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IIMB Management Review (2013) 25, 49e62 available at www.sciencedirect.com journal homepage: www.elsevier.com/locate/iimb Production and hosting by Elsevier ROUND TABLE Ethical...

IIMB Management Review (2013) 25, 49e62 available at www.sciencedirect.com journal homepage: www.elsevier.com/locate/iimb Production and hosting by Elsevier ROUND TABLE Ethical issues in health care sector in India Chirantan Chatterjee, Vasanthi Srinivasan* HR/OB, Indian Institute of Management, Bannerghatta Road, Bangalore, India KEYWORDS Abstract The issue of ethics and economic efficiency in the provisioning and delivery of Health care; services becomes complex in the Indian context where health indicators are poor. In an Ethics; attempt to explore this issue, this round table article first provides an overview of the field Efficiency; of ethics in health care, the health care sector in India and its facilities, the key institutional Emerging economy; actors and finally, the key ethical issues concerning the different players in health care e the India physician, the bio-pharmaceutical industry, and the chemist. In its second part, the article reports on a discussion of the issues with a panel of experts across geographic and organisa- tional settings. ª 2012 Indian Institute of Management Bangalore. Production and hosting by Elsevier Ltd. All rights reserved. Academic perspective with the idea that some people should be denied access to health care that might relieve their suffering or save their Health care institutions across the world are facing chal- lives because they cannot pay for it (Enthoven, 1993). In the lenges in the delivery and provisioning of services with Indian context, where health indicators of the country are financial solvency. Patient care now competes with poor, the discourse on ethics assumes greater complexity the financial solvency of the health care institutions and requires a more nuanced understanding and apprecia- (Silverman, 2000), and the issue of ethics has become more tion of the contextual elements. This note attempts to relevant than at any other point in time. Health care provide a brief overview of the field of ethics in health care, services have a special moral quality. The purposes of health the status of the health care sector in India, the key insti- care services include saving lives, preventing or relieving tutional actors and finally, the key ethical issues arising out suffering, preventing and curing disease and disability, and of the interactions across the various actors. ameliorating the consequences of disease when it cannot be prevented or cured. Few people can be morally comfortable Ethics and health care The field of medical ethics has long existed, arising from * Corresponding author. Tel.: þ91 80 26993046. E-mail address: [email protected] (V. Srinivasan). the Hippocrates oath, and tenets of the early religious Peer-review under responsibility of Indian Institute of Management healing traditions of the West. Several Asian traditions have Bangalore also had ethical tenets governing the physicianepatient relationship (Tsai, 1999; Desai, 1988). In the field of contemporary medical ethics, the doctors in the USA were the first to develop a modern code of ethics. At the first meeting of the American Medical Association (AMA) in 1846, 0970-3896 ª 2012 Indian Institute of Management Bangalore. Production and hosting by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.iimb.2012.11.004 50 C. Chatterjee, V. Srinivasan a committee was appointed to report on a code of ethics paid for through personal funds (Sengupta & Nandy, 2005). for the organisation. Modern medical codes of ethics are According to the Central Bureau of Health Intelligence, based on the works of Thomas Percival, a British Physician majority of Indians trust and visit private health care credited with giving much thought to the future of the despite the fact that cost of treatment in private treatment profession. The International Code of the World Medical is significantly higher than public facilities (Table 1). Association, an organisation representing physicians foun- Private sector health care is highly fragmented with over ded in 1947, ensures that physicians strive for the highest 90% of private health care being serviced by the unorgan- possible standards of ethical behaviour and care at all times ised sector. Eighty percent of the private hospitals are small (Backof & Martin, 1991). clinics and nursing homes (less than 30 beds). Six to seven In the 1970s, traditional medical ethics changed into an percent are 100e200 bed size hospitals and only 2e3% of interdisciplinary field involving theologians, lawyers, hospitals are 200- plus bed (Table 2). Most of the large philosophers, social scientists, and historians, as well as hospitals are located in the urban areas. physicians and other health professionals (Veatch, 2006). The sector however has attracted considerable private The reason for this was the increasing impact of science and investments and it appears that the participation of the technology, the growth of specialisation in the field of private sector in this field is likely to continue in the near medicine, public expectations from new medicines and future. The conflict between the financial solvency of the surgical techniques, changes in the financing and delivery of private sector players to the need for affordable quality health care, and the transformation of medical schools into health care services in ways that enhance the health and large medical centres in the West. The field of medical ethics well-being of citizens is an immediate and visible area of which focused on the moral responsibility of a physician to ethical conflict in the sector. a patient was not adequate to address the ethical aspects emerging out of the changed context. With more stake- Disease burden and adequacy of facilities holders, such as medical devices companies, pharmaceutical companies, diagnostic clinics, insurance companies, clinical In the course of development, countries undergo an trial organisations, and other service providers entering the “epidemiologic transition”. Initially the developing nations field, there was a need to expand the scope of the definition have high morbidity and mortality due to communicable of ethics within the field of medicine. In recent years, the diseases and maternal and child mortality. As economic terms “bio-medical ethics”, “bio-pharmaceutical ethics”, development occurs, these morbidities decline significantly and “health care ethics” are gaining importance. The term and there is an upsurge of diseases of the affluent class, bio-medical ethics includes the issues related to reproduc- that is, non-communicable diseases, injuries and geriatric tive biology, such as stem cell research and human cloning problems. India, however, faces a dual burden of high and the ethical dimensions arising out of these changes. The incidence of infectious diseases (Tables 3 and 4) and a rising term bio-pharmaceutical ethics refers to the ethics associ- epidemic of non-communicable diseases. The trend of dual ated with the discovery and development of the products. burden is consistent across urban and rural areas with The term health care ethics is increasingly being used as an a slightly higher proportion of non-communicable diseases umbrella term to encompass ethical aspects previously in urban areas (Table 5). With the changing trends in the included in medical-, bio medical-, bio-pharmaceutical- and communicable diseases, changing demographics, increasing also organisational- and business ethics of different stake- urbanisation, and increased lifespan, the burden of disease holders involved in the provisioning and delivery of health is likely to increase further, putting a burden on an already care services. It is this broad definition of health care ethics insufficient health care system. that is being used in this note and the round table discussion Given the cost of treatment, disease burden, and the poor that follows the note. public health care facilities, the moral and ethical discussion on the “right to live” assumes a greater significance in India. Indian health care sector In the next section, we introduce the typical experiences of an imaginary patient in the health care system in India. The health indicators of India have consistently lagged behind the economic development that has been witnessed over the last decade and the need for increased investment An imaginary patient in health care has been acknowledged. The public expen- diture on health in India remained at about 1.1% of GDP in This section outlines the trajectory for an imaginary patient 2010 (Ministry of Health and Family Welfare, GOI). Public (Patient X) traversing through the value chain in Indian health health care delivery is done through a network of over care. Patient X might be a poor farmer, an entrepreneur, or 146,036 health sub-centres, 23,458 Primary Health Centres (PHCs) and 4276 Community Health Centres (CHCs). There is Table 1 Average cost (in rupees) of a typical illness a 150-bed civil hospital at the district level to provide episode in public and private sector. tertiary care. Only 23.5% of urban population and 30.6% of the rural people choose government facilities, thus reflect- Public Private ing the widespread lack of confidence in the public health facilities facilities care system (Central Bureau of Health Intelligence, 2010). Cost of an out-patient episode 242 310 Studies have acknowledged that India ranks among the Cost of an in-patient episode 859 9352 top 20 countries in the world in its private health care Source: Selvaraj & Karan, 2009 funding and that 82% of the total medical expense in India is Ethical issues in health care sector in India 51 Table 2 Classification of hospitals in India. Types of hospitals in India Government Private Nursing homes Mid tier Top tier Health care centres, Primarily nursing Corporate hospitals Major corporate hospital district hospitals homes and recovery with in house staff chains and specialty hospitals and general hospitals rooms with adequate and consulting physicians infrastructure Variable: based on types 100 beds Source: Ministry of Health and Family Welfare, 2010, http://mohfw.nic.in/index.php a settled professional. Patient X visits a general physician, Health care is a key aspect of any developing nation and who advises diagnostic tests, and cautionary medicines and the need for quality, accessible and affordable health care could also refer X to a specialist. Patient X has bills to pay and is a necessity. A particularly central role in health care the following options of payment: if Patient X has been delivery in modern societies is that of the physician. Francis treated at a public hospital she may have the option of not Moore the respected American physician noted, that “the paying any of the bills; Patient X could approach her insurance surgical investigator must be a bridge tender, channelling provider if she is employed in a big company and has knowledge from biological science to the patient’s bedside employer-provided insurance; Patient X could approach her and back again”, adding also that the surgical investigator insurance provider from the state if she comes from below- was open to the charge of not being a very good scientist the-poverty-line and has state provided insurance. Despite from one end of the bridge and of not spending enough time the options, it is an arduous journey, and one hopes, without in the operating room, from the other (Murray & Moore, serious implications. 2002). In contexts like India, the role of the physician is The above anecdote is educative of how as a patient or more nuanced and tricky, especially since physicians have a consumer, one is dependant on so many stakeholders been historically revered in the society and their decision- across the value chain in the Indian health care industry. making powers are further enhanced. But such a role also There are the doctors e the generalists and the specialists, brings along with it responsibility. It is arguable if the two the medicine-makers, local firms and multinational corpo- key nodal organisations of physicians in the country, the rations (MNCs), and the diagnostic device producers e Medical Council of India (MCI) and the Indian Medical domestic and multinational e supplying their equipment to Association (IMA) have been able to live up to that the hospitals who can afford them. Finally there is the responsibility in recent times. concerned insurance provider to turn to for settling the bills, provided one is among the privileged few in society to Institutional structures and ethics have insurance support. A brief overview of the key stakeholders in the value The IMA, organised in 1928, was the result of efforts in Cal- chain is provided in Fig. 1. It must be noted that several cutta to form an association of doctors in pre-independence private and public actors are present in different parts of India. It currently has over 178,000 members with about 1700 the value chain. Therefore, the inter-relationships across local branches. With antecedents that can be traced to the the actors are complex and raise several issues pertaining Bengal Medical Association, IMA has historically seen to conflicts of interest. respected doctors as its president. A key name in this regard is Dr. B C Roy in 1929e1930 who later on became the Chief Minister of West Bengal. (However, in recent times, the reputation of the presiding doctors has been in question.) It is Table 3 Pattern of communicable diseases. also important to note that the IMA has played a global role Trends of communicable diseases in India Diseases showing Diseases showing increasing trends decreasing trends Table 4 Burden of communicable diseases. Communicable Magnitude of the burden Dengue, chikungunya Poliomyelitis diseases HIV-TB co-infection Tuberculosis Cholera O139 Neonatal tetanus TB 283 cases per lakh population Japanese encephalitis Measles in 2007 Leptospirosis HIV/AIDS HIV 2.27 million HIV-positive Novel H1N1 infections persons in 2008 Eradicated: smallpox, guinea worm Malaria 2 million deaths per year Eliminated: yaws, leprosy Leprosy 130,000 affected people Source: Ministry of Health and Family Welfare, 2010, (http:// Source: Ministry of Health and Family Welfare, 2010, (http:// mohfw.nic.in/index.php) mohfw.nic.in/index.php) 52 C. Chatterjee, V. Srinivasan On 25th June 2012, the nation witnessed an unprece- Table 5 The causes of death. dented one-day strike by the IMA1which contested the Causes of death Overall Rural proposed promulgation of the Clinical Establishments Act and areas the formation of the National Council for Human Resources in Communicable 38% 41% Health (NCHRH) by the Government of India. Physicians diseases, maternal, across the country affiliated to IMA could foresee through peri-natal and these developments, a diminishing role of IMA in Indian nutritional society. This event followed Bollywood actor Aamir Khan’s Non-communicable 42% 40% show on national television channels highlighting the diseases controversial roles of doctors around the country.2 These Injuries 10% 10% events were not in isolation e coming after the arrest of the Ill-defined causes 10% 9% MCI president Dr. Ketan Desai by the Central Bureau of Investigation for allegedly accepting a bribe to permit Source: Ministry of Health and Family Welfare, 2010, (http:// mohfw.nic.in/index.php) Patiala-based Gyan Sagar Medical College to recruit a fresh batch of students without having adequate infrastructure.3 Subsequent to this, MCI was superseded by the President of too; some of its members were earlier members of the British India and its functions entrusted to a Board of Governors. The Medical Association and IMA members were also influential in present Board of Governors was notified on 13 May 2011. the setting up of the World Medical Association in 1962. At It is clear that while doctors have a bridging role to play around the time of IMA’s formation, the Medical Council of as alluded to by Francis Moore e their position is particu- India (MCI) was established in 1934 under the Indian Medical larly under the radar today in India. A recent article Council Act, 1933. The Council was later reconstituted under effectively points to this, highlighting the role of “doctors the Indian Medical Council Act, 1956 that replaced the earlier in entrepreneurial gowns”, and pointing to how various Act. The main functions of the MCI are the following: estab- private-sector physicians are also holding a conflicting lishment and maintenance of uniform standards for under- position with the IMA and are breeding industries such as in graduate medical education; regulation of postgraduate the “treatment of obesity” (Nagral, 2012). medical education in medical colleges accredited by it (The At various points in this round table discussion, we come National Board of Examinations is another statutory body for back to the key role of physicians and doctors in our lives. postgraduate medical education in India); recognition of While we certainly try to outline the role of firm-level medical qualifications granted by medical institutions in instruments and address issues for pharmaceutical firms, India; recognition of foreign medical qualifications in India; domestic and multinational, and further discuss issues accreditation of medical colleges; registration of doctors about harmonisation of various regulatory bodies, physi- with recognised medical qualifications; and maintaining cians e being central to the act of health care delivery e a directory of all registered doctors (called the Indian Medical have a key role to play in the context of ethical behaviour Register). Finally, registration of doctors and their qualifica- in health care markets. They form a key component of our tions is usually done by state medical councils. discussion. Figure 1 Health care value chain in India. Source: (Chandwani, Devare & Srinivasan, 2011) Ethical issues in health care sector in India 53 Dr. Richard Manning begins the round table discussion by that Arrow (1963) has highlighted as historically prevailing underlining the issue of ethics and efficiency as they relate in health care markets around the world, more so in India. to health care markets. This is a particularly salient guiding Mr. Sapra’s thoughts are given logical completion by Dr. framework since it is important to note that what might be Ravikumar Banda, Founder and Managing Director of Xcyton ethical might not necessarily be efficient and with the Diagnostics. Dr. Banda an erstwhile physician and now an particular case of health care markets this problem might entrepreneur starts off by highlighting the “physician- be aggravated. Andrew Shleifer (2004) discusses this trade- centricity” of health care markets, more so in contexts like off, pointing out that: “When unethical behavior cuts costs, India. Dr. Banda’s thoughts particularly are contextual in competition drives down prices and entrepreneurs’ relation to the role of the MCI and the IMA, the two key incomes, and thereby reduces their willingness to pay for nodal bodies of physicians in the country. Dr. Banda touches ethical conduct. However competition might be good for upon various aspects where society and these institutions ethical behavior in the long run, because it promotes need to buckle up and raise their voices when it comes to growth and raises incomes. Higher incomes raise the will- how physician behaviour affects the ordinary Indian citi- ingness to pay for ethical behavior, but may also change zen’s life. Dr. Banda also brings out in his discussion the what people believe to be ethical for the better.” With pivotal role of the Central Drug Controller General of India regard to child labour, Shleifer points out that in many parts in installing formal regulatory systems to promote ethical of the developing world, without good access to capital behaviour in Indian health care markets. markets and educational opportunities, the alternative to We highlight in Box 1, the key issues that get covered in child labour could well be malnutrition and disease. the round table. The area is vast and there are several Thus the overlying issue of ethics and efficiency is important and among other elements can be guided by two key firm-level instruments that Dr. Manning outlines. Both of these instruments could enhance or destroy social welfare depending on how they are used and relate to Box 1. Key issues covered in the round pricing and marketing methods used by pharmaceutical table. firms. In the context of India this is particularly pertinent with a large section of the population having inadequate access to medicines, more so patented ones sold by multinationals at prices far beyond their reach. Dr. Manning The bio-pharmaceutical industry raises the possibility of an important policy lever of differential pricing and wonders whether it might have the a. Pricing of drugs (brand vs. generic) potential to address this problem. Theoretically speaking, b. Investments of MNCs in tropical disease drug marketing and promotional activities might have an infor- discovery to life style mational contribution about products such as medicines. c. Advertising e information disclosure in ads; Dr. Manning alludes to them, but in the context of India this doctor-pharmaceutical firm nexus to promote is again salient since it might not be used by firms as a social certain drugs over others through samples, spon- good. The Indian Medical Association is currently consid- sorship and other practices, with little attention ering this particular area in careful detail and contem- to quality plating regulations to be put in place for implementing d. Availability of banned drugs and counterfeits. checks on marketing and promotion activities of firms; it is e. Disregard of regulations in sponsoring clinical trials but pertinent that Dr. Manning’s thoughts would ring a bell f. Private health care providers and the issue of in that policy discussion. “inappropriate care”. The next speaker at the round table, Mr. Rijit Sengupta extends Dr. Manning’s thoughts. An overarching theme of Mr. Sengupta’s views is the role of non-market mechanisms in ensuring ethical behaviour within the context of Indian Physician health care markets. He terms these as the twin roles of co- regulation and self-regulation, his thoughts falling broadly a. Irrational prescription of drugs under three key aspects that economists have earlier b. Prescription by brand names instead of equivalent pointed to in their efforts to raise the willingness to pay for generics ethical conduct: those of long run market pressures, moral c. Commission received for referrals to diagnostic suasion, and governmental regulation. centres Carrying forward Mr. Sengupta’s thoughts, Mr. Deepak d. Prescription of non-essential drugs Sapra from Dr. Reddy’s Laboratories points out to issues e. Monitoring of the Medical Council of India and its around “wellness” for an emerging economy like India. code-of-conduct. Several of Mr. Sapra’s thoughts ring a bell with issues highlighted earlier by Dr. Manning or Mr. Sengupta; in particular with the role of pricing, drug discovery, and Pharmacy/chemist research in neglected diseases. As an alumnus of IIM Ban- galore it is also heartening to notice Mr. Sapra pointing to a. Use of the MRP as the price the game-changing role that digitisation and information b. Collusion by pharmacists on price technology can play in reducing uncertainty of the nature 54 C. Chatterjee, V. Srinivasan issues around ethical behaviour in the context of health that people will tend to act in ways that they perceive to be care markets in India that merit attention. With the pres- in their own best interest. When society has in place ence of international and domestic participants, experts appropriate structures and protections, individuals acting from consulting and not-for-profit institutions, the phar- in their own interest often lead to outcomes that leave maceutical industry and a physician e we have attempted others better off as well. Not to be trite, but my view is that in the discussion, to make a fair representation of all issues Adam Smith was keenfully insightful when he described under the overarching theme. the power of the “invisible hand.” Economic growth and development have done a great deal to lift individuals out Ethical issues in health care sector in India: of poverty and to foster prosperity in societies. There is a great deal of overlap between the search for economic discussion efficiency and the betterment of mankind, which is to me a key standard by which ethical behaviour ought to be measured. As economies, particularly the emerging econ- omies, continue to grow, individuals will desire more and better quality of life. Health care can be a major compo- Anchors nent of that improved quality of life and can be an impor- Chirantan Chatterjee and Vasanthi Srinivasan, IIMB tant factor in enabling continued economic growth and Panellists development. Ravikumar Banda: Founder and MD, Xycton Diagnostics. In short, the ethical responsibilities held by both Email: [email protected] governments and biopharmaceutical companies have to do Richard Manning: Partner, Bates White, an economics with allowing/helping individuals achieve their goals with consulting firm based in Washington DC, USA. respect to quality of life. As economies grow, individuals [email protected] will naturally desire better quality of health care for Deepak Sapra: Senior Director (Business Development themselves and those they care about. The rules govern- and Portfolio), Dr. Reddy’s Laboratories. ments put in place can either foster or retard that progress. [email protected] Rijit Sengupta: Director, Consumer Unity and Trust Society (CUTS) International. [email protected] Two key issues in ethics: pricing and marketing Pricing Chirantan Chatterjee Relative to the pharmaceutical industry, no issue raises more ethical considerations in the emerging markets (or in The theme of this round table is ethical issues in the Indian the developed ones) than pricing. health care sector and we have speakers from different Ethical issues in pricing cluster around two poles: 1) parts of the value chain to get practitioner inputs on ethical providing access to existing medicines for those that cannot behaviour in health care. I will start by alluding to Nobel pay and 2) maintaining the incentive to continue to develop Prize winning economist Kenneth Arrow’s seminal paper medicines that address unmet needs. Essentially these from1963,4 where he first talks about the curious nature of problems come down to caring for the needs of present ‘uncertainty’ in health care markets that engenders patients as opposed to caring for the needs of future particular problems of adverse selection and moral hazard. patients. Critics of the pharmaceutical industry sometimes Arrow also focused on the physician-centricity of health appear to give too little attention to the latter; the industry care markets, where the final consumer and the provider sometimes appears to give too little attention to the are almost always intermediated by an agent in-between, former. In fact, a wholly ethical approach to the problem of the physician concerned in most cases. Since the area is pricing must consider both current and future needs. vast what we will try today is to cover various issues with Some argue that the developed world is a sufficiently Professor Arrow’s thoughts in the background. It is also large and wealthy market to bring forth innovation in a pleasure to bring in Richard, Ravi, Deepak, and Rijit in the medicines and that ignoring the property rights of compa- ambit of this discussion. They come from various parts of nies in lower income countries through compulsory the value chain in the industry and their thoughts poten- licensing, voiding of patents, strict price controls, or tially will cover the entire gamut of issues relevant to whatever mechanism can do no meaningful harm to the health care markets and ethical behaviour. Over to you future flow of medicines. For medicines that treat condi- Richard. tions prevalent in both developed and emerging markets, it is almost certainly true that the lost sales from “free riding” in low income countries are not a large deterrent to Richard Manning innovation at least in the near term. However, such static effects are not the only ethical consideration. Ethics in health care Companies that might start selling at very low prices in lower income markets have a natural interest in moving into Given my background, it is natural for me to think about higher income markets, and products sold at low prices in low things in terms of efficiency and markets. My view is that income countries will naturally tend to flow into higher a discussion of ethics needs to be grounded in a recognition income markets whether through legitimate channels or Ethical issues in health care sector in India 55 otherwise. Additionally, generics manufacturers seeing those efforts have not and cannot be central to their opportunities to challenge patents in developed countries mission. While economic growth and development will go have an incentive to turn their attention to those markets as a long way towards lessening the burden of those diseases, well. Both these forces threaten to leave those with low many scholars agree that some non-market mechanisms incomes without the supply they need. will be necessary to address those issues. While these ideas Additionally, as the emerging markets countries to grow, have resulted in some successes, meaningful progress has they become meaningful markets and larger and larger not yet been achieved. segments of their populations will have the capacity to pay An interesting question in this realm is who has the for innovative medicines. Should they not? Is there no ethical responsibility to bear the burden for research into ethical responsibility for people who can afford to pay for treatments for neglected diseases? No doubt, because the innovative products to do so regardless of where they live? infrastructure of discovery and development that already A key example of this tension, and the need to solve it, is resides in the private biopharmaceutical companies HIV. Thanks to innovation in medicines, access to appro- conveys on them a cost advantage in the search for new priate medications can turn this disease into a manageable cures, they will play a role. Exactly what the dimensions of health challenge. Without access, it remains a nearly that role should be seems less obvious. Certainly those certain death sentence. The gains to treatment are companies have financial resources, but that alone should exceptionally large as it allows people to remain productive not lead them to bear the burden alone. in the most productive years of their lives. Although more On the one hand, recent market developments have remains to be done, great progress has been made to foster knocked the innovative industry down the ranks of most access to HIV therapies and to bring down their cost to profitable companies in the world. Both in the US and on those that cannot pay. a global scale, companies with the largest market value and Philipson and Jena5 demonstrated that despite the rela- income reside largely in the oil and finance industries or in tively high perceived prices for the medicines, the compa- information technology. If ethical responsibility is appor- nies that developed HIV therapies captured only about 5% of tioned according to ability to pay, certainly a wider set of the value of their innovation. In short, prices could easily contributors than the biopharmaceutical companies would have been much higher and patients would still have be identified. Additionally, why is it that shareholders of captured the bulk of the gains from the new therapies. private companies should support this cause? Are they the To current beneficiaries this is obviously good. However, disproportionate beneficiaries? The answer to the question trouble looms due to dynamic factors. The HIV virus is not obvious. Who should pay for the benefit of others is mutates over time and the medicines that currently keep it not something about which economics typically has a lot to at bay will probably not always do so. Short of eradicating offer. It only seems clear that the answer is unclear. the virus, which is most likely impossible, there will be a continuing need for new HIV therapies over time. Who will Ethics and marketing develop those? As prices are driven down naturally by patent expiration and perhaps less naturally through political pressure, the potential reward to the innovator A second key issue involving ethics in health care is the that brings new HIV therapies to market become small. marketing of prescription drugs. As in any industry, there Today there are relatively few HIV research programmes are legitimate concerns about the incentives the seller of under way. Without an incentive to continue the search for a good might have to distort information conveyed about cures, the gains of the present are coming at the expense of their product. In health care, this concern is heightened by the gains in the future. the fact that the ultimate consumer, the patient, is typi- The challenge in HIV and other therapeutic areas is to cally somewhat disconnected from the choice of medical make products available for people that are unable to pay approach to use. When the physician acts in the patient’s while not destroying the markets for those that are able. best interest, the ethical concern about marketing is less That is no simple task as it pits the interest of the present serious. So a first step in thinking about the ethical chal- against the interests of the future. lenge in marketing pharmaceuticals might be to consider One potential solution to the dynamic efficiency the incentives facing the care-giving physician. When problem is fostering differential pricing through partner- patients have the ability and freedom to compare and ships among private companies, NGOs and governments. In select a physician based on how well he or she represents a functioning differential pricing system, individuals or the patient’s interest, the concern that the physician might population segments that can afford to pay only nominal be unduly swayed by marketing efforts of the pharmaceu- prices (or perhaps no price at all) would have drug supplies tical company is diminished. segregated to allow them access while not threatening It is also important to recognise that marketing activities existing commercial markets. While simple in concept, the are a means of providing information to people as they application is extremely difficult. Efforts have been made make economic choices. Information is costly to acquire to develop differential pricing schemes, but the alignment and process. Brands and trademarks exist because they of interests is very challenging. Making real progress will convey information to consumers about characteristics of require the commitment of various parties to ignore strong a good or service at a relatively low cost. Advertisers immediate interests. Exactly how to obtain that commit- remind people of their goods and service offerings because ment is unclear. people have many things to pay attention to and reminders Finally, although private companies have demonstrated can help sort through information to help people decide a willingness to invest in treatments for neglected diseases, what to do with scarce time and resources. 56 C. Chatterjee, V. Srinivasan Likewise, physicians are more able to make appropriate Rijit Sengupta therapeutic recommendations to patients when they know more about the products they prescribe. Although in Regulation in the health sector and the realities of a perfect world, it might seem desirable for physicians and implementation patients to learn all they need to know from completely disinterested parties, the reality is that pharmaceutical Ethics and health care companies know more about their products than anyone I have segregated my presentation on regulation in the else, and absolutely independent sources of information health sector into six sub-points. The first point is are costly to acquire. In modern health care systems, a comment on the topic itself. There are two leading words a physician’s time is scarce. Although academic publica- in the topic: one is “ethics” and the other is “health care”. tions provide an important source of new information, the As far as ethics is concerned, we now have the National cost of staying on top of the latest advances is not small. Voluntary Guidelines (NVG) on Social, Environmental, Hence, allowing companies to provide information to Economic Responsibilities of Business, which was adopted patients and physicians can be an important component of by the Government of India, Ministry of Corporate Affairs. improved quality of care. It is common among economists The NVG tries to define responsible business conduct and it to argue that the best solution to concerns about biases in presents a framework consisting of nine principles with the provision of information is the provision of more certain core elements to actualise each of the principles. information. When competitors each convey information to We can use principle one of the NVG to lay out broadly what physicians, they are able to determine credibility of various we mean by ethics in business and apply that specifically in sources and filter out better from worse. the health care sector. Principle one, which states that Of course, inappropriate inducements to prescribe businesses should conduct and govern themselves with specific products should not be allowed, but it is easy to go ethics, transparency and accountability, emphasises that too far and forget that the provision of information is ethical conduct in all its functions and processes is the a complicated, costly, and valuable exercise. Sometimes cornerstone of responsible business. There is an emphasis combining lunch or dinner with information about medical on the accepted or written and non-written codes, and treatment may be a problem, but sometimes it may be the principles and values which define ethical behaviour. It best way to lower the cost of the physician obtaining that emphasises transparent communication and a culture of information. Limiting contact between physicians and integrity. It asserts that businesses should refrain from marketing professionals can have unintended consequences. indulging in corrupt practices and honestly discharge their A recently published article6 examined the impact of access responsibility on financial and other areas pertaining to to sales representatives in the US on prescribing patterns of mandatory disclosures. physicians treating cardiovascular and diabetes patients. Perhaps not surprisingly, the study found that physicians working in settings with greater access to pharmaceutical Health care market company representatives had more rapid adoption of new What do we understand by the term “health care market” medicines than those working in settings with restricted and what are its salient features in the context of this access to sales representatives. One can argue about the discussion? First, the health care market is an extremely merits of rapid response to the launch of a new medicine. diverse market as far as the states are concerned, given that Certainly, however, delaying treatment in cases where health care is a state subject. Second, it is characterised by a new medicine would provide a substantial benefit to considerable information asymmetry. Third, it is driven by patients presents an ethical problem. a weak market regulatory framework which does not have A more obvious ethical problem would be continuing to a very satisfactory implementation record. As far as the topic expose patients to a newly discovered risk. Importantly, is concerned, when you talk about health care from a holistic Chressanthis and his colleagues found evidence that this perspective, it is difficult to separate practices in the phar- was an unintended consequence of restricting interactions maceutical sub-sector from the health care sub-sector. The between physicians and sales professionals. Physicians in pharmaceutical sector is extremely heterogeneous and has their sample that had low access to sales reps took signifi- been undergoing considerable consolidation through cantly longer to reduce prescribing in response to a newly mergers and acquisitions recently. This is going to change the discovered risk than those with high access to sales topography of the pharmaceutical sector as far as the nature professionals. and kind of players are concerned. The health care sector is Of course, the applicability of these specific findings to equally heterogeneous, an extremely dispersed and unreg- India or other emerging markets with different information ulated market. It is often difficult to identify the scope/ structures, different regulatory environments and different borders of this market. education levels is not obvious, but the reality that infor- mation is costly and that providing more information allows Regulation of the health care/pharma sector people to make better decisions is universal. Allowing My next point is about regulation in the health care sector manufacturers to provide information to professionals and and I will enumerate certain issues related to the experi- perhaps to patients as well is a fundamental step along the ence of regulatory enforcement in this sector. The first is ethical course. Any structure that dictates the conditions about pharmaceutical pricing. The National Pharmaceutical on which information can flow should account for the Pricing Authority (NPPA) which is the regulator for prices in potential gains from having more and better information in the pharmaceutical market is located under the Depart- the hands of prescribers and patients. ment of Pharmaceuticals which is situated under the Ethical issues in health care sector in India 57 Ministry of Chemicals and Fertilizers. We are talking about The fourth and the last point pertaining to experiences health care here and the Ministry of Health and Family in regulation is registration of health care institutions. The Welfare should have been the ministry or the custodian of Clinical Establishment Act, 2010, which was notified earlier the drug regulator in this case. The NPPA’s motto is to serve in May 2012, still remains a model law and is yet to be the consumers while encouraging the pharmaceutical adopted and adapted across most of the states. Only seven manufacturers to produce adequate quantity of quality states have adopted this Act to date, namely, Arunachal products to meet the rising demand. However, we know Pradesh, Himachal Pradesh, Uttar Pradesh, Rajasthan, from experience that often protecting the interests of the Jharkhand, Mizoram, and Sikkim, and the Union Territories. industry becomes a priority over protecting the interests of There is still a lot of resistance from the states in adopting the consumers. For instance, if you look at the list of the Clinical Establishment Act. Related to this, in terms of essential medicines, there has been a considerable reduc- the performance of the health care institutions, according tion in the number of medicines which are covered in the to the National Antibiotic Policy of 2010, the government National List of Essential Medicines (NLEM) over time. While has been toying with the idea of prescription audit to assess at the same time more and more private companies have adherence to “rational use of drugs” (RuD) by the doctors been given licenses to produce drugs in our country. and health care institutions. But there has been resistance The second point about regulatory enforcement is about to this suggestion, especially from the Drug Traders Asso- the quality of the drugs which are available in the market and ciations in the country. what the regulator has done in order to ensure that quality is Recently, there were reports in the media about maintained. The Central Drug Standard Control Organisation continuing friction between the Planning Commission (CDSCO) which controls the in-flow of drugs into the country (Government of India) and the Ministry of Health and Family and oversees clinical trials, is placed under the Ministry of Welfare regarding recommendations made by the High Health and Family welfare. However, if you discuss issues Level Expert Group on Universal Health Care headed by Dr. with them, they say that their sole responsibility is to ensure Srinivas Reddy. If one looks at the chapter on Health in the that they provide licenses to international firms entering the Five Year Plan (2012e17), it talks more about managed care market. The license for domestic drug firms is provided by which has not gone down well with the Ministry of Health the state drug controllers, who are also responsible for and Family Welfare for obvious reasons. The Health Ministry monitoring the performance of these firms in the market had hoped to receive greater financial support for with regard to availability and quality of the drugs they enhancing the capacity of the sector to provide better produce. Having worked in this sector for the last few years, health services, especially to the poor. CUTS feels that if the enforcement of such regulatory It is appalling that our country still doesn’t have responsibility (of availability and quality of drugs in the a National Health Policy. A draft has been lingering for market) is left with the state, it might be counter- a long time. There is a lack of political will in supporting productive. There is a large variation in the capacity of the and streamlining the health care sector as far as regulations state drug controller and also in factors that determine the are concerned, which has had major implications for market at state-level. In one of our recent projects7 for a majority of our fellow citizens. The first is the high cost of example, we met with the drug controller of one state who health care, and according to a World Bank estimate based used modern technology and was able to locate or monitor on 2004 data, several million households fall into poverty in the activities of the drug inspectors across various locations our country due to high health care expenses in India. of the state on his fingertips. This state drug controller was fairly well endowed with resources. When we visited another Private health care state and met with the drug controller there, we realised The next concern is about private health care expenditures that he had weak resource base (both physical and in terms of in our country and implications for the economically disad- human resources), which had implications on the perfor- vantaged. According to a report,8 private expenses in health mance of this drug controller (ability to monitor and regulate care constitute 80% of the total health care expenses in the sector). So, there is a need to re-visit the approach India, which is very high as compared to other developing (driven by the present policy framework/administrative countries. The issue which is of even more concern is that arrangement) where the state drug controller monitors the expenditure on drugs comprises 72% of the total out-of- performance of the drug firms in the state. One cannot pocket expenses in our country. A third issue on which we expect a weak (state level) regulator to effectively regulate have done some work9 is the nexus between various health such an extremely strong sector at the state level. care providers in the country. In our report prepared on The third issue concerns marketing. Under the Indian the basis of primary information gathered from the two Medical Council (Professional Conduct, Etiquette and Ethics) states e Assam and Chhattisgarh e what we saw was that the Regulations, 2002, pharmaceutical companies are not pharmaceutical companies were continuing to influence supposed to influence the behaviour of doctors by offering doctors through promises of foreign visits and continued gifts/commissions. But evidence suggests otherwise, going medical education. The job of the medical representatives by the large number of complaints which have been received too has become part of this loop. by the MCI about such practices. Recently there has been an Another thing that we need to think about is the size of attempt by the Health Ministry to come up with a Uniform the pharmaceutical industry in the country e do we need so Code of Pharmaceutical Marketing Practices (UCPMP). It is many pharmaceutical companies/drugs in the market? The a voluntary guideline but the ministry is very keen to enforce nexus between the doctor and the diagnostic clinic is it given the prevailing concerns related to marketing of drugs considered as “usual practice” and operationalised through in the country. “cuts and commissions” even though this is prevented 58 C. Chatterjee, V. Srinivasan under the MCI Regulations. It is not private health care the level of the state. Even with co-regulatory activities, alone that is affected by these kinds of practices. Even in for e.g. the sectoral regulation, much depends on the public health care, we have evidence to suggest deliberate nature of the market and that requires some thought. We suppression of medicine supply in public hospitals, of have also been lobbying for the adoption of the national consumers being forced to go outside public hospitals for competition policy in India, looking into the policy imped- medicines which were otherwise available at low cost (or iments that have hindered a level playing field in the no cost) from the medical store within the public hospitals. pharmaceutical sector, and affected entry and operations We need to deliberate on the kind of regulations that we of pharma firms in the country. We try to balance both: as are looking at and looking for. a consumer organisation we try to enforce the agenda of consumer protection on the one hand, while on the other Co-regulation and self-regulation we try to assess what is good for the industry. There has been a considerable amount of stress on public regulation and we have ignored the two other extremely important types of regulation: the first being co-regulation, Deepak Sapra and the other, voluntary self-regulation. Co-regulation sees the government regulating through the sectoral association Ethics in health care (i.e., the pharmaceutical association in the pharmaceutical sector and hospital association in the health care sector). My starting point for any discussion on health care ethics is We have seen that sectoral associations have remained the fact that it is imperative for a society to have healthy extremely meek in monitoring the behaviour of their citizens and therefore provision of universal, affordable members. We need to find ways in which the government health care should be a core objective. can work hand in hand with sectoral associations and The other fundamental premise is that health care is an empower them. The sectoral associations must become important aspect of our life and part of the society we live more active and penalise members who are indulging in in. So any discussion on ethics in health care cannot be in malpractices and/or not complying with applicable rules isolation of ethics in society. that have implications on their behaviour. I want to list out some of the major issues that I see around The most appropriate analogy that I was able to draw health care and especially pharmaceuticals where the was of a school where you have a teacher who disciplines question of ethics comes in and there are several grey areas. the class; she can be equated with the public regulator/ We use terms like health “care”, and pharmaceutical government. Yet you also have a monitor who is elected “industry”, and pharmaceutical “market”. While these are from within the class but is accountable to the teacher. This seemingly just definitions, the words used in these terms is the role that sectoral association should carry out, and appear to be at odds with each other e “care” and “industry”, remain accountable to the government. This is probably the “care” and “market”. The question is whether we can recon- kind of model we need to explore for the pharmaceutical cile these intended outcomes in a manner that is winewin. and health care sectors. It is time to see how that can be Some of the issues I wish to point out are done. It is also necessary to assess the catalytic forces for self-regulation, and promote them in the sector.  Drug pricing e Are drugs priced in a manner that they can serve the needs of people who need them? Can pricing Role of CUTS improve access? To what extent do market forces help in shaping pricing and impacting accessibility. Finally, I would like to inform you about our organisation and what we are doing to deal with this situation as How does pricing link to who the payer is, i.e. whether it a consumer protection organisation. Firstly, we are trying is out of pocket, insurance company, or the state? to gather some of the evidence that is otherwise difficult to get and use that to raise a debate on the need for reviewing  Drug discovery e are the efforts towards research tar- the regulatory framework for the sector. Secondly, we are getted to those segments where there are glaring trying to push the agenda that the main objective of the health care gaps? pharmaceutical or the health care sector is to promote  Influencing doctors and other health care service consumer interest. Unlike in any other purely economic providers in order to generate prescriptions. What kind of sector such as steel, retail, apparel or automobile e influence is acceptable e scientific, medical, academic, consumer/public interest issues are of prime interest in the commercial. pharmaceutical and health care sectors. Therefore, the geography and the framework for regulation are different Where do the lines get blurred? and have to be resolved by the government, both at the  Pharmaceutical research and clinical trials (CTs) e How central and the state level. much of it is ethical and to what extent do we go? We have to see how we can promote the NVG to effect a more responsible pharmaceutical, medical or health care sector in India e such discussions/processes should not be Drug pricing restricted to the national level but should take place across the states. I would like to share some specific examples. Let me start There has to be a consistent process or forum to ensure with the example of AIDS which is prevalent in several parts transparency across implementation of public regulation at of the world, including some of its most disadvantaged Ethical issues in health care sector in India 59 parts, especially sub Saharan Africa, parts of Latin America, there are no drugs targetting such resurgence. We must and Southeast Asia. Typically the cost of first line therapy provide incentives and funding for the right kind of research. for an individual afflicted with AIDS used to be $50e60$ per day irrespective of which part of the world the individual Influencing doctors lived in. As a consequence, many people were denied access because the drugs were simply unaffordable, espe- The third issue is around influencing doctors and others in cially so as several patients were living at below $1 a day the industry on the drugs that are prescribed. Many phar- With genericisation and competition, several players came maceutical companies have been questioned or criticised in, providing cheaper versions of the same therapy which for the way they achieve their financial targets, and the led to costs coming down to $1 a day. My next example is of financial metrics that they adopt, for example, categorising Rituximab, a monoclonal antibody, the biosimilar version of doctors by the value of prescriptions they generate, and which is manufactured by Dr Reddy’s, the company I work the methods used to influence doctors and generate for. The number of patients in India who were deriving the prescriptions. Even with regard to unbranded generics, benefit of this therapy was a handful, a few thousand, when concerns have been raised in the US about influence over the product was being sold only by Company X, the inno- another set of players in the value chain e the pharmacy vator. Enter the biosimilar version, at a price point that was chains, aggregators, and super markets, who are customers about 50% lower, and the number of patients getting and influence drug usage. benefitted expanded dramatically to several fold. Thus, for the right kind of price and the right kind of free market play, there can be a substantial impact on the number of Clinical trials beneficiaries. This can be especially effective in scenarios where the payer pays from the pocket, in countries such as Clinical trials are performed while establishing the safety India, Brazil, Latin America, Africa, and other parts of and efficacy of drugs intended for use on human beings. Southeast Asia. The coming in of competition immensely There are a series of tests which need to be undertaken, on increases affordability. While these kinds of drugs are still healthy volunteers as well as patients. One of the most very expensive for several patients, the coverage increases controversial ones is the issue of trials on human beings. Are disproportionately with the fall in price. we treating patients in the right manner? Are they aware of This is one of the most important issues around ethics what is happening? Are we providing the right kind of post- and health care. It should be possible for someone to access trial support to volunteers? This impacts us in India a lot, as an intervention/drug at the right time and in a manner that India is a preferred CT destination owing to lower costs. One doesn’t cripple him/her financially. This is a very important estimate put the comparative cost of CTs in the ratio 1:4; issue that generic companies and competition in the phar- that is if it costs $10M in India, then it will cost $40M in the US. maceutical space have been able to address. I feel happy The important thing to note here is that there is a need for and proud to be a part of this sector in India especially transparency and this is not a very strongly established because we are making a tremendous impact towards system in India. Concerns have been cited about the medical, improving the affordability of drugs, in every part of the ethical and financial treatment of volunteers and subjects. A world. pharma report suggests that in 2012, more than 200 people have died as a result of clinical trials in India. This brings us to the question whether all was fair and square, and whether Drug discovery the subjects were made fully congnisant of the issues around enrolment and subsequent medical attention. So, how do we Drug development is a high risk, high investment and create health care ethically and legally? resource intensive game. It takes 10e12 years to get a drug There is debate around reducing clinical trials on humans, to the market; it costs anywhere between USD 800 mn to wherever possible. Can we use more of technology and IT? a billion. If companies cannot recoup the money, as Can we use more statistical tools and be accepting of them? corporations they will find it difficult to invest in specific Can we do more predictive in vitro experiments to reduce areas. This determines choice of areas to invest in, and in vivo activity? Can we formalise authorities’ responses, so commercial attractiveness often scores over public health that there is mutual recognition of each other’s approvals? concerns. This is one reason we see so many new drugs in Some of these questions could show us the way. the neuropsychiatry space and so little, for example, in tuberculosis. As a synthesis, we must harness and leverage the power Ravikumar Banda of free markets with the benefits of collaboration, espe- cially on research in areas of public health concerns. Perspective on Indian health care Technology is an enabler and the more we use it to impact how drugs are researched and manufactured, and how My perspective is likely to be different from that of the diseases are diagnosed, the easier it will be for new drugs other panellists on this subject. Let me tell you where I to get to the market. come from. I have done my medicine, post-graduation in Investments in research also have to be a collaborative psychiatry and I practised for some time. I then worked effort between the public and private sectors with higher with Astra Zeneca research foundation after which I started funding for non-profitable drugs. Several old diseases, for my own company. So I have seen the industry from within, example malaria, are coming back with a vengeance and plus I know what a medical practitioner feels. 60 C. Chatterjee, V. Srinivasan Paradox of health care industry at the end of the process, and we lack the confidence that Health care is a very peculiar industry in that the consumer a private company could make medicines affordable to has no rights. The consumer is completely governed by people. Since the product has come with peer-funding, it a middleman who doesn’t pay for it, and that is the doctor. comes with fewer problems, so the company could make it In this situation, there is one thing that is quite frightening; more affordable. a clinician crossing ethical borders can cause lot more They do not also understand the issues connected with damage than the pharmaceutical industry crossing the legal commercialisation of a product. Let me give you the borders. So we require phenomenal ethical regulation example of a company X that came up with a medical which includes both the doctors and the other people diagnostic device that could be plugged into the Internet concerned within the same framework. To enable this, we and would provide excellent tele-medicine services, con- have one organisation, the MCI. While MCI is an august body necting doctors and patients in remote villages. But that in this country, it has zero capability of enforcing regula- product has gone nowhere because of the insistence that tions or taking anybody to task. They do not have recourse the price should be kept very low and within that pricing, to legal aid that can help them to take action if something there was no distribution margin for 2e3 levels as required. goes wrong. Even when legalities have been breached by We need to think through the whole distribution chain and clinicians it is very difficult for MCI to intervene and do incentivise the whole system, if not it won’t reach the last something about it when somebody complains to them. man. They have to seek justice through the courts. We have a paradoxical situation in this country, where Ethical practices and positions we have a huge disease burden when compared to the I now come to a problem that Rijit alluded to: the cuts Western world, but we are doing little to effectively taken by doctors. It’s a huge problem in our diagnostics manage the abundant sickness. We have a lot of plans but I industry. Where did the cuts get created? The doctors don’t think we are implementing any of them. blame it on pharmaceutical industry; I completely blame the doctors. We need to have highest ethical practices with The need for innovative health care delivery diagnostics and drugs as the cuts and incentives add to the What we require is two things, namely, inventions to tackle patient’s burden. The doctors within their own fraternity, some of these problems, and innovation in delivering the and with the MCI and all the others concerned, need to get solution to the last man in the remotest village. We lack together and see that the highest ethical standards are innovative health care delivery. Quite often, we blame the maintained. person who invented the solution for the disease. We, the Let me demonstrate what I mean by unethical practice. government and society have been opportunistic. While As a diagnostic provider let us say that I sell an HIV test kit many people have been benefited by making some drug at a price between Rs. 17 and Rs. 25 depending on the tax generic we have killed innovation in the process. We don’t structure of that state to the hospital but the hospital in see how we can keep the person still interested in the solu- turn charges the patient anywhere from Rs. 325 onwards. Is tion, in going further. At the end of the day, the pipeline will there so much of value addition in the hospital on this dry up. Patent and patent protection is not a problem. The diagnostic kit? Definitely not. The charges are arbitrary and problem lies in intellectual property rights (IPR) manage- this is largely an unethical practice. Hospitals are built at ment, the pricing of the new drug, negotiating with a certain cost and they generally want to earn their costs a company when a new innovation has been made in making back on everything that goes through that hospital and that available to people, and so on. There we don’t have that’s where everything gets overcharged. I don’t know solutions and we require a lot of inventions in that space. who will control it, but it’s a huge problem in making health However, we have the problem of poor performance care affordable in this country. Whatever the manufacturer with regard to inventions, ethically as well as on the does, it does not reach the people because the hospital will management side. Big corporations are scared of investing hike up the price. in inventions and SMEs are enthusiastic in niche areas, they Coming to the regulatory hurdles, we have a Central think that it can give them a unique position if they have Drugs Controller General of India (DCGI) who reports to the a new invention but they don’t have the money to see the Union Health Minister. Each state has a drug controller who problem through. There are government initiatives such as runs the day to day business of regulating, inspecting and New Millennium Indian Technological Leadership initiative prosecuting. This is under each state government sepa- (NMITLI), Biotechnology Industry Research Assistance Pro- rately and it is a very confusing situation for the industry gramme (BIRAP), where part of the funding comes from and it needs to be rectified. The second problem in this private initiatives. However, we have ethical issues when it area is the lack of a clearly defined work ethic. Even if we comes to supporting inventions in this country or supporting put aside things like corruption, delay in issuing license e funding. We have committees which look at publiceprivate sometimes for years together, is an unethical practice partnerships and they are worried that at the end of the which is not punished. On the other hand, if a drug is day, there is public money coming into a project that ulti- granted a license and is used effectively for four years, and mately can be taken up as a product in the private sector. in the fifth year there is a problem, the manufacturer will Though one may have price controls, it is the company that be punished severely and the Drug Controller gets a black makes a profit. They feel that the private investors in the mark. So many people feel that inaction is the best way. company have been made rich by expenditure at the This is how it is all over the world, not only in India. public’s expense. Amidst these confusions and ethical However, the US FDI says there are ethics within that. If dilemmas we forget that they there could be a public good a new drug is going to improve health care by even 5% or 2% Ethical issues in health care sector in India 61 more than what the current drug is doing then it is your Discussion ethical duty to see that the drug reaches society in the shortest time. This is lacking in India. We have not ever Vasanthi Srinivasan: Thank you. You have laid out the stated the ethical position, that it is also the duty of the range of issues on the subject of ethics in health care quite government to see that a drug reaches the people within comprehensively. The issues discussed reflect the a stipulated time. Therefore, some ethics has to be brought complexity of the sector, the multiple stakeholders into the regulatory process. One important point that involved, the different interests of each of these stake- everybody forgets, including the health ministry, is that if holders, the weak regulatory framework, and the question we delay a drug then the cost of this delay is loaded on to of self-regulation at the level of medical professionals and the price of the drug. We have to think through every delay organisations. and include it in the process. What would be the three recommendations or sugges- Public-private partnership tions that each of you has to any of the stakeholders that Next, I would like to continue what Deepak brought up e would contribute to building a more ethical health care about public-private partnership and the point of trust and I systems? will say that trust is lacking on both sides. Both the industry Rijit Sengupta: A critical issue, which was raised by Ravi and the bureaucracy are culpable in their own way but if we as well, is the role of the drug controller (DCGI) both at the keep blaming each other and carry on a game of one- centre and at the state level. The Ministry of Health and upmanship, this will go nowhere. At some point we need to Family Welfare must develop a mechanism that promotes say stop and restore the ethical balance. The most impor- co-operation and consistency across the drug controller tant aspect of this is, what is the effect on the ethics of the functions in the states. whole society. We need to be responsible as a society on Most of the services in this country have a dedicated many of these issues. sector regulator but the private health care sector (private Let me give you an example from clinical trials. There hospitals and clinics) neither has a regulatory framework have been instances where committees working under the nor a regulator. The government must articulate its position Drugs Controller General of India (DCGI) have given oppo- in terms of regulating the private health care sector, given site decisions in similar situations. Very often committee the proliferation of private providers in this sector which is members though academically qualified do not understand only going to increase. The third thing would be with regard the ground realities of public health, and they take deci- to the marketing of drugs. The government must move from sions based on convenience. developing voluntary guidelines to stricter regulatory norms It is a clinical trial which costs the maximum while as far as marketing and distribution of drugs is concerned. developing a drug. If we want to develop generic drugs, These are my key recommendations. which are important for the common man, we would Deepak Sapra: The core of my argument is based around probably have the following situation. An anti-tuberculosis affordability and I have a few recommendations on that. In drug was developed by a company in India, which went the Indian context, one aspect that really impacts afford- through toxicology successfully, and through phase one of ability is the time it takes for drugs to get approval e this the clinical trials, after which nothing further was heard aspect was pointed out by Ravi in his presentation. It would about the drug. Do you know why? The next step is a big be a very important aspect in health care overall. In order trial that would cost about S750M. The company is in to increase affordability we would have to reduce the time a dilemma whether to proceed or not because when this it takes to get approval for various kinds of drugs and we product is successful, every country poor or rich will want have to make sure of getting more people into the market to procure it. It would be the governments of countries who as early as possible. Another aspect, on the same point, would want to procure it and they would negotiate over the concerns the affordability of drugs which are still governed price. But who will finally pay for this $750M worth of by patent. On this my recommendation is that we must look clinical trials? This dilemma could prevent the drug from at compulsory licensing not just from the perspective of seeing the light of day because if this question is not patent protection but also from the perspective of number settled, the company could cap the drug indefinitely. This is of patients it is likely to impact. To my mind, compulsory where public-private partnership can come into play. licensing could be one way, especially in certain critical Maybe the Government of India should permit the company diseases where alternatives are not available. This could to conduct the clinical trial in India and negotiate for get more drugs into the market in a manner that is a differential price in India. But nobody is doing that. affordable to a wider mass of people in a country like India. Everybody is willing to do what is called open source drug I am conscious that it is a very dangerous argument, discovery platform in which first discovery costs $100M or because it could open the flood gates and therefore you less. That part they want to subsidise. But nobody is talking need to be very careful. It needs to be selectively done in about the remaining $650M. We need that kind of pub- the case of those products where there are no substitutes liceprivate partnership if you want to take the new drugs available and where there is a real case for public health or which are invented elsewhere to the masses; you are where a large number of patients are not being able to gain required to support them too and their inventions, other- the benefits of that medication. wise you will have a big problem of demoralising the My third point draws upon the emerging thinking around inventive companies. innovation, which Ravi and Rijit also spoke of. I agree that The foremost point is we need to think about how to the scope for innovation in this sector is phenomenally high bring ethics back into medical community back. at the moment because of the various kinds of possibilities 62 C. Chatterjee, V. Srinivasan that exist in the value chain. My recommendation to medical college hospitals attached. We were providing venture capitalists would be to be consciously on the good medicine through that system where the poor would lookout for the models which incorporate innovation in the get a certain amount of care. Today they are all in health care industry, especially around delivery, and to a dilapidated state, and we need to improve them. The start in places which are not conventionally considered funds allotted by the World Bank to improve the public important markets or important customer segments. There health system are not being used effectively. is a lot of value at the bottom of the pyramid and there is We need to urgently strengthen the public health care a lot of value in taking it forward. There are various inno- system. Thirdly and most importantly we need to integrate vative approaches that people are trying out and people the regulatory mechanism of the pharmaceutical industry have done it in different parts of the world. We should be into one body. We need to put in place much more rigour able to encourage innovation and get it into the Indian and time lines in executing these regulations, be trans- scenario. Another aspect I would like to draw attention to is parent and evolve guidelines by involving the pharma that there is tremendous potential to leverage technology industry. to reduce many of the barriers that exist, especially around Vasanthi Srinivasan: Thank you all for making this such information asymmetry. We could collaborate with the an enlightening discussion. leaders in the field over this. Vasanthi Srinivasan: I have a PhD student who is researching on scaling up of health care services and one of Appendix A his areas of interest has been telemedicine. Many tele- Supplementary data medicine initiatives have been announced in the public- private partnership mode but the incentive structures Supplementary data related to this article can be found at that are built in are unclear. What is likely to be the future http://dx.doi.org/10.1016/j.iimb.2012.11.004. of telemedicine given that it could enable affordable access to health care in rural areas? References Deepak Sapra: For this, we would have to look at collaboration with different players in the value chain. Backof, J. E., & Martin, C. L., Jr. (1991). Historical perspectives: Ravikumar Banda: Telemedicine is a subject close to my development of the codes of ethics in the legal, medical and heart. There are all sorts of problems around it and I have accounting professions. Journal of Business Ethics, 10, 99e110. seen companies struggle. The point in telemedicine is Chandwani, R; Devare, D T & Srinivasan, V (2011). Future fit HR in taking the product to the end customer. How do you reach health care sector: issues and challenges. In Presented at the NHRDN National conference, Bangalore, October, 2011. it and how do you make the whole path smooth? It’s like Desai, P. N. (1988). Medical ethics in India. 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Economic and Political Weekly, XLVII(36). proposition. Only if we bridge that gap, I think more and Selvaraj, S., & Karan, A. K. (2009). Deepening health insecurity in more innovations will occur which will simplify telemedi- India: evidence from national sample surveys since 1980s. cine. People forget that if a farmer can be saved a trip from Economic and Political Weekly, 44(40), 55e60. his village to his city for medical consultation, he is willing Sengupta, A., & Nandy, S. (2005). The private Health sector in to pay for the telemedicine service. So we must think of India. British Medical Journal, 331(7526), 1157e1158. how we can cost telemedicine cleverly to make it acces- Shleifer, A. (2004). Does competition destroy ethical behavior? In sible to the end user. NBER Working Paper 10269 and American Economic Review To reply to Vasanthi’s question, my three suggestions Papers and Proceedings, 94 (pp. 414e418). would be: Firstly we need to integrate MIC with the Silverman, H. J. (2000). Organizational ethics in health care orga- enforcement agency. We need to have MCI tie up with IMAs nizations: proactively managing the ethical climate to ensure organizational integrity. HEC Forum, 12(3), 202e215. (which are very powerful bodies in this country) to inte- Tsai, D. J. (1999). Ancient Chinese medical ethics and the four grate all the doctors and put back a programme in which principles of biomedical ethics. Journal of Medical Ethics, 25, they are exposed to ethical values and made aware of what 315e321. that would do to their practice. I think their own living will Veatch, R. M. (2006). How philosophy of medicine has changed improve. Secondly, we seem to have forgotten the existing medical ethics. Journal of Medicine and Philosophy: A Forum public health care system through general hospitals and for Bioethics and Philosophy of Medicine, 31(6), 585e600.