Tag Archives: Health

Pharma Marketing: Time For A Disruptive Change with A New Breed of Marketers

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In Today’s fast-changing world, as I indicated in several of my previous articles, more and more people first try to understand the causative factors of their ailments, and options available for effective remedial measures. They strive to get such information, either from the cyberspace or by word of mouth from well informed individuals or other sources. This process starts before treatment, and continues, at times, even after remission of the disease.

Even in the developed countries, a scope exists for self-medication for common ailments with OTC drugs, duly approved by respective country’s drug regulators. A point to ponder, most of these were ‘only prescription’ medicines before going off-patent, and after enjoying 20 years of exclusivity with pricing freedom. During their patent life, self-treatment was illegal with any of these molecules, if not dangerous. The same tradition continues today.

The bottom-line is, many patients are now trying to understand their diseases from sources other than the physician. Good or bad, the reality is, such patients generally prefer to visit a doctor as and when they deem it necessary. While visiting a clinic, they already have, not just some idea of the ailment, but also in what way they would prefer to get themselves treated and approximate cost of each. One should not presume, either, that majority of them are unaware of the risks involved with this approach.

Pharma marketers today can’t just wish away this emerging trend of patients and patient groups getting increasingly more informed. Trying to stop this trend will be a Herculean task, similar to swimming against a very strong current. Managing this situation in a win-win way is now a key task of a pharma marketer. In this article, dwelling on this trend, I shall focus on the need for a disruptive change in pharma marketing and the new breed of drug marketers.

Calls for a fundamental shift in pharma ‘marketing focus’:

Achieving this objective warrants a fundamental, if not a disruptive shift, in the ‘marketing focus’ of pharma companies – from traditional ‘product management’ to modern ‘brand management.’

With patented ‘me-too’ drugs, including ‘Fixed Dose Combinations (FDCs)’, as well as generics, now dominating the market, some sort of ‘commoditization’ of drugs are taking place in the pharma industry, whether one likes it or not.

No significant differential advantages oruniqueness exist between such products manufactured by different drug companies. Consequently, doctors or patients have enough choices to prescribe or buy, drugs with comparable efficacy, safety, quality standards and matching price range, from different pharma players.

Shift from product marketing to brand marketing:

One may possibly ask aren’t both quite the same? Is there any meaningful difference between these two? Thus, taking a pause, let us try to understand what’s the difference between these two.

Yes, for many there is not much difference between these two, especially in the pharma industry. Hence, many drug companies name this function as ‘product management’, while others call it ‘brand management’. In fact, these two are often used as interchangeable terminologies in the drug industry. Nonetheless, this understanding is far from being correct.

The key focus in ‘pharma product marketing’ is on the drug itself – its intrinsic value offerings to patients in terms of efficacy, safety, quality and often the cost. Thus, ‘product marketing’ approach may work for breakthrough drugs, but not for ‘me-too’ patented drugs or generic ones to achieve the desired goals of the respective companies, consistently.

Whereas, pharma ‘brand marketing’ in its true form, creates much more value than pharma ‘product marketing.’ The former dovetails intrinsic values of the drug with a set of strong feelings and emotions around the brand, purely based on what patients or consumers would want to experience from it. This process makes even a me-too brand stand out, creating a strong personality around it and differentiating itself head and shoulder above competitors. Importantly, the bedrock of conceptualizing these powerful feelings and emotions, must necessarily be robust, relevant and fresh research data. No doubt, the task is a challenging one– and not every marketer’s cup of tea.

Why building personality for pharma brands and services is necessary?

If we look around the healthcare industry, we shall be able to realize the importance of building personality for a medicine, especially generic drugs with a brand name, in the Indian context.

For example, many hospitals offer similar medical treatment facilities, follow similar treatment guidelines and their cost may also not be very different. But why different people prefer different ones among these, and all hospitals don’t get a similar number of patients? Same thing happens during the patients’ selection of doctors from many, having similar qualification, experience and expertise.

This happens mainly due to the attachment of a persona around each that creates a particular feeling and emotion among patients while choosing one of them. The process and reasons of creation of a persona may be different, but it certainly differentiates one from the other for the consumer. The same thing happens with virtually undifferentiated ‘me-too’ patented drugs or generic medicines.

Time to create a ‘strong pull’ for a drug, instead of ‘push’ by any means:

To create a ‘strong pull’ successfully, specifically for ‘me-too’ patented molecule or generic drugs, there is an urgent need for a fundamental change in the organization’s marketing approach – a shift in focus from ‘product marketing’ to ‘brand marketing’.

Otherwise, current pharma marketing practices for creating a ‘strong push’ for drugs that often involve alleged serious malpractices’ will continue. But continuation of this approach is not sustainable any longer, for scores of reasons.

The benefits of pharma ‘brand marketing’ in bullet points:

To summarize the key benefits of ‘brand marketing’ in pharma, the following points come at the top of mind:

  • ‘Brand marketing’ of drugs helps escaping avoidable and unsustainable heavy expenditure to create a ‘strong product push,’ often resorting to contentious marketing practices.
  • Proper ‘brand marketing’ of drugs needs high quality cerebral and multi-talented marketing teams, rather than the power of ‘deep pocket’ to buy prescriptions. This creates a snowballing effect of cutting edge talent development within the organization, along with a culture of leading by examples, for a sustainable future success.
  • ‘Brand marketing’ is a better, if not the best way to make a drug most preferred choice in a crowd of similar branded generics or ‘me-too’ patented drugs.
  • Paying doctors for prescribing a drug does not help developing loyal customers, but creating feelings and emotions for a brand among them, helps foster brand allegiance.
  • Creative ‘brand marketing’ of drugs will appreciably boost the image of the organization, as well, but ‘pharma product’ marketing in its present form, will not.

Pharma ‘brand marketing’ and ‘patient-centricity’ to work in tandem:

My article, ‘Increasing Consumerism: A Prime Mover For Change in Healthcare’, published in this blog on June 11, 2018, deliberated an important point. It was:

If the pharma strategic marketing process is really effective in every way, why is healthcare consumerism increasing across the world, including India?

The focal point of rising consumerism in the pharma industry is unsatisfied, if not anguished or angry patients and patient groups – in other words consumers. There could be various different reasons for the same. But the core point is, contentious marketing practices that pharma players generally follow, is self-serving in nature. These are not patient-centric, and mostly devoid of efforts to create feelings or emotions for the product, among both prescribers and other consumers.

The pharma marketers to keep pace with changing environmental demands:

As I discussed several times in the past, pharma marketers are often found wanting to meet the changing demands of the business environment. This is important, as the general pharma practices of influencing the prescribing decision of the doctors are facing a strong headwind of increasing consumerism, India included. This is slowly but surely gaining momentum. For example, patients in India are realizing:

  • That a vast majority of people pay ‘out of pocket’, almost the total cost of health care, without having even a participatory role in their treatment choice, including drugs.
  • That they no longer should remain unassertive consumers, just as what happens in other industries when a consumer buys a product or service.
  • That they need to involve themselves more and be assertive when a decision about their health is taken by doctors, hospitals, realizing that pharma and medical device companies often ‘unfairly’ influence doctors’ prescribing decisions.

The role and requisite talent required for pharma marketers have changed:

Keeping aside ‘one size fits all’ type of strategy, even if I look at so called ‘targeted marketing’ in pharma, it appears somewhat baffling. It is somewhat like, ‘empty your machine gun magazine at the target with a hope to win over competition.’ Whereas, today’s environment requires making healthcare product marketing, including drugs and services, more personal, and in some cases even individual, like latest cancer therapy. The wherewithal for technological support to move towards this direction is also available. State of the art marketing and product research tools and analytics should be put to use to facilitate this process.

Increasing usage of digital marketing, in an integrated or holistic way, is going to make traditional pharma marketing less and less productive, whether we like it or not. To maintain a sharp competitive edge in this new ball game, on an ongoing basis, pharma marketers will need to keep raising the bar.

Consequently, the role and requisite talent required for pharma marketers have also changed. The new generation of drug marketers will not just be creative, but their creativity will be guided by a huge pool of credible research-based data, avoiding gut-feel. All guesses in this area must pass the acid test of validation by what the research data reveals. Moreover, pharma marketers will need to possess, at least the working knowledge of various digital platforms and possible usages for each of these.

Conclusion:

There is an urgent need to realize that drug marketing is now at the crossroads, pharma players will have a choice, either to follow the same beaten path or gradually make a course correction to keep pace with changing environmental demands. If a company decides to choose the second one, the role of pharma marketers and the talent required for doing the job effectively, will be significantly different from what it is today.Maintaining the status quo in this area, carries an inherent risk for the future success of pharma companies.

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 ‘Patient-Centricity’ Now Sound Like A Cliché?

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Today, many pharma companies claim ‘patient-centricity’ as one of their primary focus areas in business. Many industry experts, as well, have been advocating so, over a period of time. A number of research studies, published during the last several years, also recommended that ‘patient centricity’ should be the key focus area for long-term sustainability of any pharma business, across the world, including India. In the fast unfolding scenario of date, this is absolutely essential to keep pace with the changing needs and aspirations of a new generation of well-informed patients.

Currently, one can easily spot inclusion ‘patient-centricity’ even in the corporate vision and mission statements of many drug companies, especially those with global footprints. But the question arises, how efficient is its implementation in the field?

In this article, I shall try to fathom whether patients are in sync with pharma’s claim of moving towards this goal, or the term ‘patient centricity’ just sounds like a cliché, at least, as of now. Let me start by giving a brief perspective of the subject to illustrate the point, why it represents a fundamental shift in the healthcare space.

‘Patient-centricity’ – a fundamental shift in healthcare space:

As I discussed in my article, titled ‘Increasing Consumerism: A Prime Mover For Change in Healthcare’: ‘Patients’ longing for better participative treatment experience at an affordable cost, has started gathering momentum as a major disrupting force in the healthcare space of India, as well.

This is a fundamental shift in the healthcare space, especially in terms of patients’ behavior, needs, aspirations and expectations while charting across any end-to-end treatment process. This change is taking place over the last couple of decades, pushing many pharma players to adopt a ‘patient-centric’ approach for greater sustainability in the business.

‘Patient-centricity’ has started occupying the center stage in the successful pharma business, as patients are becoming more and more informative. The reasons for this change are many. I have already discussed many of these, along with suggestions on corrective measures, in my various articles, published in this blog on the subject.

What’s happening on the ground?

Drug manufacturers’ various strategic communications aimed at stakeholders, signal that the ball has started rolling. According to a report, well-known pharma majors, such as Novartis, GSK, Janssen Pharmaceutical, UCB, LEO Pharma, among others, are actively participating in conversation on ‘patient-centricity.’ Apace with, a number of research studies also point towards a clear dichotomy, and a glaring disparity between drug companies’ claims and people’s perception of ‘patient-centricity’ in real life. Let me first touch upon the glaring dichotomy in this area.

A glaring dichotomy exists:

That more organizations are becoming more ‘patient-centric’, will get captured by the increasing trust of patients – both on the individual companies and also the pharma industry, in general. But today, what we witness is a clear dichotomy between the claims of many pharma companies of being ‘patient-centric’ and the declining patients’ trust, along with dented reputation and image of the industry, in general.

Declining public trust towards pharma industry is also evident from increasing consumerism in the healthcare space, besides stringent policy and price regulatory measures being taken by various governments, across the world. It also significantly increases their cost of advocacy with governments, through their own trade associations. Either patients pay for such avoidable costs indirectly, by paying higher drug price, or the pharma players absorb its impact with reduced margin, which is also avoidable.

This gets reinforced by another measure of disparity. It also points to the widening gap between drug companies’ claim on becoming ‘patient-centric’ – together with their employee perceptions on the same, and the reality as experienced by patients. Let me illustrate this point below by quoting from another recent research study.

Measuring disparity between the claim and reality:

Interestingly, the August 2018 annual benchmarking survey carried out by the Aurora Project, also finds a disparity in perception and reality related to the much often-used terminology – ‘patient-centricity’. Aurora Project is a non-profit group, founded by eyeforpharma and Excellerate. It is made up of more than 200 health sector leaders from around the world, with an objective ‘to move ‘patient-centricity’ from words to actions and outcomes’.

The study was conducted between July and November 2018. It covered 1,282 respondents, which include patients, HCPs and employees from biopharmaceutical and medical device companies. Expert perspectives were obtained from senior managers working with 10 of the world’s leading pharma companies, and views from specialists in behavior change and organizational psychology.

The respondents were asked to score the degree of ‘patient-centricity’ in pharma across 10 metrics, and patients consistently rated companies lower than industry employees. Some of the important findings that came out clearly while measuring the disparity between pharma’s claim and the reality, are as follows:

  • In total, 72 percent of employees agreed with the statement “my company communicates with care and compassion, transparent and unbiased information on diseases, treatment options and available resources”.

- Whereas only 32 percent of patients agreed with the equivalent statement.

  • More than half (53 percent) of the employee participants said they were “actively looking for what to do and how to teach” patient centricity.

- Whereas only 22 percent said they knew “exactly what to do

- And 16 percent said they “didn’t know what to do or how to teach it”.

  • Only 36 percent of the patients surveyed indicate that they have “quite a bit” or “a lot” of trust in the pharmaceutical industry overall.

The survey brought to the fore, while people believe in the importance of pharma delivering on its ‘patient-centered’ mission, most are not confident in pharma’s ability to deliver.

Most companies focus sharper on meeting short-term goals than ‘patient-centricity’:

That most companies focus sharper on achieving short term goals than ‘Patient-centricity’, as also captured unambiguously in the above survey, as it noted:

  • 90 percent of survey participants employed by biopharmaceutical and medical device companies agree that a long-term focus is key to the success of patient- centric efforts. However, the need for a long-term view is sometimes at odds with business realities, and 53 percent agree that their companies are mostly concerned about results this quarter (9 percent) or this year (44 percent).

Thus, there is a clear need for not just of ‘patient-centricity’, but also an appetite for it among those best placed to make it happen. Therefore, the question to ponder for pharma companies is: How best to be ‘patient-centric’? While trying to ferret out a robust answer to this question, many domain experts suggest that ‘patient centricity’ demands a fundamental shift in the cultural mindset of the organization.

Demands a fundamental shift in corporate cultural mindset:

As I pointed out in several of my articles in the past, the need for creating an appropriate ‘patient-centric’ corporate cultural mindset is to reverse the organizational pyramid. This means transforming the business from being product focused to patient focused.

That ‘patient-centricity’ demands a shift in the corporate cultural mindset within the pharmaceutical industry, was also emphasized in the article published in the Journal of Therapeutic Innovation & Regulatory Science (TIRS) onMarch 28, 2017, titled ‘Patient Centricity and Pharmaceutical Companies: Is It Feasible?’

Elaborating this point further, the paper said that at the highest level, it involves listening to and partnering with the patient, and understanding the patient perspective, rather than simply inserting patient views into the established process. Aided by the top management, the answers to the following questions on ‘patient-centricity’ should be crystal clear to all employees:

  • Why are we doing this?
  • How should we do it?
  • What are the results we aim to achieve?

Conclusion:

Quoting the December 2012 NHS document, the essence of ‘patient-centricity’ may be expressed as – ‘making “no decision about me, without me” a reality, all along the patient pathway: in primary care, before a diagnosis, at referral and after a diagnosis.’ This is applicable to all in the healthcare space, equally, including the pharma industry. There doesn’t seem to be any alternative to it, either. Which is why, ‘patient-centricity’ is emerging as a ‘take it or perish’ type of a situation for all pharma players. It may not happen immediately, but eventually it would certainly form the bedrock of pharmaceutical business.

Probably due to this reason, ‘patient-centricity’ has become a new a new buzz word to demonstrate how a pharma player is keeping pace with time. Consequently, more and more companies are joining this chorus of informing the stakeholders that ‘I am game’. Be that as it may, the core concept of ‘patient centricity’ is still not yet getting properly translated into better patient outcomes, through actionable strategies on the ground.

There are several studies on the measurement of ‘patient centricity’. The Aurora Project, as discussed above, is one such. It clearly brings out that there is still a significant gap between words and actions of many drug companies on ‘patient-centricity’. Consequently, a large number of patients are still unable to reap the consequential benefits of ‘patient centricity’, the way it is publicized by several companies. Despite this, the terminology continues to be overused, sans proper application of mind to translate the pharma’s good intent into reality.

By: Tapan J. Ray    

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

Pharma To Facilitate Self-Managing Chronic Diseases For Better Outcomes?

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“India’s burden of non-communicable disease (NCD) is escalating, but still the country does not have sufficiently detailed data on NCDs for research and policy purposes.” This was captured in a recent study, titled “India’s escalating burden of non-communicable diseases,” published in The Lancet Global Health on October 03, 2018. Thus, many experts are pondering, how to contain this menace and lower the disease burden of NCDs, in this situation. One of the ways to address this issue is exploring some unconventional ways.

As several studies have established, improving ‘self-management’ of chronic diseases by patients, after proper diagnosis and a treatment plan being in place, is one of the pillars to lower the disease burden. One such study is titled, ‘Patients’ knowledge of their chronic disease,’ appeared on June 2013 – Vol 42 (6) issue in the journal of afp – Australian Family Physician. The paper highlights that effective tools, policies and other measures to help self-management, would facilitate the process. These arecritical not just for better outcomes, but also to reduce the overall treatment cost.

In a similar context, another recent article, titled ‘Why Apps for Managing Chronic Disease Haven’t Been Widely Used, and How to Fix It,’ published in The Harvard Business Review (HBR) on April 04, 2018 made an interesting observation. The authors wondered: “In an era where nearly, every consumer good and service — from books and groceries to babysitting and shared rides — can be purchased through an electronic transaction on a mobile device, it seems reasonable to think that more and more of our health care can also be managed using apps on mobile devices.”

This article will dwell in this area, based on several interesting and credible research findings. Nevertheless, to give a proper perspective, I shall start with a brief outline on the incidence of chronic diseases in India.

Increasing incidence of chronic diseases in India:

There are several recent reports confirming the ascending trend of non-infectious chronic diseases in India, two of which are as follows:

The National Health profile 2018, published by the Ministry of Health also records that between 1990 and 2016 the disease burden due to:

  • Communicable, maternal, neonatal, and nutritional diseases, as measured using Disability-adjusted life years (DALYs), dropped from 61 per cent to 33 per cent.
  • Noncommunicable diseases increased from 30 per cent to 55 per cent.
  • The epidemiological transition varies widely among Indian states: 48 percent to 75 percent for non-communicable diseases, 14 percent to 43 percent related to infectious and associated diseases; and 9 percent to 14 percent associated with injuries.

Alongside, the above article of The Lancet Global Health also underscores the following takeaways from its comprehensive analyses of NCDs in the Indian situation:

  • The three leading causes of mortality—cardiovascular diseases, respiratory diseases, and diabetes.
  • In absolute terms, these three diseases together kill around 4 million Indians annually (as in 2016).
  • Most of these deaths are premature, occurring among Indians aged 30–70 years, representing some of the world’s largest health losses, with enormous policy ramifications.
  • India’s Ministry of Health and Family Welfare is making efforts to establish policies and intervention strategies for prevention and control NCDs. For example, the National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke, launched in 2010, and the National Program for Health Care of Elderly, launched in 2010–11, the article noted.

As none of the measures taken so far could create an appreciable impact, India needs to come up with a major intervention to tackle this escalating health issue, the article concluded. In my view, optimal use of modern technology in the self-management of such virtually lifelong diseases, can be a great enabler for patients to bring down the disease treatment and management cost, significantly. Let me hasten to add again, the question of self-management comes only after a proper medical diagnosis and a prescribed treatment plan for the same being in place.

The key benefits of self-management and the unmet need:

The key benefits of effective self-management of chronic diseases are many. However, the following four clearly stands out:

  • Improves Patients’ quality of life significantly.
  • Arrests progression of the ailment – containing associated disease related complications.
  • Substantially reduces the interval and number of follow-up visits with doctors.
  • Thus, reduces the disease burden appreciably.

Curiously, most traditional pharma companies are yet to take any major step to address, at least, the above four critical areas. They don’t seem to go beyond the conventional methods of disease related advices. Whereas, the crucial need to fetch a behavioral change in patients for participative self-management of NCDs, keeps lingering.

A number of research studies have also confirmed that ‘mobile health applications are promising tools for improving outcomes in patients suffering from various chronic conditions.’ One of these studies titled, ‘Smartphone app in self-management of chronic low back pain: a randomized controlled trial’, was published in the November 27, 2018 issue of the European Spine Journal.

Sensing an unmet need in this area, besides a large number of brilliant tech startups, many large and pure technology companies, such as Apple and Google have already entered this fray.

 A recent example:

Let me cite a recent example to drive home the above point. On December 12, 2018, CNBC featured an article carrying the headline ‘Apple now has dozens of doctors on staff, showing it’s serious about health tech.’ Some of the key points of this article are as follows:

  • The number of doctors on staff is an indication that Apple is serious about helping customers manage diseases, and not just wellness or fitness.
  • Doctors can also help Apple guide the medical community on how to use Apple’s new health technologies and to deflect criticism and also to win approval among doctors who fear liability and are already overburdened by technology.
  • Many of these doctors are also still continuing to see patients. That might also give Apple an edge by emphasizing the patient experience.

This example demonstrates how detail are the plans of these tech companies for gaining a firm foothold in the healthcare space.

‘Effectiveness’ and ‘future scope’ of self-management of diseases:

The article titled, ‘Self-Management: A Comprehensive Approach to Management of Chronic Conditions,’ featured in the August 2014 edition of the American Journal of Public Health (AJPH) reiterated some important points. It established the relevance, future scope and effectiveness of self-management of chronic diseases, as follows:

  • As chronic conditions emerge as a major public health concern, self-management will continue to grow as a crucial approach to managing these conditions, preventing illness and promoting wellness.
  • Chronic disease conditions are generally slow in their progression and long in their duration. Thus, self-management can offer those living with these conditions, a means to maintain or even improve their capacity to live well, over the course of their lives.
  • Self-management intervention programs that address specific diseases are showing success across multiple chronic conditions.
  • These programs have particular value that represents an amalgamation of the goals of the patient, family, community, and the clinician with everyone working in partnership to best manage the individual’s illness while facilitating comprehensive care.
  • Self-management reaches beyond traditional illness management by incorporating the larger concept of prevention by emphasizing the notion that those who are chronically ill still have a need for preventive interventions to promote wellness and mitigate the further deterioration of health.
  • If one considers the nature of self-management in all its elements and practical characteristics, it is not only a logical approach to health and health care, but also an optimal way to address chronic conditions as a major issue in public health.

Inducing a behavioral change in chronic disorders with health apps:

For effective self-management of chronic diseases, there is a need to neutralize the negative influence of the individual’s behavioral traits. Research studies have also established that behavior-change-focused interventions play an important role in this effort.

However, not all patients take adequate care for such changes to take place. While the treating doctor may play an important role of a coach in this area, in reality, they usually don’t find enough time to spend on each patient with NCDs. The McKinsey & Company’s publication titled, ‘Changing patient behavior: the next frontier in health care value,’ also reiterates that to address the rising cost of chronic conditions, health systems must find effective ways to get people to adopt healthier behaviors.

As I mentioned before, this space has attracted active interest of many tech players in business expansion. More evidence-based health apps are being introduced to help drive patient-behavior change for effective self-management of chronic diseases. There are reported surveys on weight management aided by health apps, where ‘ninety-six percent of respondents agreed or strongly agreed that using a diet or nutrition app helped drive positive behavior change and healthy eating habits.’

In my article, titled ‘Prescription Digital Therapy Now A Reality,’ published in this blog on May 07, 2018, I mentioned that in September 2017, the first USFDA-cleared mobile app has been made available to patients. The app has both safety and efficacy label to help treat patients with ‘Substance Use Disorder’. Studies have established that it is two-times more effective than conventional in person therapy sessions.

More recently, in September 2018, Apple’s smart-watch version 4 included a US-FDA cleared electrocardiogram (ECG), officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms. In the same context, US-FDA Commissioner Scott Gottlieb, M.D., said that digital advances, creating a new technological paradigm of health tools and health apps., are empowering consumers to take better informed decisions on their medical care and healthy living.

Conclusion:

It has been well-demonstrated by research studies that evidence-based health-apps for self-managing chronic diseases improve outcomes, remarkably. Consequently, this has triggered some critical activities by purely tech companies in the health care space, even in India. The primary driver being a strong consideration of this segment as an opportunity area to meet an unmet need, where most pharma players don’t seem to be doing enough, as on date.

Before it gets too late, there appears a need to take a serious note of this shifting paradigm. The awareness of which should then play a critical role in developing marketing strategies for brands used in NCDs. Otherwise, non-pharma tech companies will eventually dominate this segment, armed with a different genre of technological prowess that they possess.

The article titled, “Evidence-Based mHealth Chronic Disease Mobile App Intervention Design: Development of a Framework,” published inJan-Mar 2016 edition of the Journal of JPMIR Research Protocols, epitomizes it succinctly:

“Mobile health technology creates a shift in the paradigm of chronic disease management. It offers new possibilities to engage patients in self-management of their chronic diseases in ways that did not exist in the past. To maximize the potential of mHealth requires the integration of research and expertise from multiple disciplines including clinical, behavioral, data analytics, and technology to achieve patient engagement and health outcomes. This paradigm shift also triggers a need for new approaches to designing clinical and behavioral support for chronic disease management that can be implemented through existing health care services and programs.”

These developments send a strong signal for pharma to facilitate self-managing chronic diseases, soon enough, for better patient outcomes and, in tandem, creating a win-win situation for both.

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.

 

 

Access To Comprehensive Healthcare Merits Multipronged Approach

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Since the turn of the new millennium, several high profile and flagship health schemes are being announced in India by the Union successive governments. Some of the important ones will include the National Health Mission, Rashtriya Swasthya Bima Yojana (RSBY) - a Health Insurance Scheme for the Below Poverty Line families and now Ayushman Bharat – National Health Protection Mission - expected to cover over 100 million poor and vulnerable families providing coverage up to 500,000 rupees per family per year for hospitalization related to secondary and tertiary care.

Besides, the Mental Health Care Act 2017 has been operational since last year. It was passed by the Rajya Sabha in August 2016, and the Lok Sabha on March 2017. The right to mental health care is the core of the Act.

Each of these announcements look good on paper and was accompanied with lofty government promises. Riding on the waves of hypes thus created, public expectations increased commensurately for getting easy access to a comprehensive and affordable health care, which now includes ‘Mental Health’ as well. Unfortunately, the Gordian knot in Indian public healthcare space continued to exist. As various reports  indicate, for example, one that appeared on November 27, 2018, – even Ayushman Bharat is apparently moving towards the same detection driven by some critical basic issues.

Consequently, scores of people still do not have adequate and affordable access to basic health care, including essential drugs – clamping price control notwithstanding. The government knows it well, as it increases vigil on drug pricing. Pharma industry also feels its scorching heat. Overall storyline remains mostly unchanged. The vicious cycle continues.

In this article, I shall dwell on a system-approach to delivering comprehensive public health care. The key objective is trying to figure out what is the core problem that most of these schemes are either not addressing or doing it with a ‘band-aid’ approach. One of the key requirements for improving access to health care significantly, I reckon, is a clear understanding on the characterizations of the critical stages of healthcare access and their dimensions, from the patients’ perspective.

However, before doing so, let me glance upon some health care related current and important facts, as uploaded in the government’s National Health Profile 2018.  

National Health Profile 2018:

As available in the National Health Profile (NHP) of India – 2018, following are some of the important facts, which are worth noting:

  • In the current budget year, public (government) spending on health is just 1.3 per cent of the GDP against the global average for the same at 6 percent.
  • Just one doctor serves a population of 11,000 people, which is way below W.H.O recommended a doctor to population ratio of 1:1,000. The scenario is even worse in many states, such asBihar with 1: 28,391, Uttar Pradesh records 1:19,962, Jharkhand with 1:18,518, Madhya Pradesh shows 1:16,996 and Chhattisgarh at 1:15,916.
  • Per capita public expenditure by the government on health, stands at Rs 1,112 that comes to Rs 3 per day. This puts India below other low-income nations like the Maldives (9.4), Bhutan (2.5), Sri Lanka (1.6) and Nepal (1.1).

These numbers provide just a flavor of the Indian healthcare space, as it stands today. Some may of course talk about legacy factor, but to move ahead more important for all is what is happening today in this regard. Yes, one more health mission, as mentioned above, has been launched on September 25, 2018 with similar hype as the past ones, if not more. Only the future will tell us what changed it brings to the ground. That said, I am not very upbeat about it either, as providing a comprehensive health care access has always been multi-factorial and will remain so. Let me now dwell on why I am saying so.

Understanding health care access:

The 2013 research paper on “Improving Healthcare Access in India” by erstwhile IMS Consulting group (now IQVIA), said that ‘health care access characterizes 3 stages,’ which from the patient’s perspective has 4 key dimensions. In the Indian context, these three stages are:

  • Accessing care: Physical reach and location
  • Receiving care: Availability/capacity, Quality/functionality
  • Paying for care: Affordability

Accordingly, healthcare access is a function of 4 key aspects:

  • Physical reaches to health care facility
  • Availability of doctors and medicines in those places
  • Quality of care provided by these centers
  • Affordability of treatment, if available there

Access to healthcare is slowly improving, but far from being enough:

All the above schemes of the government are primarily focused on ‘paying for care’ stage and ‘affordability’ of treatment, including drugs. To a limited extent it makes sense as the above study vindicates that ‘availability’ and ‘affordability’ have good impact on ‘access to health care’.

Since the inception of NHM, this approach, no doubt, has made some improvement in the overall access to health care in the country, as many studies indicate. The IMS Consulting study also observes that compared to 2004, more patients received free medicines in outpatient care in 2013 – over 50 percent of patients going to Government hospitals say that they get free medicines there. However, the outcomes of the same across the Indian states vary quite a lot.

Inadequate healthcare infrastructure and physical reach in rural areas:

Having noted that, grossly inadequate availability of public health care infrastructure – or when available physical access to many of those from remote villages, coupled with lack of availability of required doctors, paramedics, nurses and medicines in those dispensaries – often become major issues. Moreover, their capacity to providing quality care, besides longer waiting time, often pushes many – either to remain virtually untreated or to go to private care centers costing much more.

The study finds that such movement of people from public to private facilities leads to higher health care costs. Consequently, high usage of private channels drives up the out of pocket (oop) cost of treatment. Some of the details are as follows:

  • 74 percent of patients sought private consultation
  • 85 percent of ‘oop’ spending on health care was in the private sector
  • 81percent of patients incurred ‘oop’ expenditure for medicines

Curiously, 35 percent of patients in the study rated public health facilities as – good. Whereas an overwhelming 81 percent said so for private facilities. Nevertheless, associated high ‘oop’ expenditure for the same often becomes an economic burden. The large number of patients with chronic ailments, are the major sufferers.

Application of mobile-health could help improve access:

On improving access to health care in India, an interesting ‘Review Article’ titled, “Applications of m-Health and e-Health in Public Health Sector: The Challenges and Opportunities”, appeared in the International Journal of Medicine and Public Health, April-June, 2018 issue, makes some thought-provoking observations.

It says, while the use of mobile phone (MPs) has become commonplace in many industry sectors, such as banking, railways, airlines – the public health sector has been somewhat slow in adopting MP technologies into routine operations. Its innovative use can benefit patients and providers alike by enhancing access to health care.Smartphones’ usefulness in the treatment of chronic diseases – for example, monitoring of blood pressure, blood sugar, body weight, electro- cardiograph (ECG), has already been established.

The paper also suggests, mobile health (m-H) is more effective when tailored to specific social, ethnic, demographic group using colloquial language. If implemented craftily and systematically, m-H can revolutionize the scenario of the health care delivery system, in many ways. Optimal doctor-patient engagement policy for m-H needs to be formulated, outlining a legal framework and with multi-stakeholder collaboration.

Mental health still largely ignored:

Another important aspect of comprehensive health care is ‘Mental Health’, as more than 60 million Indians suffer from mental disorders, suicides being one of the major killers in India (Source: W.H.O, IndiaSpend). However, it is disturbing to note that awareness and access to mental health treatment, especially in the hinterland of the country, continue to remain ignored. Increasing incidences of farmers’ suicides, for example, notwithstanding.

This was further elaborated by the IndiaSpend report of January 30, 2018, which underscored:“Allocation to the National Program for Mental Health has been stagnant for the past three years. At Rs 350 million, the program received 0.07 percent of India’s 2017-18 health budget.This is despite the fact that an estimated 10-20 million Indians (1-2% of the population) suffer from severe mental disorders such as schizophrenia and bipolar disorder, and nearly 50 million (5 percent of the population) – almost equal to the population of South Africa–suffer from common mental disorders such as depression and anxiety.”

The report further highlights that, notwithstanding 15 suicides every hour and 133,623 suicides in 2015, India is short of 66,200 psychiatrists and 269,750 psychiatric nurses. It is also noteworthy, while a frugal sum of 0.06 percent of India’s health budget is for mental health care, the same for even Bangladesh stands at 0.44 percent (Source: W.H.O, IndiaSpend).

Conclusion:

From the above perspective, I reckon, although access to health care in India, except ‘mental health care’, is improving at a modest pace, it doesn’t seem to be anywhere near adequate, as on date. A holistic approach for a comprehensive health care access to all, through the public health system, seems to be the need of the hour.

That said, currently India is not meeting the minimum W.H.O recommendations for healthcare workforce and also in bed density. A large section of the population continues to lack affordable access to quality health care. Moreover, the importance of mental health is still unknown to many in the country.

Thus, in tandem with addressing all the three stages and four key dimensions of comprehensive health care access, it is imperative to leverage new technology-based       e-healthcare and digital devices like m-Health. Together, these will help provide and facilitate not just quality care to patients, but also complement the healthcare infrastructure, including doctors and paramedics – making quality and affordable health care accessible to all.

As I said in my article, titled ‘Mental Health Problem: A Growing Concern in The Healthcare Space of India, the ‘Mental Health Care Bill’, which is now an Act, redefines mental illness to better understand various conditions that are persistent among the Indian population.This is a good development, as it aims at protecting the rights of persons with mental illness and promote access to mental health care. Since, the current ground reality in this area is a cause of great concern, when will it be effectively implemented for all, is the all-important question.

It is imperative for all concerned to understand that improving access to comprehensive health care is multi-factorial issue. Therefore, it needs nothing less than a well-thought out multi-pronged approach for an effective solution.

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.

‘One Indian, One Health Record’: Is EHR A Tentative Intent?

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The ongoing march of technology, at a scorching pace, transforming our everyday personal – working and social lives. This is palpable. In tandem, it is also making traditional processes of doing successful business less and less productive, over a period of time. The same is more than visible in the healthcare space too. One such field – although not so widely discussed just yet, is maintaining Electronic Health Record (EHR). This is so important for both patients and healthcare providers to ensure significantly better treatment outcomes at a lesser cost, and reducing disease burden of disease too, in that endeavor.

EHR being a systematic, ongoing process of maintaining health records of every individual, help provide prompt, effective and safe health care for all. It helps immensely whenever the person visits a doctor either in private clinics or in any health center for treatment of any disease condition, or even for preventive measures.

Health profession bodies in various countries have articulated what should get included in the health record of individuals. Let me draw an example from one of the BRICS nations. The Health Profession Council of South Africa (HPCSA) defines health records as “any relevant record made by a health care practitioner at the time of, or subsequent to, a consultation and/or examination or the application of health management”. Since, over any person’s lifetime a massive health data gets generated, the current trend is to capture and store such medical data electronically and is, therefore, called ‘Electronic Health Record’ or EHR.

Laudably, India also formally notified its detail intent to make EHR system work in the country. In this article, I shall deliberate on what is the current status of EHR in India, and the key barriers that need to be overcome to make the process gain momentum, in the days ahead.

What EHR can do:

Before zeroing on to India specific initiative on EHR, let me recapitulate what it entails, quoting from a credible global source. According to Health IT- the official website of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services, being real-time- patient-centered records, EHRs make health information available instantly, “whenever and wherever it is needed”. As this process brings together in one place everything about a patient’s health, EHRs can:

  • Contain information about a patient’s medical history, diagnoses, medications, immunization dates, allergies, radiology images, and lab and test results
  • Offer access to evidence-based tools that providers can use in making decisions about a patient’s care
  • Automate and streamline provider’s workflow
  • Increase organization and accuracy of patient information
  • Support key market changes in payer requirements and consumer expectations

Let me reiterate at this point, a person’ EHR can bring together all health information from all the doctors visited at private clinics, hospital, health centers, school and workplace clinics, pharmacies and diagnostic facilities. In many countries, EHRs can be created, managed, and consulted by authorized providers and staff across more than one health care organization. This process has been followed, though in a very limited way, in India, as well.

EHR initiative in India:

In sync with Prime Minister Narendra Modi’s Digital India initiative, India reconfirmed its EHR initiative, just as ‘Aadhar’. By a notification, it explained how a cloud-based hospital application system will receive real-time health data of all individuals generated during any clinical encounter or events. Interestingly, EHR standards were first notified by the Indian government in 2013.

Be that as it may, with a fresh vow to popularize EHR in the country, especially among the health care providers, the Ministry of Health and Family Welfares revised the 2013 EHR standards and notified the same on December 30, 2016. A paper titled ‘EHR Adoption in India: Potential and the Challenges’, published in the Indian Journal of Science and Technology in September 2016, presents some interesting findings. Some of these are as follows:

  • Adoption of EHR has been significantly less in India as compared to other developed nations. This is despite the government’s enhancing the budget to US$ 19.2 billion for HIT for its greater acceptance and influence returns.
  • The reason may be attributed to the fact that EHR is not yet mandatory in India. (In my personal view, this is quite unlike what was Aadhar, for a plethora of government and private services, till the Supreme Court verdict came.)
  • In many countries implementation of EHR in the health care system is working very well, benefiting both healthcare providers and the patients, immensely.

The key barriers: 

The above paper identified the following as the key barriers to EHR implementation in India:

  • Legacy System: Most of the patient records are paper based documents. It’s challenging to convert the paper-based records to an electronic format.
  • Cost: High cost of implementation.
  • Policy: Absence of coordinated policy of Government. Lack of clarity in the existing policies of HIT.
  • Funding: Current actual funding of the government for HIT is grossly inadequate, besides lack of well-trained medical informatics professionals.
  • Standards: Most systems don’t adhere to standards, besides usage of multiple local languages by patients and staff.
  • Computer Literacy: Low Computer literacy among government staff and private hospital community, and lack of adequate system training on proper usage of the HER.
  • Coordination and Infrastructure: Lack of coordination and supporting infrastructure (including the hardware and software) among both public and private sector hospitals.
  • Privacy Concerns: Privacy concern on the confidentiality of patient health record needs to be properly addressed.

That’s a 2016 report, what’s happening in 2018?

One may justifiably comment and ask – the above details are of 2016, what is happening today – in 2018?

Even after 2 years since then, EHR still remains at a nascent stage in India, with the keep barriers refusing to get dislodged. The July 16, 2018 media headline – ‘Adoption of e-medical records facing infra hurdles’ clarifies it. It says: “The government is facing serious challenges in its efforts to adopt an electronic health record (EHR) system.” This news report quotes the latest report prepared by the ministry of electronics and information technology (MeitY), titled ‘Adoption of Electronic Health Records: A Roadmap for India’.

This paper highlights that the government is still facing serious challenges in adopting (EHR) system for every Indian’s medical record that can be accessed by doctors and hospitals – transforming the speed, quality and cost of healthcare in India.  Intriguingly, the challenges, continue to range from infrastructure creation, policy and regulations, standards and interoperability to research and development.

The report also emphasized: “With more than 75 percent of outpatients and more than 60 percent of inpatients in India being treated in private health care facilities, it is necessary for the government to bring these establishments on-board for using EHR. In view of the size of the country, there is a need to take a Free and Open Source Software (FOSS) approach to make good quality software available to hospitals and individual practitioners.”

EHR in the United Staes and other countries:

According to the ASHP National Survey of Pharmacy Practice in Hospital Settings: Prescribing and Transcribing – 2016, ninety-nine percent of hospitals across the United States now use EHR systems, compared to about 31 percent in 2003. Computerized prescriber-order-entry (CPOE) systems with clinical decision support are used by 96 percent of hospitals.

As indicated in the above September 2016 article of the published in the Indian Journal of Science and Technology the EHR implementation rate in China is 96 percent, Brazil – 92 percent, France – 85 percent, and even in Russia the same is at 93 percent.

EHR, in various form is working in many other countries of the world. Let me cite an example from nearer home. As captured in the Accenture paper titled “Singapore’s Journey to Build a National Electronic Health Record System,” Singapore government has articulated the essence of EHR with its vision that is easy to understand and remember by all – “One Singaporean, One Health Record.” To improve health care quality for all residents, increase patient safety, lower health care costs and develop more effective health policies, Singapore’s MOH created this vision that enables patient health records to be shared across the nation’s healthcare ecosystem.

Conclusion:

Borrowing the concept of Singapore, I reckon, EHR should also mean to all Indians: “One Indian, One Health Record.” I fully agree that this process isn’t easy. Many barriers require to be overcome in pursuit of this pathway – successfully. No country found this process easy, neither it is expected in India.

That said, the key question is, can India do it successfully in a relatively short period of time? My answer undoubtedly will be an emphatic yes. This is because India has the world-class IT service providers, such as Infosys, TCS and Wipro, to name a few. It means, India has the capability. Does India have the financial resources, as well? Going by the incumbent government notification on the implementation of the revised EHR standards in India, together with what it says about the country’s economic robustness – I would again say – yes, the country possibly has the financial resources too.

It seems very much possible, also considering what the last two successive governments could conceptualize, structure and implement – a massive project of similar nature and magnitude for all Indians – ‘Aadhar’. When ‘Aadhar’ could so quickly be linked with all services – provided virtually by all public and private organizations, why can’t EHR be linked with all health records of every Indian, backed by appropriate infrastructure, human resources, laws and policies?

If a new law is required for addressing privacy and ownership concerns on health data generated for all, so be it! Doesn’t this initiative need to be visible to all – just as ‘Aadhar’ project, with a priority tag attached to it?

Thus, from the perspective of ‘One Indian, One Health Record’, government notification on EHR standards in 2013, and then revising and notifying the same in 2016, appears to be no more than a tentative intent. It has been happening to several important public health care initiatives for long, and continues to happen even today.

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.

Patients’ Trust And Pharma Remain Strange Bedfellows?

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Like many other industries, pharmaceutical companies too often talk about improving focus on effective ‘stakeholder-relationship management’. The doctors obviously form an integral part of this process. There is nothing wrong with it. Nevertheless, serious concern of ‘conflict of interest’ between the two entities is being raised on the means adopted to achieve the targeted end results.

Much as the drug makers expect that these methods are easily justifiable and would not bother anyone, it usually doesn’t happen that way, especially among the informed patients. When patient-interest gets compromised in this complex transactional web, the residual impact is awfully negative. Over a period of time, such episodes lead to a patient-doctor trust-gap, having a snowballing effect on the integral constituent of this saga – the pharma industry.

In this article, I shall briefly explore the scale and depth of such trust-gap and try to fathom who can effectively address this cancerous spread. This initiative when implemented well, won’t just protect patients’ health interest, ensuring affordable health care of good quality for all. It will also help rejuvenate pharma players’ declining reputation, facilitating long-term business interest –unchained by too many stifling regulations.  

For being in the paradise of health care…

‘Trust’ is the bedrock of any meaningful relationship and is usually built based on one’s experience, perception and feelings, besides a few other factors. It falls apart in the presence of deception or lies, even if these are well camouflaged. Similarly, clandestine acts when unearthed could also lead to the same outcome. The charted pathways for development or collapse of patients’ trust regarding doctors, or government policy makers trust towards pharma players are fundamentally no different.

In a scenario where patients can trust doctors for suggesting the best affordable treatment of good quality, including safe and effective drugs; hospitals and caregivers are just and conscientious; insurance companies are caring and fair in their dealings; drug prices are rational; published clinical trial reports on drug efficacy and safety are unbiased, the communication from pharma companies are trustworthy without any hidden agenda – we are living in the paradise of health care.

Nonetheless, the same paradise built on patients’ valuable trust would get shattered, as the drug regulators and the media get to know and unearth lies and clandestine dealings between doctors and pharma companies. Patients soon realize, though the hard way that they are being short-changed. A trust-gap is created, giving rise to an avoidable vicious cycle in the healthcare space. It is difficult to break, as one witness today, but not impossible, either.

The trust-gap is all pervasive:

Although, we are discussing here the trust-gap between doctors and drug companies on the one hand, and patients, drug policy makers and the regulators on the other – the trust-gap is all pervasive. This is vindicated by a startling headline of the January 16, 2018 edition of a leading Indian business daily. It says: “Over 92% people don’t trust the health care system in India: Study”.

It quotes the GOQii India Fit 2018 report saying a large part of which includes doctors, hospitals, pharma, insurance companies and diagnostic labs. The following table shows the ranking of some these constituents in terms of trust gap of Indians.

Rank Healthcare system People don’t trust (%)
1. Hospitals 74
2. Pharma companies 62.8
3. Insurance companies 62.8
4. Medical clinics 52.6
5. Doctors 50.6
6. Diagnostic Labs 46.1

The survey emphasizes that a series of failure, particularly the negligence of hospitals in the recent past has made it hard to trust in the system. The lack of transparency was the other reason that stands out.

Not a recent phenomenon, but increasing:

A trust-deficit in the healthcare system isn’t a recent phenomenon. This was corroborated in the article, titled ‘Doctors, patients, and the drug industry: Partners, friends, or foes?’ It was published almost a decade ago – in the February 07, 2009 edition (Volume 338) of the British Medical Journal (BMJ). The authors quoted a contemporary report issued by the ‘Royal College of Physicians’, which captured an all-time low relationship between the drug industry, academia, healthcare professionals, and patients, even at that time. The paper suggested that it is in the interests of all parties to bridge the trust-gap, without further delay.

As mentioned before, this particular discussion will focus on just two areas – pharma companies and the doctors – not all constituents of the health care system. This is primarily to have a congruity with my previous discussion on the importance of ‘perception’ in pharma. From that perspective, it is evident from the BMJ paper that a trust-gap exists not just in the doctor-patient relationship, but also between the drug policy makers and the pharma industry. I shall try to drive home this point with the following two examples.

 A. The trust-gap in doctor-patient relationships for ‘Conflict of Interests’:

The article titled, “Conflict of Interest in Medicine” featuring in the JAMA Network on May 02, 2017 described ‘Conflict of Interest’ as ‘a situation in which a person is or appears to be at risk of acting in a biased way because of personal interests.’

The article further elaborated thatdoctors’ relationships with drug companies (including any payments or gifts received from the companies) might affect how they report the results of research studies, what they teach medical students about particular drugs, or what treatments they recommend for patients. Moreover, doctors may preferentially refer patients to those diagnostic facilities for tests that may financially benefit them for doing so.

B. The trust gap between the government policy makers and the pharma industry:

That such trust-deficit is all pervasive, gets reverberated even through the speeches of no less than the Prime Minister of India.

On April 18, 2018, during an interactive session of theBharat Ki Baat, Sabka Saath‘ diaspora event at the Central Hall in Westminster, UK, Prime Minister Modi,reportedly said that doctors visit Singapore and Dubai to attend conferences, and not because someone is sick. “The pharma companies invite them for that. To finally break the resultant sale of expensive medicines, the government has launched generic stores where medicines of similar quality are sold at cheaper prices” – the PM further added during his interaction with the audience present in this function at London.

As expected, the medical community in India expressed displeasure over the remark of the PM on doctors and pharma companies on a foreign soil, the same media report highlighted.

Interestingly, just a year ago, on April 17, 2017, while inaugurating a hospital in Surat, a home to several top Indian generic drug makers Prime Minister Modi had said: “We are going to make legal arrangements to ensure that when doctors write prescriptions they write that generic medicines are sufficient and that there is no need for any other medicine.”

Some ineffective interventions:

As I said before, this downward spiral with a widening trust-gap in the healthcare space of the country needs to be arrested soon, with effective steps. The best remedial measure in such cases will obviously be self-regulation by all concerned, keeping patients’ interest at the center.

As an antidote to this problem, in the previous Government regime, ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ was put in place, but only for voluntary implementation by the drug companies.

Enough time has elapsed in experimenting with this process, since then. Regrettably, like many other countries, self-regulation in this area to address the malady of trust deficit hasn’t worked in India too. Both the ‘Professional Conduct and Ethics’ of Medical Council of India (MCI) for doctors, and the UCPMP of the Department of Pharmaceuticals (DoP) for drug companies intended to address the so-called doctor-pharma industry unholy nexus, have not yielded expected results. The saga continues, unabated.

Conclusion:

From the patient-interest perspective, what is happening today in the global healthcare space is indeed baffling. Improving access to good quality, affordable drugs for all, has become a challenge in many countries, just as in India. Consequently, alleged unholy doctor-industry nexus that contributes a significant part to this problem, is attracting greater public attention today. The issue is being often raised even at the highest echelon of the incumbent government. But, more puzzling is, even after the PM’s public anguish, the DoP doesn’t seem to have walked the talk. Much hyped – the proposed mandatory UCPMP has not yet seen the light of the day, despite a clear indication of the same.

The question then arises, what happens if it does not happen due to political or any other compulsions? In that case, I reckon, the primary initiative to bridge the existing trust-gap, should rest on pharma companies. They may not always agree with all public allegations leveled against them, as the creator of this ungodly collaboration, and rightly so. Nonetheless, remaining in a perpetual denial mode in this regard, won’t help the pharma industry, anymore. More so, when the number of net-savvy, reasonably well-informed and globally connected patient groups, are fast increasing. Besides being fair in all business transactions, drug players need to sincerely engage with patients, not in usual condescending ways, but with due respect, for mutual benefits.

Otherwise, despite pharma industry and patients being interdependent in so many ways, sans a strict regulatory framework with legal teeth, ‘patients’ trust’ and ‘pharma’ will continue to remain uneasy, if not strange bedfellows.

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.

Creating ‘Shared Value’ in Pharma – The Way Forward

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Many Pharmaceutical companies, both global and local, are struggling with a plethora of critical challenges. With the industry reputation diving south successful navigation through this headwind has become an onerous task, more than ever before.

Under this backdrop, the article, titled “Creating Shared Value” of Michael Porter and Mark Kramer, published in the Harvard Business Review (HBR) in its January – February 2011 issue, becomes very relevant to analyze the situation.

The paper says: “Companies are widely thought to be prospering at the expense of their communities. Trust in business has fallen to new lows, leading government officials to set policies that undermine competitiveness and sap economic growth. Business is caught in a vicious circle. A big part of the problem lies with companies themselves, which remain trapped in an outdated, narrow approach to value creation.”

The authors also articulated that pharma players, generally focus on optimizing short-term financial performance, overlooking the greatest unmet needs in the market as well as broader influences on their long-term success. They questioned: “Why else would companies ignore the well-being of their customers and the economic distress of the communities in which they produce and sell?”

Porter and Kramer advised the companies to bring business and society back together – redefining their purpose as creating “shared values”. It means generating economic value in a way that also produces value for society by addressing its challenges.In this article, I shall explore in this area.

Not CSR or Philanthropy, its engaging business as business, for social progress:

Creation of “Shared values” for a business is quite different from “Philanthropy” or “Corporate Social Responsivity (CSR)”. Philanthropy usually involves ‘donations to worthy social causes’ and CSR is primarily directed at compliance with community standards and good corporate citizenship. Whereas the creation of “shared value” means integrating societal improvement into economic value creation, making social improvement as an integral part of with a business model.

To create “shared values”, it is imperative for business organizations to create “social value” through active participation in addressing the social issues and needs related to the business. Or in other words, the creation of “shared values” would entail striking a right balance between “social value” and the “business value.”

An article titled “What Is the Social Value of Pharmaceuticals?”, published by FSG on February 13, 2014 dwells on the business relevance of creation of “social value” in the pharma industry. It writes,creation of “social value” corresponds to effecting positive change along the major societal challenges, such as affordable health care, by working more in collaboration with other stakeholders to address the needs of the underserved through commensurate value creation. This entails engagement of a business as a business, not as a charitable donor, nor through public relations, for social progress.

A resolution to create “shared value” in the pharma industry:

An interesting article, featured in SFGATE of the San Francisco Chronicle on July 11, 2018, elucidated that the reputations of drug makers have taken a hit over the past few years as the public and politicians have called out the companies for high prescription drug prices that even Americans are facing. Recently, President Donald Trump, reportedly, singled out the top pharma companies of the world  for raising the list prices on some of its prescriptions.

Possibly it’s a sheer coincidence, but on the same day, an intent of creating “shared values” with the society got reflected in the statement of the president of the Novartis Institutes for Biomedical Research. The officialexplained, why his company has a ‘contract with society’. He admitted that: The cost of health care, which has been rising has left many on the hook for a larger amount of their prescription drug cost that can place a big burden on patients in many countries, including the United States.

Consequently, the pressure from the people who need medications is now on the pharmaceutical companies for doing right, he added. Thus, Novartis feels:”We have a contract with society, and society is our shareholder. A company like ours exists to have a definitive impact on life threatening diseases, to keep people alive and healthy for a long, long time, full stop” – the official concluded.

A laudable intent, but is it credible?

The concept of pharma having a contract with the society ‘to keep people alive and healthy for a long, long time,’ is laudable, but is it credible? This question arises because, just before public articulation of this intent, the same company, reportedly, entered into USD 1.2-million contract with President Trump’s lawyer, Michael Cohen, allegedly, to provide access to the US President.

The exact reason for the same is being investigated by competent authorities, including the US Senators. However, another report highlighted, “Novartis is among the drug companies that has put through significant price increases for its products since Trump took office in 2017 – in some cases more than 20 percent.”

Another  repot of July 09, 2018, quoting a tweet of the US President, poured more cold water on the warm intent of pharma’s ‘contract with the society.’ According to this article President Trump tweeted: “Pfizer & others should be ashamed that they have raised drug prices for no reason. They are merely taking advantage of the poor & others unable to defend themselves, while at the same time giving bargain basement prices to other countries in Europe & elsewhere. We will respond!”

Consistently declining pharma’s image and public trust:

Many believe that due to such hyperbolic statements and conflicting actions of pharma, over a long period time, are driving down the public image and trust on the industry, in general, from deep to deeper level, which has not found its bottom, just yet.

The reality gets reflected in various well-recognized polls, conducted even in the top pharma market of the world, which is also one of the richest nations, globally. August 2017 Gallup Poll on ‘Business and Industry Sector Ratings,’ features pharma industry at the very bottom of the ranking, just above the Federal government.

The concern gets reverberated in the February 03, 2017 article titled, ‘How Pharma Can Fix Its Reputation and Its Business at the Same Time,’ published in the Harvard Business Review (HBR). The paper observes that the worrisome mix of little growth potential and low reputation prompts the pharma players, among other actions, developing new treatments for neglected populations, and pricing existing products at affordable levels – avoiding corruption and price collusion.

How will “shared value” creation help pharma?

The process of creating “shared values” will involve creating “social value” with all sincerity and a clearly defined purpose. Its outcome should be measurable, and the impact felt by the society. In tandem, striking a right balance between “social value” and the “business value” would call for a metamorphosis in the concept of doing business.

There aren’t too many examples of creation ‘shared values’ by pharma companies, yet. However, to illustrate this point, let me quote one such that was originated from India, which I had the privilege to observe closely. This initiative is ‘Arogya Parivar (healthy family) of Novartis in India.

‘Arogya Parivar’ is a ‘for-profit’ social initiative developed by Novartis to reach the under-served millions living at the bottom of the pyramid in rural India. As Novartis claims, since its launch in 2007, ‘Arogya Parivar’ is proving to be both a force for improving health in rural communities and a sustainable business. ‘Arogya Parivar’ is a commercially-viable program and began returning a profit after 30 months with sales increasing 25-fold, since launch. After successful implementation of this initiative in India, the company has created similar programs in Kenya, Indonesia and Vietnam, according to Novartis.

Conclusion:

The concept of ‘shared values’ emphasizes that business success of a company is closely related to the progress, development and wellbeing of the society where it transacts the business. This can be achieved by striking a right balance between the social need and the business need. In the pharma space too, the value creation in the business value chain may need to be redesigned to meet the ‘social value’. This happened as in the case of ‘Arogya Parivar’ initiative of Novartis in India.

Creating robust business models based on ‘shared values’, in sync with the business-specific needs of the society can help make more profit in areas where there is none, at present. It will also facilitate achieving additional growth of the organization and improve long-term competitiveness.

Consequently, pharma can earn recognition of the society as a powerful contributor for containing suffering and even death of many ailing patients, by increasing access to affordable medicines for those who need these most. This, in turn, would help pharma companies to improve their public image and reputation. Let me hasten to add that provided, of course, no countermeasures are taken by them, surreptitiously, as I have discussed above.

The good news is, some pharma players have already initiated action in this direction. Thus, I reckon, many of them would soon realize that creating ‘shared value – based’ business models are the way forward 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.

Blockchain: A Game Changer For Safe Medicines

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‘Your medicine box may have fake drugs’ was the March 18, 2018 headline of a popular pan Indian news daily. Just the year before, the 2017 report of the World Health Organization (WHO), also flagged that around 10.5 percent of all medicines in low-and middle-income countries, including India are substandard or fake. Even prior to this, another news headline of February 15, 2016 highlighted: ‘1 In 7 Indian Drugs Revealed As Substandard.’ These reports paint a scary situation for consumers of medicine in India, especially when the same incidence is just around one percent in the high-income countries of the world. Nevertheless, getting into a protracted discussion to prove the veracity of this issue, may not yield much, either. Some may even term these as efforts to ‘sensationalizing’ the situation.

That said, the good news is, the Government Think Tank Niti Aayog and also the Drug Technical Advisory Board (DTAB) of India,are reportedly contemplating to combat this menace with cutting-edge technology. In this article, I shall dwell on this threat, starting with its profound impact, not just on human health, but also on the economic and the socioeconomic space of India.

Why is it so important?

The most obvious fallout of this hazard is of course borne by the consuming patient.  The other two critical impact areas has also been well captured by the World Health Organization (WHO) in its 2017 study, titled ‘A study on the public health and socioeconomic impact of substandard and falsified medical products’. I am summarizing those 3 key impact areas hereunder:

A. Health impact: 

  • Adverse effects (for example, toxicity or lack of efficacy) from incorrect active ingredients
  • Failure to cure or prevent future disease, increasing mortality, morbidity and the prevalence of disease
  • Progression of antimicrobial resistance and drug-resistant infections, loss of confidence in health care professionals, health programs and health systems

B. Economic impact:

  • Increased out-of-pocket and health system spending on health care
  • Economic loss for patients, their families, health systems and manufacturers (and other actors in the supply chain) of quality medical products
  • Waste of human effort and financial outlay across the health system, further straining resources, staff and infrastructure
  • Increased burden for health care professionals, national medicine regulatory authorities, law enforcement and criminal justice systems.

C. Socioeconomic impact:

  • Lost income due to prolonged illness or death
  • Lost productivity costs to patients and households when seeking additional medical care, the effects of which are felt by businesses and the wider economy
  • Lack of social mobility and increased poverty

What the Government contemplates in India? 

According to the April 09, 2018 news report, “Indian policy think tank Niti Aayog is working to put the entire inventory of drugs made and consumed in the country on blockchain with an intent to crack down on counterfeit and spurious drugs, according to two government sources. The government wants to complete a proof of concept (PoC) solution by the year-end and begin implementation in 2019.”

On May 16, 2018, DTAB reportedly deliberated and approved a Track and Trace mechanism to address this issue. The proposal is a stand-alone measure to combat fake or counterfeit drugs covering 300 pharma products. However, it does not intend to cover the entire drug supply chain integrity with Blockchain technology, in a comprehensive manner.

According to the above report, this particular approach involves asking the pharma manufacturers to print a unique 14-digit alphanumeric code on the package of the drug. While buying any medicine, the individual can inquire via a text message, whether the drug bearing that code is genuine or not.

I wrote an article in this Blog on the use Blockchain by pharma players, on January 22, 2018. You may wish to refer that to know more about it in context of the pharma industry.

Recent Blockchain initiatives by global pharma majors:

Some global pharma layers have already covered some ground with Blockchain, especially in this area.On September 21, 2017, an article titled ‘Big Pharma Turns to Blockchain to Track Meds’, published in Fortune, presented some interesting facts. It indicated: to stop a flow of fake, spurious or counterfeit medicines entering the supply chain and reaching patientshow the pharma industry appears to be on the verge of resolving this long-time problem with the intervention of one of the most modern technology – Blockchain.

A group of companies, including Genentech and Pfizer has announced the MediLedger Project for creating blockchain tools to manage pharmaceutical supply chains. The group, has completed a successful pilot program to track medicines, where all concerned – from drug manufacturers to wholesalers to hospitals and retailers will be recording drug deliveries on a blockchain. This would ensure that, at each step of the distribution process, a network of computers will vouch for the ‘provenance and authenticity’ of a drug shipment—making it virtually impossible for counterfeiters to introduce fake drugs – the article highlighted.

Quoting domain experts, the authors underscored the key difference between current practices in this area and managing supply chain through Blockchain technology. At present, most companies use various software to manage the supply chain. However, these usually consist of a mishmash of different databases. ‘The introduction of a Blockchain system, in which each participant controls a node on the network, and transactions require a consensus, is thus a significant leap forward’ – the experts noted.

On scaling up, if this project achieves the intended goals, it would possibly be a game changer for the pharma companies in addressing the counterfeit or fake drug menace, effectively.

How will Blockchain combat fake or counterfeit drugs?

In India, there are basically four constituents in the pharma supply chain: source of procurement of various ingredients – manufacturers – C&F Agents – wholesalers – retailers, besides hospitals and dispensaries. To avoid counterfeit or fake/spurious drugs in a comprehensive way, it is critical for these constituents to see and share relevant data based on a modern and tamper-proof technology platform. Unfortunately, the current practices mostly fail to address this serious threat in a holistic way.

Experts envisage Blockchain delivering a superior value in this area, as it has the potential to cover end-to-end supply chain network of a pharma business. A November 14, 2017 article appeared in a Harvard Business School publication of Technology and Operations Management (TOM) explains its rationale very well. The paper is titled “Can blockchain help solve the problem of counterfeit drugs?”

In the context of a supply chain it says, blockchain can be used to track the flow of goods and services between businesses and even across borders. At each step of the distribution process, a network of computers can unmistakably indicate the provenance and authenticity of a shipment, making it harder or counterfeiters to introduce fake drugs. The key advantage of this technological process is that

it is virtually impossible for malicious actors to alter the event logs. Another advantage is speed: should a shipment be disrupted or go missing, the data stored on the common ledger would provide a rapid way for all parties trace it, and determine who handled the shipment last, the author elaborates.

Common anti-counterfeit-measures:

In many countries, including India, drug regulators are focusing on putting in place various anti-counterfeit measures, such as, ‘track and trace’ and ‘mass serialization.’ In some nations these mandatory in nature. At present, the most common process, globally, is to have machine-readable codes carrying a serial number featuring on each and every pack of medicines. Many anti-counterfeit solution providers call these in various different names, to position themselves on a marketing high ground. Other such measures include, forensic markers, cloud-based supply chain data repositories are also being talked about.

So far so good, but the current reality continues to remain scary for patients, probably more in India. Each year ‘tens of thousands dying from $30 billion fake drug trade,’ – reported Reuters just recently – on November 28, 2017. As reported by IntelligentHQ on November 3, 2016, ‘studies have shown that the pharmaceutical industry still struggles on two main counts: interoperability between all the participants, from the manufacturer to the dispenser and data management, to better integrate the serialization systems. Being able to avoid drug counterfeiting is just one of the reasons for which it is so critical to successfully track products down the supply chain.’

Conclusion:

Ensuring safety and security of the pharma supply chain – from sourcing to manufacturing to logistics to retail chemist and ultimately to the final consumer, is now possible with the application of Blockchain. In fact, this process has already been developed, and tried in many continents of the world, including Africa (video).

Thus, in my view, for an effective anti-counterfeiting system to work or even a substandard drug ingredient going into any original final product that ultimately will be consumed by patients, the most important requirement is to ensureend-to-end supply chain visibility and integrity.Any stand-alone anti-counterfeit measure can’t possibly provide such holistic solution.

Just to emphasize on this point – what happens, if anything goes wrong during sourcing of ingredients, or during the manufacturing of the original drug? The drug in question, although could be substandard, can’t be termed counterfeit. Hence, any standalone anti-counterfeit mechanism will obviously indicate ‘all is well’ for the patients to consume this original medicine – before the product is ultimately recalled, if and when the defect is detected by other means.

From this perspective, the application of Blockchain technology covering end-to-end supply chain network has the wherewithal of being a game changer – offering safe medicines to patients.

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.