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The Global Interface of Medicine, Business and Governmant

The Global Interface of Medicine, Business and Governmant. Timothy F Christian, MD, MPA. The Interface. Regulation, FDA Health Care System Social Insurance IP, Trade. Delivery, Cost Prevention Research. Pharmaceuticals Devices Costs, R&D Insurance IT IP. Some Definitions.

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The Global Interface of Medicine, Business and Governmant

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  1. The Global Interface of Medicine, Business and Governmant Timothy F Christian, MD, MPA

  2. The Interface Regulation, FDA Health Care System Social Insurance IP, Trade Delivery, Cost Prevention Research Pharmaceuticals Devices Costs, R&D Insurance IT IP

  3. Some Definitions • Cost benefit analysis: Cost of an intervention/cost of an outcome.\ • Requires placing monetary value on an outcome such as death • Cost effective analysis (CER): cost A-cost B/outcome A-outcome B) • outcomes are in yrs of life saved or events averted • Cost Utility Analysis: same as CER except outcomes are measured in quality adjusted life years (QALY)-a subjective measure

  4. Where does Healthcare Spending Come from?

  5. TAVI case • Should Medicare cover the cost of the procedure? • If not, who should, if anyone • What type of metric should UK NICE use? • Is their a political line that is crossed or is “rule of rescue” invoked? • Who should decide where the line is? • Is the price from Edwards fair? • Would Edwards have developed the device knowing the price would need to be reduced or disapproved based if CER data used?

  6. Anthrax Case Background • 1980’s pharma companies and IBM push US Gov to establish IP protection. • Film and music companies jump on board • Uruguay Round: US leads GATT to adopt TRIPS • LDCs do not block TRIPS in exchange for Ag • LDCs get exception to TRIPS in Doha Round after threatening to walk (consensus format) for emergent public health issues • HIV epidemic, Brazil challenges US drug pat. Not LDC • US plans retaliation against Brazil through WTO for patent infringement of retrovirals

  7. Anthrax Case Background • Ciprofloxacin FDA-approved against anthrax • Patented by Bayer, sells for $1.83/pill • 1 week after 9/11, letters containing anthrax spores kill 5 people • There is a run on Cipro and US gov unsure it can supply Nation with adequate stock. • US Gov decides to acquire 100 million doses • US states Bayer patent void for pub health emerg. And plans to produce generics to cover pop.

  8. Anthrax Case Questions • Was the US wrong to threaten Bayer? • Would Bayer be likely to develop more such drugs against potential terror vectors? • Should Bayer Profit from a health emergency? • What is the difference between HIV infection in Brazil and Anthrax infection in the US? Is the US trying to have it both ways? • What if a new drug were found to cure cancer, would we as a society, insist it be given out free? If not, who decides who gets it and at what cost? • If the new drug will be given out at min. cost, does this diminish the chance it will exist?

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