VZCZCXRO4491
RR RUEHCHI RUEHCN RUEHDT RUEHGH RUEHHM RUEHVC
DE RUEHHK #2014/01 3030946
ZNR UUUUU ZZH
R 300946Z OCT 09
FM AMCONSUL HONG KONG
TO RUEHC/SECSTATE WASHDC 8849
INFO RUEHZS/ASSOCIATION OF SOUTHEAST ASIAN NATIONS
RUEHOO/CHINA POSTS COLLECTIVE
RUCPDOC/DEPT OF COMMERCE WASHDC

UNCLAS SECTION 01 OF 02 HONG KONG 002014 
 
SENSITIVE 
SIPDIS 
 
STATE FOR EAP/CM, PASS USTR FOR ALTBACH 
 
E.O. 12958: N/A 
TAGS: ECON EFIN EINV ETRDGK KIPR HK CH
SUBJECT: HONG KONG GOVERNMENT ANNOUNCES DRUG SAFETY 
RECOMMENDATIONS 
 
REF: HONG KONG 1687 
 
(U) Summary: A Hong Kong government-led pharmaceutical 
regulation committee announced October 23 eighteen 
recommendations designed to improve drug safety.  The 
recommendations will form the basis for a final report to be 
released by year-end, with a special focus on improving the 
safety of generic drugs.  The committee's proposals are aimed 
at addressing deficiencies in Hong Kong's regulatory 
framework governing drug safety at all levels of the supply 
chain as well as enhancing the operating scope and 
responsibilities of the Department of Health's drug safety 
officials.  While industry observers generally welcomed the 
recommendations, they cautioned that further details were 
needed to assess their likely efficacy and implementation 
timeframes.  End Summary. 
 
¶2. (SBU) Comment: The 20-member drug regulation review 
committee produced a battery of recommendations that could 
significantly improve the safety of generic drugs in Hong 
Kong.  However, before implementation timeframes are fixed, 
regulatory texts are revised, and the amendments take effect, 
the committee's recommendations require further analysis and 
input from healthcare professionals in both the public and 
private sectors.  This will significantly delay enactment of 
the proposals likely to have the greatest impact on drug 
safety, i.e., those involving generic drug manufacturing 
standards and Department of Health oversight of the supply 
chain.  The HKG continues to allow local doctors to both 
prescribe and sell pharmaceuticals in their offices, despite 
the clear conflict of interest and safety concerns. 
Recommendations on enhanced regulation of the local generic 
drug industry will undoubtedly take into account the costs - 
in terms of dollars and jobs - to be incurred by local 
manufacturers.  Despite these challenges, we view the 
committee's work as a potentially large step forward in 
improving drug safety in Hong Kong.  End Comment. 
 
Background 
---------- 
 
¶3. (U) Following the deaths of five Hong Kong residents who 
ingested a tainted locally manufactured generic drug, the 
Hong Kong Government (HKG) on March 24 established a Review 
Committee on Regulation of Pharmaceutical Products (the "Drug 
Review Committee")(reftel).  Committee members include 
doctors, pharmacists, patients' rights advocates, the 
Consumer Council, the public Hospital Authority, and private 
hospital administrators.  Permanent Secretary for Food and 
Health Sandra Lee serves as the Drug Review Committee's 
chairman. 
 
Committee Announces Drug Safety Recommendations 
--------------------------------------------- -- 
 
¶4. (U) Lee announced on October 23 eighteen consensus 
recommendations from the committee that are intended to 
enhance the regulatory regime governing pharmaceutical 
products sold in Hong Kong, particularly generic drugs.  The 
recommendations encompass the entire supply chain of 
pharmaceutical products - manufacturing, importation, 
procurement, distribution and inventory control - as well as 
risk communication, education and training.  The Drug Review 
Committee intends to submit a final report by year-end that 
provides the committee's analytical assumptions and more 
details about its recommendations.  The report is intended to 
guide the HKG as it attempts to solicit more public feedback 
and revamp its regulatory and legal framework governing drug 
safety. 
 
Attention Focused on Drug Supply Chain... 
----------------------------------------- 
 
¶5. (SBU) Local manufacturers of generic drugs have been the 
primary culprits in recent drug safety incidents, and they 
were a primary target of the Drug Review Committee's 
assessments.  The committee proposed upgrading Hong Kong's 
current Good Manufacturing Practices (GMP) requirements for 
local drug manufacturers to the more demanding international 
best-practice standards enforced in the most highly developed 
nations.  It recommended microbiological monitoring for 
non-sterile drugs and drug ingredients during the 
manufacturing process.  (Note: The five March 2009 deaths 
from a tainted drug were caused by fungal contamination of 
granule powder, prior to compression into the tablets that 
were consumed.  End Note)  Other recommendations included 
tightening the qualification requirements for the "Authorized 
 
HONG KONG 00002014  002 OF 002 
 
 
Person" each local manufacturer must employ to oversee the 
quality, safety and efficacy of its products. 
 
¶6. (U) The Drug Review Committee recommended broadening 
licensing requirements for drug wholesalers and retailers to 
include over-the-counter pharmaceutical products.  The 
committee also proposed establishment of a dedicated team of 
Customs and Excise Department (C&ED) pharmaceutical officers 
to serve at ports of entry and engage in surveillance 
activities.  In addition, pharmacies would be required to 
maintain written records for all drug orders and have a 
registered pharmacist on duty, whenever the pharmacy was open 
for business.  Society of Hospital Pharmacists Vice Chairman 
William Chui welcomed the latter recommendation but cautioned 
it would require 250 additional pharmacists to be employed at 
retail outlets.  He encouraged a gradual phase-in of the new 
rule. 
 
...And the Department of Health 
------------------------------- 
 
¶7. (U) One-third of the Drug Review Committee's 
recommendations targeted the Department of Health (DOH).  The 
committee proposed that the DOH shorten the processing time 
for drug registration approval and require bioavailability 
and bioequivalence certification for all generic drugs.  DOH 
was also asked to liaise more closely with healthcare 
professionals regarding professional certification programs, 
continuing education requirements, and training efforts 
related to newly registered drugs.  The Drug Review Committee 
also recommended that the DOH provide more information on 
registered drugs to the general public, healthcare 
professionals and the drug industry.  It also called for 
revamping of the DOH's website to include more information 
about possible adverse side effects from registered drugs. 
 
Healthcare Industry Awaits Final Report 
--------------------------------------- 
 
¶8. (U) While healthcare industry professionals largely 
welcomed the committee's proposals, several committee members 
cautioned that further details and more analysis were needed. 
 Practicing Pharmacists Association of Hong Kong President 
Iris Chang, one of twenty members of the Drug Review 
Committee, described the committee's recommendations as "too 
vague."  She said the group's final report needed to more 
narrowly define its proposals and provide the HKG with more 
specific guidance on the steps and resources necessary to 
implement the various recommendations.  Industry observers 
told media sources that the recommendations would likely 
drive several small local manufacturers of generic drugs out 
of business and force generic drug costs up by 10-20 percent. 
MARUT