Coroners and Human Tissue Acts (Amendment) Bill Introduction Print EXPLANATORY MEMORANDUM General This Bill amends the Coroners Act 1985 in relation to autopsies and expands the list of objects and functions of the Victorian Institute of Forensic Medicine (the Institute). The Bill also makes miscellaneous amendments to the Human Tissue Act 1982. Clause Notes PART 1—PRELIMINARY Clause 1 sets out the main purposes of the Bill. Clause 2 is the commencement provision. It provides for all of the Bill except section 13(4) to come into operation on the day after the day on which the Bill receives the Royal Assent. Section 13(4) relates to the definition of a registered dentist and will commence when the relevant provision of the Health Professions Registration Act 2005 comes into operation. PART 2—AMENDMENT OF THE CORONERS ACT 1985 Clause 3 amends section 3(1) of the Coroners Act 1985 by inserting definitions of "corresponding law" and "transplantation". "Corresponding law" means one that relates to donation of human tissue for transplantation or for other therapeutic, medical or scientific purposes that substantially corresponds to the Human Tissue Act 1982 or is prescribed. "Transplantation" has the same meaning as in the Human Tissue Act 1982, which includes a reference to the transplantation of any part of the tissue and to the transplantation of a substance obtained from the tissue. 551472 1 BILL LA INTRODUCTION 18/7/2006 Clause 4 inserts a new sub-section (1A) into section 27 of the Coroners Act 1985. This section deals with coronial autopsies and sets out who the coroner may direct to perform an autopsy on a body i.e. the Institute, a pathologist or a doctor under the supervision of a pathologist. The new section 27(1A) makes it clear that a mortuary technician, forensic technician or scientist, who is under the general supervision of the pathologist or doctor responsible for the performance of the autopsy, may remove or assist in the removal of tissue during that autopsy. Clause 5 amends the list of objects of the Institute in section 64 (2) of the Coroners Act 1985. New section 64(2)(i) states that it is an object of the Institute to provide tissue banking facilities and services. The details of those facilities and services are listed in the amendments being made by clause 6. Clause 6 enlarges the functions of the Institute by inserting a new subsection (4) into section 66 of the Coroners Act 1985. Sections 66(4)(a) and 66(4)(b) clarify that the Institute can receive tissue taken from living and dead persons in Victoria in accordance with the Human Tissue Act 1982 and can process, store and supply the tissue for transplantation to living persons or for other therapeutic, medical or scientific purposes, both within and outside Victoria. The Institute can also remove tissue from dead persons in Victoria in accordance with the Human Tissue Act 1982. Section 66(4)(c) adds the function of the removal or receipt of tissue taken in accordance with corresponding laws of other States and Territories, and the processing, storage and supply of such tissue for transplantation to living persons and for other therapeutic, medical or scientific purposes. This will enable the Institute to undertake retrieval of tissue in another State or Territory for use in Victoria or elsewhere. Finally, the functions of the Institute have also been expanded by section 66(4)(d) to include receipt of tissue from overseas jurisdictions with corresponding laws, and the processing, storage and supply of such tissue for transplantation to living persons and for other therapeutic, medical or scientific purposes. This amendment recognises that some therapeutic technologies have been developed overseas that are not yet available in Australia, but can be imported with the permission of the Therapeutic Goods Administration and used in local clinical procedures, such as the treatment of full thickness burns. 2 Clause 7 validates anything done under the Coroners Act 1985 before the commencement of this Bill that would have been validly done if this Bill had been in operation at the time that the thing was done. PART 3—AMENDMENT OF THE HUMAN TISSUE ACT 1982 Clause 8 substitutes a new section 25(b) of the Human Tissue Act 1982. Section 25 sets out the persons who may remove tissue from a deceased person pursuant to an authority under section 26 of the Human Tissue Act 1982. Section 25(b) applies in the case of persons who are not registered medical practitioners and currently enables prescribed persons to remove skin and/or ocular tissue. The new section 25(b) is broader and makes it clear that an authority under either section 26 (1) or (2) is sufficient authority for a prescribed person or a person belonging to a prescribed class to remove any type of tissue, or a prescribed class of tissue, from the body of a deceased person. Clause 9 inserts a new section 26A into the Human Tissue Act 1982. Section 26 requires various inquiries to be made, before authorisation may be given to remove tissue from a deceased person for donation. New section 26A clarifies that a reference in section 26 to senior available next of kin making their consent known to a designated officer, a registered medical practitioner or authorised person, or a reference to a designated officer, a registered medical practitioner or authorised person making inquiries or advising the senior available next of kin may be taken to be a reference to the designated officer, registered medical practitioner or authorised person being satisfied that consent has been given, inquiries have been made or advice has been given. This reflects the degree of specialisation within hospitals and the Institute whereby the person who grants the authorization to remove the tissue does not necessarily make all the inquiries themselves, but may rely on them being carried out by other responsible persons. In such a case the person authorising the removal of tissue must be satisfied that the requirements of the Act have been met. Clause 10 inserts a new section 28A into the Human Tissue Act 1982 in the same vein as the amendment made by clause 9 of this Bill. This amendment deals with inquiries that must be made in order to have sufficient authority for a non-coronial post-mortem to be conducted on the body of a deceased person. The new section clarifies that a reference in section 28 to senior available next of kin making their consent known to a designated officer or a registered medical practitioner, or a reference to a designated officer or a registered medical practitioner making inquiries or 3 advising the senior available next of kin may be taken to be a reference to the designated officer or registered medical practitioner being satisfied that consent has been given, inquiries have been made or advice has been given. Clause 11 inserts a new section 30(1A) into the Human Tissue Act 1982. Section 30(1) allows a registered medical practitioner to conduct a post-mortem examination, where the post-mortem is authorised under Part 5 of the Act. The new section 30(1A) makes it clear that a mortuary technician, forensic technician or scientist, who is under the general supervision of the registered medical practitioner responsible for the conduct of the autopsy, may remove or assist in the removal of tissue during that autopsy. Clause 12 This clause makes a similar amendment to those made by clauses 9 and 10 of this Bill. Section 32 of the Human Tissue Act 1982 sets out the inquiries that must be made by a designated officer or a registered medical practitioner before authority can be granted for the body of a deceased person to be made available to a school of anatomy for anatomical examinations or for use in studying and teaching anatomy. Clause 12 inserts a new section 32A into the Act, and has the effect of clarifying that the designated officer or a registered medical practitioner is not required to make those inquiries personally, provided that they are satisfied that the inquiries have been made. Clause 13 substitutes a new section 42(1)(a) into the Human Tissue Act 1982, as well as inserting new section 42(1)(ab). Section 42 provides that the Human Tissue Act 1982 does not apply to the removal of tissue from a person in certain circumstances. The exceptions reflect the fact that the requirements of the Human Tissue Act 1982 governing removal of tissue are designed with tissue donation in mind, not the necessary removal of tissue in the course of the provision of treatment to a patient or detection of disease in a patient. Section 42(1)(a) currently provides that the Act does not apply to such removals in the course of treatment provided by a registered medical practitioner or to save the life of a patient. New paragraphs (a) and (ab) expand on the existing exceptions to the application of the Act in order to recognise the role that other health service providers may play in removing tissue in certain situations. In addition to retaining the current exceptions, this clause also inserts the following new exceptions— 4 Removal of regenerative or non-regenerative tissue from a living person by a registered dentist in the course of dental treatment which is carried out with consent and in the interests of the health of the person (i.e. removal of teeth). Removal of blood or other regenerative tissue from a living person by a health service provider in the course of medical treatment or a procedure that is carried out with consent, and in the interests of the health of the person. This includes removal of blood by nurses for the purpose of testing. This clause also inserts definitions of "health service provider" and "registered dentist". "Health service provider" is to have the same meaning as in the Health Records Act 2001, as well as including a person employed or engaged by, or who performs work for a health service provider in the performance of that service. Clause 14 amends the offence provisions in sections 44(4)(a) and 44(4)(b) of the Human Tissue Act 1982 to reflect the amendments made by clauses 9, 10 and 12 of the Bill. The amendments to the offences clarify that a person must not give an authority, remove tissue or carry out a post-mortem examination under the Act without having made the inquiries that they are required to make, or without having been satisfied that those inquiries have been made. Clause 15 inserts two new sub-sections into section 45 of the Human Tissue Act 1982. Section 45 deals with disclosure of information. New section 45(4) permits hospitals, the Institute and tissue or organ donation services, as well as a donor's registered medical practitioner, to collect, use and disclose health information for specified purposes in connection with the removal of tissue from the body of a deceased person under Part IV (donation of tissue for transplant or other medical purposes), V (autopsy) or VI (anatomical examination) of the Human Tissue Act 1982. The main reason for this amendment is to ensure that responsible practitioners can have access to relevant health information in relation to such a person to assess whether their tissue would be suitable for transplantation, and whether the criteria in the Act that authorise removal have been met. Information can also be collected, used or disclosed in order to locate the senior available next of kin of the donor. Such contact details are often held on a person's health record. It may be necessary to use this information to locate the senior 5 available next kin to ascertain whether the deceased may have objected to donation, or to seek consent of the next of kin. Clause 16 inserts new section 45A into the Human Tissue Act 1982. Section 45A validates anything done under the Human Tissue Act 1982 before the commencement of this Bill that would have been validly done if this Bill had been in operation at the time that the thing was done, and had persons referred to in regulation 4A of the Human Tissue Regulations 2006 been prescribed to remove tissue of any kind. For instance this clause ensures that where the relevant authorising criteria in the Act have been met, if a scientist at the Institute, rather than a medical practitioner, has removed tissue for transplant (such as musculoskeletal tissue) prior to commencement of the Bill, that their involvement in that removal is authorised. Clause 17 inserts a transitional provision into the Human Tissue Act 1982. New section 47 deems persons referred to in the Human Tissue Regulations 2006 to have been prescribed to remove tissue of any kind and their duties are deemed to include removal of tissue of any kind. This ensures that from the day of commencement of this Bill until new regulations are made under the Act (as amended by clause 8), persons prescribed under the Human Tissue Regulations 2006 are able to continue to remove tissue in the course of their employment or work, if the removal is otherwise authorised under the general criteria in the Act. 6