Create Purpose-Driven-Brands To Win Marketing Warfare In The New Reality

Posted on October 5, 2020 by Tapan Ray

As we navigate through the Covid days, the hope of somehow getting back to the pre-pandemic normal still lingers – notwithstanding a host of uncertainties in its way. The longing is driven by the hype of availability of scientifically proven, safe and effective drugs and vaccines – unrealistically soon, despite top experts still keeping their fingers crossed. Some are even more forthright in their expression, as reflected in a September 30, 2020 report. It flashed a headline - “There is no getting ‘back to normal. The sooner we accept that, the better.”

Alongside, COVID-19 crisis has also triggered some disruptive changes in the business processes around the world. Amid this global health crisis, interestingly, several global pharma CEOs are sensing a number of game-changing opportunities – having business implications, even much beyond the pandemic.

One such example, as Bloomberg reported on September 29, 2020, the CEO of GlaxoSmithKline Plc feels: The Covid Pandemic is ‘a Shot at Redemption in Pharma Industry.’ Elaborating the point, she said: ‘the sector’s push to find vaccines and drugs to end the crisis, if successful, could change the perception of pharmaceutical companies in the future.’ Coincidentally, the researchers from The Harris Poll found:

As of May, 40 percent of the American public said pharma’s reputation had improved since the beginning of the COVID-19 outbreak
And 81percent recalled seeing or hearing something about the industry during that time.
This is a continuation of the former trend that The Harris Poll first noted on March 2020.

There shouldn’t much doubt, either, that similar general impression on the pharma industry, with a varying degree, may now be felt in most countries, across the globe.

Curiously, flowing from this ‘redemption of pharma reputation’ angle – with new drugs and vaccines, the scope for leveraging another opportunity is also surfacing. This is from pharma ‘branding’ perspective and pertains to creating ‘purpose-driven brands’ for success in the new reality – during the pandemic and much beyond. In this article, I shall focus on the second area, and would start with its relevance to increasingly more informed health care consumers of date.

‘Purpose driven brands’ – attained greater relevance in Covid time:

The concept of creating ‘purpose driven brands,’ is profound – it goes much beyond product features, benefits and intrinsic values. It is motivated by – why the brands exist not just for providing a solution to manage or cure a disease, but also to meet a crucial need in society.

Studies have unfolded, with better stakeholder connection – and greater share of their mind, ‘purpose driven brands’ help improve brand loyalty, resulting into increased revenue and profit. We will see below, why in Covid time, this trend has started gathering wind on its sail, and deserves to find its place at the very core of any pharma branding strategy.

The consulting arm of The Beautiful Truth, also echoed the same sentiment in the article – ‘How Pharma Can Navigate Change With Purpose.’ It reconfirmed, at times of external crisis, like the global pandemic, creation of ‘purpose-driven brands’ is vital. Not just ‘for saving and maintaining business, but also for boosting internal team morale, and reconciling public trust.’

The pandemic has redefined the core purpose of a brand:

Another recent article –‘Through COVID-19, Leading Brands Have Found Their Purpose,’ published in CMO by Adobe, among many others, vindicated this point. Acknowledging that the COVID-19 pandemic has redefined the meaning of brand purpose, the paper explained the reason for the same.

In pre-Covid days, many organizations used to build brands following traditional norms – curing or effectively managing a disease is the purpose of a brand. But, since last few years, a growing number of new generation health care customers expect a brand’s ‘purpose’ to expand beyond the product and the company. It has to be inclusive in nature – benefiting the macro-environment, including governments, health care professionals, and the public. With this expectation gathering momentum during Covid time, pharma players would also need to redefine the core ‘purpose’ of a brand. Incidentally, many pharma CEOs also believe, if this trend continues, the image of the industry would probably undergo a metamorphosis.

Surveys vindicate the rationale for redefinition:

Several top consulting organizations have published excellent articles covering a number of critical points in this area. One such paper - ‘Purpose is everything,’ was published in Deloitte Insights, on October 15, 2019. It wrote on how brands that authentically lead with ‘purpose’ are changing the nature of business today.

The rationale for redefinition of brand purpose, also gets reflected in a contemporary Deloitte survey, as quoted in the above article. It revealed the following top three issues that stakeholders identify with, while making decisions about brands:

Top Issues	% of respondents
How the company treats its own people/employees	28
How the company treats the environment	20
How the company supports the community in which it operates	19

Aligning purpose to create deeper connections with stakeholders:

Especially at the Covid time, if companies try to align their purpose in doing good – for the society, they can build deeper connections with their stakeholders. And, in turn, amplify the company’s relevance in their stakeholders’ lives. From this perspective, it’s good to note in the above Bloomberg article, that one of the top pharma CEOs articulating the same in public. I reckon, increasingly, pharma businesses would endeavor harnessing the power and opportunity of aligning the ‘core purpose of brands’ with societal good, as came out in the above Deloitte article.

Mostly millennial generation favor ‘purpose-driven’ brands:

The initiation of this trend dates back to pre-Covid time with wider usage of internet. However, with the increasing democratization of health care - social media based instant information sharing, the ability to communicate with others as needed, have increased manifold. Consequently, stakeholders, particularly, the millennial generation with a different mindset, aspirations and expectations are expecting pharma players to act more on the pressing societal issues. This makes them lean towards a purpose driven brands and companies. The unprecedented Covid health crisis is acting as a force multiplier in this area.

Another study – ‘Why Customers Are Supporting ‘Purpose-Driven’ Brands,’ published in Link fluence epitomized this evolving customer preference succinctly. It reiterated, ‘It’s no longer enough for brands to deliver great products and experiences. Instead, consumers are demanding for brands to be more proactive and conscious in delivering value to society as a whole.’

‘Purpose-driven brands’ – the latest ‘marketing buzzword’?

This question was conclusively answered about two years ago - from the 2018 Cone/Porter Novelli Purpose Study. Although, this survey was conducted in the United States, it has a global relevance amid Covid pandemic. Some of the key findings include:

78 percent believe companies must do more than just make money; they must positively impact society as well.
77 percent feel a stronger emotional connection to Purpose-driven companies over traditional companies.
66 percent would switch from a product they typically buy, for a new product from a purpose-driven company.
68 percent is more willing to share content with their social networks over that of traditional companies.

Examples of ‘purpose-driven’ pharma brands/companies:

Let me give just two examples each – from pre-Covid and Covid times. The article – ‘Mission-Drive Pharma Brands,’ published by Wonder on January 15, 2018, cited several examples of ‘purpose-driven’ pharma brands. This was based on a research of individual drug campaigns for top-selling drugs around that time. These include promotional campaigns on:

Humira: Highlighted the participation in a community food drive, and volunteering in a playground construction project.

Lyrica: Highlighted the engagement in a multi-generational interaction and helping others.

Encouragingly, while combating COVID-19, several pharma companies have also displayed a sense of ‘purpose’ to save the humanity from the pandemic, mainly through collaborative approaches. Let me quote below two such examples:

On April 14, 2020 GlaxoSmithKline and Sanofi announced a very unusual collaboration to develop a COVID-19 vaccine, expeditiously. This was done for a greater purpose, responding to the critical need of the society – saving millions of lives.

Roche called on and campaigned for the governments for focusing on testing and prevention, to maintain adequate medical supplies for health care professionals around the world. It also urged the health authorities to work closely with the life sciences industry to tackle the Covid-19 pandemic through international collaboration to tackle Covid-19 pandemic.

Conclusion:

Meanwhile, as on October 04, 2020 morning, India recorded a staggering figure of 6,549,373 of Coronavirus cases with 101,812 deaths. Still there is no respite from Covid-19’s unprecedented onslaught on the country. Be that as it may, coming back to the creation of ‘purpose-driven brands’ in the Covid time, let me quote again from the above CMO by Adobe article, where it underscored:“Never before have brands been asked to show their true purpose and leadership as they are today. It’s inspiring to see companies across industries and throughout the world come together to address some of the most pressing needs brought about by this crisis.”

As Accenture had articulated: ‘In an era of radical visibility, technology and media have given individuals the power to stand up for their opinions and beliefs on a grand scale.’ Keeping this in view, with gradually changing stakeholder mindset and expectations, the ‘purpose of a brand’ deserves to be a critical centerpiece in the pharma ‘branding’ process. Various studies have established – since pre-Covid time, and more during this pandemic – brands, reflecting a robust sense of ‘purpose’ on societal values, people and the environment, connect better with customers.

Consequently, as the stakeholders find these companies walk the talk, they develop a strong and sustainable brand preference, and reward the manufacturers commensurately, both directly and also through word of mouth. Alternatively, if the stated ‘brand purpose’ is not genuine – which customers can quickly find out through digital transparency, they shift their preferences to the deserving ones. Going by this growing trend, I reckon, creating ‘Purpose-Driven-Brands’ assumes a critical importance to win marketing warfare, in the new reality.

By: Tapan J. Ray

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

Holistic Disease Treatment Solution: Critical For Pharma Success

Posted on October 29, 2018 by Tapan Ray

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

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

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

A fundamental change is taking shape:

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

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

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

What prompts this change?

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

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

A flowchart of the disease-treatment-process:

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

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

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

Has it changed now?

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

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

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

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

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

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

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

Researchers at the John Radcliffe Hospital in Oxford, England, developed an AI diagnostics system that’s more accurate than doctors at diagnosing heart disease, at least 80 percent of the time.

At Harvard University, researchers created a “smart” microscope that can detect potentially lethal blood infections with a 95 percent accuracy rate.

A study from Showa University in Yokohama, Japan revealed that a new computer-aided endoscopic system can reveal signs of potentially cancerous growths in the colon with 94 percent sensitivity, 79 percent specificity, and 86 percent accuracy.

In one study, published in December 2017 by JAMA, it was found that deep learning algorithms were able to better diagnose metastatic breast cancer than human radiologists when under a time crunch. While human radiologists may do well when they have unrestricted time to review cases, in the real world a rapid diagnosis could make the difference between life and death for patients.

When challenged to glean meaningful insights from the genetic data of tumor cells, human experts took about 160 hours to review and provide treatment recommendations based on their findings. IBM’s Watson took just ten minutes to deliver the same actionable advice.

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

Technological players are making forays:

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

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

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

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

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

Onduo, a US$500-million diabetes-focused joint venture between Sanofi and Verily Life Sciences, an Alphabet company was founded in September 2016. Onduo recently launched its first product – an app plus, a continuous glucose-monitoring device plus an insulin pump that are all linked together. The Onduo app has a built-in coach (i.e., an electronic assistant) to help patients better manage their diabetes and accomplish their health goals.

GlaxoSmithKline (GSK) and Verily (formerly Google Life Sciences) have formed a joint venture to develop and commercialize bioelectronic medicine – miniaturized nerve implants that modulate electrical impulses to treat certain diseases.

Lack of digital leadership talent within the pharma industry?

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

Conclusion:

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

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

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

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

By: Tapan J. Ray

Relevance of Artificial Intelligence In Creative Pharma Marketing

Posted on October 31, 2016 by Tapan Ray

Keeping pace with the challenge of change globally, the macro environment in the pharma business is also undergoing a metamorphosis. This includes areas, such as, strong product pricing pressure, dwindling new product pipelines, increasing operating expenses, stringent regulatory requirements, rising stakeholder expectations, and several others. All these developments collectively, are making the drug companies, both global and local, feel the tailwind of various intensities, in their efforts to achieve the corporate financial goals, more than ever before.

Despite this continuous change, most pharma players’ overall strategic business models to meet with the increasing economic expectations of the shareholders, other investors and the stock markets, have hardly undergone any path breaking, radical, or disruptive advancement, just yet. This includes even the most critical interface between an organization and the consumers – pharma sales and marketing.

That said, it is not uncommon, either, to witness some sporadic initiatives of major business process reengineering with sophisticated digital applications. Interestingly, all these measures are mostly replacements or for realignment of the same age old, and traditional strategic pharma sales and marketing models. Most of these are aimed at adding more speed and accuracy to the same business core process, along with ensuring greater management information and control to support the decision making process.

Despite this palpable environmental shift, general inertia within the pharma industry to respond to all these, with commensurate strategic game plans of surgical accuracy, is glaring. Currently, the general response to this transformation is mostly reactive and traditionally defensive in nature, rather than proactive, as the overall business environment around the industry keep becoming increasingly demanding. Most pharma players may not, but the time keeps galloping ahead, offering a mind boggling rapid advances in disruptive technological innovations – the potential game changers for its several business domains.

In the midst of such all-embracing changes, yet another disruptive technology – ‘Artificial Intelligence (AI)’, is prompting many business leaders to step on to a brand new paradigm, making use of AI to the extent required, especially, while preparing a detail strategic roadmap for the business with high precision.

A clear intent to seize this moment is now visible in many industries, though in varying degrees and scale, but surely it is happening. This is vindicated by the gradual increase in demand for AI, across a wide variety of its application areas.

Marketing to turn upside down?

On October 26, 2016 an article published in ‘The Huffington Post’ on how AI could ‘Turn the Marketing World Upside Down’ indicated its disruptive impact on the way innovative marketing strategies are conceived, created and implemented on the ground.

The article gave an interesting example of how paradigm shift follows a predictable pattern of development that starts with substitution, followed by augmentation, modification, and finally redefinition.

For example, the evolution of today’s smartphones also followed the same pattern, as follows:

First replaced simpler landline phones
Then adapted with the addition of a camera
And finally redefined “phone” altogether, not just by replacing cameras, pagers, and many functions of personal computers, but by being able to perform with great precision an incredible number of various other serious requirements, well supported by related digital apps.

With the application of AI in marketing, the conventional ball game right from conception, to charting out and execution of marketing strategies, will be catapulted to a new and fascinating orbit altogether. I have no intent to romanticizing it. This is going to happen sooner than later, as we move on.

Artificial Intelligence (AI):

In a simple and commonly understandable way ‘Artificial Intelligence (AI)’ can be explained as the theory and development of computer systems, which are able to perform tasks normally requiring human intelligence, such as, machine learning, visual perception, image processing, speech recognition, decision-making, and language processing, besides many others.

In the Hollywood film industry, several sci-fi movies have already been made, based on AI as the core theme. Some of these international blockbuster films are ‘The Terminator’, ‘Transcendence’, ‘The Matrix’, ‘Ex Machina’, ‘Ex Machina’ or even ‘2001: A Space Odyssey’, among many others.

Some concern, but…:

Alongside, a serious concern has also been expressed by some global icons, that the evolution of AI could reach a dangerous threshold, where mankind will no longer remain in control of the creation of its own progeny, besides other living beings. This could, as they believe, jeopardize the continuity of an entire civilization, at least, in its present form.

In 2014, globally acclaimed Professor Stephen Hawking commented in an interview with the BBC: “Humans, limited by slow biological evolution, couldn’t compete and would be superseded by A.I.”

In fact, in July 2015, Professor Hawking reportedly joined Elon Musk, Steve Wozniak, and many others, warning that AI can potentially be more dangerous than nuclear weapons.

In the same year, even Bill Gates, co-founder of Microsoft, reportedly expressed his concerns, saying, “I am in the camp that is concerned about super intelligence…”

On the other hand, despite such apprehensions, AI based technology keeps evolving at a rapid pace, with the funding in AI research taking giant leaps forward. The technology has already found its cutting edge extensive applications in several warfare. We now hear almost every day about unmanned drones not just doing defense surveillance, but destroying strategic targets with jaw-dropping precision. Or for that matter, use of robots has become rather common to diffusive explosive devices of various kinds, intensity, and planted in important places to kill people. As reported by the media, ‘autonomous and self-aware robots to diminish the need for human soldiers to risk their lives.’

Google’s driverless cars also use similar AI technology offering advanced analytics-based algorithms, machine learning and deep learning processes, which could well be another game changing example in this area.

The benefits far outweigh the risks?

Be that as it may, the benefits of AI seem to far outweigh the risks, in various areas. This includes its strategic applications in the pharma industry.

This gets vindicated by the February 2016 research report of ‘Markets and Markets’ (claimed as the world’s second largest firm in publishing premium market research reports, per year), which estimated that AI market would record a turnover of around US$ 5.05 Billion by 2020, growing at a CAGR of 53.65 percent between 2015 and 2020. This market is currently dominated by the ‘Machine Learning’ technology, as it provides the computers with the ability to learn without being explicitly programmed, and are capable of updating themselves when exposed to new data.

Some of the key players operating in the artificial intelligence market are IBM Corp. (U.S.), Microsoft Corp. (U.S.), Google Inc. (U.S.), IPsoft (U.S.), FinGenius Corp. (U.K.), Rocket Fuel Inc. (U.S.), Mobileye N.V. (Israel), Kensho Technologies, Inc. (U.S.), Sentient Technologies (U.S.), and Zephyr Health (U.S.), the report revealed.

AI in pharma:

Over the last decade, AI is being increasingly used by various industries, as a key support to the strategic decision making process, in various areas of business. Understandably, in pharma its use has been rather limited, as on date. Nevertheless, there are several key domains within the pharma industry, where effective use of AI has the potential to be a critical performance enhancer. These areas include, not just in discovery research, or in clinical trials, or in sales and marketing, but also in setting the right strategic direction for the company.

However, in this article, I shall focus mainly on the application of AI in pharma marketing.

AI in pharma marketing:

Although AI is now being sparsely used, it is expected to be more widely used in pharma research and development. It also shows tremendous potential in developing creative sales and marketing strategies, with great accuracy.

So far, pharma marketing strategies are based more on the qualitative data, some traditional quantitative data, and a huge dose of marketers ‘gut feel’. It continues to happen, when the world, including India, is moving towards innovative data driven decision models. If one chooses to, now a pharma marketer also can make effective use of an abundantly available wide variety of quality data to feel the pulse of the markets, consumers and any identified issues, with great precision. Thereafter, based on these real life hard facts, the team needs to put in place for implementation, with an open and innovative mind, a creative sales and marketing game plan, to achieve the set goals.

Would that mean, a pharma marketer should necessarily be an expert in a huge volume of data analysis? I don’t guess so. ‘Machine Learning’, ‘Deep Learning’ and other analytics-based processes of AI can help them enormously to do so.

AI based analytics has now been proved to be far more reliable than any human analysis of the humongous volume of different kinds of quality data. Doing so is even beyond the capacity of any conventional computers that a marketing professional generally uses for this purpose.

The prime requirement for this purpose, therefore, is not just huge volume of data per se, but good quality of a decent volume of data, that a state of the art analytics would be able to meaningfully deliver, that is tailor made to meet the specific requirements of pharma marketers to create a cutting edge marketing strategy.

Areas of AI use in pharma – some examples:

AI will be extremely useful to arrive at the most effective strategic options available, with pros and cons, to achieve the core sales and marketing objectives of the organization, both long and short term.

It can also add immense value right at the decision making stages to determine the key ingredients of an effective strategic plan in a number of critical areas, such as:

Arriving at the optimal product-portfolio-mix with the right expense tag attached to each brand
Deep learning about market dynamics, customer behavior and their interplay
Matching unmet customer needs with enhanced and differentiated value offerings – both tangible and intangible
Effective bundling of brand offerings and associated services for each patient segment
Selecting the right mix of communication channels, including social media, to ensure maximum productivity in reaching each category of the target audience
Detailed strategic blueprint for each type of stakeholder engagement, along with related value offerings
Arriving at the best possible resource-mix with the available budget
Real-time monitoring of each strategic action steps, consistently, making quick changes on the run, if and when required

Pharma AI platforms are already available:

There are a number of AI platforms now available for the pharmaceutical companies, across the world. For example, in September 2015, by a Press Release, Eularis – a leading provider of next-generation advanced marketing analytics to the Pharma industry, announced the release of the E-VAI, the latest development in sophisticated machine learning technology delivering next-generation analytics and decision making for Pharma marketers globally.

Another recent example of AI in this area, as well, is ‘Salesforce Einstein’. It delivers advanced AI capabilities in sales, service, and marketing, and enables anyone to build AI-powered apps that get smarter with every interaction. According to Salesforce, it will enable everyone in every role and industry to use AI to be their best.

Conclusion:

The use of AI in pharma is still in its nascent stage today. However, for a sustainable business excellence in its various domains, AI is increasingly proving to be of great relevance, now and also in the future. Sales and marketing is one such domains.

With the passage of time, both the macro and micro pharma business operating environments are changing fast, primarily driven by changing expectations of stakeholders, the public at large, and disruptive algorithmic technical innovations, based on advanced science, statistics and mathematics.

The scope to effectively utilize the full potential of advanced algorithmic technical tools, is huge. It is easier now to capture a massive volume of pharma related high quality raw data of different kinds, for tailor-made innovative analysis, with the help of AI based analytics, while creating cutting-edge strategic game plans.

Nonetheless, pharma players apparently continue to chart the same strategic frontier where there are many footsteps to follow. Many of them have restricted themselves to no more than digitally re-engineering the same overall business processes that they have been already following, since long. Just a few of them are making use of the leading edge analytics involving AI, such as ‘Machine Learning’, ‘Deep Learning’, ‘Visual Perception’, ‘Image Processing, besides many others, which can be more ‘patient-centric’ and at the same help deliver a strong business performance.

Thus, quicker adaptation, and thereafter continuous scaling up applications of high quality AI based analytics in creative pharma marketing, are not just of immense relevance today, they also bring with them the commensurate potential for sustainable excellence in financial performance of the organization, fueled by critical early mover advantage.

By: Tapan J. Ray

Recomposing Notes of Pharma Marketing Playbook

Posted on June 20, 2016 by Tapan Ray

The global management guru Peter Drucker, in one of his management classics – “The Practice of Management”, published in 1954, that created the discipline of modern management practices, had underscored the following:

“As the core purpose of any business is to create a customer, a business has two, and only two functions, marketing and innovation. Only these two produce business results. All the rest are costs.”

The Harvard Business Review also had rated ‘The Practice of Management’ as Drucker’s best book on the managerial profession. Far more crisp than the larger compendium on Management, nicely balanced between precept and example, this book is eminently practical yet of genuine intellectual breadth. If Drucker’s work holds anything of immediate value for you, you will most likely find it here…”

Thus, Peter Drucker’s above concept is so fundamental that the pharmaceutical business can’t be any exception to it, in any way. That the old customers need to be retained, and the new customers are to be created on an ongoing basis, even in the modern times, still remain a basic requirement.

Nevertheless, the marketing process of doing so needs to change, according to the changing market dynamics. Continuation of playing the same notes from the grand old marketing playbook, with minor alterations here or there, would no longer suffice to keep pace with the changing market, and to effectively address the new stakeholders’ needs and wants.

Need to recompose notes of the playbook:

Both the current processes of pharma marketing and the patent claim for any type of drug innovation that the majority of the global pharma companies is currently following, have become highly contentious over a period of time, to say the least.

Even otherwise, in my view, both these processes have already hit the ceiling of the famous ‘law of diminishing returns’, where very simply put, the level of profits or benefits gained is less than the amount of money or energy invested.

Therefore, the question that comes up: Are the notes of the pharma marketing and innovation playbook fair, right, inclusive, and sustainable? However, in this article, I shall focus only on contemporary pharma marketing, and the opportunities that are coming up along with waves of changes in the business environment.

An example of ‘Change the logo’ saga:

Going by my personal experience, I have worked with many pharma marketing professionals, some of whom are still working in the industry. Post recruitment in the new company, having gone through a rigorous screening process, most of them would probably give a similar feedback that an anonymous quote captures as follows:

“The optimist says, ‘the glass is half full’; The pessimist says, ‘The glass is half empty.’ The marketing consultant says, ‘The glass needs resizing and a different logo.”

On a lighter vein, I am using below an example of one ‘change the logo’ approach. This is just one of many of my real life experiences. This may give you a panoramic view of how things generally are. The stretching of the same old marketing paradigm beyond its elastic limit is rather common, of course, with some sporadic digital tweaking. Nonetheless, the notes in the marketing playbook remain almost the same, producing the same tunes for some, and noise for many others.

This ‘logo change’ saga may sound quite familiar to many of my ex-colleagues of not so distant past. This approach exemplifies the limitations of a new recruit for a senior position to identify the core issues that would lead to the organization’s performance improvement.

It does not surprise me at all, when I find some top managements, who were an integral part of that selection process, promptly buying these shallow, and at the most peripheral ideas. It is quite evident that some of these top management members also suffer from similar analytical and management myopia. It is needless to mention that such things usually happen during the ‘honeymoon’ period’ of the new recruits.

Accordingly, the ‘logo change’ takes place in no time, paying a huge sum to the creative agency. Commensurate hype is simultaneously created around the new logo, backed by massive efforts to communicate its ‘ethereal design’ to as many targets as possible, often with no tangible outcome. Alongside, attempts are also made to change as many old things as possible, generating a multitude of seemingly high-voltage activities, though the performance on the ground remains unchanged, or rather deteriorates.

I fully understand, there is nothing wrong in changing anything, including a logo, that is not working or has outlived its time. However, when this assumes the top priority of a new and a top recruit, immediately after assuming office with a new responsibility, it somewhat doesn’t gel, and very often does not achieve the desired purpose.

Pharma marketing over-dependent on the likes of ‘Surrogate CMEs’?

Today, when there is a need to hear more from all the major stakeholders, one sided ‘telling my story’ mostly to the doctors continues to occupy a major part of pharma marketing, besides company sponsored or allegedly surrogate ‘Continuing Medical Education (CME)’ even for old branded generics.

The preparation of a canned brand communication in India is a routine pharma marketing process, with a plethora of avoidable and unproductive activities. This canned message is delivered to the doctors, usually through the Medical Representatives, conforming to a structured ‘tool-kit’, and heavily backed by free samples and gifts.

A large number of doctors too, continue to take this process, particularly in India, as an unavoidable routine, and also an integral part of their professional activities. It is widely believed, and frequently reported that the ‘magic wand’ for large scale prescription generation for pharma brands lies somewhere else.

Apparently, it is where the financial relationship between the doctors’ and pharma players is usually built and strengthened. One allegation is, in the garb of so called ‘CMEs’, even for old branded generic or as some folks call these as ‘classic’ brands, this financial relationship continues to thrive.

This gives rise to a suspicion in many, as to why pharma marketing is so over-dependent on the so called ‘CMEs’, even for old branded generics in India.

The vicious circle continues:

When the financial relationship of various hues, between the drug players and the doctors take the center stage, which pharma company has a deeper pocket counts. More expenses incurred in such relationship building process, may consequently drive the drug prices higher. In this situation, the patients get literally caught between the devil and the deep blue sea, where the Governments are compelled to intervene, as has started happening now in many countries.

In tandem, the pressure on performance keeps mounting on the marketers from the same top management, ultimately repeating the old vicious circle, where it may not be the ‘logo change’ that time, but another different sets of the same genre of hectic activities would commence, in pursuit of the illusive sweet smell of business success.

Recompose notes of the marketing playbook:

Even today, the marketing communication in the pharma industry remains primarily a monologue. Many training programs are currently sold to the industry to make this process a dialogue, as the Medical Representatives detail their products to the doctors.

However, on the ground, as I witnessed even in the last month while seating incognito in the clinics of some doctor friends, that the practice of monologue continues reflecting a great visible hurry in the product communicators’ end. Some from large pharma companies were using electronic gadgets, instead of a usual spirally bound product detailing folder, but their overall communication approaches were monologue too.

Thus, the modern age pharma marketers need to recompose the notes of their marketing playbook, soon. Some of the areas of active consideration may include the following:

A. Brand messages to be “pulled” by doctors, not “pushed” by marketers:

An interesting worldwide survey of 228 senior global marketing executives was conducted in February 2006 by the Economist Intelligence Unit, in co-operation with Google. The study highlights the need to transform the marketing communication platforms from a monologue to a more intense process of engagement, through effective dialogue with the stakeholders.

In this new environment, the relevance is more important than repetition, and marketing messages should be “pulled” by the consumer rather than “pushed” by the marketer. This calls for a transformation of the internal marketing organization. All the deliverables of pharma marketers’ must have a relevance to time, and measurable, with total accountability for top and bottom line growth in the areas of responsibility.

In the consumer products’ industry, the last decade has witnessed several innovative two-way marketing “conversations” between the customers and some of the world’s leading consumer brands. Driven by a confluence of innovation, competition and big shifts in consumer behavior, the dialogue between brands and their customers is replacing the traditional marketing monologue, the study observes.

Some recent developments:

In this regard, on Jun 2016, an IBM News Release announced that ‘The Weather Company’, an IBM Business has developed an industry-first capability in which consumers will be able to interact with IBM Watson through advertising, by being able to ask questions via voice or text and receive relevant information about the product or offering. It can create a one-to-one connection with the consumer, that can be personal, relevant and valuable; and can scale across millions of interactions and touch points. This digital tool can also help the marketers uncover consumer and product insights faster than ever before, revealing connections previously invisible to human data scientists, IBM claims.

For example, an anti-allergy brand could enable visitors to Weather.com to ask questions about whether the product is appropriate for children or what sort of side effects it might cause, as WSJ mentioned in its news item of the same date.

However, only the FMCG companies, such as, Unilever, Campbell Soup Co. and GSK Healthcare have, so far, reportedly signed on with Weather Co. to start running Watson-powered ads on both desktop and mobile devices this year.

According to another 2014 report of IMS Health on Social Media, among the top 50 pharmaceutical companies, more than half do not engage with consumers or patients through social media on healthcare-related topics. The top 3 pharma companies in this regard are: Johnson & Johnson, GlaxoSmithkline (GSK), and Novo Nordisk.

Thus, in the pharma industry, the old tradition, by and large, prevails. This scenario, I reckon, signals a pressing need to recompose the notes of the pharma marketing playbook, in general, and very soon.

B. Studying the future digital trends and customize:

To find out about what digital trends to expect in future, the February 2006 survey by the Economist Intelligence Unit had asked survey takers and executives about the online trends they learned during the previous 12 months from their children or other young people. The top three new trends came out as follows:

Social networking,
Podcasting
Multi-player video games

These are just examples, individual pharma marketers would need to take calls about the relevance of specific digital tools and trends relevant to their business and customize them accordingly.

C. Two important marketing tactics proposed:

It is becoming quite evident now, across the world, that with the stakeholders-mix and the traditional doctor-focused “push” messaging delivered mainly through a large sales force coverage, are not generating commensurate a return on investments.

While this approach still remains somewhat relevant for the doctors, one needs to find out what is happening to effectively engage the other important stakeholders. For example, what is happening to those patients who are seeking meaningful engagement through various digital platforms for healthcare?

Recently, the Wharton School, Google and McKinsey & Company teamed up to write a new e-book entitled ‘Pharma 3D’, which proposes the following two important marketing tactics:

To reach patients, pharma companies need to leverage broader engagement models through alternative digital channels (including wearable, online, and social media).

Pharma companies can no longer rely solely on their relationships with physicians; they also need to engage with other influencers, like online communities and social networks.

D. Pharma marketing organizations may consider doing 3 things for success:

The authors of ‘Pharma 3D’ suggested that the pharma marketing organizations may consider doing the following three things really well, for success:

They Discover the behaviors, beliefs and needs of the people they are marketing to.
They Design experiences relevant to the people they are marketing to.
They Deliver those experiences consistently, superbly, and efficiently.

Conclusion:

Though Peter Drucker had said long ago that marketing and innovation are two most critical functions of any business and only these two produce business results, in the overall pharma marketing activities a wide gap between the modern marketing realities and the current marketing practices still exist, rather glaringly.

It is true that digital tools are now being selectively used by some pharma companies, these largely fall in the area of digitizing the manual functions, with some add on gimmickry, and glamor quotient built into it.

In my view, pharma companies, especially in India, should no longer rely solely on building relationships with the physicians. Their top marketers also need to directly engage with all other crucial influencers, including the expert groups, online communities, and the social media, whenever required, leveraging the broader stakeholder engagement models.

The old pharma marketing playbook is slowly, but surely going out of sync with the stark market realities of date. So are the mindsets of a large section of the pharma marketers. It is now high time for the top management to create an appropriate marketing organization, and then encourage it composing the new notes for a contemporary, and a more relevant marketing playbook, jettisoning the old one, for good.

By: Tapan J. Ray

Pharma Innovation Absolutely Critical: But NOT Shorn from Ethics, Propriety, Compliance and Values

Posted on May 20, 2013 by Tapan Ray

Significant value added innovation is the bedrock of progress of the pharmaceutical industry and is essential for the patients. This is a hard fact.

However, this current buzzword – ‘innovation’ can in no way be shorn from soft business necessities like, ethics, propriety, compliance and values… not just for longer term sustainability of business, but more in the larger interest of patients and patient groups.

Most importantly, ‘ethics, propriety, compliance and values’ are not meant for mere display in the corporate websites like, any other business showpieces. These should neither be leveraged to create a false positive impression in the minds of the stakeholders with frequent PR blitzkriegs.

The creators of these soft ‘X factors’ are now being increasingly hauled up for gross violations of the same by the Governments in various parts of the world .These are not just legal issues. The net impact of all such acts goes much beyond.

In this article, I shall deliberate on these continuing and annoying issues both in global and local perspectives, quoting relevant examples at random.

The sole purpose of my argument is to drive home that all such repeated gross violations, as reported in the media, go against patients’ interests, directly or indirectly. None of these incidents, in any way, can be negated with stories of great innovations or with any other make of craftily designed shields.

Under increasing scrutiny in the developed world:

Ethics, propriety and business value standards of big pharma, besides various types of legal compliance, are coming under increasing stakeholders’ scrutiny, especially in the developed markets of the world.

Very frequently media reports from across the world, highlight serous indictments of the Government and even judiciary for bribery, corrupt business practices and other unbecoming conduct, aimed at the the global mascot for healthcare.

It is indeed flabbergasting to note that more and more corporates, with all guns blazing at the same time, publicize with equal zest various initiatives being taken by them to uphold high ethical standards and business practices, if not propriety, as the juggernaut keeps on moving forward, unabated.

The scope of ‘ethics and propriety’:

The scope of ‘ethical business conducts, propriety and value standards’ of a company usually encompasses the following, among many others:

The employees, suppliers, customers and other stakeholders

Caring for the society and environment

Fiduciary responsibilities

Business and marketing practices

R&D activities, including clinical trials

Corporate Governance

Corporate espionage

That said, such scope should not be restricted to the top management, but must be allowed to percolate downwards in a structured manner, looking beyond the legal and regulatory boundaries.

Statistics of compliance to ‘codes of business ethics and corporate values’ are important to know, but the qualitative change in the ethics and value standards of an organization should always be the most important goal to drive any corporation and the pharmaceutical sector is no exception.

‘Business Ethics and Values’ in the globalized economy:

Globalization of business makes the process of formulating the ‘codes of ethics and values’ indeed very challenging for many organizations in many ways. This is mainly because, the cultural differences at times create a conflict on ethics and values involving different countries.

For this purpose, many business organizations prefer to interact with the cultural and religious leaders in the foreign countries, mainly to ascertain what really drives culturally diverse people to act in certain ways.

With the wealth of knowledge of the local customs and people, the cultural and religious leaders can help an organization to unify the code of ethics and values of the globalized business.

Such leaders can also help identifying the ‘common meeting ground of minds’ from a specific country perspective, after carefully assessing the cultural differences, which are difficult to resolve in the near term.

The ‘common meeting ground of minds’ within a given society, thus worked out, could form the bedrock to initiate further steps to strengthen global business standards of ethics and values of an organization.

OECD with USA started early enacting ‘Foreign Corrupt Practices Act (FCPA)’:

To prevent bribery and corrupt practices, especially in a foreign land, in 1997, along with 33 other countries belonging to the ‘Organization for Economic Co-operation and Development (OECD)’, the United States Congress enacted a law against the bribery of foreign officials, which is known as ‘Foreign Corrupt Practices Act (FCPA)’.

This Act marked the early beginnings of ethical compliance program in the United States and disallows the US companies from paying, offering to pay or authorizing to pay money or anything of value either directly or through third parties or middlemen. FCPA currently has significant impact on the way American companies are required to run their business, especially in the foreign land.

A dichotomy exists with ‘Grease Payment’:

OECD classified ‘Grease payment’ as “facilitating one, if it is paid to government employees to speed up an administrative process where the outcome is already pre-determined.”

In the FCPA of the US, ‘Grease Payment’, has been defined as “a payment to a foreign official, political party or party official for ‘routine governmental action,’ such as processing papers, issuing permits, and other actions of an official, in order to expedite performance of duties of non-discretionary nature, i.e., which they are already bound to perform. The payment is not intended to influence the outcome of the official’s action, only its timing.”

Many observers opine, ‘Grease Payments’ is an absolute dichotomy to the overall US policy for ethical standards and against corruption.

Currently besides US, only Canada, Australia, New Zealand and South Korea are the countries that permit ‘Grease payments’.

Notwithstanding, the governments of the US and four other countries allow companies to keep doing business without undue delay by making ‘Grease Payments’ to the lower government officials, such payments are considered illegal in most other countries, in which they are paid, including India.

In India such a business practice is viewed as bribery, which is not only perceived as unethical and immoral, but also a criminal offense under the law of the land. Even otherwise, right or wrong, ‘Grease Payments’ are viewed by a vast majority of the population as a morally questionable standard of ‘business conduct’.

Many companies are setting-up the ethical business standards globally:

While visiting the website of especially the large global and local companies, one finds that all these companies, barring a very few exceptions, have already put in place a comprehensive ‘code of business ethics and values’. Some of these companies have also put in place dedicated code compliance officers across the globe.

‘Practice as you preach’:

Despite all these commendable initiatives towards establishing corporate codes of business ethics and values, the moot question that keeps haunting many times and again: “Do all these companies ‘practice what they preach’ in real life?”

Instances are too many for breach in ethics, propriety and value standards:

The media is now increasingly reporting such instances of violations both locally and globally.

Some Indian examples: (At random, not in a chronological order)

Criminal drug regulatory manipulation:

One of India’s top pharma players reportedly will pay a record fine of US$ 500 million in the US for lying to officials and selling badly made generic drugs.

The company has pleaded guilty to improper manufacturing, storing and testing of drugs, closing a year long civil and criminal investigation into the matter.

Compensation for deaths related to Clinical Trials not paid:

In 2011 the Drug Controller General of India (DCGI) reportedly summoned nine pharma companies on June 6 to question them on the amount of compensation they have decided to pay the ‘victims of their clinical trials’, which is a mandatory part of any clinical trial, or else all other trials of these nine companies going on at that time or yet to start, will not be allowed.

Clinical Trial is another area of pharmaceutical business, especially in the Indian context, where more often than not, issues related to ethics and values are being raised. In an article titled, ‘Clinical trials in India: ethical concerns’ published by the World Health Organization (WHO) following observations have been made:

“The latest developments in India reflect a concerted effort on the part of the global public health community to push clinical trials issues to the fore in the wake of several high-profile cases in which pharmaceutical companies were shown to be withholding information from regulators.”

Alleged marketing malpractices:

In 2010, the Parliamentary Standing committee on Health reportedly expressed concern that the “evil practice” of inducement of doctors by the pharma players continues.

Congress MP Jyoti Mirdha sent a bunch of photocopies of air tickets to Prime Minister Manmohan Singh to claim that doctors and their families were ‘beating the scorching Indian summer’ with a trip to England and Scotland, courtesy a pharmaceutical company.

30 family members of 11 doctors from all over the country reportedly enjoyed the hospitality of the concerned company.

Department of Pharmaceuticals reportedly roped in the Revenue Department under Finance Ministry to work out methods to link the money trail to offending companies.

Some global examples: (At random, not in a chronological order)

United States Government sues a Swiss pharma major for alleged multi-million dollar kickbacks:

The United States Government very recently reportedly announced its second civil fraud lawsuit against a Swiss drug major accusing the company of paying multimillion-dollar kickbacks to doctors in exchange for prescribing its drugs.

Fraud fines:

Two largest drug makers of the world reportedly paid US$ 8 billion in fraud fines for repeatedly defrauding Medicare and Medicaid in the USA over the past decade.

Denigrating generics:

Another global pharma major reportedly has been recently fined US$ 52.8 million for denigrating generic copies.

Drug overcharging:

Another global drug major reportedly stirred an ethics scandal and paid US$ 499 million towards overcharging the US government for medicines.

Bribing doctors:

A top global pharma player reportedly paid total US$ 60.2 million to settle a federal investigation on alleged bribing overseas doctors and other health officials to prescribe medicines.

Another European pharma group reportedly was fined US$ 3bn after admitting bribing doctors and encouraging the prescription of unsuitable antidepressants to children.

Concealment of important facts:

A judge in USA reportedly ordered a large pharma company to pay more than $1.2 billion in fines after a jury found that the company had minimized or concealed the dangers associated with an antipsychotic drug.

Off-label marketing:

A Swiss pharma major reportedly agreed to pay US$ 422.5 million to resolve an investigation into alleged off-label promotion of a drug, as well as civil allegations relating to five other products.

The U.S. Justice Department reportedly hit an American drug major with a US$ 322 million penalty for illegally promoting a drug before it received approval by the Food and Drug Administration for that condition.

Other illegal marketing practices:

Yet another European pharma group was reportedly fined USD 34 million by a court in the United States for illegal marketing practices for its medicine.

‘Illegal’ Clinical Trials:

It was revealed on May 17, 2013 that global pharmaceutical companies reportedly paid millions of pounds to former communist East Germany to use more that 50,000 patients in state-run hospitals as unwitting guinea pigs for drug tests in which several people died.

All these are some random examples of alleged malpractices associated with ‘ethics, propriety, compliance and values’ in the pharma world, both local and global.

Middle and lower management becomes the ‘fall guy’:

It is interesting to note that whenever, such incidents take place, the fingers are usually pointed towards the middle or lower management cadre of the corporations concerned for violations and non-compliance.

Corporate or top management ownership of such seemingly deplorable incidents still remains confined within a ‘black box’ and probably a distant reality.

Public perception is not encouraging:

In the pharmaceutical sector all over the world, many business practices have still remained very contentious, despite many well-publicized attempts of self-regulation by the industry. The flow of complaints for alleged unethical business practices have not slowed down either, across the world, even after so many years of self-regulation, penalty and severe indictments.

Government apathy in India:

Nearer home, the Government apathy, despite being pressured by the respective Parliamentary Committees and sometimes including judiciary in repose to Public Interest Litigations (PIL), has indeed been appalling, thus far.

The Department of Pharmaceuticals of the Government of India has already circulated a draft ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ for stakeholders to comment on it. The final UCPMP, when it comes into force, if not implemented by the pharmaceutical players in its ‘letter and spirit’, may attract government’s ire in form of strong doses of regulatory measures. However, the moot question remains, will the UCPMP come at all?

Similar issues are there in drug regulatory areas falling under the Ministry of Health, especially in the clinical trial area. In this matter, very fortunately Supreme Court has intervened against a Public Interest Litigation (PIL). Thus, one can expect to witness some tangible steps being taken in this area, sooner than later.

Walking the talk:

The need to formulate and more importantly effectively implement ‘Codes of Business Ethics & Values’ should gain increasing relevance in the globalized business environment, including in India.

It appears from the media reports, many companies across the world are increasingly resorting to ‘unethical behavior, impropriety and business malpractices’ due to intense pressure for business performance, as demanded primarily by the stock markets.

There is no global consensus, as yet, on what is ethically and morally acceptable ‘Business Ethics and Values’ across the world. However, even if these are implemented in a country-specific way, the most challenging obstacle to overcome by the corporates would still remain ‘walking the talk’ and owning responsibility at the top.

Conclusion:

Pharmaceutical innovation will continue to remain the launch pad for the industry growth in the battle against diseases of all types, forms and severity. However, that alone should in no way deserve to receive encouragement from any corner shorn from Ethics, Propriety, Compliance and Values.

Balancing pharmaceutical innovation with Ethics, Propriety, Compliance and Values, I reckon, will in turn help striking a right balance, to a considerable extent, between pharmaceutical innovation and public health interest for everyones’ satisfaction, mostly the patients.

Being equipped with the wherewithal to bring new drugs for the global population and being the fundamental source of growth momentum for the generic drug industry of the world, the innovator companies are expected to lead by setting examples in this area too. After all, as the saying goes:

“Caesar’s wife ought to be above suspicion. ‥Caesar himself ought to be so too”.

By: Tapan J. Ray

A Ten Step Strategy Prescribed

Posted on December 24, 2012 by Tapan Ray

In India, there are various hurdles to address the healthcare issues in a comprehensive way. Though, these do not seem to be insurmountable, the country needs a clear time-bound grand strategy to squarely address this vexing concern, which also has its consequent socioeconomic fallout.

If we look at the history of development of the industrialized countries of the world, we shall easily be able to fathom that all of them not only had heavily invested, but even now are investing to improve the socioeconomic framework of the country where education and health are the center pieces. Continuous reform measures in these two key areas are proven key drivers of economic growth of any nation.

Just as focus on education is of utmost importance to realize the economic potential of any country, so is the healthcare. It will be extremely challenging for India to realize its dream of becoming one of the economic superpowers of the world, without a sharp strategic focus and significant resource allocation in these two areas.

The World Health Statistics:

As reported by the ‘World Health Statistics 2011′, India spends around 4.2 percent of its Gross Domestic Product (GDP) on health, which is quite in line with other BRIC countries like, China and Russia.This has been possible mainly due to increasing participation of the private players in the healthcare sector and not so much by the government. The following table on ‘Health Expenditure’ will highlight this point:

Type	Brazil	Russia	India	China
Exp. on Health (% of GDP)	8.4	4.8	4.2	4.3
Govt. Exp. on Health(% of Total Exp. on Health)	44	64.3	32.4	47.3
Pvt. Exp. on Health (% of Total Exp. on Health)	56	35.7	67.6	52.7
Govt. Exp. on Health (% of Total Govt. Exp.)	6	9.2	4.4	10.3
Social Security Exp. on Health (% of General Govt. Exp. on Health)	-	38.7	17.2	66.3

Key healthcare goals:

As articulated in a recent paper titled ‘Meeting the Challenges of Healthcare Needs in India: Paths to Innovation’, the key healthcare goals of any country have been described as follows:

Improved quality of care and population health as measured by life expectancy and other measures of wellness

Cost containment and pooled risk-sharing by the population to allow financial access to care as well as avoid catastrophic ruin
Provide access to care in an equitable manner for all citizens

Specifically to India one of the key challenges to healthcare is ‘Universal Access’ to care and health equity. However, in terms of pure concept the country has a universal healthcare system, where theoretically any citizen is entitled to avail the public health facilities irrespective of socioeconomic status. Unfortunately, the reality is far out of the line.

Health is a ‘State subject’:

In Indian system, health is primarily a state subject and the Central Government deals with:

Health related policies
Health related regulations
Initiatives related to identified disease prevention and control

Whereas, each state needs to take care of:

Healthcare administration
Healthcare delivery
Healthcare financing
Training of personnel related to healthcare

The system:

Primary Health Centers (PHCs) of India located in the cities, districts or rural villages are expected to provide medical treatment free of cost to the local citizens. The focus areas of these PHCs, as articulated by the government, are the treatment of common illnesses, immunization, malnutrition, pregnancy and child birth. For secondary or tertiary care, patients are referred to the state or district level hospitals.
The public healthcare delivery system is grossly inadequate and does not function, by and large, with an optimal degree of efficiency, though some of the government hospitals like, All India Institute of Medical Science (AIIMS) are among the best hospitals in India.

Most essential drugs, if available, are dispensed free of cost from the public hospitals/clinics. Outpatient treatment facilities available in the government hospitals are either free or available at a nominal cost. In AIIMS an outpatient card is available at a nominal onetime fee and thereafter outpatient medical advice is free to the patient.

However, the cost of inpatient treatment in the public hospitals though significantly less than the private hospitals, depends on the economic condition of the patient and the type of facilities that the individual will require. The patients who are from Below Poverty Line (BPL) families are usually not required to pay the cost of treatment. Such costs are subsidized or borne by the government.

Private sector is expensive:

That said, in India health facilities in the public sector being inadequate, generally under-staffed and under-financed, a large section of population still does not have access to affordable modern healthcare. As a result, more often than not, common patients are compelled to go to expensive private healthcare providers. Majority of the population of India cannot afford such high cost private healthcare, though comes with a much better quality.

Thus, as things stand today the public sector actually provides just about 20% of actual care services. The balance is catered by the private sector.

A great potential:

A 2012 report on ‘Indian Healthcare Industry’ indicates that in 2010 the size of the industry was around US$ 50 billion and is expected to register a turnover of US$ 140 billion in 2017 with a CAGR of 15 percent. This growth momentum, despite all these, positions India as one of the most lucrative markets within the developing countries of the world. On a global perspective as well, healthcare industry is one of the fastest growing segments clocking a turnover of US$ 5.5 trillion in 2010.

Growth drivers:

The main drivers of growth for the Indian healthcare industry are considered as follows:

Second highest growing economy in the world
Changing demographic profile
Increasing disposable income
Higher incidence of Non-infectious Chronic Diseases (NCD)
New investment avenues
A large talent pool
Cost-effective human resource

Besides above, other growth drivers are as follows:

Increased penetration of pharmaceuticals in the rural markets
Increased export potential for low cost and high quality generic pharmaceuticals, as a large number of patents are going to expire in the next 5 years
Emergence of various health cities and also single specialty clinics offering quality healthcare
Health insurance portability is expected to increase the penetration of insurance, improve quality of service and raise competition among insurers to retain customers
Telemedicine: E-healthcare in rural areas is gaining popularity with the involvement of both
public and private players like, ISRO, Mazumdar Shaw Cancer Center and Narayana Hrudayalaya. Some telecom companies like, Nokia and BlackBerry are also contemplating to extend the use of mobile phones for remote disease monitoring as well as diagnostic and treatment support. Introduction of 3G and in the near future 4G telecom services will
further enhance opportunities of e-healthcare through mobile phones, expanding the field of healthcare.

Promising sectors:

Within the healthcare industry, the most promising sectors are:

Pharmaceuticals
Hospitals and Nursing Homes
Medical equipment
Pathological labs and other diagnostic service providers

According to the Investment Commission of India, the healthcare sector of the country has registered a robust CAGR of over 12 percent during the last four years and the trend is expected to be ascending further.

Quite in tandem, other important areas of the healthcare sector, besides pharmaceuticals, have also recorded impressive performance as follows:

Areas	Growth %
Hospitals/Nursing Homes	20
Medical Equipment	15
Clinical Lab Diagnostics	30
Imaging Diagnostics	30
Other Services (includes Training & Education; Aesthetics & Weight loss; Retail Pharmacy, etc.)	40

Government initiatives:

On its part, the Indian government is also in the process of giving a thrust to the healthcare sector as a whole by:

Increasing public expenditure on healthcare from 1 percent to 2.5 percent of GDP in the 12th Five Year Plan Period
Encouraging public-private partnerships (PPP) in hospital infrastructure and R&D
Encouraging medical tourism
Attracting Indian and foreign players to invest in Tier-II and Tier-III cities with huge untapped market potential. For example:

- Expansion of major healthcare players in tier-II and tier-III cities of India like, Apollo, Narayana Hrudayalaya, Max Hospitals, Aravind Eye Hospitals and Fortis

- BCG Group will reportedly open shortly a multidisciplinary health mall that would provide a one-stop solution for all healthcare needs starting from doctors, hospitals, ayurvedic centers, pharmacies including insurance referral units at Palarivattom in Kochi, Kerala.

BCG’s long-term plan, as reported in the media, is to set up a health village spanning across an area of a 750,000 sq. ft. with an estimated cost of US$ 88.91 million. Along the same line, to set up more facilities for diagnostic services in India, GE Healthcare reportedly has planned to invest US$ 50 million for this purpose

Introduction of the ‘National Commission for Human Resources for Health Bill 2011( NCHRH Bill 2011)’, which will bring all independent bodies like the Medical Council of India (MCI), the Dental Council of India (DCI), the Pharmacy Council of India (PCI) and the Nursing Council of India (NCI) under a centralized authority for a more cohesive action.

Attracting FDI:

According to the Department of Industrial Policy & Promotion (DIPP), the healthcare sector is undergoing significant transformation and attracting investments not only from within the country but also from overseas.

The Cumulative FDI inflow in the healthcare sector from April 2000 to October 2012, as per DIPP publications, is as follows:

Sector	FDI inflow (US$ million)
Hospital and diagnostic centers	1482.86
Medical and surgical appliances	571.91
Drugs and pharmaceuticals	9775.03

(Source: Fact Sheet on FDI – April 2000 to October 2012, DIPP)

Job creation:

The trend of new job creation in the healthcare sector of India is also quite encouraging, as supported by the following facts:

The Healthcare sector in India recorded a maximum post-recession recruitment to a total employee base of 36, 21,177 with a new job creation of 2, 73, 571, according to ‘Ma Foi Employment Trends Survey 2012’.

Despite slowdown in other industries, in the healthcare sector the new job creation continues at a faster pace.

With many new hospital beds added and increasing access to primary, secondary and tertiary / specialty healthcare, among others, the ascending trend in job creation is expected to continue in the healthcare sectors of India in the years ahead.

A Strategy Prescribed:

Though the report of the High Level Expert Group (HLEG) on the ‘Universal Health Coverage (UHC)’ is already in place, without going into the implementability issues of the report in this article, I would like to propose a ten pronged approach towards a new healthcare reform process to achieve the national healthcare objectives:

1. The government should focus on its role as provider of preventive and primary healthcare to all, through public hospitals, dispensaries and PHCs, including free distribution of essential medicines.

2. In tandem, the government should play the role of enabler to create Public-Private partnership (PPP) projects for secondary and tertiary healthcare services at the state and district levels with appropriate fiscal and other incentives.

3. PPP also may be extended to create a robust health insurance infrastructure urgently.

4. The insurance companies will be empowered to negotiate with concerned doctors, hospitals and other organizations, all fees payable by the patients to doctors, hospitals, for diagnostic services etc., including cost of medicines for both inpatients and outpatients treatment, with the sole objective to ensure access to affordable high quality healthcare to all.

5. Create an independent regulatory body for healthcare services to regulate and monitor the operations of both public and private healthcare providers/institutions, including the health insurance sector.

6. Levy a ‘healthcare cess’ to all, for effective implementation of this new healthcare reform process.

7. Effectively manage the corpus thus generated to achieve the healthcare objectives of the nation through the Healthcare Services Regulatory Authority (HSRA).

8. Make HSRS accountable for ensuring access to affordable high quality healthcare to the entire population of the country together with a grievance redressal mechanism.

9. Make HSRS accountable, its operation transparent to the civil society through HSRS website and cost-neutral to the government, through innovative pricing model based on economic status of an individual.

10. Allow independent private healthcare providers to make reasonable profit out of the investments made by them

Conclusion:

All the ten steps prescribed as above, will help ensure a holistic approach to healthcare needs of India and reduce prevailing socioeconomic inequalities within the healthcare delivery systems of the country.

Rapidly growing urban centric five-star private healthcare initiatives are welcome but these are now just catering to the privileged few, perpetuating the pressing healthcare issues unanswered.

Only a well-orchestrated, comprehensive, time-bound and holistic approach is capable of addressing the humongous healthcare needs of India and at the same time providing much required growth momentum to the Indian healthcare industry, positioning India as one of the most lucrative healthcare hubs within the emerging economies of the world.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion and also do not contribute to any other blog or website with the same article that I post in this website. Any such act of reproducing my articles, which I write in my personal capacity, in other blogs or websites by anyone is unauthorized and prohibited.

Hysteria on Corporate Lobbying in India

Posted on December 17, 2012 by Tapan Ray

The ‘hysteria’ on ‘Corporate Lobbying’ influencing the key policy decisions of India, reverberated in the corridors of power of the Indian Parliament last week with consequent media attraction and triggering a raging public debate.

On Monday, December 10, 2012 the Upper House of the Indian Parliament reportedly expressed itshuge concern over a lobbying disclosure in the United States related to a contentious government policy decision India.

Taking part in the debate a distinguished Member of the Parliament and an eminent lawyer Mr.Ravishankar Prasad reportedly articulated, “Lobbying is illegal in India and is a kind of bribe. If Wal-Mart has said that hundreds of crores of rupees were spent on India, then it is a kind of bribe.Government should tell who was given this bribe.”

Responding to the opposition demand on this subject, the Government has already ordered a judicial probe on this allegation.

Corporate Lobbying:

The term ‘Lobbying’ has been defined as “a form of advocacy with the intention of influencing decisions made by the government by individuals or more usually by Lobby groups; it includes all attempts to influence legislators and officials, whether by other legislators, constituents, or organized groups”.

April 21, 2012 edition of ‘The Economist’ in an article titled. “The Chamber of Secrets - The biggest business lobby in the United States is more influential than ever”, reported that ‘Americas first chamber of commerce was founded in Charleston in 1773.

Many a times the key issues of corruption, morality and ethics are being used with ‘lobbying’ activity. However, following two different perceptions remain generally associated with this terminology:

Corporates or people with mighty socioeconomic power, by themselves or through their industry bodies, corrupt the laws to serve a self-serving agenda by bending or deflecting them away from general fairness to majority of the population.
It gives an opportunity to defend minority interest against corruption and tyranny of the majority.

An article published in the ‘The Washington Post’ on August 14, 2011 argued that “Blame for financial mess starts with the corporate lobby” in America.

In a recent book titled, “Time to Start Thinking – America and the Specter of Decline”, the author described how the big money in America has almost completely bought over the political process along with a pen picture of the organized lobbying group continuing to wield their mighty power despite reported ban of this activity in the ‘White House’ by President Barrack Obama.

Lobbying is legal in many countries:

It is worth mentioning that lobbying is a legal activity in many countries, such as, the United States of America, Europe and Canada. In the US, many Indian companies, including the government of India have been lobbying since so many years to present their cases and argument with the American law and policy makers.

When President Obama came to power in the US, it was reported: ‘one of the first acts of the Obama administration in office was to have an executive order which prohibited the Obama Administration either from hiring lobbyists – those who had lobbied within two years of joining the administration or allowing people who had left the Obama administration to service lobbyists for two years. The idea is that you want to break the chains where there is undue influence of special interest groups upon the government’.

‘Disclosure’ required in the US:

In the US, lobbying being recognized as a legitimate business activity, the companies are required to inform all such activities through quarterly disclosure reports to the US Senate.

In America, in 2012 alone and only in Washington DC there were reportedly 12,016 active registered lobbyists, who spent a whopping US$ 2.45 Billion for lobbying activities . Similarly, as per publishedreports, there are currently an estimated 15,000 individual lobbyists and 2,500 lobbyist organizations in Brussels to seek favorable business decisions through the legislative process of the European Union.

It has been reported that in the U.S. lobbying is a huge and established industry. This is quite contrary to Indian situation, where lobbying has not been legalized and the activity, going by general perception, ‘smacks of illegal gratification and is ravished by corruption scandals like 2G scams”.

Indian corporates also lobby in the US:

Records with the US House of Representatives reportedly show that around 27 Indian companies have spent money on lobbying in the US. Some examples are as follows:

Reliance Industries (RIL): Unspecified issue
Tata Sons:
Ranbaxy Lab,
The National Association of Software and Service Companies (Nasscom )
Wipro
Gems and Jewellery Export Promotion Council, among others.

Some sensational recent reports:

Following are some sensational recent reports on Corporate Lobbying:

The ‘Pharma Letter’ in its in its March 29, 2012 edition reported that “New research reveals that the pharmaceutical industry lobby is spending more than 40 million Euros (US$ 53.5 million) annually to influence decision making in European Union.”

Back home ‘Live Mint (The wall Street Journal)’ reported on October 6, 2011 as follows:

“Wal-Mart has disclosed earlier, “discussion related to India FDI (Foreign Direct Investment)” as one of the issues in its lobbying with the US lawmakers in the first two quarters of 2011, during which it spent nearly US$ 4 million on various lobbying activities.”

On December 13, 2012, ‘The Telegraph‘ reported that in a recent regulatory disclosure in the United States, Walmart has stated that it spent US$ 25 million in the last four years on lobbying for, among other its hopes for “enhanced market access for investment in India”.

Not legalized in India:

As stated above, though Lobbying is considered a legal business activity in many countries, in India it is still not considered as a legally and recognized business activity. However, many industrial sectors have formed their respective associations primarily for lobbying with the government, which is generally termed as ‘advocacy’.

A recent article published in the India Law Journal titled, ‘Corporate Lobbying and Corruption-Manipulating Capital’ articulates that “lobbying is the preferred means for exerting political influence in developed countries and corruption the preferred one in developing countries. However, lobbying and corruption are symbiotic in nature as both are ways of obtaining help from the public sector in exchange for favors.”

The article further states that corporate lobbying or advocacy has expanded in India mostly as intensive briefings and presentations to the ministers and senior bureaucrats, though it is not yet recognized in a statutory or non-statutory form in the country.

Thus, right from the debate on Bofors Guns to the telephone tapes of high profile lobbyist Niira Radia related to 2G telecom scam and then Tatra trucks scam of the Indian Army and now on Walmart debate in the Parliament, one gets a clear feel that corporate lobbying falls in a grey zone under the Indian law.

Difference between ‘Lobbying’ and ‘Advocacy’:

According to the article titled, ‘Lobbying and Advocacy—Similarities and Differences, published by Charity Lobbying for the Public Interest’, when nonprofit organizations advocate on their own behalf, they seek to positively affect majority of the society, whereas lobbying refers specifically to advocacy efforts that attempt to influence policy or legislation of a country by interested groups, irrespective of its best outcome to the society.

More debate:

In a very recent reported debate published on December 15, 2012 titled, “Is lobbying an acceptable business practice? “, one distinguished professional said, ‘While lobbying can be considered routine, the response to it should not be, as it can be deeply harmful to our country’.

In the same debate, another equally distinguished person commented, ‘Lobbying may be a legitimate activity subject to strict regulatory oversight in the US. But in India, it a sophisticated alibi for the more brazen bribe-giving, what with cash still ruling the roost with its subterranean links lubricating all sections of the economy.”

More controversy:

Not so very long ago, some consumer activists from the civil society vehemently protested against the ‘Intellectual Property Conferences’ held in India, which were allegedly sponsored by some interested groups in a guise to influence the policy makers and the judiciary of India.

It was widely reported that the consumer activists viewed these IP summits, organized by the George Washington University Law School of USA as ‘attempts to influence sitting judges on patent law enforcement issues that are pending in Indian courts.’

In a letter dated February 26, 2010 addressed to Shri Anand Sharma, Minister of Commerce and Industry of India, over 20 NGOs demanded transparency and more information on such meetings and wanted the government of India ‘to put a stop to such industry sponsored lobbying with Indian judges and policymakers to promote their own requirements for intellectual property and to lobby for either law amendments or even to plead their cases currently pending before, various courts and the Indian Patent Office.”

In raising their concerns, the civil society groups argued that the posture adopted by the lobbyists and their supporters is to “force India to adopt greater standards” of IP protection “beyond the mandatory levels” required by the WTO, which may ‘go against public health interest of India’.

The need for a middle path:

In the current volatile scenario, it is quite reasonable to expect that lobbying activities in India, especially after the current uproar in the Parliament, may come under greater scrutiny both by the media and the government. The intervention of the courts against ‘Public Interest Litigation (PIL)’ cannot also be ruled out.

However, it is also believed by many that long-term interest of India is expected to ultimately prevail in this closely watched raging debate with the acceptance of a middle path.

A strong argument in favor of lobbying/advocacy:

As stated above, there is also a strong argument in support of lobbying or advocacy, based on the following grounds:

In a democratic country like India, people from across the spectrum, including the industries and its associations, should have the right to convey their views to policy makers.
Lobbying should be regarded as a “fundamental basis to express a point of view”, industry included.
Trying to influence the government is a natural process by all, including the civil society, other stakeholders and the industry alike.

Regulating lobbying activities – An option:

Considering the fast changing environment and arising out of some recent very sensational lobbying related financial/policy scams in India, as mentioned above, the moot question, as is being raised by many across the country is: “Should the government regulate lobbying activities in the country with appropriate regulations?”

Surrogate lobbying:

The instances of ‘surrogate lobbying’ by the industries with funds coming from various parts of the world are also being raised by the civil society, media and recently by the Government. The contentious issue became the subject of a heated debate related to ‘Kudankulam Nuclear Power Plant’ in Tamil Nadu.

In February 2012, Prime Minister Manmohan Singh’s reportedly charged that foreign NGOs for stoking protests with foreign funds at the ‘Kudankulam Nuclear power Plant’ for vested interests and ordered further investigation by the Ministry of Home Affairs to track the trails of funds.

As a result of all these developments, the Government is reportedly becoming increasingly more vigilant against direct or indirect ‘foreign hand’ through surrogate lobbying in the policy related issues of the country, against majority interest of the society. The ‘Walmart saga’ is a case in point, at this stage.

Industry observers have opined, probably many other forms of surrogate lobbying are currently operational in India, which needs to be thoroughly probed and in case of any illegal activity, the perpetrators must be brought to justice, sooner than later, whether it is related to ‘Kundamkulam Nuclear Power Plant’ or any other .

Examples of political fall-out of lobbying activities:

On June 1, 2012, FiercePharma reported as follows:

“The cat is out of the bag so to speak with the disclosure of memos today detailing the level of drug industry support for passage of President Obama’s prized healthcare reform”

It continued to state, “Big Pharma came around to support the original bill, trading about $80 billion in additional taxes and some price rebates to federal programs for an expanded pool of insured.”

Back home in India, The Outlook Magazine reported on June 6, 2010 on the political fall-out of lobbying related to 2G telecom spectrum allocation scam in India as follows:

“Since Outlook published extracts from the CD of Radia’s phone conversations (submitted to the court) taped by the I-T department and put the 140 conversations up on its website, there has been a raging debate on what they tell us about the role of lobbyists in the 2G spectrum allocation scam, how the media interplays in such a system, and how our political class and retired bureaucrats are more often than not willing partners in the game.”

“These debates do not detract from the aim of punishing the guilty behind the 2G scam; rather they raise disturbing questions we all have to answer. Who is this woman who can speak to the “highest and mightiest” in this country in this way? From where does she draw her power? And what does it tell us about our society? When ‘Outlook’ asked her, whether she would like to give her version of these recent events, Radia SMSed back: “No. Thank You.” This is her story..”

Conclusion:

Despite a long history of regulated and legalized lobbying in the US, there are still severe criticisms even in that country about the way lobbying activities have worked there in the past so many decades. India has plenty to learn from such experiences.

In the prevailing situation within India many experts often question, whether the economic/ other critical policy decisions of the country are mostly based on what the local population would require or depend on the money power of vested interests or business houses within and outside the country to influence such decisions.

To eliminate any possibility of illegal gratification, directly or indirectly or in any other manner or form, the process of lobbying or advocacy should be made absolutely transparent for all through appropriate rules and regulations, legally acceptable lobbyists and an appropriate disclosure mechanism for all such related expenses, just as exists in the United States of America.

In absence of these transparent and robust measures, lobbying or advocacy will continue to be perceived not just as an illegitimate activity, but also an ignoble and dubious profession in the eyes of majority living in India.

The fantastic vocabulary of ‘Good Governance’ should not be used just for others to practice. It is a time to ‘walk the talk’ for all stakeholders, including the government to douse histrionics of various kinds like, what happened last week on ‘Corporate Lobbying in India’.

By: Tapan J Ray

A NEW Study on Ballooning Pharma R&D Cost: Exploring a Sustainable Model for Greater Patients’ Access

Posted on December 10, 2012 by Tapan Ray

The high-decibel debate on increasing prices for patented drugs affecting patients’ access to innovative medicines gets a new fuel. A brand new study dated December 2012 carried out by the Office of Health Economics (OHE), UK, which was partly supported by a grant from AstraZeneca, estimated that the cost of developing new medicine has risen by ten times from US$100 million in the 1970s to as high as US$ 1.9 billion in 2011.

The study identifies the following key reasons for a galloping increase in the cost of research and development:

Inflation-adjusted investments
Sharp increase in the rate of failure
Stringent regulatory demands together with scientific complexity
Longer time for clinical development
Significant increase in the cost of capital

Another recent study goes even beyond:

Many experts have gone even further on this subject, arguing that pharmaceutical R&D expenses are over stated and the real cost is much less.

An article titled “Demythologizing the high costs of pharmaceutical research”, published by the London School of Economics and Political Science in 2011 indicates that the total cost from the discovery and development stages of a new drug to its market launch was around US$ 802 million in the year 2000. This was worked out in 2003 by the ‘Tuft Center for the Study of Drug Development’ in Boston, USA.

However, in 2006 the same figure increased by 64 per cent to US$ 1.32 billion, as reported by a pharmaceutical industry association. Maintaining similar trend, if one assumes that the R&D cost will increase by another 64 per cent by 2012, the cost to bring a new drug to the market through its discovery and development stages will be around US $2.16 billion. This will mean a 2.7 times increase from its year 2000 estimate, the article articulates.

The important caveat:

The authors also mentioned that the following factors were not considered while working out the 2006 figure of US$ 1.32 billion:

The tax exemptions that the companies avail for investing in R&D.
Tax write-offs amount to taxpayers’ contributing almost 40% of the R&D cost.
The cost of basic research (should not have been included), as these are mostly done in public funded universities or laboratories.

The article commented that ‘half the R&D costs are inflated estimates of profits that companies could have made if they had invested in the stock market instead of R&D and include exaggerated expenses on clinical trials’.

The authors alleged that “Pharmaceutical companies have a strong vested interest in maximizing figures for R&D as high research and development costs have been the industry’s excuse for charging high prices. It has also helped generating political capital worth billions in tax concessions and price protection in the form of increasing patent terms and extending data exclusivity.”

The study concludes by highlighting that “the real R&D cost for a drug borne by a pharmaceutical company is probably about US$ 60 million.”

A positive side of the story:

The book titled “Pharmaceutical R&D: Costs, Risks, and Rewards”, published by the government of USA states that the three most important components of R&D investment are:

Money
Time
Risk

Money is just one component of investment, along with a long duration of time, to reap benefits of success intertwined with a very high risk of failure. The investors in the pharmaceutical R&D projects not only take into account how much investment is required for the project against expected financial returns, but also the timing of inflow and outflow of fund with associated risks. It is thus quite understandable that longer is the wait for the investors to get their return, greater will be their expectations for the same.

This publication also highlights that the cost of bringing a new drug from ‘mind to market’ depends on quality and sophistication of science and technology involved in a particular R&D process together with associated investment requirements for the same. In addition, regulatory demand to get marketing approval of a complex molecule for various serious disease types are also getting more and more stringent, significantly increasing their cost of clinical development simultaneously. All these factors when taken together make the cost of R&D not only very high, but unpredictable too.

Thus to summarize from the above study, high pharmaceutical R&D costs involve:

Sophisticated science and technology dependent high up-front financial investments
A long and indefinite period of negative cash flow
High tangible and intangible costs for acquiring technology with rapid trend of obsolescence
High risk of failure at any stage of product development

The ground reality: R&D productivity is going south

That pharmaceutical R&D productivity is fast declining has been vindicated by ‘2011 Pharmaceutical R&D Factbook’ complied by Thomson Reuters, the key highlights of which are as follows:

21 new molecular entities (NMEs) were launched in the global market in 2010, which is a decrease from 26 NMEs of the previous year.
2010 saw the lowest number of NMEs launched by major Pharma players in the last 10 years
The number of drugs entering Phase I and Phase II clinical trials fell 47% and 53% respectively during the year.

According to findings of the latest review of ‘Pharmaceutical R&D returns performance’ by Deloitte and Thomson Reuters of December 2012, the R&D Internal Rate of Return (IRR) of leading pharmaceutical companies has fallen for a second successive year to 7.2 percent in 2012 from 7.7 percent in 2011.

High cost of failure:

By challenging the status quo, Andrew Witty, the global CEO of GlaxoSmithKline (GSK) in his speech in Mumbai on September 27, 2011 to the members of the Indian pharmaceutical industry commented that the cost of over a billion dollar to bring a new molecule to the market through its discovery and development stages is “unacceptable.” He attributed such high R&D expenses to the ‘cost of failure’ by the industry.

Witty said, “High in-house failure rates are slowing progress on pricing affordability… We need to fail less and deliver more”.

He commented during his deliberation that success in reducing the R&D cost to make innovative drugs more affordable to the patients of all income levels, across the globe, will be the way forward in the years ahead.

Conventional thinking and an unsustainable model:

Research scientists have already articulated that sharp focus in the following areas may help containing the R&D expenditure to a great extent and the savings thus made, in turn, can fund a larger number of R&D projects:

Early stage identification of unviable new molecules and jettisoning them quickly
Newer cost efficient R&D models, like one implemented by GSK
Significant reduction in drug development time.

Unfortunately, sustainability of the above model still remains a wishful thinking and a question mark to many for various other reasons.

Exploring a seemingly ‘Sustainable Model’:

Should Pharmaceutical R&D move from the traditional models to a much less charted frontier?

Perhaps towards this direction, in November, 2010 a report of Frost & Sullivan titled, “Open Source Innovation Increasingly Being Used to Promote Innovation in the Drug Discovery Process and Boost Bottom-line”, underscored the urgent need of the global pharmaceutical companies to respond to the challenges of high cost and low productivity in their respective Research and Development initiatives, in general.

‘Open Innovation’ model, they proposed, will be most appropriate in the current scenario to improve not only profit, but also to promote more innovative approaches in the drug discovery process. Currently, on an average it takes about 8 to 10 years to bring an NCE/NME to market with a cost of around U.S$ 1.9 billion.

The concept of ‘Open Innovation’ is being quite successfully used by the Information Technology (IT) industry since nearly three decades all over the world, including India. Web Technology, the Linux Operating System (OS) and even the modern day ‘Android’ – the open source mobile OS, are excellent examples of commercially successful ‘Open innovation’ in IT.

In the sphere of Biotechnology Human Genome Sequencing is another remarkable outcome of such type of R&D model.

On May 12, 2011, in an International Seminar held in New Delhi, the former President of India Dr. A.P.J. Abdul Kalam commented, “Open Source Drug Discovery (OSDD) explores new models of drug discovery”. He highlighted the need for the scientists, researchers and academics to get effectively engaged in ‘open source philosophy’ by pooling talent, patents, knowledge and resources for specific R&D initiatives from across the world. In today’s world ‘Open Innovation’ in the pharmaceutical R&D has a global relevance, especially, for the developing world of many ‘have-nots’.

‘Open Innovation’:

As the name suggest, ‘Open Innovation’ or the ‘Open Source Drug Discovery (OSDD)’ is an open source code model of discovering a New Chemical Entity (NCE) or a New Molecular Entity (NME). In this model all data generated related to the discovery research will be available in the open for collaborative inputs. The licensing arrangement of OSDD where both invention and copyrights will be involved, will be quite different from any ‘Open Source’ license for a software development.

In ‘Open Innovation’, the key component is the supportive pathway of its information network, which is driven by three key parameters of:

Open development
Open access
Open source

As stated earlier, ‘Open Innovation’ concept was successfully used in the ‘Human Genome Project’ where a large number of scientists, and microbiologists participated from across the world to sequence and understand the human genes. However, this innovation process was first used to understand the mechanics of proteins by the experts of the biotech and pharmaceutical industries.

Making innovative drugs affordable through ‘Open Innovation’:

The key objective of ‘Open Innovation’ in pharmaceuticals is to encourage drug discovery initiatives at a reasonably cheaper price, especially for Non-infectious Chronic Diseases (NCD) or the dreaded ailments like Cancer, Parkinson’s, Alzheimer, Multiple Sclerosis etc. and also many neglected diseases of the developing countries, to make innovative drugs affordable even to the marginalized people of the world.

Multiple benefits:

According to the above report of Frost & Sullivan on the subject, the key benefits of ‘Open Innovation’ in pharmaceuticals will include:

Bringing together the best available minds to tackle “extremely challenging” diseases
Speed of innovation
Risk-sharing
Affordability

The key barrier: Shared IPR

Industry observers feel that the key barrier to ‘Open Innovation’ is that IPR needs to be shared. Hence, large innovator companies, by and large, have not evinced much commercial interest in this initiative as yet. Other issues for ‘Open Innovation’ model are:

Who will fund the project and how much?
Who will lead the project?
Who will coordinate the project and find talents?
Who will take it through clinical development and regulatory approval process?

However, the experts feel that all these do not seem to be an insurmountable problem at all, as the saying goes, ‘where there is a will, there is a way’.

The Global initiatives on ‘Open Innovation’:

In June 2008, GlaxoSmithKline announced that it was donating an important slice of its research on cancer cells to the cancer research community to boost the collaborative battle against this disease. With this announcement, genomic profiling data for over 300 sets of cancer cell lines was released by GSK to the National Cancer Institute’s bioinformatics grid. It has been reported that over 900 researchers actively contribute to this grid from across the industry, research institutes, academia and NGOs. Many believe that this initiative will further gain momentum to encourage many more academic institutions, researchers and even smaller companies to add speed to the drug discovery pathways and at the same time make the NCE/NME coming through such process much less expensive and affordable to a large section of the society, across the globe.

The Alzheimer Disease Neuroimaging Initiative (ADNI) is another example of a Private Public Partnership (PPP) project with an objective ‘to define the rate of progress of mild cognitive impairment and Alzheimer’s disease, develop improved methods for clinical trials in this area and provide a large database which will improve design of treatment trials’.

Recently announced ‘Open invitation’ strategy of GlaxoSmithKline (GSK) to discover innovative drugs for malaria is yet another example where GSK has collaborated with European Bioinformatics Institute and U.S. National Library of Medicine to make the details of the molecule available to the researchers free of cost with an initial investment of US$ 8 million to set up the research facility in Spain involving around 60 scientists from across the world to work in this facility.

Indian initiative:

In India, Dr. Samir Brahmachari, the Director General of the Council of Scientific and Industrial Research (CSIR) is the champion of the OSDD movement. CSIR believes that for a developing country like India OSDD will help the common people to meet their unmet medical needs in the areas of neglected tropical diseases.

‘Open Innovation’ project of CSIR is a now a global platform to address the neglected tropical diseases like, tuberculosis, malaria, leishmaniasis by the best research brains of the world working together for a common cause.

To fund this initiative of the CSIR the Government of India has allocated around U.S$ 40 million and an equivalent amount of funding would be raised from international agencies and philanthropists.

Conclusion:

Currently pharmaceutical R&D is an in-house initiative of innovator global companies. Mainly for commercial security reasons, only limited number of scientists working for the respective innovator companies will have access to the projects.

‘Open Innovation’ on the other hand, is believed to have the potential to create a win-win situation, bringing in substantial benefits to both the pharmaceutical innovators and the patients.

According to available reports, the key advantage of the ‘Open Innovation’ model will be substantial reduction in the costs and time of R&D projects, which could be achieved through voluntary participation of a large number of Researchers/Scientists/Institutions in key R&D initiatives. This in turn will significantly reduce ‘mind-to-market’ time of more affordable New Chemical/Molecular Entities in various disease areas making innovative medicines affordable to all.

Thus, many experts argue, high prices of new patented drugs, giving rise to low access to majority of patients, at least, in the developing world, should by and large be attributed to high R&D cost. They feel, such ballooning increase in research and development expenditures is commercially unsustainable even in the medium term.

Many thought leaders now believe, despite hard commercial consideration related to IPR, which perhaps has to be amicably sorted out willy-nilly in the long run, ‘Open Innovation’ concept could well be an important commercial model for tomorrow’s global R&D initiatives. This sustainable model would possibly address the issue of improving access to innovative affordable Medicines to a larger number of patients of the world, meeting their unmet medical needs, more effectively and with greater care.

By: Tapan J Ray

PILMAN

A Tapan Ray Website

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