THAIS PLAN FOR TAMIFLU PRODUCTION

UNCLAS BANGKOK 006663

SIPDIS

HHS FOR OGHA - STEIGER, ELVANDER, BHAT

E.O. 12958: N/A
TAGS: EAGR KIPR SENV TBIO TH
SUBJECT: THAIS PLAN FOR TAMIFLU PRODUCTION


1. Summary: The RTG is actively stockpiling the antiviral
medicine Tamiflu and considering producing the drug in
Thailand, with or without a license, in preparation for a
possible avian flu pandemic. The RTG is procuring
ingredients for production of the drug, but it is unclear if
the Thai pharmaceutical industry could produce a sufficient
supply of the drug, or whether they would have the technical
skill to produce it without assistance from the original
producer. Thailand,s thirteenth confirmed human death from
avian influenza, the first in just over a year, will likely
increase local interest in the issue of antiviral medication
availability. End Summary.


2. The RTG Ministry of Public Health (MoPH) has set a goal
of amassing a stockpile of one million capsules of the Swiss
pharmaceutical company Roche's antiviral medicine Tamiflu by
the end of January, 2006. MoPH claims to have 700,000
capsules on hand and is working to acquire an additional
300,000. An individual treatment of Tamiflu is considered to
be ten capsules, meaning MoPH's planned stockpile would be
sufficient to treat 100,000 people. MoPH is also discussing
with Roche to purchase Tamiflu in powder form which has a
longer shelf life than capsules and would be easier to
administer if a pandemic did occur. The powder form would
not need approval by the Thai Food and Drug Administration as
the ingredients are the same as the capsule form.


3. Dr. Thawat Sungrajarn, director general of the Department
of Disease Control, made comments to the press that the RTG
was prepared to issue a compulsory license of the drug in
order to begin production without a license from Roche.
However, the Department of Intellectual Property's Patent
Office which has responsibility for compulsory licenses had
not received any word that such a proposal was being
considered.


4. Mr. Robert Mitchell, Managing Director of Roche in
Bangkok, said that his firm had been in discussions with MoPH
about importing large quantities of Tamiflu, but that no RTG
official had mentioned to him a possible move to pursue
compulsory licensing and was surprised by the news accounts.
In fact, according to Roche, Gilead Sciences, the original
right holder for the drug, never filed a patent for Tamiflu
in Thailand and the drug remains unpatented.


5. Mitchell said there had been discussions with the RTG
regarding manufacturing the drug in Thailand, but that it was
too early to say where those discussions could lead.
Mitchell was somewhat dismissive of the Thai intention to
produce the drug, saying that the RTG could purchase
substantially greater quantities than they could ever produce
on their own.


6. The Government Pharmaceutical Organization (GPO) is the
lead drug manufacturer in Thailand and would produce any Thai
version of Tamiflu. GPO claims they can develop the drug and
produce 50,000 treatments by October, 2006, at a cost 40%
below the purchase price from Roche. MoPH said they have
already ordered precursor ingredients from a supplier in
India.


7. Prime Minister Thaksin Shinawatra announced on October 20
Thailand,s thirteenth confirmed human death from avian flu,
the first since October 8, 2004. The man died one day
earlier in Kanchanaburi province, about 150 kilometers west
of Bangkok, after slaughtering and eating poultry that had
apparently died from avian flu. His eleven year old son is
currently hospitalized in Bangkok with similar, but less
severe, symptoms.


8. Comment: Despite RTG claims that they could produce a
substantial supply of Tamiflu within a year, with or without
a license, it is unclear if GPO has the capability or the
capacity to produce Tamiflu in sufficient quantity. Roche
has said publicly that the production process consists of a
complicated ten-step procedure, some of which are time
consuming and at least one step is quite difficult, involving
volatile or dangerous compounds. GPO has had success reverse
engineering and producing other drugs, but without direct
assistance from Roche under a licensing agreement, production
of a generic form of Tamiflu could prove a difficult venture.
End Comment.
BOYCE