- An INDIAN Perspective

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US Healthcare Policy - An INDIAN Perspective Tapan Ray Director General Organisation of Pharmaceutical Producers of India 3 rd Annual Pharmaceutical Leadership Summit Mumbai - 25 th June, 2010

US Healthcare Reform Key Highlights Arguments Favor / Against Immediate Impact on US Pharma Companies Impact in India Content Should the landmark US Healthcare Reform be replicated in India?

2009 Market Share, US$ Rest of world 8% US 39% Pharmerging 13% Rest of Europe 9% Canada 2% US EUS Japan Canada Rest of Europe* Pharmerging Rest of World Japan 11% EUS 18% *Turkey & Russia excluded from Europe, included in Pharmerging Source : IMS Health, Market Prognosis, October 2009

2009 Growth Share, % Percentage Growth Share of Countries 100% 80% 60% 40% 20% 0% Rest of World Pharmerging Rest of Europe* Canada Japan EUS US 2006 2007 2008 2009(f) 2010(f) -20%

US Healthcare and World Comparisons Healthcare reform is a priority for Barack Obama. The US spends about $2.5tn a year on its system - which includes private, federal or employer schemes.

What is Obama's Health Care Reform Plan?

Key Features US Healthcare Reform Cost Coverage $ 940 billion over 10 years. Expected to reduce projected federal budget deficits by $ 143 billion by 2019 95% people would gain coverage, leaving 22 million uninsured Timeline Most provisions would take effect in 2014 Sources of Funding New Taxes Tax on high-income earners Tax on Cadillac health plans 10 year industry fees imposed on: 1. Insurance Companies 2. Medical Device Manufacturers 3. Drug Makers Individual Responsibility Penalty: People without coverage would pay a fine of $ 95 in 2014, which would rise to $ 695 or 2.5% of income, whichever is higher by 2016

Key Features US Healthcare Reform Employer Responsibility Penalty: Raises the fee that employers must pay if they don t provide insurance to $ 2,000 per employee. Also, exempts companies from paying the fee for the first 30 employees Employer Subsidies Small businesses can immediately apply for tax credits of upto 35% of their contributions toward employee health insurance premia. Beginning in 2014, these tax credits will cover 50% of contributions toward employee premiums. Fraud and Abuse Deterrence / Civil and Criminal Penalties: Penalties increased to $50,000 for each false statement or misrepresentation

Impact on Health Insurance Coverage Coverage changes over the next nine years due to health reform

Some Arguments in favour of the Act More security to the lives of so many Americans. Will protect against worst practices of insurance companies. Will give chance to uninsured and small businesses choose an affordable plan from a more competitive market.

Some Arguments in favour of the Act Every insurance plan will cover preventive care. Reduce cost of premium because of intense competition and regulations. Would bring down the deficit by US$ 1 trillion.

Some Arguments against the Act Goes against popular wisdom Complex difficult to implement Expensive Appeasement to Insurance Companies Political suicide

Immediate Impact on US Pharmaceutical Companies Impact on Sales & Profit due to higher rebates on drugs sold through Medicaid Program. 50% discount for patients in Medicare part D Program.

Immediate Impact on US Pharmaceutical Companies J&J, Eli Lilly, Abbott, Amgen and Gilead have given guidance on adverse impact on 2010 performance Companies with high US sales dependency like, Forest, King, Cephalon, Amgen and Shire could be the biggest losers Bayer, Sanofi-aventis, Novartis and Roche may have lesser impact

Impact on Indian Generic Business The Act promotes use of generic drugs. India produces 20% of the global requirement for generic drugs. Indian companies account for 35% of ANDAs.

The Flipside Increase in demand will attract more domestic generic players to compete. Will attract more MNCs in generic business. Immense cost competition. Intense pressure on margin.

Impact on Indian Bio-similar Drug Business A pathway for entry of Biosimilar drugs is now in place. 12 year DE could be an impediment. Since Biosimilar opportunity in US comes in 2015, many such drugs developed in India will cross 12 year exclusivity period by then. Many US biotech companies are looking for lower cost bio-manufacturing destinations.

Impact on BPO Opportunities in India 35 million more Americans will come under insurance cover. Involve millions of new enrollment and transactions. Will require more customer support services. Healthcare Reform makes digitalized records mandatory.

Impact on BPO Opportunities in India Currently less than 30% of physicians in USA have Electronic Health Records (EHRs). Conversion of archival data into compatible formats (Data Entry, Validation, Maintenance) will be a must. Online submission of applications through payers portal will start. High volume claim adjudication will follow

The Flipside Lesser Willingness to Outsource Regulatory and Privacy concerns related to patients records Knowledge of medical procedures and codes Variation between the states within USA

Expected Volume of BPO Business U.S. Government is likely to spend US$ 15-20 billion on healthcare technology services alone. Bulk of the business is likely to come to India.

What is happening now? Call Centers, Medical Record Transcribers, Software Developers have started building commensurate capacities. Telecom, Banking, Financial Services, Customer Services are the main BPO from US. Currently the size of India s outsourcing industry is US$ 61 billion.

What is happening now? Healthcare BPO now represents only 5% of the total this will increase significantly India s big outsourcing firms are setting up operations in the US ET says this is India s biggest BPO Bonanza yet bigger than even Y 2 K

Indian BPO Companies Spreading Wings WIPRO - Opened a Development Center in Atlanta employing 500 people. - Runs a Call Center for US Healthcare Clients. TCS in Cincinnati employs 300 people. Infosys planning a subsidiary in Dallas.