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‘Indian Pharma’s Apathy Towards Digital Marketing’ – A Misgiving Or Real?

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As I gather from different sources, an increasing number of Indian pharma companies are increasingly embracing digitalization in their marketing operations, especially after the crippling experience during the Covid lockdown period. They realize the use of digital platforms would be a great enabler for them to reach a wider audience, promote their products, and engage with healthcare professionals more effectively, in any given situation. The depth, span, and speed of adaptation of this initiative is fast gathering momentum in the capable hands of astute marketers.

In this article, I shall explore this area to ferret out the fact, whether ‘The Indian pharma industry’s apathy towards Digital Marketing’ is a misgiving or still a reality. However, I would start with an important note about getting caught in some possible controversies due to occasional overenthusiasm in this space. 

Some possible reasons for a brouhaha or controversy:

There may be several reasons why a brouhaha or controversy could continue surrounding the use of digitalization in Indian pharma companies’ marketing operations. Some possible factors include:

  • Compliance and Regulatory Issues: Digital marketing practices must ensure full compliance with regulations set by regulatory bodies, such as the Drug Controller General of India (DCGI) and the Medical Council of India (MCI). Any violation of these regulations can lead to legal consequences and damage the reputation of the companies involved.
  • Misinformation, data Integrity and Misleading Claims: The widespread use of digital platforms can make it easier for misleading, breach of data integrity and false claims to be disseminated. Regulators and critics may raise concerns about the accuracy of information being shared and the potential impact on patient health. 
  • Privacy, cyberthreats and Data Security: The use of digital platforms involves the collection and storage of user data. Privacy concerns, including cyberthreats, can arise if pharmaceutical companies do not handle personal information responsibly or if patient data is compromised due to inadequate security measures. 
  • Unethical Practices: There have been instances where pharmaceutical companies have been accused of engaging in unethical practices in their marketing efforts. These may include off-label promotion (promoting a drug for an unapproved use), undue influence on healthcare professionals, or aggressive marketing tactics that prioritize sales over patient welfare. 

It is important to recognize that the specific reasons for the ongoing brouhaha on this topic may have further evolved. From this perspective, let me now focus on a few Indian examples where using digital tools and analytics could offer several advantages for domestic pharmaceutical companies, as available from different sources.  

Examples of some areas where Indian players are using digital tools:

Here are some recent examples of how Indian pharmaceutical companies have utilized digital tools and analytics in their marketing operations, as available in the public domain:

  • Enhanced Targeting: Aurobindo Pharma Limited has implemented data analytics to identify key customer segments for targeted marketing. By analyzing prescribing patterns and patient demographics, they tailor their marketing efforts to reach specific healthcare professionals and patient groups more effectively. 
  • Personalized Marketing: Biocon Limited has embraced digital tools to deliver personalized marketing content. Through their digital platforms, such as websites and mobile applications, they provide customized information about their products, disease education materials, and patient support resources.
  • Improved Marketing ROI: Lupin Limited has utilized digital analytics to measure the performance of their marketing campaigns. By tracking key metrics, such as website engagement, social media interactions, and email response rates, they can optimize their marketing spend and allocate resources to channels that yield higher returns. 
  • Efficient Resource Allocation: Sun Pharmaceutical Industries Ltd has leveraged digital tools and analytics to optimize resource allocation. They analyze market data and customer behavior to identify regions and healthcare facilities with the highest growth potential, enabling them to allocate their sales resources strategically.
  • Real-time Market Insights: Dr. Reddy’s Laboratories Ltd utilizes digital tools and analytics to monitor real-time market insights. By leveraging social listening tools and data analytics platforms, they stay updated on market trends, competitor activities, and customer feedback, enabling them to adapt their marketing strategies accordingly.
  • Improved Customer Engagement: Cipla Ltd has focused on improving customer engagement through digital channels. They utilize social media platforms, online forums, and chatbots to interact with healthcare professionals and patients, providing information, answering queries, and offering support. 
  • Streamlined Communication: Torrent Pharmaceuticals Ltd has implemented digital communication tools to streamline interactions with healthcare professionals. They utilize virtual meeting platforms, webinars, and online training sessions to engage with physicians, pharmacists, and other stakeholders more efficiently, eliminating geographical barriers.
  • Data-driven Decision Making: Glenmark Pharmaceuticals Limited leverages data analytics for data-driven decision making. By analyzing sales data, market trends, and customer feedback, they gain insights that inform their strategic decisions regarding product launches, marketing campaigns, and market expansion. 

These examples demonstrate how Indian pharmaceutical companies have harnessed digital tools and analytics while recomposing notes in a pharma marketing playbook to enhance their business operations. However, please note that specific initiatives and strategies are still evolving, and the extent of adoption may vary among different companies. 

Conclusion:

From the above perspective, I reckon, Indian drug companies are increasingly embracing digital toolsand analytics to enhance their marketing efforts. With the advancement of technology and the growing importance of digital channels, pharmaceutical players in India are recognizing the need to adapt and leverage digital tools to stay competitive and effectively reach their target audience. Hence, any feeling about the ‘Indian pharma industry’s apathy towards Digital Marketing’ seems to be a misgiving to me.

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.

Creative Pharma Marketers To Unshackle Covid Fetters

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Pharma industry, just as most others, has started recognizing that the business needs to be brought back to normal, despite Covid fetters. Some early evidences suggest, a new breed of pharma marketers is refusing to get confined to Covid triggered operational limits, without breaching any prescribed safety norms.

These pacesetters no longer grapple with finding right answers to the question – when and how the brand building activities can be brought back to the old normal? Truly speaking, none has its answer, as yet. Covid has the power to strike back, anytime – anywhere, in waves, when the guards are even slightly down. Moreover, as and when vaccines will come, these may not be ‘silver bullets’ for many – throughout a lifetime, at least, in the foreseeable future.

Accordingly, these forerunners are effectively leveraging the art of turning challenges into opportunities. They are conceptualizing new business models for making path-breaking progress in contemporary purpose driven branding exercises. For all pharma marketers, I reckon, this is the moment of truth, when what you do reflects what you really are, in this area. Thus, in this article. I shall deliberate, with examples, how these creative new age pharma marketers are trying to unshackle Covid fetters.

Today’s reality on the ground: 

A number of global surveys on how patients’ have reacted to Covid-19 pandemic with reasons behind the same, are now available. One such study was conducted by Medisafe, during March and April, 2020. Some of its key findings are as follows:

  • More than half of the respondents, especially those with comorbidities, worry about getting Covid infected while accessing to in-person treatments.
  • Over 9 out of 10 respondents were practicing social distancing, as a remedial measure.
  • Consequently, they are missing doctors’ appointments, and many are opting for telehealth wherever appropriate and necessary.

In many situations, such as,  common and repetitive health issues, including some mental health conditions, virtual health care are more convenient. It has also been established during the pandemic that telehealth can deliver similar outcomes at a lower cost, than in-person visits. In addition, remote monitoring of some key health parameters, like heart rhythm, blood sugar, weight, respiratory rate, also help people control their chronic conditions better, and assist clinicians with diagnosis and treatment.

More doctors prefer telehealth, but the majority wants some in-person visits too: 

An interesting study – ‘Want Both In-Person and Virtual Visits with Sales Reps,’ published by Bain & Company on June 02, 2020, ferreted out today’s reality, in this space. It found, prior to Covid, about three-fourths of physicians preferred face-to-face engagement with sales reps. In contrast, today more of them are asking for a reduction in Rep visit frequency and more remote support or virtual approaches. Curiously, a majority still prefers, at least some in-person interaction ‘once the pandemic passes.’

Interestingly, no one seems to know, just yet, when exactly will this pandemic get over. Besides, whether or not Covid will keep coming back in waves, for an indefinite period. Or, any similar or even worse global health crisis, in future, could bring greater disruption for the industry.

Driven by such apprehensions, it is possible that more and more patients will prefer telehealth, expanding access to health care for an increasing number of people. Nonetheless, one should also take into consideration that virtual health care has also some significant limitations, especially those which may lead to serious or life-threatening conditions.

Some key limitations to overcome:

Alongside multiple advantages of telehealth, it has some significant limitations, which can’t be wished away, either. This point was also well articulated in the article – ‘Where Telemedicine Falls Short,’ published in the Harvard Business Review (HBR) on June 30, 2020. The author, who is also a primary care physician gave a number of examples in this regard. For example, in one place he wrote:

‘I have found treatable cancers multiple times in routine exams that would be impossible to replicate in the virtual world. Could a Zoom visit detect a lymph node too firm, a spleen or liver too large, or an unexpected prostate nodule (with a normal PSA)?’ The paper also emphasized: ‘Trust and face-to-face encounters are even more important for patients with complex and intertwined problems.’

Be that as it may, the task to encourage patients, even with serious ailments, for in-person consultation and examination by doctors’ in their clinics, won’t be ‘a piece of cake’ too. On the contrary, it will be rather a colossal exercise.

Why will this task be colossal?

One can get a sense of tough challenges involved in this effort from the IQVIA report titled, ‘COVID-19 Pandemic and the Impact on SEA Healthcare Market.’ Along with other areas, the study captured several details of the above area, specifically for the South East Asia (SEA), as follows:

  • Decrease in patient visits (Out-Patient): 2 out of 3 hospital doctors are experiencing >60% decrease in patient visits.
  • Extended period of time before patient load resumes to normal: ~50% of doctors think that it will take 4 to 6 months to resume normal operations.
  • Increase in prescription duration: ~25% of doctors have 2x their standard prescription duration to reduce patient visits.

The study also observed, ‘in order to reduce the risk of getting infected, patients are reducing their visits to the HCPs.’ Such an unusual situation is unlikely to be mitigated, soon, with any traditional or ‘one size-fits all’ type strategy. Particularly when Covid threat still looms large on the population. As is happening today, even after signs of waning, Covid may return in waves – for an indefinite period. Thus, innovative marketing interventions, backed by actionable insights, are essential to help overcome the fear of getting Covid infected, by both patients and doctors.

How to respond to this situation in a creative way?

The creative marketing response to overcoming the possible barriers on the way, would call for predictive rather than reactive pharma strategies. The game plan not only needs to be purpose drivenfor the marketers, but should also be perceived that way by all concerned. For example, the core purpose of marketing in this scenario, will be to provide a life-saving patient ‘service’, with win-win outcomes.

And the additional ‘service’ in this case is encouragement in-person physician visits during early symptoms of life-threatening health conditions – taking all safety precautions and overcoming ‘paranoia’ of getting infected. The win-win outcomes will include – saving lives, preventing deterioration of the disease condition, and of course, facilitation of the brand demand. The good news is some global pharma majors have already started making progress in this direction.

Promoting doctor visits during the pandemic – an example:

Leaving footprints to follow, some pharma marketers have already started creatively working on it. Let me cite a recent example of this unique initiative. This was reported by Fierce Pharma in its November 02, 2020 issue. The marketing process carries all the required ingredients for excellence, as mentioned above.

It wrote, ‘Pfizer and Bristol Myers Squibb are the latest drugmakers to join the swell of campaigns promoting doctor visits during the pandemic.’ This decision was based on data, showing many people haven’t been going to their primary care appointments for symptoms that may lead to potentially serious conditions.

This initiative is focused on three critical health conditions, namely, atrial fibrillation, deep vein thrombosis and pulmonary embolism. The rationale for selecting these three indications is, these are all treated by the partners’ anticoagulant Eliquis.

Accordingly, the BMS-Pfizer Alliance launched a campaign to raise awareness and encourage people to seek prompt medical attention. The American campaign was built around the theme – ‘Your symptoms could mean something serious, so this is no time to wait.’ In tandem, the companies also widely communicated through multiple channels that ‘Decreases in Americans’ Primary Care Visits May Lead to Late Diagnoses of Potentially Serious Conditions.’

According to reports, the net result of this creative marketing, so far, is no less than outstanding, as compared to many other pharma players operating in similar situations. ‘Eliquis’ brand sales for the first six months of 2020 topped $4.8 billion, a 21% increase over the same time period last year. Doesn’t this initiative demonstrate that creative pharma marketers can unshackle even Covid fetters?

Conclusion:

Meanwhile, as on November 08, 2020 morning, India recorded a staggering figure of 8,507,754 of Coronavirus cases with 126,162 deaths. The average number of daily new cases appeared to have slowed down in the last few weeks. But, the threat of further spread of Covid infection, in waves, still looms large in the country.

Most scientists agree – while effective vaccines offer the best chance of reaching zero COVID-19 – eliminating the virus across much of the world, while not unthinkable, could take a significant number of years. Thus, it may be realistic for some time to focus on flattening the curve with stringent control measures, involving efficient contact tracing, testing and isolation, together with social distancing and mask wearing – till it happens, ultimately.

Meanwhile, the business must flourish, even amid a new normal. And this is, in no way, a pipe dream, but a proven reality, as we have seen above. No doubt, this calls for most pharma marketers wearing a fresh thinking cap, equipped with more cerebral power, as it were, to unshackle Covid fetters on their way – effectively.

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.

 

Prescription Digital Therapy Now A Reality

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The pursuit of offering ‘prescription digital therapeutics’ or ‘digiceuticals’ by Big Pharma, to ensure better clinical outcomes for patients, has apparently come to fruition now.

On April 18, 2018, by a media release, Novartis announced that the Sandoz Division of the Company has entered into collaboration with Pear Therapeutics to commercialize and continued development of digital therapeutics, designed to effectively treat disease and improve clinical outcomes for patients.

The collaboration brings on to the table, a synergy between Sandoz expertise in launching and commercializing various disease treatments, with Pear’s leading experience in digital therapeutics design and implementation. This deal has attracted attention of many. Mainly because, any pharma player will, for the first-time, detail a digital therapy treatment directly to the medical profession, and seek their prescription support.

It is worth noting that Pear’s flagship digital therapeutic – reSET is the first USFDA-cleared mobile medical application with both a safety and efficacy label to help treat patients with Substance Use Disorder, in September 2017. According to published reports, several studies have established that it is two-times more effective than conventional in person therapy sessions. Interestingly, the rate of treatment efficacy increases even up to tenfold, in refractory patients.

Just the beginning of a long run: 

The above market launch of a digital therapy by Novartis signals just the beginning of a long run in changing in the disease treatment archetype for better outcomes. Incidentally, prior to this announcement, on March 1, 2018, the same Company had announced, “Novartis and Pear Therapeutics to collaborate on prescription software applications aimed to treat patients with schizophrenia and multiple sclerosis.”

The media release underscored:“Psychiatric and neurodegenerative diseases place a heavy physical, mental and economic burden on patients and their families. With widespread adoption of digital devices, prescription digital therapeutics could potentially play an important role in future treatment models for a range of diseases with high unmet medical need”.

The scope and potential:

An article titled – ‘Digital therapeutics: Preparing for takeoff’,published by McKinsey & Company in February 2018, captures its scope succinctly. It says, “digital therapeutics tend to target conditions that are poorly addressed by the healthcare system today, such as chronic diseases or neurological disorders. In addition, they can often deliver treatment more cheaply than traditional therapy by reducing demands on clinicians’ time.”

A separate McKinsey interview article, titled ‘Exploring the potential of digital therapeutics’, published in the same month, elucidated the potential of digital therapy equally well.  It highlighted:“A digital therapeutic is an intervention based on software as the key ingredient, which has a direct impact on a disease. This is what distinguishes this category from the broader term digital health. We will see digital therapeutics and digital diagnostics integrate into the health system…”

‘Prescription digital therapy’ are not just ‘Fitness and Well-being’ Apps:

Prescription digital therapy are not just to monitor a person’s general fitness level against pre-identified parameters, and overall well-being. Whereas, digital therapeutics help patients to regularly and consistently monitor relevant and tailor-made disease related data - in real-time to detect behavioral, lifestyle and requisite biological changes on a daily basis. However, this is not ‘a so well-realized necessity’ today, especially, in the treatment of certain serious disease conditions, to ensure significantly better clinical outcomes for patients.

Digital therapeutics can ensure making a favorable change in patient behavior, which is not merely as efficient as administering medicines, but could also ensure greater effectiveness than conventional medications. Further, it assists patients to better understand, manage and control several disease conditions, and more importantly, sans any untoward side-effects.

Besides, with digital therapy, the required treatment interventions will reach patients faster than traditional treatment processes. Both the patient request and the medical response for the same can be quickly exchanged, together with relevant data support, through smartphones or other wearable digital interfaces – either in the form of voice or text or both. I shall dwell on this later in the article. Thus, digital therapy may not require patients to meet the doctor every time a need arises.

Moreover, fitness and wellbeing Apps do not require marketing approval from a country’s drug regulator. Mostly because, they help monitoring general and generic fitness parameters, capturing some low-risk changes. Whereas, a custom-made prescription digital therapy would necessarily require such regulatory nod.

In tandem, various studies are also being conducted on wearables, such as an Apple Watch, as an interface. The following are examples of some of these studies:

Digital therapy study with Apple Watch as an interface:

In February 2017, Takeda Pharmaceuticals U.S.A. and Cognition Kit Limited, announced a collaboration to pilot the use of a specially designed app on an Apple Watch wearable to monitor and assess cognitive function in patients with Major Depressive Disorder (MDD).

In November 2017, they presented results from ‘Digital Wearable Technology Study’ in patients with MDD. The observational study involved 30 participants, aged 18-65, with a clinical diagnosis of mild to moderate depression who have been prescribed antidepressant monotherapy for MDD.

The study also evaluated feasibility and participant compliance with measures of mood and cognition on wearable technology; and compared measures of mood and cognition on wearable technology using traditional neuropsychological testing and patient reported outcomes on depression symptoms at 6 weeks. Participants were provided with an Apple Watch on which brief cognitive and mood tests were administered daily.

The researchers observed that patients were compliant with the wearable Apple Watch device on a daily basis to evaluate mood (95 percent) and cognition (96 percent). The study also demonstrated that abbreviated daily assessments delivered through the wearable Apple Watch device corresponded with objective Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive tests and full-length patient reported outcomes, PHQ-9 and PDQ-D, assessed during weeks 1, 3 and 6. No adverse events were reported in the study.

According to another report, this user interface with Apple’s smart-watch versions 2 and 3 is now being used in a number of studies for chronic conditions, such as Parkinson’s disease – combining biometric data with user input. Again, in February 2017, Johns Hopkins University announced a project to use the smart-watch for research on possible triggers of epileptic seizures.

When used as an interface with prescription digital therapy, the provision of e-SIM and GPS in Apple Watch Series 3, I reckon, would also help patients to immediately communicate with the remote therapy centers using the same device, anytime – as and when the patients want.

Digital therapy initiatives in India:

Initiative on digital therapy has already started rolling in India, as well. Its pace is also quite encouraging. For example, Wellthy Therapeutics is building a patient centric solution for diabetes through digital intervention and management. On February 20, 2018, the Company, reportedly, shared the interim results of an ongoing real-world pilot to evaluate the effectiveness of the Wellthy Diabetes Smartphone App (WD). The results were shared at the 11th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2018) in Vienna, Austria.

The data demonstrated how the use of WD improved glycemic control. On completion of 16 weeks, participants showed a reduction in their HbA1c by (-0.61%) on average, with 61.5% of participants having showed significant reduction in their HbA1c with an average of (-1.17%) reduction.

Conclusion:

As indicated in my article titled, ‘Digiceuticals: A Force Multiplier to Contain Chronic Diseases’, published in this blog on October 23, 2017,prescription digital therapies are primarily of two types – one for “medication augmentation” and the other for “medication replacement.”

Be that as it may, prescription digital therapyimproves clinical outcomes for patients by manifold. It also shows potential to take over from traditional treatment with medicines in several serious and virtually crippling ailments, mostly related to human behavior and lifestyle, such as a host of chronic diseases, and without causing any side-effects.

Thus, prescription digital therapy is now a reality. It has come to stay for long – can’t be wished away, any longer.

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.

Define And Adapt To Reality: Two Pivotal Pharma Leadership Skills For Sustainable Excellence

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Max DePree – a much quoted American businessman and author had once said: “The first responsibility of a leader is to define reality.”

While defining the reality within the drug industry today, it makes many industry leaders to ponder, despite so much of the good work done by the industry in various fields of pharma business, across the world, including India, why is the public perception on the overall leadership of this sector still so negative, and continue going south? Pharma leaders know the reasons too, but they seem to be still searching for the right set of answers without breaking the traditional mold of business.

Around end 2007, being concerned with this trend, the then Chairman of Eli Lilly reportedly expressed 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”.

On the general apathy of breaking the traditional mold after having defined the business reality, an interesting article titled, “Healthcare Leadership Must Shift From A Cottage Industry To Big Business”, published on June 2, 2014 in Forbes, made some interesting observations, which are as relevant to India, just as many other countries of the world.

The article 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 health care business model. Thus, unlike many other knowledge industries, pharma sector is still struggling hard to convert the tough environmental challenges into bright business opportunities. This leads to an important question: Being mostly inward looking, are these leaders failing to properly define reality around them, and therefore, not adapting to the critical external business environmental needs, soon enough?

Is current pharma leadership too inward looking?

From the available details, it appears that today, many inward-looking pharma leaders tend to ignore many serious voices demanding access to high quality medicines at affordable prices, especially for life threatening ailments, such as, cancer. Instead of engaging with the stakeholders in search of a win-win solution, global pharma leadership apparently tries to push the ball out its court with a barrage of mundane and arrogant arguments highlighting the importance of ‘drug innovation’ and hyping how expensive it is. Notwithstanding that by now, many people are aware of its frequent use, generally by the global pharma players, mostly as a veil, whenever required. Even then, many pharma leaders, instead of accepting the reality, continue to remain insensitive to the concerns not just of most patients, but other stakeholders and their respective governments also. This mindset further reinforces their inward-looking and self-serving image. This brings to the fore the key issue: Is this high time to pass the baton to a new breed of pharma leaders?

In the above backdrop, this article dwells on some intrinsic issues involved with the leadership puzzle of the industry, as it were. Thereafter, it deliberates on the importance of making some easy self-tests available to the young and especially the millennial pharma professionals, to facilitate them to self-discover themselves in this space, and that too at an early stage of their professional career, as they try to understand and define the business and environmental realities facing the industry.

Leadership skills are difficult to find:

Focusing on the pharma industry, I would say, especially in the pharma sector, leadership skill in all its functional areas though is considered as the most important one, but are equally challenging while identifying the right persons.

The 20th Pharma CEO Survey, March 2017 of PwC, vindicates this point. The survey covered 89 pharma CEOs from 37 countries. Nearly all the Pharma CEOs participating in this survey picked out leadership as the most important for their organization, giving it the top spot, closely followed by problem-solving, creativity and innovation, all bracketed in the second, with collaboration and adaptability occupying the equal third rank, as follows:

Relative importance of skills in pharma industry Skill sets Respondents answering somewhat difficult or very difficult to get each one of these
1. Leadership 79
2. Creativity & Innovation 75
3. Emotional intelligence 72
4. Adaptability 63
5. Problem-solving 55

Over two-thirds of the CEOs face difficulty in recruiting people with the requisite skills that they consider most important to their organization, such as, leadership, problem-solving, and creative skills, the report highlighted. For further deliberation hereunder, I shall pick up the top one – the leadership skill for the pharma industry, as I see it.

The age-old question – ‘Are leaders born or made?’

A critical question that is often asked even today – ‘Are leaders born or made?’ The question keeps coming as some enthusiasts continue to argue that successful leaders are born with visible or apparently invisible leadership traits.

Are leaders born?

To answer this question, let me quote an example. The Management Study Guide (MSG), well-articulated an approach to the study of leadership known as the ‘Great Man Theory’, giving examples of the great leaders of the past, such as, Alexander the Great, Julius Caesar, Napoleon, Queen Elizabeth I, Abraham Lincoln and Mahatma Gandhi. They all seem to differ from ordinary human beings in several aspects, possessing high levels of ambition coupled with clear visions of precisely where they want to go.

Added to these examples are many top business executives, sports personalities, and even contemporary politicians, who often seem to possess an aura that sets them apart from others. These persons are cited as naturally great leaders, born with a set of personal qualities that made them effective leaders. Thus, even today, the belief that truly great leaders are born, is not uncommon. Thus, according to the contemporary theorists, leaders are not like other people. They do not need to be intellectually genius or omniscient prophets to succeed, but they should certainly have the ‘right stuff’, which is not equally present in all people, MSG highlights.

Even today, some continue to believe in the ‘Great Man Theory’, regardless of many well carried out research studies of the behavioral scientists establishing that it is quite possible for individuals becoming leaders through various processes, such as, self-learning, keenly observing or working with some good leaders, following their advices, training, and practicing the experiences thus gained in one’s real life.

Are leaders made?

Just as above, to answer this question, as well, I would cite another important example.

A September 21, 2016 article titled, “What Science Tells Us About Leadership Potential”, published in the ‘Harvard Business Review (HBR)’, while answering the question ‘who becomes a leader’, stated as follows:

“Any observable pattern of human behaviors is the byproduct of genetic and environmental influences, so the answer to this question is ‘both’.  Estimates suggest that leadership is 30%-60% heritable, largely because the character traits that shape leadership - personality and intelligence - are heritable. While this suggests strong biological influences on leadership, it does not imply that nurture is trivial. Even more-heritable traits, such as weight (80%) and height (90%), are affected by environmental factors. Although there is no clear recipe for manipulating the environment in order to boost leadership potential, well-crafted coaching interventions boost critical leadership competencies by about 20%–30%.”

What would a young pharma professional do in this situation?

The current breed of top leaders would continue grooming and promoting mostly those who fit their profile, while in the family owned businesses succession usually takes place from within the family. The situation is no different in the pharma industry. However, various studies indicate that millennial professionals with leadership traits will develop themselves.

Keeping this in mind and, at the same time, going by the above HBR article, I would tend to accept the dictum that, “Any observable pattern of human behaviors is the byproduct of genetic and environmental influences”. Thus, for identifying and then honing leadership skills in the pharma business, just as many other industries, I would prefer the process of dovetailing the heritable leadership traits with various environmental influences.

An ambitious pharma professional with high aspiration to make a difference in the organization that the individual represents, would obviously wonder what the way forward for him to achieve the goals. In my view, an honest self-test is the first and basic move in this direction.

The self-test:

Taking a cue from the article titled “Strategic Leadership: The Essential Skills”, published in the January-February 2013 issue of The Harvard Business Review (HBR), I would suggest that the young professionals may wish to ask themselves the following important questions:

  • Do I have the right networks to help myself see opportunities before competitors do?
  • Am I comfortable challenging my own and others’ assumptions?
  • Can I get a diverse group to buy into a common vision?
  • Do I learn from mistakes?

The answer to each of these ones should be clear and honest, as one doesn’t need to disclose those answers to anyone else. Nonetheless, by following this process, a young professional gets a clear view of where he or she stands in each of these important areas, which cover some of the basic traits of a leader.

The leadership package:

Irrespective of whether an individual has some heritable leadership traits or not, the above self-test would reveal a person’s strengths and weaknesses, help address the deficits and optimize the full portfolio of leadership skills, independently or otherwise.

Nevertheless, it is important to bear in mind, as several research studies have already established, though leadership skills are important and difficult to find, a few other salient skills such as, ability to apply in real life a creative and innovative mindset, supported by high emotional intelligence or emotional quotient (EQ) are also critical. This is because, together these offer the all-important leadership package for an all-round successful leader.

Should pharma leadership be eclectic?

I guess so, as there does not seem to be any better alternative either. Thus, I reckon, traditional pharma leadership needs to be eclectic. It has still got a lot to learn from other industries too. Let me give a relevant example here – to speed up development of electric cars by all manufacturers, the Cofounder 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 radical, gutsy and an exemplary decision to underscore Tesla Motor’s concern about global warming.

Why such type of leadership is so rare in the global pharma world, even today? Besides sanctimonies, as these appear, why the global pharma leaders are not taking similar large scale initiatives for drug innovation, especially in the areas of difficult diseases, such as, Cancer, Alzheimer’s, Multiple Sclerosis and Metabolic disorders, just to name a few? For this purpose, pharma organizations would require mettlesome change agents who can break the traditional mold –new leaders of the millennial generation having a different business outlook altogether, could possibly do so.

Becoming a change agent:

Today, more than ever before, the ultimate goal of pharma leaders requires moving beyond making more money to satisfy the shareholders and stock markets. It also needs to include the requirements of society, in general, more than what mandatory CSR demands. This is palpable today, as many stakeholders vehemently questioning the business game plan of many pharma players. Would this situation change? I don’t know, but it should, which prompts a change in the overall quality of pharma leadership, at all levels. I have had reason to believe that a good number of bright, millennial pharma professionals look for empowerment to discover themselves early. Right at that stage, they also need to chart a road map for self-development, which would facilitate attaining their professional goals, quite in sync with the broad societal expectations, as they move on in life.

New pharma leadership would require greater focus on ethics and engagement:

While pharma industry leaders, in general, have been impressive articulators of all right things that need to happen, ‘Talking the Talk’ and ‘Walking the Walk’ in the frontiers of business ethics, values and shared goals are found wanting in many of them. These articulations are probably used to run expensive global ‘Public Relations (PR)’ campaigns, lobbying and advocacy initiatives in the corridors of power.

What else then could possibly be the reason for such perception gap that this great industry has allowed to increase, over a long period of time? Could it be that many pharma leaders have not been able to adequately adapt themselves to the demands of the changing healthcare environment and the needs of various stakeholders in this sector? Is the leadership, therefore, too archaic and it’s a time for a change?

Thus, unlike the current pharma leadership, the new age leadership needs to be ethically grounded, and engage all stakeholders effectively in a transparent manner with impeccable processes of governance involving all areas of business. Such leaders may not be know-all individuals in the pharma business, but must possess a clear vision of where they want to lead the company to, and don’t slip back, especially in terms of public image and meeting patients’ expectations.

In conclusion:

Pharma business in modern times faces rapidly changing stakeholder expectations, which are generally difficult to predict well in advance. Thus, today’s pharma leaders require to adapt their strategic approach and the tactical game plans accordingly for business excellence in an inclusive manner, and simultaneously try to shape the environment to the extent possible.

There is a growing expectation from the pharma leaders to do business by imbibing a caring outlook towards the society, where it operates. Spending time and money to transplant the past practices in the changed environment, or continuing with the traditional business approaches, I reckon, is a no-win game today.

Thus, there arises a need to help the young pharma professionals, from the early stages in their professional life, for shaping up as the chief change agent in the organization that they would lead. Even after reaching where they wanted to reach, these leaders should keep studying on a continuous basis, various other successful leadership styles, approaches and visions, to splice them into a more productive strategic approach for the business or functional areas that they lead.

This new breed of leaders would also require defining the reality prevailing in the industry on an ongoing basis, to pave the way for a glorious future for their respective organizations. This effort would call for regular and effective engagement with all the stakeholders through various digital and other platforms. The critical question that the new pharma leadership should never forget to continually ask themselves: “How can my organization provide better access to high quality and effective medicines to most patients along with achieving commercial excellence in business?”

Properly defining and quickly adapting to associated environmental realities with a creative mind, requisite emotional intelligence and ethical business practices, would call for coming out of the zone of comfort with promptness. These, I reckon, would be the two pivotal success factors for new pharma leaders for inclusive and sustainable success in business, as the industry moves on.

By: Tapan J. Ray

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

Access to Medicine: Losing Track in Cacophony

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Indian Healthcare space is by and large an arena, where perceptions prevail over the changing reality in many important areas. Consequently, fierce discourse in those areas mostly gives rise to a cacophony of ‘Your Perceptions Against Mine’.

It is intriguing, why even in some well-hyped research studies of recent times, multiple interpretations are made not based on specific analytics-based numbers, but around critical data gaps and then the vital ‘conclusion’ is craftily packaged in a particular way to reinforce a set of perceptions and view points.

Serious discourse on ‘Access to Medicine’ in India often falls in these data crevasses, resulting nothing more than abject cynicism and expert sermons sans accountability from all quarters. Suggestions for precise quantification of magnitude of the problem, so far as ‘Access to Medicine’ is concerned, and then measuring the same periodically for sustainable corrective measures, obviously fade away in the din of multiple shrill voices, heavily loaded with self-perceptions attempting to score favorable brownie points.

A quantifiable number on overall ‘access to medicines’ remains illusive:

A quantifiable recent number on overall ‘Access to Modern Medicines’ in India, which could well form the base to measure progress of the country in this critical area subsequently, still remains illusive.

It is an irony, no one seems to know today what is the current ‘Access to Modern Medicines’ in India, in real term.

A recent study too goes around it, but NOT into it:

A 2012 industry sponsored study carried out by IMS Consulting, instead of giving just one number for overall ‘Access to Modern Medicines’ in India, went around it by reiterating the obvious that ‘access’ has 4 dimensions such as, Physical Reach, Availability/Capacity, Quality/Functionality and Affordability.

That is fine. No issue. However, the much sought after number of overall ‘Access to Modern Medicines’ still remained illusory in this study too. Interestingly, there are no numbers available to public for each of the above 4 important dimensions either. Thus the cacophony got shriller.

Clutching on to ‘Dinosaurian data’ in modern times:

Against the above backdrop, like many others, both local and global, even the honorable President of India on January 16, 2013, while addressing the ASSOCHAM 10th Knowledge Millennium Summit, quoted the ‘World Medicines Situation of 2004 report’, the base year of which is reportedly 1999. This study indicated, ‘only 35% of the population of India, against 53% in Africa and 85% in China has access to modern medicines’.

Thus in the absence of any recently updated number, the ‘Dinosaurian data’ of 1999 (published in 2004) is being considered relevant by many even in 2013, including the esteemed industry body that probably provided those irrelevant data to the president of India’s office for his speech, at the beginning of this year.

Importance of capturing today’s ‘Access’ data to provide ‘Healthcare to all’:

There should not be even an iota of doubt that the above reported scenario has changed quite significantly, at least, during the last decade in India, making the 1999 (published in 2004) ‘Access to Medicines’ numbers irrelevant, having no sense whatsoever in 2013.

To drive home this point, I shall now focus on just three sets of parameters, besides many others, to vindicate my comment on ‘dinosaurian data’. These parameters are as follows:

  1. Compounded Annual Growth Rate (CAGR) in per-capita expenditure on healthcare from 2006-11
  2. Compounded Annual Growth Rate (CAGR) of the domestic pharmaceutical industry in this period
  3. Quantum of increase in use of public healthcare facilities

1. Per capita Healthcare expenditure from 2006-11:

Year US $
1999 18.2
2004 28.7
2006 33.0
2007 39.9
2008 42.7
2009 43.6
2010 51.4
2011 59.1

(Source WHO Data)

The above table vey clearly highlights that in 1999, the base year of the above study, per capita healthcare expenditure in India was just US$ 18.2. The figure rose to US$ 28.7 in year 2004, when that study was published. The number reached to US $ 59.1 in 2011. This reflects a double digit Compounded Annual Growth Rate (CAGR) in per capita healthcare expenditure of the country from the 2004 study to 2011.

No doubt, this number is still much less than many other countries. Nevertheless, in 2013, per capita healthcare expenditure in India will be even more, indicating significant increase in ‘Access’ as compared to 2004.

2. Growth of domestic pharmaceutical market: 

According to the PwC – CII report titled “India Pharma Inc.: Gearing up for the next level of growth”, the domestic drug market has been clocking a CAGR of more than 15 percent over the last five years. Thus, high growth of the Indian Pharmaceutical Market (IPM) since the last decade, both from the urban and the rural areas, would certainly signal towards significant increase in the domestic consumption of medicines. Moreover, fast growing rural and semi-urban markets would also clearly support the argument in favor of increasing ‘Access to Modern Medicines’ in India.

A back of the envelope calculation:

Improvement in access as compared to what ‘World Medicines Situation of 2004 report’ had highlighted, may not have a linear relationship to the volume growth of the industry during this period. However, a large part of this growth could indeed be attributed to increase in overall consumption of drugs, leading to improvement in access to medicines in India.

For example, out of the reported 15 percent CAGR of the IPM, if one attributes just 8 percent volume growth/year to increased access to drugs, a back of the envelope calculation would indicate that during last nine years over the base year of 2004, the access to medicines has improved at least to 70 percent of the population, if not more, and has NOT remained just at 35 percent, as many tend to establish a point or two by quoting the above dated report.

Unfortunately, even the Government of India does not seem to be aware of this gradually improving trend, as evidenced in the honorable President of India’s speech in 2013, as quoted above. Official communications of the government also keep quoting the outdated statistics stating that 65 percent of the population of India does not have ‘Access to Modern Medicines’ even today.

Be that as it may, around 30 percent of Indian population would still perhaps not have ‘Access to Medicines’ in India. This issue needs immediate attention of the policy makers and can possibly be achieved through effective implementation of a holistic public health policy model like, ‘Universal Health Care (UHC)’.

3. Increase in use of public healthcare facilities:

According to a study done by the IMS Consulting Group in 2012, in rural India, which constitutes around 70 percent of the total 1.2 billion populations of India, usage of Government facilities for Out Patient (OP) care has increased from 22 percent in 2004 to 29 percent in 2012, mainly due to the impact of National Rural Health Mission (NRHM). This increase will have significant impact in reducing ‘Out of pocket (OoP)’ healthcare expenses of the rural poor.

Overall impact on some key health indicators: 

The same 2012 study of IMS Consulting highlights that an objective and comprehensive assessment of healthcare access in India was last undertaken in 2004, through a survey performed by the National Survey Sample Organization (NSSO). 
The survey reported on multiple parameters related to healthcare, including morbidity in broad age groups, immunization status, episodes of outpatient/ inpatient treatment across geography/ income segments together with expenditure on treatment. These measures, the study indicates, were taken collectively to indicate the status of healthcare access.

According to this report, the Government of India had undertaken multiple programs to improve healthcare access. These programs have addressed numerous issues, in varying proportion, that are linked to healthcare access, including lack of infrastructure, high cost of treatment, and the quality and availability of treatment. Some of these programs have been enormously successful: for example, India is a polio-free country today, the study reinforces.

The study also highlights significant progress in some basic healthcare indicators. The examples cited are as follows:

  • Maternal mortality rate has decreased by ~50 percent, and was reported at 200 deaths per 100,000 live births in the year 2010 as compared to 390 a decade ago. A few states such as Tamil Nadu, Maharashtra, and Kerala have already achieved the Millennium Development Goal (MDG) of a maternal mortality ratio less than 109 maternal death per 100,000 live births, with multiple other states close to achieving this target.
  • Infant mortality rate has decreased by greater than 25 percent over the period 2000–2009, and was reported at 50 deaths per 1,000 live births. Correspondingly, the under-5 child mortality rate (U5MR) has decreased by similar percentage levels, and was reported at 64 deaths per 1,000 live births. While U5MR for urban India has achieved the MDG target of 42 the same for rural of 71 is significantly lagging the target level.
  • Immunization coverage has increased significantly, for example diphtheria-tetanus-pertussis immunization among 1 year olds has increased from 60% to 70%, and the Hepatitis B coverage has increased from 68% in 2005 to 91% in 2010.
  • National programs have successfully improved detection and cure rates for tuberculosis and leprosy.

No direct relationship established between healthcare spend and outcomes:

Though India’s per-capita healthcare spend has been lowest among the usually compared BRIC countries, the following quick example would clearly establish that the healthcare outcomes do not have a linear relationship with the per-capita healthcare spend either:

Per capita Healthcare expenditure in 2011: Country Comparison

Country US $ World Rank Physician/1000 people Hospital/1000 people Life expectancy at birth (years)
Brazil 1120.56   41 1.76 2.3 73.4
Russia 806.7   55 4.31 9.6 69.0
India 59.1 152 0.65 0.9 67.08
China 278.02   99 1.82 3.8 73.5 

(Source: WHO data)

Thus, taking a cue from these numbers, India should decide at what percapita spend the country would possibly be able to ensure quality ‘access’ to healthcare for 100 percent of its population. Mere, comparison of percapita spend of each country, I reckon, may thus not mean much.

Conclusion:

The moot point, I reckon, is that, to measure progress in any sphere of activity, one will need to have a robust well-derived base point. Thereafter, progress needs to be monitored and quantified periodically from one point to the next.

So far as the access to healthcare in general and medicines in particular are concerned, it becomes difficult to fathom why is this basic approach still not being considered to measure progress in ‘Access’ and its rate in India.

As a result, discussions among the stakeholders do not take place around those updated numbers, either. Instead, what we hear is a high decibel cacophony of perceptions, at times groping around various dimensions of ‘Access’ and that too without quantification of each, as stated above.  This makes the task all the more complicated in pursuit of providing ‘Healthcare to All’ in India.

That said, the question to ponder now:

Does any one know what is the current ‘Access to Modern Medicines’ number in India and at what rate the progress is being made in that direction to achieve ‘Health for All’ objective of the country?

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.

‘Disease Oriented Treatment’ to ‘Patient Oriented Treatment’ – An evolving trend

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The quest for moving away from conventional and error-prone ‘Disease Oriented Treatment’ paving the way for unconventional individual patient-specific ones, may soon come to fruition. Dramatic progress in the research for developing ‘Personalized Medicines’ could soon offer a choice for individual ‘Patient Oriented Treatment’ with precisely predictable efficacy and safety, especially for the treatment of various intractable and dreaded diseases.

Sir John Bell, Professor of Medicine at Oxford University, adviser on genetics to the government and chair of its human genomics strategy group has reportedly said in early December 2012 that ‘Personalized Medicine’ for all could soon be a clear possibility, as everybody will be able to have their entire DNA make-up mapped for as little as £100 (Rs.8, 700 approx.).

This estimate seems to be quite realistic as Sir John said, the price of genome sequencing has fallen by 100,000-fold in 10 years and genetics being a key component of all common diseases, genome sequencing will help immensely in the use of new drugs, as well.

Raising a flag:

While watching the pursuit of excellence by the genetic scientists in the realm of disease treatment, some experts have reportedly been sounding a note of caution. They strongly feel that DNA code sequencing brings to light a “very real privacy concerns” of individuals.

GeneWatch UK, is an organization that investigate how genetic science and technologies will impact on our food, health, agriculture, environment and society. They have been strongly arguing, if genome sequencing is extended to entire population, individuals and their relatives could then be identified and tracked by matching their DNA with the genome stored in the respective health records. This move, as contemplated by them, could “wipe out privacy” with an impact on the society.

Thus, the ethical and social issues in the development of ‘Personalized medicines’ primarily in the area of genetic testing and consideration of race in the development of such medicines, these thought leaders feel, need to be effectively addressed, sooner.

That said, the Prime Minister of UK Mr David Cameron has reportedly said:

“By unlocking the power of DNA data, the NHS will lead the global race for better tests, better drugs and above all better care. We are turning an important scientific breakthrough into a potentially life-saving reality for NHS patients across the country. If we get this right, we could transform how we diagnose and treat our most complex diseases not only here but across the world, while enabling our best scientists to discover the next wonder drug or breakthrough technology.”

Increasingly more in development pipeline:

Rapid strides in pharmacogenomics bring in a promise of radically different ways of treating diseases, as major pharmaceutical companies of the world make progress in developing much more effective medicines designed to target smaller populations.

Tufts Center for the Study of Drug Development (Tufts University) in its publication named ‘Impact Report’, November/December 2010 articulated, “Bio-pharmaceutical companies are committed to researching and developing personalized medicines and within their development pipelines, 12% – 50% of compounds are personalized medicines.”

Experts envisage that over a period of time ‘Personalized Medicines’ will be targeted to biological/genomic profile of a patient or patient types to significantly improve the quality of treatment.

The definition:

The above report defines Personalized Medicines as “Tailoring of medical treatment and delivery of health care to individual characteristics of each patient, including their genetic, molecular, imaging and other personal determinants. Using this approach has the potential to speed accurate diagnosis, decrease side effects, and increase the likelihood that a medicine will work for an individual patient.”

Mainly due to all these reasons, ‘Personalized Medicines’ are expected to be an effective alternative to quite unwieldy current ‘blockbuster drug’ business model.

Makes a perfect fit:

The aim of ‘personalized medicines’ is, therefore, to make a perfect fit between the drug and the patient. It is worth noting that genotyping is currently not a part of clinically accepted routine. However, it is expected to acquire this status in the western world, very shortly.

Consequent changes and shifts:

This potential paradigm shift in the healthcare space would prompt similar changes in various disease diagnostic technologies, which will not only be able to detect a disease well before appearance of symptoms, but would also indicate which patients will best respond to or be adversely affected by which medications.

‘Personalized Medicines’ will in that process ensure a critical shift from the ‘Disease Oriented Treatment’ to a ‘Patient Oriented Treatment’, which can be initiated even before the clinical manifestations of a disease are detected.

The technological march towards this direction is indeed risky and arduous one. However, the benefits that the humanity will accrue out of this disruptive innovation will far outweigh the risks in all forms.

Towards this direction:

  • The Economist, March 12-18, 2011 in its article titled “Toward the 15-minute genome” reported that ‘nanopore sequencing’ of human genome is now gaining momentum. This could make sequencing of entire genome of cancerous and healthy cells possible to accurately point out what has exactly changed in individual patients, enabling the oncologists to determine patient specific drugs for best possible results in each case, separately.
  • New cancer marker has been reported to aid earlier detection of the disease, where repetitive stretches of RNA are found in high concentrations in cancer cells.
  • A new blood test will accurately detect early cancer of all types with an accuracy of greater than 95%, when repeated the accuracy will even be even greater than 99%.
  • ‘Breast On A Chip’ will test nano-medical detection and treatment options for breast cancer.
  • A brain scan will detect the telltale “amyloid plaques” ,the protein fragments that accumulate between nerves in Alzheimer’s disease.

A difference that matters:

With ‘Personalized Medicines’ the health of a patient will be managed based on personal characteristics of the individual, including height, weight, diet, age, sex etc. instead of defined “standards of care”, based on averaging response across a patient group. Pharmacogenomics tests like, sequencing of human genome will determine a patient’s likely response to such drugs.

All these are expected to offer more targeted and effective treatment with much safer drugs, and in all probability at a lesser real cost. Such medicines will also help identify individuals prone to serious ailments like, diabetes, cardiovascular diseases and cancer and help physicians to take appropriate preventive measures, simultaneously.

Each patient is unique:

‘Personalized medicines’ in that process will focus on what makes each patient so unique, instead of going by the generalities of a disease.

To give a quick example, genetic differences within individuals determine how their bodies react to drugs such as Warfarin – a blood thinner taken to prevent clotting. It is of utmost importance to get the dosing right, as more of the drug will cause bleeding and less of it will not have any therapeutic effect.

‘Personalized medicines’, therefore, have the potential to usher in a revolutionary change, the way patients are offered treatment by the medical profession. Genomic research will enable physicians to use a patient’s genetic code to arrive at how each patient will respond to different types of available treatments.

In the field of cancer, genetic tests are currently being done by many oncologists to determine which patients will be benefited most, say by Herceptin, in the treatment of breast cancer.

Indian initiatives:

Some companies, both well known and little known, are making quiet collaborative progress in the genome sequencing area in India, which will ultimately make expensive treatments like cancer more affordable to many.

Other advantages:

The expected benefits from the ‘Personalized Medicines’, besides very early diagnosis as stated above, are the following:

1. More Accurate Dosing: Instead of dose being decided based on age and body weight of the patients, the physicians may decide and adjust the dose of the medicines based on the genetic profiling of the patients.

2. More Targeted Drugs: It will be possible for the pharmaceutical companies to develop and market drugs for patients with specific genetic profiles. In that process, a drug needs to be tested only on those who are likely to derive benefits from it. This in turn will be able to effectively tailor clinical trials, expediting the process of market launch of these drugs.

3. Improved Healthcare: ‘Personalized Medicines’ will enable the physicians to prescribe ‘the right dose of the right medicine the first time for everyone’ without any trial or error. This would give rise to much better overall healthcare.

Reduced Clinical Trial cost:

Genome sequencing will help identifying a patient population, which will be far more likely to respond positively to the new treatment. In that process, if it reduces costs of clinical trial by even 5%, expected net savings for the industry towards clinical trial in real term will be significant.

With ‘personalized medicines’ the innovator companies will be able to significantly reduce both time, costs and the risks involved in obtaining regulatory approvals and penetrating new markets with simultaneous development of necessary diagnostic tests. Such tests will be able to identify patients group who will not only most likely to be benefited from such medicines, but also will be least likely to suffer from adverse drug reactions.

Therefore, considerable cost advantages coupled with much lesser risks of failure and significant reduction in the lead time for clinical trials are expected to make ‘personalized medicines’ much more cost effective, compared to conventional ‘blockbuster drugs’.

A sustainable business model:

Realization of deficiencies in the deep-pocket economics of ‘block buster drug R&D business model’ has made ‘personalized medicines’ a reality today. Large number of smaller and exclusive markets for ‘personalized medicines’ is also expected to be quite profitable for the pharmaceutical companies. On the other hand, better efficacy and safety profile of ‘personalized medicines’ will prove to be cost-effective in the overall healthcare systems.

However, smaller segmentation of the market may not leave enough space for the conventional ‘blockbuster model’, which is the prime mover of the global pharmaceutical industry, even today.

Reports indicate that some renowned global pharmaceutical companies like, Roche, AstraZeneca, GlaxoSmithKline are making good progress towards this direction through collaborative initiatives.

A different marketing ball game:

With ‘personalized medicines’ the ball game of marketing pharmaceuticals is expected to undergo a paradigm shift. Roche’s model of combining necessary diagnostic tests with new drugs will play a very important role in the new ball game.

Roche is reportedly ensuring that with accompanying required diagnostic tests, the new oncology products developed at Genentech can be precisely matched to patients.

Use in ‘Primary Care’:

Currently there is no widely successful model for use of ‘personalized medicines’ in a ‘primary care’ situation. However, it has been reported that in states like, Wisconsin in the U.S, initiative to integrate genomic medicines with ‘primary care’ has already been undertaken.

Scaling-up operations of such pilot projects will give a big boost to revolutionize the use of ‘personalized medicines’ for precision and targeted treatment for the ailing population.

Current Applications:

Though these are still the early days, initial benefits of ‘personalized medicines’ are now being reported in many areas like:

  • Genetic analysis of patients dealing with blood clots: Since 2007, the U.S. Food and Drug Administration has been recommending genotyping for all patients being assessed for therapy involving Warfarin.
  • Colorectal cancer: For colon cancer patients, the biomarker that predicts how a tumor will respond to certain drugs is a protein encoded by the KRAS gene, which can now be determined through a simple test.
  • Breast cancer: Women with breast tumors can now be effectively screened to determine which receptors their tumor cells contain.

Above applications of ‘personalized medicines’ will help saving not only significant expenses, but also precious time, which is usually spent for ‘trial-and-error treatments’. In addition, this approach also helps clinicians to determine quickly which therapies are most likely to succeed.

A truly patient centric treatment approach:

Generally speaking, unlike conventional ‘one size fits all’ type treatment approach, where same medicine with varying efficacy is tried on a large number of patients with equally varying rates of failure, ‘personalized medicines’ in true sense starts with the patients.

This may not necessarily mean unique treatment for each patient every time. With ‘personalized medicine’-based treatment approach, depending on biological, genetic and genomic characteristics, patients can be divided into groups and targeted treatment with specific drugs showing most efficacy and least side-effects can be worked out for each of these groups. Hence ‘personalized medicines’ by all means are truly patient centric.

Conclusion:

One of the key issues today in the realm of conventional ‘Disease Oriented Treatment’ is that lot many drugs do not work on significantly large number of patients with same efficacy and safety standards. ‘Personalized medicines’ will be able to address this issue with right diagnosis, ensuring treatment with the right medicine in right doses for the right type of patients.

Though in Europe and to some extent in the US, ‘Patient Oriented Treatment’ approaches with ‘personalized medicines’ have already been initiated, these are still early days for this novel concept to get translated into reality for wider use.

Lot many grounds may still need to be covered especially in the areas of medical research and also to work out the regulatory pathways for ‘personalized medicines’ in healthcare by the pioneers of this great concept.

That said, the evolving transition from the conventional ‘Disease Oriented Treatment’ to unconventional ‘Patient Oriented Treatment’ seems to be irreversible 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 and also do not contribute to any other blog or website with the same article that I post in this website. Any such act of reproducing my articles, which I write in my personal capacity, in other blogs or websites by anyone is unauthorized and prohibited.

 

 

Regulatory Data Protection (RDP) and its need in India: The Myth versus Reality

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THE MYTH:

An attempt to delay the launch of Indian generics:

Some in India feel that Regulatory Data Protection (RDP), is a deliberate attempt by the innovator companies to delay the launch of the generic equivalent of patented products in India, as long as they possibly can.

Thus they feel that why should one re-invent the wheel? Why should the generic pharmaceutical companies be not allowed to continue with the current requirement by the Drug Controller General of India (DCGI) to establish only the ‘bio-equivalence of an innovator drug to get the marketing approval of the generic equivalent in India?

RDP will effect export in non-regulated markets:
They further argue that India currently exports its pharmaceutical products to around 50 non-regulated markets of the world. Thus the enforcement of RDP would jeopardize Indian Pharmaceutical exports in those countries affecting the economy of the country.

RDP is a non-binding clause in TRIPS:

Regarding Article 39(3) of TRIPS, which indicates protection of regulatory data against “disclosure” and “unfair-commercial use”, this group opines that this is a non-binding Article of TRIPS, neither does it specify any timeline to protect such data. Moreover, they feel, that only the “undisclosed data” may be protected and the data already “disclosed” ‘need not to be protected’.

RDP is an attempt towards “evergreening” the patent:

The proponents of this interpretation believe that RDP is just an attempt to “evergreen” a patent, extending the patent life of a New Chemical Entity (NCE) or (NME) beyond 20 years.

THE REALITY:

Just Like Patents, Regulatory Data need to be protected to encourage innovation in India:

This group feels that generation of exhaustive regulatory data entails very significant investment in terms of money, energy and time. These are very high risk investments as approximately one in 5000 molecules researched will eventually see the light of the day in the market place. It is worth noting that clinical development of an NCE/NME costs around 70%, while the cost of discovery of the same NCE/NME is around 30% of the total costs. It is estimated that the entire process of drug development from discovery to market takes an average of 10 years and costs on an average U.S.$ 1.7 Billion in the developed markets of the world.

Since such voluminous regulatory data are not only costly and time consuming but also proprietary in nature, these need to be protected by the regulators. Regulatory Data Protection (RDP), therefore, has been widely recognized as an integral part of the Intellectual Property Rights (IPR).

The agreement on Trade Related aspects of Intellectual Property Rights (TRIPs) also recognizes the “protection of undisclosed information” as being an Intellectual Property, which needs to be protected.

Article 39.3 of TRIPs Agreement clearly articulates the following:

“Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”

Intellectual Property Rights (IPRs) mentioned in Article 39.3 of TRIPS are commonly referred to as “Data Exclusivity” in the U.S. and “Data Protection” or “Regulatory Data Protection” in the European Union (EU). These are all the very same.

RDP is an independent IPR; and should not be confused with other IPRs, such as patents:

Bringing an NCE/NME to the market involves two critical steps:

1. Discovery of NCE/NME:

The drug discovery right of the originator is protected in the form of a patent.

2. Drug development:

The innovator will require generating intensive, time consuming and expensive pre-clinical and
clinical data to meet the regulatory needs for bringing the new drug to the market. Such data
needs to be protected by the drug regulators.

It is understood that both the above steps are absolutely necessary to meet the unmet needs of the patients. The civil society gets the benefits of the new drugs only after these two steps are successfully completed.

The rationale for Regulatory Data Protection (RDP):

Irrespective of what has been indicated in Article 39.3 of TRIPS, RDP is clearly justifiable on the following grounds:

Generation of Data by the originator consists of “considerable efforts”. Submission of clinical data is a statutory regulatory requirement. Were it not for the obligation to provide these data to the Government, such data would have remained completely under control of the originator. It is, therefore, a reasonable obligation on the part of the Government as a ‘gate keeper’ to respect confidentiality of the data in terms of non-reliance and non-disclosure. Any failure by the Government to provide required protection to the data could lead to “unfair commercial use”.

Since such data are collected through various phases of clinical evaluation, involving considerable costs, time and energy, these are immensely valuable to the originator and need to be adequately protected by the drug regulators.

As these data are proprietary in nature, any access or permissibility for use of such data by the second applicant without concurrence of the originator is unfair on grounds of propriety and business ethics.

Given the imbalance between the costs to the originator of getting marketing approval for its product and the costs of the ‘copy cat’ coming to the market, the research based industry will not have adequate incentive without RDP to continue to get engaged in important R&D activities. In that scenario, newer and better drugs, particularly for untreated and under-treated medical conditions will not be available to the patients.

Without RDP, the originator of the innovative drugs would be placed at an unfair, commercial disadvantage when compared to their generic competitors, who do not incur similar costs of meeting the mandatory requirements of drug regulatory authorities for marketing approval of the drug.

The distinctiveness of the two incentives, namely, Patent Protection and Data Protection is recognized in countries which are leading in research and development in pharmaceuticals.

RDP will not affect exports of Indian pharmaceutical products to the non-regulated markets:

This is because RDP deals with marketing of products patented in India within the territory of India. RDP will in no way affect the ability of any generic manufacturer either to produce the bulk drug active or to formulate its dosage forms for exports in the non-regulated markets, as long as the product is not sold within the territory of India for which both the patent and RDP will be valid.

Disadvantages of not having RDP in India:

According to the U.S. National Institute of Health (NIH), lack of RDP in India is the primary reason why India ranks only 9th (compared to China which ranks 2nd), in funding given by NIH outside U.S.A.

An Expert Committee under the Chairmanship of Dr. R.A. Mashelkar, an eminent scientist, also highlighted significance of Regulatory Data Protection, as below:

“In order to ensure enabling environment, the regulatory division dealing with the applications concerning new drugs and clinical trials would be required to develop suitable mechanisms to ensure confidentiality of the submissions.”

RDP – The International Scenario:

A review of National Laws relating to the protection of Registration Data in the major WTO Member-States reveals that most of the countries have recognized and appreciated the role of RDP.

Although there is no uniform standard that is followed by the countries while enacting and implementing the laws related to RDP, there is however a common principle that is followed. The laws generally specify the conditions under which Regulatory Data Protection can be sought and the period for which the “originator” can enjoy the exclusivity after the marketing approval is granted in the country. The period of RDP is typically between 5 – 10 years.

As per an article titled “Complying with Article 39.3 of TRIPs… A Myth or Evolving Reality” by Dr. Prabuddha Ganguli, around sixty nations around the world including China follow RDP in their respective countries.

RDP and the generics:

Regarding the arguments that RDP provisions will act as a barrier to the development of generics, resulting in the erosion of generics market. This argument is based on invalid assumptions. The following facts will prove the irrelevance of these arguments propounded by the domestic generic lobby:

1. Data Protection refers only to new products registered/patented in India. It will not affect the generic drugs already in the market.

2. U.S.A. is an outstanding example which shows that research based industry and generic industry can co-exist, giving dual benefits of innovative medicines and cheaper copies of off-patent medicines to the general public.

3. More the patented medicines, more will be generic drugs after expiry of their patents.

4. In the U.S.A. which has a long standing Data Protection (Exclusivity) regime, the market penetration of generics is amongst the highest in the world and stands at nearly half of all the prescriptions.

5. After introduction of Hatch Waxman Act in 1984, which provided for a 5 year period of Data Protection, there has been a spurt of development of new drugs as also entry of off-patent generics into the US market.

RDP is not ‘evergreening’ :

In most of the cases, the period of patent protection and RDP will run concurrently. The ground reality will be that innovator companies will launch their products in India within as short a time gap as possible from the launch of those products anywhere in the world. The period between introduction of new drugs elsewhere and their introduction in India has been continuously shrinking. The range of such period between 1965 and 1988 was 4 years to 13 years. The period during 1990 to 1999 ranges between 0.25 year and less than 2 years.

During the debate on Data Protection it is asserted in some quarters that RDP and patents offer “double protection”. They do not, by any means. Fundamentally, the two forms of Intellectual Property are like different elements of a house which needs both a strong foundation and a roof to protect its inhabitants. RDP cannot extend the length of a patent which is a totally separate legal instrument. While patent protects the invention underlying the product, RDP protects invaluable clinical dossier submitted to the drugs regulatory authority, from unfair commercial use and disclosure. The duration of RDP, as stated above, is typically half or less of the product patent life.

Conclusions:

In my view RDP will benefit the pharmaceutical innovation eco system India, as it has done to many other countries. Hence India should implement RDP without further delay. It will be reasonable to have a provision of at least 5 years of RDP from the date of marketing approval in India, on the same lines as China.

RDP should be provided by making an appropriate amendment in Schedule Y of the Drugs & Cosmetics Act to bring India into conformity with its international legal obligations and with the practices of other members of the WTO from both the developed and developing nations of the world.

These provisions, in my view, will go a long way in sending a very positive signal to the international community as well as to our own research based pharmaceutical companies to accelerate investment in this vital sector making India emerge as a global powerhouse in pharmaceuticals, sooner than later.

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.

Regulatory Data Protection (RDP) and its need in India: The Myth versus Reality

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THE MYTH:

An attempt to delay the launch of Indian generics:

Some in India feel that Regulatory Data Protection (RDP), is a deliberate attempt by the innovator companies to delay the launch of the generic equivalent of patented products in India, as long as they possibly can.

Thus they feel that why should one re-invent the wheel? Why should the generic pharmaceutical companies be not allowed to continue with the current requirement by the Drug Controller General of India (DCGI) to establish only the ‘bio-equivalence of an innovator drug to get the marketing approval of the generic equivalent in India?

RDP will effect export in non-regulated markets:
They further argue that India currently exports its pharmaceutical products to around 50 non-regulated markets of the world. Thus the enforcement of RDP would jeopardize Indian Pharmaceutical exports in those countries affecting the economy of the country.

RDP is a non-binding clause in TRIPS:

Regarding Article 39(3) of TRIPS, which indicates protection of regulatory data against “disclosure” and “unfair-commercial use”, this group opines that this is a non-binding Article of TRIPS, neither does it specify any timeline to protect such data. Moreover, they feel, that only the “undisclosed data” may be protected and the data already “disclosed” ‘need not to be protected’.

RDP is an attempt towards “evergreening” the patent:

The proponents of this interpretation believe that RDP is just an attempt to “evergreen” a patent, extending the patent life of a New Chemical Entity (NCE) or (NME) beyond 20 years.

THE REALITY:

Just Like Patents, Regulatory Data need to be protected to encourage innovation in India:

This group feels that generation of exhaustive regulatory data entails very significant investment in terms of money, energy and time. These are very high risk investments as approximately one in 5000 molecules researched will eventually see the light of the day in the market place. It is worth noting that clinical development of an NCE/NME costs around 70%, while the cost of discovery of the same NCE/NME is around 30% of the total costs. It is estimated that the entire process of drug development from discovery to market takes an average of 10 years and costs on an average U.S.$ 1.7 Billion in the developed markets of the world.

Since such voluminous regulatory data are not only costly and time consuming but also proprietary in nature, these need to be protected by the regulators. Regulatory Data Protection (RDP), therefore, has been widely recognized as an integral part of the Intellectual Property Rights (IPR).

The agreement on Trade Related aspects of Intellectual Property Rights (TRIPs) also recognizes the “protection of undisclosed information” as being an Intellectual Property, which needs to be protected.

Article 39.3 of TRIPs Agreement clearly articulates the following:

“Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”

Intellectual Property Rights (IPRs) mentioned in Article 39.3 of TRIPS are commonly referred to as “Data Exclusivity” in the U.S. and “Data Protection” or “Regulatory Data Protection” in the European Union (EU). These are all the very same.

RDP is an independent IPR; and should not be confused with other IPRs, such as patents:

Bringing an NCE/NME to the market involves two critical steps:

1. Discovery of NCE/NME:

The drug discovery right of the originator is protected in the form of a patent.

2. Drug development:

The innovator will require generating intensive, time consuming and expensive pre-clinical and
clinical data to meet the regulatory needs for bringing the new drug to the market. Such data
needs to be protected by the drug regulators.

It is understood that both the above steps are absolutely necessary to meet the unmet needs of the patients. The civil society gets the benefits of the new drugs only after these two steps are successfully completed.

The rationale for Regulatory Data Protection (RDP):

Irrespective of what has been indicated in Article 39.3 of TRIPS, RDP is clearly justifiable on the following grounds:

Generation of Data by the originator consists of “considerable efforts”. Submission of clinical data is a statutory regulatory requirement. Were it not for the obligation to provide these data to the Government, such data would have remained completely under control of the originator. It is, therefore, a reasonable obligation on the part of the Government as a ‘gate keeper’ to respect confidentiality of the data in terms of non-reliance and non-disclosure. Any failure by the Government to provide required protection to the data could lead to “unfair commercial use”.

Since such data are collected through various phases of clinical evaluation, involving considerable costs, time and energy, these are immensely valuable to the originator and need to be adequately protected by the drug regulators.

As these data are proprietary in nature, any access or permissibility for use of such data by the second applicant without concurrence of the originator is unfair on grounds of propriety and business ethics.

Given the imbalance between the costs to the originator of getting marketing approval for its product and the costs of the ‘copy cat’ coming to the market, the research based industry will not have adequate incentive without RDP to continue to get engaged in important R&D activities. In that scenario, newer and better drugs, particularly for untreated and under-treated medical conditions will not be available to the patients.

Without RDP, the originator of the innovative drugs would be placed at an unfair, commercial disadvantage when compared to their generic competitors, who do not incur similar costs of meeting the mandatory requirements of drug regulatory authorities for marketing approval of the drug.

The distinctiveness of the two incentives, namely, Patent Protection and Data Protection is recognized in countries which are leading in research and development in pharmaceuticals.

RDP will not affect exports of Indian pharmaceutical products to the non-regulated markets:

This is because RDP deals with marketing of products patented in India within the territory of India. RDP will in no way affect the ability of any generic manufacturer either to produce the bulk drug active or to formulate its dosage forms for exports in the non-regulated markets, as long as the product is not sold within the territory of India for which both the patent and RDP will be valid.

Disadvantages of not having RDP in India:

According to the U.S. National Institute of Health (NIH), lack of RDP in India is the primary reason why India ranks only 9th (compared to China which ranks 2nd), in funding given by NIH outside U.S.A.

An Expert Committee under the Chairmanship of Dr. R.A. Mashelkar, an eminent scientist, also highlighted significance of Regulatory Data Protection, as below:

“In order to ensure enabling environment, the regulatory division dealing with the applications concerning new drugs and clinical trials would be required to develop suitable mechanisms to ensure confidentiality of the submissions.”

RDP – The International Scenario:

A review of National Laws relating to the protection of Registration Data in the major WTO Member-States reveals that most of the countries have recognized and appreciated the role of RDP.

Although there is no uniform standard that is followed by the countries while enacting and implementing the laws related to RDP, there is however a common principle that is followed. The laws generally specify the conditions under which Regulatory Data Protection can be sought and the period for which the “originator” can enjoy the exclusivity after the marketing approval is granted in the country. The period of RDP is typically between 5 – 10 years.

As per an article titled “Complying with Article 39.3 of TRIPs… A Myth or Evolving Reality” by Dr. Prabuddha Ganguli, around sixty nations around the world including China follow RDP in their respective countries.

RDP and the generics:

Regarding the arguments that RDP provisions will act as a barrier to the development of generics, resulting in the erosion of generics market. This argument is based on invalid assumptions. The following facts will prove the irrelevance of these arguments propounded by the domestic generic lobby:

1. Data Protection refers only to new products registered/patented in India. It will not affect the generic drugs already in the market.

2. U.S.A. is an outstanding example which shows that research based industry and generic industry can co-exist, giving dual benefits of innovative medicines and cheaper copies of off-patent medicines to the general public.

3. More the patented medicines, more will be generic drugs after expiry of their patents.

4. In the U.S.A. which has a long standing Data Protection (Exclusivity) regime, the market penetration of generics is amongst the highest in the world and stands at nearly half of all the prescriptions.

5. After introduction of Hatch Waxman Act in 1984, which provided for a 5 year period of Data Protection, there has been a spurt of development of new drugs as also entry of off-patent generics into the US market.

RDP is not ‘evergreening’ :

In most of the cases, the period of patent protection and RDP will run concurrently. The ground reality will be that innovator companies will launch their products in India within as short a time gap as possible from the launch of those products anywhere in the world. The period between introduction of new drugs elsewhere and their introduction in India has been continuously shrinking. The range of such period between 1965 and 1988 was 4 years to 13 years. The period during 1990 to 1999 ranges between 0.25 year and less than 2 years.

During the debate on Data Protection it is asserted in some quarters that RDP and patents offer “double protection”. They do not, by any means. Fundamentally, the two forms of Intellectual Property are like different elements of a house which needs both a strong foundation and a roof to protect its inhabitants. RDP cannot extend the length of a patent which is a totally separate legal instrument. While patent protects the invention underlying the product, RDP protects invaluable clinical dossier submitted to the drugs regulatory authority, from unfair commercial use and disclosure. The duration of RDP, as stated above, is typically half or less of the product patent life.

Conclusions:

In my view RDP will benefit the pharmaceutical innovation eco system India, as it has done to many other countries. Hence India should implement RDP without further delay. It will be reasonable to have a provision of at least 5 years of RDP from the date of marketing approval in India, on the same lines as China.

RDP should be provided by making an appropriate amendment in Schedule Y of the Drugs & Cosmetics Act to bring India into conformity with its international legal obligations and with the practices of other members of the WTO from both the developed and developing nations of the world.

These provisions, in my view, will go a long way in sending a very positive signal to the international community as well as to our own research based pharmaceutical companies to accelerate investment in this vital sector making India emerge as a global powerhouse in pharmaceuticals, sooner than later.

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.