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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2002 (NO. 5) 2002 NO. 315
EXPLANATORY STATEMENTSTATUTORY RULES 2002 No. 315
Issued by the authority of the Parliamentary Secretary to the Minister for Health and Ageing
Therapeutic Goods Act 1989
Therapeutic Goods Amendment Regulations 2002 (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.
Section 63 of the Act provides that the Governor-General may make Regulations for the purposes of the Act.
Subsection 9A(4) of the Act provides that the Regulations may prescribe the therapeutic goods, or the classes of therapeutic goods, to be included in each part of the Australian Register of Therapeutic Goods (the ARTG).
The purpose of the Regulations is to:
(i) make a series of changes relating to the regulation of advertisements of therapeutic goods;
(ii) require that patient information documents be included in all prescription medicines;
(iii) permit medicines containing L-arginine as listable medicines in the ARTG; and
(iv) make minor technical amendments.
These Regulations:
• enable the Complaints Resolution Panel (CRP) to make public its determinations and register of complaints;
• enable the Secretary of the Department of Health and Ageing, on the recommendation of the CRP, to order the withdrawal of advertisements or generic information for therapeutic goods that have been found to be in breach of the advertising requirements;
• enable the inclusion of two representatives from the media as observers on the Therapeutic Goods Advertising Code Council (Code Council);
• allow a member of the CRP or an organisation represented by a member of the CRP to submit complaints;
• require that "all prescription medicines" regulated by the Drug Safety and Evaluation Branch (DSEB) of the TGA be accompanied by a patient information document;
• permit medicines for topical application and containing the amino acid L-arginine as an active ingredient, to be listable medicines in the ARTG; and
• make technical amendments.
A Regulation Impact Statement has been prepared in relation to the measures relating to the inclusion of patient information in all prescription medicines. Details of the Regulations are set out in the Attachment.
The Regulations set out in Schedule 1 commence on the date of gazettal. The Regulations set out in Schedule 2 commence on 1 January 2003 as agreed by industry.
ATTACHMENT
Details of the Therapeutic Goods Amendment Regulations 2002 (No. 5)
Regulation 1 states that the title of the Regulations will be the Therapeutic Goods Amendment Regulations 2001 (No. 5).
Regulation 2 provides that Schedule 1 of these Regulations will commence from the date of gazettal and Schedule 2 of these Regulations will commence from 1 January 2003.
Regulation 3 provides that the Regulations amend the Therapeutic Goods Regulations 1990 as provided in Schedules 1 and 2.
SCHEDULE 1-AMENDMENTS
Items 1 and 2
These amendments enable the Secretary, on the recommendation of the CRP under subregulation 42ZCAI(3), to order the withdrawal of advertisements and /or generic information that has been determined by the CRP to be in breach of the advertising requirements under the Act, the Regulations and the TGAC.
Currently there are no provisions under the Regulations to enable the Secretary, on the recommendation o£ the CRP, to order the withdrawal of an advertisement or generic information. This forces the Secretary, in circumstances where withdrawal of the advertisement or generic information would be appropriate, to opt for a more severe sanction such as ordering the destruction of the advertisement or the publication of corrective advertising. The amendment would have a positive effect on industry and it will reduce the costs associated with correcting minor breaches in advertising
Item 3 This amendment enables the media organisations to nominate two representatives to participate in the Code Council meetings as observers. The Federation of Australian Commercial Television Stations and the Federation of Australian Radio Broadcasters will be able to jointly nominate 1 observer. The Australian Publishers Bureau and the Outdoor Advertising Association of Australia will also be able to jointly nominate one representative.
These organisations are key stakeholders and have an important role to play in the effective operation of the co-regulatory system in the advertising of medicines in Australia. This amendment is unlikely to have any impact on the financial or business activities of industry but should add value to the functions of the Code Council and the stakeholder representation.
Items 4, 5 and 6
These amendments enable organisations represented on the CRP, to submit complaints to the CRP about advertisements and /or generic information for therapeutic goods appearing in specified media and broadcast media. In order to prevent the possibility of bias, item 6 of the amendments will require the representative of the organisation submitting the complaint to abstain from participating in the deliberations. In situations where that representative is essential for the quorum, items 4 and 5 of the amendments will enable the quorum to be reduced for the deliberations of that complaint.
This amendment should have minimal impact on industry but will enable the CRP to consider those consumer complaints, which are often sent to the TGA and the consumer associations, while preserving the integrity of the CRP.
Item 7
This amendment makes it clear that that the CRP has the power to recommend the Secretary to order the withdrawal of an advertisement or generic information. Under the current Regulations this power is implied rather than stated (refer to subregulation 41ZCAI(3)). The amendment should not impact on the financial or business activities of industry, but rather clarify a process within the complaints handling system under the Regulations.
Item 8
This amendment will enable the CRP to make public it's register of complaints and determinations on complaints about advertisements and generic information that have been published or inserted in specified and broadcast media. These determinations provide valuable information about how the CRP interprets the principles of the Code and will enhance the transparency of the complaints handling process. It will also assist stakeholders with the relevant interpretation of the TGAC and reduce the risk of repetition of similar advertising claims.
Item 9
This item is a technical amendment, which omits a repetition of a clause in paragraph (a) of item 2B of Part 1 of Schedule 3 to the Regulations.
Item 10
Item 10 permits medicines containing the amino acid L-arginine as an active ingredient to be listable medicines in the ARTG. However, the route of administration of these medicines is limited to ,the skin for localised effect. A warning label is also required stating that the medicine is to be applied only to the skin, and not to the mucosa, vagina or rectum.
SCHEDULE 2-AMENDMENTS
Item 1
Item 1 amends subregulation 9A(1) to the effect that from 1 January 2003, all prescription medicines (except medicines specified in Schedule 3 of the Poisons Schedule), and approved for registration in the ARTG must not be supplied to consumers unless accompanied by a patient information document described in Schedule 12 of the Regulations.
This amendment is consistent with Professor Peter Baume's recommendations in his review of drug regulation in 1991. Professor Baume recommended at that time a new mandatory requirement for the provision of patient information documents for all new prescription medicines and variations to existing prescription medicines approved after 1 January 1993. This requirement was implemented in the Regulations and commenced its operation on 1 January 1993 (refer to regulation 9A(1)). Professor Baume at that time also recommended that patient information documents be included in all existing prescription medicines by 1 January 2002, including those prescription medicines registered prior to 1 January 1993. The pharmaceutical industry has already been on notice for the last 10 years in relation to this requirement. The industry has agreed that for orderly transition this requirement would take effect from 1 January 2003.