Therapeutic Goods Amendment Regulations 2003 (No. 5) 2003 No. 301
EXPLANATORY STATEMENT
STATUTORY RULES 2003 NO. 301
Issued by the authority of the Parliamentary Secretary to the
Minister for Health and Ageing
Therapeutic Goods Act 1989
Therapeutic Goods Amendment Regulations 2003 (No. 5)
The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.
The purpose of the Regulations is to:
• amend the regulations as a consequence of the changes made to the Act by the Therapeutic Goods Amendment Act (No. 1) 2003 (the amendment Act);
• allow individual Therapeutic Goods Advertising Code Council members to refer matters to the Council; and
• amend the requirements for the number of persons constituting a quorum at meetings of the Complaints Resolution Panel.
Changes introduced by the amendment Act, which received Royal Assent on 27 May 2003, require consequential changes to be made to the Therapeutic Goods Regulations 1990 ("the Principal Regulations"):
• the transfer of advertising offences from the Principal Regulations to the Act requires the removal of all advertising offence provisions from the Principal Regulations;
• pre-approval of advertisements about medicines that are intended for broadcast in broadcast media (which was previously provided for in the Broadcasting Services Act 1992) is now to be provided for in the Principal Regulations. This is a consequence of the amendments made by the amendment Act to the Broadcasting Services Act 1992; and
• changes to the Act also ensured that the principles of the Therapeutic Goods Advertising Code which are to be prescribed in the Principal Regulations will be enforceable in relation to generic information and advertisements published in all major forms of media, including broadcast media. Therefore, consequential changes are required in the Principal Regulations to specify the relevant parts of the Code to be prescribed under the relevant provisions of the Act.
In addition, amendments to regulation 42ZCAI of the Principal Regulations address a current weakness in Division 3 of Part 6 of the Principal Regulations which deals with the Complaints Resolution Panel. These amendments ensure that specific advertising claims or any other representations in an advertisement or generic information which were found to be in breach of the advertising requirements cannot be re-used in subsequent advertisements or generic information.
The Regulations also:
• allow the Complaints Resolution Panel to request the person responsible for an advertisement or generic information, found to be in contravention of the legislative requirements, to withdraw a particular claim or any other representation included within an advertisement or generic information, and not re-use the particular claim or any other representation in any other advertisement or generic information. The Panel would also be able to recommend to the Secretary that an order be made regarding the same action;
• allow the Secretary to order a person to withdraw a particular claim or any other representation within an advertisement or generic information and not re-use the particular claim or representation included within that advertisement or generic information;
The amendment to regulation 42B(1)(d) allows individual Therapeutic Goods Advertising Code Council members to also refer matters to the Council for consideration. Under the existing provisions, observers, but not members, are permitted to refer matters to the Council for consideration.
The amendment to regulation 42Y amends the quorum requirements for meetings of the Complaints Resolution Panel. Under the existing provisions, the quorum must be constituted by specific members who have been nominated by certain organisations. There have been situations where neither a member nor their alternate (who is part of the prescribed quorum) has been able to attend a Panel meeting. This has prevented the Panel from proceeding with some of its scheduled meetings, thereby creating unacceptable delays in the time taken to address complaints against advertisements. This amendment addresses this current weakness with the Panel's processes by reducing, and not specifying, the members constituting the quorum.
The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.
Details of the Regulations are set out in the Attachment.
The Regulations commence on gazettal.
ATTACHMENT
DETAILS OF THE THERAPEUTIC GOODS AMENDMENT REGULATIONS 2003 (NO. 5)
Regulation 1 states that the title of the Regulations is the Therapeutic Goods Amendment Regulations 2003 (No. 5).
Regulation 2 provides that these Regulations commence on gazettal.
Regulation 3 provides that Schedule 1 amends the Therapeutic Goods Regulations 1990 (the Principal Regulations).
SCHEDULE 1 - AMENDMENTS
Item 1
Item 1 omits the definitions of generic information, prohibited representation, required representation, restricted representation and specified media in regulation 2. These definitions are now provided in section 42B of the Act.
Item 2
Item 2 inserts the definition of "unacceptable presentation" in Part 1 of the Principal Regulations. This provision now becomes regulation 3A (it was previously regulation 6A).
Item 3
Item 3 substitutes a new Division 1 of Part 2 to the Principal Regulations. The current Division 1 of Part 2 is now included in the Act and is provided under sections 42AA, 42AB and 42AC.
New regulation 4 provides that Division 1 of Part 2 applies to advertisements to which Part 5.1 of the Act - Advertising and generic information applies.
New regulation 4A is the interpretation regulation which provides that the definition of terms in Part 5.1 of the Act also apply to Division 1 of Part 2 of the Principal Regulations.
Item 4
Item 4 omits the definition of "approved advertisement" in regulation 5B as this is already provided in section 42B of the Act.
Item 5
Item 5 inserts new regulation 5BA. New regulation 5BA provides that for the definition of broadcast media in section 42B of the Act in relation to an advertisement to which Division 2 applies, the following means are declared to be exempted means:
(a) internet;
(b) electronic mail;
(c) narrowcast transmission;
(d) short message service (SMS); and
(e) multimedia messaging service (MMS).
Declaring a means of broadcasting to be an exempted means has the effect of excluding these means from the approval process under Division 2, Part 2 of the Principal Regulations.
Item 6
Item 6 omits the reference to regulation 6A in paragraph 5G(1)(d), which has been renumbered to regulation 3A (refer to Item 2).
Item 7
Item 7 substitutes new "paragraph 5G(1)(e)" as subregulations 7C(1) and 9(1), which are offence provisions, have now been transferred to the Act. The effect of this amendment is to remove the reference to subregulations 7C(1) and 9(1) in paragraph 5G(1)(e) and replace with their corresponding sections in the Act.
Item 8
Item 8 substitutes new subregulations 5Q(3) and (4). These new subregulations take into account the approval process for advertisements which are broadcast in broadcast media. In addition to existing delegations under regulation 5Q(4), the Secretary may now delegate to the Australian Self-Medication Industry Incorporated the powers of the Secretary under regulation 5G to approve an advertisement about designated therapeutic goods, if the advertisement is to be broadcast in broadcast media.
Item 9
Item 9 substitutes new Divisions 3, 4 and 5 in the Principal Regulations.
New regulation 6 under new Division 3 prescribes that those representations listed in Part 2 of Appendix 6 of the Therapeutic Goods Advertising Code are "restricted representations" about therapeutic goods for the purposes of sections 42DD (1). Subsection 42DD(2) of the Act prohibits a person from using a restricted representation in an advertisement about therapeutic goods, unless the Secretary has approved its use under subsection 42DF(1) or has permitted its use under subsection 42DK(1).
New regulation 6A under new Division 3 prescribes the public interest criteria listed in Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code for the purposes of paragraph 42DF(4)(c) of the Act. Paragraph 42DF(4)(c) of the Act provides that in deciding whether to approve or refuse to approve the use of a restricted representation, the Secretary must take into consideration the public interest criteria mentioned in a part of the Therapeutic Goods Advertising Code that is prescribed by the regulations made for the purposes of this paragraph.
New subregulation 6B(1) under new Division 3 prescribes "prohibited representations" for the purposes of section 42DJ (1) of the Act as those representations listed in column 2 of an item in Part 1 of Schedule 2 about therapeutic goods in column 3 of that item,of the Principal Regulations and those representations in Part 1 of Appendix 6 of the Therapeutic Goods Advertising Code.
New subregulation 6B(2) under new Division 3 prescribes "required representations" for the purposes of section 42DJ (2) of the Act as those representations listed in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3, of the Principal Regulations.
New regulation 7 under new Division 3 prescribes exempt goods and exempt devices for the purposes of subparagraph 42DL(1)(h) (i) of the Act. The effect of this provision is that it is now an offence if a person publishes or broadcasts an advertisement about therapeutic goods or classes of therapeutic goods which are prescribed under regulation 7. The exempt therapeutic goods which are prescribed under regulation 7 are those goods that are exempt from the operation of Part 3-2 of the Act under subregulation 12(1A) or regulation 12A and goods specified in Item 1 of Schedule 5 to the Principal Regulations.
The exempt devices prescribed under regulation 7 are those devices exempt from the operation of Division 3 of Part 4-11 of the Act under subregulation 7.1(2) or regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002 and devices of a kind mentioned in item 1.1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.
New regulation 8 under new Division 4 specifies that clauses 4.1, 4.2, 4.3 and 4.4 of Part 4 of the Therapeutic Goods Advertising Code are those with which generic information about ingredients or components of therapeutic goods must comply, for the purposes of section 42DO of the Act.
New regulation 8A under new Division 4 specifies the principles contained in clauses 4.1, 4.2, 4.3 and 4.4 of Part 4 of the Therapeutic Goods Advertising Code for the purposes of paragraph 42DP(1)(b) of the Act. Subsection 42DP(1) provides that a person is guilty of an offence, if (a) the person publishes or broadcasts generic information about therapeutic goods and (b) the publication or broadcasting of that generic information does not comply with the principles contained in the part of the Therapeutic Goods Advertising Code that are specified in the regulations.
Regulations 9AA and 9S give the Secretary power to make orders about advertisements and generic information respectively. The new subregulation 9 under new Division 5 consolidates these two existing regulations into one. A new paragraph 9(1)(f) is added to the effect that the Secretary, on the recommendation of the Complaints Resolution Panel under subregulation 42ZCAI(3) in relation to an advertisement or generic information about therapeutic goods, may order a person in writing to (a) withdraw a particular claim or representation made by the advertisement or generic information, and (b) not use that claim or representation in any other advertisement or generic information. The Secretary may order the person not to use that claim or representation in another advertisement or generic information unless the person satisfies the Secretary that the use of the claim or representation would not result in a contravention of the Act, the Principal Regulations or the Therapeutic Goods Advertising Code. The additional paragraph is required to give effect to the amendment to subregulation 42ZCAI(4) (refer to Item 19).
Item 10
Item 10 omits Part 2B as it is now included in the Act. Part 2B applies to generic information about goods that may be used as an ingredient or component in the manufacture of therapeutic goods, and although not presented for supply as therapeutic goods, come within that meaning because of the way they are represented. This Part also includes provisions relating to compliance of generic information with the Therapeutic Goods Advertising Code, and offences in relation to the publication of generic information.
Item 11
Item 11 omits the word "observers" in paragraph 42B(1)(d) and inserts the term "Council members or observers". This amendment has the effect of also allowing members of the Therapeutic Goods Advertising Code Council to raise matters for consideration by the Council.
Item 12
Item 12 substitutes a new subregulation 42Y. This amendment has the effect of reducing the quorum required at meetings of the Complaints Resolution Panel and simplifying the requirement in relation to the constitution of the quorum. The current quorum may consist of 6 or 7 persons; if the meeting is one at which a complaint about a medical device or other therapeutic goods is to be considered, the quorum must include the person nominated by the chairperson under subregulation 42T(1A) for that meeting as a seventh member. The new quorum now requires the presence of the chairperson and 4 other persons, being members of the Panel or observers to the Panel, but without specifying the members which constitute the quorum. If a complaint about a medical device or other therapeutic goods is to be considered at a meeting of the Panel, the quorum must include the member nominated under subregulation 42T(1A) for that meeting.
Item 13
Item 13 substitutes a new subregulation 42ZCAB(2) in view of the transfer of Part 2B of the Principal Regulations to Division 4 of Part 5.1 of the Act.
Item 14
Item 14 is a minor technical amendment.
Item 15
Item 15 inserts a new paragraph 42ZCAI(1)(d). Regulation 42ZCAI(1) provides that if, in relation to a complaint about an advertisement, the Complaints Resolution Panel is satisfied that there has been a contravention of the Act, the Principal Regulations and/or the Therapeutic Goods Advertising Code, the Panel may request in writing the person apparently responsible for the advertisement to take certain actions.
This new paragraph now allows the Complaints Resolution Panel under regulation 42ZCAI(1) to request the person apparently responsible to (a) withdraw a particular claim or representation made by the advertisement and (b) to not use that claim or representation in any other subsequent advertisement. The Panel may request the person not to use that claim or representation in any other subsequent advertisement unless the person satisfies the Panel that the use of the claim or representation would not result in the contravention of the Act, the Principal Regulations and/or the Therapeutic Goods Advertising Code.
Item 16
Item 16 is a minor technical amendment.
Item 17
Item 17 inserts a new paragraph 42ZCAI(2)(d). Regulation 42ZCAI(2) provides that if, in relation to a complaint about generic information, the Complaints Resolution Panel is satisfied that there has been a contravention of the Act, the Principal Regulations and/or the Therapeutic Goods Advertising Code, the Panel may request in writing the person apparently responsible for the generic information to take certain actions.
This new paragraph now allows the Complaints Resolution Panel under regulation 42ZCAI(2) to request the person apparently responsible to (a) withdraw a particular claim or representation made by the generic information and (b) to not use that claim or representation in any other subsequent generic information. The Panel may request the person not to use that claim or representation in any other subsequent generic information unless the person satisfies the Panel that the use of the claim or representation would not result in the contravention of the Act, the Principal Regulations and/or the Therapeutic Goods Advertising Code
Item 18
Item 18 is a minor technical amendment.
Item 19
Item 19 inserts a new paragraph 42ZCAI(4)(i). This new paragraph now allows the Complaints Resolution Panel to recommend to the Secretary to take an additional action under subregulation 42ZCAI(4). The Panel can now recommend the Secretary to order a person (a) that a particular claim or representation made by the advertisement or generic information be withdrawn and (b) not be used in any other subsequent advertisement or generic information. The Panel may recommend to the Secretary to request the person not to use that claim or representation in any other subsequent advertisement unless the person apparently responsible satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, the Principal Regulations and/or the Therapeutic Goods Advertising Code.
Item 20
Item 20 omits the references to regulations 7 and 9, and subregulations 9AA(1) and 9S(1) respectively in subregulation 48(1), replacing them with a reference to subregulation 9(1). Regulations 9AA and 9S have been combined into regulation 9 (refer to Item 9), and regulations 7 and 9 have now been transferred to the Act.
Item 21
Item 21 substitutes a new heading to Schedule 2 to the Regulations and is a minor technical amendment.