AIDS DRUGS, NATIONAL
EMERGENCY & CIPRO
Srividhya Ragavan
Nat. Academy For Legal Studies &
Research
Current Realities
• International
• National
International Realities Doha Declaration
• Protects Public Health &
Access to Drugs (Clause 4)
• Incorporates Flexibilties under
TRIPS (Clause 5)
International Realities Doha Declaration
• Interpretation of TRIPS vis-àvis Article 7 & 8
• Compulsory Licensing Powers
• National Emergency
• Establishing own regimes of
Exhaustion
International Realities Doha Declaration
• Establishment of Generic Drug
Industry (Clause 6)
• Extension of Time (Clause 7)
Why did Doha Happen
• South Africa
• Thailand
• Brazil
• India
America’s Reaction to Doha
• Pre-September 11th Reaction
• Post War on Terror Reaction
American Reiterating
International Trend
• Anthrax & Effect
• Price Control By States
• Florida
• Maine Rx Program
• Vermont
National Realities
• Amendment to Hatch-Waxman
• Authorizing Parallel Imports
from Canada
Effect of the Changes General
• International Law’s Direction
• Legitimization of the generic
drug industry
• The Status of TRIPS as a
Treaty
Effect of the Changes Developing Countries
• Understanding of TRIPS in
Developing Countries
• Bargaining Power - Anthrax &
The war on terror
Effect of the Changes Developed Countries
• Loss of Stature
• Loss of the Trade Sanction
stick
• Loss of Bargaining Power
• New Focus on Trade Policy
Effect of the Changes Pharmaceutical Industry
• Loss of ‘Capitol’
• Alteration of Basic Social
Contract
• Market losses
How?
• Strategy
• Legal Issues
Pharma Strategy
• Issues for Developing
Countries
– Not Patentability
• Choice for Pharmaceutical
Industry
Pharma Strategy
• Impractical Assumptions
– Leading to generic drug industry
• People’s Reactions
• Unrealistic Expectations from the
Government
Legal Perspectives
• Traditional Economic
Rationales of Patent policies
• Research & Development
A Future Strategy
• Strategy Focus
– Investments and Relaxation
–Indian Computer Industry
– Better access leads to less price
control
– Drug Price Control Order