Identifier
Created
Classification
Origin
05TAIPEI3807
2005-09-14 10:19:00
UNCLASSIFIED
American Institute Taiwan, Taipei
Cable title:  

TAIWAN DOH PROMISES DATA EXCLUSIVITY REGULATIONS

Tags:  ETRD KIPR TW IPR ESTH 
pdf how-to read a cable
This record is a partial extract of the original cable. The full text of the original cable is not available.

141019Z Sep 05
UNCLAS TAIPEI 003807 

SIPDIS

STATE FOR EAP/RSP/TC AND EB/MPP/BTA, STATE PASS AIT/W AND
USTR, USTR FOR WINTER AND WINELAND, USDOC FOR
4431/ITA/MAC/AP/OPB/TAIWAN/MBMORGAN AND DUTTON

E.O. 12958: N/A
TAGS: ETRD KIPR TW IPR ESTH
SUBJECT: TAIWAN DOH PROMISES DATA EXCLUSIVITY REGULATIONS
COMING SOON

REF: TAIPEI 0313

UNCLAS TAIPEI 003807

SIPDIS

STATE FOR EAP/RSP/TC AND EB/MPP/BTA, STATE PASS AIT/W AND
USTR, USTR FOR WINTER AND WINELAND, USDOC FOR
4431/ITA/MAC/AP/OPB/TAIWAN/MBMORGAN AND DUTTON

E.O. 12958: N/A
TAGS: ETRD KIPR TW IPR ESTH
SUBJECT: TAIWAN DOH PROMISES DATA EXCLUSIVITY REGULATIONS
COMING SOON

REF: TAIPEI 0313


1. AIT accompanied members of PhRMA, the Japanese
Pharmaceutical Manufacturers Association (JPMA) and the
European Federation of Pharmaceutical Industries and
Associations (EFPIA) to meetings with Taiwan's Department of
Health, Bureau of Pharmaceutical Affairs (BOPA) and Bureau of
Food and Drug Analysis (BFDA -- reported septel).
Discussions with BOPA Deputy Director General Liu Li-ling
focused on the status of draft regulations to implement
amendments to Taiwan's Pharmaceutical Law passed in January

2005. These amendments provide data protection for
innovative pharmaceuticals for five years but require
manufacturers to register their product with Taiwan
authorities within three years of release in one of ten major
markets. Implementing regulations were expected in August,
but have yet to be circulated for public comment.


2. DDG Liu told those assembled that the Data Exclusivity
(DE) implementing regulations were delayed by the appointment
of a new BOPA Director General (Dr. Liao Chi-chou, who came
from National Taiwan University Hospital in June 2005),but
that they expected to release the draft implementing
regulations for public comment by the end of September. The
draft regulations will be posted on the DOH website
(www.doh.gov.tw) and DOH will accept comments for one month,
after which they will forward the regulations to the EY for
adoption. Liu suggested that regulations would be in place
by the end of November 2005. Liu confirmed that companies do
not have to take any additional actions beyond registration,
and that data protection would be automatic. All products
registered after the date the new amendments were promulgated
(2/7/05) will be protected in spite of the fact that
implementing regulations have not yet been adopted.

=========================================
BOPA wants to Adopt First Mover Standards
=========================================


3. Industry representatives had particular concerns about
provisions in the draft regulations that would allow for the
public release of data on specifications and methods for
testing final products, noting that these could be trade
secrets. Liu responded that BOPA wants to be able to adopt

SIPDIS
these specifications and methods as a standard so that
subsequent generic producers will have to meet the same
manufacturing standards. When BOPA plans to adopt these
specifications, they will be published in the Chinese
Pharmacopoeia. Liu assured industry representatives that DOH
wanted to inform companies before this kind of standard was
made public, but noted that neither the Taiwan pharmaceutical
law or WTO regulations required it.


4. US industry representatives noted that the U.S.
Pharmacopoeia was beginning to take steps to encourage
innovators to provide similar information in order to
establish standards and that some innovators that were
reluctant to provide this information had found themselves
forced to meet specifications and methods standards
established by generic producers. Liu promised to consider
whether foreign firms would be allowed to review information
before it is published in the Chinese pharmacopia.

============================================= =========
Considering Releasing Protocol Summaries, Patent Terms
============================================= =========


5. PhRMA representatives raised similar concerns about the
DOH plan to release protocol summaries of clinical trials.
BOPA senior staff responded that this information had been
released for more than ten years and did not violate the
requirements of the new law. PhRMA also urged DOH to
consider making patent term information available when
information on a product is released under data protection
provisions. In some cases DE protection will expire before
the patent, potentially leading some generic manufacturers to
mistakenly believe that they can legally produce these
products. Releasing patent expiry dates could reduce the
need for expensive lawsuits. DOH noted that these cases
would normally be addressed through the legal system, but
would consider whether it would be possible to include this
information.
KEEGAN