Replies to LegCo questions

LCQ21: Regulation of proprietary Chinese medicines

Following is a question by the Hon Chan Han-pan and a written reply by the Secretary for Food and Health, Dr Ko Wing-man, in the Legislative Council today (October 14):

Question:

It has been reported that some traders have sold products containing western herbs and Chinese medicines as health food products. As the packaging and names of such products are very similar to those of registered proprietary Chinese medicines (pCm), it is difficult for consumers to differentiate between them. Since such products are not required to meet the requirements in respect of safety, quality and efficacy applicable to registered pCm, consumption of them by members of the public may be harmful to their health. In this connection, will the Government inform this Council:

(1) whether the authorities received complaints about pCm and health food products in the past three years; if they did, of the number and details of such complaints; whether they instituted prosecutions against the persons concerned; if they did, of the number of such prosecutions;

(2) whether the authorities uncovered cases in the past three years in which traders sold products originally required to be registered as pCm as health food products by using tactics such as adding non-Chinese medicines to the products, changing product names and packaging, etc.; if they did, of the number of such products;

(3) whether any legislation is currently in place to regulate the sale of health food products whose names and packaging are very similar to those of pCm; if so, of the details; and

(4) whether the authorities will conduct studies on formulating specific legislation and framework to regulate health food products containing Chinese medicines, so as to protect the health of consumers and prevent the reputation of Hong Kong's pCm trade from being tarnished?

Reply:

President,

(1) From January 2013 to end-September 2015, the Department of Health (DH) received a total of 128 complaints about suspected contravention of the Chinese Medicine Ordinance (Cap 549) involving unregistered proprietary Chinese medicines (pCm), failure to comply with pCm labelling and package insert requirements, adulteration of pCm and engagement in pCm wholesale/manufacture business without a licence. The DH has already followed up on all the complaints, among which 22 cases are still under investigation. The types of cases are set out in Annex.

Centre for Food Safety (CFS) of the Food and Environmental Hygiene Department received a total of 115 complaints about food products with health claims from January 2013 to end-September 2015, and issued warning letters for three of these cases which have been confirmed with failure to comply with the food labelling requirements of the Food and Drugs (Composition and Labelling) Regulations (Cap 132W). Subsequent follow-up investigations discovered that the labelling of the food products of the cases concerned had been rectified.

(2) The provisions governing the mandatory registration of pCm came into force on December 3, 2010. The provisions stipulate that all pCm must be registered with the Chinese Medicine Council of Hong Kong (CMCHK) before they can be imported, manufactured or sold in Hong Kong. Offenders are liable to a maximum fine of $100,000 and imprisonment for two years. To get registered, all pCm must meet the registration requirements of the CMCHK in terms of safety, quality and efficacy. Provisions governing the labelling and package inserts of pCm also came into force on December 1, 2011. The provisions stipulate that no person is allowed to sell, or have in his possession for the purpose of selling, any pCm without a label or a package insert which complies with the prescribed requirements. Offenders are liable to a maximum fine of $100,000 and imprisonment for two years.

As products vary in their ingredients, the DH will consider each suspected case of unregistered pCm according to the actual circumstances. When it is found that a product on the market does not comply with the Chinese Medicine Ordinance, the DH will take prompt actions, including tracing the source of the product in question, instituting prosecution, requiring the shops involved to recall the product immediately and informing the public, the trade or the relevant overseas drug regulatory organisations about the incident as and when necessary. Depending on the circumstances, the DH will refer the Chinese medicines traders concerned to the CMCHK to consider whether disciplinary action should be taken. From January 2013 to end-September 2015, the DH received a total of 104 complaints relating to unregistered pCm. Among the 84 cases with investigations completed, there are 10 cases in which prosecution was instituted and the offenders were convicted. The remaining 20 complaints are still under investigation.

(3) The orally consumed products sold on the local market are classified into two categories, namely, medicine and food, according to their ingredients and the content of their claims. These products are subject to more specific regulation under different sets of legislation. While currently there is no international standard for naming and defining health food products, the Government has implemented a number of measures to monitor the relevant products on the market to ensure their safety and quality with a view to protecting public health. The relevant measures include:

(a) Chinese Medicine Ordinance
All products that fall within the definition of pCm under the Chinese Medicine Ordinance, i.e. products which are composed solely of Chinese medicines as active ingredients, and for treatment or health maintenance purposes, are regulated by this ordinance. Such products should meet the relevant requirements in respect of safety, quality and efficacy before they can be registered. The Chinese Medicine Ordinance also requires that the labels of registered pCm should contain information such as main ingredients, method of usage, dosage, packing specifications and place of production. The DH has put in place a market surveillance system to monitor if there are any unregistered pCm sold on the market and to regularly collect samples of pCm from the market for testing. To safeguard public health, the DH has also established a mechanism for reporting adverse incidents relating to Chinese medicines to collate information through various channels, so as to conduct risk assessment, management and reporting. If any substandard pCm are found, the DH may take actions such as requesting the Chinese medicine traders concerned to recall the products and referring the cases to the CMCHK for follow-up actions, and issuing relevant press statements.

(b) Pharmacy and Poisons Ordinance (Cap 138)
Health products which contain medicines are regulated by the Pharmacy and Poisons Ordinance. These products must meet the requirements in respect of safety, quality and efficacy, and must be registered before they can be sold on the market. They should also be labelled with particulars such as ingredients, dosage and method of usage. Inspectors of the DH conduct regular inspections of pharmacies and medicine stores to see if the medicines for sale are registered, or whether they have particulars different from those as approved at the time of registration. Besides, the DH will take samples of medicines and health products sold on the market for tests from time to time. Moreover, the DH has put in place a mechanism for reporting adverse drug reactions and a complaint mechanism against any persons violating the above ordinance. If a product is found to contain unregistered western medicines after investigation and testing, the DH will take legal actions and, where necessary, require the shops to recall such products immediately. The DH will continue to maintain close surveillance and take appropriate follow-up actions where necessary.

(c) Public Health and Municipal Services Ordinance (Cap 132) and Food and Drugs (Composition and Labelling) Regulations
For food products which do not fall under the scope of Chinese medicines, pCm or western medicines, they are regulated by the Public Health and Municipal Services Ordinance like other general food products. Prepackaged food, other than those exempted, must be appropriately marked or labelled according to the Food and Drugs (Composition and Labelling) Regulations. In addition, according to section 61 of the Public Health and Municipal Services Ordinance, if a label attached on any food falsely describes the food or is calculated to mislead, the person selling the food is guilty of an offence. The ordinance also provides that any person who publishes an advertisement which falsely describes any food or is likely to mislead shall be guilty of an offence. The CFS will take appropriate follow-up actions in respect of food products that do not comply with the above legislation.

(d) Undesirable Medical Advertisements Ordinance (Cap. 231)
To protect the public from being induced by advertisements or health claims to seek improper self-medication, which may result in delay in seeking treatment, the Undesirable Medical Advertisements Ordinance prohibits the publication of any advertisement likely to lead to the use of any medicine, surgical appliance or treatment for the purpose of prevention or treatment of certain diseases or conditions specified in the schedules to that ordinance. Since June 1, 2012, the Undesirable Medical Advertisements Ordinance has been extended to prohibit or restrict the use of six types of health claims as specified in the newly added schedule in advertising orally consumed products. In addition, the DH has established a system to regularly screen advertisements published in newspapers. Actions would be taken against persons who violate the relevant legislation.

(e) Other relevant legislation
The claims of health products are also subject to regulation by the Trade Description Ordinance (Cap 362). The Customs and Excise Department (C&ED) has been taking rigorous enforcement actions against the retail, distribution, storage, manufacturing, import and export of counterfeit goods (including counterfeit health products) according to the provisions against counterfeiting under that ordinance. The C&ED has also been maintaining close liaison with the business sector and trade mark proprietors for joint surveillance of the market situation so that prompt enforcement actions can be taken against shops which have breached the law. In addition, the claims of health products are also subject to regulation by the relevant provisions or codes under the Broadcasting Ordinance (Cap 562) and the Broadcasting (Miscellaneous Provisions) Ordinance (Cap 391). The C&ED and the Communications Authority will take law enforcement and regulatory actions in accordance with the relevant provisions and codes.

(4) Health products containing medicines are regulated by the Pharmacy and Poisons Ordinance. Such products must meet the requirements in respect of safety, quality and efficacy, and must be registered before they can be sold on the market. Since the establishment of Drug Office of the DH in September 2011, one of the important tasks is to step up publicity and education for the general public. This includes strengthening efforts in issuing safety alerts and announcements on drugs or health products which do not comply with the relevant requirements, updating the Drug Office's website to enhance information dissemination, and providing more health information on different categories of drugs and health products. It also disseminated messages about the safe use of medicines to the general public, the trade and other stakeholders through various channels. In 2012, the DH conducted four exchange sessions on the content of the Undesirable Medical Advertisements Ordinance.

In addition, all products falling within the definition of pCm in the Chinese Medicine Ordinance are subject to regulation by that ordinance. Such products must meet the relevant requirements in respect of safety, quality and efficacy before they can be registered. The regulatory regime of Chinese medicines specified in the Chinese Medicine Ordinance, including the establishment of a sound regulatory framework by the DH to safeguard public health, was fully implemented in 2011. The Government will continue to step up law enforcement actions under the existing legislation. If the DH receives any complaints about unregistered pCm, it will conduct investigation and take follow-up actions according to the Chinese Medicine Ordinance. The Government will also step up publicity and education to enhance public understanding of pCm products.

Ends/Wednesday, October 14, 2015
Issued at HKT 18:43

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LCQ21 Annex