Guidance

Artificial Intelligence (AI) IFPMA Guidance

This webpage outlines the IFPMA AI Ethics Principles, which guide pharmaceutical companies in the responsible and ethical use of Artificial Intelligence in healthcare. It contains multiple useful resources such as a webinar, position paper, case studies, and a list of ethical considerations.

Balance in product related materials

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.

CEP: A summary

A summary of the Continuing Educational Program (CEP), its key principles, and completion requirements. References Code Section 9.

CEP: Good Practice Guide to creating CEP Policy

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 Continuing Education Program (CEP), as relevant to their role.

Committee Membership Selection 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.

Complaint process – for Industry

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.

Complaint process – for Non-Industry

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.

Events: Hospitality and Venues

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.

Events: Virtual Meetings

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.

Gifts, Offers and Company Branded Items

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

Hospitality: Good Practice Guide to creating hospitality policy

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.

Intercompany Dialogue Standards

This document describes the expected Standards for Intercompany Dialogue (‘ICD Standards’) which promote meaningful communication and interaction between a Complainant Company and Subject Company in relation to a complaint under the Medicines Australia Code of Conduct. By being referenced in the Code, this Guidance is binding.

Overarching Principles - Code of Conduct

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

Patient Community: Ethical Communication

Code Edition 20 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 and the patient community, highlighting several scenarios, inherent risks, and practical considerations.

Prescribing information in product-related materials

Guidance to support the application of hyperlinks and QR codes in product related materials. It delves into practical considerations to ensure healthcare professionals have access to prescribing information when developing any product-related material.

Promotional Claims Guidance

Guidance to support companies in applying Section 1 of the Code when developing promotional claims. It outlines requirements and considerations related to substantiating data, avoiding misleading claims and consistency with the PI.

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.

Scientific Exchange

An FAQ style document designed to support companies in complying with the Code when conducting Scientific Exchange. It covers commonly asked questions and provides guidance on the introduction of a two-way exchange requirement in Edition 20.

Social Media: 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.