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Viewing cable 07SINGAPORE371, SINGAPORE 2007 SPECIAL 301 REVIEW: RECOMMEND NO

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Reference ID Created Released Classification Origin
07SINGAPORE371 2007-02-23 06:56 2011-08-25 00:00 UNCLASSIFIED//FOR OFFICIAL USE ONLY Embassy Singapore
VZCZCXRO9591
PP RUEHCHI RUEHDT RUEHHM RUEHNH
DE RUEHGP #0371/01 0540656
ZNR UUUUU ZZH
P 230656Z FEB 07
FM AMEMBASSY SINGAPORE
TO RUEHC/SECSTATE WASHDC PRIORITY 2509
INFO RUCNASE/ASEAN MEMBER COLLECTIVE
RUEHGV/USMISSION GENEVA 0843
RUEHC/DEPT OF LABOR WASHDC
RUCPDOC/DEPT OF COMMERCE WASHDC
RUEATRS/DEPT OF TREASURY WASHDC
UNCLAS SECTION 01 OF 02 SINGAPORE 000371 
 
SIPDIS 
 
C O R R E C T E D  C O P Y (ADDED PARA MARKINGS) 
 
SENSITIVE 
SIPDIS 
 
STATE FOR EB/IPC, EAP/MTS 
STATE PASS TO USTR FOR VESPINEL AND JJENSEN 
COMMERCE FOR JBAKER 
USPTO FOR PFOWLER 
COPYRIGHT OFFICE FOR MPOOR 
 
E.O. 12958: N/A 
TAGS: KIPR ECON ETRD EINV USTR WTRO SN
SUBJECT: SINGAPORE 2007 SPECIAL 301 REVIEW: RECOMMEND NO 
CHANGE IN STATUS 
 
REF: A. STATE 7944 
 
     B. 06 SINGAPORE 3442 
 
SINGAPORE 00000371  001.2 OF 002 
 
 
1.  (SBU) Summary:  Post recommends maintaining Singapore's current 
Special 301 status in 2007, i.e., not on the Watch List. 
Singapore remains committed to enhancing what is already one 
of Asia's strongest intellectual property regimes.  The 
government continues to implement its IPR-related commitments 
under the U.S.-Singapore Free Trade Agreement (FTA), 
including amendments to its Copyright, Trademarks, and 
Patents Acts, and a new Optical Disk Act.  The Pharmaceutical 
Research and Manufacturers of America (PhRMA) has cited 
certain "market access barriers;"  We recommend using the 
annual FTA review mechanism rather than the Special 301 
process to address the issues.  End Summary. 
 
Parallel Import Regulations 
--------------------------- 
 
2. (SBU) PhRMA voiced concern that Singapore's issuing licenses to 
import pharmaceuticals from third countries could lead to 
greater risks of counterfeiting, improper handling, and 
inadequate or inappropriate packaging.  Parallel imports do 
not contravene Singapore's FTA commitments as described in 
Article 16.7.2 and Footnote 16.10, which deem parallel 
imports to be restricted only if the product is not currently 
sold in the domestic market.  Singapore amended its Patents 
Act to conform to the FTA, and imposes no other restrictions 
on parallel imports except for certain controlled substances. 
 
3.  (SBU) Singapore's Health Sciences Authority (HSA) reports that 
it has received no accounts of counterfeit drugs' entering 
Singapore through parallel import.  Similarly, Post's 
Immigrations and Customs Enforcement (ICE) office says it is 
not aware of any specific examples of counterfeits entering 
via this channel. 
 
4.  (SBU) HSA maintains strict control of pharmaceutical imports. 
According to HSA, applicants must provide extensive 
documentation prior to importation, including: 
 
--A statement from the exporter showing that it is a 
registered pharmaceuticals dealer in the exporting country; 
--Documentation showing that the product is registered in the 
exporting country; 
--An invoice from the exporting agent indicating the batch 
number of the proposed import; 
--A certificate of analysis of the proposed import from the 
manufacturer or approved laboratory; 
--A statement from the company accepting responsibility for 
the quality, safety, and efficacy of the proposed import; 
--Documentation showing compliance with internationally 
recognized practices throughout the supply chain from source 
of manufacture to importation; 
--Proposed product and locally registered product packaging 
and labeling; and 
--A copy of the company business registration certificate. 
 
Standard Drug List 
------------------ 
 
5.  (SBU) PhRMA also raised concerns with the transparency of 
Singapore's Standard Drug List (SDL) process.  We do not 
accept the Ministry of Health's explanation that the fairness 
of the current process is in part due to the non-involvement 
of industry, and we will raise the matter with the GOS. 
While a legitimate market access concern, we believe SDL 
transparency is an issue that would be more effectively 
addressed through alternative channels such as our annual FTA 
review process. 
 
Separation of Prescription and Dispensing Authorities 
--------------------------------------------- -------- 
 
6.  (SBU) PhRMA also said it was concerned about Singapore's lack 
of a required separation of prescription and dispensing 
authorities (e.g., between physicians and pharmacies).  We 
recommend handling this issue through the FTA review process 
as well. 
 
Pharmaceutical Investment in Singapore 
 
SINGAPORE 00000371  002.2 OF 002 
 
 
-------------------------------------- 
 
7.  (SBU) At the time of its submission, PhRMA could not estimate 
the damages incurred in 2006 attributable to trade barriers 
related to intellectual property protection and market 
access.  We also were unable to determine these damages, but 
note that, according to the Singapore Economic Development 
Board, more than 20 pharmaceutical companies currently have 
manufacturing and research and development operations in 
Singapore.  Several U.S. companies have cited the strength of 
Singapore's IPR laws and enforcement capabilities as a 
determining factor in their decisions to increase existing 
investments or commence new operations here since the FTA 
came into effect in January 2004.  According to the Ministry 
of Trade and Industry, pharmaceutical output, in terms of 
GDP, has nearly doubled over the last four years to 11 
percent.  In 2006, investment commitments by PhRMA 
member-companies Abbott, Merck, and GlaxoSmithKline exceeded 
US$ 500 million. 
 
8.  (SBU) We will address septel the "special mention" of Singapore 
made by the International Intellectual Property Alliance 
(IIPA). 
HERBOLD