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Protect Generic Drug Margin Moving Up The Value Chain

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As an innovative drug molecule goes off-patent, it paves the way for market-entry of cheaper generic equivalents of the same. It benefits not just the patients, but all generic drug players awaiting this opportunity. But, in case of even those generic drugs enjoying 180-day exclusivity in the United States, the price erosion would still be significant, at least, 20 percent to 30 percent. Post 180-day exclusivity, intense competition between different formulations of the same molecule can bring the price down by even 85 percent or more, as compared to the original one.

While looking at the world’s largest pharma market, one sees an interesting scenario unfolding in this area. The Generic Access and Savings Report in the United States 2018 released on July 10, 2018 by the Association for Accessible Medicines, captures it well. Some of the key findings of which on generic drugs are as follows:

  • In 2017, generic medicines account for nine out of every 10 prescriptions filled in the United States.
  • Patients fail to fill their prescriptions for brand-name drugs at a rate 2-3 times higher than for generics.
  • 93 percent of generic prescriptions are filled at $20 or less.
  • Average patient copay for a generic prescription is $6.06.
  • Generic medicines generated a total of $265 billion in savings.

That’s a good story for the patients in general, and specifically for those who are in the United States. That said, there is a business aspect of this story, as well. In this article, I shall focus on that, venturing into the way forward. However, before proceeding further, for the understanding of all, let me briefly explain, what is this 180-day exclusivity period as described by the FDA in the United States (USFDA).

180-day exclusivity period for generic drug:

USFDA may grant some exclusivity to Abbreviated New Drug Applications (ANDAs) for generic drugs. For this purpose, under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from the FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The first company to submit an ANDA with the FDA has the exclusive right to market the generic drug for 180 days. This is called 180-day exclusivity and:

  • Provides an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and running the risk of having to defend a patent infringement suit.
  • Begins either from the date the sponsor begins commercial marketing of the generic drug product, or from the date of a court decision finding the patent invalid, unenforceable or not infringed, whichever is first.
  • In some circumstances, an applicant who obtains 180-day exclusivity may be the sole marketer of a generic competitor to the innovator product for 180 days
  • FDA does not send letters to the sponsor indicating the grant of exclusivity. The Orange Book is the official vehicle for dissemination of this information.

It is worth noting that some drugs have both patent and exclusivity protections while others have just one or none. Patents and exclusivity may or may not run concurrently and may or may not encompass the same claims.

Increasing pressure on margin:

Nevertheless, after 180-day exclusivity period or as in most other cases, cut-throat price competition starts among product proliferation. On the other hand, even after patent expiry, the prices of original brand name drugs keep attracting a substantial premium. According to another study: “Brand-name drugs have been shown to be priced 20 percent higher than generic drugs in the Netherlands, 30 percent higher in Germany, 50 percent higher in Canada, 50–90 percent higher in the US, and 80 percent higher in the UK.”

In today’s environment, generic drugs are under severe cost pressure also because of direct government interventions in many large markets, such as the United States. A couple of other factors also play a major role in squeezing the generic drug margin in several countries, such as:

  • Large wholesalers while fighting with each other to get the pharmacy business, often exert tough pressure on generic manufacturers to lower the price.
  • Other bulk buyers also do the same making the margin wafer-thin.

Its cumulative impact leads to commoditization of generic drugs.

Commoditization of generic drugs:

As is known to many, for a commodity there are many suppliers mostly without any tangible differentiating features and benefits. The same thing happens to generic medicines of the same molecule without any worthwhile difference in efficacy, quality and safety standards. Thus, the price of a generic formulation generally includes its total cost, plus a margin, and depends market demand and supply for products outside any price control. Intense competition within many players with more supply of the same molecule, often squeezes the margin out to a dangerous level.

This scenario was well captured in an 2018 article published in the Journal of Bioequivalence & Bioavailability (volume 10(3): 48-49 (2018) –48). It reiterated, cutthroat competition and public pressure pose challenges for ethical and generic pharma companies. 7 to 10 percent annual price erosion, increased competition coupled with other pressure push margins lower leading to decreased profitability.

Major costs did not change much:

Moreover, the major fixed costs involving raw materials, packing materials, labor and conversion expenditure did not change commensurately. The manufacturing process and yield improvement measures did help. But up to a certain point and not beyond that, to keep the quality of finished formulations within the accepted regulatory requirements of the respective countries, such as the United States.

The trend prevails in 2018: 

The above trend prevails even in 2018, in continuation with the previous year. One may recall that in August 2017, due to serious price erosion, several billion dollars in market value were wiped out for some top generic companies. These names include India’s homegrown Dr. Reddy’s Lab., besides Teva and Mylan.

The article titled, ‘Opportunities and Obstacles for Generic Drugs,’ published in PharmTechalso emphasized: ‘Continued pressure on generic-drug prices may reduce product development and limit manufacturing in the US. Numerous state officials have filed lawsuits against generic-drug makers for alleged price-fixing, and debate continues over brand vs. generic product labeling to warn consumers about safety issues. All these trends will shape generic-drug production and costs in the coming months.’

In this situation, the ability of the generic companies to find ways to increase their margin will be the key to success in this business, if not for a long-term survival too.

Ways to achieve it:

One of the novel ways to achieve this goal is entry into ‘Complex Generics’ business.

According to Market Realist – an independent investment research organization, ‘Complex Generics’ are attractive due to high margins. Unlike, commoditized generic formulations, ‘complex generics’ are not easy to manufacture and are generally used in specialty care, namely for treating serious chronic diseases or several life-threatening ailments, such as cancer, HIV or hepatitis C. To some extent complex generics create a market entry barrier for many generic players, due to higher manufacturing cost and complex processes involved in developing this genre of drugs.Complex generics may be classified into several categories, such as:

  • Complex Active Ingredients: like, peptides
  • Complex Formulations: like, liposomes, iron colloids
  • Complex Delivery System: like, locally acting drugs
  • Complex Drug-Device Combinations: like respiratory metered dose inhalers, transdermal system or a medicated adhesive patch
  • Biosimilar drugs

On October 09, 2018, a statement from USFDA Commissioner Scott Gottlieb highlighted a new effort to advance the development of generic copies of complex drugs to improve patient access to medicines. Gottlieb said, complex generics “aredrugs that, by nature of their formulation or delivery systems for example, are harder to ‘genericize’ under our traditional approaches. As a result, these drugs often face less competition. Today, we’re announcing a series of guidance documents that will advance the development of generic transdermal and topical delivery systems (TDS).”

This is an interesting development in the world’s largest pharma market.

Lucrative prices of complex generics:

Prices of complex generics are much higher than conventional generic drugs. According to Market Realist a complex generic could cost around US$ 6,000 per month to patients, but would still remain way below the cost of related original brand. Hence, it is a win-win situation – both for patients and also the generic drug manufacturers. Additionally, alongside benefiting patients in terms of cost, complex generics show potential to fetch higher profitability with a reasonable product differentiation.

The ball has started rolling:

It happened in a big way this year, when due to intense price pressure on generics, Sandoz division of Novartis took a major step. On September 6, 2018 - Novartis announced that it has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solid portfolio, to Aurobindo Pharma USA Inc. It also said, ‘this transaction supports the Sandoz strategy of focusing on complex-generics, value-added medicines and biosimilars to achieve sustainable and profitable growth in the US over the long-term.’

Indian generic drug manufacturers have also sniffed this opportunity. Several Indian players, such as Sun Pharma, Cipla, Lupin, Reliance Life Science, Dr. Reddy’s Laboratories, Glenmark, Biocon and Aurobindo Pharma, to name a few, have made forays into complex generics, including biosimilars. All put together Indian companies have filed around 50 ANDAs in the United States. This number is good, but may not guarantee success for all the applicants. Only the quality of these ANDAs will determine how soon, or how late, or how expensive would be the process of getting marketing approval for complex generics in the United States.

Conclusion:

As ‘The Lancet Oncology’ editorial of June 2015 noted: ‘In recent years, generics manufacturers have increased investment in the development of complex generics.” I reckon, this won’t include a large number of drug exporters from India – not just yet.

The development process of complex generics isn’t everybody’s cup of tea. Thus, venturing into this area by any generic player of all sizes and scale, would call for greater commitment from the company concerned. This path is arduous as compared to conventional generics. If not navigated properly, cost may also be high in certain circumstances. For example, if and when the regulator asks more elaborate trial, or repeat trials, or even the marketing approval process itself could be tough to conform with. That said, complex generics are expected to eventually contribute a significant percentage of the generic market, as their approval challenges are overcome.

Be that as it may, to improve, if not for protecting the profitability of the generic drug business, transacted especially in the developed world, there doesn’t seem to be much option left now, but to move up the value chain.

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.

 

Should Pharma-Doctor Communication Be Also Gender-Specific?

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Regardless of situations, while selecting a suitable doctor for patients, or for that matter, pharma companies engage with them for commercial reasons, their gender doesn’t matter much to many.

What one generally looks for is, whether they are General Practitioners (GPs), General Surgeons (GSs) or Specialists in various disease areas, such as cardiac, metabolic, bones and joints, cancer and so on. This has been happening, despite several research studies pointing out a number of important gender-based behavioral differences between most male and female doctors, often leading to a significant difference in patient outcomes.

Before proceeding further, let me admit up front that there may be some exceptions to this general scenario. For example, certain female patients may prefer being examined by the female doctors only. Similarly, a few drug companies may be tailoring the content and the process of their communication based on the target doctors’ age.

In this article, I shall try to focus on this area based on a number of important research findings. The objective being whether medical communications of pharma players should also factor-in the gender-specific nuances among male and female doctors. This is because, such differences impact clinical outcomes and happens irrespective of whether they are GPs or specialists. Let me kick-start the discussion with the following question:

“Does gender matter when choosing a doctor?”

This interesting point was raised in an article, titled “Should You Choose a Female Doctor?”, appeared in ‘The New York Times (NYT)’ on August 14, 2018. Let me put across the essence of it, quoting from some large research findings.

The August 21, 2018 study, titled “Patient–physician gender concordance and increased mortality among female heart attack patients,” published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS). This study covered more than 580,000 heart patients admitted to emergency rooms in Florida between 1991 and 2010. After a thorough scrutiny, the researchers noted that:

  • The mortality rates for both women and men were lower when the treating physician was female.

Consequently, it appears, gender does matter, while choosing a doctor for better treatment outcomes. Nevertheless, just one illustration in this regard may not possibly be enough to drive home this point. Thus, let me quote from another important study. This one is a Harvard study that included more than 1.5 million hospitalized Medicare patients and arrived at similar conclusions, with the finding as stated hereunder.

Lower 30-day mortality under female internists than male counterparts:

This large study, published in JAMA Internal Medicine on February 2017 also concludes:Hospitalized patients who receive care from female general internists have lower 30-day mortality and readmission rates than those patients cared for by male internists.

“The difference in mortality was slight – about half a percentage point – but when applied to the entire Medicare population, it translates to 32,000 fewer deaths,” reported the above NYT article while commenting on this subject. I shall come to this finding in just a bit.

Why patient outcomes are different under the care of male and female doctors? 

To get an answer to this question, just as several other previous studies, the findings of the above issue of JAMA Internal Medicine also suggest more studies in this area. The aim is to zero-in on the key differences in practice patterns between male and female physicians, which may have important clinical implications for patient outcomes.

The researchers observed, understanding exactly why these differences in care quality and practice patterns exist may provide valuable insights into improving quality of care for all patients, irrespective of who provides their care.

Curiously, this question was answered in a 2002 study published in the JAMA that found female doctors spend more times with patients.

Female doctors spend more times with patients:

The paper, titled “Physician gender effects in medical communication: a meta-analytic review” wanted to find out why patient outcomes are different under the care of male and female doctors?This study was published in the August 14, 2002 issue of JAMA. It found, “Female primary care physicians engage in more communication that can be considered patient centered and have longer visits than their male colleagues.”The average difference in time spent with patients between male and female physicians is about 2 minutes, or 10 percent, per visit.

The researchers also found that female physicians engage in communication that mostly relates to the larger life context of patient conditions. It includes addressing psychosocial issues through related questions and counseling, greater use of emotional talk, more positive talk, and more active enlistment of patient input. From this perspective, they commented: When taken together, these elements comprise a pattern that can be broadly considered ‘patient-centered’ interviewing.

Would tailoring pharma communication accordingly fetch better dividend? 

Such highly similar findings, as evidenced by many reports, over a considerable period of time, add much credence to an important fact. These vindicate the concept that ‘patient-outcomes are better when cared by female doctors as compared to their male counterparts.’ In the pharma context, the subsequent question that surfaces: Can this finding be put to use while developing a tailor-made communication strategy with appropriate content for female doctors, harvesting a rich commercial dividend?

No doubt, before doing so, more data need to be generated and analyzed to corroborate the utility of the same in the pharma business. That said, the good news is, the work has already started in this area.

Some interesting recent findings on pharma-doctor interactions:

As reported by Fierce Pharma on October 26, 2018, moving towards this direction, CMI/Compas ventured into testing the water. It planned to find out whether drug companies should develop male and female doctor-specific communication strategy and content for more productive engagement with them. After an elaborate data analysis, CMI/Compas found the following:

  • As the most important source of new product information 59 percent of older-male-doctors rank pharma sales reps much higher. Whereas, only 46 percent of older-female-doctors’ think so.
  • 47 percent of older-male-doctors were most likely to see sales reps without any restrictions. Whereas, less than 40 percent of the other group saw reps without placing any hurdles to their visits.
  • Female physicians of all generations were found more likely to rank medical websites and online drug reference guides as more important tools than their male counterparts.
  • Women doctors are also likely to encourage patients using websites, electronic medical records and patient support programs more frequently than their male counterparts.
  • After receiving requisite information from pharma source, especially younger women doctors, are more likely:

- To change a patient’s treatment (20 percent).

- Try a new product (22 percent).

- Conduct more research using other sources (40 percent).

Conclusion:

These research findings do provide a fresh food for thought for the pharma strategists to ascertain whether a new ground exists to further hone the conversation between drug companies and the doctors. More specific point to ponder is, whether an avant-garde, as it were, customer-segmentation strategy be put to use, while devising a sharply focused communication and content for the male and female doctors, separately for each.

Coming back to where I started from: Should pharma-doctor communication be gender-specific? In my view, enough credible evidences, as captured in several large studies, send a clear signal towards an affirmative answer. Nevertheless, individual company would still be required to meticulously vet it out internally, for the best possible results.

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.

An Interesting demand: No Price Control For OTC Drugs

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Since over a decade, some pharma trade organizations operating in India, have been advocating for a separate regulatory policy for ‘Over The Counter (OTC)’ drugs, which can be legally sold without any medical prescriptions. Such a new policy initiative, if taken by the Indian Government, would call for inclusion of a separate Rule and a Schedule in the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.

In the midst of cacophony related to Intellectual Property (IP) related priority of the industry in multiple areas, OTC drug advocacy took a back-seat, temporarily. Some recent developments indicate, it has again been taken out of the trade associations’ archive, well-dusted, rehashed and re-presented. Today’s key driver is likely to be increasingly stringent drug price control measures of the government. An emphatic demand of the pharma trade associations that OTC drugs should be kept outside drug price control measures, vindicates this point.

In this article, I shall deliberate this issue, especially on raising the same old demand – yet again, and my concerns on the demand of free-pricing for essential OTC drugs, in the Indian context.

OTC drugs – no legal status in India:

Currently, OTC drugs have no legal status in India. However, those drugs which don’t feature under ‘prescription only’ medicines are construed as ‘non-prescription’ drugs and sold over the counter at pharma retail outlets.

Neither is there any concept currently existing in India, which is similar to ‘prescription only to OTC drug switch,’ unlike many developed countries, such as UK, EU and United States. Thus, before proceeding further, let me deliberate on the important point – why is ‘prescription only drug’ to ‘OTC drug’ switch. Let me briefly dwell on this issue, quoting from a neutral source – the World Health Organization (W.H.O).

‘The basic purpose of re-designation of a drug as an OTC product is commercial’:  

The Essential Medicines and Health Products Information Portal – A World Health Organization resource illustrates the point as: After a new drug has been in use as a prescription-only medicine (POM) for an agreed period after licensing – usually five years – and has proved to be safe and effective during that time, regulatory authorities are prepared to consider submissions for re-designating the product where appropriate so that it becomes available for non-prescription “over the counter” (OTC) use.

The article further states: “The basic purpose of re-designation of a drug as an OTC product is frankly commercial; the manufacturer requests the change in the hope that, without the need for a prescription, the sale of the drug will increase. However, the change also has a secondary effect in that the drug will no longer – at least in its OTC form – be primarily funded by a national health system or insurance fund; if he had obtained the drug by private purchase, the patient will pay for it in cash, and this will therefore result in cost savings to the health system.”

Benefits of OTC drugs to patients in the western world:

An article titled, ‘When Rx-to-OTC Switch Medications Become Generic’,published in the U.S. Pharmacist on June 19, 2008, highlights the key benefits of generic OTC drugs to patients, mostly in the western world as follows:

  • Prices for generic OTC versions are lower than those for the branded products.
  • The savings vary from product to product, but they can be as little as 11 percent (some omeprazole generics) to over 75 percent (some loratadine generics).
  • The cost savings can be critical in making self-care decisions.
  • For patients with a chronic, self-treatable medical condition, the addition of a new generic OTC with that indication expands the range of therapeutic options.

Endorsing the point that ‘OTC drug’ cost significantly less than the ‘prescription only drug’ other studies also point out the following:

  • Less lost work time and costs saved by not needing to visit a doctor are important considerations.
  • Growing sophistication and self-reliance among consumers, with increasing interest in and knowledge about appropriate self-medication.
  • Older adults in particular tend to experience increased minor medical problems, such as arthritis, sleeping difficulties, muscle aches and pains, headaches and colds. Thus, as the population ages the demand for non-prescription drugs escalates.

To illustrate the point of greater choice to patients, the article cited an example of allergic rhinitis patients. It pointed out that at one time, such patients had little to choose from other than older (first-generation) antihistamines. When loratadine (Claritin) and cetirizine (Zyrtec) switched from ‘prescription only’ to generic OTC drugs, price-conscious patients got the expanded option to choose from them based on their unique advantages and lower prices.

Benefits of OTC drugs for drug manufacturers:

Several studies concluded the following when it comes to benefits of OTC drugs for the drug manufacturers:

  • When an innovative drug loses patent protection, expanding into OTC segment with the same product can help a lot in the product life-cycle management.
  • Additional revenue with OTC drugs help increasing the concerned company’s both top and the bottom-lines.

Does ‘only prescription drug’ to ‘OTC drug’ switch help Indian patients?

The key benefit that patients derive out of any switch from ‘prescription only drug’ to ‘OTC drug’ switch, has been shown as cheaper price of generic OTC drugs. In India that question doesn’t arise, because an ‘OTC generic drug’ can’t possibly be cheaper than ‘prescription only generic drugs’ of the same molecule. On the contrary, if the demand for putting generic drug outside price control is implemented, it would likely to make ‘OTC generic essential drugs’ more expensive- increasing already high out of pocket (OOP) drug expenses, without benefitting patients, tangibly.

How would OTC drugs help patients in India?

According to reports, pharma trade associations claim that ‘OTC drugs will help Indian patients. Some of the reasons given by them are as follows:

  • Responsible self-medication: Empowers patients to make responsible and wise choices and self-manage their health outcomes.
  • Improves access to medicines: ‘Access to medicines’ in India has long ignored the critical role of the viability of OTC medicine, which could play a critical role in improving access to medicines in India, especially in the remote areas.
  • Help both health system and consumers saving money: OTC medicines save health systems valuable resources and can save consumers time and money.

While the basic purpose of re-designation of a drug as an OTC product is commercial – as articulated in the above article of the W.H.O, it is interesting to note, how it is being camouflaged in India by a trade association. The association demands a brand new OTC drug regulatory policy without any price control, and at the same time says, ‘the patient is at the core of all our activities.’ I wonder how – by increasing the burden of OOP drug expenses for patients? Let me try to fathom it raising some basic questions, in context.

Some basic questions:

While trying to understand each of the above three ‘patient benefits with OTC drugs’, as highlighted by the pharma trade association, I would strive to ferret out the basic questions in this regard, as follows:

  • Responsible self-medication:Fine. But again, won’t it make totally price and promotion deregulated OTC drugs more expensive than the existing equivalents of essential drugs – significantly increasing OOP for patients?
  • Improves access to medicines: Improving drug access comes with increasing affordability, especially in India. With OTC drugs being presumably higher priced than other generic equivalents, how would it improve access? Just to illustrate this point, one pharma trade association has cited examples of the following drugs, for inclusion in the OTC category:

“Paracetamol, Aspirin, Antacids, Topical preparations of certain NSAIDs (Ibuprofen, Diclofenac), Cetirizine, Albendazole, Mebendazole, Povidone‐Iodine preparations, Ranitidine, Ibuprofen (200mg), Normal saline nasal drops, Xymetazoline nasal drops, etc. In addition to all Drugs which are currently under Schedule K.”

If the prices of OTC versions of the above drugs are kept more than the prevailing ceiling prices for essential, would it benefit the patients and improve access to these drugs for them?

  • Help both health system and consumers saving money: Doesn’t the same reason hold good for this one too?

One may also justifiably ask, why am I presuming that OTC drug prices will be more than their non-OTC equivalents? My counter question will be, why is the demand for total regulation of price for OTC drugs? In any case, if a non-schedule drug is included in the OTC category, the question of any price control doesn’t arise in any way.

The current status in India:

Unrestricted sale of ‘prescription only drugs’, including all antibiotics and psychotropic drugs, is rampant in India, causing great harm to the Indian population. In tandem with strict enforcement of the drug dispensing rules in India, a separate patient-friendly category of OTC drugs would certainly help significantly. As a concept, there is no question to it. But the devil is in the detail of demand for the same.

Accordingly, in November 2016, the Drugs Consultative Committee (DCC) formed a sub-committee for charting a regulatory pathway for sale of OTC drugs in India, specifying punitive measures for any violation of the same. As I indicated above, currently, any drug that doesn’t not fall under a prescribed schedule could be sold and purchased without a medical prescription. This panel has sought all stakeholders’ comments and suggestions on the same. Some of the responses from pharma trade associations, as requested for, I have deliberated above. Nevertheless, the bottom-line is, nothing tangible in this regard has happened till date.

Conclusion:

As I envisage – if, as and when it happens, it is also likely to have an adverse impact on the sales and profits of many pharma players. This is primarily because, indiscriminate drug use – irrespective of self-medication or irrational prescription, do fetch good sales for them. But it shouldn’t continue any more – for the benefit of patients.

More importantly, the key argument showcased in favor of OTC drugs in India, seems to be a borrowed one – borrowed from a totally different pharma environment of the western world. Out of Pocket drug expenditure for patients, which is already very high in India, shouldn’t be allowed to go further north. Some of the India-specific intents of pharma trade associations also appear blatantly self-serving, such as total deregulation of price and promotion. It rekindles huge concerns, such as:

  • What could possibly be the key intent behind keeping essential OTC drugs outside existing price control?
  • If so, won’t it open yet another floodgate of hoodwinking price regulation of ‘essential drugs’ through crafty manipulations?

It would be a different matter though, if such OTC drugs do not fall under ‘essential drugs’ category.

Thus, in my overall perspective – ‘no price control for OTC drugs’, is an interesting demand of pharma players, but not surprising in any way – at all.

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.

Why Many Successful CEOs Don’t Want to Retire – in Pharma Too?

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“On Eve of Retirement, Jack Welch Decides to Stick Around GE a Bit,” reported the Wall Street Journal (WSJ) on October 23, 2000. Nevertheless, even the legendary Jack Welsh was made no exception to GE’s mandatory retirement policy for the CEO at 65. After holding the position of Chairman and CEO of GE for 20 years – with stellar performances, Welsh had to retire on September 07, 2001, as he attained that age.

This happened almost immediately after the US$ 45 billion merger with Honeywell. Welsh spearheaded this initiative, intending to create one of the world’s largest industrial companies, with manufacturing operations in plastics, chemicals and aerospace products, at that time. It’s a different matter altogether that later on, the report onThe Anatomy of the GE-Honeywell Disaster narrated a different reality on the consequences of this acquisition.

The key point to ponder – why many successful CEOs don’t want to easily retire, passing on the baton to a younger generation, unless directly or indirectly compelled by the investors or the regulators. In this article, I shall try to explore this point.

Many older CEOs not eager to head into retirement:

While discussing a similar point, an article titled: “For older CEOs, the issue is knowing when to bow out,” published in the USA Today on April 19, 2016, made some interesting observations. It said: “Just as older employees stay in jobs out of desire or necessity, some of those occupying the C-suite aren’t eager to head into retirement.”

According to a survey done by Korn Ferry among Fortune 500 CEOs, over the past decade:

  • The number of CEOs with age between 65 and 60 years, nearly doubled to 36.
  • Those with age between 70 and 74 increased from 9 to 13.

Korn Ferry also found in another survey that CEOs are the oldest and longest-tenured individuals compared with other prominent C-suite roles. Some of the oldest and famous global CEO names would include, Warren Buffett – 85 years of Berkshire Hathaway and Rupert Murdoch – also aged 85 years and is the Executive Chairman of News Corp. and Twenty-First Century Fox.

A couple of Indian examples of large Indian business conglomerates would include, A. M. Naik (born on June 09, 1942) who served as the Group Executive Chairman of L&T even at the age of 75 and the other – Y.V. Yogeshwar (born on February 04, 1947) was at the helm as the Executive Chairman and Chief Executive Officer at ITC Ltd till February 4, 2017, at the age of 70. More recently, on October 22, 2018, the Reserve Bank of India accorded its approval for reappointment of Mr. Aditya Puri as its MD & CEO of HDFC Bank Ltd. till October 26, 2020 – the date of his attaining age of 70 years.

What’s happening in the pharma industry?

The pharma industry too is no different. For example, Merck & Co’s distinguished top leader – Kenneth Frazier, who turns 65 on December 2019, will stay on as CEO beyond 2019. This was reported on September 26, 2018 stating that Merck has scrapped the policy requiring its CEO to retire at the age of 65. Curiously, this announcement is quite unlike what we witnessed in a similar case with GE where no exception made to the CEO retirement policy even for someone as globally famous as Jack Welsh.

Another recent example from the pharma industry, would possibly include one more celebrated pharma CEO – Abbott’s Miles White. He is currently at 63 and in his 20th year as the Chairman and Chief Executive of Abbott Laboratories. Just as Merck & Co, Abbott also announced that White doesn’t have any plans to leave his position as Chairman and CEO “anytime soon.” This happened, after the appointment of company’s President and Chief Operating Officer (COO), which is the first official No. 2 executive and COO Abbott happening after more than a decade, as reported on October 18, 2018.

A couple of similar examples from India that I gathered from the available data, may include: Pankaj Patel, 67 years (born 1951), the Executive Chairman of Cadila Healthcare and Basudeo Narain Singh,  reportedly 77 years of age, currently the Executive Chairman at Alkem Laboratories Ltd. Let me hasten to add, these names are absolutely illustrative, and not intended to be specific to individuals, in any way.

All publicly listed companies and not privately held:

The companies that I have quoted above, both global and local, are publicly listed companies. Thus, their ownership is dispersed among the general public in many shares of stock, which are freely traded on a stock exchange, or in over the counter markets. In view of this, the general questions come up:

  • Why the incumbent CEO can’t develop a successor from within or even outside the company during his/her tenure spanning over so many years?
  • Is there any other underlying reason for the same? If so, what it is?

Not considering the country-heads of MNCs in India:

Let me admit upfront with all due respect, for the purpose of this discussion, I am not considering the country-heads of pharma MNCs in India. This is mainly because, they don’t fall in the same category as the CEOs of Indian publicly listed pharma companies, having much broader global responsibility, commensurate authority and accountability.

At the most, the country heads of pharma MNCs may be compared with those managers who are in charge of only India, or South Asia operations of the domestic pharma players. Which is why, country heads of MNCs are commonly called ‘General Managers’ – internally, especially by their respective headquarters.

Is mandatory CEO retirement policy a good idea?

There are many studies on whether a mandatory CEO retirement policy is a good idea. I shall quote below one such important study to illustrate the point.

‘Should Older CEOs Be Forced to Retire?’ That’s the title of an article, published in the Harvard Business Review (HBR) on February 15, 2016. The author found that more than a third of S&P 500 firms have a mandatory retirement policy for their CEOs. The aim is to drive out executives who are past their prime. In the overall perspective, the HBR article is in sync with the idea.

Referring to a research paper recently published in the Journal of Empirical Finance, the above article highlighted some important findings of the researchers, as below:

  • Older CEOs were less “active,” as measured by a mix of hiring, firing, mergers, joint ventures, and more.
  • Mandatory retirement helped firms avoid the declining performance associated with older CEOs.
  • The negative correlation between CEO age and firm performance disappeared in companies with mandatory CEO retirement policies.
  • Mandatory retirement seemed to be helping firms with older CEOs to avoid the under-performance trap.
  • Length of CEOs’ executive experience plays a great role in a company’s financial success.
  • When there are two CEO candidates, both having requisite experience of equal number of years, the data suggests the younger one should be preferred.
  • Conversely, when there are two CEO candidates of the same age, bet on the one who’s been with the firm longer.

Should CEO retire at the peak of his/her golden era? 

This issue seems to be a contentious one. Be that as it may, about one third of S&P 500 firms have mandatory retirement policies for their CEOs. The goal is to systematically let go of leaders who are past their peak performance years.

An article published in The Washington Post on September 27, 2018 came with a headline: ‘Fewer companies are forcing CEOs to retire when they hit their golden years.’ It observed: ‘Sometimes a mandatory retirement age is lifted to give the current chief executive a little more time on the job, potentially clearing the way for a successor to prepare. For instance, in June 2017, manufacturing giant 3M said its board of directors was waiving the mandatory retirement age of 65 for its then-CEO, Inge Thulin, and then named a successor, chief operating officer Michael Roman, earlier this year.’

While retirement norms may be shifting, there’s seems to be a trend of indirect pressure on companies to add younger executives and directors to the board. This is primarily prompted by a growing demand for digital insights and technology experience in the CEO position – commented another article published in the Los Angeles Times on September 28, 2018. It also reported, many experts on corporate governance and executive succession believe that rescinding its policy requiring the CEO to retire at the age of 65, Merck & Co, ‘added to a long downward trend in the companies that have mandatory retirement ages for their top executives.’

Conclusion:

Regardless of whether a mandatory CEO retirement policy is a good idea or not, the aging high performing CEO’s desire to continue with the job for an indefinite period, has some downsides. It could thwart aspiration of similar high performing younger direct reports of the CEO. They include especially those who are ready to take charge and catapult the organization to a greater height of success, sooner.

A CEO’s desire to continue with the job, even after a generally accepted age of retirement, could also adversely impact a well-charted succession planning process for the top position. A time-bound succession plan is essential not only for a natural and smooth transition in the CEO position of an organization, but also to address any unforeseen emergency, such as a ‘drop dead like situation.’

Further, if there is no mandatory CEO retirement policy, or even rescinding it when there is one for a high a performing CEO, why there should be such policy for other C-suite, or many other important leadership positions of the same organization, with similar performance records?

One of the reasons behind a high performing aging CEO or an Executive Chairman not wanting to retire may also include the intent of the Board members to play safe. Nevertheless, it is a complicated and contentious issue. Regardless of whatever reasons lead to such a situation, the point to ponder is: What signal does it send to other high performing leaders? Does it convey, even the CEO is governed by similar policies as applied to other leaders of the corporation? Or, it smacks of a a discretionary corporate culture of governance? There is a need to ferret out a robust answer to this question – for a long-term sustainable success of any organization, including pharma.

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.

‘One Indian, One Health Record’: Is EHR A Tentative Intent?

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The ongoing march of technology, at a scorching pace, transforming our everyday personal – working and social lives. This is palpable. In tandem, it is also making traditional processes of doing successful business less and less productive, over a period of time. The same is more than visible in the healthcare space too. One such field – although not so widely discussed just yet, is maintaining Electronic Health Record (EHR). This is so important for both patients and healthcare providers to ensure significantly better treatment outcomes at a lesser cost, and reducing disease burden of disease too, in that endeavor.

EHR being a systematic, ongoing process of maintaining health records of every individual, help provide prompt, effective and safe health care for all. It helps immensely whenever the person visits a doctor either in private clinics or in any health center for treatment of any disease condition, or even for preventive measures.

Health profession bodies in various countries have articulated what should get included in the health record of individuals. Let me draw an example from one of the BRICS nations. The Health Profession Council of South Africa (HPCSA) defines health records as “any relevant record made by a health care practitioner at the time of, or subsequent to, a consultation and/or examination or the application of health management”. Since, over any person’s lifetime a massive health data gets generated, the current trend is to capture and store such medical data electronically and is, therefore, called ‘Electronic Health Record’ or EHR.

Laudably, India also formally notified its detail intent to make EHR system work in the country. In this article, I shall deliberate on what is the current status of EHR in India, and the key barriers that need to be overcome to make the process gain momentum, in the days ahead.

What EHR can do:

Before zeroing on to India specific initiative on EHR, let me recapitulate what it entails, quoting from a credible global source. According to Health IT- the official website of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services, being real-time- patient-centered records, EHRs make health information available instantly, “whenever and wherever it is needed”. As this process brings together in one place everything about a patient’s health, EHRs can:

  • Contain information about a patient’s medical history, diagnoses, medications, immunization dates, allergies, radiology images, and lab and test results
  • Offer access to evidence-based tools that providers can use in making decisions about a patient’s care
  • Automate and streamline provider’s workflow
  • Increase organization and accuracy of patient information
  • Support key market changes in payer requirements and consumer expectations

Let me reiterate at this point, a person’ EHR can bring together all health information from all the doctors visited at private clinics, hospital, health centers, school and workplace clinics, pharmacies and diagnostic facilities. In many countries, EHRs can be created, managed, and consulted by authorized providers and staff across more than one health care organization. This process has been followed, though in a very limited way, in India, as well.

EHR initiative in India:

In sync with Prime Minister Narendra Modi’s Digital India initiative, India reconfirmed its EHR initiative, just as ‘Aadhar’. By a notification, it explained how a cloud-based hospital application system will receive real-time health data of all individuals generated during any clinical encounter or events. Interestingly, EHR standards were first notified by the Indian government in 2013.

Be that as it may, with a fresh vow to popularize EHR in the country, especially among the health care providers, the Ministry of Health and Family Welfares revised the 2013 EHR standards and notified the same on December 30, 2016. A paper titled ‘EHR Adoption in India: Potential and the Challenges’, published in the Indian Journal of Science and Technology in September 2016, presents some interesting findings. Some of these are as follows:

  • Adoption of EHR has been significantly less in India as compared to other developed nations. This is despite the government’s enhancing the budget to US$ 19.2 billion for HIT for its greater acceptance and influence returns.
  • The reason may be attributed to the fact that EHR is not yet mandatory in India. (In my personal view, this is quite unlike what was Aadhar, for a plethora of government and private services, till the Supreme Court verdict came.)
  • In many countries implementation of EHR in the health care system is working very well, benefiting both healthcare providers and the patients, immensely.

The key barriers: 

The above paper identified the following as the key barriers to EHR implementation in India:

  • Legacy System: Most of the patient records are paper based documents. It’s challenging to convert the paper-based records to an electronic format.
  • Cost: High cost of implementation.
  • Policy: Absence of coordinated policy of Government. Lack of clarity in the existing policies of HIT.
  • Funding: Current actual funding of the government for HIT is grossly inadequate, besides lack of well-trained medical informatics professionals.
  • Standards: Most systems don’t adhere to standards, besides usage of multiple local languages by patients and staff.
  • Computer Literacy: Low Computer literacy among government staff and private hospital community, and lack of adequate system training on proper usage of the HER.
  • Coordination and Infrastructure: Lack of coordination and supporting infrastructure (including the hardware and software) among both public and private sector hospitals.
  • Privacy Concerns: Privacy concern on the confidentiality of patient health record needs to be properly addressed.

That’s a 2016 report, what’s happening in 2018?

One may justifiably comment and ask – the above details are of 2016, what is happening today – in 2018?

Even after 2 years since then, EHR still remains at a nascent stage in India, with the keep barriers refusing to get dislodged. The July 16, 2018 media headline – ‘Adoption of e-medical records facing infra hurdles’ clarifies it. It says: “The government is facing serious challenges in its efforts to adopt an electronic health record (EHR) system.” This news report quotes the latest report prepared by the ministry of electronics and information technology (MeitY), titled ‘Adoption of Electronic Health Records: A Roadmap for India’.

This paper highlights that the government is still facing serious challenges in adopting (EHR) system for every Indian’s medical record that can be accessed by doctors and hospitals – transforming the speed, quality and cost of healthcare in India.  Intriguingly, the challenges, continue to range from infrastructure creation, policy and regulations, standards and interoperability to research and development.

The report also emphasized: “With more than 75 percent of outpatients and more than 60 percent of inpatients in India being treated in private health care facilities, it is necessary for the government to bring these establishments on-board for using EHR. In view of the size of the country, there is a need to take a Free and Open Source Software (FOSS) approach to make good quality software available to hospitals and individual practitioners.”

EHR in the United Staes and other countries:

According to the ASHP National Survey of Pharmacy Practice in Hospital Settings: Prescribing and Transcribing – 2016, ninety-nine percent of hospitals across the United States now use EHR systems, compared to about 31 percent in 2003. Computerized prescriber-order-entry (CPOE) systems with clinical decision support are used by 96 percent of hospitals.

As indicated in the above September 2016 article of the published in the Indian Journal of Science and Technology the EHR implementation rate in China is 96 percent, Brazil – 92 percent, France – 85 percent, and even in Russia the same is at 93 percent.

EHR, in various form is working in many other countries of the world. Let me cite an example from nearer home. As captured in the Accenture paper titled “Singapore’s Journey to Build a National Electronic Health Record System,” Singapore government has articulated the essence of EHR with its vision that is easy to understand and remember by all – “One Singaporean, One Health Record.” To improve health care quality for all residents, increase patient safety, lower health care costs and develop more effective health policies, Singapore’s MOH created this vision that enables patient health records to be shared across the nation’s healthcare ecosystem.

Conclusion:

Borrowing the concept of Singapore, I reckon, EHR should also mean to all Indians: “One Indian, One Health Record.” I fully agree that this process isn’t easy. Many barriers require to be overcome in pursuit of this pathway – successfully. No country found this process easy, neither it is expected in India.

That said, the key question is, can India do it successfully in a relatively short period of time? My answer undoubtedly will be an emphatic yes. This is because India has the world-class IT service providers, such as Infosys, TCS and Wipro, to name a few. It means, India has the capability. Does India have the financial resources, as well? Going by the incumbent government notification on the implementation of the revised EHR standards in India, together with what it says about the country’s economic robustness – I would again say – yes, the country possibly has the financial resources too.

It seems very much possible, also considering what the last two successive governments could conceptualize, structure and implement – a massive project of similar nature and magnitude for all Indians – ‘Aadhar’. When ‘Aadhar’ could so quickly be linked with all services – provided virtually by all public and private organizations, why can’t EHR be linked with all health records of every Indian, backed by appropriate infrastructure, human resources, laws and policies?

If a new law is required for addressing privacy and ownership concerns on health data generated for all, so be it! Doesn’t this initiative need to be visible to all – just as ‘Aadhar’ project, with a priority tag attached to it?

Thus, from the perspective of ‘One Indian, One Health Record’, government notification on EHR standards in 2013, and then revising and notifying the same in 2016, appears to be no more than a tentative intent. It has been happening to several important public health care initiatives for long, and continues to happen even today.

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.

Holistic Disease Treatment Solution: Critical For Pharma Success

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The speculation over quite some time has ended now. The most important C-suite office of the world’s top pharma company will find a brand-new occupant at the dawn of a brand-new year, on January 01, 2019. Albert Bourla will now be on the saddle to lead Pfizer moving towards a new horizon of success, in place of Ian Read.

What makes this change interesting to me, is the new leader’s not just shaking up the top team at Pfizer, but his simultaneous announcement for another brand-new C-Suite role in the company – The Chief Digital Officer (CDO). She will ‘lead the company’s digital efforts across research, discovery and business processes.’

Merck & Co. also joined ‘the chief digital officer parade’ on October 17, 2018 when it announced the appointment of chief information and digital officer, also as a member of the company’s Executive Committee. Notwithstanding a few global pharma companies’ have already started creating this role, the timing of this initiative by the top global pharma player, sends an interesting signal to many. Undoubtedly, it is a strategic move, and is surely backed by a profound intent. In this article, while exploring this point I shall try to fathom whether or not any fundamental change is taking shape in the strategic space of pharma business.

A fundamental change is taking shape:

This fundamental change, I reckon, is driven by realization that just discovery of new medicines, high quality manufacturing and high voltage marketing can no longer be regarded as success potent in the industry. There emerges a palpable and growing demand for holistic solutions in the disease treatment process, for optimal clinical outcomes and reduction of the burden of disease.

That several top global pharma companies have recognized this fact, is vindicated by what the Sandoz Division of Novartis acknowledged on its website. It quoted Vas Narasimhan – CEO of Novartis saying: “We are on the verge of a digital revolution across every aspect of the healthcare sector, from the lab bench to the patient’s bedside.”

Interestingly, pharma stakeholders’ interests and expectations, including those of patients, are also progressing in the same direction. This, in turn, is changing the way of leading and managing a pharma business – requiring a kind leadership with specific expertise in several new areas. The new C-suite position for a CDO is a proof of this change gathering strong tailwind.

What prompts this change?

As I see it, besides scores of other associated factors that digital technology offers to all, a single characteristic that stands out is the changing patients’ expectations for optimal clinical outcomes out of an affordable and involved disease treatment process.

This has always been so, but is now changing from mere expectations or just a hope, to patients’ demand, from both physicians and the pharma companies. This is a clear writing on the wall in the days ahead, and all concerned should take note of it, seriously. Does it mean that the broad flowchart of the disease-treatment-process, as I call it, has changed? Before delving into that area, let me briefly explain what exactly I mean by saying so.

A flowchart of the disease-treatment-process:

The broad flowchart for most of the disease-treatment-process, have primarily 6 ‘touchpoints’ or points of references, as I see it, which may be summarized as follows:

Patients – Signs & Symptoms – Doctors – Diagnosis – Medicines – Clinical outcomes

This means, patients with signs and symptoms of a disease come to the doctors. With various diagnostic tests, the disease or a combination of diseases is diagnosed. Then, doctors prescribe medicines or any other required medical interventions for desired clinical outcomes.

Has it changed now?

There doesn’t seem to be any fundamental change in this flowchart even today. But, the way the pharma players cherry-pick their areas of focus from its various touch points, is undergoing a metamorphosis.

As it stands today, to sell medicines – innovative or even generic pharma companies primarily focus on the doctors and off-late on patients – but just a few of them, to offer clinical outcomes better or same as others. In the evolving new paradigm, a successful drug companies would need to focus on each of these six elements of the flowchart with great expertise and sensitivity, from the patients’ perspective.

The position of CDO is expected to be a great enabler to facilitate the process of integrating all the touchpoints in the disease-treatment-flow. This will, in turn, offer a holistic treatment solution for patients – selling more medicines being the endpoint of this objective. If it doesn’t happen, the touchpoints where pharma is not focusing today would be captured soon by the non-pharma tech players. This will make achieving the financial goals of the organization even more difficult.

Let me illustrate this point by adding just one important area from this flowchart to the traditional pharma focus areas. This touchpoint goes hand in hand with the prescription of medicines – medical diagnosis. Providing patient- friendly disease prevention and monitoring tools may be yet another such area.

Current accuracy of medical diagnosis – ‘only correct in 80 percent of cases’:

The above was quoted by Sandoz (a Division of Novartis) in its website. It highlighted that the researchers at John Radcliffe Hospital in Oxford, UK found that several medical diagnoses based on a limited range of factors are only correct in 80 percent of cases. It means ‘a diagnosis may miss imminent heart attacks, or it may lead to an unnecessary operation,’ it said.

The January 31, 2018 article published by Futurism.com - the publishing arm of Futurism, based in New York City, also underscores some interesting facts in this regard, including the above example. Some of these are fascinating, as I quote hereunder:

  • Researchers at the John Radcliffe Hospital in Oxford, England, developed an AI diagnostics system that’s more accurate than doctors at diagnosing heart disease, at least 80 percent of the time.
  • At Harvard University, researchers created a “smart” microscope that can detect potentially lethal blood infections with a 95 percent accuracy rate.
  • A study from Showa University in Yokohama, Japan revealed that a new computer-aided endoscopic system can reveal signs of potentially cancerous growths in the colon with 94 percent sensitivity, 79 percent specificity, and 86 percent accuracy.
  • In one study, published in December 2017 by JAMA, it was found that deep learning algorithms were able to better diagnose metastatic breast cancer than human radiologists when under a time crunch. While human radiologists may do well when they have unrestricted time to review cases, in the real world a rapid diagnosis could make the difference between life and death for patients.
  • When challenged to glean meaningful insights from the genetic data of tumor cells, human experts took about 160 hours to review and provide treatment recommendations based on their findings. IBM’s Watson took just ten minutes to deliver the same actionable advice.

Thus, the bottom-line is: Medical or clinical diagnosis is a crucial area where the tech savvy environment can add significant unmet needs to save lives of many. Consequently, this space is emerging as an Eldorado, as it were, for all those who are seriously interested in diving deep in search of a golden future in the related business.

Technological players are making forays:

Several tech companies have sensed the reward of a pot of gold in the above space, despite the journey being quite arduous. Consequently, many of them are coming up with user-friendly and disease-specific digital tools and health apps, compatible with smart phones or smart watches. These help patients monitoring their own health data, independently, and be aware of the disease progression, if any. Simultaneously, it also enables physicians not only to accurately diagnose a disease, but also to keep a careful vigil on the progress of the treatment.

To illustrate the point with an example – say about Apple. The company began making inroads into the healthcare space with health apps and fitness-tracking via iPhone and Apple Watch. Interestingly, riding on partnership and acquisition initiatives, it is now carving a niche for itself to provide complete health records of the users by capturing relevant disease-specific clinical data.

Apple Watch Series 4, for example, has ECG feature and the ability to detect irregular heart-rhythm, which is US-FDA approved. Reports indicate the company is also in the process of developing a non-invasive glucose monitoring tool, besides many others. Curiously, the company has already given a signal to extend the usage of iPhone to a reliable diagnostic tool for many disease conditions. Most important to note is, this concept is fast gaining popularity.

Calls for of a holistic approach in the disease-treatment process-flow: 

As this trend keeps going north, many pharma companies are realizing the underlying opportunity to adopt a holistic strategic business approach to move into the new frontier. This would encompass the entire disease-treatment-process-flow with digital technology, across the organization. Before other non-pharma companies firmly position themselves on the saddle while entering into this area, pharma needs to move fast. This calls for an urgent action to collaborate with tech companies in all the critical touchpoints of this flow, including diagnosis. That this realization gas dawned in pharma is evident from a number of related developments. Let me quote just a couple of examples, as follows:

  • Onduo, a US$500-million diabetes-focused joint venture between Sanofi and Verily Life Sciences, an Alphabet company was founded in September 2016. Onduo recently launched its first product – an app plus, a continuous glucose-monitoring device plus an insulin pump that are all linked together. The Onduo app has a built-in coach (i.e., an electronic assistant) to help patients better manage their diabetes and accomplish their health goals.
  • GlaxoSmithKline (GSK) and Verily (formerly Google Life Sciences) have formed a joint venture to develop and commercialize bioelectronic medicine – miniaturized nerve implants that modulate electrical impulses to treat certain diseases.

Lack of digital leadership talent within the pharma industry?

It is interesting to note that both the Pfizer and Merck CDOs were recruited from non-pharma companies – Pfizer’s from Quest Diagnostics and Merck’s from Nike.  Earlier, in mid 2017, former Walmart CIO was named the Chief Digital and Technology Officer of GlaxoSmithKline. This trend probably brings to the fore, the lack of top digital leadership talent within the pharma industry.

Conclusion:

Increasingly pharma companies are realizing that enormous efforts and money spent in just marketing a drug, is producing a lesser and lesser yield, as the new paradigm unfolds. As we move on, patients no longer will want to buy just a medicine from the pharma players. They will want an integrated solution for prevention, cure or management of a disease.

At the same time, strong technology players, such as Apple, Google, IBM’s Watson are on the verge of capturing a sizeable ground, offering a gamut of patient-friendly offerings in the healthcare space. This would eventually make prescription of digital therapy a new reality. These tech companies are now entering through several virtually open doors in the disease-treatment-flow process, as I call it, primarily covering – diagnosis, disease monitoring and preventive care.

To effectively compete and grow in this environment, drug companies have to cover all the touchpoints of this process, not just the selective ones as are generally happening even today.

Creation of a new C-suite position of Chief Digital Officer to address this issue in a holistic away, across the organization, gives a clear signal to this realization. Thus, I reckon, offering a holistic treatment solution, covering all the touchpoints in the disease-treatment-flow process will be a new normal for pharma, not just for excellence in business, but for a long-term survival too.

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.

Trees Die From The Top: Apt For Pharma Leadership Too?

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The Management Guru of all-time – Peter F. Drucker once said: “The spirit of an organization is created from the top… If an organization is great in spirit, it is because the spirit of its top people is great.” As “Trees die from the top”, no one should ever become a strategist unless he or she is willing to have his or her character serve as a model for subordinates – Drucker emphasized.

Decades after this assertion from Drucker, meant for management practitioners, it is discernible even today how irrefutable these axioms are.  In the contemporary times, as well, particularly when reality bites a company hard, being caught on the wrong side of ‘generally acceptable’ ethics, value and compliance standards.

While zeroing in to pharma, soundbites usually generated at that time, especially from the top echelon of the management, seem to hint that employees down the rung are responsible for such misdeeds, besides, of course, the legacy factor.

At this moment of truth, it is also not unusual for them to romancing the utopia, as it were. Senior management comes out with several ideas, which are squeaky clean in terms of optics. Some of them also talk about introducing behavior metric on ethics and values in employee performance appraisal before releasing any performance related pay out. In this article, I shall focus on this leadership issue in view of some latest developments in this area.

The latest developments:  

Let me now come straight to the latest developments in this area, as I see around.

“Novartis links bonuses to ethics in bid to rebuild reputation” – was a headline of Reuters on September 18, 2018. It reported: “Swiss drug maker Novartis has revealed its employees only get a bonus if they meet or exceed expectations for ethical behavior as it seeks to address past shortcomings that have damaged its reputation.”

Some interesting points stand out from this report on the ownership of such alleged malpractices. These reconfirm that the reasons for the same, including the repeated allegations of such nature, are being passed on to others by the top management. For example:

  • To past practices or the legacy factor, even if the current CEO has been a part of that corporate environment, since long.
  • To employees responsible down the line, and a new system is being adopted to address the issue.

In this case, as Reuters reports: “Chief Executive Vas Narasimhan has made strengthening the Swiss drug maker’s ethics culture a priority after costly bribery scandals or legal settlements in South Korea, China and the United States.”

Interestingly, as reported by the media, “the company was also this year embroiled in a political controversy over payments it made to U.S. President Donald Trump’s ex-attorney.”  Previously, even in the clinical trial area, Japanese authorities, reportedly “uncovered serious misconduct during a trial of its leukemia drug, Tasigna.”

As I said above, in response to such incidents, the General Counsel of Novartis, reportedly expressed: “This allows us to look at the behavior metric before any money leaves Novartis and catch potential misconduct before there is any risk to our reputation.” The official further added, “You can expect us to continue focusing on resolving the legacy issues that we read about in the press, ensuring we address any remaining underlying behaviors.”

Such steps not taken for the first time by a pharma company: 

EvenGlaxoSmithKline tried something akin in the past.

“GSK scraps sales rep targets after scandal,” was the headline of December 17, 2013 edition of the Financial Times. It reported: “GlaxoSmithKline is to scrap individual sales targets for its commercial staff as it seeks to repair its image and reform working practices in the wake of allegations in China that its staff paid officials up to $500m in bribes. The move comes amid concerns over aggressive marketing across the pharmaceutical industry and follows a series of damaging regulatory probes leading to a record $ 3bn fine in the US last year.”

However, later on GlaxoSmithKline, reportedly “altered the plan when its sales began to suffer in the world’s largest market.”

Where is the real issue lying?

As“PwC‘s 21st CEO Survey: Preparing for disruption” found, 71 percent of CEOs surveyed said that their organizations face greater pressure to deliver business results in less time.

There isn’t an iota of doubt, I reckon, that pharma CEOs are under constant performance pressure from the investors and other stakeholders to deliver expected financial results. This makes them keep their eyes primarily glued on to the grindstone for churning out expected profits from the business. This also means that they expect management efforts to be generally directed to deliver ‘values’ at the least possible cost.

On the other hand, the same PwC survey findings reiterated that with rising drug costs, the demand for the drug companies to demonstrate the treatment efficacy, is increasing by manifold. Thus, “to remain competitive, Big Pharma will have to do things faster (like drug development) and cheaper for the patient, add more value for the same money, and become more proactive partners with patients and doctors in both wellness and cure” - one of the findings of this study emphasized.

It is quite common for most large to medium sized pharma companies to have in place a well-articulated organizational ‘ethics, compliance and values’, together with requisite checks and balances in the form of rigorous rules, regulations and other guidelines.

Most often these adorn the respective websites too, for public knowledge. The question, therefore, surfaces what could then possibly go wrong in the organization and where exactly does the real issue lie, while effectively managing the organizational growth?

“Non-compliance – A serious challenge to growth”: 

Serious malpractices and their related fallout in pharma business – not just in marketing, but clinical trials, manufacturing, quality assurance and other areas, are not usually due to any lack of requisite processes or expertise. These are generally serious consequences of non-compliance of various organizational norms. At times, with the indirect support of senior management, or senior management keeps their eyes closed on such non-compliances, under demanding obligation for delivering expected financial results and business growth.

Tweaking areas, such as employee performance-incentive norms, as happened in the cases of GSK or Novartis, can’t fetch a long-lasting solution in such a situation, as I see it. Nonetheless, the survey report findings of Deloitte, titled “Non-compliance – A serious challenge to growth,” are interesting to get a sense of the reasons behind the same.

Key reasons for non-compliance: 

The Deloitte report identifies some key contributors to malpractices and non-compliance in the pharma sector, indicating the percentage of survey respondents involved against each, as follows:

  • Lack of an efficient internal control/ compliance system:  61 percent
  • Weak regulatory enforcement / action taken against fraudsters:  55 percent
  • Inadequate utilization of technology tools available to identify red flags:  45 percent
  • Lack of a zero-tolerance approach towards malpractice and regulatory non-compliance:  45 percent
  • Inadequate due diligence on employees/ third party associates:  36 percent
  • Unrealistic targets/goals linked to monetary compensations:  33 percent
  • Senior management override of controls:  24 percent
  • Inadequate oversight by the Board/ Audit Committee:  06 percent

As I mentioned before, most key contributors to malpractice and non-compliance point towards a lack of senior management efficiency in internal controls, systems, and “inadequate utilization of technology tools available to identify red flags.” Curiously, no one mentions about the requirements for any fresh measures or systems to curb such incidents, in the future.

Just tweaking the present system may not help:

Just for changing the optics, tweaking the present system often doesn’t help. Many similar instances in the past, such as GSK’s example, as cited above, would vindicate this point. In the GSK case, at least, it’s the then CEO – Sir Andrew Witty expectedly realized that ‘unrealistic targets/goals linked to monetary compensations’ lead to such corruptions.

But total delinking of the core responsibility of any sales staff, namely ‘generation of top-level numbers both in volume and value’, with performance incentive, could throw some future challenges. Similar reason, presumably prompted GSK altering the plan when its sales began to suffer, at a later date.

Similarly, Novartis is, reportedly introducing a new behavioral metric as qualifying criteria for its employees to earn bonuses or incentives. Intriguingly, despite the existence of rigorous rules, regulations, guidelines and associated punitive provisions for not complying with the company ethics and values for a long-time, malpractices are still being reported today.

Thus, I wonder, how will an additional system of similar nature prevent recurrence of such incidents in the future? Anyway, only the future will tell whether a tweaking of this nature in the present system that did not work in the past, will work in this particular case effectively.

Conclusion:

The reasons for less than adequate internal controls of an organization, I reckon, fall squarely on the senior management, especially for repeat offences. Passing the blame to employees down the line or tweaking their performance appraisal system by introducing a ‘behavioral metric’, is likely to be short term, finger-pointing on the legacy factor notwithstanding.

On the contrary, these may likely to be construed as manifestations of knee-jerk reactions, and not so well-thought-out strategic measures. Neither do such repeated malpractices demonstrate a great spirit of the organization, nor do these evince astute leadership qualities of its top management.

Coming back to where I started from, quoting what the management guru Peter Drucker once said: “The spirit of an organization is created from the top… If an organization is great in spirit, it is because the spirit of its top people is great.” He also reiterated, no one should ever become a strategist unless he or she is willing to have his or her character serve as a model for subordinates This is certainly not the situation for those pharma players mired with alleged malpractices, repeatedly – not just in marketing, but in other operational areas too.

As the good old saying goes: “trees die from the top,” so is also an organization when its senior management lacks a moral compass on ethics, compliance and values. Considering what is being often reported on business malpractices within the drug industry, isn’t the saying equally apt for pharma leadership, as well?

By: Tapan J. Ray   

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

Pharma Policy Execution Gap Limits Access To Affordable Medicines?

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“The cost of new drugs is putting increasing pressure on people in both rich and poor countries”- was eloquently expressed in an article, titled “Why do new medicines cost so much, and what can we do about it?”. This was published by “The Guardian” on April 09, 2018.

Almost synchronically, expressing concern on this issue, the World Health Organization (W.H.O) advised the world leaders ‘to take bold new approaches’ for increasing access to medicines for all. A UN high-level panel on ‘access to medicines’ spent almost a year deliberating over related issues. The panel members were from pharma companies, as well as civil society and academics. The final report coming in September, backed de-linkage of the costs of R&D from the eventual price of the drug. Notably, the author who is also the health editor of the above publication, feels that any positive outcome in this direction is unlikely to materialize soon.

The majority of big pharma constituents, with the possible exception of GSK, whose then chief executive Sir Andrew Witty was unenthusiastic about the UN report. Probably because, it supported governments’ right to invoke ‘a get-out’ from the World Trade Organization’s TRIPS agreement. This is to bypass drug patents and make cheaper versions of the respective generic equivalents, in the interests of public health, in accordance with the 2001 Doha declaration. However, the author is hopeful that, “as happened with AIDS, each new crisis over access to medicines – whether concerning a common liver disease or a rare cancer, and particularly over the antibiotics that are under threat and vital to all our lives – is likely to put pressure on companies to find ways to bring the costs of medicines down.”

Stakeholder pressure for increasing access to medicines continues. Even in smaller developed countries, such as Switzerland, a section of the public demands that “Swiss authorities must act to make lifesaving drugs more affordable by introducing compulsory licensing.” Or, one can now see reports saying,“Irish patients are being denied access to nine drugs that are widely available across Europe, largely, on cost grounds.”

Nevertheless, regardless of mounting pressure for drawing a reasonable symmetry between cost of, especially new drugs and their improved access to patients, ongoing status-quo continues. In this article, I shall dwell on this concern from the Indian perspective, focusing on an agonizingly stark implementation-gap related to the current Indian pharma pricing policy.

Under pressure, pharma now recognizes the need for affordable drugs:

Coming under intense pressure of patients and other stakeholders, even the largest trade association of Big Pharma has recently changed its stance on this issue, though clearly sharking any responsibility for the same. It just recognized the need for affordable medicines for improved patient access to treatments by saying: “Too often patients have to fight to access breakthrough medicines that are revolutionizing how we fight disease.” It also accepted the fact that “many Americans are struggling to afford their medicines.”

“We can improve patient access and affordability by moving toward a system that prioritizes results for patients. Biopharmaceutical companies are working with insurers to develop innovative and flexible ways to pay for medicines that focus on results, lower out-of-pocket costs and enable patients to access the right treatments the first time” – it added.

What it really means: 

What it really means ‘treatment outcomes-based drug pricing’ or ‘value-based drug pricing (VBP)’. In other words, a situation where drug prices are set in line with their real and demonstrated clinical and economic value to patients, against other available products. This model will also ensure that patients’ money doesn’t get wasted from drugs that aren’t effective on them. The VBP model is, thus, significantly different from product pricing, based on ‘undisclosed’ cost of ongoing innovation for new drugs.

Is this Big Pharma’s new way to change optics?

The intent for imbibing VBP, as expressed by the above pharma association, throws open the door for discussion of its core intent. Is the intention real, or another Big Pharma way of changing general optics on the sensitive issue of new drug pricing? This doubt creeps in from the findings of some important studies on this issue. One such is an interesting paper, titled “Pricing for Survival” from KPMG. The analysis highlighted very limited application of VBP concept, and also why it is not yet viable – despite the hype being created around it.

According to KPMG, “there were 25 drugs engaged in various types of VBP with payers in the fragmented United States market as of September 2017. The problem is, these models appear to be limited in applicability to disease states with more standardized protocols and dominated by drug therapies with single indications – notably osteoporosis, diabetes and hepatitis C.” To date, VBP models seem to be facing several constraints, such as it is appealing mostly to payers that are fully integrated with healthcare delivery i.e., closed-loop payer-provider health systems or integrated delivery networks.

“The takeaway is, when it comes to specialty and orphan drugs, outcomes-based pricing simply faces too many barriers at present” – the article elaborated. Be that as it may, let me now explore the relevance of VBP in India.

Any relevance of VBP in India?

VBP has been tried in a health care environment where payers and drug companies are two critical players for access to affordable medicines, as we see in the KPMG study. Under any value-based pricing agreements for pharmaceuticals, both payers and pharma companies agree to link payment for a medicine to the value achieved, rather than volume.

Whereas, in the Indian healthcare scenario, as we are experiencing today, payers are mostly individuals.  Despite various well-publicized health schemes, expenditure on health, including drugs, remains by and large ‘out of pocket (OoP)’ – for a large Indian population. Hence, copying western framework for implementation VBP in India, would call for scores of ‘pharma – individual payer agreements.’ This would be a daunting task, if not impractical, to even try it out.

In this context, let me touch upon the Ayushman Bharat scheme that was launched by the Prime Minister on September 23, 2018, but just in one of the 29 states of India – Jharkhand. If, or as and when it will cover the entire country, the scheme is expected to bring 107.4 million families and more than 550 million people under health insurance coverage. However, the work seems to be still in progress.

There are three financing models for this scheme – insurance model, trust model and hybrid model – and the 19 states that have come on board for the scheme’s implementation in the country, have chosen a trust model, according to the Union Health Minister. The minister also reiterated: “Things are still unfolding. Only when the letters reach the beneficiaries will they understand and react.”

Nevertheless, the Union Health Minister himself, just like his counterparts in the previous governments, exhibited confidence that the country is “moving towards universal health cover with Ayushman Bharat scheme,” – as was the headline of the above media report.

Going by the past and current outcomes of several such government schemes in the country, and what the minister himself articulated on September 17, 2018, a large section of the Indian population still remains  apprehensive on the fast pan-India rollout and overall success of this ambitious health scheme. Hence, at this stage, I reckon, it may not be relevant to discuss the application of VBP model on Ayushman Bharat project. I wrote about such apprehensions in this Blog on June 18, 2018.

Having said that, VBP still remains relevant when we look at the government’s intent captured in the National Pharmaceutical Pricing Policy (NPPP) 2012,’ as I shall discuss below.

VBP and the policy implementation gap:

For making the point clearer, let me keep the Ayushman Bharat scheme aside because of its associated uncertainties. Even in the current health care environment of high OoP expenditure on drugs, especially on high priced new drugs, if one tries to make use of the VBP model, it is very much possible.

This is because, the National Pharmaceutical Pricing Policy 2012, under point 4 (XV) on ‘Patented Drugs, categorically states:  “There is a separate Committee constituted by the Government order dated February 01, 2007 for finalizing the pricing of Patented Drugs, and decisions on pricing of patented drugs would be taken based on the recommendations of the Committee.”

Curiously, even 6 years down the line, no meaningful decision has been taken on patented drug pricing in India by the successive governments. As I wrote in this Blog on December 12, 2016, Price Negotiation For Patented Drugs: Still A Policy Paralysis.

Parliamentary Standing Committee intervenes:

Six years after the constitution of the committee by the Department of Pharmaceutical (DoP), the long-awaited report was eventually submitted with a vague formula for pricing patented drugs in India. Intriguingly,the issue remained as such, until the Parliamentary Standing Committee’s August 2016 report was placed before the parliament. It strongly criticized the DoP’s efforts to recommend measures in regulating prices of life-saving patented drugs, despite government assurances for the same.

On September 23, 2016, media reported: “Upbraided by the parliamentary standing committee for its gross negligence and lackadaisical attitude, the department of pharmaceuticals has set about seeking suggestions from different ministries on price regulation of patented drugs.”

According to reports, a new inter-ministerial committee was formed thereafter, under the chairmanship of one of the Joint Secretaries of the DoP to suggest a new mechanism to fix prices of patented drugs in the country.
The other members of the committee are Joint Secretary – Department of Industrial Policy and Promotion (DIPP); Joint Secretary – Ministry of Health and Family Welfare; and Member Secretary – National Pharmaceutical Pricing Authority (NPPA). But, the saga continues – at the cost of patients’ health interest.

Conclusion:

As it appears, there still lies a clear opportunity for Indian drug pricing policy makers introduce VBP concept for patented drugs in the country. Following this model, the prices of new and innovative drugs under patents can be set in line with their real and demonstrated clinical and economic value to patients, over the available existing products. Health Technology Assessment (HTA), for example, could be an effective tool in this process.

Additionally, the VBP model could also minimize, if not eliminate the risk of patients paying a high a price for new drugs coming through incremental innovation, adding too little clinical and economic value over existing drugs. There may, of course, be some teething trouble or even important issues in arriving at consensus on value-metrics for VBP. But, this can be sorted out through meaningful engagement with concerned parties.

Strikingly, even after 6 years since the NPPP 2012 was announced, nothing tangible has been made known to stakeholders on the execution of ‘patented drug pricing policy’ in India. An avoidable policy execution gap continues, limiting access to affordable new medicines to a vast majority of the Indian population, even today.

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.