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Meeting India’s Unmet Biologic Drug Needs Some Global Synergy Evident – But Patients Need More

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Many reports have vindicated the rapidly growing importance of biologic drugs in the treatment of a wide range of complex ailments. These include autoimmune diseases, cancers, hormonal irregularities, anemia, and to prevent various diseases such as vaccines, have drawn healthcare experts’ attention globally.

As defined by experts, Biologics are larger, more complex molecules compared to traditional small molecule pharmaceutical drugs. Unlike traditional pharmaceuticals, they require some components from a living organism to be manufactured.

The critical importance of biologic drugs lies in their ability to provide innovative treatment options, address unmet medical needs, and significantly impact patient outcomes in various disease areas. Towards this endeavor, a clear pathway for focused initiatives is warranted, especially in countries like India.

This article will explore this domain to get a sense of how much and how fast the country is progressing in this space, having huge healthcare significance, for all. Let me start with a quick recap on the areas of seminal importance of biologic drugs – to help all to be on the same page – as I start this deliberation.

The critical importance of biologic drugs:

The critical importance of biologic drugs, I reckon, lies in their unique properties and therapeutic potential:

Targeted Therapies: Designed to interact with specific molecules or receptors in the body, allowing for targeted treatment. This specificity can enhance the efficacy of the drug while reducing potential side effects on healthy cells and tissues.

Novel Treatment Options: Offer novel treatment options for diseases that were previously difficult to manage or had limited treatment options. They have revolutionized the management of conditions such as rheumatoid arthritis, psoriasis, multiple sclerosis, and certain types of cancer.

Personalized Medicine: Paving the way for personalized medicine, as it can be tailored to individual patients based on factors like genetic profiles or specific disease characteristics. This approach allows for more precise and effective treatment strategies.

Disease Modification: Unlike some traditional drugs that primarily alleviate symptoms, biologics can often modify the underlying disease process. They can target specific pathways or molecules involved in disease progression, potentially leading to long-term benefits and improved outcomes.

Improved Quality of Life: Has the potential to significantly improve the quality of life for patients living with chronic or debilitating conditions. By effectively managing symptoms and slowing disease progression, they can reduce pain, disability, and the need for other interventions.

It is important to note that biologic drugs are complex to manufacture, often require specialized infrastructure, and can be costly. No wonder why the India specific research paper - published on January 18, 2023 commented: “Although various biologic drugs are already available, they are still not within reach of the common person due to financial constraints.”  This prompts me to explore with examples some of the key issues that Indian patients confront while meeting this health need.

Patient access to original biologic drugs in India faces several key barriers:

Patient access to original biologic drugs in India faces several key barriers, including: 

1. Cost and Affordability:

- Trastuzumab (Herceptin): The cost of a single course of Herceptin, used in the treatment of breast cancer, can range from several lakhs to crores of rupees, making it financially burdensome for many patients in India.

- Eculizumab (Soliris): Eculizumab, used in the treatment of rare blood disorders, can cost several lakhs of rupees per month, making it unaffordable for most patients.

2. Limited Healthcare Coverage:

- Many health insurance policies in India have limitations or restrictions on coverage for expensive biologic drugs, requiring patients to bear a significant portion of the cost out of pocket.

- Some government-funded healthcare schemes, such as the Pradhan Mantri Jan Arogya Yojana (PMJAY), may have restrictions on coverage for expensive biologic therapies, limiting patient access.

3. Regulatory Barriers:

- The approval process for biosimilar versions of original biologic drugs could face delays in India. For example, the biosimilar version of Trastuzumab (Herceptin) faced delays in obtaining regulatory clearance, resulting in delayed patient access to more affordable alternatives.

- The regulatory requirements for original biologic drugs can be complex and time-consuming, leading to delays in drug approvals and subsequent patient access.

4. Limited Local Manufacturing:

- Drugs like Bevacizumab (Avastin) and Adalimumab (Humira) used in India are often imported, leading to supply chain challenges and potential delays in availability.

- Limited local manufacturing of certain original biologic drugs can result in dependence on imported versions, leading to potential pricing issues and supply disruptions.

5. Physician Awareness and Education:

- Some physicians may have limited awareness or familiarity with prescribing guidelines and clinical benefits of certain original biologic drugs. This can result in underutilization or hesitation in prescribing these therapies.

- Lack of specific training and education programs for physicians regarding the latest advancements in original biologic drugs can impact their knowledge and confidence in prescribing them.

6. Patient Education and Understanding:

- Patients may have limited knowledge about the availability and benefits of original biologic drugs. For instance, patients with chronic diseases like rheumatoid arthritis may not be aware of the benefits of newer biologic treatments over traditional therapies.

- Lack of patient education about the appropriate use and potential side effects of original biologic drugs can lead to hesitancy or misconceptions among patients, affecting their willingness to pursue these therapies.

These specific examples illustrate how cost, limited healthcare coverage, regulatory barriers, limited local manufacturing, physician awareness, and patient education can act as barriers to patient access to original biologic drugs in India.

Healthcare impact of inadequate access and availability of biologic drugs in India:

The inadequate access and availability of biologic drugs in India can have several significant healthcare impacts: 

Suboptimal Disease Management: Biologic drugs often provide highly effective and targeted treatments for complex diseases such as cancer, autoimmune disorders, and rare genetic conditions. The lack of access to these therapies can result in suboptimal disease management, leading to poorer patient outcomes, increased disease progression, and reduced quality of life for affected individuals.

Delayed or Incomplete Treatment: Inadequate access to biologic drugs can result in delays or interruptions in treatment. For chronic or progressive diseases, timely initiation and consistent use of these therapies are critical. Delayed or incomplete treatment can compromise the effectiveness of interventions, leading to prolonged disease activity, exacerbation of symptoms, and potential irreversible damage in some cases.

Increased Healthcare Burden: Without access to appropriate biologic therapies, patients may require more frequent hospitalizations, emergency room visits, or other healthcare interventions to manage their conditions. This can place an additional burden on healthcare systems, leading to increased healthcare costs and strain on resources.

Reduced Treatment Options: Biologic drugs often represent the most advanced and effective treatments available for certain diseases. Inadequate access to these therapies limits treatment options for patients, forcing them to rely on less effective or outdated treatments. This restricts the ability of healthcare providers to offer the best available care to patients, potentially leading to compromised treatment outcomes.

Health Inequity: Inadequate access to biologic drugs can exacerbate health inequities in India. Patients from lower socioeconomic backgrounds or those without sufficient insurance coverage may face greater barriers to accessing these expensive therapies. This can result in disparities in healthcare outcomes, with some individuals being unable to afford or access the best available treatments for their conditions.

Impact on Research and Innovation: Inadequate access to biologic drugs can hinder clinical research and innovation in India. Limited availability may reduce opportunities for conducting clinical trials and studying the effectiveness of these therapies in the local population. This, in turn, can hamper the development of new treatments and advancements in healthcare.

Addressing the inadequate access and availability of biologic drugs is crucial to ensure equitable healthcare outcomes, optimize disease management, and reduce the burden of complex diseases in India.  

Increasing need for biosimilar drugs in India and issues involved:

From the above perspective, increasing the availability of biosimilar drugs in India is crucial. Fostering competition may improve affordability. Thereby, it would increase access to essential therapies – bridging treatment gaps, disease management, healthcare system sustainability and foster market competition and innovation.

However, it can ensure that patients receive appropriate and effective treatments while addressing the healthcare challenges faced by a diverse population, only when some key barriers created for biosimilar drug entry, besides patent thickets, are also adequately addressed. One such way is creating a global synergy in this space by collaborating with MNC pharma – having deep pockets and other requisite wherewithal.

Some global synergy is evident in this critical healthcare space:

The good news in this space has started flowing. There have been several collaborations between multinational pharmaceutical companies (MNCs) and domestic Indian drug companies to develop even high potential interchangeable biosimilar drugs in India. Here are a few examples:

- Biocon and Mylan: Biocon has collaborated with Mylan, a global pharmaceutical company, to develop and market biosimilar products. This collaboration has resulted in the development and approval of biosimilar drugs such as Trastuzumab (Herceptin) and Adalimumab (Humira) in India. 

- Dr. Reddy’s Laboratories and Merck: Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, entered into a collaboration with Merck & Co., a global pharmaceutical company, to develop biosimilar versions of biologic drugs. This collaboration has resulted in the development and launch of biosimilars such as Pegfilgrastim (Neulasta) and Rituximab (Rituxan) in India.

- Cadila Healthcare and Novartis: Cadila Healthcare, an Indian pharmaceutical company, collaborated with Novartis, a multinational pharmaceutical company, to develop and manufacture biosimilars. This collaboration has resulted in the development of biosimilar drugs such as Rituximab (Ritucad) and Bevacizumab (Bevatas) in India.

These are just a few examples of collaborations between MNCs and Indian drug companies in the field of interchangeable biologic drugs. The landscape of collaborations and partnerships in this area is dynamic, and there may be more ongoing collaborations between companies to develop and commercialize biosimilars in India.

Conclusion:

Overall, patient access to biosimilar drugs in India is crucial for ensuring affordable and comprehensive healthcare, improving patient outcomes, and promoting a competitive pharmaceutical market. It helps address the challenges of access and affordability of biologic drugs, ultimately benefiting the well-being of patients across the country – promoting healthcare equity, and the sustainability of the healthcare system in the country. But patients need more…much more.

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.

Fostering EQ For Pharma’s Excellence In The New Normal

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On February 25, 2021, one of the top Indian business daily flashed a headline – “It will be working from home, post-pandemic too at many top companies.” It wrote, companies like, Tata Steel, Philips, Infosys and Maruti Suzuki are evaluating job roles to permanently enable employees working from home, or remotely – even after the pandemic. This is just one example, out of many unique outcomes of last year’s disruptive business turbulence, causing a potential mental or emotional impact on many employees.

Virtually across industries, many such significant changes have taken place in several facets of businesses including traditional operational processes. As has been widely witnessed, many desk-bound office jobs – temporarily, partly or fully – shifted to remote working – almost overnight, as it were. Such a shift is being contemplated in several work-areas by a number of drug companies, as well.

For understandable reasons, another concurrent and instant demand surfaced for a critical hard skill – involving applications digital tools and platforms. This was mostly to ensure that key business communications and customer engagements, at least, keep ticking during the crisis, despite unprecedented initial headwinds.

However, sans a catalytic soft skill that helps address several current-environment specific several organizational needs, even applications of digital skills are unlikely to be able to leverage the full potential of digitalization. While navigating through today’s uncharted frontiers, where there are no footsteps to follow, the organization will need flexibility and resilience among leadership, ensuring employee adaptability to change, and creating a new climate of fostering creativity with digital technology.

Interestingly, this soft skill – ‘Emotional Intelligence’ – often referred as ‘Emotional Quotient’ or EQ, wasn’t discussed, as much, for various reasons. In this article, I shall deliberate, why this much-known soft skill is indispensable for business excellence in the new normal – from the pharma industry perspective.

EI/EQ in business isn’t a new idea, but more important now than ever before:

Peter Salovey and John D. Mayer coined the term ‘Emotional Intelligence (EI)’ in 1990 describing it as “a form of social intelligence that involves the ability to monitor one’s own and others’ feelings and emotions, to discriminate among them, and to use this information to guide one’s thinking and action”.

In 1995, Daniel Goleman in his book ‘Emotional Intelligence’ defined EI as the ability to:

  • Recognize, understand and manage our own emotions and,
  • Recognize, understand and influence the emotions of others.

In other words, ‘this means being aware that emotions can drive our behavior and impact people (positively and negatively) and learning how to manage those emotions – both our own and others.’The ability to manage emotions is measured through Emotional Quotient (EQ).

EQ – a cutting edge of excellence, especially in the new normal:

Much before the pandemic, in 2018, McKinsey & Company had projected that between 2016 and 2030, demand for people with high EQ would grow across all industries. Again, in May 2021, the Company reiterated: ‘To meet this challenge, companies should craft a talent strategy that develops employees’ critical digital and cognitive capabilities, their social and emotional skills, and their adaptability and resilience.’

However, with unprecedented changes in pharma business dynamics, the process has been further accelerated. EQ is now expected to be a cutting edge for performance excellence – in any organization. Hence, digital savviness may not be just enough in the new order for organizational turnaround aspirants. Sans people with high EQ, among both – the leadership and staff members, digital transformation alone may not be enough for commercial success.

Long ago, Daniel Goleman epitomized it in his article - ‘What Makes a Leader?’ This was published in the Harvard Business Review (HBR) in January 2004, where he wrote: ‘IQ and technical skills are important, but emotional intelligence is the sine qua non of leadership.’ This old advice assumes even greater importance, in the new normal. 

With emotions prevailing in workplaces, high EQ improves performance:

COVID pandemic has demonstrated to all, including highly tradition bound and slow to change – the pharma industry that the name of the game of survival, particularly when a crisis strikes as a bolt from blue, is quickly adapting to changes. A time came as ‘national lockdown’ started – when a sense of losing control and confusion, virtually engulfed the work environment, which is so necessary for livelihood. A key example of these changes include, a sudden shift from remote working, related to remaining engaged with customers.

Alongside, home life and work life got merged for many. New ways of remaining in touch with customers, sometimes gave rise to a sense of seclusion or alienation, causing mental or emotional stress. Many employees’ keen desire and expectation of the return of the old normal – in the same form, are causing more emotional complications with them.

A study by EQ training provider TalentSmart also found that emotional intelligence is responsible for 58% of one’s job performance. Thus, any pharma company’s ability to be in sync with all employees, at the emotional level, is one the key requirements to boost performance. It will determine the effectiveness of digital tools given to employees to deliver the deliverables. Further, as other studies established, ‘the ability to connect with people on an emotional level – is crucial to maintaining strong and resilient teams.’

Some telltale signs of low EQ in an organization:

Some common telltale signs of low EQ in an organization, were well captured in an article with Covid pandemic in the backdrop. This was published in Inside HR on September 01, 2020. The manifestations of low EQ include, when employees:

  • Don’t want to take responsibility for their own feelings, but blame others for those,
  • Let things build up and then blow up,
  • Often overreact to life’s minor events while struggling to remain in emotional control.
  • Lack empathy and compassion,
  • Tend not to consider others’ feelings before acting,
  • Lack self-awareness of their own emotions and the emotions of others around them.

Such signals, if not addressed promptly, can lead to a number of adverse business outcomes. Especially when, quick adaptation to fundamental changes in the business environment, business operations and key customer behavior, is the name of the game. People’s EQ in an organization, could often stand between business success and failure – in the new normal, more than ever before.

Conclusion:

As pharma industry has started navigating through the new normal with wide-scale application of digital technology, employees also need to keep pace with these changes, and come on board. In such a ‘never before’ situation, emotional needs of both internal and external customers are to be properly understood, and effectively addressed, just as the need for digitalization within the organization.

Notably, low or high EQ are not genetic, neither are these pre-implanted in the brain by God. EQ comes as one learns through ongoing experience in life, and also from the advices of elderly, interaction with peers, superiors and training by professionals. This is a lifelong process of learning, which is continuously honed through practice in real life situations. It’s not bizarre, at all, if EQ of an individual has changed before, during and after the pandemic. What really matters is fathoming, how is the employee EQ today, monitor it continuously, and help the individual as and when required – to help the organization.

Several studies have established high employee EQ as a stronger predictor of success, that helps strengthen hard skills like digitalization by helping to think more creatively while using the tech tools and platforms. Thus, amid unparalleled changes in business operations, customer behavior and the need for quick adaptation to digital technology, fostering employee EQ to encourage them committing to the corporate shared goal, is an imperative for pharma’s performance excellence - more than ever before.

By: Tapan J. Ray      

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

 

Spirit Behind Drug Patent Grant: Secondary Patents: Impact on Drug Access

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For more effective treatment against existing diseases, besides combating new or a more complicated form of existing ailments with precision, drug innovation is absolutely necessary and on an ongoing basis. This makes innovative drugs so important for the population, globally.

Besides academia, the pharma industry has remained in the forefront of the search for new drugs, for so long. What makes this process so crucial is, cheaper generic drugs flow from the innovative drugs, post market exclusivity period, which together form the bedrock of the pharma industry’s business model. Consequently, a robust patent protection for the new molecular entities, not only enable the drug innovators to make a reasonably good profit, but also encourage them to keep this virtuous circle moving, faster.

Although, the drug patents are granted for 20 years, after obtaining marketing approval from the respective drug regulators, a time period - ranging between 7 and 12 years, is available to the company to realize its maximum commercial benefits. Thereafter, the patent expires, paving the way of market entry of cheaper generic equivalents to make the drug accessible to a larger population. This is the playbook, which deserves to be accepted and respected by all, both in the letter and spirit.

Currently, the narrative has started changing, apparently, repudiating the spirit behind the grant of new drug patents, especially with the entry of a number of expensive, large molecule biopharmaceutical drugs. After obtaining a fixed-term market exclusivity, more intricate legal measures are being taken to extend the fixed-term market monopoly for an unknown period, delaying market entry of cheaper biosimilar equivalents, post patent expiry, as long as possible.

In this milieu, India appears to be the only country in the world, where the country’s ‘Patents Act’ provides enough safeguard to blunt those legal tools, effectively, to protect patients’ health interest. Quite expectedly, this new narrative of the drug innovators is yielding the best return in the Eldorado of the pharma world – the Unites States. It is also no secret that US vehemently opposes several provisions of the Indian Patents Act 2005, under pressure from the most powerful pharma lobby group, as many believe.

Using the spirit behind drug patent protection as the backdrop, I shall dwell in this article, how this so precious spirit is gradually losing its basic purpose, especially for blockbuster biopharma drugs. Is the key intent behind sacrificing the spirit behind drug patent grant to keep their brands money spinners and big – even after expiry of original patent – as long as possible – at the cost of patients’ health interest?

Despite the original patent expiry, biggest biologic drugs remain big:

The fact that original patent expiries have done little to halt sales of some of the industry’s biggest products – mostly biologic drugs, was clearly elucidated in an  Evaluate Pharma article – “Biopharma’s biggest sellers – the oldies that just keep giving,” published on August 14, 2019. This gets vindicated, as we look at the ‘top ten pharma brands with biggest lifetime sales – from launch to 2018’, in the following Table I:

Product Company Launch year USD Billion
1. Lipitor Pfizer 1997 164.43
2 Humira AbbVie 2003 136.55
3. Rituxan Genentech/Biogen 1997 111.50
4. Enbrel Amgen 1998 108.16
5. Epogen Amgen 1988 107.90
6. Advair GSK 1998 104.20
7. Remicade Janssen 1998   98.00
8. Zantac GSK 1981   97.42
9. Plavix Sanofi/BMS 1998   90.63
10. Herceptin Genentech/Roche 1998   87.97

(Adapted from Evaluate Pharma data of August 14, 2019)

The point to take note of:

The point worth noting here, with the exception of Advair, Zantac, Lipitor and Plavix, all others – among the top ten brands, are biologic drugs. Moreover, what is most striking in the Table I, despite the expiry of the original patents, a large number of biologic brands were able to expand their sales, pretty impressively, for well over two decades. As we shall see later, this situation is expected to continue, at least, till 2024.  As the Evaluate Pharma article states, for various reasons, these multibillion dollar brands have been able to avoid the expected post patent expiry ‘onslaught from biosimilars in the key US market’, which is incidentally the most valuable pharma market in the world.

One of the key reasons that helps delaying cheaper biosimilar drug entry expanding patient access, is a crafty strategic measure adopted by these companies through the creation of a Patent Thicket with secondary patents. As I discussed in this Blog on April 22, 2019, this is a crafty way of ‘evergreening’ patent term beyond 20 years, legally. Whether such measures conform to the spirit of granting 20 years product patent, becomes a moral question, or an issue of probity for the concerned companies, at the most. Be that as it may, a concern over this situation has been raised in many countries, including the United States.

Barrier of secondary patents: 

Biosimilar drug developers continue facing multiple non-financial challenges, such as, scientific, regulatory, pricing. I have already discussed some of these barriers in this blog on July 31, 2017. Instead, I shall focus in this article, with greater detail, on the intricate and a well-woven net of secondary patents. However,before delving into this area, it will be worthwhile to have a quick recap on the basic differences between original patents and secondary patents.

According to WIPO, “Patents on active ingredients are referred to as primary patents. In later phases of the drug development, patents are filed on other aspects of active ingredients such as different dosage forms, formulations, production methods etc. These types of patents are referred to as secondary patents.”

Another excellent paper, authored by two distinguished researchers from Columbia University and LSE, makes some important points on this subject. It says, secondary patents have become increasingly important to the pharma industry, especially in the U.S. and Europe over the past three decades. The basic purpose of ‘taking out multiple patents on different aspects of a drug in order to cordon off competitors is now standard practice in the pharmaceutical industry.’ As the authors further said, this is primarily because: ‘Secondary patents can protect market shares by extending periods of exclusivity beyond the dates in which patent protection would otherwise lapse.’

Interestingly. devising patent strategies to extend periods of market exclusivity is generally considered in the industry, as a key component of ‘product life cycle management,’ – not by the marketing whiz kids, but by astute patent attorneys. Nevertheless, as the paper articulates, critics of this practice often use the more pejorative – evergreening, to describe it.

Examples of impact of secondary patents:

Many research papers suggest, besides scientific complexity in biosimilar drug development being a key reason for their delayed market entry, secondary patents are even tougher barriers for the same. This was brought to light a few years ago in a ‘Review Article’ – ‘The Economics of Biosimilars’, published in the September/October 2013 issue of American Health & Drug Benefits.

Some of the key points made on this issue include,AbbVie plan to defend Humira (adalimumab) with more than 200 secondary patents, Merck’s giving up its biosimilar project on Enbrel when Amgen got its expanded patent life. There are many other such instances.

Its effect would last longer: 

Experts believe, the effect of creating a strong secondary patent shield around blockbuster biologic would last much longer. As the above Evaluate Pharma article underscores: ‘This ability to fend off biosimilar competition is one of the reasons Humira is set to snatch Lipitor’s crown next year as the industry’s most successful drug.’

The Table II below that lists ‘top 10 pharma brands from their respective launch date, including estimated forecast till 2024’, vindicates its long-lasting impact:

Product Company Launch year USD Billion
1. Humira AbbVie 2003 240.05
2 Lipitor Pfizer 1997 180.19
3. Enbrel Amgen 1998 139.83
4. Rituxan Genentech/Biogen 1997 136.07
5. Revlimid Celgene 2008 123.64
6. Remicade Janssen 1998 117.20
7. Epogen Amgen 1988 115.87
8. Herceptin Genentech/Roche 1998 114.89
9. Avastin Genentech/Roche 2004 114.27
10. Advair GSK 1998 113.61

(Adapted from Evaluate Pharma data of August 14, 2019)

Although, Zantac and Plavix no longer feature in this table, one drug that leapfrogged much of the competition to become one of the industry’s biggest future bestsellers is Revlimid. The projected sales of the drug over the next six years will actually outstrip its sales to date. However, much of this is dependent on whether generic competition will arrive ahead of Revlimid’s 2022 patent expiry, the paper indicated.

Concern expressed even in the US for the delay in biosimilar market entry:

Many big spending countries on health care, such as the United States expected that timely biosimilar drug entry will help contain health expenditure significantly. However, the article published in the Fierce Pharma on August 29, 2019, raises an alarm, but with a hope for the future. It says: “It’s no secret biosimilars haven’t made a big dent in U.S. drug spending. Some experts have even said it’s time to give up on copycat biologic.”

This hope gets resonated with what, ‘the former US-FDA commissioner Scott Gottlieb argues’. He feels, ‘It’s too soon for that’, while ‘calling on Congress to bolster the budding market.’ However, in my personal view, this will remain a difficult proposition to implement, as biologic drug players will continue using their relatively new, but powerful weapon of filing a number of complex ‘secondary patents.’ These will help extend the market exclusivity period of their respective brands, much beyond the original patent grant period, unless a counter legal measures are taken by the lawmakers of various countries, including the United States. But, India is an exception in this regard.

Indian patent law doesn’t encourage ‘secondary patents’:

The good news is, Indian Patent Act 2005, doesn’t encourage ‘secondary patent.’ This is because, section 3 (d) of the Indian Patent Act 2005 limits grant of ‘secondary pharmaceutical patents.’ An interesting study reported on February 08, 2018, discussed about 1,700 rejections for pharma patents at the IPO spanning over the last decade. But, there is a huge scope for improvement in this area.

Which is why, the not so good news is under-utilization of the same section 3.d by the Indian Patent Office (IPO), as are being voiced in many reports. One such paper of April 25, 2018 highlighted,72 per cent of pharma patent grants are secondary patents. These were granted for marginal improvements over previously known drugs for which primary patents exist. That said, despite such reported lapses, blocking of some crucial secondary patent grant has benefited a large number of patient population of India.

Blocking secondary patent grant has helped India immensely:

While US recognizes secondary patents, blocking secondary patent grant, especially for biologic drugs has helped Indian patients immensely, with expanded access to those medicines. This was also captured in the above study. Besides the classic case of Novartis losing its secondary patent challenge for Glivec in the Supreme Court of India in 2013, several other examples of secondary patent rejection are also available. This includes, among others, Glivec of Novartis and the world’s top selling drug for several years – Humira of AbbVie.Against a month’s therapy cost of ₹1,6o, ooo for Glivec in the US, its Indian biosimilar version costs for the same period ₹11,100. Similarly, while the treatment cost with Humira in the US is ₹85,000, the same with its biosimilar version in India is ₹ 13,500, as the above study finds.

Conclusion:

The core purpose of drug innovation, as widely touted by the R&D-based drug companies, is meeting the unmet needs of patients in the battles against diseases. Thus, drug innovation of this genre must not just be encouraged, but also be adequately protected and rewarded by granting product monopoly for a 20-year period from the date of the original patent grant. Curiously, piggybacking on this basic spirit behind the drug patent grant, pharma lobby groups are now vocal on their demand for giving similar treatment to secondary patents on various molecules. The tone of demand gets shriller when it comes to section 3. d of the Indian Patents Act, which doesn’t allow such ‘evergreening’ through secondary patents.

Thus, the key question that surfaces, while the original patent grant for innovative drugs help meeting unmet needs of some patients, whose unmet needs would a secondary patent grant meet, except making the concerned company richer? Further, for highly expensive biologic drugs, delayed market entry of cheaper biosimilars in that process, would deny their expanded access – failing to meet the unmet needs of scores of others.

Hopefully, India won’t give in to pressure of multinational pharma lobby groups, channeled through various powerful overseas government entities. At the same time, I hope, the government in power at the Eldorado of the pharma industry, will consider giving a fair chance of market entry to cheaper biosimilars, including those from India, to also grow their business globally, but in a win-win way.

The key objective of all stakeholders involved in this process, should be to uphold the basic spirit behind drug patent grant. It may even call for challenging the core intent behind secondary patent applications, the world over, that deny quicker market entry for cheaper biosimilars, sans heavy litigation expenses. This will help expand access to cheaper biologic medicines to all those who can’t afford those, otherwise.

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.

 

 

 

 

Healthcare in India And Hierarchy of Needs

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“Russia and India climb World Bank’s Doing Business rankings”, was a headline in the Financial Times on October 31, 2017. India jumped 30 places – from 130 out of 190. Almost instantly, the domestic media flashed it all across the country, as the prime news item of the day. It brought great satisfaction to many, and very rightly so.

The news is also worth cheering as it ignites the hope of a large section of the society that sometime in the future more business will come into the country, more jobs will be created, and in that process India will emerge as a more healthy and wealthy nation, just as many other countries around the world.

This loud cheer, in tandem, also transcends into a hope for a well-oiled public healthcare system functioning efficiently in India, alongside greater wealth creation. This is because, while expecting a healthier nation, one can’t possibly keep the public healthcare system of the country out of it, altogether. Thus, I reckon, it won’t be quite out of place to have a quick look at India’s current ranking on other healthcare related indices too, such as ‘Healthcare Index’ and ‘Human Development Index’ and ‘Hunger Index’:

Healthcare index:

With that perspective, when go through the Global Burden of Disease Study 2016, published in The Lancet on September 16, 2017, it will be difficult to wish away the fact that India ranks 154 among 195 countries in ‘Healthcare Index’. Surprisingly, India ranks much behind Sri Lanka (72.8), Bangladesh (51.7), Bhutan (52.7) and Nepal (50.8) though, of course, above Pakistan (43.1) and Afghanistan (32.5). This is what it is, regardless of the fact that India’s Healthcare Access and Quality (HAQ) index has increased by 14.1 – from 30.7 in 1990 to 44.8 in 2015.

Human Development Index:

The ranking of India in the Human Development Index (HDI) is also not encouraging, either. Many would know, HDI is a composite index of life expectancy, education, and per capita income, which are used to rank countries in human development. As life expectancy also depends on the quality of healthcare, HDI has a significant bearing on this count, as well.

The ‘2016 Human Development Index Report (HDR)’ released by the United Nations Development Program (UNDP) in March 2017 shows that India has slipped by one rank from 130 to 131, among 188 countries. According to UNDP, ‘in the past decades, there has been significant gains in human development levels almost in every country, but millions of people have not benefited from this progress. This report highlights who have been left behind and why?’

I shall dwell on the ‘Global Hunger Index Report’ below at an appropriate context.

Why is this comparison between different indices…and now?

The above question is indeed a very valid one. Nonetheless, it is important to do so. I am quoting these rankings to flag the sharp contrast in our mindset to rejoice the good rankings, and lampooning the adverse ones, citing one reason or the other.

It is obvious from the general euphoria witnessed by many on such good news –  highlighted so well by the print, television and social media, with high decibel discussions by experts and politicians. There is nothing wrong in doing that, in any way. However, similar media discussions were not evident for taking effective corrective measures, soon, when ‘global burden of disease rankings’ or ‘Human Development Index Report (HDR)’ or the ‘Global Hunger Index’ rankings were published in September, March and October 2017, respectively.

Does it therefore mean that effectively addressing issues related to crumbling public healthcare infrastructure in the country attracts much lesser importance than ensuring ease of doing business in the country? Do both the politicians and the voters also consider so? Perhaps the answer is yes, as many would envisage in the largest democracy of the world.

What’s happening elsewhere?

In many developed and also the developing countries of the world, general public or voters’ expectations for having an affordable and robust public healthcare delivery system from the respective Governments seem to be high. Consequently, it also directs the focus of the politicians or lawmakers on the same. This scenario includes even the oldest democracy of the world – America. Such expectations on comprehensive healthcare covers the need for affordable drug prices too.

That voters are greatly concerned about healthcare in those countries is supported by many contemporary surveys. Just before the last year’s American Presidential election, Kaiser Health Tracking Poll: September 2016, substantiated this point. It said, besides considering personal characteristics of the candidates, the voters clearly articulated their priority on patient-friendly healthcare laws and affordable drug prices, as follows:

  • Over 66 percent of voters expressed that healthcare law is very important to their vote
  • 77 percent said prescription drug costs are unreasonable, expressing widespread support for a variety of actions in order to keep healthcare costs down

Accordingly, The New York Times on September 17, 2017 reported: “The public is angry about the skyrocketing cost of prescription drugs. Surveys have shown that high drug prices rank near the top of consumers’ health care concerns, and politicians in both parties - including President Trump — have vowed to do something about it.”

I haven’t come across such widespread demand from the voters getting captured in any survey, before either any State Assembly or the Parliament elections in India. Hence, public healthcare continues to languish in the country, as various Governments come and go.

What happens post-election in the oldest democracy?

We have enough examples that post-election, the oldest democracy of the world tries to satisfy the well-articulated healthcare needs of the voters, on priority. To illustrate the point, let me help recapitulate what happened in this regard, immediately after the last two Presidential elections in America.

After swearing in on January 20, 2009, then American President Barack Obama, as expected by the voters and promised by him accordingly, enacted the Affordable Care Act (ACA), popularly known as ‘Obamacare’, almost within a year’s time – on March 23, 2010. Similarly, within a few months of swearing in as the American President, Donald Trump administration is mulling to address the voters demand and his electoral promise to make the prescription drugs more affordable.

Public demand and outcry for affordable healthcare, including affordable drugs have led to several serious consequential developments in the United States. Let me illustrate this point with another example of recent lawsuits filed against alleged price fixing of generic drugs – many of these are new, but a few started in the last few years.

Vigil on drug prices continues:

As high drug prices are a burning issue even in America, a lot many steps are being taken there on that issue – just as many other developed and developing countries are taking.

It is rather well known that even after enactment of the Affordable Care Act (ACA) in 2010, the Department of Justice of the country expanded probing into the allegation of price fixing by many generic drug manufacturers operating in America. One such illustration is October 31, 2017 public notice of the State Attorney General (AG) of Connecticut. It states that the AG is leading a coalition of 46-states in new, expanded complaint in Federal Generic Drug Antitrust Lawsuit. It further mentioned: States allege broad, industry-wide understanding among numerous drug manufacturers to restrain competition and raise prices on 15 generic drugs, where some senior executives have been sued.

Interestingly, in this notice the AG said, “The generic drug market was conceived as a way to help bring down the cost of prescription medications. For years, those savings have not been realized, and instead the prices of many generic drugs have skyrocketed.” He alleged that the defendant companies’ collusion was so pervasive that it essentially eliminated competition from the market for the identified 15 drugs in its entirety. ‘Ongoing investigation continues to uncover additional evidence, and we anticipate bringing more claims involving additional companies and drugs at the appropriate time,” the Attorney General further added.

By the way, the expanded complaint of the states reportedly also includes several large Indian companies, such Dr. Reddy’s Laboratories, Emcure, Glenmark, Sun Pharma, and Zydus Pharma. Curiously, the expanded complaint also names two individual defendants, one among them is the promoter, the chief executive officer and managing director of a large Indian pharma manufacturer.

Examples such as this vindicate, even if a robust public healthcare system is put in place, the regulators would still keep a careful vigil on drug prices.

Getting back to the key link between some indices:

Let me now get back to where I started from – the link between ‘ease of doing business’ and ‘becoming a healthy and wealthy’ nation, over a period of time. This would subsequently bring us to the link between healthy nation and the existence of a robust and functioning affordable public healthcare system in the country.

From that angle, I raised a key question. Why the general public, and specifically the voters in India aren’t making effective delivery of an affordable public healthcare as one of the top priority areas while voting for or against a political dispensation? The question assumes greater relevance when one sees it happening in many other countries, as discussed above. Is it, therefore, worth pondering whether this issue can be explained, at least to a great extent, by applying the well-known ‘Maslow’s theory of hierarchy of needs.’

Maslow’s hierarchy of needs and hunger index:

As the literature says, ‘Maslow’s hierarchy of needs’ is a theory of motivation in psychology developed by Abraham Maslow in 1943. He believed people move through different stages of five needs that motivate our behavior. He called these needs physiological, safety, love and belonging (social), esteem, and self-actualization.

As we see, the first two basic needs are physiological and then safety. Maslow explains the ‘physiological needs’ as food, water, sleep, and basic biological functions. When these physiological needs are adequately met, our safety needs would usually dominate individual behavior.

Similarly, Maslow’s ‘safety needs’ in the modern era are generally expressed as the needs of job security, financial security, and health and well-being, among a few others. Thus, the need for healthcare falls under ‘safety needs’, following the most basic ‘physiological needs’.

As Food is one the first basic needs, India’s current ranking in the ‘Global Hunger Index (GHI)’, would suggest this primary need of having at least two square meals of nutritious food a day, has not been adequately met by a large population of Indians, not just yet.

India’s ranking in the Global Hunger Index (GHI):

The Global Hunger Index (GHI) has been defined as a multidimensional statistical tool used to describe the state of countries’ hunger situation. The GHI measures progress and failures in the global fight against hunger. It is now, reportedly, in its 12th year, ranking countries based on four key indicators – undernourishment, child mortality, child wasting and child stunting.

The International Food Policy Research Institute (IFPRI) report, titled ‘2017 global hunger index: The inequalities of hunger ’, indicates that India ranks below many of its neighboring countries, such as China (29th in rank), Nepal (72), Myanmar (77), Sri Lank (84) and Bangladesh (88), but ahead of Pakistan (106) and Afghanistan (107). Just for the sake of interest, North Korea ranks 93rd while Iraq is in 78th position.

The primary basic need of food and nutrition does not seem to have been fully met for a large Indian voter population, as yet. Many of them are still struggling and searching for appropriate means of earning a dignified livelihood. It includes support in agricultural production and the likes. Thus, many voters don’t feel yet, the second level of need that prompts a vocal demand for an affordable and robust public healthcare system in the country. The same situation continues, despite ‘out of pocket’ expenditure on healthcare being one of the highest in India, alongside the cost of drugs too.

Conclusion:

This brings us to the key question – When would the demand for having an affordable and robust public healthcare system in the country, assume priority for the general public in India, and the voters, in particular?

Sans Government’s sharp focus on public healthcare, including the cost of drugs, devices, and education, it will be challenging for a democracy of India’s size to make a decisive move, for a long term – from average to good – and then from good to great, even in the economic parameters.

Applying Maslow’s hierarchy of needs onto various health related global indices, it appears that the primary basic need of food and nutrition has not been fully met for a large Indian voter population, as yet. This possibly makes a large section of Indian voters to move into the second level of need, raising a widespread vocal demand for an affordable and robust public healthcare system in the country.

Rejoicing country’s advancement in the World Bank’s ranking on the ease of doing business by 30 points in a year has its own merits. However, in the same yardstick, doesn’t health care losing the priority focus of the nation also highlight the demerits of misplaced priority in a country’s governance process, and just because the voters are not quite demanding on this issue?

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.

Wide Gap Between Health Care Needs, And Delivery: Is The Bridge Still Too Far?

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“Health inequities which abound in India must be corrected through investments in a robust primary health care system,” said Professor K Srinath Reddy, chairman, Public Health Foundation of India (PHFI), not too long ago.

The equity gap between health care needs and delivery for the general population of India continues to widen.

As the next Union Budget of India is coming nearer, the question in this regard that comes at the top of mind is:

Would adequate resources be allocated by the Union Finance Minister to bridge this gap effectively now or the elusive bridge continue to remain too Far?

The growing challenges: 

Up until now, despite making some progress in improving access to health care, India continues to face the growing challenges of:

  • Gross inequalities in this area by socioeconomic status, geography and gender. 
  • High out-of-pocket health expenditure pushes its ever increasing financial burden overwhelming on the private households, that accounts for over three-quarters of health spending in India.
  • Exorbitant out-of-pocket health spending is also responsible for mercilessly driving into poverty more than half of Indian households, or around 39 million Indians, each year.

The paper titled, “Health care and equity in India”, published by ‘The Lancet’ on February 05, 2011, well deliberated on this issue. 

The paper identifies 3 key challenges to equity in health care:

  • In service delivery
  • In financing
  • In financial risk protection

In the article titled, “My Expectations From The Union Budget (2016-17)”, written in this Blog on December 07, 2015, I also suggested that adequate resource deployment be made by the Government now in power, in all these three areas, while presenting the forthcoming Union Budget on February 28, 2016.

The root cause of inequity in healthcare:

I reckon, there are, at least, the following three key reasons that can be attributed to this failure, on the part of various Governments in power, till today:

  • Inability, primarily on the part of the central government, to effectively integrate healthcare with socioeconomic, social hygiene, education, nutrition and sanitation related issues of the nation. 
  • Health being a state subject, not much of coordinated and robust planning has so far been taken place in this area, between the Central and the State Governments, to effectively address the pressing health care related growing inequity across the country, in general.
  • Budgetary allocation and other fiscal measures towards health care, both by the central and most of the state governments, are grossly inadequate. 

As I said before, in another article published by this blog titled, “With Highest Billionaire Wealth Concentration, India Tops Malnutrition Chart in South Asia” on January 26, 2015, it is a well accepted fact that reduction of social inequalities ultimately helps to effectively resolve many important health care issues.

Otherwise, only a much smaller population of the country having adequate access to knowledge, social and monetary power, will continue to have the necessary resources to address their health care needs, appropriately.

UNICEF highlights stark inequalities in India:

According to UNICEF, every year, 1 million children below the age of five years die, due to malnutrition related causes in India. This number is worrisome as it is far higher than the emergency threshold, according to the World Health Organization (WHO) classification of the severity of malnutrition.

Highlighting stark inequality in India, the report says, “The net worth of a household that is among the top 10 per cent can support its consumption for more than 23 years, while the net worth of a household in the bottom 10 percent can support its consumption for less than three months.”

Are so called “patient centric approaches” real?

Patients are also bearing a different kind of brunt altogether, from several other corners, on their health related issues.

Today, most of the important stakeholders of the health care industry, in general, seem to be using various facades of ‘patient centric approaches’, just for petty commercial gains, or for gaining some key strategic commercial advantages.

Such entities could well be pharmaceutical industry, doctors, hospitals, diagnostic centers, politicians or any other stakeholders.

It is unfortunate that most of them, at various different times, either pontificate about following ‘patient centric approaches’ or use the patients cleverly just to achieve their respective commercial or political goals, solely driven by vested interests. While on the ground, growing inequity in health care keeps marching north.

A recent paper of NITI Ayog:

In a discussion paper of July 18, 2015 titled, “Health System in India: Bridging the Gap Between Current Performance and Potential”, The National Institution for Transforming India Aayog (NITI Aayog), the policy think tank of the new Indian Government, has also accepted the following 3 critical realities, currently prevailing in the health care environment of India: 

  • India’s progress in health outcomes has been slower in comparison to other countries with comparable incomes and at similar stages of development. 
  • Impressive gains in per capita income should match with an increase in life expectancy or health status. 
  • Out of pocket expenditure in India is high (70 percent of total health expenditure). This is catastrophic for the poor and pushes an estimated 37 million into poverty every year. 

The NITI Ayog paper also emphasized, although health is a subject allotted to the State List, under the Seventh Schedule of the Indian Constitution, the Central Government is jointly responsible for items in the Concurrent List. 

Conclusion:

Currently, India is the global numero uno in the GDP growth rate. Thus, there cannot probably be any better time for the nation to leapfrog in the health care space, with a quantum increase in public financial commitments, to radically revamp the fragile public health system in the country. 

I repeat, incremental progress in the public health care system is just not enough for the country, extensive application of cutting edge Information Technology (IT) effectively, dovetailing with the creation of modern brick and mortar public health care infrastructure, top class human resource namely, doctors, nurses and related skill development process, on an ongoing basis.                                                                             

The Government should also ensure that the domestic health care industry comes forward to shoulder higher responsibility to enable the country in offering greater equity in health care, in tandem with the Union Ministry of Health and the State Governments.

This path, in my view, would help building a more equitable health system with a strong foundation of public health for more than 1.2 billion Indians. In that process the fast widening gap in equity, between health care needs and availability, could be bridged much sooner, and in a sustainable way.

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.

“Meeting Unmet Needs of Patients”: A New Direction

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The much-hyped phrase of the global pharma majors – ‘meeting unmet needs of patients’, is very often used to create an aura around newer patented drugs of all kinds, from original to banal, including evergreen varieties such as:

Evergreen Drug/Brand Medical Condition Original Drug/Brand
Levocetirizine (Vozet) Allergies Cetirizine (Zyrtec)
Escitalopram (Lexapro) Depression Citalopram (Celexa)
Esomeprazole (Nexium) Acid reflux Omeprazole (Prilosec)
Desloratadine (Clarinex) Allergies Loratadine (Claritan)
Pregabalin (Lyrica) Seizures Gabapentin (Neurotonin)

I do not have any terrible issue with this usage, as many stakeholders, including various governments, have already started differentiating between the ‘Chalk’ and the ‘Cheese’ kinds of patented products and contemplating future course of action, accordingly. The recent development in South Africa is one such example.

That said, there is now a greater need to ponder over the much bigger picture in the same context and direction, which would improve predictability of treatment outcomes by manifold. Simultaneously, such R&D initiatives would help reducing the overall cost, especially for dreaded diseases like cancer, mainly through highly targeted drugs and consequently avoiding the risk and associated wastage, as often happens with the prevailing ‘trial and error’ therapy approach, thereby benefitting the patients immensely. This is mainly because no drug is 100 percent effective with inconsequential side-effects for all patients of any disease type.

Genetics and Genomics Science made it possible:

With already acquired knowledge in genetics, genomics and genome sequencing capability, it is now possible to precisely predict a person’s susceptibility to various disease types and proactively working out measures to help either avoiding ailments, such as, non-infectious life threatening and chronic diseases altogether, if not, making their treatment more predictable and less expensive, as stated above.

If organized efforts are made to extend the application and benefits of this science to a larger section of population, those R&D initiatives can really be construed, unquestionably, as ‘meeting unmet needs of the patients’, just as ‘first in kind’ category of innovative drugs are recognized by the scientific community and the civil society as a whole.

A treatment revolution in the offing:

Expectations are rapidly building up that evolving genetics and genomics science based technological know-how would ultimately revolutionize the practice of medicine ushering-in the pathway of personalized medicine for a large number of patients.

Definition: 

A report from the Tufts Center for the Study of Drug Development defines personalized medicine as “Tailoring of medical treatment and delivery of health care to individual characteristics of each patient, including their genetic, molecular, imaging and other personal determinants. Using this approach has the potential to speed accurate diagnosis, decrease side effects, and increase the likelihood that a medicine will work for an individual patient.”

The aim: 

The aim of personalized medicine is, therefore, to make a perfect fit between the drug and the patient. It is worth noting that genotyping is currently not a part of clinically accepted routine. However, it is expected to acquire this status in the western world, shortly.

To give a very quick example, genetic differences within individuals determine how their bodies react to drugs such as Warfarin – a blood thinner taken to prevent clotting. It is of utmost importance to get the dosing right, as more of the drug will cause bleeding and less of it will not have any therapeutic effect.

In the field of cancer, genetic tests are now being done by some oncologists to determine which patients will be benefited most; say with Herceptin, in the treatment of breast cancer.

Thus, with personalized medicine the health of a patient will be managed based on personal characteristics of the individual, including height, weight, diet, age, sex etc. instead of defined “standards of care”, based on averaging response across a patient group. Pharmacogenomics tests like, sequencing of human genome will determine a patient’s likely response to drugs.

Disease prevention: 

In addition, such medicines would help identifying individuals prone to serious ailments such as, metabolic, cardiac, endocrine, auto-immune, psychosomatic, including cancer of various types; enabling physicians to take appropriate preventive measures much before disease manifestations and in that process would help containing the overall treatment cost.

Cost of genome sequencing:

Sir John Bell, Professor of Medicine at Oxford University, reportedly said in early December 2012 that personalized medicine for all could soon be a clear possibility, as everybody will be able to have their entire DNA make-up mapped for as little as £100 (Rs.10, 000 approx.).

This estimate seems to be realistic, as the price of genome sequencing has fallen by 100,000-fold in 10 years. This cost is expected to further decline, as genome of any person essentially remains unchanged over time. Thus, this information might become a part of an individual’s medical record allowing the doctors to use it as necessary.

Summary of key advantages: 

To summarize, the expected benefits from personalized medicine, besides very early diagnosis as stated above, are the following:

1. More Accurate Dosing: Instead of dose being decided based on age and body weight of the patients, the physicians may decide and adjust the dose of the medicines based on the genetic profiling of the patients.

2. More Targeted Drugs: It will be possible for the pharmaceutical companies to develop and market drugs for patients with specific genetic profiles. In that process, a drug needs to be tested only on those who are likely to derive benefits from it. This in turn will be able to effectively tailor clinical trials, expediting the process of market launch of these drugs.

3. Improved Healthcare: personalized medicine would enable the physicians to prescribe ‘the right dose of the right medicine the first time for everyone’ without any trial or error approach, resulting in much better overall healthcare.

Current use:

Though these are still the early days, initial usage of personalized medicine is now being reported in many areas, such as:

Genetic analysis of patients dealing with blood clots: Since 2007, the U.S. Food and Drug Administration has been recommending genotyping for all patients being assessed for therapy involving Warfarin.

Colorectal cancer: For colon cancer patients, the biomarker that predicts how a tumor will respond to certain drugs is a protein encoded by the KRAS gene, which can now be determined through a simple test.

Breast cancer: Women with breast tumors can now be effectively screened to determine which receptors their tumor cells contain.

In addition, this approach would also help clinicians to determine which particular therapy is most likely to succeed on which patient.

Present outlook: 

A September 2013 article published in Forbes Magazine titled, “Personalized Medicine May Be Good For Patients But Bad For Drug Companies’ Bottom Line” says, although personalized medicine offers tremendous potential for patients, because of the dual burdens of expensive clinical trials and diminished revenue potential, the concept may become unsustainable in the long term, the attitude of regulators will be critical to drug companies’ willingness to embrace personalized medicine, and to its wider application.

In my view, for greater interest of patients to ‘meet their unmet needs’ global pharma, majors, academics, respective governments and the drug regulators should find a way out in this new direction, sooner.

Indian initiatives:

Some companies, both well known and lesser known, are making collaborative progress, keeping low profile, in the genome sequencing area in India, which will ultimately make expensive treatments, such as cancer, more predictable and simultaneously affordable to many.

The concerns:

While the progress in the field of personalized medicine is quite heartening, some experts have reportedly been sounding a note of caution. They strongly feel that DNA code sequencing brings to light a “very real privacy concerns” of individuals.

The key argument being, if genome sequencing is extended to entire population, individuals and their relatives could then be identified and tracked by matching their DNA with the genome stored in the respective health records. This move, as contemplated by the opponents, could “wipe out privacy” with a significant impact on the society.

A paper published in ‘Scientific American’ dated January 2014, titled “What Fetal Genome Screening Could Mean for Babies and Parents” deliberated that today doctors are closer than ever before to routinely glimpsing the full genetic blueprints of a fetus just months after sperm meets egg. That genomic reconstruction would reveal future disease risk and genetic traits even as early as the first trimester of pregnancy – raising another ethical issue that could hugely impact parents’ decision threshold for deciding to terminate a pregnancy or influencing how they rear their child.

Thus, all these ethical and social issues in the development and usage of personalized medicine must be appropriately addressed under a well deliberated ethical, social, legal and regulatory framework of each country.

Conclusion:

Though in Europe and to some extent in the United States, treatments based on personalized medicine have already been initiated, we are still in a nascent stage for this novel concept to get translated into reality for the benefit of a much wider population across the world.

Lot of grounds may still need to be covered, especially in the realm of medical research and also to work out the regulatory pathways for personalized medicine in healthcare by the pioneers of this great concept and more importantly by effectively addressing the ethical concerns raised on this subject.

If collaborative initiatives are taken jointly by academia, R&D based global pharma majors and medical diagnostic players towards this new direction with a clearer focus and  supported by the law makers, a huge unmet needs of patients will truly be met, giving yet again a fresh impetus to the much hyped phrase “Meeting Unmet Needs of Patients”, though in a refreshingly new direction.

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.

Supreme Court Intervened…But ‘Price Control’ needs striking a right balance between ‘Affordability’ and ‘Availability’ of medicines for Patients’ Sake

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On October 3, 2012, the Supreme Court bench of Justice GS Singhvi and Justice SJ Mukhopadhayareportedly asked the government not to disturb the existing price control mechanism while including all medicines featuring  in the National List of Essential Medicines 2011 (NLEM 2011) therein and posted the matter for further hearing on October 11, 2012.

This happened during the hearing of a Public Interest Litigation (PIL) filed by All India Drugs Action Network (AIDAN) and others, way back in 2003, complaining that the span of price control of only 74 bulk drugs and their formulations under the existing Drugs Prices Control Order, 1995 (DPCO  95) does not include lot many essential medicines, making those drugs unaffordable to the general population.

It is worth mentioning that during earlier hearing on the subject the council of the petitioner had expressed apprehensions to the honorable Supreme Court that the proposed Drug Policy recommending Market Based Pricing may lead to a steep increase in prices of essential medicines in India.

The purpose of ‘Price Control’:

As we know, the key purpose of the Drug Price Control in India is to ensure adequate access to essential medicines for the common man. To achieve this objective meaningfully, the process that the price regulator should follow must always ensure that all such medicines are:

  • Adequately Available
  • Reasonably Affordable

Therefore, maintaining a right balance between ‘affordability’ and ‘availability’ of medicines, while framing any drug policy, is of critical importance.

DPCO 95 does not meet the above two criteria: 

The prevailing price control mechanism has failed to meet the above two critical criteria. This is mainly because the following 26 out of 74 bulk drugs featuring in DPCO 95, though still very important, are not currently manufactured in India due to unremunerative pricing:

No

Molecule

Therapeutic Segment

No.

Molecule

Therapeutic Segment
AMODIAQUIN Anti-Malarial 14. SULPHADIMIDINE Anti-Infective
CAPTOPRIL Anti-Hypertensive 15. SULPHAMOXOLE Anti-Infective
CHLORPROPAMIDE Anti-Diabetic 16. HALOGENATED HYDROXYQUINOLONE Anti-Infective
SALAZOSULPHAPYRINE Gastrointestinal 17. TRIMIPRAMINE Anti-Depressant
MEBHYDROLINE Anti-Histamine 18. LYNESTRANOL Hormone
CHLOROXYLENOLS Anti-Infective 19. METHENDIENONE Steroid
CEPHAZOLIN Anti-Infective 20. DIOSMINE Anti- Haemorrhoidal
PENICILLINS Anti-Infective 21. PYRANTEL Anthelmintic
NALIDIXIC ACID Anti-Infective 22. PYRITHIOXINE Vitamin
STREPTOMYCIN Anti-Infective 23. VITAMIN-B1  (THIAMINE) Vitamin
CHLORPROMAZINE Anti-Psychotic 24. VITAMIN-B2 (RIBOFLAVIN) Vitamin
BECAMPICILLIN Anti-Infective 25. PANTHONATES & PANTHENOLS Vitamin
SULPHADOXINE Anti-Infective 26. VITAMIN E Vitamin

(Source: BDMA-26th May 2012)

This makes one to conclude that the honest attempt of the government to make the above drugs affordable to the patients through DPCO 95 has resulted into their non-availability, making ‘affordability’ irrelevant. Thus, such a mechanism defeats the core purpose of any drug price regulation and should not be continued with.

What happens when NLEM 2011 is included in DPCO 95?

As explained above, if all the essential medicines featuring in the NLEM 2011 are brought under DPCO 95, solely to make them more affordable to patients, there will be a high possibility that market factors, as stated above, may make many of these important medicines unavailable to the patients, as happened in case of so many bulk drugs covered under DPCO 95.

Search for a balancing formula: 

To correct this imbalance between availability and affordability of essential medicines, there is an urgent need to first work out a balancing formula and then build that into the new price control mechanism, jettisoning DPCO 95.

This will help addressing the issue of improving access to essential medicines for the common man in India much more meaningfully.

Dr. Pronab Sen Committee Report vindicates the point:

In 2005, to explore this possibility, the government constituted a special taskforce, which is widely known as ‘Dr. Pronab Sen Committee’. This committee was mandated to recommend options other than existing methodology of price control (DPCO 95) for achieving the objective of making available life-saving and essential drugs at reasonable prices.

In its report, the committee did suggest an alternative measure at that time, concluding that the present price control system (DPCO 95) is inappropriate, inadequate, cumbersome and time consuming.

High transaction costs make essential medicines more expensive:

Current transaction costs of medicines in India are over 50 percent of their ex-factory cost, excluding Excise Duty (ED). The various components of the transaction cost include ED, VAT, CST etc. and distribution (trade) margin.

As the Honorable Supreme Court arrives at the final decision on price control measures for NLEM 2011, there is a need for the government to abolish all duties and taxes like ED, VAT, CST etc. levied on such medicines for the sole benefits of the patients.

For an important policy decision involving essential drugs, all ‘patient centric’ cost-cuts, in my considered view, should be shared by both the government and the Pharmaceutical Industry together.

‘Drug Price’ control alone cannot improve access to medicines significantly: 

It is a recognized fact that to improve access to medicines, the Governments even in countries like, Germany, Spain, UK, Korea, Brazil and China have recently mulled strict price control measures in their respective countries.

However, it is equally important to note that in India, we have witnessed since almost the past four decades that drug price control alone could not improve access to modern medicines for the common man very significantly, especially in the current socioeconomic and healthcare environment of the country. Thus, there is a dire need to augment other healthcare access related initiatives in tandem for a holistic approach.

Recently the Government of India has taken ‘Public Health Interest’ oriented a landmark initiative of providing unbranded generic formulations of all essential drugs, featuring in the ‘National List of Essential Medicines 2011’, free of cost to all patients from the public hospitals and dispensaries, across the country. This laudable step could well address the issue of availability and affordability of essential drugs for a vast majority of the population in India.

Taming drug price inflation only has not helped improving access to medicines: 

It is quite clear from the following table that food prices impact health more than medicine costs:

Year

Pharma Price Increases

Food Inflation

2008

1.1%

5.6%

2009

1.3%

8.0%

2010

0.5%

14.4%

(Source: CMIE)

Exploring a realistic approach:

Imbibing the direction, as provided in ‘Dr. Pronab Sen Committee Report’ and considering other pros and cons of the key methodologies of price control of formulations featuring in NLEM, I wouldreemphasize that a middle path with a win-win strategy to overcome the weaknesses of DPCO 95 effectively, would be in the best interest of both patients and the industry alike, in the current situation. This path, I reckon, may be explored as follows with a four step approach:

  • The inclusion criteria for price control in the new Drug Policy should be based on the ‘essentiality’ criteria of the drugs, which will mean all formulations featuring in the NLEM, as announced by the Ministry of Health from time to time, will come under price control.
  • Take ‘Weighted Average Price’ of each formulation featuring in the National List of Essential Medicines (NLEM) based on Maximum Retail Prices (MRP) of all brands of high, medium and low, above a certain cut-off point, if required.
  • Abolish all duties and taxes like ED, VAT, CST etc. as currently being levied on essential medicines and rationalize high trade margins of total 24 percent to further improve affordability of such drugs to the patients.
  • Put in place effectively enough checks and balances to ensure proper availability of NLEM drugs for all and also to avoid any possible situation of artificial shortages of such drugs. 

Conclusion:

Come October 11, 2012, let us hope that the honorable Supreme Court of India will pass an order related to drug price control, which will help striking a right balance between ‘availability’ and ‘affordability’ of essential medicines in India and the government will rationalize the transaction costs of such medicines thereafter.

In that case, it will be a win-win solution both for the patients and the industry alike, paving the way for improving access to essential medicines for the entire population of India along with other related strategic initiatives towards this goal. Such measures are absolutely essential, especially when medicines contribute around 72 percent of the total ‘Out of Pocket Expenses’ of the common man of the country.

That said, it is important to realize that there is no single or only right way to arrive at the ‘affordable price’ of any medicine, essential or otherwise. However, how much the government or an apex court will allow the pharmaceutical manufacturers to charge for a drug to make the prices ‘reasonably affordable’, will continue to remain an important, complex and a difficult task, both locally and globally.

By: Tapan 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.

Healthcare Tourism: India needs to step on the gas

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Healthcare Tourism or Medical Tourism are the terminologies initially coined by the travel agents and the media when patients travel outside their national boundaries to seek either more specialized and/or cheaper but high quality healthcare available in other countries.

World Health Organization (WHO) defines Healthcare Tourism as an activity that covers:

  • Medical care
  • Sickness & well-being
  • Rehabilitation & recuperation

The reasons:

The main reasons of healthcare tourism are:

  1. High medical costs, especially for those patients who are under-insured or uninsured
  2. Long waiting period for elective surgery
  3. To avail technologically more advanced medical treatment and care

For example, USA though globally recognized as one of the technologically most advanced countries in providing high quality healthcare to the patients, the cost of comprehensive healthcare in the country is often beyond reach of many Americans.

In not too distant past (2000), the World Health Organization (WHO) ranked USA as the country with most expensive healthcare systems in the world. Moreover, it has also been reported that in the US, the fees paid to doctors for medical services are usually much higher for an ‘uninsured’ patient than one who is ‘insured’.

Such a scenario has given rise to situation where many Americans travel out of the country for a lower cost medical care, if not adequately insured.

‘Time Health’ in an article titled ‘A Brief History of Medical Tourism’ stated as follows:

-       In 2006: 150,000 US citizens underwent medical treatment abroad

-       In 2007: the number grew to an estimated 750,000

-       In 2008: it increased to 1.3 million

-       In 2010: the figure further swelled to an estimated 6 million citizens.

The article commented that “Patients are packing suitcases and boarding planes for everything from face lifts to heart bypasses to fertility treatments.”

The key influencers and preferred destinations:

The most common influencer for healthcare tourism globally, as stated earlier, is lack of or inadequate health insurance and the most common emerging destinations for healthcare tourism in the world are Thailand, Singapore, Costa Rica, Panama, Brazil, Mexico, Malaysia and India. This is mainly because of fact that the costs of availing high quality healthcare services in these countries are much cheaper- on an average around 80%. For example, a cardiac surgery, which will cost more than US$ 50,000 in the US, can be availed for US$ 20,000 in Singapore, US$ 12,000 in Thailand and between US$ 3,000 and US$ 10,000 in India.

Other factors influencing Healthcare Tourism, particularly in India, besides significant cost advantages, are:

  1. High quality treatment and hospital stay with world class medical technological support
  2. Rigid compliance with international treatment standards
  3. No language barrier with the western world
  4. Government taking active steps and interest in the medical tourism sector

In all these four areas significant advantages that India offers will need to be adequately leveraged in a sustainable manner by the country.

Most popular treatment areas:

The most popular treatment areas are as follows:

  1. Alternative medicines
  2. IVF treatment
  3. Bone-marrow transplant
  4. Cardiac bypass
  5. Eye surgery
  6. Dental care
  7. Cosmetic surgery
  8. Other areas of advanced medicine

Evolving scenario:

Since last several years healthcare tourism is fast evolving as one of the key growth drivers of the global healthcare sector as a whole.

Dr. Fred Hansen in his article titled, ‘A Revolution in Healthcare’, highlighted that increasing number of high-quality healthcare facilities in the developing coun­tries are attracting medical tourists from the developed countries like the US and the European Union (EU).

Apprehension in the US about growing Healthcare Tourism of India:

India Knowledge@Wharton in its June 2, 2011 issue reported as under:

  • In the past, US President Barack Obama had singled out India for what he sees as the country usurping American jobs and business.
  • In May 2009, he removed some tax incentives for US companies who allegedly preferred to outsource rather than create domestic jobs. “Buffalo before Bangalore” was his rallying call at the time.
  • In April 2011, he told a town hall gathering in Virginia that Americans shouldn’t have to go to India or Mexico for “cheap” health care. “I would like you to get it right here in the U.S.,” he said.
  • In January 2012, President Obama reiterated the same intent in the run up to the forthcoming US presidential election for his second term.

The Global Market:

In 2006 the global market for healthcare tourism was around US$ 60 billion. According to McKinsey & Company, this market is expected to expand to over US$110 billion by 2012.

India – a contender for supremacy:

Healthcare tourism in India, despite being smaller compared to the western world, is surging ahead both at the national and the regional levels with enormous potential for future growth, if explored appropriately with a carefully charted strategic game plan in its evolution process.

Currently India is emerging as one of the preferred destinations for global health tourists. The country received 150,000 medical tourists in 2004, which grew by 33% to 200,000 in 2008, mainly from the USA, UK and the Gulf countries, primarily due to low-priced and high quality healthcare in wide ranging disease areas. More and more people from these countries are finding the prospect of high quality and value added medical care in India financially attractive.  As per estimates, India will receive over 500,000 medical tourists per year come 2015.

While visiting India for healthcare, patients not only get treated by the best medical professionals with western medical training, but also are able to stay in deluxe accommodations fully equipped with the latest television set, refrigerator and in some cases even a personal computer, without facing any language barrier and that too by paying just around 1/10th of the price charged in the developed nations.

Moreover, according to John Lancaster of ‘The Washington Post’ (October 21, 2004) Indian private hospitals have a better mortality rate for heart surgery than American hospitals.

With over 8,500 beds ‘Apollo Hospitals’ chain runs 53 different hospitals across the country, followed by “Max Healthcare” that runs 8 medical centers in the National Capital Region (NCR) in India.

Indian Market:

Economic Times, in its January 6, 2009 edition reported, “Indian medical tourism to touch Rs 9,500 Crore (around US $ 2.1 billion) by 2015”.  Another report titled “Booming Medical Tourism in India”, published in December 2010 estimated that the medical tourism industry will generate revenues of around US$ 3 billion by 2013, though with a market share of just around 3% of the of global healthcare tourism industry.  Thus, in healthcare tourism, India still remains a smaller player with enormous growth potential.

New job creation:

Both Public and private sector studies estimate that healthcare tourism in India could attract around US$ 3 billion to the country by 2013 with around 40 million direct and indirect job opportunities.

Cost advantage in India:

Cost Comparison: India vs UK:

Nature of Treatment

Treatment Approximate Cost in India ($) *

Cost in other Major Healthcare Destination ($) *

Approximate Waiting Periods in USA / UK    (in months)

Open heart Surgery

4,500

> 18,000

9 – 11

Cranio-facial Surgery and skull base

4,300

> 13,000

6 – 8

Neuro-surgery with Hypothermia

6,500

> 21,000

12 – 14

Complex spine surgery with implants

4,300

> 13,000

9 – 11

Simple Spine surgery

2,100

> 6,500

9 – 11

Simple Brain Tumor -Biopsy -Surgery

1,000 4,300

> 4,300 > 10,000

6 – 8

Parkinson -Lesion -DBS

2,100 17,000

> 6,500 > 26,000

9 – 11

Hip Replacement

4,300

> 13,000

9 – 11

* These costs are an average and may not be the actual cost to be incurred.

(Source: Health Line)

The key components:

The following four basic components constitute the healthcare tourism industry: • Healthcare Providers: Hospitals, mainly corporate hospitals and doctors • Payers: Medical/ Health insurance companies • Pharmaceutical Companies: for high quality affordable medicines • IT Companies: operating in the healthcare space

Growth drivers and barriers:

Following are the key growth drivers:

  1. Government support through policies and initiatives
  2. High quality, yet low cost care
  3. Much less or no waiting time
  4. World class private healthcare infrastructure
  5. Rich source of natural and traditional medicines. Ministry of Tourism is  promoting the traditional systems of medicines, like,  Ayurveda, Siddha, and Yoga to project India as a the destination of choice for spiritual wellness and healing

In future, the world class and low cost private sector healthcare services are expected to drive the growth of the medical tourism in India.

However, any shortages in the talent pool and inadequacy in other basic infrastructural support like roads, airports and power could pose to be barriers to growth of this sector, if not addressed immediately.

Government Assistance:

The government of India is now supporting the hospitals to get the Joint Commission International (JCI) accreditation.

In 2009 the government announced a revised guidelines for ‘Marketing Development Assistance (MDA)’ scheme for approved Medical Tourism service providers like, representatives of hospitals accredited by Joint Commission for International Accredited Hospitals (JCI) and National Accreditation Board of Hospitals (NABH) and Medical Tourism facilitators (Travel Agents/Tour Operators approved by Ministry of Tourism, Government of India and engaged in Medical Tourism (MTSP) and to the approved Wellness Centers i.e. representatives of the Wellness Centers accredited by the State Governments.

All these measures are expected to accelerate the growth of healthcare Tourism industry in India.

List of JCI Accredited Hospitals in India:

Following are the JCI Accredited Hospitals in India till 2007:

Name and Place Accredited on
1. Indraprasta Apollo Hospital, New Delhi June 18, 2005
2. Wockhardt Hospital, Mumbai August 25, 2005
3. Apollo Hospitals, Chennai January 29, 2006Disease- or Condition-Specific Care (DCSC)Certification for Acute Stroke: 29 April 2006
4. Shroff Eye Hospital, Mumbai February 18, 2006
5. Apollo Hospitals, Hyderabad April 28, 2006
6. Asian Heart Institute, Mumbai October 20, 2006
7. Satguru Pratap Singh Apollo Hospital, Punjab February 3, 2007
8. Fortis Hospital, Mohali June 15, 2007

Source: Joint Commission International, 2007

The challenges:

Following are the key challenges that India will need to address to emerge as a healthcare tourism hub of the world:

  • Improving the infrastructure
  • Adequate training of the staff
  • Enhancement of the image of India as a corruption-free country
  • Continuous improvement of overall service to the patients

Conclusion:

While encountering the global economic meltdown many corporate business houses, even in the developed nations of the world, are under a serious cost containment pressure, which includes medical expenses for their employees. Such cost pressure has already started prompting many companies to send their employees to low cost destinations for treatment, without compromising on the quality of their healthcare needs. This trend could offer an additional growth opportunity in the healthcare tourism sector in India.

According to the ‘Medical Tourism Climate Survey 2010’ report, the leading medical tourism destinations are currently India, Thailand, Hungary and Malaysia and the leading source of patients being again the USA, UK and Russian Federation.

The survey rates Thailand, India and Singapore as the best in terms of quality of overall patients’ care. Insurance and liability issues for the patients from some major markets of the world could pose to be a challenge for speedy growth of this industry.

Countries like, Thailand, Singapore and Malaysia, located in quite closer proximity to India, will continue to offer a tough competition in the healthcare tourism space of the country.

In an increasingly heated-up fast evolving competitive scenario, the name of the game for India will be to ‘step on the gas’, sooner and effectively.

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.