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Exploiting India’s Weakness For Monopolistic Commercial Gain?

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Public access to healthcare in India is a complex issue with several challenges. While India has been making progress over the years in improving healthcare access and reducing the burden of disease, there are still significant disparities in healthcare access and outcomes across the country. The three primary barriers continue to remain:

  • Affordable access to quality healthcare: This arises out of the shortage of healthcare infrastructure and resources, more in rural areas. The shortage includes an inadequate number of doctors, nurses, and other healthcare professionals, as well as inadequate facilities and equipment.
  • Cost of healthcare: While India has a largely publicly funded healthcare system, the quality of care in public hospitals is often poor, and many people are forced to opt for private healthcare, which can be expensive.
  • Access to affordable drugs: Despite India being a major producer of generic drugs, many people in India still lack access to essential medicines. This is due in part to the high cost of branded medicines, which are often out of reach for many people, as well as a lack of availability of certain medicines in some areas.

Undoubtedly, this remains a weak area for the country, till date. Successive Indian governments have taken steps to address these challenges. However, public funding on healthcare as a percentage of GDP and implementation of policies to increase access to medicine, continue to remain below par. Much work needs to be done to ensure that all people have access to quality healthcare and essential medicines.

Amid this situation, especially on the international political front, drug MNCs are continuously blaming India for the fact that the Indian Patents Act is not robust enough to protect their drug patents on NMEs and technologies. For example, in its 2022 Special 301 Report, the USTR designated seven countries on the Priority Watch List. These are Argentina, Chile, China, India, Indonesia, Russia, and Venezuela. To give some more examples from the available reports:

  • In February 2021, PhRMA, a trade group representing multinational pharmaceutical companies, raised concerns about India’s policies related to IP rights and access to medicines. PhRMA argued that India’s policies were undermining innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 
  • In March 2021, Pfizer’s CEO also expressed concerns about India’s policies related to IP rights and access to medicines. He said that Pfizer was facing challenges in obtaining patents for its products in India, and that the lack of adequate patent protection was discouraging investment in research and development.
  • In May 2021, Novartis’s CEO criticized India’s policies related to IP rights and access to medicines. HE stated that the lack of adequate patent protection in India was discouraging innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 

Against this backdrop, in today’s article I shall deliberate on this vexing issue – starting from some key grievances of drug MNCs in this regard. Thereafter we will look at the Indian industry response to drug MNCs’ concern about the robustness of the Indian Patents Acts. This could possibly help us to understand the key question – Is it then an attempt to exploit India’s weakness regarding inadequate overall access to medicines for monopolistic gain by the vested interest?

Key grievances of drug MNCs for poor access to medicines in India: 

One can recall that the Patent Act in India was amended in 2005 to comply with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The amendment made it more difficult for multinational pharmaceutical companies to obtain patents for their products in India for the ‘me too’ type of innovation, which has led to lower prices for medicines and increased access to affordable drugs for the Indian population.

However, drug MNCs generally argue that:

  • The lack of adequate patent protection in India discourages innovation and investment in research and development, which ultimately limits the availability of new drugs for patients in India.
  • They have also criticized the Indian government’s use of compulsory licensing, which allows the government to authorize a third party to produce a patented drug without the consent of the patent holder. They argue that this undermines their intellectual property rights and discourages investment in research and development, which ultimately limits access to new and innovative drugs for patients in India.

Counter argument by Indian companies:

Indian companies, on the contrary, defend their position and policies related to access to medicines and healthcare in India, and have responded to the accusations made by drug MNCs in the following ways:

  • Provides adequate patent protection: The Indian Patents Act provides adequate IP protection, in accordance with the TRIPS agreement. They have also pointed out that the patent laws in India allow for the grant of patents for genuine inventions, while preventing the grant of frivolous or secondary patents (the me-too types), which can result in excessive monopolies and high prices for medicine. 
  • Encourage innovation: Indian policies have not discouraged innovation in the pharmaceutical industry. They have pointed out that Indian companies invest heavily in research and development and have developed several innovative drugs that have been approved by regulatory authorities in India and around the world. 
  • Rare occurrence of Compulsory licensing: The use of compulsory licensing is a legitimate tool under international law and is aimed at promoting public health and ensuring that life-saving drugs are accessible and affordable to patients in India. They have also pointed out that the use of compulsory licensing is a rare occurrence in India and is only used in exceptional circumstances.

Overall, Indian drug companies have emphasized their commitment to improving access to medicines and healthcare in India, while ensuring that their policies are in line with international laws and regulations. They have also emphasized the need for collaboration and dialogue with multinational pharmaceutical companies to find mutually acceptable solutions that benefit patients in India and around the world.

Examples of innovative drugs developed by Indian drug companies:

It’s interesting to note that in the same IP scenario, Indian companies with limited resources, are developing innovative drugs that have been approved by regulatory authorities around the world. Here are a few examples, as reported at different times:

  • Lipaglyn: Developed by Zydus Cadila, Lipaglyn is the first-ever drug approved for the treatment of diabetic dyslipidemia. It has been approved in India and several other countries, including the European Union. 
  • Tafinlar: Developed by Dr. Reddy’s Laboratories, Tafinlar is a kinase inhibitor that has been approved by the US FDA for the treatment of advanced melanoma. 
  • Mycapssa: Developed by Sun Pharma, Mycapssa is a novel oral formulation of octreotide, a hormone therapy used to treat acromegaly. It has been approved by the US FDA. 
  • Saroglitazar: Developed by Zydus Cadila, Saroglitazar is a dual PPAR agonist that has been approved in India for the treatment of diabetic dyslipidemia and non-alcoholic fatty liver disease (NAFLD). 
  • Nexavar: This much discussed drug, originally developed by Bayer and by Natco Pharma, is a kinase inhibitor that has been approved by the US FDA for the treatment of liver and kidney cancers.

Conclusion:

The IP issues keep haunting India and are being captured in different Special 301 Reports of the USTR, even after The Indian Patents Act 2005 came into force – till 2022. Any change to this Act seems very unlikely now as this is an important piece of legislation that helps balance the interests of protecting intellectual property, promoting innovation and access to affordable medicines. Any dilution of this Act could have negative consequences for India and its citizens.

From this perspective, I reckon, any further pressure in this area may be construed as an attempt to exploit India’s weakness of inadequate access to medicines for monopolistic gain by vested interests. 

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.

Unfettered ‘Access To Drug Innovation’ – An Oxymoron?

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The mass paranoia, as it were, over Covid pandemic has now started fading with drug regulators’ ‘emergency approval’ of several Covid -19 vaccines, and its free of cost access to all, generally in most countries. As the endgame of the pandemic, supposedly, depends on the speed of Covid-19 vaccination, the drug industry’s public reputation in the interim period, driven by its rapid response to the crisis, got an unsurprising boost (62%). This was captured by the Harris Poll, released on March 15, 2021.

Interestingly, soon after the high of 62% approval rating, the decline began. It came down to 60% in May and then 56% in June 2021—and now down three more percentage points, according to the Harris Polls that followed. No wonder, why the FiercePharma article of August 24, 2021, carried a caption: ’Pharma’s reputation drops again. Could it foreshadow a return to the bottom?’

Further, in the new normal, especially when customer expectations and requirements from drug companies have significantly changed, MNC Pharma industry still appears to be in the old normal mode in this space. It still, reportedly, ‘believes that the need for innovation must be balanced with the necessity for more accessible medicines, within a robust IP and regulatory environment,’ in India.

The hidden purpose of the same could possibly be, as several industry watchers believe – availing benefits of greater access to one kind innovation, making access to other kind of innovation more difficult. Consequently, two critical points are reemerging, even in the new normal, as follows:

  • Aren’t Indian IP and regulatory ecosystems still conducive enough for MNC pharma players’ access to drug innovation?
  • In the name of greater access to pharma product innovation, are they creating barriers to pharma process innovation, delaying market access to complex generics and Biosimilar drugs – besides systematically eroding consumer confidence on such products?

In this article, under the above backdrop, I shall try to explore why the epithet – ‘access to drug innovation’ is considered an oxymoron – with contemporary examples from around the word, including India.

Aren’t Indian IP and regulatory ecosystems conducive to drug innovation? 

This allegation doesn’t seem to hold much water, as several successful local initiatives in Covid-19 vaccine development will confirm the same. Besides, already marketed Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and Zydus Cadila’s ZyCov-D, there are several others waiting in the wings. These include domestic drug makers like, Hyderabad based Biological-E, Bengaluru-based medical pharma startup’s – Mynvax, and Pune-based Gennova Biopharmaceutical’s m-RNA vaccine candidates. However, only critical difference is – Indian made Covid vaccines are more affordable and accessible to patients, as against those manufactured by MNCs, such as, Pfizer, Moderna and J&J.

If we look back to the old normal, one will also find similar instances of new drug discovery in India, which deliberated in my article of September 02, 2013. Let me give just a couple of examples below:

  • Ranbaxy developed and launched its first homegrown ‘New Drug’ for malaria - Synriam, on April 25, 2012
  • Zydus Cadila announced in June 2013 that the company is ready for launch in India its first New Chemical Entity (NCE) for the treatment of diabetic dyslipidemia –Lipaglyn.

Hence, meager wherewithal for R&D notwithstanding, as compared to the MNCs, Indian pharma players don’t seem to find the country’s IP and regulatory ecosystems not conducive to innovation of affordable new drugs with wider patient access.

Off-patent drugs also involve another type of major innovation:

Discovering an NCE is, unquestionably, a product of drug innovation. Similarly, developing a new – cost-effective, non-infringing manufacturing process to market off-patent drugs, like biosimilars, also involve another type of major innovation. Intriguingly, when the MNC pharma industry talks about ‘access to innovation’, the latter type of innovation isn’t publicly acknowledged and included in their drug innovation spectrum. This practice, reportedly, remains unchanged in their advocacy campaign, even in the new normal.

However, the fact is, the manufacturers of off-patent drugs, such as biosimilars, also need to follow a major innovative process, for which they require access to innovation. This was also captured in an editorial of the newsletter – Biosimilar Development. The deliberation addressed the question - Do biosimilars fit into the innovation paradigm? The editor began by articulating – hardly anyone publicly argues that the development of new manufacturing process of Biosimilar drugs is not an innovation. The industry can’t call them as a copy of an existing innovation, either.

This is also vindicated in the Amgen paper, published on February 11, 2018. It acknowledges, “Unlike small molecule generic drugs, biosimilars are not identical to the reference biologic or to other approved biosimilars of the same reference biologic, because they are developed using different cell lines and undergo different manufacturing and purification processes.” Moreover, biosimilars also carry a different International Nonproprietary Name (INN), because of their molecular differences from the reference drug. This has been specified in the nonproprietary naming Guidance document of the US-FDA of January 2017.

From this perspective, the next question that logically follows: Is process innovation as important as product innovation?

Is process innovation as critical a capability as product innovation?

This question was unambiguously answered by a pharma industry-centric Harvard Business Review(HBR) article – ‘The New Logic of High-Tech R&D’, published in its September–October 1995, issue. The paper emphasized, for the commercial success of a product ‘manufacturing-process innovation is becoming an increasingly critical capability for product innovation.’

When to meet patient-needs ‘access to innovation’ an oxymoron: 

‘Access to innovation’ is an interesting epithet that is often used by many drug companies for meeting unmet needs of patients. However, the same is also often used to create barriers to meeting unmet needs of more patients with cheaper biologic drugs, like Biosimilars, immediately after their basic patent expiry. This is mostly practiced by creating a patent thicket. Hence, drug companies’ advocacy for greater access to innovation is an oxymoron to many.

The same was echoed in another article – ‘How originator companies delay generic medicines,’ published by GaBI. It wrote, such practices delay generic entry and lead to healthcare systems and consumers paying more than they would otherwise have done for medicines. These include the following:

  • Strategic patenting
  • Patent litigation
  • Patent settlements
  • Interventions before national regulatory authorities
  • Lifecycle strategies for follow-on products.

A very recent piece on the subject, published by Fierce Pharma on August 31, 2021, vindicates that the patent life extension through the patent thicket is happening on the ground – denying patients access to cheaper equivalent, especially of off-patent biologic drugs within a reasonable time period. It highlighted:

  • The exclusivity of AbbVie’s Humira, which hit the market in 2002 and generated nearly $20 billion in sales last year was extended by 130 patents.
  • The same company has applied for 165 patents for its another blockbuster Imbruvica. Launched in 2013, Imbruvica has already generated sales of $5.3 billion for AbbVie.

No wonder, why in February 2021, during a Senate Finance Committee hearing, Sen. John Cornyn blasted the company saying:

“I support drug companies recovering a profit based on their research and development of innovative drugs,” Cornyn said. “But at some point, that patent has to end, that the exclusivity has to end, to be able to get it at a much cheaper cost.”

More reports are also available on attempts to erode consumer confidence in Biosimilar drugs, as compared to the originals.

Work for innovation sans eroding consumer confidence in Biosimilars: 

Making affordable new drugs and vaccines available to patients with ‘access to innovation’, deserves inspiration from all concerned. Curiously, even in the new normal, some big companies continue trying to erode consumer confidence in off-patent drugs, especially Biosimilars and complex generics.

For example, an article on Biosimilars moving to the center stage, published in the Pharmaceutical Executive on August 12, 2021, quoted an interesting development in this space. The article highlighted that US legislators are now ‘eyeing measures to deter innovator promotional messages that disparage follow-on competitors.’ This initiative was spurred by US-FDA criticism of an Amgen promotional communication for undermining consumer confidence in Biosimilars to its Neulasta (pegfilgrastim) injection.

On July 14, 2021, US-FDA’s Office of Prescription Drug Promotion (OPDP) sent a letter to Amgen carrying a caption ‘FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or  misleading promotional communication about its product’s benefit.

The letter, as reported in the above article, criticized the company for making a false claim of greater adverse events with the injection system used by Biosimilars compared to the Amgen product. OPDP advised Amgen and other firms to “carefully evaluate the information presented in promotional materials for reference products, or Biosimilar products” to ensure correct product identification and avoid consumer confusion.

Conclusion:

When the point is, creating a conducive ecosystem to promote access to innovation, it should be patient-centric – always, and, more so in the new normal, considering changing needs and expectations of health care customers.

The innovation of usually pricey new molecular entities, no doubt, meets unmet needs of those who can afford these. Whereas, manufacturing process innovation expands access to the same molecule, particularly when they go off-patent, by making them affordable to a vast majority of the population.

But powerful industry lobby groups continue pressing harder for unfettered ‘access to innovation’ with greater relaxation of the IP and regulatory framework of countries, like India. The situation prompts striking a right balance between encouraging more profit by helping to extend patent exclusivity and encouraging greater access to off-patent cheaper Biosimilars as soon as the basic patent expires.

The bottom-line is, both need to be actively encouraged, even if it requires new laws to discourage practices like, creating patent thickets or undermining the use of generics or Biosimilars, and the likes. The good news is lawmakers have started deliberating on this issue – along with increasing public awareness, which gets reflected in the pharma industry’s current reputation ratings.

Left unresolved soon, such piggyback ride on ‘access to drug innovation’ bandwagon to serve self-serving interests, would continue denying speedy entry of cheaper Biosimilars. From this perspective, it isn’t difficult to fathom, why unfettered access to drug innovation is considered an oxymoron, by many.

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.

A Rare Strategic Acrobatic Feat in Covid Time

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‘Keep nose to the grindstone while lifting eyes to the hills.’ Quite a while ago, all-time global management guru – Peter Drucker used this essential acrobatic feat as an example, for the business strategists. This illustration signifies the criticality of harmonizing decisions affecting both the short and the long-term goals of an organization, for a sustainable business excellence.

In most recent times, the pharma major AstraZeneca that has virtually become one of the household names, for developing a Covid-19 vaccine candidate with the University of Oxford, has performed the above acrobatic feat – with precision. During the prevailing unprecedented health crisis, the Company has unequivocally proven that it remains on course – in achieving its dual objectives, as Drucker had prescribed in his management classic – ‘The Practice of Management.’

It happened in tandem – without getting overwhelmed by the disruptive forced of Covid pandemic, unlike most others. Immediately, the Company focused on an urgent objective of saving the humanity – by developing, manufacturing and delivering a Covid vaccine to the world, in a record time. This was possibly a relatively short-term goal. And closely followed the other – a critical strategic decision for the organization’s long-term sustainable business excellence.

I have discussed before, the Company’s first initiative – developing a Covid vaccine candidate with the University of Oxford. Hence, in this article, I shall focus on two other related areas:

  • Deadly impact of rare diseases in some Covid infected young patients.
  • Why not some large Indian companies also explore similar strategies as demonstrated by AstraZeneca – and the reasons behind the same?

Before going into those areas up front, let me start with a brief description of AstraZeneca’s intent to expand its footprint in the of area of rare diseases, besides immunology area to help treat rare types of cancer.

The acquisition:

On December 12, 2020 AstraZeneca announced that to accelerate its strategic and financial development, the company will acquire Alexion valuing $39 billion. Subject to all statutory approvals, the deal is expected to close in the third quarter of 2021. Interestingly, Alexion’s top brand – Soliris, is the world’s one of the most expensive drugs in the world. It is prescribed to treat a rare – life-threatening blood disease paroxysmal nocturnal hemoglobinuria (PNH). Incidentally, rare diseases have also some significant relevance for Covid infected patients. Let me now recapitulate, some key aspects of rare diseases.

Some key aspects of rare diseases: 

Rare Diseases (RD) – also referred to as Orphan Disease (OD), are diseases affecting a small percentage of the population, and include genetic diseases, rare cancers, infectious tropical diseases and degenerative diseases. There is no universally accepted definition of a rare disease, yet. Different countries define these differently. However, the common considerations in the definitions are, primarily, disease prevalence and to a varying extent – severity and existence of alternative therapeutic options.

Impact of some rare diseases in Covid infected patients: 

Since the beginning of the Covid pandemic, people with underlying diseases, such as, hypertension, diabetes, cardiovascular and kidney disorders, are considered to fall in the high-risk group. They are more likely to have severe disease and complications and need to be extra cautious of the infection. Importantly, it has been recently reported that some rare diseases also increase risk of dying during Covid-19 pandemic at a younger age.

For example, as reported on December 07, 2020, recent studies indicate, rare autoimmune rheumatic diseases increase risk of dying during Covid-19 pandemic for younger patients. The researchers also found that women with rare autoimmune rheumatological diseases (RAIRD) had a greater increase in all-cause mortality rates during the pandemic when compared to men with RAIRD. However, there seems to be an India specific issue also in this situation, as well.

India specific issue for Covid infected patients with some rare diseases:

Some India specific issues on RD, could have a significant adverse impact on Covid infected patients in the country. One such critical issues is the ‘Baseline Knowledge of Rare Diseases in India.’ This fact was well captured in an important survey that was published with the same name, as an original article, in the ‘International Journal of Rare Diseases & Disorders,’ on November 06, 2019.

The study noted, among others:

  • Although, rare diseases have recently received worldwide attention, the developing countries are seriously behind in regard to awareness, drug development, diagnosis, and social services, in this area. India, which has one-third of the world’s rare disease population, has no accurate assessment of the problem.
  • The drugs for ‘Rare Diseases (RD), also called Orphan Drugs (OD)’, often cost exorbitant with difficulties in diagnosis and treatments.
  • Indian policymakers want to find out the number of RD and the extent of the population suffering from them and help provide treatment for them, which is a challenging task with 1.45% GDP health care budget for 1.3 billion people.
  • The health care professionals appear to have some awareness as compared with non-healthcare professionals, but even among health care professionals, only one third had a rudimentary understanding of RD and OD, whereas three-fourths have virtually no knowledge of RD.
  • Forty-three percent of health professionals had not seen rare disease patients, and a large percent of practicing physicians had not seen even one rare disease patient in their entire professional practice.

Thus, it is clear from this survey that the most important issues are awareness and diagnosis, as many rare diseases are not diagnosed or possibly misdiagnosed. Besides, the survey also observed, since 1983, many global companies started developing orphan drugs after the Orphan Drug Act implementation. There is none at this time in India, although in 2017, the Drugs & Cosmetic Act. 1945 has been amended to include “rare diseases and orphan drugs”.

The National Policy on Rare Diseases flagged some of these facts:

The ‘National Policy on Rare Diseases 2020,’ for India, released by the Union Ministry of Health on February 07, 2020, acknowledged many of these important facts. It also said, ‘Considering the limited data available on rare diseases, and in the light of competing health priorities, the focus of the draft policy is on prevention of rare diseases as a priority as identified by experts.’

Interestingly, the first of such policy was prepared by India in 2017 and a committee was appointed to review it in 2028. However, recently published the National Policy on Rare diseases, has also noted one more important point. It noted: ‘Paradoxically, though rare diseases are of low prevalence and individually rare, collectively they affect a considerable proportion of the population in any country, which according to generally accepted international research is – between 6% and 8%.’ Currently, India, reportedly, doesn’t have any registry of rare disease, which has now been entrusted to the Indian Council of Medical Research (ICMR) in the National policy.

Common symptoms can hide underlying rare diseases, leading to misdiagnosis:

The above policy has also noted, rare diseases are characterized by a wide diversity of signs and symptoms that not only, reportedly, vary from disease to disease, but also from patient-to-patient suffering from the same disease. Importantly, relatively common symptoms can hide underlying rare diseases, leading to misdiagnosis.

During Covid treatment, similar circumstances could lead to a serious life-threatening situation. The 2020 RD Policy also reiterates: “Early diagnosis of rare diseases is a challenge owing to multiple factors that include lack of awareness among primary care physicians, lack of adequate screening and diagnostic facilities etc.” That said, yet another key question arises – will developing and marketing such drugs be profitable for the pharma industry?

Will developing such drugs be profitable for the pharma industry?

It is worth noting that the National Policy on Rare Diseases 2020, aims more at lowering the incidence and prevalence of rare diseases based on an integrated and comprehensive prevention strategy, rather than ensuring patient access to affordable treatments. Nonetheless, it also says, within the constraints on resources and competing health care priorities, India will try to enable access to affordable health care to patients of rare diseases which are amenable to one-time treatment. In general, the policy suggests, ‘voluntary crowdfunding for treatment’ of rare diseases.

With this being the prevailing situation in India, even during Covid pandemic, an interesting article – ‘How Orphan Drugs Became a Highly Profitable Industry,’ published in The Scientist, noted some important facts in this area. It highlighted: ‘Government incentives, advances in technology, and an army of patient advocates have spun a successful market—but abuses of the system and exorbitant prices could cause a backlash.’

It also articulated, despite higher costs and less-certain returns, investments in drug development on the rare diseases side appear to ‘be bucking the trend.’ The result of the global focus on RD nowadays is: ‘Firms with marketing authorization for orphan products, are now more profitable than those without.’

This also partly explains the financial rationale behind AstraZeneca’s recent acquisition of Alexion Pharmaceuticals, valuing $39 billion.

Conclusion: 

As of December 20, 2020 morning, India recorded a staggering figure of 10,031,659 of new Coronavirus cases with 145,513 deaths. The country has already crossed 10 million in Covid cases as the vaccine approval remains pending. The threat of subsequent waves for further spread of Covid infection continues to loom large in many states. Meanwhile, many studies indicate that comorbidity should now include rare diseases, as well, especially to prevent deaths in younger patients. From this perspective effective diagnosis and treatment of RD are also coming under spotlights. Curiously, the National Policy on Rare Diseases 2020 focuses more on awareness and prevention of RD rather than access to affordable treatment, particularly in Covid infected patients to save precious younger lives. As I wrote previously and still believe, the ‘National Policy on Rare Diseases’ becomes more meaningful with ‘Orphan Drugs Act.’

Vaccines to prevent Covid infections are also expected to get emergency approval in India, shortly. At lease, some of these being available at affordable prices, including AstraZeneca-Oxford vaccine, according to reports. As recent reports indicate the same company, is also entering into RD therapy areas, through a key acquisition, yet another hope looms large. A hope for availability of relevant RD drugs at an affordable price for Covid infected patients, despite other apprehension, as I wrote before.

That apart, purely from the business management perspective, as well, this rare strategic acrobatic feat of AstraZeneca - ‘Keep nose to the grindstone while lifting eyes to the hills,’ during the Covid crisis, I reckon, is exemplary for the practicing managers.

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.

 

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.

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.

 

Access To Comprehensive Healthcare Merits Multipronged Approach

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Since the turn of the new millennium, several high profile and flagship health schemes are being announced in India by the Union successive governments. Some of the important ones will include the National Health Mission, Rashtriya Swasthya Bima Yojana (RSBY) - a Health Insurance Scheme for the Below Poverty Line families and now Ayushman Bharat – National Health Protection Mission - expected to cover over 100 million poor and vulnerable families providing coverage up to 500,000 rupees per family per year for hospitalization related to secondary and tertiary care.

Besides, the Mental Health Care Act 2017 has been operational since last year. It was passed by the Rajya Sabha in August 2016, and the Lok Sabha on March 2017. The right to mental health care is the core of the Act.

Each of these announcements look good on paper and was accompanied with lofty government promises. Riding on the waves of hypes thus created, public expectations increased commensurately for getting easy access to a comprehensive and affordable health care, which now includes ‘Mental Health’ as well. Unfortunately, the Gordian knot in Indian public healthcare space continued to exist. As various reports  indicate, for example, one that appeared on November 27, 2018, – even Ayushman Bharat is apparently moving towards the same detection driven by some critical basic issues.

Consequently, scores of people still do not have adequate and affordable access to basic health care, including essential drugs – clamping price control notwithstanding. The government knows it well, as it increases vigil on drug pricing. Pharma industry also feels its scorching heat. Overall storyline remains mostly unchanged. The vicious cycle continues.

In this article, I shall dwell on a system-approach to delivering comprehensive public health care. The key objective is trying to figure out what is the core problem that most of these schemes are either not addressing or doing it with a ‘band-aid’ approach. One of the key requirements for improving access to health care significantly, I reckon, is a clear understanding on the characterizations of the critical stages of healthcare access and their dimensions, from the patients’ perspective.

However, before doing so, let me glance upon some health care related current and important facts, as uploaded in the government’s National Health Profile 2018.  

National Health Profile 2018:

As available in the National Health Profile (NHP) of India – 2018, following are some of the important facts, which are worth noting:

  • In the current budget year, public (government) spending on health is just 1.3 per cent of the GDP against the global average for the same at 6 percent.
  • Just one doctor serves a population of 11,000 people, which is way below W.H.O recommended a doctor to population ratio of 1:1,000. The scenario is even worse in many states, such asBihar with 1: 28,391, Uttar Pradesh records 1:19,962, Jharkhand with 1:18,518, Madhya Pradesh shows 1:16,996 and Chhattisgarh at 1:15,916.
  • Per capita public expenditure by the government on health, stands at Rs 1,112 that comes to Rs 3 per day. This puts India below other low-income nations like the Maldives (9.4), Bhutan (2.5), Sri Lanka (1.6) and Nepal (1.1).

These numbers provide just a flavor of the Indian healthcare space, as it stands today. Some may of course talk about legacy factor, but to move ahead more important for all is what is happening today in this regard. Yes, one more health mission, as mentioned above, has been launched on September 25, 2018 with similar hype as the past ones, if not more. Only the future will tell us what changed it brings to the ground. That said, I am not very upbeat about it either, as providing a comprehensive health care access has always been multi-factorial and will remain so. Let me now dwell on why I am saying so.

Understanding health care access:

The 2013 research paper on “Improving Healthcare Access in India” by erstwhile IMS Consulting group (now IQVIA), said that ‘health care access characterizes 3 stages,’ which from the patient’s perspective has 4 key dimensions. In the Indian context, these three stages are:

  • Accessing care: Physical reach and location
  • Receiving care: Availability/capacity, Quality/functionality
  • Paying for care: Affordability

Accordingly, healthcare access is a function of 4 key aspects:

  • Physical reaches to health care facility
  • Availability of doctors and medicines in those places
  • Quality of care provided by these centers
  • Affordability of treatment, if available there

Access to healthcare is slowly improving, but far from being enough:

All the above schemes of the government are primarily focused on ‘paying for care’ stage and ‘affordability’ of treatment, including drugs. To a limited extent it makes sense as the above study vindicates that ‘availability’ and ‘affordability’ have good impact on ‘access to health care’.

Since the inception of NHM, this approach, no doubt, has made some improvement in the overall access to health care in the country, as many studies indicate. The IMS Consulting study also observes that compared to 2004, more patients received free medicines in outpatient care in 2013 – over 50 percent of patients going to Government hospitals say that they get free medicines there. However, the outcomes of the same across the Indian states vary quite a lot.

Inadequate healthcare infrastructure and physical reach in rural areas:

Having noted that, grossly inadequate availability of public health care infrastructure – or when available physical access to many of those from remote villages, coupled with lack of availability of required doctors, paramedics, nurses and medicines in those dispensaries – often become major issues. Moreover, their capacity to providing quality care, besides longer waiting time, often pushes many – either to remain virtually untreated or to go to private care centers costing much more.

The study finds that such movement of people from public to private facilities leads to higher health care costs. Consequently, high usage of private channels drives up the out of pocket (oop) cost of treatment. Some of the details are as follows:

  • 74 percent of patients sought private consultation
  • 85 percent of ‘oop’ spending on health care was in the private sector
  • 81percent of patients incurred ‘oop’ expenditure for medicines

Curiously, 35 percent of patients in the study rated public health facilities as – good. Whereas an overwhelming 81 percent said so for private facilities. Nevertheless, associated high ‘oop’ expenditure for the same often becomes an economic burden. The large number of patients with chronic ailments, are the major sufferers.

Application of mobile-health could help improve access:

On improving access to health care in India, an interesting ‘Review Article’ titled, “Applications of m-Health and e-Health in Public Health Sector: The Challenges and Opportunities”, appeared in the International Journal of Medicine and Public Health, April-June, 2018 issue, makes some thought-provoking observations.

It says, while the use of mobile phone (MPs) has become commonplace in many industry sectors, such as banking, railways, airlines – the public health sector has been somewhat slow in adopting MP technologies into routine operations. Its innovative use can benefit patients and providers alike by enhancing access to health care.Smartphones’ usefulness in the treatment of chronic diseases – for example, monitoring of blood pressure, blood sugar, body weight, electro- cardiograph (ECG), has already been established.

The paper also suggests, mobile health (m-H) is more effective when tailored to specific social, ethnic, demographic group using colloquial language. If implemented craftily and systematically, m-H can revolutionize the scenario of the health care delivery system, in many ways. Optimal doctor-patient engagement policy for m-H needs to be formulated, outlining a legal framework and with multi-stakeholder collaboration.

Mental health still largely ignored:

Another important aspect of comprehensive health care is ‘Mental Health’, as more than 60 million Indians suffer from mental disorders, suicides being one of the major killers in India (Source: W.H.O, IndiaSpend). However, it is disturbing to note that awareness and access to mental health treatment, especially in the hinterland of the country, continue to remain ignored. Increasing incidences of farmers’ suicides, for example, notwithstanding.

This was further elaborated by the IndiaSpend report of January 30, 2018, which underscored:“Allocation to the National Program for Mental Health has been stagnant for the past three years. At Rs 350 million, the program received 0.07 percent of India’s 2017-18 health budget.This is despite the fact that an estimated 10-20 million Indians (1-2% of the population) suffer from severe mental disorders such as schizophrenia and bipolar disorder, and nearly 50 million (5 percent of the population) – almost equal to the population of South Africa–suffer from common mental disorders such as depression and anxiety.”

The report further highlights that, notwithstanding 15 suicides every hour and 133,623 suicides in 2015, India is short of 66,200 psychiatrists and 269,750 psychiatric nurses. It is also noteworthy, while a frugal sum of 0.06 percent of India’s health budget is for mental health care, the same for even Bangladesh stands at 0.44 percent (Source: W.H.O, IndiaSpend).

Conclusion:

From the above perspective, I reckon, although access to health care in India, except ‘mental health care’, is improving at a modest pace, it doesn’t seem to be anywhere near adequate, as on date. A holistic approach for a comprehensive health care access to all, through the public health system, seems to be the need of the hour.

That said, currently India is not meeting the minimum W.H.O recommendations for healthcare workforce and also in bed density. A large section of the population continues to lack affordable access to quality health care. Moreover, the importance of mental health is still unknown to many in the country.

Thus, in tandem with addressing all the three stages and four key dimensions of comprehensive health care access, it is imperative to leverage new technology-based       e-healthcare and digital devices like m-Health. Together, these will help provide and facilitate not just quality care to patients, but also complement the healthcare infrastructure, including doctors and paramedics – making quality and affordable health care accessible to all.

As I said in my article, titled ‘Mental Health Problem: A Growing Concern in The Healthcare Space of India, the ‘Mental Health Care Bill’, which is now an Act, redefines mental illness to better understand various conditions that are persistent among the Indian population.This is a good development, as it aims at protecting the rights of persons with mental illness and promote access to mental health care. Since, the current ground reality in this area is a cause of great concern, when will it be effectively implemented for all, is the all-important question.

It is imperative for all concerned to understand that improving access to comprehensive health care is multi-factorial issue. Therefore, it needs nothing less than a well-thought out multi-pronged approach for an effective solution.

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.

Making ‘National Policy For Rare Diseases’ More Meaningful With ‘Orphan Drugs Act’

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In November 2016, while hearing a related case, the Delhi High Court reportedly directed the Union Government to finalize and implement a policy on rare diseases, with a provision for free treatment with the expensive medications, as will be required by patients.

Earlier in 2014, while passing the judgement in response to a petition filed by a seven-year-old son of a rickshaw puller seeking affordable treatment for the rare disease that he is suffering from, the Delhi High Court concluded that, “every person has a fundamental right to quality health care that is affordable, accessible and compassionate.”

Currently, the treatment for rare diseases costs the patients an arm and a leg, ranging between Rs. 40 lakhs (US$ 62,000 approx.) to Rs 1.70 crores (US$ 267,000 approx.), which is way beyond the reach of most Indians.

Subsequently, on May 26, 2017, the Ministry of Health and Family Welfare filed an affidavit before the honorable Court, submitting a copy of the National Policy for Rare Diseases 2017, stating that it will aim to facilitate effective diagnosis and affordable treatment. This development is indeed good news, especially considering around 6 to 8 percent of the world population suffer from ‘rare diseases’, and India is no exception.

The key highlights of the new policy:

As per available information, following are the 10 major highlights of the National Policy for Rare Diseases 2017:

  • The Union Government to create a corpus with an initial funding of Rs 100 crores (US$ 16 million). The State Governments would also provide for a similar fund with a 60 percent contribution from the Centre. This corpus is primarily for the treatment of genetic disorders, excluding rare blood diseases, such as, thalassemia and sickle-cell anemia.
  • For the sustainability of the corpus, Public Sector Units and Corporates will be encouraged for the contribution in these earmarked funds, as part of their corporate social responsibility.
  • Appropriate institutions will be accredited by the government for diagnosis and treatment of rare diseases.
  • To ensure adequate availability and reasonable affordability of the drugs for rare diseases, the Drug Controller General of India (DCGI) will consider amending the Drug and Cosmetics Act with requisite provisions to make clinical trials and import of ERTs possible.
  • The Department of Financial Services to ensure coverage of rare diseases under insurance schemes.
  • Employees State Insurance Corporation (ESIC) will explore whether the ceiling limit of funding the treatments for rare diseases can be increased through suitable amendments.
  • The policy recognizes that rare diseases are, in most cases, serious, chronic, debilitating and life-threatening, often requiring long – specialized treatments, and may also lead to some form of handicap, at times extremely severe in nature.
  • About 50 percent of new cases of rare diseases are in children and responsible for 35 percent of deaths before the age of one, 10 percent between the ages of one, and five years and 12 percent between five and 15 years.
  • As a preventive measure, the policy may consider the feasibility of providing pre-conception and ante-natal genetic counselling and screening programs for diagnosing genetic disorders, which would provide a choice to parents about giving birth to children with genetic disorders, especially for families that have a diagnosed genetic disorder, or a high risk profile for it.
  • The policy gives Indian Council for Medical Research (ICMR) the responsibility of creating a patient registry, as India has no epidemiological data on rare diseases.

Rare diseases – definition:

There is no universal definition of rare diseases. For example, while the US defines a rare disease as one that affects less than 200,000 people nationwide, in China, this number changes to 1 in 500,000 people (or neonatal morbidity of less than 1 in 10,000). India doesn’t yet have a clear definition for the same – not even in its new policy for rare diseases.

However, according to Rare Diseases India (RDI) – a foundation for research on rare diseases and disorders, any disease having fewer than 100 patients per 100,000 population fall into this category. Whereas, those ones affecting 2 patients per 100,000 population are described as ultra-rare diseases.

Rare Diseases in India:

The Organization for Rare Diseases in India (ORD), states that 1 in 20 Indians is affected by such diseases. About 6000 to 8000 rare diseases, mostly genetic in nature, have been identified in India. It was initially estimated that over 31 million Indians are suffering from such disorders in the country, many of which still do not have any cure. Moreover, epidemiological data for most of these ailments is hardly available.

To increase awareness for rare diseases, Rare Diseases Day was observed for the first time in India (New Delhi) on February 28, 2010.

Orphan diseases and orphan drugs:

According to RDI, rare diseases are often referred to as ‘orphan’ diseases. Consequently, the drugs that are specifically developed to treat ‘orphan’ or ‘rare disease conditions’ are called ‘orphan drugs’. The reason being, pharma companies do not generally take such drugs through further stages of development for market launch, or in other words, these are orphaned for economic considerations, though are important to save many precious lives.

Need to encourage orphan drug development in India:

According to SanOrphan SA, Geneva, Switzerland, around 65 percent of rare diseases is serious and disabling. Interestingly, about 250 new rare diseases are discovered each year, corresponding to five new rare diseases per week. As the scenario is no different in India, it prompts the need to encourage development of effective and affordable orphan drugs in the country.

However, without appropriate ecosystem being in place, developing an orphan drug in India, specifically to treat a very small number of such patient populations, through a cost intensive R&D initiative with a low potential of return on investments, is indeed a challenging proposition for many pharma players. Although, in the western world, this trend has started changing now, driven by various other commercial reasons.

Why should ‘Orphan Drugs Act’ follow the National Policy on rare diseases?

National Policy for Rare Diseases is undoubtedly a good beginning, though was brought under the directive of Delhi High Court. Nevertheless, to encourage ‘Orphan Drugs’ development within the country, a robust ‘Orphan Drugs Act’ should now logically follow.

One may well ask, why is this Act is so necessary in India? This is because, the new ‘National Policy for Rare Diseases’ charts just the pathway of a course of action that the Government is planning to take in this area. Policies, as we know, though, are a set of well-articulated intents, do not guarantee that these will be successfully followed to achieve the pre-set long-term goals. Whereas, all legislative Acts or duly enacted laws, are legally enforceable. It is worth noting, while the national policies can be formulated by the government, an Act must be passed by the lawmakers in the Parliament.

Consequently, it is now a well-accepted fact that ‘Orphan Drugs Act’ encourages development of drugs for rare diseases. In an article titled, “What the Orphan Drug Act has done lately for children with rare diseases: a 10-year analysis”, published by the National Center for Biotechnology Information (NCBI), U.S, National Library of Medicine, the authors highlighted that in the U.S. 1138 orphan drugs were designated and 148 received marketing approval, of which 38 (26 percent) were for pediatric diseases, from 2000 to 2009. The percentage of approvals for pediatric products increased from 17.5 (10 of 57) in the first half of the decade, as compared to 30.8 (28 of 91) in the second half. Based on these data, the paper concluded that the incentives provided in the ‘Orphan Drugs Act (ODA)’ of the United States of America, have led to increased availability of specific drugs for the treatment of ‘Rare Diseases’ in the country.

Other countries did – why not India?

1983 signaled the importance of ‘Orphan Drugs’ with the ‘Orphan Drugs Act (ODA) in the U.S.A. A decade after, in 1993, Japan took similar initiative followed by Australia in 1999. Currently, Singapore, South Korea, Canada and New Zealand are also having their country specific ODAs.

Following similar footsteps, India should also encourage its domestic pharmaceutical industry to get engaged in research to discover drugs for rare diseases by putting an ‘Orphan Drugs Act’ in place, extending financial support, tax exemptions and regulatory concessions like smaller and shorter clinical trials, among several other areas, without delay.

Opportunities galore:

The above constraints in the development of orphan drugs have now been turned into an opportunity galore by the global pharma industry, where the domestic players should not lag much behind. Orphan drugs, backed by adequate financial incentives provided by laws in different countries, are now seen as a research and development priority to significantly boost the top and the bottom-line of pharma business.

As IgeaHub has highlighted, orphan drugs, though, cater to a small patient pool, the remunerative price of these drugs offsets the commercial challenges, as mentioned earlier. For example, in 2010, Soliris, which treats paroxysmal nocturnal hemoglobinuria (PNH) that affects 1 out of 500,000, was considered as the industry’s most expensive drug amounting to US$ 409,000 per year of treatment, which generated a total of US$ 541 million revenue for Alexion Pharmaceuticals in that year. In 2012, Soliris recorded a sales turnover of US$ 1.13 billion, which is expected to cross the mark of US$ 3.40 billion in 2018. Further, in 2012, the top selling orphan drug in the USA – Rituxan of Roche – used for the treatment of chronic lymphocytic leukemia, generated US$ 7.15 billion in total sales. Post patent expiry, in 2018, the same drug is expected to yield a revenue of US$ 6.99 billion.

The market:

Evaluate Pharma’s Orphan Drug Report 2017 estimates the worldwide Orphan Drug Sales of total US$ 209 billion, with CAGR of +11 percent for 2017 to 2022 period, which is double of the overall prescription Market Growth. Excluding generics orphan drugs are set to contribute 21.4 percent of Worldwide Prescription Sales by 2022.

Big pharma dominates this segment. Seven of the top 10 companies’ orphan drug sales are from global industry players, who have won approval for their biggest products in various niche indications.

Other commercial benefits:

Thomson Reuters reported additional commercial opportunities with an appropriate ODA, which in the United States are as follows:

  • 15 percent of the ‘Orphan Drugs’ analyzed by them had subsequent launches for other rare illnesses.
  • 6 out of the top 10 ‘Orphan Drugs’ had more than one rare disease indication, with an average peak sales of US$ 34.3 billion in overall sales potential, against around US$ 8.1 billion of the same for drugs with single indication.
  • Time taken for Clinical Trials (CT) focused on orphan drugs is significantly shorter with much quicker review time than trials involving non-orphan drugs.

Conclusion:

Some of the ‘orphan diseases’ are now being diagnosed also in India, and with precision. As the nation takes rapid strides in the medical science, more of such rare diseases are likely to be diagnosed in our country. The global pharma industry has already started taking rapid strides in this area, supported by ODA in various countries. Similar opportunities, both for the patients, as well as, for the industry, need to be made available in India too.

One of the ways to encourage the orphan drug development in India is to follow the model of the Council of Scientific and Industrial Research (CSIR) for ‘Open Source Drug Discovery’ (OSDD)’ with both global and local partnerships and collaboration.

However, speedy enactment of an appropriate ODA for the country, providing adequate financial incentives to the pharma players, for developing and marketing such drugs, both in the local and global markets, at a reasonably affordable price, would go a long way, and be a win-win situation for all.

Alongside, leveraging the knowledge of OSDD acquired by the CSIR, and framing a robust win-win Public Private Partnership (PPP) model to discover and commercialize the orphan drugs, India could well demonstrate the zeal of the country to move beyond the National Policy for Rare Diseases. In that process, it would be able to offer more meaningful and sustainable benefits, both to the domestic pharma industry and the patients, alike, for a long time to come.

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.

Dwindling Drug Innovation: Declining Image: Unchanged Business And Advocacy Models

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A report of ‘The United States International Trade Commission (USITC)’ released on December 22, 2014 suggested, if tariffs and investment restrictions were fully eliminated, and standards of IP protection were made comparable to the U.S and Western European levels, American exports to India would rise by two-thirds.

A year later, on February 01, 2015 an interesting news article highlighted that the flashpoint of this issue “has clearly been pharmaceutical companies and their lobby group Pharmaceutical Research and Manufacturers of America (PhRMA), which have made some of the strongest representations to the US government against India’s IPR regime.” The same report also indicated that many other companies including the aircraft maker Boeing and the generic drug giant Abbott felt that India offered adequate IP protection and that they had not experienced major IP problems in the country.

The above stance of USITC continued echoing right from the beginning of this year. In January 2017, the CEO of US Biotechnology Innovation Organization (BIO) reportedly told our Prime Minister Narendra Modi, ‘if he follows western practices on intellectual property protection, his country would see a “tidal wave” of biotech industry investment.’

On February 08, 2017, when the fifth edition of ‘U.S. Chamber International IP Index’ report was released by the ‘Global Intellectual Property Center (GIPC)’, India featured in the 43rd rank out of 45 countries. With this India remained virtually at the bottom of the IP index for the fourth year on the trot. The GIPC report underscored India’s “anaemic IPR policy”, Section 3.d of the Indian Patents Act, besides several others, as major market access barriers.

On February 14, 2017, another news article reported that America’s pharma sector has asked the US Trade Representative (USTR) to continue to keep India on its Priority Watch List (PWL), which includes countries that are alleged violators of US patent laws, claiming that the environment on the ground remains ‘challenging’ in India. Among the areas of concern for the US pharma companies operating in India, unpredictable IP environment, high tariffs and taxes on medicines, regulatory data protection failure, discriminatory and non-transparent market access policies and unpredictable environment for clinical research were listed among others.

With this backdrop, the key question that haunts many industry watchers, when the World Trade Organization (WTO) has no complaint with the Indian Patents Act 2005, and finds it TRIPS compliant, why are these reports coming from the United States consistently emphasizing that the current IP regime of the country is a key barrier to market access, especially for research-based pharma companies?

Is the core issue of the global pharma industry in India is predominantly not encouraging innovation well enough, or the dearth of inadequate Intellectual Property (IP) protection – or it is something beyond that, and is more fundamental in nature. In this article, I shall dwell in this area, first in the global perspective, and then zeroing-in to India.

A global perspective:

“The past 60 years have seen huge advances in many of the scientific, technological and managerial factors that should tend to raise the efficiency of commercial drug research and development (R&D). Yet the number of new drugs approved per billion US dollars spent on R&D has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms.  There have been many proposed solutions to the problem of declining R&D efficiency. However, their apparent lack of impact so far and the contrast between improving inputs and declining output in terms of the number of new drugs make it sensible to ask whether the underlying problems have been correctly diagnosed,” articulated an important article published on March 01, 2012 in the Nature Reviews Drug Discovery.

This trend continues, virtually unchanged. R&D efficiency continues to remain a cause of great concern to the research-based global pharmaceutical companies. Accordingly, a 2016 report of the Deloitte Center for Health Solutions titled, ‘Measuring the return of pharmaceutical innovation’, among other findings, has captured the following:

  • Annual projected pharma R&D return declines to 3.7 percent from 10.1 percent in 2010
  • Peak sales per asset fall 11.4 percent year-on-year since 2010

What then is its basic solution?

When the right solution eludes:             

In this scenario, when the right solution is still eluding, to record growth in corporate profit and earning to meet shareholders’ expectations, keeping the existing business model intact, the global research-based pharma companies have the following two limited options, which they are actively pursuing:

  • Take high price increases for the existing products
  • Launch the limited new products at a very high price

A report published in The First Word Pharma on October 06, 2015 quoting The Wall Street Journal (WSJ) vindicated exercising the first option. It reported that many drug makers have succeeded in increasing revenue on products despite a flat or declining demand by consistently increasing prices. An analysis revealed that revenue for the top 30 products in the United States zoomed by 61 percent over the past five years, three times the increase in the number of prescriptions sold over that period. While another report by Credit Suisse illustrated that 80 percent of the growth in net profit for the top 20 drug makers was attributable to price hikes.

To substantiate application of the second option, I quote from the CBS News, which on April 05, 2016 reported that an investigation into the cost of prescription drugs revealed huge price hikes over the past five years. Several brand name medications more than doubled in price. Again, on  August 24, 2016, it gave a sense of this trend with the following examples, covering the launch price of innovative drug, and price increases of generic drugs:

  • Gilead fixed their new hepatitis C drug Sovaldi’s cost at US$ 900 – 1,000 per pill
  • Mylan Pharmaceuticals’ increased the cost of its anti-allergic drug EpiPen from about US$ 57 in 2007 to more than US$ 500 in 2016
  • Turing Pharmaceuticals increased the price of the anti-malaria drug Daraprim by 5,000 percent last year, charging US$ 750 per pill for a drug that used to cost US$ 13.50 per pill.

PhRMA – the often quoted trade association in America, representing the country’s leading pharma and bio-pharmaceutical research-based companies, reportedly said in a statement: “Focusing solely on the list prices of medicines is misleading because it ignores the significant discounts and rebates negotiated by insurers and pharmacy benefit managers.”

Even if, this argument is accepted as such, the tough impact of regular hefty drug price increases on the consumers is real, unquestionably.

The current business model leaves behind many patients:

The ‘Access to Medicine Index 2016’ report also finds that companies generally do not systematically target populations with the highest needs in their registration, pricing and licensing actions. Although, we continue to make progress toward major public health goals, such as, polio is close to being eradicated, as is guinea worm; more than 45 percent of people living with HIV/AIDS have access to ARVs; important vaccines for malaria and dengue fever are being implemented, still business models for providing healthcare are leaving many people behind. Globally, two billion people cannot access the medicines they need, most of whom live hand to mouth.

Particularly, the big global pharma companies, as the innovators and producers of life-saving medicines, need to act much earlier in the patients’ value chain. Without or inadequate action by these companies, alongside governments, NGOs and others, it will be impossible to bring modern medicine to everyone.

Public outrage over high drug prices:

Many studies indicate that the research-based global pharma and biotech companies, still strive hard to stick to their existing overall business models with a sharp focus on improving both the top and bottom lines of the business, though the R&D projects are becoming lesser and lesser productive. This prompts them resorting to hefty price increases, and introducing new products with high price. Fueled by this self-serving mindset, a simmering public outrage, globally, over high drug prices is fast catching up, further undermining the trust in the industry, as another report says.

No wonder why in the Gallup Poll of August 15, 2016, pharmaceutical industry featured just one above the bottom among the ‘Worst-Rated U.S. Business Sectors’. Moreover, even the Harris Poll released on January 17, 2017 found that 91 percent of U.S. consumers believe pharmaceutical and biotechnology companies put profits over patients.

The industry continues chasing rainbows:

In response to this mounting stakeholders’ criticism, arguably the richest pharma association in the world in its member subscriptions – PhRMA, reportedly launched a new ad campaign costing tens of millions of dollars on January 25, 2017. It aims to highlight innovation and scientific breakthroughs to change the public’s negative perception of the industry. This campaign will span across television, print, digital, and radio, the report elaborates.

Following is an example, as reported, listing three important and interesting comments on this campaign for pharma image revamp from some of those who matter:

  • Lawmaker Peter Welch, who chairs the House Democratic Caucus’ task force on drug pricing, said, “The issue here is not whether drugs have some benefits … The issue is whether pharma is going to be able to kill us with their pricing power or whether we will get transparency and competition.” He added, “The campaign is all about defending their pricing power and pushing their product.”
  • Similarly, another lawmaker Sen. Chuck Grassley (R-Iowa) said, “This is [PhRMA] trying to change the subject and to try and divert people’s attention away from drug pricing. Continuing to ignore drug pricing is probably not going to work.”
  • Ameet Sarpatwari, a drug pricing policy researcher at Harvard University said, “It’s really a matter of being tone deaf in terms of thinking somehow that this is going to change public perception”

Isn’t a great example of chasing rainbows by the industry association, in the number one pharma and biotech market of the world, instead of amending to the root cause of this burning issue?

The situation in India:

In this backdrop, amid a tough global situation, let me assess the related Indian scenario.

The research-based global pharma companies, apparently want to introduce the whole range of their patented products at a high price and in a monopolistic situation in India too, for much higher growth in revenue and profits. Thus, they are consistently pushing hard, with all guns blazing, for major changes in the Indian Patents Act 2005, which would involve jettisoning many patients’ health interest related safeguard conditions enshrined in the Act, such as Section 3.d that restricts ever-greening of patents, and introducing several other tougher IP measures, such as data exclusivity under the garb of imaginary patient safety issues with generic drugs.

They don’t seem to like price control of essential drugs in India, either. While intensely lobbying for it, the lobbyists vehemently argue in favor of the absurd, which is the affordability of medicines does not help to increase drug access to all those who need these most, even when on the ground, the out of pocket expenses for drugs in the country is as high as around 65 percent and universal health care does exist in the country, much to the dismay of many.

It has now been generally established by many global experts, including our own National Pharmaceutical Pricing Authority (NPPA) that market competition does not necessarily bring down drug prices, including for generics, quite unlike many other industries, but various pressure groups, including the media, can catalyze it, and quite effectively. What has happened recently with the cardiac stents price in the country, is just an example.

Is the devil in the traditional pharma business model?

An article titled, “How Pharma Can Fix Its Reputation and Its Business at the Same Time”, published on February 03, 2017 in The Harvard Business Review, emphatically states: “It’s a fact that the current business model of pharma companies is not working efficiently.” It suggests, besides enhancing the current unenviable public image of the industry, expanding access to medicines will help pharma companies enhance shareholder value. The success of a new business model depends on both the willingness and the ability of pharmaceutical companies to fully integrate access to medicine into their business strategies, the article emphasizes.

A July 2015 paper of McKinsey & Company titled, “Pharma’s next challenge”, also reiterates that in the developed economies, market access is chiefly concerned with pricing, and with satisfying local conditions. Whereas, in the emerging markets, to overcome the barriers, pharma players need to shift the focus of their commercial models from marketing and sales to access, and from brand-by-brand access planning to integrated cross-brand planning.

In pursuit of a new model:

Based on the above premises, the search for a new pharma business model, especially for the research-based pharma companies, in my view, may broadly focus on the following areas:

  • Learn from innovation models of the IT industry: Win-Win collaborative innovation models, including ‘Open Source Drug Discovery’, if scaled up, could reduce the cost of innovation significantly and making the new innovative drugs generally affordable. Thus, larger volume sales may adequately offset a voluntary cut in the product margin, creating a multiplier effect.
  • Be a part of the solution and not the problem: Because of fiercely pushing the blatant self-serving agenda, inconveniencing many patients, the core mindset of the pharma industry is considered by many as an integral part of the main problem. While pharma industry, quite rightly, seek more market access, they need to act as a facilitator too, to improve general access to medicines, in various imaginative ways, which is, of course, possible. This will make the pharma industry to be a part of the solution to the national problem, over a period of time.
  • Walk the talk: While pharma industry speaks all right things, in terms of ethical conduct of business, at a time when both national and international media frequently expose their gross wrongdoings. This continues, unabated. Sales and marketing functions are indeed very important, but not at the cost of good corporate governance. I am aware, all compliance rules exist immaculately on paper for many companies, but the senior management officials should demonstrate that they walk the talk, giving exemplary punishment to the wrongdoers, including their peers.
  • Change the current advocacy model: The current advocacy model of the research-based pharma companies is too self-serving. For example, in India it mostly demands, which is bordering obsession, to change the IP laws of a sovereign country, when the World Trade Organization (WTO) has no problem with these, whatsoever. There is a need for them to demonstrate, sans any shade of arrogance, visible respect to any country’s general sentiment on its Patents Act, as it’s their own decision to operate in those countries. An imaginative win-win change in this area, would significantly help to create a strong bond and mutual respect with other important stakeholders.

Are senior citizens in pharma business a barrier to change?

A recent white paper of ‘Eye for Pharma’, says in its conclusion “many of those now running pharma organizations have come through the ‘golden age’ of pharma and so may be reluctant to change”. Does this issue need to be addressed first by the Independent Directors of the respective Boards of the pharma companies?

In conclusion:

Many questions do spring up while addressing this issue. One common belief is that, pharma industry, in general, is reluctant to change its traditional business model, beyond just tweaking, despite declining overall productivity and in its public image.

In advocacy initiatives, while drawing stakeholders’ attention to the core grievance agenda, though they try hard to project their business focus on patients, especially using the buzzwords, such as, ‘patient centric approach’ or ‘patient engagement’, among many others, has anything visibly changed, just yet?

As the business environment is getting tougher and consumer expectations are fast changing, drug innovation is also steadily dwindling, so is the declining industry image. However, pharma business and advocacy models continue to remain mostly unchanged. It remains intriguing, why are the ‘wise guys’ of pharma business still so deeply obsessed with chasing rainbows, with so much of zeal, hectic activity and money, while majority of patients keeps bearing the brunt?

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.