European Commission Proposes Regulations Allowing Export of Generic AIDS Drugs to Developing Countries
The European Commission on Friday proposed new regulations that would allow the export of generic antiretroviral drugs to countries most affected by the HIV/AIDS pandemic that are unable to manufacture the drugs domestically, the AP/Forbes.com reports. The European Parliament and the 25 member countries of the European Union must approve the proposal, which would implement a World Trade Organization agreement reached last year (AP/Forbes.com, 10/29). WTO negotiators in August 2003 reached an agreement to allow developing countries to issue compulsory licenses in order to import generic drugs if the country confirms that it cannot domestically manufacture them. Currently, only Mozambique, Malaysia and Canada have adopted legislation to implement the agreement (Kaiser Daily HIV/AIDS Report, 7/7). The E.C. proposal also includes regulations on the labeling and packaging of generic antiretrovirals to prevent reimportation of the drugs into Europe, according to AFP/EUbusiness (AFP/EUbusiness, 10/29). Patent holders also would be able to implement existing national laws to enforce patents if drugs were reimported. The proposal is expected to be submitted to the European Commission next year for approval (AP/Forbes.com, 10/29).
"By adopting this proposal, the E.U. leads the way in ensuring access to affordable medicines for poor countries," E.U. Trade Commissioner Pascal Lamy said, adding, "I now hope that it can be taken forward quickly by the E.U. member states and the European Parliament." The advocacy group Oxfam International "welcomed" the proposal, saying that the European Union is "sending a positive political signal to developing countries that they can override patents to gain access to cheaper generic medicines, vital to combating deadly and debilitating diseases," according to AFP/EUbusiness. "With 14 million people dying every year from infectious diseases, it is essential that developing countries feel confident about supplying cheaper generic medicines to their citizens in the face of hostility from the giant drug companies and the United States government," Oxfam official Michael Bailey said in a statement (AFP/EUbusiness, 10/29). However, the organization added that the European Union must ensure that the proposal does not carry "too much red tape that could slow" the export of generic drugs to developing countries in a "health emergency," the AP/Forbes.com reports (AP/Forbes.com, 10/29).