captured by the Center for Health and the Global Environment (CHanGE), University of Washington. This is sans any charts and maps, unlike the usual practice:

  • Increasing temperatures are causing poor air quality that can affect the heart and worsen cardiovascular disease.
  • Increasing exposure to pollen, molds, and air pollution, all of which can worsen allergies and other lung diseases, such as asthma.
  • Changes in the geographic range of disease-carrying insects, such as mosquitoes, ticks, fleas and other similar ones, which can fast spread many tropical ailments, such as dengue fever and malaria to humans.
  • Increasing frequency and severity of extreme weather and climate events can cause, besides many physical illnesses, several kinds of mental illnesses – increasing both morbidity and mortality.
  • Frequent flooding events and sea level rise can contaminate water with harmful pathogens and chemicals, potentially causing food-borne and waterborne illnesses.
  • Changing weather patterns affect the quality and quantity of nutritious foods with increasing incidence of under-nutrition and micronutrient deficiencies.
  • Additional stress placed on hospital and public health systems, could limit people’s ability to obtain adequate health care during extreme weather events and disease outbreaks.

Most specific and the deadly one:

The World Health Organization (W.H.O) publication - ‘Climate change and human health – Risks and Responses,’ clearly flagged that ‘Changes in infectious disease transmission patterns are a likely major consequence of climate change.’

Citing a pertinent analogy to explain the reason, it said: “Humans have known that climatic conditions affect epidemic diseases from long before the role of infectious agents was discovered, late in the nineteenth century. Roman aristocrats retreated to hill resorts each summer to avoid malaria. South Asians learnt early that, in high summer, strongly curried foods were less likely to cause diarrhea.”

Would pharma players convert these problems into opportunities?

Curiously, some pharmaceutical investors are researching to fathom potential business opportunities lying underneath the above problem, especially for vaccines and newer antimicrobials. It’s probably a blessing in disguise not just for the drug companies, but also for the general public, considering the following two issues, prevailing in the current scenario:

  • According to W.H.O, Antimicrobial Resistance (AMR) is an increasingly serious threat to global public health. It threatens the effective prevention and treatment of an ever-increasing range of infections caused by bacteria, parasites, viruses and fungi, causing the success of even major surgery and cancer chemotherapy seriously compromised.
  • ‘Pharmaceutical companies are backing away from a growing threat that could kill 10 million people a year by 2050’, reported a July 19, 2018 article. This is because, ‘Antibiotics Aren’t Profitable Enough for Big Pharma to Make More,’ wrote another article, published in Bloomberg Businessweek, on May 3, 2019.

Interestingly, a recent report analyzed and evaluated how this can be done, and which companies will be benefitted most in that process. 

“Climate change to fetch a big business opportunity for pharma”:

As reported on July 25, 2019, Morgan Stanley told investors that climate change will cause an increased prevalence and rapid spread of infectious diseases that may be a boon for some drug companies with big vaccine portfolios. It also highlighted, between 383 million and 725 million more people may be exposed to Zika, dengue and other diseases by 2050, depending on the pace and severity of global warming.

The analysts estimated, especially 7 pharma companies will be critical to fighting infectious diseases brought on by climate change. According to the research note of thebank, ‘the USD 500 billion infectious disease market could see demand for an added USD 125 billion in new vaccines, or as much as USD 200 billion assuming premium pricing for more complex new treatments.’

The top possible gainers:

Identifying the top possible gainers, Morgan Stanley apprised, vaccine development being more difficult and expensive, companies that are already in that business will have an upper hand.

Hence, Sanofi and GlaxoSmithKline are expected at the top, given their existing pipelines and manufacturing capacity. Takeda and Merck both have vaccines in the works for dengue fever, one of the diseases that climate change is likely to exacerbate. Janssen and Pfizer are both active in the vaccines market, but would need to establish new research programs to take on tropical diseases. ‘Moderna’ is also in a good position because it has demonstrated a potential pipeline for drugs combating the Zika virus., as Morgan Stanley further elaborated.

Nevertheless, Morgan Stanley isn’t the only bank looking at investment opportunities from climate change, on July 24, 2019, Goldman Sachs also, reportedly, said it was hiring a sustainable-finance group that is looking into issues related to sustainability. Thus, on the positive side, climate change could fetch a big business opportunity for many pharma players, across the world.

600 million people at risk for climate change in India:

On June 24, 2019, a reputed national business news daily of India reported, “600 million people at risk: Climate change may soon turn critical in India.” Against this threat, the current public health care infrastructure in the country, continues to remain fragile, as stated in India’s National Health Profile, 13th Issue.

It also states, the cost of treatment has been on the rise in India and it has led to inequity in access to health care services. Intriguingly, the country spends around 1.02 percent of its GDP towards public health, which has remained static to declining over a long period of time. Although, health insurance is a growing segment, it hasn’t taken off fully. Several measures are needed to improve and expand insurance coverage.

Further, according to the report by the Center for Disease Dynamics, Economics & Policy (CDDEP) in the US, India is facing shortage of 600,000 doctors and 2 million nurses. This report was widely quoted by the Indian media, on April 14, 2019.

These facts give a perspective on what is India’s level of preparedness to address the critical health issues related to climate change, especially the havoc that the dreaded infectious diseases can cause to so many.

Conclusion:

Astute health policy makers, including a large section of the top political echelon of the country are, apparently, aware of various ill effects of climate change. They also seem to be cognizant that these are likely to accelerate the worsening health problems of the population, including infectious diseases, asthma and other respiratory diseases.

Assuming, new and modern drugs will keep coming to help treat these ailments, do we have a functioning and efficient public health infrastructure to grapple with such issues. What about high out of pocket expenditure towards healthcare for a large section of the population, regardless of Ayushman Bharat?

As the (W.H.O) publication - ‘Climate change and human health – Risks and Responses’ recommended, ‘early planning for health is essential to reduce, hopefully avoid, near future and long-term health impacts of global climate change. The optimal solution, however, is in the hands of governments, society and every individual—a commitment to a change in values, to enable a full transition to sustainable development.’

That said, as India is also a signatory to the latest Paris Agreement on Climate Change, can we assume, India will walk the talk to significantly contain its deadly impact on human health? How is India preparing itself to meet this great challenge of Probably it is anybody’s guess, at least, as on date?

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.

Self-made Barriers To Business Transparency Impacting Drug Access

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A recently published book on pharma industry tried to expose the deceit behind many generic-drug manufacturing—and the consequent risks to global health. This publication is described as an ‘explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale.’ However, I reckon, this is just a part of the story, and its huge adverse impact on public health flows generally from the following facts:

  • Greater use of generic drugs is hailed as one of the most important public-health developments of the twenty-first century.
  • Today, almost 90 percent of global pharma market, in volume terms, is comprised of generics.
  • These are mostly manufactured in China and India.
  • The drug regulators continuously assure patients and doctors that generic drugs are identical to their brand-name counterparts, just less expensive.

No question, such deceit, blatant fraud and data manipulation – seriously affecting drug quality of generic medicines, shake the very purpose of making affordable drugs accessible to many. But, simultaneously, lack of transparency – right across the various functions of a pharma business, is also making a host of modern life-saving drugs unaffordable and inaccessible to even more patients. Although, both are despicable acts, but the latter one is not discussed as much.

Thus, in this article, I shall dwell on the second one – how attempts for pharma business ‘transparency’ for expanded drug access to patients, getting repeatedly foiled, especially in light of what happened on May 28, 2019, in the 72nd World Health Assembly (WHA).

Does pharma want low business transparency to continue?

Despite so many encouraging initiatives being taken in the pharma industry over a period of time, gross lack of transparency in its business continues, since long, despite this is being a raging issue. The obvious question, therefore, remains: Does pharma want low business transparency to continue? Thus, to give a perspective to this pertinent point, I shall quote two important observations, appeared in ‘MIMS Today’ – the first one on April 17, 2017, and the other came a year before that, on November 20, 2016, as follows:

  • “A market cannot function when purchasers have limited information and, in the case of prescription drugs, pricing is a black box. Prices for drugs are clearly rising at rates that far exceed inflation and the level of any rebates or discounts offered by manufacturers,” experts opined. They further said, to hold the industry accountable, Access to Medicine Foundation (AMF)’ regularly compiles an index to rank the progress made by each large drug maker in the area of business transparency. Curiously, they concluded, ‘the number and quality of evaluations for the effectiveness of these programs are lacking.’
  • “Lack of transparency of drug makers was also identified. Their policy positions, political contributions, marketing activities and memberships in associations and the associated financial support provided and board seats held were all analyzed. And only then, the ‘AMF’ reached a consensus that transparency remains low in all areas. The analysts further added, ‘there is a lack of transparency and rigor in monitoring and evaluating the access-to-medicines initiatives as well as the link between prices and development costs. Thus, ‘greater transparency from manufacturers to disclose R&D costs for drugs and evaluation of the initiatives’ is imperative.

Despite key policy makers’ favoring transparency, it remains elusive:

To illustrate this point, let me draw a recent example from the United States.

Alex M. Azar II, who is currently the Secretary of Health and Human Services of the United States, also served as president of Eli Lilly USA. LLC from 2012 to 2017 supports the need of business transparency in the pharma industry. Last year, he also emphasized:

“Putting patients in charge of this information is a key priority. But if we’re talking about trying to drive not just better outcomes, but lower costs, we also have to do a better job of informing patients about those costs. That is where our emphasis on price transparency comes in.” By naming the key health care product and service providers, Azar added, “So this administration is calling on not just doctors and hospitals, but also drug companies and pharmacies, to become more transparent about pricing and outcomes of their services and products.”

Like Secretary Azar, policy makers in several other countries, including India, are also talking and seemingly in favor of transparency in health care business systems, but it remains elusive, as we shall see below.

Do vested interests create over-powering pressure to maintain status-quo?

The above examples give some idea about the pressure created by vested interested to maintain a status-quo in this important area. Although, business transparency is a must, pharma influence on policy makers is so powerful that even a recent global resolution on the subject, had to dilute its original version in its final avatar, significantly, which I shall now focus on, as yet another vindication on this issue.

The final version of the 2019 WHA resolution made weaker in transparency:

On May 28, 2019, by a News Release in Geneva, the World Health Organization (W.H.O) announced, to help expand access to medicines for all, the72nd World Health Assembly (WHA) adopted a significant resolution on improving the transparency of markets for medicines, vaccines and other health products, globally. I repeat, this was a global effort to expand access. The assembly brought together delegates from 194 Member States of the W.H.O, including India – from 20 to 28 May 2019, in Geneva, Switzerland.

Intriguingly, as several reports highlighted, ‘the final resolution is considerably weaker than the original draft.’ Nevertheless, it still provides, at least, some measures, which have potential to make an impact on market access, globally.

What exactly was the 2019 WHA original resolution?

The original WHA draft resolution, titled ‘Roadmap for access 2019-2023 – Comprehensive support for access to medicines and vaccines’, urged the Member states the following:

  • To enhance public sharing of information on actual prices paid by governments and other buyers for health products,
  • Greater transparency on pharmaceutical patents, clinical trial results and other determinants of pricing along the value chain from laboratory to patient.
  • Requests the WHO secretariat to support efforts towards transparency and monitor the impact of transparency on affordability and availability of health products, including the effect of differential pricing.

Highlighting that access to medicines is the key to advancing the Universal Health Coverage (UHC), the resolution aims to help the Member States:

  • To make more informed decisions when purchasing health products,
  • Negotiate more affordable prices
  • And ultimately expand access to health products for the populations.

Palpable discomfort of large pharma associations:

The May 30, 2019 article of the Pharm Exec Magazine on this resolution, carried a headline with a query: Is it ‘A Watershed on Transparency and International Collaboration in Drug Pricing?’ The paper brought out some important points that may help explain why the 2019 original WHA resolution, could not be adopted as such. Apparent discomfort in this regard of some top industry associations, which were created and fully funded by large global drug companies, was palpable, according to this report.

For example, “the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), warned governments ‘to carefully consider potential risks to patients, particularly in less developed countries, of sharing outcomes of confidential price negotiations across countries.’ The implication is that prices in less-affluent countries could rise if the wealthier nations used international transparency to demand lower prices for their markets.”

Why couldn’t the original resolution on business transparency be adopted?

To instantiate the level of discomfort of vested interests, let me highlight some critical changes made in the 2019 in final WHA resolution at the international level, as I get from the above paper. A few of which are as follows:

In the original draft Changes in the final resolution
1. “Undertake measures to publicly share information on prices and reimbursement cost of medicines, vaccines, cell and gene-based therapies and other health technologies.” Refers to publicly sharing of information only on net prices.
2. “Require the dissemination of results and costs from human subject clinical trials, regardless of outcome or whether the results will support an application for marketing approval.” “Take the necessary steps, as appropriate, to support dissemination of and enhanced availability of and access to aggregated results data and, if already publicly-available or voluntarily-provided, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval.”
3. “Require the publication of annual reports on sales revenue, prices, units sold, and marketing costs for individual products, as well as details of the costs of each trial used to support a marketing authorization application and information on financial support from public sources used in the development of a drug.” Calls on the member states to “work collaboratively to improve the reporting of information by suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives.”
4. Wanted the WHO Director-General to “propose a model/concept for the possible creation of a web-based tool for national governments to share information, where appropriate, on medicines prices, revenues, units sold, patent landscapes, R&D costs, the public sector investments and subsidies for R&D, marketing costs, and other related information, on a voluntary basis.” Diluted only to “assessing the feasibility and potential value of establishing a web-based tool to share information relevant to the transparency of markets for health products, including investments, incentives, and subsidies.”
5. Proposed the creation of a forum to “develop suitable options for alternative incentive frameworks to patent or regulatory monopolies for new medicines and vaccines” that would both promote universal health coverage and adequately reward innovation. This point doesn’t find any place in the final resolution.

It appears, the final 2019 WHA resolution has been able to remove the key points of discomfort for the drug industry – caused by greater business transparency. It is largely due to the fact that the final pledges ‘consist largely of recommendations for voluntary action rather than the requirements for comprehensive disclosure proposed in the original draft.’

Conclusion:

To arrive at a consensus, especially over promoting transparency in costs incurred towards R&D of drugs and health-related technologies, appeared challenging for the W.H.O Member States, inthe 72nd World Health Assemblythat concluded on May 28, 2019.Overall resolution changed the narrative from a mandatory process to a voluntary initiative. As I said before, it still prescribes several measures, which can help expand access to medicines for all, across the world.

In tandem, it also comes out clearly that barriers to business transparency to ensure better access to drugs for all, across the world, are not easy to uproot, either. Especially, when it comes to fighting against concerted efforts of powerful pharma lobby groups, other vested interests and some looney fringes.

The process of adoption of the May 2019 WHA final resolution of the world’s most relevant public health issues, is just an example.

By: Tapan J. Ray   

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

Pharma ‘Chatbots’: For Better Stakeholder Engagement

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The critical value of meaningful interaction and engagement with individual customers – responding to their specific needs, is fast drawing attention of many businesses, for sustainable performance excellence. The same is happening in the pharma industry, as well. Creative use of this process leveraging modern technological support systems, would also provide a unique scope of cutting-edge brand service differentiation, in well researched areas.

That, it is a very important focus area for the pharma players, is no-brainer. Nonetheless, what really matters most is the novelty in strategizing such interactions and engagements, especially with patients and doctors. I also wrote about it in my article, titled ‘Indian Pharma To Stay Ahead of Technology Curve,’ published in this blog on May 22, 2017. Over two years ago, I clearly indicated there that application of AI via digital tools, called ‘Chatbots’ – the shorter form of ‘Chat Robot’, is one of the ways that pharma may wish to explore this area.

Illustrating this point in that article, I mentioned that on March 05, 2017, a leading bank in India announced the launch of an AI-driven Chatbot named Eva, coined from the words Electronic Virtual Assistant (EVA), to add more value to their services for greater customer satisfaction. ‘According to reports, Eva is India’s first AI driven banking Chatbot that can answer millions of customer queries on its own, across multiple channels, immediately.’

In this article, I shall dwell on this interesting area, with a primary focus on pharma sales and marketing, and assess the progress made in this space, thus far, by several drug companies, including some Indian players. Let me start by recapitulating the basic function and purpose of ‘Chatbots’ in pharma.

Pharma ‘Chatbots’ – the function and purpose:

Simply speaking, pharma ‘Chatbots’ are also AI-powered, fully automated virtual assistants. Its basic function is to mimic one-to-one human conversation on particular areas, as desired by the user. Likewise, its basic purpose is to genuinely help and assist the customers who are in search of right answers to specific disease related questions, in a one-to-one conversational format, having a higher source-credibility.

In that process, ‘Chatbots’ can effectively satisfy the patients and doctors by providing them the required information, immediately. In tandem, pharma companies also reap a rich harvest, by developing not just a trust-based healthy relationship with them, but also in building a robust corporate brand – creating a long-term goodwill that competition would possibly envy.  

Effective customer satisfaction is an area that can’t be ignored:

In the digital age, a new type of general need is all pervasive, with its demand shooting north. This is the need to satisfy a voracious appetite among a large section of the population for all types of information, with effortless and prompt availability of the required details – as and when these come to one’s mind.

When such information need relates to health concern of a person, such as – available treatment options against affordability, or drug price comparisons – factoring in effectiveness, safety concern – exactly the same thing happens. Most individuals won’t have patience even to write an email and wait for an answer, even the wait is just for a short while.

In the current scenario, it will be interesting to fathom, how would a pharma company, generally, interact or engage with such patients, to further business and creating a possible long-time customer? Some companies have started responding to this need – effectively and efficiently, by providing easy access to information through ‘Chatbots’, created on advances AI platforms. But, such players are a few in number.

Can pharma also think of ‘Chatbots’, like ‘Siri’ or ‘Alexa’?

Today, several people are using standalone and branded Chatbot devices in everyday life, such as, Siri (Apple), Alexa (Amazon), Cortana (Microsoft) or Google Now (Android). Interestingly, many industries, including a few companies in pharma, have also started developing their own version of ‘Chatbot dialog application systems.’

Industry specific ‘Chatbots’ are designed to meet with some specific purpose of human communication, including a variety of customer interaction, information acquisition and engagement – by providing a range of customized services to the target group.’ ‘Siri’ or ‘Alexa’ or the likes, on the other hand, are all-purpose general Chatbots, though, for everyday use of individuals. Thus, the question that comes up, in which areas pharma companies can use Chatbots to add value to their interactions and engagements with patients, in general, and also doctors.

Where to use ‘Chatbots’ as a new pharma marketing channel?

Some of the findings on the application of ‘Chatbots’, especially in pharma sales and marketing, featured in the CMI Media publication in December, 2016. It found that drug companies have a unique scope to leverage this new sales and marketing – channel, by developing ‘Chatbots’ in the company represented therapy areas. Following are just a few most simple illustrations of possible types ‘Chatbots’ for interaction and engagement with patients, which can be designed in interesting ways:

  • That can answer all types of patient questions on specific diseases, educate them about the disease and available treatment options with details.
  • That allows patients or physicians to get all relevant information about the prescription drugs that they require to prescribe for patients to start treatment, including potential side effects, adverse events, tolerability, dosing, efficacy and costs, besides others.
  • Once a treatment option is chosen, a third kind of Chatbot can help with patient adherence to treatment, provide reminders when the treatment should be administered, explain how to properly dose and administer the treatment, and other relevant information.

Chatbots could also be useful for doctors and nurses:

As the above paper finds, ‘Chatbots have value for serving healthcare professionals as well, for example:

  • When, physicians and nurses want to understand the pathogenesis, pathophysiology, and/or progression of a specific disease in their patients.
  • Although, such content may also be available on disease state awareness sites, but branded Chatbots would make that content readily available in more of an FAQ format.
  • When health care professionals would like to get data around safety/toxicity, or information about dosing strengths, calculations, and titrations, while using specific brands.

Chatbots can also be effectively utilized by the drug manufacturer to gain deep insights into customer behavior across all touchpoints, to enhance end-to-end customer experience, as I wrote in this blog on July 02, 2018. The data created through this process, can also be put to strategic use to design unique brand offerings.

Need to chart this frontier with caution:

Pharma, being a highly regulated industry in every country of the world, with a varying degree, though, the ‘Chatbot’ development process should strictly conform to all ‘Dos’ and ‘Don’ts’, as prescribed by the regulators of each country. Each and every content of the ‘Chatbot’ should pass through intense, not just regulatory, but also legal and medical scrutiny. Yet another, critical redline that ‘Chatbots’ should never cross is the ‘privacy’ of any individual involved in the process.

Three critical areas to consider for pharma ‘Chatbots’:

Effective pharma ‘Chatbots’ are expected to get ticks on all three of the following critical boxes:

  • Meeting clearly defined unmet needs of patients in search of a health care solution or most suitable disease treatment options.
  • Brand value offerings should match or be very close to the targeted patients’ and doctors’ expectations.
  • Should facilitate achieving company’s business objectives in a quantifiable manner, directly or indirectly, as was planned in advance.

Pharma has made some progress in this area, even in India:

To facilitate more meaningful and deeper engagements with patients, some drug companies, including, in India, are using ‘Chatbots.’ Here, I shall give just three examples to drive home the point – two from outside India and one from India.

October 23, 2018 issue of the pharma letter reported, a study from DRG Digital Manhattan Research found, ‘Novo Nordisk and Sanofi brands rank best for the digital type 2 diabetes patient experience.’ The article wrote, about some pharma players ‘facilitating deeper engagement through the use of automated tools like Chatbots to triage inquiries and get patients the answers they need faster, and through interactive content like quizzes and questionnaires that pull patients in and help them navigate health decisions,’ as follows:

  • Novo Nordisk‘s diabetes website includes an automated Chat feature dubbed “Ask Sophia,” helping patients access disease and condition management information more quickly.
  • Likewise, Merck & Co‘s website for Januvia employs interactive quizzes to educate patients and caregivers.

Similarly, on November 23, 2018, a leading Indian business daily came with a headline, ‘Lupin launches first Chatbot for patients to know about their ailments.’ It further elaborated, the Chatbot named ‘ANYA’, is designed to provide medically verified information for health-related queries. The disease awareness bot aims to answer patient queries related to ailments,’ the report highlighted.

Chatbots – global market outlook:

According to the report, titled ‘Healthcare Chatbots – Global Market Outlook (2017-2026),’the Global Healthcare Chat bots market accounted for USD 97.46 million in 2017 and is expected to reach USD 618.54 million by 2026 growing at a CAGR of 22.8 percent.

The increasing demand for Chatbot ‘virtual health assistance’, is fueled primarily by the following two key growth drivers, the report added:

  • Increasing penetration of high-speed Internet.
  • Rising adoption of smart devices.

Conclusion:

With the steep increase of the usage of the Internet and smart phones, general demand to have greater access to customized information is also showing a sharp ascending trend, over a period of time. A general expectation of individuals is to get such information immediately and in a user-friendly way.

Encouraged by this trend, and after a reasonably thorough information gathering process, mainly from the cyberspace, many patients now want to more actively participate in their treatment decision making process with the doctors. This new development has a great relevance to drug companies, besides other health service providers. They get an opportunity to proactively interact and engage with patients in various innovative ways, responding to individual health needs and requirements, thereby boosting the sales revenue of the corporation.

The unique AI-driven technological platform of pharma ‘Chatbots’, is emerging as cutting-edge tools for more productive stakeholder engagement – so important for achieving business excellence in the digital world. The recent growth trajectory of ‘Chatbots’ in the health care space, vindicates this point.

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.