Health and Health Care in India National opportunities, global impacts Summary • India’s evolving social structure has throughout recorded history allowed extremes of poverty and wealth. The country covers only a little over 2 per cent of the earth’s land surface. Yet its population is approaching 20 per cent of the world total. Because of its scale, strengths and vulnerabilities the future of India and its ability to safeguard the health and wellbeing of its citizens raises issues of importance to the entire world community. • Since independence in 1947 life expectancy at birth for men and women combined has doubled to 65 years. However, India has experienced delayed demographic and epidemiological transitions as compared with China and many other parts of Asia. Despite the gradual progress of recent decades infant mortality is still over 40 per 1000, while maternal mortality is 2 per 1000 live births. Healthy life expectancy in India remains about 55 years, compared with close to 70 years reported in countries such as China, the US and Japan. • India’s population of 1.2 billion is still rising by approaching 1.5 per cent per annum, or about 18 million people a year. Some commentators see this as a strength. Others regard it as a major threat to future prosperity and social stability. Although the Indian economy grew strongly since liberalising reforms in the late 1980s, it has recently slowed. In exchange rate adjusted terms average per capita income is only about US $1,500, compared to about $50,000 in America and Western Europe. Even in purchasing power parity terms it is under a tenth of the EU/US average. • About 40 per cent of all deaths in India are still due to infections. The majority of the remainder are mainly due to non-communicable conditions such as cardiovascular diseases (heart attacks and associated conditions, including strokes, are alone responsible for a quarter of all mortality), chronic respiratory disorders and cancers. • Presently, the burden of ill health imposed on Indian society is equivalent in lost potential welfare terms to 12.5 per cent of GDP for infectious and allied complaints and 12.5 per cent of GDP for NCDs. However, the harm and loss caused by NCDs will in future rise in its relative significance, especially if tobacco consumption does not fall and the use of medicines along with other interventions to prevent and manage disorders such as hypertension, hyperlipidaemia and type 2 diabetes is not markedly increased. It is anticipated that 100 million people in India will be living with type 2 diabetes by 2040. • India currently spends only 1.2 per cent of its GDP on publicly funded health care. This is considerably less than most other comparable countries. Total Indian health spending is conventionally estimated at a little over 4 per cent of GDP. The public health care system has been strengthened since the start of the 21st century by initiatives such as the National Rural Health Mission (NRHM). But it still suffers from significant limitations in areas such as the (free) provision of essential medicines to the 400-600 million poorest Indians. c • Most health care in India is presently provided via the private sector. Because of a lack of affordable insurance protection it is principally funded via out-of-pocket payments. A majority of Indians believe they have adequate access to services. But there is evidence that the current system often fails to meet medically defined need and is ill-suited to meeting the requirements of communities characterised by increasing chronic/noncommunicable disease burdens. • The Planning Commission for India, which complements the directly elected elements of Government, instituted a High Level Expert Group (HLEG) on Universal Healthcare Coverage (UHC). This was chaired by Dr Srinath Reddy of the Public Health Foundation of India and reported in 2011. Subsequently, the country’s 12th Five Year Plan projected an increase in public health spending to 2.5 per cent of GDP by 2017. The Indian Prime Minister, Dr Monmahan Singh, has set a goal of this total reaching at least 3 per cent of GDP by 2022. • The Prime Minister also announced extensions in the publicly funded supply of free generic medicines to the less advantaged half of the Indian population by 2017. A five year cumulative sum of US $5 billion, or about 0.3 per cent of annual GDP, was to be allocated to this reform. However, the HLG on Universal Health Coverage recommended increasing Indian annual public spending on medicines from 0.1 per cent of GDP to 0.5 per cent of GDP, and it now appears that because of reductions in India’s rate of economic growth improvements to generic medicines supply are to be delayed or abandoned. • About 70 per cent of overall Indian health spending is presently met by private out-of-pocket outlays. A similar proportion of this total is accounted for by medicine costs. These figures imply that 50 per cent of India’s low health spending is accounted for by pharmaceutical costs. But the household survey data from which such estimates are derived may include professional fees and other items, including the purchase of traditional remedies. The cost of allopathic (western) medicines is at manufacturers’ prices unlikely to account for more than 20 per cent of total Indian health spending. • Many members of the Indian public appear to believe that a key way of achieving better public health is via reducing the prices of medicines for treating conditions such as advanced cancers. Yet this is not the case. Measures like issuing compulsory licenses on such products can at best benefit only small numbers of better-off people and some local pharmaceutical companies. The public as a whole will benefit much more from the introduction of universal health coverage and a wider use of medicines for preventing and treating early stage vascular diseases, diabetes and cancers. • India is now the world’s 3rd largest medicines producer by volume. But it is not yet in the top 10 by value. The available sources indicate that the domestic Indian pharmaceutical market for allopathic drugs is today worth in the order of US $13-14 billion a year. India’s pharmaceutical exports – which the Government is seeking to expand – are of comparable value. • In financial terms India’s most important external pharmaceutical markets are the US and the EU. Low cost Indian made medicines have been important in extending access to treatments for conditions such as HIV in poorer parts of the world. However, India does not as yet have a strong record in fundamental pharmaceutical innovation. • Critics argue that current Indian policies are narrowing and limiting intellectual property protection for products such as medicines and that this is inconsistent with long term Indian as well as global public interests in both enhancing universal access to essential medicines and increasing world-wide investment in biomedical research and development. A future global way forward could be to strengthen intellectual property rights for new medicines while in addition extending the requirements placed on IPR holders to provide affordable and/ or free essential treatment in poor areas through measures such as stratified pricing. • Another route to further progress could be through enabling Indian public service users to report problems such as failures to provide public services to which people are entitled via, for example, SMS texting to confidential monitoring centres. The country is vulnerable to internal and external challenges associated with, for example, continuing gender inequalities and global warming. At worst there is a risk of a stalled demographic transition coupled with increased rates of non-communicable illnesses. But if India invests adequately in improving universally accessible health care and preventing and treating not only infectious disorders but also NCDs these dangers should prove avoidable. The country could in time again become one of the world’s wealthiest and healthiest nations. 2 Health and Health Care in India Introduction Indian commentators have observed that there are two ways of looking at their country in its modern context. Viewed positively, the information presented in Box 1 underlines the fact that India has long enjoyed centres of wealth and a rich social diversity. Seen from this perspective, it is today in the process of recovering its position as a global ‘super-power’. Discounting the EU as a collective entity and as measured in purchasing power parity (PPP) based terms, India’s economy is already the third largest in the world. Since market oriented reforms introduced at the end of the 1980s it has enjoyed strong growth, driven by success in areas ranging from pharmaceutical manufacturing and exporting to information technology. Although China’s economic development from around that time has been faster (even in 1990 the two countries had roughly the same per capita GDP) India, which is home to over 1.2 billion people, has made important progress. For example, average life expectancy at birth has risen to over 65 years for men and women combined. This is about twice the figure recorded when the nation became independent in the late 1940s. In the southern State of Kerala average life expectancy is, at 74 years, comparable to that presently reported for China as a whole. For comparison, when health care systems such as the UK’s NHS were established at the end of the 1940s, life expectancy at birth in Western Europe and the US was at the same level that India enjoys today. Since then it has increased in the ‘mature industrialised’ economies by another 10 years. This is only a third of the absolute gain achieved by India in the same period, albeit that enhancing fitness and survival rates in older people is a fundamentally different task from that of cutting infant and child mortality. The challenges facing India today relate to bridging the transition from fighting infections to reducing the burden of chronic disease and living healthily in later life. Conventional proponents of the ‘demographic dividend’ associated with when the relative numbers of children in a population fall and the proportion of people over ‘retirement age’ has not yet risen markedly believe that India’s still young population is a valuable resource in terms of future world-wide competition. The number of people in India is presently increasing by approaching 1.5 per cent per annum (Figure 1). Two thirds of its population is aged 35 or less. Some authorities argue that as the Box 1. Wealth, caste and class in India In modern India a little under 20 per cent of the world’s people live on a little over 2 per cent of earth’s land surface. They collectively enjoy an income of – in purchasing power adjusted terms – between 5 and 6 per cent of global GDP. However, within that overall picture there are major disparities in wealth. The country has about 50 billionaires whose combined personal revenues represent in the order of 10 per cent of India’s total earnings, and approaching 100 million citizens with standards of living comparable to those of affluent people in countries like the US and Germany. Against this some 400 million Indians live in severe poverty. Extremes of wealth and deprivation have been a long standing characteristic of Indian society, albeit that over the millennia of its existence there have also been periods of relatively evenly distributed prosperity. The country was until the last few centuries one of the richest on earth. At the start of the seventeenth century, at the time the term caste was first gaining currency, India was responsible for about a quarter of all global wealth generation. In the early 1600s only China was of a similar standing. In the Mughal, Marathan and British dominated periods that followed the country’s relative prosperity gradually declined. Yet some individual Maharajahs (local ‘Great Kings’) retained considerable (and often highly conspicuous) personal fortunes into the current era. This pattern of ‘accepted inequity’ has been underpinned by India’s unique system of social stratification. The latter evolved over two to three thousand years in response to various waves of invasion and economic as well as military struggle and enterprise. Health and Health Care in India The word ‘caste’ is of European (Portuguese and English) origin. In the colonial period British and other external actors exploited social, religious and racial divides between the peoples of the Indian sub-continent for administrative and social control purposes. The consequences of this may to a degree live on in – for example – the continuing tensions between today’s India and Pakistan. Yet ‘foreigners’ did not create the Jati (in essence, non inter-marrying clan and occupational/community group) based structure that, along with ancient Hindu categorisations such as the four Varna, have served to underpin what is now referred to as the caste system. Nor were the inequitable gender divides that still exist within substantial parts of India and in many other Asian communities introduced by Europeans. A detailed analysis of how caste and broader socioeconomic class based values and practices continue to influence Indian social and economic development cannot be attempted here. But from a health perspective there is compelling evidence that steep gradients in the distribution of wealth within societies impact negatively upon not only the poorest within them, but the physical and mental wellbeing of all sections of the community (see CSDH, 2008). In order to overcome the remaining barriers to extending overall and healthy life expectancy to or beyond the levels presently observed in, for instance, Western Europe and Japan, it is likely that twenty first century Indian policy makers will need to find ways of further promoting a communally accepted commitment to greater equity. Developing better funded and ethically provided public health services will probably prove integral to achieving this fundamental goal, as well as to more specific objectives such as improving access to medicines for the prevention and treatment of noncommunicable diseases. 3 twenty first century progresses India will become a vital source of the skilled workers needed in the more mature communities of regions such as Europe, North America and East Asia (Kurian, 2007). Figure 2: Healthy life expectancy, selected countries, circa 2010 Figure 1: Crude birth and death rates and population size, India 1901-2011 Source: (Salomon et al., 2012) Source: Office of the Registrar General and Census Commisioner of India, various years However, there is an alternative to this positive picture. Viewed less favourably, India’s nominal (exchange rate based) GDP per capita currently stands at only a little over US $1,500 ($3,700 PPP adjusted). This contrasts with figures of about US $50,000 per head recorded in North America and Western Europe, and a current Chinese real per capita income of over twice the Indian level. Although a relatively small minority in the Indian population enjoy standards of living above EU and US norms, 400 million or more of the nation’s citizen’s live in severe poverty. In rural areas, where two thirds of the nation’s people are still located, the median household income is little more than US $500 a year. Such figures help to explain why a quarter of the current global total of child deaths occurs in India, along with a similar proportion of the world’s maternal deaths. Concerned Indian observers might also regard the nation’s large, young and mainly poor population as a potential social ‘time bomb’, rather than an unalloyed economic asset. They may in addition point to the sometimes under-estimated strengths of communities with higher proportions of older people. Provided that due attention is paid to preventing and treating conditions like strokes, type 2 diabetes, cancers and the dementias the potentially undesirable aspects of longer life spans can to a considerable degree, if not entirely, be counterbalanced by increases in healthy life expectancy and extended working and active social lives. As Figure 2 indicates, healthy life expectancy in India is about 15 years less than that recorded in Japan (Salomon et al, 2012). Furthermore, despite its reputation for plurality and tolerance, the Indian community is fractured by multiple social and allied divides. These relate to not only ethnicity and religion, but also caste, class and gender (see again Box 1 – Balarajan et al, 2011). Such factors help in part to explain not only why birth rates have remained high, but also why – notwithstanding sixty years of existence 4 as an independent republic – large sections of the Indian population do not as yet have reliable and affordable access to good quality health care (High Level Expert Group on Universal Health Coverage, 2011). Comprehensive private health insurance covering chronic as well as acute health needs is not as yet generally available, while reported public spending on health care in India is presently only a little above 1 per cent of GDP. Notwithstanding the increase to 2.5 per cent of GDP by 2017 anticipated in the country’s 12th Five Year Plan, this is one of the lowest proportions recorded anywhere in the world. Recent figures from sources such as the OECD and the World Bank put total Indian health spending at just over 4 per cent of GDP, compared with about 5 per cent in ‘BRICS’ like China and Russia and 9 per cent in Brazil and South Africa. In the US some 18 per cent of GDP is now spent on health care. In India out-of-pocket personal and family payments provide the largest reported element (about 70 percent) of health care funding. Indian health service users are already facing increasing difficulties with regard to the prevention and treatment of non-communicable conditions (IMS 2012; Reddy et al, 2005). This threatens health in middle life and beyond. At the same time there is a significant residual burden of infectious disorders. Diarrhoeal diseases, for example, still represent – along with pneumonia – a major threat to infants in less advantaged rural and urban communities living without adequate clean water supplies. Rates of TB related mortality and morbidity remain high in adults. In the area of pharmaceutical care the low prices and generally good quality of Indian manufactured generic products ought to have facilitated the supply of essential medicines and vaccines for all. Yet the existence of an often apparently dysfunctional private market for nonpatented branded medicines, coupled with problems such as ‘stock outs’ and corruption affecting the public sector pharmaceutical supply chain, has meant that standards of treatment are not as high as could otherwise have been attained. Some observers interviewed during research for Health and Health Care in India this analysis1 fear that controversies about, for instance, the prices of patent protected medicines developed by ‘multinationals’ for conditions like cancer (and that in the main have – at least to date – limited life extending rather than saving applications) have served to conceal much more important public health questions about the supply of basic established treatments to the mass of the population. It is understandable that the Indian public is concerned about the cost of pharmaceutical products. On a day-today basis many people experience outlays on drugs (which to varying degrees also encompass professional and institutional fees, as well as taxes) as the dominant element in the out-of-pocket expenditures they believe are needed to protect their health. Many sources suggest that a half of total health care outlays are spent on purchasing ‘drugs’. Yet the available data can be difficult to interpret. It is concluded here that spending on allopathic (western science based as opposed to other traditional) medicines expressed in manufacturer’s prices (net of mark-ups by suppliers of all sorts, which may encompass practitioners’ fees) is unlikely to account for more than about 20 per cent of total health spending in India2. This is not far out of line with equivalent figures reported elsewhere. What has been more atypical is India’s to date low overall level of health investment. It is also worth stressing that tragedies such as families being driven into poverty because of health care costs can in large part be seen as resulting from a collective failure adequately to provide systems that protect patients from potentially catastrophic risks, including those of hospital care that is not available via public agencies. There is a widespread perception that ‘health care has not been a political priority in India’. To the extent to which this is genuinely the case today, an undue concentration on controversies in areas like pharmaceutical pricing as opposed to the importance of achieving equitable – risk sharing – financial arrangements for enabling universal health care access could, despite the recent efforts of bodies such as the High Level Expert Group (HLEG) on Universal Health Coverage established by the Planning Commission for India, have perpetuated an absence of well grounded political and wider public debate about health improvement. Against this background, the central goal of this analysis is to inform in a balanced and welfare oriented manner European and North American stakeholders’ understandings of the challenges and opportunities facing India and her people. As already indicated, it is particularly concerned with the growing burden of long-term non-communicable conditions (NCDs) being recorded in India, along with other emergent economies such as, for instance, China and Turkey. (See, for example, Carter et al, 2012). 1 In addition to a structured literature review, twenty semi-structured interviews were conducted in India and elsewhere with relevant experts on health and health care over a period of about 18 months. 2 Sources such as IMS suggest that the domestic market for allopathic medicines in India was worth in the order of US $13-14 billion in 2011/12. This is roughly the same as the value of Indian pharmaceutical exports to the US and other countries. The Indian GDP stood at about US $1.8 trillion at that time. Even allowing for incomplete reporting these data indicate a domestic sale value of under 1 per cent of GDP. Health and Health Care in India The experience of countries like Russia where, despite relatively low infant mortality and a relatively high per capita GDP, male life expectancy has in recent decades been similar to or even below the Indian average, underlines the importance of addressing the threat of rising NCD and lifestyle linked mortality and morbidity in timely and effective ways. That is, by combinations of health behaviour change and the judicious use of medicines and other health care interventions for the primary, secondary and tertiary prevention of conditions such as vascular and renal diseases. This study also explores how the strategies India adopts may impinge on global human interests in areas such as assuring continuing investment in high risk biomedical research and development, as well as facilitating affordable world-wide access to medicines. It begins with an overview of demographic and epidemiological transition in India, followed by a discussion of the present provision of health care and the potential importance of recently proposed reforms. It then turns to issues relating to the ongoing development of better medicines and India’s ambitions to be ‘the pharmacy of the world’. Continuing concerns surrounding TRIPS (the Agreement on Trade Related Aspects of Intellectual Property Rights) are explored, alongside the significance of recent Indian decisions to issue compulsory licenses (CLs) for a number of patented medicines. Such actions – which are clearly popular with the Indian public – have been applauded by some observers. But they are seen by others as threatening not only industrial but global public health improvement related interests. A secondary objective of this report is to explore why this is the case, and to suggest ways of reducing the potential for damage. However, there are two more introductory points that first require emphasis. It is important initially to emphasise that, for successful implementation, public health initiatives of all types need to be consistent with the beliefs, values, resources and needs of the communities they are intended to benefit. They cannot normally be imposed without meaningful consultation, or be copied uncritically across from one cultural setting to another. Academic and other commentators should be aware that solutions to problems that have proven effective in countries such as, say, the US, the UK or Brazil may not work in India’s social and economic context. Likewise, within a country the size of India it should not be assumed that approaches that are viable and demonstrably cost effective in one State will prove equally desirable in another. Following on from this, today’s India covers less than 2.5 per cent of the world’s land surface. Yet a second point to stress is that the 28 States included in its Federal structure (along with the 7 centrally administered Union territories) typically have populations that are comparable in size to, or larger than, those of nations such as, for instance, Spain or Canada. Some, such as Uttar Pradesh, Maharashtra and West Bengal, have individual populations as great as those of countries like Brazil, Mexico and Turkey – see Figure 3. 5 Figure 3: Population and literacy per Indian state, 2011 Source: Office of the Registrar General and Census Commisioner of India, 2011 India’s total population is over twice that of the entire European Union and four times that of the US. Within the country States differ greatly in respect of, for instance, average literacy rates and in their capacity locally to fund and deliver health care. At the same time the power of the Federal Government to provide support for activities such as health services development has to date been limited. The reasons for this include not only the physical scale of the tasks involved but also the social distance between elites in Delhi and the leaderships of national programmes and Institutes located in or near other major cities and the equally important but far less advantaged people working to provide local services. Such factors mean that it is often difficult and/or potentially misleading to attempt to understand India as a single entity. Parts of the country are much more resistant than others to change, and to concepts such as universal health coverage and care. If disputes relating to this last and those surrounding Indian as opposed to American and European approaches to issues such as intellectual property protection are to be equitably resolved, the wider global community will need to be sensitively aware of the immediate physical needs of India’s people. Those seeking to support the country’s ongoing development will also need to understand the fundamental social drivers beneath current patterns of national and local governance, and the historically defined concepts of status and justice underpinning the modern day working of the world’s most populace democracy. 6 Population trends and changing patterns of disease – health in India in the early 21st Century The terms demographic and epidemiological transition relate to the closely intertwined population and disease incidence and prevalence changes that have characterised the global human development process of the last two centuries. These accompany movements from rural subsistence living towards more urbanised and affluent ways of life. The nature and timing of the shifts involved, which include both individual life expectancy gains and population ageing, are outlined in Figures 4 and 5. Before the early 1800s – that is, 200 years after the establishment of the British and Dutch East India trading companies and over 2,000 years after the nations of the Indian peninsula had begun routinely trading spices with the Roman Empire – no population group anywhere on earth had an average life expectancy of much over 40 years. This was first and foremost a consequence of high – typically up to 20 per cent – annual infant mortality rates. But because of the benefits of ‘low pressure’ demographic systems3, coupled with agricultural 3 There is evidence – for instance – of planned family size limitation in the UK dating from the 1600s. This was achieved partly via a later age of marriage than that typically recorded elsewhere in the world in the same period. Health and Health Care in India Figure 4: Stages of demographic and epidemiological transition Stages of epidemiological transition Pestilence and famine Receding pandemics Increasing NCDs (lifestyle related) Delayed NCDs and emerging infections Population growth Stages of demographic transition Pre Early Late Post Crude death rate Crude birth rate Source: The authors advances and early stage industrialisation, people in England and The Netherlands were by the end of the Napoleonic wars (in 1815) a little wealthier and healthier than populations elsewhere. The technical progress such countries made in time helped to open the way to the global developments taking place today. But this was at the price of the colonialism initially facilitated by the demographic, technical and material advantages enjoyed by Western Europe as compared to the rest of the world. Global average life expectancy at birth remained under 35 years throughout the nineteenth century. In both India and China, for example, it did not rise much above this level until the second half of the twentieth century. It is still (in part due to the only partially contained, if declining, HIV pandemic, as well as ongoing military conflicts) little more than 40 years in parts of Africa today. However, once commenced demographic transition – despite exceptional experiences, most notably like that of France – tends to follow the same basic path everywhere. As environmental conditions and food supplies start to improve, death rates among younger adults begin gradually to fall. This is at first because of reduced risks from infectious diseases. Better sanitation, for example, cuts the spread of water borne conditions. So too does an improved immune status in individuals and across populations. Enhanced immune responses resulting from improved nutrition (coupled in the modern era with access to pharmaceutical products like vaccines and antibiotic and anti-parasitic drugs) boost recovery rates and classically facilitate further productivity gains. Child and then infant survival rates also rise, as conditions become still more favourable. Although cultures vary in the speed at which religious and other variables inhibit or encourage behavioural and societal adaptations, declines in birth rates and increases in the status of women follow the achievement of lowered infant mortality. Protection from malnutrition and debilitating parasitic and other infectious illnesses in infancy and childhood coupled with the additional benefits of smaller families, better child care and changed patterns of education lead on to other gains. These include a 15-20 point rise in average IQ, as between preand post transitional communities (Flynn, 2009). Such advances enhance workforce participation and reduce the ratio of ‘dependents’ to working age adults, partly by allowing older people to use their skills for longer. This supports continued economic and societal development, including improved health and social care provision. The social processes that help result in the establishment of universal health coverage and care (UHC) systems have been termed ‘care transition’ (Taylor and Bury, 2007). From the perspective of this analysis the achievement of UHC is a common characteristic of all mature post-transitional societies. (See, for example, Rodin and de Ferranti, 2012.) Yet as the contrasting patterns of health service provision in, say, the US and the UK illustrate, this end point can be achieved in different ways and with differing levels of efficiency. Figure 5: Population ageing: time for the proportion of the population aged 65 or older to increase from 7 per cent to 14 per cent, selected nations 1860 1880 1900 1920 1940 1960 1980 2000 2020 2040 2060 Percentage of population aged 65+ 14% India Brazil Rep. of Korea China Thailand Japan USA UK Sweden France 7% Source: The authors adapted from WHO, 2012 Health and Health Care in India 7 There is evidence that, when poorly planned and regulated, market based ‘solutions’ are (at least in the ‘late infectious disease’ transitional phase) more costly and less beneficial to the health of populations than well planned, effectively regulated, tax funded health services. But in order to enhance public (health) interests and provide good individual care, systems of the latter type demand greater pre-existing levels of social infrastructure and political/electoral support for equitable care than is sometimes recognised4. They may therefore be very difficult, if not impossible, to introduce successfully in heterogeneous nations in the mid-transition phase. Russian history might be taken to illustrate the price that may have to be paid for attempts to force cohesion and/ or change before communities are ready ‘naturally’ to accept it. In the Indian context continuing economic and social development will demand intensified efforts to introduce UHC. However, despite the recent findings of the High Level Working Group on Universal Health Coverage instituted by the Planning Commission of India (see below) it could prove counter-productive to prescribe a single theoretically ‘optimal’ national model. Many commentators believe that in the foreseeable future a flexible mix of public and private systems designed to facilitate better health service funding and provision is likely to emerge, albeit that in the case of the poorer segments of the Indian population better medicines and care provision will very probably require free-at-the-pointof-use supply. To be viable, such measures must be supported by resource transfers from richer community groups to their less advantaged peers. These may well need to be introduced via Federal action and sustained by Federally supported mechanisms. The special characteristics of India’s demographic development The earliest stages of demographic transition in India date back to before the 1940s. As Figure 1 on page 4 shows, the crude birth rate in the sub-continent as a whole initially commenced its gradual fall two to three decades before the partition into what were at first called the ‘dominions’ of India and East and West Pakistan. With subsequent support from the Republic of India the latter became the fully independent People’s Republic of Bangladesh in 1971. 4 It was not a coincidence that the establishment of the UK NHS took place at the end of the 1939-45 conflict, close to what can be regarded as the final stage of Western Europe’s demographic transition and around the opening of the Indian process. The social and psychological impacts of the 1939-45 war, combined with the anticipated loss of Empire, created a ‘window of opportunity’ for those wishing to create a new welfare state in Britain. Similar conditions will not necessarily exist again elsewhere. Global population movements may also mean that relatively few future diverse communities will be as united and willing to accept a centralised and fully public funded UHC system as Britain was in the late 1940s. India is today in some ways more comparable to America in the early decades of the twentieth century, even though its history and population density are very different. 8 At the start of the 1970s India was arguably ahead of China in terms of its economic development. The nation’s GDP per capita was still marginally higher than that recorded in the Chinese People’s Republic. Yet it was also around that time that the Cultural Revolution heralded dramatic declines in the latter nation’s fertility rate. The ‘one child’ policy introduced in China in 1979 can be seen as securing the initial falls in birth rate triggered by the painful social upheaval of the late 1960s and early 1970s. Until that point most Confucians, like many believers in the other monotheistic religions founded around 2,500 to 1,500 years ago5, had espoused the view that women should be subservient to men. By the end of the Cultural Revolution such views were less likely to be expressed, albeit that the extent of fundamental social change achieved even today in areas as complex and deep rooted as gender relationships should not be exaggerated. By contrast, in the Indian democracy of the early 1970s Ghandi administration led attempts to curb population growth by measures such as encouraging men (and often forcing poorer males) to have vasectomies were not successful. This strategy was rejected by the Indian democracy – see Box 2. Reactions against it, some commentators believe, set back attempts to extend family planning in India by several decades. Figures 6a and 6b describe relevant trends, and from a demographic perspective cast light on the core reasons why China’s economic performance has in recent decades outstripped that of India. In summary, India can be said to be in the process of a protracted demographic transition. It has lagged that of countries such as France and the UK by a century or more, that of the US and Japan by over 50 years, and that of China and Brazil by around three decades. This record in some ways reflects the strengths of India’s traditions and the fact that its domestic population has not been directly victim to a major war in living memory. Yet the slowness of India’s demographic and epidemiological adaptation means that at the beginning of the 21st century the nation’s population is still challenged by a high prevalence of infectious disease, alongside an already large and growing non-communicable illness burden. The next section of this brief UCL School of Pharmacy report considers the part that public health interventions 5 The first pharmacopeias and comprehensive medical treatises, such as in Asia the Charak(a) Samhita and the Huangdi Neijing and in Europe the Hippocratic Corpus, also date from roughly 2,500 to 1,500 years ago. As human populations slowly grew and consolidated it became possible to draw together verbal traditions into substantive collections of written knowledge. However, the threats of large scale organised conflict also grew. This was a factor in the development of patriarchal, militaristic, societies. The values and belief structures of the latter may now be becoming redundant in post-transition settings, depending perhaps on the future state of the environment and the global availability of energy and raw materials. Hinduism draws on a variety of beliefs and traditions that date back well over 2,500 years. It can hence claim to be the ‘oldest living’ major religion, albeit that Hindus are now faced with a rapidly changing world. Health and Health Care in India and universally accessible health care could play in further reducing factors like infant mortality and maternal deaths, and extending healthy life expectancy in India. Before this, however, the remainder of this section offers an overview of the disease specific issues and trends of particular relevance to achieving better health in India. Box 2: Family planning in India The first family planning clinic in India opened in 1915 in Karnataka, at around the time that the crude birth rate for India as whole initially started slowly to fall. However, the latter was still 40 per 1000 population at the time of independence. In 1951 the first Five Year Plan for the then new nation highlighted family planning and welfare. These topics have been explicitly addressed in all subsequent Five Year Plans. Yet it was not until the start of the 1970s that India moved to adopt a proactive family planning programme. At that time only about one in ten married women was using ‘modern’ contraceptive methods (including female sterilisation). It is claimed that Sanjay Gandhi influenced his mother, the then Prime Minister Indira Gandhi, to introduce a radically new approach to birth control (Mukhuti, 2010). As well as seeking to incentivise men who had had two or more children to accept a vasectomy, the approach he and the wider Ghandi administration promulgated sought to abolish the dowry and caste systems and to focus increased national effort on goals such as protecting the natural environment. Viewed sympathetically, this initiative can be seen as an attempt to enhance per capita prosperity in a self-sufficient and sustainable manner. It sought to tackle ‘head on’ some if not all of the reasons for continuing mass poverty and widespread ill health. However, in practice this programme did not challenge entrenched interests and questionable male attitudes to women and reproduction in an effective and acceptable manner. It in fact turned into little more than a forced sterilisation campaign. Local officials, police officers and doctors reportedly behaved in authoritarian ways in order to meet vasectomy and allied quotas, in some cases sterilising both young men and women against their will. It was in particular feared that unmarried males of low socioeconomic status or with ‘anti-Congress’ political views were being targeted and involuntarily sterilised. Such concerns have been widely blamed for setting back the uptake of family planning in India for decades. Even though steady declines in fertility have been achieved since the end of the 1960s, this in turn may be seen as one of the reasons why China has in economic and some other respects out-performed India since the mid 1970s – see main text. Currently, about a half of all married women are using contraception, including sterilisation. However, there remain large regional variations. Uptake rates in, for instance Bihar, Sikkim and Assam have been lower than in States such as the Punjab, Karnataka, Gujarat, Andhra Pradesh and Maharashtra. The latter, for instance, introduced in 2010 a scheme whereby couples are paid a little over US $100 if they wait two years after marriage to have their first child. The current fertility rate in India is about 2.5 children per woman, compared with 3.4 in Pakistan and 1.6 (below the long term replacement rate) in China. This means that average fertility in India has halved since the start of the 1970s. But it is still driving an overall growth of over 1.4 per cent per annum, which is adding 18 million extra people a year to the Indian population. Figures 6a and 6b: Demographic changes in India and China, 1950-2050 6 3.0 projected projected Ratio of working-age to non-working population Children per woman 7 5 4 3 2 1 1950 19752000 2025 2050 China India 2.5 2.0 1.5 1.0 1950 19752000 2025 2050 China India Source: Bloom, 2011 Health and Health Care in India 9 Figure 7a: Estimated number of deaths due to selected diseases and injuries in India (2004). Figure 7b: Estimated disability burden of selected diseases and injuries in India (2004) Source: Patel et al., 2011 Parasitic, bacterial and viral disorders Poor standards of reproductive and child health are associated with inadequate maternal and infant nutrition in all less advantaged communities. Relevant health determinants include those linked to religious beliefs and taboos, together with factors like caste and the status of women (Paul et al, 2011, Pall 2012)6. There is evidence, for example, that there are still about 50 million children in India suffering from stunted growth. Female infants appear to be at greater risk of malnutrition than males. Likewise, unlike the case in any other world region, women in India are at greater risk of death from causes such as burns than men. Along with associated indicators such as the relatively high reported prevalence of acid attacks by men on women and data revealing the selective medical abortion of female foetuses, this suggests a community that has not as yet universally undergone the social transitions needed to sustain ‘post transitional’ health development. High levels of infection may in addition be related to problems such as the fact that microbial pathogens tend not to be recognised as the root cause of infections in traditionally based forms of medicine7. This may help to explain why, for instance, open-field defecation continues to be widespread in poor rural communities. Coupled with the inadequate sewage removal problems that have been compounded by rapid urbanisation, this can lead to the contamination of water supplies and domestic environments alike (John et al., 2011). 6 India scores 0.54 on the Human Development Index, an aggregate measure of wellbeing devised by (with colleagues) the Nobel Prize winning Indian economist Amartya Sen (UNDP, 2011). This relatively low score, which is similar to that of African nations such as Ghana, is in part due to high levels of inequality within the country. For comparison Norway (with a population of less than 0.5 per cent that of India) has an HDI score of over 0.95, the US 0.94, South Korea 0.9, the UK 0.87, Russia 0.79, Brazil 0.73, China 0.7 and Nigeria 0.47. 7 Such medicines remain important for many people in India. There is evidence that world-wide approaching 50 per cent of the global population still relies on traditional medicines as their most widely used form of day-to-day treatment. 10 Figures 7a and 7b illustrate the fact that diarrhoeal illness remains a major cause of child morbidity and mortality in India, alongside respiratory tract infections. Around a quarter of all child deaths are due to pneumonia. Infectious conditions ranging from tuberculosis and HIV infection through to parasitic complaints like lymphatic filariasis and visceral leishmaniasis are also relatively prevalent, while Dengue fever is an important example of a potentially life threatening viral infection which, like malaria, is spread via mosquitoes. In aggregate, infections still cause some 40 per cent of deaths in India, as compared with about 60 per cent in 1990. (Global Burden of Disease Study, 2012). In the case of TB, for instance, 2 million new cases were recorded in 2009, along with close to 300,000 deaths (John et al, 2011). Despite the establishment of a National Tuberculosis Control Progamme in the 1960s, the incidence of this condition has remained stubbornly high for decades. There is now a growing risk from drug resistant strains. Dengue fever provides an example of a condition which, as may also be true with malaria in India, is widely under-recorded. Published figures, based on laboratory confirmed infections identified in public hospitals, fall far short of the 30 million cases that probably occur annually (Harris, 2012). Some authorities argue that tracking hospital confirmed data gives a consistent basis for disease monitoring. Yet the reality remains that India is suffering a large Dengue fever epidemic which is being poorly recorded. A lack of the local (State) level public health resources needed to generate disease surveillance information required to inform specific efforts to control infections and when possible eliminate their sources has impaired the nation’s capacity to respond to such challenges efficiently and effectively. Indian observers have noted that the fact that the British inspired 1897 Public Health Act remained un-amended for over a century implies that this area has not received a level of attention Health and Health Care in India commensurate with public interests in health protection and improvement. One suggested reason for this has been an inappropriate division of Federal and State responsibilities. Actors at the former level are empowered to invest in national (public) health programmes. But less well resourced people working at the State and locality levels carry responsibility for service delivery (Reddy et al, 2011). Having said this, malaria control national prevention and treatment policies appear to have been relatively successful. However, even in this field mortality underrecording is a controversial topic. The ratio of the actual number of deaths occurring to those officially acknowledged may, as with Dengue fever, be over 100:1. The total number of recognised malaria cases in India was 1.6 million in 2009, with a steadily rising proportion being due to Plasmodium falciparum. Treatment failures due to drug resistance also appear to be increasing. This underlines the need for good access to high quality anti-malarial medicines, and sufficient strategic and field professional support to facilitate their appropriate use and preserve their effectiveness. HIV/AIDS rates provide a further example of infectious disease related controversy and partial success in India. It is presently estimated that there are about 2.5 million people with this infection. Its prevalence is highest in southern peninsula States like Andhra Pradesh and Karnataka and also in the extreme north east, where viral transmission has been associated with drug use – see Figure 8. Yet overall the nationally reported incidence of HIV is falling. The available data indicate that there are now over 300,000 individuals in receipt of publicly funded first line anti-retroviral treatment. Figure 8: Estimated adult HIV/AIDS prevalence in the States of India, 2007 HIV/AIDS prevalence <0.25% Jammu and Kashmir 0.25%–0.50% 0.51%–0.75% Himachal Pradesh 0.76%–1.00% >1.00% Chandigarh Punjab Uttarakhand Haryana Delhi Rajasthan Arunachal Pradesh Sikkim Uttar Pradesh Assam Bihar Nagaland Meghalaya Manipur Jharkhand Madhya Pradesh Gujarat Tripura West Bengal Mizoram Chhattisgarh Orissa Daman and Diu Dadra and Nagar Haveli Maharashtra Andhra Pradesh Goa Karnataka Pondicherry Kerala Tamil Nadu Lakshadweep Source: John et al., 2011 Health and Health Care in India Andaman and Nicobar Islands The establishment of the National Aids Control Programme in 1987 and the subsequent launch – with financial support from agencies such as the World Bank – of the National Aids Control Organisation (NACO) has, together with programmes in areas such as the prevention of mother-to-child-transmission and sex worker and other ‘at risk’ group education, been credited with the country’s success in this area. By 2009 over 13 million Indian citizens had, for instance, been tested for HIV infection in integrated counselling and testing centres (ICTCs) dedicated to this purpose. However, the WHO has claimed that only about a quarter of the Indian citizens infected with HIV/AIDS who could benefit from antiretroviral medicines are receiving them. About a half of those living with HIV are said to be unaware of their diagnosis. Access to second and third line treatment also appears very limited. In the order of 150,000 people a year die from HIV linked causes (Sinha, 2012). A combination of a strong emphasis in States such as Tamil Nadu on preventing viral transmission amongst sex workers and other groups at high risk, coupled with the limited but important nationally supported access to life saving anti-retroviral drugs available, helps to explain falling prevalence rates. Given the Indian based pharmaceutical industry’s capacity to supply low cost anti-HIV medicines in areas such as sub-Saharan Africa it is perhaps disappointing that better domestic supply has not as yet been achieved, albeit that – as in other care contexts – providing low cost drugs alone does not in itself ensure that effective care is affordable. Further improvements in India’s HIV/AIDS prevention and treatment record is again likely to depend on strengthening local capacity to understand and respond to relevant aspects of the disease’s epidemiology and transmission, while also successfully integrating this aspect of health protection and care into a more unified overall system. As with many other conditions, the establishment of nationally led top-down, vertically oriented, specialist Institutes and programmes has brought benefits. But achieving greater health gain in the future may well demand horizontal integration and an enhanced emphasis on the robust provision of generalist primary and community services, backed by specialists only when genuinely needed. A final point to make in the infectious disease context is that although in the past India’s delivery of vaccines to children in rural and poor urban communities has been variable, performance is also improving in this area. There is good reason to hope, for instance, that (notwithstanding a continuing threat from the disease in Pakistan) polio has now been eradicated. Immunisation rates for other conditions are continuing to rise. In most of south India over 60 per cent of infants aged under two years now receive full immunisation courses, as defined by national protocols. However, in the so-called BIMARU (which translates from Hindi as ‘sick’) States of Bihar, Madhya Pradesh, Rajasthan and Uttar Pradesh the equivalent proportion was still under 50 per cent in 2007/08. The lowest under-two immunisation rate 11 recorded at that time was 30 per cent in Uttar Pradesh, India’s most populace State (Paul et al, 2011). Given the nation’s proven capacity to develop and manufacture vaccines, there is good reason to hope that in future well managed immunisation programmes using an expanded range of products will facilitate further health gains in areas such as reducing the toll of child deaths caused by respiratory tract infections. Ongoing investment by Government agencies and research based pharmaceutical companies will in time lead to new and/ or enhanced vaccines in areas like TB and Dengue fever prevention8, and the control of other currently prevalent bacterial, viral and parasitic conditions. Alongside progress in areas such as improving the heat stability of vaccines and, when and where needed, more rapid and accurate diagnostic testing and better curative treatment, Indian children and adults have as much or more to gain from continuing investment in better pharmaceutical products for infectious indications as any other population on earth. Preventing and managing vascular diseases and type 2 diabetes As noted earlier, India was until the 1980s unique in the world for having a longer life expectancy at birth for males than for females. But now that both women and men are enjoying longer lives, the burdens imposed by noncommunicable disease such as heart disease, stroke and the physical and sensory problems associated with type 2 diabetes are becoming more apparent. So too are the impacts of respiratory conditions such as COPD and mental health disorders. Box 3 describes issues relating to the very limited provision of psychiatric and other forms of mental health care in India. At one stage it was believed that at any given age the harm caused by conditions like CHD/ischaemic heart disease and other consequences of raised blood pressure and high low density lipoprotein (LDL) lipid levels rises as countries grow more affluent, and people can afford more fatty foods and sedentary lifestyles as well as the use of (more) tobacco, alcohol and/or other harmful leisure drugs. But the full picture is more complex, not least because in today’s global society age specific death rates from vascular diseases of all types are (as with COPD) typically greater in low income countries than they are in more affluent nations (WHO, 2012). This is partly due to the fact that poorer populations are often exposed to multiple risk factors like untreated hypertension and indoor cooking smoke. Figure 9 provides an outline of the relative levels of mortality associated with such variables in India, although it 8 For example, Sabchareon et al (2012) recently reported a Thai trial of a Dengue vaccine produced by the French company Sanofi Pasteur. It achieved a limited protective effect but nevertheless marks an important step forward. Other vaccines are being developed for the protection of the global population against parasitic diseases such as leishmaniasis and malaria, as well as for additional viral and bacterial indications. Immunology based technologies may also have an important future role to play in areas such as preventing and treating cancers. 12 Figure 9: Estimated percentages of deaths in India attributable to the major chronic disease risk factors Source: Patel et al., 2011 should be noted there are significant difficulties in accurately ascribing cause and effect. Vested interests may also influence the appreciation of the extent of the relative harm due to commercially supplied goods such as tobacco products. Prolonged smoking kills 50 per cent of all smokers, and contributes to disabling the great majority of the remainder. Post transitional communities have proportionately more older people than those at earlier stages in the development cycle, and so normally have to carry increased absolute chronic disease burdens. Yet the factors that enable people in richer countries to survive longer also tend keep them in better health at any given age than their contemporaries living in less advantaged settings. Over and above care access variables, another sometimes neglected consideration is that people living in settings such as rural India are at relatively high risk from infections that can, for example, cause kidney damage. This may lead on to non-communicable complaints in later life, as too may problems such as foetal and child malnutrition. The thrifty phenotype hypothesis (Hales and Barker, 1992; Barker, 1997) could help to explain why India already suffers an unusually high loss of potentially productive years of life due to deaths from cardiovascular disease in people aged 35-64 years. By 2030 the volume of premature disability and loss of life suffered by Indians of working age is projected to have doubled to almost 10 times the corresponding loss experienced in the US (Reddy et al., 2005). By that time non-communicable conditions will probably account for about three-quarters of all deaths in India (Patel et al., 2011). Estimates from different sources vary, but approaching 60 million Indians are already believed to have type 2 diabetes (Shetty, 2012). This figure is also projected to almost double to around 100 million within twenty years. Rates of diagnosed type 2 diabetes are increasing in all world regions. However, India is unusual with regard to the age of onset. This may be because of thrifty phenotype or other epigenetic phenomena of the type touched on above, or perhaps because of immutable inheritable variances. In populations of European ethnicity type 2 diabetes is relatively unusual below the age of 50. But in Health and Health Care in India Box 3: Mental health care in India As with other NCDs, mental illnesses tend to be better recognised as societies develop and infectious disease burdens fall, so revealing other forms of distress. Communities typically become more able and willing to fund services for their most vulnerable members as they progress on from subsistence agriculture as their main means of production. With development, people become less likely to ascribe religious or other supernatural causes to psychiatric and psychological phenomena. Stigma against individuals living with mental illness – driven by combinations of ignorance, superstition, prejudice and excluding behaviours – also tends to decline as populations become better educated and physically and socially more secure. Such trends increase rates of openly recognised anxiety, depression and psychotic distress, along with problems like learning disabilities. Due to factors associated with the transition processes presently in progress there are significant variances in the estimated incidence and prevalence rates for mental health problems in India. But a number of studies suggest that roughly six per cent of the current Indian population have significant mental illnesses. This implies that in the order of 70 million people could directly benefit from appropriate treatment and support (Chatterjee, 2012). The global epidemiological evidence suggests that about twice that number are likely to be experiencing less serious emotional and allied problems like anxiety states at any one time, a burden which could also be relieved by more effective services. One indicator of the scale of potential demand for mental health care is the fact that there are approaching 140,000 recorded suicides each year in India. Notwithstanding differences in population age structures, such data imply a rate at least equivalent to or above those recorded in post transitional societies like, for example, the UK and France. Some challenges, such as increases in the risk of suicide amongst poor Indian farmers, may on occasions have been exaggerated. But in international terms there is clear evidence that younger women are at particularly high risk of suicide and other forms of violent death in India. Despite the fact that the country was in 1982 one of the first in the developing world to initiate a ‘high level’ India it often occurs one or two decades earlier (Mohan et al, 2007). Some southern Indian cities are already reporting type 2 diabetes prevalence rates of 20 per cent in their adult populations, and there are now said to be rising rates of this disease in village settings. As discussed in Box 4, attaching valid economic costs to losses of life and/or disability adjusted life years is problematic. Nevertheless, in welfare terms the harm caused by non-communicable diseases can already reasonably be said to represent in the order of 12.5 per cent of Indian GDP foregone. In currency equivalent terms Health and Health Care in India National Mental Health Programme (NMHP - Sinha and Kaur, 2011), access to effective publicly funded mental health care remains very limited. In 1996 a District Mental Health Programme (DMHP) was launched under the umbrella of the NMHP. It was intended to focus on areas like early detection and treatment, rapid training for primary care doctors on the diagnosis and treatment of common mental illnesses, raising public awareness of mental health issues and monitoring trends in the occurrence of mental health problems. By the end of the ninth Five Year Plan the programme was established in 27 of India’s 600 plus districts. Yet its overall impact has been judged disappointing (Patel et al., 2011). In 2009 a revised NMHP was approved, partly in the face of a recognised national shortage of psychiatrists. With only one such medically qualified individual for every 500,000 people and one publicly funded psychiatric hospital bed for every 50,000 persons, India has amongst the lowest levels of medical psychiatric care provision in the world. Access to psychiatric nursing, clinical psychology and specialised psychiatric pharmaceutical care appears to be even more limited. The 2009 NMHP aimed to increase psychiatric ‘manpower’, upgrade mental health hospitals and destigmatise mental illness via interventions such as public advertising campaigns. Primary healthcare doctors working in villages were also to receive additional mental health training (Sinha, 2009; Sinha and Kaur, 2011). Such attempts to improve provision are to be welcomed, particularly when they can be backed by adequate financial investment. But there are clearly major challenges still to be overcome in this area of health and social care, and in developing appropriately sensitive local understandings of the cultural and allied social as well as the biomedical determinates of mental health in India (UCL Cultural Consultation Service, 2012). As suggested above, for example, the difficult situation for many women in India can exacerbate mental health problems (Basu, 2012). Members of marginalised populations such as Dalits (once termed ‘untouchables’) may also suffer particular forms of mental distress that might be relieved by appropriate forms of care and support, alongside wider social interventions. this represents a welfare loss of between US $250 (nominal value) and US $500 billion (PPP adjusted $) a year. The scale of such welfare opportunity costs will continue to rise to the detriment of the happiness and wellbeing of India’s people and, potentially at least, the ability of the nation’s economy to compete with others unless prompt and effective action is taken to prevent and/or treat conditions such as such a CHD, COPD and type 2 diabetes. The recent establishment of the National Programme of Prevention and Control of Cancer, Diabetes and Cardiovascular Disease and Stroke 13 Box 4. The costs of acute and chronic illness in India Attaching meaningful economic costs to losses of life and/or the impacts of avoidable disability in India is inherently difficult, as it is in all other environments. This is not least because it is debateable from a theoretical perspective as to whether or not the lives of people living in poor communities should be valued any less than those of people in richer ones. Important questions also exist as to whether or not future health gains should be discounted in the same way as other forms of investment benefit, and about the extent to which in countries that have large labour surpluses premature losses of life and/or functional capacity have negative impacts for people other than those directly involved. However, it can broadly be estimated that noncommunicable conditions (including mental health problems) and infectious and allied forms of harm (including injuries) presently each cost Indian society about 150 million Disability Adjusted Life Years (DALYs) per annum. This 300 million lost DALY million total implies a gross welfare loss equivalent to some 25 per cent of the country’s productive potential, or 12.5 per cent of GDP for NCD imposed costs and 12.5 per cent of GDP for those caused by infections and other acute/external causes (Patel et al, 2011). Assuming a present gross national product of a little under US $2 (NPCDCS) indicates national level recognition of the importance of this task. Key ways forward range from curbing tobacco use and promoting increased physical activity through to extending the use of medicines that can lower risk factors such as high blood pressure, hyper-glycaemia and/or hyper-cholesterolaemia. Cancer in modern India Reported cancer incidence and mortality levels vary significantly within the country. For instance, relatively recent reports show the age adjusted male cancer death rate in Delhi is 121/100,000, compared with 44/100,000 in rural Maharashtra. The probable reasons for such observations include differing patterns of alcohol and tobacco use, together perhaps with varying rates of access to diagnostic testing. Smoking and other forms of tobacco use is associated with about a half of all male and approaching a fifth of female cancers in India, which is globally the third largest producer and consumer of tobacco products. Because of the traditionally high use of ‘smokeless’ products the country suffers the highest rate of oral cancers in the world (Coelho, 2012). Dietary and environmental factors such as low fruit and vegetable consumption amongst some groups and exposure to pollutants also impact on cancer incidence. India has unusually high rates of oral and cervical cancer, the occurrence of which is in part related to HPV infections (which could if afforded be prevented by immunisation) and a subsequent lack of screening services. Nevertheless, because cancer is an acquired genetic disease associated with breakdowns 14 trillion, current levels of non-communicable disease can therefore be said to be costing India (in lost welfare as opposed to realisable cash based terms) approaching $250 billion a year at exchange rate values. When expressed in purchasing power parity (PPP) adjusted terms this figure rises to some $500 billion. Over the next 20 years the losses due to chronic non-communicable disease are presently projected to remain constant in terms of lost DALYs, while the infectious disease burden should halve. However, such estimates (which are set against an anticipated further rise in India’s population of some 250 million people between 2010 and 2030) are subject to a number of caveats. If either or both infectious and chronic illnesses mortality and morbidity rates were to fall at an accelerated rate, considerable additional welfare gains would be generated. To illustrate this, if healthy life expectancy in India could be enhanced by 10 years (that is, to the level China is currently reporting – see Figure 2, page 4) by reducing the currently growing burden of disability associated with vascular disease and type 2 diabetes, then a conservative view is that this would lead to annual welfare gains similar to India’s total investment in health care. That is, some 4-5 per cent of GDP. in the integrity of cell division regulation, individual and population ageing is the single most important driver of its occurrence. This helps to explain the ‘across the board’ rise in projected cancer case numbers shown in Figure 10. For a country with a ‘young’ population India was unusually advanced when the National Cancer Control Programme (NCCP) was established in 1975, shortly after Figure 10: Projected cancer incidence rates in India to 2020 Note: Tobacco related (lip, tongue, mouth, pharynx, oesophagus, larynx, lung, bladder), digestive system (oesophagus, stomach, small intestine, colon, rectum, anus, anal canal), head and neck (lip, tongue, mouth, salivary gland, tonsil, oropharynx, nasopharynx, hypopharynx, pharynx, nose, thyroid, sinus, larynx), lymphoid and haemopoitic system (Hodgkins disease, NHL, multiple myeloma, lymphoid leukaemia, myeloid leukaemia), gynaecological (vulva, vagina, cervix uteri, corpus uteri, ovary, placenta) Source: Takiar et al., 2010 Health and Health Care in India the then US President Richard Nixon’s declaration of a ‘war against cancer’. There was an understanding at that time that cancers affect poor people in large numbers, primarily because the less affluent communities are the more likely people in them are to contract cancer causing infections (Reddy, 2005). But it is also true that better-off sections of the community have to date arguably had the most to gain from public as well as private investments in specialist hospital care and the enhanced supply of medicines (other than analgesics like morphine, which are currently inadequately available to many less affluent Indians) for later stage cancer treatment. Recent developments such as the actual or proposed granting by the Indian Courts of Compulsory Licences for some oncology products should be understood from this perspective. However, the NCCP has highlighted the importance of primary prevention, and Indian policy makers are now taking active steps to discourage smoking and other forms of hazardous tobacco use. The Cancer Control Programme has also been pro-active in areas like screening for cervical cancer and its precursor states, and improving pain relief during end of life care. But despite this, access to early stage disease detection and treatment services remains very limited in much of the country. Raising the rate of early stage cancer identification is a vital first step in improving cancer care quality. It is to the organisation of health care in India that this study therefore turns. Transforming Health Care in India In 2012 the agency IMS, with research based pharmaceutical industry funding, conducted nearly 15,000 household interviews across 12 Indian States. This work took place in rural and urban areas and examined experiences of both hospital and outpatient care. It found that over 90 per cent of respondents said they felt able to get medical help when they are ill, albeit that this was less often the case in rural areas than in urban localities. This research also confirmed that the cost of medicines is the health care concern most frequently expressed by modern Indians, and that affordable access to treatment for chronic illnesses is more of a problem than access to drugs for acute illness episodes. Box 5: Better access to essential medicines – the Prime Minister’s initiative The Indian Prime Minister Manmohan Singh announced on the country’s 66th Independence Day in August 2012 that his Government’s National Common Minimum Programme would be extended, starting later in that year, to supply free medicines through public hospitals and health centres. He indicated that by 2017 over half the total population will have access to free public health care (as opposed to about a fifth in 2013) that includes a comprehensive range of essential generic medicines supplied via the country’s 160,000 sub-centres, 23,000 primary health centres, 5000 community health centres and 600-plus district hospitals. It was proposed that the Federal Government would directly fund 75 per cent of the relatively limited cost of extending public health service generic medicines supply. This important, although now postponed or abandoned, policy initiative also envisaged that doctors working in the public service should cease prescribing branded drugs and that the National List of Essential Medicines (NLEM), which presently includes some 350 treatments ranging from anti-HIV medicines to analgesics, was to be used by States as a guide to what should be supplied free of charge to all those entitled to publicly funded treatment (Munshi, 2012). It is of note that a number of States, such as, for example, Chhattisgarh, are already seeking to introduce extended free medicines supply arrangements. A proposal to set up a Central Procurement Agency for the bulk ordering of drugs was also approved by the UPA Government Cabinet, albeit that this too may now have been abandoned. States should still, however, be required to procure medicinal drugs directly from their manufacturers or importers through an open tender system, and should provide state-ofthe-art warehouses for drug storage and distribution Health and Health Care in India (Dutta, 2012). Such actions help to address criticisms made by agencies such as the WHO to the effect that, although India has rapidly developed pharmaceutical manufacturing capabilities and achieved a relatively strong exporting record, its health policy makers have not to date been as effective as their industrial policy equivalents in ensuring that free or low cost, good quality, medicines are consistently available to the poorer half to two thirds of the domestic population. The country’s future success in this area will in large part depend on reducing levels of corrupt and allied perverse behaviours amongst prescribers and publicly funded medicines suppliers and purchasers. One possible way forward in this context could be the development of enhanced mechanisms for consumer reporting of public health service failures to supply free medicines, through – for example – the anonymous use of SMS (short message service) texting to independently run national health service quality surveillance centres (see main text conclusions). To date, local Indian pharmaceutical manufacturers have had little or no need for intellectual property protection other than the use of trade names. Their domestic earnings have been in large part derived from promoting the sale of branded mature medicines. But if the use of minimum cost high quality generic medicines is significantly extended progressive Indian companies may become more motivated to invest in developing new, more effective, products. It is by no means certain this will prove possible. But if it can be achieved they will consequently become more dependent on provisions other than brand name protection, including patents or alternatives such as periods of ‘regulatory exclusivity’, for the successful continuation of their businesses. 15 In the case of outpatient (ie primary and community care) services, private facilities are today typically more accessible – in the sense that most people find it easier to travel to them – than publicly provided services. This was not found to be so with hospital care. People in rural and poorer urban areas are, unsurprisingly, more likely to be public service users than the remainder of the population. This is mainly – respondents said – because of the opportunity to obtain free medication. Yet it is of note that other observers have reported recurrent drug shortages in public service settings. There is evidence that patients – for reasons often related to provider side corruption, and inappropriate purchasing and/or the diversion of products away from public facilities – have frequently been denied access to free medicines they are in fact entitled to receive. It was also found by IMS that most people said that they would use public services if their quality was felt to be as good as that of private sector services (IMS, 2012). Improving perceptions of the adequacy, integrity and responsiveness of public services is therefore an important goal, if they are in future to play a more extensive role. Presently, the Indian health care system is, in urban areas especially, largely private provider dominated. Taking the findings of this research in the round, they help to explain why the provision of health care has not been a high profile political issue in India. In essence, the majority of interviewees said that they feel subjectively that they have satisfactory access to services. They may also value looking to their families rather than publicly funded agencies for help when in particular need. Because medicine costs are a clear public concern the above findings may also be taken to confirm that it is understandable that political and media attention has often focused on cutting the prices of medicines, even if in reality the latter can have little impact on overall care costs and/or outcomes in poorly structured markets and health service environments. What is relatively certain is that no informed observer of the Indian situation would argue that the recent (but now postponed or abandoned) Indian Federal Government announcement of a US $5 billion nationwide programme aimed at improving the provision of good quality, free to the consumer, generic medicines via the public health system in the five years to 2017 was anything less than timely and appropriate (Box 5). Free publicly funded medicines supply has fundamental advantages for poor and vulnerable service users. Potentially distorting factors such as the fact that household expenditure based surveys cannot show the extent to which reported drug spending involves outlays on not only items such as distributor margins and national or local taxes but also professional and institutional fees need to be understood when approaching the issue of controlling pharmaceutical costs in India. It should also be stressed that the IMS research referred to above did not investigate the extent to which respondents were receiving good quality care as defined in terms of evidence based medical, nursing and/or pharmaceutical best practice. In a country where a significant proportion of practitioners do not have the qualifications they may or may not claim, and in which the importance of preventing and managing chronic illnesses as opposed to treating acute conditions is as yet inadequately appreciated, evidence of subjective public satisfaction does not confirm diagnostic quality or service appropriateness. It is of note, for instance, that past analyses have shown that the self reported health status of people in India is typically higher than it is in countries such as the US, despite a plethora of epidemiological evidence showing that the inverse is true (Sen, 2002). Figure 11, taken from the IMS analysis, highlights the fact that Indian States differ significantly with regard to the longevity of their populations and their health policy Figure 11: A categorisation of States based on selected healthcare and economic indicators Source: IMS, 2012 16 Health and Health Care in India related competencies. Its categorisation of, for instance, Uttar Pradesh as a ‘middling’ rather than a lagging State may – on the basis of recorded life expectancies and infant mortality rates – seem questionable, despite recent progress there. But the key point to make is that health progress in the south of India has been more satisfactory than in most other parts of the country. The central band of BIMARU States faces special challenges linked to factors such as illiteracy and high population density, as compared to the relative success of examples such as Punjab and Himachal Pradesh9 to the north and the Dravidian tradition States of Tamil Nadu and Kerala to the south. In Kerala there is a long standing and internationally celebrated combination of female education, near universal literacy and low infant mortality. Kerala also enjoys relatively high spending on health and low levels of corruption as compared to the rest of the country. Early origins India has, in the shape of the knowledge and practices like those embodied in Ayurvedic medicine, health care traditions dating back as far as those found anywhere else in the world. For instance, over 2,300 years ago in Ashoka’s Mauryan Empire10 (Ashoka lived shortly after Hippocrates was alive in Greece, and ruled over almost the whole Indian sub-continent) there was a relatively sophisticated health system. It included public hospitals and the allocation of physicians to serve rural areas. Some commentators argue that concepts like that of ‘humoral balance’, which existed in the Galenical beliefs of medieval Europe and in related forms survive in Indian traditional medicine in its various manifestations today, draw attention away from science based explanations of disease and its effective treatment. But viewed positively the focus of Ayurveda and allied AYUSH11 disciplines on lifestyle moderation, coupled with the use of biologically active therapies as and when available, remains relevant to promoting good health in the modern world. Around a millennium ago practitioners of Indian traditional medicine adapted to accommodate the use of opiates and other drugs associated with the introduction of Islamic 9 Himachal Pradesh is in economic terms relatively successful and has been classed as the second-least corrupt State in India after Kerala. However, in contrast to Kerala, Punjab, along with nearby Haryana, reportedly has the highest rates of sex selective abortion in the country. In the latter State in particular this has allegedly become linked to the trafficking of young women from other poorer parts of India. Such observations underline the complexity of the current Indian situation. 10 Ashoka Maurya or Ashoka the Great (whose name means pain free or without sorrow) ruled nearly all of modern Indian, Pakistan and Bangladesh for a period of approaching 40 years in the 3rd century BC. He played a significant part in establishing Buddhism as a world religion and is widely regarded as, after an initial period of war, having become a philanthropic and effective ruler. Historians suggest that he saw both sharing Buddhist philosophy and practical interventions such as health care provision as of value in creating an equitable and stable social order. Ashoka and his edicts, through which he sought to communicate the practical implications of Buddhist philosophy, are referred to again in the conclusions of this report. 11 Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy Health and Health Care in India medicinal expertise into India. They were able, as was so in the case of European medical practice at about the same time, to accommodate new knowledge and skills into their thinking and therapeutic approaches. Arguably, Ayurveda and other forms of Indian (and other) traditional medicine should go on progressing in similar ways today. During the 19th and early 20th century decades of the British colonial State traditional Indian medicine remained at the heart of the population’s care. Some new facilities and services were established and important individual contributions were made, not least in areas such as understanding the epidemiology and causation of infectious diseases, by European physicians. Yet it is fair to say that the British were principally concerned with the health of the armed forces and the small numbers of expatriate staff responsible for administrative functions. In the context of medicines, relatively little effort was made to supply allopathic products to the Indian population or – more importantly at that time – to share surgical good practice, including concepts of antisepsis and effective anaesthesia. Even when available, ‘western’ treatments were expensive and tended to be of low quality. Colonial policy involved taxing pharmaceutical and other products imported from anywhere other than the UK highly, and doing virtually nothing to support Indian based manufacturing (Thum Bonanno et al, 2012). In the period between the end of the first World War (in which Punjabi and other Indian Army divisions were extensively involved) and India’s independence after the 1939-46 conflict, progress in developing health care facilities for the mass of the population remained slow. Following very limited constitutional changes in 1919 – which some Indian and British reformers had originally hoped would open a ‘painless path’ to independence – and the subsequent and (in Winston Churchill’s contemporary words) deeply shameful massacre perpetrated by British officer led Gurkha riflemen on Punjabi civilians in Amritsar, health improvement was further impeded by the delegation of key public health related duties to what were then termed ‘the Provinces’. The failings of this last measure were related to a lack of the effort and investment needed to ensure the competent execution of delegated responsibilities in local settings. As commentators such as Professor Srinath Reddy of the Public Health Foundation for India have observed, kindred problems have lived on into modern India. Nevertheless, in the run up to independence the then Indian Government in 194312 recognised a need to improve the public health system. A Health Survey and Development Committee (HSDC) was formed and charged with making recommendations for future health service reform and improvement. The Bhore report (as it became known after the HSDC’s civil servant chairman) noted in 1946 that ‘if it were possible to evaluate the loss which this country annually suffers through the avoidable waste of valuable human material 12 Immediately after the publication of the Beveridge Report in the UK. This heralded the establishment of the British welfare state. 17 and the lowering of human efficiency through malnutrition and preventable morbidity, we feel that the result would be so startling that the whole country would be aroused and would not rest until a radical change had been brought about’ (Health Survey and Development Committee, 1946). At this point there were only 1.5 doctors per 10,000 population in India and hospitals largely ran in the absence of trained nurses (Rao et al., 2011). The report also stated, in line with the subsequently established Indian Republic’s Constitution, that access to primary care is a basic right to be respected regardless of an individual’s socioeconomic standing. It saw primary care as the foundation of an improved national health care system and proposed a three tiered system of primary health centres and local sub-centres, served by community centres and district hospitals to which patients could be referred. The structure of the Indian public health service of today (see Figure 12) still partly reflects that early vision. The Bhore Committee in addition introduced the concept of five year planning to the health arena. The latter chimed well with the overall approach to economic and social development planning instituted by Jawaharlal Nehru soon after the establishment of India as a newly independent State (Box 6). Improving the public’s health was from the inception of modern India accepted as an important end. Yet despite the good will of the Government of the newly independent India and the fact that the nation’s leaders wanted to address health inequalities, the 1959 Mudaliar Committee was able to report only very limited success. Established to evaluate the health progress made during India’s first two Five Year Plans, it found that while epidemic disease management was working relatively well too little importance was being assigned to assuring excellence at the Primary Health Centre (PHC) level (Nayar, 2011). This particularly negated the interests of the poorest half of the nation. Much the same can be said half a century later (High Level Expert Group on Universal Health Coverage, 2011). In 1978 the WHO led Alma Ata declaration highlighted the importance of good quality primary care. In India this prompted at the start of the 1980s the adoption of the country’s first free standing National Health Policy. But progress remained ‘patchy’, and problems of uneven development were arguably compounded by the increasing reliance on private investment engendered by the in many respects highly beneficial liberalisation of the Indian economy in the 1990s. Private resources have tended to flow more towards States with higher levels of social and material infrastructure, like – for example – Maharashtra, Gujarat, Tamil Nadu, Karnataka and Andra Pradesh. Poorer States have fared less well in Box 6: Planning in India When India gained independence on August 15th 1947 its leaders sought to establish governance mechanisms capable of promoting robust economic growth and defending the wider social interests of the country’s citizens. The then Prime Minister, Jawaharlal Nehru, had witnessed the rapid industrialisation of the Soviet Union in the pre-war era. Joseph Stalin adopted a system based on Five Year Plans in the USSR in 1928. Nehru believed – notwithstanding the disadvantages of Stalin’s autocratic and murderous rule – that this had contributed significantly to Soviet advancement (Maheshwari et al., 2008). Building on measures first introduced in India during the 1930s and early 1940s, Nehru and his colleagues decided to incorporate a similar planning function into India’s much more democratic political system. The Indian leadership of the late 1940s tried to create an alternative to extreme versions of both socialism and capitalism, combining the best features of these two contrasting approaches to organising society. They were seeking to establish a ‘third way’. To put this decision into its historical context, the USSR had very recently played a decisive role in defeating Nazi Germany. Further, its economy (as symbolised by the launch of Sputnik 1) was to grow faster than that of the US throughout the 1950s. It was not until the 1960s that Soviet progress began to falter, and the life expectancy of Russian working age men in particular began to gradually to decline. In 1950 the Planning Commission was formed as an expert advisory organisation. It was (and is) positioned in parallel with the directly elected organs of State, with 18 Nehru (by right as Prime Minister) as its chairman. Its role was then, as it is today, to assess the physical, capital and human resources available within India, and to prepare plans for their optimally effective utilisation. The Planning Commission seeks to advise central government and the State administrations on priority issues as they arise, to evaluate policy successes and failures, and to identify barriers to continuing economic and social development. The first Five Year Plan (1951-1956) was primarily focused on raising the standard of living of the nation’s at that time 300 million people through strengthening agricultural output. Since then the structure of the Commission and its links with other branches of government has been substantially reformed. Yet it’s underlying purpose remains – despite trends such as industrialisation and the country’s shift to a less regulated, freer market oriented, economic approach – essentially similar to that envisaged in the 1950s. The demise of the original Soviet model was related to the fact that although in the health context it had contained infectious disease it proved unable to respond to subsequent chronic/noncommunicable disease related public health challenges, which are more reliant on autonomous citizen action for their solution. The core issues the Planning Commission for India faces today in large part centre on understanding the long term dynamics of (healthy) population ageing. Effectively responding to this transition will be as or more critical to the success of twenty first century India as improving agricultural practices was to the nation at the start of the 1950s. Health and Health Care in India Figure 12: Rural Health Care system, with numbers of centre type District Hospitals 613 in the country’s 640 districts •Secondary referral level responsible for a district of a defined geographical area with a defined population •Provides comprehensive secondary health care to the population of the district •Responsive and sensitive to the needs of the people and referring centres •Should be at least one in each district Sub-District Hospitals Roughly 1000 in the country •Receive referred cases from CHCs, PHCs and SCs •Provide emergency obstetrics care and neonatal care helping reduce maternal and infant mortality Community Health Centres (CHC): Aim = one per 100,000 people (on average) Actual = one per 200,000 people •Four medical specialists (surgeon, physician, gynaecologist and paediatrician) supported by paramedical and other staff •Thirty inpatient beds plus X-ray, labour and laboratory facilities •Serves as referral centre for four PHCs Primary Health Centres (PHC): Aim = one per 25,000 people Actual = one per 50,000 people •1st contact between village community and medical officer •Medical officer supported by 14 paramedical and other staff •Integrated curative and preventive health care •Each acts as referral unit for six sub centres and has roughly five inpatient beds Sub Centres: Aim = one per 4000 people Actual = one per 8000 people •1st contact between community and health care •One Auxiliary Nurse Midwife (ANM) and one Male Health Worker •Skills/medicines to cover essential health needs of men, women and children •Maternal and child health, welfare, nutrition, immunisation, diarrhoea control and control of communicable diseases Source: The authors based on various primary sources terms of attracting both inward financial investment and skilled people, so perpetuating the ‘healthier is wealthier’ cycle within the Indian environment (Bloom, 2011). Injections of money from organisations such as the World Bank and USAID may also have meant that Indian Government funds and attention were on occasions (paradoxically) diverted away from health to other priorities. This opened the way to a greater reliance on the private sector for health development resources (Ma and Sood, 2008), while at Federal level the Indian Government continued to concentrate more on areas like defence and the development of an enhanced transport system. Health and Health Care in India Advances such as providing better road connections can be of great value to not only industry but also in improving the lives of people residing in isolated villages. Even so, in failing to address robustly issues such as primary health care improvement, successive Indian administrations could well have missed important opportunities to promote demographic and epidemiological transition and fundamentally enhance welfare and productivity. In relation to this key issues include: 1.An over-reliance on vertically organised, single condition, programmes Such initiatives can be very attractive to politicians and policy makers seeking highly visible successes within a specific time frame. They also tend to be popular amongst specialist medical and allied professional interests, and with external funding agencies. In areas ranging from malaria and HIV control to recent actions aimed at eradicating polio in India and elsewhere, there is evidence from across the world of positive vertical programme achievements. Yet because of the need for independent staffing for each separate disease programme they are relatively expensive to sustain (Ministry of Health and Family Welfare, 2002). Over and above this they are normally ill-fitted to supporting the integrated care developments needed to extend healthy and/or valued life as populations age and chronic illness related problems become more prevalent. 2.Low Federal and State (public) expenditures on health services, coupled with high out-of-pocket (OOP) payments by (private) service users As noted previously, total public spending on health in India is – at presently little more that 1.2 per cent of GDP – unusually low in international terms. At the same time private spending frequently takes the form of direct personal payments rather than insurance contributions. This combination can, amongst other things, serve to make expenditure on medicines seem a particular problem, despite the fact that absolute pharmaceutical outlays in India are low (Figures 13a and 13b). In fact, recorded overall Indian spending on medicines is average for the BRIC nations when expressed as a percentage of GDP (WHO-EMP, 2012), despite the fact that (as discussed earlier) the use of household survey based data leads to confusions as to the amount of money spent on allopathic medicines charged at manufacturers’ prices13. If, as Nayar (2011) has suggested, the quality of public health services can be defined by the demonstrable efficacy, safety and epidemiological rational of their provision together with the attitudes and behaviours of staff and the extent of their affordability and accessibility 13 Some observers may take trends such as the growing levels of antibiotic resistance associated with the weakly regulated use of such drugs in India as evidence that access to medicines is not unduly restricted. However, the capacity to grossly over-use such pharmaceutical products is likely to be confined to more affluent sections of the population, while the fact that poorer people may contribute to resistance problems by taking only partial courses arguably reflects inadequate basic health care provision. Factors such as counterfeiting and poor quality production may also be relevant to resistence, although they should not be exaggerated. 19 Figure 13a: Total pharmaceutical expenditure in the BRICS countries (per capita in US $) Figure 13b: Total recorded pharmaceutical spending as a percentage of total recorded health spending Source: WHO-EMP Department, 2012 to all sections of society, then India is facing challenges on multiple fronts. The divide between Federal and State financing responsibilities has been a key structural driver of the problems the country is now fighting to overcome. Table 1: A comparison of healthcare personnel numbers in India and the OECD average 3.State level variances in the willingness and ability of responsible bodies to fund health services, purchase supplies and manage the delivery of care Doctors 3.1 0.6 Nurses 8.6 0.8 Kerala, for example, spends three times as much on health per capita as Bihar, and has three times as many doctors relative to its population than less well off States like, for instance, Odisha and Chhattisgarh (De et al., 2012). The latter are disproportionately dependent on central Government finances for health care support, even though the per-person funding dispersed to the States is fairly constant, irrespective of their differing capabilities and needs (Balarajan et al., 2011). Midwives 0.27* 0.47 Dentists 0.61* 0.06 Pharmacists 0.76* 0.56 Around 80 per cent of outpatient treatment is currently undertaken in the private sector, which can on occasions be both unreliable and expensive for vulnerable users. Because of the lack of health insurance some ten per cent of households devote ten per cent or more of their total expenditure to obtaining health care in any one year. About three per cent of the population are annually reduced to poverty because of health related expenses. Notwithstanding the IMS findings presented earlier, it is also the case that around 15 per cent of recognised illness episodes are left untreated because of financial concerns (Ernst and Young and FICCI, 2012). Rural households are most at risk of impoverishment because of ‘catastrophic’ health costs (Government of India Ministry of Health and Family Welfare, 2011). 4.Inadequate numbers of appropriately qualified staff in areas of deprivation Table 1 presents data on the numbers of qualified health personnel in India as compared with mean OECD levels. Although the contributions of traditional practitioners and unqualified care workers ought also to be taken into account, it is apparent that substantial shortfalls exist. There is evidence that these are often most acute in areas of high need. Similar concerns apply to facilities such as hospitals. It is sometimes claimed that those in urban areas are at risk of being ‘overrun’ with people from rural areas who cannot access adequate care nearer their homes. 20 OECD average (per India Ratio (per 1000 population) 1000 population) Source: WHO, 2006 and OECD 2012. * OECD Health Data 2009. Relatively recent data indicate that rural India, with two thirds of the nation’s total population, has only a little over ten percent of the hospital beds and a quarter of the human health resources available in the country as a whole. It is also the case that at the start of the 21st century, before the introduction of the National Rural Health Mission (NRHM – see below) only a third of the (publicly funded) primary health centres and two thirds of the community health centres were judged to have adequate human and other infrastructural resources (Paul et al, 2011). Many commentators have stressed the service constraints caused by the lack of adequate numbers of qualified doctors14, especially in rural areas (see, for example, Das et al., 2012). This is an important concern, albeit that shortages of qualified nursing staff in both hospital and community settings might be seen as an even more pressing issue. The shortfalls in nursing resources apparent in India may to a degree be linked to religious and allied beliefs which have affected attitudes to female (and male) employment in ‘unclean’ areas of 14 India trains roughly 40,000 doctors per year in 335 medical colleges. However, a significant proportion of able individuals have historically chosen to emigrate, while relatively few have elected to work in public health centres. The fact that over two thirds of medical workers in the country are male may also affect poorer women’s access to health care. Despite recent measures to increase medical manpower (Garg et al., 2012) it appears likely that radically new forms of financial incentive will in time be needed to ensure significantly improved access to conventionally trained doctors in less advantaged regions. Health and Health Care in India work. Southern States like Kerala have comparatively strong nursing traditions. Pharmacy, by contrast, has not been affected by the stigma sometimes associated with nursing and ‘unclean’ physical contact. But within the health arena its social status is not comparable with that of medicine (which can in a sense be seen as either more warrior-like or more priest-like). The pharmacy profession’s clinical and wider public health (as opposed to it’s commercially driven supply) role has not – as yet at least – been developed in the Indian setting. Many better qualified Indian pharmacists15 have to date worked in pharmaceutical manufacturing and/or areas such as the marketing of branded medicines to doctors. In an effort to address human resource shortages, a three year ‘intermediate’ medical course for a qualification termed the Bachelor of Science in Community Health is being introduced. Strong objections to this were expressed by the Indian Medical Association (IMA). Yet from a public health as opposed to sectional interest perspective the case for this and similar initiatives appears strong. Professional categorisations and boundaries that evolved in 19th century Europe are not necessarily fit for meeting the requirements of modern Asian super-States, or indeed those of modern European and the US service users. It is currently planned that those completing the intermediate course will be employed as Community Health Officers in sub-centres or primary health centres, following further training in district hospitals. They will contribute to the diagnosis and treatment of common illnesses and acute health problems, and to immunisation and other preventive and public health programmes (Sinha, 2012). The Government has in addition pledged to add over 4,000 under-graduate and 2,000 post graduate places to the existing numbers of conventionally defined places available in medical schools. It has been suggested that in order to strengthen primary care provisions Indian policy makers might wish to establish an independent contractor based General Medical Practitioner (GP) system like that embodied in the original UK NHS (Rao and Mant, 2012). There is a case for this. However, the extent to which it would be practicable across the whole of India is questionable. It may be that in the 21st century a more flexible use of less highly qualified health professionals backed by robust IT support systems could, at least in environments that do not attract doctors, offer a more viable ‘first line’ service tier. 5.Problems associated with conflicted values and corrupt behaviours All societies are to varying levels affected by public and private sector corruption, as along with other types of criminality. In emergent economies individuals 15 Schools of pharmacy in India are in many instances located within University faculties such as engineering, rather than with medicine or even ‘life sciences’. There are various levels of pharmacy qualification. It is claimed that individuals with longer periods of education do not typically elect to work in health care as opposed to industrial settings. Health and Health Care in India are particularly likely to find themselves torn between traditionally defined personal responsibilities to their families and wider kinship groups on the one hand and their ‘impersonal’ duties as members of modern communities on the other. Such tensions are exacerbated by factors such as low wages and/or weak regulatory infrastructures. India provides a clear example of an environment in which undesirable behaviours have become widespread in the health sector, along with the rest of the economy. Effective reform needs to be systematic and based on a humane understanding of the causes of institutionalised corruption and the individually and collectively damaging behaviours to which it leads. As in parts of the EU, demand for ‘informal’ payments are common in all Indian health service contexts, from childbirth support to conducting post mortems. It is typically the poorest people who are in relative terms hardest hit by such practices. Drug supply and procurement is a well recognised example of an area in which there is evidence of corruption, in part because of the actions of local companies operating outside the ambit of legislation like the US Foreign Corrupt Practices Act. Unethical practices (including doctors and other professionals inappropriately charging fees for referring patients to specialists, or for delivering care to which patients are legally entitled) may also have been driven by the fact that healthcare in India in the past few decades has often been provided on a primarily commercial basis (Mudur, 2012). But even if this is true it cannot alone explain the full extent of the problems being encountered. Research in Karnataka has, for example, found that a quarter of the public health budget was at one time being diverted away from its intended use by people at all levels, ranging from low-paid workers to the investigational officers responsible for maintaining ethical practice standards. Subsequent action involved the introduction of fresh approaches to community planning and health service monitoring. This followed the recognition that seeking to police people’s behaviour without enabling them to participate in making the policies, plans and service rules intended to govern their daily lives tends to be futile (Sudarshan and Prashanth, 2011). 6.The need to understand and modify the social determinants of health and health care The observation that concepts of ‘clean’ as opposed to ‘unclean’ work may have affected the evolution of nursing, medicine and pharmacy in India illustrates the fact that deep rooted beliefs, coupled with a population’s related values and behaviours, often impinge upon health service development. The influence of caste linked judgements and assumptions combined with the impacts of superficially more meritocratic class based and related stratification systems has also shaped health care provision in India, as well as determining access to educational and other services/resources. Approaches towards illness prevention, early stage disease detection and the treatment of chronic as opposed acute illnesses are also important to 21 understand. As indicated earlier, traditional beliefs about the importance of lifestyle moderation can fit with modern messages about the protection of both physical and mental health. However, attitudes that are fatalistic or negatively prejudiced in the sense that individuals affected by painful and or disabling conditions are seen as the authors of their own misfortune because of, say, their actions in a previous life, cannot be reconciled with a science based approach to individual and population wide welfare improvement. Likewise, the idea that some groups of people should be classified as ‘untouchables’ or Dalits, and hence deprived of opportunities enjoyed by others as of right should – as Indian law makes clear – have no place in a modern community. Although social change is continuing, one in every seven people in the Indian population were recorded as being Dalits at the start of the 21st century. Accelerated progress since 2000 The barriers to improving health in India are, as described above, plural and substantive. Yet as the scale and scope of initiatives like the Individual Identification Project (IIP)16 16 Which is giving all Indian citizens individual identification numbers in order, it is intended, to clarify and assure benefit rights and extend access to services such as banking and insurance. now highlight, the country is modernising and seeking to respond effectively to the challenges and opportunities ahead. As, for instance, the potential for computer based systems to support both self care and personal care provided by doctors or other health professionals grows, health and health care in India will also be likely to improve. One of the most important successes achieved in the last decade has been the establishment of the National Rural Health Mission (NRHM – see Box 7). This had the initial objective of providing more accessible, affordable and good quality health care to the rural population. As with the Karnataka anti-corruption programme referred to above, the NRHM has sought to decentralise planning and increase community involvement in decision making, together with introducing more flexible financing and allied grant arrangements. Although the initial implementation of the NRHM appeared slow (Ghuman and Mehta, 2009) it is today credited with significantly reducing the incidence of a range of infectious diseases. As a result of this a new National Urban Health Mission (NUHM) is being launched to cater for the health needs of the urban poor. This may in future be combined with the NRHM to form a single National Health Mission. The NUHM will cover the country’s seven large metropolitan areas and 772 cities with a population of more than 50,000 individuals (Bhaumik, 2012). Box 7: The National Rural Health Mission First launched in April 2005, the National Rural Health Mission’s (NRHM’s) aim is to provide accessible, affordable and good quality healthcare to the rural population (Government of India Ministry of Health and Family Welfare, 2011). Its introduction can be seen as an indication of the Indian Government’s increasing if still cautious willingness to increase public spending on health. The NRHM has principally been focused on 18 northern States with relatively weak public health indicators and infrastructures. These include Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Himachal Pradesh, Jharkhand, Jammu and Kashmir, Manipur, Mizoram, Meghalaya, Madhya Pradesh, Nagaland, Odisha (formerly Orissa), Rajasthan, Sikkim, Tripura, Uttaranchal and Uttar Pradesh. The Mission has sought to enhance healthcare delivery via a comprehensive series of measures revolving around local communities. Key programme components include supporting the work of female health activists in each village; the promotion of village health plans prepared via local teams headed by the Health and Sanitation Committees of the Panchayats (local assemblies of elders); strengthening rural hospitals; and integrating previously ‘vertical’ health and family welfare programmes and funds into more effective horizontally oriented models (Ministry of Health and Family Welfare, 2005). The NRHM’s initial goals were to reduce maternal mortality to 100 (from over 400) per 100,000 live births, 22 to cut infant mortality from 60 to 30 per 1000 live births and to reduce the Indian total fertility rate from 3 to 2.1 by 2012. To facilitate this sub centres, primary health centres and community health centres were strengthened and the AYUSH disciplines (Ayurveda, Yoga and Naturopathy, Unani, Siddha, Sowa Rigpa and Homoeopathy) were ‘mainstreamed’ in an attempt to revitalise and enhance local traditional health care. Limitations in the implementation of NRHM programmes have been associated with administrative constraints, governance issues, inadequacies in human resources and sub-optimal investment in public health services (Ghuman and Mehta, 2009). In particular, there has recently been a major scandal in Uttar Pradesh. This involved the murder and unexplained deaths of a number of health officials and the reported misuse of approaching US $2 billion of public funds. As yet the 2012 health improvement targets have not yet been fully attained. Maternal mortality currently stands at about 200 deaths per 100,000 live births. The overall Indian infant mortality rate is still 40 per 1000 (or one in every 25) live births, while the total fertility rate is presently about 2.5 births per woman. Nevertheless, the NRHM is widely regarded as a success. Hence the development of a wider National Health Mission has recently been supported. This will extend the NRHM approach to the protection of less advantaged urban populations. Health and Health Care in India With regard to the widespread lack of affordable health insurance the Rashitriya Swasthya Bima Yojana (RSBY) was launched in 2008. This gives poor families the freedom to seek care at almost 1000 public and over 3000 private hospitals. In excess of 14 million people were already able to use it by 2010, and the RSBY has since been extended to cover workers in the informal sector. The latter include beneficiaries of the Mahatma Gandhi National Rural Employment Guarantee Scheme, street vendors, domestic workers and construction workers. Funded through general public revenues, it employs ‘smart card’ technology to permit the immediate enrolment of new beneficiaries and facilitate cashless provider reimbursement payments (Lagomarsino et al., 2012). However, the scheme is only availabe to the poorest families, and is restricted to meeting the cost of serious episodes of illness normally needing hospital admission. Day-to-day outpatient care and drug expenses are not covered. Some States have also established local health insurance arrangements. For example, Assam has, despite being relatively poor, set up such a scheme, while more affluent Goa has contracted with a private insurer to provide cover to anyone who has lived there for more than five years. However, both these arrangements are focused on acute rather than chronic care provision. Incentivising employment in rural settings With regard to enhancing (health sector) labour supply a number of incentives designed to attract staff to and retain them in rural areas are now in place. These stand in addition to the establishment of the new three year medical training programme referred to earlier. For example, a majority of States already offer relatively high salaries to public sector doctors serving in rural and remote areas. Compulsory rural service bonds have also been introduced in parts of India. In essence, medical education costs are subsidised in exchange for graduates working in less advantaged areas for an agreed period of time. Accredited AYUSH practitioners are additionally being recruited to primary health centres, where they are able to serve as medical officers (Rao et al., 2011). Targeting maternal care A number of schemes have also been developed to provide better care for women and promote infant health. Established as a part of the NRHM, the Janani Suraksha Yojana (JSY) is – for example – a ‘safe motherhood’ intervention which provides cash rewards for women to give birth in health centres or Government hospitals. In 2009-10 almost a half of all women who had a baby in India received such an incentive. However, many mothers and babies are discharged from hospital only hours after delivery. Some commentators say this means that there is too little time for the stabilisation of postpartum conditions and the detection of danger signs in either mothers or their babies, or for activities such as supporting the establishment of breastfeeding. Health and Health Care in India Another illustration of a service innovation aimed at protecting mothers and children stems from Gujarat. There a public private partnership (PPP) called the Chiranjeevi scheme provides childbirth and emergency obstetric services in private hospitals free of charge to those entitled to benefit. This model is now being replicated in other States (Paul et al., 2011). Likewise, in 2011 the Ministry of Health and Family Welfare launched the Janani-Shishu Suraksha Karyakram, or JSSK. This too aims to make better health facilities available to women and children. Women benefit from delivery in a public health institution where caesarean sections, medication, food and diagnostics are supplied free of charge. The JSSK is intended to benefit over one crore17 (that is, 10 million) women and babies a year. The service provided should also improve immunisation rates for conditions like measles, administer vitamin A as and when required, and facilitate activities such as paediatric anaemia and worm/helminthic disease management (Government of India Ministry of Health and Family Welfare, 2011). Improving pharmaceutical care NCD prevention and management Other examples of nationally and internationally supported initiatives intended to further accelerate health improvement in India range from the establishment in 2010 of an India-UK Forum intended to both boost mutual trade and promote collaborations and shared learning in areas like primary care development (Rao and Mant, 2012) to the Jan Aushadhi initiative. This last was intended to supply good quality low cost branded medicines via Government supported pharmacies, although in practice it has encountered a number of problems (Box 8). In the context of the rising burden of ‘later life’ illnesses, States like Kerala and Tamil Nadu have already identified chronic disease prevention and control as a high priority. Across India more widely The National Programme of Prevention and Control of Cancer, Diabetes and Cardiovascular Diseases and Stroke (NPCDCS) was established in 2010, initially to cover 100 districts in 21 States. It is intended to encourage healthy lifestyles, foster early disease diagnosis and promote better disease management in the contexts of diabetes, hypertension, vascular diseases and common cancers, and aims initially to cover roughly 200 million people (Government of India Ministry of Health and Family Welfare, 2011). A ‘National Programme for Health Care of the Elderly’ (NPHCE) was also launched around the same time. 17 One crore is 10 million, written 1,00,00,000. A lakh is 100 thousand, written 1,00,000. There are therefore 100 lakh to a crore. In the Indian numbering system a US billion (ie 100 crore) is an arab, while a US trillion can be referred to either as a lakh crore or 10 kharab. 23 Box 8. The Jan Aushadhi initiative The Jan Aushadhi initiative was launched in 2008 under the chairmanship of Shri Ram Vilas Paswan (the Minister of Chemicals and Fertilisers and Steel, who has pharmaceutical sector responsibilities) as a vehicle for putting into practice recommendations made by the Pronab Sen Task Force on improving medicines supply – see main text. It involved the development of publicly supported pharmacies, tasked with providing unbranded good quality generic medicines at low cost to the public. The goal was to supply most products at 50 per cent below the average market price of branded generic versions. It was hoped that a proportion might be supplied for as little as 10 per cent of the branded product average (John et al., 2011). By 2009 there were in total twenty such pharmacy stores. It was intended that each of the 660 districts of India (with average populations of nearing two million) would eventually have at least one Jan Aushadhi outlet. However, the fact that they were supplied by India’s five Central Public Sector Pharmaceutical Manufacturing Units (CPSUs) limited the impact of this measure. Because other domestic manufacturers did not wish to offer undifferentiated generic products at commodity or near commodity prices (Gopal, 2011) only those medicines produced by the CPSUs were normally available, rather than a full range of the treatments on the national and/or State lists of essential medicines. Some critics suggested that the true purpose of the Jan Aushadhi scheme was to protect the interests of government-owned CPSU companies (Kotwani, 2010). Its problems were compounded by the fact that A universal health system for India – the third transition? Initiatives such as those outlined above should be welcomed in as much as they will lead on to better individual and community health outcomes. But in looking to the future they at best represent a patchwork of measures that in the absence of further over-arching steps is unlikely to lead on to a fully comprehensive universal health coverage (UHC) system. In addition, an increased spend on health services alone will, it can be argued, probably be insufficient to improve the health status of the poorer people of India to the level they are likely to desire in the future, unless accompanied by additional interventions aimed at facilitating informed self care and enhancing the efficiency and effectiveness of professional care. Dr Margaret Chan, the present Director-General of the WHO, recently described UHC as ‘the single most powerful concept that public health has to offer’. The development of universally available, collectively funded, health systems is arguably so central to the wellbeing of ageing nations that it is – as previously noted – becoming increasingly seen as a third key health transition. Advocates of this line of thought argue that, unless 24 a significant proportion of Indian consumers presently have little faith in the quality of unbranded generics. Those who can afford it often prefer to buy branded products from private retail pharmacies, albeit that the available research suggests that if people were sure of the quality of the medicines being supplied a majority would be happy to receive free unbranded treatments from publicly funded dispensaries. It is in addition apparent that very poor people are often unable to purchase allopathic medicines at any price. Hence by 2011 it had become clear that the initiative was failing. Some observers blamed doctors for this because of their continued prescribing of branded generic medicines. This may on occasions have been related to financial rather than patient interests. It now appears that the Jan Aushadhi pharmacies will not be able to make the contribution to improving medicines supply that was originally hoped for. However, their introduction in 2008 helped to open up a debate about pharmaceutical care in India, and the extent to which the nation’s 500,000 community pharmacies might in time be able to offer an extended range of preventive and/or clinical services directly to the public. Presently, they tend to be clustered close to doctor’/prescribers’ premises, and relatively few have appropriately trained staff in constant attendance. But as India continues to develop and technical advances in not only pharmaceutical treatment but also ICT assisted diagnostics and self care support continue to be made, it may in future be possible to develop extended roles for pharmacists similar to those already being explored in settings like the USA and the UK. India’s development is to stall, ‘care transition’ (defined in terms that include the establishment of universally accessible health services) must follow closely on the processes of demographic and epidemiological change through which the nation is currently passing. At his Independence Day Address in August 2011 the Prime Minister of India, Dr Manmohan Singh, announced that health would be given high priority in the 12th Five Year Plan for 2012-2017. He said that it was his Government’s intent to increase the public financing of health care to 2.5 per cent of GDP during the period to 2017, from the 1.2 per cent recorded in 2011/12. He also set a goal for this total to reach at least 3 per cent of GDP by 2022. These plans are now in some doubt because of a reduced rate of economic growth. But if private outlays on items such as medicines and private medical and hospital fees were to decline by corresponding amounts in the same period (which is perhaps possible – Nayar, 2011) the overall proportion of Indian GDP devoted to health would stay constant. That is, real growth in the sector would have run parallel with real growth in the economy as a whole. However, there is in reality likely to be considerable pressure from health care providers Health and Health Care in India The scenario indicated by Dr Singh was consistent with the report on Universal Health Coverage published by the High Level Expert Group (HLEG) in November 2011 – see, for instance, Figure 14. The HLEG had 15 members from organisations such as the Public Health Foundation of India (PHFI), the All India Institute of Medical Sciences (AIIMS) and the Ministry of Health and Family Welfare. Its mandate was to develop a framework for providing optimally accessible and affordable healthcare in India by reconfiguring and strengthening the existing health system to ensure its alignment with the key objectives of UHC. It defined providing UHC in terms of: “Ensuring equitable access for all Indian citizens, resident in any part of the country, regardless of income level, social status, gender, caste or religion, to affordable, accountable, appropriate health services of assured quality (promotive, preventive, curative, rehabilitative) as well as public health services addressing the wider determinants of health delivered to individuals and populations, with the Government being the guarantor and enabler, although not necessarily the only provider, of health and related services.” (High Level Expert Group on UHC, 2011) The extensive analysis offered by the HLEG indicated that moving towards a tax-based system of financing will be essential for achieving UHC in India. This was because it judged systems of private health insurance as being unable – at least at the country’s current stage of development – to fund universal coverage for chronic disease as well as acute condition risks in all parts of the nation. Other authorities have commented that even if it is not as yet possible to raise taxes via European or North American style income taxes (only about 3 per cent of Indian’s currently pay the latter) or payroll or other social security levies, extensions of consumption taxes on items like alcohol, tobacco or processed food products might offer a viable way forward (Kumar et al., 2011). However, although perhaps politically attractive in India and increasingly other developing and developed country settings, this option would potentially carry highly inequitable consequences. The HLEG also stressed the fact that India’s extended public health care system will need to be flexible enough to accommodate rapid urbanisation, increased socio-cultural diversity and the differential health care requirements of all the nation’s minority groups. Its vision was that every citizen should be entitled to essential primary, secondary and tertiary health care, guaranteed by central Government in the form of a National Health Package (NHP). This, the Group argued, should cover all common conditions and provide as of right high-impact, Health and Health Care in India Figure 14: Projected proportions of public and private health spending in India, 2011/12-2021/22 Percentage of total spending on health and service users alike to increase the proportion of India’s income that is spent on preventing and treating ill health, over and above any possible increases in public sector service spending funded by the Federal or State Governments. 100% 90% 80% 33 53 70% 60% 67 50% 40% 30% 20% Private spending 67 47 10% 0% Public spending 33 2011-12 2016-172021-22 Source: High Level Expert Group on UHC, 2011 cost effective health care interventions for reducing health-related mortality and disability. The NHP services will, were the HLEG’s approach to be fully endorsed and implemented, be available either through public sector facilities or via contracted-in private providers working within a public-private partnership (PPP) framework. States will be free to supplement the NHP with additional services using their own funds and patients would also be able to add to their care by paying out-of-pocket (OOP) for services not covered by the NHP. Cashless transactions were, the HLEG envisaged, to be facilitated by National Health Entitlement Cards (NHEC) distributed to each citizen. Health worker density was to be increased to achieve WHO suggested norms of 25 doctors, nurses and midwives per 10,000 population. A key component of all UHC systems involves meeting costs incurred in the process of treating the sick and relatively poor via a common system of pooled financing. Raising money through equitably designed taxes or other hypothecated contributions that everyone must pay will result in everyone paying less at times of ill health. The latter could and arguably should contribute to increased health spending by raising demand for health care. Yet against this it could decrease costs as and when care is managed more efficiently than would otherwise be possible. Although the latter prospect may seem unattractive to some sectional interests, containing health care costs while improving health outcomes is increasingly being regarded as a high priority goal in all parts of the world. Overcoming barriers There is a strong Indian public interest case for supporting the HLEG’s proposals. However, it is not as yet clear whether or not they will be accepted in their entirety by either the Government or by the wider Indian community, or how those elements which are accepted will in practice be taken forward. 25 Examples of issues to be addressed include: • gaining acceptance for transferring significantly more resources gathered via taxation from the richest and healthiest to less advantaged individuals and communities. The current situation in India appears to be that although the country’s overall ‘fiscal capacity’ is comparable to or greater than that of other similar nations, there has not in most instances been the will needed to use the funds raised via national or State taxes to increase transfer payments to the levels needed to sustain universal health coverage. It might be that political debate has lagged behind private sentiment. But the size, plurality and diverse traditions of India may mean that it will continue to face special problems in this area as compared to those encountered in Western European countries at similar points in their development; • the challenges associated with increasing demand for ‘high tech’ medicine in ‘first world’ India, while hundreds of millions of people in ‘third world’ India do not as yet enjoy assured access to essential medicines and basic health care. Following on from the above, when much smaller OECD countries like say Denmark, Germany or Italy were first introducing their UHC systems the medical technologies then available were far less sophisticated than is the case today. Hence the perceived needs and consequent care costs of people in the ‘higher’ and ‘lower’ social strata were less divergent than is so in emergent societies today (Savedoff et al., 2012). The extent to which it will over time be acceptable to all but the richest Indian citizens for their future health service to offer a basic health package which then has to be topped up by private outlays in order to obtain more costly and/or less cost effective treatments is uncertain; and • the difficulties inherent in resisting popular demands for ‘irrational care’ and overcoming sectional political, professional and commercial interests in its provision. At present the Indian market for health services and products such as medicines is in some respects chaotic, and sometimes characterised by patterns of service provision and consumer behaviour that are – at least in conventional evidence based medicine terms – sub-optimal. Failures to invest sufficiently in the long term protective use of medicines to reduce vascular disease and type 2 diabetes linked risks, while at the same time permitting poorly regulated and sometimes excessive antibiotic usage, illustrate this point. Yet many aspects of the current system and its relative freedom from intrusive regulation are popular with professionals and patients alike, and can on many occasions deliver what users say they experience as satisfactory results. Many groups may therefore wish to oppose better planned approaches. It is also the case that in countries such as the UK, where NHS managerial and professional staff have significant ‘demand management’ and allied public health justified control and optimisation roles, abuses and scandals have 26 occurred because of institutionalised power imbalances between those receiving care and those providing it. Similar events might be more likely to occur in India if staff employed in expanded publicly funded facilities were required to take on an extended role in rationing access to treatments. Reduced private expenditure driven competition could exacerbate such risks. Such concerns do not imply that the HLEG’s recommendations should not be pursued. Universal health coverage and allied care systems can have important advantages over alternative approaches, not least in terms of reducing incentives for supplying unnecessary treatments. But such proposals will need to be implemented with care, and may at first need to focus most firmly on those areas where there is the greatest publicly agreed need for enhanced public service provision. Improving affordable access to demonstrably essential medicines and the support needed to help ensure their effective use amongst the less well off areas of rural and urban India provides an important example of this type of opportunity. Better Access and Better Medicines? Instituting reliable access to essential medicines is not the only, or necessarily the most important, measure needed for protecting personal health or assuring long term population health improvement. However, the fact that good quality manufacture, supply (including appropriate prescribing, safe dispensing and effective patient support) and use of medicines is nevertheless a vital part of good quality modern health care provision in affluent and less affluent countries alike is reflected in, for instance, the UN’s Millennium Development Goals. Along with the wider national economy, the Indian pharmaceutical industry has developed rapidly in recent decades. Its exports alone are presently reported to be worth some US $13 billion a year. This is approaching the total reported value of the domestic Indian market for allopathic medicines18. In the 1950s 20 per cent or less of the pharmaceuticals consumed in India were manufactured in the country. Today the proportion is in the order of 80 per cent. It is widely claimed that India is in volume terms now the third largest producer of medicines in the world, albeit that by value of the pharmaceuticals it makes and sells it is not yet in the top ten. The US and EU markets currently account for some 70 per cent of the Indian based export industry’s returns. The country is also a large supplier of lower cost medicines and vaccines to international aid programmes. In settings such as Nigeria Indian made drugs now account for 18 Data from both Government and private sources are consistent with these estimates, although they should nevertheless be treated with caution. If it were accurate that the total market for allopathic pharmaceuticals in India is worth only US $13-14 billion, this would represent no more than 15 per cent of the country’s unusually low public and private health spending as expressed in international exchange rate terms. Health and Health Care in India about a third of all sales, and the Government of India is seeking to double the nation’s global pharmaceutical exports in the next two to three years. There are also good prospects for a continuing expansion of both privately and publicly funded demand within the nation’s borders. A number of sources suggest that India is able to produce many medicines and – subject to regulatory, clinical and other relevant capacities and capabilities – undertake research for about a tenth of the costs likely to be incurred in Europe and America. But notwithstanding these data the scale and sustainability of this success should not be over-stated. Set against the whole Indian economy, the total value of conventionally defined pharmaceutical industry activity probably amounts to no more than 1.5-2 per cent of GDP, even though some sources imply 3 per cent plus. The proportion of world pharmaceutical sector revenues enjoyed by the Indian industry is similarly only around 3 per cent. Indian companies are in addition facing strong competition from Chinese and other emergent producers of small molecule and other pharmaceutical products. This will intensify, not least as major international companies seek to enhance their performance in response to their changing environment and highly capable and resource rich countries like Russia move to invest more in manufacturing ‘biologicals’. Alongside this there is criticism from within the US and India’s other more profitable external markets that its policies in areas like narrowing the opportunities available for obtaining patent protection for new medicines and issuing compulsory licenses for treatments that have been successfully patented are undermining international public (along with research based corporate) interests in financing high risk biomedical development projects. Combined with concerns in India about the to date disappointing domestic access to medicines despite the low prices of essential generic drugs19 amongst the nation’s most needy, such observations pose significant policy questions for the future. Issues such as the undesirability of some local branded generic medicine marketing practices and the extent to which private manufacturing investments (which may be supplemented by individual State grants) are benefiting the wider community as opposed to only a privileged minority might also be raised. Aspects of the hurdles to be overcome in assuring better medicines supply are further explored below. But before this the unusual nature of modern pharmaceuticals as high technology products is worth emphasis. As Box 9 highlights, they are – although typically difficult and expensive to develop – once marketed often relatively inexpensive (especially given adequate scale) to copy. In the case of the small molecule drugs characteristic of 19 Low imposed prices tend to discourage supply in any sector. The function of (varying) prices in markets is not to reflect the abstracted ‘absolute’ value of items, but rather to balance supply and demand via indicating their relative worth at a given point in time. Failures to understand this can in the absence of subsidised production capacity able to operate at a loss or on a non-profit basis lead to unrealistic expectations that imposing low prices will ensure cheap supply. Health and Health Care in India the years between the beginning of the modern antibiotic era that started when India gained independence in the late 1940s and the marketing of innovations such as trastuzumab (Herceptin) and imatinib mesylate (Glivec or Gleevec)20 at the end of twentieth century, comparatively little of their value lies in the direct manufacturing cost of the substances they contain. It lies rather in the expertise and investment needed to develop their safe and effective use. Even with the next generation of typically lower volume sale ‘stratified medicines’ now emerging this is still largely the case, albeit that fabrication expertise and consistency is important in the biological products context. This combination of factors has made medicines as high technology products uniquely dependent on the existence of intellectual property rights (IPRs). Critics of provisions such as patent laws (brand names can be taken to represent a different form of intellectual property protection or IPP, alongside copyrights and exclusivity rights relating to the regulatory data needed to licence medicinal drugs) may argue that they make new medicines too expensive for poor people living without access to universal health coverage to afford. To underline points like this, agencies such as the British and French charities Oxfam and Médecins Sans Frontières (MSF) have highlighted the important role that some Indian companies have played in producing low cost anti-HIV medicines (see below). Yet there is no evidence based alternative to IP protection and the temporary periods of exclusive product supply they grant for incentivising private (and public) spending on high risk pharmaceutical research (Jacob, 2013). Without intellectual property ownership rights like those granted by patents effective AIDS treatments would almost certainly not have become available as rapidly as proved to be the case in the last two to three decades. At worst, the world might still be waiting for such technologies to emerge. Policy after the 1962 conflict with China Despite the courage shown by members of the Indian Army, the poor level of preparedness revealed by the 1962 Sino-Indian clash increased awareness of strategic vulnerabilities like the nation’s dependence on imported medical supplies. During the first half of the 20th century only very limited progress towards local production had been made. The most notable examples include the establishment of the Bengal Chemical and Pharmaceutical Works in West Bengal and the Alembic Chemical Works in Gujarat (Chatterjee, 2008). Even at the start of the 1960s the country was not able to manufacture most of the medicines it required. 20 Imatinib mesylate was first marketed as a treatment for CML in 2001, about half a century after the Philadelphia chromosome was initially identified. It provides an early example of ‘rational design’, and may be taken to serve as a landmark in the transition of the research based pharmaceutical industry away from its 19th and 20th century origins towards more specifically targeted approaches to disease treatment. 27 Box 9. The economics of pharmaceutical research, production and supply Medicines are unique as high technology products. They are expensive to develop, especially when outlays on not only clinical trials of successful products but also the opportunity costs of medicines which fail to demonstrate safety and efficacy in the later stages of research are taken into full account. Yet the marginal costs of their production and supply after they have been marketed are – even in the case of large molecule biological products – often comparatively low. This is why the price of a new medicine during the relatively short period that it is covered by IP provisions that give innovators exclusive marketing rights may legitimately be many times the price at which a generic manufacturer can subsequently supply. However, this reality can be difficult for many observers to accept. Viewed unsympathetically, IPP is seen as unfairly making new medicines unaffordable in poor communities. But it is also the case that without intellectual property rights it is likely that fewer pharmaceutical innovations would be developed, and that once IPRs are exhausted pharmaceutical products are often much more cost effective than labour intensive approaches to disease prevention, cure and alleviation. In this context it is important to emphasise that public and private investments are frequently inter-dependent. Just as, for example, organisations such as Universities benefit from royalties on medicines sold by private companies, the latter may draw on research findings derived from public spending. Governments could well be reluctant to authorise the latter without the long term prospect of not only health improvements but also financial gains generated via private sector activities. Pharmaceuticals have a variety of other characteristics that tend to make them controversial. These encompass – in addition to their perceived life saving value – the fact that they are superficially at least relatively easy to copy or counterfeit as compared to, say, complex multi-component products like jet engines or electronic devices such as ‘smart phones’. They also normally have unusually high value to weight and volume ratios, especially while under IP protection. This facilitates both legal trading and illicit movements of goods, albeit that pharmaceutical manufacture and sale is heavily regulated as compared with most if not all other sectors. The most important economic points to highlight in relation to the emergence of Indian pharmaceutical manufacturing and the health care challenges the country is currently facing are linked to the risks of investing in fundamental therapeutic innovation, as opposed to researching more cost effective ways of producing existing proven medicines. Spending on the latter generates predictable returns. By contrast it is The shock of the Chinese military advances on the northern borders led over time to strategic measures aimed inter alia at assuring better pharmaceutical supplies. 28 much less certain that spending tens or hundreds of millions of dollars on seeking to discover and licence radically new ways of preventing or treating disease will bear fruit. The term ‘risk capital premium’ relates to the supra-normal returns investors need to anticipate on successful products for them to continue to channel funds into areas in which there is a high probability of project failure. At present the Indian pharmaceutical industry spends very little on high risk research and development. Its main priorities lie in supplying established treatments at affordable costs, and where possible exporting such medicines to other nations. In value terms the US is the single biggest importer of Indian generic pharmaceuticals, in part because when drugs go off patent in America new generic suppliers enjoy a six month period in which they have exclusive marketing rights. Because of low wages and other advantages relating to manufacturing capacity (including, as and when available, State level subsidies) the country is normally able to produce branded and other generics at costs well below those presently incurred in regions such as North America and Western Europe. Indian companies are therefore unlikely to be concerned with defending global public interests in the IP law infrastructure that research based concerns and many policy makers in countries with stronger research sectors regard as vital for the continuance of pharmaceutical innovation. Given the current absence of insurance based or other financial mechanisms for protecting Indian citizens in need of newer medicines from having to meet high costs, patients and the wider public also have little immediate reason to favour world standard IP protection for the producers of innovative treatments. If the economic position of India strengthens and its science base and health care system continues to develop this situation could in time naturally adjust. Yet for the moment the most probable way forward may demand an increased international acceptance of the need for the differential pricing of innovative treatments in low per capita income countries such as India as compared to more affluent communities, coupled on the Indian side with a more sympathetic understanding of factors such as the cost of the high risk capital required to sustain ongoing innovation in the bio-pharmaceutical sphere. Such progress is unlikely to be achieved via disputes between opposed sectional interests with rigid views. Rather, it will require flexible dialogue based wherever possible on common values and an informed awareness of the processes and demands of worldwide health and health care improvement. They first took the form of, from 1963 onwards, a series of Drug Price Control Orders (DPCOs). These were the progenitors of the current National Pharmaceutical Pricing Health and Health Care in India Policy21. The Indian Patent Act of 1970 followed. This abolished the IP regimen inherited from Britain at the time of independence. It made only manufacturing processes (instead of final products) patentable, and reduced patent term durations to either just five years from the date of sealing (ie granting) or seven years from the date of filing. This reform, coupled with measures designed to promote the local manufacturing of active pharmaceutical ingredients (APIs) via the imposition of import duties, created opportunities for Indian companies to ‘reverse engineer’ new medicines and find progressively more economic ways of producing them. In the following decade the Drug Price Competition and Patent Restoration Act (otherwise known as the 1984 Hatch Waxman Act) restored patent terms in the US. It also incentivised and facilitated the introduction of generic medicines into the American market immediately after patent expiry. This key reform, along with the subsequent liberalisation of the Indian economy, helped the Indian pharmaceutical industry to expand. Its exports increased significantly from around the middle 1990s onwards. One recent illustration of the continuing value of the Hatch Waxman reforms to India was provided by the lipid lowering medicine atorvastatin (Lipitor). This was by 2010-2011 the most successful ‘blockbuster’ medicine of all time. It lost patent protection in November 2011 and Ranbaxy (the second biggest Indian pharmaceutical company in terms of revenue, which had been purchased by the Japanese pharmaceutical company Daiichi Sankyo in 2008), won approval from the FDA to sell generic atorvastatin in the American market at about a fifth of the innovator’s price. The American legislation meant that the Indian company enjoyed a 180 day exclusivity period, which protected its sales efforts in the US22. Twenty first century opportunities Following a model initially put forward by the WHO in the 1970s, India eventually introduced the first version of its National List of Essential Medicines (NELM) in 1996. This today contains some 350 different medicinal entities, all of which are subject to price controls. In the first decade of the 21st century additional developments included: • the marketing by Cipla of a low cost HAART (highly active antiretroviral therapy) combination, capable of effectively treating people living with HIV – see Box 10. Cipla was founded in 1935 and began bulk pharmaceutical production in the 1960s. It provides an important example of Indian industrial 21 This in essence controls the prices of essential medicines. Details relating to disputes over the precise methodologies employed to determine production cost as opposed to market based prices are not explored here. However, it is again appropriate to emphasise that if unrealistically low ceilings are imposed this may well create supply shortages which can paradoxically help force poor people to have to purchase relatively high cost treatments privately. 22 In relation to a separate historical matter, Ranbaxy agreed in May 2013 to pay a fine of $500 million for selling adulterated drugs in the US market. The company pleaded guilty to seven criminal counts, including intention to defraud and failing to report that its drugs did not meet specifications. Health and Health Care in India success, despite the fact that its outgoing managing director Dr Yusuf Hamied was recently quoted as saying that ‘the time may have come to say goodbye to India’ (Chatterjee and Balakrishnan, 2013) • the publication in 2004 by the World Health Organisation of the first edition of a seminal report entitled The World Medicines Situation (WHO, 2004). This publicly criticised the then limitations in the supply of essential medicines to up to two thirds of India’s population, and by implication the country’s domestic pharmaceutical and public health policy stance; and • India’s acceptance, effective from 2005, of the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. This obliged the country to introduce, in return for continued or enhanced access to ‘rich’ markets across the globe, a 20 year patent term for all products, including medicines. The latter requirement was originally intended to accelerate progress towards more uniform global IP provisions. But in the wake of the HIV treatment crisis discussed in Box 10 the 2001 Doha Declaration enabled TRIPS participants to take measures to protect against ‘public health emergencies’, including issuing compulsory licences (CLs) to permit the production of patented medicines by third parties (Reichman, 2009). This was widely welcomed, although there are international disagreements relating to how ‘public health emergencies’ should be defined and no central mechanisms for resolving such disputes. India’s 2005 Patent Act can therefore be seen as both introducing extended product patent provisions and opening the way to the use of ‘Doha flexibilities’ in ways that, despite their undoubted popularity within India, some external authorities believe are inconsistent with the intent and global social purpose of the TRIPS agreement. The WHO’s 2004 World Medicines Situation intervention led in India to the establishment of a Task Force to investigate improving medicines supply by means other than price restrictions. This worked under the chairmanship of a senior Planning Commission member, Pronab Sen. Its recommendations included increasing the use of ‘true’ – as opposed to branded – generic pharmaceutical products; establishing special funds for meeting medicine costs for patients in need; cutting excise duties on medicines; and improving State’s purchasing arrangements for obtaining products to be supplied via the public sector. The 2005 Task Force report also called for better public education about medicines and health care, and an enhanced role for pharmacies in supplying good quality, low cost, medicines. This led in 2008 the Jan Aushadhi initiative, referred to earlier in this analysis. As discussed above, the latter (unlike an in part similar ‘popular pharmacy’ scheme in Brazil) has not proved successful, although this is not to say that the health care role of pharmacists could not in future usefully be extended in India. The Pronab Sen Task Force’s conclusions contributed to thinking subsequently taken 29 Box 10. The HIV pandemic and its role in improving access to essential medicines When the first cases of AIDS were identified in the US at the start of the 1980s little could be done for those affected other than offering palliative care. But following the introduction of AZT (zidovudine) in 1987 and the subsequent development of combination anti-HIV drugs in 1992, progressively more effective highly active anti-retroviral treatments (HAARTs) have emerged. Today, individuals who have access to good pharmaceutical care and who can take their medicines as recommended are unlikely to die prematurely as a result of HIV infection. Even if the development of a vaccine remains elusive, drug therapies coupled with public health interventions might in time – with continuing investment in innovation and treatment supply – prove capable of eliminating HIV globally. However, despite the importance of the successes achieved to date and the future potential of drug based anti-HIV strategies to contribute further health gains, the cost of patented HIV treatments has been a matter of frequent concern in not only the least developed nations but in emerging economies ranging from India and Brazil to Russia and South Africa. In the 1980s US based health activists were driven by fears that because HIV was regarded as a ‘gay’ disease it would be neglected by both Governments and pharmaceutical companies. These worries proved unfounded. But as during the 1990s better drugs were marketed and in settings from the US White House to the villages of southern India it became understood that entire populations were at risk from HIV, questions about the prices of patent protected anti-retroviral products became increasingly pressing. At $10,000 or more per capita per annum their costs were and remain acceptable in richer communities with robust universal health care systems. Yet even in America uninsured people (especially perhaps those in minority group members) were on occasions unable to get access to effective care. For most individuals and families in the developing world it was clearly unaffordable. In response to this situation, the Indian company Cipla developed a $1 a day combination therapy. This action is widely seen as having opened the way to transforming HIV/AIDS treatment worldwide. It was also at the start of the twenty first century that the Doha Declaration made provisions for countries to take action to in effect override patent protection when confronted with national health emergencies that required mass access to high cost pharmaceutical products. The controversy that has surrounded this area carries a number of important lessons relating to the need to recognise health emergencies in a timely and effective manner. There is now common acceptance that 30 not only pharmaceutical companies but also many Governments were initially slow to respond to the AIDS pandemic. One reason for this may be that it atypically involved the rapid emergence of a need to supply some of the world’s newest medicines to people living in very poor communities. Even in the 1980s many health professionals saw improving sanitation, nutrition, vaccination and the supply of well established medicines as the almost exclusive key to achieving better health in pre and mid transitional settings. However, health emergencies must be defined appropriately if the integrity of the global intellectual property system is to be maintained. In contexts like cancer care (where the Indian Courts have recently facilitated the compulsory licensing of a number of potentially life extending, but not in most instances life saving, patent protected medicines) there is arguably little apparent justification for removing the temporary ability of innovators to generate profit from their products when the high costs of diagnostic and other necessary services mean that only the wealthiest are likely to benefit from low cost access to such ‘cutting edge’ medicines. India has made significant progress in preventing and treating HIV infections in the last decade, albeit that access to effective therapy could still be significantly improved – see main text. But as the global population continues to age and the demand for better treatments for conditions like the cancers and neurological disorders increases new challenges relating to equitable access to new vaccines and medicines will inevitably arise. This will be so not only in India but in all emergent economies without UHC. From a worldwide public interest perspective this challenge should be met in ways that neither neglect the needs of those who urgently require effective care nor undermine the ability of the global community to continue investing in therapeutic innovation. One possible way forward is through the development of international mechanisms for funding the development and supply of new pharmaceutical and allied products. The GAVI Alliance (originally known as The Global Alliance for Vaccines and Immunisation) provides an early illustration of this type of progress. Another future option might be that world-wide changes in IP law could serve, through strengthened protection terms coupled with extended low cost or free supply obligations in less advantaged communities, to secure a sustainable balance between protecting long term public interests in the ongoing evolution of improved biomedical interventions on the one hand and meeting the immediate health care needs of vulnerable individuals and communities on the other. Health and Health Care in India forward by the High Level Expert Group on UHC and the suggested, although now uncertain, goal of extending free generic medicines supply to half the population by the year 2017. As already described, the 12th Five Year Plan had anticipated that this last will be achievable at the relatively modest cumulative cost of US $5 billion, which is equivalent to about 0.3 per cent of India’s annual GDP. (The 2011 HLEG report had originally called for an increase in yearly Indian public spending on medicines from about 0.1 per cent of GDP to 0.5 per cent.) It also supported the introduction of new price controls applying to an extended essential medicines list, more transparent drug procurement arrangements, an enhanced regulatory system and a more effective use of information technology to track medicines use and support patient care. India is now to varying degrees moving forward in all these areas. There is good reason to believe that over time further improvements in health will be achieved, notwithstanding the broader challenges that all countries will in future have to face in contexts such as climate change and its impacts in spheres such as food production. Yet it should also be recognised that there remain problems such as ill-informed public expectations of medicines in areas ranging from the use of antibiotics to the effectiveness of presently available anti-cancer medicines. Undesirable professional and managerial attitudes and behaviours also threaten to impede health improvements. Given the finding that in lost welfare terms disability and premature deaths due to non-communicable diseases23 alone are already costing India the equivalent of 12.5 per cent of its GDP, and that this total will in future rise markedly unless appropriate preventive action is taken, it is arguably vital that the preventive and public health role of pharmaceuticals in fields such as hypertension, CVD and diabetes management becomes better understood. Likewise, realistic approaches to pharmaceutical price regulation and State level public sector pharmaceutical purchasing arrangements are needed. In the former context it ought to be more widely appreciated, for example, that imposing unduly low prices for essential products can critically undermine medicines supply. An undue reliance on supply side price controls when the root cause problems to be overcome stem from demand side failures such as corrupted purchasing practices could inhibit necessary reforms. With regard to drug procurement systems there is mounting evidence that ‘arms length’, functionally independent yet publicly accountable, agency arrangements like those pioneered in Tamil Nardu and Kerala can reduce corruption and achieve better value for money. However, even here technically better 23 As described earlier, infectious diseases currently impose a similar burden upon the Indian populace. This should continue to fall as living conditions and health services are enhanced. But there is a risk that such gains will be more than outweighed by an increased middle and early later life incidence and prevalence of chronic/ non-communicable conditions such as strokes, CHD, heart failure and type 2 diabetes. Health and Health Care in India systems alone cannot fully counter compromising social environments (Singh et al, 2013). Achieving ethical integrity in all aspects of pharmaceutical supply will be essential for the delivery of optimal care, whether or not appropriate price control and/or purchasing structures are in place. In the medium term the equitable provision of innovative pharmaceutical products in India and elsewhere may well demand fresh inter-Governmental agreements on the principles and application of stratified pricing strategies, and the extent to which the amounts innovators’ charge for their products should vary between regions and/or within communities in accordance with different levels of (collective) ability to pay. Achieving stratified pricing in ways which protect the interests of all those in need of new medicines without undermining the interests of those willing to invest in the ongoing development of better therapies is also important. In the immediate future the issue most likely to cause overt conflicts between Indian and other national/regional stakeholders, and which may also impede the development of the nation’s pharmaceutical sector as it seeks to become more research oriented, is that of intellectual property protection. Intellectual property and the affordable supply of more effective medicines At present the domestic Indian pharmaceutical industry is, like the country’s pharmaceutical market, highly disparate. There are currently tens of thousands of competing branded generic medicines, supported on occasions by questionable marketing practices. Along with this there are some 300 larger producers/plants functioning at levels credited as operating in a manner consistent with the US FDA’s good manufacturing practice (GMP) standards. (The FDA has a Delhi based office, which is in communication with State level inspectorates via the Indian Central Drugs Standards and Control Organisation.) Beneath this level there are at any one time as many as 5,000-10,000 small manufacturers which can open and close fluidly across India. Such concerns typically make branded goods that they market themselves and/or supply active pharmaceutical ingredients (APIs) and other items to ‘higher tier’ companies, although low cost APIs are also imported in significant volumes from China. Pharmaceutical production is conventionally regarded as a capital intensive activity, likely to benefit from savings to scale. But Indian sources describe the small to medium sized local companies that the country currently has in abundance as the mainstay of the domestic industry. This is because of their flexibility and capacity to keep costs very low. Over the past few decades the Indian pharmaceutical sector has performed robustly. But as compared to the size of the overall Indian economy and the world pharmaceutical market as a whole its earnings remain relatively modest. The extent to which the Indian based industry’s performance can continue to improve as the 31 global production of generic versions of established medicines continues to consolidate and become more efficient is uncertain. Likewise as the world market for ‘biologics’ both expands and matures, this too will demand changes in the form and functioning of the Indian and wider international industry. It is possible that in coming decades the Indian pharmaceutical sector will rebalance, and move from concentrating on manufacturing low cost generic products towards making higher margin ‘biological’ medicines and other innovative forms of treatment. If this proves to be the case then Indian stakeholders in not only pharmaceutical research and development but health improvement more broadly may come to value relevant forms of intellectual property protection for medicines and allied products more positively, domestically and in regions such as North America and Europe. This is not to imply that important priorities such as ensuring affordable universal access to (reasonably defined) essential medicines should be neglected. Nor ought (or can) resolving urgent challenges such as those linked to extending the survival chances and quality of life of less affluent people and groups living with, for instance, cancer in settings which currently lack adequate public health care systems be ignored. Yet the above does mean that recent levels of conflict and misunderstanding surrounding issues such as the compulsory licensing of high cost tertiary oncology treatments and events such as the recent Indian Supreme Court decision not to grant a patent for imatinib mesylate (Gleevec) are undesirable, and threaten to undermine both Indian and world-wide public interests in better care and better medicines. Unless positive action can be taken to establish an informed consensus this could lead to defensive actions which will create long lasting barriers to the establishment of an optimally equitable and efficient global pharmaceutical market. This would almost certainly harm the interests of not only patients and the wider world public, but all the individual Governments and companies involved. The Gleevec case was more complex than is sometimes assumed. It can only be fully understood within its particular context and the almost half a century of research and development which took place between the discovery of the ‘Philadelphia chromosome’ (the genetic lesion at the heart of chronic myeloid leukaemia, for which Gleevec was primarily developed) at the end of the 1950s and the product’s first approval in 2001. But from a general perspective it can be argued that current Indian policies and provisions relating to intellectual property are in some respects questionable from a broad international perspective. They at worst threaten to weaken structures vital to the continuing development of medicines to prevent or treat conditions such as cancers or neurological diseases, and a more robustly knowledge based global health economy. Critics may, for example, argue that: • Indian State level powers to grant supply licences for new medicines when they have been available for sale 32 for only four years can cut across nationally awarded patent rights. This risk is linked to the fact that no adequate mechanisms exist for resolving relevant disputes until after alternative products have been marketed; • the granting of compulsory licences (CLs) on medicines such as sorafenib (Nexavar) on grounds relating to their not being manufactured in India is inappropriate; and • section 3(d) of India’s 2005 Patents (Amendment) Act is difficult to reconcile with the spirit of the TRIPS agreement that India accepted for implementation in that same year. The latter concern relates to the Doha Declaration issues noted previously. Section 3(d) seeks to prevent IP ‘ever greening’ (extension) by curbing innovators’ rights to patent salts or other derivatives of previously known substances. However, in the biomedical context the differences between the properties of such alternative molecules can be profoundly important. It is also worth stressing that in normal circumstances it is not in any jurisdiction possible for such ‘minor’ alterations to be used to extend an existing patent24. Rather, a new patent (plus a new product licence) would be required for any such innovation, leaving – after the expiry of its IPP – the original product free for generic manufacturers to make and supply as they wish. The interests most likely to oppose incremental pharmaceutical developments are commercial companies and/or health care funders seeking to limit market competition or control costs by denying professionals and/or consumers new, potentially more effective if also temporarily more costly, choices. For example, a generic medicine manufacturer might well want to block the emergence of better alternatives. It will in the short term be difficult to resolve the international and intra-industrial conflicts of interest such observations indicate. It is possible that current work in areas such as promoting free(r) trade between India and the EU (and the EU and the US) may foster closer alignments. However, there is little prospect of a ‘magic bullet’ solution, particularly while Indian public opinion remains focused falsely on the perception that reducing innovative medicines prices as distinct from remedying the nation’s lack of an adequate health care system is the most important step to be taken towards achieving better public health. Perhaps the most that can realistically be hoped for is in the more immediate future the continuation of high level dialogue about issues such as medicines price stratification, coupled with the promotion of greater public understanding of the roles of established and new medicines alongside lifestyle modifications in disease prevention and treatment – see Box 11. 24 In the Gleevec case, for instance, it should be noted that although in other parts of the world a patent designed to protect a range of possible imatinib presentations had been granted before the one taken out specifically on imatinib mesolate, only the latter was applied for in India. Health and Health Care in India Box 11. The public health role of medicines use In the pre-transitional world illness was often regarded as the result of fate and an absolute lack of choice – children and adults died because they did not have enough food or adequate access to clean water, or were the unlucky victims of unavoidable disease. Medicines use, to the extent that it existed, was commonly seen as relieving symptoms and on occasions curing individuals’ complaints, but not as a fundamental way of enhancing population wide health through human agency. However, it was recognised at a relatively early stage in human development that the mass use of psychoactive agents such as alcohol and opium could impact negatively upon the health of whole communities. In the modern era tobacco smoking has provided another example of a form of personal drug use that can undermine public as well as individual health. The availability of cigarettes has often been historically associated with increasing incomes, and hence can be said to illustrate the fact that with rising affluence the main causes of death and disability become associated with the (semi) voluntary selection of hazardous lifestyle options rather than a total absence of choice. India contains groups of people at both ends of this spectrum, from those facing rising rates of obesity at all ages to those whose children still suffer stunting because of malnutrition. Throughout the 20th century immunisation has been regarded as a public health intervention. It protects populations via its collective (or ‘herd’) effects, as well as engendering individual resistance to infectious (and today some forms of neoplastic) disease. However, it is only very recently that it has become understood that medicines used strategically can have similar positive effects. For instance, the appropriate supply of antiretroviral medicines is now known to reduce disease transmission within populations. It might even in time lead to the eradication of HIV/AIDS (see Box 10). Conclusions The fundamental tasks facing India in the early 21st century include completing its delayed demographic and epidemiological transitions as swiftly as possible, and building a sustainable post-transitional society with the material, intellectual and moral resources needed to provide all its members with an optimal opportunity for achieving good health in later life. There is no simple way of guaranteeing progress towards this goal, which will demand ethical as well as technical competence and leadership. As the Emperor Ashoka’s Edicts, written and publicly displayed in the India of over 2,000 years ago, were in part intended to communicate, excellence in governance is dependent on not only rationality but also on characteristics and values such as courage, generosity, compassion and truthfulness. Modern India, like the world as a whole, has many divisions between and within its various communities. Health and Health Care in India Water fluoridation has also (despite some vocal opposition) been shown to be a safe and effective way of preventing dental caries. Likewise the extended use of anti-hypertensive and cholesterol lowering agents has a considerable potential to (along with smoking cessation) reduce the incidence of cardiovascular conditions in ageing populations, over and above the health gains likely to be achievable via dietary and exercise changes alone (Wald and Misselbrook, 2011). Such observations have considerable implications for India, where a quarter of all deaths are already caused by vascular disease and the incidence and prevalence of type 2 diabetes is rising rapidly. Some important research on concepts such as the development of a safe and effective ‘polypill’ for the primary prevention of atheroma and events like strokes and myocardial infarctions has already been undertaken in the country. But against this the ‘public health’ use of medicines to reduce average health risks in broad population groups such as, say, people aged over 50 or 55 is in some ways threatening to traditional pharmaceutical thinking and the perceived interests of medical practitioners and health educators alike. For example, it minimises the need for individual diagnostic testing and personalised risk assessments, and can (wrongly) be seen as obviating requirements for health protecting lifestyles. At the current stage of India’s progress it may therefore be that many health professionals, along with regulatory and allied agencies, will oppose such developments, regardless of current service limitations and the strength of the evidence in their favour. Nevertheless, in the longer term an extended and optimally cost effective use of medicines to prevent and/or arrest the progression of NCDs should become more generally accepted and seen as vital for further extending healthy life expectation in all communities. It is also faced with problems like gender related inequalities and pressing needs in areas ranging from preventing malnutrition amongst vulnerable children to enhancing energy production in an environmentally acceptable manner. However, despite ongoing restraints and challenges, the emergence of health care and nationwide health improvement as accepted political priorities represents an important step forward. It is to be hoped that the recent work of the Planning Commission instituted High Level Expert Group on Universal Health Coverage will lead on to a care system able to serve the entire 21st century population. Viewed positively, it is possible that the country’s established expertise in areas like information technology and vaccine production will prove useful in recasting current models of self care and professional care and opening the way to a unique and potentially world leading Indian health service model. Likewise, if the lessons of 33 the past relating to, for instance, failures to adequately support the local implementation of well intended policies and the repeated twentieth century mistake of under-investing in primary and community services are accepted, the current threat from the rising prevalence of chronic disease in India should prove containable in ways that permit significant further extension in healthy life expectancy. Even if this were to mean raising the total proportion of GDP devoted to health to, say, 6 per cent in the coming decade or so, as compared to the current figure of a little over 4 per cent and an OECD average of around 10 per cent, this could well be a sound, desirable, investment. Without prompt additional action to prevent the avoidable losses of wellbeing, skills and abilities caused by non-communicable conditions in middle and later life, Indian society will ultimately have to bear very heavy costs. If not effectively addressed, a growing NCD burden might undermine the country’s ability to complete its demographic and allied transitions and stall its overall economic and social development. Any such failure would almost certainly have signficant global repercussions. Ultimate responsibility for forming India’s health and health care policies lies with the nation’s elected Government. Democracy also requires that decisions should be consistent with the leadership’s vision of the Indian people’s best interests, alongside more immediate voter preferences. Given this key understanding, one of the main recommendations offered here is that alongside the welcome but still relatively cautious and now apparently delayed measures recently proposed in the context of extending access to free generic medicines as part of the country’s overall journey to universal health coverage, policy makers may also in the coming decade wish to consider further reforms relating to intellectual property law. It is apparent today that the 1970 Patents Act marked the start of a new phase of Indian development in relation to pharmaceutical production and sales. Approaching half a century later a re-modernised approach to intellectual property law might mark the beginnings of the country’s rise as a post transitional community. As India’s capacity for innovation increases and its health services continue to improve, ongoing public interests in both the affordability of health care and the development of better therapies might best be defended, nationally and internationally, through strengthening the IPP available to the creators of more effective treatments in return for new types of supply guarantee in poor communities. Such ideas presently conflict with much popular sentiment. Yet if in future it were supported by nations like India, such an approach could build on the spirit of the US Hatch Waxman reforms of the 1980s to deliver a global intellectual property system better fitted for meeting 21st century needs. However, another key message of this analysis is that achieving better public health requires more than better medicines supply alone. Similarly, it also needs more 34 than the high technology hospital care that ‘first world India’ can now offer not only its more affluent citizens but relatively well-off patients from across the world. Improving health in ‘third world India’ will centrally demand enhanced primary care together with significant advances in areas like communicating the knowledge and skills needed to prevent disease wherever possible and access optimally cost effective treatments for established conditions whenever necessary. Such solutions need to be understood and ‘owned’ by not only the medical and other health professionals charged with providing formal health care, but everyone seeking to live in ways that protect their health and that of their families. One example of an option for enhancing consumer involvement in health care and balancing more effectively the power of professional providers against that of service users could, as noted earlier, involve the use of SMS messaging to permit patients or others to record inappropriate restrictions in drug or other forms of public service provision. For some observers proposals of this nature may appear controversial. But without such consumer empowerment measures – coupled with suitable mechanisms for supporting good practices and penalising corruption – the pace of health and health care improvement will be slower than the majority of the Indian electorate is in future likely to judge acceptable. In the final analysis, achieving further social and economic progress in India – with a sixth of the entire human population – is important for everyone everywhere. 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(2011) Future of Prevention in Cardiovascular Disease, London: Royal Society of Medicine WHO (2004) The World Medicines Situation Geneva: WHO WHO (2006) The World Health Report 2006 - working together for health, Geneva: WHO WHO (2012) Good health adds life to years: Global brief for World Health Day 2012, Geneva: WHO WHO-EMP Department (2012) The pharmaceutical sector in BRICS countries: A chart-book of national health account’s expenditure data and the World Trade Organization’s pharmaceutical imports and exports data, Geneva: WHO 35 The Emperor Ashoka Maurya ruled most of the Indian subcontinent over 2,300 years ago. He established a health service and communicated through personally written edicts about his Buddhist philosophy based approach to just governance and the maintainance of social unity. This report was written by Dr Jennifer Gill and Professor David Taylor of the UCL School of Pharmacy. They gratefully acknowledge the help and advice given by all those interviewed during the research phase of this project, which was funded via an unconditional grant from the PhRMA, the US research based pharmaceutical manufacturers association. Dr Gill and Professor Taylor worked independently, and editorial accountability for its content lies with Professor Taylor. Copyright © UCL School of Pharmacy, July 2013 ISBN 978-0-902936-27-0 Price £7.50 Design & print: www.intertype.co.uk