Drug Prescription In Generic Names Only, No Branded Generics

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.

 

‘Indian Pharma’s Apathy Towards Digital Marketing’ – A Misgiving Or Real?

As I gather from different sources, an increasing number of Indian pharma companies are increasingly embracing digitalization in their marketing operations, especially after the crippling experience during the Covid lockdown period. They realize the use of digital platforms would be a great enabler for them to reach a wider audience, promote their products, and engage with healthcare professionals more effectively, in any given situation. The depth, span, and speed of adaptation of this initiative is fast gathering momentum in the capable hands of astute marketers.

In this article, I shall explore this area to ferret out the fact, whether ‘The Indian pharma industry’s apathy towards Digital Marketing’ is a misgiving or still a reality. However, I would start with an important note about getting caught in some possible controversies due to occasional overenthusiasm in this space. 

Some possible reasons for a brouhaha or controversy:

There may be several reasons why a brouhaha or controversy could continue surrounding the use of digitalization in Indian pharma companies’ marketing operations. Some possible factors include:

  • Compliance and Regulatory Issues: Digital marketing practices must ensure full compliance with regulations set by regulatory bodies, such as the Drug Controller General of India (DCGI) and the Medical Council of India (MCI). Any violation of these regulations can lead to legal consequences and damage the reputation of the companies involved.
  • Misinformation, data Integrity and Misleading Claims: The widespread use of digital platforms can make it easier for misleading, breach of data integrity and false claims to be disseminated. Regulators and critics may raise concerns about the accuracy of information being shared and the potential impact on patient health. 
  • Privacy, cyberthreats and Data Security: The use of digital platforms involves the collection and storage of user data. Privacy concerns, including cyberthreatscan arise if pharmaceutical companies do not handle personal information responsibly or if patient data is compromised due to inadequate security measures. 
  • Unethical Practices: There have been instances where pharmaceutical companies have been accused of engaging in unethical practices in their marketing efforts. These may include off-label promotion (promoting a drug for an unapproved use), undue influence on healthcare professionals, or aggressive marketing tactics that prioritize sales over patient welfare. 

It is important to recognize that the specific reasons for the ongoing brouhaha on this topic may have further evolved. From this perspective, let me now focus on a few Indian examples where using digital tools and analytics could offer several advantages for domestic pharmaceutical companies, as available from different sources.  

Examples of some areas where Indian players are using digital tools:

Here are some recent examples of how Indian pharmaceutical companies have utilized digital tools and analytics in their marketing operations, as available in the public domain:

  • Enhanced Targeting: Aurobindo Pharma Limited has implemented data analytics to identify key customer segments for targeted marketing. By analyzing prescribing patterns and patient demographics, they tailor their marketing efforts to reach specific healthcare professionals and patient groups more effectively. 
  • Personalized Marketing: Biocon Limited has embraced digital tools to deliver personalized marketing content. Through their digital platforms, such as websites and mobile applications, they provide customized information about their products, disease education materials, and patient support resources.
  • Improved Marketing ROI: Lupin Limited has utilized digital analytics to measure the performance of their marketing campaigns. By tracking key metrics, such as website engagement, social media interactions, and email response rates, they can optimize their marketing spend and allocate resources to channels that yield higher returns. 
  • Efficient Resource Allocation: Sun Pharmaceutical Industries Ltd has leveraged digital tools and analytics to optimize resource allocation. They analyze market data and customer behavior to identify regions and healthcare facilities with the highest growth potential, enabling them to allocate their sales resources strategically.
  • Real-time Market Insights: Dr. Reddy’s Laboratories Ltd utilizes digital tools and analytics to monitor real-time market insights. By leveraging social listening tools and data analytics platforms, they stay updated on market trends, competitor activities, and customer feedback, enabling them to adapt their marketing strategies accordingly.
  • Improved Customer Engagement: Cipla Ltd has focused on improving customer engagement through digital channels. They utilize social media platforms, online forums, and chatbots to interact with healthcare professionals and patients, providing information, answering queries, and offering support. 
  • Streamlined Communication: Torrent Pharmaceuticals Ltd has implemented digital communication tools to streamline interactions with healthcare professionals. They utilize virtual meeting platforms, webinars, and online training sessions to engage with physicians, pharmacists, and other stakeholders more efficiently, eliminating geographical barriers.
  • Data-driven Decision Making: Glenmark Pharmaceuticals Limited leverages data analytics for data-driven decision making. By analyzing sales data, market trends, and customer feedback, they gain insights that inform their strategic decisions regarding product launches, marketing campaigns, and market expansion. 

These examples demonstrate how Indian pharmaceutical companies have harnessed digital tools and analytics while recomposing notes in a pharma marketing playbook to enhance their business operations. However, please note that specific initiatives and strategies are still evolving, and the extent of adoption may vary among different companies. 

Conclusion:

From the above perspective, I reckon, Indian drug companies are increasingly embracing digital toolsand analytics to enhance their marketing efforts. With the advancement of technology and the growing importance of digital channels, pharmaceutical players in India are recognizing the need to adapt and leverage digital tools to stay competitive and effectively reach their target audience. Hence, any feeling about the ‘Indian pharma industry’s apathy towards Digital Marketing’ seems to be a misgiving to me.

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.

Collaboration For Sustainable Excellence – The Name of The Game in The New Normal

The union minister of health and family welfare of India recently invited Japanese companies to collaborate with Indian companies on research and innovation in emerging therapies, like precision medicine, cell and gene therapy, biological products, and on the utilization of digital tools and technologies. This was reported on May 16, 2023.

Underscoring this objective, the minister articulated, “such collaboration on research and innovation would help enhance the domestic availability and affordability of these innovative therapeutic options.”

The area of research and drug innovation in emerging therapies and on the utilization of digital tools and technologies has emerged as one of the top focus areas of the country in the new normal. Currently, the Indian pharmaceutical industry is primarily focused on manufacturing generic medicines, exporting bulk drugs, and supplying active pharmaceutical ingredients.

Thus, this goal can be quickly achieved through global collaborations – at a time when India plays a pivotal role in improving health outcomes worldwide by serving as a dependable supplier of affordable and high-quality generic drugs. The country is currently providing approximately 60 per cent of the global vaccine supply, and 20-22 per cent of generic exports. Importantly, ‘In the battle against the Covid-19 pandemic, India has supplied essential drugs to around 185 countries,” he underscored.

Interestingly, after the Covid-19 pandemic, there has been a significant shift in the approach of both Indian and multinational drug companies towards business collaboration. This article will focus on this area with recent Indian examples, culled from available reports. However, before delving into this space, let me also point out that drug MNCs operating in India are also changing focus on their India operations, as reported in recent times.

Drug MNCs operating in India are also changing business focus: 

This was brought to the fore by several recent reports. For example, in February 2022, The Economic Times reported: 

  • In February, Novartis India passed on the sales and distribution rights of three of its established brands to Dr Reddy’s Labs and terminated the employment of 400 staffers.  
  • In October, US drugmaker Eli Lilly sold the marketing rights of its anti-diabetes drugs to Cipla and laid off 120 employees in India. 
  • Around the same time, Danish pharma company Lundbeck decided to exit India as part of its global strategy. 

However, their key goal remains - delivering new patient-perceived value – not just incremental, but in quantum measure for business growth.

The need for increased collaboration and shared resources:

Against the above backdrop, it appears to me that the pandemic has highlighted the need for accelerated cooperation and sharing resources to address global healthcare challenges, effectively. As a result of which, both Indian and MNC drug companies are recognizing the benefits of working together, and are actively seeking collaboration opportunities in the following areas. 

  • Access to Emerging Markets: Indian pharma companies have a strong presence in emerging markets due to their cost-effective generic drug manufacturing capabilities. Multinational companies recognize the potential of these markets and are looking to collaborate with Indian firms to gain access to these regions. By partnering with Indian companies, MNCs can tap into local expertise, distribution networks, and regulatory knowledge. 

- Example: In 2022, Cadila Healthcare entered into a collaboration with Novartis to develop and commercialize multiple oral solids and injectable generics for global markets, including emerging markets.

  • Research and Development: Collaboration in research and development (R&D) activities has become crucial for drug companies. MNCs bring advanced research capabilities, cutting-edge technologies, and substantial financial resources, while Indian companies offer a skilled workforce and a cost-effective environment for R&D. By joining forces, they can pool their strengths and accelerate the discovery and development of new drugs and therapies.

- Example: In 2021, Bharat Biotech collaborated with the Washington University School of Medicine in St. Louis and the International AIDS Vaccine Initiative (IAVI) to develop a novel vaccine candidate for HIV. This collaboration aims to combine the strengths of all three organizations to advance HIV vaccine research.

  • Manufacturing and Supply Chain: The pandemic exposed vulnerabilities in global supply chains, particularly in the pharmaceutical sector. Collaborations between Indian and MNC drug companies can help diversify manufacturing locations and strengthen supply chain resilience. Indian companies’ expertise in large-scale generic drug production can complement the specialized manufacturing capabilities of multinational firms.

- Example: In 2021, Hetero entered into a partnership with the Russian Direct Investment Fund (RDIF) to manufacture the Sputnik V Covid-19 vaccine in India. This collaboration aimed to increase the production capacity of the vaccine to meet global demand.

  • Regulatory Compliance: Regulatory compliance is a critical aspect of the pharmaceutical industry. Indian companies have been working closely with regulatory authorities to meet global standards and gain approvals for their products. Collaborating with Indian companies enables MNCs to leverage their understanding of regulatory processes, navigate local regulations efficiently, and ensure compliance with diverse international requirements.

- Example, in 2022, Biocon Biologics partnered with Adagio Therapeutics, a US-based biotechnology company, to develop and commercialize an antibody treatment for COVID-19. This collaboration involves regulatory support from both companies to navigate global regulatory processes.

  • Market Expansion: Collaborations provide an opportunity for both Indian and multinational companies to expand their market presence. Indian companies can benefit from the MNCs’ established marketing networks, while MNCs can leverage the Indian companies’ extensive distribution channels and market knowledge. Joint ventures and partnerships facilitate market entry, improve market penetration, and help companies capture a larger share of the global pharmaceutical market. 

- Example: In 2022, Torrent Pharmaceuticals collaborated with Swedish multinational company Handicare Group AB to distribute and market Handicare’s range of mobility solutions in India. This collaboration enables Torrent Pharmaceuticals to diversify its product portfolio and expand into the healthcare mobility market. 

  • Technology and Innovation Sharing: Collaborations foster knowledge exchange between Indian and multinational drug companies. MNCs can share their technological advancements and research findings, while Indian companies can contribute their insights and expertise in managing large-scale production. Such knowledge-sharing initiatives can drive innovation, improve manufacturing processes, and enhance overall operational efficiency. 

- Example: In 2022, Glenmark Pharmaceuticals entered into a collaboration with the Canadian multinational company SaNOtize Research and Development Corp. to develop a nitric oxide nasal spray for the treatment of COVID-19. This collaboration combines Glenmark’s expertise in drug development with SaNOtize’s innovative nitric oxide platform.

  • Intellectual Property and Licensing: Collaboration often involves the exchange of intellectual property (IP) rights and licensing agreements. Indian companies possess a vast pool of generic drug formulations and manufacturing capabilities. MNCs can license their patented drugs or technology to Indian partners for production and distribution in specific markets. These licensing arrangements benefit both parties by expanding the product portfolio and maximizing revenue potential. 

- Example: In 2021, Glenmark Pharmaceuticals signed a licensing agreement with Canadian biopharmaceutical company Xenon Pharmaceuticals to develop and commercialize a potential treatment for epilepsy. This collaboration involves the licensing of Xenon Pharmaceuticals’ proprietary technology for the development of a novel therapeutic product.

Conclusion:

Overall, as the recent trends indicate, the post-pandemic era has accelerated initiatives of strategic collaboration between Indian and multinational drug companies. By leveraging each other’s strengths and with shared value and resources, these collaborations aim to drive innovation, address global healthcare challenges, and deliver affordable and accessible healthcare solutions to patients worldwide. And thereby, will help deliver a unique patient experience.

Additionally, the examples, as available from published sources, highlight an increasing number of such recent collaborations, besides operational re-focusing by several MNC drug majors in India.  

These strategic steps clearly emphasize their joint efforts to drive innovation, expand their market presence, and address critical healthcare needs. From this angle, I believe, for sustainable business excellence and for staying relevant to customers in the new digital world, one of the top focus areas for Indian pharma players deserves to be strategic collaboration initiatives.

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

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.

 

Deliver Patient-Perceived Value – Not Incrementally But In Quantum Measure

Many critical functional areas of most drug companies, such as, marketing, manufacturing, supply chain, medical affairs, human resource, R&D, quality assurance, information technology – traditionally work in silos. It doesn’t mean, though, that there isn’t any interaction between them. Nevertheless, a large majority of them don’t work as a team with a purpose or to achieve a shared goal of delighting customers with value delivered. Such a silo-mindset could often be detrimental to smooth and sustainable business operations. This was also vindicated during the recent pandemic.

Having gone through the harrowing experience of recent disruptions in the lifesaving pharma business operations, a fresh realization has dawned on many leaders’ mind. This point also came to the fore in many studies. One such is the article on ‘Overcoming industry obstacles with a cross-functional strategy’, published by the strategy&, which is a part of PwC network.

The paper came out with some thought-provoking findings. It said, while in the pre-Covid days, mostly competing business pressures used to drive the operational strategies, today the drivers are quite different. ‘Factors such as the COVID-19 pandemic, inflation, geopolitics, new therapeutic modalities, and new ways of working make it vital’ for pharma players to make such transformational operational overhaul for long term excellence.

The spotlight needs to shift from continuous incremental improvement, such as, cost savings, quality assurance, and readiness to deliver—to long-term external challenges. ‘These include high inflation and an increase in complexity and risk, as well as the compounding effects these forces have on each other.”

Several studies have underscored that this approach can ‘make sure operations can protect enterprise continuity while still delivering to patients.’ this article will venture to simplify this complex, yet critical issue. The aim is to achieve a quantum increase in value offering to customers that this strategic approach can potentially deliver to accelerate growth momentum the pharma business.

Some see pharma business as usual, astute leaders see a unique opportunity for change:

An interesting point to note. As the disruptions caused by the Covid pandemic are fading away, some critical health safety norms are also being eased by the authorities. Apparently, the overall daily working-life seems to be limping back to normal. Many pharma leaders are, therefore, considering that the industry operations are going back to pre-pandemic normal, and the business operations will soon revert to the old normal mode soon.

On the other hand, we find some astute leadership who could derive a long-term lesson from the above disruptions and are already in the process of executing those operational changes. This leadership mindset gets reflected in two recent media reports related to two pharma majors – Sanofi and GSK.

On November 28, 2022, it was reported, ‘Sanofi moves into swanky new Paris HQ designed around hybrid work and sustainability.’ Again, on December 12, 2022, another media headline flashed as ‘GSK embraces hybrid work for the long haul at new London HQ.’

To me these are interesting examples to convert problems into opportunities for long-term business success and sustainability, in the new normal. These tasks entail the transformation of business infrastructure alongside its operational strategies.

The need for re-strategizing reverberates across several recent studies:

The need for such an action, as captured by researchers, is prompted by more waves of innovation coming in various operations and functions of pharma business, mostly triggered by the pandemic. The spectrum of innovation, as reports reveal, ranges ‘from new treatment modalities, to smart machines, advanced analytics, and digital connectivity.’

Hence, the future of pharma operations strategy needs to be different now from the past. This finding was also published by the McKinsey & Company on October 10, 2022. It reiterated, as pharma companies are emerging from two years of intense firefighting, now is exactly the right time for their renewed emphasis on a new operations strategy. It emphasized: ‘Succeeding in pharma under these new and challenging conditions will require succeeding in operations.’

This point was further vindicated by the results of the latest McKinsey Global Survey, which states:‘Less than one-third of the surveyed respondents, all of whom had been part of a transformation in the past five years, said their companies’ transformations had achieved a sustained performance improvement.’

Another study very specific to India:

Another survey on ‘Indian consumer sentiment during the coronavirus crisis,’ published by theMcKinsey & Company on October 13, 2022, also reconfirms the subtle changing trend in Indian consumer behavior. Its findings include some of the following areas:

  • More than 70 percent consumers are engaging in modified out-of-home behavior, even as social gathering returning to almost normalcy.
  • Digital continues to hold sway with more than 75 percent consumers using either digital or omnichannel while purchasing across categories.
  • Social media continues to be an important influence while shopping.
  • Gen Z and millennial are leading in new shopping behavior, with value being the top reason and sustainability as an emerging factor.

Hence, to engage with such healthcare consumers and deliver the value as they perceive, pharma operational strategies may call for a rejig – for longer term success and sustainability. That said, a key point to remember is that the marketing function is central while redrawing new operational strategy.

The marketing function is central while redrawing new operational strategy:

The need for the above was well articulated in another study published by ResearchGate in May 2020. It pointed out that many drug companies invest lots of funds to be more productive in various key operational areas, like R&D, manufacturing, or supply chain. However, if marketing strategies are not in sync with contemporary market dynamics and customer behavioral trends, despite game changing improvements in those areas, achieving business growth objectives will be challenging.

Based on the study, the researchers concluded, “an effective marketing in the organization has significant impact in achieving Organizational goals and Operational Excellence in Pharmaceuticals.” The study further emphasized, ‘Operational Excellence and marketing are always interlinked. Therefore, marketing plays a vital role in achieving Operational Excellence in Pharmaceuticals or any other industry.”

Conclusion:

As we know, market dynamics keep changing with time. Generally, some strong trigger factors, such as, Covid related disruptions of lives and livelihoods, may hasten the process of this crucial change. Such changes necessitate long-term transformation of pharma operational strategies, as initiated, for example, by GSK and Sanofi.

As McKinsey & Company articles have articulated, the transformation process and scale may differ from company to company with common long-term challenges remaining the same. Such operating model transformations – involving digital tools, data science with analytics capabilities across the company, often ‘help companies interact with healthcare professionals and other stakeholders more effectively’.

Consequently, the company garners greater capabilities to deliver new patient-perceived value – not just for incremental, but quantum business growth. This, I reckon, could be a game changer for long-term success and sustainability in the pharma business.

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.

 

This New Engagement Model Garners Significant Rewards For Pharma

Last year, on July 26, 2021, I wrote in this blog on gaining a competitive edge with Omnichannel pharma marketing Omnichannel pharma marketing. However, from several recent studies, it appears, it’s still remains in a nascent stage. Most players in the industry haven’t been able to get there, just yet.

This is evident from a paper, published in the Reuters Events on November 08, 2022. It underscored, ‘But few, perhaps none, can say they have yet mastered omnichannel. A 360-degree view of the customer remains a work in progress. The seamless customer experience that physicians have come to expect in their private lives as customers in retail, finance, or hospitality, remains an aspiration.’

That said, the good news is – today – with rapidly declining Covid-19 onslaught, many drug companies have realized that their earlier assumption of ‘we know what our customers want,’ is invalid in the emerging perspective. Thus, it is foolhardy for their marketing strategy planners to believe that have a 360-degree view of their customers. This realization has prompted several companies to find out, based on the data, what the key customers’ needs are and engage with them accordingly.

In this article, I shall, therefore, reemphasize for the consideration of the young marketers that Omnichannel customer engagement, including patients and doctors, would help fetch significant and sustained financial rewards for drug companies.

However, another visualization of 6 years ago seems to have come true:

About 6 years ago, on December 26, 2016, I visualized in this blog: ‘a majority of the doctors’ choices in India would, possibly, involve MRs, while a good number of other important doctors’ choices may probably be independent of them. Nevertheless, from this emerging trend, it’s clear now that multi-channel engagement would be a new normal in pharma sales and marketing, sooner than later.’

This visualization seems to have come true by a great extent, as vindicated by the above study of the Reuters Events. It confirms, currently, most companies are stuck in multi-channel content delivery and, in fact, are still a long way of enjoying the benefits of truly aligned – Omnichannel engagement. This brings us to the question: ‘What’s the difference between Multi-Channel and Omnichannel content delivery strategy for customer engagement?’

Difference between Multi-Channel and Omnichannel content delivery strategy:

The article published in the Pharmaceutical Executive, on June 30, 2021, indicated: ‘An integrated strategy based on Omnichannel marketing is now increasingly replacing multichannel marketing.’

Nonetheless, in my article of July 26, 2021, I highlighted, although both omnichannel and multichannel engagement will be able to deliver targeted contents to patients through several interactive digital platforms, these two aren’t the same. Omnichannel approach connects these channels, including smartphone-based Apps, specially formatted websites, social media, community, and the likes – bridging technology-communication gaps that may exist in multichannel solutions.

Notably, any change from the fragmented and siloed multichannel approach to Omnichannel marketing would entail simultaneous orchestration of channels across personal, non-personal, and media. Besides orchestration of channels, the message of course, needs to be unified, interrelated – without being repetitive. From this perspective: ‘Bringing the channels and stakeholders together in a truly integrated manner is the pivotal shift required to break through today’s noisy and crowded pharmaceutical marketplace,’ as the above Pharmaceutical Executive article concluded.

More and more people are charting the digital space:

Fast increasing penetration into the cyberspace by a large section of the population, especially in the healthcare space – triggered by Covid related lockdowns, is now all pervasive. An increasing number of people now want to know more and more about various disease states, their treatment and prevention options, in the digital space. Patients and healthcare providers’ key requirements include, where to get the right information from, and how.

Information-needs expanding beyond disease or drug efficacy and safety:

A discussion, arranged by the Fingerpaint Group and published in the Fierce Pharma on November 14, 2022, covered some interesting points in this area. It acknowledged that in the digital space: “You’ve got the efficacy, the safety information, all that.” The discussion then pointed out: “But for a consumer, it’s a different type of journey. It’s, how do I learn more about the disease I’m dealing with? What is it I want to know, not only either for me, or if I’m a caregiver for somebody in my family, even, how do I help support them?”

Thus, it comes out clearly that patients’ or care givers’ quest for information isn’t just about the disease, it’s also about the quality of information that will help the person, as a whole. The drug companies, I reckon, should now accept it as one of their responsibilities. As one of the participants in this discussion said, ‘finding ways to reach everybody in the whole continuum so that they’re educated and informed, so that they can make better decisions for themselves,’ are imperatives for the marketers.

Personal detailing or other personal engagements don’t become irrelevant: 

Omnichannel approach doesn’t make traditional in-person detailing or other personal engagements irrelevant or obsolete. However, those alone, will no longer help a pharma player to achieve performance excellence. The new challenge is how does a company get to the right audience, get the right product to the right patient, or caregivers, amongst this vast ocean of digital noise.

Moreover, the ongoing digital push – beyond several essential personal outreach, will only accelerate in different ways. Omnichannel customer engagement, based on their own terms of engagement, including time, speed, and quality of information, will be the name of the new the game for success.

Many pharma companies aren’t sure where to start, But…

McKinsey & Company in a paper, published on January 05, 2022, also said so. It observed: ‘An analytics-enabled omnichannel commercial model can elevate HCP engagement, but many pharma companies are not sure where to start.’ However, it reiterated: ‘An analytics-enabled omnichannel commercial model can create value; Companies should start now.’

Thus, many pharma marketers may require hand-holding by domain experts, at least, to begin with. However, selection of experts being the key, should go through a structured validation process, including their previous success record in this initiative. As I articulated above, the challenge remains, how does a company use Omnichannel platform to engage the right customers with the right products and associated details, navigating through the noisy cyberspace.

That said, it won’t be unfair to acknowledge that many pharma companies are moving in the right direction.

But many pharma companies are moving in the right direction:

As I mentioned in my article of May 31, 2021: COVID-19 is driving lasting changes in what HCPs need and value,’ found the Accenture Healthcare Provider Survey May 2020, named – ‘Reinventing Relevance.’ Several physicians from the US, Europe and Asia were found to have experienced a significant change taking place in many pharma companies’ communication with them – going much beyond just product information.

Accenture’s follow-up study in August 2020 also reiterated, ‘pharma companies have improved how they engage with healthcare providers during Covid-19.’ It, therefore, appears that the new value expectations of many physicians are being met with a newer value delivery model, significantly deviating from pre-Covid practices.

However, in the above article, I discussed about value delivery through content – not about the channels used.

Conclusion:

The paper by McKinsey & Company, as mentioned above, also indicates another important point. While channels to engage HCPs and other customers are proliferating, the line between online and offline engagement is rapidly blurring. It further adds, managing this imperative has become more and more overwhelming for sales reps. The reason being, they “have traditionally relied on their ‘instincts’ to build relationships with HCPs.

It is now becoming challenging even for many experienced reps to tailor and optimize today’s complex mix of channels, content, and frequency of interactions for individual HCPs, the paper underscores. Which is why, today, transforming the existing commercial model is considered both inevitable and urgent, and:

“Pioneers that have adopted analytics and omnichannel approaches as part of their commercial model have garnered significant rewards.” the paper concluded.

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.

 

Leveraging Data Science To Deliver Unique Patient-experience

“Changes in consumer behavior, many of which were accelerated by the COVID-19 pandemic, are fueling a redesign of the health ecosystem.” This finding was revealed by a recent study of the PwC’s Health Research Institute (HRI). The research provided insights about how and why specific groups of consumers used health services during the pandemic – from mental health and telehealth to in-home care and other non-traditional care sites.

The study also captured ‘their willingness to use them again in the future,’ and suggested, those pharma companies that closely monitor these consumer signals and design, accordingly, will likely emerge as more customer centric, as the pandemic wanes.

From this perspective, effective application of data science for creating a unique patient experience by listening to patient voice, is now an imperative for pharma players. Which is why, this approach is nowa key business success ingredient in the changing paradigm. It helps offering a holistic disease treatment solution to patients searching for an effective and affordable disease treatment process.

This article will, therefore, focus on leveraging data science for strategic use of Real-World Evidence (RWE) based on Real World Data (RWD) – on how customer characteristics and behavior impact health outcomes. This initiative is fast becoming a key driver to excel in contemporary pharma business.

Strategic use of RWD/RWE increasing in pharma marketing plans:

RWE, as the name suggests, is the evidence derived from RWD. These are collected outside of clinical trials from various sources, such as, patients and HCP surveys on treatment outcomes, electronic health records wherever available, Wearable Health Devices (WHD), insurance claims, data from connected healthcare records, custom study and many others.

The McKinsey & Company article in this area, published on July 23, 2020, also indicated so. Although, some leading pharma companies have already been using RWE. However, recent progress in digital and advanced analytics allows it to be employed in new ways to deliver impact at scale, the article highlighted. When used by hands-on- professionals of repute in this area, RWE can help pharma marketers understand how patient characteristics and behaviors affect health outcomes.

The research paper on how Biopharmaceutical companies are embedding real-world data and evidence use across the enterprise, published in Deloitte Insights on September 21, 2022, presented an interesting contemporary example. It wrote: ‘During the COVID-19 pandemic, RWD/E played a key role in enabling Biopharma companies to innovate and bring novel vaccines and therapies against this highly contagious disease to market in record time.’id-19,

The approach gained momentum during the Covid-19 pandemic:

The above research study of Deloitte brought out this fact succinctly. It found; unprecedented challenge posed by COVID-19 pandemic prompted several drug companies to leverage RWD/E to innovate faster than ever before. More than half of the companies surveyed by Deloitte used RWD/E to understand the incidence and severity of COVID-19 and its variants for vaccine and drug development.’

The survey found: ‘Many vaccine developers, such as Johnson & Johnson analyzed RWD to predict COVID-19 hotspots across geographies to optimize site selection and collect data from diverse racial and ethnic groups.’ Besides, RWE also played a critical role for these companies in understanding vaccine effectiveness across demographics such as age, gender, race, and ethnicity and determining the need for boosters.

Improves patient experience for business excellence:

A systematic and ongoing tracking and analysis of well-identified RWD, by pharma marketing analytics professionals, can help in-depth understanding of changing pharma customer characteristics and behavior, more precisely. Such initiatives include patients, HCPs, hospitals and even the policy makers. Several drug majors have adopted this practice, immediately after absorbing the initial shock of unprecedented disruptions during the Covid-19 pandemic.

Similarly, RWD can help map the exact available space for demand where a brand is being used and potential competitive value-space for its further demand extension – based on real time customer behavior with changing characteristics. To shape customer journeys, such findings may immensely help while strategizing for more targeted content delivery, with sharper segmentation and brand positioning.

Therefore, finding such gaps in various areas of patients’ journey – in their search for an effective and affordable treatment, and appropriately filling these up with brand value delivery is critical. This will help improve patient experience manifold, accelerating business excellence, in tandem.

A recent paper titled, ‘Maximizing your role as a newly appointed real-world evidence leader,’ published by the ZS on March 23, 2022, made similar observations, as above. The study reiterated that patient-generated insights obtained through RWE, are uniquely capable of adding value at different stages of a pharma brand’s life cycle. Or, throughout a patient’s journey on the care pathway of the value delivery system. It concluded: “Carrying out a successful RWE study is a fine balancing act – but its inconveniences and risks are almost certain to be outweighed by the eventual benefits.”

Increasingly used to gain actionable insights to improve patient experience:

In the contemporary market dynamics – driven by changing customer characteristics and behavior, several pharma companies are now effectively combining and analyzing RWD to retrieve RWE. The objective is to gain actionable insights for effective customer engagement for better patient outcomes, to drive business growth. According to a recent podcast by PwC on using data to shape customer journey, the process includes the following:

  • Focusing on the value and outcomes of treatment protocols and less about specific products.
  • Gaining a better understanding of pharma customers and what drives their behavior.
  • Reaching beyond the barrier in driving differentiation amongst competitors.

Conclusion:   

The Forbes article on the Data Science trend in 2022, published on October 04, 2021, aptly epitomized its relevance in today’s business, including pharma industry. It articulated, data science encompasses the practical application of ideas generated by credible and meaningful data from various relevant sources, predictive analytics, and artificial intelligence. Our ability to use such data to our advantage across wide areas in business, would help deliver increasingly worthwhile, valuable, and enjoyable patient experience. 

The article also underscored: ‘If data is the oil of the information age and Machine Learning (ML) is the engine, then data science is the digital domain’s equivalent of the laws of physics that cause combustion to occur and pistons to move.’

Thus, I reckon, both intrinsic and extrinsic brand value creation process, driven by its effectiveness, would increasingly call for Real World Evidence (RWE) based on top-quality Real-World Data (RWD). This is increasingly becoming so critical for success – spanning right across, from product development, launch planning with value propositions – to launch and beyond.

The core purpose of leveraging data science in pharma is, as I see it, is effective decision making throughout the brand life cycle, to deliver a unique patient experience in patients’ journey – with better treatment outcomes.

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.

Big Pharma Fails Avoiding Drug Price ‘Control’? Even In The US? Why?

It ultimately happened – even in the United States, as the US President signed a bill on August 16, 2022 that aims to reduce healthcare costs, alongside fighting climate change, besides raising taxes on the rich. This new law was enacted, despite powerful lobbying and the vehement opposition of big pharma associations and that too in their home turf.

According to the Fierce Pharma report of the same day, since the current US President moved into the White House in 2020, the drug industry left no stone unturned battling to preserve pricing status-quo. It further added, the ‘pharmaceutical industry, including, PhRMA, its allies, and the nation’s largest pharmaceutical firms’ have spent more than $205 million in multi-media ads opposing ‘Medicare price negotiations’ and lobbying against efforts to lower drug prices for consumers.’

No wonder, when the bill was just introduced to the US lawmakers, big pharma’s disappointment on the bill was palpable. This gets well-captured in what the AbbVie CEO pointed out at that time. He said, ‘the legislation would force manufacturers to accept the government’s proposed price or face a harsh tax on their revenues from a given product.’ He also said: “So, it’s not a negotiation,” as stated in the bill. He further opined in his conference call: “We should just call it what it is. It’s price controls,’ which is what the lawmakers are ‘basically putting in place, if the language stays the same,’ the AbbVie chief added.

Capturing this new development in the United States, at least, in the recent past - Fierce Pharma in its August 08, 2022, issue commented: “The seemingly unstoppable pharma lobbying force has lost its charm. With the passage of a new bill, the U.S. Senate is opening the door to major drug pricing reform, leaving the drug industry licking its wounds.”

In the Eldorado of the global drug industry, this is indeed an unprecedented initiative to significantly reduce costs of many important drugs and reduce patients’ out of pocket expenses. Consequently, it has created so much of hullabaloo, across the world, for various reasons. In this article, I shall track this emerging scenario along with the message that it sends across the globe, and its possible impact on new drug innovation to meet unmet needs of patients. In India, one such area could be revisiting the price negotiation proposal for patented drugs, a government initiative that failed to take off earlier.

Would lowering prices stifle new drug innovation?

The apprehension, I reckon, that big pharma will continue to play with - price control will stifle new product innovation – adversely impacting patient interest. Notably, to many industry experts, this argument doesn’t just lack robustness, seems more a conjecture rather than the outcome of any peer- reviewed research study findings. On ewthe contrary, several highly credible and independent studies prove otherwise. Thus, let me put hereunder:

  • One – what big pharma directly and through their powerful industry associations or some financially sponsored studies are saying
  • And – what the top experts concluded from their independent analysis in this regard, as published in the globally acclaimed journals.

I leave it to my readers to evaluate the credibility of each to form their views.

Drug industry arguments supported by recent studies:

The findings of a study conducted recently, with the financial support of the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization (BIO), Amgen, Pfizer, Alexion, AbbVie, Genentech, and Bristol Myers Squibb, were released by PhRMA on November 23, 2021. The study was conducted by Vital Transformation. The key findings of this study highlighted: ‘Every 10% drop in the price of medicines in price-controlled EU markets was associated with a:

  • 14% decrease in total VC funding (10% early stage and 17% late stage)
  • 7% decrease in biotech patents
  • 9% decrease in biotech start-up funding relative to the US
  • An 8% increase in the delay of access to medicines.

It concluded: ‘Drug pricing controls implemented in the US would likely have an even greater impact on Biopharma KPIs given its global leadership in investment and innovation.’

Independent expert studies, published in highly reputed journals:

Around the same time as the above report, an independent study published in the Harvard Business Review (HBR) on October 01, 2021, found exactly the opposite. It categorically stated: ‘The U.S. can lower drug prices without sacrificing innovation.’

The paper summed up: ‘With Congress considering legislation to allow Medicare to use its bargaining power to negotiate lower drug prices, large pharmaceutical companies are once again waging a campaign that contends that doing so would seriously harm the development of breakthrough drugs. This is not true. Smaller companies now account for the lion’s share of such breakthroughs. The key to supporting drug innovation is to increase NIH funding of the efforts that give rise to these new companies, cut the costs, and accelerate the speed of clinical trials, and reform patent law.’

Drug pricing in the Indian context:

Prices of, especially, new drugs and the overall cost of healthcare are two major concerns – more in the developing countries like India. Responding to this need drug price control for pre-defined essential medicines are already in place in the country. More recent studies further vindicate the relevance of such regulation from the perspective of affordability of drugs for the poorer section of the society, and where out of pocket expenses are very high.

Let me quote one such paper, published on June 04, 2022, which received no outside financial support from this study, where the researchers concluded: ‘With induced demand and an inadequate competitive environment, the pharmaceutical industry fails to reduce prices. Supply-chain trade margins are very high. Hence, government intervention through price control of essential and life-saving drugs is a necessity in India.’

In this context, another question that is being raised – are there other alternatives to expand access to high-priced life-saving drugs at an affordable cost to all those who need those most? The most common alternative that floats, encourage more competition for those drugs as soon as they go off patent. Let me examine what’s big pharma players are doing in that area.

Does Big Pharma encourage increasing competition to reduce drug prices?

Another way to reduce the price of an expensive product is encouraging competition to enable market forces bring down the price. An interesting article on breaking the rule of drug pricing by pharma companies was published in the Forbes magazine on June 29, 2022. I also wrote on June 10, 2013: ‘To scale-up access to health care, especially for the marginalized population of any country, greater access to affordable generic drugs will always remain fundamental, besides improving healthcare infrastructure and its delivery mechanism.’

Thus, there should be a robust mechanism, across the world, to facilitate quick entry of cheaper generic equivalents immediately after patent expiry of the original molecule. Increasing attempts of blocking entry of generics surreptitiously by vested interests, leaves no other alternative, but price control. This is imperative, ‘as without the availability of newer generics, unmet medical needs of the most vulnerable section of the society cannot be met effectively by any country, as I wrote there.

Attempts to game the system to minimize competition continue unabated:

Even after my article, this red flag is being raised for quite some time. It will be evident from another Harvard Business Review article titled, ‘How Pharma Companies Game the System to Keep Drugs Expensive,’ published in the on April 06, 2017. Acknowledging: ‘Drug development is risky and expensive, thanks to the long testing and approval process,’ the author concluded from their study – ‘But, increasingly, makers of branded drugs are using a variety of tactics to extend their exclusive rights,’ enabling them to maintain high drug prices for much longer time.

More recently, the above Forbes article of June 10, 2022 also highlighted, ‘even the most generous patent protections come to an end and companies must face the potential for generic competition. That’s when major drug manufacturers shift tactics from influencing policy to crushing the competition.’ There are several legal and semi-legal approaches that big pharma players adapt to game the system and maintain pricing monopoly. Let’s recap it with just three of these examples:

- ‘Patent Thicket: Delaying entry of lower price off-patent molecule through a Patent Thicket. This involves creation of ‘a dense web of overlapping intellectual property rights that a generic pharma company must hack its way through in order to actually commercialize new technology of a drug molecule,’ even after the original patent expires. For example, AbbVie’s Humira, the world’s best-selling drug for a long time. I also discussed this issue in my blog over three years ago – on April 22, 2019.

- ‘Pay-for-delay deals’:  I discussed this issue in this blog on June 19, 2013. Moreover, the above Forbes article of June 29, 2022, also underscored this tactic. It explained that this is a deal in which drug companies agree not to compete for a set amount of time to maintain high prices of their brand-name drugs. The article, published in Bloomberg Law on February 20, 2020, captures it nicely.

- Authorized generics: As many would know, law permits six months of exclusivity to the first generic version of an off-patent new molecule coming into the market. Interestingly, just before patent expiry of an innovative drug, several drug makers roll out their own generics to stifle competition. Although, they keep different names for the generic versions, but pricing remains almost similar. Such a practice obliviously delays the entry of cheaper generics, at least by six months.

In this scenario, the new drug prices continue racing north. Something was to be surely done – for patients’ sake, as many believe, at least, where it all started – the US.

New drug prices are highest in 2022:

As reported by Reuters on August 16, 2022:

  • Eight of 13 drugs launched in 2022 priced over $200,000 per year
  • Median annual price for new U.S. drugs this year is $257,000
  • Some drugmakers disclose less information on pricing

Despite this, as reported on August 15, 2022: ‘The main U.S. drug lobby has said it will push back against the legislation, which includes policies that drug makers have opposed for decades.’

Conclusion:

The significance of the above development in the US healthcare scenario, was aptly summed-up by the US House Speaker, as she said: “If you are sitting at your kitchen table and wonder how you’re going to pay the bills – your health care bills, your prescription drug bills – this bill is for you.” For the first time in the US – the champion of champions of free-drug pricing market, will negotiate the drug price with their manufacturers to become patient -centric.

The reverberations of this difficult decision, especially on new drug prices, are expected to prompt the need for price negotiation or price control, primarily for expanding access to new drugs for a larger number of patients. This deserves to be a focus area for the Government, including India. Moreover, the August 18, 2022, media report also suggests that the top court of India may now encourage the Government to investigate, report and take remedial action on drug industry malpractices.

Finally, it’s worth noting that over a decade ago, international media widely reported -  ‘India considering price controls for patented drugs.’ Its objective was to address the aggressive new drug pricing trend in the country. Accordingly, the price negotiation proposal for patented drugs was notified by the Department of Pharmaceuticals (DoP) in 2007. The constituted Committee submitted a report, as well, on February 21, 2013. But it did not take off as on date. Many apprehend, this is due to intensive and ongoing lobbying by big pharma, just as what happened in the US. Nevertheless, the question that surfaces – will the above new drug law in the largest pharma market in the world encourage the DoP to revisit price negotiation for patented drugs - to make modern drugs affordable to a larger patient population in India – now?

By: Tapan J. Ray

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