The Global Interface of Medicine, Business and Governmant
-
Upload
randall-randall -
Category
Documents
-
view
28 -
download
0
description
Transcript of The Global Interface of Medicine, Business and Governmant
![Page 1: The Global Interface of Medicine, Business and Governmant](https://reader036.fdocuments.us/reader036/viewer/2022071807/56812a67550346895d8de7f4/html5/thumbnails/1.jpg)
The Global Interface of Medicine, Business and
GovernmantTimothy F Christian, MD, MPA
![Page 2: The Global Interface of Medicine, Business and Governmant](https://reader036.fdocuments.us/reader036/viewer/2022071807/56812a67550346895d8de7f4/html5/thumbnails/2.jpg)
The InterfaceRegulation, FDAHealth Care SystemSocial InsuranceIP, Trade
Delivery, CostPreventionResearch
PharmaceuticalsDevicesCosts, R&DInsuranceITIP
![Page 3: The Global Interface of Medicine, Business and Governmant](https://reader036.fdocuments.us/reader036/viewer/2022071807/56812a67550346895d8de7f4/html5/thumbnails/3.jpg)
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
![Page 4: The Global Interface of Medicine, Business and Governmant](https://reader036.fdocuments.us/reader036/viewer/2022071807/56812a67550346895d8de7f4/html5/thumbnails/4.jpg)
![Page 5: The Global Interface of Medicine, Business and Governmant](https://reader036.fdocuments.us/reader036/viewer/2022071807/56812a67550346895d8de7f4/html5/thumbnails/5.jpg)
Where does Healthcare Spending Come from?
![Page 6: The Global Interface of Medicine, Business and Governmant](https://reader036.fdocuments.us/reader036/viewer/2022071807/56812a67550346895d8de7f4/html5/thumbnails/6.jpg)
TAVI case
1. Should Medicare cover the cost of the procedure?– If not, who should, if anyone
2. What type of metric should UK NICE use?3. Is their a political line that is crossed or is “rule of
rescue” invoked?– Who should decide where the line is?
4. Is the price from Edwards fair?5. Would Edwards have developed the device knowing
the price would need to be reduced or disapproved based if CER data used?
![Page 7: The Global Interface of Medicine, Business and Governmant](https://reader036.fdocuments.us/reader036/viewer/2022071807/56812a67550346895d8de7f4/html5/thumbnails/7.jpg)
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
![Page 8: The Global Interface of Medicine, Business and Governmant](https://reader036.fdocuments.us/reader036/viewer/2022071807/56812a67550346895d8de7f4/html5/thumbnails/8.jpg)
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.
![Page 9: The Global Interface of Medicine, Business and Governmant](https://reader036.fdocuments.us/reader036/viewer/2022071807/56812a67550346895d8de7f4/html5/thumbnails/9.jpg)
Anthrax Case Questions1. Was the US wrong to threaten Bayer?2. Would Bayer be likely to develop more such drugs
against potential terror vectors?3. Should Bayer Profit from a health emergency?4. What is the difference between HIV infection in
Brazil and Anthrax infection in the US? Is the US trying to have it both ways?
5. 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?
6. If the new drug will be given out at min. cost, does this diminish the chance it will exist?