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National Rural Health Mission (NRHM), a much hyped public healthcare initiative – has it delivered since its inception in 2005?

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National Rural Health Mission (NRHM), a very ambitious and noble initiative for the rural population of India was launched by the Government of India on April 12, 2005. The interim budget allocation of NRHM for the year 2009–10 has been increased to Rs. 12,070 crore. The primary purpose of NRHM, as announced by the Government, was to improve access to quality healthcare for the poor population of 18 states, to start with, of rural India.

Along with such a commendable initiative, the Government declared an increase in its spending towards public health from mere 0.9% to 2–3% of the GDP over a five year period. This decision was in line with the well articulated prime focus of the Government on public health and education.

During the launch of NRHM, the Health Minister of India announced that the nation would see the results of these efforts in three years time.

Three years are over now. Let us, therefore, have a look at the key achievement areas of this ambitious scheme for the budget year 2008-09, as announced by the Finance Minister recently in his interim budget speech for 2009–10.

The performance areas were highlighted as follows:

• 462,000 Associated Social Health Activists were trained
• 177,924 villages have sanitation committees functional
• 323 district hospitals have been taken for up gradation

Against such a soft performance parameters of the Government, let us see some hard facts, which are real indicators of performance of NRHM. A report on the recent study done by Chronic Care Foundation indicates that in India about 86% of highly populated rural districts still do not have provisions for basic diagnostic tests for chronic ailments.

The study also highlights that in rural areas, as a percentage of total expenses, out of pocket healthcare costs are more than the urban areas, with hospitalization expenses contributing the most to the total costs. In many rural areas the healthcare costs have been reported to be as high as around 80% of the total expenses. Such a high out of pocket expenses have mainly been attributed to the lack of facilities in these rural areas, requiring patients to travel to distant areas for medical treatment. It was also reported that even in rural areas due to inefficient and inadequate services at the Government healthcare units, there has been a very high dependence on more expensive private healthcare facilities.

After almost four years from the inception of NRHM, if this is the state of affairs for rural public healthcare, the obvious questions which come to my mind are as follows:

• Where is the huge money allocated for NRHM going?
• Who is or are accountable for such a poor performance of this great scheme?

In my opinion, to make NRHM work satisfactorily the Government should outline, decide and announce the key success parameters for performance evaluation of the scheme. This is to be done disclosing the names and designations of the responsible senior Government officials who will be held accountable for the success or failure to deliver the deliverables. All these details should be uploaded on to the website of the Ministry of Health for public scrutiny, at least half yearly. With tax-payers money being utilised for this important and critical public health arena, no non-performance should escape attention and go unpunished.

Moreover, with the help of experts, the Government should decide, which elements of each identified success parameters the Government will be able to deliver better with its own internal resources and which are those areas where the Government should outsource.

Such an approach when worked out in great details will be able to ensure whether through NHRM the country is making progress to improve access to quality healthcare for a vast majority of its rural population. Otherwise this scheme may well be treated just as one of those which failed to deliver and vanished in the oblivion.

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.

‘Orphan Drugs’ for ‘Orphan Diseases’ – is ‘Open Source Drug Discovery (OSDD)’ platform for discovery research the way forward?

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To meet the unmet needs of common and dreaded diseases intensive R&D activities are being undertaken by the Pharmaceutical Industry, the world over. At the same time, a percentage of human population, however small, also suffers from some rare diseases, for which there are no approved medical treatments even in the twenty first century, for the rich and poor alike.These rare diseases are also termed as ‘orphan diseases’, which are often chronic, progressive, degenerative, life-threatening or disabling. Many patients suffering from such rare diseases are denied their right to get their ailments effectively treated.It is indeed heartening to note that European Organization for Rare Diseases (EURORDIS) and National Alliances announced February 29, 2008 as the first ‘Rare Disease day’. Thereafter, the last day of February has been designated as ‘Rare Disease Day’ worldwide to call attention to the public health issues associated with rare diseases, which have been reported to affect around 30 million patients around the world.

People with rare diseases remain a medically underserved population even in a developed country. We can then well imagine the plight of such patients in India. The ‘Rare Disease Day’ is intended to bring together the patients and families with rare diseases to discuss the need for greater awareness, more research, and better access to diagnosis and treatment. I am not sure how various authorities, including our Government, are deliberating on this healthcare issue.

People suffering from ‘orphan diseases’ often face huge challenges compared to more common diseases. These include delay in getting an accurate diagnosis, few treatment options and difficulty finding medical experts. Many such rare diseases have no approved treatment. Moreover, treatments for ‘orphan diseases’ tend to be in most cases more expensive than treatments for more common diseases.

This year, the “Rare Disease Day” will be observed in India also, on February 28, though these are not very much talked about in our country, nor is there any proper definition in place for such diseases, as yet.

The drugs meant for treating ‘orphan diseases’ have been very appropriately termed as ‘orphan drugs’, mainly due to commercial reasons, as such drugs will be used on much fewer patients with commensurate return on investments towards R&D. Thus spending expensive R&D resources toward such drugs may not make sound commercial sense.

To address this need, in 1983, the Orphan Drug Act was passed by the Congress in the USA to extend financial incentives for companies to develop treatments for rare diseases. Since then, nearly 330 ‘orphan drugs’ and biologics have been approved by the U.S. FDA, which estimates that from 11 to 14 million Americans would benefit from these ‘orphan drugs’. However, despite such commendable measures taken by the US FDA, around 15 million Americans still leave with such ‘orphan diseases’ for which there is no approved treatment.

It is interesting to note that some of these ‘orphan diseases’ are now being diagnosed in India, as well. As India takes rapid strides in medical science, more of such ‘orphan diseases’ are likely to be known in our country.

Thus the moot question is how does India address this issue with pro-active measures? In the USA, even by giving adequate financial incentives, this problem could not be effectively addressed for commercial reasons.

In my view, one of the ways to properly address this issue is to follow the model of our very own the Council of Scientific and Industrial Research (CSIR) for an ‘Open Source Drug Discovery’ (OSDD) program with global partnerships, wherever required. This initiative has been pioneered by the well known scientist and Director General of CSIR Dr. Samir Brahmachari. Andrew Witty, the CEO of GlaxoSmithKline also had mooted a similar idea in another context in not too distant past.

Therefore, to address the issue of ‘orphan diseases’, in my opinion, the OSDD model with partnerships between private, public and academia will not only prove to be a viable and more practical model to discover ‘orphan drugs’, but will also help India to effectively contribute to this important global issue – not just by observing the ‘Rare Diseases Day’ on February 28 or 29, each year.

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.

65% of Indians do not have access to affordable modern medical treatment – why?

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India is indeed a country of many paradoxes. Not just peaceful co-existence of luxurious sky scrapers and dilapidated shanties side by side. In the healthcare sector as well, we witness on one side booming medical tourism of foreign nationals to get various types of ailments treated with the best possible medical amenities, just when on the other side common diseases like, malaria and tuberculosis are taking the common man on a rampage. Is India, therefore, ignoring the crying need to strike a balance between extending cost competitive healthcare benefits to the ‘haves’ of the world without neglecting the domestic ‘have nots’?Another paradox, when India caters significantly to the growing needs of the world for low cost generic medicines, 65% of Indian population cannot afford the same and do not have access even to a doctor.In a situation like this, what sort of equitable distribution of healthcare benefits are we then talking about? Isolated attempts of opening low cost generic medicine shops, enforcing rigorous non-transparent price control, attempt to divert the debate on the price of patented medicines which contribute miniscule decimal points on the total pharma market in India, can at best be termed as populist measures, instead of trying to look at the macro picture to address the pressing healthcare issues of the country.

When we talk about affordability, why do we not talk about affordability of medical treatment as a whole and not just affordability of medicine, for one or many ailments that the common man suffers from? Will our government try to address this bigger issue in a holistic way?

What could possibly be the reasons for such inaction? Is it because improper co-ordination, if not lack of co-ordination, between various Government departments, the ultimate victim of which is the common man?

Such a situation reminds me of an old story of three blind men and an elephant. After touching the trunk of the elephant, one blind man describes the elephant as a large Python, touching a leg of the elephant, the other blind man describes it as a pillar. The third blind man while touching the body of the elephant describes it as a strong wall. Unfortunately no one could describe the elephant as it really is and no one in this particular case was helping them to do so, either.

Could it be that various departments of our Governments are acting like these blind men and are not seeing the big picture – the elephant of the above story? It appears that the Pharmaceutical department of the Ministry of Chemicals and Fertilizers believes that only the price of medicines is the key issue for an ailing patient while going for a medical treatment and not the cost of total treatment. Thus, they seem to be working full time to drive down only the price of medicines.

The Ministry of Health is also trying to do a little bit of something in some not so known areas. The Ministry possibly believes that they are effectively helping everybody to address the pressing healthcare issues. It does not so appear that the Ministry realizes that majority of our population does not have access to affordable modern treatment for the ailments that they are suffering from. Number of doctors, nurses, hospital beds etc. per 1000 of Indian population is still abysmally low even compared to some developing nations. Cost of getting a disease diagnosed even before any medicine is prescribed is sky rocketing, at a break neck speed. Which Government department is trying to address the cost of disease burden and trying to alleviate it for all of us, in a holistic way?

Here comes another paradox. While the Pharmaceutical Department intends to bring down the price to make the drug affordable, the Finance Ministry keeps the transaction cost of medicines at a high level by levying various taxes to improve its revenue collection, ultimately making the same medicine less affordable.

In the developed nations and also in many emerging markets healthcare financing or health insurance for all strata of the society is being successfully implemented to address the key issue of improving access to affordable modern treatment to a vast majority of the population. Even after 61 years of independence we have not been able to address this critical healthcare financing issue effectively.

Piece meal approach of our Government has not succeeded much to address this important issue of the country. Taking one-off populist measures of various types and creating media hype may not help sorting out this issue, at all.

The way forward, very broadly speaking, is to bring the entire healthcare policy making and implementation functions under one ministry. If that is not possible, the concerned ministries should work in unison, with effective procedural interfaces being put in place for proper co-ordination with a clear goal of improving access to affordable modern treatment to all.

Is it not a shame on us that even today, 65% of Indian population does not have access to affordable modern medical treatment?

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.

We need to encourage the new product patent regime

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Ushering in the Product Patent Regime in India heralds the dawn of a new era. The era that vindicates not only the need to encourage, protect and reward innovation for the rapid progress of our nation but also to compete effectively, in the knowledge economy with the best in the world to establish India as a leading country with a significant share of the global economy.However, it is quite unfortunate that the patents that protect today’s innovations and drive research and development to create tomorrow’s life-saving treatments are under criticism from some quarters.India chose to follow an alternative to Product Patent regime for many years. In 1970, the Government of India amended its IP laws with a clear objective in mind to reduce the prices of medicines to improve their access to the ailing population of the country.

As a result, some drugs were made cheaper. However, the moot question that we need to address now: was it a panacea? While looking back, it does not really appear so. On the contrary, the situation remained as gloomy thereafter, so far as the access of medicines is concerned. After almost 4 decades of continuation with the above policy, around 65% of Indian population still do not have access to cheaper off-patent medicines against comparative figures of 47% in Africa and 15% in China (Source: International Policy Network, November 2004).

Children still go without routine vaccinations, though the Government has made the primary vaccination programs free in our country, for all. Even in a situation like this, where affordability is no issue, only about 44% of infants (12 – 23 months) are fully vaccinated against six major childhood diseases – tuberculosis, diphtheria, pertussis, tetanus, polio and measles.

Moreover, as we know, despite distribution of cheaper generic HIV-AIDS drugs by the Government and others mostly free for years, only 5% of India’s AIDS patients were receiving any drugs by the end of 2006.

The above two important examples prove the point very clearly that, addressing the issue of price alone will not help our country to solve the issue of poor access of medicine to the ailing population of India. Only a sharp focus on rejuvenation of our fragile healthcare system, healthcare financing and rapid development of healthcare infrastructure of the country by the Government or through Public Private Partnership (PPP), will help address this pressing issue.

Indian Patent Act 2005 has paved the way for innovation and hi-tech research and development within the country. Contrary to adverse forecasts from some quarters, prices of medicines have not gone up.

However, while medicines play a relatively small role in rising overall health care spending including hospitalization, it is important to ensure that individuals with large healthcare expenses have affordable access to their medicines. Thus a good affordable insurance coverage (both Government and Private) available to all Indians belonging to various socio-economic strata, together with the above measures, will help address the key issues of both access and affordability of medicines for all, in a holistic way.

The attack on patents is not really a defense of patients or the poor. Such attacks help diverting attention from the core healthcare issues, as mentioned above, which are healthcare system, healthcare financing and healthcare infrastructure. Health of our nation will depend on how well these key issues are being addressed by the policy and decision makers. Our country cannot afford to ignore that Intellectual Property is one of the keys to prosperity of a great nation like India and it should be encouraged, protected and rewarded under a robust Patent Act of the country for inclusive growth.

By Tapan Ray

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

An integrated approach towards Public Private Partnership (PPP) initiatives to improve access to healthcare in India is the way forward.

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Despite so much of stringent government control, debate and activism on the affordability of modern medicines in India, on the one hand, and the success of the government to make medicines available in the country at a price, which is cheaper than even Pakistan, Bangladesh and Sri Lanka, on the other, the fact still remains, about 65% of Indian population do not have access to affordable modern medicines, compared to 15% in China and 22% in Africa.The moot question therefore is, despite all these stringent price regulation measures by the government and prolonged public debates over nearly four decades or so to ensure better ‘affordability of medicines’, why then the situation on ‘access to modern medicines’has remained so abysmal to a vast majority of the population, in India?This, in my view, is mainly because; no single minister or ministry can now be held accountable by the civil society for such a dismal performance in the access to healthcare, in India.

Poor healthcare infrastructure:

As per the Government’s own estimate, India records:

1. A shortage of 4803 Primary Health Centres (PHC)

2. A shortage of 2653 Community Health Centres (CHC)

3. No large Public Hospitals in rural areas where over 70% of the populations live

4. Density of doctors in India is just 0.6 per 1000 population against 1.4 and 0.8 per 1000 population in China and Pakistan respectively, as reported by WHO.

The Government spending in India towards healthcare is just 1.1% of GDP, against 2% by China and 1.6% by Sri Lanka, as reported by the WHO.

Some good but sporadic public healthcare initiatives:

The government allocation of around US$ 2.3 billion for the National Rural Health Mission (NRHM), is a good initiative to bring about uniformity in quality of preventive and curative healthcare in rural areas across the country.
While hoping for the success of NRHM, inadequacy of the current rural healthcare infrastructure with about 80 percent of doctors, 75 percent dispensaries and 60 percent of hospitals located only in the urban India, may encourage skepticism.

Addressing the issue of improving access to healthcare:

While addressing the issue of improving access of healthcare, following three important ‘Public Private Partnership (PPP)’ initiatives would be most appropriate.

1. PPP to improve affordability:

To address this vexing problem, industry associations had jointly suggested a policy shift towards public-private-partnership (PPP) model to the government in 2006-07, instead of a stringent price control mechanism, which has not worked thus far to improve access of modern medicines, in India. Instead, the associations seemed to have suggested that the pharmaceutical industry will supply to the government the essential medicines at 50% of their Maximum Retail Price (MRP), to cater to the need of below the poverty line (BPL) families.

It is worth mentioning, many OPPI member companies like, Novartis, GSK, Pfizer, Sanofi-Aventis etc. have their own access to medicines programs in India.

Although the government did not respond to this proposal, to make it effective the ministry of health will require to quickly initiate significant ‘capacity building’ exercises, both in the primary and also in the secondary public healthcare facilities in the country. FICCI is reported to have suggested to the Government for an investment of around US$ 80 billion to create over 2 million hospital beds, for such capacity building exercises .

Frugal budget allocation by the government towards healthcare of the country, suggests that Government is gradually shifting its role in this very important area, primarily from healthcare provider to healthcare facilitator for the private sectors to develop it further. If it is so, it is imperative for the government to realize that the lack of even basic primary healthcare infrastructure, leave aside other incentives, impede effective penetration of private sectors into semi-urban and rural areas. Effective PPP model should be worked out to address such issues, without further delay.

2. PPP to leverage the strength of Information Technology (IT) to considerably neutralize the system weaknesses:

Excellence in ‘Information Technology’ (IT) is one of the well recognized strengths that India currently possesses. This strengths needs to be adequately leveraged through PPP to neutralize the above weaknesses. Harnessing IT strengths, especially in the areas of drug procurement and delivery processes, especially in remote places, could hone the healthcare delivery mechanism, immensely.

Another IT enabled technology that India can widely use across the nation to address rural healthcare issues is ‘‘Telemedicine’ for distant diagnosis and treatment of ailments. Required medicines for treatment could be made available to the patients through ‘Jan Aushadhi’ initiative of the Department of Pharmaceuticals (DoP), by utilising the Government controlled distribution outlets like, public distribution system (ration shops) and post offices, which are located even in far flung and remote villages of India.

3. PPP in healthcare financing for all:

Unlike many other countries, even as compared to China, over 72 percent of Indian population pay out of pocket to meet their healthcare expenses.

Out of a population of 1.3 billion in China, 250 million are covered by insurance; another 250 million are partially covered by insurance and balance 800 million are not covered by any insurance. Converse to this scenario, in India total number of population who may have some sort of healthcare financing coverage will be around 200 million with penetration of health insurance at just around 3.5% of the population. India is fast losing grounds to China mainly due to better response to healthcare infrastructure.

Even after leveraging IT for ‘Telemedicine’ and improving healthcare delivery processes, together with availability of low priced quality medicines from ‘Jan Aushadhi’ outlets, a robust healthcare financing model for all strata of society to make healthcare products/services affordable to a vast majority of the population, will remain an essential requirement for the country to address the issue of improving access to healthcare to all.

According to a survey done by National Sample Survey Organisation (NSSO), 40% of the people hospitalised in India borrow money or sell assets to cover their medical expenses. A large number of populations cannot afford to pay for the required treatment, at all.

Conclusion:

In my view an integrated approach for creating effective healthcare infrastructure throughout the country, leveraging IT in the entire healthcare space, appropriately structured ‘Health Insurance’ schemes for all strata of society ably supported by well spread out ‘Jan Aushadhi’ outlets even in far flung rural areas, deserve careful consideration by the Government.

A PPP model in all these three areas needs to be worked out in detail to address the pressing issue of improving ‘Access to Affordable Integrated Healthcare to ALL’.

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.