LCQ10: Regulating corrective and non-corrective contact lenses
According to the Supplementary Medical Professions Ordinance (Cap 359), only registered optometrists or persons who are exempted from regulation by the relevant section according to Schedule 4 to the Optometrists (Registration and Disciplinary Procedure) Regulation (Cap 359 sub leg F) (such as registered medical practitioners while practising medicine), (approved persons) are allowed to prescribe, fit or supply on prescription optical appliances (e.g. corrective contact lenses). However, it is doubtful whether the sale of non-corrective contact lenses is subject to regulation by the Ordinance. It has been reported that there have been cases from time to time in recent years in which members of the public suffered from eye diseases or visual impairment after wearing contact lenses bought from shops or through the Internet. In this connection, will the Government inform this Council:
(1) whether the authorities investigated in the past five years the situation of non-approved persons selling corrective and non-corrective contact lenses at shops and through the Internet; if so, of the details; if not, the reasons for that;
(2) how the authorities currently monitor the situation of non-approved persons selling non-corrective contact lenses; and
(3) whether the authorities will consider, by making reference to the practice of the United Kingdom, enacting legislation to explicitly prohibit non-approved persons from selling non-corrective contact lenses; if so, of the details (including the legislative timetable); if not, the reasons for that?
(1) The Optometrists Board (the Board), under the Supplementary Medical Professions Council (the Council), is a statutory body established under section 5 of the Supplementary Medical Professions Ordinance (Cap 359) (the Ordinance). The Board is responsible for registration and regulation of professional conduct and act of optometrists. At present, the Board handles complaints related to optometrists in accordance with the Optometrists (Registration and Disciplinary Procedure) Regulation (Cap 359F) (the Regulation).
According to section 21 of the Ordinance and section 6 of the 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 Ordinance according to Schedule 4 to the Regulation (such as registered medical practitioners while practising), are allowed to prescribe, fit or supply on prescription optical appliances (including contact lenses). Any person who practises the optometry profession without being registered or exempted from registration, or employs such a person 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 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 complaints related to the sale of contact lenses by non-registered healthcare professionals.
(2) and (3) At present, the 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 Department of Health (DH) has published on its website information leaflets on using contact lenses (including decorative contact lenses), covering "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 also 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. In addition, the DH will promote the message of "Proper Use of Contact Lenses" during festivals (such as Halloween, Christmas and New Year) through television and radio broadcasting.
Notwithstanding the above, the Government is in the process of drafting legislation related to the regulation of medical devices which would cover product safety and quality of contact lenses. 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 is now considering bringing non-corrective contact lenses under regulatory control. According to the legislative proposal now being drafted, contact lenses (both corrective and non-corrective) are classified as general medical devices at a low-moderate or moderate-high risk level. The devices and their authorised representatives (ARs) are required to be registered with the DH, and the importers and distributors of such devices must have obtained a licence from the DH before they can supply the medical devices in Hong Kong. The ARs, licensed manufacturers, licensed importers and licensed distributors or suppliers of such medical devices are also subject to the mandatory requirements of reporting and investigating adverse incidents associated with the medical devices, and implementing the corresponding remedial measures to the satisfaction of the DH. The Food and Health Bureau is actively communicating with and seeking the views of different stakeholders, with the aim of introducing the Bill to the Legislative Council as soon as possible after fine-tuning the legislative proposal.
Ends/Wednesday, January 17, 2018
Issued at HKT 14:25
Issued at HKT 14:25