JORDAN FOCUSING ON PHARMACEUTICAL IPR ISSUES

C O N F I D E N T I A L AMMAN 001019

SIPDIS

SIPDIS

STATE PASS TO USTR

E.O. 12958: DECL: 02/12/2016
TAGS: ETRD KIPR KTIA BEXP PGOV ECON EIND JO
SUBJECT: JORDAN FOCUSING ON PHARMACEUTICAL IPR ISSUES

REF: A. GROVES/SAUMS (USTR) - LAWLESS EMAIL OF 02/11/06

B. 05 AMMAN 9748

Classified By: CDA DANIEL RUBINSTEIN FOR REASONS 1.4 (B, D)


1. (C) SUMMARY: Charge delivered ref (A) points from the
Office of the U.S. Trade Representative (USTR) to Jordan Food
and Drug Administration (JFDA) Director General Salah
Mawajdeh February 12, noting they answered ref (B) request
for the USG assessment of pharmaceutical IPR protection in
Jordan. Charge emphasized the U.S. takes seriously the issue
of IPR protection; in the context of a positive and
cooperative trading relationship, there was an expectation
the Government of Jordan (GoJ) could take additional measures
in the very near future. DG Mawajdeh said he had met with
PhRMA companies on IPR issues in what he termed a "positive"
exchange (with more meetings scheduled),and wondered why
there still appeared to be a "gap" in communications. Charge
noted that USTR,s views had been presented to Trade Minister
Zu'bi during his recent visit to Washington and that these
views still held, inasmuch as they reflected the "snapshot"
reality on the ground today. He encouraged the JFDA to
pursue an outcomes-based approach. If the JFDA were
contemplating taking actions to address IPR concerns, this
should be communicated in the GoJ's Special 301 Review
submission. NOTE: Later the same day, DG Mawajdeh met with
PhRMA representatives, who reportedly told him that they had
little choice but to recommend Jordan for the Special 301
Watch List unless the GoJ finally put in writing its
commitments, with a timetable for progress by late March.
END NOTE. Post believes that GoJ authorities are now more
focused on the pharmaceutical IPR issue, although Ministry of
Industry and Trade contacts suggest that these highly
technical issues could take time to resolve. END SUMMARY.

No Time Like Now
--------------


2. (C) Charge reviewed the Special 301 process with DG
Mawajdeh, noting that it would generally rely on a snapshot
of Jordan's actions up through April, 2006. He highlighted
data exclusivity, new uses, and marketing approvals among the
technical IPR issues unresolved after the December 2004
deadline for compliance, and still of concern to the USG. It
appeared, he said, that Jordan is doing less than all which
it is required to by its FTA obligations. He urged the JFDA
to communicate in a February 13 Special 301 Review country
submission what actions it planned to take to address the IPR
concerns in play, and noted that the USTR would be prepared
to discuss these issues directly with the JFDA and to provide
technical assistance if required. If the GoJ planned to
implement additional measures, there was no time like now.


3. (C) Mawajdeh said the JFDA participated in a "gap
analysis" on the FTA and IPR obligations prepared by the
USAID Achievements in Market Friendly Initiatives and Results
(AMIR) program that was published January 26. Mawajdeh also
met with PhRMA company representatives on February 8 to
decide what to do about the IPR issues. They agreed to form
four working groups on IPR, regulatory, and pricing issues
which would make recommendations to be reviewed by the JFDA
Higher Council by the end of March, he said. He did not see
all of the PhRMA points as issues of concern, or in other
instances there was no practical solution, but the JFDA would
work on them. Given the new, positive platform for
discussion and review of the issues, he expressed surprise
that there still appeared to be some industry discontent.

No Regulations, Yet
--------------


4. (C) Charge reiterated the importance of the USTR
analysis, independent of any other views. The USTR points
reflect our understanding of the actual picture on the ground
today. DG Mawajdeh expressed the view that it was enough for
JFDA to have committed to discuss the idea of making explicit
the protections being offered "new uses" and related
implications (a point in the ref (A) USTR paper) in a
committee. When asked, he acknowledged that these FTA
commitments were not presently contained in any official
documents such as regulations or instructions.



5. (C) Charge stressed that the USG wanted to have a fair
process of review, which included an assessment of Jordan's
IPR actions that was accurate, fair and complete. There may
be definitional issues or matters of tone or emphasis that
could best be worked out through continued and timely
communication. Mawajdeh acknowledged the Embassy offer to
convey new developments, and took on board the need to
arrange direct meetings with a USG technical group, noting
digital video conferences might be possible.


6. (C) NOTE: Later on February 12, five representatives of
PhRMA companies called on DG Mawajdeh, according to a
conference call read-out to Econoff. Their mission was to
convey the group's consensus decision on February 11 to
recommend Jordan for Watch List status. They said that
Mawajdeh expressed dismay that their actions since the
February 8 JFDA-PhRMA meeting had not been consistent with
the "spirit of cooperation" he thought they achieved.
Privately, PhRMA members revealed to Econoff the decision was
driven by a sense of frustration at various verbal promises
made without concrete action, and the sense that the JFDA
Higher Council was being brought too deeply into the
implementation of government commitments made by bilateral
agreement in 2001. One PhRMA member said that Mawajdeh was
now "on the run" and would be more focused on achieving
results.


7. (C) COMMENT: Notwithstanding continual Embassy efforts
since late 2003 to encourage JFDA action on the pharma IPR
front, JFDA historically has seen its main function as acting
on each drug registration case from a drug approval stance,
with safety and efficacy for the patient being the primary
concerns. With the transmission of USG viewpoints in Ref (A)
and the most recent, candid interaction between JFDA and
industry representatives, it would appear that JFDA now
understands there is a pressing need to reach closure on IPR
issues. However, while the Ministry of Industry and Trade is
expecting a brief summary from JFDA to insert into the GoJ
Special 301 Review submission on February 13, Trade Ministry
contacts warn that these technical issues are not easily
resolved. We take that as a hint that Jordan's increasingly
powerful generic pharmaceutical industry will be in the
background, pressing for any advantage it can secure in
pharmaceutical market access issues.
Rubinstein