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Viewing cable 06LIMA1595, HOW THE ANDEAN COMMUNITY IPR DECISION AFFECTS PERU

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Reference ID Created Released Classification Origin
06LIMA1595 2006-04-26 12:30 2011-08-25 00:00 UNCLASSIFIED//FOR OFFICIAL USE ONLY Embassy Lima
VZCZCXYZ0000
RR RUEHWEB

DE RUEHPE #1595/01 1161230
ZNR UUUUU ZZH
R 261230Z APR 06
FM AMEMBASSY LIMA
TO RUEHC/SECSTATE WASHDC 0036
INFO RUEHBO/AMEMBASSY BOGOTA 3314
RUEHQT/AMEMBASSY QUITO 0277
RUEHLP/AMEMBASSY LA PAZ APR SANTIAGO 0454
RUEHCV/AMEMBASSY CARACAS 9353
RUEHBU/AMEMBASSY BUENOS AIRES 2357
RUCPDOC/DEPT OF COMMERCE WASHINGTON DC
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