Cablegate: Health Minister Readies New Drug Registration Rules, Plans

Published: Tue 25 Nov 2008 01:40 PM
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R 251340Z NOV 08
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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.
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.
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
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.
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.
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.
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