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A Transformational Approach To Patient-Driven Pharma Marketing

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This new-era approach to gain a cutting-edge in drug marketing is fast gathering winds on its sail – the world over and is being accepted as a transformational one, in tandem. It is primarily a two-pronged approach that involves merging or convergence of RWE (real-world evidence) and AI (artificial intelligence) into a unified approach for tasks like healthcare research, drug discovery, and patient care optimization.

However, in the context of this article, the process would involve a perfect synthesis between RWE (Real-World Evidence) and AI (Artificial Intelligence) for achieving a cutting edge in patient-driven marketing. A well-crafted shift to this strategic direction, I reckon, holds immense potential to revolutionize the way pharmaceutical companies connect with patients and build trust in today’s complex market environment.

Provides benefits both to patients and drug companies in equal measure:

Following reasons may give a sense of how this transformational strategic initiative provides benefits both to patients, as well as the drug companies in equal measure, which, consequently, makes this fusion or synthetization is so crucial:

1. Unveiling Deeper Patient Understanding:

  • AI-powered insights: AI excels at analyzing vast amounts of RWE data, uncovering hidden patterns and relationships that might escape human analysis. This translates to a deeper understanding of patient journeys, preferences, and unmet needs.

2. Crafting Personalized Engagement:

  • Tailored communication: By leveraging RWE and AI, pharma companies can move beyond generic marketing messages. They can tailor their communication to specific patient segments, addressing their unique concerns and delivering relevant information about treatment options.
  • Empowering patients: Access to clear, personalized information empowers patients to actively participate in their healthcare decisions. RWE and AI can provide insights into potential benefits and risks, allowing patients to make informed choices alongside their healthcare provider.

3. Optimizing Marketing Strategies:

  • Enhanced targeting: Traditional marketing often involves a scattershot approach. RWE and AI enable precise targeting, reaching the right patients with the right message at the right time. This improves marketing ROI and ensures patients receive relevant information about potential treatments.
  • Data-driven decisions: By analyzing RWE data, AI can identify trends and predict patient behavior, allowing pharma companies to optimize their marketing strategies and campaigns for maximum impact.

4. Demonstrating Real-World Value:

  • Moving beyond clinical trial data: Clinical trial data, while essential, doesn’t always translate perfectly to real-world settings. RWE provides a more holistic picture of drug effectiveness and safety in everyday clinical practice, building trust with patients and healthcare professionals.
  • Supporting regulatory approvals: RWE, backed by AI analysis, can provide robust evidence to support regulatory applications for new indications or expanded use of existing drugs.

These are a few reasons why this novel approach is gaining traction across the world.

Some recent global and Indian examples related to the synthesis of RWE & AI in patient-driven drug marketing:

Let me now give just 5 examples each for both global and Indian companies, as available in the public domain, of how pharmaceutical companies are deriving benefits from this process.

Examples from global companies:

1. AstraZeneca: Analyzed RWE data from EHRs to identify subgroups of patients who respond best to their lung cancer drug Tagrisso. This enabled them to target marketing efforts towards these specific groups, leading to increased adoption and sales.

2. Roche: Employed AI to analyze social media data to understand patient sentiment towards their hemophilia drug Hemlibra. This helped them tailor their marketing messages to address patient concerns and anxieties, improving patients’ experience.

3. Pfizer: Leveraged RWE from registries to demonstrate the long-term effectiveness and safety of their pneumococcal vaccine Prevnar13 in older adults. This data supported regulatory approval for a new indication, expanding market reach.

4. Novartis: Utilized AI to analyze large datasets from clinical trials and RWD to predict patient response to their heart failure drug Entresto. This personalized treatment approach improved patient outcomes and reduced hospital readmissions.

5. AbbVie: Used RWE to identify factors influencing physician prescribing behavior for their immunology drug Humira. This data helped to tailor their marketing efforts towards relevant healthcare professionals, enhancing brand awareness and adoption.

These are just a few examples, and the field is constantly evolving. As RWE and AI technologies become more sophisticated, we can expect even more innovative Patient – Centric marketing approaches from global drug companies.

A few examples from domestic Indian companies:

While the use of RWE and AI in patient-driven drug marketing is still at an earlier stage in India compared to global giants. This is mainly due to the relatively nascent stage of adoption in India. As the field evolves, we can expect more examples of innovative applications for greater impact in the future. That said, there are some interesting examples emerging, such as:

1. Sun Pharma: Launched a mobile app called “SunRx” that leverages AI to analyze past medication history and suggest personalized recommendations for over-the-counter (OTC) products. This app uses patient data anonymously and adheres to privacy regulations.

2. Cipla: Partnered with a US-based AI company to develop a platform that analyzes RWE data from patient registries to identify new treatment opportunities for complex diseases like chronic kidney disease. This data will be used to inform future drug development and marketing strategies.

3. Dr. Reddy’s Laboratories: Implemented a pilot program using AI to analyze social media data to understand patient sentiment towards their diabetes medication. This helped them identify key concerns and tailor their communication strategies accordingly.

4. Glenmark Pharmaceuticals: Leveraged RWE data from electronic health records (EHRs) to demonstrate the real-world effectiveness of their respiratory drug Brocacef. This data was used to support regulatory approval for a new indication, expanding market reach.

5. Lupin Limited: Partnered with a healthcare analytics company to analyze claims data and identify patient segments with unmet needs. This data will be used to develop and market targeted solutions for these specific patient groups.

It’s important to acknowledge here that the Indian drug industry faces several challenges in adopting RWE and AI for patient-driven marketing in the country. These include access to high-quality and standardized RWE, scarce availability of skilled professionals for building and implementing industry-oriented AI-based solutions. Besides, the regulatory framework for using RWE data in marketing is still evolving, while robust ethical frameworks and transparent data handling practices are essential for this process to be sustainable.

Conclusion:

Synthesizing RWE and AI in pharmaceutical marketing is not just an option now, but a critical step towards a more Patient-Centric and data-driven approach that benefits both patients and pharmaceutical companies. By addressing the challenges and ensuring ethical practices, this powerful combination can pave the way for a future where patients are empowered partners in their health journeys, and pharmaceutical companies can deliver targeted, effective marketing that truly benefits patients.

By: Tapan J. Ray

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

Unleash The Power of RWE in Indian Pharma Marketing

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An IQIVIA event titled, “RWE in 2024: Recognizing opportunity and demonstrating value with confidence,” held on October 25-26, 2023, made several interesting observations such as:

  • The future of healthcare is being reshaped and RWE is playing an increasing role in revolutionizing patient care, drug development, and healthcare policy.
  • Generative AI and new technologies create new opportunities and ways of working, increasing acceptance of RWE by regulators and payers, and ever-evolving and diverse patient needs.

In recent days, post-launch of a new product, several drug companies, although more globally and some locally, are using Real-World Evidence (RWE) to showcase how their product is providing value - not just clinically and economically, but also from a humanitarian perspective, in a real-life situation. Besides, RWE is also increasingly being used to improve product detailing outcomes, taking a quantum leap in enhancing brand awareness among prescribers.

Thus, while exploring the emerging space of RWE, I shall focus in this article on the increasing importance of leveraging this area for greater effectiveness of pharmaceutical marketing strategies, especially in India. To be on the same page with my readers, let me start with a quick recap of what I really mean, as I use this terminology.

RWE – A quick recap:

As I talk about “using Real-World Evidence (RWE) in pharmaceutical marketing,” I mean ‘leveraging Real-World Data (RWD)’ to gain insights that inform and shape marketing strategies for pharmaceutical products. Obviously, this could raise a pertinent question – why RWE is gaining ground in drug marketing now.

Why is RWE gaining ground in recent pharmaceutical marketing globally?

The growing popularity of RWE in recent drug marketing, globally, can be attributed to several key factors, as flagged in various studies. Some of these include:

1.  Addressing limitations of clinical trials: While clinical trials provide valuable insights, they often have limitations. RWE complements clinical trials by offering insights into how drugs perform in the real world, addressing these limitations.

2.  Evolving regulatory landscape: Top regulatory agencies of the world like the US FDA and EMA are now recognizing the value of RWE. This incentivizes drug companies to embrace RWE for marketing purposes.

3.  Advancements in data analytics: Sophisticated data analytics techniques and tools are enabling researchers to extract meaningful insights from complex RWE datasets. This allows for more robust and reliable evidence generation, enabling marketers to create more effective sales and marketing strategies. In one of my articles -‘Data-giri’: Critical For A Rewarding New Product Launch, written on December 24, 2018, I deliberated on this area. 

4.   Precision medicine: The rise of precision medicine necessitates understanding how drugs work in specific patient subgroups. RWE can identify these subgroups and their responses to treatment, facilitating targeted marketing campaigns.

5. Transparency and Patient-Centricity: Patients and healthcare professionals increasingly demand transparency and real-world evidence to support treatment decisions. RWE demonstrates a commitment to transparency and provides evidence grounded in real-world settings, fostering trust and confidence. 

As data analytics capabilities continue to advance and regulations evolve, we can expect RWE to play a more prominent role in shaping future pharmaceutical marketing strategies. 

Real-Life Advantages of using Real-World Evidence (RWE) in Indian pharmaceutical marketing:

A.   Increased relevance and credibility, including more accurate measuring of cost-effectiveness.

B.   Improved decision-making, enabling more targeted marketing campaigns and improved resource allocation.

C.   Added regulatory benefits, as it can provide additional evidence to support claims of effectiveness and safety, potentially influencing regulatory decisions and gaining new indications for existing drugs.

D.   Help become more patient-centric, as utilization of RWE findings enhance quality of communication with patients and healthcare professionals – fostering trust and transparency. RWE can also help identify areas where current treatments are inadequate, prompting research and development efforts towards better solutions.

Challenges to consider:

  • Data quality and access: Ensuring data quality and ethical access to patient data remains a challenge in India.
  • Data analysis expertise: Utilizing complex RWE data effectively requires skilled data analysts and statisticians.
  • Regulatory framework: The regulatory framework in India for RWE is still evolving, requiring careful navigation.

Despite these challenges, the potential benefits of RWE for Indian pharmaceutical marketing appear to be significant. By overcoming these hurdles and embracing RWE with collective advocacy, when required – pharmaceutical companies can gain valuable insights, improve decision-making, and ultimately serve patients better.

Some recent international examples of RWE in pharmaceutical marketing:

Here are some recent international examples of how pharmaceutical companies are using real-world evidence (RWE) in their marketing strategies:

1. Novartis:

  • Campaign: Leveraged RWE from a large observational study to demonstrate the effectiveness of their drug Entresto in reducing heart failure hospitalizations in real-world patients compared to other standard treatments. This evidence supported claims beyond the initial clinical trials and resonated with healthcare professionals.
  • Results: The campaign helped increase market share for Entresto and positioned it as a more effective option for managing heart failure.

2. AstraZeneca:

  • Campaign: Utilized RWE from claims data to identify specific patient sub-populations most likely to benefit from their oncology drug Tagrisso. They then targeted these segments with personalized marketing messages highlighting the drug’s effectiveness in their specific situation.
  • Results: This data-driven approach led to a significant increase in prescriptions for Tagrisso among the targeted patient groups.

3. Sanofi:

  • Campaign: Analyzed RWD from multiple sources to understand the real-world disease burden and treatment patterns for diabetes in different regions. This information informed their marketing strategy by tailoring messaging and product offerings to specific regional needs and patient populations.
  • Results: This data-driven approach enabled Sanofi to develop more relevant and targeted marketing campaigns, potentially increasing market share in key regions.

4. Roche:

  • Campaign: Used RWE from registries and claims data to track the long-term safety and effectiveness of their cancer drug, Avastin, in real-world patients. This ongoing monitoring allowed them to proactively address potential safety concerns and update their marketing messages accordingly.
  • Results: By demonstrating transparency and commitment to patient safety, Roche maintained trust and confidence in Avastin, even after initial safety concerns emerged in clinical trials.

The above examples possibly showcase how RWE can be used for various marketing objectives, including:

  • Demonstrating real-world effectiveness beyond clinical trials
  • Targeting specific patient segments for personalized marketing
  • Building trust and confidence through safety monitoring
  • Tailoring marketing strategies to regional needs

Nevertheless, it’s important to note that these are just a few examples, and the specific ways RWE is used in marketing will vary depending on the company, drug, and market conditions. Be that as it may, these examples illustrate the growing trend and potential of RWE as a valuable tool for pharmaceutical marketing strategies.

Some Indian examples of RWE in pharmaceutical marketing:

While specific examples from current marketing campaigns might be limited, the Indian pharmaceutical industry, as I fathom, is actively exploring the potential of RWE, and we can expect its impact on marketing strategies to grow in the future.

That said, from publicly available data, I can offer some general examples that demonstrate the growing interest and potential applications of RWE in the Indian drug industry:

1. Sun Pharma:

  • Partnered with IQVIA to leverage real-world data for clinical research and potentially future marketing insights.
  • Developed a real-world data platform aimed at understanding treatment patterns and patient outcomes, which could inform future marketing strategies.

2. Cipla:

  • Collaborated with Pharm Easy to analyze anonymized prescription data, potentially generating insights for targeted marketing campaigns.
  • Invested in building data analytics capabilities, suggesting an intent to utilize RWD for various purposes, including marketing.

3. Dr. Reddy’s Laboratories:

  • Partnered with Apollo Hospitals to create a real-world data platform focusing on disease registries and patient outcomes, paving the way for future RWE -   based marketing strategies.
  • Established a dedicated data science team, indicating an interest in leveraging RWD for various applications, potentially including marketing.

4. Torrent Pharmaceuticals:

  • Entered a strategic partnership with IQVIA to utilize real-world data for market research and potentially inform future marketing decisions.
  • Invested in building data analytics capabilities, suggesting an intent to utilize RWD for various purposes, including marketing.

5. Lupin:

  • Partnered with Pfizer to analyze real-world data on the effectiveness of their co-developed tuberculosis treatment, which could potentially inform future marketing efforts.
  • Invested in digital health initiatives, which can generate real-world data that could be utilized for future marketing strategies.

It’s important to remember that these are just examples of companies investing in RWD and RWE, and not necessarily evidence of direct use in current marketing campaigns. Nonetheless, they showcase the growing trend and potential for future applications in the Indian pharma industry.

Recently reported couple of other developments and initiatives in India:

  • The Indian Society for Clinical Research (ISCR) released a white paper in 2022 outlining recommendations for implementing RWE in India, highlighting its potential for drug development, regulatory submissions, and post-marketing surveillance.
  • The IQVIA Institute for Human Data Science India was established in 2023 with the aim of advancing capabilities leveraging real-world data and analytics in the Indian healthcare ecosystem.

Conclusion:

In a recent publication named, ‘Real-world evidence comes of age for pharma’ - the global consulting company - PwC, has also reaffirmed the critical need to understand how medicine performs in the real world. The authors highlighted, RWE has the potential to transform the pharmaceuticals business – from driving increased efficiency and cost savings in drug development, to helping identify new patient populations for marketed drugs. This can, in turn, translate into higher profitability and shareholder returns, while driving value growth. The big challenge for industry leaders now is learning how to leverage RWE as a sustainable competitive advantage in a landscape that has changed dramatically over the past few years.

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.

 

How Pharma Growth Strategy Now Extends Beyond Human Intelligence

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That the drug Industry’s growth strategy now extends beyond human intelligence, across the value chain, are being vindicated by several reports, around the world since several years. Illustratively, on September 1, 2019, Novartis and Microsoft announced a multiyear alliance which will leverage data & Artificial Intelligence (AI) to transform how medicines are discovered, developed and commercialized.

The trend is going north and fast. For example, on November 28, 2023 another such report highlighted yet another interesting initiative. It reported that to advance – mind boggling generative AI and foundation models. These extend the technology’s use beyond language models, for which Boehringer Ingelheim collaborates with IBM to accelerate its pace of creation of new therapeutics.

There isn’t an iota of doubt now that AI is rapidly transforming the pharmaceutical industry, including the way companies market their products. The technology is being used in a variety of ways to improve marketing effectiveness, reach new audiences, and personalize patient interactions, among many others.

I wrote about the need to leverage AI in pharma marketing on July 26, 2021. However, in today’s article, I shall focus on the criticality of investment in collaborative partnership in the AI space including generative AI, to acquire a cutting edge in the business process, for performance excellence. Let me start with some specific areas of relevance of using AI in pharma marketing space:

Examples of the relevance of using AI in pharmaceutical marketing:

  • Personalized drug recommendations: AI can be used to analyze patient data and recommend the most appropriate drug treatments for each individual patient. This can help to improve patient outcomes and reduce the risk of adverse drug events.
  • Patient education and support: AI can be used to provide patients with personalized education and support materials. This can help patients to better understand their conditions and make informed decisions about their treatment options. 
  • Real-time feedback and insights: AI can be used to collect and analyze real-time feedback from patients. This feedback can be used to improve the effectiveness of marketing campaigns and develop new products and services.

Several years ago, on October 31, 2016, I wrote in this blog on the relevance of Artificial Intelligence (AI) in creative pharma marketing. Interestingly, today it appears that many pharmaceutical companies are fast realizing that AI is rapidly transforming the drug industry, in its entire value chain. Now from its relevance let me dwell on the examples of specific areas where the pharma companies have started leveraging AI in their marketing processes.

Several areas where pharma companies are using AI in marketing:

  • Improving marketing effectiveness with targeted advertising and audience segmentation: AI algorithms can analyze vast amounts of data to identify the most effective channels and messaging for specific patient populations. This allows pharma companies to reach the right people with the right message at the right time, maximizing the impact of their marketing campaigns. 
  • Reaching new audiences: AI can help pharma companies to identify and reach new patient populations that may not have been accessible through traditional marketing channels. This can be especially helpful for reaching patients with rare diseases or who live in remote areas. 
  • Patient journey mapping and engagement: AI can be used to track patient interactions with a company’s brand, from initial awareness to post-purchase behavior. This data can be used to create personalized patient journeys, providing the right information and support at each stage of the healthcare process.
  • Chatbots and virtual assistants: AI-powered chatbots can provide 24/7 customer support, answering patient questions and addressing concerns. Virtual assistants can also help patients manage their medications, schedule appointments, and track their health data. 
  • Personalized patient interactions: AI can help pharma companies to create personalized patient experiences that are tailored to the individual needs and preferences of each patient. This can lead to improved patient satisfaction and adherence to treatment plans. 
  • Predictive analytics and market forecasting: AI can analyze historical data and current trends to predict future market demand for specific products or therapies. This information can help pharma companies make informed decisions about product development, marketing strategies, and resource allocation. 
  • Targeted drug discovery and development: AI is being used to accelerate the drug discovery and development process by identifying potential drug candidates, predicting clinical trial outcomes, and optimizing the design of new therapies. 

These point out, with the use of AI in pharmaceutical marketing, drug players can reap a rich harvest of several important benefits. Now, let me illustrate this point with some of both global and local examples of companies in this area, from available reports.

Global examples of how pharma companies are using AI in marketing:

As reported:

  • Novartis is using AI to personalize patient interactions and improve adherence to treatment plans. 
  • Pfizer is using AI to develop targeted advertising campaigns that reach the right patients with the right message.
  • Merck is using AI to identify new drug targets and accelerate the drug discovery process.
  • AstraZeneca is using AI to improve patient safety and reduce adverse drug events.

It is also gathering momentum within Indian healthcare industry:

As AI technology advances across the globe, we can expect to see more and more innovative applications of AI within different areas of the Indian healthcare industry, including pharma marketing. Encouragingly, several organization specific initiatives are now being reported on the use of even generative AI in the healthcare space. These include, as reported:

1.  Targeted advertising and audience segmentation in India: 

  • Sun Pharma is using AI to target its marketing campaigns to specific patient populations based on their demographics, medical history, and online behavior. This has helped the company to increase the reach and effectiveness of its marketing campaigns. For example, in 2023, Sun Pharma partnered with an AI startup to develop a new algorithm that can identify potential patients for its diabetes medication Lipaglyn. The algorithm uses data from patient electronic health records, social media, and wearable devices to create a profile of each patient. This information is then used to target Lipaglyn ads to patients who are most likely to benefit from the medication.
  • Dr. Reddy’s Laboratories is using AI to segment its patient audience based on their risk of developing certain diseases. This information is then used to develop targeted marketing campaigns that promote the company’s preventive healthcare products. Illustratively, in 2023, Dr. Reddy’s Laboratories launched a new marketing campaign for its cholesterol medication Ezetimibe. The campaign uses AI to target ads to patients who are at risk of developing heart disease. The AI algorithm uses data from patient demographics, medical history, and lifestyle factors to identify patients who are at high risk.

 2. Patient journey mapping and engagement:

  • Apollo Hospitals is using AI to track patient interactions with its brand and create personalized patient journeys. This includes providing patients with relevant information and support at each stage of their healthcare journey, from diagnosis to treatment to follow-up care. Even in In 2023, Apollo Hospitals launched a new patient engagement platform that uses AI to provide patients with personalized information and support throughout their healthcare journey. The platform includes a chatbot that can answer patient questions, a virtual assistant that can help patients schedule appointments, and a personalized health dashboard that tracks patient progress.  
  • Fortis Healthcare is using AI to develop chatbots that can answer patient questions and provide 24/7 customer support. This has helped the company to improve patient satisfaction and reduce call center costs. As reported, Fortis Healthcare’s 2023 AI initiatives demonstrate their commitment to leveraging technology for better patient care, efficient operations, and improved healthcare experience. By integrating AI across various departments and functions, they are paving the way for a more intelligent and personalized future of healthcare in India. 

4. Predictive analytics and market forecasting:

  • Cipla is using AI to predict future market demand for its products. This information is then used to optimize the company’s supply chain and production processes.
  • Lupin is using AI to forecast the potential success of new drug candidates in clinical trials. This information is then used to make informed decisions about which drugs to invest in further development.

5.  Drug discovery and development: 

  • Glenmark Pharmaceuticals is using AI to identify potential drug targets and design new therapies. This has helped the company to accelerate the drug discovery and development process.
  • Syngene International is a contract research organization (CRO) that uses AI to analyze preclinical data and predict clinical trial outcomes. This information is then used to help pharmaceutical companies make informed decisions about their clinical trial programs.

Conclusion:

Despite a plethora of pathbreaking and business performance enhancement opportunities that advanced application of AI offers, there are also some key challenges, which need to be effectively addressed by engaging with the Indian policy makers and the regulators. These areas include:

  • Data privacy: Pharma companies need to be careful to protect patient data when using AI. This includes obtaining patient consent for data collection and using anonymized data whenever possible.
  • Transparency: Pharma companies need to be transparent about how they are using AI in their marketing campaigns. This will help to build trust with patients and regulators.
  • Regulatory compliance: Pharma companies need to ensure that their use of AI complies with all applicable laws and regulations.

That said, regardless of these challenges – as I wrote on July 15, 2019, about the potential of disruptive impact of AI in Indian pharma marketing – such initiatives are fast gaining momentum.

Which is why, more often, an organizational growth strategy has now the scope to germinate beyond the human intelligence of marketers. In this scenario, I reckon, those pharma companies who will be capable enough to overcome these challenges, whatever it takes, to get the best of rapidly advancing technology of AI – will be better positioned to excel in the future.  

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.

With Covid’s Second Wave ‘A Nation In Distress’ – Why?

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If someone tries to see a silver lining in the disruptive Covid-19 pandemic, besides its vaccine rollout in some countries, there will be at least one. As of April 17, 2021- over 119 million patients (India – over 12 million), reportedly, have recovered out of 141 million (India – over 15 million) of Covid infected patients.

But this can’t mask the grim reality of over 18 million patients remain still infected, with over 3 million deaths (India – 175,673), since the beginning of the Covid menace. In the Indian perspective, this is the highest ever incidence of death – in absolute numbers – for any reason, so far. Now comes the Covid second wave with its more devastation onslaught on human lives and other consequences for the nation.

In this article, I shall explore this area, as apparently a Tsunami-like the second Covid wave starts sweeping across the India states, posing a greater danger than the first one, to the lives and livelihoods of millions of Indians, yet again. Let me start with a perspective, leading to the current situation.

No clinically proven drugs, as yet:

There aren’t any definite or clinically proven drugs after completion of Phase III studies, as yet, for curing patients from Covid infection. Nor are there any such well proven vaccines with fully known efficacy, safety, time interval between two doses, duration of prevention from Covid infection, in the future. All drugs and vaccines are currently being used under ‘emergency use’ approval by country drug regulators, based on interim results.

At the very onset of Covid-19 first wave, other than some attempts of repurposing older drugs, the world did not have any proven drugs to fight against this deadly infection. The old antimalarial drug Hydroxychloroquine – was tried first, followed by other medications, such as, Lopinavir/Ritonavir. Both created a huge global demand and subsequent shortages, including in the pharmacy of the world– India. Subsequently, W.H.O discontinued hydroxychloroquine and lopinavir/ritonavir treatment arms for COVID-19 based on interim clinical trial data. These results showed, hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care.

At the beginning of the second wave of Covid-19, one of the latest repurposed drugs – remdesivir that is being widely used, especially for hospitalized patients, is also facing a shortage, even in the pharmacy of the world. Interestingly, even ‘Remdesivir has little or no impact on survival, WHO trial shows’.

Also – no clinically fully proven Covid-19 vaccines, as yet:

Possibly, the second-best antidote as of date, against rapidly mutating Covid-19 – after Covid-appropriate behavior by all, comes vaccines. All comes with ‘emergency use’ approval, based on interim results only, and with several challenges. These include efficacy against all mutating Covid-19 variants, exact safety profile, dosage interval and duration of protection. Interestingly, on April 16, 2021, Pfizer indicated that ‘Covid-19 vaccine recipients will “likely” need a third dose between six to 12 months after they’re fully vaccinated and suggested vaccinations for coronavirus could be needed every year.’ In this evolving scenario, Indian experts also acknowledge that - abidance to the defined health norms stays as a lifeguard, and will remain so for an indefinite period.

Several countries, including India, are making, and gradually expanding requisite arrangements to vaccinate their population. Whereas a large number of countries – mostly in the developing world, are still awaiting access to Covid vaccines. Meanwhile, another issue has started bothering many, which the April 10, 2021 issue of The Guardian had captured in its headline – ‘Global Covid vaccine rollout is threatened by a shortage of vital components,’ besides manufacturing capacity constraints compared to the current demand.

Global challenges with Covid vaccines in 2021:

As things have progressed with Covid vaccines, thus far, the year 2021 doesn’t seem to be a smooth run to vaccinate people across the world, deriving a significant outcome against the battle of this global menace. This gets vindicated by the following numbers, as published in the ‘Down to Earth’ magazine on April 13, 2021.

  • According to the Johns Hopkins University, United States, as of April 12, 2021, only 773 million Covid-19 vaccines had been administered across the world. This means, only a little more than 2 per cent of the world’s adult population, has been inoculated so far.
  • According to data analytics firm Airfinity, the world will manufacture 9.5 billion doses by the end 2021. Whereas immediate global need exceeds 14 billion doses to vaccinate the entire adult population.
  • According to Gavi – The Vaccine Alliance, this represents almost three times the number of vaccines the world was producing in the pre-pandemic period for other diseases.

In the midst of these, inoculation with, at least, two major Covid-19 vaccines – one from AstraZenecaand other from Johnson & Johnson, have raised safety concern in the United States and many European countries. These ongoing developments complicate Covid vaccine challenges further.

The Indian scenario – ‘a nation in distress?’

Despite building new and a workable emergency health infrastructure by several state governments to combat Covid-19 pandemic, the fierce attack of the second wave with mutating Covid-19 virus, has already made these bursting at the seams. The article - ‘A tsunami of cases’: desperation as Covid second wave batters India, appeared in ‘The Guardian’ on April 14, 2021, captures this desperate struggle of the nation. Another recent report depicted with grim pictures, how India is grappling with the second wave of Covid-19, terming it as ‘a nation in distress.’ There are enough indications that India’s fragile health infrastructure has already collapsed in some places.

According to another news item on April 14, 2021, more than 111 million people has been vaccinated in India, by that time. Notably, this number was achieved after fears of AstraZeneca’s Covishield vaccine shortages, which subsequently prompted the Indian Government to temporarily halt its exports by the Pune-based vaccine manufacturer – Serum Institute of India (SII).

Going by another estimate, if the current momentum continues, India would be able to vaccinate 40% of its population by December 2021, and 60% of the population by May 2022. The report cautions that ‘the non-availability of vaccines may scuttle the pace.’ As per the W.H.O release, three in five Indians need to be vaccinated, to reach herd immunity. For which, the country needs 145 crore doses of vaccine by May 2022. India currently has the capacity to manufacture 100 crore-130 crore doses per year, as per a Rajya Sabha committee report. Another report of April 10, 2021 also highlights, ‘at least 10 states in India have reported a vaccine shortage and many vaccine centers have been reported shut.’

My wife and I also experienced the Covishield vaccine shortage in Mumbai. Our scheduled online appointment for vaccination through Co-Win website of the Government at Sir HN Reliance Hospital,Girgaon, Mumbai, for April 17, 2021, was cancelled. At past 10 pm on April 16, 2021, the hospital rang us up to inform that they have closed their Covid vaccination center till fresh vaccine stocks reach them.

To combat the Covid pandemic – ‘Pharmacy of the World’ goes local:

Yes, to combat the Covid pandemic, the ‘Pharmacy of the World’ goes local for some critical Covid drugs and vaccines, several times in the past. This happened earlier with drugs, like Hydroxychloroquine, when India banned its export to cater to the domestic need for Covid treatment. It happened again now, as ‘Remdesivir, API and formulation were placed under Export ban on 11.04.2021.’

Similarly, India has now, reportedly, put a temporary hold on all major exports of the AstraZeneca’sCoronavirus vaccine (Covishield in India), made by the SII, amid an increase in domestic demand due to a surge in infection. As the news item highlights: ‘It will also affect supplies to Gavi, the W.H.O backed vaccine alliance, through which more than 190 participating economies – 98 higher-income and 92 low and middle-income, are expected to get vaccine doses.’ Such temporary measures are now necessary for India to effectively respond to India’s Covid fight – especially the vaccine crunch.

India’s current vaccine imbroglio, as Covid second wave strikes hard:

Besides the SII, a second Indian company — Hyderabad-based Bharat Biotech, was given permission in January for emergency use of its Covaxin, developed in collaboration with the ICMR. Although, Bharat Biotech can make 12.5 million doses each month, these will be a small proportion of the doses administered in the country, so far.

To effectively respond to the prevailing vaccine crunch, Indian Government already approved the ‘emergency use’ of Sputnik V vaccine, which will be imported till its domestic production commences. Further, the country’s health authorities have now decided to consider the grant of ‘emergency use’ approval of several other internationally developed vaccines, such as, Pfizer – BioNTech double-dose vaccine and Johnson & Johnson’s single-shot vaccine. At least, till then, India’s vaccine imbroglio to vaccinate all adult population in the country, irrespective of age – particularly when Covid second wave is not sparing the young adults, is expected to continue.

Conclusion:

The jaw-dropping pandemic situation, and the pathway to deal with this crisis, especially in India, is getting increasingly complicated in every passing day. As reported on April 16, 2021, Covid-19 is now fooling RT-PCR tests – the most reliable type of Covid test as on date. It is so alarming because: ‘A false negative report is bad for the patient as they might delay consulting a doctor. It’s also bad for others, as the patient might not isolate, and spread the virus around,’ as the report underscores. It has started happening because: ‘Multiple mutations in the coronavirus over 15 months are making parts of it unrecognizable to lab tests.’

Experts are trying to fathom, whether or not more people are dying in India’s Covid second wave, as compared to the equivalent time period of the first wave. This causes an added cause of great concern because, in the six months before the start of the second wave (from September 2020 to January 2021), India’s overall case fatality rate (CFR) was only around 1.1%. This means only 1.1% of cases resulted in deaths. Currently, at the very beginning of the second wave, CFR has already increased to 1.3% and remains below peak levels seen in the first wave – as of date.

Above all, many people – virtually from all social, political, religious and economic strata, are openly flouting the basic norms of Covid appropriate behavior, as daily seen on different TV news channels. Ironically, these are happening at a time, when Indian health care infrastructure is creaking against the enormous and devastating power of the second wave Covid pandemic.

‘Pharmacy of the world’ has also gone local for some critical Covid-19 drugs and vaccines, to save lives and livelihoods of the Indian population, having no other better alternative in sight, at this hour. Isn’t this a sign of ‘A Nation in Distress’ that makes a fervent appeal to all of us, at least, to behave properly – by religiously following the lifesaving Covid guidelines?

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.

 

Shifting Pharma Supply Chain Strategy From Global To Local

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Alongside large-scale disruptions of many critical industrial operations, Covid-19 global pandemic took the wind out of the sail of pharma supply chain, as well, at the very onset of lockdowns. This happened in many countries around the world, including the largest global pharma market – the United States, and also in ‘the pharmacy of the world’ – India.

That there were such disruptions in India, both in procurement and logistics, during the national lockdown, was widely reported in the media. Besides product non-availability, cost of goods also went up significantly in several cases.

From this perspective, I shall deliberate in this article, how different countries are contemplating to respond to any similar crisis in the future, primarily to safeguard patients’ health interest, despite some opposition, though. To drive home the points, I shall cite examples from India and the United States, as specified above.

Supply Chain vulnerability of the ‘largest pharma market of the world’:

There are several examples to vindicate such vulnerability, both for the US and also India. From the US perspective, the country’s supply of generic and branded medicines are, reportedly, heavily rely on emerging markets, like India and China.

This point has now ‘come under close scrutiny of the American policy makers, as COVID-19 sends shockwaves through the industry. According to the US Food and Drug Administration, China and India represent 31 percent of the plants that are registered with the US to supply Active Pharmaceutical Ingredients (API), as of August 2019. The details are as hereunder:

Place

United States

European Union

India

China

Rest of the world

Canada

%

28

26

18

13

13

2

It is worth noting, the number of facilities in China supplying APIs has, reportedly, more than doubled since 2010 – to 13 percent of all those serving the US market.

Examples from India:

The outbreak of Coronavirus had just not shut factories in China - impacting supplies and leading to fears of a shortage of drugs and medicines. It happened in India, too. Several critical supply chain issues were reported during this period. For example,  a major Indian drug manufacturing hub - Baddi,reportedly, was either shut down or operated with reduced capacity, since COVID-19 pandemic related national lockdown.

Its impact also got captured by the twitter handle of the former USFDA Commissioner – Scott Gottlieb. He twitted, “Drug supply chain at risk as Asia’s largest pharmaceutical manufacturing hub in Baddi (an industrial town in southwestern Solan district of Himachal Pradesh, India) is declared a #COVID19 containment zone – forcing many pharma units to slow or stop operations.”

Supply Chain vulnerability of the ‘pharmacy of the world’:

Supply Chain vulnerability related to the domestic issues in India, can possibly be sorted out by the country’s decision-making authorities. However, the country’s vulnerability arising out of the reasons originating in the other countries, needs a greater priority focus of the nation.

As is widely known – India caters to about 20 percent of the world’s generic drug supply. However, according to Bloomberg, 70 percent of the country’s imports of APIs come from China, ‘totaling US$ 2.4 billion of India’s US$ 3.56 billion in import spending for those products each year.

Consequently, ‘pharma companies in the country are dependent on China for two-thirds of the chemical components needed to make them.’ Exposures of such nature are now coming on to the center table – mostly triggered by Covid-19 pandemic, both in India, as well as in the United States.

India is reevaluating its import dependence from China:

To illustrate this point, let me begin with some related recent developments. While reevaluating the import dependence, India has taken both immediate and medium to long term measures – at the policy level.

The immediate reaction of India to Covid-19 outbreak, was to shift focus on local with restricted export of common medicines, such as paracetamol and 25 other pharmaceutical ingredients and drugs made from China. Curiously, prior to the national lockdown, on March 17, 2020 by a written reply the Government had informed the Indian Parliament about the import of APIs /drugs and the extent of the country’s dependence on China for the same.

Be that as it may, to protect the local interest, the above ban was followed by another export ban of the age-old malarial drug - hydroxychloroquine, ‘touted by President Trump as a possible weapon in the fight against Covid-19,’ but has been in short supply, globally. Interestingly, India produces around 47 percent of the U.S. supply of hydroxychloroquine. Thus, understandably, Indian Government had to partially lift this ban after the U.S. President Donald Trump sought supplies for the United States.

For medium longer-term measures, while announcing a ₹20 lakh crore stimulus package, Prime Minister Narendra Modi articulated that Covid-19 pandemic had taught India to ramp up domestic production and create supply chains to meet internal demands. Earlier, for safeguarding ‘national healthcare security’, the Government had allocated US$ 1.2 billion for the pharma industry to be self-reliant, by reducing its import dependence, especially for APIs. The government also wants to finance the construction of three bulk drugs with an investment of ₹300 Crores.

The United States is reevaluating import dependence from one region:

The Fierce Pharma article of June 03, 2020 also reported a shifting focus of supply chain from global to local, as the United States seeks to ‘onshore’ drug production, with the fallout of Covid-19 pandemic looming large on its drug supply chain.

U.S. legislators have argued that ‘U.S. reliance on drugs made or sourced outside the country has created a security issue that could be addressed by erecting parallel supply chains stateside and eliminating reliance on potential bad actors abroad.’ Accordingly, they have put forward ‘a raft of legislation’ that would seek to “onshore” drug manufacturing at the expense of major producers abroad.

Its biggest obstacle could be the pharma industry and its lobbyists:

Nevertheless, the same article also underscores that the biggest obstacle to that plan could be the pharmaceutical industry and its lobbyists on Capitol Hill. This is because, PhRMA - the industry’s biggest lobbying group, has pushed back against Congressional support for a supply chain shake-up. It said, “Policymakers must take a long-term, more holistic look at global pharmaceutical manufacturing supply chains before jumping to rash proposals that may cause significant disruptions to the U.S. supply of medicines.”

Will it happen in India?

My article, published in this blog on February 03, 2020, also focused on this issue. There I had emphasized, about five years back - the Government of India had also announced on February 25, 2015 – terming ‘2015 – Year of Active Pharmaceutical Ingredients’ (API). This came after ascertaining that over-dependence on imports of bulk drugs or API, especially from China, is detrimental to India’s health interest. This decision was also in sync with the freshly announced, and well-publicized government objective regarding ‘Make in India’, I wrote.

Two years down the line from the above date, on July 15, 2017, eHEALTH publication also deliberated on this issue in an article – ‘Why over dependence on APIs imported from China is harmful for India?’ However, not much change has been witnessed till date, in this regard. The same vow is now being taken afresh. Nonetheless, let me hasten to add, Covid-19 has changed the life of all – in several respects. Thus, no one can possibly vouch with a high degree of certainty what can happen hereafter, as we move on.

Conclusion:

As the ‘Lockdown. 05’ or ‘Unlock down. 01’ begins in India – the ‘pharmacy of the world, as on June 02, 2020 morning, the recorded Coronavirus cases in the country reached 247,040 with 6,946 deaths. India is now racing ahead with its number Covid-19 cases, surpassing Italy and Spain, occupying the global fifth rank, in this regard. Whereas, the top ranked pharma market in the world – the United States, where Covid-19 struck hard before India, recorded 1,988,545 cases with 112,096 deaths, on the same day.

Thus, the need to have a fresh look at the strategic design of pharma supply chain is being felt in both these countries. The requirement for becoming less global and more local is attracting a priority focus of Governments in both countries. With an increasing State-push for safeguarding the health security of the country, the need to reshape pharma supply chain – call it transient or otherwise, is now more palpable 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.

 

Pharma ‘Chatbots’: For Better Stakeholder Engagement

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The critical value of meaningful interaction and engagement with individual customers – responding to their specific needs, is fast drawing attention of many businesses, for sustainable performance excellence. The same is happening in the pharma industry, as well. Creative use of this process leveraging modern technological support systems, would also provide a unique scope of cutting-edge brand service differentiation, in well researched areas.

That, it is a very important focus area for the pharma players, is no-brainer. Nonetheless, what really matters most is the novelty in strategizing such interactions and engagements, especially with patients and doctors. I also wrote about it in my article, titled ‘Indian Pharma To Stay Ahead of Technology Curve,’ published in this blog on May 22, 2017. Over two years ago, I clearly indicated there that application of AI via digital tools, called ‘Chatbots’ – the shorter form of ‘Chat Robot’, is one of the ways that pharma may wish to explore this area.

Illustrating this point in that article, I mentioned that on March 05, 2017, a leading bank in India announced the launch of an AI-driven Chatbot named Eva, coined from the words Electronic Virtual Assistant (EVA), to add more value to their services for greater customer satisfaction. ‘According to reports, Eva is India’s first AI driven banking Chatbot that can answer millions of customer queries on its own, across multiple channels, immediately.’

In this article, I shall dwell on this interesting area, with a primary focus on pharma sales and marketing, and assess the progress made in this space, thus far, by several drug companies, including some Indian players. Let me start by recapitulating the basic function and purpose of ‘Chatbots’ in pharma.

Pharma ‘Chatbots’ – the function and purpose:

Simply speaking, pharma ‘Chatbots’ are also AI-powered, fully automated virtual assistants. Its basic function is to mimic one-to-one human conversation on particular areas, as desired by the user. Likewise, its basic purpose is to genuinely help and assist the customers who are in search of right answers to specific disease related questions, in a one-to-one conversational format, having a higher source-credibility.

In that process, ‘Chatbots’ can effectively satisfy the patients and doctors by providing them the required information, immediately. In tandem, pharma companies also reap a rich harvest, by developing not just a trust-based healthy relationship with them, but also in building a robust corporate brand – creating a long-term goodwill that competition would possibly envy.  

Effective customer satisfaction is an area that can’t be ignored:

In the digital age, a new type of general need is all pervasive, with its demand shooting north. This is the need to satisfy a voracious appetite among a large section of the population for all types of information, with effortless and prompt availability of the required details – as and when these come to one’s mind.

When such information need relates to health concern of a person, such as – available treatment options against affordability, or drug price comparisons – factoring in effectiveness, safety concern – exactly the same thing happens. Most individuals won’t have patience even to write an email and wait for an answer, even the wait is just for a short while.

In the current scenario, it will be interesting to fathom, how would a pharma company, generally, interact or engage with such patients, to further business and creating a possible long-time customer? Some companies have started responding to this need – effectively and efficiently, by providing easy access to information through ‘Chatbots’, created on advances AI platforms. But, such players are a few in number.

Can pharma also think of ‘Chatbots’, like ‘Siri’ or ‘Alexa’?

Today, several people are using standalone and branded Chatbot devices in everyday life, such as, Siri (Apple), Alexa (Amazon), Cortana (Microsoft) or Google Now (Android). Interestingly, many industries, including a few companies in pharma, have also started developing their own version of ‘Chatbot dialog application systems.’

Industry specific ‘Chatbots’ are designed to meet with some specific purpose of human communication, including a variety of customer interaction, information acquisition and engagement – by providing a range of customized services to the target group.’ ‘Siri’ or ‘Alexa’ or the likes, on the other hand, are all-purpose general Chatbots, though, for everyday use of individuals. Thus, the question that comes up, in which areas pharma companies can use Chatbots to add value to their interactions and engagements with patients, in general, and also doctors.

Where to use ‘Chatbots’ as a new pharma marketing channel?

Some of the findings on the application of ‘Chatbots’, especially in pharma sales and marketing, featured in the CMI Media publication in December, 2016. It found that drug companies have a unique scope to leverage this new sales and marketing – channel, by developing ‘Chatbots’ in the company represented therapy areas. Following are just a few most simple illustrations of possible types ‘Chatbots’ for interaction and engagement with patients, which can be designed in interesting ways:

  • That can answer all types of patient questions on specific diseases, educate them about the disease and available treatment options with details.
  • That allows patients or physicians to get all relevant information about the prescription drugs that they require to prescribe for patients to start treatment, including potential side effects, adverse events, tolerability, dosing, efficacy and costs, besides others.
  • Once a treatment option is chosen, a third kind of Chatbot can help with patient adherence to treatment, provide reminders when the treatment should be administered, explain how to properly dose and administer the treatment, and other relevant information.

Chatbots could also be useful for doctors and nurses:

As the above paper finds, ‘Chatbots have value for serving healthcare professionals as well, for example:

  • When, physicians and nurses want to understand the pathogenesis, pathophysiology, and/or progression of a specific disease in their patients.
  • Although, such content may also be available on disease state awareness sites, but branded Chatbots would make that content readily available in more of an FAQ format.
  • When health care professionals would like to get data around safety/toxicity, or information about dosing strengths, calculations, and titrations, while using specific brands.

Chatbots can also be effectively utilized by the drug manufacturer to gain deep insights into customer behavior across all touchpoints, to enhance end-to-end customer experience, as I wrote in this blog on July 02, 2018. The data created through this process, can also be put to strategic use to design unique brand offerings.

Need to chart this frontier with caution:

Pharma, being a highly regulated industry in every country of the world, with a varying degree, though, the ‘Chatbot’ development process should strictly conform to all ‘Dos’ and ‘Don’ts’, as prescribed by the regulators of each country. Each and every content of the ‘Chatbot’ should pass through intense, not just regulatory, but also legal and medical scrutiny. Yet another, critical redline that ‘Chatbots’ should never cross is the ‘privacy’ of any individual involved in the process.

Three critical areas to consider for pharma ‘Chatbots’:

Effective pharma ‘Chatbots’ are expected to get ticks on all three of the following critical boxes:

  • Meeting clearly defined unmet needs of patients in search of a health care solution or most suitable disease treatment options.
  • Brand value offerings should match or be very close to the targeted patients’ and doctors’ expectations.
  • Should facilitate achieving company’s business objectives in a quantifiable manner, directly or indirectly, as was planned in advance.

Pharma has made some progress in this area, even in India:

To facilitate more meaningful and deeper engagements with patients, some drug companies, including, in India, are using ‘Chatbots.’ Here, I shall give just three examples to drive home the point – two from outside India and one from India.

October 23, 2018 issue of the pharma letter reported, a study from DRG Digital Manhattan Research found, ‘Novo Nordisk and Sanofi brands rank best for the digital type 2 diabetes patient experience.’ The article wrote, about some pharma players ‘facilitating deeper engagement through the use of automated tools like Chatbots to triage inquiries and get patients the answers they need faster, and through interactive content like quizzes and questionnaires that pull patients in and help them navigate health decisions,’ as follows:

  • Novo Nordisk‘s diabetes website includes an automated Chat feature dubbed “Ask Sophia,” helping patients access disease and condition management information more quickly.
  • Likewise, Merck & Co‘s website for Januvia employs interactive quizzes to educate patients and caregivers.

Similarly, on November 23, 2018, a leading Indian business daily came with a headline, ‘Lupin launches first Chatbot for patients to know about their ailments.’ It further elaborated, the Chatbot named ‘ANYA’, is designed to provide medically verified information for health-related queries. The disease awareness bot aims to answer patient queries related to ailments,’ the report highlighted.

Chatbots – global market outlook:

According to the report, titled ‘Healthcare Chatbots – Global Market Outlook (2017-2026),’the Global Healthcare Chat bots market accounted for USD 97.46 million in 2017 and is expected to reach USD 618.54 million by 2026 growing at a CAGR of 22.8 percent.

The increasing demand for Chatbot ‘virtual health assistance’, is fueled primarily by the following two key growth drivers, the report added:

  • Increasing penetration of high-speed Internet.
  • Rising adoption of smart devices.

Conclusion:

With the steep increase of the usage of the Internet and smart phones, general demand to have greater access to customized information is also showing a sharp ascending trend, over a period of time. A general expectation of individuals is to get such information immediately and in a user-friendly way.

Encouraged by this trend, and after a reasonably thorough information gathering process, mainly from the cyberspace, many patients now want to more actively participate in their treatment decision making process with the doctors. This new development has a great relevance to drug companies, besides other health service providers. They get an opportunity to proactively interact and engage with patients in various innovative ways, responding to individual health needs and requirements, thereby boosting the sales revenue of the corporation.

The unique AI-driven technological platform of pharma ‘Chatbots’, is emerging as cutting-edge tools for more productive stakeholder engagement – so important for achieving business excellence in the digital world. The recent growth trajectory of ‘Chatbots’ in the health care space, vindicates this point.

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.

‘Diversity And Inclusion’: A Missing Link For Indian Pharma

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Inadequate access to affordable health care to a vast majority of the population has been a favorite topic of debate, since long, globally. This discourse is generally centered around the least developed and the developing world, such as India. However, in the recent time, the reverberations of the same can be heard even from the most developed countries, like the United States.

Possible solutions in this area generally encompass several tangible issues, e.g. high cost of drugs and care, alleged unethical practices of the providers, infrastructure bottlenecks – to name a few. Curiously, despite the availability of an increasing number of innovative drugs, state of the art facilities and diagnostics, brilliant healthcare professionals and so on, disparities in the degree of access to all these, between different members of the civil society, keep steadily mounting.

This cascading socioeconomic issue, creating a widening the trust deficit, especially on pharma, throws a critical management challenge for long term sustainability of business, if not survival too.

Transformation to a customer-oriented, profit-making organization:

Building a profit-making organization is not an easy task. However, transforming a profit-making organization to a profit making through customer-centric policies, is several times more challenging. That’s because, making a true external customer-centric organization gets kick started from a significant cultural change within the organization. Systematically creating a pool of requisite internal customers (employees), with diverse background, experience, gender, belief, perspective, talent and, more importantly, ably supported by the organizational vision of inclusion, forms the nerve center of this transformative process. No doubt, why the quality of ‘Diversity and Inclusion (DI)’ culture of an organization is assuming the importance of a differential success factor in business excellence.

The August 25, 2016 E&Y article, titled “Embracing customer experience in the pharmaceutical industry” epitomizes its relevance by articulating: “It is the companies that focus on continuously delivering a better customer experience to build a trusted and transparent relationship over time that will win in the market. They will not only acquire customers that will remain loyal, but also win advocates that will refer the company or brand to more customers.”

The missing link:

It is now being widely established that creating a culture of ‘Diversity and Inclusion (DI)’ across the organization, is of critical importance to maintain sustainable business excellence, with a win-win outcome. Going a step forward, I reckon, although, this is an arduous task for any organization, but an essential one – even for long-term survival of a business. However, today, the very concept of DI is apparently a ‘missing link’ in the chain of sustainable organizational-building initiatives, particularly for most Indian pharma companies.

The role of DI in making a customer-centric business:

Health care customers, like many others, are generally of diverse backgrounds, financial status, ethnicity, gender, health care needs, expectations, and also in their overall perspective. Thus, to make a customer-centric organization for greater market success, and drive product and service innovation accordingly, pharma companies need to deeply understand them, empathetically. A competent pool of well-selected employees with diverse backgrounds, race, ethnicity, gender, perspectives, could facilitate this process, more effectively. However, the company should also create an environment and culture of inclusion for all to listen to each other’s well-reasoned views – expressed uninhibited and fearlessly for this purpose.

In making this process more effective to add a huge tangible and intangible worth to the business, pharma players need to untether the employee potential through empowerment, making them feel valued and grow. This would also help immensely in charting newer pathways of all-round success in many other high-voltage complexities of pharma business.

‘Why diversity matters’?

That diversity within an organization matters in several ways, has been established in several studies. For example, the February 2015 article, titled “Why diversity matters”, of McKinsey & Company says, “More diverse companies are better able to win top talent, and improve their customer orientation, employee satisfaction, and decision making, leading to a virtuous cycle of increasing returns.” The analysis found a statistically significant relationship between a more diverse leadership team and better financial performance (measured as average EBIT 2010–2013).

Why is inclusion so important?

In a large number of organizations that include Indian pharma, senior management staffs generally seem to appreciate hearing more of what they want to hear. This culture quickly percolates top-down – encompassing the entire company, probably with a few exceptions. Personal ‘likes’ and ‘dislikes’ of various nature and degree spread wings within many organizations. Such a situation is created from intrinsic apathy to patiently listen to and accept another employee’s viewpoint – even on critical customer-centric issues. Employees, in that process, also get branded as ‘argumentative’ and often ‘disloyal’, if not a ‘socialist’. The major decisions often get biased accordingly – sometimes unknowingly.

Whereas, inclusion entails empowerment and close involvement of a diverse pool of employees with dignity, by recognizing their intrinsic worth and value. Moving towards a culture of inclusion would require creation of an organizational desire to communicate professionally and learn how to listen to each other’s well-thought-through arguments with interest.

The business should accept that it is not really important in getting along with everybody on all issues – every time. Neither, does it make sense for professionals to develop personal ‘likes’ or ‘dislikes’ on other fellow colleagues, based on issue-based differences, while finding out ways and means to improve organizational performance, image or reputation. Inclusion helps employees to learn to work closely, despite personal differences on all important issues.

Has Global pharma industry started imbibing DI?

Yes, many global pharma majors, such as, GSK, Novartis and Merck and several others, have started practicing DI as a way of organizational life and culture. Some of them like GSK India has put it on its country website. But, generally in India, the scenario is not quite similar. Though, many head honchos in the country talk about DI, the February 16, 2017 edition of Bloomberg/Quint carried a headline “Most Indian Companies Do Not Value Diversity At Board-Level Hirings,” quoting Oxfam India.

A voluntary survey of ‘company diversity’ conducted by US-based DiversityInc at Princeton, ranks the companies on four key areas of diversity management: talent pipeline, equitable talent development, CEO/leadership commitment, and supplier diversity. It revealed an interesting fact in its 2016 study. The survey reported, while diversity continues to improve in the overall perspective, its ‘Pharma 50’, as a group, ‘is right in the middle of the industry pack when benchmarked against the Fortune 500.’  The survey also brought to light significant differences in the levels of gender, national, and ethnic diversity even at the company boards and executive committees of individual companies. Nonetheless, some global pharma entities are taking significant steps in this direction. But, these are still early days in many organizations.

Conclusion:

The E&Y article quoted above, also says that pharma “customers are becoming resistant to push sales and marketing, and are instead preferring to relate to the overall experience provided in their pull interactions with the company. The customer experience will be the next battleground for the pharmaceutical industry. The deployment of a customer experience capability is a transformational journey in often unchartered territories. The key to success is to start early and drive a process that is both rigorous and iterative, allowing the organization – and its customers – to learn along the way and always to be ready with the next best action in place.” DI, I reckon, plays a critical role in attaining this goal.

Pharma companies are also realizing that building a profit-making organization with blockbuster high-priced, high-profit making molecules, such as Sovaldi is possible, but this may not be sustainable. It isn’t an easy task either, not anymore. There lies the urgency of transforming a profit-making organization to a profit making through customer-centric business entity. This process, I repeat, is several times more challenging, but the business success is much more sustainable.

Organizational transformation of this nature is prompting the global pharma majors to use Diversity and Inclusion (D&I) while achieving their key financial and people goals. Both D (Diversity) and I (inclusion) work in tandem for taking any fairness-based organizational decisions, irrespective of whether it’s staff or customer decision.

DI has the potential to help an organization to create and chart new and more productive pathways almost in all functions within the company – right from R&D, communication, service delivery to market access. In all these initiatives, customer focus to occupy the center stage – for a win-win outcome – significantly reducing the degree of difficulty for access to affordable medicines. DI is not a panacea to mitigate this problem totally, but would help significantly, nonetheless – with the help of employees with diverse background but having fresh eyes. Many global pharma majors have initiated action in this direction. However, in Indian pharma business generally, DI still remains a missing link, as it is seen 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.

Why MNC Pharma Still Moans Over Indian IP Ecosystem?

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Improving patient access to expensive drugs, paving the way for entry of their cheaper generic equivalents, post patent expiry, and avoiding evergreening, is assuming priority a priority focus area in many countries. The United States is no exception, in this area. The Keynote Address of Scott Gottlieb, Commissioner of Food and Drug at the 2018 Food and Drug Law Institute Annual Conference inWashington, DC by, on May 3, 2018, confirms this. Where, in sharp contrast with what the MNC Pharma players and their trade associations propagated, the US-FDA commissioner himself admitted by saying, “Let’s face it. Right now, we don’t have a truly free market when it comes to drug pricing, and in too many cases, that’s driving prices to unaffordable levels for some patients.”

Does US talk differently outside the country?

At least, it appears so to many. For example, in April 2018, the Office of the United States Trade Representative (USTR) released its 2018 Special 301 Report. In this exercise, the USPTO names the country’s trading partners for not adequately protecting and enforcing Intellectual Property (IP) rights or otherwise deny market access to U.S. innovators that rely on the protection of their IP rights.’ Accordingly, U.S. trading partners are asked to address IP-related challenges, with a special focus on the countries identified on the Watch List (WL) and Priority Watch List (PWL).

In 2018, just as the past years, India continues to feature, along with 11 other countries, on the PWL, for the so called longstanding challenges in its IP framework and lack of sufficient measurable improvements that have negatively affected U.S. right holders over the past year.

From Patient access to affordable drugs to Market access for Expensive Drugs: 

Curiously, the USTR Report highlights its concerns not just related to IP, but also on market access barriers for patented drugs and medical devices, irrespective of a country’s socioeconomic compulsion. Nevertheless, comparing it to what the US-FDA Commissioner articulated above, one gets an impression, while the US priority is improving patient access to affordable drugs for Americans, it changes to supporting MNC pharma to improve market access for expensive patented drugs, outside its shores.

Insisting others to improve global IP Index while the same for the US slides:

In the context of the 2018 report, the U.S. Trade Representative, reportedly said, “the ideas and creativity of American entrepreneurs’ fuel economic growth and employ millions of hardworking Americans.” However, on a closer look at the U.S. Chamber of Commerce’s annual Global IP Index for 2018, a contrasting fact surfaces, quite clearly. It shows, America, which once was at the very top of the overall IP Index score, is no longer so – in 2018, the world rank of the US in offering patent protection to innovators, dropped to 12thposition from its 10thglobal ranking in 2017. Does it mean, what the US is asking its trading partners to follow, it is unable to hold its own ground against similar parameters, any longer.

Should IP laws ignore country’s socioeconomic reality? 

MNC Pharma often articulated, it doesn’t generally fall within its areas of concern, and is the Government responsibility. However, an affirmative answer, echoes from many independent sources on this issue. No wonder, some astute and credible voices, such as an article titled “U.S. IP Policy Spins Out of Control in the 2018 Special 301 Report”, published by the Electronic Frontier Foundation on May 01, 2018, termed 2018 Special 301 Report – ‘A Tired, Repetitive Report.’ It reiterates in no ambiguous term: ‘The report maintains the line that there is only one adequate and effective level of IP protection and enforcement that every country should adhere to, regardless of its social and economic circumstances or its international legal obligations.

The ever-expanding MNC Pharma list of concerns on Indian IP laws:

The areas of MNC Pharma concern, related to Indian IP laws, continues to grow even in 2018. The letter dated February 8, 2018 of the Intellectual Property Owners Association, Washington, DC to the USTR, makes these areas rather clear. I shall quote below some major pharma related ones, from this ever-expanding list:

  • Additional Patentability Criteria – section 3 (d): The law makes it difficult for them to secure patent protection for certain types of pharma inventions.
  • TADF (Technology Acquisition and Development Fund)is empowered to request Compulsory Licensing (CL) from the Government:Section 4.4 of India’s National Manufacturing Policy discusses the use of CL to help domestic companies access the latest patented green technology.This helps in situations when a patent holder is unwilling to license, either at all or “at reasonable rates,” or when an invention is not being “worked” within India.
  • India’s National Competition Policyrequires IP owners to grant access to “essential facilities” on “agreed and nondiscriminatory terms” without reservation. They are not comfortable with it.
  • Regulatory Data Protection: The Indian Regulatory Authority relies on test data submitted by originators to another country when granting marketing approval to follow-on pharma products. It discourages them to develop new medicines that could meet unmet medical needs.
  • Requirement of local working of patents: The Controller of Patents is empowered to require patent holders and any licensees to provide details on how the invention is being worked in India. Statements of the Working, (Form 27),must be provided annually.Failure to provide the requested information is punishable by fine or imprisonment. It makes pharma patent holders facing the risk of CL, if they fail to “work” their inventions in India within three years of the respective patent grant.
  • Disclosure of Foreign Filings: Section 8 of India’s Patent Act requires disclosure and regular updates on foreign applications that are substantially “the same or substantially the same invention.” They feel it is irrelevant today.

Pharma MNCs’ self-serving tirade is insensitive to Indian patient interest:

Continuing its tirade against some developed and developing countries, such as India, the US drug manufacturers lobby group – Pharmaceutical Research and Manufacturers of America (PhRMA) has urged the office of the US Trade Representative (USTR) to take immediate action to address serious market access and intellectual property (IP) barriers in 19 overseas markets, including India, reports reported The Pharma Letter on February 28, 2018. It will be interesting to watch and note the level active and passive participation of India based stakeholders of this powerful US lobby group, as well.

Government of India holds its ground… but the saga continues:

India Government’s stand in this regard, including 2018 Special 301 Report, has been well articulated in its report released on January 24, 2018, titled “Intellectual Property Rights Regime in India – An Overview”, released by the Department of Industrial Policy and Promotion Ministry of Commerce and Industry (DIPP). The paper also includes asummary of some of the main recommendations, as captured in the September 2016 Report of the High-Level Panel on Access to Medicines, constituted by the Secretary-General Ban Ki-Moon of the United Nations in November 2015.  Some of these observations are as follows:

  • WTO members must make full use of the TRIPS flexibilities as confirmed by the Doha Declaration to promote access to health technologies when necessary.
  • WTO members should make full use of the policy space available in Article 27 of the TRIPS agreement by adopting and applying rigorous definitions of invention and patentability that are in the interests of public health of the country and its inhabitants. This includes amending laws to curtail the evergreening of patents and awarding patents only when genuine innovation has occurred.
  • Governments should adopt and implement legislation that facilitates the issuance of Compulsory Licenses (CL). The use of CL should be based on the provisions found in the Doha Declaration and the grounds for the issuance left to the discretion of the governments.
  • WTO members should revise the paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory license.
  • Governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO Members to use TRIPS flexibilities.
  • Governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfill the rights to health.

The DIPP report includes two important quotes, among several others, as follows:

Joseph Stiglitz, Nobel Prize for Economics (2001) – an American Citizen:

-       “If patent rights are too strong and maintained for too long, they prevent access to knowledge, the most important input in the innovation process. In the US, there is growing recognition that the balance has been too far tilted towards patent protection in general (not just in medicine).”

-       “Greater IP protection for medicines would, we fear, limit access to life-saving drugs and seriously undermine the very capable indigenous generics industry that has been critical for people’s well-being in not only India but other developing countries as well”.

Bernie Sanders, an American Citizen and Senior U.S. Senator:

-      “Access to health care is a human right, and that includes access to safe and affordable prescription drugs. It is time to enact prescription drug policies that work for everyone, not just the CEOs of the pharmaceutical industry.”

-      “Healthcare must be recognized as a right, not a privilege. Every man, woman and child in our country should be able to access the health care they need regardless of their income.”

Conclusion:

Why is then this orchestrated moaning and accompanying pressure for making Indian IP laws more stringent, which apparently continues under the façade of ‘innovation at risk’, which isn’t so – in any case. But, cleverly marketed high priced ‘me too’ drugs with molecular tweaking do impact patient access. So is the practice of delaying off-patent generic drugs entry, surreptitiously. Instead, why not encourage Voluntary Licensing (VL) of patented drugs against a mutually agreed fee, for achieving greater market access to the developing countries, like India?

Whatever intense advocacy is done by the vested interests to change Indian patent laws in favor of MNC pharma, the intense efforts so far, I reckon, have been akin to running on a treadmill – without moving an inch from where they were, since and even prior to 2005. The moaning of MNC Pharma on the Indian IP ecosystem, as I see it, will continue, as no Indian Government will wish to take any risk in this area. It appears irreversible and is likely to remain so, for a long time to come. The time demands from all concerned to be part of the solution, and not continue to be a part of the problem, especially by trying to tamper with the IP ecosystem of the country.

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.