EU Implementing Compulsory Drug License Regime for Exports

The European Union will allow companies in the 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. The move follows domestic law changes in Canada, Norway, India and China.

According to the press release from the European Commission, there is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are required to address public health problems since that is the context of the Decision. The text of the Regulation will be adopted shortly after finalisation by legal and linguistic experts and enters into force on the 20th day after publication in the Official Journal (see IP/04/1332).

According to the IPR Helpdesk, the manufacturing and exporting of generic medicines to poor countries would be permitted through the use of compulsory licences which will be granted by the national authorities. The regime for granting the compulsory licences of exporting is different in every EU Member State, thus needing to be harmonised through the adoption of a EU document. This is the reason why the Commission proposed this new Regulation, the European Community having committed to fully contributing to the implementation of WTO?s Decision.

In order to ensure exported products reach those who need them and are not further re-imported, the Commission's proposal prohibits re-importation of the concerned products into the European Community and gives customs authorities the capacity of taking action against goods being re-imported.