Tag Archives: Healthcare

Have the successive ‘Drug Policies’ of India delivered? If not, why not?

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January 11, 2011 edition of ‘The Lancet’ in its article titled, “Financing health care for all: challenges and opportunities” commented as follows:
“India’s health financing system is a cause of and an exacerbating factor in the challenges of health inequity, inadequate availability and reach, unequal access, and poor-quality and costly health-care services. The Government of India has made a commitment to increase public spending on health from less than 1% to 3% of the gross domestic product during the next few years…. Enhanced public spending can be used to introduce universal medical insurance that can help to substantially reduce the burden of private out-of-pocket expenditures on health.”
The “Drug Policy “of India:
The new ‘Drug Policy’ of India, which is long overdue, should address all these key issues, as articulated by ‘The Lancet’. Unfortunately, outdated ‘1995 Drug Policy’ is still operational, since last fifteen years. The reason for inordinate delay in putting a new, robust and more reform oriented ‘Drug Policy ’in place is still not known to many, as it is probably languishing in the prison of indecision of the bureaucracy of the country.
The ‘Drug Policy 1986’ clearly enunciated the basic policy objectives relating to drugs and pharmaceuticals in India. After around 25 years, should not the government, at the very least, ponder to assess whether the successive drug policies have delivered to the nation the desirable outcome or not?
In my view, the objectives of the new ‘Drug Policy’ should help accelerating the all-round inclusive growth of the Indian pharmaceutical industry to make it a force to reckon with in the global pharmaceutical space. The drug policies are surely not formulated just to implement rigorous price control measures for drugs. The policy should also formulate other key measurable initiatives, assigning specific accountabilities, to contribute significantly towards achieving the healthcare objectives of the nation. The policy should also encourage working closely and in tandem of all the related ministries of the government.
Financial protection against medical expenses for all is very important:
One of the very major issues in the healthcare space of the country is high out of pocket expenses by the majority of our population. “Financial protection against medical expenditures is far from universal with only 10% of the population having medical insurance” in India. (Source: Lancet Jan 11, 2011).
A comparison of private (out of pocket) health expenditure: (Source: Lancet)
1. Pakistan: 82.5% 2. India: 78% 3. China: 61% 4. Sri Lanka: 53% 5. Thailand: 31% 6. Bhutan: 29% 7. Maldives: 14%
The key issue remains unresolved:
The above edition of ‘The Lancet’ has highlighted that outpatient (non-hospitalization) expenses in India is around 74% of the total health expenses in India and the drugs account for 72% of this total outpatient expenditure. The study has also highlighted that 47% and 31% hospitalization in rural and urban areas respectively are financed by loans and sell of assets.
Drug Prices in India:
The cost of medicines, especially the essential medicines in India, is one of the lowest in the world, even more economical than our neighboring countries like, Bangladesh, Sri Lanka and Pakistan. Moreover, as per DIPP data the inflation index of medicine in 2009 was much lower at 112.32 against the same for all commodities in the same year at 127.47. National Pharmaceutical Pricing Authority (NPPA) also indicated that there was almost no rise (+0.5%) of drug prices in 2010 over the previous year because of effective ‘Drug Price Monitoring mechanism’ by the regulator and fierce market competition.
Around 38% – 40% of Indian population can’t afford to spend on medicines:
While framing the ‘Drug Policy’, the government should also keep in mind that a population of around 38 to 40% of India, still lives below the poverty line and will not be able to afford any expenditure towards medicines. Adding more drugs in the list of essential medicines and even bringing them all under stringent price control will not help the country to resolve this important issue, in the prevailing situation.
The key focus area of successive ‘Drug Policies’ of India has been just ‘price’:
The reform initiatives enunciated by the government in the successive drug policies have been considered by the pharmaceutical industry, in general, as far from satisfactory. In the era of globalization, where market forces play a dominant role to control prices, including the essential commodities, the rigors of stringent price control on pharmaceuticals need to be addressed urgently. This was re-enforced even in the ‘National Economic Survey Report of 2009′.
Will continuation of the same focus be able to resolve the issue?
I do not think so. Continuation of the focus on price since last four decades has certainly enabled the government to ensure that drugs prices in India are cheapest in the world. However and very unfortunately the ‘Drug Policies’ with focus on price alone have not been able to ensure even today that 47% and 31% of hospitalization in rural and urban areas, respectively, are financed by robust healthcare financing systems and not by private loans and selling of assets by individuals.
Expectations from the new ‘Drug Policy’:
Adequate and immediate policy measures to respond to the needs of a robust healthcare financing model for all strata of the society are absolutely critical to address this pressing issue. Effective penetration of health insurance, will, therefore, be one of the key growth drivers not only for the Indian pharmaceutical industry, but also to ensure its inclusive growth, as desired by many.
Conclusion:
Unfortunately, the ‘Drug Policies’ of India have not been able to keep pace with the globalization process of the country as compared to even those industries, which are dealing with the essential commodities, like pharmaceuticals. The amended Indian Patents Act came into force in the country in January 2005. The drug policy of India, for various reasons, has not been able to articulate, as yet, specific key measures to encourage innovation, giving a new thrust to the pharmaceutical R&D space of the country, as much as it should have been.
The ‘New Drug Policy’ should have clear and transparent provisions of stringent drugs ‘price monitoring’ mechanism by the NPPA. The policy should also include an equally transparent system to ensure that errant pharmaceutical players, if any, who will be caught with profiteering motives, under any garb, at the cost of precious lives of the ailing patients, are brought to justice with exemplary punishments, as will be defined by law.

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.

Gone 2010…Comes 2011: Looking Back…Looking Ahead at the Healthcare Space of India

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Our country, especially the media and the politicians (perhaps not so much the ‘Aam Aadmi’), appears to be totally engrossed now in uprooting the issue of corruption from the soil of India, once and for all. Politicians of all hues are not showing any sign of respite to let go this opportunity, without squeezing out the last drop of ‘political elixir’, out of the current high level of self-created cynicism. This is very important for them in the run-up to the next general and state elections for ultimate win in the political power-game. The ‘common man’, like you and me, on the contrary, is perhaps thinking about job creation, financial progress, infrastructure development, education and health.

The Fourth Estate of the country, especially the Electronic Media, seems to be lapping up any news, which could even remotely help the TRPs of their respective news channels going north.

In a chaotic situation like this, when even the country’s parliament is defunct, it appears, by and large the entire nation is currently being encouraged to get deeply engaged in ‘self-flagellation’, as it were. There seems to be a desperate need to prove to the world, time and again, how bad the Indians are. The ‘Brand India’ after taking so many powerful blows on its chin, is in tears now.

Be that as it may, has India achieved anything in the year 2010 with a public spend of just around 1% of the GDP towards healthcare? Let me try to capture some of those hard facts, which could appear as a laundry list though, at the very onset of the brand New Year. I have collated these details from various published sources.

Some doomsayers with ever ‘pontifying’ mind-set would nevertheless keep brushing all these aside. However, acknowledging these achievements, I would rather say, “all these are too little even for too few”.

Whatever it is, I am trying to put these details in one place for a comprehensive record of the year, just gone by.

Here it goes:

I. Healthcare Indicators:

I. The number of polio cases has sharply declined during the year. Only 41 polio cases have been reported as on November 30, 2010, against 633 in the corresponding period of 2009.

II. Adult HIV prevalence has declined from 0.41% in 2000 to 0.31% in 2009. The number of new annual HIV infections has declined by more than 50% from 2000 to 2010.(Source: National AIDS Control Organization )

III. Leprosy Prevalence Rate has declined to 0.71/10,000 in March, 2010. 32 State/UTs have achieved elimination by March 2010, leaving only Bihar, Chhattisgarh and Dadra & Nagar Haveli.

IV.TB mortality in has gone down from over 42/lakh population in 1990 to 23/lakh population in 2009 as per the WHO global report 2010. The prevalence of the disease in the country has reduced from 338/lakh population in 1990 to 249/lakh population by the year 2009 (Source: WHO global TB report, 2010).

II. New Initiatives:

  1. A bivalent oral polio vaccine (bOPV) was launched in the country in Bihar on January 9, 2010.
  2. A ‘Sports Injury Centre’ was dedicated to the nation at the Safdarjung Hospital, Delhi, with an inpatient capacity of 35 beds with all modern facilities.
  3. The Indian Pharmacopeia Commission published the 2010 version of Indian Pharmacopeia.
  4. Upgradation of the National Centre for Disease Control (NCDC), Delhi with an estimated cost of Rs 382.41. Crore.
  5. A scheme to support the State Government Medical Colleges for conducting paramedical courses with a total proposed project cost of Rs.1156.43 Crore.
  6. Setting up of 132 Auxiliary Nurse Midwives training schools at an estimated cost of Rs.5.00 Crores per school and 137 General Nursing and Midwifery training schools at an estimated cost of Rs.10.00 Crores per school.
  7. Ministry of Health and Family Welfare and Ministry of Railways signed a memorandum of Understanding for development of healthcare infrastructure along the railway network of the country.
  8. A new ‘National Program for Health Care of the Elderly’ (NPHCE) was approved with an outlay of Rs. 288.00 Crore for 2010-11 & 2011-12.
  9. Urban Slum Health Check-up Scheme for Diabetes and Blood pressure was launched in New Delhi on November 14, 2010. Pilot project is in progress in Bangalore, Hyderabad, Kolkata, Mumbai, Chennai and Ahmedabad.
  10. The revised National Program for Prevention & Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) was approved with a budgetary provision of Rs. 1230.90 Crore
  11. Under Central Government Health Scheme (CGHS), a pilot project of a standalone hemodialysis center has started at Sadiq Nagar CGHS Wellness center in collaboration with M/S Alliance Medicorp (India) Limited, Chennai, under Public Private Partnership (PPP).

III. National Rural Health Mission (NRHM)

  1. Healthcare Infrastructure:

I. New construction and upgradation of 433 District Hospitals, 2921 Community Health Centers (CHCs), 4165 Primary Health Centers (PHCs) and 11856 Health Sub-Centers.

II. 9120 PHCs became functional for 24 hours, as compared to only 1262 in 2005.

  1.                III.  2426 health facilities which include District Hospitals, Sub-District Hospitals and Community Health Centers started functioning as First Referral Units (FRUs) as compared to 955 in 2005.

 

  1.                IV.  1653 Mobile Medical Units are operating in different States providing services in the interior areas.
  2. Human Resource:

I. 2394 Specialists, 8284 MBBS doctors, 9578 AYUSH doctors, 26734 staff nurses, 53552 ANMs and 18272 other Para-medical staff were added to the health system to improve the services.

II. Over 8.33 lakh trained ASHA/community workers were engaged to link the households with the health facility.

 

3.  Healthcare System:

 

I. State and District Health Societies were set up in all the States and Union Territories (UTs).

  1.                               II.  Planning capacity at the district level was strengthened and Integrated District Health Action Plan prepared by 540 districts.

4. Community Engagement:

Effective and efficient decentralized management of health system is being achieved through communalization of facilities, adequate and flexible financing with community accountability, monitoring progress against Indian Public Health Standards, innovations in human resources, together with engagement and building of capacity at all levels.

I. 29904 ‘Rogi Kalyan Samitis’ were registered in the health facilities up to PHC level.

  1.                               II.  4.93 lakh Village Health and Sanitation Committees (VHSCs) were constituted and 4.82 lakh joint accounts at the Village Health and Sanitation Committees and Health Sub-Centers were opened.
  2.                            III.  23.61 million Village Health & Nutrition Days were held at village level over the last three years to provide immunization, maternal and child healthcare and other public health related services at ‘Anganwadi’ centers.

5. Service Delivery:

I. Under the ‘Janani Suraksha Yojana (JSY)’, which is cash transfer scheme to promote institutional delivery, over 100.78 lakh pregnant mothers were covered in 2009-10 as against 7.39 lakh in 2005-06.

  1.                               II.  53500 male health workers were hired for all the Sub Health Centers (SHC) in 235 high focus districts for disease control with a total costs of Rs. 385.52 Crores per year.

6. Family Planning:

  1.                                 I.  Fixed day Fixed Place Family Planning Services round the year through PHCs
  2.                               II.  ‘Santushti’ strategy was implemented through ‘Janasankhya Sthrirata Kosh’, to provide private sector gynecologists and vasectomy surgeons an opportunity to conduct sterilization operations through Public Private Partnership (PPP) initiatives.

7. Disease Control:

  • National Tuberculosis Control Program:

I. Treatment success rates increased from 25% to 87% in 2010.

II. Death rates have declined from 29% to 4% in 2010

III. Treatment success rate is now >85% and new sputum positive (NSP) case detection rate is currently more than the global target of 70%.

  • The National Program for Control of Blindness started providing financial assistance to NGOs for cataract operations and treatment of other eye diseases.
  • 75 districts were added to the National Program for Prevention and Control of Deafness (NPPCD), making it a total of 176 districts of 15 States and 4 UTs. Rs.11.50 Crore has been provided for the current year.
  • Phase–I of ‘Pradhan Mantri Swasthya Suraksha Yojana’ projects commenced with an allocation of Rs 9307.60 Crore.

IV. Healthcare Legislation:

1. The Indian Medical Council (Amendment) Bill 2010 was introduced in the ‘Lok Sabha’ to give effect to amendments to the IMC Act 1956 by which in certain specified situations Government can dissolve the elected Medical Council and replace it, for a period not exceeding one year with a nominated Board of governors.

2. The “National Institute of Mental Health and Neuro Sciences Bangalore Bill, 2010” was introduced in the ‘Rajya Sabha’ to facilitate NIMHANS to develop as an Institute of National Importance on the lines of All India Institute of Medical Sciences, New Delhi,

3. The Clinical Establishments (Registration & Regulation) Bill, 2010 was passed by both Houses of Parliament and notified. The Act aims at providing registration & regulation of clinical establishments in the country with a view to prescribing minimum standards of facilities and services.

V. International Cooperation:

  • A MoU on the Establishment and Operation of Global Disease Detection (GDD) – India Centre, between National Centre for Disease Control, New Delhi and Centre of Disease Control and Prevention, Atlanta, USA, was signed during the recent visit of the US President Mr. Barack Obama in November 2010.
  • India raised the issue of counterfeit medicines and “urged countries to steer clear from the commercially motivated debates over the ‘counterfeit’ issue which have hampered public health by preventing access to good quality and low cost generic drugs”. As a result WHA adopted a resolution establishing a time limited and result oriented working group on substandard / spurious / falsely-labeled / falsified / counterfeit medical products comprised of and open to all Member States.

VI. Health Research:

I. Draft National Health Research Policy prepared during the year, is being debated across the country.

II. Draft Policy for Knowledge Management Policy for Health – services, education and research prepared and debates completed.

III. Based on guidelines for use of assisted reproductive technologies a draft Bill has been prepared.

IV. Guidelines for management of cancers of buccal mucosa, stomach & cervix has been developed.

My wish-list for 2011:

In my view, the following 5 important issues, if addressed effectively in 2011,could make a significant impact on the Healthcare space of India:

1. Announcement of a robust, reform oriented long overdue pharmaceutical ‘Drug Policy’ in India.

2. More budgetary allocation and a transparent delivery system for the National Rural Health Mission (NRHM) and the Rashtriya Bima Yojana (RBY) to improve access to healthcare and ensure inclusive growth in the healthcare sector, covering majority of the population of the country.

  1.               3.  A strong healthcare financing model covering all strata of  society to reduce  the burden of huge ‘out of pocket’ healthcare expenses and make healthcare more accessible and affordable to all.

- The 2010 ‘World Health Report’ of the ‘World Health Organization (WHO)’ “provided governments of various countries with practical guidance on ways to finance healthcare expenses. Taking evidence from all over the world, the report showed how all countries, rich and poor, can adjust their health financing mechanisms so more people get the healthcare they need.” I reckon, policy makers in India will exert enough efforts in 2011 for speedy implementation of such reform oriented healthcare initiatives in the country in its endeavor to fulfill the long overdue promise – ‘health for all.’

4. Progressive policy and fiscal measures to encourage innovation and pharmaceutical R&D within the country

5. Speedy resolution of all Intellectual Property related disputes through ‘Fast Track IP Courts’ to create appropriate innovation oriented ‘Echo System’ in the country.

Conclusion: 

All the achievements of the year just gone by, are good… but are these enough? India in its ‘Healthcare Policy’ statement, way back in mid-1980 promised, ‘health for all’ by the year 2000. We are not there, not just yet.

Though the country is trying hard to achieve the ‘Millennium Development Goals (MDG)’ by 2015, as the situation stands today, it appears a remote possibility, in many areas.

Non-communicable diseases are now posing a major threat to the country, significantly increasing the burden of disease. The World Health Organization (WHO) has cautioned that India would be the ‘diabetic capital’ of the world with a population of around 80 million diabetic patients by 2030. Further, the ‘Cardiological Society of India’ predicts that there would be around 100 million cardiac patients in the country by 2020, which roughly works out to be around 60% of the total cardiac patient population of the world.

Keeping all these in view, the achievements made by the country in the year 2010, though should be taken note of… but the moot question still remains, ‘aren’t all these too little even for too few?’

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.

To accelerate increasing ‘Access to Modern Medicines’ in India: A Strategic Approach

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Currently no one knows what the ‘Access to Modern Medicines’ in India is, in real term. Like many others, both local and global. I myself was quoting the World Medicines Situation of 2004 report, the base year of which is actually 1999. Thus there should not be even an iota of doubt in anybody’s mind that the above reported situation has changed quite significantly during the last decade in India and the statement that both the government and the industry alike has been making since then, ‘only 35% of the population of the country, against 53% in Africa and 85% in China has access to modern medicines’, is indeed quite dated. It does not make sense, at all, in the recent times of the Pharmaceutical industry in India.

More surprisingly, an updated information on the subject does not seem to be available anywhere, as yet, not even with the World Health Organization (WHO). However, the good news is, it has been reported that the ‘World Medicines Situation’ is currently being updated by the WHO.

 Access to modern medicines is improving in India:

Be that as it may, CAGR volume growth of the pharmaceutical industry since the last ten years has been around 10%, leave aside another robust growth factor being contributed through the introduction of new products, every year. Encouraging growth of the Indian Pharmaceutical Market (IPM), since the last decade, both from the urban and the rural areas certainly signals towards significant increase in the domestic consumption of medicines in India. In addition, extension of focus of the Indian pharmaceutical Industry, in general, to the fast growing rural markets clearly supports the argument  of increasing ‘Access to Modern Medicines’ in India. The improve in access may not exactly be commensurate to the volume growth of the industry during this period, but a major part of the industry growth could certainly be attributed towards increase in access to medicines in India.

For arguments sake, out of this rapid growth of the IPM, year after year consistently, if I attribute just 5% of the growth per year, for the last nine year over the base year, to improved access to medicines, it will indicate, at least, 57% of the population of India is currently having access to modern medicines and NOT just 35%, as I wrote in this blog earlier.

Unfortunately, even the Government of India does not seem to be aware of this gradually improving trend. Official communications of the government still quote the outdated statistics, which states that 65% of the population of India does not have ‘Access to Modern Medicines’ even today. No wonder, why many of us still prefers to live on to our past.

Be that as it may, around 43% of the population will still not have ‘Access to Medicines’ in India. This issue needs immediate attention of the policy makers and can be achieved with a holistic approach to resolve this issue. A robust model of healthcare financing for all socio-economic strata of the population, further improvement of healthcare infrastructure and healthcare delivery systems are the need of the hour.

Percentage growth in the healthcare budget is higher than that of the GDP:

With the increase of healthcare expenditure by 15% for 2008-09 and further increase in 2010-11, as announced by the Finance Minister in his recent Budget Speech, the healthcare expenditure as a percentage to GDP still remains around 1.0%, which is quite inadequate to address the key healthcare issues of the country.

The Prime Minister has already has expressed his intent that India will be able to increase its public healthcare spend to around 2.5% of the GDP, when GDP growth will touch the double digit figure of 10%, which I reckon, is no longer a pipe dream.

Explore a Public-Private Partnership (PPP) with the stakeholders of the Pharmaceutical Industry:

To address the critical issue of access to modern medicines, policy makers should now actively consider a series of closely integrated PPP initiatives. These PPP initiatives will initially include ‘Below the Poverty Line’ (BPL) families of our country, which not only constitute a significant part of our population, but also will have almost nil purchasing power for medicines. Thereafter, the scheme, slightly modified, should be extended to all ration card holders in India.

Possible impact of such PPP initiatives on improving access to medicines:

If such PPP initiatives are carefully and innovatively strategized, carefully planned and diligently executed, the access to modern medicines in India could increase from current 57% to over 63% of our population within a year’s time  and to over 82% of the population over a period of next five years.

A ‘Back of the Envelope’ Strategy Outline:

The Objective:

To improve access to medicines to over 60% of the population one year after the execution of the strategy and to over 80% within the next five years. The key stakeholders, especially the pharmaceutical companies in India, will work closely with the Government under PPP initiatives for the improvement of access to modern medicines initially to the BPL families, significantly, who have almost no purchasing power for medicines.

The Plan:

- The stakeholders, mainly the pharmaceutical industry, to work out a suitable methodology to help the Government to reach all pharmaceutical formulations covered under ‘National List of Essential Medicines (NLEM)’ to the BPL families across the country and gradually extend it to all ration card holders in India.

- The government would extend appropriate Tax cuts to the concerned companies, as an incentive towards their involvement in the PPP initiatives.

- The National Pharmaceutical Pricing Authority (NPPA) would continue to strictly implement its drug price monitoring mechanism for all categories of drugs to keep their prices well under control, always.
Key Assumptions:
- According to Planning Commission of India (2007) the population of India is 116.9 Crore or 1.169 billion.

- According to ‘Centre for Science & Environment (August 2007)’ the latest figures on poverty place 27% of India’s population below the poverty line (BPL) out of which 72% reside in rural areas.

- No price of medicines will be affordable to the BPL families.

- The National Sample Survey Organization (NSSO) report on “Public Distribution System & Other Sources of Household Consumption, 2004 – 05” shows that only 28% of the rural poor have benefited from any type of government food assistance schemes, including ‘Public Distribution System’ and for urban areas the figure is just 9.5%. That means about 72 Million people below the poverty line are having ration cards.

- According to 1995 World Bank Study, the established per capita health spending is around Rs.320 per year.

- McKinsey in their report “India Pharma 2015” has stated that expenditure on medicines is 15% of total healthcare spend i.e. Rs.48 per year.

Methodology:

- Identify the number of BPL families who hold ration cards to receive free/subsidized medicine.

- Determine the cost to be incurred by the Government for purchase of medicines under NLEM.

- Devise a system of generating commensurate funds to improve access to BPL families.

- Operationalize the distribution of medicines to BPL families with public transparency

- Increase penetration of ‘Jan Aushadhi’ outlets simultaneously as a supportive incremental measure

Projected increase in ‘Access to NLEM Drugs’:

Million
Population of India

1169
27% of Population is BPL

316
72% rural

228
28% urban

88
28% of 228 million have ration cards

64
9.5% of 88 million have ration cards

8
Total BPL ration card holders

72
Current Access to Modern medicines of 57%

666
When all ration card holders get NLEM drugs the access improves to:

738

�
SO, IF AT LEAST THE BPL RATION CARD HOLDERS GET NLEM MEDICINES, ACCESS IMPROVES FROM 57% TO 63.2%.

Cost implications of Increasing Access from 57% to 63.2%:

  1.  72 million ration card holders will need Rs.48 worth medicines per year i.e. Rs.3456 million or Rs.346 Crores.
  2. If Industry contributes 0.6% of its turnover which will attract full tax (both direct and indirect) exemptions from the Government, the industry contribution works out to Rs.170 Crores.
  3. A similar amount should be provided by the Government for purchase of free/subsidized medicines for exclusive dispensing to the BPL families.

To operationalize improved ‘Access to Medicines’:

- All ration card holders to be provided with a separate card (if not a smart card) for issue of medicines with a Unique Identification Number.

- Each ration shop will have a separate counter named ‘Jan Aushadhi’ for medicine, which will cater to only registered BPL families.

- Government to arrange to train the Ration Shop owners/employees in Pharmaceutical storage and dispensing

- Doctors of Primary Healthcare Centers, Block Dispensaries will be directed to provide free treatment and prescribe NLEM medicines to the members of BPL families holding such ration cards.

- Subsidized/free supply of medicines will be made against prescriptions from the ‘Jan Aushadhi’ counters of the Ration Shops to these families.

- The doctors’ prescriptions with a copy of the bill will be retained by the respective Ration Shops to account for such purchases of medicines by the BPL families.

- More & more members of BPL family will be encouraged to register for ration cards and be eligible for free / subsidized medicines.

Conclusion:

On completion of this scheme for BPL families and after covering all ration card holders, overall the access to modern medicines in India could increase from 57% to over 80% over a period of 5 years.

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 concept of ‘Value Based Pricing (VBP)’ gaining ground to reduce cost of healthcare and improve access…but India is quite different

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So far as the pharmaceutical pricing and increasing access to healthcare are concerned, year 2010 perhaps will be remembered as one of the very significant years, at least, in the recent times. In this year with new healthcare reform, President Obama expanded access to Health Insurance to additional around 40 million Americans, the Government in Japan brought in, not much talked about, “premium for the development of new drugs and elimination of off-label drug use” and the Governments in UK and European Union, including the largest market in the EU – Germany, introduced stringent cost containment measures for pharmaceutical products.

Pharmaceutical pricing model is changing across the world:

Overall scenario for pharmaceutical pricing model has undergone significant changes across the world. The old concept of pharmaceutical price being treated as almost given and usually determined only by the market forces with very less regulatory scrutiny is gradually but surely giving away to a new regime.

It started, especially in the developed world, with the generation and submission of pharmacoeconomics data to the regulators for pharmaceutical pricing, by the pharmaceutical companies. However, shortcomings in that system gradually became subject of a raging debate. The newer concepts of Health Technology Assessment (HTA), Health Outcomes Analysis (HOA) and Value Based Pricing (VBP), have started gaining grounds.

Value Based Pricing (VBP):

Value based pricing is basically offering the best value for the money spent. It ‘is the costs and consequences of one treatment compared with the costs and consequences of alternative treatments’.
For pharmaceutical players, VBP perhaps would mean not charging more than the actual value of the product.

On the other hand, price being a function of value that a product would offer, it is also important for the regulators to understand what value in totality that the product would offer, not just for the patients’ treatment in particular, but for the civil society at large.

However, in India, the regulators are still far behind and groping in the dark to find out an appropriate solution to this critical issue. They seem to be quite contended with taking arbitrary, non-transparent populist decisions.

The concept is gaining ground:

The concept of ‘evidence-based medicine’ , as stated earlier, is gaining ground in the developed markets of the world, prompting the pharmaceutical companies generate requisite ‘health outcomes’ data using similar or equivalent products. Cost of incremental value that a product will deliver is of key significance. Some independent organizations like, the National Institute for Health and Clinical Excellence (NICE) in the UK have taken a leading role in this matter.

VBP could help in ‘freeing-up’ resources to go to front-line healthcare:

On November 11, 2010 ‘Pharma Times’ in a news item titled, “Government (UK) to consult on drug pricing in December’ reported the following:

“Consultation on the government’s plans to introduce value-based pricing (VBP) for medicines will begin next month, the Department of Health has announced.
The consultation will run until next March, the Department reveals in its newly-published business plan for 2011-15. The plan sets out the coalition government’s structural reform priorities for health care, which are to: – create a patient-led NHS; – promote better healthcare outcomes; – revolutionize NHS accountability; – promote public health; and -reform social care.
These reforms ‘will help to create a world-class NHS that saves thousands more lives every year by freeing up resources to go to the front line, giving professionals power and patients choice, and maintaining the principle that healthcare should be delivered to patients on the basis of need, not their ability to pay,’ says the Department”.

Global pharmaceutical companies using more ‘health outcome’ data to set pricing strategies:

Some global pharmaceutical majors have already taken pro-active measures on the subject. In early 2009, reported agreements between Sanofi-Aventis, Procter & Gamble and Health Alliance as well as Merck and Cigna vindicate this point. These agreements signify a major shift in the global pharmaceutical industry’s approach to gathering and using ‘health outcomes’ data

In the Sanofi-Aventis/Procter & Gamble-Health Alliance agreement, the concerned companies agreed to reimburse Health Insurance companies expenses incurred for patients suffering from non-spinal bone fracture while undergoing treatment with their drug Actonel.

In the Merck/Cigna agreement, Cigna will have the flexibility to price two diabetes drugs based on ‘health outcomes’ data.

‘Outcomes-based’ pricing strategies are expected to become the order of the day, in not too distant future, all over the world.

The ground realities in India are very different:

Medicines are very important and constitute a significant cost component of modern healthcare systems, across the world. In India, overall healthcare system is fundamentally different from many other countries, even China. In most of those countries around 80% of expenses towards healthcare including medicines are reimbursed either by the Governments or through Health Insurance or similar mechanisms. However, in India situation is just the reverse, about 80% of overall healthcare costs including medicines are private or out of pocket expenses incurred by the individuals/families.

Since 1970, the Government of India (GoI) has been adopting various regulatory measures like cost based price control and price monitoring to make medicines affordable to the common man. For those products, which are patented in India, it has now been reported that the Government is mulling the approach of price negotiation with the respective companies.

However, we should keep in mind that making drugs just affordable in India, where a large number of population does not have access to modern medicines for non-price related factors, is indeed not a core determinant of either healthcare value or proven health outcomes or both.

Till VBP is considered, cost-effective ‘health outcome’ based medical prescriptions should get priority:

Expenditure towards medicines can be considered as an investment made by the patients to improve their health and productivity at work. Maximizing benefits from such spending will require avoidance of those medicines, which will not be effective together with the use of lowest cost option with comparable ‘health outcomes’.

For this reason, many countries have started engaging the regulatory authorities to come out with head to head clinical comparison of similar or equivalent drugs keeping ultimate ‘health outcomes’ of patients in mind. A day may come in India, as well, when the regulatory authorities will concentrate on ‘outcomes-based’ pricing. However, in the Indian context, it appears, this will take some more time. Till then for ‘health outcome’ based medical prescriptions, working out ‘Standard Treatment Guidelines (STG)’ , especially for those diseases which are most prevalent in India, should assume high importance.

Standard Treatment Guidelines (STG):

STG is usually defined as a systematically developed statement designed to assist practitioners and patients in making decisions about appropriate cost-effective treatment for specific disease areas.

For each disease area, the treatment should include “the name, dosage form, strength, average dose (pediatric and adult), number of doses per day, and number of days of treatment.” STG also includes specific referral criteria from a lower to a higher level of the diagnostic and treatment requirements.

For an emerging economy, like India, formulation of STGs will ensure cost-effective healthcare benefits to a vast majority of population.

In India, STGs have already been developed for some diseases by the experts. These are based on review of current published scientific evidence towards acceptable way forward in diagnosis, management and prevention of various disease conditions. STGs, therefore, will provide:

- Standardized guidance to practitioners.
- Cost-effective ‘health outcomes’ based services.

GoI should encourage the medical professionals/institutions to lay more emphasis and refer to such ‘heath-outcomes’ based evidences, while prescribing medicines. This will ensure more cost effective ‘health outcomes’ for their patients.

Steps necessary for ‘Standard Treatment Guidelines (STG):

1. Get Standard Treatment Guidelines (STG) prepared for the diseases more prevalent in India, based on, among other data, ‘health outcomes’ studies.

2. Put the STG in place for all government establishments and private hospitals to start with.

3. Gradually extend STG in private medical practices.

4. Make implementation of STG a regulatory requirement.

Conclusions:

Till VBP concept is considered appropriate for India by the regulators, STG model for drug usage would help both the doctors and the patients equally to contain the cost of treatment in general and the total cost of medicines in particular. Encouraging implementation of STGs in India, as a first step towards VBP, especially for prescription medicines, the country will require, above all, a change in the overall mindset of all concerned. The use of an expensive drug with no significant improvement in ‘health outcome’ should be avoided by the prescribers at any cost, initially through self-regulation and if it does not work, stringent regulatory measures must be strictly enforced for the same… for patients’ sake.

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.

Prescribing 10 steps for comprehensive Healthcare Reforms in India

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Recently President Barack Obama, by enacting historic healthcare reform legislation, fulfilled his election campaign pledge to provide healthcare to all in the United States of America. This piece of legislation will provide health insurance benefits to another around 34 million poor and uninsured Americans. The key highlight of this health insurance scheme is that it will compel the insurers to extend insurance to even those with any pre-existing illness and impose stringent criteria on expenditure towards medical treatment to cut healthcare costs. The new healthcare reform will cost around US $940 billion over 10 years to the US Government. To partly recover this cost, President Obama administration will levy new fees to the healthcare and pharmaceutical companies along with a new tax for the high income groups.

So far as healthcare reform in the US is concerned, President Obama, has therefore, ‘walked the talk’.

Closer home, just prior to the US healthcare reform, our Prime Minister Dr. Manmohan Singh reiterated in his speech delivered at the 30th Convocation of PGIMER, Chandigarh on November 3, 2009, the dire need of the country to strike a right balance between preventive and curative healthcare for the common man. The Prime Minister articulated his thoughts as follows:

” 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”.

However, the Prime Minister has not walked the talk, not just yet.

The key issues of Indian healthcare system:

Access: mostly due to inadequate healthcare infrastructure and affordability issues
Affordability: Socio-economic complexities and lack of adequate healthcare financing model in the country

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.

Tweaking of the existing system is not enough:

An increase in allocation of Rs. 27,000 for healthcare, over the previous year, in the Union Budget 2010-11 covering as large as 1.13 billion population, is just not enough. The public expenditure towards healthcare, as indicated by Dr. Manmohan Singh should be around 2.5% – 3% of the GDP, against the current expenditure on the same of just 1%. To effectively address the key issues of affordability and access to healthcare the country will need a radical reform in its healthcare space with a sharp focus on preventive healthcare of the population of the country, education and related critical socio-economic issues, as has already been enunciated by the Prime Minister of our country.

Where does India stand in 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. As stated before, earlier 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, which will require similar leadership passion to make it happen.

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 always proved to be the most effective 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.

A recent report from KPMG also reiterates “One of the major challenges remains the need to develop scalable and sustainable healthcare delivery models to deal with India’s diversity and changing socio-economic population profiles”.

Path breaking medicines are desirable, but 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 process.

Sharp focus on both education and healthcare is very important to realize the economic potential of any nation. India will not be able to realize its dream to be one of the economic superpowers of the world without this 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

Recent healthcare initiatives in India:

There are various hurdles though, to address the healthcare issues of the country effectively. However, these are not definitely insurmountable. ‘National Rural health Mission (NRHM)’ is indeed an admirable scheme announced by the Government. Similar initiative, like, ‘Rashtriya Bima Yojana (RBY)’ to provide health insurance program for below the poverty line (BPL) population of the country, is also equally 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 (please see below) 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 public 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 has increased to around 4.5 per cent of the GDP.

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 percent 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 around 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. It is encouraging that the Deputy Chairman of the Planning Commission of India, Mr. Montek Singh Ahluwalia has recently commented to the media that the commission is working on it.

A 10 pronged strategy prescribed:

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

1. Government should assume the role of provider of preventive and basic primary healthcare across the
nation to ensure adequate access to healthcare for 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 the regulatory authority accountable for ensuring access to affordable high quality healthcare
to the entire population of the country.

9. Make operations of 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. The US
model of Medicare and Medicaid could be examined in this regard..

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

Conclusion:

A comprehensive healthcare reform in India is long overdue. The magnitude of the task is equally daunting. The pace of change in the healthcare space of the country has been very slow over the last six decades, despite sharp ascending GDP growth trend of the nation. Private sector can play the role of the game changer, provided government plays the role of an effective enabler through various policy measures, fiscal/ other incentives and by creating enough competition within the healthcare providers. Such healthy competition will trigger introduction of innovative healthcare solution models, the ultimate beneficiary of which will be none other than the patients. Health being a state subject in India and as the respective state governments control healthcare spending, quality of involvement of all the states in this reform process will determine its success or failure.

Right to education has now become a fundamental right of the citizens of the country. Will right to health continue to remain far behind?

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.

 

Pragmatic intervention of all the states for Preventive Healthcare could significantly reduce the burden of disease of ‘We, the People of India’.

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Overall disease pattern in India is showing a perceptible shift from the age old ‘Infectious Diseases’ to ‘Non-infectious Chronic Illnesses’. As reported by IMS, incidence of chronic ailments in India has increased from 23% in 2005 to 26% in 2009.

It is estimated that chronic illnesses will be the leading cause of both morbidity and mortality by the next decade in the country, significantly increasing the burden of disease across the socio-economic strata of the nation. It goes without saying that poor people will be hit harder, if corrective actions are not undertaken right now.

As a consequence of such changing disease pattern, healthcare needs and related systems of the country should undergo a paradigm shift together with the emergence of a carefully planned concept of ‘Preventive Healthcare’ for the entire population of the nation.

It is a myth that non-infectious illnesses are more prevalent in higher socio-economic strata:

There is a common perception that Non-Communicable Diseases (NCDs) are more prevalent within higher socio-economic strata of the society. However, a national survey done in India shows that diseases related to misuse of alcohol and tobacco are higher in the poorest 20 percent quintile of our society.

However, a research recently study done in 1600 villages, spanning across 18 states of India and published on the September 27, 2010 edition of the British Medical Journal (BMJ), reported that the risk-factors of non-communicable diseases are high in rural India, which is the home of over 70% of the population of India. (Non-communicable Disease Risk Factors High in Rural India.

As this population has limited access and affordability to healthcare in general, the situation demands greater importance and focus.

Risk-factors of NCDs in rural India:

The above BMJ study highlighted prevalence of the following key risk-factors for the vulnerable population:

• Tobacco use (40% men, 4% women)
• Low fruit and vegetable intake (69% men, 75% women)
• Obesity (19% men, 28% women)
• High cholesterol (33% men, 35% women)
• Hypertension (20% men, 22% women)
• Diabetes (6% men, 5% women)
• Underweight (21% men, 18% women)

Current healthcare system in India:

Currently with appropriate disease treatment measures, alleviation of acute symptoms of the disease that a particular patient is suffering from, is the key concern of all concerned, starting from the doctors to the patients including their families. The process of the medical intervention revolves round treatment protocols and procedures based on the diagnosis of the current ailments and not so much on preventive measures for other underlying diseases, except with the use of vaccines for some specific diseases.

Developing a protocol for ‘Preventive Healthcare’ for non-communicable diseases is very important:

In the above process, while addressing the acute problems of the patients’ current ailments is very important, proper risk assessment of other underlying diseases, if any, which the patient could suffer from in future, for various reasons, do not attract any organized attention. As a result the important advice on preventive healthcare from the doctors, properly highlighting its importance, is not available to most of the patients to enable them to significantly reduce, if not eliminate, their future burden of disease.

Keeping such common practices in view and noting that ‘Preventive Healthcare’ is significantly different from ‘Curative Healthcare’, developing an appropriate protocol for ‘Preventive Healthcare’ has become a crying need of the hour.

‘Preventive Healthcare’ in India should attract high priority of the healthcare policy makers with a careful vigil on its effective implementation at the ground level:

All said and done, the ‘Preventive Healthcare’ system in India is in its very nascent stage. If appropriate measures are taken in this area, like learning to reduce the impact of mental and physical stress, avoiding sedentary life style, taking healthy diet, avoidance of tobacco and alcohol consumption, leading healthy sex life etc., it can in turn immensely help the population to remain disease free and healthy, thereby contributing to improvement of their respective work productivity in a very substantial way.

Recently re-structured Medical Council of India should also step in:

Thus the role of medical professionals in the disease prevention process is also very important. The interaction of the patients with the doctors when they meet to address any ailment provides huge opportunity to the doctors to advise those patients about various measures of underlying disease prevention, for which different patients have different types of exposures.

Keeping all these points in view, through regulatory initiatives, the newly restructured Medical Council of India (MCI) should consider making ‘Preventive Healthcare’ an integral part of each interaction of a patient with a doctor.

Include the civil society in the preventive healthcare initiatives:

The risk factors of many of the diseases like, cancer, chronic respiratory disorders, cardiovascular, diabetes, and hypertension can be identified well in advance and appropriately assessed. Therefore, such diseases can be prevented effectively, to a great extent, provided the healthcare policy of the country supports the ‘Disease Prevention’ process, program and initiatives through adequate resource allocation, improving awareness of the civil society and above all including them in this healthcare improvement process of the nation.

Need to raise general awareness towards ‘Preventive Healthcare’:

Raising the level of awareness of ‘Preventive Healthcare’ is indeed very important. It requires a change in the mindset of the community in general, together with the healthcare policy makers, medical profession, employers, patients and their families.

National Non-Communicable Disease (NCD) prevention program of the government:

As per the planning commission, the government of India has initiated the following structured measures for the prevention of NCD:

• “Health education for primary and secondary prevention of NCDs through mobilizing community action;
• Development of treatment protocols for education and training of physicians in the prevention and management of NCDs:
• Strengthening/creation of facilities for the diagnosis and treatment of CVD and stroke, and the establishment of referral linkages;
• Promotion of the production of affordable drugs to combat diabetes, hypertension, and myocardial infarction;
• Development and support of institutions for the rehabilitation of people with disabilities;
• Research support for: Multispectral population-based interventions to reduce risk factors;
• The role of nutrition and lifestyle-related factors;
• The development of cost effective interventions at each level of care”.

Conclusion:

Many diseases in India, with proper ‘Disease Prevention’ measures can be effectively averted. It is worth repeating that some common measures which can be easily practiced through community initiatives are maintenance of proper hygiene, sanitation, adequate physical activities, moderation in alcohol and tobacco consumption, healthy sexual activities, avoidance of unhealthy food etc.

All the state governments of India through Public Private Partnership (PPP) initiatives with all stakeholders, including the pharmaceutical industry and the civil society, should make the movement of ‘Preventive healthcare’ self-sustainable across the nation. Health being a state subject in India, the role and initiatives of the respective state governments towards this important initiative will be the key determinant of success or failure.

Such a movement, at the same time, needs to be strengthened by appropriate government policy measures and regulations wherever necessary. Pan India roll out of innovative disease awareness campaigns in tandem, highlighting sustainable and effective disease prevention processes will help reducing longer term healthcare cost significantly, thereby translating the well-known dictum into reality, ‘Prevention is better than cure’.

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.

Why does the Government divert focus on to fringe issues to address critical healthcare concerns of the nation?

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The Department of Industrial Policy and Promotion (DIPP) of the Ministry of Commerce and Industry of the Government of India has recently initiated a public debate through a ‘Discussion Paper on Compulsory Licensing (CL) of Patented Pharmaceutical Products’.

The key intent of the discussion is presumably to improve access to quality medicines at an affordable price to the people of the country.

Could such debate serve any meaningful purpose?

Since the issue of CL involves only patented products, I wonder, whether this debate would in any way help sorting out the issue of poor access to modern medicines in our country or this is just another ‘hog wash’ or ‘diversion ploy’ of the decision makers to divert the attention of the stakeholders from the core issues of poor access to healthcare for the common man of India.

Will CL be able to address abysmally poor access to medicines issues in India?

A quick analysis of the prevailing situation related to access to modern medicines in India suggests that the usage of patented pharmaceutical products account for much less than 1% of the sum total of all medicines consumed in India in value terms. In volume terms it will be even more miniscule in terms of percentage.

As per IMS (MAT July, 2010) Indian Pharmaceutical Market size is Rs. 44,476 Crore, even 1% market share of the patented pharmaceutical products will mean Rs. 445 Crore, which is quite far from reality.

Thus, CL of patented medicines would have no sustainable and meaningful impact on improving access to modern medicines for the common man of the country. Moreover, around 40% of the population of India live below the poverty line (BPL). These ‘Children of a lesser God‘ very unfortunately, will not be able to afford any price of medicine, however cheap these could be. Vast majority of the such population who lack the financial capability to pay for even the cheapest off-patent generic medicines, which comprise more than 99% of the total medicines consumed within the country, will continue to be left in the lurch.

65% of Indians do not have access to WHO list of essential medicines, which surpasses even the African countries:

Our government also admits that 65% of Indians do not have access to even WHO list of essential medicines, none of which holds a valid patent in the country. This should be the key concern in the country. Moreover, the World Health Organization (WHO) reported that during 2000-2007, India had poorer access to essential medicines than even many African countries. It is worth noting that many of these African countries has a patent life for pharmaceuticals for around 30 years, against of 20 years in India. What are we then talking about?

Provisions of CL in the Indian Patents Acts are robust enough:

In any case, the provisions of CL in the Indian Patents Acts are not only quite clear and well articulated, but also at the same time offer flexibility in the decision making process to the Indian Patent Offices (IPOs) to invoke CL in a justifiable situation. Thus proposed guidelines related to CL would possibly invite more questions than answers. Consequently, it will be an extremely complicated process for the IPOs to categorize all the situations related to CL. Therefore, in my view, such initiatives, as initiated by the DIPP to frame guidelines for CL could prove to be totally counterproductive, as such guidelines, as stated above, would seriously limit the flexibility of the IPOs to take appropriate action, even when it would require to do so.

Moreover, it is absolutely imperative for the Government to ensure that the primacy of the patent statutes is not disturbed in any way, as such guidelines related to CL would only be consistent with the appropriate provisions within the statute and cannot be used beyond the Patent Law of the land. It goes without saying that any dispute between the parties related to the interpretation of the provisions within the statute related to CL, should only be resolved by the judiciary.

Conclusion:

How could then CL possibly offer answers to the vexing healthcare access issues of the nation? Is the Government not wasting its precious little time, instead of trying to ‘take the bull by the horns’ and resolve the critical ‘access to affordable quality medicines’ issue of India through Public Private Partnership (PPP) initiatives?

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.

Exploring a new ‘Business Model’ to improve access to healthcare in rural India with the industry participation

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Rural India – the home of around 72% of 1.12 billion population of India is undergoing a metamorphosis, as it were. Disposable income of this population is slowly but steadily rising, as evidenced by rapid market penetration of the ‘Fast Moving Consume Goods (FMCG)’ industry in general and companies like Hindustan Unilever Limited (HUL) and Dabur in particular.

Size of the Healthcare Sector in India:

It has been reported that the current size of the healthcare industry in India ia around US $ 23 billion or around 5.2% of the GDP. Though the sector is showing an overall healthy growth of around 13%, public expenditure towards healthcare is just around 0.9% of the GDP of the country. As per WHO (2005) per capita government expenditure on health in India was just around US $7, against US $31 of China, US $24 of Sri Lanka, US $11 of Kenya and US $12 of Indonesia.

Currently the number of Government Hospitals/Healthcare centers in India are grossly inadequate and are as follows:

  • Medical Colleges: 242
  • Community Health centers: 3346
  • District Hospitals: 4400
  • Other Public Hospitals: 1200
  • Primary Health Centers: 23236
  • Subcenters: 146026
  • Number of Hospitals in rural areas: 53400
  • Population to rely on Public Hospitals: 43%

Even with the above network of public healthcare centers in India, overall effectiveness of public healthcare delivery system is very poor in the country. Increasing penetration of Information Technology could perhaps partially address this problem.

Growth drivers of rural India?

I reckon, mainly the following reasons attribute to the growth of the rural economy:

- Gradual increase in procurement prices of food grains by the government and waiver of agricultural loans to the tune of US$13.9 billion

- Growing non-farm income: Currently more than 50% of rural income is through non-farm sources, fuelled by various non-farm activities like food-processing, manufacturing, trading, in addition to the income flow from the rural migrants.

– Increased spending by the Government, which is expected to be around US$ 20 billion by March 2010, in the rural areas through various projects and schemes, like National Rural Employment Guarantee Scheme (NREGS), Bharat Nirman Program etc. coupled with easier access to requisite loans and credits, have improved the spending power of rural households significantly.

Though the government is making heavy budgetary allocations in rural India to improve the basic infrastructural facilities, healthcare and education, the implementation of most of these schemes still remains far from satisfactory, as of now.

A gaping hole in the rural healthcare space:
In the healthcare space of rural India there is still a gaping hole in various efforts of both the government and the private players to create a robust primary healthcare infrastructure for the common man. Thus poor access to healthcare services, coupled with lack of ability to pay for such services and medicines round the year, are the key challenges that the country will need to overcome. Lack of disease awareness and poor affordability towards healthcare services, still account for 60% of rural ailments not getting treated at all.

Key shortcomings of the current rural healthcare infrastructure:

Despite the numbers quoted above, following shortcomings continue to exist in the healthcare infrastructure of the country:
- Number of Primary Health Centers (PHC) are far less than the budgetary estimate/allocation
- Inadequate treatment facilities even where the PHCs exist
- Shortage of doctors, nurses and paramedics
- Very high rate of absenteeism

Pharmaceutical companies in India should now explore fortune at the ‘Bottom of the Pyramid’ to reap a rich harvest, creating a win-win situation:

If the pharmaceutical companies operating within the country, partner with the government and other key stakeholders, as a part of their corporate business strategy, to make a fortune from the ‘bottom of the pyramid’, this critical issue can be effectively resolved, sooner. Novartis India has already ventured into this area and has tasted reasonable success with their ‘Arogya Parivar’ program.

However, in my view additional sets of the following value delivery objectives need to be considered to make this the rural healthcare mission with PPP initiatives successful:

- Affordable medicines of high quality standard
- Increase in health awareness by collaborating with the NGOs and rural institutions for various common diseases.
- Continuing Medical Education (CME) for the rural doctors and para-medics
- Arranging microfinance for the healthcare professionals to create small micro- level healthcare infrastructure and also for the patients to undergo treatment
- Help reducing the transaction cost of medicines and healthcare services through fiscal measures by collaborating with the government
- The product portfolio to be tailor made to address the common healthcare needs of rural India

Private healthcare facilities are preferred to public healthcare facilities even in the rural India:

Irrespective of rich or poor, around 80% of the population in India prefer private domiciliary treatment facilities and 50% of the same prefer private hospital treatment services. However, let me hasten to add that even within the private healthcare space in rural India, a lot needs to be done. Many so called ‘doctors’, who are practicing in rural India, have no formal medical qualifications. Moreover, even such doctors are not available in villages with a population of around 300 to 500 households.

The key success factors of the rural marketing ‘Business Model’:

Urban pharmaceutical marketing model, I reckon, should not be replicated for ‘rural pharmaceutical marketing’, as the success factors required for each of them, is quite different. In rural marketing the stakeholders’ needs and wants are quite different. If these are not properly identified and thereafter adequately addressed, mostly through collaborative initiatives, the rural pharmaceutical marketing ‘Business Model’ may not fly at all.

Partnership with Microfinance Institutions will be a key requirement:

Interested pharmaceutical companies will need to collaborate with the rural microfinance institutions for such business initiatives. This will ensure that appropriate loans can be extended to doctors and retailers, wherever needed, to help them create requisite local healthcare infrastructure to make such projects viable and successful. At the same time, such institutions will also require to help the needy rural population with requisite loans to help meeting their cost of medical treatment.

Conclusion:

From a ‘back of the envelope calculation’ it appears that such projects can definitely be made profitable with a modest gross margin of around 40% – 50% and operating profit of around 6% to 8% . The high volume of turnover from over 650 million population of India, will make these ‘rural pharmaceutical marketing projects’ viable. Simultaneously, such corporate business initiatives will help alleviating pain and suffering from diseases of a vast majority of the rural population of India.

By Tapan Ray

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