AMBASSADOR DISCUSSES NEW FDA, PHRMA ISSUES WITH

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