Cablegate: Abbott Labs Halts New Drug Registrations
RR RUEHCHI RUEHDT RUEHHM RUEHNH
DE RUEHBK #1524 0732323
ZNR UUUUU ZZH
R 142323Z MAR 07
FM AMEMBASSY BANGKOK
TO RUEHC/SECSTATE WASHDC 5544
RUCNASE/ASEAN MEMBER COLLECTIVE
RUEHGV/USMISSION GENEVA 1793
RUCPDOC/USDOC WASHINGTON DC
RUEAUSA/DEPT OF HHS WASHINGTON DC
UNCLAS BANGKOK 001524
STATE PASS USTR FOR B. WEISEL, C. WILSON
STATE PASS USPTO
HHS/OHGA FOR AMAR BHAT
USDOC FOR JKELLY
TAGS: ECON ETRD KIPR TH
SUBJECT: ABBOTT LABS HALTS NEW DRUG REGISTRATIONS
1. Abbott Labs, the recent target of a compulsory license on their
patented antiretroviral Kaletra, confirmed to Embassy that the
company had withdrawn applications for registration of seven new
pharmaceutical products in Thailand, and had no plans to introduce
new products until its intellectual property was properly respected.
The seven drugs include Aluvia, a new heat-stable version of
Kaletra. Although the two drugs are identical in effect, the new
version is considered ideal for tropical environments such as
Thailand. Other drug applications pulled include treatments for
hypertension, kidney disease, auto-immune disease and congestive
heart failure. The applications had been on file with the Thai FDA
for up to ten months awaiting approval.
2. Abbott said they had notified the FDA's Drug Control Division
(DCD), but RTG officials interviewed by press said they were unaware
of Abbott's actions (Embassy's calls to FDA officials were not
returned today). The DCD's Senior Pharmacist Dr. Suchart
Chongprasert told a Wall Street Journal reporter that he was
surprised that Abbott would choose to unilaterally restrict its
sales in Thailand and was waiting to see the actual documentation
withdrawing the applications. Asked if the RTG would respond with
further CLs, Dr. Suchart said the process of identifying drugs to
license was lengthy and no more CLs were in the pipeline.
3. Matichon newspaper quoted Dr. Siriwat Tiptaradol, Secretary
General of the Thai FDA, that the Ministry of Public Health planned
to invite relevant parties, especially the three companies whose
patents were broken, to meet on March 26 to negotiate. However,
none of the three had yet to receive an invitation.
4. Comment: Abbott's actions will certainly be controversial.
However, the action may strengthen the hand of Abbott and the rest
of industry in future dealings with the RTG. Abbott's move puts the
RTG on notice that there are visible consequences for its actions,
rather than solely a vague weakening of the investment environment.
Whether this focuses the minds of RTG officials at upcoming
negotiations remains to be seen. End Comment.