DOH DRAFTING REGS FOR TAIWAN'S NATIONAL BLOOD LAW

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