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Drug Prescription In Generic Names Only, No Branded Generics

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The World Bank Report released on April 07, 2023 highlights that patients’ Out-of-Pocket (OoP) expenses as a percentage of their total healthcare expenditure in India still accounted for as high as 50.59%. This means that patients in India generally pay for the majority of their healthcare costs themselves, rather than through insurance or government funding. The high level of OoP expenses in India has been a major problem for many patients, even today. Studies indicate it often leads to financial hardship, especially for low-income families.

A number of factors contribute to the high level of OoP in the country, as a whole, with regional variations. According to several studies, the healthcare costs in India are rising faster than inflation, making it increasingly difficult for more people to afford the care they need, especially for life threatening ailments, such as cancer.

Different union governments while in power have taken several steps to address this problem, such as, in 2018, the launch of the Pradhan Mantri Jan Arogya Yojana (PMJAY), a national health insurance scheme. It provides free coverage for poor and vulnerable families. The PMJAY is expected to have helped in reducing OoP for some patients, but it is not yet clear how much of an impact it has had overall.

On April 24, 2017, I asked on this blog – would drug ‘Prescriptions in Generic Names Be Made A Must in India?’. Interestingly, in August 2023, a new circular from the National Medical Commission (NMC) notified professional conduct regulations for Registered Medical Practitioners (RMP), including guidance to doctors on drug prescriptions.  This has raised a furor, as it were, among many medical practitioners and their associations. In this article, I shall deliberate on the pros and cons of this decision and its practicality in India. Let me start with the rationale behind such thinking, as I see it.

The rationales behind drug prescription only in generic names in India:

As I see it, there are several rationales behind doctors prescribing drugs only under generic names in India. Here are some of the most important ones:

  • Cost savings: Generic drugs are typically much cheaper than brand-name drugs. This is because generic drugs do not have to go through the same expensive clinical trials and marketing campaigns as brand-name drugs. As a result, they can be sold at a much lower price. This can save patients a significant amount of money, especially for expensive medications. 
  • Increased access to medicines: The lower cost of generic drugs can make them more accessible to people who might not otherwise be able to afford them. This is especially important in India, where a large proportion of the population lives below access, the poverty line. Generic drugs can help to ensure that everyone has access to the medicines they need. 
  • Improved competition: The availability of generic drugs can lead to increased competition in the pharmaceutical market. This can drive down prices even further and benefit patients.
  • Reduced risk of counterfeit drugs: Generic drugs are regulated by the government and must meet the same quality standards as brand-name drugs. This means that patients can be confident that they are getting a safe and effective product, regardless of whether it is a generic or brand-name drug. Counterfeit drugs, on the other hand, are often made with substandard ingredients and can be dangerous to take. By prescribing generic drugs, doctors can help to reduce the risk of patients getting counterfeit drugs. 
  • Transparency and accountability: In addition to these benefits, prescribing drugs under generic names can also help to promote transparency and accountability in the pharmaceutical industry. When doctors prescribe drugs under generic names, it is easier for patients to compare prices and choose the best option for their needs. This can help to drive down prices and improve the quality of care. 

A draft regulation was notified in 2022 for comments by all concerned:

For this purpose, a draft regulation was issued by the National Medical Commission (NMC) on May 23, 2022, for comments by all concerned, before it becomes mandatory in 2023. The NMC has also stated that it will take steps to ensure that the quality of generic drugs is maintained. The NMC will work with the Drug Controller General of India (DCGI) to ensure that generic drugs meet the required quality standards.

The final notification goes beyond drug prescription in generic names:

On August 03, 2023, The National Medical Commission (NMC) notified the professional conduct regulation for Registered Medical Practitioners (RMP). It not only provides guidance to avoid branded generic drugs and prescribing drugs with generic, non-proprietary and pharmacological names only, but also, restricts doctors from getting involved in any third-party educational activity like Continuing Professional Development, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector. 

It justified its decision by saying, “India’s out-of-pocket spending on medication accounts for a major proportion of public spending on health care. Further, generic medicines are 30% to 80% cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down health care costs and improve access to quality care.” The notification also provided guidance on telemedicine consultation and prescriptions.  

The Indian Medical Association (IMA) Protested against it:

The Indian Medical Association (IMA) submitted a memorandum to the Indian regulator, the National Medical Commission (NMC), on February 7, 2023, protesting against the compulsory prescription of generic drugs. The memorandum argued that the regulations would harm patients and doctors, and that they were being implemented without proper consultation with stakeholders.

The IMA also stated that the regulations would violate the fundamental right to freedom of speech and expression of doctors. The memorandum said that doctors should be free to prescribe drugs based on their medical judgment, and that they should not be forced to prescribe generic drugs.

The IMA’s protest is significant because it is the first major challenge to the NMC’s regulations on compulsory prescription of generic drugs. The protest could have a significant impact on the implementation of the regulations, and it could also lead to changes in the regulations.

It is important to note that the IMA is not the only organization that has expressed concerns about the NMC’s regulations. Several other medical associations have also expressed concerns, and some doctors have also spoken out against the regulations.

The controversy over the NMC’s regulations is likely to continue for some time. It is important to note that there are valid concerns on both sides of the issue. It is also important to remember that the regulations are still in the early stages of implementation, and that it is too early to say what their long-term impact will be.

A few reasons why doctors in India may be hesitant to prescribe drugs under generic names. 

Here are some of the most common reasons:

  • Lack of awareness: Some doctors may not be aware of the benefits of generic drugs. They may believe that brand-name drugs are always better than generic drugs, even though this is not always the case. 
  • Influence from pharmaceutical companies: Pharmaceutical companies often give doctors incentives to prescribe their brand-name drugs. This can create a conflict of interest for doctors, who may be more likely to prescribe brand-name drugs even if they believe that generic drugs are just as effective.
  • Patient demand: Some patients may specifically ask for brand-name drugs, even if generic drugs are available. This can put pressure on doctors to prescribe brand-name drugs, even if they believe that generic drugs are a better option.
  • Quality concerns: There have been some cases of counterfeit generic drugs being sold in India. This can lead to doctors being hesitant to prescribe generic drugs, as they may be concerned about the quality of the drugs.

Some ways to encourage doctors to prescribe generic drugs:

  • Educate doctors about the benefits of generic drugs. Doctors need to be aware of the benefits of generic drugs in order to be willing to prescribe them. They should be taught about the cost savings, increased access, and improved quality of generic drugs.
  • Reduce the influence of pharmaceutical companies on doctors. Pharmaceutical companies should not be allowed to give doctors incentives to prescribe their brand-name drugs. This would help to ensure that doctors are prescribing drugs based on the best interests of their patients, rather than on financial considerations. 
  • Encourage patients to ask for generic drugs. Patients should be aware of the benefits of generic drugs and should ask their doctors to prescribe them whenever possible. This will help to create a demand for generic drugs and encourage doctors to prescribe them. 
  • Improve the quality control of generic drugs. The government should take steps to improve the quality control of generic drugs in India. This would help to reduce the risk of patients getting counterfeit drugs. 

By taking these steps, we can encourage doctors to prescribe generic drugs and make them more accessible to patients. This would help to save patients money, improve access to medicines, and reduce the number of counterfeit drugs in circulation.

Conclusion:

I now revert to this month’s notification of the National Medical Commission (NMC) on the professional conduct regulation for Registered Medical Practitioners (RMP), providing  new guidance for drug prescriptions in India. It clearly indicates that doctors should avoid prescribing branded generic drugs, instead prescribe drugs with generic, non-proprietary and pharmacological names only. ‘However, in the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, the practice of prescribing generic names only, can be relaxed,’ it elaborated.

Weighing the pros and cons of this notification, I reckon, despite the reasons articulated by doctors and their associations, besides the branded generic manufacturers, there are many benefits to prescribing drugs under generic names only. Generic drugs are typically much cheaper than brand-name drugs, and they are just as effective. They can also help to reduce the number of counterfeit drugs in circulation, besides several other benefits, as cited above. As a result, doctors should be encouraged to prescribe generic drugs whenever possible. Let me hasten to add, changing the prescribing practices of doctors and addressing concerns about the quality of generics can be a complex and gradual process.

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.

 

Growing Intricacies of Today’s Field Staff Role And The Path Ahead

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With a varying degree, and in various forms, a hybrid working model is now gaining greater acceptance of several top pharma companies, across the world, just as in many other industries.

This trend gets echoed in an article of December 07, 2022, published in the Reuters Events Pharma. It recalled, how pharma industry, since nearly the last three years, was compelled to adopt fully digitalengagement models initially triggered by the Covid pandemic. Gradually, more pharma players are preparing themselves to adopt a more complex and hybrid customer engagement model, with a diverse mix of engagement modalities.

Consequently, in many ways the medical rep’s role is undergoing a metamorphosis and becoming more complex. Thus: ‘There is a growing requirement for them to connect the right decision-makers at the provider with the right subject matter experts in pharma’, as the above study recommends.

This situation demands, more flexible customer engagement strategies, based on ongoing data-science based indicators – replacing the traditional static outreach schedules and content that remain in place for months at a time. In today’s article, I shall dwell in this rapidly emerging area.

This changing trend is obvious:

The above change is obvious, and also gets reflected in an article, published by the McKinsey & Company on September 30, 2022. The paper indicated, although some physician’s preference for in-person meetings with the reps has rebounded since November 2020, it was still below pre-pandemic levels (58 percent compared to 76 percent) as of August 2021. Thus, there is a need for a change.

The need for a hybrid approach – why?

The need for a hybrid approach in modern sales and marketing has been vindicated by several recent studies. The doctors or other healthcare customers can now broadly be put in three categories, as follows:

  • Doctors looking for a Rep’s personal visit for product briefing.
  • Difficult to meet doctors, who prefer to get relevant product/ disease information through remote platforms, as they want and when they want.
  • Doctors who now prefer a hybrid engagement, some personal and some remotely.

Thus, no wonder why the top players are upending their traditional go-to-market (GTM) strategies by augmenting their field sales forces with remote-sales organizations for better meeting the needs and preferences of physicians and other customers. The above McKinsey study also underscored, ‘’the shift to a hybrid sales approach has been demonstrated to unlock growth opportunities and reduce the cost to serve across care settings.

Hybridization of a pharma field staff job with push and pull strategies:

For pharma field staff, like Medical Representatives, one may wonder how their work can be made hybrid for increased effectiveness by manifold. Let me illustrate this point with the example of hybrid drug detailing to its target audience.

As many would know, drug companies have been traditionally engaging with physicians mostly with face-to-face product detailing, for increased prescription demand generation. This approach primarily entails a ‘push strategy’.

Whereas e-detailing is crafted with a built-in ‘pull strategy’, allowing customers to fetch what they want – how they want and when they want. E-detailing in various sophisticated forms is now receiving a strong tailwind on its sails, after getting a strong boost during the lockdown period of the recent Covid-19 pandemic.

The key benefits for hybridization:

As a research paper in this regard, published in the i-manager’s Journal on Management found that high technology based e-detailing not only reduce selling costs, but more importantly, increase the company’s physician reach and communication effectiveness powered by a pull driven system.

This study, after thoroughly examining the strength and weaknesses of both the traditional and the technology driven approach to drug detailing, proposed a blended or hybrid selling model as superior. The researchers found that ‘by integrating push and pull strategies with the use of new information tools, pharmaceutical marketers can best maximize the process of diffusing drug knowledge, while best considering the demanding needs of selling to time pressured physicians.’

The paper then concluded that – “Hybrid detailing can enhance physician knowledge by providing pharmaceutical marketers with more effective digital information tools that can further support and improve an adaptive and relational selling approach.’

That’s why, many pharma majors now believe that a hybrid detailing model, can help the company to better assess, track, and evaluate their selling effectiveness by employing information tools, systematically. This approach can be an integral part of the overall Omnichannel communication platform of the organization.

Transformation to Hybrid Customer engagement model – some options:

There could be several options to make a transition into a hybrid customer engagement model from a traditional one. One way could be to create a fresh infrastructure for a state-of-the-art e-marketing platform, alongside, of course, traditional sales and marketing.

Another way may well be, to keep traditional sales and marketing in-house, and outsource Omnichannel digital sales and marketing activities. The choice of the right options will be decided by the leadership of individual companies, based on their wherewithal, and other strength and weaknesses.

Outsourcing of digital marketing – an option worth pondering:

Outsourcing of digital sales and marketing aren’t new in the global pharma industry, many large pharma companies, including Merck, Johnson & Johnson, Amgen, and several others are, reportedly, availing such services for quite some time, with a significant return.

These custom-made digital services, as reported, could be many, such as, e-marketing, remote detailing, multi-channel interaction management, online video, mobile, and smart device detailing, besides permission-based email and targeted advertising services to name a few. Thus, reckon, while considering a hybrid pharma sales and marketing model, outsourcing of digital sales and marketing is worth pondering, especially in India with so much of talents in this area.

Conclusion: 

It is important to note that unlike many other fields, hybrid models of pharma sales and marketing, don’t just involve Work from Home (WFH). For this critical transformation drug companies would need first to create a commensurate organizational ecosystem to take on board all individuals in the hybrid workforce. The aim is to deliver differentiated deliverables in the marketplace with an expected return.

As I see around, building a hybrid sales and marketing model in-house from the very beginning could be more challenging, especially for mid-size companies due to various reasons. Outsourcing the non-traditional digital part of this initiative may add speed and exponential value, if the selection is right.

Either way, the pharma leaders, I guess, are already witnessing increasing intricacies in the traditional role of field staff. It needs to be resolved, soon – undoubtedly.

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.

 

Restart Pharma Demand Generation Activities With Actionable Insight

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As the ‘Lockdown. 04’ in India passes by, a time comes to press the restart button of all business activities in the country, in a calibrated manner, though, keeping in mind, the Covid-19 cases is yet to find its peak in the country. The process would naturally include all activities of the pharma industry. And more specifically, the prescription demand generation activity, where personal selling has remained pivotal in all these years.

But now, while living with the new Coronavirus, it would require greater cerebral interventions of astute pharma marketers. Creating an innovative pathway for recovery – driven by actionable insights, through an agile and digitally empowered workforce, would be the name of the game for success. In this article, I shall focus on this important area, as the industry moves on.

The bedrock of the new pathway:

The ‘restarting’ process of the prescription demand generation mechanism, I reckon, would no longer be the same ball game. It will now entail gaining cutting-edge actionable insights on the evolving dynamics of the changing business processes. It involves customers’ new preferences for consumption in the healthcare space and ascertaining the most effective demand generation processes or tools in the prevailing new normal.

Therefore, the bedrock of the new pathway, in my view, will necessarily need to be based on:

  • A huge pool of relevant, credible and preferably real-time ‘Data.’
  • ‘Information’ obtained by analyzing the ‘Data’ as desired.
  • ‘Actionable Insight’ gathered from the collected ‘information.’

The encouraging point is, several companies, even in India, have already started testing the water to chart the way forward.

Some fundamental changes in the path to recovery:

The McKinsey article of May 12, 2020 titled, ‘Pharma operations: The path to recovery and the next normal,’ also noted: ‘Given the shifts that have taken place seemingly overnight in response to the immediate crisis, companies are also turning their attention to recovery and the path to the next normal. It will likely bring about fundamental changes in pharma operations.’

Besides, the future of work will become more remote and distributed, and demand may shift to new capabilities and talent. Moreover, ‘the post-COVID-19 workforce and organization will also likely adopt new, more efficient ways of working.’ Thus, pharma organizations should consider adapting quickly in the path to the next normal, the article added.

The change and increasing relevance of ‘Data’, ‘Information’ and ‘Insight’: 

While discussing about ‘Data’, ‘Information’ and ‘Actionable Insight,’ let us first try to understand the differences between each of these three. Voccii, the US based market research firm, captured this difference eloquently, as follows:

  • Data: the raw and unprocessed facts, captured according to some agreed-upon standards. It could be a number, an image, an audio clip, a transcription, or similar.
  • Information: the data that has been processed, aggregated, and organized into a more human-friendly format. Data visualizations, reports and dashboards are common ways to present information.
  • Insight: gained by analyzing data and information to understand the context of a particular situation and draw conclusions. Those conclusions lead to actions that one can apply to business operations.

To facilitate the process of desired changes, translating research data into actionable insights will now be a crucial strategic input. In fact, these are essential while recomposing notes in pharma sales and marketing playbook, more than ever before. Notably, it has now been established in other industries that actionable insights facilitate prompt business process transformation, putting the organization ahead of competition for excellence.

What really are ‘actionable insights?’

Although, these two words are self-explanatory, it’s better to reiterate again – what ‘actionable insights’- based ventures are. It will help all to be on the same page while reading this piece. As I understand, ‘actionable insights’ mean gaining an accurate and deep understanding of someone or something or some situation based on relevant and credible data, that can help generate specific actions for a successful outcome.

However, what generally happens instead, and particularly in the Indian pharma industry, is usually very different. Quite often, many marketers get drowned in a large pool of available data and information, sans the cerebral skill of gaining actionable insights out of those – they start relying more on their ‘gut-feel’. As a result, ‘gut feel’ driven actions try to be in the driver’s seat, rather than data-based ‘actionable insights’ of high value.

Digital insights would be ‘The new currency of business’ in the new normal:

Today, it’s not quite uncommon to find pharma companies, especially in India, having loads of data and information. What they perhaps need to learn is, how to convert those inputs into actionable insights, the lack of which could make even the best of market research initiatives unproductive. That’s why, around the world, many believe that Digital Insights Are The New Currency Of Business. More so, in the new normal of living with Covid-19.

The article – ‘Actionable Insights: The Missing Link Between Data And Business Value,’ published in Forbes on April 26, 2016 also emphasized this point. It said. ‘With many companies struggling to make sense of their data and create value with their big data investments, the promise of actionable insights sounds wonderful. Forrester reports 74% of firms say they want to be “data-driven,” but only 29% are actually successful at connecting analytics to action. Actionable insights appear to be the missing link for companies that want to drive business outcomes from their data.’

Harvesting insights from data can fetch huge financial returns for the company. Which is why, sitting at the apex of the data pyramid, actionable insights help drive strategic action. It prompts rethink the status quo, pushing marketers to move into a new strategic direction. From this perspective, in the new normal of living with Coronavirus, actionable insight based unique brand strategy, content development and the process for reaching out to patients, doctors and other health care consumers, I consider, will decide the degree of business success.

Some focus areas for ‘actionable insights’ in the changing scenario:

Although, ‘actionable insights’ would help strategize a whole new chain of activities for increasing ‘prescription demand generation,’ some of these areas, for example, may include:

  • Capturing changes in patients’ behavior and preferences, specifically during the national ‘Lockdown’ period, besides, ‘compliance to social-distancing’ norms.
  • New ways of regrouping patient population, alongside, effective content creation and choosing right platforms for a sharper focus on them in the new situation. 
  • Doctors’ changing preferences for interacting with drug companies for the same reasons.
  • Making remote prescription demand generating actions highly productive, ensuring a cutting-edge over the competition.
  • Taking a quantum leap in improving the level of engagement for a greater share of mind with doctors, patients and other stakeholders, without bombarding them with ‘me-too’ emails, messages and calls. 

Conclusion:

As the ‘Lockdown. 04’ in India – the second most populous country of the world – ends, as on May 31, 2020 morning, the recorded Coronavirus cases in the country reached 182,490 with 5,186 deaths. Comparing the same with the most populous country of the world – China, where Covid-19 struck first ever – in December 2019, one finds it recording 83,001 cases with 4634 deaths, on the same day.

Be that as it may, after the national ‘Lockdown’ of about two and half months to save lives, it’s about time to restart initiatives for the livelihood of millions of Indians. Accordingly, pharma industry would also hit the restart button of its all business activities in the country – understandably, in a calibrated manner. The restart would include one of its most critical activities – generation of prescription demand, where personal selling has been pivotal in the years passed by. Several research studies have already highlighted a changing pattern in this area.

In the coming days of work while living with Covid-19, all would need to take measures to prevent the Coronavirus infection. Thus, strict compliance with the social distancing guidelines and other norms, as prescribed by the Government, will be ne necessary for all. This would also make the working life of pharma professionals, along with the practices of its stakeholders, significantly different from the traditional past.

From this perspective, while reaching for the restart button in the new normal, pharma sales and marketing leadership would need to create an innovative pathway to recovery. This would call for actionable insights about changes in the behavioral and preference pattern, especially of the healthcare consumers and providers. These will be absolutely critical for commercial success in the ‘new world,’ as it were – more than ever before.

By: Tapan J. Ray     

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

Come Covid-19 Drug And Vaccine, Pharma Will Get Back To The Traditional Mode

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‘Corona will remain a part of our lives for a long time. But at the same time, we cannot allow this to happen that our lives will be confined only around the corona. We would wear masks, follow two yards distance and pursue our goals. Therefore, the fourth phase of lockdown, lockdown 4, will be completely redesigned, with new rules,’ said the Prime Minster of India, during his televised address to the nation on May 12, 2020.

Many countries around the world, have already decided to move ahead, phasing out Covid-19 lockdowns cautiously, in a manner that each country will deem appropriate. Alongside, in line with many other industries, several pharmaceutical companies seem to have also started accepting this new reality. For example, Novartis, which reportedly, started digitizing its sales and marketing even before the COVID-19 pandemic, has hit the fast forward button.

This is evident from what Novartis said: “We were already on a journey in terms of our commercial model where digital and other channels and virtual detailing were becoming a bigger part of our mix.” The Company is planning an omnichannel digital launch for its latest new product – Tabrecta for metastatic lung cancer. This was prompted by the very sensitive situation that the world is going through ‘and the extra burden that’s put-on physicians and patients” as the pandemic continues - the company clarified.

This leads to the key question, are most companies on the same wavelength as Novartis, in this area? Or, a large majority of drug players, is still nurturing the hope that prescription demand generation activity from doctors and hospitals will soon return to the traditional mode of what was prevailing during pre-Covid-19 pandemic days? This flows from an age-old experience – a large number of sales or medical representatives have always spearheaded the demand generation mechanism for any patented or brand-generic medicine.

Still, for many it is difficult to even think of any quantum shift in this space, as the traditional core mechanism continues, despite so much hype of digitalizing pharma operations. Whereas, several others do feel, at least, a Covid-19 vaccine or a drug for its effective treatment, which, apparently, are almost knocking at the door, will bring the current situation back to the previous normal. Will vaccine or an effective drug be a panacea to win the war of Covid-19 pandemic, decisively? In this article, I shall dwell on this subject. To set the ball rolling, let us fathom whether or not coming out with a safe and effective Covid-19 vaccine, in a jiffy, is rather a certainty.

Is Covid-19 vaccine a certainty?

No doubt, a large majority of people believe, a vaccine to prevent COVID-19 is perhaps the best hope for ending the pandemic, as Mayo Clinic has also said so. However, it also records the following major apprehensions or challenges in developing a COVID-19 vaccine, based on the research data:

  • Ensuring vaccine safety
  • Providing long-term protection
  • Protecting older people

On May 12, 2020, at the US Senate hearing about the path forward from pandemic lockdowns in the United States, NIAID director Anthony Fauci also said, there’s “no guarantee” any of the vaccines in testing will be effective, though based on his knowledge of other viruses, he is “cautiously optimistic.” Thus, projections about how COVID-19 will play out, are still mostly speculative.

Why ‘projections about how COVID-19 will play out are still speculative’?

A recent article – ‘How the COVID-19 Pandemic Could End,’ published in the ‘Scientific American,’ also commented so. It said, the end game will most likely involve a mix of everything that checked past pandemics:

  • Continued social-control measures to buy time,
  • New antiviral medications to ease symptoms,
  • And a vaccine.

Citing the famous example of the H1N1 influenza outbreak of 1918–1919, it said, doctors and public health officials had far fewer weapons than they do today. Thus, the effectiveness of control measures, such as school closures depended on how early and decisively, they were implemented. Over two years and three waves, the pandemic infected 500 million and killed between 50 million and 100 million. It ended only as natural infections conferred immunity on those who recovered.

Which is why, as on date the pursuit to achieve all three goals as mentioned above, would likely to continue. That said, a safe an effective Covid-19 vaccine will be the most preferred way to stop rapid transmission of the Coronavirus outbreak. However, this comes with a critical caveat.

Would the entire population need to be vaccinated?

Experts believe, unless a vaccine is administered to all of the world’s eight billion inhabitants who are not currently sick or recovered, COVID-19 is likely to become endemic. It will circulate and make people sick seasonally—sometimes very sick. But if the virus stays in the human population long enough, it will start to infect children, showing mild symptoms.

In that process, children appear less likely to develop severe disease if they get re-infected as adults.  Thus, the combination of vaccination and natural immunity will protect many of us. ‘The Coronavirus, like most viruses, will live on—but not as a planetary plague,’ the ‘Scientific American,’ article concluded.

Covid-19 end game to involve a mix of those that checked past pandemics:

Let us now look at the possible mix of the Covid-19 end game, which were involved in checking the past pandemics, one by one:

Continued social-control measures to buy time:

The social control measures would include compliance with the prescribed social distancing norms, in tandem with aggressive testing for the infected individuals, isolating them, and quarantining their contacts. These measures were well tested in the past epidemics and useful if followed well, by all.

Therefore, from the pharma industry perspective, getting back to the traditional ‘pre Covid-19 mode’ of prescription demand generation mechanism, will indeed be challenging for most drug players.

Availability of well-tested antiviral medications to ease Covid-19 symptoms:

So far, there is no scientifically and well-tested medications for the treatment of Covid-19. However, many different medications are under clinical trials in various parts of the world. So far, most hyped among them appears to be remdesivir, an experimental antiviral developed by Gilead for the treatment of Ebola.

However, the clinical study result of ‘Remdesivir in adults with severe COVID-19,’ published in The Lancet on April 29, 2020 found that the dose regimen of intravenous remdesivir used in the study, was adequately tolerated, but did not provide significant clinical or antiviral effects in seriously ill patients with COVID-19.

The World Health Organization (WHO) also, reportedly, announced a large global trial, called ‘Solidarity’, to find out whether any of those drugs can treat infections with the Covid-19. In India, several drug companies are also testing the water, with their shortlisted drugs, such as, Zydus Cadila want to test a form of interferon, usually used against hepatitis B and C, as a potential treatment for COVID-19. More trials on remdesivir are ongoing, let us keep our fingers crossed.

Interestingly, Gilead has, reportedly, signed nonexclusive licensing agreements with five Indian generic drug makers – Cipla, Mylan, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences,  to produce COVID-19 therapy remdesivir for low- and lower-middle income countries. Under the agreements, Gilead will share its manufacturing know-how with them to help gear up remdesivir local production. Moreover, each of these companies will be allowed to set the price for its own generic version of the drug.

In any case, scientifically proven safety and efficacy of any drug or vaccine for the prevention or treatment of Covid-19, is yet to be known. Hence, for all individuals, strict compliance with social distancing measures is the only way to avoid this highly contagious infection. The same is also applicable to doctors and sales representatives while working in the field, at least, till an effective Covid-19 vaccine or drug comes.

Affordability and access to Covid-19 drug and vaccine:  

Assuming that a safe, effective and clinically proven vaccine or a drug for Covid-19 will be available sooner than what experts anticipate now, yet another critical issue needs to be resolved, soon. This is related to their affordability and access, to contain the mortality and morbidity of the disease, for a vast majority of the population, especially in the developing nations, like India.

Even Gavi noted: ‘In the race to produce a safe and effective vaccine against the COVID-19 virus, one of the many challenges will be the cost of developing the vaccine and eventually getting it to the vast number of people worldwide who will need it.’ However, it is generally anticipated that ‘COVID-19 vaccine or a drug may end up costing people a small fortune.’ Another article also echoed the same sentiment by saying, ‘Covid-19 treatments won’t work if people can’t afford them.

However, India’s Serum Institute based at Pune, has announced that it is ready for 20-40 million vaccine shots at Rs 1,000/dose, by September-October 2020. The company is ‘’putting its weight behind an Oxford University-led consortium, which announced the start of human clinical trials on April 23 and is one of the first such projects to get underway globally.’

At the same time, another report emphasized: “Even after India approves the Coronavirus vaccine, it might not be possible to produce more than 10-20 million doses in the first year,” again raising the availability and access issue for a Covid-19 vaccine, as and when available in India.

Conclusion:

As on May 17, 2020 morning, the recorded Coronavirus cases continue to climb sharply to 90,927 with 2,872 deaths.. Moreover, on May 13, 2020, the world Health organization has also warned that “this virus may become just another endemic virus in our communities, and this virus may never go away.” Thus, the world has to live with it. By the way, the accuracy of many Covid-19 test kits has also been widely questioned. This reportedly includes speedy Abbott test, as well.

In this scenario, people may have to necessary live with social distancing norms and the practice of wearing a mask outside the home, always. Besides, the template for relief from Covid-19 becomes more complex, particularly considering availability, affordability and access to a safe and effective drug or vaccine in India, as and when these will come. Taking these together, the end game for Covid-19 in the foreseeable future, becomes anybody’s guess.

Coming back to the pharma industry, curiously, some people are still hoping for ‘business as usual’ in the traditional pre-Covid-19 mode, although the writing on the wall is increasingly getting clearer. The only alternative that people can possibly follow under the circumstances, is strict compliance to social distancing norms, which pharma companies, doctors, healthcare consumers and others would also require to adhere to, with as much earnest. Thus, envisaging a return to pre-Covid-19 prescription generation mode, may not be prudent choice, anymore.

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.

While Pharma Leadership Change This Atypical Skill Counts

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Effective September 01, 2019, the global pharma major Sanofi will have a new CEO, as the present CEO retires attaining his retirement age of 65 years. This appears to be a mandatory announcement from the company, as is required during the top leadership change in any large and listed organization.

However, there is something novel, as well, in this announcement, especially when specific qualities, skills and experience of the new CEO were highlighted by the company’s Board of Directors. According to Sanofi Press Release, the new CEO – Paul Hudson “has proven his strategic vision, his strong leadership and his ability to achieve the greatest challenges, particularly in terms of innovation and digital transformation.”

Among the stated experience and skills, the one that appeared atypical to me, is the experience of digital transformation, particularly in the position of the CEO of a global pharma major. I In this article, I shall, therefore, explore, why knowledge and experience in this atypical skill is gradually becoming critically important for pharma leadership positions, at all levels.

Why is the need for digital transformation of pharma business?

According to the Internet Trends Report 2019 by Mary Meeker, at 3.8 billion internet users, more than half the world’s population is now online and it is growing. This number would obviously include patients.

As we know, the core purpose of pharma business is to offer a unique patient experience during any disease treatment process. And, the expectations of which from Internet-savvy individuals will be significantly more for various related reasons.

To achieve this objective, drug players would always require to be in sync with customers’ perceptions, expectations and aspirations, among others. Moreover, it’s also not ‘one size fits all’ type of a solution. These will significantly vary for different patient groups, so are the processes of engagement with them – based virtually on real-time information.

Interestingly, the core purpose of digital transformation is also to facilitate this process, with a great amount of precision. The entire process of creating a unique patient experience, involves generation of a massive amount of customized data, customize analysis of which is done through sophisticated analytics, and thereafter, translating and using them as key strategic business inputs, on an ongoing basis. Traditional organizational methods, systems and processes are incapable to deliver the same. Hence arises the crucial need of digital transformation of the organization, across the board.

The transformation is not just about software, hardware and data: 

That said, it is also essential to realize that digital transformation is not just about software, high-tech hardware, mobile apps and sophisticated wearables and data. These are, of course, some of the vital tools – used while transforming a company into battle readiness to create and provide a unique customer experience.

Such unique experience for each customer should cover all touchpoints, spanning across – before, during and after treatment with the company’s medication. This, in turn, helps generate an increasing number of prescriptions from doctors, which otherwise would not have been possible, following the conventional means.

Why this atypical skill is in demand today?

Like any other transformation process within an organization, digital transformation should necessarily be driven by the company CEO, having adequate experience in this area. Even the Board of Directors of many pharma players believes that such a CEO can facilitate the process faster and more effectively. Hence, the demand for this atypical skill is increasing, also for a pharma CEO position, besides leaders in various functional areas, as it is being considered as pivotal to achieve the core purpose of a pharma business, in the digital world.

Thus, if a CEO doesn’t properly understand, how the digital world operates with increasing number of visitors in the cyberspace and convinced about its relevance for business excellence, the organization would ultimately lose its competitive edge. One may, therefore, question, did the need for this atypical skill also arise during the selection of the new CEO of Sanofi?

Is this atypical skill for a new CEO more important now?

The answer, I reckon, could be both, ‘probably yes’ and also ‘no’.

‘Probably yes’, mostly because, being an uncommon skill for a pharma CEO, so far, it arrested the attention of many while reading ‘Sanofi Press Release’, for the appointment of their new CEO. Nevertheless, Sanofi is not the first pharma company placing so much of importance on digital transformation, especially for the key leadership positions. In an interview with the Wall Street Journal (WSJ) of February 18, 2018, the CEO of Novartis said: “We need to become a focused medicines company that’s powered by data science and digital technologies.”

Why it is so important for a pharma CEO?

The AT Kearney paper titled, “New Medicine for a New World – Time for Pharma to Dive into Digital,” also captured that an increasing number of pharma customers are now getting engaged and have started interacting in the digital space, more than ever before. This trend is fast going north – becoming an ‘in-thing’ of the industry, as it were. But more probably to be seen as trendy or display that they are also in it, by ‘dipping a toe in the digital waters.’ Whereas, ‘it’s time to take the plunge,’ as the paper cautions them.

‘Plunging into the digital water,’ doesn’t mean sending people to some external training program – with the word ‘digital’ prominently featuring as the course objective. It means bringing out ‘digital transformation’ of the entire organization, spearheaded by the CEO. The leadership of each functional area would then implement from the same playbook, with a structured and custom-made plan designed specifically to achieve the vision, mission, goals and values of the company.

We have recent examples of, at least, two top global pharma majors taking a plunge in the digital water to make the digital transformation of the organization a reality. The key purpose of the same, is to create a unique customer experience, being on the same page with them, in more effective ways, for business excellence. To move in this direction, the organization must imbibe the non-negotiable principle – ‘digital first,’ across the organization.

Only the CEO can decide ‘digital first’ as guiding organizational principle:

None other than the CEO of a drug company, can decide that ‘digital first’ will be the guiding principle of the company, across all the functional areas of the business. As the above paper articulates, it ‘should be explicitly incorporated into core business processes.’ It further says: ‘Top management must challenge any parts of the business that have not explicitly considered the opportunities from digital in their plans.’

Functional leaders to be in sync with digital transformation: 

All in the pharma organization, across all functions, must work for the end consumer of any pharma business – the patients. Every single employee in the company should strive delighting them with the company’s products and services, at every touchpoints, during their quest for relief from illnesses. As I said before, this is the single most important factor that determines not just the pace of growth of a drug company, but help enhance its reputation, too. It goes without saying, its ultimately the patients who are playing a catalytic role in the digital transformation of an organization.

It is essential for the CEO to make sure that entire corporate, functional and even departmental leadership teams are in tune with the need of digital transformation of the organization. Despite the detail explanation, if some remain unconvinced about the rationale behind the transformation of the core business process, the right leader should assume the responsibility.

This is because, even with one loose knot at the leadership level in this area, the entire objective can seriously get thwarted – down the line. Such changes, as, if and when required, can be achieved in various different ways, not through attrition alone. For example, by encouraging them to work with members of his peer group who can set good examples to emulate.

Brand promotion to physicians will still remain as important:

In tandem, no company should lose sight of the fact that their face-to-face interaction with physicians, will continue to play an important role in brand promotion. Primarily because, doctors and hospitals help patients to get desired solace from ill-health by prescribing recommended medicines, and consequently, will keep prevailing as an integral part of the pharma marketing process, supported directly or indirectly by every employee in the company.

The key challenge in digital transformation:

The key challenge in the digital transformation of a pharma company is broadly possible inflexible or a rigid mindset of some of its leaders. This is generally fueled by the fear of moving out of their respective comfort zones – rather than resources and expertise required to make the technology put to use. A well-running-business with a grand idea for the future, will generally be able to garner necessary resources and other wherewithal, without much problem.

All pharma leaders should always consider themselves as an important solution for the future success of the organization, Otherwise, he or she may be construed as a part of the problem and a hindrance in achieving the corporate goal and should make way for the capable ones, in this area. Hence, selecting leaders with the right spirit to make digital transformation effective, is so critical for the CEO.

To commence this journey, the leaders may either be willing to acquire the experience of a disruptive digital transformation, guided by the domain experts or may be recruited from outside having the necessary experience. Collective and well-coordinated steps towards this transformation can neither be tentative, nor should it commence without having the right leader at the right place with required will and experience.

Digital players entering into health space with game changing ideas:

Pharma players should also note, how the big technology companies, such as, Apple, Google, Microsoft and Amazon, besides many startups, are trying to create space for themselves in the health care arena. Several of them are also trying to reinvent health care with zest, much beyond what traditional drug companies could even envisage, till recently.

The digital transformation of the organization would help drug players to align the company’s business model with the tech companies in those specific areas to reap a rich harvest. More opportunities will also unfold – either to collaborate with them for targeted projects or moving into the tech space with well-calibrated measures, for business synergy. Without digital transformation of business, either facing such competition or benefitting from the available opportunities, will be challenging for drug companies.

Conclusion:

In the digital world, while patients are emerging as a key driver of change in the health care space, traditional pharma operational systems, including sales and marketing are likely to give a diminishing return on investment. Although, many drug companies can sense this ongoing metamorphosis, several of them are still wondering how to go about it. Moreover, to test the ‘digital water’, some of them have started converting several traditional operational methods, systems and processes in the digital format, as well. Yet, are unable to fathom, why such efforts are not clicking – leading to a quantum increase in the operational efficiency – in pursuit of excellence.

The good news is, global pharma organizations, such as, Sanofi and Novartis, besides several others, have realized that incremental performance improvements with small tweaking here or there, across the organization, aren’t just enough. The corporation needs to move towards a holistic digital transformation, spearheaded by its CEO, having experience in this process. This new breed of pharma CEOs, well-supported by his team of leaders, fostering a burning desire to produce pace setting results, can usher in this ‘disruptive’ transformation. Because, they realize, traditional pharma operational systems, when tempered through the fire of the digital transformation process, can yield game changing outcomes for the organization.  The entire process, as it comes to fruition, helps delivering greater customer value, creating a unique customer experience – similar to what customers want – on an ongoing basis.

In fine, strategic intervention of this genre, initiated by the CEO and cascading down the organizational hierarchy, creates a whole new patient-centric outcome, which is much more than what a company can get through re-engineering the operational processes. Hence, especially the young mangers of date, may wish to note note that during virtually every leadership transition, this atypical skill is now likely count much more than ever before – with an ascending trend.

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.

Will ‘Patent Thicket’ Delay Biosimilar Drug Entry in India?

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Do pharma and biotech investors encourage companies indulging in ‘patent thicket?’ This question recently grabbed media headlines. On April 02, 2019, one such report brought out: AbbVie investors are calling for the Chair-CEO power split, flagging the CEO’s USD 4 million bonus payout, fueled by the company’s Humira ‘patent thicket’ strategy related aggressive price hikes. It prolonged the brand’s market monopoly, blocking entries of its cheaper biosimilar equivalents.

I have discussed some related issues in this blog, previously. As the issue is gaining relevance also in the Indian context, this article will deliberate the ill-effects of ‘patent thicket’ on patient health-interest. The sole beneficiaries for the creation of this self-serving labyrinth are the manufacturers of high-priced patented drugs, as reported above. Before I proceed further, let me recapitulate what exactly is a ‘patent thicket.’

‘Patent Thicket’:

The dictionary definition of patent thicket is: ‘A group of patents in a field of technology which collectively impede a party from commercializing its own patents or products in that field.’In the current context, it means a dense web of overlapping patent rights that restrict a generic or a biosimilar drug maker from commercializing its cheaper equivalents post expiry of the original patent.

This scenario has been well-captured by the above media report, which states: “AbbVie leadership has also been accused of creating a ‘patent thicket’ in its battle to stave off biosimilar competitors to Humira.” Boehringer Ingelheim is among the few still fighting AbbVie’s ‘patent thicket’ hoping to launch its Humira biosimilar - Cyltezo, even after receiving US-FDA approval on August 29, 2017. ‘Top biosimilar makers, including Novartis’ Sandoz unit and Mylan, have settled their own Humira patent fights with deals that put off launches until 2023,’ the report indicated.

In its favor: AbbVie says, Cyltezo infringes about 70 patents the company currently holds for Humira. Whereas, ‘Boehringer’s lawyers say AbbVie’s copious patents overlapped in an attempt to exclude competitors from the market.’ Notably, in March this year, New York’s UFCW Local 1500 Welfare Fund, reportedly, also accused AbbVie of using overlapping patents to exclude biosimilars.

‘Patent thicket’ – a way of ‘evergreening’ beyond 20 years patent term:

Much concern is being raised about various ploys of especially by the drug MNC and their lobby groups – directly or under a façade, to delay entry of cheaper generic drugs for greater patient access. Mostly the following two ways are followed for patent ‘evergreening’ beyond the term of 20 years:

  • ‘Incremental innovation’ of the existing patented drugs through molecular manipulation, with its clinical performance and safety profile remaining similar to the original one. As the cost benefits of such drugs are not shared with patients, cannibalizing the sales of the older molecular version with the newer one highlighting its newness, the sales revenue can be protected. With this approach, coupled with marketing muscle power with deep-pocket the impact of generic entry of the older version can almost be made redundant. For example: Omeprazole was first marketed in 1989 by AstraZeneca, under the brand name Losec (later changed to Prilosec at the behest of the US-FDA). When Prilosec’s US patent expired in April 2001, AstraZeneca introduced esomeprazole (Nexium) as a patented replacement drug. Both are nearly identical in their clinical efficacy and safety.
  • ‘Patent thicket’ is yet another tool for ‘evergreening’, delaying launch of similar drugs, or resorting to ‘pay for delay’ sort of deals. As another recent report reiterates, AbbVie’s ‘patent thicket’ for Humira, has deterred other potential challengers, such as Amgen, Samsung Bioepis and most recently Mylan, each of which struck settlements with AbbVie to delay their biosimilar challenges in the United States.

Goes against patients’ health interest:

On May 09, 2018, the Biosimilars Council reported, just as generic medicines saved Americans USD 1.67 trillion in the last decade, biosimilars are poised to do the same – ‘if they aren’t thwarted by delaying tactics instituted by some pharmaceutical companies.’ Echoing similar concern, the outgoing US-FDA Commissioner Scott Gottlieb also, reportedly said, ‘some drugmakers are using unacceptable tactics such as litigation and rebate schemes to stall the entry of cheaper copies.’

‘Of the nine biosimilars the FDA has approved to date, only three have made it into the hands of patients – an alarmingly small number. Patients can’t access the six others due to barriers thrown in their way by pharmaceutical companies that want to protect their monopolies and keep prices high,’ highlights the Biosimilars Council report. Net sufferer of this self-serving ‘patent thicket’ strategy of pharma and biotech players to extend product patents beyond 20 years, are those patients who need these drugs the most – to save their lives.

Despite law, patent ‘evergreening’ still not uncommon in India:

With section (3d) on the Indian Patents Act 2005 in place, the country is expected to protect itself from patent ‘evergreening’ through ‘incremental innovation.’ This section articulates:“For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”

On this ground, Indian Patent Office (IPO) rejected Novartis’ drug Glivec (imatinib mesylate) patent application, which was ultimately upheld by the Supreme Court in 2013. Nevertheless, a study report of April 30, 2018 emphasized: ‘Though the law with regard to anti-evergreening, upheld and clarified by Indian courts, remains on the books, its application by the IPO has been far from satisfactory.’

The esteemed author of the report, after analyzing about 2,300 drug patents, granted between 2009 and 2016 concluded that evergreening practices may be rampant in India. The report pointed out, ‘the IPO could be operating with an error rate as high as 72 percent for secondary patents, despite provisions to keep them in check.’

Are these IPO’s mistakes, or due to external pressure?

As the paper, published in the January 2016 edition of the Journal of Intellectual Property Rights (JIPR) said,‘The multi-national pharma companies (MNCs) and the US-India Business Council (USIBC) have suggested in their report for elimination of Section 3 (d) so that drug patents can be granted in India for incremental improvement and modification. As per US 301 report, India is listed among countries with inadequate IP regime.’ Keeping all these aspects into consideration, the article expressed some key concerns pertaining to the impact of Section 3 (d) with special emphasis on its interpretation. Does it mean any possibility of wilting under such extraneous and high impact pressure?

A fresh pressure from drug MNC on the DCGI:

Since long drug MNCs have been attempting to delay the entry of even those generics, which are fully compliant with the Indian Patent Law 2005. One such effort was their demand for ‘patent linkage’ with the marketing approval of new generic drugs. However, it could not pass through legal scrutiny – first by the Delhi High Court in the Bayer Cipla case in 2010, and then by the Supreme Court – on the same case. The Court, reportedly, ‘noted the Indian patent system was distinct from the drug regulatory system with no linkage between them and so Bayer can’t prevent DCGI from granting marketing approval to generic versions of patented drugs.’

According to another recent media report of April 04, 2019, in a fresh endeavor ‘to delay launch of low priced generic medicine, multinational drug makers have asked the government to create a registry providing information about all drug applications pending manufacturing and marketing approval. The proposal, which is still pending with the Department of Pharmaceuticals (DoP), if accepted, could involve the generic players into expensive and time-consuming litigations, delaying early market entry of the cheaper generic or biosimilar equivalents.

To date, the health ministry has opposed the proposal, as it will be “unfair to local drug manufacturers to disclose their product strategy” and also has “the potential to substantially increase health care costs for the public.” The government further argued, “such information about product applications filed for approval are not disclosed anywhere in the world.”

India encourages new drug innovation, but not at any cost:

Despite shrill and disparaging comments of MNC lobbyists and the strong vested interests, that India’s Patent Law 2005, doesn’t encourage innovation, many independent international experts do praise the same for the following reasons:

  • Does encourage new drug innovation
  • Does extend product exclusivity for twenty years
  • Strikes a right balance with patients’ health interest
  • Indian judicial system deals with patient infringements and disputes, just as any other developed countries
  • Even 14 years after the enactment of patent laws, just one compulsory license has been granted, which is much less than other countries, including the United States.

What India doesn’t legally allow is, unfettered profit making through ‘evergreening of drug patents’ – at the cost of millions of patients-lives. Nonetheless, powered by deep pockets, the pharma and biotech players are unlikely to cease from this practice, anytime soon. Only patient-awareness, and stringent counter-legal measures can contain this unfair game of drug monopoly practices – in the name of ‘encouraging innovation’.

Conclusion:

The article titled, ‘Over patented, overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices’ revealed:“Top grossing drugs have on average 125 patent applications, which are filed with a strategic intent to extend the commercial monopolies far beyond the intended twenty years of protection.” It also quoted American President Donald Trump as saying, “Our patent system will reward innovation, but it will not be used as a shield to protect unfair monopolies.”

Coming back to ‘patent thicket’ and the same classic case, another report of March 20, 2019 indicated, a new class action lawsuit filed by New York’s largest grocery union has accused AbbVie of violating antitrust and consumer protection laws, which AbbVie has defended by saying that its patent strategy for Humira has protected the investments that are necessary to “advance healthcare.”

Pharma and biotech companies’ maintaining patent monopolies far beyond twenty years has significant consequences on India’s healthcare system. Only patent lawyers and experts can possibly answer whether or not the Indian Patent Law 2005 can effectively deal with the practice of ‘evergreening’ with patent thicket. Intriguingly, taking a cue from recent developments, it seems many pharma and biotech investors too, deem ‘patent thicket’ rather distracting for longer-term undiluted focus on new product development, and sustainable investors’ return.

That apart, the question also comes, whether just as ‘antitrust and consumer protection laws’ in the US, the Competition Law of India will be able to do contain such unfair practices? Otherwise, with MNC lobbyists’ renewed activities in this area, ‘patent thicket’, especially for expensive biologic drugs, will delay market-entry of their cheaper biosimilar versions in India, as well, just as what is happening in the developed nations.

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.

In VUCA World: Changing Dynamics of Prescription Generation Process

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The acronym VUCA is often being used to emphasize upon the Volatility, Uncertainty, Complexity and Ambiguity in various situations. The term has been derived from military vocabulary and is being used since 1990s in the business management parlance. VUCA is also considered as a practical code for awareness and readiness.

I find all the elements of VUCA playing an active role in the prescription demand generation space too, as it is based on various assumptions of what will work and what won’t in a fast changing pharmaceuticals business environment. 

The interplay:

Primary interplay in the sustainable prescription demand generation process of today’s digitally empowered VUCA environment, I reckon, could be as follows:

  • Volatility: Fast changing dynamics of medical communication with interfaces made of emerging modern technological tools carrying high risks of rapid obsolescence.
  • Uncertainty: Lack of predictability in assessing outcomes of increasingly expensive product detailing inputs, coupled with too many surprise elements popping-up in the environment almost from nowhere and more frequently.
  • Complexity: Multi-factorial Doctor-Medical Representative (MR) interactions, which get even more complicated with increasing time constraints for effective product detailing to take place.
  • Ambiguity: Difficult to fathom changing needs of the doctors/payors, leading to increasing cause-and-effect confusion by the pharma marketing strategy planners.

Keeping these in view, today I shall deliberate on the ‘Criticality of Optimal Mix of Human and State of Art Digital Interfaces’ for sustainable prescription demand generation in a VUCA environment.

The key influencer – a new study:

A research study published in June 2013, in the ‘American Heart Journal (AHJ)’ establishes that the interaction between physicians and MRs, though essential for  improvement of medical care, is indeed complex. This is mainly because of the apprehension that conflict of interests may affect the doctors’ prescription decision-making process. 

However, the fact comes out, the doctors tend to prescribe more of expensive medical products after interacting with MRs from the concerned manufacturing companies, which, in turn, raises the treatment costs for patients.

Study established MRs influence prescription decision:

This particular AHJ study compared the use of Bare-Metal Stents, Drug-Eluting Stents (DES), and Balloon Catheters according to company presence in the hospital. It concluded that MR presence was associated with increased use of the concerned company’s stents during percutaneous coronary interventions. The effect was more pronounced on the use of DES, and resulted in higher procedural cost of US$ 250 per patient.

In this particular study, it was found that DESs were used in about 56 percent of the cases, when the MRs concerned were at the hospital, against 51 percent when they weren’t there.

Interestingly on such interactions between the MRs and the drug/devices industry two opposite viewpoints emerge.

‘MR-Doctor interaction important‘ – Industry:

Quoting the Associate General Counsel and Director of Legal and Medical Affairs at the Advanced Medical Technology Association, a medical technology trade association, Reuters reported, “interactions between sales representatives and doctors benefit patients and are supported by professional medical organizations.”

‘MR interaction should not influence prescription decision’ – Doctors:

In the same report, the study’s lead author was quoted saying, “We need to evaluate carefully any interactions with medical industry to ensure that we minimize an effect on our decision making process.”

The bottom-line, though the debate continues:

This debate will keep continuing even in the years ahead. Be that as it may, the key fact that emerges out of the above study is, MRs do play a critical role in the prescription decision-making process of the doctors, especially for expensive medical products . Consequently, the pharmaceutical companies will prefer maintaining such ‘influencing’ roles of MRs to boost revenues of their respective brands.

This process assumes even greater importance in a VUCA world, as situation specific more frequent human interventions, strongly backed by state of art technological supports, would need to be effectively deployed for generation of sustainable prescription demand to excel in business.

The X-Factor:

However, one of the most challenging issues even in a VUCA situation is that pharma players continue and will continue to target the same sets of prolific prescribers for any given class of products in pursuit of success. As a result, time being so limited, very often even after waiting for hours MRs may not be able to meet the key prescribers.

Moreover, as and when the meeting takes place, it may well get restricted to just a very brief discussion due to the X Factor – paucity of the doctors’ time. Thus, delivering an effective product message in such a short time becomes increasingly challenging. Further, the difficulty in arresting un-interrupted attention of the busy practitioners due to X-Factor when they are with patients, compounds the problem.

Pivotal role of state of art technological tools:

The effectiveness of connection between respective brands of different drug makers and the doctors can be greatly facilitated with the application of state of art technology and modern internet based tools in varying proportions, as the sales and marketing communication strategy would dictate.

This area is emerging as a crafty game, which calls for wide-scale application of analytics.

Traditional strategies not enough:

In a VUCA world, while traditional face-to-face product detailing to doctors may continue to be the primary means for prescription demand generation, experimentation with a good number of new Internet based initiatives has already been started, as I discussed in my earlier article.

Hence, the concepts of digital marketing and e-detailing are gaining ground fast. Such initiatives of augmented digital communication of key marketing messages to doctors, would also help driving the key customers’ traffic to respective product Websites of the concerned companies for more detailed and convincing medical treatment solutions, as and when required by the busy doctors.

Types of digital interventions:

These digital interventions may include:

  • Highly targeted brand specific e-mailing responding to pre-identified needs of individual doctors
  • Sample ordering as per requirements of doctors
  • Live online product presentations at a time convenient to individual doctors
  • Quick and need-based problem solution centric online chats 24×7
  • Strategic usage of social media, backed by a robust pre-decided key output measuring matrix

However, the mix of each of these digital applications will need to be carefully worked out as robust supporting measures to key prescription demand generation activities, spearheaded by the MRs. 

MRs to remain as ‘Spearheads’:

In my view, MRs would still remain the frontline force in the emerging world (dis)order, may be lesser in number, for sustainable prescription demand generation process. Therefore, there is an urgent need to take them on board upfront and train suitably to make the modern digital interfaces successful as powerful differentiating support tools.

Technology based training on digital marketing and e-detailing as empowering initiatives, demonstrating tangible benefits that such high tech-interventions can offer in the overall sales performance of MRs, would play a critical role. Such efforts would, in turn, immensely help making digital augmentation strategies for pharma detailing successful, in the long run.

MR involvement is critical:

In my view, to be successful in a VUCA environment with all these endeavors, however tech-intensives those may be, there will be a critical need to make the MRs understand and learn the process. In tandem, it is equally important to actively engage them in the execution of the integrated medical communication strategy of the concerned companies.

Keeping this perspective in mind, I guess, it will be quite apt to quote Ben Franklyn, one of the Founding Fathers of the United States and a leading author, printer, political theorist, politician, scientist, musician, inventor and economist, all in one, who once wrote:

“Tell me and I forget, 

 Teach me and I remember,

 Involve me and I learn”

Thus, MRs would continue to have a critical role to play in the demand generation process for prescription medicines. However, they must be properly trained to be able to provide the types of knowledge and information that the doctors may not have ready access from elsewhere.

The entire process would, at the same time, require massive technological interventions, not incremental in nature but radical in scope and dimensions, and at a much wider scale than what we have been attempting today.

Challenges in India:

The very concept of VUCA in the changing dynamics of sustainable prescription demand generation, brings to the fore the issue of quality of MRs in India.

Currently there is a wide, both inter and intra company, variation in the educational qualifications, relevant product and disease area knowledge, professional conduct and ethical standards between MRs in our country.

Employability of MR in a VUCA world:

Just when we talk about augmented digital interfaces in medical communications, there exists a huge challenge in the country to strike a right balance between the level/quality of sales pitch generated by the MRs for a brand.

At times, many of them may not be properly armed with requisite scientific knowledge, and the basic norms of professional conduct/ ethical standards, while rendering their services.

They may not also be able to handle the sophisticated technological tools with quick application of minds. Hence, the subject of employability of MR in a VUCA world needs to be addressed afresh in India.

‘One size fits all’ strategies:

To make it happen, the pharmaceutical players would require to jettison, ‘one size fits all’ types of strategies in a VUCA world.

In tandem, pharma marketing strategists will need to be intimately conversant with a relatively difficult process of cerebral gymnastics to help formulating individual key prescriber-centric communication strategies, where MRs can play a key role with optimal digital interventions.

This is possible, if supported by the respective employers creating an environment of empowerment, backed by requisite product training, technological tools, modern behavioral inputs and above all by making investments to create of a large sustainable emotional capital for longer term  business excellence.

Conclusion:

All the elements of VUCA would keep playing very critical roles in sustainable prescription demand generation process in the years to come, more than ever before.

There is a critical need to understand the interplay between each of these dynamics on an ongoing basis to make strategic modifications quickly, whenever required. This is important, as the prowess to introduce right changes at right times will differentiate men from the boys in this ultimate ball game of the pharma industry. 

To succeed in a VUCA environment, pharmaceutical companies may choose to predominantly focus on harnessing their technological expertise. 

However, to face the waves of virtually unpredictable continuous change, only technology based efforts, I reckon, are less likely to fructify. Unless, these high- tech interventions are spearheaded by time-specific fast enough and intelligent skilled human responses in form of MRs. 

Having said that, it would be foolhardy to even think of completely taming VUCA with whatever human and technological wherewithal that any pharma player may be able to garner to achieve its goals. It is, in fact, a matter of relativity in managing VUCA in a given situation at a given time. 

Thus I believe, there is, on the contrary, a need to leverage a VUCA environment, for creation of an ‘Optimal Mix of Human and State of Art Digital Interfaces’ in the product detailing process with a high sense of urgency. This would be critical to gain cutting edge advantages for generation of increased prescription demand in a sustainable way.

For the pharmaceutical marketing strategists, this new ball game would obviously not be a piece of cake either, as the key success factors would involve the right mindset of first unlearning and then relearning the process on an ongoing basis, virtually in all time to come

With this perspective, I conclude by quoting the famous American writer and futurist Alvin Toffler, who once said,

“The illiterate of the 21st century will not be those who cannot read and write, but those who cannot learn, unlearn, and relearn.”

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.