Effective Change Management – The Magic Wand For Business Success And Sustainability

Posted on February 27, 2023 by Tapan Ray

Change – just as it’s an integral part of our life, so is for any business, including pharmaceutical or healthcare. Interestingly, the phase of transition of such changes isn’t always slow and gradual. In many cases, especially for business, or for a lifestyle too, these transitions could also be faster and disruptive.

The speed of many such changes is now driven by rapidly evolving technology. Or these could often be triggered by some unanticipated event, like the Covid-19 pandemic that we all experienced, very recently. Such changes may impact people working in different functions, in different ways. Which is why, organizations need to be all-time ready, with a robust process in place – known as Change Management.

In this article, I shall focus on the relevance of putting in place a well-validated system driven Change Management process within, especially, the Indian pharmaceutical organizations. Let me start with my understanding on what is the Change Management, so that all of us be on the same page in this regard.

To be on the same page on what is Change Management:

There are several definitions of the change management process expressed differently, but it’s core concept remains unchanged. One such illustration comes from The TechTarget network. It says:“Change management is a systematic approach to dealing with the transition or transformation of an organization’s goals, processes, or technologies. The purpose of change management is to implement strategies for effecting change, controlling change, and helping people to adapt to change.”

Why many pharma majors are considering it now, more than ever before:

Being amid a technological revolution, encompassing almost all aspects of life and then in the post-pandemic area, change is being expected as a way of life and business, more than ever in the past. Although pharma industry a late learner - and is also traditionally late to change – these can’t be now pushed to the back burner, any longer, as was happening in the pre-pandemic era.

‘Change Management’ can’t be pushed to the back burner, any longer:

This process has now attracted a sense of urgency for many pharma players, as we read and look around. Several big companies have already started addressing the leadership challenges to manage and leverage the evolving changes, as I wrote in my article of October 3, 2022, in this blog.

To be in sync with both customers and employee expectations on an ongoing basis, the change management process in an organization has assumed a priority. User friendly state of the art technology is facilitating to effectively address the growing intricacies of today’s field staff role by infusing leadership mindset change in the organizational culture. Emphasizing this point in my article on July 19, 2021, I underscored that such change should necessarily reflect the company’s vision for the future, unambiguously.

Most companies have changed over a period of time in varying degree:

Most companies have changed over a period of time. Nonetheless, today’s need, pace and the process of change demand a data science based customized approach. The good news is several pharma majors have also started feeling that they require not just to change with time, but also need to put more data science based cerebral input to fathom why and how it changed to be more effective in the future.

An insightful understanding is essential to put in place and kick start a right change management process. To give a sense of it, let me cite a contemporary example of one of the successful global pharma majors – GSK. This case study was prepared by the Project Management Institute.

Achievement of a key milestone could make all the difference:

When GSK initiated this process in 2009, the organization realized that an important milestone in the implementation of the company’s change initiative must be to gain the trust and belief of leadership—many of whom were neutral or cynical about it.

To achieve this goal a custom made ‘Accelerating Delivery and Performance (ADP) program; was found to be quite effective for the company. It delivered both hard business benefits as well as softer organizational development benefits. This approach allowed the team to gain the attention of those leaders who wanted both.

Five principles formed the bedrock of the ADP approach:

The following ADP principles are time-tested, contemporary, and several of these were practiced by GSK in their change management process when it started in 2009.

Changes should begin with the initiator of change and focusing on greater customer satisfaction.
Active support of all stakeholders in the process of change is critical.
Include all staff who will be impacted by the change – while defining, explaining, and ensuring accountability and continuously measuring the time bound shared goals, especially the business and financial ones.
Make sure they all share ownership for the outcome of change, through seamless teamwork.
Make a pilot study before pan organization implementation.

The change management process continues:

That the change management process needs to be ongoing even for successful drug majors – such as GSK, is particularly evident from their Press Release on June 23, 2021.

The communique giving details of the organization’s strategic and other transformation pathways, also highlighted, “New GSK to deliver step-change in growth and performance over the next ten years driven by high-quality Vaccines and Specialty Medicines portfolio and late-stage pipeline.”

Specific areas of change, as the pandemic wanes:

There are several studies in this area, such as the one published in the Growth Faculty Learn, published on February 07, 2023. Let me paraphrase its summary as follows:

Although the pace of change in different businesses may vary but will certainly keep changing. The leaders should, therefore, act proactively to lead their teams through a well validated change management process to gain a competitive edge.

Full preparedness for the change and garnering change management skills before the process begins are critical.

Advance planning for employee wellbeing, well structured individual and collective communication strategy, deciding on specifics of a hybrid work culture – all based on data-science, are of great importance.

To ensure the effectiveness of the change management process a positive workplace environment is a must, which will stand on five pillars - Trustworthiness, Empathy, Genuineness, Self-awareness, and a Learning mindset.

Thus, it’s high time for all to realize that the pharma business ball game is now changing fast for all, creating an urgent need to focus on the critical areas of change.

Conclusion:

It now boils down to an important point, which was also echoed in an article on this area published in the Pharma IQ on November 23, 2022. It underscored just as any living being keeps moving on the pathway of change, pharma and healthcare industry should proactively follow a similar path.

External environmental factors would play a catalytic role to accelerate the speed of change. These include fast evolving consumer friendly digital applications and health apps - newer, better, and more targeted drugs and treatment processes, or even unprecedented disruptions of lives and livelihoods, just what we all have recently experienced.

A study published in the Pharma Marketing Network on October 27, 2021, also reiterated that the main goal of any change management approach is to foster support of all concerned that leads to good outcomes within an organization. It found that an effective way to implement a change is by engaging and inspiring employees to adopt new (and improved) ways of working.

Against the above backdrop, putting a structured change management process in place by Indian pharma players, I reckon, is now essential. This approach seems to be a Magic Wand, as it were, for ongoing business success and sustainability in today’s rapidly evolving paradigm.

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.

Covid Propels Healthcare Into A Virtual World: A New Growth Driver For Pharma?

Posted on October 19, 2020 by Tapan Ray

Amid ongoing Covid pandemic, most discussions on pharma specific ‘digitalization’ initiatives continue to predominantly hover around its traditional business growth drivers. In fact, even before the Covid time, it was no different, in a smaller scale and with a lesser intensity, though.

Incidentally, since quite some time, with the explosion of different types of web-based businesses, offering opportunities to buy and receive, virtually everything, at one’s doorstep, many things started changing rapidly. Almost all businesses started offering the state of the art, easy to use smartphone app-based e-commerce solutions, in different formats, to grow their businesses. Alongside, more and more people started managing their daily needs and wants online, even in India. Intriguingly, despite the availability of telemedicine, telehealth and e-pharmacies, even in the old normal, most people continue to prefer in-person health care solutions, including buying medicines.

Then came a bolt from the blue – the unprecedented global health crisis, caused by Covid-19. Almost overnight, amid requirements of maintaining stringent personal measures to keep Covid at bay, making in-person doctor-calls for brand demand generation activities, posed a great challenge. Doctors, too, became hesitant to meet general patients and medical representatives, in that situation. Thus, to keep the business up and running, most pharma companies gave top priority in finding out a digital solution for the brand demand generation processes. Interestingly, this was happening, when many patients, especially those with non-Covid ailments, also faced a similar situation to meet their health care needs.

Finding no other viable alternatives, many patients were pushed to search for a robust digital solution for health care needs, as well – just as they were already meeting their other regular needs – online. In that sense, Covid propelled many patients to step into a new virtual world of healthcare - telehealth or telemedicine. As mentioned above, although, these services were up there in pre-Covid days, many patients, apparently rediscovered them, in a new Avatar, to get relief from ailments and also save their lives.

On a hindsight, it appears, why the need to leverage telehealth or telemedicine in that crisis, did not appear to be a priority for most pharma companies to foster patient-centric growth of the business. Thus, continuing with the core concept of my previous article, – this article, will focus on the possibility of pharma spearheading the process, aiming for a win-win outcome – boosting access to high quality affordable care for all, on the one hand. And simultaneously, harnessing this new growth driver to excel in the business, on the other.

Telehealth or e-health will grow just as other e-businesses, unhindered:

With the Government of India issuing guideline for telemedicine practices on March 25, 2020 and later, on May 12, 2020, publishing those guidelines in the gazette, ‘Telemedicine’ has been made a high priority health care enabler. The notified guidelines also make telemedicine consultation provided by a Registered Medical Practitioner (RMP) under the Indian Medical Council Act, 1956, legally permissible. In addition, effective October 01, 2020, Telemedicine costs will be covered under medical insurance in accordance with the Insurance Regulatory and Development Authority of India’s (IRDAI) new guidelines.

The net effect of these measures will not just help reduce pressure on the fragile public healthcare infrastructure of the country, but will also expand access to lower cost and high-quality private care to a large number of people.

Telemedicine is here to stay and be a key pharma growth driver:

With Covid propelling health care into virtual platforms, providing and receiving medical care through telehealth has become a necessity for many people, for different reasons. However, the question that surfaces, will patients return to the old normal, if and when the pandemic ends?

The article – ‘3 reasons telehealth is here to stay,’ published by the MedCity News on October 09, 2020, presents a practicing physician’s perspective on this issue. The author envisages, ‘telemedicine will continue to gain traction with my colleagues and most likely, become a permanent clinical option for patient care.’ Going by such hands-on experience, I reckon, telemedicine will continue to grow for several important reasons, such as:

Technology to make telehealth increasingly user friendly: Ongoing IT innovation is making telehealth platforms simple and more effective for doctors and a large number of patients belonging to all age groups. “All they have to do is click a link on their smartphones, which is sent to them via text automatically.” Thus, these tools will increasingly become the best option for treating a broad range of conditions, long after the pandemic subsides.

Telemedicine costs are covered under medical insurance, now: Effective October 01, 2020,Telemedicine costs will be covered under medical insurance, even in India. Moreover,‘Telemedicine’ has now been made a high priority health care enabler, carrying a permanent legal status in India.

Health Equity and affordable care: Access to affordable health care is not evenly distributed across the India. Telehealth can help fill these gaps, with increased affordable access for all, even in rural India, as patient location won’t be a problem in getting prompt and quality care at a low cost.

From the above perspective, it appears, it’s high time for pharma to leverage Telemedicine and Telehealth as a major growth driver, powered by innovative business strategies.

Is there any difference between Telemedicine and Telehealth?

Very often these two words are used interchangeably. Mostly because, both telemedicine and telehealth are the practice of medicine using technology to deliver care at a distance.

Telemedicine offers remote clinical services, such as, virtual consultations, diagnosis, prescriptions, preventative care, monitoring via telecommunication platforms, including text, video chat, wearable devices or even phone calls. Whereas, telehealth, in addition, can include remote non-clinical services, such as health care training, administrations and continuing medical education.

Reasons for pharma’s cashing on this new growth driver at a low cost:

Besides Government’s support to telehealth and telemedicine, growing health care consumer demand and user-friendly technologies, are catapulting virtual care to the mainstream health care delivery systems. In tandem, driven by unique and long-term value offerings, telemedicine is being increasingly recognized as a critical means to get prompt care for minor but urgent ailments. Consequently, moreusers are getting attracted to its convenience and benefits, which may have a snowballing effect. Some of which are as follows:

Prompt access to disease treatment services, as and when needed by patients, without any long waiting time, for any reason.

Significant health care cost saving for all – more for rural population who will be able to avoid long distance travel, involving both time and money, besides associating hassles.

Prompt follow-up consultation facilities, will help avoid disease complications, reducing the burden to hospitals for secondary or tertiary care.

Further, pharma can offer even greater patient satisfaction by leveraging virtual healthcare platforms, as these will help ensure more effective follow-up and enhanced treatment convenience than traditional in-person visits. Several studies, such as the article, published in ‘The American Journal of Managed Care,’ on January 15, 2020, vindicate this point.

In short, accelerating rate of use – with the increasing need for prompt, easy and affordable access to care, are driving telemedicine to be an integral part of healthcare service delivery system. Which is why, expansion of pharma business in this new virtual space, with well-integrated collaborative strategies, could prove to be a key growth driver – over a long period of time.

Moreover, there doesn’t seem to be any need to deploy a large and cost-intensive field force, as is usually followed for expansion of pharma business in newer areas. This is because, ‘telemedicine requires a different approach to promotion.’

Telemedicine requires a different approach to promotion

That telehealth requires a different approach to marketing and promotion from traditional pharma marketing, was deliberated by ZS in the article -‘Four telemedicine myths for pharma to avoid,’ published on July 05, 2020. The paper underscored, ‘instead of building brand awareness and engaging patients in education and information, telehealth promotion needs to drive patients to take one specific action: call today!’ It further elaborated:

Brands that bury the telehealth link on page 8 of their website or make linking to a physician one of more than 20 different calls to action, will find low patient engagement and low pull through.

As virtual health care is here to stay, telehealth itself should be a strategy for active promotion, by optimizing the steps to get patients connected to a physician in the shortest and the easiest way possible.

From this perspective, brands that will find the right pathway for engaging in telehealth, will reap the benefits of increased engagement with patients and telehealth physicians. To achieve this objective, with a robust, commercial strategy, the first step for each brand will start with understanding the needs of patients and physicians that needs to be addressed on priority. Then comes, mapping out how the brand will get used to meet those needs.

Conclusion:

We are still in the midst of an unprecedented new Coronavirus pandemic. As of October 18, 2020 morning, India recorded a staggering figure of 7,494,551 of Coronavirus cases with 114,064 deaths.

With the pandemic severely curbing most patients’ access to care – following the traditional process, Covid propelled health care into a virtual world, almost in no time. Telemedicine brought to the fore, its game changing potential to provide expanded access to high quality and affordable health care, through multiple channels, sans physical presence. Location of a patient or of a competent physician isn’t an issue, any longer, in the disease treatment process. With telemedicine patients will be able to get treated as and when they will want.

The future of Telehealth or telemedicine appears to be promising even beyond Covid time, with more people preferring digital platforms for affordable and more convenient medical care than in-person visits. With virtual care getting integrated into traditional health care delivery systems, pharma players will need to explore this space, as a new growth driver – for wider reach, and greater share of mind of customers for their respective brands.

For Telemedicine to be successful – benefitting a vast majority of both urban and rural populations, country’s health policy makers and, especially the pharma industry should work in unison. Only then, the net outcome will offer a win-win situation – both for the Government and also for the drug industry. It will help expand access to high quality and affordable care to all – seamlessly, irrespective of location. Consequently, pharma marketers will get access to another powerful business growth driver – in telemedicine. Its time about time for all to act – sooner the better.

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.

Time For Predictive Rather Than Reactive Pharma Strategy

Posted on June 15, 2020 by Tapan Ray

Traditionally, pharmaceutical industry, across the world, is mostly reactive – rather than proactive or predictive in its strategic approach – spanning across all its business domains. A large number of pharma players – both innovators and generic drug makers, formulate their business strategy – generally reacting to competition, changing market dynamics and patient/ doctor /other stakeholder preferences. The same is being witnessed even during Covid-19 pandemic. However, this trend seems to be more prevalent in India – as one looks around.

For example, in R&D – be it a statin drug, proton pump inhibitors and right up to monoclonal antibodies or cancer immunotherapies – after a first-in-class molecule comes, a plethora of ‘me-too’ – but patented molecules soon follow. A comparable trend in the generic drug categories is also all-pervasive, including fixed-dose combinations (FDCs).

Similarly, even in the good old days of sales and marketing, we have seen – after the first product detailing folder was successfully introduced by a leading pharma company in India, how competition lapped the concept up – considering this change as a magic wand for brand demand generation!

In recent days, a similar trend is surfacing for ‘Digitalization’ of pharma business, mostly reacting to the changing practices of key competitors, or involving patients or doctors’ preferences. It gets reflected in other business domains, as well. With this perspective, in this article, I shall deliberate on this area, especially in view of the current situation.

Traditional ‘safe sailing’ is no longer an option:

The Coronavirus pandemic could be a stronger catalytic factor for the drug industry to initiate the much-desired transition from being reactive to predictive in its strategic business approach- faster. Interestingly, way back in June 2007, the PwC Whitepaper titled “Pharma 2020: The vision”, had also articulated: ‘The social, demographic and economic context in which the pharmaceutical industry (Pharma) operates is changing dramatically.’

Some drug players have already opted to transform their organizations in sync with the changes in the operating environment. But, a vast majority of them preferred to stick to the traditional reactive mindset, for a safe sail, as it were. However, this doesn’t seem to be an option, any longer. Be that as it may, there is nothing wrong in being reactive in strategic business practices, although formulating a predictive or proactive growth strategy demands more cerebral prowess and is much different from the reactive ones.

The difference, I reckon, is similar to that of a leader and the followers, with nearly similar impact on overall corporate image and performance, besides a prime-mover advantage of the latter. Nevertheless, there could be a predictive approach even within a reactive approach to competition. To illustrate the point, let me cite an example related to ‘me-too’ – patented-drug development.

Making an overall reactive strategic approach proactive in nature:

Among several examples of making a reactive strategic approach – proactive in nature with innovative goals, let me quote a very recent one. For decades, drug companies have been selling ‘me too’ but patented drugs, at prices similar to the original and ‘first-in-class’ drugs, which are successful and enjoying a market monopoly.

Moving away from this trend, a startup drug maker, reportedly, wants to disrupt the traditional pharma industry practices by delivering what most patients and healthcare stakeholders want. It has set a novel goal of becoming patient-centric in its offering by making innovative drugs available at affordable prices. The startup wants to achieve this objective ‘by changing long-held industry practices for developing, pricing, and selling slightly different versions of costly brand-name drugs.’

Accordingly, with a proactive or predictive approach within an overall ‘reactive’ trend, it wants to create a unique niche for itself. The entity ‘will focus on developing “me too” drugs, which imitate the biological functions of existing drugs, but use distinct molecular structures so they don’t infringe on existing drug patents.’

Evolving a new demand of value-based health care system:

During disruptive changes and uncertainties in the business environment, such as what is being experienced today, gaining actionable insight on how these changes will call for new strategies to excel, would require a predictive mindset. This is of critical importance, particularly when a new demand for a value-based health care system is fast unfolding. This subject was well deliberated also in the book – ‘Healthcare Disrupted: Next Generation Business Models and Strategies.’

About six years back what the authors of this book predicted, seems to be a reality today. They had said: The concept of “value” rules the day, undoubtedly. The transition from the old ‘fee-for-service’ to ‘fee for value’, is game changing. On the same subject, another article - Focus on Value 1: The “Tsunami of Change”, published in the ‘eye for pharma’ on March 22, 2026, quoted the authors of this book – explaining the scenario lucidly.

They said, today’s health care system is largely reactionary, as the health services react to the persistence of consumers, their phone calls, queuing for services, waiting in the waiting room and calls to healthcare insurers. Whereas, ‘tomorrow’s system would prompt the health care providers to answer a seemingly simple question: how will they become relevant to a customer group?

Even six years down the line, especially in the current global pandemic situation with an evolving demand of a value-based health care system, this concept remains so relevant, possibly more than ever before. That said, an unforeseen and unprecedented situation could also force a pharma player – already moving on a predictive strategic path, to choose a reactive path – mostly for survival and progress of business.

When a company moves into a ‘reactive’ path from a ‘predictive’ one:

Such instances are infrequent. But a major event like Covid -19 may give rise to such a situation. For example, in the Pharma and Biopharma R&D space, it happened and is still happening. As ‘Evaluate Vantage Covid-19 Report’ of April 16, 2020 highlighted, as follows:

‘Anyone thinking that 2020 might travel down a predictable path for the biopharma sector was swiftly disabused of this view in the opening weeks of the year. The Coronavirus pandemic has changed the focus for almost every drug developer, whether they are working on potential treatments or trying to keep their businesses on track – or both.’ Good or bad, this is the reality today.

However, many of these organizations are unlikely to jettison their well-thought out ‘predictive’ pathway and are expected to soon find ways to move back to it. Thus, the question that one may pose, how does a company move into a predictive pathway from a reactive one? And particularly considering, if Covid-19 pandemic has caused some irreversible changes, or even – a long-term change in the business environment.

Getting back to predictive strategic path from a reactive one:

This issue was also covered in the article – ‘Three Proactive Response Strategies to COVID-19 Business Challenges,’ published in the MIT Sloan Management Review, on April 17, 2020. It wrote, as organizations move from a reactive to a proactive approach to dealing with COVID-19, they should ask themselves the following three questions:

Can we offer a version of our products and/or services through an online channel? Going online is the closest equivalent to low-hanging fruit in the current environment.

Can we use our existing infrastructure to produce products and/or offer services that are in demand? Many organizations have allocated infrastructure to produce goods and services to support the fight against COVID-19, but some strategic companies would think beyond the crisis to future changes in consumer needs.

How can we rapidly increase our capacity to produce and distribute on-demand products and/or services? Turning to partnerships with other companies can boost capacity in a crunch situation, such as today.

The need for collaboration, in such extraordinary situation, has also been underscored by the European Pharmaceutical Review. It pointed out - how academia, government and the pharmaceutical industry can work together to potentially ‘repurpose drugs’ for the treatment of COVID-19. This is another example of formulating a predictive growth strategy to create a win-win situation, while being in the midst of a reactive one.

Conclusion:

Meanwhile, despite national Lockdowns at a very early stage on March 24, 2020, India has now climbed up to occupy the fourth highest position in terms of the number of Coronavirus infected cases. Continuing the steep ascending trend, as on June 14, 2020 morning, the recorded Coronavirus cases in the country reached 321,616 with 9,199 deaths.

During the current global pandemic of a humongous scale, drug companies are trying to respond to rapid challenges across their business operations, right from planned R&D programs to effectively maintaining supply chain, including manufacturing activities. If the current COVID-19 pandemic lasts for medium/long term, there could also be significant delays in the execution of various other ongoing projects/programs. This was the analysis of Deloitte in a paper, titled, ‘COVID-19 response for Pharma companies – Respond. Recover. Thrive’

While the full impact of the Coronavirus pandemic is still unknown, adopting a predictive strategy in the prevailing overall reactive environment, is expected to yield a significantly better business performance. As I said earlier, the core difference between adopting a ‘predictive’ and a ‘reactive’ business pathway, under the circumstances, is akin to the difference between a leader and a follower.

Unlocking the value innovation in all areas of pharma business is the name of the game, for excellence. Leveraging Artificial Intelligence (AI) based contemporary ‘predictive’ tools will help pharma players break the new ground, even in such trying times. Coming from this perspective, a ‘predictive’ strategy rather than a ‘reactive’ one, apparently, is the demand of time – where we all are in – today.

By: Tapan J. Ray

Patient Services Aren’t Optional Any More For Pharma Business Excellence

Posted on March 20, 2017 by Tapan Ray

In the modern world of abundance of information through various sources and platforms, patients are increasingly looking for greater engagement in their healthcare decision-making process with the doctors, slowly but steadily, and in that process seeking better services from different service providers in this area, including the pharmaceutical companies.

This trend has now been well-captured, globally. Various research studies have conclusively established that greater patient’s engagement in health care contributes to improved health outcomes. The obvious question that surfaces in this context is what is this patient engagement?

Patient engagement:

It broadly means a process that realizes the importance of providing adequate knowledge, skills and related services to people effectively, making them understand various disease management and alternative treatment measures, and thereby facilitating them to be an integral part of their health care related interventions, for better health outcomes.

When patients, physicians, other related constituents, including the pharma companies share both the process and goal of disease management or treatment processes, a win-win situation evolves to everybody’s full satisfaction. This has immense commercial relevance too.

Deserves to be a part of the grand design:

In that sense, pharmaceutical companies, especially those operating in India, would need to roll up sleeves and pull up socks to play a greater role in delivering a better experience for patients through effective engagement and offering relevant high quality services. This exercise now deserves to be an integral part of a grand design and planning of any sales and marketing strategy. A recent survey by Accenture Consulting also concluded that patient services from pharma companies are most important to patients.

Key patient service providers:

Besides several others, especially the following two important constituents can play defining roles as patient service providers by directly engaging with patients, to achieve this objective:

Patient advocacy groups or organizations (PAO): These entities provide a special attention to patient care and protection of their rights, and engage them accordingly. Patient advocates of these groups are a liaison between patients and various healthcare providers to improve or maintain a high quality of health care for the former. Some global drug players also recognize that these groups possess a highly influential voice in the healthcare system.

Pharmaceutical, biotech or device companies: Some of these companies, mostly in the developed world have established strategic patient advocacy functions within their corporate structure to foster relationships with patients, their caregivers, and the disease-specific nonprofit advocacy groups usually support them. These interactions should ideally ensure that the voice of patients is understood across every function within the company, from R&D to commercialization, as articulated in a recent Whitepaper of BioNJ on this subject.

There is a need to strengthen this approach within the Indian pharma industry, as well, for the benefit of local patients, of course, by scrupulously avoiding any possible serious controversy, which I shall discuss below.

A recent study:

A 2016 report by Accenture concludes that patient services are no longer optional for pharma companies, as they are gradually becoming a cutting edge competitive driver. In a situation like this, the question isn’t whether they should really gear up to offer such services, the immediate need, instead, is to put their ears on the ground to carefully decide which ones would be most appropriate for the individual players, and how best to offer them.

For this study, Accenture surveyed more than 200 patient services executives, covering seven therapeutic areas: heart, lungs, brain, immune systems, bones, hormone/metabolism and cancer. The respondents agreed that much work and greater resources need to be invested in this area to gain a competitive edge in business.

This is further evident from the trend that around 84 percent of pharma companies in the United States plans to invest more in patient-centric services, such as adherence, remote monitoring and medication delivery – over the next 18 months, as the report highlights.

For marketing patient services alone to facilitate direct communications to patients, the digital platforms are most preferred with social media and web page usages being 51 percent and 49 percent, respectively.

A serious concern:

Providing various health related services useful to patients, by the PAOs or by pharma, biotech or device companies separately, without any form of financial relationship or influence of any kind to one another, would probably earn a great appreciation from all stakeholders.

Nevertheless, serious concerns are often expressed on the core intent of various pharma company’s generous funding to various patient advocacy organizations, including the eminent ones involved with patients suffering from cancer, HIV, Alzheimer’s, and other diseases. Several of them don’t even report such contributions, besides providing justifiable explanations on the objectives and actual use of such financial contributions.

If one wants to draw a simile, this is what exactly allegedly happening today, because of such type relationship, between pharma, biotech or device companies on the one hand, and doctors, many other health care providers, including retail chemists, on the other. In the Indian context, as well, it holds good. A paper from ‘CUTS International’, aptly drives home this point. Another September 17, 2016 article published in ‘The New York Times’, reiterates the same.

What’s wrong in funding PAOs?

Some may argue, what’s wrong with pharma industry’s funding the PAOs. On the face of it, there may not appear to be anything wrong either. However, scholarly articles still express serious concern on such practices, mainly for conflicts of interest. For example, a September 2013 article titled, “Patient Advocacy Organizations: Institutional Conflicts of Interest, Trust, and Trustworthiness”, published in The Journal of Law Medicine & Ethics unambiguously states as follows:

“Numerous studies have found that even established and respected researchers and physicians are influenced by drug company money and gifts, which can bias study conclusions and encourage increased prescribing of potentially harmful medications. There is no reason to believe that PAOs are any less susceptible to such influence. In fact, there is little oversight of relations between PAOs and their for-profit donors, which in itself increases the potential for undue influence. Similar concerns regarding the lack of oversight have been raised regarding the physician professional groups that develop clinical care guidelines.”

Why is it a potential conflict of interest?

Many construe such financial relationships as potential conflicts of interest, because pharma players appear to be more interested in earning maximum possible profit through high drug pricing, while PAOs advocate for highly efficacious, safer and more affordable medicines for all, besides some other interests and rights of patients. Moreover, some large constituents of patient advocacy groups aren’t even seen lending their voices to the concerted protests of other stakeholders, including the political leaders – irrespective of their affiliations, against the sharp increase in prices of many life-saving drugs, covering both patented and generic medicines.

Several studies on this concern:

A March 02, 2017 report titled, “Conflicts of Interest for Patient-Advocacy Organizations”,

published in ‘The New England Journal of Medicine (NEJM)’, probably vindicates this point. This is mainly because, if pharma funding gets reciprocated through their remaining quiet, passive or even indirectly supporting any possible bias in the physicians prescribing decisions for high cost drugs – having other cheaper alternatives, that may not be in the best health and economic interest of many patients.

After examining and analyzing 104 large patient-advocacy organizations with an annual revenue of minimum USD 7.5 million, the researchers of the above study found that 83 percent of PAOs receive significant financial support from drug, device and biotechnology companies; and more interestingly, industry executives often serve on these groups’ governing boards.

Another article on this report commented though, that this study may have some limitations as the most organizations examined in this study did not provide exact figures for their reported donations, besides only 10 percent of patient-advocacy organizations revealed how they used the industry donations.

This NEJM study is not just one of its kind, another January 2017 report published in JAMA Internal Medicine, also concluded that there is a need to improve this conflict of interest issue of the patient advocacy groups or PAOs on their conflict of interest policies to help maintain public trust.

In conclusion:

Keeping aside altogether the contentious issue of funding PACs by the pharma, biotech or device companies, I would submit that it’s about time that the pharma industry in India realizes that patients have started perceiving themselves as consumers of health care. This perception is increasing by a manifold with improving access to not just the Internet, but consequent word of mouth sharing of such information with even those who do not have digital or health literacy.

The quest of many patients to ride the crest of this wave by gaining relevant information, especially through numerous digital platforms, besides word of mouth, is increasing. A lot more would eventually seek a wide range of relevant information on various disease treatment options and their effective management processes. Facilitated by this knowledge, many patients would opt only for those ones offering the best value within their respective economic means. Some enlightened individuals have already started expressing their preference to take part in the treatment and prescribing decision making process with the doctors. This visibly ascending trend is unstoppable now, as patients increasingly perceive themselves as consumers of health care.

Consequently, the pharma, biotech or device players in India would require to deeply understand the patients’ needs on the ground, not what they think those are, and treat patients as the key partner for business excellence – at least, as much as what they consider for other stakeholders, such as doctors and hospitals, if not even much more than that. Some companies are trying to make it happen through doctors, which don’t seem to be working as much as these should, according to another Accenture study.

Currently, several global pharma, biotech or device players claim that they follow ‘patient-centered’ approaches, and try to drive home this point through advocacy campaigns. However, many stakeholders don’t buy it any more. This is because such an approach must always lead to a win-win outcome. It, therefore, requires passing the acid test of conformance to the very definition of a ‘patient-centered’ approach, which requires establishing a partnership to ensure that all related decisions would respect patients’ wants, needs and preferences and solicit patients’ input on the education and support they need to make decisions.’

Thus, respective players in this arena need to shift gears fast, as the ball game is fast changing with its traditional version unlikely to yield the desired business results any longer. The name of the new version of this game is ‘direct engagement with patients’ to impart high quality of meaningful services in the therapy areas that the respective companies are in, by charting clear, innovative and well integrated strategies, and not just through single minded focus on sales and marketing. It’s important for all of us to realize that providing patient services aren’t optional any more for pharma business excellence.

By: Tapan J. Ray

Is Criticizing Pharma Now Just A Fad?

Posted on October 10, 2016 by Tapan Ray

Is criticizing pharma now just a fad of its stakeholders? Fathoming the right answer to this seemingly simple question may not be too easy, either, for some. The task could even be more onerous, especially when the global ‘researched based’ pharma and biotech companies, well chorused by their trade associations, are exerting serious efforts to garner the much required trust of all stakeholders on their ‘patient centric’ focus in the process of transacting business.

This often repeated pledge, as it were, on ‘patient centric’ approach is indeed praiseworthy. There’s no two opinions about it, either. The new found interest of several ‘research-based’ pharma and biologic players to develop less expensive biosimilar drugs, to possibly improve patient access to otherwise expensive biologic medicines, post patent expiry, could well be a reiteration of the same and well publicized vow, of course if not proven otherwise.

A recent example:

In the context of ‘patient-centric’ approach with biosimilar product development by the world’s largest innovative biologic drug makers, let me quote the following recent example.

On September 23, 2016, by a Press Release, the Food and Drug Administration of the United States (US-FDA) announced regulatory approval of Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. This is the fourth FDA-approved biosimilar, after the new biosimilar pathway became effective in the US. Amjevita has been developed by Amgen Inc. – one of the global pioneers in the development of innovative biologic drugs.

According to US-FDA, a biosimilar is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

Although, Amjevita is biosimilar to Humira, it has not been approved as an interchangeable product with Humira. This issue is considered as a major regulatory roadblock in the US for substitution of original biologic brands with their biosimilar equivalents, which can, therefore, be prescribed mostly to the new patients. It’s worth noting here that Humira – the blockbuster arthritis drug of AbbVie Inc. clocked a sale of US$ 14 billion in 2015, and probably will continue to do so in the foreseeable future, even long after patent expiry. I shall touch upon that point below, briefly.

It is estimated that the savings of putting just new patients on much less expensive biosimilar drugs, sans substitution of the expensive original brand, will be billions of dollars. Nonetheless, this will help reduce the cost of treatment with biologic medications, improving their access to many others.

A key barrier:

Interestingly, the barriers to following the biosimilar path are being mostly created none other than the innovative drug companies themselves, even post patent expiry, presumably to extend market exclusivity and monopoly pricing.

Arising out of one such key barrier, in the form of patent litigation, Amgen’s Amjevita, in all probability, may not be available to deserving patients for years. This could involve a protracted process of skillfully navigating through the labyrinth of legalities.

On August 05, 2016, The Wall Street Journal (WSJ) reported that AbbVie Inc. has filed a patent-infringement lawsuit against rival Amgen Inc., seeking to block sales of a lower-priced biosimilar of AbbVie’s top-selling, now generally considered as an off-patent drug – Humira.

When the narrative gets paradoxical:

While all the ‘research-based’ drug companies claim to be ‘patient-centric’ in their business approaches, be it with the development of biosimilars or in other areas, somewhere this narrative gets paradoxical.

On September 02, 2016, Reuters reported that global ‘research-based’ companies are now ‘waging courtroom patent battles against each other over biosimilars, as the line blurs between companies known for their innovative medicines, and those that produce cheaper biotech knockoffs.’

Some of the recent high-profile examples were reported as follows:

Sanofi sued Merck in the US federal court over its biosimilar version of Lantus insulin with around US$7 billion in annual sales.

Eli Lilly reached a royalties deal with Sanofi to end a similar Lantus-related lawsuit, but their pact means the biosimilar launch was likely delayed.

Pfizer and Korea’s Celltrion in August beat back a court challenge from Johnson & Johnson over US$10 billion autoimmune drug Remicade, though J&J’s Janssen unit promised to appeal.

In a closely watched case, Novartis wants the US Supreme Court to dump a six-month marketing delay for biosimilars, in what would be the first time the high court took up a biosimilar case.

Samsung Bioepis, along with partner and minority shareholder Biogen Inc, filed a lawsuit against AbbVie in Britain in March to stop the US company from blocking the launch of yet another Humira biosimilar.

It is equally noteworthy, while Amgen is keen to launch its own biosimilars, the company’s aggressive legal strategy delayed Novartis’s efforts to introduce the first US biosimilar, Zarxio, before the copy of Amgen’s US $1 billion drug Neupogen finally went on sale last year.

Further, Amgen has also filed a legal suit against a biosimilar version of its Enbrel (etanercept) developed by Novartis (Sandoz), which has already received regulatory approval from the US-FDA on August 30, 2016 for multiple inflammatory diseases.

Taking these into consideration, isn’t, therefore, about time to ponder afresh, whether the innovative drug makers’ general mindset of maintaining drug exclusivity with a very high price, on techno-legal grounds, even after enjoying price monopoly over a long period of the specified time, be termed as ‘patient-centric’?

Indian scenario:

Indian players have already started developing biosimilar drugs in the country. This market offers a lucrative future opportunity considering that original biologic brands with a global turnover of around US$ 70 billion will expire by 2020.

The first biosimilar was approved and marketed in India for a hepatitis B vaccine in 2000 (GaBI Online). By now, around 30 such products have reportedly received the Drug Controller General of India (DCGI)’s approval for marketing in India. Even after the new biosimilar guidelines were framed and implemented locally, since 2012, there has not been any worthwhile legal suits filed by the global innovative biologic manufacturers, against the Indian companies or such products developed and approved in India, till 2014.

Since then, this scenario has changed with Roche suing Biocon and its partner Mylan on their biosimilar versions of Roche’s Herceptin (Trastuzumab) for breast cancer, and also making the DCGI a party to this suit. This litigation is broadly on the following grounds:

Non-adherence to the Indian biosimilar guidelines
Misrepresentation of drugs as biosimilar and passing off

Be that as it may, its key impact is on affordable biosimilar drugs that can save more lives of breast cancer patients in India. If it is so, do such litigations demonstrate a patient-centric perspective for so important a drug, which is not even protected by a product patent in India, any longer?

Are biosimilars the only examples?

Lest I am not seen as highlighting only the instances of blocking market entry of biosimilar drugs, as sole examples of ‘patient-centric focus’, or lack of it, of many global innovative drug manufacturers, I would now expand it, just a bit. This is only to fathom the bottom-line – whether it is a ‘patients-centric’ focus, or solely a ‘profit-centric’ outlook.

‘Patients-centric’ or ‘Profit-centric’?

To get a sense on this vexing issue, it would be worthwhile for us to find out by ourselves the most appropriate reason behind each of the following. Of course it’s just an illustration. This reason could be either a ‘patient centric’ focus, or simply a ‘profit centric’ outlook. …And then let’s try to make out which way the overall balance tilts, on the ground:

Discovering new drugs, delivery systems, and finding new indications

Lack of transparency and widely reported bias towards mainly positive results in clinical trial data, both for publication and regulatory approval of various new drugs, and associated global furor.

Exorbitant high prices of many new patented medicines and some generic drugs too

Widely reported marketing/other malpractices, and associated fines paid by the respective players

Causing entry delay for cheaper small molecule generics and large molecule biosimilar drugs post patent expiry restricting gtreaterr patient access

What’s your relative score now?

Conclusion:

Let me sign off here by raising the following relevant questions in this area, for all of us to think and address, as we deem appropriate:

Is the narrative of ‘patient centric’ approach of the ‘research-based’ global drug companies’ now getting clearer with the widely reported credible examples, as above?

Is there still a paradox between their two different strategic business approaches – one entry into off-patent drug development, such as biosimilars, and the other in blocking or delaying entry of such drugs, whenever possible, even after enjoying a specified period of product pricing monopoly?

Does it then mean, what a large section of pharma industry constituents is now publicly demonstrating, at least in the above areas, more than negates their protracted sound bites on ‘patient centric’ focus?

Despite these facts, would pharma related criticism in this space be termed as just a fad of the stakeholders?

If not, what should be the way forward from here to ensure that remedial measures are taken in so important an area of ‘patient-centric’ outlook, soon enough?

By: Tapan J. Ray

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

Pharma Sales Communication: Would ‘Cafeteria Approach’ Be More Productive Today?

Posted on March 23, 2015 by Tapan Ray

For sales communication, quality of access of pharma Medical Representatives (MRs) to many important and busy doctors has been steadily declining over the past several years, all over the world, and India is no exception.

This is mainly because the number of patients coming to these busy practitioners is fast increasing and the doctors are trying to see all these patients within the same limited time that was available to them in even earlier days. In tandem, their other obligations of various kinds, personal or otherwise, are also overcrowding the same highly squeezed time space.

In a situation like this, increasing number of MRs, which has almost doubled in the past decade, is now fiercely competing with each other to get a share of lesser and lesser available time of the busy doctors.

Added to this, a gross mismatch between the inflow of doctors with similar prescription potential and ever increasing inflow of patients, is making the situation even worse.

According to a study done by CMI Communication Media Research, about half of physicians restrict visits from MRs in one-way or another.

Thus the critical question that needs to be answered now, from purely pharma sales and marketing perspective is:

How to make sales communication effective to such busy medical practitioners in this extremely challenging scenario?

Pharma players are trying to respond:

This pressing issue has prompted many pharma companies, across the globe, to reevaluate their traditional sales communication models, which are becoming increasingly expensive as a result of diminishing commensurate returns from the MR calls.

Some drug companies have also introduced interesting digital interventions, though within the same traditional pharma sales communication process, to add speed and novelty, especially in sales administration and its execution processes.

Experimentations are visible even in India:

In India too, pharma companies are trying with several different approaches, in various combinations to make the prescription generation process through sales communication more productive.

Some pharma players also tried to push up the overall sales productivity through additional rural market coverage. In this regard, a 2012 report of ‘IMS Consulting’ states, acknowledging the seriousness around rural consumers, many drug companies in India are now expanding their sales operation to Tier IV cities and below. Quite a few of them even succeeded in their endeavor to create profitable business models around the hinterland and rural geographies.

These pharma players believe that extra-urban geographies require different approaches, though with the same traditional sales communication models. These approaches include, different product portfolio, distribution-mix, pricing/packaging and promotional tools, considering majority of the doctors are not as busy as their counterparts in the metro cities and large towns.

Initial strategic changes:

The above ‘IMS Consulting’ paper also highlights a few of the initial changes in the following lines:

Business Unit Structure (SBU): To bring more accountability, manage evolving business needs and use equity of organization for reaching to the middle of the accessible pyramid.

Therapy Focus Promotion: Generally seen where a portfolio is specialized, therapy focused, and scripts are driven through chosen few doctors; generally in chronic segment.

Channel Management: Mostly adopted in OTC /OTX business; mature products with wider portfolio width.

Hospital Task Force: Exclusively to manage hospital business.

Specialty Driven Sales Model: Applicable in scenarios where portfolio is built around 2 or 3 specialties.

Task Force: Generally adopted for niche products in urban areas, such as fertility clinics or for new launches where the focus is on select top rung physicians only.

Out-Sourced Sales Force: Generally used for expansion in extra-urban geographies or with companies for whom medico marketing is secondary (such as OTC or Consumer Healthcare companies).

Pharma MNCs took greater strides:

In addition, to increase sales revenue further, many innovator pharma MNCs engaged themselves in co-promotion of their patented products, besides out-licensing. A few of them pushed further ahead by adopting newer innovative promotional models like Patient Activation Teams, Therapy Specialists, or creating patient awareness through mass media.

Brand value augmentation offering a mix of tangibles and intangibles:

Realizing quickly that patients are increasingly becoming strong stakeholders in the business, some of the pharma MNCs also started engaging the customers by extending disease management services to patients administering their products.

This is indeed a clever way of augmenting the brand perception, through a mix of well-differentiated tangible and intangible product related value offerings.

These pharma MNCs engage even the patients by providing a basket of services at their home. Typical services include:

Counseling
Starter kits
Diagnostic tests
Medical insurance
Personalized visits
Exercising equipment
Emergency help
Physiotherapy sessions
Call centers for chronic disease management

Related doctors are reported about the status of the patients and the patients do not require paying anything extra for availing these services from the MNC pharma companies.

Despite all these, declining productivity of the traditional pharma sales communication models continue, predominantly from the extremely busy and very high value medical practitioners/experts/specialists, as mentioned above.

Communication preferences of busy doctors need to be factored-in:

From the above facts, it appears that pharma sales communication is usually tailored to focus on customer/market types and characteristics, rather than emerging unique customer preferences towards medium of sales communication and also differentiated message requirements for specific brands.

Should status quo be maintained?

Probably not, as many still believe that MR’s quality of access to doctors for productive sales communication would continue to remain a critical issue and become increasingly complex.

Even in this changing scenario, pharma companies, by and large, have kept the basic communication medium and traditional process of messaging unchanged, except some digital tweaking here or there. Some of these innovative means and user-friendly digital interfaces, at times, may attract quality attention to sales communication for top of mind brand recall by the doctors.

Is it enough? Again, probably not, as there is an urgent need to exploring various other medium and new ways of delivering strong and effective tailor-made brand messages, based on hard data of painstaking research.

e-marketing started taking roots, though in bits and pieces:

In 2013, facing this challenge of change, Pfizer reportedly started using digital drug representatives to market medicines, leaving the decision in doctors’ hands as to whether they would want to see them.

Prior to that, in 2011, a paper published in the WSJ titled, “Drug Makers Replace Reps With Digital Tools” stated that pharmaceutical companies in the United States are downsizing their sales force with increasing usage of iPad applications and other digital tools for interacting with doctors.

Lot many other fascinating experimentations with pharma e-marketing have now commenced in several places of the world, many with considerable initial success.

However, most of these efforts seem to be swinging from one end of ‘face-to-face’ sales communication with doctors, to the other end of ‘cyber space driven’ need-based product value sharing with customers through digital toolkits.

Two key questions:

All these experimentations and developments with various pharma sales communication models would probably prompt the following two key questions:

Whether or not traditional sales approach would continue to be as relevant as opposed to digitally customized sales applications?

Whether or not MRs would continue to remain as relevant in all areas of pharma prescription generation process, in the years ahead?

Not an ‘Either/Or’ situation:

According to AffinityMonitor™ 2014 Research Report, pharmaceutical and biotech companies have today at their disposal more than a dozen of promotional channels to include in their strategy, including traditional methods, like detailing and speaker programs, and digital ones, including email, microsites and videos.

The report states, every doctor engages with these channels in his or her own unique manner. Some physicians want to interact with MRs; others restrict MR details and instead get information from their peers. One doctor might regularly use a mobile application for product information, often during a patient consultation. Conversely, another physician, who might work in the same practice, would rarely wish to surf the Web for information. And some doctors simply won’t engage with any sales communication no matter what the channels are.

Thus, ‘one size fits all’ type of sales communication, delivered even by the best of MRs, is not likely to be productive in the changing macro environment.

Many facets of communication preferences:

Today, there are many facets of doctors’ choices and preferences to brand value communication medium.

As AffinityMonitor 2014 Research Report states, based on the availability of time and interest, each doctor engages with these channels in his or her own unique manner. For example, some doctors may want to interact with the MRs, while some others may restrict MR’s product details. A few others may prefer getting information from their peers, instead

Since doctors’ engagement with pharma brands is critical for the drug companies, it has now become absolutely imperative for them to know individual affinities of the doctors in this regard, or what channels and processes each physician would typically prefer to get engaged with a brand, directly or indirectly.

Pharma companies should, therefore, gather this particular information doctor-wise, to customize both the medium and the message for effective brand value communication, accordingly.

A shift to ‘Cafeteria Approach’:

Taking all the above research inputs into consideration, it appears, when many busy physicians’ doors appear closed to traditional pharma sales communication, drug companies should have the keys to unlock them with ‘Cafeteria Approach’ of sales communication, purely based on customer research. This approach would offer the ‘difficult to meet doctors’ a variety of choices regarding both the medium and also the message, that would best suit their temperaments, needs, time and interests, as discussed above.

It is important to repeat, to ensure productive outcome of the ‘Cafeteria Approach’, customized sales communication strategy for each important and otherwise busy doctor should purely be based on contemporary customer research.

Sales force remains the top channel out of several others:

According to AffinityMonitor Research Study, though MR’s quality access to busy doctors has declined steadily over the past decade, the sales force still remains the top channel for physician engagement, closely followed by ‘Digital’ ones.

Overall, around 47 percent of all Health-Care Providers (HCPs) consider ‘face-to-face’ promotion as one of the top three channels, which includes about 80,000 physicians, who favor the sales force as their second or third-strongest channel.

Of the 514,000 HCPs examined in AffinityMonitor Research Study, 162,000 show the strong affinity for ‘face-to-face’ promotion, 118,000 for digital push and 65,000 for digital pull or personal remote channels.

Increasing just ‘Sales Force Effectiveness’ not enough:

Thus, generally speaking, even the best of global sales force excellence programs could at best increase the MR productivity primarily for these 47 percent of doctors.

Brand sales communication reach and effectiveness to a large number of rests of the doctors would, therefore, call for innovative thinking and willingness to chart the uncharted frontiers.

Conclusion:

The decline in pharmaceutical MR’s quality of access to physicians for sales communication is now well documented. For example, in 2008, 23 percent of US doctors had restrictions on MRs, but that number rose to 49 percent in 2014, according to AffinityMonitor Research Study.

Therefore, the knowledge of whether a doctor would like to engage with traditional sales communication method by seeing a MR, or would just prefer to get his/her required information through any digital medium, is critical for success in the new ball game of generating increasing number prescriptions for any pharma brand.

Majority of the doctors’ choices would, in all probability, involve MRs, while a notable number of other choices may probably be independent of MRs.

In any case, that’s not going to be the main issue, as MRs are not going to disappear – not in any foreseeable future and would continue to remain a critical part of the overall pharmaceutical selling process, all over the world.

However, closely following the emerging trend, I reckon, ‘Cafeteria Approach’ is worth considering for effective customized brand communication, ensuring productive sales outcome.

By: Tapan J. Ray

Pharma FDI: Damning Report of Parliamentary Panel, PM Vetoes…and Avoids Ruffling Feathers?

Posted on August 19, 2013 by Tapan Ray

An interesting situation emerged last week. The Parliamentary Standing Committee (PSC) on Commerce proposed a blanket ban on all FDI in brownfield pharma sector. Just two days after that, the Prime Minister of India vetoed the joint opposition of the Department of Industrial Policy and Promotion (DIPP) and the Ministry of Health to clear the way for all pending pharma FDIs under the current policy.

On August 13, 2013, Department related Parliamentary Standing Committee on Commerce laid on the Table of both the Houses of the Indian Parliament its 154 pages Report on ‘FDI in Pharmaceutical Sector.’

The damning report of the Parliamentary Standing Committee flags several serious concerns over FDI in brownfield pharma sector, which include, among others, the following:

1. Out of 67 FDI investments till September 2011, only one has been in green field, while all the remaining FDI has come in the brown field projects. Moreover, FDI in brown field investments have of late been predominantly used to acquire the domestic pharma companies.

2. Shift of ownership of Indian generic companies to the MNCs also results in significant change of the business model, including the marketing strategy of the acquired entity, which are quite in sync with the same of the acquirer company. In this situation, the acquired entity will not be allowed to use flexibilities such as patent challenges or compulsory license to introduce new affordable generic medicines.

The withdrawal of all patent challenges by Ranbaxy on Pfizer’s blockbuster medicine Lipitor filed in more than eight countries immediately after its acquisition by Daiichi-Sankyo is a case in point.

3. Serial acquisitions of the Indian generic companies by the MNCs will have significant impact on competition, price level and availability. The price difference between Indian ‘generics’ and MNCs’ ‘branded generic’ drugs could sometimes be as high as 80 to 85 times. A few more larger scale brownfield takeovers may even destroy all the benefits of India’s generics revolution.

4. FDI inflow into Research & Development of the Pharma Industry has been totally unsatisfactory.

5. FDI flow into brown field projects has not added any significant fresh capacity in manufacturing, distribution network or asset creation. Over last 15 years, MNCs have contributed only 5 per cent of the gross fixed assets creation, that is Rs 3,022 crore against Rs 54,010 crore by the domestic companies. Further, through brownfield acquisitions significant strides have not been made by the MNCs, as yet, for new job creation and technology transfer in the country.

6. Once a foreign company takes over an Indian company, it gets the marketing network of the major Indian companies and, through that network, it changes the product mix and pushes the products, which are more profitable and expensive. There is no legal provision in India to stop any MNC from changing the product mix.

7. Though the drug prices may not have increased significantly after such acquisitions yet, there is still a lurking threat that once India’s highly cost efficient domestic capacity is crushed under the weight of the dominant force of MNCs, the supply of low priced medicines to the people will get circumvented.

8. The ‘decimation’ of the strength of local pharma companies runs contrary to achieving the drug security of the country under any situation, since there would be few or no Indian companies left having necessary wherewithal to manufacture affordable generics once a drug goes off patent or comply with a Compulsory License (CL).

9. Current FIPB approval mechanism for brownfield pharma acquisitions is inadequate and would not be able to measure up to the challenges as mentioned above.

The Committee is also of the opinion that foreign investments per se are not bad. The purpose of liberalizing FDI in pharma was not intended to be just about takeovers or acquisitions of domestic pharma units, but to promote more investments into the pharma industry for greater focus on R&D and high tech manufacturing, ensuring improved availability of affordable essential drugs and greater access to newer medicines, in tandem with creating more competition.

Based on all these, The Committee felt that FDI in brown field pharma sector has encroached upon the generics base of India and adversely affected Indian pharma industry. Therefore, the considered opinion of the Parliamentary Committee is that the Government must impose a blanket ban on all FDI in brownfield pharma projects.

PM clears pending pharma FDI proposals:

Unmoved by the above report of the Parliamentary Committee, just two days later, on August 16, 2013, the Prime Minister of India, in a meeting of an inter-ministerial group chaired by him, reportedly ruled that the existing FDI policy will apply for approval of all pharmaceutical FDI proposals pending before the Foreign Investments Promotion Board (FIPB). Media reported this decision as, “PM vetoes to clear the way for pharma FDI.”

This veto of the PM includes US $1.6-billion buyout of the injectable facility of Agila Specialties, by US pharma major Mylan, which has already been cleared by the Competition Commission of India (CCI).

This decision was deferred earlier, as the DIPP supported by the Ministry of Health had expressed concerns stating, if MNCs are allowed to acquire existing Indian units, especially those engaged in specialized affordable life-saving drugs, it could possibly lead to lower production of those essential drugs, vaccines and injectibles with consequent price increases. They also expressed the need to protect oncology facilities, manufacturing essential cancer drugs, with assured supply at an affordable price, to protect patients’ interest of the country.

Interestingly, according to Reserve Bank of India, over 96 per cent of FDI in the pharma sector in the last fiscal year came into brownfield projects. FDI in the brownfield projects was US$ 2.02 billion against just US$ 87 million in the green field ventures.

Fresh curb mooted in the PM’s meeting:

In the same August 16, 2013 inter-ministerial group meeting chaired by the Prime Minister, it was also reportedly decided that DIPP will soon float a discussion paper regarding curbs that could be imposed on foreign takeovers or stake purchases in existing Indian drug companies, after consultations with the ministries concerned.

Arguments allaying apprehensions:

The arguments allaying fears underlying some of the key apprehensions, as raised by the Parliamentary Standing Committee on Commerce, are as follows:

1. FDI in pharma brownfield will reduce competition creating an oligopolistic market:

Indian Pharmaceutical Market (IPM) has over 23,000 players and around 60,000 brands. Even after, all the recent acquisitions, the top ranked pharmaceutical company of India – Abbott enjoys a market share of just 6.6%. The Top 10 groups of companies (each belonging to the same promoter groups and not the individual companies) contribute just over 40% of the IPM (Source: AIOCD/AWACS – Apr. 2013). Thus, IPM is highly fragmented. No company or group of companies enjoys any clear market domination.

In a scenario like this, the apprehension of oligopolistic market being created through brownfield acquisitions by the MNCs, which could compromise with country’s drug security, needs more informed deliberation.

2. Will limit the power of government to grant Compulsory Licensing (CL):

With more than 20,000 registered pharmaceutical producers in India, there is expected to be enough skilled manufacturers available to make needed medicines during any emergency e.g. during H1N1 influenza pandemic, several local companies stepped forward to supply the required medicine for the patients.

Thus, some argue, the idea of creating a legal barrier by fixing a cap on the FDIs to prevent domestic pharma players from selling their respective companies at a price, which they would consider lucrative otherwise, just from the CL point of view may sound unreasonable, if not protectionist in a globalized economy.

3. Lesser competition will push up drug prices:

Equity holding of a company is believed by some to have no bearing on pricing or access, especially when medicine prices are controlled by the NPPA guidelines and ‘competitive pressure’.

In an environment like this, any threat to ‘public health interest’ due to irresponsible pricing, is unlikely, especially when the medicine prices in India are cheapest in the world, cheaper than even Bangladesh, Pakistan and Sri Lanka (comment: whatever it means).

India still draws lowest FDI within the BRIC countries:

A study of the United Nations has indicated that large global companies still consider India as their third most favored destination for FDI, after China and the United States.

However, with the attraction of FDI of just US$ 32 billion in 2011, against US$ 124 billion of China, US$ 67 billion of Brazil and US$ 53 billion of Russia during the same period, India still draws the lowest FDI among the BRIC countries.

Commerce Minister concerned on value addition with pharma FDI:

Even after paying heed to all the above arguments, the Commerce Minister of India has been expressing his concerns since quite some time, as follows:

“Foreign Direct Investment (FDI) in the pharma sector has neither proved to be an additionality in terms of creation of production facilities nor has it strengthened the R&D in the country. These facts make a compelling case for revisiting the FDI policy on brownfield pharma.”

As a consequence of which, the Department of Industrial Policy and Promotion (DIPP) has reportedly been opposing FDI in pharma brownfield projects on the grounds that it is likely to make generic life-saving drugs expensive, given the surge in acquisitions of domestic pharma firms by the MNCs.

Critical Indian pharma assets going to MNCs:

Further, the DIPP and the Ministry of Health reportedly fear that besides large generic companies like Ranbaxy and Piramal, highly specialized state-of-the-art facilities for oncology drugs and injectibles in India are becoming the targets of MNCs and cite some examples as follows:

Through the big-ticket Mylan-Agila deal, the country would lose yet another critical cancer drug and vaccine plant.

In 2009 Shantha Biotechnics, which was bought over by Sanofi, was the only facility to manufacture the Hepatitis B vaccine in India, which used to supply this vaccine at a fraction of the price as compared to MNCs.

Mylan, just before announcing the Agila deal, bought over Hyderabad based SMS Pharma’s manufacturing plants, including some of its advanced oncology units in late 2012.

In 2008, German pharma company Fresenius Kabi acquired 73 percent stake in India’s largest anti-cancer drug maker Dabur Pharma.

Other major injectable firms acquired by MNCs include taking over of India’s Orchid Chemicals & Pharma by Hospira of the United States.

With the US market facing acute shortage of many injectibles, especially cancer therapies in the past few years, companies manufacturing these drugs in India have become lucrative targets for MNCs.

An alternative FDI policy is being mooted:

DIPP reportedly is also working on an alternate policy suggesting:

“It should be made mandatory to invest average profits of last three years in the R&D for the next five years. Further, the foreign entity should continue investing average profit of the last three years in the listed essential drugs for the next five years and report the development to the government.”

Another report indicated, a special group set up by the Department of Economic Affairs suggested the government to consider allowing up to 49 per cent FDI for pharma brownfield investments under the automatic route.However, investments of more than 49 per cent would be referred to the Foreign Investment Promotion Board (FIPB).

It now appears, a final decision on the subject would be taken by the Prime Minister after a larger inter-mimisterial consultation, as was decided by him on August 14, 2013.

The cut-off date to ascertain price increases after M&A:

Usually, the cut off point to ascertain any price increases post M&A is taken as the date of acquisition. This process could show false positive results, as no MNC will take the risk of increasing drug prices significantly or changing the product-mix, immediately after acquisition.

Significant price increases could well be initiated even a year before conclusion of M&As and progressed in consultation by both the entities, in tandem with the progress of the deal. Thus, it will be virtually impossible to make out any significant price changes or alteration in the product-mix immediately after M&As.

Some positive fallouts of the current policy:

It is argued that M&As, both in ‘Greenfield’ and ‘Brownfield’ areas, and joint ventures contribute not only to the creation of high-value jobs for Indians but also access to high-tech equipment and capital goods. It cannot be refuted that technology transfer by the MNCs not only stimulates growth in manufacturing and R&D spaces of the domestic industry, but also positively impacts patients’ health with increased access to breakthrough medicines and vaccines. However, examples of technology transfer by the MNCs in India are indeed few and far between.

This school of thought cautions, any restriction to FDI in the pharmaceutical industry could make overseas investments even in the R&D sector of India less inviting.

As listed in the United Nation’s World Investment Report, the pharmaceutical industry offers greater prospects for future FDI relative to other industries. Thus, restrictive policies on pharmaceutical FDI, some believe, could promote disinvestments and encourage foreign investors to look elsewhere.

Finally, they highlight, while the Government of India is contemplating modification of pharma FDI policy, other countries have stepped forward to attract FDI in pharmaceuticals. Between October 2010 and January 2011, more than 27 countries and economies have adopted policy measures to attract foreign investment.

Need to attract FDI in pharma:

At a time when the Global Companies are sitting on a huge cash pile and waiting for the Euro Zone crisis to melt away before investing overseas, any hasty step by India related to FDI in its pharmaceutical sector may not augur well for the nation.

While India is publicly debating policies to restructure FDI in the ‘Brownfield’ pharma sector, other countries have stepped forward to attract FDI in their respective countries. Between October 2010 and January 2011, as mentioned earlier, more than 27 countries and economies have adopted policy measures to attract foreign investment.

Thus the moot question is, what type of FDI in the pharma brownfield sector would be good for the country in the longer term and how would the government incentivize such FDIs without jeopardizing the drug security of India in its endeavor to squarely deal with any conceivable eventualities in future?

Conclusion:

In principle, FDI in the pharma sector, like in any other identified sectors, would indeed benefit India immensely. There is no question about it…but with appropriate checks and balances well in place to protect the national interest, unapologetically.

At the same time, the apprehensions expressed by the Government, other stakeholders and now the honorable members of the Parliament, across the political party lines, in their above report, should not just be wished away by anyone.

This issue calls for an urgent need of a time bound, comprehensive, independent and quantitative assessment of all tangible and intangible gains and losses, along with opportunities and threats to the nation arising out of all the past FDIs in the brownfield pharma sector.

After a well informed debate by experts on these findings, a decision needs to be taken by the law and policy makers, whether or not any change is warranted in the structure of the current pharma FDI policy, especially in the brownfield sector. Loose knots, if any, in its implementation process to achieve the desired national outcome, should be tightened appropriately.

I reckon, it is impractical to expect, come what may, the law and policy makers will keep remaining mere spectators, when Indian Pharma Crown Jewels would be tempted with sacks full of dollars for change in ownerships, jeopardizing presumably long term drug security of the country, created painstakingly over decades, besides leveraging immense and fast growing drug export potential across the world.

The Competition Commission of India (CCI) can only assess any possible adverse impact of Mergers & Acquisitions on competition, not all the apprehensions, as expressed by the Parliamentary Standing Committee and so is FIPB.

That said, in absence of a comprehensive impact analysis on pharma FDIs just yet, would the proposal of PSC to ban foreign investments in pharma brownfield sector and the PM’s subsequent one time veto to clear all pending FDI proposals under the current policy, be construed as irreconcilable internal differences…Or a clever attempt to create a win-win situation without ruffling MNC feathers?

By: Tapan J. Ray

To accelerate increasing ‘Access to Modern Medicines’ in India: A Strategic Approach

Posted on December 27, 2010 by Tapan Ray

Currently no one knows what the ‘Access to Modern Medicines’ in India is, in real term. Like many others, both local and global. I myself was quoting the World Medicines Situation of 2004 report, the base year of which is actually 1999. Thus there should not be even an iota of doubt in anybody’s mind that the above reported situation has changed quite significantly during the last decade in India and the statement that both the government and the industry alike has been making since then, ‘only 35% of the population of the country, against 53% in Africa and 85% in China has access to modern medicines’, is indeed quite dated. It does not make sense, at all, in the recent times of the Pharmaceutical industry in India.

More surprisingly, an updated information on the subject does not seem to be available anywhere, as yet, not even with the World Health Organization (WHO). However, the good news is, it has been reported that the ‘World Medicines Situation’ is currently being updated by the WHO.

Access to modern medicines is improving in India:

Be that as it may, CAGR volume growth of the pharmaceutical industry since the last ten years has been around 10%, leave aside another robust growth factor being contributed through the introduction of new products, every year. Encouraging growth of the Indian Pharmaceutical Market (IPM), since the last decade, both from the urban and the rural areas certainly signals towards significant increase in the domestic consumption of medicines in India. In addition, extension of focus of the Indian pharmaceutical Industry, in general, to the fast growing rural markets clearly supports the argument of increasing ‘Access to Modern Medicines’ in India. The improve in access may not exactly be commensurate to the volume growth of the industry during this period, but a major part of the industry growth could certainly be attributed towards increase in access to medicines in India.

For arguments sake, out of this rapid growth of the IPM, year after year consistently, if I attribute just 5% of the growth per year, for the last nine year over the base year, to improved access to medicines, it will indicate, at least, 57% of the population of India is currently having access to modern medicines and NOT just 35%, as I wrote in this blog earlier.

Unfortunately, even the Government of India does not seem to be aware of this gradually improving trend. Official communications of the government still quote the outdated statistics, which states that 65% of the population of India does not have ‘Access to Modern Medicines’ even today. No wonder, why many of us still prefers to live on to our past.

Be that as it may, around 43% of the population will still not have ‘Access to Medicines’ in India. This issue needs immediate attention of the policy makers and can be achieved with a holistic approach to resolve this issue. A robust model of healthcare financing for all socio-economic strata of the population, further improvement of healthcare infrastructure and healthcare delivery systems are the need of the hour.

Percentage growth in the healthcare budget is higher than that of the GDP:

With the increase of healthcare expenditure by 15% for 2008-09 and further increase in 2010-11, as announced by the Finance Minister in his recent Budget Speech, the healthcare expenditure as a percentage to GDP still remains around 1.0%, which is quite inadequate to address the key healthcare issues of the country.

The Prime Minister has already has expressed his intent that India will be able to increase its public healthcare spend to around 2.5% of the GDP, when GDP growth will touch the double digit figure of 10%, which I reckon, is no longer a pipe dream.

Explore a Public-Private Partnership (PPP) with the stakeholders of the Pharmaceutical Industry:

To address the critical issue of access to modern medicines, policy makers should now actively consider a series of closely integrated PPP initiatives. These PPP initiatives will initially include ‘Below the Poverty Line’ (BPL) families of our country, which not only constitute a significant part of our population, but also will have almost nil purchasing power for medicines. Thereafter, the scheme, slightly modified, should be extended to all ration card holders in India.

Possible impact of such PPP initiatives on improving access to medicines:

If such PPP initiatives are carefully and innovatively strategized, carefully planned and diligently executed, the access to modern medicines in India could increase from current 57% to over 63% of our population within a year’s time and to over 82% of the population over a period of next five years.

A ‘Back of the Envelope’ Strategy Outline:

The Objective:

To improve access to medicines to over 60% of the population one year after the execution of the strategy and to over 80% within the next five years. The key stakeholders, especially the pharmaceutical companies in India, will work closely with the Government under PPP initiatives for the improvement of access to modern medicines initially to the BPL families, significantly, who have almost no purchasing power for medicines.

The Plan:

- The stakeholders, mainly the pharmaceutical industry, to work out a suitable methodology to help the Government to reach all pharmaceutical formulations covered under ‘National List of Essential Medicines (NLEM)’ to the BPL families across the country and gradually extend it to all ration card holders in India.

- The government would extend appropriate Tax cuts to the concerned companies, as an incentive towards their involvement in the PPP initiatives.

- The National Pharmaceutical Pricing Authority (NPPA) would continue to strictly implement its drug price monitoring mechanism for all categories of drugs to keep their prices well under control, always.
Key Assumptions:
- According to Planning Commission of India (2007) the population of India is 116.9 Crore or 1.169 billion.

- According to ‘Centre for Science & Environment (August 2007)’ the latest figures on poverty place 27% of India’s population below the poverty line (BPL) out of which 72% reside in rural areas.

- No price of medicines will be affordable to the BPL families.

- The National Sample Survey Organization (NSSO) report on “Public Distribution System & Other Sources of Household Consumption, 2004 – 05” shows that only 28% of the rural poor have benefited from any type of government food assistance schemes, including ‘Public Distribution System’ and for urban areas the figure is just 9.5%. That means about 72 Million people below the poverty line are having ration cards.

- According to 1995 World Bank Study, the established per capita health spending is around Rs.320 per year.

- McKinsey in their report “India Pharma 2015” has stated that expenditure on medicines is 15% of total healthcare spend i.e. Rs.48 per year.

Methodology:

- Identify the number of BPL families who hold ration cards to receive free/subsidized medicine.

- Determine the cost to be incurred by the Government for purchase of medicines under NLEM.

- Devise a system of generating commensurate funds to improve access to BPL families.

- Operationalize the distribution of medicines to BPL families with public transparency

- Increase penetration of ‘Jan Aushadhi’ outlets simultaneously as a supportive incremental measure

Projected increase in ‘Access to NLEM Drugs’:

	Million
Population of India	1169
27% of Population is BPL	316
72% rural	228
28% urban	88
28% of 228 million have ration cards	64
9.5% of 88 million have ration cards	8
Total BPL ration card holders	72
Current Access to Modern medicines of 57%	666
When all ration card holders get NLEM drugs the access improves to:	738

�
SO, IF AT LEAST THE BPL RATION CARD HOLDERS GET NLEM MEDICINES, ACCESS IMPROVES FROM 57% TO 63.2%.

Cost implications of Increasing Access from 57% to 63.2%:

72 million ration card holders will need Rs.48 worth medicines per year i.e. Rs.3456 million or Rs.346 Crores.
If Industry contributes 0.6% of its turnover which will attract full tax (both direct and indirect) exemptions from the Government, the industry contribution works out to Rs.170 Crores.
A similar amount should be provided by the Government for purchase of free/subsidized medicines for exclusive dispensing to the BPL families.

To operationalize improved ‘Access to Medicines’:

- All ration card holders to be provided with a separate card (if not a smart card) for issue of medicines with a Unique Identification Number.

- Each ration shop will have a separate counter named ‘Jan Aushadhi’ for medicine, which will cater to only registered BPL families.

- Government to arrange to train the Ration Shop owners/employees in Pharmaceutical storage and dispensing

- Doctors of Primary Healthcare Centers, Block Dispensaries will be directed to provide free treatment and prescribe NLEM medicines to the members of BPL families holding such ration cards.

- Subsidized/free supply of medicines will be made against prescriptions from the ‘Jan Aushadhi’ counters of the Ration Shops to these families.

- The doctors’ prescriptions with a copy of the bill will be retained by the respective Ration Shops to account for such purchases of medicines by the BPL families.

- More & more members of BPL family will be encouraged to register for ration cards and be eligible for free / subsidized medicines.

Conclusion:

On completion of this scheme for BPL families and after covering all ration card holders, overall the access to modern medicines in India could increase from 57% to over 80% over a period of 5 years.

PILMAN

A Tapan Ray Website

Tag Archives: Approach

Effective Change Management – The Magic Wand For Business Success And Sustainability

Covid Propels Healthcare Into A Virtual World: A New Growth Driver For Pharma?

Time For Predictive Rather Than Reactive Pharma Strategy

Patient Services Aren’t Optional Any More For Pharma Business Excellence

Is Criticizing Pharma Now Just A Fad?

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

Pharma Sales Communication: Would ‘Cafeteria Approach’ Be More Productive Today?

Pharma FDI: Damning Report of Parliamentary Panel, PM Vetoes…and Avoids Ruffling Feathers?

To accelerate increasing ‘Access to Modern Medicines’ in India: A Strategic Approach