European Parliament backs waiving of patents to aid developing countries
The European Commission (EC) has welcomed the European Parliament's approval of regulation allowing companies to produce copies of patented medicines under license for export to developing countries.
The European Commission (EC) has welcomed the European Parliament's approval of regulation allowing companies to produce copies of patented medicines under license for export to developing countries.
The regulation sets out a mechanism in line with the WTO General Council Decision of August 2003 enabling companies in the European Union (EU) to apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health problems.
Charlie McCreevy, internal market and services commissioner, said: 'The adoption of the compromise package underlines the EU's commitment to the WTO Decision, which allows signatory states to impose compulsory licenses on pharmaceutical companies for the benefit of some of the poorest countries in the world. At the same time the patent system will continue to support investment in the r&d of new medicines.'
Peter Mandelson, trade commissioner, added: 'The simple possibility of granting compulsory licenses for export of drugs to developing countries will make an important contribution to bringing down drug prices in the third world. Europe urges other potential exporters of drugs to implement the WTO Decision as soon as possible to allow their generic manufacturers to produce medicines for export to countries in need.'
The proposal will allow the compulsory licensing procedure of the WTO decision to fit within the context of Member States' national patent law and their compulsory licensing procedures. Safety and efficacy of medicines for export will be certified through the EU's scientific opinion procedure or equivalent national procedures.
Once export takes place, the Commission's proposal would prohibit re-importation into the EU and provide for customs authorities to take action against goods being re-imported. The patent holder could use existing national procedures to enforce its rights against re-imported goods if they do enter the EU, and the licence could be terminated.
The text of the regulation will be adopted shortly and comes into force 20 days after publication in the Official Journal. It can be found through the 'Regulation text' link below.