Background, context, process and principles


Disclosure of previously discretionary information is fundamental to the public’s trust in medicine. As a consequence of growing concerns about financial conflicts of interest in research, increasingly stringent disclosure rules have been introduced in many countries, including in Australia and New Zealand, especially since the early 1990s.

The first edition of the RACP Guidelines, published in 1992, took the form of a set of comparatively abstract principles to help guide physicians to make their own decisions regarding the drug industry. However, increasing awareness about the potential implications of the influence of the pharmaceutical industry on prescribers, medical societies and expert bodies, as well as on research outcomes, led to calls for further regulation in the late 1990s and early 2000s.

The third edition of the RACP Guidelines, published in 2006, laid out detailed, practical advice to physicians for managing dualities and multiplicities of interest, and avoiding any appearance of impropriety in such areas as authorship of pharmaceutical-sponsored research, society meetings and gifts.

The developing empirical understanding of pharmaceutical industry influence since 2006, as well as further intensification of public concerns, has set the stage for a new revision of the Guidelines. Goals of the present revision include expansion of their scope to other (non-pharmaceutical) industries, recognise the close involvement of nurses and allied health professionals in the operation of healthcare teams, integration of the approach to industry across the areas of clinical practice, social policy development, research and education, and explicit acknowledgment of the concomitant unequivocal constructive roles of industry.

International events have affected public awareness of the importance of these issues and have led to changed cultural expectations. The gradual but important strengthening of the Medicines Australia Code of Conduct has been another important step forward. Recognition of the need for a unified approach to the issues across different sectors, including generic and non-generic pharmaceuticals and complementary medicines, has increased. Overseas legislation mandating greater disclosure of relationships with industry and increasing public pressure are reflected in the present text.

The Guidelines include expanded discussion of electronic advertising, non-pecuniary interests, global issues, the role of ‘educational’ activities and various other topics. There has also been recognition of the fact that not all consumer groups express views independent of industry or government.

It is important to note that physicians working in occupational and environmental health have a unique relationship with industry, as indeed do other physicians who undertake medico-legal work. These physicians may need to manage conflicting responsibilities relating to individual patients under their care, workers in a particular workplace, employers, the general public and specific responsibilities under legislation. The Australasian Faculty of Occupational and Environmental Medicine has published its Ethical Guidelines for Occupational and Environmental Physicians (PDF), which should be referred to for more detailed guidance on the specific issues relating to these professions.

Purpose of the Guidelines

The current Guidelines present views and recommendations that may not be universally shared. They have been developed by consensus through an extended process of discussion, debate and consultation, on occasions with vigorous contention.

The Guidelines are not only a philosophical statement. They seek also to outline the ethical and philosophical issues that arise when health professionals interact with industry, to represent continuing debates within the College and the community in a fair and constructive manner and to provide a guide or map to inform and assist physicians in making practical decisions.

It is intended to provide guidance and advice, not to compel or limit decision making. Increased ethical competency requires free and voluntary decision making. A decision not made in an informed and voluntary manner is not ethically valid. Accordingly, practitioners consulting these Guidelines are encouraged to consider the arguments and recommendations included within it, but to make their own decisions. The Guidelines have attempted to link advice to the evidence regarding the influence of specific activities on patient care. While it is generally accepted by physicians that there are negative effects from certain interactions with industry, many physicians still think they are personally immune to the influence of industry. Although the broad perspective of the Guidelines represents official RACP policy, in the case of decisions by individual physicians regarding their clinical practice or personal affairs, the College respects their right to make decisions that vary from the recommendations presented here.

It is recognised and acknowledged that the issues facing individual health practitioners often differ sharply from those facing the various institutions comprising the healthcare industry. In particular, the responsibilities and interests of health practitioners may be distinguished from those of pharmaceutical companies and other commercial organisations. This is, in part, because health practitioners have an active responsibility to advocate for their patients and the community, which is not shared by industry. Accordingly, while we have sought to ensure as far as possible consistency between these Guidelines and those of other organisations, including Medicines Australia, the primary test we have applied where differences have emerged is the welfare of individual patients, their families and carers and the wider community.

As we have stressed, these Guidelines are primarily advisory in nature and we support the rights of individuals and institutions to make decisions about their interactions with industry. Nonetheless, it is recognised that other bodies, such as the Australian Health Practitioner Regulation Agency, the Medical Council of New Zealand, the Australian Competition and Consumer Commission, the Consumer Protection branch within the New Zealand Ministry of Business, Innovation & Employment, Medicines Australia, Medicines New Zealand, Health Research Council of New Zealand and the National Health and Medical Research Council (Australia) might from time to time issue requirements of a mandatory nature relating to any of the matters discussed herein to which individual readers are subject.

Key points
  • Practitioners consulting these Guidelines are encouraged to consider the arguments and recommendations included within it, but to make their own decisions.

  • While it is generally accepted by physicians that there are negative effects from certain interactions with industry, many physicians still think they are personally immune to the influence of industry.

Target audience

The Guidelines are intended to offer guidance for individual Fellows, practitioners and other readers, rather than binding imperatives. The provisions relating to medical trainees and students and education are also offered to provide guidance to groups within the community who often lack protection from the codes of professional organisations; those active in this area as teachers, administrators and mentors are encouraged to seek ways to promote further discussion and understanding among their trainees and students.

Interests – general definitions, scope, summaries of issues, problems

The definitions of interests and the management of dualities and conflicts of interest are presented in Interests, dualities of interest and conflicts of interest. Here, we consider briefly the broad problems the Guidelines seek to address.

Interests arise in clinical settings in many ways and affect all aspects of clinical decision making. They include both pecuniary and non-pecuniary interests, the latter on many occasions being much more powerful than the former.

Pecuniary interests giving rise to dualities and conflicts of interest may be associated with the relationships between health practitioners and industry, in the settings of clinical care and research, teaching, and other professional and employment responsibilities. These interests can include involvement of clinicians in and interactions with owners of private hospitals and pathology providers, educational opportunities funded by third parties, and honoraria for participation in education programs.

The principle that should guide decision making in all clinical settings is that the safety, wellbeing and other interests of patients and populations are primary and must not be compromised by pecuniary or non-pecuniary concerns.

Interests that may influence the decisions of all clinical practitioners should be clear and transparent. In the specific case of pecuniary interests, the relevant arrangements between clinical practitioners and the organisations concerned should be openly stated in a manner that is accessible to all individuals who could be affected. Where the possibility of a conflict of interest arises, regardless of the context, this should be declared openly to all relevant parties. A process should also be established to resolve any concerns. This may require disclosures to institutions, Human Research Ethics Committees, patients, potential research participants and others of financial arrangements or other commitments, and of values or obligations that might affect decision making.

Such disclosures of interests do not in themselves imply the existence of conflicts of interest. They do, however, facilitate the identification of conflicts where they do exist and help to avoid them where it is possible to do so. The ultimate test for the effective management of conflicts of interest in this setting is that practitioners’ independence of judgment and decisions they might make concerning the safety and wellbeing of patients, their families and the wider community remain unimpaired by other interests, including benefits received from industry or non-pecuniary commitments.

Key points
  • The safety and interests of patients are the primary concerns of medical and other health professionals.

  • In healthcare decisions, the safety and wellbeing of patients and population groups take priority over commercial, financial, personal or other interests.

  • Where the possibility of a conflict of interest arises, regardless of the context, this should be declared openly to all relevant parties.

The issue

The work undertaken to prevent, diagnose and treat disease, including the production and use of medicines and other therapies and the conduct of research directed towards these ends, is the result of contributions from many people, including medical and other health professionals, researchers, employees of industry, consumers, governments, administrators of hospitals, and members of professional and community organisations. These people interact in different ways to facilitate the realisation of their various goals and purposes.

Although they undoubtedly share many common interests, all the parties have their own specific objectives that are not always consistent with each other. For example, in the for- profit sector, which includes the pharmaceutical industry, the biotechnology industry, manufacturers of devices and providers of various services, the generation of profit for owners and shareholders is a natural goal which may conflict with the primary ethical purpose of the healthcare system, which is to provide for the healthcare needs of the community. Similarly, professional associations are interested both in maintaining professional standards and in protecting the incomes and authority of their members, universities and research institutes have interests that are not limited to the realisation of the values of science, education and knowledge, and political and religious bodies have other interests. Universities, research institutes and community organisations enter into partnerships with the pharmaceutical industry and in some cases rely heavily on income derived in this way to conduct their day-to-day business.

In all these relationships, diverging interests can arise that affect the provision of enhanced healthcare to the community. Because of this potential for conflict and in spite of widespread recognition that contending perspectives can often lead to productive dialogues many health professionals feel uncomfortable in their relationships with any component of industry, a sentiment that has also been expressed both in the community and by government agencies.

To respond to these concerns, it is important to clarify each of the interests involved, to identify dualities and conflicts among them, to develop ways of averting or managing actual conflicts, and to communicate openly with each of the constituencies. At times this will be a complex task because of the number and variety of both participants and interests, difficulties in identifying non-pecuniary interests, and the fact that many clinicians and researchers occupy multiple roles, as educators, advisers or paid consultants. The purpose of these Guidelines is to assist both individual health professionals and organisations to be able to recognise these problems and to develop effective strategies to address them. While the development of a productive and interactive relationship between industry, health professionals, consumers, government, and professional and community organisations has obvious community benefits, physicians involved in such relationships should be aware that the primary objective of industry is the promotion of their company and its products.

Key points
  • Many health professionals feel uncomfortable in their relationships with any component of industry, as unavoidable as these relationships may be.

  • It is important to clarify each of the interests involved, to identify dualities and conflicts among them, to develop ways of averting or managing actual conflicts, and to communicate openly with each of the constituencies

Special questions relating to the pharmaceutical, devices and complementary medicines industries

One of the particular concerns of healthcare professionals and the wider community has been the promotional activities of the pharmaceutical, devices and complementary medicines industries. These activities take many forms, including overt advertising, the provision of gifts to individual practitioners or employing institutions, travel assistance, support for meetings and educational programs, and dissemination of information to the community via the popular and electronic media. The concern is heightened by the fact that the targets of these activities, usually health practitioners, are not the actual consumers of the products but rather act as the agents of both patients and the wider community whose welfare they are entrusted to protect and promote.

Healthcare professionals of all kinds often assume they are immune from skilled advertising techniques. However, evidence shows that both health care decision making and the conduct of research are profoundly affected by such influences, in ways not always beneficial to the wider community (see the bibliography for representative references). This raises the possibility that health professionals may unwittingly become agents of industry and draws attention to the need for them to consider establishing systematic ways of recognising potential sources of influence and ensuring that they are not inappropriately affected by them.

Similar issues are raised by relationships involving educational and research activities and the management of hospitals and professional organisations, including those with religious and political affiliations. These Guidelines are intended to contribute to the process of clarifying all these issues and developing potential ways of responding that protect and preserve the interests of patients and the wider community.

Health professionals have a range of responsibilities in relation to the development and use of medicinal agents and other therapeutic devices. Clinical practitioners have specific responsibilities to their patients, researchers have responsibilities to the community of scientists and administrators have responsibilities to those who set the policies they are appointed to execute. Depending on the professional roles involved, these responsibilities may include:

  • using existing medicinal agents and devices in the most effective and appropriate way as part of treatment and care

  • monitoring their use and reporting adverse reactions

  • participating in clinical trials of new drugs and other therapeutic agents and in company-sponsored trials of marketed drugs

  • participating in post-marketing surveillance of new drugs and therapeutic devices

  • keeping up to date with scientific developments in their fields and with available information about new drugs and changed information about established ones

  • considering the implications of new technologies and pharmaceutical agents for the community as a whole and contributing to discussion about the most appropriate use of resources

  • contributing to community knowledge about therapeutics in order to enhance the abilities of patients and consumers to make informed choices

  • engaging directly in research or contributing to or supporting such research

These responsibilities substantially overlap with the objectives of many aspects of industry, with which health professionals often develop and maintain fruitful relationships. It is important to acknowledge these constructive engagements, which are often beneficial both to the participants and to the community as a whole. Health professionals can provide knowledge and experience which can enhance the outcomes of the work undertaken by industry. Conversely, industry can supply resources that facilitate development of new diagnostic and therapeutic possibilities.

Key points
  • Evidence shows that both healthcare decision-making and the conduct of research are profoundly affected by all these influences, in ways not always beneficial to the wider community.

  • Health professionals may unwittingly become agents of industry.

Why relationships between health professionals and industry are important

In summary, while the interests of health professionals and the various components of industry overlap, they are not identical and at times may diverge or come into conflict with each other.

If the relations between healthcare professionals and industry are inadequately managed, this may lead to:

  • a loss of commitment to or change in underlying goals or purposes

  • undermining of the processes of professional judgment

  • inappropriate outcomes or outcomes at variance with the underlying values of the healthcare professions or of the community

  • a negative impact on the quality of care and ultimately patient health

  • loss of trust by patients, government and the wider community

In other words, inappropriate or poorly managed relationships between health professions and industry can lead to an erosion of the integrity of the professions and an undermining of the trust between practitioners and the community on which the healthcare system depends. To address these risks, we offer guidance to individual practitioners in their interactions with industry, to researchers in the planning and execution of their work, and to institutions and professional organisations charged with the responsibility of delivering healthcare and overseeing educational activities and research practice.

We stress that the Guidelines are only advisory. There is no universal consensus about how to assess the influence of industry on healthcare and research or about optimal courses of action to respond to issues arising in specific settings. It is recognised that there are often differing views about the most appropriate course of action – indeed, such diversity of views is encouraged and welcomed. In addition, it is emphasised that judgments must be made in relation to the specific details of individual cases, which may be infinitely variable. Together, these factors impose limitations on the extent to which effective guidance can be provided in the form of general principles and summary formulations.

We consider that matters as complex and varied as those discussed here should be regulated on a voluntary basis, according to local conditions and needs, by individuals who are themselves engaged in practice and administration. We accept and welcome the fact that not everyone will agree with our recommendations and that on occasion, individuals and organisations will choose other courses of action. Regardless of their conclusions however, we strongly urge all those involved in the broad field of healthcare 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.

The question of evidence

These Guidelines have evolved from guidance developed by the RACP over more than two decades. They are based on identifying and interpreting the best practice currently available. Although we have undertaken extensive reviews of the literature, we have not attempted to reference every factual claim we have made. This reflects the necessity that guidelines represent the results of extensive and often complex processes of interpretation and debate concerning not only data but also cultural attitudes and possibilities.

To provide guidance regarding the now very extensive literature in the field, we have included an extensive, annotated bibliography.

Feedback invited

Suggestions and critical comments from all members of the community are welcome at any time. Email us at

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