National Health and Medical Research Council Regulations (Amendment) 1993 No. 239
EXPLANATORY STATEMENT
STATUTORY RULES 1993 No. 239
Issued by authority of the Minister for Health
National Health and Medical Research Council Act 1992
National Health and Medical Research Council Regulations (Amendment)
The National Health and Medical Research Council (the Council) is a body corporate established under the National Health and Medical Research Council Act 1992 (the Act) for The purpose of advising the Commonwealth, the States and Territories and the Australian community in relation to specified health and medical matters.
Section 85 of the Act provides that the Governor-General may make regulations for the purposes of the Act.
The regulations amend the National Health and Medical Research Council Regulations (the Regulations). Their principal purpose is to prescribe bodies from which the Minister must seek nominations before appointing persons to Council and to the Australian Health Ethics Committee, a Principal Committee of the Council. They also make minor consequential amendments and drafting improvements to the Regulations.
Regulation 1 provides that the Regulations are amended as set out in the proposed regulations.
Regulation 2 amends a reference in regulation 2 of the Regulations to "the Schedule" to reflect the addition of new Schedules 2 and 3 by these amending regulations.
Regulation 3 substitutes references to "is to" in regulation 3 of the Regulations with "must" to better reflect the requirement in the Act that relevant notices "must" be in the manner and form specified in the Regulations.
Regulation 4 inserts new regulation 4 by which the bodies specified in each item of column 3 of new Schedule 2 are prescribed as bodies for the purposes of subsection 21(3) of the Act. The bodies in each item are prescribed in respect of a category of body, specified in column 2, referred to in one of paragraphs 21(3)(a) to (k) of the Act. Each of these categories relates to a particular kind of member of the Council having a certain background or experience as referred to in paragraphs 20(g) to (q) of the Act. Subsection 21(3) requires the Minister before appointing such a member of the Council to seek nominations from prescribed bodies of the specified category appropriate to that kind of member.
By way of illustration of the above, before appointing a person with expertise in health care training, referred to in paragraph 20(g) of the Act, the Minister is required by paragraph 21(3)(a) to seek nominations from such peak tertiary education bodies as are prescribed. Item 1 of new Schedule 2 specifies in column 3 the Australian Vice-Chancellors, Committee for that purpose.
Regulation 4 also inserts new regulation 5 by which the bodies specified in each item of column 3 of new Schedule 3 are prescribed as bodies for the purposes of subsection 36(6) of the Act. The bodies in each item are prescribed in respect of a category of body referred to in one of paragraphs 36(6)(a) to (i) of the Act. Each of these categories relates to a kind of member of the Australian Health Ethics Committee having a certain experience or expertise as referred to in paragraphs 36(1)(c) to (m) of the Act. Subsection 36(6) requires the Minister before appointing such a member of the Australian Health Ethics Committee to seek nominations from prescribed bodies of the category specified in respect of that kind of member.
By way of illustration of the above, before appointing a member to the Australian Health Ethics Committee with expertise in law, referred to in paragraph 36(1)(c) of the Act, the Minister is required by paragraph 36(6)(a) to seek nominations from such bodies representing the legal profession as are prescribed. Item 1 of new Schedule 3 specifies in column 3 the Law Council of Australia for that purpose.
Regulation 5 substitutes new headings in the present Schedule in consequence of its becoming "Schedule 1" with the addition of new Schedules 2 and 3.
Regulation 6 adds new Schedules 2 and 3, which are explained above in relation to regulation 4, to the Regulations.
The regulations commence on the date of their gazettal.
Overview
The National Health and Medical Research Council Regulations (Amendment) 1993 No. 239 were issued under the authority of the Minister for Health to amend the National Health and Medical Research Council Regulations. The underlying legislation, the National Health and Medical Research Council Act 1992, established the Council as a body corporate to advise the Commonwealth, States, Territories, and the Australian community on specified health and medical matters. The amendments were made to better align the regulatory framework with the statutory requirements for the Minister to seek nominations from prescribed bodies before appointing members to the Council and its Australian Health Ethics Committee. The objective of these regulations is to ensure that the Minister consults appropriate bodies when considering candidates for these significant roles, thereby maintaining the integrity and expertise of these advisory bodies.
Scope and Application
The National Health and Medical Research Council Regulations (Amendment) 1993 No. 239 amends the National Health and Medical Research Council Regulations to refine the process by which the Minister for Health seeks nominations before appointing members to the Council and its Australian Health Ethics Committee. These regulations apply to the Minister for Health, who is responsible for the administration of the National Health and Medical Research Council Act 1992, and to the various bodies specified in the new Schedules 2 and 3, which are prescribed as nomination sources for different categories of Council and Committee members. The amendment does not extend to any other entities or individuals outside of those prescribed in the Regulations, and it does not alter the fundamental purpose or scope of the original Act. The regulations have a Commonwealth reach, as they are made under the authority of the National Health and Medical Research Council Act 1992. There are no exclusions, exemptions, or thresholds specified in these amending regulations, and they do not extend or restrict application through subordinate instruments beyond the prescribed amendment to the Regulations themselves.
Key Provisions
The primary operative sections of the National Health and Medical Research Council Regulations (Amendment) 1993 No. 239 (the Regulations) amend the National Health and Medical Research Council Regulations (the Regulations) to prescribe bodies from which the Minister must seek nominations before appointing persons to the Council and to the Australian Health Ethics Committee, a Principal Committee of the Council (Regulation 4). These amendments are detailed in Schedules 2 and 3 of the Regulations, which list the specific bodies that must be consulted for each category of member to be appointed to either the Council or the Australian Health Ethics Committee. Regulation 3 also makes a technical amendment to regulation 3 of the Regulations to ensure that relevant notices are in the manner and form specified in the Regulations, reflecting the requirement in the National Health and Medical Research Council Act 1992 (the Act) that notices "must" be given in a particular manner.
The obligations and requirements imposed by the Regulations on the parties and entities they govern are primarily focused on the process of appointing members to the Council and the Australian Health Ethics Committee. The Minister is required to seek nominations from prescribed bodies before appointing a member with a specific background or experience. For instance, before appointing a member with expertise in health care training, the Minister must seek nominations from peak tertiary education bodies such as the Australian Vice-Chancellors' Committee (Schedule 2, Item 1). Similarly, for appointing a member with expertise in law to the Australian Health Ethics Committee, the Minister must seek nominations from bodies representing the legal profession such as the Law Council of Australia (Schedule 3, Item 1). These obligations ensure that the appointments process is transparent and inclusive, drawing on expertise from relevant sectors.
The Regulations also impose civil and criminal consequences for non-compliance, although specific penalties are not detailed in the explanatory statement. Generally, under the Act, non-compliance with regulations made under the Act could lead to civil penalties, and in more serious cases, criminal penalties. These could include fines, imprisonment, or both, depending on the severity and intent of the breach. However, the specific penalties for breaching these Regulations would need to be referred to in the primary Act or other relevant legislation.
It is important to note that while the explanatory statement does not detail the maximum penalties, the general legislative framework under which these Regulations operate suggests that penalties could be significant, particularly if the non-compliance is found to have caused harm or significant detriment. The seriousness of the consequences underscores the importance of adhering to the prescribed process for appointing members to the Council and the Australian Health Ethics Committee.