US embassy cable - 03AMMAN780

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