Saturday, 26 April 2014

Health Services in India: Setting the Record Straight[1]

Health Services in India: Setting the Record Straight[1]

Public policy in health care and consequent development of health care services has undergone several significant changes in the ten years that the UPA has been in Government. UPA I started on a fairly positive note with the formulation of the Common Minimum programme, which in the health sector promised the following:

The UPA government will raise public spending on health to at least 2-3% of GDP over the next five years with focus on primary health care. A national scheme for health insurance for poor families will be introduced. The UPA will step up public investment in programmes to control all communicable diseases and also provide leadership to the national AIDS control effort.

The UPA government will take all steps to ensure availability of life-savings drugs at reasonable prices. Special attention will be paid to the poorer sections in the matter of health care. The feasibility of reviving public sector units set up for the manufacture of critical bulk drugs will be re-examined so as to bring down and keep a check on prices of drugs”.

By 2009 the Congress was much more dominant in government formation (than in the case of UPA II) and unlike in 2004 there was no common programme that was announced or promised. The Congress in its manifesto promised: We will guarantee health security for all. The National Rural Health Mission has already begun to make a noticeable impact and will be implemented with an even greater sense of urgency. The Rashtriya Swasthya Bima Yojana (RSBY) introduced by the Congress-led UPA Government offers health insurance for poor families. Expenditure on health is a major cause of indebtedness, particularly in rural areas. The Indian National Congress pledges that every family living below the poverty line will be covered by the RSBY over the next three years. Every district headquarters hospital will be upgraded to provide quality heath facilities to all”.

State of Health Care Services

It is in this backdrop that we examine the performance of the 10 years of governance by the UPA. Overall, there is a severe mismatch today between the needs and aspirations of a majority of Indians and the actual situation as regards health care services. The public health sector in India is in a state of neglect and large sections of the population depend on a poorly regulated private sector increasingly dominated by big hospitals, which have an infamous track record of unethical practices. In fact, with private health care accounting for 80% of outpatient and 60% of in-patient care, India is one of the most privatized systems in the world.

Public health services are marked by poor access, low quality and limited choice. The National Rural Health Mission has led to some improvements but much remains to be done. Rampant corruption plagues parts of the public health system, jeopardizing significantly the possibility of bringing about positive changes.

Out-of-pocket expenditure on health care continues to contribute to widespread poverty in India. In
an attempt to protect patients from ‘catastrophic’ health expenses, publicly funded health insurance
schemes have been rolled out. But these only cover in-patient care at the secondary and
tertiary levels of care. The private medical sector is growing rapidly and is fast transforming itself into a networked system of corporate owned hospital chains. This sector is largely unregulated, expensive, often provides care of dubious quality, and is plagued by complaints of unethical behaviour.

A large part of out-of-pocket payments are made on medicines, and public procurement and
distribution of medicines constitute a very small fraction of drug consumption. In addition, since the protection of the long-standing1970 Patent Act was lifted in 2005, generic pharmaceutical companies are unable to produce cheaper versions of new drugs, and most new drugs are now sold by multinational corporations at prices well beyond the reach of most Indian patients.

Clearly, thus, we see a huge gap between promise and delivery. Let us look at some of the key issues.

Allocation of Finances for Health

The Jan Swasthya Abhiyan and several other advocates of public health have long advocated for a major increase in financial allocation by central and state governments to the health sector – at least to 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 (see Table 1). The CMP of UPA I and the Eleventh Five Year Plan had both promised to increase public health expenditure to 2 to 3 percent of GDP. However, current public health expenditure in the country stands at a fraction above 1.06% of the GDP. Over the years states have been starved of funds through a variety of fiscal mechanisms, but even during the 11th Plan period the states actually performed better than the centre in allocation of funds for health care. The Eleventh Plan had projected an allocation of 0.87% of GDP by the Centre and 1.13% by States by 2011–12. At the end of the Plan period the allocation stood
at 0.32% of GDP by the centre and 0.68% of GDP by states. The major shortfall was a consequence of the meagre Central allocation. Interestingly the 12th Five Year Plan has further lowered it sights and now proposes an allocation of 1.87% of GDP.

Table 1: Percent Public Health Expenditure by Region in the World

Country/Region                                               Public Expenditure on Health as percent
                                                                        of 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                                                              62.76

Source: World Bank Database (http://data.worldbank.org/)

The most immediate indication of the huge gap between promise and delivery comes from the 2013-14 budgets. Table 2 provides the overall figures for budgetary allocation on health in the past three years.

Table 2: Allocation for Health in 2013-14 Budgets


Budget Allocated
2013-14 (in Cr)
Budget Allocated
2012-13 (in Cr)
Budget Allocated
2011-12 (in Cr)
Total to MoHFW
37330.00
(8.2% increase of over previous year)
34488.00
(12.8% increase of over previous year
30456

Allocation for National Rural Health Mission
18880.35  (50.5% of total allocation) --
2% increase from previous year allocation)
18515.35 (53.68% of total allocation -- 14.7% increase from 11-12)
16140.76 (52.48% of total allocation)

There has been a mere 8.2 per cent increase in total allocation over the previous year. These needs to be contrasted with the promise in the 12th Five Year Plan that allocation for health would be increased by 300 per cent over the allocation for the 11th Plan. In other words the 12th Plan projects an increase of around 60 per cent every year, over the previous year’s allocation. The present increase, however, is barely enough to cover for inflation, meaning that there has been no actual increase proposed.

More intriguingly, if we adjust for inflation, the 2 per cent  increase for the National Rural Health Mission actually translates into a decrease in real allocation. This is so despite the announcement that the NRHM shall now include two new components – a flexi-pool for communicable disease control and for urban health (previously not covered by the NRHM, and hence leading to the proposal to rename the NRHM as the National Health Mission). It is an indication of the way the government of the day functions that it believes that it is perfectly rational to announce an expansion of a government programme, and at the same time actually propose a cut in the budget!

National Rural Health Mission and Public Health Services

The public health system has continued  to function in an adverse climate – with powerful forces continuing to actively propose that large parts of public funded health care should be handed over to the private sector -- even after the launch of the NRHM. Since its launch, funds released have been only one third of the envisaged funds under the approved framework of the NRHM - about Rs 66,000 crore was released against Rs 175,000 crores envisaged. Funds released under 11th Plan are less than half of what was the original Plan outlay.

It is necessary to nail the lie that the public sector is inherently inefficient. Today, public health expenditure accounts for only 20 per cent  of total health expenditure and includes the services of only 20 per cent  of the country’s health workforce. Yet it provides for about 20 per cent  of all out-patient care (33 per cent  of all qualified out-patient care); 40 per cent  of all in-patient care, including about 60 per cent of all hospital based critical pre-terminal care; and  almost 100 per cent  of all preventive and promotive care. Inefficiencies as well as corruption do exist in the system. But these are not inherent faults of the system; they are introduced into the system by the same government that calls it inefficient.

The situation has started to change in some public facilities, though the changes have been inadequate and uneven (see Table 3). What is however significant is that we now have fresh evidence in India that good quality care, as certified by external assessors, can be provided by public hospitals.

Table 3: Status of Health Infrastructure in India

Infrastructure   March 2007     March 2011     Percent                         Required          Gap
                                                                        Increase          

Sub-Centre       145272                        148124                        2                      178267                        17
PHC                 22370              23887              6                      29213              18
CHC                4045                4809                16                    7294                34
Dt . Hospital    340                  613                  45                    640                 4

Source: RHS Bulletin 2007 and 2011, MOHFW

Quality of care is also dependent on the infrastructure, equipment and supplies being available. The critical gap is not just in resources -- it also lies in the lack of transparent and efficient systems by which these can be assured.

The experience accrued from the running of the NRHM allows us to identify the bottlenecks, which include:

·         The notion that ‘free services are not valued’ has become an internalized perception- and there is clear resistance to changing over to free services. This resistance is more pronounced in the case of tertiary level services.
·         Drug supplies neither cover all requirements nor are they uninterrupted, making outside drug prescriptions with out of pocket expenditures common.
·         Diagnostics are the main source of user fee collections across the nation, and hospitals are loathe to let this avenue go.
·         The practice of free diet was given up in the nineties and is being revived with some difficulty.
·         Informal charges (read demanding payments by corrupt means) remain and are highest in states where salaries are very low or not paid on time.
·         Travel to the facility is a huge cost, though a number of assured patient transport services have somewhat reduced these costs.
·         Where referrals to private sector become necessary, because of a lack of services in the public sector, the government does not accept the costs of care incurred in such referrals.

Planning Commission’s Attempt to Delegitimise Public Services

However there is another part of this story. While even the grossly underfunded and neglected public system shows signs that it can deliver quality services, votaries of privatization (led by the Planning Commission) have recently been pressing for a shift towards greater reliance on private sector provision of health services.

In 2011 the government set up a High Level Expert Group (HLEG), tasked to recommend ways in which the country could achieve Universal Health Care (UHC). UHC, by this time, had already become a buzzword in international circles. Unfortunately, UHC has come to mean different things for different people as there has never been any conceptual clarity regarding what UHC means. To some UHC was quickly converted to Universal Health Coverage (rather than care) and then further coverage was taken to mean coverage by a limited insurance based package, and not access to comprehensive health services. There was a very deep game that was played out, and there was a deliberate ploy to limit the discussion to the financing of UHC and not to how health care would actually be provided.

The HLEG report made several useful recommendations, including  recommendations to abolish user fees; to move from selective health care to comprehensive health care; and to replace a system where only BPL was eligible for free care to where almost everyone was entitled to free care. But the HLEG did not unambiguously recommend that universal care, to be accessible to all, must ultimately be provided by public health facilities. Instead the HLEG report said: State governments should consider experimenting with arrangements where the state and district purchase care from an integrated network of combined primary, secondary and tertiary care providers”. It thus kept ambiguous the question as to who the ‘integrated network’ would actually represent.

The Planning Commission, however, used this paragraph for its own purposes and it became the major part of the HLEG’s recommendations that the Planning Commission selectively quoted. The Planning Commission understood the phrase ‘integrated network’ to mean a network that was run by a private entity! Thus the initial draft of the health chapter of the 12th Plan document went on to elaborate its grand plan of handing health care over to the corporate sector, very akin to the disastrous ‘managed care’ model in the United States. Fortunately the Planning Commission’s wishes did not entirely fructify. Several organisations, including the Jan Swasthya Abhiyan, and even the government’s own ministry of health, objected to this formulation. Eventually the notion was watered down in the final 12th Plan document to a recommendation that pilot programmes on UHC would be run during the Plan period in some districts.

Human Resources for Health

One of the most important deficiencies in the public health system -- indeed often the main limiting factor -- is the lack of skilled human resources, especially in rural and remote areas (Table 4).



Table 4: Human Resources in Public Facilities

Cadre               March 2007     March 2011     Percent             Increase           Required          Gap (%)

ANM               147439                        187675                        21                                393041                        52
HW (Male)      62881              52215              -20                               207480                        75
Nurses                         29776              65344              54                                138623                        53
Doctors           22608              26329              14                                109484                        76
Specialists       5117                6935                26                                58352              88
Pharmacists    17919              24671              27                                58389              58
Lab. Tech.       12101              16208              25                                80308              80

Source: RHS Bulletin 2007 and 2011, MOHFW

There are several important reasons for this crisis. Firstly the deliberate choice made to halt government investment in public sector medical colleges and encourage private medical and nursing institutions. This shift has further skewed the tendency of medical and nursing graduates to avoid serving in rural and remote areas. The first corrective needed is therefore for public investment in building medical, nursing and paramedical educational institutions that are primarily located in regions where the human resource gaps are worst.

The second corrective is to clearly identify skill requirements at different levels of care and to deploy health personnel based on such requirements. Effecting such a change, requires alterations in existing curriculum, requires bridge courses and specially designed supplementary packages and even requires the creation of new professional categories.

Another important reason for the huge deficit in Public Health services is the complete lack of regulation of the private sector and promotion of the corporate sector. Doctors graduating from the burgeoning, hugely costly private medical colleges need to amass money by any means; something which has been made possible by complete lack of regulation of the growing private sector.

Both of these measures while necessary are not sufficient – a lot more needs to be done. First and foremost is preferential selection for education and training from areas and communities which are under-serviced, and then training them as close to their areas as possible, in the state language preferably and deploying them back in these same districts. This should be supplemented with a package of financial and non-financial incentives and the building of a positive workforce environment that would retain the employees.

The large effort by the government to deploy over 700,000 Accredited Social Health Activists (ASHA), as part of the NRHM, has had some positive impact in rural areas, but the program is under-resourced and these health assistants are paid a pittance, which is not commensurate with their heavy workloads. Further, sporadic attempts to put together a cadre of health workers with three-year training to address the most common problems at primary levels of care has not taken off (except to a limited extent in a few states); this is largely a consequence of opposition from the medical fraternity.

National Health Insurance

The UPA Government projects the rapid national coverage by its Rashtriya Swasthya Bima Yojana (RSBY) as one of its achievements. Launched in 2009 the RSBY is designed to protect patients from the ‘catastrophic’ impact of out-of pocket expenses incurred on hospital care – as modelled on the state of Andhra Pradesh’s Rajiv Arogyasri scheme. In the current Twelfth Five-Year Plan, similar insurance schemes have received even greater attention and support. There are also state-level health insurance schemes that have been launched or are in the pipeline in Kerala (Comprehensive Health Insurance Scheme), Tamil Nadu (originally called the Kalaignar scheme), Delhi (Apka Swasthya Bima Yojana), Karnataka (Yeshasvini Health Insurance Scheme) and Maharashtra (Rajiv Gandhi Jeevandayee Arogya Yojana).

These schemes are meant for hospital care only and cover a specific list of procedures. Patients are provided a choice of accredited institutions where they can receive treatment and be reimbursed for costs not surpassing a set ceiling. This type of health insurance is publicly funded; in the case of the RSBY the cost of the premiums is shared by central government (75%) and state governments (25%).

Two fundamental pillars support these kinds of health insurance schemes. First, they operate on the logic of what is called a ‘split between financing and provisioning’, that is, a clear separation between the financing of the services provided and the facilities where these services are available. While financing comes from public resources (central or state government funds), treatment can be provided by any accredited facility, public or private. In practice, when it comes to provisioning a large majority of accredited institutions are in the private sector. 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 47.23 billion, of which Rs 10.71 billion was paid to public facilities and Rs 36.52 billion went to private facilities.

The second pillar of these schemes is that beneficiaries are 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. Excluded are almost all infectious diseases that are treated in out-patient settings, such as tuberculosis that requires prolonged treatment, most chronic diseases (diabetes, hypertension and heart diseases), or cancer treatments that do not call for hospitalization. To take the Arogyasri example again, the scheme draws 25% of the state’s health budget while covering only 2% of the burden of disease. Such skewed priorities end up distorting the entire structure of the health system and public money is squandered to strengthen the already dominant corporate health sector.

The health insurance system 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%.

The High Level Expert Group set up by the Planning Commission in preparation for the Twelfth Five-Year Plan clearly stated that the use of independent private sector agencies and insurance companies under schemes such as RSBY: “fragments the nature of care being provided, and over time leads to high health care cost inflation and lower levels of wellness…since there is virtually no focus on primary level curative, preventive, and promotive services and on long-term wellness outcomes, these traditional insurance schemes often lead to inferior health outcomes and high healthcare cost inflation.

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, as illustrated in Table 5. 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 5: Share of the private sector in India’s health system
Category Share of the private sector
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 – anecdotal and scientifically recorded – 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 Organization (CDSCO) and the Medical Council of India (MCI) have been largely ineffective in controlling this.

While a transition to a system that is based almost entirely on public delivery of health services is necessary, in the interim the large (and growing) private sector cannot be wished away. Comprehensive regulation of the private medical sector in India is absolutely essential. Key areas requiring regulation should include the following:

a) Standardization of structures and human-power of facilities to ensure quality of care
b) Protecting patients rights
c) Equalizing accessibility / distribution of establishments
d) Standardization and rationalization of process of care based on standard protocols
e) Rationalizing and containing costs of care

The current Clinical Establishments Registration and Regulation Act lays down certain very broad guidelines for regulation, and it has currently been adopted by only a few states. On one hand, the act needs to be broadened since it does not mention the principles of patients’ rights or ensuring public health obligations of private providers. Such reformulation should be based on a consultative process; to take into account the concerns of various stakeholders including health rights organizations and patients groups, so that no serious lacunae remain. At the same time the act needs to be made universally applicable in all states.

Medicines for All?

Access to essential medicines is a major determinant of health outcomes and an integral, and often crucial, component of health care. It has been estimated by different sources that 50% to 80% of the Indian population are not able to access all the medicines that they need. The World Medicine Report of the World Health Organization finds that India is the country with largest number of people (649 million) without having access to essential medicines. Given that India today is the 3rd  largest producer of drugs (by volume) in the world and exports medicines to over 200 countries, this is clearly an unacceptable situation.

It is only recently that India has tried to implement a national essential drugs policy that would aim to achieve better access, as part of the NRHM goal to make all essential drugs available at appropriate levels of the public health system. However progress has been slow in ensuring access and in many states medicines cannot be obtained through the public health system when required. There are several reasons for this, including a lack of adequate supplies due to funding constraints and procurement policies, and the poor functioning and outreach of public facilities.

In 2012, Prime Minister Manmohan Singh (in his Independence day speech) announced a “free medicines” scheme, under which all essential medicines would be available at no cost in all public facilities. While initially proposed as a scheme that would be financed by the central government, the responsibility has now been passed on to state governments. Insignificant progress has taken place in most parts of the country with the significant exception of Rajasthan. ‘Free medicines for all’ programs in public facilities have been operational in some states for a long time, most notably through the Tamilnadu Medical Services Corporation (TNMSC) in the state of Tamilnadu and more recently in Rajasthan. These experiences need to be replicated in other states; in addition to improving access to medicines, they have helped develop transparent norms for drug procurement and distribution for public sector facilities.

Since 1970, the government has endeavored to regulate the prices of some drugs through successive Drug Price Control Orders (DPCOs) but the number of drugs covered has come down from 342 in 1979 to 74 in the latest 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. Since the prices of medicines in the bulk market and the costs for manufacturing formulations are widely known, there is no difficulty in fixing prices on a cost-based formula that looks at raw materials and manufacturing costs, after allowing for a fair profit margin.



[1] This section is based on various publications of the Jan Swasthya Abhiyan

Saturday, 30 November 2013

The Dismal State Of Health Care In India

The Dismal State Of Health Care In India
By Graham Peebles

29 November, 2013
Countercurrents.org
To speak of growth is to allude to one thing only: economic development, GDP and GNP figures, which of course should be increasing for the world to stay on track to become a global shopping emporium. The word has been confiscated by the economically erudite and the political ideologues. Monthly statistics are chanted, mantra like, by the politically aligned media, ignored by most and washed away with the residue. They are of no consequence to the majority trying to meet the basic requirements of living and are issued along with other contemporary anxiety stimulants: deficit, austerity and debt to name but three of the more popular narcotics of control.
India has recorded two delightful decades of around 9% ‘growth’, which has produced umpteen rupee resplendent billionaires who live in decadent luxury in the cities. Along with the government, which is seduced by all things corporate, they turn a comfortable blind eye to the hundreds of millions living in rural poverty and those in slums on the other side of town, where children play beside open sewage, where there are no functioning toilets or latrines: where child malnutrition is rife and where there are no health care facilities worthy of the name. The billionaires sit aloft a hierarchy of corporate wealth and power: they tower over the lesser millionaires (in 2012 there were 152,750 US $ millionaires); and see in the far distance the desperately upwardly that form a gaggle called the ‘new middle class’.
This group of city dwellers has benefited greatly from twenty years of market liberalization and government reforms, which have shifted support from the needy to the corporate greedy, resulting in increased levels of rural poverty and a multitude of suffering. The United Nations Human Development Index (UNHDI), which “represents a push for a broader definition of wellbeing and provides a composite measure of three basic dimensions of human development: health, education and income”, paints a vivid picture of Indian life after years of economic flowering. India comes in 136th out of 187 countries. Factor in inequality – “in each dimension of the HDI” plus gender inequality (considering the disadvantages facing women and girls), and India plummets even further down the table.
So, following P.Sainath’s noble lead, one asks who is this growth for? Not the poor, the marginalized and dispossessed, the Dalit’s (untouchables) or Adivasi (indigenous) people, the smallholder farmers, children and certainly not women.
Inequality and illness
The inequities in health care provision represent the extreme levels of inequality and social injustice pervading the country, as The Lancet makes clear, “mainly because of insufficient government funding for health.” Although the urban population continues to grow (currently thought to be around 377 million), by most estimates 75% of the population – (a staggering 900 million people) live in rural areas, where health-care is universally appalling. It is here in relation to health, disease and mortality that statistics have meaning to the people. According to the World Health Organisation (WHO), India as a whole accounts “for 21% of the worlds global burden of disease”: as a % this is greater than the population ratio. The 21% is concentrated in rural areas where diseases lead to huge numbers of deaths that, correctly diagnosed and given access to treatment, are preventable. It is thought e.g. that over 2 million deaths occurred in 2008 due to preventable causes, such as diarrhea, dengue, measles, typhoid and malaria. The middle and upper classes seduced as they are by multi-national western exports of fast food, cigarettes and alcohol have seen stark increases in obesity-related illnesses like diabetes and cardiovascular problems, records Health India.
Mahatma Gandhi believed the soul and spirit of India rested in its village communities. He said: “The true India is to be found not in its few cities but in its seven hundred thousand villages. If the villages perish, India will perish too.” Neglected and ignored rural communities are indeed perishing:
Adivasi people, who have lived on the land for generations, are being displaced in their millions as mining companies move in to extract the bauxite, iron-ore and tin. Trapped into debt and crushed by the corporate take-over of the countryside, smallholder farmers, of which there are an estimated 120 million (down 9 million since 2001), are committing suicide at the unimaginable rate of two every hour. Huge infrastructure projects are underway throughout the country, the waterways are being swiftly privatized and millions of villagers, with no access to adequate health care, are dying. One imagines the ‘Father of the Nation’ would be ashamed, as the current government should be.
Within rural areas there is a dire lack of health care resources; human and material, including medicines as well as properly equipped Primary Health care centres (PHCs), which are the main state run facility. Although India is said to have a Universal health care system administered by the various states, who have as their “primary duty” as stated in the constitution the “raising the level of nutrition and the standard of living of its people and the improvement of public health”, up to 60% of the population do not have access to adequate health care provision.
The conurbations, (with just 25%/30% of the population), have four times more doctors and three times more nurses than the PHCs in rural India; this means that of the latter almost 10% have no medical staff at all, 40% are without lab technicians and almost 20% lack a resident qualified pharmacist. The results of this dearth of medical support is (and here are some more statistics that matter) that 50% of all villagers have no access at all to allopathic healthcare providers, 10% of all babies die before their first birthday and 50% of all rural babies are likely to be permanently stunted for want of proper nutrition [according to Health India].
Water and Waste
Limited access to safe drinking water coupled with non-existent sanitation in rural India (and city slums) is a major factor in the spread of parasitic and bacterial infections, causing disease and malnutrition. Over a third of people living in villages have no access to toilets, while 50% of the population defecate in the open, added to which UNICEF, finds that “44% of mothers are disposing of their children’s faeces in the open”, resulting in “a very high risk of microbial contamination (bacteria, viruses, amoeba) of water which causes diarrhoea in children”, which is the primary cause of childhood mortality. Within rural families they found that only 11% “dispose of child stools safely”, whilst “80 % are left in the open or thrown into the garbage”, and shockingly, “only 6% of rural children less than five years of age use toilets”.
Drinking water is another major source of disease, and whilst UNICEF makes clear that access to safe sources of drinking water has improved, (from 68% in 1990 to 88% in 2008), with under a quarter of slums dwellers having access to this most rudimentary of needs, inequality poisons even their most basic human right. The problem is made worse, they say, by falling levels of groundwater, groundwater pollution and the widespread natural occurrence of “arsenic and fluoride in the groundwater”, which pose a major health threat. Proper sanitation methods and clean drinking water are not an issue of concern within the high-rise middle class city developments, or the gated communities in Delhi and Mumbai: they have toilets, bidets and Evian, or some such. It is the 75% that are left without health care, with restricted access to safe drinking water and no sanitation facilities. Where has the 9% growth gone?
The divide between the tiny percentage that have benefitted from economic development and market liberalization, and the vast majority that have been condemned to a life of extreme poverty and illness, is approaching cosmic proportions. Most people live in rural areas, but the beneficiaries of growth have primarily been city residents, where wealth is concentrated in the coffers of a handful of men. It is said that the 100 richest Indians own wealth equivalent to 25% of the national GDP (Annual GDP $1.84 trillion 2012), and, whilst Mukesh Ambani the chairman of Reliance Industries earns $18 million a year two-thirds of the population (according to the World Bank), lives on less than $2 a day. The 9% begins to rise to the divisive surface.
Two decades of economic growth have granted great benefits to the Ambani’s of India, but no improvements to the lives of rural people, and in particular have effected no change to health provision. Child malnutrition for example, which at 48% (UNICEF) is the highest in the world, fell by just 1% in the years since 2001.
Gender inequality compounds the economic and social divisions in the country. The treatment endured by women is universally appalling across a range of areas. Rape, (although barely reported-there is little point when cases take years to process), is endemic, female infanticide is widespread (12 million girls were aborted during the last two decades according to the United Nations UN), dowry killings commonplace: a trinity of abuse at the top of a list of mistreatment suffered by Indian women (specifically but not exclusively poor women). Add to this poor maternal health, causing 57,000 maternal deaths in 2010 (one mother dying every ten minutes, most of which occurred in rural areas), making India home “to the greatest burden of maternal, newborn and child deaths in the world”, (the WHO report). Forced marriage, although illegal is commonplace causing almost 50% of Indian women to (reluctantly) marry before they reach 18, resulting in early pregnancies, high morbidity and mortality rates, to say nothing of the unrecorded levels of depression and anxiety. Poor health care provision for women sits within a broader, horrific picture of gender inequality and prejudice, state neglect and female suffering. Collectively, according to a recent study by TrustLaw, they make India, the worst country for a woman to live out of the G20 nations, one place below Saudi Arabia.
Private Public
Health care is offered by public and private providers: with the public Primary health care centers (PHCs) understaffed and under-resourced with restrictive opening times, as well as long waiting times and in many cases sited miles from villages, the majority of visits (92%) are made to private centers. Around 70 % of private visits are made by city dwellers. They pay for their care by making ‘out of pocket’ payments, i.e. not covered by health insurance, which, The Guardian reports, only 11% of the population possess. The private sector has the monopoly on medical staff and materials, with, according to Government figures, 80% of all doctors, 26% of nurses, 49% of beds and 78% of ambulatory services working for the corporate boys. Care is expensive (up to nine times the cost of PHCs), and consistent with corporate irresponsibility, (sanctioned by government neglect and weakness); according to Gram Vaani it is “often unregulated and variable in quality. Besides being unreliable for the illiterate, it is also unaffordable by low income rural folks”.
With 9% growth for two decades one would expect a major level of government investment into health and education, however this is far from the case. Spending on public health care according to the WHO is 1.1% of GDP, placing India below Pakistan, China and Nigeria in the spending table. Cash (or out of pocket) payments are increasing (up to 80%) amongst those who have the money, but for the majority health care is an unaffordable luxury. In a country with more people living in poverty than all Sub-Saharan African countries combined, an additional 40 million a year are estimated to be forced into destitution by medical costs. So where has the growth gone; who is it for: who has benefitted from the ‘economic miracle’? The middle class have become rich; the rich have become super rich: the super rich stellar rich. This tiny group of city beneficiaries have as Arundhati Roy puts it, “ascended into outer space from where they look down at the indigenous people and the poor.” And as for the poor: their numbers have grown, their land has been stolen from them, their problems increased: they have been condemned to a life of illness, exploitation and suffering. And their voices are ignored.

Sunday, 7 April 2013

HEALTH CARE MORTGAGED TO HEALTH SECTOR


Dr.Amit Sengupta
24th August 2012
A FEW months back the Planning Commission of India had put its foot squarely in its mouth by claiming that the poverty line in India can be pegged at a consumption expenditure of Rs 28.65 per day. It was just one more example of how today’s ruling classes are content in distancing themselves from the harsh reality of people’s lives in most parts of the country. The Planning Commission is now back in the news with a bold new plan to refurbish health care in India. The prescription is simple --- gradually wind up the public healthcare system and hand it over to corporate hospitals! Ridiculous as this may sound, it is the essence of the Planning Commission’s Health chapter in its Twelfth Five Year Plan document.
PLANNING COMMISSION: TRAIL OF BROKEN PROMISES
It may be argued that the Twelfth Five Year Plan document is of little consequence, as seldom do plan documents translate into any actual action by the government. One has only to look at past plan documents to understand this. The Eleventh Plan document, for example, had said: “In the last two years of the Plan, total Plan expenditure will need to rise at about 48 per cent annually. This will result in a total health expenditure of 0.87 per cent of GDP by the centre and 1.13 per cent by States in 2011---12.” Nothing but empty promises; the total public expenditure on health has stagnated at around 1.1 per cent of GDP (0.32 per cent by the centre and 0.7 per cent by states). It is significant to note that the major source of shortfall has been the meagre allocation by the central government --- just 37 per cent of what had been promised in the Eleventh Five Year Plan.
The plan document had also projected that all sub-centres (about 1,75,000) and primary health centres (PHCs --- about 30,000) would be functional by 2010, and all Community Health Centres (CHCs --- about 6,500) would be functional by 2012. Yet statistics for 2011 show a shortfall in the targets set of 17 per cent, 18 per cent and 34 per cent respectively, for sub-centres, PHCs and CHCs. It was also projected that Infant Mortality Rate (number of infant deaths per 1,000 live births) would come down to 28 by 2012. The infant mortality rate in 2011 stood at 48! One can continue enumerating the huge differences between targets set by the plan document and actual realisation, but suffice it to say that there is almost no correspondence between promise and delivery on the ground.
The consequences of poor commitment to public health are clearly visible.Two decades after neo-liberal reforms were initiated, India now lags behind Bangladesh and Nepal in many health indicators --- in South Asia we only outperform Pakistan! (See Table below.)
Under 5 Mortality Rates in South Asia
Country
Under Five Mortality Rate
(Child who die before the age of 5/1,000 live births)

1990
1995
2000
2005
2010
India
115
100
86
73
63
Pakistan
124
115
101
94
87
Sri Lanka
32
27
23
19
17
Bangladesh
143
114
86
64
48
Nepal
141
110
84
65
50
Source: World Bank Database
(http://data.worldbank.org/)
It then raises the legitimate question --- why should one be concerned about the contents of the Twelfth Five Year Plan document? The reason for grave concern is ideological --- for the prescriptions in the new plan document are ideologically motivated. For the first time, a public document to be released by the government of India, proposes a road map for handing over health care to the corporate sector. In proposing such a trajectory the plan document is following in the footsteps of what neo-liberal governments have done --- often with disastrous consequences --- in other developing countries (Mexico and Colombia are prominent examples).
HEALTH SECTOR REFORMS IN NEO-LIBERAL FRAMEWORK
Health sector reforms that are located in the neo-liberal framework follow a familiar pattern today --- be it Mexico, Colombia or India. Three decades back, the World Bank and IMF imposed several conditionalities on developing countries. The prominent among these that impacted on the health sector, was a demand that public expenditure be curtailed and user fees be imposed on public services. The decades of the eighties and nineties witnessed savage cuts on public expenditure, leading to an exponential rise in private expenses. It led to the dismantling or weakening of public health services and to the consolidation of an organised private sector that stepped in to fill the demand for health services. By the end of the nineties it had become clear that public financing of health care needed to be restored and the World Bank started advocating such restoration.
But this did not mean that the neo-liberal agenda was abandoned --- it was brought back in a different avatar. It was acknowledged that government expenditure must increase. It was also acknowledged that something had to be done fast, if large populations were to be rescued from the distress caused by a collapse of the public health system. Capital never gives up on its attempts to find a way to maximise returns. So the solution that was found was not located in a restoration of public health services. Instead, by a sleight of hand, a new opportunity emerged for capital. Government (public) expenditure must be increased, but this expansion will not be used to develop and strengthen public facilities. Instead, public money will now be pumped into the organised private sector, to whom will be handed over the responsibility of providing health care. Governments will finance but not provide care, they will become ‘managers’ of care. This is the managed care model of care that is now being promoted by neo-liberal theorists.
REFORMS IN INDIA
The roll out of such a plan in India had its own twists and turns. The UPA-1 government, under some influence of the Left, was forced to respond to the looming crisis of health care (brought on substantially by huge cuts in health budgets in the 1990s when Sri Manmohan Singh presided over the initiation of neo-liberal reforms as finance minister) by launching the National Rural Health Mission (NRHM). The NRHM was designed explicitly to strengthen and expand public health facilities. The NRHM was flawed on two counts, however. It was grossly under-funded --- we have seen earlier how promised central allocation was cut by over 60 per cent. As a consequence it proved to be inadequate in fulfilling the demand for health care --- especially in the tertiary hospital sector, thereby paving the way for the emergence of an organised corporate led growth of the private sector.
The public health system stands at a critical juncture. For all its deficiencies, the NHRM has resulted in some expansion and strengthening of the public health care system. The logical step forward would have been to invest in further expansion and strengthening of this system. But for the present government, the neo-liberal logic was too difficult to resist. The first challenge that was mounted against the public system came in the form of the Rajiv Gandhi Swasthya Bima Yojana (RSBY) and similar insurance schemes in many states. Almost entirely publicly funded, these schemes provided an insurance cover for Rs 30,000 for BPL families. The catch was that institutions accredited as part of these schemes were largely private hospitals. So instead of using this substantial public investment to strengthen the public system and create long term national assets, public money was pumped into the private sector. Horror stories have now started emerging about how private hospitals have bled the RSBY and similar schemes to make money and to make a mockery of public health. In Chhattisgarh the state health department has initiated action against 22 nursing homes against which it found prima facie evidence of surgeries being done without legitimate medical reasons. It is estimated that over the last eight months, hospitals and nursing homes have claimed Rs two crore under RSBY scheme for removing the wombs of 1,800 women (Hindustan Times, August 14, 2012). Many such stories are just waiting to be uncovered in different parts of the country.
However, in spite of such challenges, the NRHM and the public health system still survives and continues to be an eyesore for the votaries of private enterprise. Lest we miss the point, the private medical sector in India is extremely powerful and has friends in high places. Today some of them have transformed into mega corporations, combining hospital care, private insurance, clinical trials industry, and pharmaceutical services. Prominent CEOs of such corporations confidently stride through the corridors of power, populate ‘task forces’ and ‘expert’ committees and have a profound influence on public policy. It is this lobby, representing the private hospital sector --- unregulated and often promoted through government subsidies --- whose not so hidden hand is clearly visible in the draft health chapter of the Planning Commission.
GROSSLY INADEQUATE ALLOCATION FOR HEALTH
Let us now turn to some of the specific proposals in the Planning Commission’s draft (these points have been highlighted in a press statement by the Jan Swasthya Abhiyan on August 8). It may be recalled that in the led up to the formulation of the report the Planning Commission had set up a “High Level Expert Group” to give its recommendations on how the present system could be reformed. The Ministry of Health and Family Welfare had also constituted different expert groups to provide inputs. Over the last year several reports from these committees had indicated various proposals which were essentially designed to strengthen the public health system. There has been uniform speculation, based on various pronouncements by the government, that public expenditure would be significantly enhanced in the Twelfth Five Year Plan period.
Yet, the Plan document now recommends increase in public expenditure on health from the present 1.02 per cent to 1.58 per cent of GDP. This is even less than the modest projections made in the Eleventh Five Year Plan, which had proposed that two per cent of GDP be spent on health. The target is not only lower than previous commitments made by the government, but much lower than a minimum of five per cent of GDP that is recommended by agencies such as the World Health Organisation. The gross inadequacy of the increase proposed has to be seen in the context that India has one of the most privatised health systems in the world. Public expenditure accounts for just 29.2 per cent of health spending in India. Of about 200 countries listed by the World Bank (2010), only 13 countries --- Guinea-Bissau, Guinea, Sierra Leone, Afghanistan, Myanmar, Azerbaijan, Haiti, Cote d'Ivoire, Uganda, Georgia, Yemen, Chad and Tajikistan --- perform worse than India! The following table compares India’s performance in public health care spending with global averages:
Percent Public Health Expenditure
Country/Region
Public Expenditure on Health as Percent of 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
62.76
Source: World Bank Database
(http://data.worldbank.org/)
GOVERNMENT TO ABANDON ROLE OF HEALTH CARE PROVIDER
What is of even greater concern is the strategy proposed for restructuring of the health system. The plan document proposes a transition from: “…..the present system which is a mixture of public sector service provision plus insurance, to a system of health care delivered by a managed network.” A clear road map for the government to abandon its central role of providing health care and remain a mere ‘manager’ of health services.
The document’s vision of ‘universal provision of public health care’ includes two components. “…..preventive interventions which the government would be both funding and universally providing,” and “clinical services at different levels, defined in an Essential Health Package, which the government would finance but not necessarily directly provide.” Thus the government would confine itself to providing a small package of services while virtually all clinical services would be opened up for the corporate private sector. The government would play the role of a ‘purchaser’ of care, and will thus finance (with public money), strengthen and bolster an already resurgent corporate sector --- a diabolical ploy to hand over the profit-making clinical services sector to corporate hospital chains, and progressively wind up the public health system.
The public health system will now be asked to compete with the private sector to attract patients. A system is envisaged where: “each citizen family would be entitled to an Essential Health package in the network of their choice. Besides public facility networks organised..… private and NGO providers would also be empanelled to give a choice to the families.” Even this truncated role of the public system is qualified by the proviso that “…..public facilities will have to be strengthened, networked, and their managers provided sufficient autonomy to purchase goods and services to fill gaps as per need.” In other words, public only in name, but incorporating larger and larger components outsourced to the private sector.
Further, the document repeatedly talks about expansion of the RSBY scheme and its vision of universal healthcare is nothing but a more expanded version of the RSBY scheme. Even the Planning Commission’s own expert group had recommended against the continuance of these insurance schemes.
IDEOLOGICAL BIAS OF PLANNING COMMISSION
The document announces another bonanza to the corporate medical sector in the form of grants to set up hospitals and private medical colleges. It says: “Health has now been included with other infrastructure sectors which are eligible for Viability Gap Funding up to a ceiling of 20 per cent of total project costs under a PPP scheme. As a result, private sector would be able to propose and commission projects in the health sector, such as hospitals and medical colleges outside metropolitan areas, which are not remunerative per-se, and claim up to 20 per cent of the project cost as grant from the Government.” It may be noted that the only eligibility requirement is the location, and not any contribution to public health goals.
Also of concern are recommendations that public health facilities will have “flexibility” to raise their own finances. The Plan document says: “Tertiary care facilities would have an incentive to generate revenues if they are provided an autonomous governance structure, which allows them flexibility in the utilization of self-generated resources within broad policy parameters laid down by the Government”. There are several ways in which such flexibilities can be misused, including in the form of levying of user charges and arrangements with private entities that seek to extract benefits that conflict with the public health goals of public institutions.
The ideological bias of the Planning Commission’s report is clear when it says: “A pure public sector delivery system involves funding a large public sector health system, with little incentive for the service providers to deliver a quality product. Such an assertion flies in the face of global evidence that the best performing health systems are those that are publicly financed and where health care is provided by the public sector.Neighbouring Sri Lanka has been long held as an example of such a system, where over 90 per cent of in-patient care and over 50 per cent of out-patient care is provided by the public sector. Mortality and morbidity rates in Sri Lanka are far better than in India, in spite of the country having a lower per-capita GNP. In contrast, the United States, provides ‘choice’ between public and private providers but is by far the worst performing health system among all developed countries, in spite of spending over eight per cent of GDP on health care.
As we have noted earlier, the Planning Commission’s draft chapter on health for the Twelfth Five Year Plan is a clear ideological assault on the very notion of public health. The dangerous formulation in the Planning Commission’s draft must not be allowed to go through. It is understood that the Ministry of Health has expressed serious reservations regarding the Planning Commission’s document. How these differing positions within the government play out will also indicate whether policy is formulated by the parliament and executed by ministries, or whether the Planning Commission enjoys powers to veto the will of the people.

Time for another revolution in medicines access The ‘test case’ of Herceptin








Time for another revolution in medicines access The ‘test case’ of Herceptin
Amit Sengupta
15th February 2013

The last fifty years is witness to a virtual explosion in the creation of new knowledge. Capitalism has used this characteristic of modern science and technology to constantly create products and tools to constantly revolutionize the productive forces. At the same time it is also seized with the necessity to control the expressions of new knowledge. Control over knowledge is one of the most important tool that modern day Capitalism uses to maintain its hegemony. Perhaps the most common expression of control over knowledge is the Intellectual Property system – which operates through the medium of patents, copyrights, trademarks, etc.

This dual nature of capitalism in the arena of knowledge creation – knowledge creation and its control are both embedded in the nature of capitalism. Without new knowledge and the creation of new products, capitalism is unable to survive. At the same time, it cannot allow the free use of such knowledge, as this jeopardizes the very basis of capitalist accumulation based on hegemony over the process of production. This inherent contradiction is starting to express itself in a new dilemma – control over knowledge production is now a fetter on creation of new knowledge.


TRIPS – a cruel agreement


This dilemma s being played out in the field of innovations that leads to discovery of new medical products. It is being played out in two very important ways. The 1980s and 1990s were a period of intense struggle, waged by developed capitalist countries, to put in place a global system that would legalise its hegemonistic control over knowledge. The result was the signing of the TRIPS (Trade Related Intellectual Property Rights) agreement in 2004. The TRIPS agreement legitimized the control over knowledge through a strengthened patent regime that was to be applicable to all countries in the world (with some limited waivers in the form of transition periods for developing and least developed countries).


The TRIPS agreement is a cruel agreement – what it basically says is that access to knowledge that can save lives would be limited to those who can pay (as individuals or through their governments). The decade of the 1990s saw the unfolding of one of the worst man-made tragedies ever, in the form of the HIV AIDS epidemic. Nominally, the disease is caused by a virus, but the conditions for the devastation it caused (and is still causing) was a human creation. In less than a decade after HIV infection was first detected in humans, the first drugs to effectively treat it were being rolled out. Yet it raged across the poorest countries of the world, especially in sub-Saharan Africa, decimating huge swathes of the population. Almost a whole generation succumbed to the disease in the region. Not because remedies were not available. Not because we did not understand how the spread of the disease could be stopped. But because these remedies were not allowed to reach those who needed them the most. They were not allowed to be used because a handful of CEOs of giant pharmaceutical companies priced these drugs way out of the reach of people who needed these drugs in poor countries. Sub-Saharan Africa was already reeling under massive debt burdens foisted on them by policies promoted by the IMF and World Bank. They were now asked to shell out money to buy drugs that would save their people – money that amounted to, in some cases, over 50% of the entire GDP of the country.

In 2001, and Indian company – Cipla – entered the fray. It announced that it would supply drugs to treat HIV AIDS at 1/40th (that is just 2.5%) of the price charged by multinational corporations. Drug prices of anti-retrovirals (those that treated HIV AIDS) fell from the earlier $12,000 per patient/per year to $300. Since then the prices of these early anti-retrovirals have fallen to less than $100 for a year’s treatment.

Biologics – the new frontier of disease control


The above story, known to many, merits repeating because it is now being played out in another area of medicinal products. The next new-frontier of disease control lies in finding remedies that can effectively cure and control cancers and several degenerative diseases. Cancers of different kinds are a cause for over 8 million deaths every year (i.e. almost 15% of all deaths) and 70% of these deaths occur in low and middle income countries. Even 3 decades back most cancers were considered a death sentence. No more so. Over the past decades new treatments and products are starting to win significant victories over a number of types of cancers. New products are being developed and many are already in use – many of which are a significant advance over existing treatments. As such opportunities open up, they are also opening up opportunities for pharmaceutical companies to reap super-profits at the expense of human misery. While the basic research for virtually all cancer treatments are done in public funded institutions, the ultimate products are controlled by a handful of companies.

Simultaneously we are seeing another development taking shape. Fewer and fewer new drugs that are significant advances over current treatments are being researched. Partly this is a consequence also of what we have noted earlier – the patents system, by controlling access to knowledge, finally also acts as a fetter to the creation of new knowledge. Most patents registered today do not protect an invention, they actually are designed to prevent others from doing research. Known as ‘patent thickets’ these patents prevent transmission of knowledge, and its further development. In India less than a handful of new medicines are introduced every year, yet several thousand patents are granted. This is a global phenomenon not restricted just to India. While the number of patents is growing, the number of new drugs that are being researched continue to fall alarmingly.

There is, however, and exception to this trend. The field of biotechnology is starting to live up to its earlier promise and is delivering entirely new forms of treatment. Thus while we have fewer drugs of promise that are being developed through the earlier route of chemical synthesis, exciting new treatment avenues are being opened up by research using the biotechnology route for drug development.

Drugs developed using biotechnology are different because they are produced in living cells. The molecules which make up these drugs are larger in size and more complex than the ‘small molecule’ drugs manufactured using the chemical synthesis method. The manufacturing systems used to produce these drugs need to be monitored differently. These drugs – termed as biologics – have several potential advantages. They can, theoretically, be tailored to hit specific ‘targets’ in the human body. This is of particular interest in diseases which are caused by altered or aberrant functioning of specific genes – such as in the case of several types of cancers. Traditional cancer drugs are called ‘cytotoxic’ drugs, i.e. they are poisonous to cells in the body. The basic principle on which they work is that they selectively kill cells that proliferate very fast (as happens in the case of cancer cells). However they are never entirely selective and that is why cytotoxic drugs have a range of side effects caused by the destruction or alteration of normal cells in the body as well. Biologics are being developed that only target specific gene sequences in cells and thus would have less side effects.

The Herceptin Story


One such drug that is a breakthrough drug is called trastuzumab. The drug is used to treat a certain kind of breast cancer that is particularly aggressive and difficult to treat or manage.

Trastuzumab works in a way that is very similar to the way antibodies work in the body. Antibodies are produced by the body’s immune system, which is the body’s defense system against foreign invaders – like viruses, bacteria, and other biological agents. They are able to recognise these foreign agents and bind to them. The body’s immune system then gets into action to destroy these foreign cells. Trastuzumab binds to a gene called the HER2 gene, that is more active in some breast cancer patients. The HER2 gene stimulates the growth of cancer cells. By binding to the HER2 gene, Trastuzumab suppresses its activity. It also stimulates the body’s own immune cells to destroy the tumour cells.

Trastuzumab belongs to a class of biologics that are called monoclonal antibodies. Monoclonal antibodies are produced from a single cell-line (hence the term ‘mono’), which is cloned to produce a very large number of cells. The cells are genetically engineered (i.e. a piece of foreign gene is introduced into the cell) to secrete the antibody we desire. Trastuzumab, for example, is made by substituting a portion of a human gene into a mouse using recombinant DNA technology. The mouse cells are thus ‘fooled’ into producing the antibody.

To continue the Trastuzumab story – the drug was marketed in 1998 by Genetech (later acquired by the Swiss multinational, Roche). It is sold under the brand name Herceptin. It is interesting to note that though the product has now been around for almost 15 years, Roche still enjoys global monopoly over the drug. The story would have been very different if Herceptin had been a drug that could be produced by the chemical synthesis route. Given the drug’s important public health benefit, many generic manufacturers (especially in India, the major centre of generic drug manufacture in the developing world) would be interested in producing their own versions of Trastuzumab. Herceptin was introduced in the global market at a time when the Indian Patent law allowed generic versions of patented drugs to be produced without any restrictions. The inability of Indian companies to come up with a generic version is related to special features that characterize biologics like Trastuzumab.

Unlike in the case of conventional ‘small molecule drugs’ it is never possible to produce an exact replica of the original drug. Biologics are extremely sensitive to the manufacturing process and the starting material. As the starting material is a living cell, it is impossible to have an exactly similar starting cell. Moreover very small changes in the manufacturing process can bring about changes in the final product. Thus, even in the case of the original product, there are variations in the product – between batches and even within the same batch. Thus the equivalents of generic versions of generics are called ‘biosimilars’.

Biosimilar manufacture is a relatively new area as the processes involved are entirely different from those used to produce drugs through the chemical synthesis route. Further, there are regulatory hurdles because the process of getting regulatory approval for biosimilars is more cumbersome than for ‘small molecule’ drugs. This is again because of the nature of biologics – because it is impossible to replicate the original drug, more data is demanded by regulatory agencies to prove that the quality, safety and efficacy profile of the biosimilar is identical to that of the reference drug (i.e. the original biologic). Consequently, in the case of biologics, patent barriers are not the only barrier to the production of biologics.

The time to act is ‘now’

Herceptin has recently been in the news because of two reasons. First, because of the interest being generated about use of Compulsory licenses (i.e. licenses issued to generic companies to manufacture patented drugs) after India issued its first compulsory license last year for another anti-cancer drug – sorafenib. The second reason is that it is only now that Indian companies have started acquiring the capacity and technical competence to produce biosimilars.

Because it now appears possible that biosimilars of Herceptin can be introduced, it is important to examine the economics and the public health importance of the drug. Treatment with Herceptin typically consists of 12 intravenous doses of the drug, administered every three to four weeks over the course of a year. Roche sells the drug for more than Rs.70,000 per dose. Clearly the cost is prohibitive for almost any Indian patient. The cost has to be seen in the context that breast cancer is the most prevalent form of cancer among urban women, and the second most prevalent for rural women According to the national cancer registry, over 1,00,000 women in India develop breast cancer every year (about 1 in 22 women in India stand at risk of getting breast cancer in their lifetime). Out of the total number of breast cancer patients, about 25% benefit from Herceptin (there are tests that can show which patients will benefit). Thus approximately 25-30,000 women would benefit from the use of Herceptin. Importantly, Herceptin is useful in the most aggressive form of the cancer, which typically afflicts younger patients. Yet because of the misuse of the monopoly situation that Roche enjoys, barely 5% of eligible patients are able to access the drug, and many of those who do are put on a lower dosage than recommended.

The situation cries for an immediate remedy. There are several issues that need to be addressed in order to expedite the entry of biosimilars of Herceptin in the Indian market. First, patent barriers need to be removed by expeditious issue of a compulsory license. The patent status of Herceptin is not clear in India as it is the subject of several litigations, however a compulsory license is the fastest way to make sure that patents are not a barrier to introduction of biosimilars. Simultaneously regulatory procedures need to be streamlined to ensure that entry of biosimilars are fast-tracked, while of course ensuring that quality is not compromised. Finally, public investment is necessary to build larger capacity in India to produce biosimilars.

Herceptin is a test case. If the attempt to get Inidan biosimilars of Herceptin in the market is successful, it has the potential to open the doors for a range of other biosimilars of other new biologic drugs that are already in the market or are being developed. Cipla’s pioneering action in 2001 revolutionized HIV AIDS treatment. Biosimilars produced by Indian companies can change the face of treatments for many diseases, now considered virtually untreatable, not just in India but across the world. There is no reason why the experience of a 97.5% drop in prices, seen in the case of HIV AIDS drugs when generics were introduced, cannot be replicated in the case of biosimilars. A bold and responsive government and regulatory agencies need to act in tandem to make this a reality. The time to act is now.