Protocol amends the TRIPS Agreement
On April 8, Law 26.662 which adopted the Protocol to amend the TRIPS Agreement, in connection with the export of pharmaceuticals manufactured under compulsory license, was published in the Official Gazette.
The protocol inserts Article 31bis, under which the obligation to supply the domestic market of an exporting Member shall not apply with respect to the grant by it of a compulsory license to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member.
The patent holderâs rights subject to a compulsory license by the exporting member shall be entitled to an adequate remuneration according the circumstances of the case, taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member.
Protocol establishes that the compulsory license issued by the exporting Member under the system shall contain different conditions, in which one of them is that only the amount necessary to meet the needs of the eligible importing Member(s) may be manufactured under the license and the entirety of this production shall be exported to it.
Eligible importing Members shall take reasonable measures to prevent re-exportation of the products that have actually been imported into their territories under the system.
Protocol also describes special provisions for the case of developing or least developed country WTO Member which is a party to a regional trade agreement.