On this page:
Medicines Australia is committed to the fair and ethical administration of the Code of Conduct, including the establishment of a Code of Conduct Committee (Code Committee), Code of Conduct Appeals Committee (Appeals Committee), and the Monitoring Committee. This Code sets out the requirements for undertaking each of these activities, and detailed guidelines for lodging a complaint, responding to a complaint, and raising an appeal can be found in the Code Tool Kit.
- Medicines Australia provides a robust and independent complaint and appeal process where all parties are entitled to fair and equitable treatment. If these general principles are not met, the complaint may be returned for more information, or the review may be conducted in the absence of a complete response.1
- On receipt of a complaint which is not covered by this Code, Medicines Australia has the discretion to refer the complaint(s) to a relevant organisation for consideration under its own Code, having regard to the category of the therapeutic good and the target audience for the conduct subject to complaint.
15.1 Acceptance of Complaints
- A Complainant has the burden of proving their complaint on the balance of probabilities.
- Anonymous complaints will not be accepted.
- For Company-initiated complaints, Companies will follow the Intercompany Dialogue Standards, which are described in the Code Tool Kit. Medicines Australia will not accept a complaint from a Company unless it has been clearly demonstrated that intercompany dialogue has taken place and the complaint has not been resolved.2
- When a non-member Company submits a complaint, the non-member must lodge a bond of $20,000 with Medicines Australia.
- The Code Committee has the discretion to refund all, part, or none of the bond in the event of finding no breach in relation to some or all of the matters subject to complaint. This bond will be retained by Medicines Australia to defray the costs of the Code Committee meeting and contribute to Code education programs.
- Medicines Australia has the discretion to not accept a complaint if the subject matter has been substantially dealt with by the Code Committee.
- Where substantially the same subject matter is, at the same time, subject to review by the TGA, or is the subject of legal proceedings between the same parties in an Australian court or Administrative Tribunal, Medicines Australia has the discretion to either not accept a complaint; or accept and delay referring a complaint to the Code Committee.
- All documentation, including findings and/or sanctions of the Code Committee, shall remain confidential and shall not be released to any third-party, except if required by law, until the Subject Company and Complainant have exhausted all appeal procedures and the outcome of any appeal is known.
15.2 Complaints Process and Handling
The following procedures shall apply in the event of Medicines Australia receiving a complaint alleging a contravention by a Company of the Code of Conduct.
- On the receipt of a complaint, the Chief Executive Officer of Medicines Australia or their delegate shall acknowledge the complaint in writing within five (5) working days of receipt. All complaints shall be dealt with as expeditiously as possible.
- The Company that is the subject of the complaint (Subject Company) shall be given full details of the complaint lodged with Medicines Australia. The Subject Company will be invited to state within ten (10) working days whether or not the information supporting the complaint is correct, and to give any answer or explanation which may be deemed necessary.
- The Subject Company may obtain external advice in order to respond to a Code of Conduct complaint. If external advice is sought, all documents relating to a complaint must be kept confidential and can only be provided for the purpose of seeking such advice.
- If external advice is sought by a Subject Company responding to a complaint, that Company must ensure that the individual to whom a request for advice is sought is provided with sufficient information to form a full and proper view of the complaint under consideration.
- The Subject Company and Complainant will provide Medicines Australia with whatever references or information is deemed by the Chief Executive Officer or their delegate to be necessary to fully investigate the complaint. The complaint and all supporting information and the Subject Company’s response shall be provided to the Code Committee.
- After the Code Committee has concluded its deliberations and having made such further enquiry as necessary or desirable, the Chief Executive Officer or their delegate will:
- within two (2) working days of the Code Committee meeting notify the Subject Company and the Complainant in writing of the Committee’s decisions. .
- within ten (10) working days of the Code Committee meeting provide reasons for the decision(s) of the Code Committee to the Subject Company and the Complainant which will include a full explanation for the decision made and the form of any sanction to be applied to the Subject Company.
- The Code Committee may also request the Code of Conduct Secretary to notify Medicines Australia’s Board, and any other bodies or individuals with a direct interest, of the Committee’s decision.
- If the Code Committee requires a Company to cease certain conduct or withdraw materials from use, the Company shall at once comply with the Code Committee’s ruling pending any appeal against the decision of the Code Committee. Conduct or materials thus suspended or withdrawn shall not be reactivated before the appeal process has been concluded.
- The Code Committee may refer questions on the interpretation of the Code to the Medicines Australia Board for determination. The Board shall consider such questions and make a determination as soon as possible after it receives notice from the Code Committee of the need for the determination.
15.3 Complaints against Non-member Companies
- Complaints concerning the conduct of non-members will be forwarded to the non-member with an invitation to have the complaint adjudicated by the Code Committee and the Company’s agreement to abide by the Code Committee’s decision and any sanctions imposed.
- If the non-member accepts the invitation to have the complaint adjudicated by the Code Committee, the complaint will proceed in accordance with the provisions of the Code of Conduct.
- If the non-member declines the invitation to have the complaint adjudicated by the Code Committee, Medicines Australia shall have the right, but not the obligation, to forward this complaint, together with the non-member Company’s response to the invitation, to the TGA or the Australian Competition and Consumer Commission (ACCC).
15.4 Frivolous or Vexatious Complaints
Medicines Australia takes its obligations of providing a fair and equitable complaints process seriously and will not tolerate misuse of the process.
- If the Code Committee forms the view that a complaint might be considered frivolous or vexatious, it will request the Complainant Company to provide its response to the concern. The Complainant Company’s response must be provided to Medicines Australia within ten (10) working days. The Complainant Company’s response will be considered at the next Code Committee meeting or at an adjourned meeting of the Code Committee.
- A Company may be found to breach this Section if a single complaint or a series of complaints by a single Complainant against one or more Companies within a therapeutic class is determined to be frivolous or vexatious.
- A complaint or series of complaints may be found to be frivolous or vexatious regardless of whether or not the complaint or complaints are sustained.
- A Complainant Company that has had fines imposed by the Code Committee under this Section may lodge an appeal against the decision or fine, in accordance with the appeals procedures described in Section 15.7.
15.5 Failure to follow Intercompany Dialogue Standards for Company-initiated Complaints
- If it is alleged in a complaint or a complaint response that the Intercompany Dialogue Standards were not appropriately followed by either the Complainant Company or the Subject Company, the Code Committee may, but is not obligated to, request the relevant Company to provide its response to the concern. The Company’s response must be provided to Medicines Australia within ten (10) working days. The Company’s response will be considered at the next Code Committee meeting or at an adjourned meeting of the Code Committee.
- A Complainant Company or a Subject Company may allege a breach of this section.
15.6 Sanctions
Sanctions may only be imposed where breaches of the Code of Conduct have been established. Sanctions may consist of one or more of the following:
| Sanction | Description |
|---|---|
| Cessation of conduct and withdrawal | The Subject Company is required to take immediate action to discontinue or modify any conduct which is determined to constitute a breach of the Code, including the cessation and withdrawal of any promotional activity. Written notification of this action must be provided to Medicines Australia within five (5) working days of receipt of the reasons for the decision(s) of the Code Committee. |
| Corrective action | The Code Committee may require retraction statements, including corrective letters and advertising, to be issued by the Subject Company. The number, format, size, wording, mode of publication, prominence, timing (including duration of publication) and method of distribution of corrective statements must be approved by the Committee or its delegates prior to release. Corrective statements will, in general, specifically correct the statement found in breach of the Code and be in the form prescribed by the Committee. No other material may accompany such statements unless the inclusion of such material has been approved by the Code Committee or its delegates. Any corrective action required by the Code Committee must be completed within 30 calendar days of the receipt of the reasons for the decision(s) of the Code Committee meeting by the Subject Company (subject to any appeal that may be lodged under this Code). A Subject Company is required to provide a statement to the effect that the action has been undertaken together with a copy of the published advertisement or a copy of the final version of a corrective letter, signed by the Subject Company Managing Director or Medical Director. |
| Monetary fine | The Code Committee may impose a monetary fine on the Subject Company in accordance with the schedule of fines below. |
The schedule of fines that may be imposed by the Code Committee or the Appeals Committee for breaches of the Code of Conduct is as follows:
| Breach | Maximum Fine |
|---|---|
Minor:
| $100,000 |
Moderate:
| $150,000 |
Severe:
| $200,000 |
| Severe breach where the activity has been completed before a breach is found and there is no opportunity for corrective action | $250,000 |
| Repeat of previous breach | $250,000 |
| Failure to complete corrective action in 30 calendar days | $50,000 |
| Failure to follow Intercompany Dialogue Standards | $100,000 |
| Frivolous or Vexatious Complaint | $100,000 |
| Failure to pay a fine in 30 calendar days | $50,000 |
- In the event that the Code Committee requires a Company to send a corrective letter or place corrective advertising, or pay a monetary fine, the Company shall at once comply with the Code Committee’s ruling, subject to the outcome of any appeal against the decision of the Code Committee. Any activity or promotional material thus suspended shall not be reactivated or recommenced before the appeal process has been completed.
- The Code Committee and the Appeals Committee have the discretion to apply a monetary fine for breaches of the Code individually or cumulatively. The fines above may be imposed for each identified breach determined under Section 16 of the Code up to a maximum of $300,000 per complaint. By way of example, if a moderate breach and a severe breach were determined within one complaint, the Committee may impose a fine of up to $300,000.
- Where a sanction has not been actioned in accordance with the decision(s) and the reasons for the decision(s) of the Code or Appeals Committee, the Code Committee may impose a fine of up to $50,000 for that breach of not completing the corrective action or paying the fine within the required period (30 calendar days).
- In addition, Medicines Australia shall have the right, but not the obligation:
- to forward the complaint, the decision(s) and the reasons for the decision(s) of the Code or Appeals Committee meeting, and the failure of the Subject Company to take the corrective action to the TGA or the ACCC; and/or
- publicise the failure of the Subject Company to take the corrective action.
15.7 Appeals
The following procedures shall apply if Medicines Australia receives an appeal from a Complainant or Subject Company concerning a decision of the Code of Conduct Committee. The appeal will be heard by the Code of Conduct Appeals Committee (Appeals Committee).
- An appeal is a rehearing of the part of the original complaint that is the subject of the appeal. The Appeals Committee has the power to affirm, set aside or vary the findings and/or any sanction which has been imposed by the Code Committee. The Appeals Committee shall not uphold an appeal unless it is persuaded that the findings of the Code Committee, or the sanction imposed by it, involved an error on the basis of which they should be set aside or varied.
- The Appeals Committee will determine the appeal on the basis of the evidence before the Code Committee, the submissions made to that Committee, and the submissions made to the Appeals Committee. The Appeals Committee shall have the discretion to receive fresh evidence (being evidence which has become available after the complaint was considered by the Code Committee). However, the Appeals Committee will make its determination in relation to the circumstances that existed at the time the conduct or activity occurred, not the circumstances existing at the time of the Code of Conduct Committee’s deliberation or at the appeal. For example, the Appeals Committee will have regard only to what substantiating clinical evidence was published and available at the time a claim subject to complaint was made.
- The appeal is to be dealt with during a meeting of the Appeals Committee. Both the Subject Company and the Complainant may provide an oral presentation to the Appeals Committee.
- Where a Company enlists the assistance of an external expert, the expert shall not act as an advocate for the Company’s conduct or activities.
- Either the Complainant or the Subject Company can appeal the findings and/or sanctions imposed by the Code Committee. Notice of an appeal by the Complainant or Subject Company must be made in writing within five (5) working days of receiving the decision(s) and the reasons for the decision(s) of the Code Committee. On receipt of an appeal the other party will be notified. The Complainant will be provided with a copy of the Subject Company’s response to the complaint.
- The Appellant must submit its written submissions in support of its appeal to Medicines Australia within a further five (5) working days. The written appeal will be provided to the other party, which shall make its written response to the appeal within ten (10) working days. The written appeal submission and any response to the appeal shall be provided to the Appeals Committee.
- In the case of an appeal by the Complainant, the Subject Company’s response to the appeal will be provided to the Complainant for review prior to the Appeals Committee meeting.
- When a Subject Company or industry Complainant submits an appeal, the Company must lodge a bond of $20,000 with Medicines Australia. This bond is in addition to any bond lodged by a non-member Company when submitting a complaint to Medicines Australia.
- The Appeals Committee has the discretion to refund all, part or none of the bond in the event of the findings and/or the sanction being removed or changed. This bond will be retained by Medicines Australia to defray the costs of the Code and Appeals Committee meetings and contribute to Code education programs.
- A non-industry Complainant will not be required to lodge an appeal bond if it lodges an appeal against the Subject Company.
- In the event of an appeal being lodged by the Subject Company and the Complainant in relation to a single complaint, both appeals will be heard concurrently by the Appeals Committee.
- After the Appeals Committee has concluded its deliberations and having made such further enquiry as necessary or desirable, the Chief Executive Officer or their delegate will:
- within two (2) working days of the Appeals Committee meeting notify the Subject Company and the Complainant in writing of the Appeals Committee’s decisions.
- within ten (10) working days of the Committee meeting provide the reasons for the decision(s) of the Appeals Committee to the Subject Company and the Complainant which will include a full explanation for the decision made and the form of any sanction to be applied to the Subject Company.
- A Complainant Company that has had fines imposed by the Code Committee under Section 15.4, Frivolous or Vexatious complaints, may lodge an appeal against the decision and/or fine. The appeal, in writing, must be submitted to Medicines Australia by the Complainant within ten (10) working days of receiving advice of the reasons for the decision. This appeal will be determined by the Appeals Committee.
15.8 Monitoring
To promote compliance with the Medicines Australia Code of Conduct and thereby support the quality use of medicines, the Medicines Australia Monitoring Committee (Monitoring Committee) will proactively monitor conduct of Companies on a regular and ongoing basis. The Monitoring Committee will review activities that are less likely to receive public or another Company’s scrutiny.
- Companies will be required to submit to the Monitoring Committee an electronic copy of materials that were in use during a specified period of time.
- The Monitoring Committee is empowered in any case to request, and Companies must provide, any further information concerning a Company’s submission.
- The Monitoring Committee’s reviews will include, but are not limited to:
- Websites with access restricted to healthcare professionals;
- Promotional materials;
- Company policies and procedures to ensure compliance with Medical Representative training; and
- Company policies and procedures to ensure interactions and activities with healthcare professionals and other stakeholders comply with the Code;
- A Company will be required to provide materials or activities for review by the Monitoring Committee on no more than two occasions within a calendar year. If a Company responds to a Monitoring Committee request that it had not distributed any materials or undertaken any activities that are specified in the request, this response will not be counted as one of the two occasions for that company.
- If, following the review of the submitted material or activities, the Monitoring Committee considers that a breach of the Code of Conduct may have occurred, the Company in question will be contacted and asked to state whether the determination of the Monitoring Committee is correct and to give any answer or explanation deemed necessary.
- The Monitoring Committee will consider the Company’s response and provide relevant advice on compliance with the Code or, if necessary, refer the matter to the Code Committee as a complaint.