Jordan Requests FDA Assessment Team

UNCLAS SECTION 01 OF 02 AMMAN 000780

SIPDIS

HHS FOR SECRETARY THOMPSON
DEPT PASS FDA FOR DR. MCCLELLAN
DEPT FOR EAP/BCLTV - LAWLESS

E.O. 12958: N/A
TAGS: ETRD EAID KIPR JO
SUBJECT: Jordan Requests FDA Assessment Team



1. (u) Embassy Amman received a letter from Jordanian
Health Minister Dr. Walid Ma'ani to HHS Secretary Tommy
Thompson requesting assistance in developing Jordan's
capacity to support a research-based pharmaceutical
industry. The request follows successful meetings
between Trade Minister Salah al Bashir and FDA
representatives during the December 2002 Joint Economic
Committee meetings in Washington, and represents a
continuation of Jordan's steps over the past several
years to strengthen IPR protections in the pharmaceutical
sector. Text of letter follows:

Begin Text

HE Mr. Tommy G. Thompson
Secretary

SIPDIS
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Rm. 615F
Washington, DC 20201

Excellency,

In view of the strong friendly relationship between
Jordan and the US which was recently demonstrated by
enacting the Jordan-US Free Trade Agreement (FTA),Jordan
now has a unique opportunity to significantly boost
private sector-led economic growth through increased U.S.
trade and investment. As only the fourth bilateral FTA
that the U.S. has entered into internationally, and the
first with an Arab country, this FTA sends a powerful
signal to potential investors and traders that Jordan is
open for business, offering unprecedented access to the
US market.

Capitalizing on our friendly ties and the recent FTA, I
would appreciate your kind assistance in supporting a
comprehensive and integrated program whose objective is
to develop, assist, and establish a self-sustaining
pharmaceutical regulatory infrastructure in the areas of
inspection, bio-equivalence studies and drug application
reviews. This program will involve all stakeholders,
such as the Drug Directorate, Jordanian Ministry of
Health, academia, and industry. I would also like to
explore the possibility of inviting an FDA assessment
team to Jordan as part of this integrated program, and
follow up with the possibility of sending some of our
inspectors to be trained at the FDA.

Our pharmaceutical industry, which is considered the
second export earner for Jordan, is expected to benefit
tremendously from such a program, as many Jordanian
companies are poised to export to new markets including
Europe and the US.

Thanking you in anticipation and looking forward to
hearing from you at your earliest convenience.

Sincerely,
/s/
Prof. Dr. Walid Ma'ani
Minister of Health

Cc/Dr. Mark B. McClellan
Commissioner
US Food and Drug Administration
HE US Ambassador/Jordan
HE Jordan Ambassador/US
JAPM
Drug Directorate

End Text


2. (u) Comment: Ma'ani who assumed office late in
2002, is a forward-looking new Minister who has ambitious
objectives for developing Jordan's health sector and
overhauling an archaic health ministry. At a January 12
opening event for a new Bristol Myers Squibb Middle East
regional office in Amman he announced the government's
intention to move quickly on plans to establish a food
and drug regulatory agency modeled on the FDA.


3. (u) Jordan leads the region in its protection of
intellectual property rights pertaining to the
pharmaceutical industry. The kingdom has stuck to its
commitments, despite some short-term pains caused to the
sector, and is looking now to strengthen those
commitments in order to become a regional center for the
research-based pharmaceutical industry. In addition,
Jordan's domestic industry already has both the capacity
and the expertise to be a platform for US generics
companies looking to export to the MENA region, or to be
a low-cost production base to supply the US market
itself. The only thing hindering even stronger growth in
the sector is the time lag involved in the FDA approval
process.


4. (u) Supporting Minister Ma'ani's request will help
cement the gains made in IPR protection in Jordan to
date, and will help make Jordan a more attractive
prospect for foreign investment in the health sector. It
will also help the local industry develop contacts with
US partners for co-production, licensing, and the like
for exports to both the MENA region and the US. Embassy
strongly supports Ma'ani's request, and would be happy to
help support further follow-up contacts between the
Health Ministry and FDA officials.
Gnehm