HOW THE ANDEAN COMMUNITY IPR DECISION AFFECTS PERU

UNCLAS LIMA 001595 SIPDIS SENSITIVE SIPDIS DEPT FOR WHA/AND, EB/IPE SWILSON COMMERCE FOR 4331/MAC/WH/MCAMERON USTR FOR B. HARMON E.O. 12958: N/A TAGS: ECON ETRD KIPR EINV PGOV PE SUBJECT: HOW THE ANDEAN COMMUNITY IPR DECISION AFFECTS PERU ¶1. (SBU) Summary. On April 6, the Andean Commission issued Decision 632, which clarified the Andean Community's regulations on data protections for patents. Under Decision 632, member countries may protect test data through the imposition of data exclusivity periods, which is consistent with TRIPs. The decision further states that a country may limit data protection if it considers it harmful to public health. Ministry of Trade officials laud the decision, noting that it will facilitate Peru, Colombia and Ecuador's implementation of data protection regulations under a U.S. trade deal. Luis Alonso Garcia, Peru's lead IPR negotiator, noted that the GOP has the political will to implement the more difficult IPR obligations, but that Peru may need technical assistance from the United States and Colombia on how to best protect test data. End Summary. Andean Community Allows Protection of Test Data -------------- ¶2. (U) The Andean Commission issued Decision 632, which clarified Article 266 of Decision 486 on the protection of test data for pharmaceutical products on April 6. (Note: The Commission included only Peru, Colombia and Ecuador. Venezuela and Bolivia chose not to attend the meeting. End Note.) The decision allows member countries to protect pharmaceutical test data through the imposition of data exclusivity periods. According to the Andean Commission, this decision makes the Andean Community regulations consistent with WTO TRIPs standards. The decision further states that a country may limit data protection if it considers it harmful to public health. ¶3. (U) The Venezuelans, who publicly opposed Peru and Colombia's request to modify Andean Community intellectual property regulations but failed to attend the meeting, issued a public statement condoning the actions of Peru, Colombia and Ecuador. Pavel Rondon, the Venezuelan Deputy Minister for Latin America, at first noted that the decision was not legal, as Bolivia and Venezuela were not present. However, Andean Community rules stipulate that if member states are not present at a meeting, there needs to be a quorum. In this case, the vote was unanimous among the three members present, thus making the decision legally binding. What It Means for Peru -------------- ¶4. (SBU) We spoke to Luis Alonso Garcia, Lead IPR Negotiator at the Ministry of Trade (Mincetur),to discuss how the Andean Community decision affects Peru. Garcia noted that the decision enables Peru, Colombia and Ecuador to more easily meet its IPR obligations under U.S. free trade accords. Peru may face challenges in implementing its IPR obligations, he stated, but noted that the GOP is already working on the implementation process. The Ministry of Health (Minsa),which argued that data exclusivity protections would increase the cost of generic medicines in Peru, now has the political will to implement the IPR regulations. Minsa has allocated funding to strengthen DIGEMID, the GOP agency that issues marketing permits for pharmaceutical products. Mincetur is working with Minsa to identify the regulatory changes necessary to implement the agreement. ¶5. (SBU) Garcia also emphasized that Peru, Colombia and Ecuador must work together to share information on how to best implement the U.S. free trade agreement. He noted that the Peruvian Government currently has no experience in data protection; Colombia, on the other hand, already has an established mechanism for data protection. Garcia explained that the Andean countries, as well as the United States, should work together to share information, technical assistance and best practices to help ease the implementation process. He stated that writing the regulations is not an issue; rather the GOP must work on enforcing current and new regulations to ensure that it meets its FTA obligations. Next Steps -------------- ¶6. (SBU) Garcia mentioned that Mincetur is in the process of identifying potential FTA implementation challenges and is preparing information for the Peruvian Congress. Once Peru's Congress approves the agreement, Mincetur, working with other key Peruvian government ministries, will begin drafting legislation for Congressional approval. ¶7. (SBU) Carlos Fernandez Davila, representative of Alafarpe (a U.S. affiliated pharmaceutical association), informed us that the pharmaceutical industry would meet with Mincetur officials after the second round of Peruvian elections to provide input into the IPR data protections regulations. Understanding that IPR issues ar often challenging for countries that implement FTAs, the pharmaceutical industry is willing to help the GOP meet its FTA obligations. Comment -------------- ¶8. (SBU) Mincetur officials are well aware of the difficulties that several Central American countries had in implementing CAFTA and are working to avoid the same types of problems. The GOP recognizes that IPR issues will be among the more challenging, but notes that the change in the Andean Community regulations is an important step in the right direction. We will continue to engage with our interlocutors in an effort to promote implementation of key regulations before ATPDEA expires at the end of 2006. STRUBLE