LCQ6: Alluded proprietary Chinese medicines and health products
According to some earlier media reports, some pharmacies sell proprietary Chinese medicines (pCms) alluding to those of well-known brands, with their names and packaging bearing strong resemblance to the latter. As some of these pCms are not attached with labels or package inserts carrying medicinal claims, they are not regulated under any legislation but regarded as health food products only. Some members of the public are worried that the consumption of such pCms alluding to well-known brands, which have unknown composition and quality, is detrimental to health. In this connection, will the Government inform this Council:
(1) whether the authorities received any complaint about pCms alluding to well-known brands in the past five years; if so, of the number and details of such complaints, as well as how they were followed up;
(2) given that some manufacturers add non-Chinese medicine ingredients to health food products adopting pCm formulae to circumvent regulation and use product names that are similar to Chinese medicines to mislead the public, and that such food products contain Chinese medicines but are not attached with usage instructions, what measures the authorities have in place to ensure that the consumption safety, quality, composition and dosage of such health food products meet the relevant safety standards and to prevent consumers from unknowingly purchasing such products; and
(3) whether it will introduce a registration system for health food products to protect the health and rights of consumers; if it will not, of the reasons for that?
Before 2014, the Customs and Excise Department (C&ED) did not keep separate figures for the numbers of complaints and successfully prosecuted cases related to alluded drugs (including proprietary Chinese medicines (pCms)). For the past three years, the numbers of complaints received by the C&ED involving sale of alluded drugs (including pCms) and successfully prosecuted cases are at Annex.
From 2014 to 2016, there were 117, 86 and 43 complaint cases respectively. The numbers of successfully prosecuted cases were eight, ten and eight respectively. The maximum penalty ranged from a fine of $12,000 to $30,000 and imprisonment from two months to four months.
There is no international standard on the definition of and regulation for "health products". The Government has imposed specific control by adopting a multi-pronged approach to regulate through a series of legislation based on the nature, composition, content of claims made, method of usage, dosage and packing specification, etc. of individual products. To protect public health, we have also adopted various targeted measures to monitor the products in the market with a view to ensuring their safety and that their functional claims and composition are true. The related measures include regulating products that fall within the definition of pharmaceutical product, pCm or food under the Pharmacy and Poisons Ordinance (Cap. 138), the Chinese Medicine Ordinance (Cap. 549), the Public Health and Municipal Services Ordinance (Cap. 132) respectively. To protect the public from being induced by advertisements or health claims and thereby seeking improper self-medication that may result in delay in seeking medical treatment, the Government also regulates the labels and advertisement of products through the Undesirable Medical Advertisements Ordinance (Cap. 231) and the Trade Descriptions Ordinance (Cap. 362). In addition, the claims of health products are subject to regulation by relevant provisions or codes under the Broadcasting Ordinance (Cap. 562) and the Broadcasting (Miscellaneous Provisions) Ordinance (Cap. 391).
Since pCms are medicines formulated on the basis of traditional Chinese medicines, some western countries where Chinese are not the majority, such as the United Kingdom and the United States, generally do not have specific regulatory measures targeted for Chinese medicines. On the other hand, for places where Chinese are the majority, such as Singapore and Taiwan, the relevant statutory regulation for Chinese medicines require that pCms must consist solely of Chinese medicine materials. In the Mainland, pCms generally also consist solely of Chinese medicine materials. Since the Mainland implements integrated practice of Chinese medicine and Western medicine, a small number of pCms are allowed to contain Western medicines but the prescription of these pCms should still comply with the principles of traditional Chinese medicine. In sum, the relevant regulations are basically same with the principles of the Chinese Medicine Ordinance for the regulation of pCms.
The Government will continue to closely monitor the regulatory measures of other regions and the situation in the local market, and conduct risk assessment. Having balanced public safety and the trade’s concerns, the Government will review the relevant legislation and regulatory arrangement in due course, which includes considering the need to formulate specific legislation to impose more targeted control on different products. Before formulating more targeted regulation, the Government will continue to enforce prevailing relevant legislation with a view to regulating products sold in the market which contain non-Chinese medicine ingredients.
Ends/Wednesday, March 29, 2017
Issued at HKT 15:00
Issued at HKT 15:00