Tag Archives: 2016

Patient Services: No Longer An Optional Competitive Driver

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The emerging global trend of patients’ demand for greater engagement in their treatment decision making process, could well be a game changer in the prescription demand generation process for pharma brands, even in India, and in not too distant future. This would assume a critical importance not just from the patients’ perspective, but also for the pharma companies and other health care players, for commercial success.

The fast penetration of Internet services is increasingly becoming a great enabler for the patients to get to know, learn and obtain more and more information about their fitness, overall health, various illnesses, disease symptoms, available diagnostic tests, including progress in various clinical trials, besides the drugs and their prices – and all these just with several clicks.

Thus, equipped with relevant information from various dependable and user-friendly sources from the cyberspace, patients have started asking probing questions about the risks and benefits of various types of treatment decisions and diagnostics tests, when recommended by the doctors. At times, especially in the Western world, such interactions even lead to changes, additions or deletions in the choice of therapy, including drugs, devices and diagnostics tests.

Even in a developing country, such as India, many of such types of patients would no longer want to play just a passive role in their disease treatment or health and fitness improvement processes. Although, they would continue to want the doctors to take a final decision on their treatment, but only after having meaningful interactions with them.

A 2016 Report: 

An April 2016 report of Accenture titled, “The Patient is IN: Pharma’s Growing Opportunity in Patient Services,” finds that the patients in the top global pharma markets want and expect consistent services coming from the pharma companies.

These patients are increasingly seeking more services from the pharma players before they are treated for a disease, regardless of the types of illnesses they have. However, it’s more important to note that patients’ responses during this survey have clearly indicated that while they highly value the services they use, a vast majority of them do not know about the services, which, as the pharma companies claim, are already available for them.

The Accenture study covered 203 executives at pharmaceutical companies, 100 in the United States and 103 in Europe (8 countries) from October to November 2015, covering seven therapeutic areas: heart, lung, brain, cancer, immune system, bones, and hormones/metabolism. Annual revenues of the surveyed companies ranged from nearly US$ 1 billion to more than US$ 25 billion.

Some important findings:

Following are some key findings of this report:

1. Patient services are delivering value with a significant increase in focus, and investment expected over the next two years, with 85 percent of companies are raising their investment in patient-centric capabilities over the next 18 months. However, the companies have only become slightly more patient-centric over the past two years. 9 of the following top 10 services are attracting above average business impact, which is an increase over hopping 73 percent that currently offer such patient services:

  • Disease education
  • Patient segmentation and insight
  • Patient experience management
  • Medication delivery/support
  • Patient risk assessment
  • Wellness information and health management
  • Nurse/ physician/patient access portal
  • Medication/ treatment reconciliation
  • Patient outreach, reminders, and scheduling
  • Adherence program management

2. Digital platforms play a dominant role in making patients aware of the services offered. Thus, companies are going big with investments in digital engagement technologies and supporting analytics, with 95 percent of companies planning to invest in patient engagement technologies over the next 18 months.

3. Much of this investment (but not all) is aligned to what patients value. 50 percent of the following top 10 fastest growing services are perceived by the patients delivering significant value:

  • Benefit coverage and access support
  • Health coach/counselor
  • Adherence program management
  • Co-payment assistance programs
  • Remote monitoring
  • Affordability and reimbursement support
  • Nursing support services
  • Reward/ incentive programs
  • Medication delivery/support
  • Patient outreach, reminders, and scheduling

Out of these, ‘medication delivery and support’, ‘remote patient monitoring’ and ‘adherence program management’ were highly valued by 85, 79 and 77 percentages of patients, respectively.

To give an example, pharma companies in the United States use digital as the primary channel for direct communications for patients. They use social media (51 percent) and web pages (49 percent) to market patient services. The use of TV is around 53 percent.

The challenge:

Let me re-emphasize here, as on date, just 19 percent of the surveyed patients are familiar with already available services meant for them. This had happened, despite respective pharma companies’ basic reliance and dependence on health care professionals for dissemination of their respective well-targeted services.

Thus, lack of awareness among patients about the services provided, throws a major challenge to pharma players to accurately ascertain, finding out effective ways, and then continuously measure and evaluate the impact of those services on outcomes, to further hone the process. Such a mechanism needs to be put in place before channeling further major investments in this important space.

Key takeaways:

Following are the key takeaways from this study:

  • Patient services will become a competitive driver and are no longer optional for pharmaceutical companies.
  • Investment should be led by what patients value, but measuring business value is critical to sustainability.
  • Clear organizational and operating strategy must be in place to ensure companies are structured for success.
  • Effective communication to patients the economic value of services, is central to healthcare professional interactions.

Patient-services strategy:

Accenture’s North American Managing Director of patient-services epitomized the findings of the report during its release on April 2016 by saying, “In this changing competitive environment, the question will no longer be if life sciences companies should offer these services, but rather which ones, and how they should be implemented.”

Thus, development of a robust patient-services strategy by the pharma players, that syncs well with the patients’ needs on the ground, will be absolutely necessary for the pharma players, as we step into the future. More importantly, there should be an effective alignment of the strategy with different health care professionals, through effective communication of various types and kinds, to ensure that the brand value offerings, well supported by carefully tailored patients’ services, generate a synergistic outcome for the target group.

Conclusion:

Patient services are increasingly assuming importance of a cutting-edge competitive driver of success in the pharma business. Accordingly, various types of such services have already started attracting greater investments, especially in the Western part of the globe, and are soon expected to become a key competitive driver of success in the healthcare market of India too.

However, while crafting an effective patient-services strategy, one-size-fit-all type of approach won’t work. This is primarily because, not just the service requirements would vary within patients or patient groups, the method of the preferred service delivery mechanism would also vary. For example, some patients may prefer to engage with their doctors for this purpose, some others’ preference could well be Internet based interactive digital platforms, or through a smart app available in a smartphone.

Thus, to succeed in this area for business excellence, pharma marketers must find out the most effective ways to offer these services to each types or groups of patients.

Moreover, the patient services strategy should be an ongoing exercise, as the target groups’ needs of the types of services, and preferred delivery platforms for the same would also keep changing over time.

In India too, quite slowly though, but steadily, the process of arriving at treatment decisions for the patients is undergoing a metamorphosis. Taking a fast mover advantage in the country, in a big way and now, would help reaping a rich harvest, in the near future.

Are Indian pharma players too taking note of this shifting paradigm for sustainable business excellence?

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. 

 

At The Indian IPR Front: ‘Ground Control, There’s No Major Storm’

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The incessant pressure of the developing countries on India, from 2005 to date, to include various restrictive conditions in the Indian Patents Act 2005, still continue. This demand spans across the inclusion of even those provisions, which many experts term as TRIPS-Plus, as these are not required by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. More interestingly, the pressure group also insists on the simultaneous deletion or dilution of some existing important provisions in the statute that guarantee public health interest of the nation.

This pressure is expected to mount in the G20 summit of September 4-5, which is now being held in China.

Refreshingly, on 30 August 2016, just ahead of this summit, the eminent economist Dr. Arvind Panagariya, who is also the incumbent Vice Chairman of Niti Aayog of India, and India’s Sherpa at the G20 summit reiterated, as follows, in an interview to a leading National English Business Daily:

“India has strongly opposed the language of the draft on Intellectual Property Protection (IPR) to be taken up at the upcoming G20 meeting in Beijing.”

In the interview, having re-emphasized the critical point that “there is a certain flexibility that we have under the TRIPS agreement and anything that dilutes that flexibility is not acceptable to India,” Dr. Panagariya clearly reaffirmed, yet again that ‘Indian IPR laws and policies are absolutely TRIPS compliant’.

This statement indeed sends a very positive signal to all on the ground, regarding the robust position maintained by the Government, to ward off any move by the overseas vested business interest to derail the flexibility that Indian well-balanced patent regime offers today, not just for public health, but also to foster innovation ecosystem in the country.

At the same time, India’s Sherpa at G20 summit also reportedly clarified that the IPR framework being proposed at the G20, in its strictest sense, cannot be construed as TRIPS-Plus. Nevertheless, some language used in the proposed G20 draft could be subject to interpretation, and India feels that it should not leave any room for ambiguity that has the potential to stretch this demand further, as we move on.

According to Dr. Panagariya: “Right now, these documents have some language where people in the Department of Industrial Policy & Promotion (DIPP) feel that it impinges a bit. We have to fight it out at the summit.”

The basis of apprehension:

There are many reasons for the recent apprehension that India may buckle under the US pressure to dilute its IP laws and policies. One of the reasons could well be a possibility that India has come to an understanding with USTR in this area.

An interesting article published in the ‘spicyip’ on March 14, 2016 also captured this scenario pretty well. I am reproducing below in verbatim a paragraph of this paper, just as an example:

“Last month, the Indian government privately assured the US-India Business Council (“USIBC’’) that it would not invoke compulsory licensing for commercial purposes, as reported in their submissions (available here) to the United States Trade Representative (“USTR”) for the 2016 Special 301 Review. The USIBIC stated that it would be “further encouraged” if the government of India were to make a public commitment, or a written declaration to only issue compulsory licenses in the event of public health emergencies, and not for commercial purposes. This, in their eyes, would “greatly enhance legal certainty for innovative industries”. While such a private assurance doesn’t give rise to any legal commitments, it may well be indicative of a policy shift.”

Prior to this, among many others, a March 3, 2016 ‘The Wire’ report captioned “India Assures the US it Will Not Issue Compulsory Licenses on Medicines”, also raised the same red flag.

The pressure continues even post engagement:

Be that as it may, America has been, repeatedly, raising its concerns over India’s patent regime, driven by its powerful pharma lobby groups.

To keep the kettle boiling, the Office of the United States Trade Representative (USTR) in its 2016 Special 301 Report released this year on April 12, continued to keep India, along with 11 countries, on the Priority Watch List (PWL) for the current year.

USTR reportedly expressed serious concern about Indian IP policies stating that the regime apparently ‘favor’ indigenous manufacturing or Indian innovators. It also alleged that such direction ‘damages’ the patent infrastructure not just in India, but across the world.

It is believed by many that the Special 301 Report is, in fact, a formal posturing of the country on their unilateral IP related business hurdles for the year, exhibiting the power to implement unilateral trade sanctions when the US demands are not met.

In that context, the 2016 Special 301 Report caught many by surprise, as the Indian ‘IPR Think Tank’ (a body of the Union Government-selected experts) was also working closely with the United States to identify and address their issues of concern, such as, patent system, copyright infringement, trademark and counterfeiting, among others.

At that time, this discussion was possibly in its final stage as, just a month after, on May 12, 2016, the Union Cabinet approved the National Intellectual Property Rights Policy (IPR) of India, as proposed by the ‘Think Tank’, in consultation with, among others, especially the United States, which reportedly expressed its overall satisfaction with the final IPR policy.

Key concerns:

From the pharma industry perspective, the key IP concerns are centered, primarily, in the following three areas, besides a few others:

  • Patentability
  • Compulsory Licensing (CL)
  • Data Exclusivity

I would, therefore, concentrate briefly on these three areas to argue how reasonable is the Indian Patents Act 2005 to create a win-win situation both for the patients and the industry while fostering pharma innovation in the country.

Patentability:

One of their key concerns on patentability, revolves round an important provision in the statute – Section 3 (d).

Pharma Multinational Corporations (MNCs), and their trade associations have been going overboard, since long, to lobby hard to make all concerned believe that section 3 (d) is a stumbling block for pharma innovation, as it does not allow patent protection on known chemical substances lacking any significant improvement in clinical efficacy.

This provision of the statute prevents ever-greening of patents with frivolous incremental innovation. Consequently, it blocks the possibility of pricing such ‘me too’ new molecules, exorbitantly, and persuading the prescribers of the existing molecule switching over to the new brand, backed by contentious marketing campaigns, adversely impacting affordability and access to the majority of the patients in India.

Notwithstanding the shrill voices of vested interests, Section 3 (d) has been upheld by the Supreme Court of India in the famous Glivec case of Novartis against Cipla.

The Submission of the Federation of Indian Chambers of Commerce and Industry (FICCI) to USTR for the Review of ‘2016 Special 301 Report’, categorically also states that the Indian Patent Act prescribes a higher threshold on inventive step for medicines, which is in keeping with the TRIPS Agreement, Paris Convention and the Doha Declaration. Hence, Section 3 (d) is sound in terms of the TRIPS, Public policy and Health policy.

Compulsory License (CL):

Besides the hard fact that India has, so far, granted just one CL in a span of more than the last ten years, the Doha Declaration on the TRIPS Agreement related public health clearly provides the flexibility to all its member states to decide on the necessary grounds for granting CL. It is noteworthy that for public health interest, TRIPS flexibilities for CL has been used even by the developed countries, such as, Canada, United States and Germany, in the not too distant past.

Data exclusivity:

The terminologies ‘Data Exclusivity’ and ‘Data Protection’ are quite often used interchangeably by many, creating a great deal of confusion on the subject. However, in a true sense these are quite different issues having a critical impact on the public health interest of a nation.

In an article published in ‘ipHandbook’, titled “Data Protection and Data Exclusivity in Pharmaceuticals and Agrochemicals”, the author Charles Clift, a former Secretary, Commission on Intellectual Property Rights, Innovation and Public Health, World Health Organization; differentiated these two terminologies as follows:

Data Protection (DP): Protection of commercially valuable data held by the drug regulator against disclosure and unfair commercial use.

Data Exclusivity (DE): A time bound form of Intellectual Property (IP) protection that seeks to allow companies recouping the cost of investment in producing data required by the regulatory authority.

According to Charles Clift, Article 39.3 only articulates widely accepted trade secret and unfair competition law, and is not an invitation to create new IP rights, per se, for test data. Nor does it prevent outside parties from relying on the test data submitted by an originator, except in case of unfair commercial practices.

Some developed countries, such as the United States and the European Union have argued that Article 39.3 of TRIPS requires countries to create a regime of DE, which is a new form of time-limited IP protection. However, it is worth noting that in both these countries DE regime was adopted prior to the TRIPS Agreement. Hence, many experts construe such approaches and pressure, thus created for DE, as ‘TRIPS-Plus’.

In its new IPR Policy, India has successfully resisted the demands of TRIPs-Plus provisions, such as, data exclusivity, patent linkage and patent-term extension.

Even the draft IPR policy had reiterated that India accepts: “Protection of undisclosed information not extending to data exclusivity.”

Any near-term possibility of a change in the statute?

While the new IPR Policy of India focuses on consolidating institutional mechanisms to create a robust IPR ecosystem in the country, besides resolving some pressing issues, such as, expediting approval processes involving patents or trademarks, it does not indicate any possible change in the important provisions in the Patents Act 2005, including the much talked about Section 3 (d) and compulsory licensing, despite concerns expressed by the US and pharma companies.

Moreover, a May 13, 2016 Press Trust of India (PTI) report on the Union Cabinet approval of Indian IPR Policy quoted a Government official, as follows, negating the apprehensions that the government may yield to the pressure of developed countries with regard to its IR regime:

“India will never go beyond its current commitments in the TRIPS. Section 3 (d), patent linkage, data exclusivity and compulsory licensing are red lines.”

On the same day and in the same context, Union Finance Minister Arun Jaitley also reportedly stressed that India’s IPR policies are TRIPS-compliant and encourage invention of life-saving drugs, while at the same time, “we must also be conscious of the need to make it available at a reasonable cost so that drug cost does not become prohibitive as has become in some parts of the world”, he articulated, unambiguously.

Conclusion:

Despite all these developments, reiterations and interpretations, a lurking fear on India’s diluting the current patent regime of the nation was refusing to die down in the country.

Many experts were also quite apprehensive about what would be India’s stand on IP in the G 20 summit on September 4-5, currently being held in China.

Is it, then, just a storm in a tea cup on the ground?

This is not a very easy question to answer, though, as many industry watchers sense. Nonetheless, yet another emphatic statement on the subject coming from a top Government echelon and none other than Dr. Arvind Panagariya, the Vice Chairman of Niti Aayog and India’s Sherpa at G20 summit, possibly sends a clear message, at least for now, to all those holding ground in the Indian IPR front:

‘Ground Control, There’s No Major Storm’.

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 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. 

 

For Drug Safety Concern: “Whistleblower’s Intention Should Be Nationalistic”

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In the recent weeks, three significant developments related to the Pharmaceutical Industry in India, have triggered rejuvenated concerns in the following critical areas: 

A. Overall drug safety standards in the country

B.  Self serving interest, rather than patients’ interest, dominate the prescribing decisions

C. Government assurance to American Trade Organization on ‘Compulsory License (CL)’ in India. 

These important issues fall under three key regulatory areas of India, as follows:

  • The Central Drugs Standard Control Organization (CDSCO)
  • The Medical Council of India (MCI)
  • The Indian Patent Office

It is worth mentioning here that the Department Related Parliamentary Committee on Health and Family Welfare in its 59th Report, placed before both the houses of the Parliament on May 08, 2012, on the functioning of the Central Drug Standards Control Organization (CDSCO), begins with the following observations:

Medicines apart from their critical role in alleviating human suffering and saving lives have very sensitive and typical dimensions for a variety of reasons. They are the only commodity for which the consumers have neither a role to play nor are they able to make any informed choices except to buy and consume whatever is prescribed or dispensed to them, for the following reasons:

  • Drug regulators decide which medicines can be marketed
  • Pharmaceutical companies either produce or import drugs that they can profitably sell
  • Doctors decide which drugs and brands to prescribe
  • Consumers are totally dependent on and at the mercy of external entities to protect their interests.

Most importantly, all these concerns, if not properly clarified and appropriately addressed by the Government, soon enough, have the potential to create an adverse snowballing impact on the uniform access to affordable quality medicines, for all sections of the society in India.

Under this backdrop, I shall discuss in this article briefly, my perspective on each of these critical areas, as they are today, and not just the drug safety concerns.

The headline of this article is expected capture not only the prevailing mood of some key regulators, but also their inertia to address critical healthcare concerns and above all how the core public health related issues are getting lost, and the trivial ones are gradually occupying the center stage.

A. Overall drug quality and safety  standards in India:

A Public Interest Litigation (PIL) suit, filed against the Drugs Consultative Committee and the Central Drugs Standard Control Organization (CDSCO), was listed on the Supreme Court website for hearing on March 11, 2016.

The PIL has been filed by one Dinesh Thakur, requesting the Supreme Court to lay down guidelines by which manufacturers could be made liable for violating drug standards and also give a direction to the government to set up a ‘Drug Approvals Review Committee’ for examining criminality in the manner in which faulty drug approvals were granted. 

Many may recall that the same Dinesh Thakur worked for Ranbaxy from 2003 for two years, and is now the Chief Executive of MedAssure Global Compliance based in Florida, US. Thakur’s Company now advises pharma manufacturers on drug safety and quality standards.

As reported by Reuters, Thakur had earlier exposed how the erstwhile largest drug maker of India, Ranbaxy Laboratories, failed to conduct proper safety and quality tests on drugs and lied to regulators about its procedures. Consequently, USFDA fined Ranbaxy US$500 million for violating federal drug safety laws, and making false statements to the US regulator.

This news report further states: “Indian Parliamentary Committee, thereafter, reportedly demanded an investigation and the drugs regulator committed to one in 2013. Thakur received a statement from the health ministry last year, seen by Reuters, showing no inquiry had begun.”

On the last Friday, however, the Supreme Court of India refused to entertain this PIL of Dinesh Thakur, saying it does not have time to adjudicate academic issues, such as, need for guidelines to regulate quality of medicines.                                                  

The core issue:

The core issue here is not at all the above PIL, not at the very least. The issue is the much reported concern being expressed, over a period of time, regarding the drug safety standards in India. The reasons include breach of of data integrity, and gross violation of the ‘Good Manufacturing Practices’ standards. Such instances are being detected, almost regularly, by the foreign drug regulators, in several manufacturing facilities run by many large and small Indian drug producers.

It is well vindicated by the fact that around 45 Indian drug manufacturing plants have been banned by the USFDA alone, from shipping generic drugs to the United States, as these were considered unsafe for consumption of patients in the US. Some other foreign regulators too had taken similar action, citing similar reasons. The USFDA website specifies the details of gross violations made in each of these cases.

Ironically, all such facilities can manufacture and sell their drugs in India, as they conform to the quality requirements of the Indian drug regulator. Consequently, the Indian patients consume even those medicines, which are considered unsafe by the USFDA for American patients, innocently, as and when prescribed by the doctors.

Arising out of these incidents, when asked about the drug safety standards in India, and the public health-safety, instead of giving credible and action oriented answers for public reassurance, some of the apparently brazen replies of the DCGI are quite stunning for many stakeholders, both within and outside the shores of India.

I would now quote below just a few of those replies, just as examples. 

“…Whistleblower’s Intentions Should Be Nationalistic” -  DCGI:

According to Reuters, it has received the following response from the Drug Controller General of India (DCGI), on the above PIL related to the drug safety standards in India:

“We welcome whistleblowers, we have got great respect, but their intentions should be genuine, should be nationalistic… I don’t have any comment on this guy.”

Thus, many industry watchers feel that in a situation like this, the honorable Supreme Court of India would possibly require to intervene, just as what it did on alleged ‘Clinical Trial’ malpractices in the country or for drug price control, solely for public health interest.

The same attitude continues:

Such brazen response of the Central Drug Regulator, and that too on a serious subject, is indeed bizarre. It becomes increasingly intriguing, as the same attitude continues without any perceptible meaningful intervention from the Ministry of Health.

For example, on February 22, 2014, in the midst of a more intense scenario on a similar issue, instead of taking transparent and stringent measures, the DCGI was quoted by the media commenting:

“We don’t recognize and are not bound by what the US is doing and is inspecting. The FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver.”

On February 26, 2014, presumably reacting to the above remarks of the DCGI, the American Enterprise Institute reportedly commented, “Indian drug regulator is seen as corrupt and colliding with pharma companies…”

Such apparently irresponsible and loose comments keep continuing, despite the 2012 report of the Parliamentary Committee of India alleging collusion between some pharmaceutical companies and officials of the CDSCO, which oversees the licensing, marketing and trials of new drugs. The report also commented that the agency is both chronically under-staffed and under-qualified.

Some possible remedial measures:

As the saying goes, “better late than never”, considering all these continuing developments, it is about time to reconsider some of the key recommendations of Dr. R. A. Mashelkar Committee on a similar subject and make amendments in the relevant Act accordingly, soon, to facilitate creation of a robust with high accountability ‘Central Drugs Authority (CDA)’. It would introduce a centralized licensing system for drug manufacturing, along with stringent drug safety standards; besides, sale, export and distribution of drugs. Perhaps, the draft bill on CDA is now lying in the heap of archival documents with the change in Government.

Why does India need CDA?

I believe, the formation of a robust CDA with high accountability, besides meeting with drug safety concerns, would provide the following significant benefits, both to the Industry and also to the Government:

  • Achieving uniform interpretation of the provisions of the Drugs & Cosmetics Act & Rules
  • Standardizing procedures and systems for drug control across the country
  • Enabling coordinated nationwide action against spurious and substandard drugs
  • Upholding uniform quality standards with respect to exports to foreign countries from anywhere in India
  • Implementing uniform enforcement action in case of banned and irrational drugs
  • Creating a Pan-Indian approach to drug control and administration
  • Evolving a single-window system for pharmaceutical manufacturing and research undertaken anywhere in the country.

B.  Self serving interest dominates the prescribing decision: 

That the self serving interest, rather than patient interest, dominate the prescribing decision, was vindicated by a key announcement of the Medical Council of India (MCI) last month.

In February 2016, apparently succumbing to continuous and powerful external pressure, the MCI announced an amendment in a clause of its Code of Ethics Regulations 2002, exempting doctors’ associations from the ambit of its ethics code, as applicable to doctors now across the country. Prior to the amendment, this section used to read as: “code of conduct for doctors and professional association of doctors in their relationship with pharmaceutical and allied health sector industry”.                      

In other words, it means that the professional associations of doctors will no longer come under the ambit of ethics regulations, legitimizing their indulgence in the identified unethical and corrupt practices, by receiving gifts in cash or kind from the pharma or healthcare industry.

A large section of the key stakeholders believes that this amendment would help creating an additional large space for the pharmaceutical marketing malpractices to thrive, unabated, at the cost of patients.

The latest report of the Parliamentary Standing Committee on MCI:

In its 92nd Report, the Department-Related Parliamentary Standing Committee on Health and Family Welfare titled, “The Functioning of Medical Council of India”, presented to the Rajya Sabha and laid on the Table of Lok Sabha on 8th March, 2016, the Committee observed on this amendment as “an action that is ethically impermissible for an individual doctor cannot become permissible, if a group of doctors carry out the same action in the name of an association.”

The report also noted the failure of MCI to instill respect for a professional code of ethics in the medical professionals and take disciplinary action against doctors found violating the code of Ethics, etc.

The Committee called for a complete restructuring of the MCI, since it believes that the Council has failed as a regulator of medical education and the profession. Casting serious aspersions on the functioning of the MCI, the house panel of the Parliament recommended that the Act under which the MCI was set up be scrapped and a new legislation be drafted “at the earliest”. 

The report castigated the health ministry:

The lawmakers castigated the Health Ministry in this report saying, “The committee also finds it intriguing that instead of intervening to thwart attempts of MCI at subverting the system, the ministry meekly surrendered to MCI.”

While summing up, the report states, “the Committee exhorts the Ministry of Health and Family Welfare to implement the recommendations made by it in this report immediately and bring a new Comprehensive Bill in Parliament for this purpose at the earliest.”

How will it pan out now?

I reckon, it will now be immensely interesting now for all concerned to follow, how does the Government deal with this report to curb, among others, the strong interference of mighty and powerful vested interests to continue with the rampant pharma marketing malpractices, at the cost of patients in India.

C. Reported Government assurance on ‘Compulsory License’: 

On March 3, 2016, a media report quoted a submission by the US Chamber of Commerce to the office of the US Trade Representative (USTR) as follows:

“While the Government of India has privately reassured (American) industry that it would not use compulsory licenses for commercial purposes, a public commitment to forgo using (this) would enhance legal certainty for innovative industries.”

This is an interesting development, primarily because there are a number of legal provisions for granting Compulsory Licenses (CL) in the Indian Patents Act 2005, including, when a drug is not widely available, extremely expensive and some other situation. In some these provisions, law should follow its own course and there is no legally permissible scope for Government’s administrative interference. Grant of CL for Nexavar of Bayar is one such example, and incidentally, that’s the sole CL that India has granted, so far, from the date of amendment of the country’s Patents Act in 2005. 

Thus, a blanket assurance of not invoking any of the provisions of the CL, as provided in the Indian Patents Act 2005, if true, would possibly require to pass through intense legal scrutiny, as that would adversely impact the access to key medicines in a necessary situation, for the public health interest.

So far, India has amply demonstrated to all, time and again, that the country does not grant a CL at the drop of a hat. That situation should continue to encourage and protect innovation. 

Nevertheless, “a written public commitment to forgo using the CL provisions for enhancing legal certainty for innovative industries,” as demanded by the US Chamber of Commerce, appears to be unreasonable, goes against the spirit of India’s Patents Act, and perhaps is not legally tenable either, unless the IP Act is amended accordingly in the Parliament.

Conclusion:

All these three areas, as discussed above, are critical from the healthcare perspective of the country.

Ironically, while deliberating on the subject, the capability, credibility and competence of some of the key regulators of the country, are being repeatedly questioned. These doubts emanate not just from Tom, Dick and Harry, but from an illustrious spectrum of constitutional institutions of India, spanning across the lawmaking Parliament, through its various committee reports, to the ultimate legal justice provider – the Supreme Court of India, through is various orders and key observations.

Regrettably, in this specific space, which is primarily related to healthcare, nothing seems to be changing on the ground, since long. The same tradition continues, without any visible sense of urgency, even from the Government.

On the contrary, we now read a new genre of comments, even from a key regulator, on the stakeholder concerns. For example, reacting to concern on drug safety standards, instead of articulating tangible actions to usher in a perceptible change, the chief action taker reportedly specified a totally judgmental and an outlandish requirement: “…Whistleblower’s intentions should be Nationalistic.”

Together with these incidents, the key public healthcare concerns of India too, are now apparently getting drowned in the high decibel ‘Nationalistic’ versus ‘Anti-nationalistic’ cacophony. But, the hope still lingers… for a change…for our nation’s sound health!

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.

2015: Pharma Industry Achieved Some, Could Achieve Some More

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Wish You And All Your Near And Dear Ones Peace, Happiness, Good Health And Prosperity in The Brand New Year 2016 

The year 2015 witnessed several noteworthy developments in the pharma industry, just as many other years before. That said, in my view, a few of these happenings were much more impactful, and probably took place for the first time ever, in the year just gone by.

Obviously, one such major development is the overall serious adverse impact on the image of the pharma industry, in general. 

During 2015, the image of the pharma industry got further tarnished by reports of high-profile alleged drug price manipulations. This avoidable saga culminated with the arrest of a pharma Chief Executive Officer (CEO) in the United States, amid a federal investigation, in December 2015.

However, I am not going to dwell on this issue in this article. Instead, I shall select some key strategic pharma business areas, which contribute to the largest chunk of the total overall cost, incurred by the global pharma industry, every year. These areas, as I see, are:

  • Drug discovery research
  • Sales and Marketing
  • Supply Chain
  • Development of new drug delivery systems
  • Patients care and engagements

I have put all these points in the above order, just for the convenience of my discussion in this article. 

With a few examples, I shall give my perspective on these areas of the global pharma industry, dividing them broadly into the following two sub-categories: 

  • Areas where the industry could have done a lot better
  • Areas where the industry made significant progress
The Pharma industry strategy continues to remain broadly traditional:

Pharma sector is globally considered as an industry, which appears to be more comfortable in maintaining and harnessing its traditional approaches, in almost all its field of activities. Although, some tweaking has certainly been taking place, which are primarily to automate or digitalize the same process, aimed at adding more speed together with virtually real time monitoring of operations.

Let me hasten to add here that, some major and newer types of modern tech based collaborative initiatives with large companies outside the pure pharma space, have also been reported, during the year.

I shall deliberate on both these areas, one after another, hereunder. 

A. Areas where the industry could have done a lot better:

Drug discovery research:

With the increasing impact of patent cliff and low productivity in drug discovery research, coming alongside big ticket generic threats, many pharma players seem to be still tweaking with its traditional blockbuster drug discovery model, in 2015.

Slightly changing from this traditional strategic focus, many of them have now started focusing more on ‘Orphan Drug’ research, though with indication of a life threatening disease with low prevalence, intending to go whole hog for very high pricing of these drugs.

By gradually adding more indications, these innovator companies plan to make the ‘Orphan drug’ molecule a money churning blockbuster drug. As a result, the number of venture capitalists, who invest in the early stages of such drug development, has increased significantly in 2015.

According to reports, over 40 percent of all approved orphan drugs are meant for high risk cancer sub-categories with low prevalence rate. Although these drugs are for lifetime treatment, the medicines are frightfully expensive, costing between US$200,000 and US$300,000 per year, for each patient. 

Intriguingly, still a very few drug companies are externalizing drug discovery research or even considering on a large scale, the use of the ‘Open Source’ drug discovery model, which is currently widely used in the Information Technology (IT) industry, as one of the main platforms to get new products.

Sales and Marketing:

Similarly, in the pharma sales and marketing space, there has been no game changing developments, during the last year.

Although, some initiatives that can at best be termed as tweaking on the traditional pharma methods, were visible, especially in the fields of digital marketing and e-detailing. The good old and much tried traditional tools, such as, Medical Representatives’ (MR) product detailing to individual doctors or a large number of ‘medical seminars’/ ‘continuing medical education’ events, of varying scale and dimensions, arranged for the medical practitioners, still ranked at the very top of this domain. 

Here, again, no signs of a paradigm shift were visible to me during the year, nor do I reckon, any game changer is likely to surface, any time soon.

Supply chain:

The immense importance of ‘Supply Chain’ in the overall pharma business does not appear to have been properly understood by the drug companies up until 2015. This has been well vindicated by various credible studies. I would refer below just two of those: 

The Chief Supply Chain Officer Report of September 2014, highlighted that just 39 percent of pharmaceutical respondents see the ‘Supply Chain’ as an equally important part of business success as R&D or sales and marketing. Whereas, 68 percent of consumer packaged goods’ respondents believe that leveraging the true potential of this domain, is one of the key requirements for business excellence.

This is noteworthy, as even ‘The McKinsey report’ of September 2013 stated that supply chains now account for around 25 percent of pharmaceutical costs. The annual spending on it is so staggering of around US$230 billion that even minor efficiency gains in this area could free up billions of dollars for investments elsewhere.

Instead of following its traditional approaches, if the pharma sector adopts even straightforward advances, well established in other industries, the total costs could fall by US$130 billion, ‘The McKinsey report’ estimates. 

Ideally, pharma ‘Supply Chain’ should be considered not just a means of getting the products at the right place, at the right time and in the right quantities, but also as a means of delivering additional value to the customers. This can be achieved with radical strategic intervention in this space with the application of the state of art technology, which was still broadly lacking in 2015. 

B. Areas where the industry made significant progress: 

In this section, by citing examples on two other important strategic business areas of the pharma industry, where significant progress has been reported during 2015, I would try to drive home my point. These two areas are new drug delivery systems and patient care/engagement.

New drug delivery systems:

On the development of new drug delivery systems, some interesting collaborative arrangements have been reported in 2015. As illustrative examples, I would cite just the following two: 

A. “Smart Inhaler”

I have picked up this important area of a new drug delivery system, out of many, as it fascinates me immensely. Here again, I would illustrate my point with just two examples – out of several others, as hereunder:

1. On December 2, 2015, the British drug major GlaxoSmithKline (GSK) reportedly entered into a technology deal with Wisconsin-based Propeller Health. Under this collaboration, Propeller will create a custom sensor for GSK’s Ellipta inhaler. The Propeller platform combines sensors, software, and care team services to improve patient outcomes by providing more insightful and efficient care. GSK is the second largest pharmaceutical company to partner with Propeller Health, which in December 2013 announced a deal with Boehringer Ingelheim to develop a custom sensor for BI’s Respimat device.

2. In September, 2015, Teva Pharmaceuticals reportedly acquired Cambridge, Massachusetts-based Gecko Health Innovations, a smart inhaler company.

Gecko’s main product is a platform for chronic respiratory disease management that also combines a sensor device that connects to most inhalers, a data analytics platform, an accessible user interface, and behavioral triggers to help asthma and COPD patients manage their condition, more effectively.

B. Sanofi and Medtronic strategic alliance in diabetes to improve patient experience and outcomes

Although not many large scale commercial ‘drug discovery’ initiatives based on the ‘Open Source’ model is still not known to me, in the ‘new drug delivery system’ area, a major global strategic alliance, between Sanofi and Medtronic in the diabetes therapy area, has been reported based on this model. This alliance is aimed at improving patient experience and outcomes for persons with diabetes, around the world. 

As I mentioned, the alliance structured as an ‘Open Innovation’ model, will initially focus on the following key priorities:

  • Development of drug-device combinations
  • Delivery of care management services to improve adherence and simplify insulin treatment
  • Help people with diabetes better manage their condition

Patient engagement and care:

Quite encouragingly, in the ‘patient engagement and care’ area too, some of the global pharma majors have taken notable tech-based strides during 2015. Some of these laudable ventures are as follows:

A. Novo Nordisk and IBM partner to build diabetes care solutions on the Watson Health Cloud

According to a Dec. 10, 2015 ‘Press Release’, Novo Nordisk and IBM Watson Health agreed to work together to create diabetes solutions, built on the Watson Health Cloud.

Under this agreement, by harnessing the potential of the Watson Health Cloud, Novo Nordisk aims to further advance its offerings to people living with diabetes and also their health care professionals.

B. Sanofi collaborates with Google to Improve diabetes health outcomes

Less than a couple of months before the Novo Nordisk – IBM partnership agreement, by a Press Release of August 31 2015, Sanofi and Google announced their collaboration to improve care and outcomes for people with type 1 and type 2 diabetes.

According to the release, this collaboration will explore how to improve diabetes care by developing new tools that bring together many of the previously siloed pieces of diabetes management and enable new kinds of interventions. This includes health indicators such as blood glucose and hemoglobin A1c levels, patient-reported information, medication regimens and sensor devices. 

Is the word “Innovation” also being used as a façade?

This important, though contentious issue, is being raised by many today, globally.

In my view, global pharma even in 2015, continued making the mistake of repeatedly highlighting, with high decibel sound bytes that the stakeholders do not understand the value, importance and necessity of innovation, which in any case is far from the truth. Nevertheless, It kept using, rather more misusing, this important word too often to cover up any action of theirs that faced government, general public or media scrutiny.

Additionally, many pharma players seemingly continued to remain contented with a very narrow definition of the word ‘innovation’, limiting its application mostly in the traditional space of drug discovery. While at the same time, many other smarter and more astute innovators, especially in the IT world, besides Google, IBM and Apple, started stepping into the vast healthcare arena, which otherwise could possibly have become pharma’s expanded market.

A am quoting below the names of just five of these amazing innovators, from the published data, just to give you a feel of this interesting area of ‘innovation’ in the health care arena:

  • Medivation: For finding the value of treatments that others ignored
  • Beijing Genomics Institute: For making DNA sequencing a mass-market
  • Medisafe: For using wireless and cloud technology to improve drug adherence
  • Ginger.IO: For harnessing behavioral data to save lives
  • Setpoint Medical: For creating a built-in pain-relief platform 
Epilogue:

Overall, the year 2015 was a mixed bag for pharma. Many pharma players, I reckon, displayed their self serving intent in a more glaring manner. Several captains of this industry generally talked all right things, which are music to many ears, but mostly acted quite differently, going against the public health interest, as reported by the global media.

Many pharma companies continued trying to woo the media cleverly during the year. Some of them, reportedly, even sponsored trips of a few Indian journalists to their respective overseas headquarters. As I understand, many newspaper readers too, had noticed the small print disclosures in this regard, at the bottom of their stories on those companies, written on the return.  I have no intention to be judgmental on such trips. Nevertheless, the global media, including the Indian media, by and large, reported all such deeds, with as much detail as possible, without slightest hesitation.

Encouragingly, a few global pharma majors, such as, Sanofi, Novo Nordisk, GlaxoSmithKline and AstraZeneca challenged this contusing status quo in 2015. They seem to dare to chart into the much uncharted frontier to squarely face the challenge of the changing demands of the changing world order. Probably not so much by trying to change others, but mostly by changing themselves. 

It appears, at least, the likes of the above global players have started accepting the new expectations of the aspiring customers and their fast transforming mindsets, including, the tougher governments enacting contemporary laws and regulations in many countries. In tandem, the exorbitantly high cost and usually low profile advocacy initiatives of drug companies seem to becoming lesser and lesser productive, as evident by the increasing number of avoidable issues that the pharma industry is now facing. Added to all this, a modern and major force-multiplier, in the form of social media, has now started unleashing its unfathomable power of shaping laws, regulations and even public opinion.

I wish this wind of change gaining more speed in 2016, and in that process, ushers in the long awaited dawn of a new paradigm. A paradigm of justice and equity in health care for all, across the world, and especially to my own country – India.

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.

Wide Gap Between Health Care Needs, And Delivery: Is The Bridge Still Too Far?

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“Health inequities which abound in India must be corrected through investments in a robust primary health care system,” said Professor K Srinath Reddy, chairman, Public Health Foundation of India (PHFI), not too long ago.

The equity gap between health care needs and delivery for the general population of India continues to widen.

As the next Union Budget of India is coming nearer, the question in this regard that comes at the top of mind is:

Would adequate resources be allocated by the Union Finance Minister to bridge this gap effectively now or the elusive bridge continue to remain too Far?

The growing challenges: 

Up until now, despite making some progress in improving access to health care, India continues to face the growing challenges of:

  • Gross inequalities in this area by socioeconomic status, geography and gender. 
  • High out-of-pocket health expenditure pushes its ever increasing financial burden overwhelming on the private households, that accounts for over three-quarters of health spending in India.
  • Exorbitant out-of-pocket health spending is also responsible for mercilessly driving into poverty more than half of Indian households, or around 39 million Indians, each year.

The paper titled, “Health care and equity in India”, published by ‘The Lancet’ on February 05, 2011, well deliberated on this issue. 

The paper identifies 3 key challenges to equity in health care:

  • In service delivery
  • In financing
  • In financial risk protection

In the article titled, “My Expectations From The Union Budget (2016-17)”, written in this Blog on December 07, 2015, I also suggested that adequate resource deployment be made by the Government now in power, in all these three areas, while presenting the forthcoming Union Budget on February 28, 2016.

The root cause of inequity in healthcare:

I reckon, there are, at least, the following three key reasons that can be attributed to this failure, on the part of various Governments in power, till today:

  • Inability, primarily on the part of the central government, to effectively integrate healthcare with socioeconomic, social hygiene, education, nutrition and sanitation related issues of the nation. 
  • Health being a state subject, not much of coordinated and robust planning has so far been taken place in this area, between the Central and the State Governments, to effectively address the pressing health care related growing inequity across the country, in general.
  • Budgetary allocation and other fiscal measures towards health care, both by the central and most of the state governments, are grossly inadequate. 

As I said before, in another article published by this blog titled, “With Highest Billionaire Wealth Concentration, India Tops Malnutrition Chart in South Asia” on January 26, 2015, it is a well accepted fact that reduction of social inequalities ultimately helps to effectively resolve many important health care issues.

Otherwise, only a much smaller population of the country having adequate access to knowledge, social and monetary power, will continue to have the necessary resources to address their health care needs, appropriately.

UNICEF highlights stark inequalities in India:

According to UNICEF, every year, 1 million children below the age of five years die, due to malnutrition related causes in India. This number is worrisome as it is far higher than the emergency threshold, according to the World Health Organization (WHO) classification of the severity of malnutrition.

Highlighting stark inequality in India, the report says, “The net worth of a household that is among the top 10 per cent can support its consumption for more than 23 years, while the net worth of a household in the bottom 10 percent can support its consumption for less than three months.”

Are so called “patient centric approaches” real?

Patients are also bearing a different kind of brunt altogether, from several other corners, on their health related issues.

Today, most of the important stakeholders of the health care industry, in general, seem to be using various facades of ‘patient centric approaches’, just for petty commercial gains, or for gaining some key strategic commercial advantages.

Such entities could well be pharmaceutical industry, doctors, hospitals, diagnostic centers, politicians or any other stakeholders.

It is unfortunate that most of them, at various different times, either pontificate about following ‘patient centric approaches’ or use the patients cleverly just to achieve their respective commercial or political goals, solely driven by vested interests. While on the ground, growing inequity in health care keeps marching north.

A recent paper of NITI Ayog:

In a discussion paper of July 18, 2015 titled, “Health System in India: Bridging the Gap Between Current Performance and Potential”, The National Institution for Transforming India Aayog (NITI Aayog), the policy think tank of the new Indian Government, has also accepted the following 3 critical realities, currently prevailing in the health care environment of India: 

  • India’s progress in health outcomes has been slower in comparison to other countries with comparable incomes and at similar stages of development. 
  • Impressive gains in per capita income should match with an increase in life expectancy or health status. 
  • Out of pocket expenditure in India is high (70 percent of total health expenditure). This is catastrophic for the poor and pushes an estimated 37 million into poverty every year. 

The NITI Ayog paper also emphasized, although health is a subject allotted to the State List, under the Seventh Schedule of the Indian Constitution, the Central Government is jointly responsible for items in the Concurrent List. 

Conclusion:

Currently, India is the global numero uno in the GDP growth rate. Thus, there cannot probably be any better time for the nation to leapfrog in the health care space, with a quantum increase in public financial commitments, to radically revamp the fragile public health system in the country. 

I repeat, incremental progress in the public health care system is just not enough for the country, extensive application of cutting edge Information Technology (IT) effectively, dovetailing with the creation of modern brick and mortar public health care infrastructure, top class human resource namely, doctors, nurses and related skill development process, on an ongoing basis.                                                                             

The Government should also ensure that the domestic health care industry comes forward to shoulder higher responsibility to enable the country in offering greater equity in health care, in tandem with the Union Ministry of Health and the State Governments.

This path, in my view, would help building a more equitable health system with a strong foundation of public health for more than 1.2 billion Indians. In that process the fast widening gap in equity, between health care needs and availability, could be bridged much sooner, and in a sustainable way.

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.

Union Budget Proposal 2015-16 of India : Is Pharma Industry Now Out of Focus?

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Budget Expectations:

Overall expectations of the Pharma Industry in India from the Union Budget perspective was very modest this year. The key areas were as follows:

- To encourage  innovation, in-house R&D exemption limit was expected to be raised from 200 percent to 250 percent

- Excise duty rationalization was expected on:

Formulations (5 percent)
API (10 percent)

- A reduction of MAT (20 percent) was expected on SEZ

Union Budget Proposals:

Status quo

Impact:

In view of this scenario, there has been virtually no sector-specific direct impact of the Union Budget 2015-16 on the Pharma Industry. This critical sector seems to be out of focus of the Government from the budget perspective, at least for now.

By: Tapan J. Ray

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

A Patient-Centric State Initiative To Revolutionize Disease Treatment

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In his State of the Union address, just before the recent visit to India in January 2015, President Barack Obama articulated the need to develop “Precision Medicine” in his country – a bold, giant and perhaps unprecedented State initiative to remarkably improve effectiveness of disease treatment.

To set the ball rolling, in his budget proposal for the year 2016, President Obama earmarked an amount of US$ 215 million for this purpose. This includes an allocation of US$130 million for the National Institutes of Health (NIH) to create a national research database of about a million American volunteers by studying their genetics together with other relevant factors, such as the environments they live in and the microbes that live in their bodies.

‘Precision Medicine’ initiative is similar to path breaking 13-year and US$3 billion Human Genome Project, that has formed the bedrock of modern genomics, President Obama said. He also expressed hope that the private healthcare sector too, including universities and foundations, will get involved to “lay the foundation” for this new initiative of the Government for the interest of patients.

Why is this approach so relevant in today’s healthcare?

In an article published in the ‘British Medical Journal (BMJ) in October 2012, Richard Smith - an editor of BMJ until 2004 and a Director of the United Health Group’s chronic disease initiative wrote:

“Doctors know that many of the patients they treat with drugs will not benefit. Many patients know that too.”

Dr. Smith also emphasized, for centuries medicine classified diseases by what could be seen, felt, and smelt. Thereafter, medical scientists in this area started defining diseases anatomically, physiologically, and biochemically. Even today, this is by and large the paradigm where most medicines fall.

Smith underscored, because of imprecise diagnosis the treatment also becomes haphazard. There is big variation in how individuals respond to drugs and yet that variation is not usually recorded. The regulators approve drugs based on their average performance even today.

The White House release also reiterates, most medical treatments have been designed for the “average patient.” This “one-size-fits-all-approach,” treatments can be very successful for some patients but not for others.

This calls for broadening the scope of disease treatment – from the conventional and error-prone ‘Disease Oriented’ approach, to relatively more unconventional and better targeted with greater value – ‘Patient-Centric’ ones, wherever needed.

Two current trends:

To address this key deficiency in the effective treatment of several dreaded diseases for many patients, following two are the current trends, as stated by William Pao, M.D., Ph.D., who led Roche’s Oncology Discovery & Translational Area research unit since May 2014:

  • We now know that on a molecular level every cancer is different – not only between different tumors, but even between different areas within a single tumor! This means that we need to match the right drug to the patient who we know will respond best to the drug, at the right time during the course of treatment.
  • Patients will have their tumors profiled not only for genetic drivers, but also for predictive immunotherapy markers at different time points in their course of treatment.

Personalized and Precision Medicine:

The above trends in the endeavor of making treatments more patient specific – thus more effective, have thrown open scientific discourse and intense research on ‘Personalized’ and ‘Precision’ medicines.

As Pfizer has described in its website:

Personalized Medicine is a unique approach to medical practice in which the individual aspects of a patient are directly considered to guide treatment planning, including his or her genetic make-up, key biomarkers, prior treatment history, environmental factors and behavioral preferences. This approach can be used to optimize pharmaceutical treatments and overall care.

Whereas, Precision Medicine is an approach to discovering and developing medicines and vaccines that deliver superior outcomes for patients, by integrating clinical and molecular information to understand the biological basis of disease. Precision medicine is the biopharmaceutical research and development paradigm that will help enable more patient-centered clinical practice, including treatment decision-making based on genetic information – an emerging standard now often described as “personalized medicine”.

As President Obama said while announcing the proposal on January 30, 2015, ‘Precision Medicine’ promises delivery of the right treatment at the right time, every time, to the right person.

He also said that the new effort will “bring us closer to curing diseases like cancer and diabetes…and give all of us access to the personalized information we need to keep ourselves and our families healthier.”

‘Precision Medicines’ Dominate Oncology segment: 

In the European Society for Medical Oncology (ESMO) 2014 Congress, pharma majors reported their latest advances on precision medicines in the cancer care. Bristol-Myers Squibb, Roche, AstraZeneca, GlaxoSmithKline (GSK), and Merck & Co. were among the companies presented updates of their most promising cancer drugs closer to this area.

According to a large pharma lobby group in the United States – The Pharmaceutical Research and Manufacturers of America (PhRMA):

“Recent advances in diseases such as cancer and cystic fibrosis are delivering on the promise of targeted treatments, and between 12 and 50 percent of all compounds currently being researched by the industry are potential personalized medicines. These advances hold great promise in improving patient outcomes and controlling costs by targeting the right medicines to the right patients.”

‘DCAT Connect’ Report of September 2014 also indicates significant increase in ‘Precision Medicines’ in the pipelines of the leading global pharma companies, which is a key change over the past decade.

In 2013, targeted therapies increased their share of the global oncology market, accounting for 46 percent of total sales, up from 11 percent a decade ago. According to IMS Institute for Healthcare Informatics, the global oncology drug market reached US$ 91 billion in 2013 with CAGR of 5.4 percent from 2008 to 2013.

Taking note of this trend, it appears that in the near future ‘Precision Medicines’ would possibly be the most promising class in the treatment of cancer, particularly in breast cancer, lung cancer and certain types of leukemia. This is mainly because medical scientists are already quite acquainted with the molecular signatures of different types of cancer related tumors.

Medical scientists and researchers are also working on ‘Precision Medicines’ to more effectively address many other diseases, such as, diabetes, cardiovascular and ailments related to several types of infections.

Increasing potential:

Realization of the potential of ‘Precision Medicines’ to improve care and speed the development of new treatments has just only begun to be tapped.

In recent times, scientists and researchers have accelerated efforts to understand more about biomarkers for this purpose. A study conducted by the German Association of Research-Based Pharmaceutical Companies (vfa) indicates that more than 20 percent of clinical trials carried out since 2005 focused not just on agents, but also on biomarkers. Before 1990, only one in twenty clinical trials addressed biomarkers.

According to another report, last year, 20 percent of all new drug approvals in the United States were for “Precision Medicine” treatments. This vindicates, yet again, the immense potential to turn genetic discoveries into innovative disease treatments for patients.

A bold state sponsored research initiative:

State funded, ‘Precision Medicine’ initiative is a bold new step of the American Government to revolutionize improvement in healthcare and treating disease. It is expected to pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

As the White House release reiterates, most medical treatments have been designed for the “average patient.” As a result of this, “one-size-fits-all-approach” treatments can be very successful for some patients but not for others. This is changing with the emergence of ‘Precision Medicine’, an innovative approach to disease prevention and treatment that takes into account individual differences in people’s genes, environments, and lifestyles.

In this process, ‘Precision Medicine’ gives clinicians tools to better understand the complex mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective.

Opposite view:

In an op-ed titled, ‘Moonshot’ Medicine Will Let Us Down, published recently in The New York Times, the author argued with his differing viewpoints.

I am quoting below three of those arguments:

  • “For most common diseases, hundreds of genetic risk variants with small effects have been identified, and it is hard to develop a clear picture of who is really at risk for what. This was actually one of the major and unexpected findings of the Human Genome Project. In the 1990s and early 2000s, it was thought that a few genetic variants would be found to account for a lot of disease risk. But for widespread diseases like diabetes, heart disease and most cancers, no clear genetic story has emerged for a vast majority of cases.”
  • “Another unexpected finding of the Human Genome Project was the problem of ‘missing heritability.’ While the statistics suggest that there is a genetic explanation for common conditions and diseases running in families or populations, it turns out that the information on genetic variants doesn’t explain that increased risk.”
  • “The idea behind the “war on cancer” was that a deep understanding of the basic biology of cancer would let us develop targeted therapies and cure the disease. Unfortunately, although we know far more today than we did 40-plus years ago, the statistics on cancer deaths have remained incredibly stubborn.”

I am sure, you will analyze the above points with the facts that you have at your disposal on this subject to arrive at a logical conclusion.

Current Applications:

Though these are still early days, initial benefits of ‘Precision Medicines’ have been reported in many areas, such as:

  • Genetic analysis of patients dealing with blood clots: Since 2007, the U.S. Food and Drug Administration has been recommending genotyping for all patients being assessed for therapy involving Warfarin.
  • Colorectal cancer: For colon cancer patients, the biomarker that predicts how a tumor will respond to certain drugs is a protein encoded by the KRAS gene, which can now be determined through a simple test.
  • Breast cancer: Women with breast tumors can now be effectively screened to determine which receptors their tumor cells contain.
  • Cystic fibrosis: In America, patients with a rare form of cystic fibrosis now can choose a drug designed specifically to target the genetic defect causing their illness. Specialized medical centers, such as “individualized medicine centers” at the Mayo Clinic, are also available to the patients for effective treatment.

Ethical issues:

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

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

Thus, the ethical and social issues in the development of ‘Precision Medicine’ primarily in the area of genetic testing need to be effectively addressed, sooner.

Conclusion:

The quest for moving away from conventional and error-prone ‘Disease Oriented Treatment’ paving the way for unconventional and value added individual patient-specific ones, may soon come to fruition.

Advances in ‘Precision Medicine’ have already led to powerful new discoveries and several new treatments that are tailored to specific characteristics of individuals, such as a person’s genetic makeup, or the genetic profile of an individual’s tumor.  This is leading to a transformation in the way the world can treat diseases such as cancer.

Patients with breast, lung, and colorectal cancers, melanomas and leukemia, for instance, should be provided with facilities in specialist hospitals to undergo molecular testing as a part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.

Although, the potential for precision medicine to improve care and speed the development of new treatments has only just begun to be tapped, some skeptics do say that tailoring medical treatments to individual characteristics of each patient is both overly optimistic and cost-prohibitive.

Be that as it may, in the balance of probability the benefits of prudent use of ‘Precision Medicine’ far outweigh the concerns expressed. This evolving new paradigm would help saving not just significant expenses, but also precious time that is usually spent on ‘trial-and-error treatments’, by enabling clinicians to determine quickly which therapies are most likely to succeed.

Though lot many grounds would still need to be covered in this area, the State sponsored ‘Precision Medicine’ initiative of America to revolutionize disease treatment, in my view, is indeed a laudable one, every way.

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.