PART 5
ENFORCEMENT AND
MONITORING COMPLIANCE
Power to obtain information
36.—(1)  The Director-General or an authorised officer may by notice require any licensee to provide, within a reasonable period or at the time or frequency, and in the form and manner, specified in the notice, all documents and information which —
(a)relate to any matter which the Director-General considers necessary to carry out the Director-General’s functions or duties under this Act; and
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(b)are —
(i)within the knowledge of that licensee; or
(ii)in the licensee’s custody or under the licensee’s control.
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(2)  The power to require a licensee to provide any document or information under subsection (1) includes the power —
(a)to require that licensee, or any individual who is or was an officer or employee of the licensee, to provide an explanation of the document or information;
(b)if the document or information is not provided, to require that licensee or individual to state, to the best of the licensee’s or individual’s knowledge and belief, where it is and how it may be obtained; and
(c)if the information is recorded otherwise than in legible form, to require the information to be made available to the Director-General in legible form.
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(3)  A person that, without reasonable excuse, fails to do anything required of the person by notice under subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.
(4)  A person —
(a)that intentionally alters, suppresses or destroys any document or information which the person is, has been or may be required by a notice under subsection (1) to provide; or
(b)that, in providing any document or information required under subsection (1), makes any statement which the person knows to be false or misleading in a material particular or recklessly makes such a statement,
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.
(5)  For the purposes of subsection (3), it is a reasonable excuse for a person to refuse or fail to provide any document or information which the person is required by a notice under subsection (1) to provide if doing so might tend to incriminate that person.
(6)  The Director-General is entitled without payment to keep any document or information provided to the Director-General under subsection (1).
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Publication of information
37.—(1)  The Director-General may publish, or cause to be published, in a form and manner determined by the Director-General, any information which the Director-General or an authorised officer has acquired or generated in the course of the Director-General or authorised officer exercising the functions, performing the duties or generally administering or enforcing this Act as the Director-General considers necessary or expedient to publish in the public interest.
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(2)  Without limiting subsection (1), the Director-General may publish information relating to —
(a)the lapsing, shortening, suspension or revocation of a licence or an exemption granted to any person;
(b)the making of a step‑in order or an expedited step‑in order against a designated licensee;
(c)the making of a direction under this Act against any person;
(d)the censure of any person;
(e)the removal of and replacement of any key appointment holder, Principal Officer or Clinical Governance Officer of a licensee;
(f)the acceptance by any person of an offer to compound any offence under this Act; and
(g)the conviction of any person for any offence under this Act.
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(3)  This section does not override any restriction on the disclosure of any information under this Act.
Codes of practice
38.—(1)  The Director-General may —
(a)issue one or more codes of practice applicable to all licensees or the licensees providing specified licensable healthcare services;
(b)approve as a code of practice applicable to all licensees or the licensees providing specified licensable healthcare services any document prepared by a person other than the Director-General if the Director-General considers the document suitable for this purpose; or
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(c)amend or revoke any code of practice issued under paragraph (a) or approved under paragraph (b),
with respect to all or any of the matters in subsection (2).
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(2)  The matters for the purposes of subsection (1) are —
(a)the conduct of licensees;
(b)the measures necessary for licensees to deal with any plague, epidemic, outbreak, fire, flood, earthquake or disaster (natural or otherwise) or any other public emergency;
(c)the clinical and ethical aspects of licensable healthcare services;
(d)the appropriateness of care in relation to the provision of licensable healthcare services;
(e)the management and operations of licensees, the provision of licensable healthcare services, the quality of licensable healthcare services and the management and care of patients and customers;
(f)the maintenance or operation of any facilities and equipment used in relation to the provision of licensable healthcare services; and
(g)the health, security and safety of persons who are engaged in any work relating to the provision of licensable healthcare services.
(3)  A code of practice may, in particular, specify the duties and obligations of any licensee in relation to the licensee’s business operation insofar as it relates to the provision of licensable healthcare services in Singapore.
(4)  If any provision in any code of practice is inconsistent with any provision of this Act, that provision, to the extent of the inconsistency —
(a)is to have effect subject to this Act; or
(b)having regard to this Act, is not to have effect.
(5)  Where any code of practice is issued, approved, amended or revoked by the Director-General under subsection (1), the Director-General must —
(a)publish a notice of the issue, approval, amendment or revocation (as the case may be) of the code of practice to every licensee to whom the code of practice applies;
(b)specify in the notice in paragraph (a) the date of issue, approval, amendment or revocation, as the case may be; and
(c)ensure that, so long as the code of practice remains in force, copies of that code of practice are made available (including on a website designated by the Director-General for this purpose), free of charge, to the licensees to whom the code of practice applies.
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(6)  Until the notice in subsection (5) is published in accordance with that subsection —
(a)no code of practice, and no amendment to any code of practice issued or approved under this section, has any force or effect as an approved code of practice; and
(b)no revocation of any code of practice issued or approved under this section has any force or effect.
(7)  A code of practice issued or approved under this section does not have legislative effect.
(8)  Subject to subsection (9), every licensee must comply with the relevant codes of practice applicable to the licensee.
(9)  The Director-General may, either generally or for any period that the Director-General may specify, waive the application of any code of practice, or any part of the code of practice, issued or approved under this section to any licensee.
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(10)  Any contravention or failure by a person to comply with a code of practice that applies to the person —
(a)does not of itself render the person liable to criminal proceedings; but
(b)in any proceedings (criminal or otherwise under this Act), may be relied on by any party to those proceedings as tending to establish or negate any liability which is in question in those proceedings.
Directions concerning health, safety or welfare of individuals, etc.
39.—(1)  The Director-General may give a direction to a licensee if the Director-General has reasonable grounds to believe that —
(a)there are circumstances that may endanger, or are likely to endanger, the health, safety or welfare of —
(i)individuals affected by the provision of a licensable healthcare service by the licensee; or
(ii)the general public in connection with the provision of a licensable healthcare service by the licensee; or
(b)the licensable healthcare service is being, or is likely to be, provided in a manner contrary to the rules of professional conduct and ethics applicable to any individual engaged in providing that service.
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(2)  A direction given under subsection (1) —
(a)may require the licensee to do, or refrain from doing, any thing or things of any description that the direction may specify; and
(b)may be varied or revoked at any time by the Director-General.
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(3)  To avoid doubt —
(a)a direction under subsection (1)(a) may require the licensee to stop the provision of a licensable healthcare service until the Director-General is satisfied that the circumstances in subsection (1)(a) no longer exist; and
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(b)a direction under subsection (1)(b) may require the licensee to stop the provision of a licensable healthcare service until the Director-General is satisfied that the licensee has ceased to, and will not, provide that service in the manner mentioned in subsection (1)(b).
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(4)  Before giving a direction under subsection (1) to a licensee, the Director-General must, unless the Director-General in respect of that direction considers that it is not practicable or desirable, give notice to the licensee —
(a)stating that the Director-General intends to give a direction to the licensee under this section and the nature of the direction; and
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(b)specifying the time (being not less than 14 days after the date the notice is served on the licensee) within which written representations may be made to the Director-General with respect to the proposed direction.
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(5)  The Director-General may give or not give the direction —
(a)after considering any written representation made to the Director-General pursuant to the notice in subsection (4); or
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(b)after the time specified in the notice under subsection (4)(b), where no representation is so made or any written representation made is subsequently withdrawn.
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(6)  The Director-General must serve on the licensee concerned a notice of the Director-General’s decision under subsection (5).
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(7)  A direction given under subsection (1) takes effect from the date on which the notice under subsection (6) is given, or on such other date as the notice may specify.
(8)  Every licensee must comply with every direction given under this section to the licensee as soon as it takes effect.
(9)  A licensee that fails to comply with any direction given to that licensee under subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $50,000 or to imprisonment for a term not exceeding 12 months or to both and, in the case of a continuing offence, to a further fine not exceeding $1,000 for every day or part of a day during which the offence continues after conviction.
Directions relating to quality assurance committees, etc.
40.—(1)  The Director-General may give a direction to a section 25 licensee to do anything required in this section, within the time and in the manner that the direction may specify.
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(2)  A direction given under subsection (1) may relate to a quality assurance committee appointed by a section 25 licensee, and require the section 25 licensee to do any of the following:
(a)to require the quality assurance committee to conduct a further evaluation of any prescribed adverse event identified by that committee;
(b)to take any steps and implement any measures that the direction may specify, and report to the Director-General on the steps taken or measures implemented so as to —
(i)prevent the occurrence or recurrence of any prescribed adverse event; or
(ii)implement any recommendation of the quality assurance committee to improve the quality of the licensable healthcare service provided by the section 25 licensee.
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(3)  A direction given under subsection (1) may relate to a service review committee appointed by a section 25 licensee, and require the licensee —
(a)to require the service review committee to conduct a further evaluation of any trend or pattern of events identified by that committee in connection with the section 25 licensee’s provision of a licensable healthcare service, or undertaking of a programme in relation to the provision of a licensable healthcare service, that does not comply with any prescribed service requirements or code of practice applicable to that licensable healthcare service or programme, as the case may be; or
(b)to take any steps and implement any measures that the direction may specify, and to report to the Director-General on the steps taken or measures implemented so as to —
(i)prevent the occurrence or recurrence of any event that does not comply with any prescribed service requirements or code of practice applicable to any licensable healthcare service or programme (as the case may be) that the service review committee is appointed for; or
(ii)ensure that the section 25 licensee complies with the prescribed service requirements or code of practice mentioned in sub‑paragraph (i).
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(4)  A direction given under subsection (1) may relate to a clinical ethics committee appointed by a section 25 licensee, and require the licensee to require that committee to conduct a further ethics review of —
(a)any proposed prescribed medical treatment mentioned in section 26 for an individual; or
(b)any other clinical case for which an ethics review is requested by the Director-General, the section 25 licensee or the medical practitioner in charge of that clinical case.
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(5)  A direction mentioned in subsection (2)(b)(ii) or (3)(b)(ii) may require the section 25 licensee —
(a)to change any of the section 25 licensee’s procedures or practices in the provision of the licensable healthcare service; or
(b)to remove an individual from that individual’s appointment as the section 25 licensee’s Principal Officer or Clinical Governance Officer (as the case may be), and appoint another individual as Principal Officer or Clinical Governance Officer, as the case may be.
(6)  Where the Director-General has reasonable grounds to believe that a quality assurance committee, service review committee or clinical ethics committee appointed by a section 25 licensee is not performing any function or discharging any duty under this Act in a proper or satisfactory manner, the Director-General may direct the section 25 licensee —
(a)to remove or replace any member of that committee;
(b)to appoint one or more additional members to that committee; or
(c)to dissolve that committee and appoint another such committee in its place.
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Powers of entry, inspection and search, etc.
41.—(1)  The Director-General or an authorised officer may, at any time and without notice and without warrant, enter, inspect and search any premises or conveyance, and the facilities in the premises or conveyance, that are being used, or that the Director-General or authorised officer has reasonable cause to believe are being used, to provide any healthcare service or to store any information relating to the provision of any healthcare service, for the purpose of —
(a)investigating an offence under this Act or a contravention of or non‑compliance with a provision under this Act;
(b)investigating whether any condition or restriction imposed on a licence or an approval is being complied with; or
(c)assessing whether the practices and procedures of a licensee are in compliance with this Act or an applicable code of practice.
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(2)  For the purposes of subsection (1), the Director-General or authorised officer may —
(a)inspect and make copies of or take extracts from, or require the occupier or any person having the management or control of the premises or conveyance to provide copies of or extracts from, any book, document, record or electronic material;
(b)inspect and make copies of or take extracts from, or require the occupier or any person having the management or control of the premises or conveyance to provide copies of or extracts from, any medical record of any individual —
(i)who has been or is being treated or examined at the premises or conveyance; or
(ii)to whom a licensee has provided or is providing a licensable healthcare service,
even though the prior consent of that individual has not been obtained;
(c)inspect, test, examine, remove and detain any apparatus, appliance, equipment or instrument used or found in the premises or conveyance;
(d)inspect any test or procedure relating to any provision of a healthcare service that has been or is being conducted in the premises or conveyance, and inspect, test, examine, remove and detain any article used for or in connection with the test or procedure;
(e)inspect, test, examine, remove and detain any blood sample, blood product, human tissue or fluid, any product of the human body, dialysate, chemical, pharmaceutical or any other substance found in the premises or conveyance; and
(f)inspect, test, examine, remove and detain any container, article or other thing that the Director-General or authorised officer reasonably believes to contain or to have contained blood, blood product, human tissue or fluid, any product of the human body, dialysate, chemical, pharmaceutical or any other substance.
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(3)  The Director-General or an authorised officer may seize from any premises or conveyance —
(a)any blood sample, blood product, human tissue or fluid, any product of the human body, dialysate, chemical, pharmaceutical or any other substance;
(b)any container, article or other thing that the Director-General or authorised officer reasonably believes to contain or to have contained blood, blood product, human tissue or fluid, any product of the human body, dialysate, chemical, pharmaceutical or any other substance; or
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(c)any book, document, record, electronic material, apparatus, appliance, equipment or instrument,
which the Director-General or authorised officer reasonably believes to be the subject matter of an offence under this Act or a contravention of or non‑compliance with a provision under this Act, or to be connected with the commission of such an offence, contravention or non‑compliance.
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(4)  Where any article or document has been seized under subsection (3) —
(a)the Director-General or authorised officer who seized the article or document must give written notice of the seizure to the person from whom it was seized, if the name and address of that person are known;
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(b)the article or document may be kept or stored at the premises or conveyance where it was seized or may, at the direction of the Director-General or authorised officer, be removed to any other place —
(i)to be kept or stored; or
(ii)for testing or examination; and
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(c)in any case under paragraph (b)(i), the Director-General or authorised officer may —
(i)mark, seal or label the article or document in any manner that the Director-General or authorised officer thinks fit for the purpose of indicating that it is under detention; and
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(ii)lock or seal the whole or part of the premises or conveyance in which the article or document is being detained.
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(5)  Any person that, without the permission of the Director-General or authorised officer —
(a)interferes, tampers with, removes or otherwise disposes of any article or document seized under subsection (3);
(b)alters, counterfeits, defaces, destroys, erases or removes any mark, seal or label placed by the Director-General or authorised officer under subsection (4)(c)(i); or
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(c)opens, breaks or otherwise tampers with the lock or seal placed by the Director-General or authorised officer on the whole or part of any premises or conveyance under subsection (4)(c)(ii),
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
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(6)  Any individual who is present at any premises or conveyance mentioned in subsection (1) must render all necessary assistance and cooperation to the Director-General or an authorised officer as are necessary for an entry, inspection, investigation or otherwise for the exercise of his or her powers under this Act in relation to those premises or that conveyance.
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(7)  The Director-General or an authorised officer may —
(a)require any person —
(i)to provide any information within the person’s knowledge; or
(ii)to produce any book, document, record, electronic material, article or thing within the person’s possession for inspection by the Director-General or authorised officer and make copies of the book, document or other record, or to provide the Director-General or authorised officer with copies of the book, document or other record;
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(b)orally examine any person supposed to be acquainted with the facts and circumstances of any contravention or suspected contravention of a provision under this Act, and must —
(i)reduce to writing any statement made by the person so examined who is bound to state truly the facts and circumstances with which the person is acquainted;
(ii)read the statement over to the person so examined;
(iii)if the person does not understand English, interpret, or cause to be interpreted, the statement in a language that the person understands; and
(iv)require the person so examined to sign the statement, after correction, if any; and
(c)require, by written order, the attendance before the Director-General or authorised officer of any person, being within the limits of Singapore, who, from information given or otherwise, appears to be acquainted with the facts and circumstances of any matter under this Act, and that person must attend as so required.
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Offence of obstructing, etc., Director-General or authorised officer in exercise of powers, etc.
42.—(1)  Any person that —
(a)refuses to give access to, or obstructs, hinders, impedes or delays, the Director-General or an authorised officer in the exercise of any power under this Act;
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(b)without reasonable excuse, neglects or refuses to provide any information or produce any book, document, record, electronic material, article or thing which that person is required by or under this Act to provide or produce to the Director-General or an authorised officer; or
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(c)neglects or refuses to attend before the Director-General or an authorised officer as required by or under this Act,
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shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
(2)  For the purposes of subsection (1)(b), it is a reasonable excuse for a person to refuse or fail to provide any information, produce any book, document or record or answer any question if doing so might tend to incriminate that person.
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False or misleading statements, information or documents
43.  A person that, in relation to any matter under this Act —
(a)makes any statement, or provides any information or document, that is false or misleading in a material particular; and
(b)knows or ought reasonably to know that, or is reckless as to whether, the statement, information or document is false or misleading in a material particular,
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
Disposal of articles, documents, substances, etc.
44.—(1)  Any article, substance or document produced, detained or seized under this Act must —
(a)where the article, substance or document is produced in any criminal trial, be dealt with in accordance with section 364(1) of the Criminal Procedure Code (Cap. 68); or
(b)in any other case, be returned to the owner or reported to a Magistrate’s Court.
(2)  Where the report of any article, substance or document is made to a Magistrate’s Court under subsection (1)(b), the Magistrate’s Court may order the article, substance or document —
(a)to be forfeited; or
(b)to be disposed of in any manner that the Magistrate’s Court thinks fit.
(3)  This section does not affect any right to retain or dispose of property which may exist in law apart from this section.
Offences by corporations
45.—(1)  Where, in a proceeding for an offence under this Act, it is necessary to prove the state of mind of a corporation in relation to a particular conduct, evidence that —
(a)an officer, employee or agent of the corporation engaged in that conduct within the scope of his or her actual or apparent authority; and
(b)the officer, employee or agent had that state of mind,
is evidence that the corporation had that state of mind.
(2)  Where a corporation commits an offence under this Act, a person —
(a)who is —
(i)an officer of the corporation; or
(ii)an individual involved in the management of the corporation and in a position to influence the conduct of the corporation in relation to the commission of the offence; and
(b)who —
(i)consented or connived, or conspired with others, to effect the commission of the offence;
(ii)is in any other way, whether by act or omission, knowingly concerned in, or is party to, the commission of the offence by the corporation; or
(iii)knew or ought reasonably to have known that the offence by the corporation (or an offence of the same type) would be or is being committed, and failed to take all reasonable steps to prevent or stop the commission of that offence,
shall be guilty of that same offence as is the corporation, and shall be liable on conviction to be punished accordingly.
(3)  A person mentioned in subsection (2) may rely on a defence that would be available to the corporation if it were charged with the offence with which the person is charged and, in doing so, the person bears the same burden of proof that the corporation would bear.
(4)  To avoid doubt, this section does not affect the application of —
(a)Chapters V and VA of the Penal Code; or
(b)the Evidence Act (Cap. 97) or any other law or practice regarding the admissibility of evidence.
(5)  To avoid doubt, subsection (2) also does not affect the liability of the corporation for an offence under this Act, and applies whether or not the corporation is convicted of the offence.
(6)  In this section —
“corporation” includes a limited liability partnership within the meaning of section 2(1) of the Limited Liability Partnerships Act (Cap. 163A);
“officer”, in relation to a corporation, means any director, partner, chief executive, manager, secretary or other similar officer of the corporation, and includes —
(a)any person purporting to act in any such capacity; and
(b)for a corporation whose affairs are managed by its members, any of those members as if the member were a director of the corporation;
“state of mind” of a person includes —
(a)the knowledge, intention, opinion, belief or purpose of the person; and
(b)the person’s reasons for the intention, opinion, belief or purpose.
Offences by unincorporated associations or partnerships
46.—(1)  Where, in a proceeding for an offence under this Act, it is necessary to prove the state of mind of an unincorporated association or a partnership in relation to a particular conduct, evidence that —
(a)an employee or agent of the unincorporated association or partnership engaged in that conduct within the scope of his or her actual or apparent authority; and
(b)the employee or agent had that state of mind,
is evidence that the unincorporated association or partnership had that state of mind.
(2)  Where an unincorporated association or a partnership commits an offence under this Act, a person —
(a)who is —
(i)an officer of the unincorporated association or a member of its governing body;
(ii)a partner in the partnership; or
(iii)an individual involved in the management of the unincorporated association or partnership and in a position to influence the conduct of the unincorporated association or partnership (as the case may be) in relation to the commission of the offence; and
(b)who —
(i)consented or connived, or conspired with others, to effect the commission of the offence;
(ii)is in any other way, whether by act or omission, knowingly concerned in, or is party to, the commission of the offence by the unincorporated association or partnership; or
(iii)knew or ought reasonably to have known that the offence by the unincorporated association or partnership (or an offence of the same type) would be or is being committed, and failed to take all reasonable steps to prevent or stop the commission of that offence,
shall be guilty of the same offence as is the unincorporated association or partnership (as the case may be), and shall be liable on conviction to be punished accordingly.
(3)  A person mentioned in subsection (2) may rely on a defence that would be available to the unincorporated association or partnership if it were charged with the offence with which the person is charged and, in doing so, the person bears the same burden of proof that the unincorporated association or partnership would bear.
(4)  To avoid doubt, this section does not affect the application of —
(a)Chapters V and VA of the Penal Code; or
(b)the Evidence Act or any other law or practice regarding the admissibility of evidence.
(5)  To avoid doubt, subsection (2) also does not affect the liability of an unincorporated association or a partnership for an offence under this Act, and applies whether or not the unincorporated association or partnership is convicted of the offence.
(6)  In this section —
“officer”, in relation to an unincorporated association (other than a partnership), means the president, the secretary, or any member of the committee of the unincorporated association, and includes —
(a)any person holding a position analogous to that of president, secretary or member of a committee of the unincorporated association; and
(b)any person purporting to act in any such capacity;
“partner” includes a person purporting to act as a partner;
“state of mind” of a person includes —
(a)the knowledge, intention, opinion, belief or purpose of the person; and
(b)the person’s reasons for the intention, opinion, belief or purpose.
Composition of offences
47.—(1)  The Director-General may compound any offence under this Act that is prescribed as a compoundable offence by collecting from a person reasonably suspected of having committed the offence a sum not exceeding the lower of the following:
(a)one half of the amount of the maximum fine that is prescribed for the offence;
(b)$10,000.
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(2)  On payment of the sum of money, no further proceedings are to be taken against that person in respect of the offence.
(3)  All sums collected under this section must be paid into the Consolidated Fund.