EU Implements WTO Agreement on Access to Medicines, Establishing Compulsory Licensing System

Strategic Insights -

The European Union has established a system to enable companies to manufacture medicines for export to developing countries under a compulsory licensing regime. The new regulation, which implements the WTO agreement on access to medicines, allows developing countries to notify the WTO of their need for specific medicines, triggering a registration procedure. Generic drug manufacturers can then apply for a production license, while the patent holder retains the right to enforce its intellectual property rights against re-imported products. The system excludes re-importation of low-price drugs into the EU and sets up a control system with specific packaging and labeling. The EU's scientific opinion procedure will be used to evaluate the safety and effectiveness of exported medicines.

Key Takeaways:

  • The EU has implemented the WTO agreement on access to medicines, establishing a compulsory licensing system for the manufacture of medicines for export to developing countries.
  • Developing countries can notify the WTO of their need for specific medicines, triggering a registration procedure.
  • Generic drug manufacturers can apply for a production license, while the patent holder retains the right to enforce its intellectual property rights against re-imported products.
  • The system excludes re-importation of low-price drugs into the EU and sets up a control system with specific packaging and labeling.
  • The EU's scientific opinion procedure will be used to evaluate the safety and effectiveness of exported medicines.
  • Exemptions are provided from data protection rules, allowing generic medicine manufacturers to obtain marketing authorizations earlier.
  • The system is already in operation, with Mozambique submitting a notification to the WTO two or three weeks ago for several products.
  • The EU, US, Japan, and other leading production areas have committed to swift implementation of the Doha decision through systematic acceptance of derogations.

Statistics:

  • The WTO agreement on access to medicines was concluded on August 30, 2003.
  • The EU has established a system to enable company registration and application for a production license.
  • Generic drug manufacturers can register and apply for a production license within a specified timeframe.
  • The EU has set up a control system to prevent re-importation of low-price drugs into the EU.
  • Exemptions from data protection rules will be granted for a period of eight years.

Sources:

  • Europe Information 2798 (no date specified)
  • World Trade Organization (WTO) (no date specified)
  • Regulation (EC) 726/2004
  • EISnet site: www.eis.be (no date specified)