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