Cap. 599 sub. leg. K

Prevention and Control of Disease (Use of Vaccines) Regulation (Made by the Chief Executive in Council under section 8 of the Prevention and Control of Disease Ordinance (Cap. 599))[24 December 2020] Part 1 Preliminary (L.N. 176 of 2022) 1. Commencement This Regulation comes into operation on 24 December 2020. 2. Interpretation (1) In this Regulation— (L.N. 176 of 2022)advisory panel (顧問專家委員會) means the panel appointed under section 9;authorization (認可) means an authorization granted under section 3(1);authorization applicant (申請認可者), in relation to an authorization, means the person on whose application the authorization is granted;authorized officer (獲授權人員) means a public officer appointed under section 8B(1); (L.N. 176 of 2022)authorized vaccine (認可疫苗) means a non-registered vaccine that is authorized under section 3(1);Cap. 138A (《第138A章》) means the Pharmacy and Poisons Regulations (Cap. 138 sub. leg. A);dispense (配發) has the meaning given by section 2(1) of the Pharmacy and Poisons Ordinance (Cap. 138); (L.N. 176 of 2022)function (職能) includes a power and a duty; (L.N. 176 of 2022)Government vaccination programme (政府疫苗接種計劃) means a programme that is conducted by the Government to administer specified vaccines to members of the public, or a section of the public, for—(a) preventing, protecting against, delaying or otherwise controlling the incidence or transmission of the specified disease; or(b) mitigating a serious or life-threatening condition arising from the specified disease; (L.N. 176 of 2022)non-registered vaccine (非註冊疫苗) means a vaccine that is not registered;pharmaceutical product (藥劑製品) has the meaning given by section 2(1) of the Pharmacy and Poisons Ordinance (Cap. 138);recipient (接種者), in relation to a vaccine, means the person to whom the vaccine is administered;registered (註冊), in relation to a vaccine, means registered under regulation 36 of Cap. 138A; (L.N. 176 of 2022)Secretary (局長) means the Secretary for Health; (L.N. 144 of 2022)specified disease (指明疾病) means the coronavirus disease 2019 (COVID-19), which is specified in item 8A of Schedule 1 to the Ordinance;specified purpose (指明目的) means—(a) the purpose of carrying out a Government vaccination programme; or(b) any other reasonable purpose that—(i) relates to the use of a specified vaccine for preventing, protecting against, delaying or otherwise controlling the incidence or transmission of, or mitigating a serious or life-threatening condition arising from, the specified disease; and(ii) is specified by the Secretary; (L.N. 176 of 2022)specified vaccine (指明疫苗) means—(a) an authorized vaccine; or(b) a registered vaccine; (L.N. 176 of 2022)use (使用), in relation to a vaccine, includes distribute, supply, offer for supply, possess, prescribe, dispense and administer;vaccine (疫苗) means a pharmaceutical product that—(a) contains an antigenic substance or is intended to stimulate, after the product has been administered to a person, the production of an antigenic substance in that person’s body; and(b) is intended to stimulate a person’s immune system to produce immunity to the specified disease.(2) For the purposes of this Regulation, a person is responsible for administering a vaccine to a recipient if—(a) the person administers the vaccine to the recipient; or(b) the person is a registered medical practitioner who supervises the administration of the vaccine to the recipient. (L.N. 176 of 2022) Part 2 Authorization of Vaccine (L.N. 176 of 2022) 3. Secretary may authorize vaccine for specified purpose (1) The Secretary may, on application, authorize a non-registered vaccine for a specified purpose. (L.N. 176 of 2022)(2) The application must be—(a) made by—(i) for a vaccine that satisfies the condition referred to in subsection (4)(a)(i)—a person who, in relation to the vaccine, is one described in regulation 36(1)(a), (b) or (c) of Cap. 138A; or(ii) for a vaccine that satisfies the condition referred to in subsection (4)(a)(ii)—(A) a person described in subparagraph (i); or(B) a manufacturer of the vaccine outside Hong Kong, or a branch, subsidiary, representative, agent or distributor of the manufacturer; and(b) made in the manner, and accompanied by the information, specified by the Secretary.(3) Before the Secretary authorizes a vaccine, the Secretary must, having regard to the advice of the advisory panel, take into consideration—(a) the safety of the vaccine;(b) the efficacy of the vaccine; and(c) the quality of the vaccine.(4) The Secretary may authorize a vaccine only if—(a) the vaccine satisfies any of the following conditions—(i) a regulatory authority in a place outside Hong Kong that performs the function of approving pharmaceutical products for use in that place has approved, whether or not with any condition, limitation or restriction, the vaccine for administration to persons other than on an experimental or trial basis, including for emergency use;(ii) the vaccine is listed in accordance with the emergency use listing procedure by WHO or is in the list of prequalified vaccines published by WHO; and(b) the Secretary considers that, for making the vaccine available to deal with the threat to public health posed by the specified disease, the authorization is necessary and is in the public interest. (L.N. 176 of 2022)(c) (Repealed L.N. 176 of 2022)(5) On determining an application for an authorization, the Secretary must—(a) notify the person who makes the application of the decision in writing; and(b) if the Secretary refuses the application—state the grounds for the refusal in the notification.(6) If the Secretary decides to grant an authorization, the Secretary must publish a notice of the authorization in the Gazette stating—(a) the name of the vaccine authorized;(b) the date on which the authorization takes effect;(c) the name and address of the authorization applicant;(d) the name and address of the manufacturer of the vaccine; and(e) the conditions (if any) attached to the authorization under section 4.(7) In this section—approve (批准) includes authorize and permit (however described). 4. Conditions of authorization (1) The Secretary may, after having regard to the advice of the advisory panel—(a) attach to an authorization any condition that the Secretary considers appropriate;(b) vary the condition; or(c) revoke the condition.(2) If the Secretary varies or revokes a condition attached to an authorization, the Secretary must—(a) notify the authorization applicant in writing of the variation or revocation; and(b) publish a notice of the variation or revocation in the Gazette. 5. Effective period of authorization (1) An authorization of a vaccine—(a) takes effect on the date referred to in section 3(6)(b); and(b) ceases to have effect when—(i) the authorization is revoked under section 6; or(ii) if the authorization is not so revoked—the period referred to in subsection (2) expires.(2) For the purposes of subsection (1)(b)(ii), the period is a period of 12 months after the date on which the authorization takes effect, but the Secretary may, by notice published in the Gazette*, extend the period, each time for a period of not more than 6 months. Editorial Note: * Please visit the Gazette website maintained by the Government Logistics Department for the vaccine authorization from 2021 to 2023. 6. Revocation of authorization (1) The Secretary may, after having regard to the advice of the advisory panel, revoke an authorization.(2) Without limiting subsection (1), the Secretary may revoke an authorization if—(a) the Secretary considers that the risks of the authorized vaccine outweigh its benefits; or(b) a condition attached to the authorization is not complied with.(3) If the Secretary revokes an authorization, the Secretary must—(a) notify the authorization applicant in writing of the revocation stating the grounds for the revocation; and(b) publish a notice of the revocation in the Gazette. Part 3 Use of Vaccine (L.N. 176 of 2022) 7. Use of vaccine (1) Regulations 36(1) and 38(1) of, and paragraph 12 of Schedule 5 to, Cap. 138A (relevant provisions) do not apply in relation to—(a) the supply by a person of a non-registered vaccine to the Government under a Government contract; or(b) the possession by a person of a non-registered vaccine for the purpose of the performance (by that person or another person) of a Government contract.(2) The relevant provisions do not apply in relation to the use of an authorized vaccine for a specified purpose.(2A) For a registered vaccine to be used for a specified purpose, if a change of any of the registrable particulars of the vaccine is approved under regulation 36A of Cap. 138A—(a) despite the change and regulations 36(1B) and 36A(6)(a) of Cap. 138A, the vaccine is taken to remain registered; and(b) regulation 36A(6)(b) and (c) of Cap. 138A does not apply in relation to the change. (L.N. 176 of 2022)(3) If specified vaccines are administered to recipients in Hong Kong for a specified purpose, the Secretary must put in place a mechanism for monitoring any adverse event occurred to the recipients associated with the administration of the vaccines. (L.N. 176 of 2022)(4) In this section—Government contract (政府合約) means a contract to which the Government is a party; (L.N. 176 of 2022)registrable particulars (須註冊詳情) has the meaning given by regulation 35A of Cap. 138A. (L.N. 176 of 2022) 8. Authorized vaccine to be administered with informed consent (1) Each person who is responsible for administering an authorized vaccine to a recipient for a specified purpose must ensure that, before the vaccine is so administered—(a) the following person has been informed that the vaccine is authorized under this Regulation instead of registered and of any other information as may be specified by the Secretary—(i) the recipient; or(ii) if the recipient is not legally capable of giving consent to the administration of the vaccine (relevant consent)—a person who is legally capable of giving the relevant consent on the recipient’s behalf; and(b) the person referred to in paragraph (a)(i) or (ii), as the case requires, has given the relevant consent.(2) (Repealed L.N. 176 of 2022)(3) Subsection (1) does not affect any other duty imposed by law or otherwise on a person who is responsible for administering an authorized vaccine. Part 4 Requirements for Administration of Specified Vaccine other than under Government Vaccination Programme (Part 4 added L.N. 176 of 2022) 8A. Collection and provision of information regarding administration of vaccine (1) A registered medical practitioner who is responsible for administering a specified vaccine to a recipient other than under a Government vaccination programme must—(a) collect the following information—(i) the name of the recipient;(ii) the date of birth of the recipient;(iii) the sex of the recipient;(iv) the following information—(A) if the recipient is the holder of an identity card—the number of the identity card; or(B) otherwise—the type and number of a valid identification document of the recipient;(v) the name and batch number of the vaccine;(vi) the date of the administration; and(vii) the dose sequence of the vaccine; and(b) in accordance with subsection (2)—(i) report, or cause to be reported, to the Director the administration of the vaccine; and(ii) provide the Director with, or cause the Director to be provided with, the information mentioned in paragraph (a).(2) For subsection (1)(b), the reporting and provision of information must be done—(a) by using the eHealth System (Subsidies) or another electronic system specified by the Director in place of the eHealth System (Subsidies); and(b) as soon as reasonably practicable (and, if a time is specified by the Director, within that time) after the administration of the vaccine.(3) A matter to be specified by the Director under subsection (2) must be specified by means of a notice published on the website of the Department of Health.(4) In this section—identity card (身分證) has the meaning given by section 1A(1) of the Registration of Persons Ordinance (Cap. 177). 8B. Authorized officers (1) The Director may, in writing, appoint any public officer as an authorized officer for the purposes of this Part.(2) An authorized officer must, if so required, produce written proof of his or her appointment before performing a function under section 8C.(3) No personal liability is incurred by an authorized officer or a person acting under the officer’s direction in respect of any act done or omitted to be done by the officer or person in good faith in the performance or purported performance of a function under section 8C.(4) Subsection (3) does not in any way affect any liability of the Government in respect of any act done or omitted to be done by an authorized officer or a person acting under the officer’s direction. 8C. Powers to conduct inquiry and require information etc. If an authorized officer has reason to suspect that section 8A(1) is not being or has not been complied with, the officer may do any or all of the following—(a) conduct any inquiry in order to obtain any information mentioned in section 8A(1)(a);(b) require any person in possession of such information to provide the officer with such information;(c) require any person to provide the officer with the assistance that the officer reasonably considers necessary to enable the officer to do anything mentioned in paragraph (a) or (b). 8D. Obstruction of authorized officer etc. prohibited (1) A person must not delay, obstruct, hinder or molest an authorized officer who is performing a function under section 8C.(2) A person must comply with a requirement made by an authorized officer under section 8C(b) or (c).(3) A person who contravenes subsection (1) or (2) commits an offence and is liable on conviction to a fine at level 3.(4) It is a defence for a person charged under subsection (3) to establish that the person had reasonable excuse for the contravention.(5) A person is taken to have established a matter that needs to be established for a defence under subsection (4) if—(a) there is sufficient evidence to raise an issue with respect to that matter; and(b) the contrary is not proved by the prosecution beyond reasonable doubt.(6) A person who, in purported compliance with a requirement made under section 8C(b), knowingly or recklessly provides any information that is false or misleading in a material particular commits an offence and is liable on conviction to a fine at level 3. Part 5 Miscellaneous (L.N. 176 of 2022) 9. Advisory panel (1) The Chief Executive may appoint a panel of persons who are considered by the Chief Executive to have relevant expertise for advising the Secretary for the purposes of section 3(3), 4(1) or 6(1).(2) A member of the advisory panel is not civilly liable for an act done or omitted to be done by the member in good faith in relation to the giving of advice for the purposes of section 3(3), 4(1) or 6(1).(3) Subsection (2) does not affect any liability of the Government for the act or omission referred to in that subsection. 9A. Immunity of members of certain committees and panel (1) A member of any of the committees and panel specified in subsection (2) is not civilly liable for an act done or omitted to be done by the member in good faith in relation to the giving of advice to the Government in respect of—(a) the use of a specified vaccine for a specified purpose; or(b) any clinical event that occurs to a recipient in Hong Kong to whom a specified vaccine was administered for a specified purpose. (L.N. 176 of 2022)(2) The committees and panel are—(a) a committee established by the Department of Health (Department) and known as the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation;(b) a committee established by the Department and known as the Scientific Committee on Emerging and Zoonotic Diseases;(c) a committee established by the Department and known as the Scientific Committee on Vaccine Preventable Diseases; and(d) a panel appointed by the Chief Executive for giving advice to the Chief Executive in respect of the specified disease and known as the Chief Executive’s Expert Advisory Panel.(3) Subsection (1) does not affect any liability of the Government for the act or omission referred to in that subsection.(L.N. 234 of 2021) 10. Jurisdiction and immunity (1) Subsection (2) applies to a person who—(a) prescribes or dispenses a specified vaccine for administration to a recipient for the purpose of carrying out a Government vaccination programme; or(b) is responsible for administering a specified vaccine to a recipient for the purpose of carrying out a Government vaccination programme. (L.N. 176 of 2022)(2) The person is not civilly liable for any loss or damage caused to the recipient by an act done or omitted to be done by the person in good faith in relation to the administration of the vaccine to the extent that the loss or damage results from any risk as to the safety of the administration of the vaccine attributable to the intrinsic property of the vaccine as manufactured.(3) Subsection (2) does not affect any liability of the Government or any person to whom that subsection does not apply for the loss or damage referred to in that subsection.(3A) For an act done or omitted to be done before the commencement* of the Prevention and Control of Disease (Use of Vaccines) (Amendment) Regulation 2022#—(a) subsections (1) and (2) as amended by the Regulation do not apply; and(b) subsections (1) and (2) as in force immediately before the commencement* continue to apply. (L.N. 176 of 2022)(4) The courts of Hong Kong have exclusive jurisdiction over a claim of a recipient of an authorized vaccine administered for a specified purpose in relation to the vaccine. (E.R. 8 of 2020) Editorial Note: * Commencement date: 9 September 2022. # L.N. 176 of 2022. 11. Certain notices are not subsidiary legislation A notice published under section 3(6), 4(2)(b), 5(2), 6(3)(b) or 8A(3) is not subsidiary legislation.(L.N. 176 of 2022) 12. Expiry (1) This Regulation expires at midnight on 23 December 2023. (L.N. 176 of 2022)(2) Despite subsection (1), the following provisions continue to have effect after the expiry of this Regulation as if those provisions had not expired—(a) section 2 (in so far as it relates to a provision set out in paragraph (b) or (c));(b) sections 8B(3) and (4), 9(2) and (3), 9A and 10(1), (2), (3) and (3A) (in so far as they relate to an act done or omitted to be done before the expiry of this Regulation); and(c) section 10(4) (in so far as it relates to the administration of an authorized vaccine before the expiry of this Regulation). (L.N. 176 of 2022)(L.N. 234 of 2021)