Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024

Type Act

Publication 2024-02-28

State In force

Source Irish Statute Book

articles 110

the institution shall, within 12 weeks of such commencement, apply to the Medical Council for a licence to carry out anatomical examinations under this Part and, where that relevant institution makes such application, the institution may continue to carry on with such examinations in accordance with the licence or licences, as the case may be, for the time being in force on the date of such application pending a decision by the Medical Council on that application.

(2) Where an institution wishes to carry out anatomical examinations, the institution (in this section referred to as an “applicant institution”) shall apply to the Medical Council for a licence authorising the institution to carry out anatomical examinations.

(3) An application under this section shall—

(a) be in such form and made in such manner as may be specified by the Medical Council,

(b) specify the name and address of the applicant institution,

(c) specify the name of the proposed responsible person and the address of his or her principal office or place of business,

(d) specify the qualifications of the proposed responsible person,

(e) provide details of the facilities of the applicant institution with respect to the activities, the subject of the application,

(f) specify the premises at which it is proposed to undertake anatomical examinations,

(g) provide such other information, including information regarding the governance of the applicant institution as the Medical Council may specify, and

(h) be accompanied by the fee as determined by the Medical Council under subsection (13).

(4) Upon receipt of an application for a licence under this section, the Medical Council shall—

(a) in the case of an applicant institution in respect of which more than 2 years has elapsed since an inspection was last carried out on the institution,

(b) where the applicant institution is making an application to become a licensed institution for the first time, or

cause an inspection to be undertaken of one or more premises which is or are identified in the application as being the premises at which anatomical examinations will be undertaken by the licensed institution if the licence is granted and prepare a written report following such inspection.

(5) Where having considered the application received in accordance with this section, the written report prepared under subsection (4) (where relevant) and the matters specified in subsection (6), the Medical Council may—

(a) issue a licence to an institution,

(b) issue the licence subject to such conditions as the Medical Council may specify, or

(6) The Medical Council shall, in determining a licence application under this section have regard to any codes of practice or guidance issued in respect of anatomical examinations by the Council and any guidelines.

(7) The Medical Council shall not issue a licence to an institution to carry out anatomical examinations unless it is satisfied that such anatomical examinations shall be carried out by that institution in accordance with the licence and this Part.

(8) A licence shall—

(a) state the name and address of the institution, the holder of the licence concerned,

(b) specify the premises at which anatomical examinations will be undertaken,

(c) record on the licence the name and business address of the proposed responsible person in respect of the institution concerned,

(d) specify the date from which the licence shall have effect, and

(e) specify the conditions attached to the licence, if any.

(9) Where the Medical Council proposes to refuse to issue a licence under subsection (5)(c), it shall notify the applicant institution in writing of the proposed refusal and the reasons for such proposed refusal, and notify the applicant institution that the institution may make representations in writing to the Council within 21 days of the date of such notice.

(10) An applicant institution which receives a notification under subsection (9) may within 21 days of the notice make representations in writing in respect of the proposal by the Medical Council to refuse the application for a licence.

(11) Where a notification has been given under subsection (9), the Medical Council shall within 21 days of receipt of any representations consider the representations made to it and shall not issue a final decision until—

(a) it has considered the representations, if any, made by the applicant institution in accordance with the notification, or

(b) the period referred to in subsection (10) has elapsed and no representations are made by the applicant institution concerned.

(12) Where the Medical Council, having considered the representations (if any) made to it in that behalf under subsection (10), decides to refuse an application for a licence, it shall notify the applicant institution in writing—

(a) of the decision and the reasons for it, and

(b) that the applicant may appeal the refusal under section 74.

(13) Without prejudice to the generality of section 36(j) of the Act of 2007, the Medical Council may, with the consent of the Minister, charge such fee as the Council may determine, to accompany an application made under subsection (1) or (2) and different fees may be determined and charged for different classes of application.

69. Notification of grant of licence to institution

69. The Medical Council shall, as soon as is practicable after it issues a licence under section 68, publish a notice in whatever form it considers appropriate stating, at a minimum—

(a) the name and address of the institution, the holder of the licence and the name of the responsible person in respect of the institution, and

(b) the physical address or addresses of the premises or locations at which anatomical examinations, the subject of the licence may be undertaken and (if applicable) the electronic address or addresses of such premises or locations as the case may be.

70. Material amendment of licence

70. A licensed institution that wishes for its licence to be amended in a material way shall make a licence application for such amendment and, in the case of such application, section 68 and the other provisions of this Part applicable to a licence application shall, with all necessary modifications, apply accordingly.

71. Removal, variation or addition of conditions

71. (1) Without prejudice to the generality of section 68(5)(b) the Medical Council, where it considers it necessary to do so may vary a licence issued under section 68, including by way of varying a condition, imposing a condition, including an additional condition, or removing a condition attached to it.

(2) Where the Medical Council proposes to vary a licence under subsection (1), it shall notify the licensed institution in writing of the proposal and any such notification shall—

(a) specify the condition to the licence which it proposes—

(i) to remove or vary and provide details of the proposed variation and the reasons for it, or

(ii) to impose on the licence and the reasons for it,

(b) specify the date from which the condition shall apply, which date shall not be less than 21 days from the date on which the notice is served, and

(c) inform the licensed institution that it may make representations in writing to the Council within 21 days of the date of receipt of such notice.

(3) A licensed institution which receives notification under subsection (2) may, within 21 days of the receipt of the notification, make representations in writing in respect of the proposal by the Medical Council to remove, vary or impose a condition on the licence.

(4) Where a notification has been given under subsection (2), the Medical Council shall, within 21 days of receipt of any representations, consider the representations made to it and shall not issue a final decision regarding its proposal until—

(a) it has considered the representations, if any, made by the licensed institution in accordance with the notification, or

(b) the period referred to in subsection (2) has elapsed and no representations are made by the institution.

(5) Where the Medical Council, having considered within 21 days the representations (if any) made to it in that behalf under subsection (3), decides to remove, vary or impose a condition to a licence, it shall notify the licensed institution in writing—

(a) of the decision and the reasons for it, and

(b) that the institution may appeal the decision under section 74.

72. Suspension and revocation of licences

72. (1) Subject to section 73, the Medical Council may suspend or revoke a licence for any of the following reasons:

(a) the licensed institution has or is undertaking anatomical examinations—

(i) on donated bodies in contravention of the anatomical consents given in respect of those bodies, or

(ii) otherwise than in accordance with the provisions of section 63;

(b) the licensed institution contravened a condition imposed under section 68 or 71, as the case may be, on the licence issued to it under section 68;

(c) that following an inspection by the Medical Council and pursuant to the issuing by it of a compliance notice under section 82, the practices at the licensed institution as regards storage, access to or use and treatment (including the treatment with dignity and respect) of anatomical specimens are such that anatomical examination cannot in the opinion of the Medical Council be carried out in accordance with this Part by the licensed institution;

(d) the information provided by the licensed institution when applying for a licence under section 68 or making representations under section 71 was false or incomplete in any material aspect;

(e) the licensed institution is not carrying out, or has informed the Council by a notice in writing that it no longer intends to carry out, the anatomical examination to which the licence relates;

(f) the licensed institution does not have the staff, premises, equipment or facilities necessary for carrying out the anatomical examination to which the licence relates.

(2) Subject to section 73, where the Medical Council proposes to suspend or revoke a licence under subsection (1), it shall—

(a) notify the licensed institution in writing of the proposal and the reasons for the proposal, and

(b) inform the licensed institution, the subject of the proposal, that the institution may make representations to the Medical Council not later than 21 days or such further period as the Medical Council allows from the date of the service of the notification and that any such representations shall be considered by the Medical Council.

(3) A licensed institution which receives a notification under subsection (2) may within 21 days of the notification make representations in writing in respect of the proposal.

(4) Where a notification has been given under subsection (2), the Medical Council shall within 21 days of any representations made to it consider the representations made to it and shall not issue a final decision until—

(a) it has considered the representations, if any, made by the licensed institution in accordance with the notification, or

(b) the period referred to in subsection (3) has elapsed and no representations are made by the licensed institution concerned.

(5) Where the Medical Council, having, within 21 days, considered any representations made by or on behalf of a licensed institution under subsection (3), decides to suspend or revoke a licence, it shall notify the licensed institution in writing of the decision, stating—

(a) the reasons on which the decision is based,

(b) the date on which the suspension or revocation, as the case may be, shall take effect,

(d) that the institution may within 21 days of the decision appeal the decision under section 74.

(6) Where the Medical Council suspends a licence under subsection (5), the Medical Council may, if where it considers it necessary in all the circumstance to do so, extend the period of suspension and where it proposes to do so, subsection (2) shall with all necessary modifications apply to the proposal to extend the suspension as it applies to the proposal to suspend a licence.

(7) Where the Medical Council decides to suspend or revoke a licence under subsection (5)—

(a) the decision takes effect, where no appeal is made within the period referred to in subsection (5)(d), upon the expiration of that period, and

(b) in the event of an appeal against the decision being made within that period, the decision stands suspended until the appeal is determined or withdrawn.

73. Medical Council may suspend licence without notice in certain circumstances

73. (1) Where the Medical Council considers that due to the manner in which anatomical specimens are stored and treated in a licensed institution—

(a) there is a serious and immediate risk to the life, health or welfare of the staff or students at the licensed institution or to the public, or

(b) the licensed institution is failing to treat the anatomical specimens held at its institution with dignity and respect,

the Medical Council may, without giving notice under section 72, suspend the licence for a period not exceeding 21 days and any such suspension shall have effect for a period not exceeding 21 days as shall be specified in a notice in writing served on the licensed institution concerned and shall cease to have effect—

(i) subject to subparagraphs (ii) and (iii), on the expiry of the date specified in the notice,

(ii) in a case which falls to be determined by the Medical Council under subsection (2) before the date specified in the notice, on the determination of the Medical Council under subsection (2), or

(iii) in a case where the licensed institution concerned, the subject matter of the suspension makes, within the period specified in the notice, an application to the High Court under subsection (3), the determination of the High Court.

(2) Where the Medical Council decides to suspend a licence under subsection (1), the Council shall, as soon as may be, notify in writing the licensed institution—

(a) of the decision and the reasons for it,

(b) the period for which the suspension shall have effect and the date on which it shall come into operation, and

(c) that the institution may on notice make an application in a summary manner to the High Court for consideration and determination by the court of the suspension of the licence concerned.

(3) A licensed institution which is aggrieved by a decision of the Medical Council under subsection (1) may make an application in a summary manner to the High Court for consideration and determination by the court of the decision of the Medical Council.

(4) The High Court may, on the hearing of an application under subsection (3) by a person, consider any evidence adduced or argument made, whether adduced or made to the Council and may—

(a) either—

(i) confirm the decision that is the subject of the application, or

(ii) cancel that decision and replace it with such other decision as the High Court considers appropriate,

and

(b) give the Medical Council such direction as the High Court considers appropriate and direct how the costs of the application are to be borne.

(5) An appeal shall lie from a decision of the High Court in respect of an appeal under this section to the Court of Appeal on a point of law only.

74. **Appeal from decision (other than decision under section 73) of Medical Council**

74. (1) A person who is aggrieved by a final decision under section 68(12), 71(5) or 72(5) may, not later than 21 days after the person received notice of the decision, appeal to the High Court against the decision.

(2) The High Court may, on the hearing of an appeal under subsection (1) by a person, consider any evidence adduced or argument made, whether adduced or made to the Council.

(3) The High Court may, on the hearing of an appeal under subsection (1) by a person—

(a) either—

(i) confirm the decision, the subject of the appeal, or

(ii) cancel that decision and replace it with such other decision as the High Court considers appropriate,

and

(b) give the Medical Council such direction as the High Court considers appropriate and direct how the costs of the appeal are to be borne.

(4) An appeal shall lie from a decision of the High Court in respect of an appeal under this section to the Court of Appeal on a point of law only.

75. Responsible persons

75. (1) Subject to subsection (7), a licensed institution shall, as soon as may be after the commencement of this section and in any event not later than 12 weeks after such commencement, designate at least one appropriately qualified person as a responsible person for the purposes of this Part.

(2) Without prejudice to the generality of subsection (1), a responsible person shall have the following functions, namely:

(a) to conduct and direct anatomical examinations at the licensed institution;

(b) to make applications to the Medical Council on behalf of the institution for authorisation for the institution to loan, transfer or import anatomical specimens for the purposes of anatomical examination;

(d) to undertake duties in respect of the annual return by the licensed institution of its annual report to the Medical Council in such form and manner as is specified by the Medical Council;

(e) to liaise with the Medical Council, as required by the licensed institution or the Medical Council.

(3) The responsible person shall be specified on the licence given by the Medical Council under section 68.

(4) A responsible person may delegate any of the functions specified in subsection (2) to other persons each of whom are suitably qualified by training and experience to perform such functions.

(5) Where a responsible person delegates or proposes to delegate functions under subsection (4), he or she shall ensure that there is in place appropriate training of such persons to enable the delegation of functions and to ensure accountability for the performance of those functions.

(6) Where a licensed institution proposes to designate, on a temporary or permanent basis, a responsible person other than the responsible person specified in the licence issued to the institution under section 68, the licensed institution shall, as soon as may be, provide to the Medical Council for approval—

(a) the name of the proposed responsible person,

(b) his or her qualifications, and

(7) A responsible person shall, notwithstanding any delegations made by him or her in accordance with this section, at all times remain accountable to the Medical Council for the performance of the function so delegated.

(8) A responsible person may revoke a delegation made under subsection (4).

(9) In this section, “an appropriately qualified person” means a person who has such relevant experience, training or expertise as is appropriate having regard to—

(a) the responsibilities of a responsible person under this Part, and

(b) any code of practice for this time being in force in respect of anatomical examinations.

76. Records to be kept in relation to donated anatomical specimens

76. (1) A responsible person shall cause to be maintained in writing or such other form as he or she considers appropriate, or the Medical Council may from time to time specify, a record (in this section referred to as “the record”) in respect of the bodies received by the licensed institution for purposes of anatomical examination at the institution.

(2) Without prejudice to the generality of subsection (1), the following documents relating to a body received by a licensed institution shall be retained as part of the record:

(a) a copy of the anatomical consent;

(b) a copy of the medical certificate of the cause of death.

(3) The record shall be—

(a) maintained in a secure and permanent form, and

(b) made available for inspection by the Medical Council or its officers duly authorised as authorised officers.

(4) Where an anatomical specimen is loaned or transferred to another licensed institution or a like institution outside the State, a copy of the record shall be transferred with the specimen and retained by each of the other institutions where that specimen is loaned or transferred, however a copy of the records shall also be retained by the responsible person at the licensed institution which first received such specimen for anatomical examination.

(5) Where an anatomical specimen is disposed of by a licensed institution, the records in respect of the specimen shall be kept and maintained in accordance with law.

(6) The responsible person shall prepare and maintain a written statement specifying the policies and procedures in place in the licensed institution to ensure that—

(a) there is in place in the licensed institution—

(i) a record management system sufficient to ensure data protection and confidentiality, and

(ii) a documented internal audit system, with an appropriate schedule and accountability,

and

(b) members of staff of the licensed institution are appropriately qualified and trained in respect of the duties to which they are assigned or delegated as the case may be.

(7) A copy of the written statement referred to in subsection (6) shall be made available for inspection by the Medical Council or its officers duly authorised as authorised officers.

77. Transfer of functions from inspectors of places in State where anatomy is carried on under and in accordance with Anatomy Act 1832 to Medical Council

77. (1) All functions that, immediately before the commencement of this section, were vested in the inspectors of places in the State where anatomical examination is carried on under and in accordance with the Anatomy Act 1832 are transferred to the Medical Council.

(2) Without prejudice to the generality of subsection (1) and (3), the Medical Council shall have the following functions, namely:

(a) to undertake or cause to be undertaken, inspections of, and provide or cause to be provided, reports on, premises identified in applications made by applicant institutions to become licensed institutions under section 68;

(b) without prejudice to the generality of paragraph (a), to conduct inspections not less than once every 3 years of all licensed institutions at which anatomical examinations are undertaken;

(i) the provisions of this Part,

(ii) any conditions which have been placed on any licence issued to a licensed institution under this Part, and

(iii) any codes of practice for the time being in force in respect of anatomical examination;

(d) without prejudice to sections 68 and 82, to request an applicant institution or a licensed institution to provide to the Medical Council as soon as it is practicable after receipt of such request, such information as the Medical Council may reasonably require for the purposes of this section and is so specified in its request;

(e) do such other things as are reasonably necessary or expedient for the purposes of monitoring compliance with this Part;

(f) appoint one or more authorised officers to undertake any of the functions referred to in paragraphs (a) to (e) of this subsection;

(g) make reports to the Minister on an annual basis or whenever requested to do so, in respect of inspections undertaken under this section;

(h) of its own motion or at the request of the Minister, to advise the Minister on any matter related to anatomical examination;

(i) at the request of the Minister and as soon as it is practicable after receipt of such request, to provide the Minister with such information as the Minister specifies in his or her request.

(3) The Medical Council shall have all such powers as are necessary or expedient for the performance of its functions under this Part.

(4) Anything commenced and not completed before the commencement of this section by or under the authority of the Inspector of Anatomy may, be carried on or completed on or after that date by the Medical Council.

78. Requests by Medical Council for information

78. Without prejudice to section 68, where the Medical Council requests an applicant institution or a licensed institution, as the case may be, to provide to the Medical Council as soon as it is practicable after receipt of such request, such information as the Medical Council may reasonably require for the purposes of this section and is so specified in its request, the applicant institution or the licensed institution, as the case may be, shall comply with that request.

79. Authorised officers for purposes of Part 4

79. (1) The Medical Council may appoint one or more persons as the Council sees fit to be authorised officers for the purposes of this Part.

(2) Each authorised officer shall be furnished with a warrant of his or her appointment and, when exercising a power conferred by this Part shall, if requested by any person affected thereby, produce such warrant of appointment to that person for inspection.

(3) An appointment under this section shall cease—

(a) if the Medical Council revokes the appointment,

(b) if the appointment is for a fixed period, on the expiry of that period, or

(c) in the case of a person who is a member of the staff of the Medical Council as the case may be, if the person ceases to be a member of the staff.

80. **Powers of authorised officers (Part 4)**

80. (1) For the purposes of this Part, an authorised officer may exercise any of the following powers:

(a) enter (if necessary, by use of reasonable force) and inspect, at any reasonable time, any premises (other than a dwelling)—

(i) specified in a licence issued under this Part,

(ii) not specified in a licence but at which he or she has reasonable grounds for believing that anatomical examinations are being undertaken, or

(iii) at which he or she has reasonable grounds for believing that documents or records relating to anatomical examinations are kept;

(b) require any person on the premises referred to in paragraph (a) to produce any documents or records relating to anatomical examinations;

(i) any documents or records relating to anatomical examinations, or

(ii) any premises (or part thereof) in which documents or records relating to anatomical examinations are kept;

(d) take samples, carry out, or have carried out, such tests, examinations, analyses, inspections or checks of any or all of the following as he or she considers reasonably necessary for the purposes of this Part:

(i) the premises;

(ii) anything at the premises;

(iii) notwithstanding the generality of subparagraph (ii), any equipment, machinery or plant at the premises;

(e) require any person at the premises or the owner or person in charge of the premises and any person employed there to give him or her such assistance and information and to produce to him or her such books, records or other documents (and in the case of documents stored in non-legible form, produce to him or her a legible reproduction thereof) that are in the person’s power or procurement, as the authorised officer may reasonably require for the purposes of this Part.

(2) An authorised officer shall not enter a dwelling, other than—

(a) with the consent of the occupier, or

(b) pursuant to a warrant under subsection (3).

(3) Upon the sworn information of an authorised officer, a judge of the District Court may, for the purposes of enabling an authorised officer to carry out an inspection under subsection (1), issue a warrant authorising a named authorised officer, accompanied by such other authorised officers or members of the Garda Síochána as may be necessary, at any time or times, before the expiration of one month from the date of issue of the warrant, to enter (if necessary by use of reasonable force) the dwelling and perform the functions of an authorised officer under subsection (1).

(4) A person shall be guilty of an offence if he or she—

(a) obstructs or interferes with an authorised officer or a member of the Garda Síochána in the course of exercising a power conferred on him or her by this Part or a warrant under subsection (3), or impedes the exercise by the person or member, as the case may be, of such power, or

(b) fails or refuses to comply with a request or requirement of, or to answer a question asked by, an authorised officer or member pursuant to this section, or in purported compliance with such request or requirement or in answer to such question, give information to an authorised officer or member that he or she knows to be false or misleading in a material particular.

(5) A person who is guilty of an offence under paragraph (a) or (b) of subsection (4) shall be liable on summary conviction to a class C fine or imprisonment for a term not exceeding one year or both.

(6) Where an authorised officer believes, upon reasonable grounds, that a person has committed an offence under this Part, the authorised officer may require the person to provide him or her with his or her name and the address at which that person ordinarily resides, and such person shall comply with that requirement.

81. Codes of practice (anatomical examination)

81. (1) Subject to subsection (2), the Medical Council—

(a) may, and, at the request of the Minister, shall prepare and publish a code of practice for the purpose of setting standards relating to the undertaking of anatomical examinations and any code of practice shall specify the period for which records shall be retained, which period shall not be less than 5 years, and

(b) may, if it thinks appropriate to do so, approve any other code of practice relating to the undertaking of anatomical examinations.

(2) Before publishing or approving of a code of practice under subsection (1), the Medical Council—

(a) shall publish in such manner as the Council considers appropriate a draft of the code and shall allow persons 30 days from the date of publication of the draft code within which to make representations in writing to the Medical Council in relation to the draft code or such further period, not exceeding 30 days, as the Medical Council in its absolute discretion thinks fit, and

(b) following consultation and, where relevant, having considered the representations (if any) made, shall submit the draft code to the Minister for his or her consent to its publication or approval.

(3) The Minister may—

(a) consent to the publication or approval of, as the case may be, a code of practice under this section with or without modification, or

(b) refuse to consent to publication or approval of such a code of practice.

(4) Where the Medical Council publishes or approves of a code of practice under this section, the Minister shall cause a notice to that effect to be published in Iris Oifigiúil—

(a) identifying or specifying the code, and

(b) specifying the date from which the code shall have effect.

(5) The Medical Council may, with the consent of the Minister but subject to subsection (6)—

(a) amend or revoke a code of practice published under this section, or

(b) withdraw its approval of any code of practice approved of under this section.

(6) Subsection (2) shall, with all necessary modifications, apply to a code of practice that the Medical Council proposes to amend or revoke, or withdraw its approval of, under subsection (5) as subsection (2) applies to a code of practice that the Medical Council proposes to publish or approve of under this section.

(7) Where the Medical Council amends or revokes, or withdraws its approval of, a code of practice published or approved of under this section, the Minister shall cause a notice to that effect to be published in Iris Oifigiúil—

(a) identifying or specifying the code to which the amendment, revocation, or withdrawal, as the case may be, relates and, if applicable, particulars of the amendment, and

(b) specifying the date from which the amendment, revocation, or withdrawal, as the case may be, shall have effect.

(8) The Medical Council shall cause to be published in such form as it considers appropriate a copy of each code of practice published or approved of under this section, as the code is in force from time to time, on and from the date on which the code has effect.

(9) A document bearing the seal of the Medical Council and purporting to be a code of practice published or approved under this section or, where such a code has been amended under subsection (7), the code as so amended shall be admissible in evidence in any proceedings under this Act or before a court or tribunal.

(10) In this section, “code of practice” includes part of a code of practice.

82. Compliance notices (anatomical examination)

82. (1) Where the Medical Council is of the opinion that a person has contravened or is contravening—

(a) the provisions of this Part,

(b) any conditions which have been placed on any licence issued to an institution under this Part, or

the Medical Council may serve a compliance notice on the person.

(2) Before serving a compliance notice on a person under subsection (1), the Medical Council shall give the person notice (in this section referred to as “advance notice”) of the proposal to serve the compliance notice and the advance notice shall—

(a) specify the act or omission constituting the contravention referred to in subsection (1) to which the advance notice relates, and

(b) inform the person that he or she may make representations to the Medical Council in accordance with subsection (3).

(3) A person who is served with an advance notice may, within 21 days of the receipt of the notice, make representations to the Medical Council about the proposed compliance notice.

(4) Where an advance notice has been given under subsection (2), the Medical Council shall within 21 days of receipt of representations (if any) consider any representations made to it and shall not issue a final decision until—

(a) it has considered the representations, if any, made by the applicant institution in accordance with the advance notice, or

(b) the period referred to in subsection (3) has elapsed and no representations are made by the applicant institution concerned.

(5) The Medical Council shall have regard to any representations made to it under subsection (3) in assessing whether to proceed with the service of the compliance notice.

(6) A compliance notice shall—

(a) specify the act or omission constituting contravention referred to in subsection (1) to which the notice relates,

(b) require the person on whom it is served not to commit or to cease committing, as the case may be, the act or omission concerned,

(d) require the person on whom it is served, within the period specified in the notice to inform the Medical Council and any other persons so specified of the steps taken in order to comply with the notice, and

(e) require the person on whom it is served to supply, within the period specified in the notice, such additional information as may be specified in the notice.

(7) A compliance notice shall, unless an appeal is brought under section 83, come into operation on the expiry of 21 days from the date of service of the notice.

(8) Where a person on whom a compliance notice has been served fails to comply with the notice at any time within a period of 21 days from the date on which the notice comes into operation, he or she shall be guilty of an offence and shall be liable on summary conviction to a class C fine or imprisonment for a term not exceeding one year or both.

83. Appeal of compliance notice

83. (1) A person on whom a compliance notice has been served may within 21 days of service of the compliance notice appeal to the District Court in respect of the notice or any requirement therein.

(2) Where an appeal is brought under this section, the District Court may—

(a) confirm the notice in whole or in part, with or without amendment of that notice, or

(b) allow the appeal.

(3) Where the District Court allows the appeal, the compliance notice shall cease to have effect.

(4) Where the District Court confirms a compliance notice, the notice as so confirmed, shall unless an appeal is brought under subsection (5) come into operation on the expiry of 21 days of the date of confirmation or such later date as the court may determine.

(5) A person may within 21 days of the confirmation appeal a confirmation of a compliance notice by the District Court to the Circuit Court.

(6) Where the Circuit Court allows the appeal, the compliance notice shall cease to have effect.

(7) Where the Circuit Court confirms the compliance notice (in whole or in part, with or without amendment), the notice as so confirmed shall come into operation on such date as the Circuit Court shall determine.

(8) Any of the parties concerned may appeal a determination of the Circuit Court to the High Court on a point of law.

(9) The jurisdiction conferred on the District Court or the Circuit Court, as the case may be, under this section shall be exercised by a judge of that court for the time being assigned to the district court district or circuit, as the case may be, in which the person on whom the compliance notice is served ordinarily resides or carries on any profession, business or occupation.

PART 5 Public Display

84. **Definitions (Part 5)**

84. In this Part—

“applicant” has the meaning assigned to it by section 89;

“body” includes a body part or tissue sample;

“Part 5 consent” has the meaning assigned to it by section 87;

“Part 5 licence holder” has the meaning assigned to it by section 86;

“public display” means, in relation to a body of a deceased person, an exhibition, show or display in which the body, body part or the tissue of a deceased person is used for the purpose of being exposed to view (whether or not free of charge) by members of the public;

“public display activities” has the meaning assigned to it by section 85;

“tissue” does not include a human foetus or gamete.

85. Public display activities

85. (1) A person shall not use the body of a child, human foetus, embryo or gamete for purposes of public display.

(2) Public display activities means, in relation to a body of a deceased person, any of the following:

(a) the use of the body for the purposes of public display;

(b) the removal, retention, storage and transport of the body for the purposes of public display;

(d) such other activities as relate to use of the body that is or is proposed to be placed on public display as may be specified by the Medical Council in accordance with subsection (4),

but does not include the activities specified in subsection (3).

(3) The activities referred to in subsection (2) are as follows, namely:

(a) display of a body of a deceased person as part of a funeral or any similar ceremony where such funeral or like ceremony is held for the purposes of paying respects to the deceased person;

(b) display of a body at a place of public religious worship and where such display is necessary to the act of religious worship;

(d) display of a body for the purposes of recording, by film or otherwise.

(4) Subject to subsection (6), the Medical Council, having had regard to the matters referred to in subsection (5), may specify as public display activities such other activities relating to the exhibition, show or display of a body of a deceased person as it considers appropriate.

(5) When specifying an activity under subsection (4) as a public display activity, the Medical Council shall have regard to the following:

(a) the purpose of the proposed exhibition, show or display;

(b) the nature of the proposed exhibition, show or display;

(6) Before specifying an activity under subsection (4) as a public display activity, the Medical Council may consult such other persons as the Medical Council considers appropriate for the purposes of subsection (4).

86. Licence required for public display activities

86. (1) Subject to subsection (2), a person shall not undertake public display activities unless the person undertaking the activity holds a licence issued in accordance with this Part in respect of such public display activity (in this Part referred to as a “Part 5 licence”).

(2) Subsection (1) shall not apply—

(a) in respect of the public display of a body of a deceased person who died before the commencement of this section, and in respect of whom at least 100 years has lapsed since the death of the person, or

(b) in respect of an anatomical specimen which immediately before the commencement of this section is held by a licensed institution (within the meaning of Part 4), hospital, university, museum, gallery or other like place, howsoever described.

(3) A person who holds a Part 5 licence (in this Part referred to as a “Part 5 licence holder”) shall ensure that the bodies of deceased persons used for the purposes of public display activities are treated at all times with dignity and respect.

(4) A Part 5 licence holder shall not use a body for public display activities where—

(a) any procedure related to anatomical examination is being carried out on the body,

(b) any similar procedure to anatomical examination is being carried out on the body, or

(c) if the identity of a body could be, or could reasonably be expected to be, ascertained by a member of the public when viewing such body.

(5) A person who contravenes—

(a) subsection (1), or

(b) subsection (4),

shall be guilty of an offence.

(6) In this section, “similar procedure” includes dissection, removal or implantation.

87. (1) Subject to subsection (6), a person shall not use a body for purposes of public display activities unless the person—

(a) is a Part 5 licence holder, and

(b) is in receipt of a consent in respect of that body, given in accordance with this section.

(2) A person who has attained the age of 18 years may give his or her consent (in this Part referred to as a “Part 5 consent”) to the donation of his or her body to a Part 5 licence holder for the purposes of public display activities.

(3) Where a person is considering whether to provide a Part 5 consent, the Part 5 licence holder shall provide or cause to be provided to the person information regarding the following matters:

(a) the nature of the public display activities for which a donated body may be used;

(b) the length of time in respect of which a donated body may be retained;

(d) information relating to the cremation, burial or disposal of a donated body;

(e) without prejudice to paragraphs (a) to (d), any other information for the time being specified by the Medical Council as being necessary information to be given to a person who is considering providing his or her consent under this section.

(4) A Part 5 consent shall be given in the form for the time being standing specified by the Medical Council for the purposes of this Part and without prejudice to the generality of the foregoing shall—

(a) be signed by the person in the presence of at least one witness who shall attest the signature,

(b) include a confirmation by the person concerned that he or she has been furnished with, and understands, the information referred to in paragraphs (a) to (e) of subsection (3),

(c) include a confirmation that the person understands that his or her body may be loaned, or transferred within the State or Northern Ireland for purposes of public display activities, and

(d) specify the duration of time, being a period of time that the person consents to his or her body being used for public display activities.

(5) A Part 5 consent given by a person may be revoked or amended by the person at any time before his or her death in like manner and subject to like conditions (if any) by notifying in writing the Part 5 licence holder in the form for the time being standing specified by the Medical Council for that purpose in respect of which the Part 5 consent relates.

(6) For the purposes of subsection (1) and without prejudice to the generality of section 86(2), a Part 5 consent shall not be required for the removal, storage or use of a deceased person’s body or material from his or her body for public display activities if—

(a) the person concerned died before the commencement of section 86, and a period of 100 years has lapsed since the death of that person, or

(b) in respect of an anatomical specimen which, immediately before the commencement of section 86, is held by a licensed institution (within the meaning of Part 4), hospital, university, museum, gallery or other like place, howsoever described.

(7) A person shall not be entitled to financial or other like reward for the giving of his or her consent under this section other than in respect of financial assistance with the provision of a coffin and transportation of the donated body to the place of burial or cremation, the subject of the consent and, any financial or other like reward given in respect of a consent shall render the consent null and void.

(8) Subject to any provisions to the contrary provided for in a Part 5 consent, a Part 5 licence holder or a person nominated for the purposes of this subsection and specified in the Part 5 licence as being such a person, may bury (whether in a place owned by or under the control of, the Part 5 licence holder concerned or in a place designated by the holder concerned for that purpose) the remains, or the cremated remains as the case may be, of a body the subject of a Part 5 consent.

(9) A Part 5 consent given by a person under this section operates as a consent given for the purposes and only the purposes of public display activities.

(10) A copy of the Part 5 consent shall be kept at the premises of the Part 5 licence holder which received the donated body for such period as shall be specified in a code of practice under section 100 which period shall not be less than 5 years.

(11) A person who contravenes subsection (1) shall be guilty of an offence.

88. Medical certificate of cause of death must be signed before public display activities can take place

88. (1) Where a person has given a Part 5 consent, to the use of his or her body after death for public display activities, on his or her death, the deceased person’s body may be brought to the premises of the Part 5 licence holder concerned before the deceased person’s death has been duly registered in the register of deaths by an tArd Chláraitheoir.

(2) No public display activities can take place until a medical certificate of the cause of death has been signed and furnished to the Part 5 licence holder in respect of the body.

(3) A copy of medical certificate of the cause of death shall be kept at the premises of the Part 5 licence holder which received the body for such period as shall be specified in a code of practice under section 100 which period shall not be less than 5 years.

89. **Application for Part 5 licence to undertake public display activities**

89. (1) A person shall not undertake public display activities unless he or she is in receipt of a licence granted under this Part to undertake public display activities (in this Part referred to as a “Part 5 licence holder”).

(2) Where a person (in this Part referred to as the “applicant”) proposes to undertake public display activities, he or she may make an application to the Medical Council for a Part 5 licence.

(3) An application for a Part 5 licence shall—

(a) be made in writing to the Medical Council in the form for the time being specified by the Medical Council,

(b) include particulars of the proposed public display activity, including particulars in respect of the premises, duration and content of the public display activity, the subject of the application concerned,

(c) specify details such as to demonstrate that sufficient procedures are in place for the purposes of this Part, including in respect of the disposal, repatriation or return of the body, which details shall include where required, the name and address of persons overseeing the implementation of those procedures,

(d) include copies of the Part 5 consents relating to each of the anatomical specimens proposed to be used for the purposes of the public display activity,

(e) without prejudice to the generality of paragraph (d) in the case of an application for a licence for public display activities (whether such public display activity is on a temporary basis or otherwise) which proposes to use anatomical specimens from a state other than the State—

(i) include documentary evidence of the country of origin of each anatomical specimen,

(ii) furnish a copy of consents or written evidence to the satisfaction of the Medical Council in respect of each of the anatomical specimens,

(iii) include evidence, in respect of each of the anatomical specimens, of compliance with the legal requirements in respect of each of the anatomical specimens of the country of origin of each of the anatomical specimens concerned, and

(iv) provide such additional particulars as may be determined in guidance drawn up by the Medical Council with respect of the importation of anatomical specimens for the purposes of public display activities,

and

(f) be accompanied by the fee as determined by the Medical Council under subsection (11).

(4) Subject to subsection (5), where the Medical Council receives an application under subsection (1), the Council may—

(a) grant the licence,

(b) grant the licence subject to such conditions as it may impose, or

(5) Where the Medical Council receives an application under subsection (2) which seeks as part of that application to import anatomical specimens from a state other than the State, the Medical Council shall not issue a licence for that purpose unless it is satisfied that the requirements relating to the donation and use of anatomical specimens in place in that state are of a like standard to the requirements of this Part.

(6) Where the Medical Council grants a licence under this section, the Council shall notify the applicant of the grant of the licence and such notification shall specify—

(a) the name of the person who is licensed to carry out the public display activities, the subject of the licence concerned,

(b) the premises at which the public display activities may be undertaken,

(d) the period of operation of the licence, and

(e) in the case of a licence which is subject to conditions under section 90, the conditions which apply to the licence concerned.

(7) Where the Medical Council proposes to refuse to grant a licence, the Council shall notify the applicant in writing of the proposed refusal and the notification shall state—

(a) the reasons for the proposed refusal,

(b) that the applicant may make representations in writing within 21 days of the notification, and

(i) the Medical Council has considered any representations made to it by or on behalf of the applicant, or

(ii) in the case of no representations being made, until the expiry of 21 days.

(8) An applicant who receives notification of a proposed refusal under subsection (7) may within 21 days of receipt of such notification, make representations in writing to the Medical Council in respect of the proposal by the Medical Council to refuse the application for a licence.

(9) Where a notification has been given under subsection (7), the Medical Council shall within 21 days of receipt of representations (if any) consider any representations made to it and shall not issue a final decision until—

(a) it has considered the representations, if any, made by the applicant institution in accordance with the notification, or

(b) the period referred to in subsection (8) has elapsed and no representations are made by the applicant institution concerned.

(10) Where the Medical Council, having considered such representations, if any, made to it in that behalf by or on behalf of the applicant, decides to refuse the application for a licence under this section, it shall notify the applicant in writing of that fact and the notice shall state—

(a) the reasons for the refusal of the licence, the subject of the application, and

(b) that the applicant may appeal the refusal under section 93.

(11) The Medical Council may, with the consent of the Minister, charge such fee as the Council may determine, to accompany an application made under subsection (1) and different fees may be determined and charged for different classes of application.

(12) A person who contravenes subsection (1) shall be guilty of an offence.

90. Placing of conditions upon licence

90. (1) Without prejudice to the generality of section 89(4)(b), the Medical Council may vary, remove or place additional conditions on a Part 5 licence granted under section 89.

(2) Where the Medical Council proposes to vary, remove or impose additional conditions on a Part 5 licence, the Council shall notify the Part 5 licence holder in writing of the proposal and the notice shall specify—

(a) particulars of the condition which the Medical Council proposes to vary, remove or additionally place on the licence, the subject of the notice concerned,

(b) the reasons for the proposed variation, removal or additional imposition of conditions,

(c) subject to paragraph (d), the date on which, being a date not earlier than 21 days from the date of the notice, the variation, removal or additional imposition of the condition concerned shall apply, and

(d) that no decision shall be finalised until—

(i) the Medical Council has considered any representations made to it, or

(ii) in the case of no representations being made, the expiry of 21 days.

(3) A Part 5 licence holder who receives notice of a proposal under subsection (2) may within 21 days of receipt of such notice, make representations in writing to the Medical Council in respect of the proposal.

(4) Where a notice has been given under subsection (2), the Medical Council shall within 21 days of receipt of representations (if any) consider any representations made to it and shall not issue a final decision until—

(a) it has considered the representations, if any, made by the applicant institution in accordance with the notice, or

(b) the period referred to in subsection (3) has elapsed and no representations are made by the Part 5 licence holder concerned.

(5) Where the Medical Council, having considered within 21 days of such representations, if any, made to it in that behalf by or on behalf of the Part 5 licence holder, decides to vary, remove or impose additional conditions on the licence under this section, it shall notify the Part 5 licence holder in writing of that fact and the notice shall—

(a) specify the particulars of the conditions varied, removed or additionally placed on the licence pursuant to the decision,

(b) state the reasons for the decision, and

91. **Suspension and revocation of Part 5 licences**

91. (1) The Medical Council may suspend or revoke a Part 5 licence, where the Council reasonably believes any of the following:

(a) the Part 5 licence holder is undertaking public display activities otherwise than in accordance with this Part;

(b) that notwithstanding the service by the Medical Council of a compliance notice under section 101, on the Part 5 licence holder for the time being in operation—

(i) the practices of the Part 5 licence holder as regards storage, access to or use, treatment (including the treatment with dignity) and display of anatomical specimens is such that the public display activities, the subject of the licence, cannot or can no longer be carried on safely and in accordance with this Part by the holder of the licence, or

(ii) the premises specified in the Part 5 licence as being the premises at which public display activities are carried on or are to be carried on is not or is no longer suitable (whether by reason of insufficient staff, equipment or facilities or otherwise) for public display activities;

(c) the information furnished to the Medical Council in the application under section 89 for a Part 5 licence was false or incomplete in any material aspect;

(d) the Part 5 licence holder has notified the Medical Council in writing that the holder of the licence is not or no longer intends to carry on public display activities to which the licence relates.

(2) Where the Medical Council proposes to suspend or revoke a Part 5 licence under subsection (1), it shall notify the Part 5 licence holder in writing of the proposal and such notice shall specify—

(a) the reasons for the proposed suspension or revocation, as the case may be,

(b) subject to paragraph (c), the date on which, being a date not earlier than 21 days from the date of the notice, the suspension or revocation, as the case may be, shall apply,

(c) that the Medical Council shall consider any representations made to it in that behalf within 21 days of receipt of those representations, and

(d) that no decision shall be finalised until—

(i) the Medical Council has considered any representations made to it by or on behalf of the Part 5 licence holder, or

(ii) in the case of no representations being made, the expiry of 21 days or such further period as the Medical Council for good reason allows.

(3) A Part 5 licence holder who receives a notification under subsection (2) may within 21 days of the notice make representations in writing in respect of the proposal by the Medical Council to suspend or revoke the licence.

(4) Where a notice has been given under subsection (3), the Medical Council shall within 21 days of the notice consider any representations made to it and shall not issue a final decision until—

(a) it has considered the representations, if any, made by the person in accordance with the notice, or

(b) the period referred to in subsection (3) has elapsed and no representations are made by the Part 5 licence holder concerned.

(5) Where the Medical Council, having considered the representations, if any, made to it by or on behalf of a Part 5 licence holder decides to suspend or revoke a licence, it shall notify the Part 5 licence holder concerned in writing of the decision and such notice shall specify—

(a) the reasons for the suspension or revocation, as the case may be of the Part 5 licence, the subject of the decision and the date on which it takes effect, and

(b) that the Part 5 licence holder may appeal the decision under section 93.

(6) Where the Medical Council suspends a Part 5 licence under subsection (5), the Medical Council may, if it considers it necessary in all the circumstances to do so, extend the period of suspension but where it proposes to do so, subsection (2) shall with all necessary modifications apply to the proposal to extend the suspension as it applies to the proposal to suspend a licence.

(7) An appeal shall lie under section 93 to the High Court from the suspension or revocation of a Part 5 licence order but the bringing of such an appeal shall not affect the operation of the suspension or prohibition order, as the case may be, unless the High Court, on application to it in that behalf within 21 days from the date of the decision of the Medical Council, makes an order staying its operation pending the determination of the appeal.

92. Suspension of licence without notice in certain circumstances

92. (1) Where the Medical Council considers that due to the manner in which anatomical specimens are stored, treated or displayed at the premises to which the Part 5 licence applies that—

(a) there is a serious and immediate risk to the life, health or welfare of the public, or

(b) the Part 5 licence holder is failing to treat the anatomical specimen with dignity and respect,

the Medical Council may without giving notice under section 91(2) suspend the licence for a period not exceeding 21 days and, the licence concerned shall stand suspended and shall have effect for a period not exceeding 21 days beginning on such date as shall be specified in a notice in writing served under this subsection on the Part 5 licence holder concerned and the suspension shall cease to have effect—

(i) subject to subparagraphs (ii) and (iii), on the expiry of the date specified in the notice,

(ii) in a case which falls to be determined by the Medical Council under section 91(2) before the date specified in the notice, on the determination of the Medical Council under section 91(2), or

(iii) in a case where the Part 5 licence holder, the subject matter of the suspension makes, within the period specified in the notice, an application to the High Court under subsection (3), on the date determined by the High Court.

(2) Where the Medical Council decides to suspend a licence under subsection (1), the Council shall, as soon as may be, notify the Part 5 licence holder in writing—

(a) of the decision and the reasons for it,

(b) of the period for which the suspension shall have effect, and

(c) that the licence holder may on notice make an application in a summary manner to the High Court for consideration and determination by the court of the suspension of the licence concerned.

(3) A Part 5 licence holder who is aggrieved by a decision of the Medical Council under subsection (1) may make an application in a summary manner to the High Court for consideration and determination by the court of the decision of the Medical Council.

(4) The High Court may, on the hearing of an application under subsection (3) by a person, consider any evidence adduced or argument made, whether adduced or made to the Council and may—

(a) either—

(i) confirm the decision the subject of the application, or

(ii) cancel that decision and replace it with such other decision as the High Court considers appropriate,

and

(b) give the Medical Council such direction as the High Court considers appropriate and direct how the costs of the application are to be borne.

93. **Appeal from decision (other than decision under section 92) of Medical Council**

93. (1) A person who is aggrieved by a decision under section 89, 90 or 91 may not later than 21 days after the person received notice of the decision under section 89, 90 or 91 as the case may be, appeal to the High Court against the decision.

(2) The High Court may, on the hearing of an appeal under subsection (1) by a person, consider any evidence adduced or argument made, whether adduced or made to the Council.

(3) The High Court may, on the hearing of an appeal under subsection (1) by a person—

(a) either—

(i) confirm the decision the subject of the appeal, or

(ii) cancel that decision and replace it with such other decision as the High Court considers appropriate,

and

(b) give the Medical Council such direction as the High Court considers appropriate and direct how the costs of the appeal are to be borne.

94. Loan or transfer of anatomical specimens for purposes of public display activities

94. (1) A Part 5 licence holder, if he or she is in receipt of a prior authorisation given to the holder by the Medical Council, may by agreement loan or transfer an anatomical specimen to another Part 5 licence holder or a holder of a like licence in Northern Ireland for the purposes of public display activities.

(2) In making an application to the Medical Council for an authorisation, a Part 5 licence holder shall specify in writing—

(a) the anatomical specimens that are the subject of the loan or transfer, as the case may be,

(b) that Part 5 consent has been given in respect of the anatomical specimens that are the subject of the loan or transfer, as the case may be,

(d) in the case of a loan, the duration of the loan period, and

(e) the name and location of the place where the anatomical specimens will be put on display.

(3) An anatomical specimen that is on loan under subsection (1) shall remain the responsibility of the Part 5 licence holder who made the loan.

(4) An anatomical specimen that is transferred to a Part 5 licence holder or transferred to a like licence holder in Northern Ireland shall be the responsibility of—

(a) in the case of a transfer to another Part 5 licence holder, that other Part 5 licence holder, or

(b) in the case of a transfer to a like licence holder in Northern Ireland in accordance with this section, the licence holder to which the anatomical specimen is transferred.

(5) It shall be for both the Part 5 licence holder which loans or transfers, as the case may be, an anatomical specimen, and the like licence holder which receives an anatomical specimen on loan or transfer, as the case may be, to satisfy himself or herself and show if so requested in writing by the Medical Council that the loan or transfer was made in accordance with any Part 5 consent in respect of the anatomical specimen concerned.

(6) All records (which shall include a copy of the records referred to in section 95 and 96 relating to anatomical specimens) shall be transferred from the Part 5 licence holder to the other Part 5 licence holder or like licence holder in Northern Ireland, as the case may be, receiving the anatomical specimen the subject of the transfer as the case may be.

(7) A Part 5 licence holder who loans or transfers an anatomical specimen under this section shall retain copies of the records transferred under subsection (6) for such period as shall be specified in a code of practice under section 100 which period shall not be less than 5 years.

(8) A Part 5 licence holder or like licence holder in Northern Ireland, as the case may be, receiving an anatomical specimen shall be responsible—

(a) in the case of a loan, for the return of that anatomical specimen to the Part 5 licence holder who made the loan, or

(b) in the case of a transfer, for the disposal of that anatomical specimen in accordance with the consent provided.

95. Importation of anatomical specimens for purposes of public display activities

95. (1) A Part 5 licence holder may, if he or she is in receipt of prior authorisation issued as part of the licence issued to the holder in that behalf by the Medical Council, import an anatomical specimen for the purposes of public display activities.

(2) In making an application to the Medical Council for an authorisation, the licence holder shall specify in writing—

(a) the anatomical specimens that are the subject of the proposed importation,

(b) that consent has been given in respect of the anatomical specimens that are the subject of the proposed importation,

(d) in the case of a loan, the duration of the loan period, and

(e) the location where the anatomical specimens will be held.

(3) An imported anatomical specimen shall be obtained, transported, used and disposed of by a Part 5 licence holder in accordance with any consent given by the donor in respect of the anatomical specimen concerned.

(4) It shall be for the Part 5 licence holder to satisfy himself or herself and show, if so requested in writing by the Medical Council, that the anatomical specimen has been obtained, transported, used and disposed of by the licence holder concerned in accordance with any consent given by the donor of the anatomical specimen concerned.

(5) Where an anatomical specimen is imported into the State by a Part 5 licence holder for the purposes of public display activities, it shall be for the Part 5 licence holder to show, if so requested in writing by the Medical Council, that the licence holder complied with the legal requirements in the country from which the anatomical specimen has been imported.

(6) Without prejudice to the generality of subsection (5), evidence of compliance referred to in that subsection may comprise of evidence to show that the anatomical specimen has been imported in accordance with rules relating to public display activities where such rules are, in the view of the Medical Council, equivalent to the provisions of this Part.

96. Records to be kept in relation to anatomical specimens

96. (1) A Part 5 licence holder shall keep a register containing the following documents (in this Part referred to as a “Part 5 Register”):

(a) in the case of anatomical specimens which are imported for the purposes of public display activities—

(i) documentary evidence of the country of origin of each anatomical specimen,

(ii) documentary evidence of consent in respect of each of the anatomical specimens,

(iii) documentary evidence of compliance with legal requirements in operation in respect of each of the anatomical specimens of the country of origin of each of the anatomical specimens concerned, and

(iv) such additional particulars as may be determined in guidance drawn up by the Medical Council with respect of the importation of anatomical specimens for the purposes of public display activities;

(b) in any other case—

(i) a copy of the medical certificate of the cause of death,

(ii) a copy of the Part 5 consent of each of the anatomical specimens used or proposed to be used for the purposes of public display activities.

(2) The Part 5 Register shall be—

(a) maintained in a secure and permanent form, and

(b) made available for inspection by the Medical Council.

(3) A person who contravenes subsection (1) shall be guilty of an offence.

97. Medical Council to monitor compliance with provisions of Part 5

97. (1) The Medical Council shall monitor compliance with this Part.

(2) For the purposes of subsection (1), the Medical Council—

(a) shall undertake or shall cause to be undertaken, inspections of, and provide or cause to be provided, reports on, premises identified in applications made by applicants for a Part 5 licence,

(b) without prejudice to the generality of paragraph (a), shall conduct inspections not less than once every 3 years of all licensed institutions at which public display activities are undertaken,

(c) without prejudice to sections 89 and 101, may request an applicant or a Part 5 licence holder to provide to the Medical Council as soon as it is practicable after receipt of such request, such information as the Medical Council may reasonably require for the purposes of this section and is so specified in its request,

(d) shall do such other things as are reasonably necessary or expedient for the purposes of monitoring compliance with this Part,

(e) may appoint one or more authorised officers to undertake any of the functions referred to in paragraphs (a) to (d) of this subsection.

98. Authorised officers for purposes of Part 5

98. (1) The Medical Council may appoint one or more persons as the Council sees fit to be authorised officers for the purposes of this Part.

(3) An appointment under this section shall cease—

(a) if the Medical Council revokes the appointment,

(b) if the appointment is for a fixed period, on the expiry of that period, or

(c) in the case of a person who is a member of the staff of the Medical Council, if the person ceases to be a member of the staff.

99. Powers of authorised officers - Part 5

99. (1) For the purposes of this Part, an authorised officer may exercise any of the following powers:

(a) enter (if necessary by use of reasonable force) and inspect, at any reasonable time, any premises (other than a dwelling)—

(i) specified in a Part 5 licence,

(ii) not specified in a Part 5 licence but at which he or she has reasonable grounds for believing that public display activities are being undertaken, or

(iii) at which he or she has reasonable grounds for believing that documents or records relating to public display activities are kept;

(b) require any person on the premises referred to in paragraph (a) to produce any documents or records relating to public display activities;

(i) any documents or records relating to public display activities, or

(ii) any premises (or part thereof) in which documents or records relating to public display activities are kept;

(i) the premises;

(ii) anything at the premises;

(iii) without prejudice to the generality of subparagraph (ii), any equipment, machinery or plant at the premises;

(2) An authorised officer shall not enter a dwelling, other than—

(a) with the consent of the occupier, or

(b) pursuant to a warrant under subsection (3).

(4) A person shall be guilty of an offence if he or she—

(5) Where an authorised officer believes, upon reasonable grounds, that a person has committed an offence under this Part, the authorised officer may require that person to provide him or her with his or her name and the address at which they ordinarily reside and the person shall comply with that requirement.

(6) A person who is guilty of an offence under paragraph (a) or (b) of subsection (4) shall be liable on summary conviction to a class C fine or imprisonment for a term not exceeding one year or both.

100. Codes of practice (public display)

100. (1) Subject to subsection (2), the Medical Council—

(a) may, and, at the request of the Minister, shall prepare and publish a code of practice for the purpose of setting standards relating to the undertaking of public display activities which standards shall include the time periods for which records are required to be retained, or

(b) may, if it thinks appropriate to do so, approve any other code of practice relating to the undertaking of public display activities.

(2) Before publishing or approving of codes of practice under this section, the Medical Council—

(a) shall publish in such manner as the Council considers appropriate a draft of the code of practice and shall allow persons 30 days from the date of publication of the draft code of practice within which to make representations in writing to the Medical Council in relation to the draft code of practice or such further period, not exceeding 30 days, as the Medical Council in its absolute discretion thinks fit, and

(b) following consultation and, where relevant, having considered the representations (if any) made, shall submit the draft code of practice to the Minister for his or her consent to its publication or approval of under this section, with or without modifications.

(3) The Minister may—

(a) consent to the publication or approval of, as the case may be, a code of practice under this section with or without modification, or

(b) refuse to consent to publication or approval of such a code of practice.

(4) Where the Medical Council publishes or approves codes of practice under this section, the Medical Council shall cause a notice to that effect to be published in Iris Oifigiúil—

(a) identifying or specifying the code of practice, and

(b) specifying the date from which the code of practice shall have effect.

(5) The Medical Council may, with the consent of the Minister but subject to subsection (6)—

(a) amend or revoke codes of practice published under this section, or

(b) withdraw its approval of any code of practice approved of under this section.

(6) Subsection (2) shall, with all necessary modifications, apply to codes of practice that the Medical Council proposes to amend or revoke, or withdraw its approval of, under subsection (5) as subsection (2) applies to a code of practice that the Medical Council proposes to publish or approve of under this section.

(7) Where the Medical Council amends or revokes, or withdraws its approval of, a code of practice published or approved of under this section, the Medical Council shall cause a notice to that effect to be published in Iris Oifigiúil—

(a) identifying or specifying the code of practice to which the amendment, revocation, or withdrawal, as the case may be, relates and, if applicable, particulars of the amendment, and

(b) specifying the date from which the amendment, revocation, or withdrawal, as the case may be, shall have effect.

(8) The Medical Council shall maintain on its website a copy of each of the codes of practice published or approved of under this section, as the codes of practice are in force from time to time, on and from the date on which the codes of practice have effect.

(9) A document bearing the seal of the Medical Council and purporting to be a code of practice published or approved of under this section or, where such codes of practice have been amended under this section, the codes of practice as so amended shall be admissible in evidence in any proceedings under this Act.

(10) In this section, “code of practice” includes part of a code of practice.

101. Compliance notices (public display)

101. (1) Where the Medical Council is of the opinion that a Part 5 licence holder has contravened or is contravening—

(a) the provisions of this Part,

(b) any conditions which have been placed on any licence issued to a Part 5 licence holder under this Part, or

the Medical Council may serve a compliance notice on the Part 5 licence holder.

(a) specify the act or omission constituting the contravention referred to in subsection (1) to which the notice relates, and

(b) inform the person that he or she may make representations to the Medical Council in accordance with subsection (3).

(3) A person who is given an advance notice may, within 21 days of the receipt of the notice, make representations to the Medical Council about the proposed compliance notice.

(a) it has considered the representations, if any, made by the Part 5 licence holder in accordance with the notice, or

(b) the period referred to in subsection (3) has elapsed and no representations are made by the Part 5 licence holder concerned.

(5) The Medical Council shall have regard to any representations made to it under subsection (3) in assessing whether to proceed with the service of the compliance notice.

(6) A compliance notice shall—

(a) specify the act or omission constituting contravention referred to in subsection (1) to which the notice relates,

(b) require the person on whom it is served not to commit or to cease committing, as the case may be, the act or omission concerned,

(e) require the person on whom it is served to supply, within the period specified in the notice, such additional information as may be specified in the notice.

(7) A compliance notice shall, unless an appeal is brought under section 102, come into operation on the expiry of 21 days from the service of the notice.

(8) Where a person on whom a compliance notice has been served fails to comply with the notice at any time within a period 21 days from the date on which the notice comes into operation, he or she shall be guilty of an offence and shall be liable on summary conviction to a class C fine or imprisonment for a term not exceeding one year or both.

102. Appeal of compliance notice

102. (1) A person on whom a compliance notice has been served may within 21 days of service of the notice appeal to the District Court in respect of the notice or any requirement therein.

(2) Where an appeal is brought under this section, the District Court may—

(a) confirm the notice in whole or in part, with or without amendment of that notice, or

(b) allow the appeal.

(3) Where the District Court allows the appeal, the compliance notice shall cease to have effect.

(4) Where the District Court confirms a compliance notice, the notice as so confirmed, shall, unless an appeal is brought under subsection (5), come into operation on the expiry of 21 days of the date of confirmation or such later date as the court may determine.

(5) A person may within 21 days appeal a confirmation of a compliance notice by the District Court to the Circuit Court.

(6) Where the Circuit Court allows the appeal, the compliance notice shall cease to have effect.

(8) Any of the parties concerned may appeal a determination of the Circuit Court to the High Court on a point of law.

PART 6 Miscellaneous

103. Amendment of Health Act 2004

103. The Health Act 2004 is amended, in section 55G, by the substitution of the following paragraph for paragraph (a):

“(a) an authorised person appointed by the Health Information and Quality Authority in accordance with section 70 of the Health Act 2007 to—

(i) monitor compliance with standards in accordance with section 8(1)(c) of the Health Act 2007,

(ii) undertake an investigation under section 9 of the Health Act 2007,

(iii) monitor compliance, under section 8(1)(o) of the Health Act 2007, with Part 3 of the Human Tissue (Transplantation, Post Mortem, Anatomical Examination and Public Display) Act 2024, or

(iv) monitor compliance, under section 8(1)(p) of the Health Act 2007, with the relevant sections (within the meaning of the Health Act 2007) of the Coroners Act 1962 and regulations made by the Minister for Justice under section 33I of that Act,”.

104. Amendment of Act of 2007

104. The Act of 2007 is amended in section 7(2), by the insertion of the following paragraphs after paragraph (k):

“(ka) issue licences under Parts 4 and 5 of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024 (“the Act of 2024”),

(kb) monitor compliance with Parts 4 and 5 of the Act of 2024,

(kc) at the request of the Minister and as soon as is practicable after it receives the request, provide the Minister with such information concerning its functions under Parts 4 and 5 of the Act of 2024 as the Minister specifies in the request,

(kd) issue codes of practice for the purposes of Part 4 of the Act of 2024,

(ke) issue codes of practice for the purposes of Part 5 of the Act of 2024,

(kf) perform any other function vested in the Council pursuant to the said Parts 4 and 5 of the Act of 2024,”.

105. Amendment of Act of 2015

105. The Act of 2015 is amended, in section 4(3), by the substitution of the following paragraph for paragraph (a):

“(a) any decision regarding the donation of an organ from a living donor shall, where the donor is a person who lacks capacity, be determined in accordance with the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024, and”.

106. Repeals

106. (1) Section 106 of the Act of 2007 is repealed.

(2) The Anatomy Act 1832 is repealed.

107. Offences and penalties

107. (1) A person guilty of an offence under—

(a) paragraph (b) or (c) of section 10(6),

(b) section 11(3),

(d) section 42(3),

(e) section 45(4)(a),

(f) section 63(10),

(g) paragraph (a) or (b) of section 86(5),

(h) section 87(11),

(i) section 89(12),

shall be liable—

(i) on summary conviction, to a class A fine or to imprisonment for a term not exceeding 6 months, or both, and

(ii) on conviction on indictment, to a fine not exceeding €120,000 or to imprisonment for a term not exceeding 3 years or both.

(2) A person guilty of an offence under—

(a) section 10(6)(a),

(b) section 16(6)(b),

(d) section 45(4)(b),

(e) section 96(3),

shall be liable on summary conviction—

(i) in the case of a first offence, to a class C fine or to imprisonment for a term not exceeding 6 months, or both, and

(ii) in the case of a second or subsequent offence, to a class A fine or to imprisonment for a term not exceeding 12 months, or both.

(3) A person guilty of an offence under—

(a) section 12(9), or

(b) section 65(4),

shall be liable—

(i) on summary conviction to a class A fine and to imprisonment for a period not exceeding 12 months or both, and

(ii) on conviction on indictment, to a fine not exceeding €120,000 and to imprisonment for a period not exceeding 3 years or both.

(4) Notwithstanding section 10(4) of the Petty Sessions (Ireland) Act 1851, summary proceedings for an offence under this Act may be instituted at any time within two years from the date on which the offence was alleged to have been committed.

(5) Where an offence under this Act is committed by a body corporate and is proved to have been so committed with the consent or connivance of, or to be attributable to any wilful neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person, as well as the body corporate, commits an offence and shall be liable to be proceeded against and punished as if he or she were guilty of the first mentioned offence.

(6) Where the affairs of a body corporate are managed by its members, subsection (5) applies in relation to the acts and defaults of a member in connection with his or her functions of management as if he or she were a director or manager of the body corporate.

108. Defences

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Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024

69. Notification of grant of licence to institution

70. Material amendment of licence

71. Removal, variation or addition of conditions

72. Suspension and revocation of licences

73. Medical Council may suspend licence without notice in certain circumstances

74. Appeal from decision (other than decision under section 73) of Medical Council

75. Responsible persons

76. Records to be kept in relation to donated anatomical specimens

77. Transfer of functions from inspectors of places in State where anatomy is carried on under and in accordance with Anatomy Act 1832 to Medical Council

78. Requests by Medical Council for information

79. Authorised officers for purposes of Part 4

80. Powers of authorised officers (Part 4)

81. Codes of practice (anatomical examination)

82. Compliance notices (anatomical examination)

83. Appeal of compliance notice

PART 5 Public Display

84. Definitions (Part 5)

85. Public display activities

86. Licence required for public display activities

87. Consent to donation of body, etc. for public display activities

88. Medical certificate of cause of death must be signed before public display activities can take place

89. Application for Part 5 licence to undertake public display activities

90. Placing of conditions upon licence

91. Suspension and revocation of Part 5 licences

92. Suspension of licence without notice in certain circumstances

93. Appeal from decision (other than decision under section 92) of Medical Council

94. Loan or transfer of anatomical specimens for purposes of public display activities

95. Importation of anatomical specimens for purposes of public display activities

96. Records to be kept in relation to anatomical specimens

97. Medical Council to monitor compliance with provisions of Part 5

98. Authorised officers for purposes of Part 5

99. Powers of authorised officers - Part 5

100. Codes of practice (public display)

101. Compliance notices (public display)

102. Appeal of compliance notice

PART 6 Miscellaneous

103. Amendment of Health Act 2004

104. Amendment of Act of 2007

105. Amendment of Act of 2015

106. Repeals

107. Offences and penalties

108. Defences

74. **Appeal from decision (other than decision under section 73) of Medical Council**

80. **Powers of authorised officers (Part 4)**

84. **Definitions (Part 5)**

89. **Application for Part 5 licence to undertake public display activities**

91. **Suspension and revocation of Part 5 licences**

93. **Appeal from decision (other than decision under section 92) of Medical Council**