US embassy cable - 05TAIPEI1901

UNCLAS TAIPEI 001901 
 
SIPDIS 
 
STATE FOR EAP/RSP/TC, PASS AIT/W AND USTR, USTR FOR KI AND 
FREEMAN 
 
E.O. 12958: N/A 
TAGS: ECON, ETRD, TW, ESTH 
SUBJECT: DOH DRAFTING REGS FOR TAIWAN'S NATIONAL BLOOD LAW 
 
 
 1.  AIT met with the Director General of the Bureau of 
Medical Affairs (BOMA) Hsueh Jiu-yuan and staff April 19 to 
discuss the status of draft implementing regulations for the 
National Blood Law passed in December 2004.   An initial 
draft of the regulations has been prepared, AIT/T is 
preparing and will transmit an informal translation to AIT, 
State, Commerce, and USTR via unclassified e-mail  Hsueh 
promised that BOMA would meet with all interested 
stakeholders prior to submitting the draft regulations to the 
Executive Yuan.  A meeting is scheduled for May 13 or 19 to 
give industry associations the opportunity to propose 
specific amendments to the regulations. 
 
2.  Specific questions from industry center on the law's 
requirement that blood product manufacturers obtain approval 
from a central competent authority before being allowed to 
import material from foreign countries; and the requirement 
that medical facilities prioritize the use of blood 
preparations manufactured using domestic blood donations. 
International providers of blood and blood products allege 
these requirements violate Taiwan,s WTO national treatment 
commitments. 
 
3.  Hsueh clarified that the law only requires Taiwan-based 
manufacturers to prioritize use of domestic blood plasma as a 
raw material.  Only when there is insufficient supply of 
locally collected blood plasma can firms apply for approval 
to import blood.  Since there are currently no international 
manufacturers processing blood or blood products in Taiwan, 
the law does not place a burden on international 
manufacturers, he said.  Hsueh took pains to emphasize that 
imported blood products need not be sourced from domestic 
blood plasma.  The DOH will be the competent authority to 
approve imports and will endeavor to make the requirement pro 
forma, although Hsueh could not say what branch of DOH will 
shoulder this responsibility. 
 
4.  When asked how the DOH would enforce the requirement that 
medical institutions prioritize the use of domestically 
sourced blood products, Hsueh admitted DOH had no real 
authority to do so.  Instead, he expects DOH will circulate a 
notice to all medical facilities, informing them of the 
requirements of the law.  Nothing in the law authorizes 
penalties for failure to prioritize the use of domestic blood 
products, nor are there any provisions to provide financial 
incentives to promote the use of domestic products. 
 
5.  The draft regulations should be submitted to the EY 
sometime soon after the scheduled meeting with industry 
associations.  Although BOMA characterized this meeting as a 
public hearing, it will be by invitation only and will not 
include representatives of individual companies or members of 
the public.  Hsueh expected the regulations would take effect 
by the beginning of 2006. 
 
6.  Comment:  It was clear during the course of AIT's meeting 
with BOMA that DOH was eager not to violate WTO principles 
regarding national treatment.  However, BOMA staff drafting 
the regulations had very little understanding of WTO 
requirements or how their proposed draft could discriminate 
against international suppliers of blood plasma raw materials 
and finished blood products.  AIT has contacted US suppliers 
of blood products active in the Taiwan market to share the 
draft regulations and advise them of DOH's willingness to 
meet privately to discuss.  End Comment. 
PAAL