SINGAPORE 2007 SPECIAL 301 REVIEW: RECOMMEND NO

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