Friday, 23 September 2016

Health for All Now



The policies of the Congress-led UPA government and now present government have led to a severe mismatch between the real needs and the actual availability of health care services for a majority of the people. 

Public sector health services are in shambles; the National Rural Health Mission (NRHM) falls far short of the needs of the people; public funded health insurance schemes of the Centre and of States are inadequate as these cover only in-patient care in hospitals and a small subset of ailments; and rampant corruption plagues the public health system.

The absence of adequate public healthcare services has created a vacuum, thereby forcing people to increasingly depend on private providers. As a result, the private health sector is growing rapidly, and is today being led by networks of corporate-owned hospital chains. This sector is largely unregulated, expensive, often provides care of dubious quality, and is plagued by complaints of unethical and negligent behaviour. India has one of the most privatized healthcare systems in the world accounting for 80% of outpatient care and 60% of in-patients care.

An estimated 8 crores people are pushed below the poverty line every year because of forced expenditure on healthcare. A large part, about 70%, of out-of-pocket payments goes towards purchase medicines. Only a small proportion of medicines are provided free of cost, while over 80% of medicines are directly purchased by patients. New medicines are especially prohibitively expensive as, after the amendment of the Indian Patent Act in 2005, Indian pharmaceutical companies are unable to produce cheaper versions of new drugs. Most new drugs are now sold by multinational corporations at prices much beyond the reach of most Indian patients.

   Meagre Allocation of Resources for Health

The financial allocation by Central and State governments to the health sector should be increased to at least 5% of GDP, as recommended by the WHO. India has for too long had among the lowest levels of public expenditure on healthcare in the world).

Both the Common minimum programme of UPA I and the Eleventh Five Year Plan had promised increase in public health expenditure to 2%-3% of GDP. However, current public health expenditure in the country stands at a mere 1.2% of GDP.

There is a massive gap between the Five Year Plan projections and actual allocation. The Eleventh Plan had projected that allocation to the health sector would be increased to 2% of GDP (0.87% of GDP by the Centre and 1.13% of GDP by States). In contrast, it stood at a mere 1% of GDP -- 0.32% of GDP by the Centre and 0.68% by the States -- at the end of the Eleventh Plan period in 2011-2012.

Table: Global Trends in Public Expenditure on Health

Country/Region
% of Public Expenditure on Health
to Total Health Expenditure
  India                                       
29.20
Average of High income countries
65.10
Average of Low income countries
38.78
Average of Middle income countries
52.04
World Average
62.76
                                     
Source: World Bank Database



National Rural Health Mission -- Starved of Funds

The National Rural Health Mission (NRHM) came into being in 2005 due to demands from different sections fighting for better health care. The Left Parties played an important role in pushing the UPA I Government to set up the NRHM. However, since its launch, funds released have been only one third of what was promised - Rs.66,000 crore as against Rs 175,000 crores envisaged under the approved framework of the NRHM. Funds released during the 11th Plan were less than half of the original Plan outlay. Powerful forces within the government, led by the Planning Commission, actively proposed that large parts of public funded health care should be handed over to the private sector.

Inadequate Public Health Services, Lack of Infrastructure Development and Employment Squeeze

Today, public health expenditure accounts for only 20% of total health expenditure and includes the services of only 20% of the country’s health workforce. There are huge gaps between the requirement of personnel and the present situation. At the sub-centre, primary health centre (PHC) and community health centre (CHC) levels the gaps are to the tune of 17 per cent, 18 per cent and 33 per cent respectively. The shortfall of specialists is even more shocking. There is a shortfall of surgeons of 76 per cent, of gyneacologists of almost 67 per cent, of physicians of over 80 per cent and of pediatricians of around 72 per cent. Such gaps exist right up to the primary level of care, including for ANMs and nursing staff.

By virtually halting government investment in public sector medical colleges and by simultaneously encouraging private medical and nursing institutions the Government has contributed to the present, extremely unhealthy, situation. The situation is further compounded by an almost complete lack of regulation of these private sector institutions and the promotion of the corporate sector.

Corporate Takeover of Health Care in India

The declining state of India’s public system is undeniably linked to the ascent of a private sector that now has a majority share in various components of health care. There has been a proliferation of private medical colleges that have created human resource shortages in the public system; the growth of an unregulated medical equipment industry contributing to booming costs of care; and of a powerful pharmaceutical industry that manufactures and sells overpriced, irrational medicines and drug combinations.

Table: Share of the private sector in India’s health system (%)

Medical graduates and post-graduates             90-95
Outpatient care                                                            80
Indoor patients                                                             60
Undergraduate seats in medical colleges                      45
Manufacture of medicines                               99.5
Manufacture of medical devices                      100

One very visible manifestation of the private takeover of health services is the mushrooming of corporate hospitals. Hospital chains’ revenues have grown exponentially in recent years. For example, the total nationwide revenue of Apollo Hospital, the largest corporate chain in India, rose from Rs 16.1 billion in 2009 to Rs 31.5 billion in 2012. The rules of the game have shifted from promoting public health to mere profiteering as made possible by corporate-friendly regulations. There is also a large body of evidence that shows how private providers entice patients with false claims and promises, fleece poor patients, and provide inadequate care. Regulatory agencies such as the Central Drugs Standards Control Organisation (CDSCO) and the Medical Council of India (MCI) have been largely ineffective in controlling these. The MCI itself is mired in corruption.

The current Clinical Establishments Registration and Regulation Act lays down guidelines for regulation, and it has currently been adopted only by a few states. The Act needs to be broadened since it does not mention the principles of patients’ rights or ensuring public health obligations of private providers.  


National Health Insurance: Who benefits?

The Employees State Insurance Scheme (ESIS), designed to protect workers health through public services has been systematically neglected. There are attempts by the Government to promote publicly funded health insurance schemes run by private insurance companies, where health care services are largely outsourced to the private sector. These include the national RSBY scheme and several state level schemes such as the Arogyashri programme in AP. They only cover in-patient care at the secondary and tertiary levels and have contributed little in improving overall access to health services. These schemes have become a way of transferring public money to private insurance companies and private hospitals. There is increasing evidence of misuse of the scheme by private service providers to make profits though unethical means, while providing poor quality services.

For example, in the case of the Arogyasri scheme in Andhra Pradesh, the total payments to facilities accredited under the scheme from 2007 to 2013 amounted to Rs. 4,723 crore, of which Rs. 1071 crore was paid to public facilities and Rs. 3652 crore went to private facilities.

Beneficiaries of these schemes are only insured against a set of ailments that require hospitalization at secondary and tertiary levels of care. They do not provide comprehensive health care, and are limited only to a pre-defined package of procedures.

The health insurance schemes also starves primary care facilities. In 2009-2010, direct government expenditure on tertiary care was slightly over 20% of total health expenditure but if one adds spending on the insurance schemes that focus entirely on hospital-based care, total public expenditure on tertiary care would be closer to 37.42% In Andhra Pradesh, following the implementation of the Arogyasri scheme the proportion of funds allocated for primary care fell by 14%.

BJP’s Vision of Health Care in India

Is the BJP’s vision for health care any different from that of the Congress led UPA? In fact the BJP promises   precisely the same disastrous, pro-private sector policies that have destroyed public health services in India. Its 2009 election manifesto says the following: The BJP will launch a massive programme, through public-private participation, to introduce a ‘Health for All’ scheme based on an innovative insurance policy. Under this scheme, the premium of BPL families will be paid by Government. Beneficiaries will have access to Government and private hospitals for cashless treatment”.

While the BJP is projecting its supposedly successful Gujarat model of development, a 2012 Planning Commission study places Gujarat at the bottom 6 of 21 major Indian states as regards access to health care services.

Table: Ranking of States’ Performance in the Health Sector, 2010

1-Kerala;  2 – Tamilnadu; 3 - West Bengal; 4 – Odisha; 5 – Bihar; 6 – Karnataka; 7 – Goa; 8 – Punjab; 9 – Himachal Pradesh; 10 – Chhattisgarh; 11 – Andhra Pradesh; 12 – Maharashtra; 13 – Jharkhand; 14 – J&K; 15 – Assam; 16 – Gujarat; 17 – Uttar Pradesh; 18 – Rajasthan; 19 – Madhya Pradesh; 20 – Haryana; 21 – Uttarakhand.

It may also be noted that Gujarat ranked 13th among 17 big states in the ‘hunger index’ (state hunger index, 2008) and worse than Orissa. Expenditure on health as percent of total state government expenditure is 2.83%, well below the national average of 3.60%. Further percent of state GDP spent on health in Gujarat is just 0.38%, well below the national average for all states at 0.59%. (2009 figures)

Abandonment of the “Free Medicines” Scheme

It is estimated that 50% to 80% of the Indian population have no access to the medicines they need. According to World Medicine Report of the World Health Organization, 649 million in India -- the largest number of the people in the world -- do not have access to essential medicines. Paradoxically,  India is the 3rd  largest producer of drugs (by volume) in the world and exports medicines to over 200 countries.

In his Independence Day speech in 2012, Prime Minister Manmohan Singh had announced that all essential medicines would be made available, free of cost, in all public facilities and this scheme would be financed by the Central government. However, the responsibility has now been shifted on to State governments. Schemes to provide free medicines in public facilities are operational in a few states like Tamilnadu, Kerala and Rajasthan. But, the free medicine scheme of Rajasthan is now being neglected by the present BJP government, which considers it as ‘Congress scheme’!

Removing Control on Drug Prices

The number of drugs covered has come down from 342 in 1979 to 74 in the Drug Price Control Orders (DPCO) of 1995. After a Public Interest Litigation was filed by the All India Drug Action Network (AIDAN) in 2003, highlighting that high drug prices were a major cause for catastrophic medical expenses in the country, the Supreme Court issued a directive to expeditiously put in place a mechanism to control essential drug prices to affordable levels.

In response to the Supreme Court directive, the government has now introduced price control on 348 drugs listed as essential. However, marginal benefits (if any) are likely to accrue because the new DPCO fixes ceiling prices based on an average of existing prices in the market (a departure from the earlier practice of fixing based on manufacturing cost). This methodology would largely reflect the price of the brand leaders, serving to legitimize the rampant overpricing of drugs today. This (the new formula for price fixation) is nothing but a parting gift by the UPA government to the pharmaceutical companies.

Proliferation of a Blatantly Unethical Clinical Trials Industry

India has become the preferred destination for conducting clinical trials, a large number of them by MNCs through Contract Research organizations (CROs). The Government has encouraged this by changing the Drugs and Cosmetics Act in 2005. There is extensive evidence that regulatory measures are being circumvented in the conduct of many such trials. Many of these trials also target women, especially poor women who are vulnerable. MNCs prefer to conduct trials in countries such as India as the costs are less than half of that in developed countries, and further, because they believe it is easier to flout regulations and laws.

The Supreme Court was forced to intervene – responding to a Public Interest Litigation -- and issued an order in January, 2013 revoking the powers of the Central Drugs Standard Control Organization and banning clinical trials for new chemical entities unless these were personally vetted and cleared by the Union Health Secretary. Subsequent rulings of the Court have asked that stringent guidelines for conduct of clinical trials, norms of compensations for those who suffer adverse effects, etc. be issued. However, there continues to be tremendous pressures from the Industry to again allow clinical trials to be conducted as before.

Promoting de-industrialization and MNCs and Destroying the Public Sector

India can take credit for the first major initiative in a developing country to achieve self reliance in the area of manufacture of medicines. This was made possible as a result of three major developments: 1) The Indian Patents Act of 1970 which superseded the colonial Act of 1911 and allowed Indian companies to produce drugs that were patented by foreign companies; 2) Initiation of manufacture of drugs from the basic stage by Indian public sector companies like Hindustan Antibiotics Limited (HAL) and Indian Drugs and Pharmaceuticals Limited (IDPL); 3) Implementation of the recommendations of the Parliamentary Committee on Drugs and Pharmaceuticals (known as the Hathi Committee), through the Drug Policy of 1978, which imposed several restrictions on the operations of MNCs and provided preferential treatment to Indian companies.

Unfortunately, all these three initiatives have been reversed in the last two decades. HAL and IDPL were systematically and deliberately undermined as a result of inept management and withdrawal of preferential treatment. Both the UPA and NDA governments have been responsible for virtually closing down almost all public sector drug units including those which were producing vaccines. The 1978 policy’s major thrusts were diluted and reversed in successive policies in 1986, 1994 and 2002. And finally, the 1970 Patent Act was amended in 2005, because of India’s joining the World Trade Organisation (WTO) in 1995.

Today the most disturbing trend in the drug industry is that de-industrialisation has increased at a frightening pace and many companies are dependant on imported bulk drugs. Further, many large Indian private sector companies, are tying up with MNCs. The ball was set rolling by the Ranbaxy – Glaxo Smith Kline tie up. This was subsequently followed by the takeover of Ranbaxy (then the largest Indian company) by a Japanese company – Daichi. In the past five years several Indian companies have been acquired by MNCs. Takeover by multinationals of Indian companies will further orient them away from the Indian market, thus reducing domestic availability of the drugs. The reversal of trends in the drug market is evident from the fact that of the 10 largest drug companies in India in 1998-99, only one (Glaxo Smith Kline) was a foreign company. Today three of the top ten companies are foreign owned (Ranbaxy, Glaxo Smith Kline and Piramal).

In spite of clear signs that MNCs are poised to take over the Indian drug Industry again, the UPA government continues to allow 100% FDI in the pharmaceutical sector through an automatic route. Contrary to the claims of the government 100% FDI companies are entering the Indian market only to repatriate profits and are not interested in bringing in any novel technology.

Drug Patent Regime

The change in the Indian Patent Act in 2005 took away a valuable tool available with Indian companies. The health safeguards in the 2005 amendments to India’s patent laws (introduced through pressure by the Left Parties at that time) are being used to an extent to ensure continued access to new drugs. There have been several positive judgments pronounced recently that have made use of the health safeguards. These include the issuing of the first compulsory license (i.e. a license to an Indian company to produce a patented drug manufactured by a foreign company) for an anti-cancer drug (Sorafenib), reversal of the first drug patent since 2005 that had been issued for a drug for Hepatitis-C (peg-interferon), and the upholding of the refusal of patent for an anti cancer drug (Gleevec) to Novartis.

In spite of these victories many new drugs are now being granted patents and are way out of the reach of almost all Indians and Multinational corporations continue to try to challenge the positive parts of the Indian law. The Government should establish an institutional mechanism to monitor the impact of patented medicine on access to medicine and recommend suitable measures to ensure access.

Enforcing US law on Indian Soil

The UPA government has allowed the US Food and Drug Administration (USFDA) to operate from within India – thus paving the way for the USFDA to opened its office in New Delhi in September, 2009 and subsequently in Mumbai. These offices conduct regular inspections in hospitals that conduct clinical trials, in drug production units in India and even on products imported into India! They regularly issue notices to drug companies in India claiming that their products are ‘adulterated’ or ‘sub-standard’ etc. under U.S. law though Indian drug control authorities have not found them to be so.  

Proliferation of Irrational and Substandard Drug

In India, an average family spends Rs.3,000 every year in buying medicines and on diagnostic investigations. It has been estimated that at least 50% of this expenditure is incurred on irrational or unnecessary drugs and diagnostic tests. This adds up to a colossal waste of Rs.30,000-40,000 crores every year, and amounts to an average unnecessary drain of Rs.1,500 per year for every family. There are an estimated 60,000 to 80,000 brands of various drugs available in the Indian market. On the other hand the essential drug list in India contains just 348 drugs. In this situation of extreme anarchy the task of an already overstretched Drug Control Authority becomes almost impossible to cope with. A majority of the estimated 80,000 products in the market are either hazardous, or irrational or useless. 
The pharmaceutical companies and the government regulatory bodies – prominently the Central Drug Standards Control Organisation (CDSCO) -- are both complicit in corrupt practices that allow this situation to continue.

At the same time an estimated 8-10% of drugs sold in India are of substandard quality. Clearly the CDSCO needs to be indicted for such a situation to prevail. Unfortunately there are a number of indications that the CDSCO is plagued with corruption at various levels.

Bringing about Real Change

Clearly the health care system in India is plagued with a range of problems, many of them deliberately introduced as part of neoliberal reforms pursued by successive Congress and BJP led governments. We will promote alternative measures that need to be instituted if the goal of Health for All is to be realized Now!

1.      Enact a Right to Health Act which assures universal access to good quality and comprehensive health care for all the entire range of primary, secondary and tertiary services, and that makes denial or non-availability for reasons of access, affordability or quality a justiciable offence.

2.      Increase Public Expenditure on Health, immediately to 3.6% of GDP and to 5% of GDP in the medium term

3.      Ensure quality and assured availability of health care services

4.      Stop Privatization of health care services

5.      Increase public investment in education and training of the entire range of health personnel.

6.      Secure access to quality assured essential medicines and diagnostic services in all public health facilities, free of charge.

7.      Reverse Exploitation by private hospitals

8.      Absorb, over a period, existing publicly funded health insurance schemes (RSBY and different state health insurance schemes) into an expanded public health system publicly financed.

9.      Ensure access to essential and safe Drugs & Devices: Cost-based price-control of all medicines, measures to ensure drug and device safety, banning of irrational medicines and irrational combinations, opening of generic medicine outlets in adequate numbers, mandatory provision for doctors to write generic names of medicines, use of the public health safeguards in the Indian Patent Act to promote access to medicines, and active promotion of indigenous manufacture of most drugs and devices.


10.  Regulation of clinical trials and ethics in biomedical research: Develop a clear framework for the ethical conduct of clinical trials in India, combined with the regulation of all those that are involved -- sponsors of trials, CROs, ethics committees etc. Fair compensation norms for trial participants who suffer from adverse events to be expeditiously developed and implemented.

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