29 October 2004 — Médecins Sans Frontières is encouraged to see a proposal by the European Commission that sets out rules to allow the export from the European Union of generic medicines to developing countries. This proposal sends a positive message to developing countries which would benefit from using compulsory licensing to access affordable versions of needed medicines and other health care products.
The proposal aims to implement the World Trade Organization’s decision of August 30, a compromise which was needlessly complex. While the Commission’s proposal does not reduce that complexity, we are encouraged that it does not include any new restrictions on which medicines or diseases it applies to (as has happened, for example, in Canada).
However, we regret that the proposal requires prior negotiations with the patent holder, which will inevitably delay the swift use of the mechanism.
Further, we note that the proposal includes an exemption from data exclusivity rules to allow the rapid registration of generic medicines by drug regulatory authorities when a compulsory license is issued. We hope that this could set a precedent for countries that are presently forced under regional or bilateral trade agreements to introduce data protection rules that hamper the registration of generic medicines.
Whether this mechanism will be effective depends in part on the willingness of the European generics industry to make use of it. Now increased funding for the purchase of essential medicines is becoming available, we hope they will do so.
Most seriously, however, even in the most optimistic scenario, this mechanism will do little to deal with the effects of the full implementation of the WTO TRIPS Agreement, which should be completed by 1 January 2005. None of the existing TRIPS flexibilities will be sufficient over time to counter the effects of a world in which pharmaceutical products may be patented in every country.
Proposal for a regulation of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems
EU Press Release: Access to medicines: Commission proposes to allow export of generic medicines to poor countries