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Cablegate: Hong Kong Government Announces Drug Safety

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

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