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Following is a question by the Professor Hon Joseph Lee and a written reply by the Secretary for Food and Health, Dr Ko Wing-man, in the Legislative Council today (April 27):
Question:
Under the existing legislation, corrective contact lenses are classified as a medical device and must be prescribed and supplied on prescription by qualified registered professionals, including optometrists and ophthalmologists. However, the sale and prescription of non-corrective contact lenses (e.g. cosmetic contact lenses which are commonly known as "big eyes") are not regulated. Some optometrists have pointed out that in order to protect the eyes from being injured, members of the public should, before wearing any corrective or non-corrective contact lenses, receive examinations by professionals in respect of the health conditions of their eyes and the curvature of their eyeballs. In this connection, will the Government inform this Council:
(1) whether the authorities examined, in the past five years, the situation in which corrective contact lenses were supplied to members of the public by persons who were not registered professionals (including the supply of such lenses at physical and online shops); if they did, of the number of known cases; whether prosecutions were instituted against the relevant offenders; if so, of the number of such cases;
(2) whether the authorities know the number of cases in each of the past five years in which members of the public who, after contracting eye diseases due to wearing non-corrective contact lenses, sought consultation at clinics under the Hospital Authority and, among such cases, the number of those involving contact lenses which were not supplied on prescription by registered professionals; if they do not know, whether they will consider collecting the figures of such type of cases;
(3) given that the consultant commissioned by the Department of Health (DH) to study the business impact of the proposed statutory regulation for medical devices has recommended, in the Executive Summary of the DH's Final Report on Business Impact Assessment on Statutory Regulation of Medical Devices, that the prescription of non-corrective contact lenses which are for cosmetic purposes at the retail level should be regulated (e.g. mandating prescription by registered optometrists only) so as to ensure that the contact lenses prescribed will be suitable for users, whether the authorities will accept the recommendation concerned; if they will, of the implementation timetable; if not, the reasons for that; and
(4) whether the authorities will step up their publicity and public education efforts so that members of the public will be aware of the risks associated with improper wearing of non-corrective contact lenses; if they will, of the details of the relevant work; if not, the reasons for that?
Reply:
President,
(1) According to section 21 of the Supplementary Medical Professions Ordinance (Cap. 359), only registered optometrists, or persons who are exempted from the regulations laid down by the above ordinance according to Schedule 4 to the Optometrists (Registration and Disciplinary Procedure) Regulation (Cap. 359F) (such as registered medical practitioners while practising medicine), are allowed to prescribe, fit or supply on prescription optical appliances (including contact lenses for vision correction). Over the past five years, the Supplementary Medical Professions Council has not received requests from the Police for professional advice on complaints related to selling of contact lenses for vision correction by unregistered medical professionals.
(2) The Hospital Authority currently does not collect data on the number of patients seeking medical treatment for eye diseases caused by wearing non-corrective contact lenses. In general, if there are public health risks associated with certain products, the Government will closely monitor and take actions, which include considering the need to collect relevant data, to tackle the situation as appropriate.
(3) Regarding product safety and quality of non-corrective contact lenses, the Government is in the process of drafting legislation related to the regulation of medical devices. The Government also plans to provide the Panel on Health Services of the Legislative Council with details of the legislative proposal regarding the regulatory regime for medical devices in the next legislative session. The proposed regulatory regime includes empowering the Director of Health to, having considered the local situation and views of relevant stakeholders, subject some specific products, such as non-corrective contact lenses, to the regulatory regime with a view to ensuring that the products concerned comply with required safety and quality standards, thereby protecting public's health.
The consultant, who submitted the "Department of Health - Business Impact Assessment on Statutory Regulation of Medical Devices - Executive Summary of Final Report", mentioned in the above report that some interviewed stakeholders from the optical trade suggested enacting legislation to regulate the prescription of non-corrective decorative contact lenses at retail level (e.g. mandating prescription by registered optometrists only). However, the consultant considered it not appropriate to regulate the fitting and prescription of contact lenses by the proposed legislation for medical devices, and recommended that the fitting and prescription of non-corrective contact lenses should be regulated through the existing legislation and Code of Practice related to the fitting and prescription of contact lenses. The Government will continue to monitor closely the situation and, if necessary, examine which proposal is appropriate to regulate the fitting and prescription of non-corrective contact lenses.
(4) To enhance public education on correct usage of contact lenses, the Department of Health (DH) has produced and published on its website information leaflets on usage of contact lenses (including decorative or coloured contact lenses), namely "Know More About Contact Lenses" and "Tips for Using Contact Lens Solution", as well as a video on "Proper Use of Contact Lenses" which is also broadcast regularly at public venues. The leaflets and video provide members of the public with information about different types of contact lenses, caring tips and health advice; and in particular remind them to strictly follow the instructions of ophthalmologists or qualified registered optometrists in using and taking care of their lenses properly. Besides, the DH will step up publicity on messages of "Proper Use of Contact Lenses" during festivals (e.g. Halloween, Christmas and New Year) through television and radio broadcasting.
Ends/Wednesday, April 27, 2016
Issued at HKT 13:10
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