Argentina Approved the Protocol Amending the GATT TRIPS Agreement

The Protocol introduced the so called “export compulsory licenses”, which allow the export of a patented pharmaceutical product from a country having manufacturing capacity to a country lacking this capacity and authorized by the WTO.

The 2001 Doha Declaration, as well as the 2003 Decision and the 2005 Protocol, permanently waives the limitation of compulsory licenses for the internal market (Article 31, paragraph f] of the TRIPS Agreement) and allows a country, without manufacturing capacity, to import pharmaceutical products in case of epidemics or other circumstances of extreme urgency.

In order to fully understand the amendment introduced by Law No. 26,662, it should be borne in mind that Article 31 of the TRIPS Agreement regulates the use of a patent without the authorization of its owner, and also sets forth the requirements for the grant of the so called compulsory licenses. Paragraph f) falls within this provision, which states that “…such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use”. Thus, and according to the original wording of the TRIPS Agreement, those products manufactured under compulsory licenses could not, in principle, be exported.

The limitation related to the supply of the internal market could have as a consequence that this section could become moot in those countries lacking manufacturing capacity. Therefore, the Protocol corrects this situation by allowing the export compulsory licenses.

For more information, please contact:

		Iván Poli
		Ignacio Sánchez Echagüe