The fourth edition of the Guidelines for ethical relationships between physicians and industry (PDF) are now available. These voluntary guidelines, developed by the RACP Ethics Committee, revise previous editions of the guidelines and seek to support health professionals in identifying, assessing and managing conflicts of interest.
It is essential that physicians have the tools to prevent, identify and manage conflicts of interest if they arise to ensure that we always act in a patient’s best interests. These guidelines are designed to help physicians make reflective, well-informed, judgments and encourage ethical relationships between health professionals and industry.
While some relations with industry are inescapable or even desirable, the guidelines explore interactions that do not further patient care or population health activities and which have the potential to bias professional judgement.
In particular, the guidelines advise against accepting gifts and hospitality and advise caution in considering industry support for conferences and other meetings. They also promote the provision of independent education for practitioners, trainees and students, and high standards of integrity in research.
This new edition of the Guidelines for ethical relationships between physicians and industry has been many years in the making and has undergone extensive consultation processes, including two full public consultations and international reviews.
The guidelines address the following key areas:
- Interests, dualities of interests and conflicts of interests
- How conflicts of interest should be managed
- Why relationships between health professionals and industry are important
- Issues affecting trainees and students
- Issues affecting health practitioners
- Issues affecting institutions and professional societies
- Issues affecting research
- Best practice key points for consideration
Frequently asked questions
What are the 'Guidelines for ethical relationships between health professionals and industry'?
The guidelines seek to support health professionals in identifying, assessing and managing conflicts of interest. Their overall goal is to preserve public trust by protecting the integrity of professional judgment in patient care.
Practitioners consulting the guidelines are encouraged to consider its advice and recommendations but are ultimately free to make their own decisions.
How is the current version of the guidelines different to previous versions?
Among the many special features of this edition is new material relating to the following topics: devices; biotechnology companies; complementary medicines; global issues and issues relating to health professionals working overseas; receipt of gifts of any value and non-service related items; education and continuing medical education; off-label prescribing; sample and starter packs and product familiarisation schemes; transparency relating to practitioners and institutions; endorsements by practitioners and organisations; promotion and advertising; occupational and environmental physicians and their relationship with industry; internet issues; publication; research; and trainees and students.
This latest edition of the guidelines offer a wider definition of ‘industry’ to extend beyond the for-profit sector with recognition of the nature, importance and management of non-pecuniary conflicts of interest; more inclusive scope of the consideration to include health professionals of all kinds; more extensive guidance regarding management of conflicts of interest; and increased emphasis on the importance of sensitivity to issues of cultural relevance.
The guidelines also provide an improved index, ‘tools’ and other points of guidance to assist in the use of the document and resolution of specific issues as they are encountered in the everyday life of the health professional.
Are the guidelines mandatory?
As with previous editions, the guidelines are voluntary. The discussions themselves and the key points are presented as constituting a resource to empower readers to make reflective, well-informed, judgments that are appropriate to local conditions and circumstances.
How can I use the guidelines?
For the most part, it is intended that each chapter can be read as a stand-alone document, although, in places, full understanding depends on familiarity with concepts developed elsewhere in the guidelines. The content is organised into several chapters. In particular:
- The key points from each chapter appear on p13 to p21 and are followed by tools for identifying and managing conflicts of interest.
- Chapters 1 and 2 describe the context of contemporary health care and provide a detailed account of values, interests and conflicts of interest.
- Chapter 3 provides guidance for individual health professionals across a range of activities, including promotional activities, meetings, employment and consultancies, research, publications and international activities.
- Chapter 4 engages with the ways in which trainees and students may be supported in developing critical awareness of, and strategies to avoid, conflicts of interest.
- Chapter 5 examines issues affecting institutions and professional organisations and provides detailed guidance on managing conflicts of interest arising in these settings.
- In Chapter 6, interests arising in the context of research are identified and discussed, including researcher responsibilities and dissemination of results. The bibliography contains a list of the materials consulted in the preparation of these guidelines and suggested further reading.
What can I do if I am experiencing a conflict of interest?
The guidelines feature four generic ‘tools’ designed for health professionals working individually as clinicians; as members of clinical teams; as teachers and researchers; and as committee members, employees of, and advisers to, organisations such as professional colleges and societies, hospitals, universities, and community and for-profit organisations. Their purpose is to assist them to:
- recognise when there could be a real or perceived conflict involving interests of the profession and those of for-profit organisations
- distinguish between a duality and a conflict of interest
- manage possible and established conflicts of interest
- confirm that they are comfortable about establishing, continuing or changing the terms of a relationship with a for-profit organisation.
The guidelines are designed to give physicians tools to identify and manage conflicts of interest.
We strongly urge all those involved in the broad field of health care to reflect on the issues we are raising and to develop their own strategies for responding to the dualities and possible conflicts that abound in our professional lives.
Who developed the guidelines?
The guidelines have been developed by a diverse group of health professionals with expertise in the multiple fields relevant to the topic.
Working parties and the RACP Ethics Advisory Group members – who produced the Guidelines
Professor Paul Komesaroff FRACP, Chair
Professor Ian Kerridge FRACP, FRCPA
Dr Wendy Lipworth MBBS PhD
Dr Jon Jureidini FRANZP
Dr Rob Loblay FRACP
Professor Russell Gruen FRACS
Dr Ken Harvey MBBS, FRCPA
Dr Phillipa Malpas PhD
Professor Cameron Stewart BEc, LLB (Hons), GradDipLegPrac, GradDipJur, PhD
Associate Professor Henry Kilham FRACP
Dr Christopher Clarke FRACP
Dr Shane Carney FRACP
Professor Wendy Rogers FRACGP
Associate Professor Peter Greenberg FRACP
Ethics Committee members – who reviewed and approved the Guidelines
Professor Ian Kerridge FRACP, FRCPA, Chair
Professor Paul Komesaroff FRACP, former Chair
Dr Greg Stewart FRACP, FAFPHM, former Chair
Dr Alina Iser FRACP
Dr Danielle Ko FRACGP, FAChPM
Dr Alastair Macdonald FRACP
Associate Professor Jillian Sewell AM, FRACP
Dr Linda Sheahan FRACP, FAChPM
Professor Ron Paterson ONZM, LLB (Hons), BCL, FRACP (Hon)
Professor Ngiare Brown FRACGP, MPHTM
Dr Hirini Kaa PhD, M.A. (Hons), B.A (Hons)
Ms Eliza McEwin BPharm, GDipHospPharm, MPH, MBioethics
Mr Peter Martin OAM, Community member
Mr Tim Benson, Community member
It is acknowledged that this text also reflects the input of a wide range of contributors from the professions, the College, consumer organisations and industry.