The Council has adopted a regulation allowing companies to produce copies of patented medicines for export to countries with insufficient capacity to produce drugs to combat their public health problems.
Following the December 2005 WTO ministerial meeting, the Council has adopted a Regulation allowing compulsory licensing of patented medicines for export to ‘countries in need’ without sufficient capacity to produce them. Compulsory licensing means that a government allows companies to produce copies of the patented product or process without the consent of the patent owner.
“This regulation is a key element in ensuring access to affordable medicines for poor countries and an important EU contribution to the fight against killer diseases in developing countries,” argued Internal Market and Services Commissioner Charlie McCreevy.
Countries in need of medicines will need to notify the WTO the medicines they need and it is up to generic companies to apply for licenses to manufacture the drugs. The regulation sets clear conditions upon the compulsory licenses as it prohibits re-importation of these drugs into the EU and bans its use for industrial of commercial policy purposes.
The Regulation is directly applicable in all EU member states 20 days after its publication in the Official Journal of the EU.