EL SALVADOR APPROVES DATA EXCLUSIVITY REGULATIONS

UNCLAS SAN SALVADOR 001083

STATE PASS USAID/LAC
STATE ALSO PASS USTR
USDOC FOR 4332/ITA/MAC/WH/MSIEGELMAN
3134/ITA/USFCS/OIO/WH/PKESHISHIAN/BARTHUR
SIPDIS
SENSITIVE

E.O. 12958: N/A
TAGS: ECON ETRD EINV KIPR ES
SUBJECT: EL SALVADOR APPROVES DATA EXCLUSIVITY REGULATIONS

SENSITIVE BUT UNCLASSIFIED; HANDLE ACCORDINGLY


1. (SBU) SUMMARY. El Salvador has passed long-awaited regulations on
data protection and data exclusivity, one of their last major
outstanding CAFTA-DR commitments. According to a leading
intellectual property lawyer, the regulations were an important step
forward for intellectual property, finally offering legal recourse
to protect clinical data. On the other hand, the domestic
pharmaceutical industry opposed the regulations as published. Given
the pharmaceutical industry's political power, implementation of the
regulations may be limited. END SUMMARY.


2. (SBU) Shortly before El Salvador's annual August holidays, the
Government of El Salvador published new regulations for data
protection and data exclusivity for pharmaceutical products. At the
same time, El Salvador also acceded to the "Convention Related to
the Distribution of Programme-Carrying Signals Transmitted by
Satellite (1974)," also known as the Brussels Convention.


3. (SBU) Danilo Rodriguez, a lawyer and head of the Salvadoran
Intellectual Property Association, told Econoff that the regulations
were "good enough to promote them to clients" and finally offered
legal recourse for firms whose data was used to produce "knock-off"
drugs. For them to be truly effective, however, the Public Health
Council would need to change its rules on product registration to
catch compliance issues early in the process, rather than waiting
for a complaint to be brought in court.


4. (SBU) Jose Mario Ancalmo, head of the domestic pharmaceutical
industry organization INQUIFAR, offered a less favorable view. In
Ancalmo's view, the Government had "completely ignored" the domestic
industry's input, and the regulations were an illegitimate way to
"extend expired patents." According to Ancalmo, the domestic
industry lacks the infrastructure to obtain the clinical data for a
new product, so he would expect fewer new releases.


5. (SBU) COMMENT: The passage of the regulations marks the last of
El Salvador's major intellectual property commitments under
CAFTA-DR. The fact that El Salvador's politically powerful domestic
pharmaceutical industry, which opposes any new intellectual property
regulations, was upset by the regulations suggests that the
regulations do what they need to do. The domestic industry's
opposition, however, may hinder effective implementation of the
regulations by the Public Health Council.


Glazer