HEALTH MINISTRY ADDRESSES US PHARMACEUTICAL

UNCLAS MUSCAT 001579

SIPDIS

SENSITIVE
SIPDIS

STATE FOR NEA/ARP, EB/TPP/MTA/IPC
STATE PASS USTR FOR JBUNTIN
COMMERCE FOR COBERG

E.O. 12958: N/A
TAGS: BEXP ECON KIPR MU
SUBJECT: HEALTH MINISTRY ADDRESSES US PHARMACEUTICAL
CONCERNS

REF: GRIMM-MANSOUR EMAIL OF 9/27/06


1. (U) In response to U.S. pharmaceutical company and PHRMA
concerns (ref),Econoff met with Dr. Batool Jaffer Suleiman,
Director of Rational Drug Use, Ministry of Health, on
November 7 to discuss Ministerial circular 5/2006, which
mandated the re-registration of pharmaceutical companies and
their products in Oman. Suleiman noted that the
re-registration process would enable the Ministry to keep its
records current on the 4,000 products currently on the market
in Oman. She also remarked that this routine procedure, to
occur every five years, would help the Ministry to update its
information on personnel changes and good manufacturing
processes.


2. (SBU) Econoff also raised ref concerns regarding the
presence of copycat pharmaceutical products in Oman.
Suleiman stated that, due to budgetary reasons, the
government routed 70% of its pharmaceutical purchases through
a centralized GCC-wide tender. As such, she commented that
the government depended on the GCC patent office in Riyadh to
keep current on potential patent infringements. She
expressed concern that the GCC office was not well-equipped
to handle patent protection issues, but noted that the
government made the decision to rely on the GCC office rather
than establishing its own patent office.


3. (SBU) Suleiman also pointed out her concern that U.S.
pharmaceutical companies did not have their products
registered with the GCC office. As a result, the GCC
purchased copycat knockoffs for Combivir (GSK),Fosamax
(MSD),and Cozaar (MSD),though these pharmaceuticals were
not available for private purchase. On the local front,
Suleiman highlighted the fact that the Minister of Health
stopped Oman-based National Pharmaceutical Industries (NPI)
from producing a copy of Fosamax, and that a copy of Lipator
produced by Indian-based Ranbaxy did not receive marketing
approval from the Ministry. NPI did receive permission from
the government, however, to produce a copycat of Pfizer,s
Viagra after noting that Viagra was not registered with the
GCC patent office.


4. (SBU) Suleiman commented that once the U.S.-Oman Free
Trade Agreement (FTA) comes into effect, the Ministry will
recognize all U.S. pharmaceutical product patent expiration
dates. In this regard, she remarked that the Ministry will
ask U.S. pharmaceutical companies, through their
representatives in Oman, to submit a master list of the
products they produce, to include trade name, chemical name,
first filing date, strength, patent expiration date, and a
copy of the original U.S. patent. Suleiman also noted that
she and her colleagues would be happy to meet with U.S.
pharmaceutical producers on the margins of the December 6
U.S.-Oman FTA awareness conference to discuss the issue
further.


GRAPPO