Code Resource Toolkit

This Toolkit has been designed to aid compliance with the Medicines Australia Code of Conduct (the Code).

You will find non-binding resources issued by Medicines Australia which address a number of topics covered by the Code. They are agile resources that allow for flexibility in approach, and will be continually updated as issues are raised by members, and the Code evolves over time.

QR codes, PI and balance – April 24 – Guidance for developing promotional material in line with the Code.

Disease Awareness and the Code – August 23 – How to conduct disease awareness activities in line with the Code.

Transparency and the Code – April 2023 – the “why” “what” “who” “when” and “how” of transparency reporting and the Code.

Educational Events and the Code – February 23 – Whether Company initiated or sponsored, activities and events should be consistent with the Code – how do we do this?

Interactions with non-healthcare professionals and the Code – June 23 – The Code affirms companies can communicate proactively or reactively with relevant stakeholders – but how and when is appropriate?

Social Media and the Code – October 22 – How to apply the Code in social media and a digital world

Introduction to the Code – August 22 – What the Code covers and how it fits in with our regulatory environment

Scientific Exchange and the Code – July 22 – How to conduct scientific exchange ethically and inline with the Code

NEW – Any hospitality provided to healthcare professionals must be moderate, reasonable and commensurate with the level of education being provided as judged by local standards. In Australia hospitality spend is capped at a maximum spend per person of $140 per person per meal (excluding gratuities and GST). This change came into effect 3 November 2022. See Hospitality Guidance for further detail.

Balance in product related materials (Guidance)

The Code of Conduct requires that companies provide balanced information on products to support their appropriate use. This Guidance is designed to support and guide a company’s ethical decision-making so they can decide upon the appropriate level of information in their materials to ensure their materials are in line with the Code’s principles and support proper assessment of a product’s risks and benefits. Reference Code Sections 1 and 2.

Communicating ethically with patients and their representatives (Guidance)

Code Edition 19 embraces our industry’s evolving needs to better engage with patients or their representatives. This Guidance addresses common questions about the application of the Code to particular scenarios between industry, patients, their carers, their families, and Health Consumer Organisations, highlighting several scenarios, inherent risks, and practical considerations. Reference Code Sections 11, 12 and 13.

Hospitality and Venues (Guidance)

The Guidance walks you through the principles and scenarios about providing hospitality to healthcare professionals at events and meetings, whether company-initiated, third-party, virtual, face-to-face, for the purposes of education or commercial. Also touches upon appropriate venue selection for these events and meetings. Reference Code Section 4.5.

Good Practice Guide – Quality inclusions for Hospitality policies (Guidance)

Guidance to assist companies to develop and improve their internal company policies and procedures which govern decisions on hospitality-spend at events, to ensure events are delivered in line with the expectations of the Code. Reference Code Section 4.5.

Good Practice Guide – Quality inclusions for staff education policies (Guidance)

Guidance to assist companies to develop a robust and compliant policy approach to ensuring relevant personnel are appropriately trained on the Medicines Australia Code of Conduct and the endorsed CEP program, as relevant to their role. Reference Code Section 10.

Guidance on social media and digital channels (IFPMA Guidance)

Global guidance to assist companies when considering their activities on social media and digital channels. This resource is a joint collaboration by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), so whilst not specific to the Australian context, it highlights some valuable principles applicable to comms on social media and the risks involved. Reference Code Section 2.5.

Transparency Reporting Quick Guide (Guidance)

Guidance on ‘how to’ meet transparency reporting requirements, designed for Medicines Australia member companies who commit to reporting transparently. Reference Code Section 15.

Transparency Reporting FAQ’s (Guidance)

Frequently Asked Questions are answered in a way that provides rationale and brief examples. Reference Code Section 15

Membership Selection for Code of Conduct Committees (Process)

A summary of Medicines Australia’s guiding principles and procedures for selecting and appointing members for the Code, Appeals and Monitoring Committees, inline with fair and equitable approach. Reference Code Section 17.4.

Gifts, Offers and Company Branded Items (Guidance)

A guide to understanding how, when and what can be provided by companies, in relation to promotional aids, company-branded items and gifts. Reference Code Sections 3 & 5.

Company Representative Training (Guidance)

A summary of the continuing educational program, its key principles, and completion requirements. Reference Code Section 10.

How to Make a Complaint – for Industry (Guidance)

Guidelines that explain the process for companies inside the pharmaceutical industry – and includes guidelines around promoting successful intercompany dialogue between companies, and providing a timeframe in pursuing these matters in the context of a complaint. Reference Code Section 16.

How to Make a Complaint – for Non-Industry (Guidance)

Guidelines that explain the complaints-handling process for anyone outside the pharmaceutical industry, such as individuals, healthcare professionals, or a member of the general public. Includes accessibility, timeframes, process and what information to include when submitting a complaint. Reference Code Section 16.

Using QR Codes or Hyperlinks (Guidance)

With QR Codes now part of our everyday lives, learn how they can be appropriately used in branded materials. Reference Code Section 2.

Transparency Decision Tool  (Guidance)

Should you sponsor? And if yes, where should it be reported? This one-pager simplifies the decision-making process. Reference Code Sections 4 & 15.

The Code’s Overarching Principles (Principles)

This one-pager sets out the overarching principles that guide all activities covered by the Code.  Reference Code, Part A

Conducting Virtual Meetings (Guidance)

This 2-pager provides guidance on ensuring virtual meetings are conducted in accordance with the Code. It covers overarching principles, hospitality, online conferences, access to online information and who is responsible. Reference Code Section 4.

Returning to face-to-face interactions with HCPs (Guidance)

This 2-pager provides guidance on aspects to be considered when it comes to returning to face-to-face interactions with healthcare professionals. Poignant to the post-pandemic environment.

State and Territory sampling Regulations (Summary table)

A snapshot of the various State and Territory approaches to regulation surrounding the provision of clinical samples; who can supply what to whom, record-keeping, storage, quantity and disposal. Reference Code Sections 6 & 7.

Medical Practice Activity Agreement (Template)

A template which can be used to formalise any supported medical practice activity which may assist pharmaceutical companies to articulate and define the nature of any activity or collaboration with a HCP. Reference Code Section 5.

Collection Statement for use in HCP engagements (Example)

An example statement that can be used by pharmaceutical companies, informing Healthcare Professionals of the collection and reporting of information pertaining to their engagement. Used in pre-engagement. Reference Code Section 15.1

Healthcare Professional Verification Letter (Template)

An example statement that can be used by pharmaceutical companies, seeking verification of reportable payments after any engagement with a Healthcare Professional. Used in post-engagement. Reference Code Section 15.1

Transfers of Value to Healthcare Professionals (Template)

An excel spreadsheet for member companies, to collect, record and submit any transfers of value to Healthcare Professionals. Reference Code Section 15.1

Verification accompanying report (Form)

Completed by all member companies and submitted to Medicines Australia accompanying any transparency report. It verifies the information provided is truthful and complete. Reference Code Section 15.

Sponsorship of Third Party Meetings and Symposia (Template)

An excel spreadsheet for member companies, to collect, record and submit any sponsorship of third party educational meetings and symposia. Reference Code Section 15.2

Health Consumer Organisation Support (Template)

An excel spreadsheet for member companies, to collect, record and submit any support to organisations that work to benefit Australian patients. Includes some examples to guide members in what is applicable for this reporting, and what is not. Reference Code Section 15.3