Regional Comprehensive Economic Partnership (RCEP)

Issues in RCEP negotiations- Data Exclusivity

  1. Two of the most worrying are the demands for ‘Data Exclusivity’ and ‘Patent Term Extensions’ — both intellectual property obligations that Least Developing Countries are exempted from till 2033
  2. Data exclusivity: A form of legal monopoly protection for a drug, over and above the patent protections & is given expressly to compensate for the investment made during clinical trials
  3. Impact: Regulators cannot approve a similar drug with similar data for the next five years, delaying the entry of generic, affordable versions
  4. For India, agreeing to data exclusivity will mean amending the Drugs & Cosmetics Act (FDA law)
  5. It would prohibit Indian Drug Regulatory Authority (DRA) from registering a more affordable version of a medicine as long as the exclusivity lasts over the clinical trial data
  1. Two of the most worrying are the demands for ‘Data Exclusivity’ and ‘Patent Term Extensions’ — both intellectual property obligations that Least Developing Countries are exempted from till 2033
  2. Data exclusivity: A form of legal monopoly protection for a drug, over and above the patent protections & is given expressly to compensate for the investment made during clinical trials
  3. Impact: Regulators cannot approve a similar drug with similar data for the next five years, delaying the entry of generic, affordable versions
  4. For India, agreeing to data exclusivity will mean amending the Drugs & Cosmetics Act (FDA law)
  5. It would prohibit Indian Drug Regulatory Authority (DRA) from registering a more affordable version of a medicine as long as the exclusivity lasts over the clinical trial data
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