US embassy cable - 05BANGKOK6663

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