Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1997 NO. 400

STATUTORY RULES 1997 No. 400

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or are exported from Australia. The Therapeutic Goods Administration (the TGA) has responsibility for administering the Act.

Section 63 of the Act enables the Governor-General to make Regulations prescribing, amongst other things, matters necessary or convenient for carrying out or giving effect to the Act. This includes paragraph 63(2)(c), which prescribes requirements for the advertising of therapeutic goods.

The purpose of the Regulations is to establish a pre-clearance scheme for advertisements, about mainly non-prescription drugs. herbal remedies and like products, that are intended to be published or inserted in mainstream print media. The scheme is designed to ensure that advertisements published in mainstream print media about these drugs will not include any claims that they can prevent. treat or cure major or serious medical conditions that usually require the intervention of a medical practitioner.

Accordingly, the Regulations:

(a)        establish a legislative scheme for the approval of advertisements relating to certain drugs prior to the publication or insertion of these advertisements in mainstream print media (Regulations 2.1 to 9.1 inclusive). These drugs are in the main non-prescription drugs, and approval to advertise the availability of these drugs directly to consumers rather than limiting such advertising to health professionals will be given providing the advertisement meets the requirements of the Therapeutic Goods Advertising Code (the Code). This Code contains prohibitions that prevent any claims being made in advertisements about the ability of these drugs to treat, cure or prevent serious medical conditions that are not amenable to self diagnosis or treatment and require the intervention of a medical practitioner. The Code also requires the inclusion of appropriate warning statements in advertisements for certain conditions which could pose a risk to consumers where symptoms persist;

(b)       establish a Therapeutic Goods Advertising Code Council ("the Council") with functions that include advising the Minister on appropriate standards for advertising and on uniform procedures for pre-clearing advertisements published, inserted or broadcast in mainstream print or electronic media (Regulation 17.1). The Council will also make recommendations to the Minister following reviews of the Secretary's decision to refuse to approve an advertisement for publication or insertion in mainstream print media;

(c)        establish a Complaints Resolution Panel that will, as part of its functions, consider complaints lodged against advertisements about designated drugs that are published or inserted in mainstream print media, and make recommendations to the Minister about what action the Minister should take pursuant to the Therapeutic Goods Act 1989 and Regulations (Regulation 17. 1).

The amendments will give a legislative basis to existing arrangements for the approval of advertisements about designated drugs published or inserted in mainstream print media that have been the subject of an interim authorisation granted by the Australian Competition Tribunal. The scheme is designed to prevent advertisements from being published that contain claims for the treatment of serious medical conditions on the grounds that such conditions are not amenable to self diagnosis or treatment.

Further details of the Regulations are set out in the Attachment.

The Regulations commenced on the date of gazettal.

ATTACHMENT

DETAILS OF PROPOSED THERAPEUTIC GOODS REGULATIONS (AMENDMENT)

Regulation 1 states that the Therapeutic Goods Regulations are amended as set out in these amending Regulations, and will commence on the date of gazettal.

Subregulations 2.1 replaces the definition of "Therapeutic Goods Advertising Code" with a new definition that refers to the document of that name published in the Gazette on 10 December 1997, and includes any amendment to that document gazetted by the Minister.

Subregulations 3.1, 4.1, 5.1, 7.1 and 9.1 insert 5 new Divisions into Part 2 of the Regulations, to divide that Part into discrete groups of provisions that provide for the regulation of advertising.

Subregulation 4.1 inserts 'Division 2' under which a number of new regulations have been included to establish a scheme for approving advertisements relating to certain drugs before they are published in, or inserted into, mainstream print media. The new provisions are:

Regulation 5B inserts new definitions for words or terms used in this Division. These include a definition for "designated therapeutic goods", "mainstream media" and "complementary medicine".

Regulation 5C describes the advertisements that require approval under this new Division. These are advertisements.

*       directed at drugs, except those falling within Schedule 3, 4 or 8 of the Poisons Standard (drugs falling within those Schedules are in the main prescription drugs, or drugs that may only be obtained through a pharmacy); and

*       intended to be published or inserted, or are published or inserted, in any magazine or newspaper that is in general circulation; and

*       for which valuable consideration will be or has been given.

The approval scheme will not cover advertisements that only contain details such as the brand name, price. type or style of the drug or the place or time at which the goods may be obtained, or advertisements that contain information to identify who is offering the goods for sale or that displays a picture or other reproduction of the goods, providing the picture or reproduction does not disclose any therapeutic claims for those goods. The scheme will commence to operate on 1 January 1998.

Regulation 5D sets out the offences under Division 2 to support the approval scheme for advertisements intended for publication in mainstream print media. It will be an offence for a person to publish an advertisement that differs from what was approved unless the difference relates only to the price, place or time at which the drugs may be obtained, or information about who is offering the goods for sale, or if there is a difference in the picture of the same goods being offered for sale. It will also be an offence for a person to publish or insert an advertisement in mainstream media without the necessary approval under this Division. Other offences include publishing an advertisement without its approval number, or publishing a false approval number or an approval number that has expired. Where any conditions apply to the publication of an advertisement, it will be an offence for a publication not to comply with those conditions. The offences under Regulation 5D will not apply to publishers who publish or insert advertisements as part of their normal course of business.

Regulation 5E provides that publishers described in Regulation 5E will commit an offence against the regulations if they knowingly or recklessly publish or insert in mainstream print media an advertisement that has not been approved under the new scheme.

Regulation 5F describes how an application for approval may be made. It must be made in writing and be addressed to the Secretary. It must be in a form approved by the Secretary, be signed by or on behalf of the applicant and be accompanied by the prescribed fee.

Regulation 5G sets out how the Secretary is to approve or refuse to approve an advertisement upon receipt of an application under Regulation 5F. The Secretary is to approve an advertisement if the Secretary is satisfied that it complies with the Therapeutic Goods Advertising Code, does not contain a pictorial representation or reproduction of goods the presentation of which would contravene Regulation 6A and meets with other advertising requirements relating to prohibited representations and required representations set out under Parts 1 and 2 of Schedule 2 of the Therapeutic Goods Regulations. -An approval may be subject to conditions imposed by the Secretary.

Regulation 5H provides that the Secretary must notify the applicants in writing of the Secretary's decision on an application to publish an advertisement. If no written notice is given within 60 days after the date of the application, or such longer period as may be agreed in writing between the Secretary and the applicant, the Secretary is taken to have approved the advertisement after the 60th day. Any condition imposed by the Secretary on the approval is to be set out in the notice. Any notice refusing to approve an advertisement must contain reasons for the refusal.

Regulation 5J provides that the Secretary must allocate an approval number to each approved advertisement (this includes an advertisement deemed to have been approved under Regulation 5H) and inform the applicant of the number at the time notice of the approval is given to the applicant. An approved number expires after 2 years from the date of its allocation.

Regulation 5K provides that the Secretary may by notice in writing given to an approval holder, vary any condition of approval of an approved advertisement.

Regulation 5L sets out the circumstances in which the Secretary may withdraw an approval, by giving written notice to an approval holder. These are where the Secretary is satisfied that:

*       information given by the applicant in the application for an approval was false or incorrect and the Secretary, when deciding whether to approve or refuse to approve the advertisement, or the Minister, upon review of the Secretary's decision to refuse, relied on that false or incorrect information;

*       a person has committed an offence under Regulation 5D in relation to the published advertisement; there has been a breach of a condition of an approval;

*       because of a change to the facts or circumstances existing when the advertisement was approved, the advertisement no longer complies with the Therapeutic Goods Advertising Code ("the Code");

*       because of a change in the requirements of the Code, the advertisement no longer complies with the Code.

The Secretary may, by notice in writing to an approval holder, withdraw an approval for an advertisement on the recommendation of the Complaints Resolution Panel to the Minister pursuant to the complaints procedure established under Division 5. Notices given by the Secretary under this regulation must set out the reasons for the decision and the review rights of the approval holder.

Regulation 5M A decision by the Secretary to refuse to give an approval for an advertisement, or to vary any condition of approval of an approved advertisement or to withdraw an approval under Subregulation 5L(1) may be reviewable by the Minister if an applicant applies for review within 30 days after notice of the decision is given to the applicant. The Minister must review the decision as soon as practicable after receiving the request and may confirm the Secretary's decision or revoke it and make a new decision, including a decision to impose conditions. In making a decision the Minister must take into account any recommendation made by the Therapeutic Goods Advertising Code Council or, where applicable, the recommendations of the Complaints Resolution Panel. Until the Minister makes a decision upon review, the decision of the Secretary stands.

Regulation 5N requires the Minister to give written notice to the applicant of the Minister's decision under Regulation 5M, and the notice must set out any conditions attaching to a decision to approve an advertisement. If the Minister does not accept the recommendations of the Therapeutic Goods Advertising Code Council, the Minister must inform the applicant or approval holder of this. The notice must also set out the reasons for the decision and include information about the applicant's or approval holder's review rights.

Regulation 5P provides for a review of the Minister's decision under Regulation 5M by the Administrative -Appeals Tribunal..

Regulation 5Q provides for the delegation of the Minister's powers and the Secretary's powers under the new approval scheme. The Minister may delegate his or her review powers under Regulation 5M or 5N to an officer of the Department or the National Manager of the Therapeutic Goods Administration, where the latter is not an officer of the Department. The Secretary's powers to approve or refuse to approve an advertisement for publication may be delegated to an officer of the Department or a medical practitioner registered to practice in a State or internal Territory who is employed by the government of a State or Territory. The Secretary may also delegate his or her powers to approve or refuse to approve an advertisement for publication under Regulation 5G to the Nutritional Foods Association of Australia where the advertisement relates to complementary medicines, and to the Proprietary Medicines Association of Australia for all other advertisements that are required to be approved under Part 2 of the Regulations before being published. The Secretary may also delegate his or her power to withdraw an approval for an advertisement to a person who has also been delegated the power to approve or refuse to approve the advertisement. The Secretary may impose conditions on his or her delegation or may give directions to the delegate, which must be complied with by the delegate.

Regulation 5.1 inserts a new Division, "Division 3 - Other Advertisements".

Regulation 6.1 inserts new Regulation 5R to clarify that the advertising offences set out under Regulation 6 that apply to published advertisements will not apply to the new approval scheme.

Regulation 7.1 inserts a new Division, "Division 4 - General" under which Regulations 6A, 7, 8 and 9 have been grouped.

Regulations 8.1 and 8.2 clarify that the requirements relating to prohibited representations and required representations set out in Schedule 2 to the Regulations apply to all classes of advertisements for therapeutic goods.

Regulation 9.1 inserts a new Division 5 that contains provisions establishing a complaints procedure for any advertisements published or inserted in mainstream print media that contravene the Regulations or the Advertising Code.

New Regulation 9AA, allows a person to complain in writing to the Complaints Resolution Panel about an advertisement published in mainstream media relating to designated therapeutic goods.

New Regulation 9AB provides that on receipt of a complaint the Panel must write to both the complainant and the person who apparently sought the publication or insertion of that advertisement, informing the person that the Panel received the complaint. Details of the complaint must be included in the notice and the parties must be invited to send written submissions together with any supporting documents, for consideration by the Panel.

New Regulation 9AC describes how the Panel may deal with the complaint. The Panel is required to consider the complaint, and take into account any written submissions and documents given to it land must decide whether the complaint is justified. If the Panel decides it is justified it may, in writing, request the person who appears to have sought the publication or insertion to withdraw the advertisement and/or publish a retraction. If the person does not comply with the request, the Panel may make a recommendation to the Secretary about what to do. This may include cancelling the registration or listing of the goods under paragraph 30(2)(e) of the Act or, where the advertisement is an approved advertisement, withdrawing the approval of the advertisement. The Panel must give written notice, including reasons, to the complainant, and the person who appears to have sought the publication or insertion of the advertisement, about any recommendations it makes to the Secretary. The complaints process will not apply where the complaint is withdrawn or where court proceedings have began in relation to the advertisement complained of.

New Regulation 9AD provides for the complainant to withdraw a complaint at any time. The Panel may also treat a complaint as withdrawn if it is properly satisfied that the complainant does not intend to proceed with the complaint or that the complaint is trivial. vexatious, misconceived or lacking in substance or the Panel is satisfied that the subject matter of the complaint has been dealt with or can be better or more conveniently dealt with by another authority. Should the Panel treat a complaint as being withdrawn, it must notify the complainant and the person apparently responsible for publishing or inserting the advertisement in writing and give its reasons for doing so.

New Regulation 9AE provides that if the subject matter of the complaint is before a court and the proceeding has not been finally determined., if a court proceeding should continue about the subject matter of the complaint, the Panel cannot deal with the complaint until the proceeding has been finally determined.

Regulations 10-1 and 17.1 insert a new Division 1 for the existing statutory committees set up under the Regulations and create 2 new Divisions under which the Therapeutic Goods Advertising Code Council and the Complaints Resolution Panel are established.

Regulations 11.1. 12.1, 12.2. 13.1. 14.1. 15.1 and 16.1 make consequential changes to the existing provisions of Part 6 of the Regulations to take into account, when making references to "Part 5" of the Regulations, the new Divisions that now make up Part 6.

Regulation 17.1 inserts a new heading "Division 2 - Therapeutic Goods Advertising Code Council´ and new regulations 42A to 42Q inclusive that establish the Council and set out its procedures and other requirements that apply to it.

New Regulation 42A establishes the Committee known as the Therapeutic Goods Advertising Code Council (the Council)

New Regulation 42B sets out the Council's functions. These include making recommendation to the Minister for achieving greater uniformity in advertising approval processes and standards relating to both print and electronic broadcast media, considering and advising the Minister on requirements for the advertising of therapeutic goods and changes to the Advertising Code, accepting submissions in relation to these functions, considering requests for a review of decisions to refuse to approve an advertisement and making recommendations to the Minister accordingly, advising the Minister on any matter referred to the Council by the Minister or Secretary or raised by an observer at a Council meeting and undertaking any other function conferred on the Council by the Regulations.

The Council may, with the approval of the Minister, appoint sub-committees of its members to inquire into and report on matters within its function.

New Regulation 42C provides for the membership of the Council, which is to have 12 members drawn from various stakeholders including industry groups representing the pharmaceutical manufacturing and advertising industries, consumer groups, health care professionals and government.

New Regulations 42D, 42E, 42F and 42G prescribe how long Council members may hold office, provide for the appointment of a chairperson and sets out the circumstances in which a member may resign from the Council or otherwise cease to be a member of the Council.

New Regulation 42H allows for the appointment of alternate members by the various groups referred to in Regulation 42C to stand in for regular members when the latter may be absent from a meeting of the Council or where the member ceases to hold office. Alternate members are to be taken to be members of the Council in the absence of members or until the member's office is filled. Alternates may resign by giving notice to the body that appointed the alternate.

New Regulation 42J provides for 3 observers to be nominated by each of the 3 industry groups, the Australian Pharmaceutical Manufacturer's Association, the Cosmetics, Toiletries and Fragrances Association of Australia and the Medical Industries Association of Australia, to attend meetings of the Council. While they remain observers, they are entitled to be given agenda papers and Minutes of Council meetings and may write to the Council chairperson to suggest agenda items for consideration and. providing notice is given to the chairperson that the observer will be attending a Council meeting, may vote on any question at that meeting that affects the interests of the body who nominated the observer.

New Regulation 42K provides that a quorum for the Council consists of 5 members, including the chairperson, and of those 5 members (including the chairperson) there must be a member nominated by the NFAA or the PMAA, a consumer member. a health care professional member, an advertising industry member and a government member.

New Regulation 42L sets out the procedures for conducting meetings of the Council, including how questions are to be decided.

New Regulation 42M states that any vacancy in the membership of the Council will not affect the exercise of any function or power of the Council.

New Regulation 42N requires members who have a direct or indirect pecuniary interest in any matter that is, or that will be, considered by the Council at a meeting to disclose the nature of the interest at the meeting as soon as the member becomes aware of his or her interest. The disclosure is to be recorded in the minutes of the meeting and, unless the Council otherwise decides, the member cannot be present while the Council deliberates on that matter or take part in any decision of the Council on that matter. In determining whether a member who has an interest in a matter should be present during deliberations or take part in deciding on that matter, any other member who has a direct or indirect pecuniary interest on this issue may not be present during deliberations to decide the issue or take part in making the decision.

New Regulation 42P provides that the Council may determine its own procedures where these are not already provided for in the Regulations.

New Regulation 42Q requires the Council to submit an Annual Report 3 months after the end of each financial year setting out the operation of the Council for that financial year.

New Regulation 42R establishes a new Committee to be known as the Complaints Resolution Panel (the Panel).

New Regulation 42S sets out the functions of the Panel. These are to consider complaints about advertisements published or inserted in mainstream print media and to take action and make recommendations to the Secretary in relation to complaints about such advertisements.

New Regulation 42T provides for the membership of the Panel, which is to be 8 members comprising a chairperson nominated by the Council, a member nominated by the NFAA, a member nominated by the PMAA, a member nominated by the Australian Consumer Association, a member nominated by the Consumers' Health Forum and 3 health care professionals nominated by three professional groups.

Membership of the Panel cannot include more than 4 members who are also members of the Council.

New Regulations 42U and 42V provide for the term of office of Panel members and the circumstances in which a person ceases to be a member of the Panel.

New Regulation 42W provides for the appointment of alternate members for the Chairperson, as well as the other members of the Panel. Alternate members may fill in for Panel members when they are absent, or may replace a member who ceases to hold office as a Panel member until the vacancy is filled. When attending meetings for members, alternates are taken to be Panel members.

New Regulation 42X provides that the Therapeutic Goods Administration of the Department of Health and Family Services must nominate at least 1 person to attend meetings of the Panel as an observer. The Australia New Zealand Food Authority may also nominate an observer to attend meetings of the Panel, Observers are entitled to agendas and minutes of Panel meetings and may give written notice to the Chairperson suggesting agenda items to be considered by the Panel and may attend meetings and vote on any matter affecting the interests of the body that nominated the observer..

New Regulation 42Y provides that a quorum consists of a chairperson, 2 members nominated by the PMAA and the NFAA, a health care professional and a TGA observer nominated under Regulation 42X.

New Regulation 42Z prescribes the procedures for conducting Panel meetings.

New Regulation 42ZA states that any vacancy in the membership of the Panel will not affect the exercise of any power or performance of any function by the Panel.

New Regulation 42ZB sets out the requirements for Panel members to disclose any direct or indirect pecuniary interests they may have in a matter being considered, or about to be considered, at a Panel meeting. The same disclosure rules applying to Council members at Council meetings, set out in Regulation 42N above, also apply to Panel members at meetings of the Panel.

New Regulation 42ZC permits the Panel to determine its own procedures where these are not provided for in the Regulations.

Regulation 18.1 makes it clear that the delegation powers of Secretary set out under new Regulation 50 are not affected by the delegation provisions under Regulation 47.

Regulation 19.1 prescribes the application fees payable by persons seeking approval to publish or insert an advertisement about designated therapeutic goods in mainstream media.

Regulation 20.1 inserts a new Schedule 14 that includes a list of designated active ingredients that may characterise complementary medicines. The NFAA will be delegated the Secretary's power to approve or refuse to approve an application to publish or insert an advertisement about complementary medicines.