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LCQ1: Regulatory system of pharmaceutical products
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     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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