Medicines constitute a significant cost component of modern healthcare systems across the world. However, in India the situation is even worse, where as per recent studies, drugs contribute as high as around 70 percent of the total treatment cost. This is mainly because overall healthcare system in the country is fundamentally different not just from the developed world, but also from many other developing countries like, China, Brazil, South Africa and Thailand, to name a few.
In most of those countries significant expenses towards healthcare including medicines are reimbursed either by the Governments or through health insurance or similar mechanisms. However, the Indian situation is just the reverse, where around 72 percent of overall healthcare costs, including medicines, are private or Out of Pocket (OoP), incurred by the individuals/families.
According to a recent report, ‘about 38 million people in India (which is more than Canada’s population) fall below the poverty line every year due to healthcare expenses, of which 70% is on purchase of drugs’, as stated above.
In this context, it is worth noting that for patented drugs, the Drug Policy of December 2012 clearly articulates that Government of India will follow the approach of price negotiation with the respective companies. Unfortunately, work done in this so important area by the concerned authority, so far, has been rather superficial, if not shoddy. Most of the patented products, which are prohibitively expensive, continue to remain out of reach of a vast majority of patients in india.
Expenditure towards healthcare – a fundamental need:
Expenditure towards healthcare in India, which is largely private, highly exploitative and thus expensive, is absolutely essential for all, either to be able to earn a living for a family or for maintaining a reasonable quality of life.
According to an ‘Access Survey’ conducted by IMS Consulting Group in 2012, ‘Out Patient (OP)’ treatment costs in private care is ~2-3 times that of public and in case of ‘In-Patient (IP)’ care it is ~4-8 times the cost of Public care.
Focus has not been just enough:
Since 1970, the Government of India and various States have been adopting measures including, National Health Mission (NHM), Rashtriya Swasthya Bima Yojana (RSBY), Drug Price Control Order (DPCO), besides others, to make healthcare in general and medicines in particular affordable and accessible to the common man. However, these measures though essential, have not delivered quite well when measured against the set objectives. This keeps on happening, due to lack of accountability and inefficient Government control over the processes involved together with fast increasing exploitative mindset in the private healthcare space, over the last several decades.
Health being a State subject inequity in access:
Health being a State subject in India, there has been large variations in public healthcare spend within various States of the country. Some of the poorer States have low per capita public healthcare expenditure and some of the richer states incur significantly more, leading to huge inequity of access, especially among the poorer sections of the society. (Source: IMS Consulting 2012)
Three fresh edicts:
In the above backdrop, the decision of the Government of India to increase the National Health Expenditure Budget from 1.2% to 2.5% of GDP in the 12th Five Year Plan of India in 2012 has the potential to be a game changer in the public healthcare space of India.
It is envisaged that this decent increase in the budgetary allocation will help initiating the process of Universal Health Care (UHC) to ensure free access to essential health services for every citizen of the country, including cashless in-patient and out-patient treatment for primary, secondary and tertiary care.
Probably as a precursor to UHC, the Government of India has announced three fresh edicts:
1. Budgetary clearance for ‘Free distribution of essential medicines’ by the States
2. Notification for operationalizing the new ‘Central Medical Services Society (CMSS)’ to streamline the drug procurement system
3. Announcement for implementation of ‘Standard Treatment Guidelines (STGs)’
The above edicts are indeed laudatory, as these measures, if taken effectively in tandem would also help maximizing overall productivity of the public healthcare delivery systems, immensely. This is expected mainly because, the process would require avoidance of unnecessary medicines and diagnostics tests, chain of multiple doctor visits starting from GPs, specialists to super specialists, besides simultaneous re-engineering of below par public healthcare delivery systems of the country.
1. Budgetary clearance for free distribution of essential medicines by the States:
Late 2012, the Union Government made its first major move by formally clearing Rs. 13,000 Crore (around US$ 2.2 billion) towards providing free medicines for all through government hospitals and health centers. The State Governments under National Health Mission to utilize this fund for purchase and free distribution of essential medicines. Some State Governments are already in the process of implementing this scheme, though effective implementation of the same, across the country, still remains a challenge.
This new scheme, I reckon, has also the potential to hasten the overall growth of the pharmaceutical industry, as poor patients who could not afford will now have access to essential medicines. On the other hand, rapidly growing middle class population will continue to favor branded generic drugs prescribed by the doctors at the private hospitals and clinics.
Some people are apprehending that generic drug makers will have brighter days as the project starts rolling on. This apprehension is based on the assumption that large branded generic players will be unable to take part in this big ticket drug procurement process of the Government, which seems to be imaginary at this stage.
However, in my view, it could well be a win-win situation for all types of players in the industry, where both the generic-generic and branded-generic businesses could continue to grow simultaneously.
That said procedural delays and drug quality issues, while procuring cheaper generics, might pose to be a great challenge for the Government to ensure speedier implementation of this project. Drug regulatory and law enforcing authorities will require to be extremely vigilant to ensure that while sourcing cheaper generic drugs, “Public health and safety” due to quality issues do not get compromised in any way.
POTENTIALITY: Significant increase in access to medicines and simultaneous sharp reduction on OoP expenses.
2. Operationalization of CMSS for drug procurement:
Recently this year, the Union Health Ministry issuing the final notification reportedly has made the drug procurement system through Central Medical Services Society (CMSS) formally operational.
The drug procurement for different flagship program, of the Government like National Health Mission, will now be done through the CMSS.
The notification says:
- The CMSS will be responsible for procuring health sector goods in a transparent and cost-effective manner and distributing them to the States/UTs by setting up an IT enabled supply chain infrastructure including warehouses in 50 locations.
- The main objective of CMSS is to ensure uninterrupted supply of health-sector goods to the state Government, which will then maintain the flow to the govt. health facilities such as district hospitals, primary health centers and community health centers.
- All decisions on procurement will be taken by the CMSS without any reference to the Ministry of Health and Family Welfare.
- The Ministry will be responsible only for policy decisions concerning procurement and for monitoring its performance.
- The CMSS will also assist the state governments to set up similar organizations in states to reform their procurement.
- The Government has appointed the Director General and other key persons to run the organization, which will look to eliminate deficiencies in the existing system of purchasing medicines, vaccines, contraceptives and medical equipment for all government’s flagship program.
- At present, the ministry procures drugs departmentally and through agents, drawing flaks and raking controversies at regular intervals.
This seemingly transparent drug procurement process for public use, would prompt tough price negotiations with the manufacturers for purchase of medicines leading to significant reduction in drug prices, as evidenced already in the States like, Tamil Nadu and Rajasthan.
POTENTIALITY: Significant reduction in public healthcare costs, especially for medicines.
3. Announcement for implementation of Standard Treatment Guidelines (STGs):
Another recent news that Standard Treatment Guidelines (STGs) for 20 disciplines will soon be put in place in India is indeed a breath of fresh air. The centers of excellence for healthcare, both public and private, for around 1.2 billion population of the country, are still rather limited.
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 would ensure cost-effective healthcare benefits to a vast majority of its population.
STGs, therefore, will provide:
- Standardized guidance to practitioners
- Cost-effective ‘health outcomes’ based services
The Ministry of Health is now reportedly mulling to streamline in a phased manner the disease treatment procedures and protocols by introducing STGs in 20 disciplines under the ‘Clinical Establishments Act’ of the country. These disciplines are Cardiovascular, Endocrinology, ENT, Gastroenterology, General Surgery, Interventional Radiology, Laboratory Medicine, Obstetrics and Gynecology, Organ Transplant, Pediatrics, Oncology, Urology, Nephrology, GI Surgery, Medicine Respiratory, Medicine Non-Respiratory, Critical Care, Ophthalmology, Neurology and Orthopedics.
The National Council for Clinical Establishments (NCCE) is the apex body under the Clinical Establishments Act. STGs, therefore, will be binding on all hospitals and establishments registered under the Clinical Establishments Act 2010.
The Council has already deliberated on the draft STGs prepared by the experts in the respective disciplines of medicines. Surgical intervention in cardiovascular diseases reportedly will assume priority while implementing the STGs.
It is expected that the first of the STGs will be announced soon.
Currently only Uttar Pradesh, Mizoram, Sikkim, Rajasthan, Arunachal Pradesh, Himachal Pradesh and Jharkhand, apart from all Union Territories, have adopted the Act. Again, health being a State subject in India, all the States of the country will need to enforce this Act to make the initiative successful. However, states like West Bengal have their own Clinical Establishment Act, while Tamil Nadu has its own STGs.
Incidentally, putting STGs in place has been one of the long-standing demands of many, including the medical insurance companies. This is mainly because, laid-down protocols will make the hospitals avoiding unnecessary procedures on insured patients, thereby reducing the cost of treatment significantly.
POTENTIALITY: Huge reduction in healthcare cost, avoiding wastage in every step of any disease treatment. This could also help the medical insurance companies containing hospitalization costs, hopefully leading to reduced insurance premium.
All these three edicts of the Government, do promise a huge potential to help containing the overall cost of treatment in general and the costs of medicines in particular.
Effective implementation of these important initiatives would call for a significant change in mindset of all concerned. Doctors, hopefully, would also avoid using those expensive drugs having no significant improvement in ‘health outcomes’ over the cheaper alternatives.
STGs would initially need to be encouraged not just through self-regulation of the medical profession, but by the pharmaceutical industry and other allied interested parties in this area, as well. If ‘self-regulation’ does not work, stringent regulatory measures must be enforced by the Government to protect patients’ health interest.
No doubt both the Union and the State Governments of India would still have lot to chew in pursuit of ensuring affordable healthcare in general and medicines in particular, to all.
That said, would expectations of crafty implementation of these edicts, at least, flicker a ray of hope in an otherwise gloomy and exploitative overall healthcare environment of the country?
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.