Meghana Aruru, Ph.D., MBA, B.S.Pharm Midwestern University J. Warren Salmon, Ph.D.

1. HIV/AIDS IN INDIA, CHINA, & BRAZIL: Comparing Pharmaceutical Context of Trade and Health Policies Meghana Aruru, Ph.D., MBA, B.S.Pharm Midwestern University J. Warren Salmon, Ph.D. University of Illinois at Chicago

2. What do the emerging economies of China, India, and Brazil have in common? • Sustained economic growths of more than double the Western nations • Huge populations (younger and growing) • Lack of societal infrastructures and modern institutional building present obstacles for sustained development ($6.3 trillion committed in emerging nations for infrastructural problems) • “Low income consumers in developing nations” represent almost 1/3 of the world’s population, who are “eager for pharmaceuticals” • These nations both compete and cooperate on many fronts, but together they are reshaping the world polity.

3. Commonalities between China, India and Brazil • IMS recorded (2007) RX market growth in Asia Pacific (excluding Japan) of 13.3% (compared to 4.2% for North America) • Business opportunities for investment by multinationals and huge population of consumers for Western products • Yet, among the three nations, there are massive trade inter-connections, scientific exchanges, joint pharmaceutical R&D efforts • Along with the Southern Hemisphere challenge to Western hegemony over access to medicines, patent protection, unfair trade terms, other public health concerns, etc. • So the “new Silk Road doesn’t lead to the U.S.” (Bloomberg Business Week, August 9, 2010)

4. Health Care Systems • Ranks of impoverished are high in China, India, and Brazil (meaning a disease burden) • Vast geographic areas challenge health care delivery, which is generally under funded for their populations’ needs • Respective HIV/AIDS epidemics are all growing with staggering numbers • All three nations have historically lagged in addressing the epidemic, though current resources could be more available and better directed but new steps seem promising • While policy changes are underway to tackle the HIV/AIDS disease spread, social, cultural, and political barriers remain in each country

5. Health Policies for HIV/AIDS • Each nation has a pharmaceutical industry of substantial size and rising capability, if only to address HIV/AIDS epidemic and co-morbidities. • Yet, health policies need to harness how their domestic pharmaceutical industries can be used to resolve the respective national epidemics • The roles of the respective pharmaceutical industries thus differ and deserve attention • Western news presentations of all three nations lack detail and often perspectives are clouded

6. HIV/AIDS 39.5 million cases worldwide; 2.7 million new per year; over 2 million persons die annually In its third decade, the global pattern of this devastating disease has rapidly changed Scientific surveillance reports remain quite difficult with insufficient number of sites to observe • While Africa has largest number of people with HIV, South and Southeast Asia is where HIV is spreading faster • Religious and social cultural milieu contribute to ineffective surveillance • Rapid diagnosis amidst poor health literacy are major barriers to control strategies

7. HIV/AIDS • Mutating virus of various strains is scientifically challenging and resource demanding • As an auto-immune disease, if untreated the resulting M&M is quick and painful • Opportunistic infections abound in poverty affected areas • Behavioral controls defy prevention interventions • Affected groups face discrimination and stigma • Forceful community activity and vibrant NGOs are vital within a strong policy framework to adequately monitor and evaluate sustainable accessibility • With treatments accelerating some, new infections in several places are though to be dropping, but a vaccine remains elusive

8. Pharmaceutical Issues • Treatment remains very costly for developing nations and generally unavailable. ARVs are powerful and dangerous with lots of ADRs • Costs of ARV treatments remain beyond reach of patients, families, and public health budgets in developing world. While tiered ARV pricing by multinationals has been beneficial for some developing areas, nations need to pursue different strategies • CIPLA broke patents in formulating twice a day triple therapy generic (2001) • Third generation ARVs are needed for many cases in the later stage in treatment given resistance of the HIV organism • Clinically trained teams of professionals are critical with modern facility backup in every country • Access to facilities and patient compliance are clear deterrents to treatment effectiveness and epidemic control (clean water, transportation, health literacy, effective health education, etc.) • Declaring a national emergency allows a sidestep for importing or manufacturing ARV substitutes around IPR of multinationals (2001 WTO TRIPS) • Compulsory licensing promotes access to needed treatment and gets around patent protection

9. Western Pharmaceutical Firms • China, India, and Brazil are among 17 PHARMERGING MARKETS expected to yield $140 billion of increase sales for the MNCs • Given US & European public and private insurers tightening reimbursements, drug sales and profits were heading down even before the economic recession began in 2008 • Big PHRMA pursuing an M&A strategy here and abroad, they are ready to build or buy for the geographic presence • Western brand drug firms gaining generics operations is part of this direction

10. China, India and Brazil

11. China, India and Brazil

13. China • 1.3 billion people live in China, ethnically diverse and scattered over vast terrain • 600 million in rural areas without adequate access • Urban dwellers face similar chronic degenerative disease patterns to the West • Privatization of China’s health care system leaves even urban employed workers with access and cost barriers • A few abortive national attempts for health coverage reveal immensity of challenges for health sector reform

14. China AIDS • Burden of disease 600,000 (according to gov’t) infected by heterosexual and MSM activity, IV drug use, and tainted blood (Henan province) • UNAIDS had predicted 1.1 million by 2010: IV drug users make up half the number • Surveillance measures are weak • Ignorance, stigma, and past low priority by government • NGOs suppressed and international aid restricted • HIV/AIDS poses threat to derail economic growth if epidemic spills over to the productive middle and working classes

15. China AIDS • China has thousands of pharmaceutical firms and its market is predicted to double by 2008-2013 with health reforms • Regulation and quality control enforcement of pharmaceutical firms remains suspect • Constraints on NGOs, civil society groups deters policy and programmatic effectiveness • Improved surveillance, monitoring and intervention with increased access to ARVs

16. India • Infectious diseases rampant among poor and underserved • Emphasis on chronic care due to western lifestyle influence • Healthcare system: Public-Private mix • Largely FFS • High purchasing power compared to middle income countries • Low spend on healthcare by government ~ 4% • Private healthcare growing as public sector stagnates

17. Indian healthcare system Historically strong generic private industry • $55 billion by 2020 • Low cost production, delivery and pricing enable presence in western markets • Drug discovery agreements with larger pharma, contract manufacturing, Rx trials and M&As Aurobindo & Cipla broke patents on 3 Brand ARVs and combined to form a triple cocktail therapy • Increased treatment options and access for developing world along with prolonged life expectancy • Sold to African country governments at $600/person/year and to NGOs at $350/person/year

18. India AIDS • India has a series of HIV epidemics, widely varied with respect to prevalence rates, risk for infection, and transmission patterns - mainly becoming women with significant differences between states, regions and subpopulations • Sentinel surveillance: Launched in 1987 • Issues in surveillance: • Only for sentinel events at public sites • No national information system existing • Most labs not in adherence to quality testing

19. India AIDS • National AIDS Control Organisation (NACO): Funded only at $38.8 million – grossly inadequate with uneven state efforts • Strong partnerships with NGOs and Civil Society Groups • AIDS task force established in 1986 • Targeting of high-risk individuals but inadequate targeting of homosexuals and IV drug users

20. Brazil • 200 mil population growing at 16% each year • Unified public health sector with free medical assistance by right of citizenship • Brazil is an emerging pharmaceutical market – growing at ~ 10% each year • Increased R&D and contracts with Big Pharma – import of raw materials for APIs may not make it the most sought after production partner for Big Pharma

21. Brazil AIDS • In 2000 the World Bank predicted 1.2 million HIV cases by 2005 but only about 600,000 were detected Government HIV/AIDS program guarantees free treatment with ARVs not costing patient • Brazil and Thailand among few developing nations to provide “universal access to HIV meds” to infected populations • Following Thailand’s issuance of compulsory licensing for RXs, Brazil threatened to follow suit, effecting Multinational Brand makers to lower their HIV/AIDS drug prices in Brazil and over 40 countries.

22. Brazil AIDS Lessons Learned Government actions stemmed the tide of the HIV epidemic with: • Abundant condom distribution • IV drug users get clean needles • Sex workers informed on condom use and safe sex practices • Over 500 NGOs enlisted for public health action • Early diagnoses and free treatment saves hospital costs • Government purchase/manufacture of HIV meds • Access to testing centers and public clinics may still be problematic in rural areas

23. Future directions • Public health advocacy for changing patent laws is crucial toward improving access to much needed meds in developing countries • Push for more R&D efforts for endemic, infectious diseases • Easing of trade rules and regulations • Could be done with bilateral or multilateral agreements (e.g.ASEAN) for ARVs without fear of repercussions from US or other western nations • Royalties under CL – prohibitive and unconscionable: Big Pharma cooperation could be elicited for more reasonable pricing and through improved access

24. Conclusions • Access to a wide range of necessary meds (antibacterials, antivirals, anti infectives etc) is essential for preventing opportunistic infections • Continuous monitoring and surveillance necessary to contain further spread of infections – particularly for HIV/AIDS orphans • Social and cultural milieus will continue to impede progress and control of HIV/AIDS epidemic • Renewed efforts in compassion to reduce stigma against commercial sex workers, MSMs, IDUs is key to stemming the tide of new infections