Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2001 (NO. 1) 2001 NO. 159

STATUTORY RULES 2001 No. 159

Issued by authority of the Parliamentary Secretary to the Minister for Health and Aged Care

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2001 (No. 1)

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.

The Governor-General may, under section 63 of the Act, make regulations required or permitted to be prescribed by the Act or that are necessary or convenient to be prescribed for carrying out or giving effect to this Act. In particular, the GovernorGeneral may make regulations to:

•       Exempt therapeutic goods from the requirement to be approved or included in the Australian Register of Therapeutic Goods (the Register) before the goods are supplied, manufactured, imported or exported (s. 18 of the Act);

•       Exempt certain therapeutic goods from the requirement to comply with manufacturing requirements (s. 3 4 of the Act);

•       Prescribe requirements for the advertising of therapeutic goods (s.63(2)(c) of the Act),.

•       Establish committees to advise the Minister or Secretary on matters relating to therapeutic goods (s.63(2)(a) of the Act);

•       Prescribe therapeutic goods, or classes of goods, that are required to be included in the Register as "listed" or "registered" goods (s. 17(4)(a) of the Act); and

•       Provide for the transfer of therapeutic goods from the part of the Register for "registered goods" to the part for "listable goods" (s. 17(4)(b) of the Act).

The purpose of the Regulations is to strengthen certain controls over the advertising of designated therapeutic goods, update the standard for sunscreens, extend the circumstances for exemptions from listing or registration in the Register and clarify certain provisions of the Principal Regulations. The Regulations will:

(a) extend the range of advertisements for designated therapeutic goods that must be approved prior to their publication, to include advertisements that are intended to be published through billboards, outdoor displays and in films (Items 3 and 8);

(b) update and add to the list of health care bodies that are permitted to receive advertising material for therapeutic goods that do not comply with the Therapeutic Goods Advertising Code (the Advertising Code)(Items 5, 18, 19 and 20).

(c) extend one of the functions of the Therapeutic Goods Advertising Code Council (the TGACC), established under Part 6 of the Regulations, to include making recommendations to the Minister about achieving greater uniformity in approval processes and standards for advertising therapeutic goods in "specified media", rather than just "print and broadcast media" as currently provided for (Item 11);

(d) enable the Complains Resolution Panel, established under Part 6 of the Regulations, to handle complaints about advertisements and generic information appearing in both broadcast media and "specified media" (Item 17);

(e) broaden the stakeholder representation on the TGACC (Items 12, 13 and 14),

(f) include definitions in the Regulations to assist with the interpretation of words used in the Regulations (Items 1 and 4);

(g) clarify the operation of three provisions in the Regulations relating to: the definition of "generic information" (R. 2 of the Regulations); a reference to "goods" included in Schedules to the Poisons Standard (R.6(1)(e) of the Regulations). and the extent of the exemption, relating to manufacturing requirements, applying to the filling of medical gases (Item 20 Schedule 7 of the Regulations) (Items 2, 10 and 27);

(h) update the standard for sunscreens (Items 22, 24 and 26);

(i)       permit additional amino acids to be used as ingredients in listed medicines (Item 23); and

(j)       extend the circumstances under which therapeutic goods may be exempt from the requirement to be included in the Register before they may be imported or supplied. These measures support the special access scheme that allows terminally ill patients to access unapproved therapeutic goods (Item 25).

Details of the Regulations are set out in the Attachment.

The Regulations commenced on gazettal.

ATTACHMENT 1

Therapeutic Goods Amendment Regulations 2001 (No. 1)

Regulation 1 states that the title of these regulations will be the Therapeutic Goods Amendment Regulations 2001 (No. 1)

Regulation 2 provides that these regulations will commence from the date of gazettal.

Regulation 3 provides that Schedule 1 amends the Therapeutic Goods Regulations 1990.

SCHEDULE 1 - AMENDMENTS

Item 1

Adds a definition for Australian Approved Names List under Regulation 2.

The Australian Approved Names List refers to a document entitled "Australian Approved Names for Therapeutic Substances", as in force from time to time, and published by the Therapeutic Goods Administration as part of a larger document currently entitled "TGA Approved Terminology for Medicines".

Schedules 12 and 13 of the Regulations refer to the term "Australian Approved Names" however there is no definition for this term.

Item 2

Removes the words "associated (directly or indirectly) with" from clause (b) of the definition of generic information under Regulation 2 of the Regulations.

The definition, as currently worded, provides that if generic information is directly or indirectly "associated" with an advertisement, then it is neither generic information nor an advertisement. This has the unintended effect of excluding this kind of "generic information" from the regulatory measures applying to both "generic information" and "advertisements" about therapeutic goods.

The purpose of this amendment is to make it clear that what is not intended to be caught by the definition of "generic information" is generic information included in an advertisement, because it then becomes part of that advertisement and as such may be regulated.

Items 3, 15 and 16

Item 3 replaces the definition of "specified media" referred to in R.42ZCAA, by inserting a new definition in R.2. The new definition removes from the current definition of 'specified media" the reference to radio and television and adds a reference to displays in shopping malls (except inside an individual shop). Item 15 deletes the current definition for "specified media" in R.42ZCAA and Item 16 removes the "note" relating to the definition of "specified media" in R.42ZCAA

The removal of references to "radio and television" in the definition will have the effect of ensuring that, when used in the context of Division 2 of Part 2 of the Regulations, advertisements for designated therapeutic goods published through broadcast media will only be pre-approved under the Broadcast Services Act 1992 and not the Therapeutic Goods Regulations. The inclusion of a definition for "specified media" in R.2 also means that, when used in the context of Division 2 of Part 2 of the Regulations, the requirement to obtain preapproval of advertisements relating to designated therapeutic goods before their publication will now extend to advertisements included in outdoor displays (including posters in or on public transport, billboards, posters in shopping malls except those inside individual shops) and advertisements published in movies. Currently, only advertisements about designated therapeutic goods to be included in "mainstream media" require pre-approval before publication

"Designated therapeutic goods" are medicines, other than those that, in the main, are pharmacy only or prescription medicines, or controlled drugs. Advertising of these medicines to the general public is not permitted.

Advertisements on displays, posters and billboards have the same impact on consumers as advertisements published in mainstream media and should therefore be subject to the same regulatory requirements relating to pre-approval before publication.

Item 4

Adds a definition for "Standard AS/NZS" under Regulation 2 of the Regulations as there are several references to "Standard AS/NZS" in the Schedules to the Regulations. The purpose of the definition is to clearly identify who publishes the AS/NZS standards.

Item 5

Adds "podiatrists" to the list of healthcare professionals under paragraph 4 (1) (a) of the Regulations who are permitted to receive advertising material (about therapeutic goods) that do not comply with the Advertising Code, Advertising material directed at consumers are subject to strict controls.

As with other healthcare professionals listed under paragraph 4(1) (a), Podiatrists are now a group of professionals who may be registered as health practitioners under a State or Territory law. It is appropriate that they be included amongst those who may receive promotional material that does not comply with the Advertising Code.

Items 6, 7 and 9

Updates the Regulations to reflect the new corporate name for the Proprietary Medicines Association (PMAA). The Association changed its corporate name to the Australian Self Medication Industry Incorporated (ASMI) in June 2000.

Item 8

Replaces the reference to "mainstream media" in R. 5C of the Regulations to "specified media". The effect of this amendment is to require advertisements for designated therapeutic goods intended to be displayed in shopping malls (except inside individual shops), movies, billboards and other outdoor displays including those in or on public transport to be pre-approved under Division 2 of Part 2 of the Regulations before they may be displayed or published.

Item 10

Clarifies the meaning of paragraph 6(1) (e) of the Regulations.

Currently, it is an offence to advertise to the public, "goods" included in Schedule 3, 4 or 8 of the Poisons Standard (these are mostly prescription only medicines, pharmacy only medicines or controlled drugs) unless the goods are included in Appendix H of the Standard.

The Schedules of the Poisons Standard list "substances" or "preparations" found in products or that make up the products, but not usually the name of the product itself. It could therefore be possible for a person to interpret the offence provision to mean that an offence is committed only if the advertisement includes a reference to the name of the product, rather than a reference to any of the preparations or substances that are listed in Schedule 3, 4 or 8 of the Poisons Standard. This is not the intention, and the amendment will make it clearer in the regulations that it is an offence for a person to advertise products that contain a reference to any substance or preparation that appears in Schedule 3, Schedule 4 or Schedule 8 of the Poisons Standard, unless the substance or preparation is included in appendix H the Standard.

Item 11

Changes the reference in R 42B of the Regulations from "print and broadcast media" to "specified media and broadcast media". This change means that the functions of the Therapeutic Goods Advertising Council under R.42B(1)(b) of the Regulations will be extended to include making recommendations to the Minister for achieving greater uniformity in approval processes and standards for advertisements appearing on displays, posters, billboards and in films, and not just advertisements published in print and broadcast media.

Items 12, 13 and 14

These Items have the effect of adding a further 2 bodies that may nominate a person to attend meetings of the Therapeutic Goods Advertising Council (TGACC) as an observer, for the purposes of Division 2 of Part 6 of the Regulations. The new bodies are the Australian Competition and Consumer Commission (ACCC) and Medsafe, the regulatory agency within the New Zealand Ministry of Health). These two organisations are key stakeholders not currently represented on the TGACC.

Item 17

Allows a person to complain to the CRP about certain advertisements for designated therapeutic goods and therapeutic devices appearing in both specified media and broadcast media (radio and television), and also generic information appearing in both specified media or broadcast media that is in contravention of R. 9Q or R.9R.

The need to include a reference to "broadcast media" is because "radio" and "television" has been removed from the original definition of "specified media" (see Item 15 and the explanatory material for Item 3 above).

Items 18, 19 and 20

Updates the list of organisations whose members, being health professionals who are regulated under a law of a State or Territory, may receive advertisements that do not comply with the Advertising Code. The new organisations are the Association of Natural Health Practitioners Limited and the Australian Unani Medicines Society Inc. Item 19 reflects a name change to an existing organisation already included in Schedule 1 of the Regulations.

Item 21

Corrects an error that occurred with an amendment to the required wording for the mandatory warning statement that must appear on the labels, or retail containers, of vitamin products.

The intent of the amendment was to allow sponsors to use one of two, warning statements on the labels of vitamin products, however the required wording for the original warning was inadvertently amended. This meant that products labelled with the original statement was technically in breach of the Regulations.

Items 22, 24 and 26

Updates the Sunscreen Standards referred to in Schedules 4, 5 and 7 of the Regulations.

The current Standards referred to are AS/NZS 2604:1997 and AS/NZS 2604:1993, however the standard for sunscreens was revised and updated to the 1998 edition.

Item 23

Allows specific amino acids to be included in listed medicines.

The Complementary Medicines Evaluation Committee (CMEC), established under Part 5C of the Act, considered the safety of these substances and recommended their suitability for inclusion in listable medicines. Currently, goods containing these specific amino acids are required to be registered in the Australian Register of Therapeutic Goods.

Item 25

Extends the circumstances under which therapeutic goods may be exempted from the requirement to be included in the Australian Register of Therapeutic Goods. The amendments support the Special Access Scheme under which special categories of patients, such as terminally ill patients, may access unapproved medicines. These amendments will allow sponsors to import unapproved therapeutic goods and hold them under their direct control for the purposes of supplying the goods only where these goods may be supplied in accordance with the requirements of subsection 19(5) of the Therapeutic Goods Act 1989 or subregulation 12A(5) of the Regulations. This will allow sponsors to import and hold under their control (but not supply) unapproved therapeutic goods until specified categories of patients require access to such goods and are permitted access to the goods in the circumstances provided in the Act and Regulations. Strict record keeping requirements apply to the sponsor who holds the unapproved therapeutic goods to enable the Secretary to be satisfied that the unapproved products will only be supplied in the circumstances permitted by the Therapeutic Goods Act 1989 (the Act) and Regulations.

Item 27

Clarifies that the only circumstances where decant filling, transfilling or cascade filling of medicinal oxygen cylinders will not be subject to manufacturing controls under Part 4 of the Act are where these activities are conducted by a hospital or an ambulance, fire or rescue service.

This amendment clarifies that the exemption from requiring a manufacturing licence for the activities described was never intended to extend to commercial operators who are not in the business of providing medical care.

Items 28 and 29

Are consequential 'housekeeping" changes to accommodate the insertion of a definition for "Australian Approved Names List", in regulation 2 of the Regulations.