VZCZCXRO5201
RR RUEHCHI RUEHDT RUEHHM RUEHNH
DE RUEHBK #5644/01 3050948
ZNR UUUUU ZZH
R 010948Z NOV 07
FM AMEMBASSY BANGKOK
TO RUEHC/SECSTATE WASHDC 0461
RUCNASE/ASEAN MEMBER COLLECTIVE
RUCPDOC/USDOC WASHINGTON DC

UNCLAS SECTION 01 OF 02 BANGKOK 005644 
 
SIPDIS 
 
SIPDIS 
 
STATE PASS USTR 
USDOC FOR 4430/EAP/MAC/OKSA 
 
E.O. 12958:N/A 
TAGS: ECON KIPR TH
 
SUBJECT:  FDA CHIEF EXPECTS NO MORE CL'S 
 
¶1.  Summary:  Dr. Siriwat Tiptaradol, Secretary General of the Thai 
Food and Drug Administration (FDA), said he expected no new 
compulsory licenses on drugs, crediting progress in recent 
discussions with European pharmaceutical companies on pricing and 
access for four cancer drugs.  However, the companies say 
discussions thus far have been preliminary and have not offered any 
concessions.  Ongoing discussions with three companies hit by 
compulsory licenses in the last year have not progressed and the 
Government Pharmaceutical Organization is moving forward with plans 
to import a generic copy of HIV drug Aluvia, nine months after 
announcing a compulsory license.  Thai political parties are vague 
on what position they will hold on the issue after December 
elections.  End Summary. 
 
¶2.  In a courtesy call by Econ Counselor and Econoff on October 25, 
Dr. Siriwat said he thought there "shouldn't have to be more 
compulsory licenses," but emphasized this was his personal opinion 
and he could not speak for the Ministry of Public Health.  The 
Ministry is considering breaking patents on four cancer drugs 
distributed by three European companies, following on the issuance 
of compulsory licenses on two HIV/AIDS medicines and a heart drug 
over the last year.  The four cancer drugs are distributed by 
Swiss-owned Novartis and Roche, and French-owned Sanofi-Aventis. 
Dr. Siriwat said initial discussions beginning October 18 had gone 
well and companies had responded positively, particularly Roche. 
Siriwat explained the Ministry's long-held position that Thailand's 
public health system was unable to cover the costs for expensive 
life-saving drugs and compulsory licenses were necessary to widen 
access.  He assured that generic versions would be provided only to 
the poor under the RTG's universal health care program.  Dr. Siriwat 
claimed the Thai program "will actually expand the companies' market 
in Thailand," as those who can afford the drugs, such as patrons of 
private hospitals and those with commercial health insurance, will 
still pay the current prices. 
 
¶3.  Dr. Rolf Ammelburg, Managing Director of Roche Thailand, said 
his initial meeting with the FDA had gone well; the company showed 
its openness to discussion and new proposals, but made no 
commitments.  Ammelburg said the FDA had proposed that Roche lower 
the price of their lung cancer drug erlotinib, submit to a voluntary 
license, or face the possibility of a compulsory license.  The FDA 
did not clearly define how a voluntary license would operate, but 
Ammelburg assumed that the FDA aimed to pursue domestic production 
under license from Roche.  He noted, however, that Thailand may not 
have the domestic capability to produce the drug.  Thailand had 
announced two years ago it would begin generic manufacture of 
another Roche drug, Tamiflu, but has yet to produce a single 
capsule.  Ammelburg felt that the FDA was not anxious to do a 
compulsory license and was strongly pushing the other options to 
avoid such a result. 
 
¶4.  There has been no further progress in discussions with Merck or 
Abbott, whose patents on antiretrovirals were broken in November 
2006 and January 2007, respectively.  The FDA announced October 17 
that it had approved the registration of a generic version of 
Aluvia, a new heat-stable form of Abbott's AIDS drug Kaletra.  The 
Government Pharmaceutical Organization (GPO) said it would soon 
begin importing the drug from Indian generic manufacturer Matrix 
Laboratories, enough for 8000 HIV-positive patients for six months. 
Matrix offered a price of USD 695 per patient per year, about three 
hundred dollars less than Abbott's listed price. 
 
¶5.  The FDA appears to have taken a questionable shortcut to approve 
the generic version of Aluvia.  When Thailand issued a compulsory 
license on Kaletra, the older version of the antiretroviral, Abbott 
retaliated by pulling the registration paperwork for the new 
version, Aluvia, which was then only months away from approval. 
Thailand has decided to import generic Aluvia, though its compulsory 
license is actually on Kaletra.  Both drugs share the same chemical 
combination, lopinavir/rotinavir, but it is unclear if the 
compulsory license on the older drug would allow importation of a 
generic version of the new drug.  As well, safety and efficacy data 
required for approval is not on file for Aluvia, and FDA officials 
say they simply accepted the data for Kaletra in its absence.  The 
FDA added a condition to the drug registration that a sample of 
patients would be tested after six months to determine if the 
generic version was effective. 
 
Abbott in the dock 
------------------ 
 
¶6.  The Thailand Competition Commission is reviewing a complaint 
local public health NGOs have brought against Abbott for its 
decision earlier this March to withdraw the pending registrations of 
seven new drugs, including Aluvia.  The complaint alleges that 
Abbott's action contravenes Section 28 of Thailand's Competition Act 
which forbids restricting opportunities for consumers "to purchase 
goods or services directly from business operators outside the 
 
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Kingdom."  The Commission is still gathering information about the 
case and has asked Abbott for market share and cost data.  If the 
Commission concludes that Abbott made anti-competitive practices, 
they can recommend the case to a court for a fine or possible 
criminal charges.  Abbott's lawyers say the case probably would not 
meet the Competition Act's criteria for market dominance for 
anti-competitive practices, but are nevertheless concerned that 
local Thai management could be brought up on criminal charges. 
 
Politics isn't over 
------------------- 
 
¶7.  Political parties vying for election this December are hedging 
on policies on compulsory licenses they might follow if elected.  In 
a forum on access to medicine hosted by public health NGOs, Mr. 
Buranaj Smutharaks, representing the Democrat Party, said his party 
would not obstruct the compulsory licensing process.  Party leader 
Abhisit Vejjajiva had earlier delivered a pro-business message on 
the issue to a business and investor audience, saying he would work 
with the pharmaceutical industry and would use compulsory licenses 
only as a last resort.  However, Buranaj told the health forum that 
"it is highly possible the last resort will get the first priority." 
 Representatives from the People Power Party and Chart Thai party 
told the forum they supported the decision to adopt compulsory 
licenses, but could not commit to how their parties would pursue the 
issue as part of a likely coalition government. 
 
¶8.  Comment:  Less than two months remain until national elections 
and a thorough change in government, but this is ample time in which 
to implement more compulsory licenses.  Despite Dr. Siriwat's view 
that no more will be necessary, the final decision will be made by 
the Minister of Public Health who may yet use his last days in 
office to push through a last-minute bid for more CLs. 
Post-election, much of the Ministry's top staff will turn over and 
there may be few opportunities in the future to pursue this policy. 
The leading political parties have paid lip service to the current 
policy, but for the most part they are pro-business and would be 
unlikely to pursue compulsory licenses as aggressively as has the 
current government.  End Comment.