US embassy cable - 05TAIPEI3807

UNCLAS TAIPEI 003807 
 
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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, Trade, 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. 
 
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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 
 
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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. 
 
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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