Why Do Drug Companies Now Need More Focus On The 5th “P” Of Marketing?

Posted on March 7, 2022 by Tapan Ray

Astute marketers understand that over several decades, the much-known phraseology – ‘marketing mix’, has remained the bedrock of marketing a product or a service. The ‘Father of Modern Marketing’ - Philip Kotler defined this terminology as the “the set of controllable variables that the firm can use to influence the buyer’s response.” In this context, the controllable variables are referred to as the 4 ‘P’s - Product, Price, Place and Promotion, which remained the basic focus areas in the brand building strategy of pharma marketers, as well.

With an unprecedented transformative impact within the pharmaceutical and biotech industry during the Covid-19 pandemic – for various reasons, ‘purpose’ is fast slotting itself as the 5th fundamental ‘P’ of the marketing-mix. The changing market - triggered by changing customer dynamics, entails the need to clearly define, to the satisfaction of customers, the”purpose” of a business, brand, or service.

As it is increasingly critical to achieve business excellence in the changing paradigm, in this article I will focus on this area from the point of view of goal-oriented pharmaceutical marketing. Although, I wrote before on the need of creating purpose driven brands, this discourse is with a different perspective.

A classic concept gets a fresh impetus in Covid pandemic:

Peter Drucker, whom the Business Week magazine termed as ‘The Man Who Invented Management,’ in 2005, once wrote: “The aim of marketing is to know and understand the customer, so well the product or service fits him and sells itself… The aim of marketing is to make selling superfluous.” I reckon, this vision epitomizes the core concept of ‘purpose driven marketing.’

Understanding ‘purpose driven marketing’:

In an article, published on February 01, 2021, Ad Council wrote that after 22 years – a recent CEO roundtable deliberation decided to amend the definition of ‘purpose-driven marketing.’ The previous one was centered around ‘maximizing shareholder return.’ Whereas the amended one, in addition to serving shareholders, defined ‘purpose-driven marketing’ as ‘a strategy used by an organization to center its external communication efforts around a social cause that aligns with its core values. The goal of purpose-driven marketing is for an organization to develop a deeper rapport with their consumers by creating authentic connections based on shared values.’

This new statement reflected the changing culture in the days before the Covid-19 pandemic, when many people are more vocal about their expectations and spending. For which, they are even switching brand or service preferences in line with their values.

Covid prompts consumers rediscovering the value the industry delivers:

Covid -19 crisis has driven the positive consumer sentiment way up, as people are rediscovering the value the industry delivers to meet their new reckoning. This was also articulated in a related article. This was published in the Fierce Pharma, on August 13, 2020, as the pandemic overwhelmed the world. The same consumer sentiment also gets reflected in a first of its kind global study - ‘The 2020 Zeno Strength of Purpose Study,’ published on June 17, 2020.

The survey was carried out against the backdrop of the Covid-19 pandemic, covering 8,000 consumers across eight countries - United States, Canada, United Kingdom, France, China, India, Singapore, Malaysia. The findings of the research ‘sheds new light and unequivocal proof that the companies leading with Purpose will prevail.’ Vast majority of the respondents ‘have spoken and stand ready to give their hearts, voices and wallets in support of Purposeful brands.’

Especially, the healthcare consumers are now stepping up to stand for something more than hard facts on the features and benefits of products and services – something very meaningful that can influence positive changes in their minds. When it happens, the companies’, in tandem, will also be positively impacted to significantly improve their bottom-lines.

Some key findings of the study:

After in-depth study over 75 brands, the researchers of the above study found that:

94 percent of the respondents value the companies with a strong sense of purpose and are willing to reciprocate through brand loyalty.

They are 4 to 6 times more likely to trust, buy, champion, and protect companies with a strong purpose over weaker ones.

Only 37 percent believe today’s companies are reaching their potential on this front

The paper concluded, ‘it has never been more important for companies to not only articulate their Purpose, but to consistently demonstrate that Purpose – how they operate, support issues and engage with all stakeholders.’ As the above Ad Council article articulated, the above findings also ‘mean that purpose-driven marketing can’t be cosmetic. It must be reflected in every aspect of a brand’s business model and culture, or that brand or organization can expect to be called out for hypocrisy – more on that later.’

Who’s driving the ‘purpose driven marketing?’

As I wrote in my previous article, today’s new generations, such as, Millennials - regarded as ‘digital pioneers,’ and Gen Z – the true digital natives, approach their health care in drastically different ways with new sets of expectations. These are quite different from the members of the Silent Generation, Baby Boomers, or Gen X. As the core concept of ‘purpose driven marketing’ is meeting Gen Z’s one such expectation, this population is regarded as the key driver of ‘purpose driven marketing’, in the pandemic-driven changes in the paradigm of the old normal.

I quoted in the above article, ‘Gen Z people are likely to turn the health industry on its head with their unique expectations for how healthcare should be delivered.’ Moreover, this genre of growing population is slowly but steadily gaining a critical mass to hasten the process of change that pharma marketers should take note of.

According to a paper of the World Economic Forum, published on November 08, 2021, there are 1.8 billion Gen Z around the world, equal to 23% of the global population. Yet, another paper of August 11, 2020, reconfirms that Gen Z comprises 1.8 billion people, making up for almost a quarter of the global population. India stands out with a population that includes 375 million Gen Z people – 27% of the total. Thus, Gen Z and millennial populations are considered at the forefront of shaping this new purpose-driven culture.

The Gen Z populations prefer companies contributing to social causes:

The third annual, international study of Gen Z, conducted by The Center for Generational Kinetics and commissioned by WP Engine, launched on July 07, 2020, reveals some interesting facts. These relate to new expectations for the web by Generation Z in comparison to other generations, including Millennials, Gen X, and Baby Boomers. The findings reiterate, ‘72% of Gen Z are more likely to support a company that contributes to social causes.’ It further emphasized, Gen Z is acutely aware that in today’s digital world, anyone can use their voice to ignite change, and that includes those brands which don’t take explicitly socially responsible stand in their branding strategy. Thus, imbibing ‘purpose driven marketing’ is likely to help pharma players to effectively engage this new breed of the target audience for desired long-term financial returns.

Further, based on the same logic, it is not difficult to fathom that ‘stakeholder-trust’ will also play a pivotal role, while delivering consumer expected value, and demonstrating the purpose driven actions of the business – to the Millennial and Gen Z population.

Stakeholder ‘Trust’ is critical in a value and purpose driven business:

This is a new reality, as vindicated by several recent global surveys that include India too. According to Edelman Trust Barometer 2022, ‘business holds on to its position as the most trusted institution, with even greater expectations due to government’s failure to lead during the pandemic.’ This survey – conducted against the backdrop of the pandemic, involved 36,000+ respondents in 28 global markets, including India to look at how institutions are trusted against the backdrop of the pandemic.

Some key findings of this latest study:

All stakeholders want business to fill the void, with nearly 60 percent of consumers buying brands based on their values and beliefs,

Almost 6 in 10 employees choose a workplace based on shared values and expect their CEO to take a stand on societal issues,

64 percent of investors looking to back businesses aligned with their values.

Most respondents (59 percent) said they tend to distrust until seeing evidence that something is trustworthy,

64 percent believe people in their country lack the ability to have constructive and civil debates.

Technology (74 percent) was the most trusted sector, followed by education (69 percent) and healthcare (69 percent). Social media (44 percent) continued its decline with a 2-point slide, solidifying its spot as the least trusted sector.

While Germany (65 percent) and Canada (65 percent) remained the most trusted country brands, India (36 percent) and China (34 percent) remain the least trusted.

The evolving trend indicates that the new generation, ‘wants to be a part of something bigger than themselves and they are looking to their employers to curate a fulfilling, stimulating and purpose-driven environment,’ as the article underscored. In that sense, ‘purpose-driven marketing’ has also the potential for pharma players to attract the best talents of the new generation. Conversely, it is quite likely that any organizations inability to do so, willingly, or otherwise, could help gather rust, blunting its cutting-edge for performance excellence.

Conclusion:

There isn’t any doubt that Covid-19 pandemic has initiated a paradigm shift in the expectations of the stakeholders, especially the customers and the employees from the companies. They no longer expect the organization just to focus on profit goals. Alongside, most of them also want the employers to focus, in equal measure, stakeholder value, expectation, dignity, besides social purpose and goals.

When a pharma player is seen solving societal issues, e.g., protecting the patient-health in a patient friendly manner, or saving the environment - with concrete, quantifiable measures, it creates a competitive edge for the company, fetching significant business returns from stakeholders. Surly, the pandemic is further augmenting expectations of the growing population of Gen Z – for responsible business operations = driven by value, purpose, and goals of the society – where we live in.

Consequently, it’s now becoming clearer that sustainable business excellence of pharma players can no longer be just on ‘maximizing shareholder’ returns, in terms of profit. Thus, it calls for the purpose-driven marketing, where organizational contribution to society would provide a significant competitive advantage. From this perspective, in my view, the Indian pharma marketers would now need much greater focus on the 5^th ‘P’ of the marketing-mix – more than ever before.

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.

Create Novel Marketing Pathways As Covid Mutants Keep Emerging

Posted on January 10, 2022 by Tapan Ray

The World’s battle against wave after wave unsettling onslaught of Coronavirus on human lives and livelihood continues, since December 2019. The first wave was triggered by the novel Covid-19 from Wuhan in China, the second by its deadly – Delta variant, and now – the third by Omicron. In India, first case of Covid-19 was reported on January 31, 2020.

Initially, global experts contemplated vaccines to prevent and contain Covid-19 and were the best hope for ending the pandemic. However, the effectiveness of existing Covid vaccines apparently declines against its subsequent mutants. This is evident even in India when the next variant Omicron commenced its onslaught.

The good news is, AstraZeneca has now claimed, a third booster shot of its Covid-19 vaccine willsignificantly boost antibody levels against the Omicron variant. However, Omicron may not be the last Covid-19 variant, as it appears today.

As the world grapples with the highly mutated Omicron, scientists have identified another new strain of the COVID-19 causing virus – in Southern France – known as ‘IHU’. This B.1.640.2 variant was reported by researchers at institute IHU Mediterranee Infection in at least 12 cases. However, it is too early to speculate on how this variant behaves as far as infection and protection from vaccines is concerned. This process is likely to take, at least, some more time.

Thus, in the current situation, when increasing numbers of even fully vaccinated individuals are getting re-infected caused by emerging mutants of Covid-19, and some more than once, the focus expanded towards more effective disease treatment. Some countries, such as the US, have decided for the 3^rd booster shot of Covid-19 vaccine. Israel has even gone for the 4^th booster shot of Covid vaccine. Be that as it may, in this fast-evolving scenario, even bright pharma marketers have been experiencing new strategic challenges, as we move on. Against the above backdrop, this article will delve into that space, focusing on some of the new trends of the new normal.

Pharma’s focus expands towards more effective Covid specific treatment:

Visualizing the way Covid-19 pandemic could possibly pan out in the foreseeable future, several global pharma and biotech companies have started focusing on specific treatment for this virus, ensuring speedy patient recovery.

For example, on November 21, 2020, the U.S. FDA issued an emergency use authorization (EUA) for a cocktail therapy of casirivimab and imdevimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients.

Just a month later, on December 22, 2021, the U.S. FDA issued another emergency use authorization (EUA) for Pfizer’s (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use). This was also for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients.

A day after Pfizer’s the first oral COVID-19 treatment, approval, on December 23, 2022, the U.S. FDA issued one more emergency use authorization (EUA) for Merck’s molnupiravir. This is the second antiviral pill authorized in the U.S, for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults. Nearer home, the Drug Controller General of India (DCGI) has also given EUA to Molnupiravir for the treatment of adult patients.

Interestingly, French regulators rejected Merck’s molnupiravir pill for low efficacy. They found other therapies were much more effective than this molecule. Even in India on January 06, 2022, the Indian Council of Medical Research (ICMR) also expressed safety concerns on Molnupiravir. Thus, it has not been included in the national list of Covid treatments in India. That said, such brilliant initiatives by several pharma companies in the battle for saving lives and livelihoods against Covid-19 pandemic, made those companies household names like never before.

Covid made several pharma companies household names, but not brands:

This point was restated in a recent article, published in the Fierce Pharma on December 22, 2021. It emphasized, Covid-19 ‘has brought the words of the pharma industry into people’s lives like never before: Moderna, Pfizer, BioNTech, AstraZeneca and Merck have become household names.’ One may not remember the names of their Covid products, but will mostly know the company.

Many people have now started referring to Covid vaccines and drugs in generic names. As from the very beginning we started hearing people saying, like – I got ‘AstraZeneca Vaccines’, ‘Remdesivir’, or ‘Covid Cocktail therapy’. Company names usually followed the generic names in most cases. Although, ‘that’s been good for pharma’s reputation, but has left marketers in a bind about branding, commented the above article.

Most Covid-19 drugs and vaccine brands are on ‘emergency use approval’

In the Covid dominated year of 2021, drug and biotech companies managed to get USFDA approval for 55 new drugs. However, many of those drugs and vaccines got only Emergency Use Approval (EUA) and only under emergency use basis. This basically means, under EUA these companies did not get full marketing approval and were handicapped to go whole hog with the usual new brand marketing campaigns. This critical issue is expected to remain even in 2022.

In a situation, such as this, when the full scale branding initiatives can’t be undertaken, intenseCorporate Branding Campaigns, I reckon, would pay a rich dividend. This process will be quite different from creative new brand marketing in the old normal. Some global innovator companies are using even the mass media to promote their respective vaccines, albeit differently.

Such promotions include, Open Letter from the Company CEO, creative use of TV shows, messages of the head honchos through twitter or word of mouth campaigns – creating a snowballing effect. Alongside, healthcare marketing professionals are also intensifying their Covid-vaccine ad campaigns, sans brand names, to increase awareness and persuade more people to get vaccinated, soon.

To move in this direction, at least, during EUA period for Covid drugs and vaccines, hybridization of pharma marketing will be necessary in many cases, which won’t be an easy task for all, though.

Hybridization of pharma marketing – necessary – but not an easy task:

Based on experience of almost the last two years, many drug companies have realized that virtual-only customer engagement models have some serious shortcomings to fetch desired outcomes. This issue was studied and well-articulated in an article, published in the Reuters Events on November 30, 2021.

It found: “Virtual-only engagement can make it harder to create a real connection.” Further, as the paper articulated: “Even if HCPs share their video, we are losing the third dimension, hence losing out on parts of that personal component.’ Besides, although, online meetings are flexible regarding timing, if a doctor doesn’t dial-in, there is only a small chance the meeting will happen later that day, unlike waiting in a clinic for the interview to take place.

To address this issue, pharma players are now in various stages of creation and adoption of their respective hybrid marketing models. However, the process offers its own challenges. Working out customer-specific hybrid engagement models are a different ball game altogether- requiring very different skill sets, continuous training and above all a very different mindset.

Conclusion:

As reported on January 06, 2022, rapidly spreading Omicron variant of the novel Coronavirus threatens to rewrite the business recovery timelines, even in India. Even recently, many CEOs and top executives have opined, businesses would have to live with Covid-19 uncertainty. The article further added: ‘Many companies have suspended their return-to-work plans and are reassessing business continuity measures as a third wave of the pandemic starts to surge.’ Most CEOs also expressed one of their top priorities was to ensure Covid-19 protocols were being followed and all employees were safe.

Similar situation arises for all Covid drugs approved under the EUA by the Drug Controller general of India, and are being marketed by Indian companies against non-exclusive voluntary licensing agreements with the innovators. Thus, an analogous marketing issue exists surrounding all such EUAs, as the company concerned can’t undertake a full brand marketing campaign. This constraint is likely to pose a major marketing challenge for several potential Covid blockbuster drugs in India, at least in 2022, which marketers need to overcome, creatively.

From the above perspective of Covid-19 drugs and vaccines, companies would need to create novel and effective strategic pathways for performance excellence. At least, as long as Covid-19 mutants will continue to emerge, causing operational disruptions in the pharma business.

By: Tapan J. Ray

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

Pharma Marketing: The New Normal: Challenges of Change

Posted on June 28, 2021 by Tapan Ray

A lot has changed in healthcare marketing prompted by the Covid pandemic. Apace with these, lots of old problems continue to remain very much the same. The aforesaid was observed in a recent article, published by WARC, on May 21, 2021. Although, this analysis was done in the United States, it has a global footprint, as the disruptions are broadly similar, with a varying degree from country to country.

Healthcare marketing leadership, including the pharma industry in India, presumably, is taking notes of these critical changes, along with their degree of impact. These are the basics for required responses in India, while managing its snowballing effect, both global and local.

Today’s article will provide a bird’s eye view of this area, to encourage marketers continue with their ongoing deep-dive data gathering exercise. Then, comes sieving the ‘catch’ with cerebral power – before using modern analytics to draw meaningful inferences for strategy making.

Some macro-changes stand out:

Some of these widely visible changes, also captured in the above WARC article, include the following:

An emerging trend of re-orientation of the healthcare industry around patient outcomes.

Need to realize that health and safety are the currency that can be used to rebuild consumer trust across categories.

Increasing need to build deeper emotional connections with customers, going beyond product-oriented features, benefits, and intrinsic brand values.

Providing healthcare consumers more data and behavioral science-driven, personalized solutions to their problems – to drive better outcomes.

More people are realizing that: ‘Healthcare, after all, is about life and death, and those stakes have been tragically reaffirmed during the pandemic,’ as the above paper underscores. Thus, affordable “health and safety will continue to be a currency that brands can use to re-establish trust with anxious consumers,” the author reiterates. To steer a company in that direction the marketers need to create a pathway for success by joining several emerging dots in the new normal. Let give just a flavor of these emerging dots with three examples, as below.

‘The end point – the price point’ - re-emerging as a core value expectation:

Interestingly, ‘The end point – the price point’ for quality treatment outcomes is re-emerging as one of the core values and expectations of the consumers, especially facing an uncertain future that everybody is witnessing today. The health system is also transitioning from ‘pay for healthcare product and services’ – to ‘pay for integrated value-based care offerings.’ In the changing environment, many pharma players seem to have realized that customers are no longer interested in paying for brand values that serve mostly self-serving interests of the respective companies.

More healthcare customers are digitally savvy now:

Today’s brand values need to be in sync with what the perceived value of the customers, enhancing their end-to-end experience of the disease treatment process, more than ever before. For example, increasing number of patients are now choosing between F2F – in-clinic consultations and remote or virtual consultations, for non-life-threatening ailments. Some often do data-driven online assessment for different treatment value offerings, against what these would cost to them.

Purpose driven corporate branding is making better impact:

Pharma industry’s purpose-driven branding initiatives, in tandem with creating robust corporate brands, are drawing much greater public attention amid the pandemic. The list includes both the original product developers and their contract manufacturers. Even in India, many held with esteem – Corporates, such as, AstraZeneca and Serum Institute of India (SII) for Covishield, or Bharat Biotech for Covaxin.

The same thing has happened world-wide with many other Covid vaccine and drug manufacturers, such as, Pfizer, Johnson &Johnson, Moderna, Eli-Lilly, Roche, and others. Interestingly, from the available data in the cyberspace or from word-of-mouth, several people have also inferred about comparative value offerings of each. At least 4 Covid vaccine manufacturers are showing-up in this year’s ‘Conscious Brands 100’ list of 2021. This is, apparently, unprecedented.

Demonstration of ‘patients’-problem solving skill’ with resilience pays:

As we all know by now, the drug industry as such – across the world, instead getting overwhelmed by the problem, pulled up socks and rolled the sleeves to find out scientific means of saving as many lives as possible, soonest.

Almost overnight, repurposing old drugs for Covid treatment and development Covid vaccines, racing against time, were initiated. The entire healthcare industry including, Medical Diagnostic and Devices companies and others, did not fall behind to offer reliable tests for Covid diagnosis, and other life support systems and equipment.

Alongside, Omnichannel digital campaigns of many companies, and favorable news reports amid the pandemic, made people realize the stellar role of the industry in saving lives and livelihoods – from the Covid menace.

Such examples include Pfizer’s What to know About Coronavirus webpage; Merck Inc’s Podcast: How Merck is looking at past epidemics and science to respond to the coronavirus outbreak; and India’s Mankind Pharma’s Mask My India digital campaign. It captures the stories of heroes, who are setting examples and doing more than their call of duty during the COVID-19 pandemic in India. The campaign also spreads the message that ‘together we can all fight with deadly Coronavirus.’

Some pandemic-triggered India-specific challenges:

According to the April 2021 KPMG paper, Covid pandemic has brought to the fore some of the following challenges for the India pharma industry, some due to years of neglect:

Heavy dependence on imported API (60%) continues even during a national health crisis, including Covid vaccine related supplies.

Fragile public health care system and laboratory testing infrastructure and supplies of life support items. This primarily due to one of the lowest Government spend (1.56% of the GDP) on health. As a result, India currently ranks 155^th out of 167 countries, in terms of hospital bed availability (Human Development Report 2020) with just 5 beds availability per 10, 000 Indians.

Changes in health care consumption pattern – especially with the increasing use of e-health or telehealth, besides, online ordering of medicines through e-pharmacies.

Apart from these, it’s also noteworthy – how pharma demonstrated its healthcare ‘problem solving’ skill to save billions of lives from deadly Covid-19 and its mutants, attracting unprecedented kudos from all corners. To keep this initiative going – meeting customers’ core expectations, in my view, could indeed be yet another challenge of change.

Conclusion:

There won’t be any ‘one size fits all’ sort of solution to address such challenges of change. Neither is all company’s challenges the same, in a relative yardstick. Each company would, therefore, need to understand what the pandemic triggered changes in market dynamics and customer expectations mean to them to pursue sustainable business excellence.

Thus, each player would require to elaborately make data-based assessment and analysis, to figure out where they currently stand, so far are the pandemic-triggered changes are concerned. With similar analysis, they should also try to fathom what are their customers’ specific value expectations, which may now go beyond the value that their brands can deliver, but critical for branding success.

Accordingly, a value delivery strategy to be worked out, taking all concerned on-board – with a carefully crafted employee and customer engagement blueprint – and mostly Omnichannel digital platforms.

To successfully navigate through the challenges of change, pharma marketers need to wear a different thinking cap. They would also need to realize that treating pharma marketing as an intrinsic product value delivery system, and by just doing digitally whatever traditionally used to be done manually, may not help generate an adequate return in the new normal. From this perspective, giving shape to a robust, comprehensive, integrated and Omnichannel digital strategic game plan for the organization, is the need of the hour.

By: Tapan J. Ray

Pharma Branding At Tough Times

Posted on November 18, 2019 by Tapan Ray

“About two-thirds of drug launches don’t meet expectations. Improving that record requires pharmaceutical companies to recognize the world has changed and adjust their marketing accordingly.” This appeared in an article – “The secret of successful drug launches,” published by McKinsey & Company in March 2014. There isn’t any recent evidence, either, that this situation has improved now.

Even innovative drugs no longer guarantee a commercial success, as greater competition is building up there, as well. Today, the number of such drugs per indication has risen by 37 percent since 2006 making the task tougher, according to another article of McKinsey & Company, titled ‘Why innovative products aren’t enough for a successful pharma launch,’ brought out in August 2017.

Top marketers’ intimate involvement in these launches, backed by robust marketing strategies notwithstanding, large scale ‘brand failures’ or rather ‘branding failures,’ still remains unavoidable. Although, its telltale signs are more often visible immediately after launch, but may happen even several years after.

Pundits are just not scratching their heads, but doing extensive research to fathom why it happens. However, with changing times – the market dynamics and the research outcomes/inferences keep changing too. And that will be the focus of my today’s discussion in this article, while I explore various facets of the same.

Is pharma branding just a marketing exercise?

That pharma branding is not just a marketing exercise and its failure at any stage – from launch to even years after, I reckon, isn’t the sole responsibility of the pharma marketer. This is mainly because, doctors would ideally prefer to prescribe specific pharma brands and patients would feel confident to use those, because of successful construction of a positive brand bias. Which in turn creates a higher perceived efficacy and a low anticipated safety concern with the brand.

Although, it will be right to assume that good pharma marketers are solely responsible for the creation of this intangible brand asset, but the tangible intrinsic brand value should necessarily be ingrained into each dose of the same that patients consume, always.

Thus, tangible brand value creation, its maintenance, if not enhancement, span across many other functional domains of a drug company. Some of these include, unbiased reporting with expected disclosures of all clinical trial results, maintaining a robust and highly efficient supply chain network or high-quality manufacturing facilities, besides a few others. Evidences exist that irrational pricing could also result in a kind of brand failure. Considering these aspects in totality, creating a positive bias during a pharma brand-building process, is a collective responsibility, and not just of the marketers.

Why creating a positive brand bias is a collective responsibility?

There are ample examples to substantiate that creating a positive stakeholder bias during its brand-building process, is a collective responsibility. Let me illustrate this point by drawing a few examples of branded failures prompted by supply-chain network, disclosures on clinical development and of course perceived ‘irrational’ pricing that falls basically in the marketing domain. It is worth noting, similar incidents may also be related to the manufacturing process, even for top selling generic drugs.

Supply-chain: In the beginning of 2008, serious adverse drug events, some even fatal, were reported with Heparin (Baxter), which used to be widely used as an injectable anticoagulant. Around 80 people died from contaminated Heparin products in the U.S. The US FDA reported that such contaminated Heparin was detected from at least 12 other countries. The primary reason of the same was a serious breach in the supply-chain integrity.

Disclosures on clinical trial results: On 30 September 2004, Vioox (rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) that had been on the market since 1999, was suddenly withdrawn by its manufacturer MSD, owing to concerns about its effect on cardiovascular health.

‘Irrational’ pricing: Like a lot of new cancer drugs, Zaltrap (aflibercept) wasn’t cheap carrying a price tag of USD 9,600 a month. But its price was quickly taken down. This followed some serious public flak, such as, doctors from Memorial Sloan-Kettering (MSK) wrote a blistering review for The New York Times in November 2012. They declared that MSK was taking the drug off the institution’s formulary, because less expensive and just as good alternative angiogenesis inhibitors were available. Although, Sanofi initially defended the price, it subsequently backed down, cutting down the price by half.

Manufacturing process: On September 13, 2019, the FDA announced that preliminary tests found low levels of N-nitrosodimethylamine (NDMA) in ranitidine (Zantac), a heartburn medication. Consequently, almost all companies, including Novartis (through its generic division, Sandoz), GSK, Apotex and many others announced its withdrawal from a large number of markets. Interestingly, these announcements came after a Connecticut-based online pharmacy informed the FDA that it had detected NDMA in multiple ranitidine products under certain test conditions. The NDMA impurity was believed to have been introduced by changes in the manufacturing process. There are several other well-reported examples, as well.

These examples vindicate that creating a positive brand bias remains a collective responsibility throughout the product lifecycle. And it involves several functional areas of drug companies. That said, let me now focus on the creation of a positive bias for pharma brands.

Creating a positive brand bias:

Skillful creation of a positive brand-bias, supported by high quality – tangible and intangible value offerings, is the net outcome of any successful branding process. It augments stakeholder confidence, leading to an increased prescription generation, alongside a favorable patient experience.

More often than not, a positive brand-bias successfully brings into being greater perceived brand-efficacy and higher perceived brand-quality, with lesser anticipated safety concerns. Consequently, the process invigorates an emotional bonding with customers for a long-term brand-loyalty. A positive brand-bias also creates a strong brand equity that often helps in working out a good pricing strategy for the company.

An interesting strategy prescribed – recently:

The October 8, 2019 issue of Fierce Pharma featured an article on creating a positive brand-bias with “Prime and prompt” marketing strategies, outlined by CMI/Compas.

According to Changing Minds: ‘Priming works by providing people with information that is easily brought to mind. The prompt that brings the information to mind can be an implanted and specific trigger or can be an associated term that will naturally bring back the primed information.’ Illustrating the point, it adds: ‘Prime-and-prompt can be a bit like firing a gun, where priming cocks and prompting pulls the trigger.’

Putting this concept in the pharma industry perspective, the CMI/Compas officials explained in the above article, ‘pharma marketers can create primes with product messages that condition people to recall their product when they need medicine or are diagnosed with a condition.’

Hence, a pharma marketer’s adroitness in the ‘priming’ strategy helps ‘prompt’ the desirable action, such as, going to a doctor to ask about a product. Hence, the persuasion technique is termed – ‘prime and prompt’, the paper explained. Naturally, the question that follows: what are the key principles behind this strategy?

Key principles behind ‘prime and prompt’ strategy:

As elucidated by the Changing Minds, when thinking and deciding, we are influenced by related information from the past. At that time, our memories would supply that information, which helps us understand, make sense, decide and act on the subject at hand. Thus, those things that come at the top of mind will have a more immediate and disproportionate influential effect, while those things which are long forgotten may have little or no effect.

It further adds: ‘Priming is driven by implicit memory, where recall is entirely unconscious as the person ‘just knows’ without having to think hard or otherwise put effort into remembering or working things out.’

How to apply the ‘prime and prompt’ strategy in pharma?

It’s no-brainer that to use ‘priming’ in the persuasion process, say for increasing prescription support, the marketers need to provide stakeholders with relevant information beforehand, and more importantly, in a different setting. And only thereafter, they need to focus on a normal brand persuasion strategy. One may most appropriately comment, this is easier said than done in the drug industry.

Taking a cue from the above interview with the CMI/Compas officials, some of the broad steps of the ‘prime and prompt’ strategy, I reckon, may be summarized as follows:

Consistent messaging through omnichannel media achieving target reach and frequency, as I had explained before.

For intended top of mind recall, a combination of print, digital, social, search, display at appropriate places and in TV, especially for OTC drugs, should consistently surround the target audience for ‘priming.’

According to a recent research, the most highly rated ‘priming’ spots for pharma ads for physicians are medical journals, conferences and the likes. Similarly, for patients, appropriate displays at doctors’ clinics and similar places also appeared to be one of the top-rated ‘priming’ spots.

Consequently, a well thought-out ‘priming’ strategy, skillfully executed – based on research findings, is expected to be effective. It will then help trigger desirable ‘prompts’ for the target-audience, augmenting a successful branding process. However, it comes with a caveat that the tangible intrinsic value of the brand, especially those which originate in other functional areas, don’t get compromised or changed in any way.

Conclusion:

Branding exercise in the pharma industry has never been more challenging, as it is today – both for innovative and generic drugs. As stated above, the number of innovative drugs per indication has risen by 37 percent since 2006, making the market competition tougher. Likewise, product proliferation with cut-throat pricing for branded generics, is also making the generic drug marketers grasping at straws, as it were.

In this challenging situation, creating a positive stakeholder bias for brands, as the net outcome of the pharma branding process, is a collective responsibility. Any non-marketing misstep in the tangible brand value offering, could sweep a brand away to oblivion – not just during launch, but at any stage of its life-cycle. Pharma marketers will of course be solely responsible to create the critical intangible brand assets, such as a positive stakeholder bias for brands.

At this tough time for pharma branding, several fresh marketing concepts like, ‘prime and prompt’ are now being seriously evaluated. Thus, I reckon, its also a time for astute marketers in the pharma industry to test the water, in pursuit of excellence.

By: Tapan J. Ray

How Relevant Is A Pharma Brand Name To Patients?

Posted on February 26, 2018 by Tapan Ray

Are brand names necessary for medicines? Well – its’s a contentious issue, at least, as on date. It becomes the subject of a raging debate when the same question is slightly modified to: – Are brand names necessary for prescription drugs?

The current reality is, almost all pharma companies believe, and have been following this practice. This has been happening for decades, regardless of the fact that unlike other branded non-pharma products, each and every drug also carries another specific name – the generic name. Which is why, questions are often raised, why can’t drugs be prescribed only in generic names by the doctors?

Before I proceed further, let me recapitulate the definition of a ‘brand’. One of the most comprehensive definitions of a brand is: Unique design, sign, symbol, words, or a combination of these that identifies a product and differentiates it from its competitors. It helps create a level of credibility, quality, and satisfaction in the consumer’s mind, by standing for certain benefits and value. And, the creative marketing practices followed in this process is termed as ‘branding’. Keeping this at the center, in this article, let me try to arrive at a relevant perspective on this subject.

The arguments in favor:

Votaries of pharma branding believe that a pharma brand helps establish an emotional connect with the consumers on various parameters, including quality, efficacy, safety and reliability. This is expected to establish a preferential advantage of a brand over its competitors. Quoting the ‘father of advertising’ David Ogilvy, some of these proponents relate the outcome of branding to offering ‘intangible sum of a product’s attributes’ to its consumers, and also prospective consumers.

Entrepreneur India puts across such favorable outcome of ‘branding’ very candidly, which is also applicable to branding medicines – both patented and generic ones. It says, “Consistent, strategic branding leads to a strong brand equity, which means the added value brought to your company’s products or services that allows you to charge more for your brand than what identical, unbranded products command.”

The general belief within the pharma industry is that, ‘branding’ facilitates doctors in choosing and prescribing medicines to patients, especially in those situations where the choices are many. Aficionados of pharma product branding argue, that to save time, doctors usually select those top of mind products, which they are familiar with and feel, can serve the purpose well. This belief prompts the necessity to go all out for ‘branding’ by the pharma companies, even when the process is an expensive one.

Where pharma ‘branding’ is necessary:

There are a few old publications of the 1980’s, which claim that studies based on human psychology have found that medicines with brand names can have a better perceived impact on the actual effectiveness of ‘Over the Counter (OTC)’ medications. One of the examples cited was of aspirin.

Be that as it may, the relevance of branding for OTC pharmaceutical products is undeniable, where a medicinal product is generally treated just as any other Fast-Moving Consumer Goods (FMCG) goods. Establishing an emotional connect of OTC brands with consumers is, therefore, considered an important process to create a preferential perceived advantage over its competitors.

There is no well-laid out legal or procedural pathway, as yet, for pharma OTC brands in India. No ‘Direct to Consumer (DTC) promotion is allowed in the country for Schedule H and Schedule X drugs – the only exceptions being Ayurvedic proprietary medicines and for homeopathy drugs. That said, the question continues to haunt, how relevant is branding for prescription drugs – now?

Relevance of ‘branding’ for prescription drugs:

The juggernaut of ‘branding prescription drugs’, riding mostly the wave of vested interests – of many hues and color, has been made to be perceived as necessary to ensure drug quality and safety for patients. It continues to move on, up until today, even for highly specialized prescription drugs. Nonetheless, some initiatives are visible from some Governments to gradually shift this contentious paradigm.

This move has been catalyzed by a blend of changing times with changing expectations of a large number of patients. They want to be an integral part in their treatment decisions, receive more personalized healthcare from both doctors and pharma companies. Patients, ultimately, want to feel confident that they’re receiving the best treatment – says a fresh study.

A number of other research papers also confirm that, a virtually static bar of patients’ expectations, in the disease treatment process – either for themselves or their near and dear ones, is slowly but surely gaining height, measurably. For better outcomes, patients have started expecting new types of services both from their doctors and the drug manufacturers. This process begins, even before a final decision is taken in the treatment process. As this paradigm shifts, pharma players would be significantly impacted – in several parameters.

Fast expanding digital empowerment options for all, across the world, is expediting this process further, including India. Placing oneself in the midst of it, one may ponder – how relevant is pharma branding today, as is being highlighted by many, since long.

In my view, a part of the answer to the above question arguably lies in a study titled, “Product Launch: The Patient Has Spoken”. The Key findings from the survey that covered 8,000 patients from three generations in the US, the UK, Germany and France, were published by ‘Accenture Life Sciences’ in January 2018. The research reveals how these patients evaluate and select new treatments in eight therapeutic areas (immune system, heart, lungs, brain, cancer, hormone/ metabolism and eye disease) across three generations, spanning across – Baby boomers, Generation X and Millennials.

Brands don’t matter to most patients…outcomes do:

69 percent of patients said, the benefits of the product are more important to them than the brand of the product. The four top factors influencing patients’ while making decisions about their healthcare are listed in the report as:

The doctor/ physician relationship: 66 percent
The patient’s ability to maintain their current lifestyle: 55 percent
Patients’ ease of access to health care they’ll need: 53 percent
Patients’ financial situation / ability to pay: 51 percent. When this is read with another finding where, 48 percent of patients believe that their doctors discuss the whole range of product options with them, a more interesting scenario emerges.

Further, lack of knowledge about the treatments available, as expressed by 42 percent of patients obviously indicate, pharma players’ intent to better inform patients by educating the doctors through brand promotion is not working. Interestingly, brand loyalty or popularity appeared relatively unimportant, ranking twelfth out of 14 influencing factors. Just 25 percent of patients characterized themselves as having a strong affinity with brands in a healthcare setting – the above report revealed.

Could there be an alternative approach?

An effective ‘branding’ exercise should lead to creating a ‘brand loyalty’ for any product. For pharma companies, doctors’ brand loyalty should lead to more number of its brand prescriptions. This expectation emanates from the idea that the prescription brand will represent something, such as quality, trust, assured relief, or may well be anything else. That means pharma product ‘branding’ is primarily aimed at the medical profession.

In an alternative approach to the current practice, an article titled, “From Managing Pills to Managing Brands”, published sometime back in the March-April 2000 issue of the Harvard Business Review (HBR), finds its great relevance, even today. It says, pharma companies can retain the loyalty of customers by building a franchise around specific therapeutic areas based on a focused approach to R&D. In other words, their corporate brand can replace individual drug brands. For example, a doctor looking for a treatment for – say asthma, would look for the latest GlaxoSmithKline medicines. Let me hasten to add, I used this example just to illustrate a point. This may appear as a long shot to some. Nonetheless, it would significantly reduce the cost of marketing, and subsequently the cost of a drug to patients. Incidentally, I also wrote about the relevance of ‘Corporate Branding’ in this Blog on June 15, 2015.

Conclusion:

With this fast-emerging backdrop, the Accenture Study raises an important issue to this effect. It wonders, whether the expenses incurred towards branding medicines, especially, during product launch be significantly reduced and be made more productive?

Illustrating the point, the report says, in 2016, the US pharmaceutical and healthcare industry alone spent US$ 15.2 billion in marketing. To earn a better business return, could a substantial part of this expenditure be reallocated to other programs that matter more to patients, such as access to patient service programs, and creating ‘Real-World Evidence (RWE)’ data that can document improved health outcomes, particularly those that matter to patients?

Well-crafted pharma branding and other associated initiatives, targeted predominantly to the medical profession, may make a doctor emotionally obligated to prescribe any company’s specific brands, for now. However, in the gradually firming-up ‘patient outcomes’-oriented environment, where patients want to participate in the treatment decision making process, will it remain so?

Dispassionately thinking, to most patients, a brand is as good or bad as the perceived value it delivers to them in the form of outcomes. Or, in other words, prescription pharma brands may not even matter to most of them, at all, but the outcomes will be. Hopefully, before it is too late pharma players would realize that, especially the well-informed patients are becoming co-decision makers in choosing the drug that a doctor will prescribe to them. If not, the current targeted process of pharma prescription drug branding, may lose its practical relevance, over a period of time.

By: Tapan J. Ray

Marketing Practices: Why Pharma Does What It Does?

Posted on September 11, 2017 by Tapan Ray

It started way back – spanning across many developed countries of the world. However, probably for the first time in the last five years, an international media group focused on this issue thriving in India, with so much detail.

Reuters reported it with a headline “In India, gift-giving drives drug makers’ marketing.” The report was supported by a detailed description of the relevant events, with ‘naming and shaming’. It drew the attention of some, apparently including the Department of Pharmaceuticals (DoP), but escaped the attention of many, and finally – got faded away with time, without any reported official investigation.

In this article, I shall revisit this subject against the backdrop of draft pharma policy 2017. My focus will be on the current marketing practices, with the moot question ‘why pharma does what it does’ occupying the center stage of this piece.

Bothering many across the world:

Pharma marketing practices wear different hues and shades. Many of these are contentious, and often perceived as gross ‘malpractices’. Nevertheless, across the world, these have mostly become an integral part of pharma business. Many law-enforcing authorities, including in the US, Europe, Japan and even China, have started taking tough penal action against those transgressions. Interestingly, the draft pharma policy 2017 intends to take this raging bull by its horn, with a multi-pronged approach, as I see it.

It’s a different debate, though, whether the policy makers should bring the mandatory Uniform Code of Pharmaceutical Marketing Practices (UCPMP) under the Essential Commodities Act, or the Drugs and Cosmetics Act of India. Let’s wait and see what exactly transpires in scripting the final version of the new National Pharma Policy to address this issue, comprehensively.

The net impact of the fast evolving ‘newer norms’ of pharma ‘marketing’ practices, has been bothering a large section of the society, including the Governments, for quite some time. Consequently, many top-quality research studies are now being carried out to ascertain the magnitude of this problem. The top ranked pharma market in the world – the United States (US) are leading the way with such analysis. However, I haven’t come across similar India-specific analytical reports, just yet, probably due to lack of enough credible data sources.

Four recent studies:

Several interesting studies supported by a robust database have been carried out in the US during 2016 and 2017 to ascertain whether any direct relationship exists between payments in various forms made to the doctors by the pharmaceutical companies and physicians’ prescribing various drugs in brand names. For better understanding of this issue, I am quoting below, as examples, the gist of just four of such studies:

One of these studies conducted by ProPublica was published in March 2016. It found that physicians in five common medical specialties who accepted, at least one industry payment were more likely to prescribe higher rates of brand-name drugs than physicians who did not receive any payments. More interestingly, the doctors receiving larger payments had a higher brand-name prescribing rate, on an average. Additionally, the type of payment also made a difference: those who received meals alone from companies had a higher rate of brand-name prescribing than physicians receiving no payments, and those who accepted speaking payments had a higher rate of the same than those drawing other types of payments.

The details of the second study published in PLOS on May 16, 2016 states, “While distribution and amount of payments differed widely across medical specialties, for each of the 12 specialties examined the receipt of payments was associated with greater prescribing costs per patient, and greater proportion of branded medication prescribing. We cannot infer a causal relationship, but interventions aimed at those physicians receiving the most payments may present an opportunity to address prescribing costs in the US.”

The third example of such investigative study appeared in the Journal of American Medical Association (JAMA) on August 2016. This cross-sectional analysis, which included 279,669 physicians found that “physicians who received a single meal promoting the drug of interest, with a mean value of less than $20, had significantly higher rates of prescribing rosuvastatin as compared with other statins; nebivolol as compared with other β-blockers; olmesartan as compared with other angiotensin-converting-enzyme inhibitors and angiotensin-receptor blockers; and desvenlafaxine as compared with other selective serotonin and serotonin-norepinephrine reuptake inhibitors.”

This study also concluded that “Receipt of industry-sponsored meals was associated with an increased rate of prescribing the brand-name medication that was being promoted. The findings represent an association, not a cause-and-effect relationship.”

And the fourth analysis on the same subject featuring in the British Medical Journal (BMJ) of 18 August 2016 concluded that “Payments by the manufacturers of pharmaceuticals to physicians were associated with greater regional prescribing of marketed drugs among Medicare Part D beneficiaries. Payments to specialists and payments for speaker and consulting fees were predominantly associated with greater regional prescribing of marketed drugs than payments to non-specialists or payments for food and beverages, gifts, or educational materials.”

Exceptional steps by a few global CEOs – would the rest follow through?

As this juggernaut continues to move unrelenting, a few global CEOs have been taking some exceptional steps in this regard, e.g.:

- In December 2013, Sir Andrew Witty – erstwhile global CEO of GlaxoSmithKline tossed out the ‘Big Pharma marketing playbook’. He announced, no longer will his company pay doctors to promote its drugs or shell out bonuses to sales reps based on their ability to boost prescription numbers.

- Around September 2015, Brent Saunders – the Global CEO of Allergan was the first major drug company chief to explicitly renounce egregious price increases. Outlining his company’s “social contract with patients,” he vowed that Allergan would:

Limit price increases to single-digit percentages, “slightly above the current annual rate of inflation,” net of rebates and discounts
Limit price increases to once per year
Forego price increases in the run-up to patent expiration, except in the case of corresponding cost increases.

- In October 2016, Joseph Jimenez – the current global CEO of Novartis said, “We tell people, we don’t want you to deliver at any cost. We want you to deliver, but we want you to deliver in the right way,”

It’s probably a different matter, though, that one of these CEOs has already stepped down, another will do so early 2018, and third iconoclast is still in the saddle. They all are still relatively young, as compared to several of their counterparts.

These are some of the laudable steps taken by a few CEOs for their respective global operations. However, the moot question remains: would rest of the Big Pharma constituents come on board, and successfully follow these initiatives through?

That said, the overall scenario in this area, both in India and abroad, continues to remain mostly unchanged.

Why pharma does what is does?

This may not be akin to a million-dollar question, as its right answer is no-brainer – to generate more, and even more prescription demand for the respective focused brands of the concerned pharma companies. In a scenario, as we have seen above, when money can buy prescriptions with relative ease, and more money buys more prescriptions, how do the prescribers differentiate between different brands of the same molecules or combination of molecules, for greater support?

As evident from various available reports, this kind of intangible product differentiation of dubious nature, doesn’t necessarily have a linear relationship with the quantum of money spent for this purpose. Many believe, it is also intimately related to the nature or kind of various ‘gratis’ extended, some of which are highly contentious. Illustratively, how exotic is the venue of so called ‘Continuing Medical Education (CME)’ event, whether located in India or beyond its shores, bundled with the quality of comfort provided by the event managers, or even whether the spouses can also join the doctors for a few days of a relaxed trip with fabulous sight-seeing arrangements.

Regardless of many pharma players’ terming these events as purely educational in nature, lots of questions in this regard – accompanied by proof, have reportedly been raised on the floor of the Indian Parliament, as well, cutting across virtually all political party lines.

Conclusion:

Should anyone tag the term ‘marketing’ against any such pharma business practices, or even remotely accept these as integral parts of any ‘branding exercise’? For better understanding of my readers, I had explained what this buzzword – ‘branding’ really means in the marketing vocabulary.

Be that as it may, where from the pharma companies recover the huge cost of such vexed business practices? Who ultimately pays for these – and, of course, why? So far, in India, the basic reasoning for the same used to be – branded generics provide significantly better and more predictable drug quality and efficacy than non-branded generics, for patients’ safety.

This logic is anchored mainly on the argument that bioequivalence (BE) and bioavailability (BA) studies are mandatory for all generic drug approvals in India. Interestingly, that loose knot has been tightened in the draft pharma policy proposals 2017. Hope, this commendable policy intent will ultimately see the light of the day, unless another innovative new reason pops-up.

Against this backdrop, many ponder: Are the current pharma ‘marketing’ practices, especially in India, akin to riding a tiger? If the answer is affirmative, the aftermath of the new pharma policy’s coming into force – broadly in its current form and with strict enforcement measures, could well be too tough to handle for those drug players without a Plan B ready.

That said, pharma ‘marketing’ ballgame is getting increasingly more complex, with the involvement of several third-parties, as is often reported. Alongside, it’s equally challenging to fathom ‘why pharma does what it does’ to generate more prescription demand at an incremental cost, which far exceeds commensurate incremental value that branded generics provide to patients in India.

By: Tapan J. Ray

Draft Pharma Policy 2017 And Branded Generics

Posted on August 28, 2017 by Tapan Ray

In its first reading, the 18-page draft Pharma Policy, 2017 gives me a sense that the Government has followed the much-desired principle of ‘walk the talk’, especially in some key areas. One such space is what Prime Minister Modi distinctly hinted on April 17, 2017, during the inauguration function of a charitable hospital in Surat. He clearly signaled that prescriptions in generic names be made a must in India, and reiterated without any ambiguity whatsoever that, to facilitate this process, his government may bring in a legal framework under which doctors will have to prescribe generic medicines.

Immediately following its wide coverage by both the national and international media, many eyebrows were raised regarding the feasibility of the intent of the Indian Prime Minister, especially by the pharma industry and its business associates, for the reasons known to many. A somewhat muted echo of the same could be sensed from some business dailies too, a few expressed through editorials, and the rest quoting the views on the likely ‘health disaster’ that may follow, if ‘branded generics’ are not prescribed by the medical profession. Obviously, the main apprehension was centered around the ‘shoddy quality parameters’ of unbranded generic drugs in India. It’s a different matter though, that none can possibly either confirm or pooh-pooh it, backed by irrefutable data with statistical significance.

Be that as it may, making high quality generic drugs accessible to most patients at affordable prices, avoiding any possible nexus between the doctors and pharma companies, which could jeopardize the patients’ economic interest, deserves general appreciation, shrill voices of some vested interests notwithstanding. Nonetheless, if the related proposals in the new pharma policy come to fruition as such, it would be a watershed decision of the government, leaving a long-lasting impact both on the patients, as well as the industry, though in different ways, altogether.

I raised this issue in my article titled, “Is Department of Pharmaceuticals On The same Page As The Prime Minister?”, published in this blog on May 15, 2017. However, in today’s discussion, I shall focus only on how has the draft pharma policy 2017 proposed to address this issue, taking well into consideration the quality concerns expressed on unbranded generics, deftly.

Before I do that, let me give a brief perspective on ‘brand name drugs’, ‘generic drugs’, ‘branded generics’ and ‘unbranded generic drugs’. This would basically serve as a preamble to arrive at the relevance of ‘branded generic’ prescriptions, along with the genesis of safety concern about the use of un-branded generic drugs.

No definition in Indian drug laws:

Although, Drugs and Cosmetics Act of India 1940 defines a drug under section 3 (b), it does not provide any legal definition of ‘brand name drugs’, ‘generic drugs’, ‘branded generic drugs’ or ‘un-branded generics’. Hence, a quick landscaping of the same, as follows, I reckon, will be important to understand the pertinence of the ongoing debate on ‘branded generic’ prescriptions in India, from the patients’ health and safety perspectives:

‘Brand name’ drugs:

Globally, ‘brand name drugs’ are known as those, which are covered by a product patent, and are usually innovative New Chemical Entity (NCE) or a New Molecular Entity (NME). Respective innovator pharma companies hold exclusive legal rights to manufacture and market the ‘brand name drugs’, without any competition till the patents expire.

Generic drugs:

Post patent expiry of, any pharma player, located anywhere in the world, is legally permitted, as defined in the Intellectual Property Rights (IPR) regulations, to manufacture, market and sell the generic equivalents of ‘brand name drugs’. However, it’s a global norm that the concerned generic manufacturer will require proving to the competent drug regulatory authorities where these will be marketed, that the generic versions are stable in all parameters, and bioequivalent to the respective original molecules. According to US-FDA, a ‘generic drug’ will require to be the same as the original ‘brand-name drug’ in dosage, safety, strength, quality, purity, the way it works, the way it is taken and the way it should be used.

‘Branded generic’ drugs:

Branded generics are generic molecules marketed and prescribed by their respective brand names. Around 90 percent of generic formulations are branded generics in India, involving heavy sales and marketing expenditure in various forms, which has become a contentious issue today in India. The reason being, although branded generics cost significantly more than unbranded generics, the former variety of generic drugs are most preferred by the medical profession, as a group, in India. Interestingly, there is no difference whatsoever in the marketing approval process between the ‘branded generics’ and other generic varieties without any brand names.

Unbranded generic drugs:

Unbranded generic drugs are those, which are sold only in the generic names, sans any brand name. I reiterate, once again, that there is no difference in the marketing approval process between the ‘branded generics’ and ‘unbranded generic medicines’.

The core issue:

The whole debate or concern related to both efficacy and safety on the use of unbranded generic drugs in India stems from a single regulatory issue, which is widely construed as scientifically improper, and totally avoidable. If this subject is addressed in a holistic way and implemented satisfactorily in the country, by and large, there should not be any worthwhile concern in prescribing or consuming single ingredient unbranded generic drugs in India, which generally cost much less than their branded generic equivalents.

This core issue is primarily related to establishing bioequivalence (BE) with the original molecules for all generic formulations, regardless of whether these are branded or unbranded generic drugs. Thus, positive results in bioequivalence studies, should be a fundamental requirement for the grant of marketing approval of any generics in India, as is required by the regulators of most countries, across the world.

This has been lucidly articulated also in the publication of the National Institute of Health (NIH), USA, underscoring the critical importance of generic drugs in healthcare is unquestionable. The article says: “it is imperative that the pharmaceutical quality and ‘in vivo’ performance of generic drugs be reliably assessed. Because generic drugs would be interchanged with innovator products in the market place, it must be demonstrated that the safety and efficacy of generics are comparable to the safety and efficacy of the corresponding innovator drugs. Assessment of ‘interchangeability’ between the generic and the innovator product is carried out by a study of ‘in vivo’ equivalence or ‘bioequivalence’ (BE).”

The paper further highlights, “the concept of BE has, therefore, been accepted worldwide by the pharmaceutical industry and national regulatory authorities for over 20 years and is applied to new as well as generic products. As a result, thousands of high-quality generic drugs at reduced costs have become available in every corner of the globe.”

Why is BE not mandatory for marketing approval of all generic drugs in India?

It is intriguing, why is this basic scientific and medical requirement of proving BE is not mandatory for granting marketing approval of all generic drugs at all time, without any exception – covering both branded generics and their unbranded equivalents, in India.

As I have already deliberated on this subject in my article titled “Generic Drug Quality: Cacophony Masks An Important Note, Creates A Pariah ”, published in this blog on May 08, 2017, I shall now proceed further to relate this critical issue with the Draft Pharma Policy 2017.

Brand, branding and branded generics:

Nevertheless, before I focus on the draft pharma policy 2017, let me skim through the definitions of a ‘brand’ and the ‘branding process’, in general, for better understanding of the subject.

American Marketing Association defines a brand as: ‘A name, term, design, symbol, or any other feature that identifies one seller’s goods or services as distinct from other sellers.’ Whereas, ‘The Branding Journal’ articulates: ‘A brand provides consumers with a decision-making-shortcut when feeling indecisive about the same product from different companies.’

Business Dictionary describes the ‘branding process’ as: ‘Creating a unique name and image for a product in the consumers’ mind, mainly through advertising campaigns with a consistent theme. Branding aims to establish a significant and differentiated presence in the market that attracts and retains loyal customers.’

How does it benefit the branded generic consumers?

One thing that comes out clearly from the above definitions that brands, and for that matter the branding process is directed to the consumers. Applying the branding process for generic drugs, the moot question that surfaces is, how does it benefit the pharma consumers, significantly?

Besides, the branding process being so very expensive, adds significant cost to a generic drug, making its price exorbitant to most patients, quite disproportionate to incremental value, if any, that a branded generic offers over its unbranded equivalents. Thus, the relevance of the branding process for a generic drug, continues to remain a contentious issue for many, especially where the out of pocket expenditure for medicines is so high, as in India.

Marketing experts’ view on the branding process for drugs:

An interesting article titled ‘From Managing Pills to Managing Brands’, authored by the Unilever Chaired Professor of Marketing and a research fellow at INSEAD, published in the Harvard Business Review made the following observations on brands and the branding process for drugs:

“…It takes a huge investment to build a successful brand, consumer goods manufacturers try to make their brands last as long as possible. Some consumer products—notably, Coca-Cola, Nescafé, and Persil (a European laundry detergent) - have stayed at the top for decades. That’s not to say the products don’t evolve, but the changes are presented as improvements and refinements rather than as breakthroughs.”

“In the pharmaceutical business, by contrast, a new product is always given a new name. Drug companies believe that only by introducing a new name can you signal to the market that the product itself is new. Unfortunately, this approach throws out the company’s previous marketing investment entirely; it has to build a new brand with each new product. That may not have mattered when pharmaceutical companies could rely on a large, high-margin market for each drug they wheeled out. But in a crowded market with tightening margins, the new-product, new-brand strategy is becoming less and less feasible.”

The above observations when applied to expensive ‘branded generics’, which are nothing but exact ‘me too’ varieties among tens other similar formulations of the same generic molecule, do not add any additional value to the patients, in a well-functioning drug regulatory environment.

Hence, to reduce the out of pocket drug cost significantly, Prime Minister Modi hinted at bringing an appropriate legal framework to address this critical issue, which gets well-reflected in the draft pharma policy 2017, as I read it.

Six key features of the draft pharma policy related to ‘branded generics’:

Following are the six key features enshrined in the draft pharma policy 2017 to translate into reality what the Prime Minister spoke about on this subject in Surat on April 17, 2017.

1. Bio-availability and Bio-equivalence tests mandatory for all drug manufacturing permissions:

For quality control of generic drugs, Bio-availability and Bio-equivalence tests (BA/BE Tests) will be made mandatory for all drug manufacturing permissions accorded by the State Drug Regulator or by the Central Drug Regulator. This will be made compulsory even for the future renewals of manufacturing licenses for all.

2. WHO GMP/GLP mandatory for all drug units:

The government shall ensure to get the World Health Organization’s Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) adopted by all manufacturing units.

3. No branded generics for single ingredient off-patent molecules:

The government will pursue the policy of sale of single ingredient drugs by their pharmacopeial name/salt name. To keep the identity of the manufacturer, the manufacturer would be allowed to stamp its name on the drug package. For patented drugs and Fixed Dose Combination (FDCs) drugs the brand names may be used.

4. ‘One company – one drug – one brand name – one price’:

The principle of ‘one company – one drug – one brand name – one price’ would be implemented for all drugs.

5. Aid and assistance to prescribe in generic names:

To aid and assist the registered medical practitioners in prescribing medicines in the generic names, e-prescription will be put into operation whereby the prescriptions will be computerized and the medicine name will be picked up from a drop-down menu of salt names.

6. UCPMP to be made mandatory:

The marketing practices of several pharmaceutical companies create an unfair advantage. To provide a level playing field, the regulation for marketing practices which is at present voluntary will be made mandatory. Penalty will be levied for violations and an agency for implementation would also be assigned.

Conclusion:

I have focused in this article only on those specific intents of the government, as captured in the draft pharma policy 2017, to reduce the out of pocket expenses on drugs for the Indian patients, which is currently one of the highest in the world. This area assumes greater importance to many, keeping in mind what Prime Minister Modi hinted at in this regard on April 17, 2017. If implemented exactly as detailed in the policy draft, this specific area would have a watershed impact both on the patients, as well as, the pharma companies, including their related business associates, lasting over a long period time.

Far reaching consequential fall outs are expected to loom large on the way pharma players’ strategic business processes generally revolve round ‘branded generics’ in India. I hope, the Plan B of many predominantly branded generic players is also receiving final touches on the drawing board by now, as this aspect of the draft policy proposal can in no way be construed as a bolt from the blue, catching the industry totally off-guard. That said, would the same changes as proposed in the draft pharma policy 2017, if and when implemented, be a ‘wow’ moment for patients?

By: Tapan J. Ray

Prescriptions in Generic Names Be Made A Must in India?

Posted on April 24, 2017 by Tapan Ray

Would prescriptions in generic names be made a must in India?

Yes, that’s what Prime Minister Modi distinctly hinted at on April 17, 2017, during the inauguration function of a charitable hospital in Surat. To facilitate this process, his government may bring in a legal framework under which doctors will have to prescribe generic medicines, the PM assured without any ambiguity whatsoever.

“In our country doctors are less, hospitals are less and medicines are expensive. If one person falls ill in a middle-class family, then the financial health of the family gets wrecked. He cannot buy a house, cannot conduct the marriage of a daughter,” he reiterated.

“It is the government’s responsibility that everybody should get health services at a minimal price,” the Prime Minister further reinforced, as he referred to the National Health Policy 2017. His clear assurance on this much-debated issue is indeed music to many ears.

Some eyebrows have already been raised on this decision of the Prime Minister, which primarily include the pharma industry, and its traditional torch bearers. Understandably, a distinct echo of the same one can also be sensed in some English business dailies. Keeping aside these expected naysayers, in this article, after giving a brief backdrop on the subject, I shall argue for the relevance of this critical issue, in today’s perspective.

Anything wrong with generic drugs sans brand names?

At the very outset, let me submit, there aren’t enough credible data to claim so. On the contrary, there are enough reports vindicating that generic drugs without brand names are generally as good as their branded equivalents. For example, a 2017 study on this subject and also in the Indian context reported, ‘93 percent of generic and 87 percent branded drug users believed that their drugs were effective in controlling their ailments.’

Thus, in my view, all generic medicines without any brand names, approved by the drug regulatory authorities can’t be inferred as inferior to equivalent branded generics – formulated with the same molecules, in the same strength and in the same dosage form; and vice versa. Both these varieties have undergone similar efficacy, safety and quality checks, if either of these are not spurious. There isn’t enough evidence either that more of generic drugs sans brand names are spurious.

However, turning the point that generic drugs without brand name cost much less to patients than their branded generic equivalents on its head, an ongoing concerted effort of vested interests is systematically trying to malign the minds of many, projecting that those cheaper drugs are inferior in quality. Many medical practitioners are also not excluded from nurturing this possible spoon-fed and make-believe perception, including a section of the media. This reminds me of the famous quote of Joseph Goebbels – the German politician and Minister of Propaganda of Nazi Germany till 1945: “If you tell a lie big enough and keep repeating it, people will eventually come to believe it.”

The lower prices of generic drugs without brand names are primarily because their manufacturers don’t need to incur huge expenditure towards marketing and sales promotion, including contentious activities, such as, so called ‘Continuing Medical Education (CME)’ for the doctors in exotic locales, and several others of its ilk.

Thus, Prime Minister Modi’s concern, I reckon, is genuine to the core. If any doctor prescribes an expensive branded generic medicine, the concerned patient should have the legal option available to ask the retailer for its substitution with a less expensive generic or even any other branded generic equivalent, which is supposed to work just as well as the prescribed branded generic. For this drug prescriptions in INN is critical.

Provide Unique Identification Code to all drug manufacturers:

When in India, we can have a digitally coded unique identification number, issued by the Government for every individual resident, in the form of ‘Aadhaar’, why can’t each drug manufacturer be also provided with a similar digitally coded number for their easy traceability and also to decipher the trail of manufacturing and sales transactions. If it’s not possible, any other effective digital ‘track and trace’ mechanism for all drugs would help bringing the wrongdoers, including those manufacturing and selling spurious and substandard drugs to justice, sooner. In case a GST system can help ferret out these details, then nothing else in this regard may probably be necessary.

Past initiatives:

In India, ‘Out of Pocket (OoP) expenditure’ as a percentage of total health care expenses being around 70 percent, is one of the highest in the world. A study by the World Bank conducted in May 2001 titled, “India – Raising the Sights: Better Health Systems for India’s Poor” indicates that out-of-pocket medical costs alone may push 2.2 percent of the population below the poverty line in one year. This situation hasn’t improved much even today, as the Prime Minister said.

Although, ‘prescribe drugs by generic names’ initiative was reported in July 2015, in the current context, I shall focus only on the recent past. Just in the last year, several initiatives were taken by the current Government to help patients reduce the OoP expenses on medicines, which constitute over 60 percent of around 70 percent of the total treatment cost. Regrettably, none of these steps have been working effectively. I shall cite hereunder, just three examples:

On February 29, 2016, during the Union Budget presentation for the financial year 2016-17 before the Parliament, the Finance Minister announced the launch of ‘Pradhan Mantri Jan-Aushadhi Yojana (PMJAY)’ to open 3,000 Stores under PMJAY during 2016-17.

On August 04, 2016, it was widely reported that a new digital initiative of the National Pharmaceutical Pricing Authority (NPPA), named, “Search Medicine Price”, would be launched on August 29, 2016. According to NPPA, “Consumers can use the app before paying for a medicine to ensure that they get the right price.”

In October 2016, a circular of the Medical Council of India (MCI), clearly directed the medical practitioners that: “Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs”

A critical hurdle to overcome:

Besides, stark inefficiency of the MCI to implement its own directive for generic prescriptions, there is a key legal hurdle too, as I see it.

For example, in the current situation, the only way the JAS can sell more of essential generic drugs for greater patient access, is by allowing the store pharmacists substituting high price branded generics with their exact generic equivalents available in the JAS. However, such substitution would be grossly illegal in India, because the section 65 (11) (c) in the Drugs and Cosmetics Rules, 1945 states as follows:

“At the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed. 20 [(11A) No person dispensing a prescription containing substances specified in 21 [Schedule H or X] may supply any other preparation, whether containing the same substances or not in lieu thereof.]”

A move that faltered:

To address this legal issue, the Ministry of Health reportedly had submitted a proposal to the Drug Technical Advisory Board (DTAB) to the Drug Controller General of India (DCGI), for consideration. In the proposal, the Health Ministry reportedly suggested an amendment of Rule 65 of the Drugs and Cosmetics Rules, 1945 to enable the retail chemists substituting a branded drug formulation with its cheaper equivalent, containing the same generic ingredient, in the same strength and the dosage form, with or without a brand name.

However, in the 71st meeting of the DTAB held on May 13, 2016, its members reportedly turned down that proposal of the ministry. DTAB apparently felt that given the structure of the Indian retail pharmaceutical market, the practical impact of this recommendation may be limited.

The focus should now move beyond affordability:

In my view, the Government focus now should move beyond just drug affordability, because affordability is a highly relative yardstick. What is affordable to an average middle class population may not be affordable to the rest of the population above the poverty line. Similarly, below the poverty line population may not be able to afford perhaps any cost towards medicines or health care, in general.

Moreover, affordability will have no meaning, if one does not have even easy access to medicines. Thus, in my view, there are five key factors, which could ensure smooth access to medicines to the common man, across the country; affordable price being one of these factors:

1. A robust healthcare infrastructure
2. Affordable health care costs, including, doctors’ fees, drugs and diagnostics
3. Rational selection and usage of drugs by all concerned
4. Availability of health care financing system like, health insurance
5. Efficient logistics and supply chain support throughout the country

In this scenario, just putting in place a legal framework for drug prescription in generic names, as the Prime Minister has articulated, may bring some temporary relief, but won’t be a long-term solution for public health care needs. There arises a crying need to put in place an appropriate Universal Health Care (UHC) model in India, soon, as detailed in the National Health Policy 2017.

Brand names aren’t going to disappear:

Prime Minister Modi’s assertion to bring in a legal framework under which doctors will have to prescribe generic medicines, probably will also legally empower the retailers for substitution of high priced branded generics with low priced generic or branded generic equivalents.

This promise of the Prime Minister, when fulfilled, will facilitate making a larger quantum of lower price and high quality generic drugs available to patients, improving overall access to essential medicines. Hopefully, similar substitution will be authorized not just for the JAS outlets, but by all retail drug stores, as well.

Brand names for generic drugs will continue to exist, but with much lesser relevance. the Drugs & Cosmetic Rules of India has already made it mandatory to mention the ‘generic names or INN’ of Drugs on all packing labels in a more conspicuous manner than the trade (brand) name, if any. Hence, if a doctor prescribes in generic names, it will be easier for all retail pharmacists and even the patients, to choose cheaper alternatives from different available price-bands.

Possible changes in the sales and marketing strategies:

If it really happens, the strategic marketing focus should shift – from primarily product-brand marketing and stakeholders’ engagement for the same, to intensive corporate-brand marketing with more intense stakeholder engagement strategies, for better top of mind recall as a patient friendly and caring corporation.

Similarly, the sales promotion strategy for branded generics would possibly shift from – primarily the doctors to also the top retailers. It won’t be unlikely to know that the major retailers are participating in pharma company sponsored ‘Continuing Pharmacy Education (CPE)’ in similar or even more exotic places than the doctor!

There are many more.

International examples:

There are enough international examples on what Prime Minister Modi has since proposed in his speech on this issue. All these are working quite well. To illustrate the point with a few examples, I shall underscore that prescribing in generic name or in other words “International Nonproprietary Name (INN)’ is permitted in two-thirds of OECD countries like the United States, and is mandatory in several other nations, such as, France, Spain, Portugal and Estonia. Similarly, pharmacists can legally substitute brand-name drugs with generic equivalents in most OECD countries, while such substitution has been mandatory in countries, such as, Denmark, Finland, Spain, Sweden, Italy. Further, in several different countries, pharmacists have also the obligation to inform patients about the availability of a cheaper alternative.

However, the naysayers would continue saying: ‘But India is different.’

Impact on the pharma industry:

The March 2017 report of ‘India Brand Equity Foundation (IBEF)’ states that Indian pharmaceutical sector accounts for about 2.4 per cent of the global pharmaceutical industry in value terms, 10 per cent in volume terms and is expected to expand at a Compound Annual Growth Rate (CAGR) of 15.92 per cent to US$ 55 billion by 2020 from US$ 20 billion in 2015. With 70 per cent market share (in terms of value), generic drugs constitute its largest segment. Over the Counter (OTC) medicines and patented drugs constitute the balance 21 percent and 9 percent, respectively. Branded generics constitute around 90 percent of the generic market. In my view, if the above decision of the Prime Minister is implemented the way I deliberated here in this article, we are likely to witness perceptible changes in the market dynamics and individual company’s performance outlook. A few of my top of mind examples are as follows:

No long-term overall adverse market impact is envisaged, as ‘the prices of 700 essential medicines have already been capped by the National Pharmaceutical Pricing Authority (NPPA). However, some short-term market adjustments are possible, because of several other factors.

There could be a significant impact on the (brand) market shares of various companies. Some will have greater exposure and some lesser, depending on their current sales and marketing models and business outlook.

Valuation of those companies, which had acquired mega branded generics, such as Piramal brands by Abbott Healthcare, or Ranbaxy brands by Sun pharma, may undergo considerable changes, unless timely, innovative and proactive measures are taken forthwith, as I had deliberated before in this blog.

Together with much awaited implementation of the mandatory Uniform Code of Pharmaceutical Marketing Practices (UCPMP) sooner than later, the sales and marketing expenditure of the branded generic players could come down significantly, improving the bottom-line.

Pharma marketing ballgame in this segment would undergo a metamorphosis, with brighter creative minds scoring higher, aided by the cutting-edge strategies, and digital marketing playing a much greater role than what it does today.

A significant reduction in the number of field forces is also possible, as the sales promotion focus gets sharper on the retailers and digitally enabled patient engagement initiatives.

The above examples are just illustrative. I hasten to add that at this stage it should not be considered as any more than an educates guess. We all need to wait, and watch how these promises get translated into reality, of course, without underestimating the quiet lobbying power of the powerful pharma industry. That said, the long-term macro picture of the Indian pharma industry continues to remain as bright, if appropriate and timely strategic interventions are put well in place, as I see it.

In conclusion:

It is an irony that despite being the 4th largest producer of pharmaceuticals, and catering to the needs of 20 percent of the global requirements for generic medicines, India is still unable to ensure access to many modern medicines to a large section of its population.

Despite this situation in India, Prime Minister Modi’s encouraging words on this issue have reportedly attracted the wrath of some section of the pharma industry, which, incidentally, he is aware of it, as evident from his speech.

Some have expressed serious concern that it would shift the decision of choosing a specific generic formulation of the same molecule for the patients from doctors to chemists. My counter question is, so what? The drug regulator of the country ensures, and has also repeatedly affirmed that there is no difference in efficacy, safety and quality profile between any approved branded generic and its generic equivalents. Moreover, by implementing an effective track and trace system for all drugs, such misgiving on spurious generic medicines, both with or without brand names, can be more effectively addressed, if not eliminated. Incidentally, reported incidences of USFDA import bans on drug quality parameters and breach of data integrity, include many large Indian branded generic manufacturers. Thus, can anyone really vouch for high drug quality even from the branded generics in India?

Further, the expensive branding exercise of essential medicines, just for commercial gain, and adversely impacting patients’ access to these drugs, has now been questioned without any ambiguity, none else than the Prime Minster of India. The generic drug manufacturers will need to quickly adapt to ‘low margin – high volume’ business models, leveraging economies of scale, and accepting the stark reality, as was expressed in an article published in Forbes – ‘the age of commodity medicines approaches’. Even otherwise, what’s wrong in the term commodity, either, especially when generic medicines have been officially and legally classified as essential commodities in India?

Overall, the clear signal from Prime Minister Modi that ‘prescriptions in generic names be made a must in India ‘, well supported by appropriate legal and regulatory mechanisms – is indeed a good beginning, while paving the way for a new era of Universal Health Care in India. God willing!

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

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