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Unleashing Pharma’s New Potential In Changing Market Dynamics

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Several pharma majors have started pondering in this space. This is evident from several recent developments, both in India, and also in other places of the world. One such articulation can be heard from the very top of the domestic pharma industry, which could be a pacesetter for many others.

The founder and Managing Director’s Message of India’s top pharma company – Sun pharmaceuticals, was released to the media on June 02, 2021. This speech is a part of the company’s Annual Report 2019-20. It is indeed interesting from overall pharma business operations’ perspective in India amid Covid-19 pandemic. It is also in sync with what many of his global counterparts have also expressed in recent times. To give a sense of Sun Pharma Chief’s reading and understanding of the fast-changing business dynamics, I am quoting below a few critical points of his above message:

  • There is a gradual realization that the COVID-19 virus is here to stay and that all of us will have to learn to coexist with the virus till an effective treatment or vaccine becomes available.
  • There will be far-reaching changes in the way in which organizations are likely to operate going forward.
  • Consumer behavior and consumption patterns are also likely to change due to the global pandemic.
  • Social distancing and maintaining individual hygiene (like using masks and hand sanitizers) have become imperative.
  • Work-from-home (WFH) option has been exercised by most organizations for certain functions and there is a likelihood that it will continue for some more time till the viral infection comes under control.
  • There is a possibility that WFH may become the new-normal for certain categories of corporate work force even after COVID-19 comes under control.
  • Also, there is a higher focus on automation, digitalization as well as an increased dependence on analytical tools for decision making.

Overall, in the global pharma and biotech arena, one can now witness a varied response to opening-up – some quite bold, others are flexible and cautious – as the scenario unfolds. In this article, I shall dwell on the importance of framing a well-thought-out plan, with clearly stated Plan B, C and D in this area, to prevent any business opportunities to slip by due to delayed action.

Key questions to answer – what to open and when to open:

It goes without saying that remote working or WFH for all pharma employees can’t remain in-force for any indefinite period. It will mostly depend on two critical drivers, mainly to avoid any reckless decision with grave consequences. One – how fast several – reasonably strong preventive measures, such as, vaccinations, can provide a reasonable herd immunity to most people around. And also, how most other similar businesses successfully start carrying out their commercial operations in the same environment.

Pharma players would then need to have a clarity on the business functions where selective personal presence of the qualified staff is necessary, as no extent of technological interventions can compensate it. Then follows the question, when to start opening – without being reckless and following all prescribed Covid related health norms. The answer to these questions should be addressed along with Plan B, C and D ready – just in case something doesn’t work out or because of competitive reasons.

To elaborate this point, let me first give an example of what an Indian tech behemoth is planning to get back some employees in the workplace, based on a sophisticated digital model. Thereafter, we will have a glimpse on how several pharma and biotech players are planning in this space. The basic assumption is – the grand show must go on – with collective scientific learnings on how to coexist with the virus, for an indefinite period, if inevitable.

Integrated digital plan to get back more employees at the workplace by TCS: 

Lilly, Amgen, PfizerAs reported on June 02, Tata Consultancy Services (TCS) are working on a plan to get back more employees to the workplace. The tech giant is focusing more ‘on increasing talent fungibility as global clients increasingly require associates with niche skills to be deployed on projects at short notices.

Thus, to evaluate how it will get a certain percentage of people back, TCS has drawn up a risk assessment model, Intelligent Urban Exchange (IUX). To effectively address the new requirements for employees’ safety, regulatory compliance, and operational efficiency, the company has devised this system. It will help TCS to get real-time insights that will help restore operations and ensure safety, while becoming nimbler and more resilient in the new normal.

What some global companies are planning now:

One will witness a mixed approach of global pharma players to get back employees at the workplace, soon. This will be evident from a few examples, as below.

A Bloomberg report on April 27, 2021, highlighted: ‘As vaccine drives ramp up and open the possibility of a return to the office, a growing number of companies have pointed to a continued role for remote work — and less of a need for pricey office space.’ It quoted Novartis CEO saying: ‘“We’ve all learned from the pandemic that we can work from home and work from the office, and it will always be a combination going forward.”

Thus, in Novartis, “hybrid-based working environment” – at-home and in-office work, will persist for the long term – extending beyond the pandemic. The Company CEO also reiterated: “We think this is the future.” The flexibility should allow Novartis to “access talent pools we would not have been able to access in the past,” he believes.

Similar approach, but with specific dates for returning to the workplace: 

By an open announcement on Linkedin, the Chairman and CEO of Eli Lilly declared the Company’s plan at the current stage of Covid pandemic. He said: “More than a year later, I’m pleased to say that we’re actively planning Lilly’s return to our workplace in downtown Indianapolis, and other facilities around the world.”

He further said, on June 1, 2021, Lilly will begin reopening their Indianapolis offices, inviting 25 percent of our workforce back – with masking and distancing indoors, and a requirement for vaccination. Barring a change in the steady downward case rate in the community, the Company will then open to all Indianapolis-based employees on July 12, 2021.

The company’s new work model will be based on the requirements for each job. Some employees will be on site all the time, others most of the time, and some will have even more flexibility. As ‘individual work’, and some ‘transactional work’, is easier done remotely, employees in those roles can choose that option in consultation with their supervisor. But collaboration, innovation and learning are best done in-person at the Company facilities, the Chairman and CEO said.

He reiterated, Lilly is not taking these steps casually, but based on a data-based approach, and will continue to do so. If external factors change, Lilly will adapt. In other countries, the Company offices will continue to follow local guidelines and open as they are allowed based on local circumstances, the Company clarified.

More remote working being planned by many other global majors:

According to another report of May 07, 2021, many other global pharma and biotech majors are now planning in favor of long-term remote working for several critical business than ever before. For example, on May 07, 2021 Amgen announced that the Company will make working from home a permanent policy for much of its international workforce, including locally.

It said, “Most of our employees who are currently working remotely will continue to do so for a majority of their time, even after the pandemic ends. Our intent is to create a more flexible environment that intentionally combines the benefits of remote and in-person working.” The statement further added. “We are not initiating any changes to our Thousand Oaks campus at the time. Though some staff may come to campus less frequently.”

As reported on April 27, 2021, Pfizer has put its large Philadelphia-area campus up for sale, as it considers the future of work. According to the company, as revealed by Fierce Pharma, “The decision to do so is primarily being driven by the company’s evolving – flexible working model, providing employees with greater flexibility to work remotely while still maintaining the ability to connect and collaborate regularly on-site.”

Conclusion:

It’s over a year of business disruptions within the pharmaceutical industry, at varying intensity and in different phases, though. For example, after more than a year since the pandemic hit India, Covid 2.0 has, reportedly, pushed up Indian pharmaceutical sales to a new high. It recorded an exponential growth of 59% year on year in April 2021, against 16 per cent – year on year in March 2021. This is obviously an outlier and is apparently unsustainable. Thus, for a sustainable good growth with greater certainty, Indian pharma players would require working out a well-researched digital blueprint of the future working framework of business operations with ‘what if’ options.

As has been revealed, remote working, wherever it makes robust business sense, will help getting hard-to-reach talent pools regardless of geography. This opportunity needs to be leveraged. However, it’s also a fact that for various reasons, everyone may not be too comfortable to work from home. Thus, the future work plan may call for a balanced and employee specific approaches.

Which is why, the process will require in-depth analysis of key functions where the personal presence of qualified staff is necessary, mainly because, no extent of technological interventions can compensate the human presence. Then follows the question – when to start opening in a responsible way – following all prescribed Covid related health norms. A representative pilot trial may help in this area.

Some of the key factors to consider will include speed of getting the staff vaccinated. Besides, arrangement for quick identification of breakthrough Covid infections among staff through quick tracing, testing, and provisions for appropriate hospitalization, if necessary, need to be put in place. Thus, I reckon, it’s time for the domestic pharma companies to diligently plan for unleashing the new potential of the respective organizations – amid the pandemic-triggered changes in market dynamics.

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.

 

 

Would ‘Connected Healthcare’ Catch Pharma Players Off-Guard?

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Rapid advancement of medical science is making several life-threatening diseases easily preventable, curable and manageable. For some conditions, such as, peptic ulcer even surgical interventions are no longer necessary. This results in the expansion of preventive and primary-care segments, with equal speed. Simultaneously, increasing complexity of many diseases, late stage disease detection, and better identification of rare diseases, are broadening the specialty hospital segment, as well.

On the other hand, the general mindset of people is also changing as fast. They dare to chart in the cyberspace, seek for more health-information, prefer participative care, expect a speedy treatment process – delivering better outcomes.

The cumulative impact of these are creating some brilliant sparks, confirming evolution of some disruptive health care business models. These are quite different from what we generally experience today.One such model is termed ‘connected healthcare.’ This is a unique business model, having potential to break the decades old status-quo – for the benefit of patients – closely involving doctors, pharma – medical device/diagnostic companies and of course the hospitals. In this article, I shall deliberate on ‘connected healthcare’ looking at its various aspects and examining whether pharma industry is ready for this change. Let me start this discussion with the role of Internet of Things (IoT), as an enabler for this process.

Internet of Things (IoT) – A great enabler for ‘connected health’:

‘Internet of Things (IoT)’ has opened new vistas of opportunities for providing healthcare with significantly better outcomes. According to Ecoconsultancy, by leveraging the IoT network, medical devices of everyday use can be made to collect, store and share invaluable medical data, providing a ‘connected healthcare’ system. Consequently, doctors, along with patients, can get speedy and deeper insights into symptoms and trends of diseases for prompt interventions, even from remote locations. The question that follows: what really is ‘connected health?’

‘Connected Health (cHealth)’ and a teething problem:

‘Connected health or (cHealth)’ refers to the process of empowering healthcare delivery through a system of connected and interrelated computing devices, mechanical and digital machines on an IoT network platform. It provides the ability for seamless data transfer and access between patients and providers, without requiring human-to-human interactions to improve both quality and outcomes of healthcare.

Two more articles, one titled ‘Connected health: How digital technology is transforming health and social care,’ and the other ‘Accelerating the adoption of connected health’, both published by Deloitte Center for Health Solutions also described ‘Connected health (cHealth)’quite eloquently.

One of the papers highlighted, being a technology driven network system, cHealth has its own teething problems. Some of its key reasons include: Many physicians ‘are often reluctant to engage with technology, partly due to the scale and pace of changes, and partly through lack of education and training, and concerns over liability and funding.’

Precise value offerings of a ‘Connected Health’ system:

The Accenture study titled, ‘Making the Case for Connected Health,’ established that ‘connected health’ approach creates value at three different levels, as follows:

  • Clinical efficacy and safety - Eliminating duplicate lab and radiology tests; improving patient safety through 24/7 access to comprehensive, legible medical records; and speeding up access to patient medical histories and vital information – the cost of treatment can be reduced, significantly.
  • Shared knowledge - Improves care quality, benefits with prompt safety alerts, such as drug interaction, enhances clinical decision-making through sophisticated tools along with evidence-based care protocols, and helps acquiring new capabilities in health care.
  • Care transformation - Advanced analytics help sharing clinical decision-making process, population health management, and facilitate building new care delivery models.

‘Connected health’ in managing chronic diseases:

‘Connected health’ is being practiced at different levels in many countries. These are particularly useful in treating or managing chronic ailments, such as cardiovascular (hypertension), metabolic (diabetes) disorders and COPD (Asthma).  Some examples are as follows:

Many hypertensive patients monitor their blood pressure and other related parameters, through self-operating digital instruments and devices. If the auto-flagged readings get transferred to the treating physicians through IoT system, physicians can promptly adjust the drug doses and offer other required advices over the same system online, and as and when required or periodically. This could avoid periodic personal visits to doctors for the similar purpose, saving time and money. At the same time, it ensures better quality of life through the desired level of disease management, always.

Similar results have been reported in the management of diabetes and Asthma with ‘connected health’ system.

 ‘Connected health’ in treating life-threatening diseases, like cancer:

The paper titled, ‘Smart technology helps improve outcomes for patients with head and neck cancer,’ published by the News Medical on May 17, 2018, which was also read at the June 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO), highlights some interesting developments in this area. This federally funded, randomized clinical trial on 357 people receiving radiation for head and neck cancer, using mobile and sensor technology to remotely monitor patient symptoms, resulted in less severe symptoms related to both the cancer and its treatment.

It also noted: ‘Patients who used the technology – which included a Bluetooth-enabled weighing scale, Bluetooth-enabled blood pressure cuff, and mobile tablet with a symptom-tracking app that sent information directly to their physician each weekday – had lower symptom severity than participants who had standard weekly visits with their doctors. In addition, daily remote tracking of patient wellbeing, according to the researchers, enabled physicians to detect concerning symptoms early and respond more rapidly, compared to usual care.’

While treating serious ailments, medical images, such as computed axial tomography (CT), magnetic resonance imaging (MRI), digital mammography and positron emission tomography (PET), can be connected, stored and shared with cloud-based connectivity and online sharing platforms, as confirmed by several studies. This would enable physicians to build better and deeper referral networks, for better diagnosis and speedier treatment inventions to patients.

‘Connected healthcare’ is fast growing:

As the above Accenture study indicates, many countries have started implementing  ‘connected healthcare’ systems to deliver cost-effective, high-quality and speedy healthcare services to the population with better outcomes. Some of these nations are, Australia, Canada, England, France, Germany, Singapore, Spain and the United States.

According to the New Market Research report titled, “Connected Healthcare Market – Global Industry Analysis, Size, Share, Trends, Growth and Forecast 2018 – 2022,” published by Wise Guy Research: ‘Globally, Asia-Pacific region is one of the fastest growing markets for ‘connected healthcare’. It was valued at USD 2.65 billion in 2015, and is expected to reach USD 23.8 billion by 2022, at the rate of 30.6% during the forecast period.’ During this span, ‘The global connected healthcare market is expected to reach $105,337.5 Million by 2022 at a CAGR of 30.27%,’ with North America commanding largest market share of 36.7%, the report highlights.

‘Connected health’ shows a high potential in India:

The above report also indicates, ‘mobile-health services’ accounts for the largest market segment in the UK, Italy, Japan, China and India. E-prescribing is the fastest growing segment in Asia Pacific and is expected to grow at the rate of 31.27% CAGR during the forecast-period.

E-Health initiative of the Government of India, which is aimed at using of Information and Communication Technology (ICT) in health signals a good potential for ‘connected health’ in India. Fast penetration of mobile technologies even at the hinterland of India will facilitate this process.

Another article titled, ‘Why Connected health is the key to reducing waste and increasing efficiency,’ published in Healthcare India on July 25, 2017, brings to the fore some key benefits of ‘connected healthcare’ in the country. It says, ‘connected healthcare’, can bring path-breaking changes in the country. Following are a few examples:

  • Today when almost 70 percent of the medical expenses are borne by the patient, a ‘connected health’ ecosystem, would reduce admissions by early intervention and potentially deter surgeries.
  • Having access to a patient’s entire medical record, physicians’ will be able to minimize ‘over diagnosis’, amounting to multiple tests, over-medication and avoidable prescriptions, thereby reducing out of pocket health expenditure of patients.
  • When patients are referred from one doctor to the other, or from the rural medical centers to district hospitals, they often need to repeat all the tests, as there is no connected health ecosystem. In doing so, they lose time and sometimes don’t show up for follow up treatments and consultations with their treatment remains incomplete.

Leading private players in ‘connected health’ area:

Some of the leading market players in the global ‘connected healthcare’ market, reportedly, include Agamatrix Inc. (USA), Airstrips Technology (San Antonio), AliveCore Inc. (Australia), Apple Inc. (USA), Athenahealth Inc. (USA), Boston Scientific Co. (USA), GE Healthcare (UK), Honeywell Life care Solutions (UK), Medtronics (Ireland) and Philips Innovation Campus (Bengaluru, India).

Would ‘Connected healthcare’ disrupt pharma’s legacy commercial model:

McKinsey Digital’s March 2012 paper titled, “Biopharma in the coming era of connected health” explains, how ‘connected healthcare’ has started disrupting the legacy commercial models of pharma and Biopharma industry. One of the related examples cited in the article is, pharma’s less emphasis on large sales forces “selling” to physicians.

As this new system gathers wind on its sail, information transparency will allow customers, regulators, and competitors to understand and independently assess the performance of various drugs, often better than what the manufacturers present. These powerful new data sources would reveal true efficacy of medicines, in the real-world settings. No doubt, it will be a significant patient empowerment.

Would pharma be caught off-guard?

Despite such clear signs of changes, the way the pharma industry continues to operate, which as perceived by a majority of the population, is generally self-serving in nature. It has remained virtually unchanged over several decades. Another strong public perception is, patients often get trapped by a two-way financial interest, existing between doctors, hospitals, pharma, biotech – medical devices/diagnostic companies, in various forms. Notwithstanding, industry lobbyists pooh-poohing it, it remains a robust general perception, nonetheless.

That said, this situation can no longer be allowed to remain frozen in time. Today, time is making many things obsolete, including human behavior and business practices, much faster than ever before. This gets fueled primarily by two catalytic factors – one, rapid progress of technology, and the other, which is even more fundamental – the changing demographic profile and social fabric. Together, these are creating a new, informed, more assertive and expressive mindset of people – signaling their needs, preferred choices and processes, even for a health care solution. It’s for the industry now to shape up, soon.

Conclusion:

Joining all these dots, one gets a clear sign of ‘connected healthcare’ gradually evolving in India. Even if, it still takes some more time for an integrated ICT system to be in place, especially in India, it’s for sure that ‘connected healthcare’ will be a reality, surely.

As and when it happens, it will be a disruptive process. The process of sharing all requisite disease prevention, treatment and management related data, between patients, doctors and other care providers, including pharma companies – over regulatory approved, interconnected IoT enabled devices, machines and applications, will benefit all.

There will, of course, be several barriers to overcome, before this new era ushers in. One such hurdle being, many doctors still don’t express a favorable attitude towards adoption of ICT technology in their everyday practice. Alongside, the government with the help of regulators, should enact the requisite laws, and frame stringent rules to ensure enough privacy and security of confidential medical information of individual patients. In tandem, appropriate authorities must ensure that ‘connected healthcare’ system is effectively implemented by all concerned.

As strong environmental needs will hasten this process, public access to high quality healthcare with better outcomes – and all at an affordable cost, will improve by manifold. Thus, I reckon, days aren’t too far to witness ‘connected health care’ in India. But, the hundred-dollar questions still remain unanswered – Are most pharma players ready for the ‘connected healthcare’ regime, or will it catch them off-guard?

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.

Prescription Digital Therapy Now A Reality

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The pursuit of offering ‘prescription digital therapeutics’ or ‘digiceuticals’ by Big Pharma, to ensure better clinical outcomes for patients, has apparently come to fruition now.

On April 18, 2018, by a media release, Novartis announced that the Sandoz Division of the Company has entered into collaboration with Pear Therapeutics to commercialize and continued development of digital therapeutics, designed to effectively treat disease and improve clinical outcomes for patients.

The collaboration brings on to the table, a synergy between Sandoz expertise in launching and commercializing various disease treatments, with Pear’s leading experience in digital therapeutics design and implementation. This deal has attracted attention of many. Mainly because, any pharma player will, for the first-time, detail a digital therapy treatment directly to the medical profession, and seek their prescription support.

It is worth noting that Pear’s flagship digital therapeutic – reSET is the first USFDA-cleared mobile medical application with both a safety and efficacy label to help treat patients with Substance Use Disorder, in September 2017. According to published reports, several studies have established that it is two-times more effective than conventional in person therapy sessions. Interestingly, the rate of treatment efficacy increases even up to tenfold, in refractory patients.

Just the beginning of a long run: 

The above market launch of a digital therapy by Novartis signals just the beginning of a long run in changing in the disease treatment archetype for better outcomes. Incidentally, prior to this announcement, on March 1, 2018, the same Company had announced, “Novartis and Pear Therapeutics to collaborate on prescription software applications aimed to treat patients with schizophrenia and multiple sclerosis.”

The media release underscored:“Psychiatric and neurodegenerative diseases place a heavy physical, mental and economic burden on patients and their families. With widespread adoption of digital devices, prescription digital therapeutics could potentially play an important role in future treatment models for a range of diseases with high unmet medical need”.

The scope and potential:

An article titled – ‘Digital therapeutics: Preparing for takeoff’,published by McKinsey & Company in February 2018, captures its scope succinctly. It says, “digital therapeutics tend to target conditions that are poorly addressed by the healthcare system today, such as chronic diseases or neurological disorders. In addition, they can often deliver treatment more cheaply than traditional therapy by reducing demands on clinicians’ time.”

A separate McKinsey interview article, titled ‘Exploring the potential of digital therapeutics’, published in the same month, elucidated the potential of digital therapy equally well.  It highlighted:“A digital therapeutic is an intervention based on software as the key ingredient, which has a direct impact on a disease. This is what distinguishes this category from the broader term digital health. We will see digital therapeutics and digital diagnostics integrate into the health system…”

‘Prescription digital therapy’ are not just ‘Fitness and Well-being’ Apps:

Prescription digital therapy are not just to monitor a person’s general fitness level against pre-identified parameters, and overall well-being. Whereas, digital therapeutics help patients to regularly and consistently monitor relevant and tailor-made disease related data - in real-time to detect behavioral, lifestyle and requisite biological changes on a daily basis. However, this is not ‘a so well-realized necessity’ today, especially, in the treatment of certain serious disease conditions, to ensure significantly better clinical outcomes for patients.

Digital therapeutics can ensure making a favorable change in patient behavior, which is not merely as efficient as administering medicines, but could also ensure greater effectiveness than conventional medications. Further, it assists patients to better understand, manage and control several disease conditions, and more importantly, sans any untoward side-effects.

Besides, with digital therapy, the required treatment interventions will reach patients faster than traditional treatment processes. Both the patient request and the medical response for the same can be quickly exchanged, together with relevant data support, through smartphones or other wearable digital interfaces – either in the form of voice or text or both. I shall dwell on this later in the article. Thus, digital therapy may not require patients to meet the doctor every time a need arises.

Moreover, fitness and wellbeing Apps do not require marketing approval from a country’s drug regulator. Mostly because, they help monitoring general and generic fitness parameters, capturing some low-risk changes. Whereas, a custom-made prescription digital therapy would necessarily require such regulatory nod.

In tandem, various studies are also being conducted on wearables, such as an Apple Watch, as an interface. The following are examples of some of these studies:

Digital therapy study with Apple Watch as an interface:

In February 2017, Takeda Pharmaceuticals U.S.A. and Cognition Kit Limited, announced a collaboration to pilot the use of a specially designed app on an Apple Watch wearable to monitor and assess cognitive function in patients with Major Depressive Disorder (MDD).

In November 2017, they presented results from ‘Digital Wearable Technology Study’ in patients with MDD. The observational study involved 30 participants, aged 18-65, with a clinical diagnosis of mild to moderate depression who have been prescribed antidepressant monotherapy for MDD.

The study also evaluated feasibility and participant compliance with measures of mood and cognition on wearable technology; and compared measures of mood and cognition on wearable technology using traditional neuropsychological testing and patient reported outcomes on depression symptoms at 6 weeks. Participants were provided with an Apple Watch on which brief cognitive and mood tests were administered daily.

The researchers observed that patients were compliant with the wearable Apple Watch device on a daily basis to evaluate mood (95 percent) and cognition (96 percent). The study also demonstrated that abbreviated daily assessments delivered through the wearable Apple Watch device corresponded with objective Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive tests and full-length patient reported outcomes, PHQ-9 and PDQ-D, assessed during weeks 1, 3 and 6. No adverse events were reported in the study.

According to another report, this user interface with Apple’s smart-watch versions 2 and 3 is now being used in a number of studies for chronic conditions, such as Parkinson’s disease – combining biometric data with user input. Again, in February 2017, Johns Hopkins University announced a project to use the smart-watch for research on possible triggers of epileptic seizures.

When used as an interface with prescription digital therapy, the provision of e-SIM and GPS in Apple Watch Series 3, I reckon, would also help patients to immediately communicate with the remote therapy centers using the same device, anytime – as and when the patients want.

Digital therapy initiatives in India:

Initiative on digital therapy has already started rolling in India, as well. Its pace is also quite encouraging. For example, Wellthy Therapeutics is building a patient centric solution for diabetes through digital intervention and management. On February 20, 2018, the Company, reportedly, shared the interim results of an ongoing real-world pilot to evaluate the effectiveness of the Wellthy Diabetes Smartphone App (WD). The results were shared at the 11th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2018) in Vienna, Austria.

The data demonstrated how the use of WD improved glycemic control. On completion of 16 weeks, participants showed a reduction in their HbA1c by (-0.61%) on average, with 61.5% of participants having showed significant reduction in their HbA1c with an average of (-1.17%) reduction.

Conclusion:

As indicated in my article titled, ‘Digiceuticals: A Force Multiplier to Contain Chronic Diseases’, published in this blog on October 23, 2017,prescription digital therapies are primarily of two types – one for “medication augmentation” and the other for “medication replacement.”

Be that as it may, prescription digital therapyimproves clinical outcomes for patients by manifold. It also shows potential to take over from traditional treatment with medicines in several serious and virtually crippling ailments, mostly related to human behavior and lifestyle, such as a host of chronic diseases, and without causing any side-effects.

Thus, prescription digital therapy is now a reality. It has come to stay for long – can’t be wished away, any longer.

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.

A Potential Game Changer For Pharma R&D

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The ghost of ‘Patent Cliff’ has been haunting the ‘Big Pharma’ since quite some time. This situation has been further aggravated by cost containment pressures of various Governments both in the developed and the emerging markets together with contentious issues on Intellectual Property Rights (IPR).

The ‘dream run’ that the innovator companies enjoyed in launching patented products so frequently and making many those blockbuster drugs of billions of dollars, is no longer a reality.

According to the findings of ‘Pharmaceutical R&D returns performance’ by Deloitte and Thomson Reuters of December 2012, the R&D Internal Rate of Return (IRR) of leading pharmaceutical companies had fallen to 7.2 percent in 2012 from 7.7 percent in 2011.

Many would, therefore, tend to believe that the paradigm is changing significantly. The new paradigm in the brand new millennium throws some obnoxious challenges, including some related to IPR, triggering a process of churning in the global pharma industry. Some astute CEOs of ‘Big Pharma’, having a deep introspection, are bracing for restructuring, not just in the business processes, but also in the process of organizational behavior, mindset, ethics and values. Unfortunately, there are many who seem to believe that this giant wheel of change can be put on the reverse gear again with might.

A new PPP initiative in pharma research:

This trying situation calls for collaborative initiatives to achieve both knowledge and cost synergies for a quantum leap in harnessing R&D output.

One such big laudable initiative has come to the fore recently in this arena. Having experienced something like the ‘law of diminishing return’ in pursuit of high resource intensive R&D projects aimed at critical disease areas such as Alzheimer’s, 10 big global pharma majors reportedly decided in February 2014 to team up with the National Institutes of Health (NIH) of the United States in a ‘game changing’ initiative to identify disease-related molecules and biological processes that could lead to future medicines.

This Public Private Partnership (PPP) for a five-year period has been named as “Accelerating Medicines Partnership (AMP)”. According to the report, this US federal government-backed initiative would hasten the discovery of new drugs in cost effective manner focusing first on Alzheimer’s disease, Type 2 diabetes, and two autoimmune disorders: rheumatoid arthritis and lupus. The group considered these four disease areas among the largest public-health threats, although the span of the project would gradually expand to other diseases depending on the initial outcome of this project.

Not the first of its kind:

AMP is not the first PPP initiative of its kind. The Biomarkers Consortium was also another initiative, not quite the same though, of a major public-private biomedical research partnership managed by the Foundation for the NIH with broad participation from a variety of stakeholders, including government, industry, academia, patient advocacy groups and other not-for-profit private sector organizations.

Open innovation strategy of GlaxoSmithKline (GSK) to discover innovative drugs for malaria is yet another example, where GSK collaborated with the European Bioinformatics Institute and U.S. National Library of Medicine to make details of the molecule available to the researchers free of cost with an initial investment of US$ 8 million to set up the research facility in Spain, involving around 60 scientists from across the world to work in this facility. 

Nearer home, ‘Open Source Drug Discovery (OSDD)’ project of the Council of Scientific and Industrial Research (CSIR) is a now a global platform to address the neglected tropical diseases like, tuberculosis, malaria, leishmaniasis by the best research brains of the world working together for a common cause.

Challenges in going solo:

In this context, it is worth mentioning that the CEO of Sanofi, Chris Viehbacher reportedly said in an interview on April 15, 2013 that his company “Won’t push hard to find an Alzheimer’s treatment because the science isn’t advanced enough to justify the costs to develop a drug. Therefore, Sanofi definitely won’t commit major resources seeking to discover an Alzheimer’s therapy.” He further stated, “I think we have to do a lot more basic science work to understand what’s going on. We really, at best, partially understand the cause of the disease. It’s hard to come up with meaningful targets.”

The above report also mentioned that the first Alzheimer’s drugs, should they prove successful, would lead to a market worth US$ 20 billion as estimated in 2012.

Long desired OSDD model:

The new AMP R&D model in the United States seems to have derived its impetus from the “open-source” wave that has swept the software industry. Keeping that spirit unchanged, in this particular ‘open source’ model too, the participants would share all scientific findings with the public and anyone would be able to use these results freely for their own research initiatives.

The collaborators of this PPP project are expected to gain a better understanding of how each disease type works, and thereafter could make use of that collaborative knowledge to discover appropriate new molecules for the target disease areas.

AMP is also expected to arrive at methods to measure a disease progression and its response to treatment much more precisely. This will enable the pharma participants getting more targets right and early, thereby reducing the high cost of failures. Just to cite an example, there have been reportedly 101 failures since 1998 in late-stage clinical trials by Pfizer, J&J and Elan Corp.

Commendable initiative in the uncharted frontier:

The ‘open source’ AMP initiative of ‘Big Pharma’ in the uncharted frontier is indeed very unusual, as the innovative drug companies are believed to be not just quite secretive about the science that they are engaged in, but also near obsessive in pursuing and clinging-on to the Intellectual Property Rights (IPR) through patents for each innovative steps related to potential new drugs.

It is worth noting that like any OSDD model, this PPP agreement also denies the participating players from using any discovery for their own drug research up until the project makes all data public on that discovery.

However, as soon as the project results will be made public, fierce competition is expected all around to develop money-spinning winning drugs.

Participating companies:

Ten pharma companies participating in AMP are reportedly, AbbVie, Biogen Idec, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Merck & Co., Pfizer, Sanofi and Takeda. It is good to find within the participants some staunch business rivals. According to a report, a number of foundations, including the American Diabetes Association and the Alzheimer’s Association have also agreed to get involved in the project.

Some key non-participants:

For various different reasons some key pharma majors, such as, Amgen, Roche and AstraZeneca have decided not to participate in AMP.

AMP project and cost:

AMP reportedly has reportedly articulated its intent to: “Map molecular paths that each disease follows and to identify key points that could be targets for treatment. In Type 2 diabetes, for instance, researchers hope to catalog the genetic changes that raise or lower a person’s risk for developing the disease. It also will seek novel methods to measure each disease’s course while assessing if a potential drug is working. Being able to measure a disease’s progress in that way, could speed drug development by raising a company’s confidence that an experimental drug is working, or let it more quickly end a project if a drug isn’t working.”

The participating companies and the NIH have jointly agreed that the AMP would put together a research system on cost sharing basis by pooling the brightest minds who are experts on each disease, along with the best drug discovery laboratories, relevant data and samples from clinical trials to decipher the diseases in ways, which none of these pharma players has been able to achieve just yet on its own.

To achieve all these, the total cost has been estimated at roughly just US$ 230 million, as compared to US$135 billion that the global drug industry claims to spend in a year on R&D.

This should also be seen in context of a study of December 2012 carried out by the Office of Health Economics (OHE), UK with a grant from AstraZeneca, which estimated that the cost of developing new medicine has risen by ten times from US$100 million in the 1970s to as high as US$ 1.9 billion in 2011.

As a head honcho of a global pharma biggie had put it earlier, a large part of these R&D expenses are the costs of failure, as stated above.

Criticism:

As usual, criticism followed even for this path-breaking project. Critics have already started questioning the rationale of the choice of the above four disease areas, with an exception perhaps for Alzheimer’s and wondered whether the participating players are making use of the federal fund to push hard the envelope of their respective commercial intents.

Another new collaborative approach: 

In another recently announced collaborative initiative, though not of the same kind, where Merck & Co has reportedly entered three separate collaboration agreements to evaluate an immunotherapy cancer treatment that is part of a promising new class of experimental drugs that unleash the body’s immune system to target cancer cells.

Conclusion:

There could still be some hiccups in the process of effective implementation of the AMP project. Hope, all these, if any, will be amicably sorted out by the participants of stature for the benefits of all.

Be that as it may, ‘open source’ model of drug discovery, as believed by many, would be most appropriate in the current scenario to improve not only profit, but also to promote more innovative approaches in the drug discovery process.

On May 12, 2011, in an International Seminar held in New Delhi, the former President of India Dr. A.P.J. Abdul Kalam highlighted the need for the scientists, researchers and academics to get effectively engaged in ‘open source’ philosophy by pooling talent, patents, knowledge and resources for specific R&D initiatives from across the world for newer and innovative drugs.

According to available reports, one of the key advantages of the ‘open source’ model would be substantial reduction in the high cost of failures of R&D projects, which coupled with significant saving in time would immensely reduce ‘mind-to-market’ span of innovative drugs in various disease areas, making these medicines affordable to many more patients.

Thus, PPP initiatives in pharmaceutical R&D, such as AMP, are expected to have immense potential to create a win-win situation for all stakeholders, harvesting substantial benefits both for the pharmaceutical innovators and the patients, across the world.

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.

 

 

 

 

The issue of ‘Counterfeit Drugs’ in India: An “Ostrich Syndrome’

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Ellen‘t Hoen, former Policy Advocacy Director of MSF’s Campaign for Access to Essential Medicines wrote in April 2009 as follows:

“People often seem to confuse counterfeit, substandard and generic medicines – using the terms interchangeably. But they are very separate issues and clearly defining their differences is critical to any discussion”.

In November 7, 2009, Financial Express reported with a headline, “Generic drug companies see a bitter pill in counterfeit“, because some believe that it has an in-built intellectual property right connotation.
The WHO debate:

‘Intellectual property Watch’ in May 20, 2010 reported as follows:

“Brazil and India claimed that WHO’s work against counterfeit and substandard medicines is being influenced by brand-name drug producers with an interest in undermining legitimate generic competition. The Brazilian ambassador told Intellectual Property Watch there is a “hidden agenda” against generics from countries like Brazil.

“India and Brazil filed requests for consultations with the European Union and the Netherlands over the seizure of generics medicines in transit through Europe. This is the first step towards a dispute settlement case, and if issues cannot be resolved via consultations then formation of a dispute settlement panel could be requested in the coming months”.

In response to such allegations the International Federation on Pharmaceutical Manufacturers and Associations (IFPMA) released a document titled, “ten principles on counterfeit medicines” and categorically stated that “patents have nothing to do with counterfeiting and counterfeiting has nothing to do with patents.”

In this seemingly volatile scenario, the key point to understand is the definition of a ‘Counterfeit Drug’.

The dictionary definition:
The word ‘Counterfeit’ may be defined as follows:
1. To make a copy of, usually with the intent to defraud
2. To carry on a deception or dissemble
4. To make fraudulent copies of something valuable
5. A fraudulent imitation.
What does the Indian Drugs and Cosmetics Act say?
Presumably in the spirit of the above definition, the Drugs and cosmetics Act (D&CA) of India has specified that manufacturing or selling of the following types of drugs are punishable offence:
Section 17: Misbranded drugs
Section 17-A: Adulterated drugs
Section 17-B: Spurious drugs
The question therefore arises, as misbranding could involve trademark and design, why does it fall under D&CA?
This was done in the past by the law makers, as they believed that any attempt to deliberately and fraudulently pass off any drug as something, which it really is not, could create a serious public health issue, leading to even loss of lives.
Be that as it may, the pharmaceutical industry all over the world sincerely believes that counterfeit drugs involve heinous crime against humanity.

Another argument:

Some voices in India have also expressed that ‘Counterfeit Drugs’ are a Health issue. Why are we then mixing up non-health IPR issues like trademarks and designs along with it?

Should the definition of ‘Counterfeit Drugs’ cover all types of medicines, which are not genuine?

Definition of counterfeit drugs should, therefore, cover the entire gamut of medicines, which are not genuine. Such medicines could be a fraudulent version of patented, generic or even traditional medicines and have nothing to do with patents or patent infringements.
At the same time it sounds very reasonable that a medicine that is authorized for marketing by the regulatory authority of one country but not by another country should not be regarded as counterfeit on this particular ground in any country, unless it has been made available fraudulently. It will be absolutely improper for anyone to term generic drugs as counterfeits, in the same way.

The magnitude of the problem:

International Medical Products Anti-Counterfeiting Task Force (IMPACT) reported in 2006 as follows:

“Indian pharmaceutical companies have suggested that in India’s major cities, one in five strips of medicines sold is a fake. They claim a loss in revenue of between 4% and 5% annually. The industry also estimates that spurious drugs have grown from 10% to 20% of the total market.”

CDSCO surveys on ‘Spurious’ and ‘Sub-standard’ drugs in India:

Central Drugs Standard Control Organization (CDSCO) of the Government of India has released the following details on ‘Counterfeit Drugs’ in India from 2006 to 2010.

Year Drugs samples tested % of sub-standard drugs % of spurious drugs Prosecution for crime Persons arrested
2006 – 07

34738

5.8

0.22

115

12
2007 – 08

39117

6.2

0.19

120

122
2008 – 09

45145

5.7

0.34

220

133
2009 -10

39248

4.95

0.29

138

147

TOTAL

158248

5.66

0.26

593

414

It is indeed very surprising to note from the above CDSCO report that from 2006 to 2010 the number of both arrests and prosecutions for this heinous crime in India is abysmally low.

To assess the magnitude of the menace of counterfeit drugs, Financial Express dated November 12, 2009 reported that much hyped “world’s largest study on counterfeit drugs” conducted by the Ministry of Health of the Government of India with the help of the Drug Controller General of India’s office, has come to the following two key conclusions:
1. Only 0.046% of the drugs in the Indian market were spurious
2. Only 0.1% of drugs are of sub-standard quality in India

Is there really nothing to worry about?

From these reports, it appears that India, at this stage, has nothing to worry about this public health hazard!

It is indeed equally baffling to understand, why did the government keep ‘misbranded drugs’, as specified in the Drugs and Cosmetics Act of India, outside the purview of this study.
In my opinion, the above recent survey has raised more questions than what it had attempted to answer. Such questions are expected to be raised not only by the pharmaceutical industry of India, its stakeholders and the civil society at large, but by the international community, also.
The problem of ‘Counterfeit Drugs’ is more prevalent in countries where regulatory enforcement is weak:
The menace of counterfeit medicines is not restricted to the developing countries like, India. It is seen in the developed countries, as well, but at a much smaller scale. Thus it is generally believed that the issue of counterfeit drugs is more common in those countries, where the regulatory enforcement mechanism is weak.
A study done by IMPACT in 2006 indicates that in countries like, the USA, EU, Japan, Australia, Canada and New Zealand, the problem is less than 1%. On the other hand, in the developing nations like parts of Asia, Latin America and Africa more than 30% of the medicines are counterfeits.
The role of ‘The World health Organization (WHO)’:
To effectively eliminate this global menace, the leadership role of the WHO is extremely important. Across the world, patients need protection from the growing menace of ‘Counterfeit Medicines’. As a premier organization to address the needs of the global public health issues and especially for the developing world, the WHO needs to play a key and much more proactive role in this matter.

Conclusion:
All stakeholders of the pharmaceutical industry must be made aware, on a continuous basis, of the health hazards posed by counterfeit medicines in India. Authorities and organizations like the Drug Controller General of India (DCGI) and its regulatory and enforcement agencies, healthcare professionals, patients, all pharmaceutical manufacturers, drug distributors, wholesalers and retailers should collaborate to play a very active and meaningful role in curbing the counterfeit drugs from reaching the innocent patients.

Instead of all these, as we witness today, the country keeps on demonstrating an ‘Ostrich Syndrome’, shouting from the roof top, as it were, that no health hazards due to prevalence of ‘Counterfeit Drugs’ exist in India.

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

India needs ‘Orphan Drugs Act (ODA)’ to counter growing threat of dreaded rare diseases and simultaneously boost global growth potential of the Indian Pharmaceutical Industry

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An orphan disease is a rare and uncommon disease and an ‘Orphan Drug’ is a pharmaceutical substance that has been developed to treat an orphan disease. The US FDA defines a rare disease, with a prevalence of 1 in 5,000 of the general population, whereas in the European Union (EU) defines it as a disease with a prevalence of 5 in 10,000 of the population.

Around 6-8% of the world population is manifested by such rare diseases. There are around 5000 of reported rare diseases with an ascending growth trend.

Despite such trend, high drug development cost coupled with low return on investment, do not encourage many innovator pharmaceutical companies to get engaged in R&D initiatives for such drugs. However, this perception is fast changing, as we shall see below.

US took the first step to encourage commercialization of ‘Orphan Drugs’:

Public awareness drives for ‘Orphan Diseases’ first originated in the USA with the formation of a rare disease support group representing around 200,000 patients suffering from such diseases. This awareness campaign ultimately culminated into a path breaking legislation in the US named, ‘Orphan Drugs Act’ (ODA), in 1983. The key purpose of ODA was to incentivize initiatives towards development of such drugs to treat around 25 million Americans suffering from ‘Orphan diseases’. The incentives included:

- Funding towards investigation for “Orphan Disease’ treatment
- Tax credit for Clinical Research
- Waiver of fees for New Drug Application (NDA)
- Offering more lucrative incentive than product patent (product patent requires the drug to be novel), as the orphan designation of the product by the US FDA and product approval by them are the only requirements for 7 year market exclusivity of an ‘Orphan Drug’ for the same indication.
- Market exclusivity of ‘Orphan Drugs’ become effective from the date of regulatory approval, unlike product patent, product development time remains outside this period.
- The drugs, which are not eligible for product patent, may be eligible for market exclusivity as an ‘Orphan Drug’ by the US-FDA

Thanks to this Act, currently around 230 ‘Orphan Drugs’ are available in the US for the treatment of around 11 million patients suffering from rare diseases. With the help of ‘Human Genome Project’ more orphan diseases are expected to be identified and newer drugs will be required to treat these rare ailments of human population.

1983 signaled the importance of ‘Orphan Drugs’ with the ODA in the US. A decade after in 1993, Japan took similar initiative followed by Australia in 1999. Currently, Singapore, South Korea, Canada and New Zealand are also having their country specific ODAs.

India needs ODA:

Unfortunately in India, we do not have any ODA, as of now. Such legislation could give a new fillip to the Indian Pharmaceutical and Bio-Pharmaceutical industry and at the same time usher in a new hope to thousands of patients suffering from rare diseases in India, with the availability of relatively lower cost medications to them.

The global market:

The global market of ‘Orphan Drugs’ is expected to grow to US $ 112 billion in 2014 from US $85 billion in 2009. Biotech products contribute around 70% of this turnover with relatively higher CAGR growth rate of around 7%. However, reluctance of the insurance companies to cover ‘Orphan Drugs’ due to higher price still remains a global issue.

Orphan drugs to create a paradigm shift in the Pharmaceutical Industry: says Frost & Sullivan:

“While the pharmaceutical industries have been focusing on ‘blockbuster’ small molecules (chemical drugs) for high revenue generation in the past, it is expected that in 5 years, around $90.0 billion worth of branded drugs will lose their exclusivity. The current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies and they are moving to a new business model – ‘Niche busters’, also called Orphan drugs.”

It is believed that Orphan drugs will now offer an attractive opportunity to the pharmaceutical companies than ever before to significantly absorb the impact of the ‘Patent Cliff’. Various financial incentives provided by the governments of various countries under the ODA coupled with many smaller collaborative projects towards this direction will further encourage the global pharmaceutical players to develop ‘Orphan Drugs.

Currently, EU has granted over 700 ‘Orphan Designations’ and over 60 new drugs have received favorable response for Market Authorization.

Sales potential for ‘Orphan Drugs’:

Generally ‘Orphan Drugs’ were not expected to be very high revenue earners. However, about 4 year ago in the year 2006, about 50 ‘Orphan Drugs’ were reported to had crossed a sales turnover of US $200 million. In 2006 the following ‘Orphan Drugs’ with expired market Exclusivity in the US, had assumed blockbuster status:

- Enbrel (Immunex): US $ 4.38 billion
- Rituxan (Genentech): US$ 3.97 billion
- Nupogen/Neulasta (Amgen): US $ 3.92 billion
- Epogen (Amgen): US $ 2.50 billion
- Avonex (Biogen): US $ 1.70 billion
- Betaseron (Novartis & Bayer): US $ 1.33 billion
- Intron A/ PEG-Intron (Schering): US $ 1.07 billion
- Kogenate (Bayer): US $ 1.07 billion
- Ceredase/Cerezyme (Genzyme): US $ 1.00 billion

Key growth drivers for ‘Orphan Drugs’:

In my view the following key factors will play critical role in driving the growth for ‘Orphan Drugs’:

- Market exclusivity options for a number of FDA recognized ‘Orphan Indications’ for the same drug
- Market exclusivity for seven years in the U.S. and ten years in the EU for each of the ‘Orphan Indications’
- Oncology could be a good segment to get such multiple ‘Orphan Indications’ for the same molecule

Glivec of Novartis obtained approval for around five new ‘Orphan Indications’, the key indications being Chronic Myelogenous Leukemia (CML) and Gastrointestinal Stomal Tumors. The product has already assumed a global blockbuster status with an estimated sales turnover of over US $4 billion by 2011.

Biotech companies are champions for the development of ‘Orphan Drugs’, globally:

Since long, the Biotech companies are taking initiatives for the development of ‘Orphan Drugs’. The path breaker in this respect was Genentech of the US, which developed two growth hormone molecules with names Protophin and Nutrophin, way back in 1985. Now, having realized the hidden potential of this segment more number of pharmaceutical players are entering into this arena. Thus, it is no wonder that 13 out of 19 blockbuster ‘Orphan Drugs’ were biologics in the year 2006.

Conclusion:

It is interesting to note that some of the ‘orphan diseases’ are now being diagnosed in India, as well. As India takes rapid strides in the medical science, more of such ‘Orphan Diseases’ are likely to be known in our country. Thus the moot question is how does India address this issue with pro-active measures?
Currently, India is curving out a strong niche for itself in the space of biogenerics. Pfizer-Biocon deal will vindicate this point.

Moreover, with Pharmacogenomics keep gaining ground at a faster pace, as I mentioned earlier, there will be a shift towards personalized medicines, in not too distant future, in which case the blockbuster drugs as defined today, will be effective only for a smaller number of patients. If the Government of India visualizes this scenario sooner, and comes out with appropriate ODA for the country, domestic pharmaceutical industry of India, in general and biopharmaceuticals industry of the country, in particular, will be able emerge as a force to reckon with, in this important global space, much faster than what one would currently anticipate.

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.

Leverage the potential of ‘Telemedicine’ to effectively address the healthcare needs of India

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The World Health Organization (WHO) has defined telemedicine as follows:

“The delivery of healthcare services, where distance is a critical factor, by all healthcare professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for continuing education of healthcare providers, all in the interests of advancing the health of individuals and their communities”

Telemedicine is gradually becoming popular in India, like in many other countries of the world. This emerging technology based healthcare service, will surely meet the unmet needs of the patients located in the far flung areas, by providing them access to medical specialists for treatment of even tertiary level of their ailments, without requiring to travel outside their villages or small towns where they reside. Telemedicine is, therefore, slowly but gradually emerging as a convenient and cost-effective way of treating even complicated diseases of the rural population.

The applications of Telemedicine:

1. To extend affordable quality healthcare services to those places where these are not available due to basic healthcare infrastructure and delivery issues.

2. Electronic transmission of clinical information of both synchronous and asynchronous types, involving voice and data transfer of patients to distantly located experts and get their treatment advice, online.

3. To effectively train the medics and the paramedics located in distant places and proper management of healthcare delivery/service systems.

4. Disaster management.

The Process:

The process can be:

- ‘Real time’ or synchronous when through a telecommunication link real time interaction between the patients and doctors/experts can take place. This technology can be used even for tele-robotic surgery.

- ‘Non-real time’ or asynchronous type when through a telecommunication link, stored diagnostics/medical data and other details of the patients are transmitted to the specialists for off-line assessment and advice at a time of convenience of the specialists.

These processes facilitate access to specialists’ healthcare services by the rural patients and the rural medical practitioners reducing avoidable travel time and related expenses. At the same time such interaction helps upgrading the knowledge of the rural medical practitioners and paramedics.

The Promise:

‘Telemedicine’ is capable of taking modern healthcare to remote rural areas using Information Technology (IT), as specialists are mostly based in the cities. As majority of the diseases do not require surgery, ‘telemedicine’ will prove to be very conducive to such patients and economical too.
Relevance of Telemedicine in India:

With its over 1.12 billion population and equally huge and not so well addressed disease burden, spreading across distant and remote semi-urban and rural areas where over 70 per cent of the population of the country lives, India by any standard is a country, which should focus on ‘Telemedicine’ to meet the unmet healthcare needs of the common man.

Telemedicine, therefore, is very relevant for the country, as it faces a scarcity of both hospitals and medical specialists. In India for every 10,000 of the population just 0.6 doctors is available. According to the Planning Commission, India is short of 600,000 doctors, 10 lakh nurses and 200,000 dental surgeons. Over 72 percent of Indians live in rural areas where facilities of healthcare are still grossly inadequate. Most of the specialists are reluctant to go to the rural areas. In addition, 80 percent of doctors, 75 percent of dispensaries and 60 percent of hospitals, are situated in urban India.

Telemedicine should be leveraged to bridge the gap of healthcare divide:

Equitable access to healthcare is the overriding goal of the National Health Policy 2002. Telemedicine has a great potential to ensure that the inequities in the access to healthcare services are adequately addressed by the country.

ISRO and the progress of Telemedicine in India:

The concept of ‘Telemedicine’ is relatively new in India and started drawing attention of the Government since 1999, when the Indian Space Research Organization (ISRO) deploying a SATCOM-based telemedicine network took its pioneering step towards this direction and is currently playing a key role in the evolution and development of ‘telemedicine’ in India. ISRO with its effective application of world class satellite communication technology with modern medical science and information technology has engaged itself very seriously to ensure availability of specialty healthcare services right at the doorsteps of a vast majority of deprived population living even in the distant and remote places of the rural India.

Government and private initiatives:

Since then the Ministry of Health and Family welfare with its initiative through information technology in some country level projects forming the National Telemedicine Taskforce, some private healthcare institutions like Apollo and various State Governments like, Tamil Nadu, Andhra Pradesh, Kerala and West Bengal also took admirable initiatives to translate the concept of ‘telemedicine’ into reality, especially for the rural India.

Subsequently, private telemedicine solution providers have now started coming-up, in a very sporadic manner though. Active participation of the civil society and meaningful Public private Partnership (PPP) projects are essential not only to get engaged in creating awareness for ‘telemedicine’ within India, but also to ensure that required blend of a high quality of technical and medical manpower that the country currently possesses are effectively utilized to establish India as a pioneering nation and a model to emulate in the field of telemedicine.

The market of Telemedicine in India:

Frost & Sullivan has estimated the telemedicine market of India at US$3.4 million, which is expected to record a CAGR of over 21 percent between 2007 and 2014.

Practices of Telemedicine in India:

Not only the central government of India, many state governments and private players are also entering into telemedicine in a big way with the Indian Space Research Organization (ISRO) playing a pivotal role, as indicated earlier. Some of the encouraging examples are as follows:

Telemedicine in Tamil Nadu:

Wi-Fi video conferencing network has now enabled ophthalmologists in the country to treat patients located in distant rural areas.

For example in an eye clinic in Andipatti village of Tamil Nadu state patients are connected through an inexpensive Wi-Fi video conferencing network with an ophthalmologist located about 15 kilometers away at the Aravind Eye Hospital in the city of Theni, for diagnosis and treatment of ophthalmological conditions. It has been reported that in the last six years eight such vision centers have been opened in the Theni district to provide eye treatment through ‘telemedicine’ to the affected population. These centers are managed by ophthalmic assistants trained to conduct a full eye examination, administer diagnostic tests, treat simple ailments and prescribe glasses. An ophthalmologist located as far away as 150 kilometers gives the final advice to the patients through videoconferencing and incurring a fraction of the expenses of what the patient would have otherwise incurred for getting treated at the district hospital of Theni.

World Health Organization (WHO) in its recent report has highlighted that about one third of the 45 million blind population of the world, live in India with majority of the causes being easily treatable cataracts and diabetes. It is worth mentioning that India has pledged to eliminate avoidable blindness in 10 years, under WHO 2020 initiative.

The Government of India is contemplating to create 20,000 more rural vision centers in the next few years.

Telemedicine in Kerala:

In Kerala selected referral Telemedicine Centers which are ‘Taluk Hospitals’ are connected to the Specialty hospitals through ISDN dial-up connection and the Telemedicine software MERCURY for creating and transferring the Electronic Medical Record (EMR) from sources like ECG, Microscope and Scanner.

A Telemedicine system for Cancer Patients called ‘CancerNet’ has also been created in the state for cancer detection, treatment, pain relief ,patient follow-up and continuity of care in peripheral hospitals (nodal centers) of Regional Cancer Centre (RCC). This facility connects RCC, Trivandrum and five nodal outreach centers. More than 3000 patients are treated or consulted in these nodal centers offering significant financial benefits to patients.

The specialty centers are located at:

• Medical College Hospital, Thiruvananthapuram
• Sree Chitra Thirunal Institute of Medical Science and Technology, Thiruvananthapuram
• Regional Cancer Center,Thiruvananthapuram
• Mental Health Centre, Thiruvananthapuram

The remote nodal centers are located at:

• Taluk Hospital, Neyyattinkara
• Taluk headquarters Hospital, Quilandy
• Taluk Hospital, Mavelikkara
• Taluk Hospital, Vythiri, Wayanad

Telemedicine in Andhra Pradesh:

Among the private initiatives the Apollo group of hospitals took a pioneering initiative in ‘telemedicine’ with a pilot project at a secondary level hospital in Aragonda village located about16 km away from the town Chittoor in Andhra Pradesh, covering a population of 5000.

Telemedicine in West Bengal:

Telemedicine for Tropical Diseases utilizing Technology developed by WEBEL & IIT Kharagpur has been developed by the state for diagnosis and monitoring of skin and blood related tropical diseases in West Bengal. The facility has been installed in School of Tropical Medicine, Kolkata and two District Hospitals. This is now being upgraded and extended to cover two referral hospitals and four District hospitals.

Telemedicine in North Eastern States:

A facility of Telemedicine Solution is being developed in Kohima Hospital of Nagaland under a Public Private Partnership (PPP) between the Government of Nagaland, Marubeni India Ltd, Apollo Hospitals and the Ministry of Communications and Information Technology. Two telemedicine centers are being set up connecting hospitals in the capitals of the North-eastern states, Sikkim and Tripura with super-specialty hospital under Community Information Centre scheme of DIT. North Eastern Council of India is planning to cover all 75 districts in seven states through Telemedicine.

Allocate more fund for Telemedicine:

Telemedicine now shows an immense potential, within the frugal healthcare infrastructure of India, to catapult rural healthcare services, especially secondary and tertiary, to a different level altogether. Current data indicate that over 278 hospitals in India have already been provided with telemedicine facilities. 235 small hospitals including those in rural areas are now connected to 43 specialty hospitals. ISRO provides the hospitals with telemedicine systems including software, hardware, communication equipment and even satellite bandwidth.

In 1999, India based one of the largest healthcare providers in Asia, The Apollo Hospitals Group also entered into telemedicine space. Today, the group has quite successfully established over 115 telemedicine locations in India, It has been reported that a ‘tele-consultation’ between the experts and the rural center ranges from 15 to 30 minutes in these facilities.

The state governments and private hospitals are now required to allocate adequate funds to further develop and improve penetration of Telemedicine facilities in India.

Issues with Telemedicine in India:

- Telemedicine is not free from various complicated legal, social, technical and consumer related issues, which need to be addressed urgently.

- Many a time, doctors feel that for Telemedicine they need to work extra hours without commensurate monetary compensation, as per their expectations.

- The myth created that setting up and running a Telemedicine facility is expensive needs to be broken, as all these costs can be easily recovered by any hospital through nominal charges to the patients.

- Inadequate and uninterrupted availability of power supply could limit proper functioning of a telemedicine center.

- High quality of Telemedicine related voice and data transfer is of utmost importance. Any compromise in this area may have significant impact on the treatment outcome of a patient.

- Lack of trained manpower for Telemedicine can be addressed by making it a part of regular medical college curriculum.

- Legal implications, if arise, out of any Telemedicine treatment need to be clearly articulated.

- A system needs to be worked out to prevent any possible misuse or abuse of the confidential Telemedicine treatment data of a patient.

- Reimbursement procedure of Telemedicine treatment costs by the medical insurance companies needs to be effectively addressed.

Conclusion:

Because of a very large population of India living in remote and distant rural areas, ‘telemedicine’ would play a very special and critical role in India to address the healthcare needs of the common man. With increasing coverage of telemedicine, it is imperative that required regulatory standards and guidelines for the same is put in place across the country.

Some significant and path breaking advances have indeed been made in the field of ‘telemedicine’ in India. It is though unfortunate that enough awareness for an optimal spread of this critical facility has been created, as yet to address the healthcare needs of a vast majority of the population in India, effectively. The pioneering role that ISRO has been playing in this field is also not known to many. All powerful ‘Fourth Estate’, I reckon, should now take more interest to initiate a healthy discussion and debate on this important healthcare solution, within the civil society.

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.

‘Medical Outsourcing’ – a fast evolving area in the healthcare space with high business potential.

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Medical outsourcing is an evolving area in the global healthcare space. It can offer immense opportunity to India, if explored appropriatly with a carefully worked out strategic game plan from the very nascent stage of its evolution process. This sector could indeed be a high potential one in terms of its significant financial attractiveness by 2015.
Key components of medical outsourcing:

The following four basic components constitute the medical outsourcing industry:

• Healthcare providers: Hospitals, mainly corporate hospitals and doctors

• Payer: Medical/ Health insurance companies

• Pharmaceutical Companies

• IT companies operating in the healthcare space

So far as payers are concerned, currently they are primarily involved in the data entry work, the present market of which in India is estimated to be around U.S$ 100 million.

Key drivers and barriers for growth:

The world class cost-effective private sector healthcare services are expected to drive the growth of the medical outsourcing sector in India. However, shortages in the talent pool and inadequate infrastructure like roads, airports and power could pose to be the major barriers to growth.

At present, majority of medical outsourcing is done by the US followed by the UK and the Gulf countries.

How is this market growing?

Medical Tourism, by itself, is not a very recent phenomenon all over the world. Not so long ago for various types of non-essential interventions like, cosmetic surgeries, people from the developed world used to look for cheaper destinations with relatively decent healthcare facilities like, India, Thailand etc.

Now with the spiraling increase in the cost of healthcare, many people from the developed world, besides those who are underinsured or uninsured have started looking for similar destinations for even very essential medical treatments like cardiac bypass surgery, knee replacement, heap bone replacements, liver and kidney transplants, to name just a few.

Significant cost advantage in India with world class care:

It has been reported that for a cardiac bypass surgery, a patient from abroad will require to pay just around U.S$ 10,000 in India, when the same will cost not less than around U.S$ 130,000 in the US. These patients not only get world class healthcare services, but also are offered to stay in high-end ‘luxury’ hospitals fully equipped with the latest television set, refrigerator and even in some cases a personal computer. All these are specially designed to cater to the needs of such groups of patients.

Recently ‘The Washington Post’ reported that the mortality rate after a cardiac bypass surgery is better in Indian private hospitals than their equivalents in the USA.

An irony:

It is indeed an irony that while such private hospitals in India are equipped to provide world class healthcare facilities for their medical outsourcing business and also to the rich and super rich Indians, around 65 percent of Indian population still does not have access to affordable modern medicines in the country.

Is the government indirectly funding the private medical outsourcing services in India?

In India, from around 1990, the government, to a great extent, changed its role from ‘healthcare provider’ to ‘healthcare facilitator’. As a result private healthcare facilities started receiving various types of government support and incentives (Sengupta, Amit and Samiran Nundy, “The Private Health Sector in India,” The British Journal of Medical Ethics 331 (2005): 1157-58).

While availing medical outsourcing services in India, the overseas patients although are paying for the services that they are availing from the private hospitals, such payments, it has been reported, only partially fund the private hospitals. If such is the case, then the question that we need to answer: Are these medical tourists also sharing the resources and benefits earmarked for the Indian nationals?

Conclusion:

Due to global economic meltdown many business houses in the developed world are under a serious cost containment pressure, which includes the medical expenses for their employees. Such cost pressure prompts them to send their employees to low cost destinations for treatment, without compromising on the quality of their healthcare needs.

Other countries in quite close proximity to ours like, Thailand, Singapore and Malaysia are offering tough competition to India in the medical outsourcing space. However, superior healthcare services with a significant cost advantage at world class and internationally accredited facilities, treated by foreign qualified doctors, supported by English speaking support staff and equipped with better healthcare related IT services, will only accelerate this trend in favor of India. In this ball game it surely is, ‘Advantage India’.

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.