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Pharma Leadership Challenge In Post Covid Paradigm

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Bringing a long cherished relief to many, on September 15, 2022, the World Health Organization said, ‘we can see the Finish Line’ for the COVID-19 pandemic but it’s not over yet’. As I see today, several things are changing pretty fast in this scenario. Such as, not so long ago – on September 27, 2021, the same global health organization predicted differently: ‘World Will Live with COVID for Foreseeable Future.’ It further highlighted “It is dangerous to assume that omicron will be the last variant, or that we are in the endgame. On the contrary, globally the conditions are ideal for more variants to emerge.” The Wall Street Journal also reported on September 18, 2022 that the US President Joe Biden too  feels, ‘Covid-19 pandemic was over’ in the United States.

Be that as it may, I reckon, the world is not going to replicate to the pre-Covid mode of working, any longer. The Covid-19 pandemic has clearly made some impactful changes in the most work scenario, across the world. This has been revealed by several recent studies. With this perspective, in this article, I shall dwell on the challenges that the pharma leadership teams will face or are already facing, as the world shifts towards the post Covid paradigm.

Four critical areas for change:

To illustrate this point, I will focus on just three critical areas for pharma players, as follows:

  1. No going back to the pre-Covid mode of working
  2. Create a more employee focused organization for future success
  3. Determine the right size of digitally savvy field force in the new paradigm 
  4. Increase online share of voice in represented therapy areas and identify pharma’s digital world opinion leaders.

Why no going back to the pre-Covid mode of working:

With the onslaught of the Covid-19 pandemic on people’s lives and livelihoods fast receding, the need for some critical changes in several areas of pharma business, is now being felt by some forward looking astute pharma leadership teams. Recent studies, such as, the Gartner paper of June 16, 2022, among others, vindicate ushering-in some of the following changes in workplaces:

  • Ongoing changes in the way people work have transformed employees’ relationship, and their expectations of work.
  • Hybrid work could be a great opportunity, particularly for diverse talent..

Another article in this regard, published in the Harvard Business Review on January 13, 2022, capture 11 trends that will shape the work, in general, from 2022 and beyond. When I put some of these in the pharma space, it may include the following:

  • Employee turnover will continue to increase, as hybrid and remote work becomes the norm for knowledge workers in pharma companies.
  • Many repeated managerial tasks at various levels, will be automated, creating greater space for them to build more human relationships with their peer group and direct reports.
  • The tools used for working remotely are also being used to measure and improve employee performance on an ongoing basis.
  • The complexity of managing a hybrid workforce may drive some employers to evaluate a ‘return to the office’ with its pitfalls and benefits.

Thus, creating an employee focused organization becomes critical.

Creating an employee focused organization will be critical:

In the current scenario, the importance of being able to afford employees maximum flexibility, adapting and flexing to their individual circumstances and needs, is increasing manifold. This, has also come out very clearly in a number of studies, including one paper of the Healthcare Consulting Group (HCG), as reported on July 25, 2022.

Thus, nurturing employees’ desire for personal and professional growth, besides motivating them with a strong sense of purpose to their work, has become foundational to being an attractive workplace, more than ever before.

Is the pharma industry right-sizing the digitally savvy field force?

One can pick up several signals in this direction from what is happening, as the industry is opening-up with a rapidly declining onslaught of the Covid-19 pandemic. Various studies vindicate the intent of field staff reduction by the pharma industry. Today’s environment requires a digitally savvy field force of optimal size, which may vary from company to company.

For example, the article published in the Reuters Events Pharma on May 5, 2022, in this regard, elucidated “While Reuters Events Pharma’s own recent polling of the industry suggests a moderate reduction in numbers over the next couple of years, others see signs of more dramatic change.”

Many pharma players are now pondering – during Covid pandemic when companies were making so many less face-to-face calls, sales were OK. Now, when the intensity of the pandemic is receding, do they need the previous sales force numbers to make more such calls?

The general feeling appears to be that the old practices aren’t as productive as they were before, in the changing scenario. Thus, the paper underscored: ‘So with the largest players are already thinking about how to do more with fewer boots on the ground, how do they go about it?’ It concluded by saying: ‘No one is saying it is easy then, but the imperative for change is clear.”

Pharma customers’ online engagement is increasing with a low share of voice of companies:

This is yet another critical area of change where drug industry needs to strengthen its online voice. Several studies indicate that even a tiny part of most pharma companies’ online conversation about their represented disease and therapy areas doesn’t get captured in Google search. For example, yet another recent paper on this subject, published in the Reuters Events Pharma on July 05, 2022, confirms this point.

The article highlights: ‘Around 80% of patients Google for a recommended or newly prescribed medication. And doctors routinely use search engines too – to stay up to date, to verify assumptions and so on. Indeed, it may be no exaggeration to say that the answers found online are possibly the biggest influence on patients and HCPs today. Understanding their real-world digital information experience is, therefore, critical to identifying the content influencing their behavior.’

In today’s world, what these customers see and hear via search engines may shock many, the author emphasized. The study also reveals, despite many pharma companies’ investment in evidence-based, balanced, and accessible content designed for HCPs and patients, this is often buried far out of reach from the billion-plus health-related questions being asked of Google each day. ‘Pharma’s online voice often simply isn’t cutting through,’ it concluded.

What needs to be addressed soon in this area:

Each pharma marketer may wish to ascertain through data-based studies, which voices are dominating these conversations. And also, the nature and quality of the company’s own digital conversation and its share of voice. This is, besides getting to know who the digital opinion leaders are. Then, the task will be to find out ways to work with these people and share the company releases with them, requesting for their inputs, if any.

Conclusion:

The experience of the Covid pandemic and lockdowns has changed work patterns in many industries from what those were in the pre-Covid days. The drug industry is no exception. According to recent studies, two out of every five workers have either switched jobs or are actively looking for another that will fit into their working needs better, and with some remote work. This trend, being a common expectation, is gaining ground.

Thus, making an employee centric organization is now more important than ever before. Bringing together the best of remote working and office locations, as centers of excellence for team building, learning and innovation, is emerging as a central part of the pharma leadership challenge, as an HCG study, reportedly, also points out. It is generally believed that employees ‘who feel connected to purpose at work are more productive and more likely to stay.’ In tandem, pharma leadership teams also would require leaving a lasting impact on everyone’s work, which will be more tangible to them.

Alongside, as several contemporary studies indicate, and I also wrote in this blog on April 29, 2019 – ‘Adopt A Hybrid Business Model For Better Sales – Not A large Field Force,’ each company’s field force number also require a fresh look now with a focus on digitally savvy individuals. Another reason being pharma customers’ online engagement is increasing fast where most companies have a very low share of voice, as the search engine reveals. Consequently, identifying, partnering and in-depthunderstanding of key digital opinion leaders has become critical in creating a digital content that will influence the customer behavior. As reported on September 26, 2022, pharma major Sanofi, apparently has taken a major step in this direction.

From this perspective, it appears that the pharma leadership teams have a task cut out for them to effectively respond to the challenges of change in the post Covid paradigm – in search of pharma business excellence.

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.

Come Covid-19 Drug And Vaccine, Pharma Will Get Back To The Traditional Mode

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‘Corona will remain a part of our lives for a long time. But at the same time, we cannot allow this to happen that our lives will be confined only around the corona. We would wear masks, follow two yards distance and pursue our goals. Therefore, the fourth phase of lockdown, lockdown 4, will be completely redesigned, with new rules,’ said the Prime Minster of India, during his televised address to the nation on May 12, 2020.

Many countries around the world, have already decided to move ahead, phasing out Covid-19 lockdowns cautiously, in a manner that each country will deem appropriate. Alongside, in line with many other industries, several pharmaceutical companies seem to have also started accepting this new reality. For example, Novartis, which reportedly, started digitizing its sales and marketing even before the COVID-19 pandemic, has hit the fast forward button.

This is evident from what Novartis said: “We were already on a journey in terms of our commercial model where digital and other channels and virtual detailing were becoming a bigger part of our mix.” The Company is planning an omnichannel digital launch for its latest new product – Tabrecta for metastatic lung cancer. This was prompted by the very sensitive situation that the world is going through ‘and the extra burden that’s put-on physicians and patients” as the pandemic continues - the company clarified.

This leads to the key question, are most companies on the same wavelength as Novartis, in this area? Or, a large majority of drug players, is still nurturing the hope that prescription demand generation activity from doctors and hospitals will soon return to the traditional mode of what was prevailing during pre-Covid-19 pandemic days? This flows from an age-old experience – a large number of sales or medical representatives have always spearheaded the demand generation mechanism for any patented or brand-generic medicine.

Still, for many it is difficult to even think of any quantum shift in this space, as the traditional core mechanism continues, despite so much hype of digitalizing pharma operations. Whereas, several others do feel, at least, a Covid-19 vaccine or a drug for its effective treatment, which, apparently, are almost knocking at the door, will bring the current situation back to the previous normal. Will vaccine or an effective drug be a panacea to win the war of Covid-19 pandemic, decisively? In this article, I shall dwell on this subject. To set the ball rolling, let us fathom whether or not coming out with a safe and effective Covid-19 vaccine, in a jiffy, is rather a certainty.

Is Covid-19 vaccine a certainty?

No doubt, a large majority of people believe, a vaccine to prevent COVID-19 is perhaps the best hope for ending the pandemic, as Mayo Clinic has also said so. However, it also records the following major apprehensions or challenges in developing a COVID-19 vaccine, based on the research data:

  • Ensuring vaccine safety
  • Providing long-term protection
  • Protecting older people

On May 12, 2020, at the US Senate hearing about the path forward from pandemic lockdowns in the United States, NIAID director Anthony Fauci also said, there’s “no guarantee” any of the vaccines in testing will be effective, though based on his knowledge of other viruses, he is “cautiously optimistic.” Thus, projections about how COVID-19 will play out, are still mostly speculative.

Why ‘projections about how COVID-19 will play out are still speculative’?

A recent article – ‘How the COVID-19 Pandemic Could End,’ published in the ‘Scientific American,’ also commented so. It said, the end game will most likely involve a mix of everything that checked past pandemics:

  • Continued social-control measures to buy time,
  • New antiviral medications to ease symptoms,
  • And a vaccine.

Citing the famous example of the H1N1 influenza outbreak of 1918–1919, it said, doctors and public health officials had far fewer weapons than they do today. Thus, the effectiveness of control measures, such as school closures depended on how early and decisively, they were implemented. Over two years and three waves, the pandemic infected 500 million and killed between 50 million and 100 million. It ended only as natural infections conferred immunity on those who recovered.

Which is why, as on date the pursuit to achieve all three goals as mentioned above, would likely to continue. That said, a safe an effective Covid-19 vaccine will be the most preferred way to stop rapid transmission of the Coronavirus outbreak. However, this comes with a critical caveat.

Would the entire population need to be vaccinated?

Experts believe, unless a vaccine is administered to all of the world’s eight billion inhabitants who are not currently sick or recovered, COVID-19 is likely to become endemic. It will circulate and make people sick seasonally—sometimes very sick. But if the virus stays in the human population long enough, it will start to infect children, showing mild symptoms.

In that process, children appear less likely to develop severe disease if they get re-infected as adults.  Thus, the combination of vaccination and natural immunity will protect many of us. ‘The Coronavirus, like most viruses, will live on—but not as a planetary plague,’ the ‘Scientific American,’ article concluded.

Covid-19 end game to involve a mix of those that checked past pandemics:

Let us now look at the possible mix of the Covid-19 end game, which were involved in checking the past pandemics, one by one:

Continued social-control measures to buy time:

The social control measures would include compliance with the prescribed social distancing norms, in tandem with aggressive testing for the infected individuals, isolating them, and quarantining their contacts. These measures were well tested in the past epidemics and useful if followed well, by all.

Therefore, from the pharma industry perspective, getting back to the traditional ‘pre Covid-19 mode’ of prescription demand generation mechanism, will indeed be challenging for most drug players.

Availability of well-tested antiviral medications to ease Covid-19 symptoms:

So far, there is no scientifically and well-tested medications for the treatment of Covid-19. However, many different medications are under clinical trials in various parts of the world. So far, most hyped among them appears to be remdesivir, an experimental antiviral developed by Gilead for the treatment of Ebola.

However, the clinical study result of ‘Remdesivir in adults with severe COVID-19,’ published in The Lancet on April 29, 2020 found that the dose regimen of intravenous remdesivir used in the study, was adequately tolerated, but did not provide significant clinical or antiviral effects in seriously ill patients with COVID-19.

The World Health Organization (WHO) also, reportedly, announced a large global trial, called ‘Solidarity’, to find out whether any of those drugs can treat infections with the Covid-19. In India, several drug companies are also testing the water, with their shortlisted drugs, such as, Zydus Cadila want to test a form of interferon, usually used against hepatitis B and C, as a potential treatment for COVID-19. More trials on remdesivir are ongoing, let us keep our fingers crossed.

Interestingly, Gilead has, reportedly, signed nonexclusive licensing agreements with five Indian generic drug makers – Cipla, Mylan, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences,  to produce COVID-19 therapy remdesivir for low- and lower-middle income countries. Under the agreements, Gilead will share its manufacturing know-how with them to help gear up remdesivir local production. Moreover, each of these companies will be allowed to set the price for its own generic version of the drug.

In any case, scientifically proven safety and efficacy of any drug or vaccine for the prevention or treatment of Covid-19, is yet to be known. Hence, for all individuals, strict compliance with social distancing measures is the only way to avoid this highly contagious infection. The same is also applicable to doctors and sales representatives while working in the field, at least, till an effective Covid-19 vaccine or drug comes.

Affordability and access to Covid-19 drug and vaccine:  

Assuming that a safe, effective and clinically proven vaccine or a drug for Covid-19 will be available sooner than what experts anticipate now, yet another critical issue needs to be resolved, soon. This is related to their affordability and access, to contain the mortality and morbidity of the disease, for a vast majority of the population, especially in the developing nations, like India.

Even Gavi noted: ‘In the race to produce a safe and effective vaccine against the COVID-19 virus, one of the many challenges will be the cost of developing the vaccine and eventually getting it to the vast number of people worldwide who will need it.’ However, it is generally anticipated that ‘COVID-19 vaccine or a drug may end up costing people a small fortune.’ Another article also echoed the same sentiment by saying, ‘Covid-19 treatments won’t work if people can’t afford them.

However, India’s Serum Institute based at Pune, has announced that it is ready for 20-40 million vaccine shots at Rs 1,000/dose, by September-October 2020. The company is ‘’putting its weight behind an Oxford University-led consortium, which announced the start of human clinical trials on April 23 and is one of the first such projects to get underway globally.’

At the same time, another report emphasized: “Even after India approves the Coronavirus vaccine, it might not be possible to produce more than 10-20 million doses in the first year,” again raising the availability and access issue for a Covid-19 vaccine, as and when available in India.

Conclusion:

As on May 17, 2020 morning, the recorded Coronavirus cases continue to climb sharply to 90,927 with 2,872 deaths.. Moreover, on May 13, 2020, the world Health organization has also warned that “this virus may become just another endemic virus in our communities, and this virus may never go away.” Thus, the world has to live with it. By the way, the accuracy of many Covid-19 test kits has also been widely questioned. This reportedly includes speedy Abbott test, as well.

In this scenario, people may have to necessary live with social distancing norms and the practice of wearing a mask outside the home, always. Besides, the template for relief from Covid-19 becomes more complex, particularly considering availability, affordability and access to a safe and effective drug or vaccine in India, as and when these will come. Taking these together, the end game for Covid-19 in the foreseeable future, becomes anybody’s guess.

Coming back to the pharma industry, curiously, some people are still hoping for ‘business as usual’ in the traditional pre-Covid-19 mode, although the writing on the wall is increasingly getting clearer. The only alternative that people can possibly follow under the circumstances, is strict compliance to social distancing norms, which pharma companies, doctors, healthcare consumers and others would also require to adhere to, with as much earnest. Thus, envisaging a return to pre-Covid-19 prescription generation mode, may not be prudent choice, anymore.

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.

Post Covid-19 Lockdown: Is Pharma Industry Ready?

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It’s over a month now since national lockdown in India came into force to win the war against Covid-19. Many promises and apprehensions about whether or not Covid-19 will keep ravaging human life, continue surfacing. As it appears today, whatever best happens post May 03, 2020, the Coronavirus outbreak is going to change the way we live and the businesses used to operate, in many respects, till an effective vaccine comes, at the very least. This change also includes the health care, in general, and the pharmaceutical industry, in particular.

It is obvious now that Covid-19 will stalk the planet for a long time to come. On April 22, 2020, the World Health Organization (WHO) also reiterated: ‘Make no mistake, Coronavirus will be with us for a long time.’ This vindicates many apprehensions against an early promise of winning the Covid19 war decisively in 21-days or even by May 03, 2020, or whenever the national lockdown is phased-out in a calibrated manner. Further, W.H.O has also cautioned: “Most countries are still in the early stages of their epidemics. And some that were affected early in the pandemic are now starting to see a resurgence in cases.”

As on April 26, 2020, the recorded Coronavirus cases in India has sharply climbed to 26,496 and 825 deaths, with the Union Health Ministry saying on April 23, 2020: ‘Doubling rate of Covid-19 cases in country is now 10 days.’ Whereas, on the same day, Indian Council of Medical Research (ICMR) also said, ‘for now, it is very difficult to tell when a peak state of COVID-19 pandemic in the country will arrive.’

The life-changing disruptions that Covid19 has caused, and may continue to cause in the near future, has apparently made a significant impact, also on how the healthcare consumers think about the available disease treatment solutions, including buying medicines. Thus, in this article, I shall, focus on this area.

Why winning the Covid-19 war can’t be immediate: 

Covid-19 pandemic brought the drug industry under a sharp focus of the entire world, with an expectation to win the war against this deadly and invisible virus. This solution could be anything – an effective prevention, such as, with a vaccine, or a curing the infection with a drug, or even a mechanism that is able to make the virus less contagious. There are still no scientifically proven and approved drugs or vaccines for Covid-19. Although, many trial and error experiments are in progress, mainly based on anecdotes and gut-feeling, for the respiratory disease caused by Coronavirus.

The good news is, since January 2020, after scientists in China provided the virus’s genetic sequence, over 40 teams of global drug companies and the academia, are working on a vaccine and drugs for Covid-19. As of now, six Coronavirus vaccines are on clinical trial. Last Thursday, human safety trial of Oxford University developed Covid-19 vaccine, with the first two of 800 healthy volunteers, has commenced. Meanwhile, Serum Institute of India (SII) has tied-up with the Oxford University to manufacture the vaccine in India, if the trial succeeds.

Some bad news in this area also came by, such as, ‘remdesivir’ – the well-hyped drug, thought to be one of the best prospects for treating Covid-19, failed to have any effect during the first full trial. However, Gilead – the drug company developing this product has said, ‘the findings were inconclusive because the study was terminated early.’

The bottom-line is, although, first tests for more new vaccines may commence within a few months, the final regulatory approval of these will take much longer - at least 18 months, i.e. not before 2022, according to W.H.O. Meanwhile, some disruptive changes within current health care delivery systems, involving both behavior and transaction practices of key stakeholders, may prompt equally disruptive changes in the Indian health care delivery mechanisms. These changes are likely to have unforeseen impact on several pharma operations, critical for business excellence in the drug industry.

Commonly followed procedures for the Indian healthcare system:

The procedures that most health care consumers currently follow for healthcare in India, require patients to be physically present in most touchpoints of a disease treatment process. These include, doctors, chemist shops, hospitals, diagnostic clinics, among others. During the national lockdown period, redressal of non-Covid-19 related common health issues, has been a great challenge for many people, such as:

  • visiting a doctor
  • going to a hospital outdoor
  • procurement of medicines from retail shops for chronic conditions
  • visiting a diagnostic clinic even for follow-up – previously advised by a doctor

This happened primarily due to the need of compliance of social distancing and mostly out of fear of getting the Covid-19 infection. Fortunately, the available digital platforms to address the pressing common health issues, proved to be of immense help to many.

Pharma business has also been greatly impacted: 

Driven by initial panic buying of regular medicines by the people, for the lockdown period and may be beyond, monthly sales of pharma might show a spurt. But, that is unlikely to be the real picture for a medium to long term. Otherwise, like many other industry sectors, pharma business has also been greatly impacted by the Covid-19 outbreak, across its various domains – right from planned R&D – through manufacturing, sales and marketing – to supply chain.

The early adopters to the new normal will be the outright winners:

For example, meeting a doctor for product detailing following the conventional chain of activities, and simultaneously maintaining strict ‘personal distancing’ or ‘social distancing norms, may not be the same again. The changes required by the pharma companies to make this process effective and productive, may also be disruptive in nature.

No-one can accurately predict toady, how exactly the important business operations can be resumed, ensuring full health-safety for all and with compromising on the effectiveness and productivity of business. Nevertheless, one thing for sure, lockdown during Covid-19 pandemic has brought the possibility and the opportunity of going digital to the fore, for both – the healthcare business and also its consumers, including various other stakeholders. The early adopters to the new normal are expected to be the outright winners.

Green shoots of digitalization within healthcare consumers and providers: 

As digital transformation at health care consumers and providers level, gain a critical mass, the healthcare business would require to be not just digitalized, but also digitally innovative. The situation would demand from them to be much more ‘customer centric’ on digital platforms, as the locked down – homebound health care consumers, complying with ‘social distancing’ norms, get increasingly more digitally empowered.

Bain & Company in its March 20 ‘Brief’, titled ‘How the Coronavirus Will Transform Healthcare in China,’ discussed some of these issues from China perspective, which are already visible there. To illustrate this point in this deliberation from the Indian perspective, let me draw examples from the country’s health care consumers’ standpoint.

Is the traditional health care system slowly undergoing a metamorphosis?

The overall impact of Covid-19 outbreak in India has made visiting general practitioner’s (GP) clinics, pathological labs or even hospital emergency facilities, a tough challenge for many patients. This is primarily out of fear of getting a Coronavirus infection from others during the process, with strict compliance to ‘social distancing’ becoming a top priority for many. Consequently, traditional healthcare related activities in India, is likely to undergo an early metamorphosis.

Being literally locked down at home, a good number of healthcare consumers in India, are utilizing innovative digital platforms, for common illnesses or follow-up consultations, such as:

  • for medical consultation on digital platforms, e.g., Skype, Facetime etc.
  • getting diagnostic tests done at home by requesting through digital apps,
  • sending test reports to doctors digitally,
  • getting doctors prescription through digital mode,
  • ordering medicines through e-pharmacy apps by uploading prescriptions,
  • getting medicines delivered at home after e-payment,
  • repeating the same process whenever required.

An upside of the situation: 

The upside of the situation is, these patients are feeling more digitally empowered and self-reliant to get non-too-serious ailments addressed against all odds. Some of these practices, such as, online consultation with doctors, getting most of the medical tests done at home, buying medicines through e-pharmacies, I reckon, may continue even after calibrated withdrawal of the national lockdown in India.  The net impact of all could trigger a meaningful attitudinal change in patients, especially towards health care delivery processes, in general.

The healthcare industry is ready to log on to this digital mode? 

Many early adopters in the global pharma industry, are going for digitalization within various functional domains of the company, at a varying scale. This has started happening in India, as well. However, as social distancing becomes the new normal in the foreseeable future, how prepared are the pharma companies to adopt themselves with the increasing number of digitally empowered consumers, is still unclear. More importantly, how will the industry meet new demands at various points of transaction and interaction with various critical stakeholders, such as, doctors, in the post Covid-19 eraof social distancing, ensuring health safety of all?

Another requirement that should form the bedrock of the grand integrated corporate strategy of a customer-centric pharma business, necessarily, in the changing times. This is – all decisions in this area must be based on a huge pool of contemporary data, analyzed by sophisticated data analytics and thereafter, the strategic and tactical pathways need to be charted, desirably, through skillful application of Artificial Intelligence (AI), because of evolving complex and multi-dimensional health care needs of the consumers.

Alongside, telemedicine in different new formats – even for GP level consultations, besides, drug procurement through e-payment from approved e-pharmacies by uploading doctor prescriptions, signal a great potential in the years ahead. This appears to be very close to reality, especially, going by the W.H.O prediction for a long-haul Covid-19 battle, where compliance with ‘social distancing,’ is one of the basic requirements of health safety for all.

Conclusion:

‘Month of lockdown impedes virus – a long battle lies ahead’. As the former President of the Unites States twitted on April 25, 2020, ‘If we want life to approach anything like normal anytime soon, we need a comprehensive testing program. It’s not going to be cheap, but it will ultimately pay off many times over in saved lives, saved businesses, and saved jobs.’

In any case the crux of the matter is, Covid-19 is not going to vanish soon, even after scaling down of the lockdown in a calibrated way. Moreover, the fear, if not the panic of a large population in India and around the world, on the possibility of getting infected by Covid-19, will continue – till one does not get vaccinated or acquire ‘herd immunity’ in a different way. Meanwhile, related behavioral changes and habits, of a large number of people, including health care consumers, will continue taking place.

From this perspective, besides the existing ones, once the lockdown-period-converted ‘e-consumers’ of health care get used to the new digital mode of availing healthcare services against e-payments, it could have a snowballing impact on many others. That will help usher in a new paradigm of medical consultation, follow-up interaction, disease diagnosis, drug procurement and all related transactions, through digital platforms.

Having experienced the convenience and user-friendliness of the digital mode, during an extended period of social or physical distancing and other new normal, instead of time-consuming legwork, it seems unlikely that the majority will try to go back to the traditional mode of pre-Covid 19 era. In that situation pharma companies will have no option but to necessarily re-engineer the business operations, bringing disruptive digitalization at the center of any strategy formulation related to mainly patients and doctors, besides others.

Covid-19 prompted lockdown and the post lockdown period, I reckon, is unlikely to be a ‘switch-off’ and ‘switch-on’ type of a situation for anyone or any industry, as threat of getting Coronavirus infected will continue for quite some time. The need of the hour for pharma players in India, therefore, is gaining deep insight, through continuous data capturing and analysis, on each component of the changing market dynamics – prompted by Coronavirus pandemic. The point to ponder, therefore, is pharma industry getting ready for a possible disruptive change in the future environment?

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’s ‘Value Delivery System’ Still Tuned To A Self-serving Mode?

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Just as any other industry, pharma business is also primarily a ‘value delivery system.’ Its each and every employee need to understand and internalize this basic philosophy of the business. This organizational mindset needs to be created by the very top – setting examples for others to embody the same. The top could encompass the promoters themselves, or the professional CEOs – truly heading the organization and not working under the shadow of the promoters, or even the Board of Directors of professionally managed companies.

Although, this mindset should prevail pan organization, pharma sales and marketing functions are usually responsible to deliver a well-thought out set of brand values and associated services to doctors, patients and other stakeholders, effectively.

Against the above backdrop, I shall explore in this article whether it is happening in the pharma industry. If yes, is the ‘value delivery system’ is tuned to a self-serving mode, wherever it is happening? If so, to what extent it is denting the reputation and image of not just of the companies concerned, but of the drug industry as a whole. Before I proceed further, let me elaborate on what exactly I mean by the ‘value delivery system (VDS).’ 

Value Delivery System (VDS):

Creating more and more customers and retaining them, as long as possible, is the core purpose of any business, as was articulated by the management guru Peter Drucker, decades ago. Thus, like others, pharma organizations, as well, require making it happen in a sustainable way for business excellence.

The entire organization – starting from product and service development activities, right up to the frontline sales and marketing, should always be engaged in delighting the customers with the values they expect – driven by this mindset. It is worth noting that value expectations of pharma customers, are expressed in various ways. These need to be properly captured, analyzed, interpreted, packaged and effectively delivered during each company- customer contact, such as, while interacting with doctors, patients, hospitals and Government.

Thus, the term ‘Value Delivery System (VDS), encompasses an integrated chain of processes within an organization. From this perspective, it should get ingrained in the culture of a pharma company – without any broken links – between the functional areas and the integrated value delivery process.

Who is deciding what patients would value in pharma?

In the real world, ‘customers point of view’ or ‘what the patients would value’ in a product, is decided by the pharma companies – derived generally from the published clinical trial results of the products. Accordingly, these are woven around the brand features and benefits.

The value delivery system of the company packages these in a way that it thinks would generate increased prescription demand and delivers to all concerned. These values, which are overall financial business performance-centric, are mostly ‘self-serving’, and was working very well to meet the internal objectives, until recently.

How to ascertain value for patients in pharma marketing?

One way to ascertain these factors is to ask patients directly. But this process has certain limitations. This was once aptly articulated by Steve Jobs in an interview, where he said: ‘I think really great products come from melding two points of view -the technology point of view and the customer point of view. You need both. You can’t just ask customers what they want and then try to give that to them. By the time you get it built, they’ll want something new.’

Taking a cue from it, I reckon, drug companies need continuously generate and analyze enough relevant data, from multiple sources, for an in-depth understanding of what patients will value. Making these values an integral part of the product and services, in a creative way, pharma should aim at delighting the customers through effective delivery.

The article titled, “Reclaim The Glory Of Value,” published in the eyeforpharma on January 08, 2019 also reiterated that such ‘value’ must always be defined by the customer.  ‘And true value can only be achieved by understanding the world of the patient and solving the issues most critical to them.’

The external impact of product centric value assessment:

This financial result focused value delivery system got exposed to the stakeholders, since sometime. Overall business performance, though generally slowed down, some companies did produce extraordinary results, even after remaining tuned-in to the self-serving mode. Nevertheless, what got dented most is the pharma industry reputation, with a long-term impact.

Although, the survey capturing fast declining reputation of the drug industry, was done in the United States, it is apparently no different in other countries. Consequently, the quality of general public’s trust in pharma started getting murkier. Strong headwinds are now limiting the pace of progress of the industry, with many governments, including India, taking stringent policy measures to protect the patient interest.

The only way is to ‘reverse the pyramid’:

The only way for the pharma industry, in general, is to take a fresh look at their business approach, which still remains a value delivering machine. The companies need to think afresh while arriving at the ‘value for the patients’, by reversing the business pyramid – positioning the patients’ core values at the top, and delivering them to all concerned with well-crafted content, on the most effective platforms.

Tuning VDS in sync with patients’ core values, is fundamental:

It has been well established today the delivering values built around the quality, efficacy and safety of a brand can no longer ensure the best clinical outcomes for patients. This holds good even when the conventional sales and marketing activities are carried out through a large sales force and backed by huge financial resources. The main reason being, the pharma value delivery system is not delivering the core value that modern day patients expect.

Many patients of the new generation value empowerment and desire greater involvement in their end-to-end disease treatment process. For example, when they want understanding and help on how to manage the high treatment cost to survive from a life-threatening illness, some companies try to compare the ‘cost of treatment’ with the ‘cost of life’, which is an undiluted self-serving value.

It may sound absurd, but I have witnessed the top echelons of pharma companies saying so. This can possibly happen only when they feel contended with a smaller patient base fetching higher profit due to high drug prices, though unaffordable to most patients. But this model is not sustainable. It would further damage already dented pharma reputation, drawing more ire from stakeholders, including the government.

Thus, tuning VDS in sync with patients’ core values is fundamental in the emerging scenario. The question that follows what then are the core values of the new generation patients?

Two ‘core values’ that patients generally expect:

In my personal view, there are the following two ‘core values’ that consumers of medicines would generally expect during their end-to-end disease treatment process. However, the signals of such expectations – direct or indirect, may come in different ways and forms that need to be properly captured by the pharma companies, with the careful application mind:

  • Value of unique product and service offerings: The need for this value arises right in the beginning, when patients are in search of a solution for prevention, cure, or management of a disease. It is, primarily, the difference felt by the customers between the product and service offerings of one pharma company from the other. While finalizing the choice for the resolution of the problem, patients may take into account one more important factor. This usually covers the quality of their interaction with the doctors, including the pharma companies, though their respective patient engagement platforms, if any.
  • Value of a unique patient experience: After making the final choice, patients would value to feel a unique experience during the entire span of the treatment process. The quality of a brand, its effectiveness, safety, affordability and accessibility, among others, would be the individual components of the whole experience. What would matter most is the residual impact, created by the sum total of each of these components. And this value may be termed as – the unique patient experience.

Effectively delivered, the wholesome impact of patients’ treatment experience will be a lot more than the sum total of each the individual components, as mentioned above. Conversely, any hurdle faced by patients even with one component of this value chain, can potentially create a bad patient experience. This may adversely affect both patients and the concerned pharma company, in tangible terms, which I shall discuss below. Thus, the perceived value of ‘unique patient experience’ is very high, and can’t be wished away, any longer.

Tangible gain of pharma for doing so, or vice versa:

Let me illustrate this point with an example – drawing from the above core values and a self-serving value delivery system.

As we know, non-adherence to medication is one of the important reasons for poor clinical outcomes, besides progression of the ailment – further compounding the disease burden. Ample research studies indicate that ‘high cost of drugs is the biggest barrier to medication adherence,’ or, at least, one of the major causes of non-adherence.

Patients pay for non-adherence by their deteriorating health conditions. Alongside, pharma companies also pay a high price in terms of lost sales and profit, besides dent in reputation – for this single factor. Another research report estimated an annual revenue loss of USD 637 billion for non-adherence to medications for the treatment of chronic conditions. The same report highlighted, globally, revenue loss has increased from USD 564 billion in 2012 to USD 637 billion in 2015, with US-based revenue losses increasing from USD 188 billion in 2012 to USD 250 billion in 2015. Otherwise, this could have been a significant tangible gain for pharma.

Conclusion:

Pharma business, just as any other industry, is a value delivery system. This system needs to be optimized, both for tangible financial gains and also for building company reputation. Creating increasingly satisfied patients, including other stakeholders, should be the prime drivers for this optimization process.

Two core values – built on signals, suggestions and indications coming from the bottom of a conventional business pyramid – the patients, need to be effectively captured, analyzed, packaged and then delivered through the VDS. In no way, these values are to be based on what the top of the pyramid thinks, based on only clinical trial results. Such values are usually self-serving in nature, the long-term impact of which is not quite favorable, either. Reversing the pyramid, patients should be allowed to play a pivotal role for the company in the core value creation of a brand, in innovative ways, for subsequent delivery on appropriate platforms.

This will create a win-win situation, both for business growth and also in delighting most patients with access to high quality and affordable novel treatments, for a healthy life. However,considering today’s reality where most pharma companies’ ‘Value Delivery Systems’ are still tuned to a self-serving mode, a serious introspection by individual companies seems to be an urgent need. More proactive players in this game, will emerge as winners with better business performance, in tandem with improved corporate image and reputation.

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.

In a Quandary of Drug Quality, Price Control, Innovation and Patient Interest in India

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The patients in India have every reason to apprehend, whether the prescription drugs that they consume are efficacious, safe and conform to the government approved prices, alongside another important question: Do they affordable access to the fruits of innovation?

The regulator responsible for drug quality in India is responsible for ensuring the first two, and the drug price regulator of the country ensures the remaining two.

Apparently, both these esteemed government bodies, are sure that they are doing the best jobs in their respective areas. Moreover, in these days of social media blitzkrieg, it won’t be uncommon to witness some of them, creating hype on some issues that many feel is better avoided, and at times even contradictory in nature.

Amid this seemingly chaotic continuity of the same or a bit deteriorating scenario, patients are often caught in an unenviable footing.

In this article, I shall discuss on these concerns afresh, quoting a few recent examples. My objective is to encourage all concerned to move away from incessant hype creation by accepting the reality, as the patients feel. This is necessary, because anyone, including the regulators can fall victim of such unfettered developments, at any point of time.

Thus, it may be appropriate for all to jettison any residual arrogance or a faint shade of narcissism, before putting the nose to the grindstone to resolve these pressing issues decisively, for patients’ sake.

Are we consuming effective and safe medicines?

I raised this question first in an article titled, “Are We Taking Safe and Effective Medicines?” published in this blog on November 13, 2013. That deliberation was primarily based on US-FDA ‘import bans’ from various drug manufacturing facilities in India, involving even the top Indian pharma players. Based on their own quality and safety audits, the US regulator had concluded that drugs produced in those factories are not safe for consumption by the patients in America.

This apprehension has now almost reached its crescendo, when on February 24, 2017, probably for the first time ever, US-FDA publicly voiced its apprehension about the efficacy of medicines being sold and consumed by patients in India.  The observation came from the India director of the US-FDA in an annual conference of a large pharma trade association of some of the top domestic pharma companies. While commenting, “I do not think any one of us wants to take such drugs which lack efficacy”, the official reportedly revealed, he occasionally gets samples sent from the US embassy health unit in Delhi, and complaints are usually about the medicines not giving the desired results.

It is noteworthy, as earlier, rubbishing claims levelled by media expressing growing concern among overseas regulators over the quality of Indian made drugs, the Drug Controller General of India (DCGI) had reportedly strongly reiterated that there have been no lapse or compromise on quality parameters of the drugs manufactured throughout the country, as the efficacy of the drugs and safety of the patients have always remained the top priority of DCGI.

Yet another news article of August 22, 2016 reported that after a year-long survey involving Government, civil society and pharmacy professionals, and testing nearly 50,000 drug samples across the country during this period, the Ministry of health of India found that medicines produced in India are safe and effective. This study was kicked off in the wake of rising concerns that several medicines made in the country posed risks to patients, the report highlighted.

Should ‘Self-certification’ by industry prevail?

Intriguingly, when questions on drug quality manufactured in India, are regularly being raised by other equally responsible drug authorities, we find ‘self-certification’, in this regard, coming from all those who are expected to resolve this issue beyond an iota of doubt, always prevails.

Apparently, not just the drug regulator and the Union Ministry of Health are in a sustained denial mode, many large pharma companies also seem to be in the same mode. On March 01, 2017, the media reported, “Close on the heels of US FDA India office raising concerns over the quality of medicines marketed in India, pharma leaders came together to defend the quality of their products. There is no question of compromising quality of Indian products meant for domestic market and export, they pointed out.” This rebuttal was expected. Nevertheless, the apprehension lingers: Should such self-certification by pharma players prevail?

That said, one may try to justify this quandary by saying that effectively regulating over 20,000 domestic pharmaceutical companies, including third party and loan license manufacturers, poses a serious challenge to the DCGI and the State Drug Controllers. However, the moot point is, who has been encouraging such over-proliferation of drug manufacturing facilities over a long period of time, in any case? In that sense, whose prime responsibility is it to ensure that drugs consumed by patients in India are efficacious and safe?

The answer to these vexing questions continues to remain unanswered.

Did patients benefit from drug price control orders?

Let me first draw a brief sketch on the global perspective of price increases in generic drugs. It appears that in all those countries where there is no drug price control in place, the entire pharma industry is being adversely impacted by huge generic drug price inflation. This finding has been well captured in a study by Elsevier. It shows, between November 2013 and November 2014, out of its research sample of 4421 generic drug groups, there were price increases in 222 drug groups by 100 percent or more. In 17 drug groups price increases were taken even over 1000 percent, which include even tetracycline. With this trend sharply moving north, many patients, across the world, are struggling hard to find ways to survive in this situation. With this backdrop, I now get back to its India perspective.

I have read some media editorials questioning, just as the pharma industry, whether it is the right approach to make essential medicines affordable through drug price control in India? Nevertheless, there isn’t an iota of doubt in my mind that yes, it is, in the prevailing health care scenario of the country sans universal health care, with out of pocket expenses on medicines being the highest in the world and when market competition doesn’t bring down the price of medicines, for obvious reasons. My questions, on the contrary, will be, is drug price control being enforced in India the way it should? Are the patients getting commensurate benefits out of it? If not, why?

However, on the face of it, the answer to the question above “Did patients benefit from drug price control orders”, may appear to be an affirmative one. This is mainly because, on July 28, 2017, no less than the Union minister for Chemicals and Fertilizers, in a written reply to the Rajya Sabha reportedly conveyed that the Indian consumers have saved nearly Rs 5,000 crore due to the Government fixing the prices of essential medicines under the Drugs Price Control Order (DPCO) 2013.

The ground reality of drug price control:

Let me try to explore a bit in this area with some recent examples.

According to the data from India’s drug pricing watchdog – the National Pharmaceutical Pricing Authority (NPPA), compliance to various Drug Price Control Orders (DPCO) is far from satisfactory. Outstanding dues for non-compliance to notified ceiling prices, including penalty, from scores of pharma companies, have now reportedly piled up over the past two decades exceeding Rs. 4,551 crore (around USD 700 million). Thus, the same question haunts: Has drug price control benefitted the patients in India, as was intended to?

The situation is no different, even with DPCO 2013. On February 23, 2017, NPPA notified the ‘Suspected cases of Noncompliance of Ceiling Price by Pharmaceutical Companies,’ of 634 drugs, along with a ‘Public Notice’ for the same. This listed included the products marketed by some leading pharma companies in India, such as, Cipla, Abbott India, Alkem Labs, AstraZeneca, Dr Reddys Lab and Cadila, among many others.

Yet another fresh allegation related to drug pricing has just come to light. Interestingly, it relates to an anti-diabetic drug that falls outside DPCO 2013. On March 01, 2017, a news articled reported, “India’s drug regulator will look into allegations that four leading pharmaceutical companies are colluding to set the price of anti-diabetic drug Vildagliptin, a move that may rattle the almost Rs. 10,000 Crore (around USD 1540 million) market in the country.” Vildagliptin is a proprietary drug of Novartis, which has licensed it to three other companies. All of them sell Vildagliptin in India under their own brand names. Abbott sells it as Zomelis, USV as Jalra and Emcure as Vysov. The combined sales of these brands stood at Rs. 822 Crore (around USD 125 million) last year, the report states.

Be that as it may, the bottom line, as many believe, continues to remain unchanged, as it has always been – the patients don’t derive intended benefits due to lackluster and apparently ineffective enforcement of the drug price control in India.

Another crucial player:

Besides the two important and powerful Government authorities – DCGI and NPPA, there is another very critical player in this game – the Indian drug industry. Without whole-hearted cooperation and result-oriented action by all the three players, in tandem, nothing can possibly change this agonizing status quo, in this area.

The industry too is in a denial mode:

Quite like the other two critical constituents, who always deny any serious allegation on their actions, not being good enough to fetch the intended benefits for the patients, the drug industry too doesn’t seem to be any different. It always appears to be in a pre-programmed denial mode against all such allegations, irrespective of whether these are on drug quality, price, or on frequent misuse of the term innovation. They always try to justify their action, playing the victim card, as it were, and expecting other stakeholders to believe that they are doing right, always.

Let me now explore each of these areas separately, basically from the pharma industry perspective:

Drug quality: Pharma players, just as the Indian drug regulator, do not seem to accept that many drugs in India do not provide desirable benefits to patients, as alleged even by the US-FDA after studying some test results, following complaints from their local establishments. Many of us, at an individual level, may also have experienced just the same, and nurture the same doubt on the efficacy and safety profile of some branded generics that we consume, but have no wherewithal to prove the same. Doctors just change the brands, when any patient comes with such complaints, as Pharmacovigilance has not taken-off in the country with full steam, just yet. Thus, both the government regulators and the industry are in sync with each other, on this issue.

Drug price control: In this specific area, unlike the issue of drug quality, the respective stands of the government and the industry are poles apart. The former believes that it is working well, and the latter says, it isn’t.

The industry, as I see it, wants to project an impression that drug price control is the root cause of all evils, including compromises on drug quality, and some drugs going out of the market. The industry further highlights that drug price control offers a crippling blow to innovation, as they can’t garner enough financial resources through increased drug prices. It is another matter that they can’t possibly claim, drug price control offers a telling blow on their profit, as despite price control pharma is one of the highest profit making industry in India and globally too.

What innovation means to patients:

Interestingly, both the domestic and multinational pharma players often use the term of innovation, mostly construed as a façade, as it were, in their different advocacy initiatives, and during media outreach, as well. For global players, it primarily means innovation of new products, which offers monopolistic marketing and pricing advantage. Whereas, for generic players, it is generally process innovation, and different generic or biosimilar product development.

This is fine, but why should patients pay high drug prices, only because pharma players want to spend more on innovation, either for a new drug or a new process? I reckon, almost none will be willing to pay just for the heck of it.

Commensurate incremental price for incremental value:

Many patients, on the other hand, will be willing to pay more for any commensurate incremental value that a drug or a process will offer for a speedy recovery from illness, or to live a better quality of life, or for a lesser net treatment cost. Thus, the price of any brand is considered by stakeholders as a function of the value that it promises to offer. Consequently, brand marketing is deemed a value delivery system. For medicines, this value must be easily perceptible, quantifiable and scientific research based. Accordingly, the outcome of any such innovation should convince the regulators, doctors, hospitals and ultimately the patients – what value delivery – path breaking or incremental, for which patients need to pay commensurate incremental prices.

Various ways of ensuring it:

There are several different ways of addressing it, even for branded generics in India. For example, when branded generics of the same drug or similar FDCs of different drugs, are marketed by different companies with a huge price difference, the pharma players should necessarily submit before appropriate authorities, prior to marketing approval, all data regarding incremental and quantifiable value offerings, especially for those branded generics falling at the top of the price band. This is necessary, as an increasing number of brands in the market of the same generic molecules or the same FDCs, may not necessarily lead to greater competition with any significant impact on price. I shall argue on this point below.

What happens, generally:

For any drug falling outside price control in India, branded generic drug makers, usually set prices based on whatever each of them considers the market will accept. This consideration is highly elastic in nature, varying from a very low to a very high price, for any specific molecule and its FDCs. As I said before, it has been well-established by now that competition doesn’t play any significant role to bring down the branded generic drug prices, unlike many other consumables in different industries.

Why market competition doesn’t work for medicines?

This is primarily because, the purchasing decision for medicines does not depend on individual patients, unlike many other consumables. This decision is taken by the doctors while writing prescriptions for them. It is widely alleged, all over the world, that many important doctors are heavily influenced by the drug companies, often through dubious and highly cost intensive means, to prescribe their respective brands or branded generics in the process of treatment of a wide variety of medical conditions. In this rat race of generation of more and more prescriptions, pharma companies require to have a deep pocket to achieve their financial goals. Thus, many brands attract high prices to generate more profit and keep moving this vicious circle. Value based brand differentiation for many leading branded generics or even me-too patented products, aren’t mostly robust enough to stand any scientific or peer scrutiny. Consequently, the prescription demand of a most branded generics or me-too patented products do not have any linear relationship with the nature of market completion, and therefore, on their prices. In this perspective, setting a price for a pharma brand doesn’t depend on quantifiable value offerings for patients, as someone said before, “It is not a science. It is a feel.”

In conclusion:

The overall concern spans across several important public health and safety related issues, which also involve general quality standards of medicines, the effectiveness of drug price control, the core intent of so frequent use of the term ‘innovation’ in various pharma advocacy initiatives, including media outreach.

In this scenario, is the pharma industry, together with the drug quality and pricing watchdogs, failing to fathom the grave residual impact of continuity of this situation? In my view, this specific assumption appears too simplistic, naïve, and unrealistic. Or else, could it be that they are actually in a quandary, not being able to decide what would be the most effective actionable blueprint to resolve these issues?

I reckon, this is high time now for all concerned to accept the reality, seriously introspect on these critical issues, opt for a dip-stick expert analysis to assess the real status, and then work out a time-bound action plan with assigned accountability on the ground.

Together they may wish to address the following queries, among several others:

  • Why are they still running on a treadmill, as it were, over the last four decades, to come nearer these issues for better understanding, without moving an inch on the ground, despite public outcry?
  • Are they really in a quandary?
  • Are these concerns not an outcome of basically governance related failures?
  • Why hypes are being created all around on significant savings over out of pocket expenses on medicines because of ‘good enforcement’ of DPCOs, when it doesn’t seem so?
  • What prompts all the key players to be in a consistent denial mode on dubious drug quality standards in India, when foreign drug regulators are pointing it out in public?
  • Isn’t the term ‘innovation’ being rampantly misused, more as a major tool for advocacy to gain free pricing advantage?
  • Shouldn’t ‘Que Sera, Sera’ days change now?

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.

Leading Through The Challenge Of Change: Is Pharma Leadership Too Archaic?

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A recent major global survey titled “Testing The Health Of The Pharmaceutical Industry” has revealed that a sizable majority of executives polled, though believe the sector is in good shape, are concerned of its reputation. Interestingly, 73 percent of respondents believe that pharma companies should become “Genuine Healthcare Providers”.

From many other reports, as well, one gets to know that the overall image of the global pharmaceutical industry, despite the high profile personas being on the saddle, is currently as good or as bad as the same of, say, Tobacco or Alcoholic beverages sectors. Lamentably, the common perception is that the industry is hugely self-serving, problem making, largely exploitative and mostly surreptitious in its dealings.

This perception prevails, despite the fact that pharma industry exists to help mankind fighting against diseases continuously, thus improving the quality of life, quite unlike the other two industries, as indicated above.

Media reports on ignoble acts of this otherwise noble industry keep coming in tidal waves regularly and unabated, from many parts of the world, the latest being the alleged mega bribery scandal involving the large global majors in China, besides many others.

While industry leadership is generally smooth articulators, ‘Talking the Talk’ and ‘Walking the Walk’ slogans in the frontiers of ethics, values and shared goals of many of these much reported companies, are probably used to run expensive global ‘Public Relations (PR)’ campaigns, lobbying and advocacy initiatives in the corridors of power.

What then could possibly be the reason of such perception gap that this great industry is allowing to increase, over a long period of time? Could it be that pharma collective leadership has not been able to adequately adapt itself with the demands of changing healthcare environment and the needs of various nations in this space, across the globe? Is the leadership, therefore, too archaic?

Is Pharma leadership too archaic?

In this context, an interesting article titled, “Healthcare Leadership Must Shift From Cottage Industry To Big Business”, published in one of the latest issues of Forbes, though deals with issues pertaining to the ‘Healthcare Industry’ in America, nevertheless makes some interesting observations, which are relevant to India as well, just as many other countries of the world.

It states that the ‘Healthcare Leadership’ has not kept up with the industry’s evolution to big business over the past 25-30 years – nor does it possess the required change management competencies to effectively lead and rapidly turn-around an adaptive healthcare business model.

As a result, unlike many other knowledge industries, pharma sector is still struggling hard to convert the tough environmental challenges into bright business opportunities.

Inward looking leadership?

From the available details, it appears that today, mostly inward looking pharma leadership tends to ignore the serious voices demanding access to medicines, especially for dreaded diseases, such as, Cancer. Instead of engaging with the stakeholders in search of a win-win solution, global pharma leadership apparently tries to unleash yet another barrage of mundane and arrogant arguments highlighting the importance of ‘Drug Innovation’ and hyping how expensive it is. The leaders do it either themselves or mostly through their own funded trade associations.

In tandem and unhesitatingly, the leadership and/or their lobbyists reportedly exert all types of pressures even to get the relevant laws of sovereign countries amended or framed to further their business interests. The leadership continues to demonstrate its insensitivity to the concerns of a vast majority of patients, other stakeholders and their respective governments, further reinforcing its self-serving image.

Does anyone really talk against ‘Drug Innovation’?

The moot question, therefore, is: Why is this hype? Who on earth really talks against drug innovation? None, I reckon. On the contrary, drug innovation is considered by all as absolutely fundamental in the continuous combat of mankind against a galore of ailments. It should certainly be encouraged, protected and rewarded all the way, following a win-win pathway for providing access to these innovative drugs for all. There is no question about and no qualms on it.

Insensitive comments do matter:

Insensitive comments from the leadership further widens the perception gap. Let me give two examples:

I. Recently while justifying the price of US$ 1000/tab of the Hepatitis C drug Sovaldi of Gilead, the CEO of Sanofi reportedly highlighted, “Unprecedented innovation comes at a price.” This is of course true, but at what price…US$ 1000/tablet? If this comment is not insensitive and outrageous, does it at least not smack of arrogance?

II. Another such insensitivity was expressed through reported proclamation in public of the Global CEO of Bayer, not so long ago, which clarified that: “Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India but for Western Patients that can afford it.” Incidentally, the above comment came from the same Bayer whose research chemists synthesized Prontosil, the first antibiotic, in 1932, more than a decade before penicillin became commercially available. Prontosil and subsequent “Sulfa” drugs – the first chemicals used to treat bacterial infections, ushered in a new era for medicine, saving millions of lives of patients globally. At that time, the then Bayer CEO probably did not say that Prontosil was developed “just for the Western Patients that can afford it.”

‘Inclusive Innovation’ for greater access:

Any innovation has to have an impact on life or life-style, depending on its type. Each innovation has a target group and to be meaningful, this group has to have access to the innovative product.

So far as drugs and pharmaceuticals are concerned, the target group for innovation is predominantly the human beings at large. Thus, to make the drug innovation meaningful, the new medicines should be made accessible to all patients across the globe, with social equity, as per the healthcare environment of each country. This underscores the point that drug innovations would have to be inclusive to make meaningful impacts on lives.

New age pharma leadership should find out ways through stakeholder engagement that innovative drugs are made accessible to majority of the patients and not just to a privileged few…fixing a price tag such as US$ 1000/tab for Sovaldi, Sanofi CEO’s above comment notwithstanding.

Leadership lessons to learn from other industries:

Traditional pharma leadership has still got a lot to learn from other industries too. For example, to speed up development of electric cars by all manufacturers, the Co-Founder and Chief Executive Officer Elon Musk of Tesla Motors has reportedly decided to share its patents under ‘Open Source’ sharing of technologies with all others. Elon Musk further reiterated:

“If we clear a path to the creation of compelling electric vehicles, but then lay Intellectual property (IP) landmines behind us to inhibit others, we are acting in a manner contrary to that goal.”

In the important ‘green’ automobile space, this is indeed a gutsy and exemplary decision to underscore Tesla Motor’s concern on global warming.

Why such type of leadership is so rare in the global pharma world? Besides some tokenisms, why the global pharma leaders are not taking similar large scale initiatives for drug innovation, especially in the areas of dreaded and difficult diseases, such as, Cancer, Alzheimer’s, Multiple Sclerosis and Metabolic disorders, just to name a few?

Finding cost-effective ways for even ‘Unprecedented’ drug innovation:

Taking a lesson from the Tesla example and also from my earlier blog post, ‘Open Source’ model of drug discovery, would be quite appropriate in the current scenario not just to promote more innovative and intensive approaches in the drug discovery process, but also to improve profit.

According to available reports, one of the key advantages of the ‘Open Source’ model would be substantial reduction of cost even for ‘Unprecedented’ innovations, besides minimizing the high cost of failures of several R&D projects. These, coupled with significant savings in time, would immensely reduce ‘mind-to-market’ span of innovative drugs in various disease areas, making these medicines accessible to many more patients and the innovation inclusive.

Indian Pharma – promoter driven leadership:

Back home in India, fast growing India Pharma businesses predominantly consist of generic drugs and are family owned. A 2011 study conducted by ‘ASK Investment Managers’ reported, “Family Owned Businesses (FOB)” account for 60 percent of market cap among the top 500 companies in India and comprise 17 percent of the IT Industry, 10 percent of refineries, 7 percent of automobiles and 6 percent of telecom, in the country. In the domestic pharmaceutical sector, almost hundred percent of the companies are currently family owned and run, barring a few loss making Public Sector Units (PSUs).

As most of these companies started showing significant growth only after 1970, we usually see the first or second-generation entrepreneurs in these family run businesses, where the owners are also the business leaders, irrespective of size and scale of operations.

However, it is unlikely that the pharma business owners in India would be willing, just yet, to go for a regime change by hiring professional leaders at the helm of a business, like what the IT giant Infosys announced the week last or Cipla did sometime back. Nevertheless, they all should, at least, attune themselves with the mindset of the new age pharma leaders to reap a rich harvest out of the opportunities, at times veiled as threats.

New leadership to be ethically grounded and engage everyone:

Unlike what is happening with the current pharma leadership today, the new age leadership needs to be ethically grounded and engage all stakeholders effectively in a transparent manner with impeccable governance.

Quoting Dr. Michael Soman, President/Chief Medical Executive of Group Health Physicians, the above Forbes article states that in the new age healthcare leadership model, the leader may not have to have all of the answers to all the problems, but he would always have a clear vision of where we wants to lead the company to.

This new leadership should create a glorious future of the pharma industry together with all other stakeholders by asking: “How can we all be part of healthcare solutions?”

Conclusion:

Unfortunately, despite so much of good work done by the pharmaceutical industry in various fields across the world, including in India, the general public perception on the leadership of the pharma world, is still very negative for various reasons. Pharma industry also knows it well.

Thus, around the close of 2007, the Chairman of Eli Lilly reportedly said publicly what many industry observers have been saying privately for some time. He said: “I think the industry is doomed, if we don’t change”.

The available statistics also paints a grim picture of the traditional big pharma business model going from blockbuster to bust with the mindset of the leadership, by and large, remaining unchanged, barring some cosmetic touch-ups here or there.

The old business model – sprawling organizations, enormous capital investments, and spiraling costs, underwritten by a steady stream of multibillion blockbuster products – is simply a pipe dream today.

Has anything much changed even thereafter? May be not. Thus, to meet the new challenge of change in the healthcare space, doesn’t the new age pharma leadership still look too archaic, at least, in its mindset and governance pattern?

Is it, therefore, not high time for them to come out of the ‘Ostrich Mode’ collectively, face the demanding environmental needs squarely as they are, try to be a part of healthcare solutions of a nation in a win-win way and avoid being perceived as a part of the problem?

Effective leadership learning process has always been eclectic, borrowing ideas and experiences from other disciplines. In case of pharma, it could well be from other knowledge industries, such as, Information Technology (IT), Telecommunications etc. But change it must. Not just for business growth creating shareholders’ value, but for long-term survival too, basking in glory.

By: Tapan J. Ray 

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

 

 

To prevent ‘counterfeit medicines’ from reaching the patients is the nation’s public health responsibility: Are we still in a denial mode to even accept the existence of this public health menace?

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In November 7, 2009, Financial Express reported with a headline,”Generic drug companies see a bitter pill in counterfeit“, because some believe that it has an in-built intellectual property right connotation.
The dictionary definition:

The word ‘counterfeit’ may be defined as follows:

1. To make a copy of, usually with the intent to defraud

2. To carry on a deception; dissemble

4. To make fraudulent copies of something valuable

5. A fraudulent imitation.

What does Indian Drugs and Cosmetics Act say?

May be for this reason the Drugs and cosmetics Act of India has specified that manufacturing or selling of the following types of drugs are punishable offence:

Section 17: Misbranded drugs

Section 17-A: Adulterated drugs

Section 17-B: Spurious drugs

No one has asked, so far, that as misbranding could involve trademark and design, why should it fall under Drugs and Cosmetics Act?

This was done in the past by the law makers because they believed that any attempt to deliberately and fraudulently pass off any drug as something, which it really is not, could create a serious public health issue, leading to even death.

Be that as it may, the pharmaceutical industry all over the world sincerely believes that counterfeit drugs involve heinous crime against humanity.

Definition of counterfeit drugs should cover the all types of medicines, which are not genuine:

Definition of counterfeit drugs should, therefore, cover the entire gamut of medicines, which are not genuine. Such medicines could be a fraudulent version of patented, generic or even traditional medicines and have nothing to do with patents or patent infringements.

At the same time it sounds very reasonable that a medicine that is authorized for marketing by the regulatory authority of one country but not by another country, should not be regarded as counterfeit on this particular ground in the other country, if it is not made available fraudulently.

The recent survey on ‘spurious’ and ‘sub-standard’ drugs by the Government of India:

To assess the magnitude of the menace of counterfeit drugs, Financial Express dated November 12, 2009 reported that much hyped “world’s largest study on counterfeit drugs” conducted by the Ministry of Health of the Government of India with the help of the Drug Controller General of India’s office, has come to the following two key conclusions:

1. Only 0.0046% of the drugs in the market were spurious

2. Quantum of sub-standard drugs in India is just 0.001%

From this report, it appears that India, at this stage, has nothing to worry about this public health hazard!!!
It is indeed quite baffling to understand, why did the government keep ‘misbranded drugs’, as specified in the Drugs and Cosmetics Act of India, outside the purview of this study.

Be that as it may, it appears that this survey has raised more questions than what it had attempted to answer. Such questions are expected to be raised not only by the pharmaceutical industry of India, its stakeholders and the civil society at large, but by the global experts, as well.

The problem of counterfeit is more prevalent in countries where regulatory enforcement is weak:

The menace of counterfeit medicines is not restricted to the developing countries like, India. It is seen in the developed countries, as well, but at a much smaller scale. Thus it is generally believed that the issue of counterfeit drugs is more common in those countries, where the regulatory enforcement mechanism is weak.

A study done by IMPACT in 2006 indicates that in countries like, the USA, EU, Japan, Australia, Canada and New Zealand, the problem is less than 1%. On the other hand, in the developing nations like parts of Asia, Latin America and Africa more than 30% of the medicines are counterfeits.

The role of ‘The World health Organization (WHO):

To effectively root out this global menace, the leadership role of the WHO is extremely important. Across the world, patients’ need protection from the growing menace of counterfeit medicines. As a premier organization to address the needs of the global public health issues and especially for the developing world, the WHO needs to play a key and much more proactive role in this matter.

Conclusion:

All stakeholders of the pharmaceutical industry must be made aware more effectively, without further delay, of the health threats posed by counterfeit medicines. Authorities and organizations like the Drug Controller General of India (DCGI) and its regulatory and enforcement agencies, healthcare professionals, patients, all pharmaceutical manufacturers, drug distributors, wholesalers and retailers should collaborate to play a very active and meaningful role in curbing the counterfeit drugs from reaching the innocent patients.

By Tapan 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