Amar Jesani Indian Journal of Medical Ethics Centre for Studies in Ethics and Rights Mumbai, India

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1 Amar Jesani Indian Journal of Medical Ethics Centre for Studies in Ethics and Rights Mumbai, India

2 Framework Context of India and its health system Case study of attempted introduction of HPV vaccine in national program Vaccines and health system Need for system building For real change Make global health policy for universal access health care system for all nations

3 The real test of global policies is in their relevance to the developing countries. Global Policies that help reproduce or strengthen existing iniquitous systems, are highly unsuited for developing countries. When applied to a health system, technologies are not neutral. When technologies drive policies rather than other way round, the existing iniquitous systems are reproduced and strengthened.

4 Most current (global) Health System Strengthening strategies are selective, diseasespecific interventions, and their effects may undermine progress towards the long-term goal of an effective, high-quality, inclusive health system (1) Global policies should not cause further harm to health systems. At best, they should strengthen efforts made by local actors for change to Universal Access Health Care systems. (1) Marchal Bruno et al, Global health actors claim to support health system strengthening: Is this reality or rhetoric? PLoS, 2009, 6(4)

5 High economic growth of last two decades Booming business including in private for- profit pharmaceutical and hospital service sectors Massive export of drugs, and country opened to Medical tourism and Clinical trials to sustain health care business At the same time Increased inequities - Substantial proportion of population below poverty line, illiterate or semiliterate, and discrimination in accessing health care Government spends only ONE percent of GDP on health care, which is one fifth or sixth of total health care expediture

6 No universal access to health care 80% of health services in for-profit private sector Less than 10% covered under voluntary health insurance High cost of health care & over 75% of health care financed by out of pocket expenditure by patients Cost of health care a major cause of poverty Health care regulations: Dominant for-profit private health sector covered under grossly inadequate regulations not even simple registration of hospitals in place, let alone they having optimum standards. Existing weak regulations hardly implemented due to lack of will, corruption and bureaucracy Regular reports of unethical medical practices & Clinical trials The imaginary laissez-faire achieved in actual practice in health

7 Vaccines are wonderful technologies, if used as one of the tools of public health Making them the sole or disproportionately large purpose of public health, would reduce public health to technology of disease control To an extent such major role for them is proposed because they are also big business - a captive market for sale of millions of dozes Let us look at the case of HPV vaccine in India

8 Under-funding combined with moves to privatisation, have rendered public health care system extremely weak and demoralised Federally funded National Immunisation program with five vaccine have also suffered Despite massive inputs and international involvement, polio vaccine program has not met its objective Cervical cancer is a serious public health problem for women in India, but the screening program for the disease is not in place

9 Market price of HPV vaccine (3 dozes): Rs (US $ 180) To vaccinate all girls of yrs age (62.5 million girls) would cost Rs. 562,500 million ($ 11,250 m) This amount is FOUR times the federal government s total annual health care budget Every year 12.5 m new girls will enter this age group: vaccination cost Rs. 11,250 m ($ 225 m) Current budget for five vaccine national program (excluding polio) is Rs. 4,000 m ($ 80 m)!!! (2) By Anant Phadke, as communicated on the egroup of the Medico Friend Circle, India (

10 Despite criticism and resistance, an international NGO with money from private charity bypassed federal vaccine policy making body, got two state (provincial) governments to participate in demonstration project for introducing the vaccine in the public health program. In tearing hurry to get into the system, the project was done in violation of ethics including poor documentation and investigation of Serious Adverse Events - seven deaths without conclusive evidence whether linked to vaccine or not. (3) (3) Sarojini NB et al, HPV vaccine: science, ethics & regulation, 2010, EPW, 45(27): Sarojini NB et al, Undeniable violations, unidentifiable violators, 2011, EPW, 46(24): 17-19)

11 Messy attempt in demonstration has temporarily stalled the distortion of system by its high cost Systematic response of Thailand that built Universal Access health system in last one decade. Technology assessment threw up evidence that the screening program (pap smears & VIA) were significantly more cost-effective HPV DNA test and vaccine. (4) Min of Public Health, Thailand Research for Development of an Optimal Policy Strategy for Prevention and Control of Cervical cancer in Thailand, IHPP & HITAP, 2008, pgs. VIII

12 More radical measures for making vaccine public goods needed than temporary reduction of prices of vaccine by companies In Ca Cx case, the establishment of screening program is not just cost effective, but also has more potential for system building The developing countries would benefit more by adopting strategies that are cost effective and at the same time strengthen the system.

13 The global health policies are increasingly shaped by (a) global trade relations giving priority to the interests of global Corporate business, (b) World bank s involvement in the field of health and (c) Private foundations. (5) Public health is getting reduced to the narrow area of economic externalities, taking us away from the ideal of treating it as a public good, the chief function of the state. (5) Amit Sengupta, Global governance of health: a minefield of contradictions and sectional interests, Ind Jn of Med Ethics, 8(2): (

14 There is enough historical evidence to show that Universal Access Health Care systems have developed only by making health a public good, delivered as a part of public policy Global health policies must align with forces demanding universal access systems in developing world For the impoverished and deprived people of the developing world that would be a real change

15 In 2008 for a brief period I was involved in reviewing the formative research in two states by the international NGO that carried out by the HPV vaccine demonstration project. After the review of formative research, I resigned from the expert or advisory committee before the commencement of the demonstration project.

16 Thank you

Clinical Trials in India Regulatory Issues

Clinical Trials in India Regulatory Issues Prem Pais MD Dean & Professor of Medicine St. John s Medical College Head, Clinical Trials Division St. John s Institute of Population Health and Clinical Research