US embassy cable - 03AMMAN1193

C O N F I D E N T I A L SECTION 01 OF 02 AMMAN 001193 
 
SIPDIS 
 
STATE PASS USAID FOR TOM OLIVER 
DOC FOR 4520/ITA/MAC/ONE/COBERG 
HHS FOR JANE COURY 
 
E.O. 12958: DECL: 02/27/2013 
TAGS: EAID, BEXP, PGOV, JO 
SUBJECT: AMBASSADOR DISCUSSES NEW FDA, PHRMA ISSUES WITH 
HEALTH MINISTER 
 
 
Classified By: Ambassador Edward W. Gnehm, reasons 1.5 (b,d) 
 
1.  (c)  Summary:  Jordanian Health Minister Dr. Walid Ma'ani 
explained his plans to create a Jordanian FDA in a meeting 
with the Ambassador February 23.  The Ambassador and Ma'ani 
also discussed drug pricing and registration concerns voiced 
by local PhRMA member company representatives.  Following the 
meeting, the Ambassador participated in a handover ceremony, 
wherein PhRMA gave computers to the Ministry to help 
streamline operations.  End summary. 
 
FDA PLANS 
 
2.  (sbu)  Health Minister told the Ambassador during a 
February 23 meeting that the GOJ is finalizing plans to 
create a Food and Drug Administration (FDA) as a means to 
streamline the food and drug trade in Jordan and to boost 
Jordanian pharmaceutical exports, especially to the U.S. and 
Europe.  Ma'ani said he passed draft legislation to the 
cabinet in mid-February, and hoped for passage of the 
legislation by the end of March.  If all went well, Ma'ani 
said he hoped to have the new FDA fully functional by the end 
of May. 
 
3.  (sbu)  To that end, Ma'ani said a state-of-the-art 
building including labs and office space was already being 
built to house the new agency, which would be devoted "90%" 
to pharmaceutical industry issues, with one small lab for 
food testing.  Ultimately, Ma'ani said another office would 
be added to certify medical equipment.  Ma'ani said the FDA 
would be a semi-autonomous regulatory agency, reporting 
directly to the cabinet instead of being subsumed under any 
one ministry.  He noted, though, that the Health Minister 
would sit on a "board of directors" for the new agency. 
 
4.  (sbu)  The Ambassador noted that we had passed on to HHS 
and FDA the Minister's letter requesting technical assistance 
from FDA.  He said the Minister could count on the Embassy's 
support in moving forward with whatever decision HHS/FDA made 
with regard to increasing cooperation with the GOJ. 
 
DRUG PRICING, REGISTRATION ISSUES 
 
5.  (c)  The Ambassador raised concerns voiced to us by local 
reps of multinational pharmaceutical companies and the 
regional PhRMA office regarding their input into proposed 
changes in Jordan's drug pricing and policies and 
registration procedures.  On pricing, the Ambassador noted 
that PhRMA companies had been left out of advisory committees 
that were developing new procedures to price new-to-market 
drugs.  He recommended the Minister meet with these companies 
to hear their ideas, and urged him to include these companies 
in committees making new policies governing the 
pharmaceutical industry.  He noted that the multinational 
companies would provide a valuable perspective, particularly 
to ensure that new pricing policies do not inadvertently 
result in reduced access to innovative drugs in Jordan.  The 
Minister agreed to involve PhRMA member companies more 
closely in such decision-making, and said he would be happy 
to meet with them. 
 
6.  (c)  On registrations, the Ambassador noted that another 
proposal coming out of the advisory committees to withhold 
registration in Jordan of new medicines for a year after FDA 
approval as a "precautionary measure" would be 
counterproductive.  First, it would deny Jordanians 
expeditious access to cutting-edge life saving drugs. 
Second, it would damage Jordan's attempts to grow its medical 
tourism industry, as prospective patients would have to go 
elsewhere to obtain these treatments.  The Minister agreed 
that any new registration policy should keep the interests of 
all actors in mind, and agreed to revisit the registration 
committees proposals. 
 
PHRMA COMPUTER DONATION 
 
7.  (u)  Following their private meeting, the Ambassador and 
the Minister participated in a handover ceremony wherein 
PhRMA donated 25 networked PC's to the Ministry's Drug 
Directorate.  The computers, according to PhRMA regional 
director Samir Mansour, should help the Ministry to reduce 
the time needed to register new drugs by creating an 
extensive database and by moving much of the registration 
process into electronic format.  PhRMA is now identifying a 
software firm to work with the Ministry to develop the 
database and registration programs.  In remarks during the 
ceremony, the Ambassador praised Jordan's strong commitment 
to IPR protection and welcomed PhRMA's continued support for 
Jordan's health sector. 
 
COMMENT 
 
8.  (c)  We understand HHS is preparing to respond favorably 
to Ma'ani's request for technical assistance.  We will work 
with Washington agencies to develop a program to address the 
GOJ's needs in setting up an FDA structure  and in certifying 
local pharmaceutical firms for export to the U.S. of generic 
drugs as appropriate.  We would note, though, that use of '03 
ESF for this program would require negotiating with the 
Planning Ministry, as '03 ESF has already been programmed. 
GNEHM