Tag Archives: Socioeconomic

Blockchain: A Game Changer For Safe Medicines

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‘Your medicine box may have fake drugs’ was the March 18, 2018 headline of a popular pan Indian news daily. Just the year before, the 2017 report of the World Health Organization (WHO), also flagged that around 10.5 percent of all medicines in low-and middle-income countries, including India are substandard or fake. Even prior to this, another news headline of February 15, 2016 highlighted: ‘1 In 7 Indian Drugs Revealed As Substandard.’ These reports paint a scary situation for consumers of medicine in India, especially when the same incidence is just around one percent in the high-income countries of the world. Nevertheless, getting into a protracted discussion to prove the veracity of this issue, may not yield much, either. Some may even term these as efforts to ‘sensationalizing’ the situation.

That said, the good news is, the Government Think Tank Niti Aayog and also the Drug Technical Advisory Board (DTAB) of India,are reportedly contemplating to combat this menace with cutting-edge technology. In this article, I shall dwell on this threat, starting with its profound impact, not just on human health, but also on the economic and the socioeconomic space of India.

Why is it so important?

The most obvious fallout of this hazard is of course borne by the consuming patient.  The other two critical impact areas has also been well captured by the World Health Organization (WHO) in its 2017 study, titled ‘A study on the public health and socioeconomic impact of substandard and falsified medical products’. I am summarizing those 3 key impact areas hereunder:

A. Health impact: 

  • Adverse effects (for example, toxicity or lack of efficacy) from incorrect active ingredients
  • Failure to cure or prevent future disease, increasing mortality, morbidity and the prevalence of disease
  • Progression of antimicrobial resistance and drug-resistant infections, loss of confidence in health care professionals, health programs and health systems

B. Economic impact:

  • Increased out-of-pocket and health system spending on health care
  • Economic loss for patients, their families, health systems and manufacturers (and other actors in the supply chain) of quality medical products
  • Waste of human effort and financial outlay across the health system, further straining resources, staff and infrastructure
  • Increased burden for health care professionals, national medicine regulatory authorities, law enforcement and criminal justice systems.

C. Socioeconomic impact:

  • Lost income due to prolonged illness or death
  • Lost productivity costs to patients and households when seeking additional medical care, the effects of which are felt by businesses and the wider economy
  • Lack of social mobility and increased poverty

What the Government contemplates in India? 

According to the April 09, 2018 news report, “Indian policy think tank Niti Aayog is working to put the entire inventory of drugs made and consumed in the country on blockchain with an intent to crack down on counterfeit and spurious drugs, according to two government sources. The government wants to complete a proof of concept (PoC) solution by the year-end and begin implementation in 2019.”

On May 16, 2018, DTAB reportedly deliberated and approved a Track and Trace mechanism to address this issue. The proposal is a stand-alone measure to combat fake or counterfeit drugs covering 300 pharma products. However, it does not intend to cover the entire drug supply chain integrity with Blockchain technology, in a comprehensive manner.

According to the above report, this particular approach involves asking the pharma manufacturers to print a unique 14-digit alphanumeric code on the package of the drug. While buying any medicine, the individual can inquire via a text message, whether the drug bearing that code is genuine or not.

I wrote an article in this Blog on the use Blockchain by pharma players, on January 22, 2018. You may wish to refer that to know more about it in context of the pharma industry.

Recent Blockchain initiatives by global pharma majors:

Some global pharma layers have already covered some ground with Blockchain, especially in this area.On September 21, 2017, an article titled ‘Big Pharma Turns to Blockchain to Track Meds’, published in Fortune, presented some interesting facts. It indicated: to stop a flow of fake, spurious or counterfeit medicines entering the supply chain and reaching patientshow the pharma industry appears to be on the verge of resolving this long-time problem with the intervention of one of the most modern technology – Blockchain.

A group of companies, including Genentech and Pfizer has announced the MediLedger Project for creating blockchain tools to manage pharmaceutical supply chains. The group, has completed a successful pilot program to track medicines, where all concerned – from drug manufacturers to wholesalers to hospitals and retailers will be recording drug deliveries on a blockchain. This would ensure that, at each step of the distribution process, a network of computers will vouch for the ‘provenance and authenticity’ of a drug shipment—making it virtually impossible for counterfeiters to introduce fake drugs – the article highlighted.

Quoting domain experts, the authors underscored the key difference between current practices in this area and managing supply chain through Blockchain technology. At present, most companies use various software to manage the supply chain. However, these usually consist of a mishmash of different databases. ‘The introduction of a Blockchain system, in which each participant controls a node on the network, and transactions require a consensus, is thus a significant leap forward’ – the experts noted.

On scaling up, if this project achieves the intended goals, it would possibly be a game changer for the pharma companies in addressing the counterfeit or fake drug menace, effectively.

How will Blockchain combat fake or counterfeit drugs?

In India, there are basically four constituents in the pharma supply chain: source of procurement of various ingredients – manufacturers – C&F Agents – wholesalers – retailers, besides hospitals and dispensaries. To avoid counterfeit or fake/spurious drugs in a comprehensive way, it is critical for these constituents to see and share relevant data based on a modern and tamper-proof technology platform. Unfortunately, the current practices mostly fail to address this serious threat in a holistic way.

Experts envisage Blockchain delivering a superior value in this area, as it has the potential to cover end-to-end supply chain network of a pharma business. A November 14, 2017 article appeared in a Harvard Business School publication of Technology and Operations Management (TOM) explains its rationale very well. The paper is titled “Can blockchain help solve the problem of counterfeit drugs?”

In the context of a supply chain it says, blockchain can be used to track the flow of goods and services between businesses and even across borders. At each step of the distribution process, a network of computers can unmistakably indicate the provenance and authenticity of a shipment, making it harder or counterfeiters to introduce fake drugs. The key advantage of this technological process is that

it is virtually impossible for malicious actors to alter the event logs. Another advantage is speed: should a shipment be disrupted or go missing, the data stored on the common ledger would provide a rapid way for all parties trace it, and determine who handled the shipment last, the author elaborates.

Common anti-counterfeit-measures:

In many countries, including India, drug regulators are focusing on putting in place various anti-counterfeit measures, such as, ‘track and trace’ and ‘mass serialization.’ In some nations these mandatory in nature. At present, the most common process, globally, is to have machine-readable codes carrying a serial number featuring on each and every pack of medicines. Many anti-counterfeit solution providers call these in various different names, to position themselves on a marketing high ground. Other such measures include, forensic markers, cloud-based supply chain data repositories are also being talked about.

So far so good, but the current reality continues to remain scary for patients, probably more in India. Each year ‘tens of thousands dying from $30 billion fake drug trade,’ – reported Reuters just recently – on November 28, 2017. As reported by IntelligentHQ on November 3, 2016, ‘studies have shown that the pharmaceutical industry still struggles on two main counts: interoperability between all the participants, from the manufacturer to the dispenser and data management, to better integrate the serialization systems. Being able to avoid drug counterfeiting is just one of the reasons for which it is so critical to successfully track products down the supply chain.’

Conclusion:

Ensuring safety and security of the pharma supply chain – from sourcing to manufacturing to logistics to retail chemist and ultimately to the final consumer, is now possible with the application of Blockchain. In fact, this process has already been developed, and tried in many continents of the world, including Africa (video).

Thus, in my view, for an effective anti-counterfeiting system to work or even a substandard drug ingredient going into any original final product that ultimately will be consumed by patients, the most important requirement is to ensureend-to-end supply chain visibility and integrity.Any stand-alone anti-counterfeit measure can’t possibly provide such holistic solution.

Just to emphasize on this point – what happens, if anything goes wrong during sourcing of ingredients, or during the manufacturing of the original drug? The drug in question, although could be substandard, can’t be termed counterfeit. Hence, any standalone anti-counterfeit mechanism will obviously indicate ‘all is well’ for the patients to consume this original medicine – before the product is ultimately recalled, if and when the defect is detected by other means.

From this perspective, the application of Blockchain technology covering end-to-end supply chain network has the wherewithal of being a game changer – offering safe medicines to patients.

By: Tapan J. Ray

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

Why MNC Pharma Still Moans Over Indian IP Ecosystem?

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

Does US talk differently outside the country?

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

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

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

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

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

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

Should IP laws ignore country’s socioeconomic reality? 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Conclusion:

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

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

By: Tapan J. Ray

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

‘Digiceuticals’: A Force Multiplier to Contain Chronic Diseases

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There is a growing need for more effective prevention, treatment or management of many serious Noninfectious Chronic Diseases (NCDs), with greater safety and at a lesser cost. As a major step in this direction, ‘digiceuticals’ or ‘digital therapeutics’ are now drawing heightened interest from the medical and scientific communities.

‘Digiceuticals’ are basically custom made digital software working as drugs. These are presented mostly in the form of user-friendly smartphone apps for various disease conditions –  both as stand-alone therapy, or to augment other treatment processes for better outcomes.

Increasing usage of digital technology enabled therapy for a gamut NCDs, prompts me to discuss in this article the relevance, scope, promise, and of course, the rationale behind the same. Its importance swells manifold when the risks of lifelong health hazards that such chronic disorders may pose are factored-in, alongside their overall socioeconomic impact.

Chronic diseases – the invisible global epidemic:

Chronic diseases, such as heart disease, stroke, chronic respiratory disorders and diabetes, including cancer, are by far the leading causes of death and disability worldwide. The World Health Organization (W.H.O) also reiterates that this invisible epidemic is spreading out globally – across every region and pervading all socioeconomic classes.

The mortality, morbidity and disability attributed to chronic diseases, as estimated by the W.H.O, is expected to rise to 73 percent of all deaths and 60 percent of the global burden of disease by 2020. Interestingly, 79 percent of the deaths attributed to chronic disorders occur in the developing countries, such as India.

Can chronic diseases be prevented?

W.H.O also emphasizes that four of the most prominent chronic disorders, namely cardiovascular (CVD), cancer, Chronic Obstructive Pulmonary Diseases (COPD), and Type 2 diabetes – are linked by common and preventable biological risk factors, notably high blood pressure, high blood cholesterol and overweight. Most importantly, these relate to major behavioral risk factors, like unhealthy diet, physical inactivity and tobacco use, among several others.

Awaits a radical change – from “Suppliers Push” to “Consumer Pull”:

In the above perspective, a series of well-integrated action related to several human behavioral factors, could help prevent many NCDs, effectively. A fundamental change in mindset of all concerned is critical to avert the merciless onslaught of this epidemic. This calls for a radical change in the existing process of addressing these disorders – from “Suppliers Push” to “Consumer Pull.”

The January 2017 White Paper titled, “Human-Centric Health: Behavior Change and the Prevention of Non- Communicable Diseases”, published by the World Economic Forum (WEF), drives home this point succinctly, as follows:

“Decreasing the burden of NCDs will require a transformation through which the threat of disease is recognized and addressed. The transformation should move us away from the present state of ‘supplier push’, which emphasizes expensive, capital-intensive, hospital-centric interventions that have so far produced disappointing results, to a system that relies on ‘consumer pull’. A consumer-focused system would recognize the principles of behavioral economics to encourage and enable people to adopt healthier behavior across all aspects of their lives. Individuals would be supported in this effort by a network of critical stakeholders ranging from government to private enterprise, from healthcare providers to payers, from the technology developers to local communities.”

NCDs are triggered by behavioral pattern and lifestyle:

Picking up the thread from here, I shall deliberate now, how the state of the art digital technology-developers are playing a stellar role in this space, with greater precision and more cost-effective way. This is because, many NCDs are triggered by consistent behavioral and lifestyle pattern of an individual. Consequently, continuously monitoring of desired changes in individual behavior, are expected to gradually become the first-line treatment to effectively address these conditions. Several published studies indicate that the process has started rolling, aided by smartphone based sophisticated digital tools – in many cases even without any expensive and lifelong medications.

The May 26, 2016 paper titled, “Clustering of Five Health-Related Behaviors for Chronic Disease Prevention Among Adults, United States, 2013”, captures a cluster of five health-related behaviors for chronic disease prevention as – never smoking, getting regular physical activity, consuming no alcohol or only moderate amounts, maintaining a normal body weight, and obtaining daily sufficient sleep. This article was published by the Centers of disease Control and Prevention of the United States.

Preventing chronic diseases with ‘digiceuticals’:

The April 7, 2017 article captioned, “Can ‘Digital Therapeutics’ Be as Good as Drugs?”, published by the MIT Technology Review, dwells on this area. The paper indicates an emerging belief among technology geeks that ‘digiceuticals’, or digital drugs will become ‘the third phase’ of medicine for many disease conditions, being the successor to the chemical and protein drugs that we have today, but without the billion-dollar cost of bringing one such drug to market. The core idea behind this new concept is to develop software that can improve a person’s health as much as a drug can, but without the same cost and side-effects, the author says.

An innovative new class of medicine:

The term digital therapeutics or ‘digiceuticals’, as many calls these, is considered as an innovative new class of medicine that gives participants access to the world’s most effective behavior therapies, enhanced with smart digital technology, and delivered directly to their front door. These can be used both as a replacing medicine, and also for enhancing efficacy of a medical treatment, as a situation would necessitate.

There doesn’t seem to be any clear-cut difference between these two – digital therapeutics and ‘digiceuticals’. Nonetheless, some do believe that there is a difference – quite akin to prescription medication versus nutritional supplements, with consequential differences in regulatory and other areas. Be that as it may, ‘digiceuticals’ when used for prevention, treatment or effective management of any chronic ailments would require to be scientifically evaluated just as any other drugs, devices and treatment processes.

The future of health care will be App-based:

Another article titled “Digital Therapeutics: The Future of Health Care Will Be App-Based”, published in Forbes on July 24, 2017, highlights how several digital technology companies are now focusing on the development of state of art smartphone app-based digital treatment programs that can be delivered at a massive scale and with a low cost to prevent progression of many debilitating NCDs, for a large population across the world, including India.

‘Digiceuticals’ versus other mobile wellness apps:

Unlike many smartphone based wellness apps to keep a regular tab on daily exercises, heart rates, calorie intakes, breathing, sleep pattern among several others; treatment processes with ‘digiceuticals’ are quite different. These softwares are tailor-made to prevent or treat specific chronic disorders, like diabetes, cardiovascular conditions, COPD, insomnia and chronic depression, to name a few. The trend is fast catching up along with an increasing general realization that the influence of individual behavior and lifestyle pattern is so crucial in the prevention, and also in arresting the progression of many debilitating NCDs.

The current status:

The latest scenario in this area has been well captured in several research studies. One such is the 2017 Report of Grand View Research, Inc., which articulated the following key findings:

  • The global ‘digiceuticals’ or digital therapeutics market size was estimated at USD1.7 Billion in 2016, which is expected to grow at 21.0 percent CAGR from 2017 to 2025.Diabetes is expected to gain the largest market share due to the increasing global prevalence, fueled by the preventive steps taken to reduce them.
  • The adoption of digital therapeutics offers a reduction in healthcare cost associated with many NCDs, and are thus being used on an increasing scale. Digital tracking, continuous monitoring of various health parameters, management of physical activity and controlling eating habits are some of the important factors expected to propel the market growth.
  • Ascending trend of its usage for prevention of a wide range of NCDs would further add to the growth momentum. Patients accounted for the largest market share in the end-user segment owing to user-friendly interface and cost-effective management of many NCDs.
  • The North American region accounted for the highest revenue owing to technological advancement and health care expenditure to curb rise in a number of chronic diseases.
  • The Asia Pacific region is expected to garner considerable growth during the forecast period owing to increasing adoption of advanced healthcare technologies and rise in the number of NCDs.

The latest development in India:

A similar initiative, though, as augmentation of physician intervention in patients with Type 2 diabetes for better treatment outcomes, has recently been reported by the Press Trust of India (PTI) on June 13, 2017.

The abstract of the report, among other points, says that an Indian digital diabetes leader has announced “the results from a pilot designed to evaluate the feasibility and scalability of an artificial intelligence-led lifestyle intervention to improve self-management of people living with type 2 diabetes as a supporting tool to existing care in India…. The pilot results suggest that continuity of care between physician appointments for people with type 2 diabetes can be achieved with positive outcomes in a clinically significant, scalable and affordable way through this program. Participants that completed the pilot on average dropped their average blood sugar levels (HbA1c) by 0.59%. Amongst the participants that completed and dropped their HbA1c, the average observed was even higher at 1.04%. In addition, the participants showed a daily active usage of 78% for the duration of the 16-week program.”

This is indeed a laudable initiative by an Indian digital tech company. More such ventures are expected to be forthcoming, taking rapid strides in India. Keeping pace with these developments, “digiceuticals,” I reckon, will spread its wings faster to play a crucial role in preventing, if not treating and managing several serious NCDs – and in most cases without even swallowing any pill.

Conclusion:

The key concept behind ‘digiceuticals’ or digital therapeutics is to exert a strong influence on individual behavior and lifestyle pattern, which are crucial both in prevention, and in controlling the progression of many NCDs.  The desired level of change in behavior and lifestyle of individuals can be achieved through custom-made digital software. These are expected to deliver the same, or even better results in such disease conditions, at a much lesser cost, sans any serious side effects.

The ball has already started rolling with considerable success and a discernible promise in this direction. However, accelerating its speed further, and ultimately flooring the gas pedal, would depend on how all concerned stakeholders’, especially the technology experts, doctors, pharma industry, and other health care providers work in-sync with each other, leveraging the true potential of ‘digiceuticals’.

The rapid pace of progress in this endeavor will be a force multiplier in arresting the fast spreading ‘invisible epidemic’, as it were, of many serious chronic diseases or disorders, in a much better and cost-effective way 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.

The ‘Moonshot’: Access To World-Class Cancer Care, For All

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As in every year, February the 4th was celebrated as the ‘World Cancer Day’, across the world, in 2016, as well. Its main objective is to commemorate all the efforts done by the World Health Organization (WHO), the United Nations (UN), including the governmental and nongovernmental health organizations towards formulating a grand strategy to fight against cancer. The strategy is expected to span across cancer prevention, detection and treatment, for all. The key goal of this commendable initiative is to reduce illness and death caused by cancer by 2020, the world over.

The event also encourages to explore various ways to align individuals and groups to do their bit in reducing both the local and the global burden of disease related to cancer.

The last Thursday, the ‘World Cancer Day’ was celebrated in India too, albeit in a low key, as I could fathom, despite its alarmingly ascending trend in the country.

In this context, I would start with my first and a very small example of a sharply contrasting mindset to address the vexing issue of cancer between the largest democracy of the world – India, and the oldest democracy of the globe – America.

The United States (US) this year, like the previous five years on a trot, made this event visible for a large section of people to encourage them to think and act against cancer, in several different ways that they can. The imposing landmark in New York – the magnificent ‘Empire State Building’ was lit in blue and orange, the colors of the ‘Union for International Cancer Control (UICC’), the organizers of this annual event.

A brief recap:

Cancer is now one of the leading causes of death, not just in India, but across the world. Its rate is expected only to go up further in the years ahead, and that too at a brisk pace. Just as the disease is fast spreading across the socioeconomic spectrum, all over, so are the tough access barriers for effective cancer diagnosis, treatment and care, for all, increasing by manifold.

Urgent action is called for in most of the countries of the world by the respective Governments to save precious lives, by effectively overcoming most of these hurdles, soon.

With this backdrop, in this article, I shall explore what is happening on the ground in this direction, at present, drawing examples from the two greatest democracies of the world.

The largest democracy of the world:

Delivering affordable and equitable care for cancer to all, is one of greatest public health challenges of the largest democracy of the world – India. The country is required to face this challenge boldly and squarely, to mitigate the devastating socioeconomic and human costs that this disease is already costing our nation.

This point was reiterated by one of the lead authors of an article published by ‘The Lancet Oncology’ on April 11, 2014. The paper discussed the epidemiology and social context of the growing burden of cancer in India.

According to this paper, around 600,000 – 700,000 deaths in India were caused by cancer in 2012, with more than 1 million new cases of this life threatening disease being diagnosed every year.

Further, the World Health Organization (WHO) also reported that every year, around 145,000 women are diagnosed with breast cancer in India. Unfortunately, around half of them had succumbed to the disease, in 2008.

However, all these numbers should be taken into consideration carefully factoring in very low rates of early-stage detection and poor treatment outcomes in the country.

In this prevailing scenario, cancer is fast becoming a major public health concern in India, with the number of new cancer cases projected to nearly double within the next 20 years.

The average cost of cancer treatment in India:

According to the above ‘Lancet Oncology’ report, in India, the average cost of treating a typical patient with cancer at a government facility would come around US$593. Whereas, the average annual income per person is only U$ 1,219, with 27.5 percent of the population living on or below a daily income level of US$ 0.4.

Besides, most district hospitals, including the regional cancer centers do not have the requisite facilities required to provide quality cancer care to all those patients who need them.

Quoting experts, a newspaper report on June 19, 2014 also stated, around 50 per cent of the diagnosed cancer patients, who also commence their treatments, stop visiting hospitals after two or three cycles of chemotherapy, as they find the cost of treatment is not affordable to them. They also drop out from regular follow-up visits, say the doctors.

Low Government funding for healthcare:

As a result of abysmally poor public funding for healthcare in India, both by the Central and most of the State Governments, the cost of diagnosis and treatment of cancer is increasingly becoming out of pocket, and being catastrophically expensive, going beyond the reach of a large number of patients suffering from this serious ailment.

The socioeconomic impact:

This pathetic public healthcare system in India adversely affects not only the debt ridden poor and middle-class cancer patients, but also the welfare and education of several generations of their respective families.

Thus, cancer has a profound, both social and economic, consequences for the general population in India. This very often leads to family impoverishment and societal inequity, as the study points out.

The oldest democracy of the world:

The oldest democracy of the world – America, is one of the richest countries in the globe, having perhaps the best healthcare facilities and systems. All the latest drugs and diagnostics are also available there. Despite all these, there is a growing inequity in the cancer treatment in America too, with access to quality diagnosis and treatment for cancer patients becoming a major health, economic and political issue for the country.

‘Mayo Clinic Proceedings’ of August 2015, also expressed concern on the high prices of cancer drugs, which are affecting the care of cancer patients and eventually the American health care system.

The report does ring an alarm bell for high cancer care cost for many patients in America. The ‘Proceedings’ highlighted the following reasons, most of which are, quite interestingly, very similar to India: 

  • Cancer will affect 1 in 3 individuals over their lifetime.
  • Recent trends in insurance coverage put a heavy financial burden on patients, with their out-of-pocket share increasing to 20 percent to 30 percent of the total cost.
  • In 2014, all new US Food and Drug Administration (US FDA) approved cancer drugs were priced above US$ 120,000 per year of use. 
  • The average annual household gross income in the United States is about US$ 52,000.
  • For a patient with cancer who needs one cancer drug that costs US$120,000 per year, the out-of-pocket expenses could be as high as US$25,000 to US$ 30,000 – more than half the average household income and possibly more than the median take-home pay for a year.
  • Thus, cancer patients have to make difficult choices between spending their incomes and liquidating assets on potentially lifesaving therapies or foregoing treatment to provide for family necessities, such as, food, housing and education.
  • This decision is even more critical for senior citizens who are more frequently affected by cancers and have lower incomes and limited assets.
  • Because of costs, about 10 to 20 percent of patients with cancer do not take the prescribed treatment or compromise it. It is documented that the greater the out-of-pocket cost for oral cancer therapies, the lower the compliance. This is a structural disincentive for compliance with some of the most effective and transformative drugs in the history of cancer treatment. 
  • Given the rising incidence of cancer in the aging American population, high cancer drug prices will affect millions of Americans and their immediate families, often repeatedly. 

General public wants the US Government to act:

‘The Mayo Clinic Proceedings’ findings were vindicated by the October 2015 Kaiser Health Tracking poll, which reported, 76 percent of the public believes that a top priority for the American president and Congress should be making high-cost drugs for chronic conditions affordable. Yet another Kaiser poll found 72 percent of Americans believe drug costs are unreasonable and 74 percent think that pharma companies, in general, care more about profits than people.

General public expectations and belief do not seem to be any different in India too. 

I reckon, due to similar reasons in most countries of the world, an urgent action is required from the respective Governments to make cancer diagnosis and treatment affordable to all, sooner than later.

Different responses to the same problem:

Let me reiterate here again, that I am comparing India with America on this issue, not for any other reason, but just to give an example and a feel of how much the promised political intent, made for the benefit of the general population of the country, gets translated into reality in the world’s oldest democracy, as compared to the world’s largest democracy.

In India, despite high sound bytes emanating from various leaders of the principal party in power today, the fragile public healthcare system is still gasping for breath, starved by grossly inadequate resource allocations. This gets reflected on the details of national and state budgetary allocations for healthcare in India.

The delay in finalizing and then putting in place for implementation of the “National Health Policy”, which proposed making health a fundamental right and denial of health an offense, also seems to be of low priority for the national Government, at present. If so, this will indeed be quite contrary to its earlier firm promises on improving healthcare in India.

In the United States, as well, similar promises were made by senior politicians during the last national election campaign. The Presidential candidate for the party, which is now in power, created as much hype with matching sound bytes for healthcare reform in America, while seeking votes.

However, the sharp difference between the two similar situations is, having come to power on November 4, 2008 President Barack Obama, fulfilled his promise with a path breaking healthcare reform in his country. On March 23, 2010 he signed into law the ‘Affordable care Act’. It’s a different matter though, like most political decisions, this one also faced its own share of criticism from the American opposition.

The ‘Moonshot’:

Zeroing in specifically to address the agony of cancer patients in America, President Obama has recently initiated a ‘National Mission’ in this area. He has asked his Vice-President Joe Biden to spearhead this mission and get it done expeditiously. Biden enthusiastically accepted to lead this noble ‘National mission’ for mankind and termed it ‘A Moonshot for Cancer Cure’. The White House also announced a resource commitment of US$1 billion on this effort over the next two years.

In his ‘White House’ Blog Post of January 13, 2016 the Vice-President wrote about this project, very close to the ‘World Cancer Day’, which is basically symbolic, just as the ‘International Day of Yoga’, but this specific American ‘National mission’ against cancer does not appear to be so, by any stretch of imagination.

The key objective of this mission is indeed profound. With is effective implementation, the American Government wants to ensure that ‘the same care provided to patients at the world’s best cancer centers, is available to everyone who needs it.’

Joe Biden admitted, though several cutting-edge areas of research and care, including cancer immunotherapy, genomics, combination therapies and innovations in data and technology are revolutionary, all these are currently trapped in silos, preventing faster progress and greater reach to patients. 

It’s not just about developing game-changing treatments. It’s about delivering them to those who need them the most. The community oncologists, who treat more than 75 percent of cancer patients, have more limited access to cutting-edge research and advances, even in America, Vice-President Biden elaborated. 

Two key focus areas:

  • Increase resources, both private and public, to fight cancer.
  • Break down silos and bring all the cancer fighters to work together, share information, and end cancer, as we know it.

The goal of this initiative is to double the rate of progress by making a decade worth of advances in five years. He also outlined the details that he would follow to get this mission implemented on the ground within the set time frame.

“If there’s one word that defines who we are as Americans…” – Biden

Joe Biden concluded this announcement with his natural statesmanship, sans any drama, by saying: “If there’s one word that defines who we are as Americans, it’s ‘possibility.’ And these are the moments when we show up.”

The good news is, the project ‘Moonshot’, as the American Vice-President calls it, has already started with the full commitment of the American Government and backed to the hilt by none other than President Obama himself. The American President has already demonstrated to the world, from the very commencement of his Presidency, that he is a project implementer per excellence, as head of the Government.

Some key barriers to effective 'cancer care' in India:

Coming back to the Indian context, experts do indicate that one of the main barriers to cancer care, in the largest democracy of the world – India, is primarily lack of enough public facilities for early detection of cancer. Thus, even when it is detected considerable disease progression usually takes place. Moreover, most patients lack access to expensive cancer treatment and are compelled to give up the treatment for this reason. Consequently, as the data reveals, less than 30 percent of patients suffering from cancer in India survive for more than five years after diagnosis, while over two-thirds of cancer related deaths occur among people aged 30 to 69.

According to the data of the Union Ministry of Health, 40 percent of over 300 cancer centers in India do not have adequate facilities for advanced cancer care. It is estimated that the country would need at least 600 additional cancer care centers by 2020 to meet this crying need.

Conclusion:

It appears to me, even meeting this basic need for cancer care will be extremely challenging with frugal public healthcare spending in India. As I said before, it gets well reflected in the successive annual budgetary allocations for the same, both by the Central and most of the State Governments. Added to this, the ‘National Health Policy’, which was first drafted and released in December 2014 by the Ministry of Health for the stakeholders’ comments, is yet to be put in place. The draft policy recommended, among many others, making health a fundamental right of Indian citizens.

According to ‘The World Bank’ report, the public expenditure for health as a percentage of GDP of the oldest democracy of the world is already hovering over 8, against around just 1 of the largest democracy of the world. On top of this, the present American Government has committed, even more resources to usher in a new era of hope for all cancer patients with its latest ‘National Mission’ – ‘A Moonshot for Cancer Cure’.

There is a lot to feel good about it, even as an Indian, as this health mission, termed as ‘‘A Moonshot for Cancer Cure’ by the American Vice-President assures that ‘the same care provided to patients at the world’s best cancer centers, is available to everyone who needs it.’ Its overall benefits could possibly reach even the Indian patients…who knows?

Like 2016, and the previous years, the ‘World Cancer Day’ would come and go with the turn of every calendar year. Hopefully, things will be quite different sometime in future. India would possibly initiate the much awaited health care reform in the country and more specifically effective ‘cancer care’ for all, with requisite budgetary provisions in place. Till then, do the cancer patients in India have any other choice, but to eagerly wait for it, hoping for the best outcome?

By: Tapan J. Ray

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

 

With Highest Billionaire Wealth Concentration, India Tops Malnutrition Chart in South Asia: “What Future Do You Want?”

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Two recent global research reports, though on different spheres, place India at the top of the respective blocks. However, the take away messages that the studies offer are indeed poles apart in qualitative terms and worth pondering over collectively.

On January 20, 2014, just before the World Economic Forum (WEF) at Davos in Switzerland, Oxfam International released a report warning that by 2016, the world’s wealthiest 1 percent will control almost half of the global assets. Since 2009, the world’s billionaires have seen their share of the asset pie grow from 44 percent to 48 percent.

Before that, a World Bank Report of October 2014 titled, “Addressing Inequality in South Asia”, highlighted that India has the highest billionaire wealth concentration in South Asia.

Billionaire wealth to gross domestic product ratio in India was 12 percent in 2012. This was was higher than other economies with similar development level, namely, Vietnam with its ratio at less than two percent, and China with less than five percent.

This report also clarifies that inequality in South Asia appears to be moderate when looking at standard indicators such as the Gini index, which are based on consumption expenditures per capita. But other pieces of evidence reveal enormous gaps, from extravagant wealth at one end to lack of access to the most basic services at the other.

Stark realities: 

Wealth creation by no means is bad and in fact, is essential for economic growth of any nation, if read in isolation. This is mainly because, as the Oxfam report says, some economic inequality is essential to drive growth and progress, rewarding those with talent, hard earned skills, and the ambition to innovate and take entrepreneurial risks.

Unfortunately, at the same time, as the same World Bank report highlights, the stunted growth of children under fiver years of age, due to malnutrition, has been 60 percent of the total number of children born in the poorest households of India, as compared to 50 per cent in Bangladesh and Nepal.

Moreover, According to UNICEF, every year 1 million children again 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 W.H.O 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 per cent can support its consumption for less than three months.”

Some poor moved above the poverty line, though grossly inadequate:

According to the same report, from 2004-05 to 2009-10 when India’s GDP registered the highest ever average growth, about 40 percent of poor households moved above the poverty line and around 11 percent of poor population even moved into the middle class. Unfortunately, during the same period around 14 percent of the non-poor population also slipped below the poverty line.

Thus, what needs to be addressed soonest is the issue of vast difference in income between the richest and the poorest leading to an equally huge difference in the access to basic human developmental needs such as, education, healthcare and nutrition.

Adverse impact on expected ‘demographic dividend’ of India:

As legendary Bill Gates said in a recent media interview, “India has got far more kids that are malnourished and whose brains are not developed, way more than any other country. That’s really the crisis.”

If this trend of inequality continues, the ‘demographic dividend’ of India that the country has factored in so intimately in its future GDP growth narrative, could well be no more than a myth.

As US Supreme Court Justice Louis Brandeis once famously said, “We may have democracy, or we may have wealth concentrated in the hands of the few, but we cannot have both.”

The Oxfam report also emphasizes, the extreme levels of wealth concentration occurring today threaten to exclude hundreds of millions of people from realizing the benefits of their talents and hard work.

Social inequality and healthcare challenges:

Health of an individual is as much an integral contituent of the socio-economic factors as it is influenced by a person’s life style and genomic configurations. Important research studies indicate that socio-economic disparities, including the educational status, lead to huge disparity in the space of healthcare.

As stated in another report, ‘About 38 million people in India (which is more than Canada’s population) fall below the poverty line every year due to healthcare expenses, of which 70 percent is on purchase of drugs’.

Thus, reduction of social inequalities ultimately helps to effectively resolve many important healthcare issues. Otherwise, mostly the minority population with adequate access to knowledge, social and monetary power will continue to have necessary resources available to address their healthcare needs, appropriately.

Regular flow of newer and path breaking medicines to cure and effectively treat many diseases has not been able to eliminate either trivial or dreaded diseases alike. Otherwise, despite having effective curative therapy for malaria, typhoid, cholera, diarrhea/dysentery and venereal diseases, why will people still suffer from such illnesses? Similarly, despite having adequate preventive therapy, like vaccines for diphtheria, tuberculosis, hepatitis and measles, our children still suffer from such diseases. All these continue to happen mainly because of socio-economic inequalities related considerations, including poor level of awareness.

A paper titled, “Healthcare and equity in India”, published in The Lancet (February, 2011) identifies key challenges to equity in service delivery, healthcare financing and financial risk protection in India.

These include: 

- Imbalanced resource allocation

- Limited physical access to quality health services and inadequate human resources for health

- High out-of-pocket health expenditures

- High health spending inflation

- Behavioral factors that affect the demand for appropriate healthcare

Research studies vindicate the point:

Following are some research studies, which I am using just as examples to vindicate the above argument on inequality adversely impacting healthcare:

• HIV/AIDs initially struck people across the socio-economic divide. However, people from higher socio-economic strata responded more positively to the disease awareness campaign and at the same time more effective and expensive drugs started becoming available to treat the disease, which everybody cannot afford. As a result, HIV/AIDS are now more prevalent within the lower socio-economic strata of the society.

• Not very long ago, people across the socio-economic strata used to consume tobacco in many form. However, when tobacco smoking and chewing were medically established as causative factors for lung and oral cancers, those coming predominantly from higher/middle echelon of the society started giving up smoking and chewing of tobacco, as they accepted the medical rationale with their power of knowledge. Unfortunately the same has not happened with the poor people of lower socio-economic status. As a consequence of which, ‘Bidi’ smoking and ‘Gutka’/tobacco chewing have not come down significantly among the population belonging to such class, with more number of them falling victim of lung and oral cancers.

Thus, in future, to meet the unmet needs when more and more sophisticated and high cost disease treatment options will be available, mostly people with higher socio-economic background will be benefitted more due to their education, knowledge, social and monetary power. This widening socio-economic inequality will consequently widen the disparity in the healthcare scenario of the country.

Phelan and Link in their research study on this subject had articulated as under:

“Breakthroughs in medical science can do a lot to improve public health, but history has shown that, more often than not, information about and access to important new interventions are enjoyed primarily by people at the upper end of the socioeconomic ladder. As a result, the wealthy and powerful get healthier, and the gap widens between them and people who are poor and less powerful.”

Recent deliberations at Davos:

In the last two decades, socio-economic inequality in India has been fuelled by rapid, but unequal economic growth of the nation. Though the overall standard of living has been rising, there still remain a large number of populations living in pockets of intense deprivation and abject poverty.

One of the Davos sessions of this year deliberated on “What Future Do You Want?” The session, among others, reportedly felt the important need to ensure people’s well being and put in place effective measures such as a social safety net and universal healthcare.

At the same WEF annual meet at Davos, United Nation’s Secretary General Ban Ki-Moon also reiterated, “All policies must be people centric. We should make a world where nobody is left behind.”

Conclusion:

Assuming the above approach as a sincere realization of the current policy makers and more importantly the powerful influencers of those policies, the key question that comes up is: In which direction would India now chart its course to address this critical issue?

One may possibly hazard a guess on the shape of the future policies to come in India from the BJP party President Amit Shah’s recent address to crème de la crème of Mumbai businessmen in a function organized by a business news channel. In this event Mr. Shah reportedly said to them that the BJP does not agree with their definition of “reforms” and will strive to build a welfare state.

Will this approach of the new political dispensation get reflected in the forthcoming union budget as well, to effectively translate the new National Health Policy of India into reality, at least this time?

I deliberated on the National Health Policy of India in my Blog Post of January 12, 2015, titled “India’s National Health Policy 2015 Needs Wings To Fly”

That said, if it really so happens, a strong signal would go to all stakeholders that India is now well poised to chart on an uncharted frontier to significantly reduce the impact of inequality, particularly in the space of healthcare.

In that process, despite the highest billionaire wealth concentration, India would set a pragmatic course to place itself at the top of the healthcare chart, not just in South Asia, but probably also within the BRIC countries, to expect the least.

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.

Does the Landmark Glivec Judgment Discourage Innovation in India?

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No, I do not think so. The 112 pages well articulated judgment of the Supreme Court of India delivered on April 1, 2013, does not even remotely discourage innovation in India, including much talked about ‘incremental innovation’. This landmark judgment reconfirms the rules of the game for pharmaceutical innovation, as captured in the Indian Patents Act 2005.

When one reads the judgment, point 191 in page number 95 very clearly states as follows:

“191. We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment.”

Thus all ‘incremental innovations’, which some people always paint with a general broad brush of ‘evergreening’, should no longer be a taboo in India. The judgment just says that Glivec is not patentable as per Section 3(d) of Indian Patents Act based on the data provided and arguments of Novartis.

To me, the judgment does also not signal that no more Glivec like case will come to the Supreme Court in future. It vindicated inclusion of Section 3(d) in the amended Indian Patents Act 2005.

It is interesting to note that honorable Supreme Court itself used the terminology of ‘incremental innovation’ for such cases.

That said, I find it extremely complex to imagine what would have happened, if the judgment had gone the opposite way.

A critical point to ponder:

The judgment will also mean that all those products, having valid product patents abroad, if fail to meet the requirements of Section 3(d), will not be patentable in India, enabling introduction of their generic equivalents much sooner in the country and at the same time causing a nightmarish situation for their innovators.

However, this again, in no way, is an outcome of this judgement or a new development, as stated above. It is just vindication of the intent behind inclusion of Section 3(d) in the amended Indian Patents Act, when it was enacted by the Parliament of India in 2005.

Patentability of ‘Incremental Innovations’ in India:

Patentability criteria for any ‘incremental innovations’ has been defined in the Section 3(d) of the Indian statute as follows:

“The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”

Supreme Court interpretation of the term “Efficacy” in Section 3(d): 

The Honorable Supreme Court in page 90 of its above order under point 180 stated that in case of medicines, efficacy can only be “therapeutic efficacy”, which must be judged strictly and narrowly. The interpretation goes as follows:

180. “What is “efficacy”? Efficacy means ‘the ability to produce a desired or intended result’. Hence, the test of efficacy in the context of section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be “therapeutic efficacy”.

The Honorable Court under the same point 180 further elaborated:

“With regard to the genesis of section 3(d), and more particularly the circumstances in which section 3(d) was amended to make it even more constrictive than before, we have no doubt that the “therapeutic efficacy” of a medicine must be judged strictly and narrowly…Further, the explanation requires the derivative to ‘differ significantly in properties with regard to efficacy’. What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seen above, is its therapeutic efficacy.” 

Based on this interpretation of Section 3(d), the Honorable Supreme Court of India ordered that Glivec does not fulfill the required criteria of the statute.

The rationale behind Section 3(d):

A report on ‘Patentability of the incremental innovation’ indicates that the policy makers keeping the following points in mind formulated the Indian Patents Act 2005:

  • The strict standards of patentability as envisaged by TRIPS pose a challenge to India’s pharmaceutical industry, whose success depended on the ability to produce generic drugs at much cheaper prices than their patented equivalents.
  • A stringent patent system would severely curtail access to expensive life saving drugs to a large number of populations in India.
  • Grant of a product patents should be restricted only to “genuine innovations” and those “incremental innovations” on existing medicines, which will be able to demonstrate significantly increased efficacy over the original drug.

IPA challenges: 86 pharmaceutical patents granted by IPO fall under Section 3(d):

A study by the ‘Indian Pharmaceutical Alliance (IPA)’ indicates that 86 pharmaceutical patents granted by the IPO post 2005 are not breakthrough inventions but only minor variations of existing pharmaceutical products and demanded re-examination of them.

Possible implications to IPA challenge:

If the argument, as expressed above in the IPA study, is true by any stretch of imagination, in that case, there exists a theoretical possibility of at least 86 already granted product patents to get revoked. This will invite again another nightmarish situation for innovators.

Examples of revocation of patents in India:

On November 26, 2012, the Intellectual Property Appellate Board (IPAB) reportedly denied patent protection for AstraZeneca’s anti-cancer drug Gefitinib on the ground that the molecule lacked invention.

The report also states that AstraZeneca suffered its first setback on Gefitinib in June 2006, when the Indian generic company Natco Pharma opposed the initial patent application filed by the global major in a pre-grant opposition. Later on, another local company, GM Pharma, joined Natco in November 2006.

After accepting the pre-grant opposition by the two Indian companies, the Indian Patent office (IPO) in March 2007 rejected the patent application for Gefitinib citing ‘known prior use’ of the drug. AstraZeneca contested the order through a review petition, which was dismissed in May 2011.

Prior to this, on November 2, 2012 the IPAB revoked the patent of Pegasys (Peginterferon alfa-2a) – the hepatitis C drug of the global pharmaceutical giant Roche.

Though Roche was granted a patent for Pegasys by the Indian Patent Office (IPO) in 2006, this was subsequently contested by a post-grant challenge by the large Indian pharma player – Wockhardt and the NGO Sankalp Rehabilitation Trust (SRT) on the ground that Pegasys is neither a “novel” product nor did it demonstrate ‘inventiveness’, as required by Section 3(d) of Patents Act of India 2005.

It is worth noting, although the IPO had rejected the patent challenges by Wockhardt and SRT in 2009, IPAB reversed IPO’s decision revoking the patent of Pegasys.

Similarly the patent for liver and kidney cancer drug of Pfizer – Sutent (Sunitinib) granted by IPO in 2007, was revoked by the IPAB in October, 2012 after a post grant challenge by Cipla and Natco Pharma on the ground that the claimed ‘invention’ does not involve inventive steps.

Patent challenges under section 3(d) may come up even more frequently in future:

Some observers in this field have expressed, although ‘public health interest’ is the primary objective for having Section 3(d) in the Indian Patents Act 2005, many generic companies, both local and global, have already started exploiting this provision as a part of their ‘business strategy’ to improve business performance in India, especially when an  injunction is usually not being granted by the honorable Courts for such cases on public health interest ground.

Thus, as stated above, there is likely to be many more cases like, Glivec coming before the Supreme Court in the years ahead.

Another related development of the last week:

It has been reported that American pharma major MSD has last week filed a suit in the Delhi High Court against Indian pharma major – Glenmark for alleged patent violation of its leading anti-diabetic drugs Januvia and Janumet. In this case also no interim injunction has reportedly been granted to MSD by the Honorable Delhi High Court.

Glenmark has stated through a media report, “It is a responsible company and has launched the products after due diligence and research.” The company has also announced that their version of the molecule named Zita and Zita Met will be available to patients at a 20 percent discount to MSD’s price.

Hence, once again, the Indian court to decide, the balance of justice would now point to which direction.

Government has no role to play – patent challenge is a legal process across the world:

The proponents of ‘no change required in the Section 3(d)’ argue, ‘Patent Challenge’ is a legal process all over the world, the Government has hardly got any role to play in settling such disputes. The law should be allowed to take its own course for all disputes related to the Patents Act of the country, including Section 3(d).

They also opine that India must be allowed to follow the law of justice without casting aspersions on the knowledge and biases of the Indian judiciary for vested interests.

That said, there is certainly an urgent need to add speed to this legal process by setting up ‘Fast-track Courts’ for resolving all Intellectual Property (IP) related disputes in a time bound manner.

Arguments against Section 3(d):

Opposition to the Section 3(d) counter-argues by saying, this is a critical period for India to help fostering an appropriate ecosystem for innovation in the country. This group emphasizes, “Providing the right incentives for incremental pharmaceutical innovation can move India forward on this path and encourage the development of drug products that meet the needs of Indian patients. Reforming Section 3(d) to encourage and protect incremental pharmaceutical innovation would create such incentives and help India become a true powerhouse of innovation.”

Another group says that the main reason in favor of Section 3(d) being the provision will prevent grant of frivolous patents, the ultimate fallout of which will result in limited access to these drugs due to high price, is rather irrelevant today. This, they point out, is mainly because the Government is now actively mulling a structured mechanism of price negotiation for all patented drugs to improve their access to patients in India.

Importance of ‘Incremental Innovation’ in India:

Incremental innovations are indeed very important for the country and have been benefiting the patients immensely over decades, across the world.

A report titled, “The Value Of Incremental Pharmaceutical Innovation” highlighted as follows:

  • As per the National Knowledge Commission, while 37.3% of Indian companies introduced breakthrough innovations in recent years, no fewer than 76.4% introduced incremental innovations.
  • 60 percent of the drugs on the World health Organization’s essential Drug list reflect incremental improvements over older drugs.

The report indicates some of the benefits of ‘Incremental Pharmaceutical Innovation’ for India as follows:

  1. Improved quality of drug products, including products that are better suited to India’s climate.
  2. Development of treatments for diseases that are prevalent in India for which new drug discovery is currently limited or otherwise inadequate.
  3. Increasing likelihood that for every therapeutic class, there is a treatment to which an Indian patient will respond.
  4. Development of the R&D capacity and expertise
 of Indian pharmaceutical companies.
  5. Reduction of healthcare and other social costs in India through improved drug quality and selection.
  6. Increased access to medicine as a result of price competition.

The study concluded by saying that Section 3(d) potentially precludes the patenting of hundreds of incremental pharmaceutical innovations that Indian companies are attempting to patent and commercialize outside India.

There are umpteen numbers of examples that can ably demonstrate, ‘incremental innovation’ of the pharmaceutical innovators help significantly improving the efficacy and safety of existing drugs. All such innovations should in no way be considered “frivolous” as they have very substantial and positive impact in improving conditions of the ailing patients.

Be that as it may, the Supreme Court judgment has categorically mentioned that all ‘Incremental innovations’ should conform to the requirement of the Section 3(d) of the statute.

“West should learn from India’s high patent standards”

An article appeared just yesterday written by a well-regarded Indian economist recommended, “West should learn from India’s high patent standards”. It observed that    over-liberal patent system of the West is now broken and it should learn from India’s much tougher patent system.

Patent monopolies needs to be given only for genuine innovations, as defined in the Indian Patents Act 2005, where the public benefits clearly exceed the monopoly cost.

The author concluded by saying, “This means setting a high bar for innovation. High standards are desirable for patents, as for everything else.”

View of the Glivec inventor: 

In another interview titled, “If you erode patents, where will innovations come from?” Dr Brian Druker, whose work resulted in the development of Glivec, re-emphasizing the need for R&D by the pharmaceutical industry, commented,  “I’m going to stay away from the legal judgment … but as a physician, I do recognize that the advances will come from new products, not modifications.”

Are discordant voices out of step with time?

The interpretation of the Section 3(d) of the statute by the Honorable Supreme Court of India is the last word for all, despite a few voices of discord from within and mostly outside India. These voices, many would reckon, could well be out of step with time, especially in relatively fast growing, modern, independent, thinking and assertive young  India.

Conclusion:

In my view, nothing materially has changed on the ground before and after the Supreme Court judgment on the Glivec case so far as the Indian Patents Act is concerned and also in its interpretation.

While encouraging all types of innovations, including incremental ones and protecting them with an effective IPR regime are very important for any country. No nation can afford to just wish away various socioeconomic expectations, demands and requirements not just of the poor, but also of the growing middle class intelligentsia, as gradually getting unfolded in many parts of the globe.

Available indicators do point out that the civil society would continue to expect in return, just, fair, responsible and reasonably affordable prices for the innovative medicines, based on the overall socioeconomic status of the local population.

This critical balancing factor is essential not only for the progress of the pharmaceutical industry, but also to alleviate sufferings of the ailing population of the country, effectively.

For arguments sake, in an ideal scenario, if the Central and State Governments in India decide to buy such drugs to supply to all patients free of cost, just like any ‘welfare state’, will even the Government be able to afford these prices and fund such schemes in India?

It is, therefore, now widely expected that innovator pharmaceutical companies, which play a pivotal role in keeping population of any nation healthy and disease free to the extent possible, should also proactively find out ways to help resolving this critical issue in India, working closely with the Government of 1.2 billion Indians, including other concerned stakeholders.

In that context, the landmark Supreme Court judgment on the Glivec case has vindicated the need of striking a right balance between encouraging and protecting innovation, including incremental ones and the public health interest of 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 – Young Today, Old Tomorrow: Emerging Issues of Aging, Health and Socioeconomic Profile of the Country

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‘World Health Day’ is celebrated every year on April 7, the day ‘World Health Organization (WHO)’ was founded in 1948.

Each year, on this day, people from all walks of life across the globe are invited by WHO to focus on a particular emerging health challenge of global relevance, which becomes the theme of the ‘World Health Day’ for the year.

In 2012, the theme for this day was, “Aging and health: Good health adds life to years”. It focuses on how good health throughout the life span can help the senior citizens to lead a full and productive life and in turn makes them valuable and experienced resources not just to their respective families, but also to the societies and communities they belong to.

Aging affects all:

The process of aging, without any exception, affects the entire population, young or old, male or female, rich or poor, alike, across the world and is considered as one of the key factors of social transformations through the passage of time.

With the advancement in medical science coupled with increasing social awareness for living a healthy life, the average life expectancy of the population in the 20th century reportedly increased by around 30 years in the developed world and is expected to maintain similar growth trend in the 21st century, as well.

Now, with an increasing life expectancy even in the developing world, the issue is assuming greater magnitude and at a much faster pace.

In the language of Steve Jobs:

Steve Jobs, the global icon and the former CEO of Apple Inc., during his commencement speech to Stanford in 2005, very aptly articulated as follows:

“No one wants to die. Even people who want to go to heaven don’t want to die to get there. And yet death is the destination we all share. No one has ever escaped it. And that is, as it should be, because Death is very likely the single best invention of Life. It is Life’s change agent. It clears out the old to make way for the new. Right now the new is you, but someday not too long from now, you will gradually become the old and be cleared away. Sorry to be so dramatic, but it is quite true.”

In a normal situation old age precedes death and just like the inevitability of death, everybody, even a baby born today will need to embrace the old age before being cleared away by death. Thus, as the population will age as a natural process, there will be growing need to make even the old age more meaningful. Sounds like a tall call, but quite pertinent indeed.

Although, an average elderly person of today is much healthier than of the past generations, they will still need appropriate health management and social security plans, especially for an emerging economy, like India.

World population aging faster:

Population Division of the Department of Economic and Social Affairs of the United Nations in its publication titled, “World Population Aging:  1950-2050”, described the trend of ageing of the global population and highlighted the following:

  • Population aging is unprecedented : This is unparallel in human history and the current century will witness even more rapid aging than the previous one.
  • Population aging is pervasive:  It is affecting every man, woman and child across the world, though currently it is at different stages of progress in different countries.
  • Population aging is enduring:  The world will not return to the young populations of our ancestors.
  • Population aging has profound implications:  It affects many facets of lives of human beings.

Increasing burden of disease:

The burden of some serious age related diseases increases by manifold as the life progresses towards its ‘twilight zone’. Even now, the treatment costs and overall burden of age related diseases, both in the developed and the developing countries, are escalating in an alarming proportion.

Age related diseases:

According WHO, in the industrialized countries over 75 percent of deaths in people of over 65 years of age are due to cancer, cardiovascular and cerebrovascular diseases, in addition to disabilities like, loss of bone density leading to osteoporosis.

As per published reports, the incidence of age related Alzheimer’s disease, which is now incurable, will almost double every 20 years to reach around 66 million in 2030 and over 115 million in 2050.

Research for delaying the onset:

Reuters in an article titled, “Is aging a disease?” published in May 20, 2010 reported that many scientists from various parts of the world are now studying the genetic mechanisms of the old persons to help delay, if not overcome, the onset of diseases like Alzheimer’s, cancers, diabetes, cardiovascular ailments and many other age-related illnesses to help leading a better quality of life during old age of the human population.

Elderly population and the impact:

As per an estimate of the United Nations (UN), there will be around 1200 million people over 65 years of age by 2025. Currently, from across the world millions of aging people are denied of proper health care for various reasons. The situation in India is much worse.

It is envisaged by many that failure, either on the part of the Government or society at large, to address this critical issue today, could have a snowballing effect tomorrow.

In Japan, currently half of the national health budget is spent on the elderly individuals, which constitute around a whopping 23 percent of the country’s population. According to another estimate of the Japanese Government, by 2055 half of their total population will constitute of retired senior citizens.

India:

With over 65 percent of the population of India being now below 30 years of age, the country is  well poised to have one of the largest numbers of young and productive population in the world, though 7 percent of country’s 1.13 billion people are now over 60 years of age and the number is growing.

The Median Age of the population will keep on increasing over a period of time as follows:

Aging Profile: India and other countries

Year 2000 2015 2025 2030 2035 2040 2050
Median Age–India 23.4 27.2 30.3 31.4 33.5 35.0 37.9
Median Age–World 26.4 29.5 31.9 33.0 34.0 34.9 36.8
Median Age–More Developed Regions 37.3 41.2 43.3 44.2 45.0 45.4 45.2
Median Age–Less Developed Regions 24.1 27.5 30.0 31.2 32.4 33.5 35.7
Median Age–Least Developed Regions 18.1 19.6 21.2 22.2 23.3 24.5 27.1

(Source: Population Division, Department of Economic and Social Affairs, United

Nations Secretariat)

Growth of elderly population is much faster than the population:

As as per the paper titled, “Implications of an Aging Population in India: Challenges and Opportunities” presented at ‘The Living to 100 and Beyond Symposium’ of the Society of Actuaries in Orlando on January 12–14, 2005, the Indian population has approximately tripled during the last 50 years, but the number of elderly Indians has increased more than fourfold.

Assuming continuation of this trend, the United Nations have predicted that the Indian population will again grow by 50 percent in the next 50 years, with the elderly population recording another fourfold growth.

Changing demographic profile:

The situation in India, therefore, by no means is a trivial one and needs to be addressed with a right earnest and sooner, mainly because of the changes in the demographic profile of the country, as follows:

Projected Changes in Indian Demography (in Million)

Age Group

2000

2015

2025

2030

2035

2040

2050
0-14 Years

347

345

337

327

313

300

285
15-59 Years

593

782

865

895

919

937

938
>60 Years

77

119

167

195

223

248

308
Total

1,017

1,246

1,369

1,417

1,455

1,485

1,531

(Source: Population Division, Department of Economic and Social Affairs, United Nations Secretariat)

Thus, over a period of time in India, increasing number of less productive elderly people and the declining trend of the younger population, could adversely impact the overall socioeconomic profile and and the disease burden of the nation.

Conclusion:

In India, there has been hardly any support in terms of social security, especially for a vast majority of people, who are unable to work after becoming senior citizens of the country.

In a situation like this, the Government of India, civil society and the private sector enterprises of the country should work in tandem to give shape to appropriate policy measures to effectively address the issues of the increasing number aging population of the country, over a period of time.

This is necessary not just for the socioeconomic reasons, but also to arrest any significant increase in the overall disease burden of the nation with its possible adverse impact on the growing economy of the country.

Continuing lack of interest to work out a long term social and policy measures to address the important issues related to population aging in India, in a holistic way, could significantly impede the pace of economic growth of the country, celebration of the ‘World Health Day’ on April 7, 2012 notwithstanding.

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.

Path-breaking medicines are just not enough… a comprehensive healthcare reform in India is long overdue

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The Prime Minister of India, Dr. Manmohan Singh reiterated the following in his speech at the 30th Convocation of PGIMER, Chandigarh on November 3, 2009:

”As in economics, so as in medicine too, it is easy to get lost in high level research and forget the ground realities. A common perception among the public is that institutions running with public money end up as ivory towers. It is widely felt that the poor and under-privileged sections of our population do not have adequate access to the health care system. The system needs structural reforms to improve the quality of delivery of services at the grass-root level. It has to be more sensitive to the needs of our women and children. We must also recognize that a hospital centered curative approach to health care has proved to be excessively costly even in the advanced rich developed countries. The debate on health sector reforms is going on in US is indicative of what I have mentioned just now. A more balanced approach would be to lay due emphasis on preventive health care”.

Some key research findings on ‘Public Health’:

Interesting research studies on public health highlight two very interesting points:

- Health of an individual is as much an integral function of the related socio-economic factors as it is

influenced by the person’s life style and genomic configurations.
- Socio-economic disparities including the educational status lead to huge disparity in the space of healthcare.

WHO ranking of the ‘World’s Health Systems’:

The WHO ranking of the ‘World’s health Systems’ was last produced in 2000. This report is no longer produced by the WHO due to huge complexity of the task.

In this interesting report, the number one pharmaceutical market of the world and the global pioneer in pharmaceutical R&D, the USA features in no. 37, Japan in no. 10, UK in no.18 and France tops the list with no.1 ranking. Among emerging BRIC countries, India stands at no. 112, Russia in no.130 and China in no. 144.

In a relative yardstick, although India scored over the remaining BRIC countries in year 2000, one should keep in mind that China has already undertaken a major healthcare reform in the last year. Early this year, we all have seen how President Obama introduced a new healthcare reform for the USA, despite all odds. India’s major reform in its healthcare space is, therefore, long overdue.

Details of WHO ‘World’s Health Systems’ ranking of the countries are available at the following link:

http://www.photius.com/rankings/healthranks.html

No need to reinvent the wheel:

When we look at the history of development of the developed countries of the world, we observe that all of them had invested and are continuously investing to improve the social framework of the country where education and health get the top priority. Continuous reform measures in these two key areas of any nation have proved to be the key drivers of economic growth. This is a work in continuous progress. Recent healthcare reforms both in China and the USA will vindicate this argument. In India we, therefore, do not require to reinvent the wheel, any more.

It has been observed that reduction of social inequalities ultimately helps to effectively resolve many important healthcare issues. Otherwise, the minority population with adequate access to knowledge, social and monetary power will always have necessary resources available to address their concern towards healthcare, appropriately.

Path breaking medicines are just not enough:

Regular flow of newer and path breaking medicines in India to cure and effectively treat many diseases, have not been able to eliminate either trivial or dreaded diseases, alike. Otherwise, despite having effective curative therapy for malaria, typhoid, cholera, diarrhea/dysentery and venereal diseases, why will people still suffer from such illnesses? Similarly, despite having adequate preventive therapy, like vaccines for diphtheria, tuberculosis, polio, hepatitis and measles, our children still suffer from such diseases.

Reducing socio-economic inequalities is equally important:

All these continue to happen in India, over so many decades, because of socio-economic considerations, as well. Thus, together with comprehensive healthcare reform measures, time bound simultaneous efforts to reduce the socio-economic inequalities will be essential to achieve desirable outcome for the progress of the nation.

Proper focus on education is critical for a desirable health outcome:

Education is of key importance to make any healthcare reform measure to work effectively. Very recently we have witnessed some major reform measures in the area of ‘primary education’ in India. The right to primary education has now been made a fundamental right of every citizen of the country, through a constitutional amendment.

As focus on education is very important to realize the economic potential of any nation, so is equally relevant in the healthcare space of the country. India will not be able to realize its dream to be one of the economic superpowers of the world without a sharp focus and significant resource allocation in these two critical areas – Health and Education, simultaneously.

Progress in the healthcare space of India:

It sounds quite unfair, when one comments that nothing has been achieved in the area of healthcare in India, as is usually done by vested interests with a condescending attitude in various guises. Since independence, India has made progress, may not be highly significant though, with various government sponsored and private healthcare related initiatives, as follows:

- Various key disease awareness/prevention programs across the country, for both communicable and non-communicable diseases.
- Eradication of smallpox
- Excellent progress in polio eradication program
- Country wide primary vaccination program
- Sharp decline in the incidence of tuberculosis
- Significant decrease in mortality rates, due to water-borne diseases.
- Good success to bring malaria under control.
- The mortality rate per thousand of population has come down from 27.4 to 14.8 percent.
- Life expectancy at birth has gone up to 63 years of age.
- Containment of HIV-AIDS
- India has been recognized as the largest producers and global suppliers of generic drugs of all categories and types.
- India has established itself as a global outsourcing hub for Contract Research and Contract Manufacturing Services (CRAMS).
- The country has now been globally recognized as one of the fastest growing emerging markets for the pharmaceuticals

New healthcare initiatives in India:

There are various hurdles though to address the healthcare issues of the country effectively, but these are not definitely insurmountable. National Rural health Mission is indeed an admirable scheme announced by the Government. Similar initiative to provide health insurance program for below the poverty line (BPL) population of the country, is also commendable. However, effectiveness of all such schemes will warrant effective leadership at all levels of their implementation.

Per capita public expenditure towards healthcare is inadequate:

Per capita public expenditure towards healthcare in India is much lower than China and well below other emerging countries like, Brazil, Russia, China, Korea, Turkey and Mexico.

Although spending on healthcare by the government gradually increased in the 80’s overall spending as a percentage of GDP has remained quite the same or marginally decreased over last several years. However, during this period private sector healthcare spend was about 1.5 times of that of the government.

It appears, the government of India is gradually changing its role from the ‘healthcare provider’ to the ‘healthcare enabler’.

High ‘out of pocket’ expenditure towards healthcare in India:

According to a study conducted by the World Bank, per capita healthcare spending in India is around Rs. 32,000 per year and as follows:

- 75 per cent by private household (out of pocket) expenditure
- 15.2 per cent by the state governments
- 5.2 per cent by the central government
- 3.3 percent medical insurance
- 1.3 percent local government and foreign donation

Out of this expenditure, besides small proportion of non-service costs, 58.7 percent is spent towards primary healthcare and 38.8% on secondary and tertiary inpatient care.

Role of the government:

In India the national health policy falls short of specific and well defined measures.

Health being a state subject in India, poor coordination between the center and the state governments and failure to align healthcare services with broader socio-economic developmental measures, throw a great challenge in bringing adequate reform measures in this critical area of the country.

Healthcare reform measures in India are governed by the five-year plans of the country. Although the National Health Policy, 1983 promised healthcare services to all by the year 2000, it fell far short of its promise.

Underutilization of funds:

It is indeed unfortunate that at the end of most of the financial years, almost as a routine, the government authorities surrender their unutilized or underutilized budgetary allocation towards healthcare. This stems mainly from inequitable budgetary allocation to the states and lack of good governance at the public sector healthcare delivery systems.

Encourage deep penetration of ‘Health Insurance’ in India:

As I indicated above, due to unusually high (75 per cent) ‘out of pocket expenses’ towards healthcare services in India, a large majority of its population do not have access to such quality, high cost private healthcare services, when public healthcare machineries fail to deliver.

In this situation an appropriate healthcare financing model, if carefully worked out under ‘public – private partnership initiatives’, is expected to address these pressing healthcare access and affordability issues effectively, especially when it comes to the private high cost and high quality healthcare providers.

Although the opportunity is very significant, due to absence of any robust model of health insurance, just above 3 percent of the Indian population is covered by the organized health insurance in India. Effective penetration of innovative health insurance scheme, looking at the needs of all strata of Indian society will be able to address the critical healthcare financing issue of the country. However, such schemes should be able to address domestic and hospitalization costs of ailments, broadly in line with the health insurance model working in the USA.

The Government of India at the same time will require bringing in some financial reform measures for the health insurance sector to enable the health insurance companies to increase penetration of affordable health insurance schemes across the length and the breadth of the country.

A recent report on healthcare in India:

A recent report published by McKinsey Quarterly, titled ‘A Healthier Future for India’, recommends, subsidizing health care and insurance for the country’s poor people would be necessary to improve the healthcare system. To make the healthcare system of India work satisfactorily, the report also recommends, public-private partnership for better insurance coverage, widespread health education and better disease prevention.

Conclusion:

In my view, the country should adopt a ten pronged approach towards a new healthcare reform process:

1. The government should assume the role of provider of preventive and primary healthcare across the nation to ensure access to healthcare to almost the entire population of the nation.

2. At the same time, the government should play the role of enabler to create public-private partnership (PPP) projects for secondary and tertiary healthcare services at the state and district levels.

3. The issue of affordability of medicine can best be addressed by putting in place a robust model of healthcare financing for all sections of the population of the country. Through PPP a strong and highly competitive health insurance infrastructure needs to be created through innovative fiscal incentives.

4. These insurance companies will be empowered to negotiate all fees payable by the patients for getting their ailments treated including doctors/hospital fees and the cost of medicines, with the concerned persons/companies, with a key objective to ensure access to affordable high quality healthcare to all.

5. Create an independent regulatory body for healthcare services to regulate and monitor the operations of both public and private healthcare providers/institutions, including the health insurance sector.

6. Levy a ‘healthcare cess’ to all, for effective implementation of this new healthcare reform process.

7. Effectively manage the corpus thus generated to achieve the healthcare objectives of the nation through the healthcare services regulatory authority.

8. Make this regulatory authority accountable for ensuring access to affordable high quality healthcare services to the entire population of the country.

9. Make operations of such public healthcare services transparent to the civil society and cost-neutral to the government, through innovative pricing model based on economic status of an individual.

10. Allow independent private healthcare providers to make reasonable profit out of the investments made by them

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.