PLC Panel on Health Services
Meeting on 9 February 1998
Test Reagent Suspected to be Contaminated by the
Causative Agent of Creutzfeldt-Jakob Disease
This paper describes the legislative control for pharmaceutical products and radioactive substances and provides a brief account of the recent incident of a diagnostic test reagent reported to have been contaminated by the causative agent of Creutzfeldt-Jakob Disease (CJD).
2.On 16 January 1998, the Department of Health was alerted that certain imported batches of serum albumin supplied with a radioactive substance to act as a diagnostic reagent could have been contaminated with CJD. Both the serum albumin and the radioactive substance were manufactured in the UK. The serum albumin was manufactured from blood collected from human donors, one of whom was subsequently found to have been affected by CJD.
3.Since the test reagent contains both a pharmaceutical component and a radioactive substance, and is for medical use in Hong Kong, it is subject to the controls of the Pharmacy and Poisons Ordinance and the Radiation Ordinance, details of which are described in subsequent paragraphs.
4.To safeguard the public against the use of ineffective, unsafe or sub-standard medicines, pharmaceutical products are required to be registered under the Pharmacy and Poisons Ordinance before they can be manufactured or imported for use in Hong Kong.
5.Applications for registration are assessed according to the manufacturing process, safety, quality and efficacy of the pharmaceutical products. Samples of a product may be sent to the Government Laboratory for quality analysis.
6.Registered pharmaceutical products are classified into different categories according to their constituents and they are sold under different restrictions. For example, some poisons, antibiotics and dangerous drugs can only be sold upon a prescription given by a doctor or dentist.
7.The Import and Export Ordinance stipulates that, before each consignment of a pharmaceutical product is imported, an import licence is required. Import licences are only granted to licensed importers and only in respect of registered medicines. This licensing system ensures that no unregistered medicines are imported for sale, and that no registered medicines are imported by unauthorised agents.
8.Furthermore, the Public Health and Municipal Services Ordinance provides that pharmaceutical products sold must be of the nature, substance and quality demanded by the purchaser and must be fit for human consumption. Pharmaceutical products are subject to continuous quality assurance by means of inspection at the manufacture, import and retail level, and sampling of medicines for analysis. These measures ensure that the safety and quality of the medicines are maintained throughout the supply chain.
9.The import, conveyance, possession, storage and use of all radioactive substances are subject to licensing control under the Radiation Ordinance. In applying for a licence, the applicant has to specify, among other things, the types of radioactive substances he/she intends to handle and the purpose of handling such substances. In many cases, radioactive substances are required for medical use, such as in the diagnosis or treatment of diseases, for surgical operations, or for medical laboratory analysis.
10.If a radioactive substance is used medically in combination with a non-radioactive, pharmaceutical component, the controls of the two Ordinances will apply concurrently. In this connection, the radioactive component will be subject to the controls under the Radiation Ordinance, and the pharmaceutical component will be required to be registered under the Pharmacy and Poisons Ordinance.
Registration of the Test Reagent
11.The importer of the test reagent involved in the incident described in para. 2 has obtained a licence in accordance with the Radiation Ordinance for the radioactive substance in the test reagent. The importer, however, has not to-date registered the non-radioactive, pharmaceutical component in the test reagent under the Pharmacy and Poisons Ordinance. An application has only just been lodged.
12.The Department of Health is now investigating the case to ascertain whether the importer is in contravention of the Pharmacy and Poisons Ordinance and whether legal action is warranted. The Department has contacted other importers of this kind of test reagent to enhance their awareness of the need for registration in accordance with relevant legislation.
Health and Welfare Bureau
9 February 1998