Purpose

The purpose of this paper is to brief Members on the existing control mechanism of unregistered pharmaceuticals, blood and blood products in Hong Kong.

Control of Unregistered Pharmaceutical Products

2. The Pharmacy and Poisons Regulations (the Regulations) under the Pharmacy and Poisons Ordinance (Cap. 138) stipulate that pharmaceutical products must be registered with the Pharmacy and Poisons Board (the Board) before sale in Hong Kong. Only pharmaceutical products which meet the required standards of safety, efficacy and quality will be approved for registration. The sale of an unregistered pharmaceutical product in Hong Kong is an offence carrying a maximum penalty of $100,000 and 2 years' imprisonment. The Department of Health (the DH) enforces the Regulations by paying both regular and surprise inspections at pharmaceutical wholesalers and retailers, and by investigation of complaints. The number of prosecutions for selling unregistered pharmaceutical products in recent years is as follows :


3. Under the Import and Export Ordinance (Cap. 60), a pharmaceutical product can only be imported (or exported) if an import licence (or export licence) has been granted. For a registered pharmaceutical product, an import licence will only be granted to the holder of the registration certificate for the pharmaceutical product concerned. An import licence will only be granted for unregistered pharmaceutical products if the importer declares on the application form that the product is imported solely for re-export. A false declaration or import without a licence is an offence carrying a maximum penalty of $500,000 and 2 years' imprisonment. The number of prosecutions for such an offence in past years is as follows :


4. The DH has distributed a pamphlet to all registered doctors, pharmacies and medicine companies in 1998 to remind them that all pharmaceutical products are required to be registered before supply and to advise them on how to determine whether a product is registered or not.

5. To further prevent the sale of unregistered pharmaceutical products, the Board is conducting a review on the existing mechanisms controlling the import of pharmaceuticals with a view to tightening them. In this connection, the Board has issued a letter to all pharmaceutical importers consulting them on the proposed measures for tightening controls. The Board will consider the submissions at its next meeting, scheduled in mid-February.

6. The Hong Kong Association of The Pharmaceutical Industry (the Association) has expressed in a letter to the Legislative Council Panel on Health Services its recommendations on how to further control the import of unregistered pharmaceuticals into Hong Kong for re-export purposes. The Administration will make reference to the deliberations of the Board on this subject, and study the Association's recommendations together with other submissions made in response to the consultation being conducted by the Board, as mentioned in Paragraph 5 above.

Control of Blood Products

7. According to the Pharmacy and Poisons Ordinance, blood products fall within the meaning of pharmaceutical products and are required to be registered with the Board. Before an application for registration is approved, the manufacturer is required to provide information on the manufacture, purification and quality control processes.

8. A separate import licence under Import and Export Ordinance (Cap. 60) is required for each consignment of any blood product. An import licence will only be granted if :

1. the blood product to be imported has been registered;
   
   
2. the importer is the one to whom the registration certificate of the blood product was issued; and
   
   
3. the importer is a registered importer under the Pharmacy and Poisons Ordinance.

9. The Administration is mindful of the need to ensure the quality of registered blood products. The DH is responsible for monitoring closely overseas news on defective blood products by checking medical news released by overseas established medical institutes and maintaining close contacts with them regularly. If there is any report about a defective blood product, the respective importer will be contacted and a recall exercise will be initiated immediately. Due diligence has been exercised by the DH for such continuous surveillance, and the monitoring has been effective.

Control of Blood Supply

10. The then Hong Kong Government appointed the Hong Kong Red Cross to take up the responsibility of establishing and operating a centralised blood programme in Hong Kong in 1974. In 1991, the Hospital Authority (HA) took up the management responsibility of the Blood Transfusion Service (BTS) of the Hong Kong Red Cross. At present, the BTS is governed by a Governing Committee represented by the Hospital Authority, the Hong Kong Red Cross and community members.

11. The BTS has voluntarily opted for the ISO 9002 quality management system in the control of its blood collection, testing and processing procedures. It also adopts and follows overseas Good Manufacturing Practice standards for relevant procedures.

12. The BTS assesses and screens all blood donors, who are all voluntary and non-renumerated, by conducting a health history questionnaire and interview, a heamoglobin test as well as blood pressure examination prior to blood donation. BTS has also established donor eligibility criteria with reference to professional standards and overseas regulatory requirements.

13. For blood testing, the BTS adopts stringent testing protocols. It uses reagents and equipment licensed by internationally recognised authority such as the US Food and Drugs Administration (FDA) or equivalent with quality assurance standards and checks built in the procedure. The BTS computer system is able to track donors, donations and blood component distribution records.

14. To ensure that blood supplied to patients in hospitals meet safety standards, the BTS Governing Committee in 1997 appointed an HA (BTS) Expert Panel on Blood and Blood Products to constantly review and make recommendations on the safety standards of blood and blood products supplied to hospitals in the light of the latest developments in transfusion medicine. In 1998, the HA issued a set of guidelines on blood transfusion practices to hospitals which, amongst other things, require hospitals to report transfusion incidents through their Hospital Transfusion Committee. In late 1998, the HA (BTS) Expert Panel has also appointed a task force to advise on the development of a central monitoring system for safety of blood and blood products used in hospitals.


Health and Welfare Bureau
February 1999