Commission proposes system for the export of generic medicines to developing countries
The Commission has drafted proposals that would allow manufacturers of generic pharmaceuticals to reproduce other companies' patented medicines for export to those 'countries in need' without the capacity to make them themselves. Under the proposals, which are the direct result of lengthy negotiations in the World Trade Organisation (WTO), national authorities will be able to grant 'compulsory licences' to generics manufacturers provided certain conditions have already been met. Chief among these is that the proposed destination country must have notified the WTO that it requires the medicine covered by the license. No restrictions have been put on the medicines or diseases that can be covered by the compulsory licenses, but in order to protect the original patent holders, customs authorities will be empowered to prevent the re-importation into the EU of medicines produced under the new system. Internal Market Commissioner Frits Bolkestein said: 'The WTO decision and our proposed regulation can help save lives by helping countries in need to acquire affordable medicines, without undermining the patent system, which is one of the main incentives for the research and development of new medicines.' At present, most national laws do not allow compulsory licenses for export, instead granting them predominantly for domestic markets. However, such a system fails to provide generic medicines to those countries often in most need, but without the manufacturing capacity to produce them. Under the proposed new rules, provided countries in need have notified the WTO of the medicines they require, it will be up to generic medicine manufacturers to decide to apply for compulsory licenses.