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Pharma In 2016 Rio Olympics

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On August 4, 2016, the ‘Adweek’ – a well-known weekly American advertising-trade publication, reported that even a day before the games began, the national ad sales revenue of just one major network in ‘2016 Rio Olympics’ had set a new record for itself, exceeding a never before turnover of US$ 1.2 billion. This figure is believed to be the most of any network for any media event in the history of the United States, and includes broadcast, cable and digital advertising.

The strongest advertising categories include automotive, beverages, telecommunications, insurance, movie studios and pharmaceuticals, as the advertisers were exceptionally bullish on Rio Games, the report highlighted.

Another report, published in the August 9, 2016 edition of ‘U. S. News’, states that the Democratic presidential nominee Hillary Clinton also aired US$ 13.6 million in campaign commercials during this Olympic games, far exceeding her nearest rival, seeking to reach the millions of television viewers who can’t skip past the commercials as they watch live coverage of the Olympics. This example underscores the perceived importance of Olympic events to various types and genres of advertisers.

My article will focus on this new found interest of many global pharma companies, their level of participation, with an idea of approximate expenditure to be incurred to run various types of ad campaigns in such well-awaited global events, held once in every four years.

The key advantages and the potential:

One of the key advantages of advertisements during Olympic games is their much larger captive audience and eyeball grabbing power, in every respect, both global and local. This, in turn, offers an attractive opportunity to the advertisers to exploit its immense potential for shaping and re-shaping public opinion and preferences, on various target areas.

Probably for this reason, a wider spectrum of new advertisers, including pharma players have now started favoring this event more than ever before.

Entry of pharma:

According to available reports, about 20 pharma brands and companies ran 293 TV ads during the coverage of Rio Olympic games. Some of these companies ran brand advertisements, while some others selected non-brand disease awareness campaigns, or in a very few instances – both.

According to real time TV ad tracker iSpot.tv, pharma contributed US$ 45 million and occupied the mid-space of the table for blockbuster TV advertisers, during the 17-day Rio events.

Two types of marketing strategies followed:

In Rio Olympics pharma companies had opted for primarily two different types of marketing strategies, as follows:

  • Product branding
  • Corporate branding, mainly through disease awareness

Global majors such as, Pfizer (for pain management – Lyrica and anti-inflammatory – Xeljanz), Novo Nordisk (Antidiabetic – Victoza), Bayer and Johnson & Johnson (anticoagulant – Xarelto) and Lundbeck and Takeda (antidepressant – Trintellix), appeared to be brand focused.

Whereas, companies such as, Merck and Mylan were disease awareness focused. Pfizer seemingly opted for both product branding and R&D focused corporate branding.

‘Product Branding’ versus ‘Corporate Branding’:

Product branding is defined as a marketing strategy wherein a business promotes and markets an individual product without the company name being at the center in the advertising campaigns.

Corporate branding, on the other hand, is broadly defined and explained as, the practice of promoting the brand name of a corporate entity, as opposed to specific products or services. The activities and thinking that go into corporate branding are different from product and service branding, because the scope of a corporate brand is typically much broader.

The success parameters:

A product branding is considered successful when it pushes up both the top and the bottom lines of the brand, with a commensurate increase in its top of mind recall and market share.

Whereas, a corporate branding is considered successful, when consumers hear or see the name of the company they will associate with a unique value and positive experiences. No matter what product or service the corporation offers, the corporate name is always an influence.

If I am to cite just one example out of many, and outside the pharma industry, I would say, ‘Apple’ has been established as a powerful corporate brand that focuses on the strength of its name as much as the features of any ‘Apple’ products.

Thus, for any successful corporate brand, the name would immediately evoke a positive reaction in the consumers’ mind, without any detailed list of product features, and for which many consumers would be willing to pay even a premium price, without any grudge or grumble.

Those who kept away from hard selling of a brand:

In Rio Olympics, as stated above, according to recent reports, some large pharma companies, interestingly, preferred to keep themselves away from hard selling of any of their brands. They, on the contrary, chose to make use of this powerful event to facilitate much wider public engagement with important and interesting health issues, like disease awareness, through craftily produced TV clips. The key intent is, of course, enhancing their corporate image to the public at large, for sustainable and long term business excellence.

A few such examples, as witnessed during Rio Olympics, are as follows:

  • Merck ran an eyeball grabbing, top class and emotional disease awareness ad for HPV vaccinations.
  • Mylan ran its “Face Your Risk” ad. This clip advises people with allergens to talk to their doctor about a prescription treatment for severe reactions, because every six minutes, someone with life-threatening food allergies is sent to the hospital.

Pfizer, in addition to brand promotion, also ran an interesting, yet fact based campaign, titled “Before it Became a Medicine”. This ad narrates an emotive story of bringing a medicine to life, which is no different from any other process of creation. It requires innovation, imagination, and restless perseverance in the face of obstacles, both expected and unforeseen.

One is a double-edged sword:

Strong high profile brand promotion in the global events such as Rio Olympics, could well be perceived as a double edged sword, having both the up and the downsides.

The upside is of course a strong boost in the sales and profit of the concerned brands. However, there is also a significant downside. When the details of huge pharma marketing expenditure, just on TV ads and also for only a 17- day event though important, would come to public knowledge, it could add more fuel to the fire on the ongoing public criticism towards humongous marketing expenditure, incurred by some pharma players, which at times exceeds the same for even R&D.

This is important, as a very large number of different stakeholders, including the patients, firmly believe that such ‘unnecessary’ expenditures on brand marketing, are ultimately passed on to the final consumers or the payers in terms of high pricing of those brands. Whereas, the possibility of triggering such type negative public opinion, with similar ads and during the similar events, with corporate brand or disease awareness campaigns, I guess, would be rather slim or improbable.

Let me hasten to add, I strongly believe that sales and marketing are absolutely necessary for pharma brands, just as any other branded consumer durables or non-durables. Nevertheless, I would also not brazenly ignore the prevailing reality, and the public optics associated with this sensitive issue, in any way.

How much does it cost?

To answer this question, I would try to give just a feel of the type of deep pocket that an interested pharma advertiser would require to have to get involved on such interesting ball game. During Rio Olympic games, the top three high spending pharma brands, reportedly, were as follows:

  • Pfizer (the pain medication Lyrica): US$ 9.1 million
  • Pfizer (the anti-inflammatory Xeljanz): US$ 5.7 million
  • Novo Nordisk (GLP-1 diabetes treatment Victoza, which featured Olympic gold medal basketball player Dominque Wilkins): US$ 9.2 million

It is worth noting that the top spending brands for consumer product such as Chrysler, spent US$ 25 million on one commercial, along with US$ 15.2 million on another. Similarly, Samsung spent US$ 17.1 million on one ad and US$ 12 million on another one.

Is there any right approach?

Instead of trying to pontificate on what sort of approach is right or wrong for pharma companies in these global events, I would only elucidate, what type of marketing approach could possibly be able to create and leave a stronger and long term residual impact on the viewers’ mind, considering the prevailing global scenario and the general sentiment towards the pharma companies, in general.

I reckon, in the events like the Olympics, it is possible for a pharma player to reap a rich harvest and get a long-term dividend with media outreach, carefully keeping away from hard-selling of clearly identifiable brands. The well-created campaigns may focus primarily on the softer aspects of public health care, such as, caring for patients, disease awareness, making life more enjoyable while fighting a disease, bringing newer drugs for better life, or even achievements in the space of corporate social responsibility.

Conclusion:

Global events such as Rio Olympics, could be well leveraged by the individual pharma players, especially to revamp the generally declining public image for greater overall business predictability and sustainability.

The types of corporate branding that some of us had witnessed in Rio Olympics, have the potential to significantly help achieving this objective.

The realization of the fast declining negative public image of pharma, in general, appears to have dawned on its global trade organizations only now. This has indeed been a long saga, though many pharma players still ignore it, rather unabashedly.

The broader impact of the creation of a positive and robust corporate public image with direct connects with consumers through the relevant ads such as on diseases awareness, could be profound, also for a sustainable business growth, even in a country like India.

Thus, the entry of pharma companies in the widely viewed global events, such as the 2016 Rio Olympics, unravels yet another new strategic platform for many other players. Its multiple judicial use, in tandem with other business blueprints, could facilitate the industry to effectively neutralize and navigate through the strong headwind of negative public perception, while managing the challenge of change.

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. 

 

The Power Of Color And Design In Pharma Branding

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On November 06, 2015, the District Court of Delaware of the United States (US) passed a temporary restraining order barring Dr. Reddy’s Laboratories (DRL) from selling in the US its generic version of AstraZeneca’s blockbuster anti-ulcerant drug Nexium, with immediate effect. 

This temporary order came in response to the petition moved by the drug innovator – AstraZeneca, objecting to the use of purple color in DRL’s generic equivalent of Nexium, launched in September 2015.

According to an estimate, this generic formulation could fetch a post tax profit of around US$25 to US$35 million to DRL in 2016. Nevertheless, the Delaware court order is pending a further hearing. The court has also asked both the companies to suggest the next course of action.

When color becomes an integral part of brand value creation: 

AstraZeneca’s effective branding of ‘purple color pills’ Nexium and Prilosec has helped the company to obtain this temporary restraining court order, which states: 

“As a result of such promotional efforts, there is undisputed evidence that the media and the public associate the color purple with AstraZeneca and its Prilosec and Nexium products.”      

The Court observed, though DRL product is not identical to AstraZeneca’s Nexium, still could confuse patients due to its association with the purple color.

In this context, it is worth noting, though a couple of other generic Nexium capsules are available in the US, none is purple in color. Teva’s capsules are green and blue and Mylan’s are white in color.

Can a right be established on branding ‘color’?

It appears so. In its Complaint to the Court against DRL, AstraZeneca (AZ) argued in favor of its successful branding of Nexium with ‘Purple Color, as follows:

  • AZ brand has offered relief to sufferers of severe heartburn and other disorders caused by stomach acid reflux through its “Purple Pills” Prilosec® and Nexium®, known as “The Purple Pill®.”
  • AZ has devoted significant resources over the years to advertise and promote its Prilosec® and Nexium® purple pills using the ‘look for’ purple advertising.                                                 
  • The preference for purple was purely for branding purposes—purple contributes nothing to the safety or efficacy of AZ’s products. 
  • AZ has continuously sold Nexium® from 2001 to present in purple colored capsules with either two or three gold-colored bands displayed on the purple capsules.
  • Thus, AZ’s Purple Pills have been famous for many years through extensive advertising both to doctors and patients and extensive publicity, among other reasons. 
  • If DRL is not enjoined from using the color purple, DRL’s purple generic pills are likely to cause confusion among consumers and others and are likely to dilute the distinctiveness of AZ’s federally registered purple color trademarks. 
  • DRL’s attempt to free-ride off the fame of AZ’s famous Purple Pills poses imminent irreparable harm to both AZ and the public if not enjoined.

I would like to remind the readers at this point that Pfizer also did branding of Viagra keeping the color of the pill as one of the key ingredients, as it is also well-known as the ‘Blue Pill’, across the world.

Does color of the pill matter to patients? 

In this regard, on July 15, 2014, an interesting study titled, “Burden of Changes in Pill Appearance for Patients Receiving Generic Cardiovascular Medications After Myocardial Infarction”, published in the journal of ‘Annals of Internal Medicine’, wanted to find out whether non persistent use of generic drugs among patients with cardiovascular disease after Myocardial Infarction (MI) is associated with the inconsistent appearance of their medications.

The study concluded, “Variation in the appearance of generic pills is associated with the nonpersistent use of these essential drugs after MI among patients with cardiovascular disease.”

Or in other words, the researchers found, 30 percent or more patients are likely to stop taking their medication because the unexpected change, can be confusing.

Impact of a branding strategy with color and design as integral parts: 

Even after a product goes off-patent, ‘Intellectual Property Rights (IPR)’ could still protect aspects of a pill design, which are not associated with product functioning.

The above study finds that in true sense, the shape and color of the tablets or capsules are very much intimately associated with the functional aspect of the product, as these characteristics established through effective branding exercise of the original product, help promoting patient compliance to various drugs, which is so important in combating serious ailments.

Effective branding with extrinsic factors: 

The above important research finding clearly establishes that even the extrinsic product features like, color and design, when used in an effective branding strategy, could have critical medical relevance for the patients.

Such clever pharma branding strategies are not just restricted to:

  • AstraZeneca’s “little purple pill” – Nexium
  • Or Pfizer’s “blue-diamond-shaped tablet” – Viagra.

There are many other examples of making extrinsic product features as effective branding tools. A few of these are as follows:

  • GlaxoSmithKline’s craftily designed a “tilt-tab” for its Parkinson’s disease brand Requip. This design makes it easier for the patients to pick up the tablets. Requip “tilt-tab” has been modeled with unconventional 5 sides and a pointed fulcrum that prevents it from lying flat.
  • Diovan blister packs of Novartis with calendar markings for pills, improved patient compliance significantly, as a research study established.
  • Special caps are now reportedly available that fit on most prescription drug bottles, containing a wireless chip that communicates with a light plug. The cap pulses orange light, when the patient forgets to take a pill.

An article published in the ‘Outsourcing-Pharma.com’ on March 11, 2014 states, Philadelphia based Colorcon, that works with many pharma manufacturers, both innovator and generic players, to shape and coat their tablets, has a library of 40,000 different colors and shapes of samples to choose from.

The color and design war in pharma branding has just begun: 

The importance of color and design as a pharma brand identity has started being realized today. The latest DRL case involving the color of AstraZeneca’s Nexium, close on the heels of similar other cases related to the blue color of Pfizer’s Viagra, has thrown open a critical question.

This query wants a specific answer, whether IP protection on Trademark would get extended to distinctive colors, which through branding initiatives have become strongly associated with a specific brand. Possibly the unprecedented lawsuit on the subject by AstraZeneca against DRL would ultimately settle the legal aspect of the issue, decisively.

Nevertheless, the importance of color and design as two key ingredients of successful pharma branding would remain unchallenged from ‘creative marketing’ stand point.

Conclusion:

There are market research studies that suggest that around 80 percent of visual information for any brand is related to color and design. Pharmaceuticals are no exceptions. Thus, these important extrinsic product features can be strategically leveraged with the intrinsic product benefits in a branding exercise, to create a cutting edge value synergy.

In today’s environment of innovative branding strategy, the state of art tablet color and design technologies may be appropriately utilized by the pharma players to successfully build and also to get limited brand protection, as happened in the case of Nexium of AstraZeneca.

The research findings, as mentioned above, that such type of branding has important medical relevance too, may be construed as an additional silver lining to this exciting process.

In my view, the aforesaid strategy would make enormous sense for branded generic drugs too, though with tailor-made approaches, which could well be a different discussion altogether.

Keeping all this in perspective, I reckon, innovative use of the power of color and design in pharma ‘branding’ exercise, including a comprehensive communication strategy with appropriate platforms, could provide an important leading edge for significant commercial success of a brand.

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.

 

Corporate Branding In Pharma: An Evolving Strategy In The Emerging Scenario

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Pharma advertisements in the mass media do not appear too frequently in India, for various reasons. Though few and far between, whenever these appear are mostly blunt and boring.

In that context, an interesting advertisement of a global pharma major featured in the May 25, 2015 Mumbai edition of the ‘Times of India’ arrested my curious attention.

The Ad does not talk about any medicine, nor does it caution us about or prevention of any disease. It does not even present the laundry lists of symptoms, urging us to rush to a doctor, whenever we experience any of those.

Though I was rushing thorough the pages of a bunch of newspapers at that time, under constraint of meeting an important deadline, the advertisement did prompt me to go into it. My eyes unknowingly followed the creative delivery of an intangible, yet unique ‘life style’ value proposition: “Life. To the fullest.” This was packaged with an innovative mix of intelligent copy writing and selection of emotive visuals with soft play of colors.

With a crisp copy, the Ad fondly takes one to the days of childhood, as it whispers…

“Remember when you were a child? The world was there just for you, to explore with bold and unbridled curiosity. A feeling of invincibility. Health fuels this state of mind, no matter your age.”

It then guides one’s attention to the corporate brand that commits to fulfill this promise and again with a cool swish tone:

“Abbott is about the power of health. We create new solutions – across the spectrum of health, for all stages of life. So every day can be just another play day.”

An innovative global ‘Corporate Branding’ strategy:

‘Wall Street Journal (WSJ)’ reported in December 2014 that in Rio de Janeiro, the same company created a WiFi channel for subway riders to listen to TED talks on their cellphones.

In Mumbai too, the Company has reportedly helped sponsor the TEDx Gateway convention, where there was an “Abbott Hive” room for participants to see new health technologies and meet speakers.

The WSJ article also underscored, “emerging markets accounted for about 40 percent of Abbott’s US$21.8 billion total sales n 2013. The sector will rise to about half of Abbott’s revenue after Mylan Inc. completes the acquisition of Abbott’s business that sells generic drugs in developed markets.”

Abbott reportedly planned to sell its generics business in the developed markets outside the United States to Mylan, retaining its generic brands in the fast-growing emerging markets.

Besides the above print Ad, I also noticed Abbott’s outdoor ‘Corporate Branding’ campaign in a couple of hoardings on Marine Drive and the Western Express Highway of Mumbai.

Just an example:

Before proceeding further, let me hasten to add that I have no intention, reason or motive to highlight any particular company’s marketing campaign, directly or indirectly, other than using it just as an example.

I reckon, this might leave a catalytic impact on an evolving frontier with a newer approach to ‘Corporate Branding’ within the global pharma industry in general and India in particular.

Such pragmatic and innovative strategic approach to create a novel corporate pharma marketing platform is indeed interesting. The domain experts in this area would be keenly watching its progress and would try to assess the net outcome of this seemingly cutting edge value creation process, on the pharma business as a whole.

It assumes greater significance as the process eventually aims at connecting with the consumers directly, creating an intangible value based robust cerebral link to overall brand portfolio offerings.

‘Corporate Branding’ versus ‘Product Branding’:

Corporate branding is broadly defined and explained as, “The practice of promoting the brand name of a corporate entity, as opposed to specific products or services. The activities and thinking that go into corporate branding are different from product and service branding because the scope of a corporate brand is typically much broader.”

Product branding, on the other hand, is “a marketing strategy wherein a business promotes and markets an individual product without the company name being at the center in the advertising or promotional campaigns.”

The success parameters:

Corporate branding is considered successful, “when consumers hear or see the name of the company they will associate, with a unique value and positive experiences. No matter what product or service the corporation offers, the corporate name is always an influence.”

If I am required to cite just one example out of many, and outside the pharma industry, I would say, ‘Apple’ has been established as a powerful corporate brand that focuses on the strength of its name as much as the features of any ‘Apple’ products.

The products usually attract a premium:

For a successful corporate brand, the name would immediately evoke a positive reaction in the consumers’ mind, without any detailed list of product features, and for which many consumers would be willing to pay a premium price, without any grumble.

Would it move the needle?

That’s really something to watch for. However, it holds that promise, undoubtedly.

The above types of corporate branding could help the concerned companies to significantly dilute the negative perception on a section of ‘Big Pharma’ constituents, acquired over a long period of time, though some of these players keep creating it even today, brazenly. This is happening as some of them continue faltering to even ‘talk the walk’ and most others do not probably want to ‘walk the talk’ either.

That said, the strength of the corporate brand image and the trust thus created on it would help building a strong positive image for the entire brand portfolio that the company offers, especially on brand promises, including efficacy, safety and overall high quality standards.

Broader impact of creation of a strong positive corporate public image with direct connects with consumers could be profound from sustainable business growth perspective, especially in a country like India.

Thus, innovative corporate branding strategies with direct connects to the consumers, like what we are discussing now, may help repositioning the pharma players as trusted healthcare partners.

‘Corporate branding’ initiatives of global pharma companies:

As reported by the ‘Wall Street Journal’, examples of initiatives taken towards this direction by some global pharma majors, besides Abbott, are as follows:

Pfizer’s “Get Old” campaign, though predominantly Internet and social media based, is aimed partly to strengthen its corporate reputation. With this campaign the company intends giving a new push to get people talking about their fear of aging, “Face your fears” being the company’s motto with its “Get Old” campaign.

Pfizer is reportedly also planning to showcase itself as “partners in health over a lifetime,” through corporate branding campaigns.

Johnson & Johnson launched a corporate advertising campaign, under the slogan “For All You Love,” focused on consumers, reportedly after the company faced recalls of children’s Tylenol and other over-the-counter medicines.

Eli Lilly & Co also has reportedly been planning to revamp its corporate brand.

Recently Biogen Idec changed back from the decade-old merger name to its original name, as the company would now be called just “Biogen”. The company used this name change to signal a new direction for the company.

The announcement of the change in name and the new logo was creatively used by Biogen to communicate the company’s broader focus beyond the multiple sclerosis treatments, which it is best known for, with the inclusion of Alzheimer’s and ALS treatments in its research and marketing portfolios.

Conclusion:

All these boil down to the important point, that the pharma marketers would ultimately be prompted to ponder, as the industry moves on.

Keeping that in mind, they may now consider brain storming with an open mind to crystallize their thought on: Whether for sustainable excellence in pharma business, the respective companies should focus on corporate branding campaigns, separately altogether, with strong and direct consumer emotional connects.

Thereafter, strengthening association between the ‘Corporate’ and ‘Product’ brands at appropriate times, directly or indirectly, could well be a strategic call.

It has been amply proved that a robust corporate brand, created painstakingly over time, would evoke stronger respect, trust and loyalty of the consumers.

While navigating through unpredictable business environment facing tough headwinds, or during product mishaps, if any, such favorable disposition of the consumers to the company as such, would prove to be an invaluable asset, in the long run. Nestle could well be an example after its Maggi saga in India.

For this reason, I reckon; it may be prudent keeping product brands at arm’s-length from the corporate brand. This could, of course, be leveraged as a dependable cushion, if situation so warrants. Otherwise ‘Corporate Branding’ campaigns should fly solo, as these keep reaping tangible and intangible sustainable significant returns for the company, over a long period of time.

To sum up, ‘Corporate Branding’, though currently is an evolving strategy in the emerging pharma scenario, shows immense potential to spread its wings to fly. Some global pharma players have already started initiating it in different parts of the world. Pharma industry in India too is expected to catch up with this new strategic ball game… sooner.

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.

Does ‘Free-Market Economy’ Work For Branded Generic Drugs In India?

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On April 20, 2015, a panel of 31 lawmakers of the Standing Committee on Chemicals and Fertilizers tabled its report in the Indian Parliament. The committee emphasized that patients in India should have access to all medicines, including life saving drugs, at affordable prices. Accordingly, it recommended expansion of the scope of price control to all medicines available in the country.

The Committee wondered why all medicines are still not listed in the ‘National List of Essential Medicines (NLEM)’ and is of the view that drugs of all kinds are essential and are required by the patients for treatment of various disease conditions.

Currently, the National Pharmaceutical Pricing Authority (NPPA) has fixed prices of 509 formulation packs, covering 348 drugs, based on NLEM, as specified in the Drugs Price Control Order (DPCO) 2013. Such price controlled essential drugs currently contribute less than 18 percent of the total pharmaceutical market of India in value terms. Whereas, according to reports, total number of formulation packs in India would be much over 60,000.

The panel noted that the ceiling prices of even all those medicines, which should come under price control under DPCO 2013, are yet to be announced by the NPPA. Accordingly, it advised the Government to expedite the process of notifying ceiling prices for all the remaining medicines featuring in the NLEM, without further delay.

The Parliamentary Standing Committee observed that Rs 17,944 Crore was spent in 2013-14 to import medicinal and pharmaceutical products. It expressed dissatisfaction on the Department of Pharmaceuticals’ (DoP) explanation that imports were made on quality and economic considerations and not necessarily because the products were unavailable at home.

“The Committee is of the strong view that to realize the dream of ‘Make in India’ concept in pharmaceutical sector, the government should boost and incentivize domestic bulk drug industry and discourage Indian pharmaceutical firms from importing”, the report said.

It also observed that to make India self-reliant in this area, revival of sick public sector units was necessary to create capacity of bulk drugs. The Committee urged the DoP to expedite formulation of ‘Make in India’ policy for APIs (active pharmaceutical ingredients) in India.

Indictment against the DoP:

The committee reportedly came down heavily on the DoP for its inability to utilize funds allocated for various purposes, which clearly speaks about “the poor performance of the department in utilization of its plan allocation.”

The report clearly mentions, “The committee therefore feels that department could not achieve its avowed objectives and targets set for various scheme/programs unless the funds are utilized by the department optimally and efficiently.”

Stating that the department “should make earnest efforts for optimum utilization of funds allocated to them”, the committee expressed it would “like to be apprised of the initiatives undertaken by the department in this regard”.

A quick recapitulation:

In may 2012, the Department Related Parliamentary Standing Committee on Health and Family Welfare in its 58th Report also expressed great concern on rampant prescription of irrational and useless drugs by many doctors with ‘ulterior motives’ and expressed the need of inclusion of the essential and lifesaving drugs under strict price regulation.

As it usually takes a very long time to effect any perceptible change in India, the above critical observations, as well, remained virtually unattended, even today.

Does ‘Competition’ impact Branded generic pricing?

I am personally a strong believer of ‘free-market economy’, driven by ‘market competition’, for the industrial sectors in general. It ensures rapid economic progress and growth, creating much needed wealth to cater to the growing needs of various kinds for the citizens of a nation.

However, I would strongly argue that Indian pharma industry is one of the key exceptions in this regard; as it is basically a branded generic market contributing over 90 percent to the total domestic pharmaceutical retail market.

Although, domestic market of branded generic drugs is quite crowded with a large number of respective ‘brands’ of exactly the same off-patent molecule/molecules available at widely different price ranges, patients do not derive any economic benefit out of such intense competition in a ‘free-market economy’. This happens, as the patients have no say or role in the brand selection process of the doctors to choose a price of their likings and affordability, especially when the basic drug/drugs are the same for all those brands.

Examples of huge rice variation in branded generics of the same drug:

A Research Paper published in The Indian Journal of Applied Research’ of May 2014, titled, “Cost Variation Study of Anti-diabetics: Indian Scenario” observed as follows:

“In Single drug therapy, among sulfonylurea group of drugs, Glimepiride (2 mg) shows maximum price variation of 829.72%, while Glipizide (10mg) shows minimum variation. In Meglitinides groups of drugs Repaglinide (0.5mg) shows maximum price variation 194.73% and Nateglinide (120mg) shows Minimum price variation. In Biguanides & Thizolidinediones groups of drugs, Metformin (500 mg) & Pioglitazone (15 mg) show maximum price variation of 384.18% & 600 % respectively. In α-glucosidase inhibitor group of drugs, Voglibose (0.2mg) shows maximum price variation of 387.17%, while Miglitol (25mg) shows minimum price variation.”

“In combination therapies, Glimepiride+Metformin (1+500mg) combination shows the maximum variation up to 475 %. In case of Insulin Premixed 30/70 100IU/ml shows maximum price variation of 1881.24%, while minimum variation is found with short acting 40IU/ml.”

Similar scenario prevails virtually in all therapy categories in India.

No qualms on branding:

It is understandable that generic drugs are branded o create differentiation even within exactly identical drugs. There are no qualms on branding per se, which comes at a reasonably high cost though. However, the question is, who pays for this branding exercise and for what additional tangible value/values?

If no additional tangible value is added to a generic medicine through branding, why should most of the patients sweat to pay significantly extra amount, just to help the pharma companies fighting with each other to increase their respective pies of revenue and profit?

Why drug price control in a ‘Free Market Economy’?

It is indeed a very pertinent question. Equally pertinent answers are also available in a 2014 paper titled, “Competition Issues in the Indian Pharmaceuticals Sector” of Delhi School Economics (DSE). The paper deals with issues related to failure of ‘Free Market Economy’, despite intense competition, especially for branded generic drugs in India.

In an ideally free-market economic model, for each of these brands of identical drugs, having similar regulatory approvals from the Indian drug regulator on efficacy, safety and quality standards, competitive forces should have prompted uniform or at least near uniform prices for all such products.

Any brand of the same drug/drugs charging more, should generally have attracted lesser customers, if consumers would have exercised their purchase decisions directly; efficacy, safety and quality standards being the same, as certified by the drug regulator.

Interestingly, for prescription medicines, the much proven process of consumers exercising their free choice to select a brand, influenced by advertising, does not happen at all.

Branded generics pricing paradox:

In the pharmaceutical market place, the scenario is almost just the reverse of what should happen in a highly competitive ‘free market’ model.

This means, highest priced branded varieties of identical drugs, mostly enjoy highest market share too. This in turn proves that competition within the pharma brands do not bring down the prices, benefiting the consumers/patients.

Branding of generic drugs:

Unlike many developed nations, in India, even the off-patent generic drugs are branded and differentiated on flimsy perception based intangibles to the prescribers, along with other contentious and dubious sales tools, decrying unbranded generics.

This is done in the guise of so-called pharma ‘sales and marketing’ strategies, which are sometimes shrewd and many times equally blatant, if not crude.

The DSE paper, very clearly says, ‘head to head’ competition between undifferentiated (non-branded) products would certainly cause a precipitous fall in prices.

However, it is generally believed, the prescription demand of branded generic drugs is basically created by influencing the prescribing behavior of the medical practitioners. Not just by personal selling through medical representatives, medical advertising and publicity of different types, but also through a chain of processes that many stakeholders, including the Government and law-makers generally consider as grossly unethical.

In January 2015, the Government directive for implementation of the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ by the pharma industry in India, further reinforces the point.

 ‘Dorfman-Steiner’ condition vindicated:

The above paper from the DSE underscores the old and well-established ‘Dorfman-Steiner’ condition that mathematically proves that the price-cost margin is positively related to the ratio of advertising expenditure to sales revenue.

Quoting a practicing surgeon, the DSE article states:

“Sometimes it could be just plain ignorance about the availability of a cheaper alternative that makes doctors continue to prescribe costlier brands. But one cannot ignore the role of what are euphemistically called marketing “incentives”, which basically mean the inappropriate influence pharmaceutical companies exert on doctors. This runs deep. Hospitals choose to stock only certain drugs in their in-house pharmacies and insist that hospitalized patients buy drugs only from the hospital pharmacy. Drug companies sell drugs to hospitals at a price much lower than what the patient is charged, further incentivizing the hospital to stock their products. The cheaper brands often get left out in this game.”

Reasons for success of high-priced branded generics:

Low priced non – branded cheaper generics have been systematically made to perceive as of low quality. In several media reports, including some recent ones even some well-known doctors castigated the low priced non- branded cheaper generics. Pharma industry lobby groups, in tandem, has been strongly resisting various Government initiatives of un-branding the generic drugs.

Over a long time, a common public perception has been painstakingly created that high-priced branded generics are more of high quality; MNC brands are of better quality than their ‘Desi’ counterparts and branded generics are more reliable than their non-branded equivalents.

This perception is fuelled by poor enforcement of the Drugs and Cosmetics Act of India that also regulates drug-manufacturing standards in the country, besides the prevailing overall drug regulatory scenario in the country.

The New Government attributes “Market Failure for pharmaceuticals”:

In its price notification dated July 10, 2014, the NPPA has categorically stated the following:

  • There exist huge inter-brand price differences in branded-generics, which is indicative of a severe market failure, as different brands of the same drug formulation, which are identical to each other in terms of active ingredient(s), strength, dosage, route of administration, quality, product characteristics, and intended use, vary disproportionately in terms of price.
  • It is observed that, the different brands of the drug formulation may sometimes differ in terms of binders, fillers, dyes, preservatives, coating agents, and dissolution agents, but these differences are not significant in terms of therapeutic value.
  • In India the market failure for pharmaceuticals can be attributed to several factors, but the main reason is that the demand for medicines is largely prescription driven and the patient has very little choice in this regard.
  • Market failure alone may not constitute sufficient grounds for government intervention, but when such failure is considered in the context of the essential role of pharmaceuticals play in the area of public health, which is a social right, such intervention becomes necessary, especially when exploitative pricing makes medicines unaffordable and beyond the reach of most and also puts huge financial burden in terms of out-of-pocket expenditure on healthcare.

Civil Society echoed the same sentiment:

In this context, it is important to note that in a letter dated August 20, 2014 written by seven large Civil Society Organizations to Mr. Ananth Kumar, the present Minister of Chemicals and Fertilizers with a copy to Prime Minister Modi, articulated similar view, as follows:

“Limiting all price regulation only to a list of 348 medicines and specified dosages and strengths in the DPCO 2013 goes against the policy objective of making medicines affordable to the public. The National List of Essential Medicines, a list of 348 rational and cost-effective medicines, is not the basis for production, promotion and prescription in India. In reality the most frequently prescribed and consumed medicines are not listed in the NLEM.”

I broached on a similar issue in my blog post of April 6, 2015 titled, “Would Affordable ‘Modicare’ Remain Just A Pipe Dream In India?”

An opposite view: ‘Bad Medicine’

On April 23, 2015, an Editorial with the above headline, articulating exactly opposite viewpoint, was published in a leading English business daily.

With all due respect to the concerned editor, it appeared quite funny, if not ‘hilarious’ to me for several reasons. One of which is seemingly total lack of understanding on the issue by the concerned editor.

I am quoting below some of the most obvious ones, just to cite as examples:

A. Quoting the above recommendation of the Parliamentary Standing Committee on drug price control the Editorial states:

“Not only will this make investors from other countries look at India with suspicion – Japanese pharma firm Daiichi just exited its disastrous investment in Ranbaxy (later taken over by Sun Pharma) – it will ensure Indian patients are deprived of good quality medicines.”

It is known to everybody that drug price control in India had got nothing to do with the exit of Daiichi. It was primarily due to import bans by the USFDA, caused by alleged falsification of GMP related data in Ranbaxy’s manufacturing plants selling drugs to America.

B. The Editorial continues:

“So much for Make-in-India—the other problem with price controls is that, with little incentive to invest in fraud-prevention, between a fourth and a third of India’s pharmaceuticals production is estimated to be spurious. Also, price caps have resulted in a situation where R&D expenses are very low, and there is little research on drugs of particular relevance to India.”

Again, it is much known fact that over 82 percent of Indian pharmaceutical market is currently outside price control, offering free-pricing opportunity. What does then prevent the drug companies to come out robust ‘fraud-prevention’ measures for all those free-pricing drugs?

C. The Editor stated:

“Since Indian prices are amongst the lowest in the world, it is not clear what exactly the committee had in mind, more so since costs of medicine are not, in any case, the most expensive part of medical treatment.”

Of course, all concerned knows that lowest range of generic drug prices in India, are perhaps the cheapest in the world. However, the point is, should it be considered in isolation? Not in relation to per capita income of the Indians? Not in terms of Purchasing Power Parity? In drug pricing context, one Committee Report of the DoP had shown, when adjusted against these two factors, drug prices in India are as high, if not more, as compared to the developed countries of the world.

I hasten to add that I fully resect all different view points. If I have made any mistakes in understanding this piece of bizarre editorial, I am more than willing to stand corrected with all humility, as this a very serious issue of ‘what is right’ and NOT ‘who is right’.

Conclusion:

India is a market of branded generics, where brand differentiation process involves creation of mostly unsubstantiated perceptions.

As the stakeholders, media and even the Indian Government have alleged, drug companies exert a strong influence in the brand prescription decision of the doctors, even at the cost of patients who cannot afford the same.

Even in a free-market economy with cutthroat competition, patients do not have any means to exercise their price preferences even within identical branded generic drugs. They are compelled to buy high priced brands, as prescribed by their doctors, even where low priced identical equivalents are available.

This condition gives rise into ‘Market Failure’, especially for branded generics in India. The NPPA has unequivocally enunciated it, which I have quoted above.

Being a strong believer and votary of ‘free-market economy’ and ‘market competition’, I find this pharma scenario unique. It is a rare example of failure of otherwise so successful free-market economy model, especially in the branded generic pharma space of India.

Around a decade ago, the ‘Indian Journal of Medical Ethics’ (IJME, January – March 2004 issue) captured the very essence of this deliberation, epitomized in the following sentence:

“If the one who decides, does not pay and the one who pays, does not decide and if the one who decides is ‘paid’, will truths stand any chance?”

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.

 

Does branding of generic drugs offer value to the patients in India?

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It appears that the government has accepted the submission of the ‘Parliamentary Standing Committee for Health and Family Welfare’ made to the ‘Rajya Sabha’ of the Indian Parliament on August 4, 2010, recommending prescription of medicines by their generic names.

It has now been reported that the Drugs Technical Advisory Board (DTAB) has already considered the proposal to amend the rules of the Drugs and Cosmetics Act of India for approval of all drug formulations containing single active ingredient only in the generic names by the State Licensing Authorities. The proposal to publish the draft rules has been forwarded to the Ministry of Health for necessary approval. The Fixed Dose Combinations (FDC) will be kept out of the purview of this amendment.

This recommendation of the  ‘Parliamentary Standing Committee for Health and Family Welfare’  appears to be based on the premises that the ‘Brand Building’ exercise of the generic drugs in India, includes ‘very high sales and marketing expenditure’, which  can easily be eliminated to make medicines available to the common man at much cheaper prices. ‘Jan Aushadhi’ scheme of the Government is often cited as an example to drive home this point.

This recommendation, on the face of it, makes immense sense. However, the moot question remains, “Is it a practical proposition to implement in India?”

The generics and the branded-generic drugs and their value proposition: As we know generic name is the actual chemical name of a drug. The brand name is selected by the producer of a formulation and is built on various differential value parameters for its proper position in the minds of health professionals as well as the patients. Thus, brand names offer a specific identity to a chemical name in their value proposition.

Some other countries are also taking similar steps:

Just to cite an example, as reported by ‘The Guardian” on August 23, 2011, the Spanish government recently enacted a law compelling the doctors of Spain to prescribe generic drugs rather than more expensive patented and branded pharmaceuticals, wherever available. This move is expected to help the Spanish government to save €2.4 billion (£2.1billion) a year, as in Spain the drugs are partly reimbursed by the government.

As a result, the doctors in Spain will now have to prescribe only in the generic or chemical names of the respective drugs. Consequently the pharmacies will be obliged to dispense ‘the cheapest available versions of drugs, which will frequently mean not the better-known brand names sold by the big drugs firms’.

Quality standards of both generic and branded generic drugs are no different:

Drugs and Cosmetics Act of India requires all generic or branded generic drugs to have the same quality and performance. Thus when a generic drug is approved by the drug regulator, one should logically accept that it has met the required standards with respect to identity, strength, quality, purity and potency. It is not uncommon that there could be some variability taking place during manufacturing process for both branded generic and generic drugs and for that matter it is applicable to all drugs. However, all formulations of both types of these drugs manufactured by different manufacturers do not need to contain the same inactive ingredients.

In any case, all formulations of both generic and branded drugs must be shown to be bioequivalent to the reference drugs with similar blood levels to the respective reference products. Regulators even in the USA believe that if blood levels are the same, the therapeutic effect will be the same.

A recent study:

As reported by the US FDA, ‘A recent study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand-name counterparts. There was no evidence that brand-name heart drugs worked any better than generic heart drugs. [Kesselheim et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21)2514-2526]‘.

Prescriptions for generic medicines were a record high in America in 2010:

As per published reports, last year i.e in 2010, generic medicines accounted for more than 78%  of the total prescriptions dispensed by retail chemists and long-term care facilities in the US. This is a record high and is four percentage points more than what it was in 2009 and came up from 63% as recorded in 2006.

Points to ponder and resolve in the current Indian situation:

While the intention of the Government is indeed good, some practical issues must be considered before its implementation, which are as follows:

1. Increased chances of error while dispensing:

Chemical names of medicines are complex. In case of any mistake of dispensing the wrong drug by the chemist inadvertently, the patients could face serious consequences.

2. There could be differences even within single ingredient formulations:

Different brands of even single ingredient medicines may have inherent differences in their formulations like, in the drug delivery systems (controlled/sustained release), kind of coatings allowing dissolution in different parts of alimentary canal, dispersible or non-dispersible tablets, chewable or non-chewable tablets etc. Since doctors are best aware of their patients’ conditions, they may wish to prescribe a specific type of formulation based on specific conditions of the patients, which may not be possible by prescribing only in generic names.

3. Price differences between branded generics and generic generics may not exist:

It is intriguing to fathom, just for a switch over from the brand name to the generic name how will the Maximum Retail Price (MRP) of a single ingredient formulation, bearing only the generic name, come down. Currently, MRPs printed on the product packs of generic formulations without any brand name, as available in the retail outlets, are similar to comparable branded generic formulations. In that case, what benefits that Government will expect a patient to get out of this well hyped change?

4. Manufacturers may switch from single ingredient formulations to FDCs:

There is a theoretical possibility that to retain brand names, the pharmaceutical companies may be encouraged to change their formulations from single ingredient to FDCs. In that situation, single ingredient formulations may not be available and comparable FDCs could cost more to the patients.

5. The key decision will shift from physicians to retail chemists:

The major issue with prescriptions by the chemical/generic names is that retail chemists will then be the sole decision makers to choose the prescribed product from within a whole lot of over 30 to 40 manufacturers for a particular product.

What then will prompt the retailers to buy, store and sell different generic formulations of various companies and what could possibly be the key selection criteria for such drugs by them?

I reckon, there could only be one criterion for the choice of such medicines by a chemist i.e. to select only those which will give them highest margin of profits.

In such a case, the ultimate decision making authority for the prescription medicines shifts from the physicians to the chemists. This could make the situation far worse for the patients.

In interest of the patients, it is, therefore, extremely important that the government, regulators, physicians, chemists and even the patients’ groups are aware of such risks and ensure that patients are not adversely impacted in any way.

Conclusion: Viewing purely from the Indian perspective, while the generic drugs per se are not bad for the patients, weighing all the above issues and possible risk factors against expected benefits, I reckon, without effectively addressing the above issues to start with, if the prescriptions of single ingredient formulations are made mandatory only in generic names, it could seriously jeopardize patients’ safety and interest.

In any case, when single ingredient formulations contribute just around 30% of the total prescriptions in India, how could then prescriptions of all single ingredient formulations only in generic names address the stated concern of the government, in a holistic way?

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.