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OFFICIAL RECORD of PROCEEDINGS Wednesday, 1 April 2009 the Council Met at Eleven O'clock

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OFFICIAL RECORD of PROCEEDINGS Wednesday, 1 April 2009 the Council Met at Eleven O'clock LEGISLATIVE COUNCIL ─ 1 April 2009 5891 OFFICIAL RECORD OF PROCEEDINGS Wednesday, 1 April 2009 The Council met at Eleven o'clock MEMBERS PRESENT: THE PRESIDENT THE HONOURABLE JASPER TSANG YOK-SING, G.B.S., J.P. THE HONOURABLE ALBERT HO CHUN-YAN IR DR THE HONOURABLE RAYMOND HO CHUNG-TAI, S.B.S., S.B.ST.J., J.P. THE HONOURABLE LEE CHEUK-YAN DR THE HONOURABLE DAVID LI KWOK-PO, G.B.M., G.B.S., J.P. THE HONOURABLE FRED LI WAH-MING, J.P. DR THE HONOURABLE MARGARET NG THE HONOURABLE JAMES TO KUN-SUN THE HONOURABLE CHEUNG MAN-KWONG THE HONOURABLE CHAN KAM-LAM, S.B.S., J.P. THE HONOURABLE MRS SOPHIE LEUNG LAU YAU-FUN, G.B.S., J.P. THE HONOURABLE LEUNG YIU-CHUNG THE HONOURABLE WONG YUNG-KAN, S.B.S., J.P. THE HONOURABLE LAU KONG-WAH, J.P. 5892 LEGISLATIVE COUNCIL ─ 1 April 2009 THE HONOURABLE LAU WONG-FAT, G.B.M., G.B.S., J.P. THE HONOURABLE MIRIAM LAU KIN-YEE, G.B.S., J.P. THE HONOURABLE EMILY LAU WAI-HING, J.P. THE HONOURABLE ANDREW CHENG KAR-FOO THE HONOURABLE TIMOTHY FOK TSUN-TING, G.B.S., J.P. THE HONOURABLE TAM YIU-CHUNG, G.B.S., J.P. THE HONOURABLE ABRAHAM SHEK LAI-HIM, S.B.S., J.P. THE HONOURABLE LI FUNG-YING, B.B.S., J.P. THE HONOURABLE TOMMY CHEUNG YU-YAN, S.B.S., J.P. THE HONOURABLE ALBERT CHAN WAI-YIP THE HONOURABLE FREDERICK FUNG KIN-KEE, S.B.S., J.P. THE HONOURABLE AUDREY EU YUET-MEE, S.C., J.P. THE HONOURABLE VINCENT FANG KANG, S.B.S., J.P. THE HONOURABLE WONG KWOK-HING, M.H. THE HONOURABLE LEE WING-TAT DR THE HONOURABLE JOSEPH LEE KOK-LONG, J.P. THE HONOURABLE JEFFREY LAM KIN-FUNG, S.B.S., J.P. THE HONOURABLE ANDREW LEUNG KWAN-YUEN, S.B.S., J.P. THE HONOURABLE ALAN LEONG KAH-KIT, S.C. THE HONOURABLE LEUNG KWOK-HUNG LEGISLATIVE COUNCIL ─ 1 April 2009 5893 THE HONOURABLE CHEUNG HOK-MING, S.B.S., J.P. THE HONOURABLE WONG TING-KWONG, B.B.S. THE HONOURABLE RONNY TONG KA-WAH, S.C. THE HONOURABLE CHIM PUI-CHUNG PROF THE HONOURABLE PATRICK LAU SAU-SHING, S.B.S., J.P. THE HONOURABLE KAM NAI-WAI, M.H. THE HONOURABLE CYD HO SAU-LAN THE HONOURABLE STARRY LEE WAI-KING DR THE HONOURABLE LAM TAI-FAI, B.B.S., J.P. THE HONOURABLE CHAN HAK-KAN THE HONOURABLE CHAN KIN-POR, J.P. THE HONOURABLE TANYA CHAN DR THE HONOURABLE PRISCILLA LEUNG MEI-FUN DR THE HONOURABLE LEUNG KA-LAU THE HONOURABLE CHEUNG KWOK-CHE THE HONOURABLE WONG SING-CHI THE HONOURABLE WONG KWOK-KIN, B.B.S. THE HONOURABLE WONG YUK-MAN THE HONOURABLE IP WAI-MING, M.H. THE HONOURABLE IP KWOK-HIM, G.B.S., J.P. 5894 LEGISLATIVE COUNCIL ─ 1 April 2009 THE HONOURABLE MRS REGINA IP LAU SUK-YEE, G.B.S., J.P. DR THE HONOURABLE PAN PEY-CHYOU THE HONOURABLE PAUL TSE WAI-CHUN DR THE HONOURABLE SAMSON TAM WAI-HO, J.P. MEMBERS ABSENT: DR THE HONOURABLE PHILIP WONG YU-HONG, G.B.S. THE HONOURABLE PAUL CHAN MO-PO, M.H., J.P. PUBLIC OFFICERS ATTENDING: THE HONOURABLE HENRY TANG YING-YEN, G.B.S., J.P. THE CHIEF SECRETARY FOR ADMINISTRATION THE HONOURABLE JOHN TSANG CHUN-WAH, J.P. THE FINANCIAL SECRETARY THE HONOURABLE WONG YAN-LUNG, S.C., J.P. THE SECRETARY FOR JUSTICE DR THE HONOURABLE YORK CHOW YAT-NGOK, S.B.S., J.P. SECRETARY FOR FOOD AND HEALTH THE HONOURABLE DENISE YUE CHUNG-YEE, G.B.S., J.P. SECRETARY FOR THE CIVIL SERVICE THE HONOURABLE MATTHEW CHEUNG KIN-CHUNG, G.B.S., J.P. SECRETARY FOR LABOUR AND WELFARE PROF THE HONOURABLE K C CHAN, S.B.S., J.P. SECRETARY FOR FINANCIAL SERVICES AND THE TREASURY LEGISLATIVE COUNCIL ─ 1 April 2009 5895 DR KITTY POON KIT, J.P. SECRETARY FOR THE ENVIRONMENT THE HONOURABLE EVA CHENG, J.P. SECRETARY FOR TRANSPORT AND HOUSING THE HONOURABLE MRS RITA LAU NG WAI-LAN, J.P. SECRETARY FOR COMMERCE AND ECONOMIC DEVELOPMENT PROF LAU SIU-KAI, J.P. HEAD, CENTRAL POLICY UNIT CLERKS IN ATTENDANCE: MS PAULINE NG MAN-WAH, SECRETARY GENERAL MRS VIVIAN KAM NG LAI-MAN, ASSISTANT SECRETARY GENERAL MRS JUSTINA LAM CHENG BO-LING, ASSISTANT SECRETARY GENERAL 5896 LEGISLATIVE COUNCIL ─ 1 April 2009 TABLING OF PAPERS The following papers were laid on the table pursuant to Rule 21(2) of the Rules of Procedure: Subsidiary Legislation/Instruments L.N. No. Building (Minor Works) Regulation.................................. 51/2009 Addiction Treatment Centre (Consolidation) (Amendment) Order 2009 ............................................................. 52/2009 Detention Centre (Consolidation) (Amendment) Order 2009 ............................................................. 53/2009 Prisons (Amendment) Order 2009 ..................................... 54/2009 Rehabilitation Centres (Appointment) (Amendment) Order 2009 ............................................................. 55/2009 Training Centre (Consolidation) (Amendment) Declaration 2009.................................................... 56/2009 Education Ordinance (Amendment of Schedule 3) Notice 2009............................................................ 57/2009 Other Papers No. 77 ─ The Financial Reporting Council Annual Report 2008 No. 78 ─ Audited Statement of Accounts together with the Director of Audit's Report of the Hong Kong Rotary Club Students' Loan Fund for the year ended 31 August 2008 No. 79 ─ Audited Statement of Accounts together with the Director of Audit's Report of the Sing Tao Foundation Students' Loan Fund for the year ended 31 August 2008 LEGISLATIVE COUNCIL ─ 1 April 2009 5897 WRITTEN ANSWERS TO QUESTIONS Medicine Incidents 1. DR PAN PEY-CHYOU (in Chinese): President, 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 Good Manufacturing Practices (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? SECRETARY FOR FOOD AND HEALTH (in Chinese): President, starting from 2002, all local pharmaceutical manufacturers have to comply with the 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 5898 LEGISLATIVE COUNCIL ─ 1 April 2009 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 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 Organization, 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. LEGISLATIVE COUNCIL ─ 1 April 2009 5899 In the short term, the DH will carry out inspection of all 25 local drug manufacturers and the inspections will be prioritized 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.
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