Trees Die From The Top: Apt For Pharma Leadership Too?

Posted on October 22, 2018 by Tapan Ray

The Management Guru of all-time – Peter F. Drucker once said: “The spirit of an organization is created from the top… If an organization is great in spirit, it is because the spirit of its top people is great.” As “Trees die from the top”, no one should ever become a strategist unless he or she is willing to have his or her character serve as a model for subordinates – Drucker emphasized.

Decades after this assertion from Drucker, meant for management practitioners, it is discernible even today how irrefutable these axioms are. In the contemporary times, as well, particularly when reality bites a company hard, being caught on the wrong side of ‘generally acceptable’ ethics, value and compliance standards.

While zeroing in to pharma, soundbites usually generated at that time, especially from the top echelon of the management, seem to hint that employees down the rung are responsible for such misdeeds, besides, of course, the legacy factor.

At this moment of truth, it is also not unusual for them to romancing the utopia, as it were. Senior management comes out with several ideas, which are squeaky clean in terms of optics. Some of them also talk about introducing behavior metric on ethics and values in employee performance appraisal before releasing any performance related pay out. In this article, I shall focus on this leadership issue in view of some latest developments in this area.

The latest developments:

Let me now come straight to the latest developments in this area, as I see around.

“Novartis links bonuses to ethics in bid to rebuild reputation” – was a headline of Reuters on September 18, 2018. It reported: “Swiss drug maker Novartis has revealed its employees only get a bonus if they meet or exceed expectations for ethical behavior as it seeks to address past shortcomings that have damaged its reputation.”

Some interesting points stand out from this report on the ownership of such alleged malpractices. These reconfirm that the reasons for the same, including the repeated allegations of such nature, are being passed on to others by the top management. For example:

To past practices or the legacy factor, even if the current CEO has been a part of that corporate environment, since long.
To employees responsible down the line, and a new system is being adopted to address the issue.

In this case, as Reuters reports: “Chief Executive Vas Narasimhan has made strengthening the Swiss drug maker’s ethics culture a priority after costly bribery scandals or legal settlements in South Korea, China and the United States.”

Interestingly, as reported by the media, “the company was also this year embroiled in a political controversy over payments it made to U.S. President Donald Trump’s ex-attorney.” Previously, even in the clinical trial area, Japanese authorities, reportedly “uncovered serious misconduct during a trial of its leukemia drug, Tasigna.”

As I said above, in response to such incidents, the General Counsel of Novartis, reportedly expressed: “This allows us to look at the behavior metric before any money leaves Novartis and catch potential misconduct before there is any risk to our reputation.” The official further added, “You can expect us to continue focusing on resolving the legacy issues that we read about in the press, ensuring we address any remaining underlying behaviors.”

Such steps not taken for the first time by a pharma company:

EvenGlaxoSmithKline tried something akin in the past.

“GSK scraps sales rep targets after scandal,” was the headline of December 17, 2013 edition of the Financial Times. It reported: “GlaxoSmithKline is to scrap individual sales targets for its commercial staff as it seeks to repair its image and reform working practices in the wake of allegations in China that its staff paid officials up to $500m in bribes. The move comes amid concerns over aggressive marketing across the pharmaceutical industry and follows a series of damaging regulatory probes leading to a record $ 3bn fine in the US last year.”

However, later on GlaxoSmithKline, reportedly “altered the plan when its sales began to suffer in the world’s largest market.”

Where is the real issue lying?

As“PwC‘s 21st CEO Survey: Preparing for disruption” found, 71 percent of CEOs surveyed said that their organizations face greater pressure to deliver business results in less time.

There isn’t an iota of doubt, I reckon, that pharma CEOs are under constant performance pressure from the investors and other stakeholders to deliver expected financial results. This makes them keep their eyes primarily glued on to the grindstone for churning out expected profits from the business. This also means that they expect management efforts to be generally directed to deliver ‘values’ at the least possible cost.

On the other hand, the same PwC survey findings reiterated that with rising drug costs, the demand for the drug companies to demonstrate the treatment efficacy, is increasing by manifold. Thus, “to remain competitive, Big Pharma will have to do things faster (like drug development) and cheaper for the patient, add more value for the same money, and become more proactive partners with patients and doctors in both wellness and cure” - one of the findings of this study emphasized.

It is quite common for most large to medium sized pharma companies to have in place a well-articulated organizational ‘ethics, compliance and values’, together with requisite checks and balances in the form of rigorous rules, regulations and other guidelines.

Most often these adorn the respective websites too, for public knowledge. The question, therefore, surfaces what could then possibly go wrong in the organization and where exactly does the real issue lie, while effectively managing the organizational growth?

“Non-compliance – A serious challenge to growth”:

Serious malpractices and their related fallout in pharma business – not just in marketing, but clinical trials, manufacturing, quality assurance and other areas, are not usually due to any lack of requisite processes or expertise. These are generally serious consequences of non-compliance of various organizational norms. At times, with the indirect support of senior management, or senior management keeps their eyes closed on such non-compliances, under demanding obligation for delivering expected financial results and business growth.

Tweaking areas, such as employee performance-incentive norms, as happened in the cases of GSK or Novartis, can’t fetch a long-lasting solution in such a situation, as I see it. Nonetheless, the survey report findings of Deloitte, titled “Non-compliance – A serious challenge to growth,” are interesting to get a sense of the reasons behind the same.

Key reasons for non-compliance:

The Deloitte report identifies some key contributors to malpractices and non-compliance in the pharma sector, indicating the percentage of survey respondents involved against each, as follows:

Lack of an efficient internal control/ compliance system: 61 percent
Weak regulatory enforcement / action taken against fraudsters: 55 percent
Inadequate utilization of technology tools available to identify red flags: 45 percent
Lack of a zero-tolerance approach towards malpractice and regulatory non-compliance: 45 percent
Inadequate due diligence on employees/ third party associates: 36 percent
Unrealistic targets/goals linked to monetary compensations: 33 percent
Senior management override of controls: 24 percent
Inadequate oversight by the Board/ Audit Committee: 06 percent

As I mentioned before, most key contributors to malpractice and non-compliance point towards a lack of senior management efficiency in internal controls, systems, and “inadequate utilization of technology tools available to identify red flags.” Curiously, no one mentions about the requirements for any fresh measures or systems to curb such incidents, in the future.

Just tweaking the present system may not help:

Just for changing the optics, tweaking the present system often doesn’t help. Many similar instances in the past, such as GSK’s example, as cited above, would vindicate this point. In the GSK case, at least, it’s the then CEO – Sir Andrew Witty expectedly realized that ‘unrealistic targets/goals linked to monetary compensations’ lead to such corruptions.

But total delinking of the core responsibility of any sales staff, namely ‘generation of top-level numbers both in volume and value’, with performance incentive, could throw some future challenges. Similar reason, presumably prompted GSK altering the plan when its sales began to suffer, at a later date.

Similarly, Novartis is, reportedly introducing a new behavioral metric as qualifying criteria for its employees to earn bonuses or incentives. Intriguingly, despite the existence of rigorous rules, regulations, guidelines and associated punitive provisions for not complying with the company ethics and values for a long-time, malpractices are still being reported today.

Thus, I wonder, how will an additional system of similar nature prevent recurrence of such incidents in the future? Anyway, only the future will tell whether a tweaking of this nature in the present system that did not work in the past, will work in this particular case effectively.

Conclusion:

The reasons for less than adequate internal controls of an organization, I reckon, fall squarely on the senior management, especially for repeat offences. Passing the blame to employees down the line or tweaking their performance appraisal system by introducing a ‘behavioral metric’, is likely to be short term, finger-pointing on the legacy factor notwithstanding.

On the contrary, these may likely to be construed as manifestations of knee-jerk reactions, and not so well-thought-out strategic measures. Neither do such repeated malpractices demonstrate a great spirit of the organization, nor do these evince astute leadership qualities of its top management.

Coming back to where I started from, quoting what the management guru Peter Drucker once said: “The spirit of an organization is created from the top… If an organization is great in spirit, it is because the spirit of its top people is great.” He also reiterated, no one should ever become a strategist unless he or she is willing to have his or her character serve as a model for subordinates This is certainly not the situation for those pharma players mired with alleged malpractices, repeatedly – not just in marketing, but in other operational areas too.

As the good old saying goes: “trees die from the top,” so is also an organization when its senior management lacks a moral compass on ethics, compliance and values. Considering what is being often reported on business malpractices within the drug industry, isn’t the saying equally apt for pharma leadership, as well?

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 Policy Execution Gap Limits Access To Affordable Medicines?

Posted on October 15, 2018 by Tapan Ray

“The cost of new drugs is putting increasing pressure on people in both rich and poor countries”- was eloquently expressed in an article, titled “Why do new medicines cost so much, and what can we do about it?”. This was published by “The Guardian” on April 09, 2018.

Almost synchronically, expressing concern on this issue, the World Health Organization (W.H.O) advised the world leaders ‘to take bold new approaches’ for increasing access to medicines for all. A UN high-level panel on ‘access to medicines’ spent almost a year deliberating over related issues. The panel members were from pharma companies, as well as civil society and academics. The final report coming in September, backed de-linkage of the costs of R&D from the eventual price of the drug. Notably, the author who is also the health editor of the above publication, feels that any positive outcome in this direction is unlikely to materialize soon.

The majority of big pharma constituents, with the possible exception of GSK, whose then chief executive Sir Andrew Witty was unenthusiastic about the UN report. Probably because, it supported governments’ right to invoke ‘a get-out’ from the World Trade Organization’s TRIPS agreement. This is to bypass drug patents and make cheaper versions of the respective generic equivalents, in the interests of public health, in accordance with the 2001 Doha declaration. However, the author is hopeful that, “as happened with AIDS, each new crisis over access to medicines – whether concerning a common liver disease or a rare cancer, and particularly over the antibiotics that are under threat and vital to all our lives – is likely to put pressure on companies to find ways to bring the costs of medicines down.”

Stakeholder pressure for increasing access to medicines continues. Even in smaller developed countries, such as Switzerland, a section of the public demands that “Swiss authorities must act to make lifesaving drugs more affordable by introducing compulsory licensing.” Or, one can now see reports saying,“Irish patients are being denied access to nine drugs that are widely available across Europe, largely, on cost grounds.”

Nevertheless, regardless of mounting pressure for drawing a reasonable symmetry between cost of, especially new drugs and their improved access to patients, ongoing status-quo continues. In this article, I shall dwell on this concern from the Indian perspective, focusing on an agonizingly stark implementation-gap related to the current Indian pharma pricing policy.

Under pressure, pharma now recognizes the need for affordable drugs:

Coming under intense pressure of patients and other stakeholders, even the largest trade association of Big Pharma has recently changed its stance on this issue, though clearly sharking any responsibility for the same. It just recognized the need for affordable medicines for improved patient access to treatments by saying: “Too often patients have to fight to access breakthrough medicines that are revolutionizing how we fight disease.” It also accepted the fact that “many Americans are struggling to afford their medicines.”

“We can improve patient access and affordability by moving toward a system that prioritizes results for patients. Biopharmaceutical companies are working with insurers to develop innovative and flexible ways to pay for medicines that focus on results, lower out-of-pocket costs and enable patients to access the right treatments the first time” – it added.

What it really means:

What it really means ‘treatment outcomes-based drug pricing’ or ‘value-based drug pricing (VBP)’. In other words, a situation where drug prices are set in line with their real and demonstrated clinical and economic value to patients, against other available products. This model will also ensure that patients’ money doesn’t get wasted from drugs that aren’t effective on them. The VBP model is, thus, significantly different from product pricing, based on ‘undisclosed’ cost of ongoing innovation for new drugs.

Is this Big Pharma’s new way to change optics?

The intent for imbibing VBP, as expressed by the above pharma association, throws open the door for discussion of its core intent. Is the intention real, or another Big Pharma way of changing general optics on the sensitive issue of new drug pricing? This doubt creeps in from the findings of some important studies on this issue. One such is an interesting paper, titled “Pricing for Survival” from KPMG. The analysis highlighted very limited application of VBP concept, and also why it is not yet viable – despite the hype being created around it.

According to KPMG, “there were 25 drugs engaged in various types of VBP with payers in the fragmented United States market as of September 2017. The problem is, these models appear to be limited in applicability to disease states with more standardized protocols and dominated by drug therapies with single indications – notably osteoporosis, diabetes and hepatitis C.” To date, VBP models seem to be facing several constraints, such as it is appealing mostly to payers that are fully integrated with healthcare delivery i.e., closed-loop payer-provider health systems or integrated delivery networks.

“The takeaway is, when it comes to specialty and orphan drugs, outcomes-based pricing simply faces too many barriers at present” – the article elaborated. Be that as it may, let me now explore the relevance of VBP in India.

Any relevance of VBP in India?

VBP has been tried in a health care environment where payers and drug companies are two critical players for access to affordable medicines, as we see in the KPMG study. Under any value-based pricing agreements for pharmaceuticals, both payers and pharma companies agree to link payment for a medicine to the value achieved, rather than volume.

Whereas, in the Indian healthcare scenario, as we are experiencing today, payers are mostly individuals. Despite various well-publicized health schemes, expenditure on health, including drugs, remains by and large ‘out of pocket (OoP)’ – for a large Indian population. Hence, copying western framework for implementation VBP in India, would call for scores of ‘pharma – individual payer agreements.’ This would be a daunting task, if not impractical, to even try it out.

In this context, let me touch upon the Ayushman Bharat scheme that was launched by the Prime Minister on September 23, 2018, but just in one of the 29 states of India – Jharkhand. If, or as and when it will cover the entire country, the scheme is expected to bring 107.4 million families and more than 550 million people under health insurance coverage. However, the work seems to be still in progress.

There are three financing models for this scheme – insurance model, trust model and hybrid model – and the 19 states that have come on board for the scheme’s implementation in the country, have chosen a trust model, according to the Union Health Minister. The minister also reiterated: “Things are still unfolding. Only when the letters reach the beneficiaries will they understand and react.”

Nevertheless, the Union Health Minister himself, just like his counterparts in the previous governments, exhibited confidence that the country is “moving towards universal health cover with Ayushman Bharat scheme,” – as was the headline of the above media report.

Going by the past and current outcomes of several such government schemes in the country, and what the minister himself articulated on September 17, 2018, a large section of the Indian population still remains apprehensive on the fast pan-India rollout and overall success of this ambitious health scheme. Hence, at this stage, I reckon, it may not be relevant to discuss the application of VBP model on Ayushman Bharat project. I wrote about such apprehensions in this Blog on June 18, 2018.

Having said that, VBP still remains relevant when we look at the government’s intent captured in the National Pharmaceutical Pricing Policy (NPPP) 2012,’ as I shall discuss below.

VBP and the policy implementation gap:

For making the point clearer, let me keep the Ayushman Bharat scheme aside because of its associated uncertainties. Even in the current health care environment of high OoP expenditure on drugs, especially on high priced new drugs, if one tries to make use of the VBP model, it is very much possible.

This is because, the National Pharmaceutical Pricing Policy 2012, under point 4 (XV) on ‘Patented Drugs, categorically states: “There is a separate Committee constituted by the Government order dated February 01, 2007 for finalizing the pricing of Patented Drugs, and decisions on pricing of patented drugs would be taken based on the recommendations of the Committee.”

Curiously, even 6 years down the line, no meaningful decision has been taken on patented drug pricing in India by the successive governments. As I wrote in this Blog on December 12, 2016, Price Negotiation For Patented Drugs: Still A Policy Paralysis.

Parliamentary Standing Committee intervenes:

Six years after the constitution of the committee by the Department of Pharmaceutical (DoP), the long-awaited report was eventually submitted with a vague formula for pricing patented drugs in India. Intriguingly,the issue remained as such, until the Parliamentary Standing Committee’s August 2016 report was placed before the parliament. It strongly criticized the DoP’s efforts to recommend measures in regulating prices of life-saving patented drugs, despite government assurances for the same.

On September 23, 2016, media reported: “Upbraided by the parliamentary standing committee for its gross negligence and lackadaisical attitude, the department of pharmaceuticals has set about seeking suggestions from different ministries on price regulation of patented drugs.”

According to reports, a new inter-ministerial committee was formed thereafter, under the chairmanship of one of the Joint Secretaries of the DoP to suggest a new mechanism to fix prices of patented drugs in the country. The other members of the committee are Joint Secretary – Department of Industrial Policy and Promotion (DIPP); Joint Secretary – Ministry of Health and Family Welfare; and Member Secretary – National Pharmaceutical Pricing Authority (NPPA). But, the saga continues – at the cost of patients’ health interest.

Conclusion:

As it appears, there still lies a clear opportunity for Indian drug pricing policy makers introduce VBP concept for patented drugs in the country. Following this model, the prices of new and innovative drugs under patents can be set in line with their real and demonstrated clinical and economic value to patients, over the available existing products. Health Technology Assessment (HTA), for example, could be an effective tool in this process.

Additionally, the VBP model could also minimize, if not eliminate the risk of patients paying a high a price for new drugs coming through incremental innovation, adding too little clinical and economic value over existing drugs. There may, of course, be some teething trouble or even important issues in arriving at consensus on value-metrics for VBP. But, this can be sorted out through meaningful engagement with concerned parties.

Strikingly, even after 6 years since the NPPP 2012 was announced, nothing tangible has been made known to stakeholders on the execution of ‘patented drug pricing policy’ in India. An avoidable policy execution gap continues, limiting access to affordable new medicines to a vast majority of the Indian population, 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.

Exigency of Cybersecurity in Digitalized Pharma

Posted on October 8, 2018 by Tapan Ray

Digitalization – as it unfolds and imbibed by most drug companies, is presumed to herald a whole new ballgame in the Indian pharma business. Equally significant is the quantum benefit that the process will deliver to pharma stakeholders – right from drug companies to patients. It has already hastened the process of new drug discovery and will also help charting newer ways to meaningfully engage with stakeholders, besides enhancing treatment outcomes for patients, appreciably.

However, the flip side is, more benefits a company accrues from digitalization, greater will be the risks of cyber-attacks. Thus, preventive measures should also be equally robust. Otherwise, hackers can bring a company’s digital system to a standstill, causing not just a temporary loss in revenue and profit, but also valuable data leak, with considerable impact on even long-term business.

Strangely, associated risks of digitalization to pharma companies are seldom outlined in any discussion, leave aside alternatives for salvaging such untoward situation, if or as and when it comes. Unless, it is felt that the scope of such discussion doesn’t cover the implementors and falls totally on cybersecurity experts.

Nonetheless, it is intriguing in the pharma space. The reason being, pharma industry believes, while talking about the efficacy of any drug, its vulnerability in terms of side-effects, contraindications or drug interactions, should also be known to its users. That’s the purpose of a packaging leaflet. It’s a different reason though, that most drug companies in India have virtually jettisoned this practice as a cost saving measure, even for drugs that are not under price control. That apart, in this article, I shall explore the relevance of cybersecurity in the digitalized pharma world.

A question that help understand its implication:

During organizational transformation through digitalization in pharma, just like any other business, all crucial documents get transferred from paper to digital formats. The key question that follows in this regard is – what happens to these digital documents post cyber-attacks, if any? Any attempt to answer this question holistically will help people realize its implication – that ‘cybersecurity must be more than an afterthought.’

‘Cybersecurity must be more than an afterthought’:

The article, ‘Cybersecurity in the Age of Digital Transformation,’ published by MIT Technology Review Insights on January 23, 2017, stressed upon this critical point. It highlighted: “As companies embrace technologies such as the Internet of Things, big data, cloud, and mobility, security must be more than an afterthought. But in the digital era, the focus needs to shift from securing network perimeters to safeguarding data spread across systems, devices, and the cloud.”

Thus, while discussing the need to digitally transform a company’s business, cybersecurity must be part of that conversation from the very start – the paper underscored in no uncertain terms. That’s exactly what we are deliberating today - ‘as companies embark on their journeys of digital transformation, they must make cybersecurity a top priority.’

The cybersecurity threat may cripple innovation and slow business:

Cisco explored the concept of Cybersecurity as a Growth Advantage by a thought leadership global study. While assessing the impact of cybersecurity on digitalization, it surveyed more than 1,000 senior finance and line-of-business executives across 10 countries. Some of the key findings, as captured in the Cisco report, may be summarized, as follows:

71 percent of executives said that concerns over cybersecurity are impeding innovation in their organizations.

39 percent stated that they had halted mission-critical initiatives due to cybersecurity issues.

Interestingly, 73 percent of survey respondents admitted that they often embrace new technologies and business processes, despite cybersecurity risk. However, as we shall see below, pharma executives are quite confident of cybersecurity, probably because of inadequate experience in this area, as on date.

Companies are struggling with their capabilities in cyber-risk management:

The paper published in the May 2014 issue of the McKinsey Quarterly journal, titled “The rising strategic risks of cyberattacks”, also flagged this issue. It said: “More and more business value and personal information worldwide are rapidly migrating into digital form on open and globally interconnected technology platforms. As that happens, the risks from cyberattacks become increasingly daunting. Criminals pursue financial gain through fraud and identity theft; competitors steal intellectual property or disrupt business to grab advantage; ‘hacktivists’ pierce online firewalls to make political statements.”

McKinsey’s research study on the subject, conducted in partnership with the World Economic Forum also upheld that companies are struggling with their capabilities in cyber-risk management. As highly visible breaches occur with growing regularity, most technology executives believe that they are losing ground to attackers. Its ongoing cyber-risk-maturity survey research also ferreted out the following important points:

Large companies reported cross-sector gaps in their risk-management capabilities.
90 percent had “nascent” or “developing” ones.
5 percent was rated “mature” overall across the practice areas studied.

Interestingly, the research found no correlation between spending levels and risk-management maturity. Some companies spend less, but do a comparatively good job of making risk-management decisions. Others spend vigorously, but without much sophistication. Even the largest firms had substantial room for improvement – McKinsey reiterated.

‘Corporate espionage’– a prime reason behind cyberattack on pharma:

An interesting article appeared in The Pharma Letter on July 18, 2017 on this subject. The paper is titled “Cyber-attacks: How prepared is pharma?” It said:“The pharmaceutical industry is a prime target for hackers. In 2015, a survey of Crown Records Management revealed that nearly, two-thirds of pharma firms had experienced breaches in data, and that one fourth of these same companies had been victims of hacking.”The paper also highlighted ‘corporate espionage’ as one of the prime reasons behind hacking.

In view of this, the author articulated that the need for pharma and healthcare companies to fortify their security systems has become clear in recent years. The best method of protection is to prevent cyber-attacks from happening, or at least reduce the risk of a hack, he advised.

Instances of cyber-attacks in pharma are many:

To drive home the point that when firms and other organizations fail to strengthen IT systems against attacks, they incur high costs -the above paper cited an example from the year 2016. It said: “The average global cost of data breach per stolen record was US$ 355 for healthcare groups, higher than losses in other fields such as education (US$ 246/record), transportation (US$ 129), and research (US$ 112).”

The author further emphasized that besides financial losses, pharma companies and other healthcare groups risk losing the trust of patients and other stakeholders. With the ongoing digitization in pharma, new threats may become even more pervasive and sophisticated. “Thus, investment in cybersecurity must be a priority, if pharma players are to protect their data and the data of their stakeholders”, he added.

Are pharma executives experienced enough on cybersecurity?

As reported by Pharma IQ on July 31, 2018, one of its recent surveys found that around 70 percent of senior pharma decision makers are “confident” or even “very confident” in their company’s IT security. But, digging deeper, the survey uncovered that:

42 percent of respondents’ companies do not routinely follow IT security policies,

49 percent said that the corporate risk profile is not firmly understood across all departments.

The survey concluded that this could potentially lead to gaps in the security process. To me it appears, this could, as well, be due to inadequate experience of pharma executives in this area.

But, investment in pharma IT is increasing:

The good news is, even in the current scenario, many pharmaceutical companieshave started making investments in IT solutions, in general. This is corroborated by the 2018 survey by Global Data. Some of its important findings are, as follows:

79 percent of them are currently making investments in identity and access management (IAM) solutions

72 percent are considering investment in the solutions over the next two years.

75 percent of the respondents are currently deploying some form of backup, archiving, alongside content and web filtering solutions to store, as well as, preserve their online information.

Conclusion:

In pharma perspective, digitalization of business promotes paperless culture. It radically changes the basic infrastructure of maintaining critical documents in the workplace. Digital document storage systems become the nerve center of information on the company. All data – strategic or related to operations – internally generated or acquired – right across all critical functional areas, such as IP, research, clinical trials, manufacturing, sales and marketing, finance, supply chain legal and even of the CEO’s office, find a space in this digital data sever.

Although, the benefits of digitalization are well known and much discussed, it has a contraposition, as well – related to the vulnerability of the system to cyber-attacks. This flags a demanding need for protection of digitally stored assets from cyber-attacks, or to frustrate even any misdemeanorfrom amateur hackers. Thus, creating an almost impregnable, well-firewalled digital data storage server assumes prime importance. Equally important is formulating and religiously implementing a robust digital policy for the same.

Creating strong awareness among employees and stakeholders regarding cybersecurity and involving them in tandem with a system-approach, sans an iota of complacency, is expected to mitigate such vulnerability, appreciably. Thus, a sense ofexigency for cybersecurity in the digitalized pharma world, I reckon, is very real.

By: Tapan J. Ray

Data: The New ‘Magic Wand’ For Pharma Business Excellence?

Posted on October 1, 2018 by Tapan Ray

Pharma companies focus more on defending their current practices, rather than doing things differently. A September 24, 2014 article by Bain & Company, titled ‘New Paths to Value Creation in Pharma’, made this observation.

This happens regardless of the credence that leaders who change too early, risk losing attractive cash flows from established business models, and those that move too late risk being disrupted by emerging competitors. However, analyzing the recent history, the authors observed that pharma leaders have more often erred on the side of holding on to old models for too long, leaving room for more aggressive players to disrupt them.

Analysis of the 10 companies in the above study also found: “With their sustained success, these companies refute the widely held assumption that serendipitous innovation is the key to success in pharma.” However, on the ground all 10 of these large global drug companies have prospered despite industry-wide trends such as declining R&D productivity and the demise of the primary care blockbuster model. The authors explained: “This is because they operate in a high-margin environment.”

Starting with this scenario, I shall submit in this article, why the importance of well targeted data-based decision-making process, across the pharma functional areas, is now more than ever before.

Rewriting notes in the business playbook, taking cue from new data:

Having charted in the high margin ambience, Big Pharma exhibit reluctance in recomposing notes in the business playbook, based on a new set of real-life data. This is essential for sustainable success in a fast-changing business, political and social environment. They keep maintaining a strong belief in what they have been believing, regardless of what a large volume of credible data overwhelmingly indicates. Ongoing near unanimity in their collective decision to further intensify expensive advocacy initiatives in the same direction, continues. Other pharma players follow the same course.

This vicious circle continues sans any positive outcome, neither for pharma, nor for the patients. Already dented reputation of the industry gets more dented. In my various articles in this blog, I deliberated on various areas that merit radical overhaul in the pharma business, including patient-centricity and transforming the business through digitalization.

Use of data and analytics leaves room for a huge improvement in pharma:

Let me express upfront, I am not trying to say, in any way, that pharma companies, in general, are not making investments for customized data generation or in analytics for use in new drug discovery and development, aiming improved process productivity. But, in many other functional areas, such as drug marketing, stakeholder engagement or even in strategic corporate communication for greater effectiveness, usage of scalable data and modern analytics leave much room for improvement.

Quality of data-use – ‘the proof of the pudding is in the eating’:

As the saying goes, the proof of the pudding is in the eating, let me give a couple of examples on the quality of data-use and their outcomes in the areas under discussion.

Sizeable data clearly establishes the wish of most stakeholders, including patients for transparency in drug pricing, alongside improved access to affordable medicines. However, Big Pharma and their associates trying to swim against the tide keep advocating how the expensive process of drug innovation merits high drug prices. Understandably, negative public perception towards the industry further intensifies. Assuming that data analytics are extensively put to use while developing such communication, can anyone possibly cite such efforts as examples of productive use data?

Similarly, if any pharma company, for example, Sanofi besides many others, claims that it aims at ‘promoting and sustaining ethics and integrity in all our activities’ and has developed a comprehensive body of policies and standards, to provide guidance on a range of challenges specific to pharma industry like anti-bribery. However, in practice, we hear and read, even very recently that ‘Sanofi to pay more than $25 million to resolve corruption charges’ and which is not a solitary instance, either. The question, therefore, surfaces, how can data play any role in the fight against corruption by uncovering, preventing and deterring corruption.

‘How data is changing the fight against corruption:’

There are many published research papers, which established that effective use of data can prevent such corruption, and surely in cases of alleged repeat or multiple offenders in the pharma industry. One such paper titled, ‘How data is changing the fight against corruption,’ published in the OECD Forum Network on February 13, 2018, also reconfirms this point. It says:Data – both big and open – is indeed changing the anti-corruption landscape, by uncovering, preventing and deterring corruption.

Is pharma leveraging the data power for holistic business success?

I am not sure, but available evidences suggest most of them are not – at least, aiming for holistic business success. This is because, in the pharma industry, including Big Pharma, as I wrotein the past, alleged corrupt practices are widespread and continue unabated. This is quite evident from the national and international business magazines and media reports, coming rather frequently. The Transparency International Report titled “Corruption in the pharmaceutical sector – Transparency International 2016”, discusses the raging issue across the various functions of many drug companies.

Besides pharma and biotech R&D, there are many other critical areas, where leveraging data power with expert application of analytics, pharma players can reap rich harvest in terms of sustainable long-term business growth. However, for that there are some prerequisites, like – an open mind, unbiased approach, a mindset to accept reality as they are, and then neutralize the unfavorable ones with cerebral power. Trying to rationalize what is not working makes the situation worse, more complex, creating stronger headwinds.

Many sources of data capturing, still limited usage:

There are many sources of abundant data availability of various kinds, for pharma players. However, targeted data gathering of scale and appropriate analysis of the same, still remain rather limited in pharma. For example, while marketing their brands, numerous drug players in India don’t venture going beyond limited sources for data capturing for broad analysis. Such data may usually include, syndicated retail and prescription audits, besides internal sales and marketing details together with associated expenses or productivity related statistics. Data mining for dip-stick analysis is done seldom, according to industry sources.

Additionally, there are copious others who operate predominantly on ‘gut feeling’ and hearsay, sans any customer related meaningful and real-time data. When we create hype on patient-centricity, and alongside witness the general outcomes of such approaches, it requires no rocket science to fathom how much intelligent data input has gone behind such strategies.

The present system itself generates an enormous amount of real-time data in various areas, though most are not effectively utilized for weighty payoff, especially in pharma. The ongoing process of data generation also includes, drug innovation initiatives, manufacturing, supply-chain, distributor–wholesaler-retailer activities, digital apps and different websites, besides scores of other sources. But, the information, as stated above, apparently, is hardly analyzed through analytics to obtain targeted strategic inputs. Leave aside, intelligent application of the same to scale newer heights of all-round business success.

Data generation for swimming against the tide of public perception:

Although, it’s not yielding positive results, I understand, pharma keeps spending a lot, both at the company level or through their trade bodies, to rationalize what they want the stakeholders to believe. For example,’ drug price control limits access to drugs’. Various reports to this effect are made public and used for the aggressive advocacy campaigns, though hardly taken seriously by those who matter.

Any price control, I reckon, may not be supported in ordinary circumstances. However, drug price control has definitely helped India to improve access to drugs without impeding any reasonable growth of the industry. That 5 or 10-year CAGR of the drug industry comes in double digit, despite continuation of drug price control regime for the last 48 years, offers a testimony to this fact. It’s a different issue, though, that Indian public health care system remains in shamble, even in the present regime. The lackadaisical attitude of all governments on public health related areas, is held responsible for this failure.

Conclusion:

The bottom-line is, expensive data generation effort, when gets primarily driven by self-serving motives, becomes increasingly counterproductive, as cited above. More informed stakeholders of date, including patients, probably other than the stock markets, want to see pharma players more in sync with the ground realities, and are acting accordingly. Thus, for sustainable business success, saner senses should prevail to generate adequate amounts of credible and targeted data, analyze them properly through analytics and use these with cerebral power to create a win-win situation in the pharma business.

In my view, any comprehensive ‘Decision Support System’ of an organization should go beyond the generation of mammoth internal business-related data. It should be integrated with the same kind of targeted external data of scale, with the use of modern analytics. This needs to happen – both at the macro level – as an organization, and also at the micro level – with its various functions. The corporate illusion of always ‘operating in a high-margin environment’ in pharma, will not guarantee sustainable business success, any longer.

From this perspective, using well-integrated internal and external data as the bedrock of all strategic decisions in pharma, I reckon, would soon prove to be a ‘magic wand,’ as it were, for pharma business excellence.

By: Tapan J. Ray

‘Design Thinking’: Translating Struggles into Positive Outcomes in Pharma

Posted on September 24, 2018 by Tapan Ray

Problems of various nature will keep coming on business, as long as long as one remains in the business. It doesn’t spare anyone in the organization – from the very top to right up to the very bottom. All is susceptible to problems. Thus, underlying part of all jobs, is one’s ability to solve problems – decisively, as these keep coming.

At the corporate level, problems could be either self-created. For example, when each functional area operates in a silo, at times restricting overall corporate business growth. This may happen not only due to lack of operational synergy, but also for setting incompatible goals. Problems may even arise out of environmental hindrances, or for smarter competitive strategies. Both would adversely impact the company performance, including the possibility of damage to reputation, and at times, even survival of the business. At the individual level, problems at the work place, may affect one’s personal life, work life, career path, key performance areas or even income, among many others.

Looking at the positive aspect of it, as the saying goes, each problem comes as a hidden opportunity, which needs to be harvested. Importantly, in a work environment, the degree of career success of an individual is often associated with the person’s problem-solving ability – in innovative ways. Conversely, one pays a commensurate price for not being able to do so.

In any case, ‘problem solving’ skill is important for all, as much as it is in any business, irrespective of whether the environment around is digital or one involving with lesser of computer technology. This skill is highly necessary for business success. Therefore, the essence of garnering differential competitive edges in any business remains deeply embedded in the quality of problem-solving ability of its people, across various organization functions.

In a broader sense, any innovation – including drug innovation that falls at the high end of the pharmaceutical value chain, is also basically a problem-solving initiative. This encompasses even some of the serendipitous discoveries, such as Viagra for erectile dysfunction. In this article, I shall try to explore the wider applications of a robust process in problem solving – the application of ‘Design Thinking’ in pharma industry.

‘Design Thinking’:

The roots of ‘Design Thinking’ hail back to the mid-1950s with the introduction of the subject, Design Science, at the Massachusetts Institute of Technology (MIT), says US Collective in a paper titled, “What is Design Thinking and how can businesses benefit from it?”

According to MIT Sloan School of Management: “Design thinking is an innovative problem-solving process rooted in a set of skills.”This process has been successfully applied to developing new products and services. It begins with understanding the unmet needs of customers. And from that insight emerges a process for innovation, encompassing concept development, applied creativity, prototyping, and experimentation. With the application of ‘design thinking’ in business, the success rate for any innovation has been seen to improve substantially.

In its analysis, MIT Sloan found that design-driven companies such as Apple, Coca-Cola, IBM, Nike, Procter & Gamble, and Whirlpool have outperformed the S&P 500 over the past 10 years by an accumulated 211 percent in what’s called the Design Value Index—a portfolio of 16 publicly traded companies that integrate design thinking into corporate strategy. According to a 2016 report from the Design Management Institute, this marks the third consecutive year the index has shown an excess of 200% over the S&P 500.

‘Design Thinking’ in pharma:

As we have seen, ‘design thinking’ approach is a human-centric way of problem-solving, understanding the user needs. In the pharma space, it’s problem solving to address its stakeholders’, including patients’ needs and requirements related to health. Thus, for innovative drug marketing, as well, ‘design thinking’ could play a very useful role to make all organizational activities patient-centric – for greater all-round corporate success.

In this context, an article on ‘design thinking’, appeared in the Financial Times on October 12, 2017 reported: “Development of a drug can take around 15 years. But by using the design-thinking process, you could make clinical trials shorter by collecting more real-time data. The manufacturing process and design of packaging could be improved by a better understanding of how drugs are being used. And costs could be reduced, enabling the more expensive drugs to be made more available.”

Four steps of ‘Design Thinking’:

MIT Sloan outlined 4 simple steps in ‘design thinking’ process, which I am summarizing in pharma perspective, as follows:

1.Understand the problem – the source could be both internal or external:

As MIT Sloan professor Steve Eppinger said: “Most people don’t make much of an effort to explore the problem space before exploring the solution space.”

This often happens in pharma too. It’s not very uncommon that looking at just manifestations of problems, a company will look for a solution – quite akin to providing symptomatic relief in the treatment of a disease.

Eppinger further articulated, the mistake that problem solvers usually make ‘is to try and empathize, connecting the stated problem only to their own experiences.’ This falsely leads to the belief that problem solvers completely understand the situation. But the actual problem is always much broader, more nuanced, or quite different from what people originally assume, he underscored.

2. Workout possible solutions – involving those who matter

3. Prototype these, test and further refine

4. Implement the best possible solution

Professor Eppinger further said, people at work can use ‘design thinking’ not only to design a new product or service, but anytime they’ve got a challenge – a problem to solve. Applying ‘design thinking’ techniques to business problems, pharma companies can offer greater value to customers, and stay relevant.

Pharma companies imbibing ‘design thinking’:

There are examples that some pharma companies are seriously nurturing the concept of ‘design thinking.’ One such an instance was captured in an interview, published in pharmaphorum on May 3, 2018. During this interaction, the head of innovationof the global pharma major – UCB,articulated how his company is creating a culture based around ‘design thinking’, right across the organization.

Acknowledging that pharma is generally accused of being distant from patients that it intends to serve, he explained how UCB is aiming to address this issue byfostering a new patient-centric organizational culture through ‘Design thinking.’

Detailed analysis of the needs of the target audience following this process, and the use of insights thus gained, will also encourage researchers to create appropriate new products. The core idea is to create products that are led by the needs of customers – something that is so critical for pharma companies, particularly in increasingly competitive commercial landscape. He advised people to be persistent and professional, as they measure and see the results, which has potential to create a snowball effect in the organization.

Conclusion:

Several studies indicate that the companies with a long track record of delivering stakeholder value, are more customer focused. Apparently, pharma players are progressively experiencing that for sustainable business excellence, their customers – including patients, should form the nucleus of corporate business strategy. The same concept should, thereafter, cascade down while developing the game plan for each functional area. There doesn’t seem to be any other viable alternative for the same, right now.

With upswing volatility in the business environment, ‘design thinking’ merits to become a relentless process, particularly for creating assertive employee-mindset to accept the challenge of perpetual change, anytime. Accordingly, a well-structured and equally well-integrated, ongoing feedback data generation mechanism, together with sophisticated analytical tools, supported by other requisite resources, should be put in place.

Ample evidences demonstrate that ‘design thinking’ helps business to stay always in sync with the market, customers and also its employees, for performance excellence. It can provide creative inputs for developing game changing business strategies, meeting customers’ new expectations, or even to reformulate those, which are yielding declining or sub-par outputs. Consequently, it becomes incumbent upon top decision makers to integrate this process into the pharma organizational culture.

Thus, I believe, ‘design thinking’ is an effective way of creative problem solving in a number of situations, having its source both within and outside the organization. It carries a promise of improved all-round corporate achievement – often translatiaing struggles into positive outcomes in the pharma business.

By: Tapan J. Ray

Innovation: Is Big Pharma Talking Differently?

Posted on September 17, 2018 by Tapan Ray

“Nearly 2 billion people have no access to basic medicines, causing a cascade of preventable misery and suffering. Good health is impossible without access to pharmaceutical products.” The World Health Organization’s (WHO) ‘Access to Medicine’ report on ‘Ten years in public health 2007–2017’ made this observation.

It also reemphasized: “A significant proportion of the world’s population, especially in developing countries, has yet to derive much benefit from innovations that are commonplace elsewhere.” Despite this, continued lobbying of many pharma companies for TRIPS-plus measures and legislation, the breaching of laws or codes relating to corruption and unethical marketing, and several blatant instances of company misconduct continues, even today.

In the midst of this situation, has Big Pharma started thinking differently about the purpose of innovation? I shall try to explore the ground reality in this article.

The argument of Big Pharma:

In response to the above observation or anything akin to that, Big Pharma has counter arguments, which are rather contentious, as many believe. They generally say, it is the responsibility of the different governments to alleviate health misery of the citizens, and not theirs. In tandem, they keep repeating the same old argument, underscoring lower prices of innovative drugs would lead to lower profit generation, significantly slowing down the process of innovation.

Drug innovation follows an arduous path and an expensive process:

Big Pharma wants people to comprehend about what it entails in the journey of discovering a New Molecular Entity (NME) and converting it to a safe and effective medicine.

For example, in its booklet Bayer explained: ‘it takes about ten to twelve years to develop a new drug. during this time, highly qualified scientists from a variety of disciplines work on filtering out a suitable active ingredient from an enormous number of compounds. Between 5,000 and 10,000 compounds are rigorously studied in numerous laboratory tests and the best ones further optimized. out of four or five drug candidates that are then tested on humans in clinical studies often only one substance is approved and becomes available to physicians and patients.”

The entire process reportedly takes around 14 years, and according to a 2016 study by the Tufts Center for the Study of Drug Development - developing a new prescription drug, which gains marketing approval, is estimated to cost drug manufacturers USD 2.6 billion. Besides, a new analysis conducted at Forbes finds that getting a single drug to market may involve an expenditure of USD 350 million before the medicine is available for sale. It concludes, large pharmaceutical companies that are working on dozens of drug projects, spend USD 5 billion per new medicine.

Drug innovation is only for those who can afford:

As is being witnessed by many, Big Pharma always tend to argue that high R&D costs drive new drug prices up in pharma. Moving a step further, that drug innovation is for only those patients who can afford, was justified even by the CEO of a major constituent of Big Pharma. An article published in Forbes Magazine on December 05, 2013 wrote: “At the Financial Times Global Pharmaceutical & Biotech Conference this week, Bayer AG CEO, Marijn Dekkers, is reported to have said that Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India but for Western patients that can afford it.”

How strong is the justification for high new drug cost?

Instead of believing the pharma argument on its face value, it will be worthwhile to go for a dip-stick analysis. One such analysis, titled “Pharmaceutical industry profits and research and development”, published by the USC-Brookings Schaeffer Initiative for Health Policy on November 17, 2017, presents some interesting facts.

It says, the pharmaceutical industry is a high-fixed-cost and low-marginal-cost industry. This means, as the authors explain, that the cost of bringing a new drug to market is very high and the process is risky, while the cost of producing an extra unit of a product that is on the market is frequently “pennies a pill”. It also, indicates, though there is a disagreement about the exact cost of bringing a new drug to market, there is general recognition that the process costs run a fewhundreds of millions of dollars per new drug. Thus, innovative drugs are supposed to be somewhat more expensive to many patients. But how much – is the question to ponder, I reckon.

An example of a new drug pricing:

Let me choose here, as an example, the pricing of one of the most contentious, but undoubtedly a breakthrough medicine – Sovaldi (Sofosbuvir) of Gilead. Sofosbuvir was discovered in 2007 – not by Gilead Sciences, but by Michael Sofia, a scientist at Pharmasset. The drug was first tested on human successfully in 2010. However, on January 17, 2012 Gilead announced completion of the acquisition of Pharmasset at approximately USD 11.2 billion.

Subsequently, on December 06, 2013, US-FDA approved Gilead’s Sovaldi (Sofosbuvir) for the treatment of Chronic Hepatitis C. Sovaldi was priced at USD 1,000 a day in the U.S., costingUSD 84,000 for a course of treatment. That Gilead can’t justify the price of its hepatitis C therapy – Sovaldi, was highlighted in an article with a similar title, published in the Forbes Magazine on June 17, 2014.

It is worth mentioning that Sovaldi costs around USD 67,000 for a course of therapy, in Germany. Whereas, it costs round USD 55,000 in Canada and the United Kingdom (UK). Gilead has accepted an altogether different pricing strategy for Sovaldi in some other countries, such as India and Egypt.

When the above concept is used to explain Sovaldi pricing:

The above Forbes paper explained its pricing by saying: “Add in other therapies that supplement Sovaldi, and now you’re talking about USD 100,000 or so to treat a single patient. To use Sovaldi to treat each of the 3 million hepatitis C patients in the United States, it would cost around USD 300 billion, or about the same amount we annually spend for all other drugs combined.”

Let me now put a couple of important numbers together to get a sense of the overall pricing scenario of a new drug. The New York Times (NYT) reported on February 03, 2015: “Gilead Sciences sold USD 10.3 billion of its new hepatitis C drug Sovaldi in 2014, a figure that brought it close to being the best-selling drug in the world in only its first year on the market.”

Against its just the first-year sale, let me put the cost of acquisition of Sovaldi at USD 11.2 billion, an expenditure of USD 350 million before the medicine is available for sale as calculated in the Forbes articleand the cost to manufacture a pill of Sovaldi at around USD 130. This reinforces the point, beyond any doubt how ‘outrageous’ its pricing is.Even Gilead’s CEO admitted to failures in setting price of Sovaldi at USD 1,000-A-Pill, said another article on the subject. More important is, the costs to Gilead for Sovaldi acquisition and launch were virtually recovered in just a little over a year, but Sovaldi’s original price tag remains unaltered.

Is the Big Pharma talking differently now?

It appears that some constituents of Big Pharma have now started talking differently in this regard, publicly – at least, in letters, if not in both letter and spirit. Be that as it may, one will possibly be too naïve to accept such sporadic signals coming from pharma, as a shift in their fundamental thought pattern on drug innovation as a profit booster. Being highly optimistic in this area, I would rather say that these are early days to conclude that Big Pharma has really accepted the reality that – drug innovation is only meaningful, if it reaches those patients who need them the most.

Changing…not changing…or early days?

Let me explain this point with examples of changing…not changing…orearly days.

Changing?

On July 24, 2018 during an interview to Pharm Exec the head of the sub-Saharan African region for Roche made some key points, such as:

Groundbreaking innovation in medical science is only meaningful, if it reaches the patients who need it.

Access to healthcare is a multidimensional challenge and key to addressing the barriers, is really understanding them

Need to create a new business model that can sustainably – and this is very important – create access for patients.

Not changing?

When one Big Pharma constituent is showing some change in its approach on the purpose of innovation, another constituent is trying to make the entry of cheaper biosimilar drugs even tougher. This creates yet another doubt – both on safety and efficacy of biosimilars, as compared to much higher priced off-patent original biologic drugs.In August 2018, Pfizer reportedly called for US-FDA guidance on ‘false or misleading information’ about biosimilars, citing some of the following examples from other Big Pharma constituents, such as:

Genentech’s “Examine Biosimilars” website, which states that “the FDA requires a biosimilar to be highly similar, but not identical to the existing biologic medicine.” Pfizer argues that Genentech’s omission of the fact that an approved biosimilar must have no clinically meaningful differences from its reference product is a failure to properly communicate the definition of a biosimilar.

Janssen Biotech’s patient brochure for brand-name Remicade, which states that a biosimilar works “in a similar way” to a biosimilar without clarifying that the biosimilar must have the same mechanism of action as the originator. Pfizer also takes issue with the brochure’s suggestion that no infliximab biosimilar has been proven to be safe or effective in a switching study.

Amgen’s April 13, 2018, tweet that states that patients may react differently to biosimilars than to reference products. Pfizer also points out an Amgen YouTube video that implies that switching to a biosimilar is unsafe for patients who are well controlled on a current therapy.

Interestingly, on July 20, 2018 Pfizer announced that the US-FDA has approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim) of Amgen, for all eligible indications of the reference product. This is the fourth US-FDA approved Pfizer biosimilar drug, the marketing and sales promotion of which expectedly, I reckon, will be no different from other biosimilars.

Early days?

Yes, it appears so. These are early days to draw any definitive conclusion on the subject.

Conclusion:

W.H.O observed in its above report that the ‘overall situation is somewhat improving’. It was also corroborated in the ‘2016 Access to Medicines Index’, which gave high marks to those companies that negotiated licenses for antiretrovirals and hepatitis C medicines through the Medicines Patent Pool (MPP). MPP was set up in 2010 as a public health organization supported by the United Nations to improve access to HIV, hepatitis and tuberculosis treatments in low- and middle- income countries.

It could well be, on the purpose of drug innovation some new realization has dawned, at least, on some few global pharma majors. However, it is still difficult to fathom its depth, at this point of time. There is no conclusive signal to believe that the Big Pharma is now thinking differently on the subject, not just yet.

By: Tapan J. Ray

Multichannel Marketing: Two Important Pharma Trends

Posted on September 10, 2018 by Tapan Ray

On September 6, 2018, Reuters reported the announcement of GlaxoSmithKline (GSK) that it would cut about 650 positions in the United States related to a global restructuring program. This includes 450 Medical (sales) Representatives (MR). Similar announcements on job cuts for MRs by other pharma companies are being made since the last several years. Last week’s GSK announcement was the continuation of the same process. This prompts me to use the aforementioned global news while focusing on two important emerging trends in the pharma industry, as we witness today.

In the rapidly digitalized world, several broader questions are often raised today. These include whether or not e-detailing in the pharma industry will eliminate the role of MRs, or for that matter will digital marketing replace the pharma print media? As the concept of ‘multichannel marketing’ (MCM) gains momentum, finding right answers to these questions or at least the right trends are assuming as much importance for business success. As I don’t have any specific answers to these queries, in this article, let me discuss just two of these emerging trends, as appears to me.

Importance of multichannel marketing in pharma:

Many pharma companies are fast realizing that their customers, such as doctors, patients and others, are showing increasing interest in getting the requisite product or treatment related information from multiple readily available channels or sources. These are accessible both in digital and print platforms, which are often of independent origin. Such behavioral preferences of pharma customers are contrary to what was mostly happening in the past, globally. However, in the pharma world of contemporary India the same old traditional path of product information flow, from drug companies through Medical Representatives to doctors, continues, by and large.

Looking ahead, ‘multichannel marketing’ for pharmaceutical and biologic products is being generally considered as the recipe for commercial success of brands. Thus, pharma players are trying to engage their customers more through multiple channels, both directly or indirectly. This is happening in many countries of the world. It is a matter of time, I reckon, that majority of large to medium Indian drug manufacturers will also follow suit.

Two interesting trends:

As multichannel marketing in pharma catches up, I find some interesting developments. These are outcomes of different channels getting balanced, based on customer preferences. Let me underscore, these are customers’ perceptions in the real world and not what the drug companies and their associates usually think, hence are worth considering. The two emerging trends, in my view, are as follows:

1. Although, the role of Medical Representatives is still important, but not as indispensable as was in the past.

2. Despite high decibel discussion over digital media, print media is still very relevant.

1. Impact on the role of Medical Representatives (MR):

“There is an ongoing debate about the effectiveness and impact of the traditional sales representative, with some arguing to discontinue the role while others sense an opportunity to improve both rep productivity and efficiency.” This was articulated in a McKinsey & McKinsey paper titled, “Death of a sales model or not.” The same article also says, even those who champion the role, point out that using richer analytics, better leadership and aligned incentives to deliver stellar results in many geographies.

To comprehend what is really happening in this area, I would quote below from two important global survey reports, with a sincere wish that similar surveys are carried out in India too. Although, these two surveys are different in nature, but address the same basic issue.

A. ZS’s Access Monitor 2014 survey:

According to this survey, “Representatives access to physicians continues to decline, particularly in certain specialties and areas of the country. Overall, close to half of all doctors in the United States are now considered “access restricted” to varying degrees.” It further says: “Since the initial ‘Access Monitor’survey in 2008, access has steadily fallen, with 77 percent of physicians considered “accessible” that year, compared with 65 percent in 2012, 55 percent in 2013 and 51 percent in 2014.

In another important finding the same study captured that “the pharmaceutical and biotech industry wastes approximately USD 1.4 billion in infeasible calls. (A call is considered infeasible if a best-in-class sales rep can’t deliver it.) The cost of infeasible calls appears to have plateaued, as companies have largely squeezed out sales force inefficiencies— making alternative channels the best path to improving access and customer engagement.”

B. CMI/Compas Media Vitals research 2018:

Despite such debate, doctors still value face to face interaction with MR, across the world. However, the digital tools and platforms of various types are increasingly used as the source of both new and existing product information, including updates.

According to CMI/Compas Media Vitals research 2018, as shown in the Table I below, doctors’ dependence on MR for information on new and existing products now stands at 51 percent and 46 percent, respectively. Similarly, for product updates their dependence stands at just 39 percent. The above McKinsey & McKinsey paper also predicts that the number of MR will gradually decline as the multichannel marketing initiatives pick up.

That said, in Table I – dinner meeting ranks seven and peer to peer information comes in the third place. Digital sources when put together now occupy a significant part of the doctors’ preferences for obtaining product information.This is also clear from the Table I that the doctors have started showing interest e-detailing, as well.

Table I: How do you want to receive information from pharma companies, for:

In %	New Products	Existing Products	Product Update
E-detailing	15	16	13
EHR	16	16	26
Reps’ Email	21	7	27
Medical Journal	22	19	12
MSL	24	23	14
Pharma Brand E-Mail	24	21	28
Direct Mail	32	29	29
Peer-to-peer	47	40	21
Dinner Meetings	49	45	24
Representatives	51	46	39

(Source CMI/Compass Media Vitals 2018)

Dinner Meetings:

As I said before, “Dinner Meetings” were rated as the second most preferred choice of the doctors for getting new and existing product information, in the above Table I. This is interesting, especially when one reads it along with the findings of the research paper, published in the August 2016 issue of JAMA Internal Medicine. The study concluded with: “The receipt of industry-sponsored meals was associated with an increased rate of prescribing the promoted brand-name medication relative to alternatives within the drug class.” The paper also clarified that “the findings represent an association, not a cause-and-effect relationship.”

2. Print media remains relevant despite digital push:

The research by CMI/Compass Media Vitals 2018 has also shown that despite the abundant availability of online versions of various medical publications, many doctors still prefer to read the print format of the same Journal, as shown below in the Table II:

Table II. How do doctors read medical Journals?

Online/Digital format (%)	Print format (%)
47	53

(Source CMI/Compass Media Vitals 2018)

Although, the professional portals are the most used to get the requisite information by the doctors, print journals still rank number three, after peer-to-peer information.

That print media is still relevant for the doctors to know about drugs, was confirmed by another study, as shown in Table III:

Table III. Print media is still relevant:

Professional Portal	Colleagues	Print Journals	CME Meetings	Online Journals	Drug Ref. App	In Person	Speaker program
72%	67%	66%	66%	53%	53%	53%	53%

(Source :Kantar Sources & Interactions report from September 2017)

It is noteworthy that ‘online journals’ rank number 5, after ‘CME meeting’.

Conclusion:

Despite Millennials in India mostly prefer reading news online through digital media, print media has still remained relevant and growing too. So are the television channels, regardless of easy availability of anytime streaming of all types of news, videos, TV serials and even movies.

Moreover, with increasing preference of digital media by an increasing number of populations, reliance of many industries such as Fast-Moving Consumer Goods (FMCG) haven’t totally shifted from magazine and newspaper advertisements, alongside targeting their customers through digital platforms. The same is expected to happen with various print formats in multichannel pharma marketing, where the physical presence of MRs still play an important role. Thus, to create a greater impact on doctors, patients and other stakeholders, pharma marketers are expected to leverage the best of both print and digital world in the form of comprehensive MCM initiatives. It could well be more on digital platforms and less with print materials, as we move on.

The new role of MRs was epitomized in an interview of the Sales Director, Roche, UK, published in the eyeforpharma on January 26, 2018. In the words of the sales director: “For us, in our market, the traditional showing a visual aid and some messages with the HCP is dead… But the face to face meeting is certainly not. Its role, however, will be more about adding value, about finding the right patients for the right drug.” He further highlighted, “the clear challenge that stands before the pharmaceutical industry’s sales organizations; a world where access to physicians is diminishing, trust in the information the industry provides is dwindling, and having a costly sales force is increasingly hard to defend.”

Against this backdrop, regardless of MCM, the role of those MRs who will be in sync with the requisite applications of technology in their focus areas of work, will continue to remain relevant, though they will be lesser in number. A few of them will also stand out and shoulder higher and higher professional responsibilities in the industry. Be that as it may, in my view, these two emerging trends are expected to gather a strong tailwind, at least in the medium to long term, heralding the dawn of a new era in the Indian pharma industry.

By: Tapan J. Ray

Patients’ Trust And Pharma Remain Strange Bedfellows?

Posted on September 3, 2018 by Tapan Ray

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

PILMAN

A Tapan Ray Website

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