Regulatory News

EC Calls for Indefinite Exemption from Pharma IP Rules for Least-Developed Countries

The European Commission on Thursday agreed to support a proposal that would allow the least-developed countries (LDCs) to have easier access to generic drugs via an indefinite exemption from World Trade Organization (WTO) intellectual property rules for pharmaceuticals.

The exemption, which must also be approved by the European Council, would allow generic drugs to be imported and manufactured locally, regardless of patents. More simply, the proposal means that manufacturers of generic drugs and other international programs can supply much-needed drugs, like HIV treatments, in affected countries without having to deal with patent infringement lawsuits.

European Commissioner for Trade Cecilia Malmström said in a statement: "The poorest countries of the world need effective access to medicines. Although patents stimulate innovation in developed and emerging economies, intellectual property rules should be a non-issue when the world's poorest are in need of treatment. This exemption will give the least developed countries the necessary legal certainty to procure or to produce generic medicines. I am confident that the Council will support this approach, and that the EU will take the lead in the WTO in this field." 

The LDC group at the World Trade Organization previously requested that the Council for the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) extend a waiver allowing them to choose not to enforce IP rights on medical products as long as they do not graduate from their LDC status, according to IP-Watch.

The council next month will make a definite determination on the position to be taken by the commission on behalf of the European Union in the WTO special Council on Intellectual Property.

European Commission