Controlled Parallel imports of pharmaceuticals and medical devices
On April 21, 2010, the Colombian Ministry of Health issued Decree 1313 setting forth the mechanisms for private and public actors to require a controlled parallel importation into Colombia of legitimate or genuine pharmaceutical and medical devices bought abroad from an authorized third party.
Decree 1313 establishes that, from now on, it is not necessary to have the consent of the manufacturer in order to import those legitimate products into Colombia and, moreover, set forth some of the conditions and requirements to petition a âcontrolled parallel importationâ to the pertinent Colombian authorities.
The Decree mentions the Doha Declaration adopted under the WTO on November 14, 2001 as one of the international legal sources supporting this measure, which, according to local authorities, has the goal of lowering the costs of such products in the very short term.
Parallel imports have been allowed in Colombia according to Decision 486, which is the mandatory IP law for the whole Andean Community setting forth the standard of international exhaustion of intellectual property rights, but the sanitary regulations that were in place limited their use.
The most relevant restriction was that the importer of a pharmaceutical or medical device had to get the authorization from the local Health Authority (INVIMA) to commercialize in Colombia. In order to do so, it was necessary to count with the consent of the foreign manufacturer who also had to permit the importer to use the mark or commercial name for the product.
Among the most relevant terms and conditions for obtaining this approval is worth mentioning that they last, at least one year; the products must be approved by INVISA but exceptions to this may be granted in certain cases; restrictions on quantities and labeling must be observed.
Some lower level regulations implementing this measure have started to be issued by local administrative authorities and others are expected to follow soon.
Thus, since these regulation entered in force, Colombian importers buying pharmaceutical or medical devices abroad from authorized third parties without having to obtain an authorization from the manufacturer can file a request with INVIMA with the health evidence of the exporting country and start commercializing those legitimate products in the country.