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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2000 (NO. 2) 2000 NO. 48
EXPLANATORY STATEMENTStatutory Rules 2000 No. 48
Issued by the Authority of the Parliamentary Secretary to the Minister for Health and Aged Care
Therapeutic Goods Act 1989
Therapeutic Goods Amendment Regulations 2000 (No. 2)
Subsection 63 (1) of the Therapeutic Goods Act 1989 (the Act) provides that the Governor-General may make regulations prescribing matters required or permitted to be prescribed or necessary or convenient for carrying out or giving effect to the Act.
The Act provides that the regulations may make provision in particular in relation to:
* the establishment of committees to advise the Minister or the Secretary of the Department of Health and Aged Care on matters relating to therapeutic goods, and the functions and powers of those committees - paragraph 63(2)(a)
* the advertising of therapeutic goods - paragraph 63(2)(c).
The Regulations implement recommendations the Government has accepted from a report on the Therapeutic Goods Advertising Code (the Code). In summary, the amendments:
* apply the Code to all advertisements for therapeutic goods ( item 14);
* limit control over information about substances, as distinct from products (generic information)
(items 3 and 18);
* change the approach to prohibited representations and introduce restricted representations,
being representation in an advertisement about therapeutic goods that refer to a serious
form of disease, condition, ailment or defect specified in the Code (items 4, 5, 6, 8, 9, 12,
13, 15 and 16);
* expand the role of the Complaints Resolution Panel when dealing with complaints about
advertisements and generic information (items 22-32);
* allow for the withdrawal of approval of advertisements (item 10);
* correct an anomaly that has arisen in relation to some medicines that may now be
advertised (item 2);
* allow for alternate members to the Therapeutic Goods Advertising Code Council and the
Complaints Resolution Panel (items 19 and 20) and for the chair of the Panel to be
observers at the Council (item 21); and
* make consequential changes to the Principal Regulations, the Therapeutic Goods
Regulations 1990 (items 33-39).
The amendments have been developed with the cooperation and support of the Therapeutic
Goods Advertising Code Council and its consumer and industry representatives.
Further details of the regulations are set out in the Attachment.
The regulations commenced on gazettal.
ATTACHMENT
DETAILS OF THERAPEUTIC GOODS AMENDMENT REGULATIONS 2000 (NO. 2)
Regulation 1 (Name of regulations)
This is a formal provision that specifies the title of the Regulations as the Therapeutic Goods Amendment Regulations 2000 (No. 2)
Regulation 2 (Commencement)
This provision provides that the Regulations will commence on gazettal.
Regulation 3 (Amendment of Therapeutic Goods Regulations 1990)
This provision provides that Schedule 1 amends the Therapeutic Goods Regulations 1990.
SCHEDULE 1 AMENDMENTS
Items 1, 2, 3, 4 and 5 insert into regulation 2, definitions for: 'Complaints Resolution Panel', 'designated therapeutic goods', 'generic information', 'restricted representation' and 'serious'. The term 'designated therapeutic goods' is removed from regulation 5B (see item 7) and modified to reflect changes made to the Standard for the Uniform Scheduling of Drugs and Poisons that enable the advertising of additional medicines.
Item 6 amends the definition of the Code in Regulation 2 so it refers to the new Code that is in force from time to time.
Items 8 and 9 adds a requirement for approval of an advertisement that it contain no restricted representation as described in Appendix 6 of the Therapeutic Goods Advertising Code - new paragraph 5G(1)(d).
Item 10 adds to subregulation 5J(3) a provision that recognises the expiry of approval of an advertisement where approval is withdrawn.
Item 11 omits the reference in regulation 5L(2) to Division 5 of Part 2 and substitutes a reference to subregulation 42ZCAB(1). This accommodates the movement of the provision for initiating complaints about advertising to new subregulation 42ZCAB(1).
Item 12 allows the Secretary to delegate to the chairperson of the Complaints Resolution Panel the power to withdraw approval of an advertisement. This provides a more timely remedy in cases where the Panel recommends the withdrawal of an advertisement that has not met the requirements that apply to advertising material.
Item 13 inserts a new offence of publishing an advertisement that contains an unapproved restricted representation (described under item 14) - paragraph 6(1)(b).
Item 14:
* inserts a definitions provision into Part 2, Division 4 to define 'applicant' and 'approval holder' in relation to the approval of a restricted representation - regulation 6AA, and
* requires all advertisements covered by Part 2 to comply with the Therapeutic Goods Advertising Code - new regulation 6AB.
Item 15 inserts new regulations that:
* Make a representation in an advertisement about therapeutic goods that refers to a serious form of disease, condition, ailment or defect specified in Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code a restricted representation - new subregulation 7A(1);
* prevent a person from using an unapproved restricted representation in an advertisement about therapeutic goods - new subregulation 7A(2);
* provide that applications for approval of a restricted representation must be made to the Secretary of the department of Health and Aged Care (the Secretary) in writing and be signed by or for the applicant - new regulation 7B;
* require the Secretary, after considering any recommendation of the Therapeutic Goods Advertising Code Council, the Complementary Medicines Evaluation Committee or the Medicines Evaluation Committee, to approve representations that are accurate, balanced, unlikely to be misleading and in the public interest - new regulation 7C;
* require the Secretary to give notice of approval or of refusal to approve a restricted representation - new regulation 7D;
* enable the Secretary to vary conditions of approval of a restricted representation, provided reasons are given - new regulation 7E;
* enable the Secretary to withdraw approval of a restricted representation if:
- the approval relied on false or incorrect information;
- the restricted representation becomes a prohibited representation under regulation 8;
- there has been a breach of a condition of approval; or
- additional safety information becomes available that would have resulted in non approval of the original application;
and provided reasons are given - new regulation 7F;
* enable a applicant or approval holder who is dissatisfied with the Secretary's decision to seek review of that decision by the Minister - new regulation 7G;
* require the Minister to give to an applicant or approval holder notice of and reasons for a decision made under regulation 7G - new regulation 7H; and
* enable the Administrative Appeals Tribunal to review the Minister's decision made under regulation 7G - new regulation 7J.
Item 16
* amends regulation 9 to enable the Secretary to permit the use of a restricted representation; and
* enables the Secretary to order action to retract, correct, recover or destroy an advertisement where the Complaints Resolution Panel has found that the advertisement has not met the requirements for advertising. The provision allows the Secretary to delegate this power to the chairperson of the Panel - new regulation 9AA
Item 17 omits Part 2, Division 5, the provisions that have dealt with the advertising complaints process as these provisions will now be contained in Part 6, Division 3, the Part that deals generally with the Complaints Resolution Panel.
Item 18:
* inserts a new Part 2B into the Regulations to deal with generic information which is defined in regulation 2 (see item 3)..
* provides that Part 2B applies to information about substances that may be ingredients in therapeutic goods or that are not normally supplied as therapeutic goods - regulation 9P;
* requires generic information to comply with the general principles clauses of the Therapeutic Goods Advertising Code - regulation 9Q;
* creates offences of publishing or inserting into mainstream media generic information that:
- is false or misleading;
- contains an unverified claim;
- is likely to arouse belief that a person is suffering from a serious medical problem or that harm may come from not using the goods;
- suggests that the goods are effective in all cases;
- encourages self-diagnosis or self-treatment of potentially serious medical problems; and
- directs to persons under 18 years information about therapeutic goods not listed in Appendix 5 to the Therapeutic Goods Advertising Code - new subregulations 9R(1) and (2);
* creates offences of publishing or inserting into mainstream media generic information that includes or implies an endorsement of the goods by:
- a government agency; - a health care professional;
- bodies of health consumers, health care professions or bodies that conduct or fund health research; unless the publication
- discloses the nature of the endorsement;
- identifies the body or association making the endorsement;
- indicates that the endorsement has been authenticated; and
- acknowledges any payment or other consideration, for the endorsement - new subregulations 9R(3) and (4); and
* enables the Secretary to order the same corrective action that may be applied to non-conforming advertisements, namely to retract, correct, recover or destroy generic information where the Complaints Resolution Panel upholds a complaint about the information. The provision allows the Secretary to delegate this power to the chairperson of the Panel - new regulation 9S.
Items 19 and 20 deal with alternate members of the Therapeutic Goods Advertising Code
Council by:
* enabling bodies that nominate members to appoint up to two alternate members instead of one - amended subregulation 42H(1); and
* providing that the alternate may take over when a member ceases to be a member - amended subregulation 42H(3).
Item 21 inserts a new provision that links more closely the activities of the Therapeutic Goods Advertising Code Council and the Complaints Resolution Panel by enabling the chairperson of the Panel to participate in and vote at meetings of the Council - new subregulation 42J(4);
Items 22- 32 consolidates in Part 6, Division 3 (which deals generally with the Complaints Resolution Panel) the provisions that deal with the advertising complaints process.
Item 22 inserts a new general subdivision into Division 3.
Item 23 inserts a new function for the Complaints Resolution Panel, to consider complaints about generic information - amended paragraph 42S(a).
Item 24 substitutes Subdivision for Division in paragraph 42S(b).
Item 25 inserts a requirement for a representative of the medical device industry to sit on the Complaints Resolution Panel when the Panel considers a complaint about a medical device-new subregulation 42T(1).
Items 26, 27 and 28 deal with alternate members of the Complaints Resolution Panel by:
* enabling bodies that nominate members of the Panel to appoint up to two alternate members instead. of one - amended subregulation 42W(2);
* providing that the alternate may attend a meeting of the Panel and act in place of that member - amended subregulation 42W(3); and
* providing for an alternate chairperson if the chairperson ceases to hold office.
Items 29, 30 and 31 deal with the quorum for meetings of the Complaints Resolution Panel by requiring:
* a consumer representative to be present to make up a quorum - new paragraph 42Y(ca); and
* a representative of the medical device industry to be present to make up a quorum when the Panel considers a complaint about a medical device - new paragraph 42Y(e).
Item 32:
* requires the Complaints Resolution Panel to report to the Therapeutic Goods Advertising Code Council at least every 12 months - amended regulation 42W;
* inserts and consolidates the procedure for dealing with complaints about advertisements and generic information by:
- defining the terms 'complaint", 'person apparently responsible' (for an advertisement), specified media' (being mainstream media, radio, television, films and outdoor displays) - new regulation 42ZCAA,
- providing for complaints to be made about advertisements in specified media for designated therapeutic goods (redefined in regulation 2, see item 2) and therapeutic devices - new regulation 42ZCAB;
- providing a complaint handling procedure of giving notice to the complainant and the person apparently responsible for the advertisement or the generic information; making initial inquiries; and inviting submissions - new regulation 42WAC;
- enabling the Panel to consider a complaint and decide if it is justified - new regulation 42ZCAD;
- giving the Panel power to inform itself as it sees fit and to require the production of evidence to it - new regulation 42ZCAE;
- allowing a complainant to withdraw a complaint and the Panel to treat a complaint as withdrawn in certain circumstances - new regulation 42ZCAF;
- allowing the Panel to deal with a complaint despite its withdrawal where the Panel considers that there may have been a material contravention of the Act, the Regulations or the Therapeutic Goods Advertising Code - new regulation
- 42ZCAG; allowing the Panel to deal with a matter that is not mentioned in a complaint if is satisfied that the subject matter of the complaint may contravene the Act, the Regulations or the Therapeutic Goods Advertising Code - new regulation 42ZCAH;
- providing for the action that Panel may take take about advertisement and generic information that do not meet the requirements of the Regulations and the code, namely recommending that the Secretary:
- withdraw approval of the advertisement
- cancel the registration or listing of the goods;
- order a publication of a correction or a retraction; or
- order the recovery or destruction of an advertisement or generic information - new regulation 42ZCAI;
- preventing the Panel from dealing with a complaint if there is an unresolved court proceeding about the subject matter of the complaint - new regulation 42ZCAJ; and
- allowing the Panel to determine its own procedure where the Regulations do not make specific provision - new regulation 42ZCAK
Items 33-39 make necessary consequential or clarifying changes by:
* making it clear that the general delegation power in regulation 47(1) does not affect the Secretary's power to delegate to the chairperson of the Complaints Resolution Panel powers to take remedial action under subregulations 9AA (2) or 9S (2) - amended subregulation 47(3);
* including decisions to take remedial action under subregulations 9AA (2) or 9S (2), in the provisions for the review of decisions made under the Regulations - new paragraphs 48(1)(ba) and (bb); and
* deleting references in the Schedules to the Regulations to medical conditions prohibited under the old advertising Code and substituting references to the medical conditions about which restricted representations can now be made under the new Code:
- amended items 1, 2, 4 and 8 and paragraph 5(b), Part 1, Schedule 2
- amended items 3, 6 and 7 and paragraphs 8(b) and 10 (e), Part 1, Schedule 4
- amended item 8, Schedule 5.