LCQ13: Regulation of the sale of contact lenses
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Question:
Under the law, only specified classes of registered healthcare professionals are allowed to prescribe, fit or supply on prescription optical appliances (including contact lenses). However, the law does not impose any restrictions on the sale of contact lenses by persons who are not registered healthcare professionals. Earlier on, some optometrist organisations found, after sending people to make test purchases, that some shops had sold contact lenses to customers without (i) performing optometric check-ups for the customers and (ii) asking the customers to produce prescriptions of contact lenses. Also, there were some shopkeepers who were not registered optometrists conducting optometric check-ups for customers. In this connection, will the Government inform this Council:
(1) whether the authorities instituted any prosecutions in the past five years against persons, who were not registered healthcare professionals, for prescribing and selling corrective contact lenses in physical shops or online; if so, of the number and details of the cases; if not, the reasons for that;
(2) of the respective numbers of cases in the past five years in which the Customs and Excise Department conducted investigations (i) on its own initiative and (ii) upon receipt of complaints, in respect of contact lenses suspected of not complying with the requirements of the Consumer Goods Safety Ordinance (Cap 456), as well as the number of prosecutions instituted against the persons concerned by invoking the Ordinance;
(3) as the Government indicated in its reply to my question in January this year that the legislation on regulating medical devices, which was being drafted, would cover product safety and quality of non-corrective contact lenses, of the progress of the law drafting work; and
(4) whether it will, by making reference to the practice of the Government of the United Kingdom, enact legislation to prohibit persons who are not registered healthcare professionals from selling corrective and non-corrective contact lenses; if so, of the details; if not, the reasons for that?
Reply:
President,
My reply to the various parts of the question raised by the Professor Hon Joseph Lee is as follows:
(1) The Optometrists Board (Board), under the Supplementary Medical Professions Council (Council), is a statutory body established under section 5 of the Supplementary Medical Professions Ordinance (Cap 359). The Board is responsible for registration of optometrists and regulation of their professional conduct and practice. At present, the Board handles complaints related to optometrists in accordance with the Optometrists (Registration and Disciplinary Procedure) Regulation (Cap 359F).
According to section 21 of the Supplementary Medical Professions Ordinance and section 6 of the Optometrists (Registration and Disciplinary Procedure) Regulation, only registered optometrists in Part I, Part II and some in Part IV of the register, or persons who are exempted from regulation by the above ordinance according to Schedule 4 to the Optometrists (Registration and Disciplinary Procedure) Regulation (such as registered medical practitioners practising medicine), are allowed to prescribe, fit or supply on prescription optical appliances (including corrective contact lenses). Any person who practises the optometry profession without being registered or exempted from registration, or employs a person who is not registered or exempted from registration to practise the optometry profession, commits an offence and is liable on conviction to a fine of $5,000 and imprisonment for six months.
Members of the public may report any suspected violation of the Supplementary Medical Professions Ordinance to the Police. In the past five years, the Council and the Board have not received any requests from the Police for their professional advice on cases related to the prescription and supply of corrective contact lenses by non-registered healthcare professionals.
(2) In the past five years, in accordance with the Consumer Goods Safety Ordinance (Cap 456), the Customs and Excise Department (C&ED) has investigated six complaints related to non-corrective contact lenses. After investigation, no contravention of regulation was found and no person concerned was prosecuted by C&ED under the ordinance.
(3) and (4) The Government is currently drafting a bill on the regulation of medical devices. The bill covers pre-market control and post-market control of medical devices to ensure that medical devices comply with the requirements on safety, quality, performance and efficacy before they can be placed on the market, and that swift control measures can be taken against defective or unsafe medical devices. Although non-corrective contact lenses (such as decorative contact lenses) do not fall within the defined scope of medical devices, their use and the potential risks posed to the human body are similar to those of corrective contact lenses, which are defined as medical devices. The Government will consider bringing non-corrective contact lenses under regulatory control. According to the legislative proposal now being drafted, both corrective and non-corrective contact lenses are classified as general medical devices at a medium-low or medium-high risk level. Such devices and their authorised representatives (ARs) are required to be registered with the Department of Health (DH), and their manufacturers (if products are manufactured locally), importers and distributors must have obtained a licence from the DH before supplying such devices in Hong Kong. ARs, licensed manufacturers, licensed importers and licensed distributors or suppliers of such devices are also subject to the requirements of reporting and investigating adverse incidents related to such devices as stipulated by the DH, and implementing remedial measures to the satisfaction of the DH. The Government plans to introduce the Medical Devices Bill into the Legislative Council for consideration in the current legislative session.
At present, the Supplementary Medical Professions Ordinance does not impose any restrictions on the sale of contact lenses by non-registered healthcare professionals. To enhance public education on the proper use of contact lenses, the DH has produced and uploaded to its website information leaflets on using contact lenses (including decorative contact lenses), namely "Know More About Contact Lenses" and "Tips on Using Contact Lens Solution", as well as a video on "Proper Use of Contact Lenses", which is broadcast regularly at public venues. The information leaflets and video remind members of the public to strictly follow the instructions of qualified registered optometrists or ophthalmologists to ensure proper use and care of contact lenses. The DH also promotes the message of "Proper Use of Contact Lenses" during festivals such as Halloween, Christmas and New Year through television and radio broadcasting.
Ends/Wednesday, November 28, 2018
Issued at HKT 14:55
Issued at HKT 14:55
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