Medical Practitioners' Relationships with Industry - 2010. Revised 2012
This document provides guidance for medical practitioners on maintaining ethical relationships with industry including the pharmaceutical industry, medical device and technology industry, and other health care product suppliers, health care facilities, medical services such as pathology and radiology, and other health services such as pharmacy and physiotherapy.
This document provides guidance for doctors (medical practitioners) on maintaining ethical relationships with industry including the pharmaceutical industry, medical device and technology industry, other health care product suppliers, health care facilities, medical services such as pathology and radiology, and other health services such as pharmacy and physiotherapy.
The doctor's primary duty is to act in the best interests of patients. In order to do this, doctors must maintain their professional autonomy, clinical independence, and integrity. Relationships between doctors and industry must not compromise, or be perceived to compromise, the doctor’s professional judgement, capacity to serve patients’ interests, or the community’s trust in the integrity of the medical profession.
1.1 Doctors are trained to think independently, to make decisions, and to discharge their duty of care in the best interests of the patient.
1.2 The history of health care delivery in Australia has been marked by close collaboration between doctors and industry. This collaboration has extended to research as well as education and it has contributed beneficially to the quality of health care that Australians have been able to receive.
1.3 Relationships between doctors and industry can take many forms. For example, doctors may:
- be involved in industry-sponsored research involving human participants, including participation in post-marketing surveillance studies;
- enter into contractual arrangements with industry;
- attend meetings sponsored or supported by industry, including scientific, educational, and continuing professional development;
- provide services to industry as an employee, consultant, director, speaker, advisory board member, or other similar capacity;
- own industry shares or similar options;
- hold intellectual property rights in a medical device or similar product;
- receive product samples, dispense products, or meet with industry representatives.
1.4 Doctors have a responsibility to ensure that their interaction with industry is consistent with their duties towards their patients and towards society at large. Doctors must safeguard their clinical independence and professional integrity from the influence of third parties including industry.
1.5 Relationships between doctors and industry are subject to the general constraints of the codes of ethics of the medical profession as well as any relevant legislative and regulatory requirements. Doctors should be aware of increasing public scrutiny of their relationships with industry.
1.6 It is important to recognise potential conflicts of interest and develop processes to deal with them.
2. Medical education
2.1 All medical professionals should accept the responsibility to be guided principally by considerations of patients’ interests and these guiding principles should be incorporated into any teaching program.
2.2 Medical curricula, including undergraduate, pre-vocational and vocational, must include formal training referring to ethical relationships with industry.
3. Managing real and potential conflicts of interest
3.1 As defined by the Medical Board of Australia1, a conflict of interest arises when a doctor, entrusted with acting in the best interests of patients, also has financial, professional or personal interests, or relationships, which may affect their care of the patient. Doctors may also be influenced by interests that extend to other persons connected to the provider.2
- employment or consultancies;
- board membership;
- research funding;
- fellowships or other educational grants;
- stock ownership;
- ownership in a medical or allied health care service;
- royalties (eg., from the development of a therapeutic device);
- real estate leases;
- receiving support for attending an educational event (such as travel, meals, accommodation, entertainment);
- receiving gifts from industry.
3.3 Whilst having multiple interests is common and generally appropriate, these interests must be secondary to the doctor’s primary duty to serve patients’ interests. When the interests compromise, or might be reasonably perceived to compromise, the doctor’s primary duty to the patient, the doctor must recognise and resolve this conflict in the best interests of the patient.1 Should patients, or the broader community, perceive that a doctor is placing their personal interests above patients’ interests, this may undermine trust in the doctor and the wider medical profession.
3.4 Managing real and perceived conflicts of interest requires openness and transparency. Interests in industry should be disclosed to relevant parties.
3.5 The decision about whether a real or perceived conflict of interest exists rests with the affected party (or parties). Affected parties may include patients, institutions, employers, ethics committees, publication editors, research funders and others, as appropriate.
3.6 If the affected party determines a real or perceived conflict of interest exists, action should be taken to manage the separation of the conflicting duties and ensure the primary duty to patients remains paramount. In some cases, this may entail withdrawal from or curtailing of a particular activity, while in others, it may be sufficient to delegate functions or roles to an individual or group. The action(s) to be taken should then be communicated to the affected party.
3.7 The doctor should inform patients when having an interest that could affect, or be perceived to affect, patient care. This includes referring patients to a medical or other health care service in which the doctor has a financial or other material interest as well as recommending a product in which the doctor has a financial or other material interest (eg., a therapeutic device).
4. Industry sponsored research involving human participants, including participation in post-marketing surveillance studies.
4.1 Any doctor who participates in medical research involving human participants has a duty to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of the individual research participants. The health and well-being of the individual research participant must take precedence over all other interests.
4.2 Doctors should participate in industry-sponsored research only if it has genuine merit, is ethically approved, socially responsible and scientifically valid.
4.3 Clinical trials should be registered in a publicly accessible register before recruitment of participants is undertaken.
4.4 Any doctor participating in a specific research project should appropriately disclose relevant interests in accordance with relevant guidelines.
4.5 Adequate provision for funding should be made. Any incremental costs directly related to an industry-sponsored research project should be covered by the research sponsor(s), not defrayed by Government or other insurance agencies. The budget for a research project should be held in a specially designated fund that is made available for audit and scrutiny according to institutional guidelines.
4.6 Patient participation in research should occur only with appropriate consent. The prescribing/treating doctor has an obligation to ensure that:
- the doctor's continuing concern for the patient's welfare is not contingent on the patient's participation in the study;
- the patient is aware of available alternatives, their comparative advantages and/or disadvantages and other related matters that would establish consent under normal circumstances;
- the patient may withdraw from the study at any time. Where it is anticipated that this may not be possible, the patient should be clearly informed of this at the outset.
4.7 It is acceptable for doctors in clinical practice to participate in appropriately designed, ethically approved post-marketing surveillance studies, the purpose of which is to monitor the performance of a product under conditions of actual use. Doctors participating in a surveillance study should:
- ensure that their involvement does not compromise, or be perceived to compromise, clinical independence and professional integrity;
- only enrol a particular patient in a post-marketing surveillance study after an independent, clinical decision to prescribe the particular treatment;
- disclose their participation in a post-marketing surveillance study to relevant patients.
4.8 It is ethically acceptable for doctors to receive remuneration for participation in approved surveillance studies when such participation involves a significant amount of professional time and skill over and above that applied directly to patient care. This remuneration should be commensurate with the work involved including the time expenditure, complexity of the study, and skill required. It may involve reimbursement of opportunity costs.
5. Meetings and activities organised independent of industry.
5.1 Industry may provide financial or other material support for clinical and scientific meetings as well as other similar activities. There is a risk that participants attending an industry-supported meeting may be unduly influenced by (or perceived by others to be unduly influenced by) industry, thus compromising their professional independence. Industry support of professional meetings and activities should be open to public scrutiny and managed very carefully so as not to compromise the participating doctors’ objectivity and capacity to recommend treatments based on their patients’ best interests (and not the best interests of the industry sponsor). Where industry provides financial or other material support for a meeting or activity, it is important to clarify whether the meeting is organised independent of industry or organised by industry.
5.2 Meetings and activities organised independent of industry should be developed for the purposes of professional education and training, not for the benefit of industry. In this setting, the meeting and activity (herein ‘meetings’) organisers are independent of industry; for example, the medical colleges, associations, and societies. ‘Support’ refers to the provision of financial and/or material support for professional meetings and activities.
5.3 It is ethically acceptable for industry to support meetings that contribute to doctors’ education and continuing professional development (CPD); however, such support should be untied, fully disclosed, at arms length to the organisation of the meeting and consistent with the following guidance:
5.3.1 Support by industry should be provided independently of the meeting’s clinical and scientific content;
5.3.2 Whilst industry has a right to sponsor and engage speakers, an independent organising committee of doctors (and others, as appropriate) should have the ultimate decision regarding the organisation, content, selection of speakers and attendees, and choice of education activities and materials;
5.3.3 Any funds provided by industry to support meetings should be controlled by the independent organising committee that may use the funds to defray the meeting costs, including support of invited speakers;
5.3.4 Meeting organisers and participants must not be in a position of conflict of interest by virtue of any affiliation with the supporters(s) of those activities. Speakers should declare any relevant interests, including direct or indirect support to attend a particular meeting. Doctors supported by industry to speak at a meeting should ensure their presentation is scientifically accurate and balanced;
5.3.5 The program for such activities should acknowledge the support and/or other aid received in the interests of transparency;
5.3.6 Support for medical students, doctors-in-training and post-graduate fellows to attend educational events may be appropriate; however, the relevant organisation must be responsible for selecting the attendees as well as controlling the sponsorship funds.
- Any payments or reimbursements to individual participants should be commensurate with any services provided and made through the meeting organisers and not the supporters;
- It is not appropriate for support to cover the costs of family or friends who may accompany a participant;
- Individuals should not accept any form of support that obliges them to promote a particular product or company;
- It is up to the individual to ensure their presentation is objective, scientifically sound, and not biased.
5.5 Doctors should exercise caution if accepting support to attend a meeting in which they are not making a formal contribution.
5.6 Institutions accrediting an educational activity should ensure that the activity is free of biases related to industry support.
6. Meetings and activities organised by industry
6.1 Some meetings and activities organised by industry may be undertaken for professional education and training, such as a medical technology demonstration, while others may be used for industry promotion and marketing.
6.2 Where industry organises its own meeting, the relevant company should take full responsibility for the organisation and promotion of the meeting and ensure it is made clear that the meeting is sponsored by the company.
6.3 Doctors attending meetings organised by industry should critically scrutinise the presentations for the possibility of misleading information.
7. Hospitality and entertainment
7.1 The acceptance of hospitality (the provision of food and beverages) in relation to a professional meeting or activity may be appropriate so long as the hospitality is secondary to the purpose of the meeting and not disproportionate in nature.
7.2 The acceptance of entertainment from industry should be avoided as it could be seen as an inducement to attend the meeting. Entertainment is the provision by industry of activities with no associated professional education (eg., tickets to a sporting event).1
8. Use of professional status to promote industry interests
8.1 Some doctors who are regarded by industry as having particular influence within the professional community may be asked to make public comments supporting a particular product. These individuals are sometimes referred to by industry as ‘key opinion leaders’.
8.2 Doctors should be aware their professional status may be used to promote the interests of industry. Doctors who provide a service for industry should ensure that any advice they provide in relation to a particular therapeutic product is objective, balanced, and evidence-based.
9. Remuneration for services
9.1 It is appropriate for doctors who provide a service to industry to receive remuneration for that service. This may include doctors who are industry employees, consultants to industry, or serve on an industry advisory board.
10. Product Samples
10.1 Product samples may be considered to be a marketing exercise by industry to accustom a doctor to prescribing a particular product or to influence a patient’s preference for a particular product. Product samples may, however, be used to serve patients’ interests in certain circumstances. For example, they allow prescribing doctors to evaluate an initial clinical response to a medication and/or permit them to initiate immediate therapy.
10.2 Distribution of samples, should not involve any material gain for the doctor or for the practice with which he or she is associated.
11. Dispensing and related issues
11.1 Practising doctors who also have a financial interest in dispensing and selling pharmaceuticals or who offer their patients health-care related or other products are in a prima facie position of conflict of interest.
11.2 Doctors should not dispense pharmaceuticals or other therapeutic products unless there is no reasonable alternative. Where dispensing does occur, it should be undertaken with care and consideration of the patient’s circumstances.
11.3 Doctors should not knowingly invest in industry manufacturing companies or related undertakings where knowledge about the success of the company or undertaking might be seen to influence inappropriately the manner of their practice or their prescribing behaviour.
11.4 Doctors in active practice should not be affiliated with industry manufacturers if the nature of their affiliation influences their medical practice in an inappropriate fashion.
12. Relationships involving industry representatives
12.1 Industry representatives seek out doctors in order to market products; however, the primary way in which doctors inform themselves about new products should be through judicious study of the appropriate professional literature.
12.2 Doctors in practice should not ask for or accept a fee, loan, or equivalent consideration from industry in exchange for seeing them in a promotional or similar capacity.
12.3 Practising doctors should not ask for, accept, nor allow their prescribing habits to be influenced by, personal gifts from industry.
12.4 Doctors in active practice may accept educational materials appropriate to their areas of practice.
- An ‘interest’ is a commitment, goal or value arising out of a social relationship or practice;
- A ‘duality of interest’ arises when two or more interests co-exist. These interests may or may not conflict, depending on the specific circumstances; and
- A duality may become a ‘conflict of interest’ when a particular relationship or practice gives rise to two or more contradictory interests.
Australian Medical Association. Code of Ethics 2004. Editorially Revised 2006
National Health and Medical Research Council. National Statement on Ethical Conduct in Human Research. Australian Government 2007.
Royal Australasian College of Physicians. Ethical aspects of conflicts of interest. January 2004.
World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. As amended by the WMA General Assembly, Seoul, Korea, October 2008.
Published: 13 Dec 2012