Replies to LegCo questions
LCQ1: Regulatory system of pharmaceutical products
Following is a question by the Hon Pan Pey-chyou and a written reply by the
Secretary for Food and Health, Dr York Chow, in the Legislative Council today
(April 1):
Question:
In connection with the recent spate of medicine incidents, resulting in the
Hospital Authority (HA) having to arrange for cessation of use and replacement
of the questionable medicines concerned, will the Government inform this
Council:
(a) whether it will consider amending the content of GMP to require that each
batch of oral medicine must be tested and proved to be free from bacteria or
other contaminants before it leaves the factory;
(b) whether it knows the amount of expenditure incurred by HA on the cessation
of use and replacement of such questionable medicines, and whether it will claim
compensation from the pharmaceutical manufacturers concerned;
(c) whether it knows if HA chose to use the medicines of such pharmaceutical
manufacturers because the selling prices were the lowest, and whether HA had
looked into the reasons for the low selling prices for medicines before making
the decision to use them; and
(d) given the spate of medicine incidents involving pharmaceutical manufacturers
with GMP certification, whether the Government has assessed if there is any
negligence or dereliction of duty on the part of the staff responsible for
regulating medicines?
Reply:
President,
Starting from 2002, all local pharmaceutical manufacturers have to comply with
the "Good Manufacturing Practices" (GMP) set by the Pharmacy and Poisons Board.
Our replies to the four parts of the question are as follows:
(a) While injections are applied directly to the body, oral medicines get into
the body through gastrointestinal absorption. As such, the international
standards on drugs (such as those adopted in the United Kingdom, the European
Union, the United States and the Mainland) require that injections must not
contain any bacteria. There are no such requirements for oral medicines.
However, these countries have set standards for the quantity of bacteria and
fungi in oral medicines.
We will review the existing GMP and introduce risk assessment principles and
microbiology testing so as to reduce the risk of microbial contamination of
drugs.
(b) In the light of the recent drug incidents, the Hospital Authority (HA) has
stopped prescribing the affected allopurinol and metformin and arranged
replacement of allopurinol and metformin by other brands for the affected HA
patients. The relevant expenses are about HK$0.63 million. Besides, as the HA
has stopped prescribing the other pharmaceutical products produced by Europharm,
it needs to procure alternative drugs from other sources to maintain normal
service. The additional costs incurred by the HA on drugs in the first month are
estimated to be about HK$8 million. The total additional costs involved as a
result of the incident are not yet available. As for compensation claims, the HA
is now in the process of seeking legal advice.
(c) In compliance with the standards and procedures required by the World Trade
Organisation, the HA procures drug items of high volume or high value with
market alternatives through open tenders. It will consider the bidding price
only after it is satisfied that the tenders comply with all the established
standards on quality and safety. Taking the problematic batch of the "100 mg
allopurinol" as example, the bid submitted by the drug manufacturer concerned
was not the lowest.
(d) The most important task ahead is to restore public confidence in the supply
and regulatory system of pharmaceutical products. In light of the problems
reflected in the recent incidents, the Food and Health Bureau, the Department of
Health (DH) and HA will take comprehensive measures to improve the system.
In the short term, the DH will carry out inspection of all 25 local drug
manufacturers and the inspections will be prioritised based on risk assessment.
The first group of manufacturers to be inspected are the sister companies of the
manufacturers involved in the recent drug incidents. The DH has also written to
the trade, including manufacturers, importers and agents to ensure that they
understand their responsibilities, including the compliance with the
requirements of the law.
Apart from reviewing its drug procurement system, the HA will also carry out a
comprehensive inspection on all existing drugs in HA hospitals and clinics to
ensure their compliance with the regulations. In addition, the HA will
strengthen its monitoring and control mechanism and instruct its staff at
various levels to increase vigilance on expired drugs so as to ensure drug
safety. The HA will also implement seven new initiatives to strengthen the
procurement and management of pharmaceutical products in the public hospitals.
In addition, we have set up a review committee to formulate medium to long term
measures. The committee is chaired by the Permanent Secretary for Food and
Health (Health), and comprises members from the pharmaceutical sector, medical
profession, academia, patient groups and consumer representatives, among others.
The review committee will conduct a comprehensive review on all the issues
relating to the regulation and control of pharmaceutical products including
safety and quality assurance of drugs, standard and practices of the
pharmaceutical industry, and whether there is a need for legislative amendments.
To support the work of the review committee, the Director of Health has set up a
task force to comprehensively review the existing control of the drug supply
chain, including manufacturers, importers, wholesalers and retailers, as well as
the control of drugs. An Expert Group on Microbiological Hazards on Drug
Manufacturing will also make proposals to the task force. Their recommendations
will be put to the review committee for deliberation. The DH will also enlist
the assistance of reputable overseas experts. The views from the stakeholders
will be sought and duly taken into account in the course of the review.
The first meeting of the review committee will be held in early April. It is
expected that the review will take six to nine months' time.
Ends/Wednesday, April 1, 2009
Issued at HKT 12:33
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