VZCZCXYZ0000
RR RUEHWEB

DE RUEHEG #2419/01 3301340
ZNR UUUUU ZZH
R 251340Z NOV 08
FM AMEMBASSY CAIRO
TO RUEHC/SECSTATE WASHDC 0934
INFO RUCPDOC/USDOC WASHDC 0432

UNCLAS CAIRO 002419 
 
SENSITIVE 
 
SIPDIS 
 
E.O. 12958:  N/A 
TAGS: ETRD ECON PGOV PREL KIPR EG
SUBJECT: HEALTH MINISTER READIES NEW DRUG REGISTRATION RULES, PLANS 
TO PUT REGISTRATION ON-LINE 
 
Sensitive but unclassified.  Please handle accordingly. 
 
¶1.  (SBU) SUMMARY  On November 23, newly appointed Ministry of 
Health Assistant Minister for Pharmaceutical Affairs Kamal Sabra 
told FCS and Econ counselor that the MOH would soon put drug 
registration on-line and that the new drug registration rules are 
almost finished.  The department's new facilities considerably limit 
public access to ministry offices and have substantially improved 
security.  Sabra asked for help from the FDA in training Egyptian 
inspectors and said that Ministry El Gabaly is very pleased about 
plans for the USPTO-sponsored counterfeit drug seminar planned for 
January 2009.  END SUMMARY. 
 
¶2.  (SBU) On November 23, FCS and econ counselors, accompanied by 
FCS's pharmaceutical expert, paid an introductory call on the 
Ministry of Health's newly appointed Assistant Minister for 
Pharmaceutical Affairs, Kamal Sabra.  Sabra, who started at the 
ministry about six weeks ago, is a former pharmacy professor at Cork 
University in Ireland, has also worked in the pharmaceutical 
industry.  He was joined by Samia Salah, head of the Drug Policy and 
Planning Center.  This department has recently moved into new 
offices.  According to Salah, the new offices provide a better work 
environment for her staff.  The public, including pharmaceutical 
companies and their agents, are confined to the main floor and are 
not permitted in the offices of the ministry staff.  Salah said her 
staff is now able to work undisturbed, and industry representatives 
no longer have free rein in the various departments. This has 
considerably improved overall security; the lack of security in the 
office has long been a concern to firms wanting their proprietary 
information safeguarded properly.  Controlling public access is 
important, as the bureaucratic burden of the application process is 
enormous.  According to Sabra, the MOH has received 4000 licensing 
applications in the past nineteen months, and have recently decided 
to open on Saturdays, in an effort to deal with the crowds. 
 
NEW REGISTRATION RULES 
---------------------- 
¶3.  (U) New drug registration rules are in draft, and should be 
ready shortly. The MOH will guarantee that new products will be 
approved within six months of the date of the submission of the 
complete application.  This is about half the time that the current 
registration requires. Registration is not of course guaranteed, 
Sabra cautioned, as part of the approval process is a 
pharma-economic analysis and some drugs are simply too expensive for 
the Egyptian market.  The legislation will establish certain 
reference countries, including the US, EU, Australia and Japan.  If 
drugs have received approval in these countries, from the FDA in the 
case of the U.S., the MOH will do less analysis and batch 
inspection.  In addition, a visit to the factory, for example, will 
not be required. 
 
¶4.  (U) In response to a question about exclusive marketing rights, 
Sabra contended that the period in the US begins when the 
application is made, not when it was approved.  He seemed to be 
arguing that dating the exclusive period from the application date 
was appropriate.  At any rate, he said that since the registration 
process would be significantly speeded up, this should not be such 
an issue. 
 
REGISTRATION PROCESS 
-------------------- 
¶5.  (SBU) Sabra announced that the MOH will move the entire 
registration process on-line, including required forms and 
regulations, in English.  He expects companies will apply for 
registration online, rather than in person.   Also, all drugs 
currently licensed in Egypt will also be listed on the site.   Sabra 
expects that putting the application process on line will solve a 
major source of information leaks for companies.  Many companies 
hire agents to represent them in the application process. These 
agents often represent more than one pharmaceutical firm at a time. 
Sabra accused the agents of copying the technical documents and 
sharing them with other firms. He also said, in response to a 
comment that MOH personnel taking registration documents often did 
not seem to know the rules, that the agents for the companies were 
just as bad.  He personally refuses to deal with the agents, and 
only deals directly with the companies in resolving any problems. 
As with many other ministries in Egypt, on-line registration is an 
effective tool at fighting corruption, at least at the working 
level. Companies gain access to the information they need, and can 
file all their forms, without having to deal with low-level MOH 
bureaucrats. 
 
FACTORY INSPECTION 
------------------ 
¶6.  (SBU)  Another area of concern is the quality of Egyptian 
inspectors.  In the US and elsewhere, Sabra said, inspectors do a 
good job of looking at the factories and so regulators don't worry 
about individual products coming out of those factories.  Here in 
Egypt, he has no confidence in the factory inspections, and so must 
test all the products individually, and relatively often, because he 
 
is not sure of the quality of the production process.  This is more 
of a problem for the local manufacturers, rather than the 
multinationals, Sabra acknowledged, because the multinationals must 
meet internal standards and are therefore to some extent 
self-regulating.  An improved inspection system would improve 
efficiency overall, he said. 
 
COMPLAINTS ABOUT THE MULTINATIONALS 
----------------------------------- 
¶7.  (SBU)  Sabra also noted he has evidence that virtually all of 
the multinational companies are selling direct to doctors. This, he 
said, is illegal and unethical.  For example, his ministry found 
pamphlets in doctors offices aimed at patients who, if they filled 
out a survey, were offered a free refill.  He also said the 
companies offer sales incentives to pharmacists.  Some of the firms, 
he said, had provided evidence that other firms were doing this but 
in several cases he had information that the firms making these 
accusations were also engaged in the practices.  In one case, the 
ministry had raised the price of certain medications to the 
consumer, at some political cost and to a chorus of media criticism. 
 The same day the MOH had raised prices, Sabra said, the American 
firm offered pharmacists a twenty percent discount for the purchase 
of one of the medications for which the price had increased.  The 
media got a hold of the invoice, with the discount, dated the same 
day of the price increase.  This, he said, had been very politically 
difficult for the ministry. 
 
¶8.  (SBU) Sabra said that he planned to raise this issue with the 
multinationals later the same day.  He said that he will offer them 
the opportunity to negotiate a formula, similar to ones in Europe, 
whereby the companies agree to a standard reduction in the price of 
medications once their exclusive marketing period is over and 
generics are also available. This, he said, was far preferable to 
negotiating price cuts on a case by case basis, and would give him 
some political cover for price hikes on name brand medications still 
covered by excusive marketing rights. Otherwise, he said, the option 
was a unilateral cut in reference prices. 
 
¶9.  (SBU) Salah said Cialis has been approved for the Egyptian 
market, but that the patent is still pending.  Lilly had told us 
that the patent office has yet to send to MOH a notification letter 
of the applications; Salah said it was not up to the MOH.  For his 
part, Sabra was somewhat dismissive of the patent issue, on the 
grounds that many companies didn't bother filing for patents but 
once they did, they did not focus on completing the application and 
getting it through the system.  He commented that Cialis has gotten 
its market registration and should be receiving its patent shortly. 
 
 
LOOKING AHEAD 
------------- 
¶10.  (SBU) The minister is looking forward to the counterfeit drug 
conference organized by USTPO in January in Cairo5 is planning to 
participate himself, and will encourage key officials and business 
people to attend.  Sabra said he would be interested in having some 
FDA inspectors visit Egypt, perhaps in connection with the 
conference, to provide training for his inspectors. He proposed that 
they do a joint inspection of two factories in Egypt, a 
multinational and a local pharmaceutical manufacturer, to give his 
inspectors some hands on training. 
Scobey