In their daily decision-making practices, individual clinical practitioners constantly negotiate a great range of interests, including personal values and aspirations, professional and institutional obligations, and interests created by relationships with for-profit providers. The latter include the pharmaceutical industry and manufacturers of devices.

Clinicians often command control of substantial resources because of their ability to call on social wealth allocated by governments. This imposes a serious responsibility on them to assess carefully the interests involved and to make the most judicious decisions possible.

Because of the influential position of clinicians, the for-profit industry, especially the pharmaceutical industry, applies significant resources to the task of influencing their behaviour. This increases the importance for practitioners of taking care to ensure that their decisions are not unduly influenced or not biased in relation to any particular drug, device or service provider.

Most of the evidence regarding the influence of the pharmaceutical industry on clinical practice relates to health practitioners, who prescribe rather than use the products themselves. Accordingly, the focus of much of the discussion that follows will be on medical practitioners, although similar considerations undoubtedly apply to nurses, allied health professionals and pharmacists.

Because of its importance and the public concern the promotion of pharmaceutical products has evoked, this section focuses especially on issues arising in relation to the effects of the latter on clinical practice. These include assessment and management of dualities and conflicts of interests, interactions with pharmaceutical representatives, gifts, entertainment, the use of drug samples, familiarisation programs and other promotion strategies, therapeutic devices, support for meetings and other educational activities, sponsorship of travel and meetings of various kinds, and employment and consultancies. It offers guidance in relation to each of these matters. In general, the view taken is that all interactions between clinical practitioners and industry should actively serve the interests of patient care and population health and that in cases where a clear benefit to clinical practice is less certain, great caution should be exercised.

The key issue in clinical decision-making is the welfare and wellbeing of patients. Negotiation is required about how best to proceed in relation to, for example, an individual patient’s value system, the preferences of family and carers, and the prevailing social and cultural milieu. Our concern here is with the additional influences and interests to which clinicians are exposed that may affect their decisions. Not all of these are negative or harmful, but all practitioners need to develop sufficient awareness to control or limit influences that have the capacity to compromise their clinical obligations.

Interests arising from sources other than the pharmaceutical industry can also affect clinical decision-making. These include pecuniary interests associated with the complementary medicines, device and fine chemicals industries, as well as personal financial interests of clinicians and pressures imposed on them by their employing institutions.

Non-pecuniary interests are also relevant. Health practitioners work not merely for financial gain but also for personal satisfaction, status, reputation and other career objectives. Their decisions also need to consider working relationships with other health professionals.

The interactions between evidence and values raise some important issues. Evidence itself inherently reflects value choices – about how to represent reality, about what constitutes legitimate or valid data or phenomena, and about how to regard contending or alternative systems of knowledge. This is important in relation to the ways in which practitioners with Western scientific training regard non-Western approaches to medicine and healing, the evidence for which may be based on widely varying epistemological principles.

Evidence provided by the conventional mechanisms of science, such as clinical trials, also reflects value choices about what is considered relevant, both in terms of the data themselves and of the relevance of the clinical context. Clinical trials, with good reason, frequently focus on a narrow and clearly defined population. Diverse comorbidities are often excluded, including those associated with the extremes of age. Consequently, clinical trial data may be of only limited assistance to a clinician who faces a more complex clinical problem. Caution is required if a clinical trial medication is used in this off-label situation.

It has repeatedly been shown that health practitioners are influenced by their contact with industry. Advertising and other forms of drug promotion, including provision of gifts and entertainment, travel assistance to meetings, sponsorship of scientific meetings and appointment to advisory boards, all increase demand for specific products. Promotional materials distributed by pharmaceutical companies are often biased, incomplete or unsupported by evidence and may encourage unapproved uses. Contact with drug retailers and advertising materials erodes physicians’ ability to identify wrong claims, increases non-rational prescribing and results in acceptance of commercial rather than scientific views. Physicians typically deny or are unaware that promotional activities influence their behaviour.

While physicians may appropriately continue to interact with pharmaceutical representatives, they should develop procedures to minimise the risks. Such behaviours should entail critical evaluation and feedback on all unsubstantiated material, including journal reprints.

Choices of speakers and topics at meetings can have significant implications for the ensuing discussion and the clinical choices that will follow from it. Biases can be introduced into any kind of event, including continuing professional development activities and departmental and other meetings. Sponsorship that is, the provision of funds in return for a benefit, which may be minimal or inapparent often enhances support in favour of a company's products, for example it is known that prescriptions for sponsors' of pharmaceuticals increase in the six months after any kind of promotional event, even when no overt advertising of the products occurs.

Financial relationships between the for-profit industry, scientific investigators and academic institutions are widespread. Sponsorship affects research outcomes. There is a significant association between sources of funding and trial outcomes. Industry sponsorship is associated with pro-industry conclusions and restrictions on publication and data sharing. Research funded by drug companies is less likely to be published than research funded by other sources and is more likely to produce outcomes favouring the sponsor. Evidence regarding the activities of nurses and allied health professionals is more limited but is likely to raise similar issues. Physicians may be unaware that promotional activities affect their behaviour and may believe themselves to be less influenced than their peers. While this is understandable, it underlines the importance of standards other than one’s own judgment about whether one is influenced.

The presentation of the achievements of, and the challenges facing medicine and science in the popular media, play an important role in shaping not just the attitudes of patients but also the choices made by clinical practitioners. Typically, news reports tend to focus on medical ‘breakthroughs’, high technology solutions to clinical problems and novel drugs, devices or procedures, at the expense of the traditional values of caring and prudent decision-making. In this sense, the popular discourses can be seen as advocating for particular interests in place of others, which may be more appropriate or relevant in the given clinical circumstances.

The popular media, including social media networks, also provide powerful mechanisms by which advocates for particular products or approaches to treatment can promote their perspectives. The growth of the internet has greatly enhanced the access of community members to a range of viewpoints and sources of data, while also making it more difficult to distinguish information sources and to determine whether the information is commercial in nature.

In recent years, much debate has focused on the extent to which pecuniary relationships into which health professionals enter should be publicly disclosed. There are very few defensible reasons to limit transparency and health professionals should commit to full disclosure of their relationships with all aspects of the for-profit industry. Such circumstances may include relationships that require commercial confidentiality or personal financial dealings that have no direct or indirect bearing on clinical or research outcomes.

The need for transparency also extends to non-pecuniary interests. These are both very varied and are capable of exerting profound influences on clinical decision-making. It is the responsibility of all clinicians to undertake a rigorous process of reflection to identify the non-pecuniary influences to which they are exposed, including institutional constraints and demands, religious and political commitments, and personal goals and ambitions. Where appropriate, these should also be declared to patients in a clear and factual manner.

It should be noted that transparent disclosure of relationships is just one aspect of the available processes for managing dualities of interests involving health professionals and industry. As indicated in these Guidelines, many other strategies may also be used according to the context.

While much of the evidence and public discussion about the interests directing clinical decisions have focused on the role of the pharmaceutical industry, it is important to remain aware that the same arguments apply to all other health products. The field of complementary medicines, which includes herbal medicines, vitamins and food supplements, is less regulated than that of pharmaceuticals, potentially posing the risk of greater abuses in some cases. The food industry, like the pharmaceutical industry, has a long history of interaction with healthcare institutions, public health bodies and individual practitioners (most notably that between paediatricians and breast milk substitute/infant formula manufacturers and retailers) and continues to exert considerable influence over public health policies and clinical guidelines. The device industry is a powerful, although less conspicuous, participant in the for-profit health industry.

Providers of other services, such as radiology and pathology services, are equally exposed to pecuniary and non-pecuniary forces, which may influence their decisions. The arguments relating to the pharmaceutical industry apply equally to these other aspects of the health industry.

Of particular concern to both the public and clinical practitioners are relationships that may affect healthcare delivery, for example those involving the pharmaceutical, complementary medicines, medical devices and biotechnology industries. Clinicians and industry share common goals in that they are engaged in the prevention, control and management of disease and the conduct of research directed towards improvements in healthcare and patient outcomes.

However, the interests of clinicians and industry diverge, because the primary obligation of for-profit organisations is to their shareholders, while that of clinical practitioners is to their patients. The main obligations of researchers are to their research participants and to the generation of knowledge.

In recent years, the promotional activities of industry have been the focus of intense public and professional debate. There are various reasons why this is the case, including the following:

• Promotional activities, by their very nature, are intended to create influence, to change prescribing behaviour, the choice of tests or interventions, and the focus and outcomes of research.


• Industry may use persuasive techniques other than arguments based upon evidence such as emotive techniques.


• Industry may present or interpret evidence in ways that reflect or promote its own interests.


• It is impossible, both practically and linguistically, to distinguish clearly between different forms of influence, including education, persuasion and coercion. Thus, while educational activities may function to increase knowledge, they can also promote particular views, ideas or interests.


• Promotion has consistently been shown to influence practice in ways that may create harm to patients, healthcare providers and the community.


• While promotional activities are increasingly aimed at consumers, including patients, they mainly still target clinicians – who are trusted agents of both their patients and the community.


• It is increasingly recognised that industry promotion adds significantly to the costs of therapeutic and diagnostic products, especially prescription pharmaceuticals. The additional costs are ultimately borne by patients themselves and by the community.

There is compelling evidence that the giving of gifts to health practitioners is an effective marketing activity which erodes the independence of their judgment. Acceptance of gifts, including discrete gift items, payment for dinners, entertainment or expenses associated with daily living, is associated with an increased likelihood that health practitioners will prescribe products produced by those pharmaceutical companies, even in the absence of supporting scientific data. Often health practitioners are unaware that they are subject to such influence, indeed they often consider that they are not affected.

There are, in fact, only rare occasions in which acceptance of gifts could be considered to be in the interests of patient care and population health. These generally involve provision of service-oriented items for example, clinical examination equipment or teaching aids, which are not otherwise readily available. Even in these cases caution should be exercised, because often such items are in fact readily available, or are unnecessary to the provision of optimal care and may come at considerable cost, such as the undermining of the assumption of independence of health professionals from industry and therefore the trust on which clinical relationships depend. In this regard it is important to note that even items of small value that superficially appear to be innocuous are intended to sway health practitioners’ judgments and, at the least, may suggest to patients that the independence of the practitioner has been compromised.

Various kinds of advice have been offered to health practitioners about accepting gifts. These range from blanket rejection, to a gradient of moral acceptability based on cost, to application of the principle that decision-making is unaffected, to the test of whether the recipient would be willing to have the arrangements publicly known. Each approach that attempts to define a gradient of acceptability is, however, problematic because it ultimately depends on arbitrary or subjective distinctions and criteria. For these reasons the simplest, and most defensible approach is for health professionals to err on the side of rejection of gifts, even those of trivial value.

While individual practitioners always need to be alert to the potential that gifts influence attitudes and practice, it should not be left to individual practitioners to determine whether or not particular gifts are accepted. Institutional policies and guidelines regarding the acceptance of gifts may be more efficient and effective and remove the burden for making decisions from individual practitioners.

Hospitality is the provision of food and beverages by industry in association with a meeting or event covering topics of relevance to professionals. Entertainment is the provision by industry of access to cultural, sporting or artistic events, that is, with no purported associated professional content.

Current practice is for health practitioners to reject industry entertainment invitations and this response is appropriate and expected. The case of hospitality, however, is somewhat more complicated and remains the subject of discussion. For example, information sessions may be held in the evening after a day’s work and it may be appropriate for them to be combined with the modest provision of food and drink. While this may be acceptable, the fact or even appearance of impropriety should be considered before accepting such benefits, even where they are accompanied by scientific presentations.

Food and drink may also be offered by industry to make grand rounds or similar meetings within hospital settings more attractive. While this may seem innocuous, it facilitates relationships between clinicians and industry providers that may adversely influence both doctors and medical trainees, and students, and influence prescribing practices. The practice may also arouse concerns within the community. For all of these reasons, hospitality at professional and institutional meetings should generally be provided by attendees themselves or by their employers.

The advent of transparency ‘sunshine’ requirements in different jurisdictions will ensure that in many cases, acceptance of hospitality or entertainment expenses by individual practitioners will become public knowledge. This is appropriate, as the information is of genuine public interest and there is no reason to conceal it. However, it is recognised that on occasions judgment on these matters will still sometimes be difficult, and in these cases it might be helpful to seek advice from colleagues, institutional representatives, the employing authority or an ethics committee.

Drug samples are pharmaceutical products distributed by manufacturers or their agents to health practitioners. Starter packs are samples that can be provided to patients who are about to commence treatment. In some cases, samples may be sought by a clinician in order to obtain a drug unavailable on the Pharmaceutical Benefits Scheme (PBS), while in others, they may be used to provide immediate access to drugs in emergency circumstances, to allow safe escalation of starting doses, or to assess patient acceptability of medications.

There are different views in the community about the appropriateness of health practitioners accepting drug samples and starter packs from industry. On occasion, it is certainly argued that there can be benefits for patient care. Nonetheless, there can be no doubt that the provision of samples is primarily a marketing exercise that is intended to create relationships of reciprocity between clinicians and industry representatives, to accustom clinicians to prescribing particular products, and to establish cohorts of patients on long-term treatment with newer and often more expensive drugs. Further, employment of product samples often compromises the quality use of medicines and works against principles of rational prescribing.

It is sometimes claimed that the use of samples is justified by the inflexibility of prescribing regulations, which make no provision for short-term trials of the acceptability of new medications. However, while this argument has obvious plausibility, it is undermined by the fact that the persistence of the sample system actively limits attempts to establish regulatory regimes that are more readily adapted and applied to patient needs.

Some manufacturers have introduced support programs that offer patients a range of services, including telephone helplines, educational literature, access to websites and even additional medical treatments. Although such programs may facilitate optimal use of a drug as well as a measure of support to patients, clinicians should bear in mind that they also often function as promotional devices. As such, they have the ability to influence the attitudes of patients and health practitioners to use particular medications and frequently contain information that favours the products or services of particular companies.

Support programs also create relationships between companies, practitioners and patients that can be used to support particular clinical and research objectives, including applications for public subsidisation of products. This may increase patient dependency, with potentially adverse consequences when a program is discontinued. Of particular concern is the possibility of direct contact between industry representatives and patients, which would undermine the independence of clinicians and the integrity of their clinical relationships. Accordingly, the conduct of support programs should be carefully monitored by members of healthcare teams.

Practitioners who have the opportunity to enrol patients in industry support programs or are asked to provide patients with information about these services, should consider the reliability of the information to be provided and whether patient care will indeed be meaningfully enhanced.

Clinicians are generally expected to adhere to the principles of ‘rational prescribing’ and ‘quality use of medicines’, which emphasise prescription of medicines that have been demonstrated to be safe and effective. In this context, a distinction is often made between ‘on-label’ and ‘off-label’ prescribing. On-label uses are those that have been approved by regulatory organisations such as the Therapeutic Goods Administration (TGA) following formal assessment of safety and efficacy data from clinical trials, whereas off-label prescribing refers to situations where medications are prescribed outside such approved indications (e.g. for a different indication, patient age range, dose or route). Off-label prescribing is particularly common in the treatment of rare or orphan diseases and in immunology, oncology, palliative care, psychiatry and paediatrics. In paediatrics in particular, many commonly used drugs have not been specifically tested on children so their use is categorised as ‘off label’ for this reason alone, even when it is fully accepted as routine.

In recent years, off-label prescribing has attracted substantial debate. On the one hand, it is argued that it is needed in order to speed access to drugs for new indications, ensure flexibility for clinicians and provide options for patients for whom alternatives are limited. It is also noted that off-label prescribing may be based on high-quality evidence that has simply not been presented to regulatory agencies for commercial or other logistical reasons.

On the other hand, a number of concerns have been raised about off-label prescribing, including that it is not always evidence based (or is based on ‘low level’ evidence such as clinical experience or anecdote) and can therefore put patients at risk, that it undermines pharmaceutical innovation, clinical research and regulatory systems and that it can add to healthcare costs. Another concern is that off-label prescribing is often the outcome of the promotional activities of pharmaceutical companies anxious to extend the market for their products. While industry promotion of off-label prescribing of their products is prohibited in Australia and elsewhere, such practices are common and are known to have significant effects on prescribing behaviour.

Given these potential dangers and untoward commercial influences, prescribers should always exercise caution about prescribing medicines for non-registered indications.

Some software programs used by health practitioners to assist with clinical functions include the advertising of pharmaceutical and other products. When computers running such programs are positioned in such a way that they can be seen by patients during consultations, they may raise in the minds of the latter the possibility that their practitioners are subject to influence from industry or bias as a result of their associations with it. More generally, by allowing commercial values to intrude into relationships between doctors and patients, such advertising may undermine the key ethical assumption of the clinical encounter of the primacy and paramount importance of the interests of patients.

For these reasons it is recommended that, where possible, practitioners should choose software that does not include industry advertising or, when using such software, they should disable the advertising functions.

Therapeutic devices are physical objects other than medicines that are employed by clinical practitioners for therapeutic purposes. A wide range of devices are available, covering many aspects of medical practice. They include, for example, devices to deliver asthma drugs, continuous positive air pressure devices for the treatment of sleep apnoea, cardiac pacemakers and stents, breast implants, artificial joint prostheses, and blood pressure and glucose monitoring devices. Because they are produced in a commercial setting, the potential exists for dualities and conflicts of interest to arise, as is the case for medications. There are also issues relating to the advertising, promotion and sponsorship of therapeutic devices. Much that has been said about medications therefore also applies to devices.

Because the regulatory systems relating to drugs and devices vary, and because devices may also be promoted and used by health practitioners, there are additional issues that need to be considered. Clinical practitioners may have financial or non-financial interests in the development, manufacture or sale of devices. For example, they may hold shares in or receive payment of royalties from a company that produces a device. If they had been personally involved in the product’s design, testing, refinement or commercialisation, they may also stand to gain benefits in the form of enhanced personal prestige or reputation.

A clinical practitioner may enter into a special arrangement with the manufacturer or distributor of a particular device or type of device. For example, special benefits either in cash or in kind, may be provided in return for prescribing or using a device. Alternatively, an arrangement may be entered into with a manufacturer to provide a device at a favourable cost to patients, to the apparent advantage of both doctor and patients.

A practitioner who stands to gain financially or non-financially from the success of a new device may be inclined to recommend its use to patients. The obvious competing interests in this case may raise issues about the independence of the clinical judgment that is being exercised. In such cases, care needs to be taken to ensure adequate disclosure and, where appropriate, referral of specific patients to other clinicians.

A manufacturer or distributor of a device may also advertise directly to the public or offer special benefits, such as free medical assessments, as an inducement to use their product. This has the potential to place pressure on clinicians to use products and may create or exacerbate any conflicts of interest of the clinician.

These examples illustrate distinctive ways in which commercial and other interests associated with devices can intrude into clinical practice. The non-pecuniary influences may be just as potent, although they may be less conspicuous to all parties. The examples given emphasise the importance of careful attention to the identification and disclosure of dualities of interests, associated with formal and transparent processes for review and management of any actual conflicts.

Relationships between clinical practitioners and producers and manufacturers of devices should be subject to the same transparency requirements as those with pharmaceutical companies. Individual interactions involving transfers of value between practitioners and commercial entities should be declared in a manner that is freely accessible to the public.

Both the pharmaceutical industry, and increasingly, the biotechnology industry provide financial and in-kind support for the organisation of meetings and for practitioners to attend them. Other industries, including the complementary medicines industry, pathology companies and other commercial service providers, and professional and political associations, might also wish to provide support for meetings.

Support provided by industry organisations for meetings can include paying for speakers, venues, satchels, refreshments and exhibitions of pharmaceutical or scientific products. This support is usually provided with the stated aim of contributing to educational or scientific activities. However, there is evidence that the association of pharmaceutical industry support for such events can affect decisions clinicians make in their practices, with the result that these decisions are not always based on objective scientific data and therefore may not contribute optimally to patient care or population health.

Pharmaceutical industry support of meetings therefore carries a risk of influencing the capacities of clinical practitioners to make disinterested decisions on behalf of their patients. In view of this, great care should be exercised before accepting support from industries, even for validly constituted meetings or other educational events. The nature of industry support, and any obligations associated with it, should be declared openly to those who might have an interest in knowing. Where a meeting is organised directly by an industry sponsor, the presentations should as a matter of course be subjected to formal critical scrutiny in relation to the possibility of bias or incomplete information.

The best way for industry to support scientific meetings is through independent organising bodies which use the funds provided by industry to defray the costs of bringing in invited speakers, and for other purposes. To qualify as independent, an organising committee should be free of industry sponsor representation (which can be difficult to define for industries that are not clearly for profit, for example where members of the association work in the military services, government departments or charitable organisations). The committee should also ensure that the relevant professional details of each committee member are placed in the public domain and dualities of interests both pecuniary and non-pecuniary are publicly declared.

The costs of travelling to and attending such meetings should in general be met by those who attend them because of their educational value. If they accept financial support outside these arrangements, individuals should determine that the meetings will have educational value, that they will not lead to loss of professional independence and that public scrutiny of them would not raise concerns.

In addition to clinical and scientific meetings organised by independent organising committees, industry organisations sometimes provide sponsorship to clinicians to participate in a variety of other events such as local meetings of specialist groups, hospital grand rounds, departmental scientific meetings, product launches and continuing professional development programs. While these meetings usually have a clearly defined primary educational aim, industry support may provoke suspicion that attendance will result in clinical decisions being influenced by associations with industry. Practitioners involved in organising or attending such meetings should have a high level of awareness of this risk. They should take deliberate steps to ensure that the source and extent of sponsorship are fully disclosed (acknowledging that disclosure alone may not be effective in countering industry influence) and that the primary educational purposes of the meetings are achieved.

Before any form of industry support is accepted, the following questions should be considered:

• Will acceptance of support be likely to result in any actual or perceived loss of professional independence, either during or after the period of support?


• Is the proffered support genuinely and clearly linked to further education or ongoing professional development which is likely to benefit the community?


• Do the potential supporter’s organisational history and practices, either locally or internationally, raise concerns?


• Have the criteria used to select invited speakers and delegates to an industry-supported meeting been publicly disclosed?


• Have the scientific and promotional components of the meeting been sufficiently separated by the organisers?


• Are there any dualities of interest that need to be declared?


• Would patients and their families be concerned by such sponsorship?


• Will the propriety of the sponsorship stand up to scrutiny by colleagues and the public?


• After consideration of the above, do the potential benefits outweigh the risks?

In general, industry support of meetings should be indirect and mediated through independent organisers, untied to the promotion of any commercial product or other industry concern and appropriately disclosed to relevant organisations and meeting attendees.

Industry support may be offered to individual health professionals to travel to meetings in which they will be involved as speakers, chairpersons or in other significant capacities such as contributors to the organisation of subsequent meetings. This form of sponsorship recognises the standing of the individuals and may be necessary if there is no other means by which these contributions can be recognised. However, it is important that the sponsorship is indirect, untied and fully disclosed. Support should be indirect. Where payments are to be made to individuals in return for participation at a meeting, such payments ought to be made by the independent meeting committee and not by the industry sponsor. Payments should be commensurate with the services provided and not excessive as judged by the independent organisers of the meeting or others.

In general, it is inappropriate for health professionals to accept sponsorship directly from industry and independently of the meeting organisers. Sponsorship (either direct or indirect) to cover the cost of travel, attendance or meals for family or friends is never acceptable.

Support should be untied. Support that is tied to the promotion of commercial products or other industry concerns should not be accepted, even if payments are received via an independent organising committee.

It is the responsibility of individual practitioners receiving support from industry to ensure that any information or research presented at meetings is unbiased and in accordance with the accepted norms of scientific inquiry. It is important that such information or research does not lend itself to be interpreted (rightly or wrongly) as an endorsement of commercial products or other industry concerns. For example, practitioners ought to be careful to use product non-specific terms when presenting (e.g. drug class rather than drug brand names). Where reference to a specific product is unavoidable, the generic name should be used and both commercial trade names and mention of individual pharmaceutical and health technology companies should be avoided.

Before payment or an honorarium is accepted in return for participation in a meeting, it should be confirmed that the scientific and commercial (or other industry-oriented) elements of the meeting have been sufficiently separated. Speakers should declare dualities of interest at the beginning of their presentations, including direct or indirect support they have received to attend the meeting. Support should be fully disclosed. Industry support received and used by a meeting organising committee to pay clinicians for their contributions ought to be fully disclosed and placed in the public domain prior to the meeting. Such disclosures should include:

• names and brief descriptions of the relevant activities of industry supporters


• statements of the nature and size of both monetary and in-kind contributions


• declarations by industry supporters attesting to the untied nature of their contributions


• statements by the committee regarding promotional rights granted in return for support (e.g. advertising space)


• list of criteria for selecting invited speakers or other participants who qualify for financial payments or honoraria

Health professionals need to be careful about accepting payments from organising committees that fail to meet high standards of public disclosure about industry support. Particular care should also be taken for meetings that are not regular meetings of recognised professional societies, especially if there is no independent organising committee and the meeting is organised by industry. In these cases, it should be recognised that invitations almost certainly arise from the fact that for profit companies and, to some degree, not-for profit organisations, consider that clinicians’ contributions will be to their benefit. In addition, the lack of an independent organising committee may call into question the independence of a speaker. If accepted, support for contributions to such events should be declared in accordance with the criteria above to hospital, university or other bodies with which the practitioner is affiliated.

The distinction, familiar in educational settings, between those presenting educational materials and those in the audience receiving them, does not always apply exactly to scientific or clinical meetings, where audience members may often be actively engaged and contribute vigorously. However, the roles of presenters and of other attendees at a meeting are nonetheless different, and in relation to questions of industry sponsorship they are associated with different levels and kinds of risk.

While concerns about supporting speakers relate primarily to the likelihood of biased messages being promulgated, support for attendees is risky mainly because of the conscious or subconscious sense of personal obligation that may be induced. This is exacerbated by the fact that in cases where a formal contribution is not being made, sponsorship is almost always provided directly by a company to an individual. Under these circumstances, even if the potential educational value of the meeting is unquestionable, acceptance of support to cover travel and attendance costs is very likely to lead to perceived or actual conflicts of interest in subsequent decisions regarding the sponsor’s products. As a result, both the risk of compromising the personal and professional standing of practitioners and the level of community concern about their conduct are high.

Accordingly, in such cases practitioners should exercise extreme care. If, after having considered the questions listed above, a health professional believes that accepting support in a particular case is reasonable, steps ought to be taken to reduce the risk of being unduly influenced. Agreement should be sought specifically from appropriate institutional committees (e.g. of a hospital, university or professional society) prior to acceptance of the sponsorship. The necessary public declarations should be made and be available for scrutiny.

Sponsorship of non-presenters to attend conferences or meetings may be less problematic where there is a clear separation between sponsorship, the decision to sponsor particular individuals, and the individuals themselves. This could be achieved, for example, by the industry sponsor creating a general fund that is managed independently by a third party (e.g. a conference organising committee).

As discussed above, it is always inappropriate for practitioners to accept sponsorship (either directly or indirectly) to cover the cost of travel, attendance or meals for family or friends. The principles for accepting group sponsorship for attendance at meetings and conferences are the same as for individuals. Group sponsorship in no way mitigates individual responsibility or ethical obligations.

Medical grand rounds are a time-honoured and valued institution within medical training and ongoing professional development. Grand rounds may also be expensive to run. Not only may funds be required to provide remuneration for an invited specialist or expert speaker, but organisers often wish to provide attendees with food and other incidentals in order to promote attendance. Financial support for grand rounds should be sought from the clinical institution or from alternative sources, including attendees. This is especially important in teaching institutions because of the additional responsibilities to trainees and students.

If industry support is accepted, organisers should minimise any real or perceived conflict of interest by:

• insisting that all industry support is untied and fully disclosed


• ensuring that the industry supporter has no part in determining the speaker, subject or content matter for the grand round


• ensuring that all speaker dualities of interest are declared prior to the event


• ensuring that all content is presented in accordance with the accepted norms of scientific practice, including that all information be presented in an unbiased and balanced manner, especially where any product of the industry support is mentioned


• ensuring that any free food and incidentals provided are standard fare and do not detract from the primary educational focus of the grand round


• ensuring that displays of industry materials and interactions with industry personnel are kept to a minimum

Given the relatively small size of such meetings, combined with the risk of the appearance of impropriety, health professionals and meeting organisers should question whether industry support is necessary, including for meals. Many of the costs for such meetings can be defrayed by nominal attendance fees and other organisational sources.

Where industry support is required for such meetings, individual practitioners and meeting organisers should take steps to ensure there are no real or perceived conflicts of interest. As stated above, all effort should be made to ensure that external support is indirect, untied and fully disclosed.

The primary purpose of product launches is promotional rather than educational. This premise should always guide decisions concerning access to such events. In teaching institutions, decisions about access should also take into account the additional educational responsibilities to trainees and students.

In some cases, an industry body selects and sponsors both the speaker(s) and the meeting. Under these circumstances, the industry body should send out invitations in its own name, provide the venue for the meeting, support the speaker and meet other costs. Such meetings should not be or purport to be under the auspices of independent practitioners or clinical organisations. If the topic is likely to be of interest to a significant number of people, then professional bodies or other sources separate from the company may decide to advise their members.

An industry body might provide a speaker for a meeting primarily organised by health professionals. Use can be made of visiting speakers, but care should always be exercised in acceptance of such offers to ensure that an unbiased presentation will be made. Companies may be disinclined to provide speakers unless it is known that the speakers are likely to support the objectives of the company. If areas are known to be contentious, care should be taken to ensure there is an appropriate balance of speakers canvassing alternative views.

At times, industry might offer support for meetings that are presented as ‘continuing professional development’ (CPD) or ‘continuing medical education’ (CME). The principles described above should apply to such meetings, and efforts should be made to ensure that they are legitimate in the sense of maintaining a primary commitment to scientific and educational objectives. The main goals of such meetings should be educational rather than commercial. As previously stated, formal processes should be established to critically evaluate the content of such events and to ensure that they are free from bias.

Privately funded educational institutions are an increasing part of the CPD landscape. Clinicians and clinical organisations making use of the services of these institutions should be aware that they may be funded by industry. To minimise the risk of marketing masquerading as education, they should ensure that:

• all industry support for the CPD organisation, and any speakers they provide, is fully disclosed


• all content is presented in accordance with the accepted norms of scientific practice, including that all information is presented in an unbiased and balanced manner, especially where any product of the industry support is mentioned


• presentation slides prepared by industry or its agents are avoided


• food and incidentals provided are standard fare and do not detract from the primary educational focus of the meetings


• there are mechanisms in place to evaluate the content of the meetings, especially in relation to the integrity of the presentations and discussion, and that the results of these evaluations are made publicly available

Practitioners are entitled to remuneration for their services except where their right to provide such services is limited by their conditions of employment. Remuneration for services provided to industry should be disclosed to patients and employers.

Health practitioners should not accept fees or equivalent considerations from companies in exchange for seeing them in a promotional or similar capacity.

In many employment settings, conditions are imposed on clinicians about what is considered acceptable or appropriate practice, including drugs available for prescription and the use of specific therapeutic devices. Such conditions may reflect limitations in resources or consensus views of panels of experts. They may raise issues for clinicians who are concerned to find that in some cases the most effective treatments for their patients are not available for use.

Individual practitioners who provide services to pharmaceutical or other companies, including those in the investment industry, are entitled to fair remuneration for these services. Such relationships with industry often create dualities, however, which may raise the question of conflicts between duties to industry and to patients. For example, when a practitioner becomes publicly associated with the products of a particular company, the independence of his or her recommendations to patients in relation to all the products that are available may be questioned.

If a clinician acts as a consultant to industry, this fact should be public knowledge and reported to relevant committees, heads of department, employing institutions and patients. The relevant institutions in accordance with the procedures laid down in these Guidelines should decide whether dualities constitute a conflict of interest and what actions need to be taken to avoid compromise of the doctor’s primary responsibility to patients.

Practitioners may be directly employed in industry or subject to contracts with other employers. They may as a result be subject to a variety of interests, including obligations imposed as conditions of employment. For example, industry may restrict communication of commercially sensitive information, managed care organisations may impose limits on the extent and kinds of treatments that are available or even actively intervene in clinical relationships to direct health practitioners’ decisions, or hospitals may impose limits or restrictions on available treatments.

The implications of such employment arrangements have been discussed elsewhere. Where conflicts arise, health practitioners should inform their patients about the details that affect them and their implications. In some cases, practitioners may need to make decisions about whether it is ethical to continue to work in this setting.

Pharmaceutical companies and other institutional bodies often establish advisory boards to give advice about products or practices, including particular drugs or techniques. In the case of the pharmaceutical industry, such advice may involve all aspects of product development, from preclinical studies to marketing. Individual practitioners may appropriately contribute to such boards; indeed, this is one way in which they can use their clinical knowledge to increase the likelihood that therapeutic and other practices satisfy community needs.

To ensure that advisory board procedures are satisfactory, prior to their appointments practitioners should ensure there are formal, defined terms of reference, agendas for each meeting and that minutes are recorded and approved in accordance with usual practices. Members should be also satisfied that their involvement is meaningful, rather than purely symbolic.

It is possible that membership of an advisory board will encourage feelings of commitment to products, and sometimes to the organisation and its representatives. While such sentiments are common following any such collaboration, practitioners should ensure that clinical recommendations are based on sound principles. A health practitioner should not be subject to any obligation to prescribe a particular product or to take a particular course of action to make particular recommendations to other clinicians.

In view of the fact that membership of an advisory board poses questions of dualities of interest, members of such boards should openly declare their involvement. This may be especially appropriate when making presentations at meetings relevant to a company or its products, when teaching and training, when consulting with patients, in meetings and discussions in institutions, when prescribing in circumstances where questions might be raised about the independence of clinical decisions, and when submitting proposals for approval to a Human Research Ethics Committee when company products are involved.

It is possible that in some circumstances an association with industry will be judged to lead to a conflict of interest and, therefore, to require that other activities of the practitioner involved are affected, for example involvement in a committee of a professional or government body or engagement in research. Outcomes might range from withdrawing from a particular discussion to withdrawal from the activity itself.

Clinical practitioners, particularly those who are regarded by members of industry as having special influence within their professional community, may be asked to make public comments supporting particular products, policies or courses of action.

There is an assumption in the community and among the patient population that health professionals are trained to analyse scientific evidence and to provide advice about health practices and community health needs. It is important to avoid using one’s status and the good faith associated with it to promote commercial interests or the interests of other organisations when they do not support the welfare of the community or of individual patients.

It is necessary to distinguish between scientific comment and support for particular products. The context in which the comments appear may be very important. A paid advertisement from a company may legitimately quote comments made in a scientific publication. However, comments should not be provided for the express purpose of supporting the advertisement of a product. If a comment is intended as an educational contribution, the appropriate procedures should be followed.

The practice of providing endorsement of a product in the form of a public statement, sometimes called an ‘advertorial’, clouds the boundary between professional responsibility and commercial interest and is unacceptable.

Companies promoting newer pharmaceutical products sometimes arrange presentations by practitioners willing to suggest that the use of older - and usually cheaper - agents may be undesirable due to their more severe side effects. Clinicians taking part in industry-sponsored presentations should not promote such suggestions unless they are supported by robust evidence.

Hospital pharmacies (public and private) have a long tradition of receiving rebates, often financial, from industry when they dispense a particular medication. More recently, this practice has occurred with highly specialised drugs used under the PBS Section 100 program and can involve significant amounts of money (as an example, this behaviour commonly occurs with erythropoiesis-stimulating agents). When more than one drug is used for a specific indication and some of them have an associated rebate program, a hospital practitioner may be asked to consider:

• deleting one or more competing products from the hospital formulary due to storage problems


• limiting the prescribing of drugs without a rebate to maximise the institutions resources

Despite the potential value of the rebate to the institution or to the clinical department, decisions should be based primarily on clinical efficacy and on what is in the best interests of patients. The cost to the PBS is an additional factor that should be considered.

Health professionals may become involved in overseas work in a variety of capacities as:

• clinicians working for aid groups


• advisers for government or non-government organisations involved in health-related activities


• clinical researchers in projects that include overseas sites


• academic researchers involved directly or indirectly in projects that involve overseas issues


• editors of journals which publish material relating to developing countries

Each of these roles raises specific ethical issues and health professionals should be aware of them. The most sensitive issues relate to developing countries.

In the international health practice setting, industrial players include overseas aid organisations, government and non-government organisations/bodies, which often support agendas that reflect their own local interests. Also, research institutes, members of the pharmaceutical, biotechnology and device industries, and universities may be engaged in overseas practice in support of the interests they represent.

At times, the various interests are difficult to define because of the number of parties involved, varying and sometimes conflicting intentions, and in the absence of formal relationships between patients and doctors. In addition, language and cultural differences may complicate relationships and communication about goals, purposes and values. Furthermore, constraints associated with limitations of resources may be severe.

Here as elsewhere, the primary interest by which actions or decisions are assessed should be the wellbeing of the individual members of the communities the professional intends to serve. In the public health setting, however, this often has to be delicately balanced with the welfare of the wider society.

The importance of effective communication and dialogue needs to be especially emphasised. Practitioners may find it very difficult to communicate with individual patients or community members. Cultural attitudes and religious practices may vary widely from those with which health professionals are familiar, based on their own backgrounds, residence and experiences.

There may be discrepancies between the motivations and values of individual practitioners and funding agencies. Health professionals working in this field are advised to seek detailed assistance as required. The following additional brief comments are intended merely to illustrate the scope of the issues that arise.

Concerns have been raised about exploitation of people from poorer countries by pharmaceutical companies. This may include non-observance of industry or practitioner guidelines, non-availability of key medications and, for workers, low wages and unsafe conditions. In places where pharmaceutical distribution is poorly regulated, the use of medications in the community may be inappropriate and excessive.

In research projects conducted by industry, issues may arise about community benefit, recruitment of participants, consent processes, coercion, use of placebos and availability of test medications after the conclusion of studies.

Ethics approval for such projects should be obtained both from the institutions from which the researchers come and from the relevant jurisdictions within which the participants are to be recruited. If there is a chance that the standards of the various institutions involved in the research may conflict, in general, it is the more stringent of the various competing rules that should prevail.

Practitioners may contribute to global health activities as advisers or mentors either based in their home country or when deployed in developing countries. Such work is important for addressing issues of health and poverty. However, it is also subject to the interests of funding agencies, including governments and private philanthropic foundations.

The agendas of foreign agencies themselves may be problematic because they are often driven by political, religious and social interests and because standards of oversight and probity may differ. Foreign aid can often result in unexpected and unwanted consequences owing to cultural, economic and political circumstances; accordingly, the sensitivities of local communities and practitioners need to be considered.

On occasions, overseas deployments can be associated with danger, either physical or psychological, to the practitioners themselves. Those involved in the planning and implementation of overseas aid programs should remain aware of this and take whatever action is needed to provide protection to aid workers.

Practitioners working in overseas settings should carefully scrutinise their relationships with the various components of industry with which they engage and clarify the purposes and practices associated with their activities. The practitioners themselves should assume responsibility for the details of these relationships, including both the short and long-term associated consequences.