International Journal of Gynecology and Obstetrics 128 (2015) 282–283
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
FIGO COMMITTEE REPORT
Recommendations on conflict of interest, including relationships with industry FIGO Committee for the Ethical Aspects of Human Reproduction and Women’s Health
The FIGO Committee for the Ethical Aspects of Human Reproduction and Women’s Health considers the ethical aspects of issues that impact the discipline of obstetrics, gynecology, and women’s health. The following document represents the result of that carefully researched and considered discussion. This material is intended to provide material for consideration and debate about these ethical aspects of our discipline for member organizations and their constituent membership. B. Dickens, Chair FIGO Committee for the Ethical Aspects of Human Reproduction and Women’s Health E-mail: figo@figo.org Website: www.figo.org Bernard Dickens University of Toronto Faculty of Law 84 Queen’s Park Toronto M5S 2C5, Canada Tel.: +1 416 978 4849 Fax: +1 416 978 7899 E-mail: [email protected]
Background 1. Medical professionals have distinctive ethical responsibilities directly to their individual patients, and to the wider population of indirect consumers of their services that has confidence in their impartial judgment, to avoid or resolve conflicts of interest. Furthermore, they often have specific responsibilities as members of professional societies and/or universities, and as participants in educational activities, whether local, national, or international. 2. Conflicts of interest arise when medical professionals give priority to their own professional or personal interests over the interests of their patients and others who rely upon their integrity, whether their interests are financial or otherwise. In nonprofessional, commercial relationships, parties each legitimately pursue and protect only their own interests, under a “let the buyer beware” (caveat emptor) rule. In their professional relationships, however, medical professionals are expected to give priority to their patients’ interests over their own, and not to exploit the power they derive from their superior knowledge and influence for their own advantage. 3. Ethically questionable conflict does not require evidence of medical professionals’ actual corrupt promotion of their self-interest, but only a reasonable concern that biased judgment could occur. An appearance of conflict of interest, such as receipt of gifts, meals, or travel opportunities from commercial manufacturers, jeopardizes public trust not only in particular medical professionals, but also in the medical profession collectively. 4. Conflict is identified by asking whether reasonable observers of medical professionals’ relationships, for example when physicians hold shares in drug companies or receive fees as consultants to industry, would consider that the relationships might bias the physicians to serve their self-interest over the interests of their patients or of the wider community. Risk of medical professionals favoring their self-interest raises obvious ethical concerns, but conflict can appear through other motivations, such as promotion of personal beliefs. 5. Examples of physicians appearing able to favor their own interests over patients’ interests may be drawn from the breadth of professional activities. They include physicians having financial investments in manufacturers of products they may prescribe, serving as consultants to drug or medical device companies, commercially promoting nontherapeutic services (see FIGO’s “Ethical considerations regarding requests and offering of cosmetic genital surgery”), forming romantic or sexual relationships with patients (see FIGO’s “Some ethical issues in the doctor–patient relationship”), and advising one’s patient from a public health facility to attend one’s private fee-paying clinic (self-referral). Feesplitting with colleagues to whom physicians refer their patients is ethically prohibited because it presents bias of referral to colleagues who provide greater shares of fees than to others whose skills would better serve the interests of referred patients. 6. In undertaking or assessing scientific research, making professional conference presentations, serving as members of professional societies, writing, editing or reviewing professional literature, and, for instance, teaching or student supervision, there are also potential conflicts of interest, such as presenting only positive study results. Nondisclosure of financial or other interests may mask goals of self-interest and falsely imply disinterest and objectivity, inducing the unjustified confidence of others such as professional colleagues, governmental regulators, students, and readers.
http://dx.doi.org/10.1016/j.ijgo.2014.10.010 0020-7292/© 2014 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
B. Dickens / International Journal of Gynecology and Obstetrics 128 (2015) 282–283
7. Nonfinancial conflict of interest arises, for instance, when physicians exclude from disclosure of patients’ choices of treatment any medical procedures to which the physicians are conscientiously opposed, such as abortion, or when they object to participation in such procedures without referring patients to nonobjecting providers (see FIGO’s “Ethical guidelines on conscientious objection”). Nondisclosure of medical errors may violate duties of truth-telling to patients to serve self-interests in avoiding embarrassment or litigation (see FIGO’s recommendations on “Disclosing adverse outcomes in medical care”). 8. An appearance of potential conflict of interest is often unavoidable. In fee-for-service delivery of care, for instance, fees may be based on what individual patients are able to pay, such as through their health insurance schemes, rather than on scheduled rates. Fee income can be increased by recommending unnecessarily frequent follow-up appointments. Similarly, busy salaried providers may reduce the burden of services they are responsible to deliver by scheduling follow-up visits at too prolonged intervals. In either case, providers may appear to exploit patients’ dependency and disadvantage to serve their own interests. Medical licensing authorities and/or professional associations with disciplinary powers may review whether providers are setting exorbitant fees or departing from medically indicated frequency of follow-up care. 9. Relationships with professional colleagues may create conflicts of interest. Collegiality among physicians is frequently in patients’ interests, for instance in hospital and clinic settings where providers treat patients in teams. This may present conflicts of interest, however, when physicians give primary allegiance to colleagues rather than to patients. Providers may remedy or relieve errors made by their colleagues, to patients’ advantage, but may also gain self-serving interests in comfortable relationships with colleagues to conceal or deny such errors, and to tolerate colleagues’ substandard performance of their responsibilities. They may similarly be motivated to protect their departments’, hospitals’, or clinics’ reputations rather than expose deficiencies that place patients’ interests at risk. 10. Conflicts of commitment differ from conflicts of interest. When physicians receive no personal benefit for instance from giving priority to some patients over others, or from giving time to instructing students over attending committees on which they have responsibilities, or vice versa, that is, when they are disinterested in which interest they prioritize, their conflicts are in choice among alternative commitments. How they resolve these conflicts also raise ethical concerns, but not physicians’ ethical condemnation for succumbing to self-interest. 11. Conflicts of interest may be avoided, such as by divestment of suspect relationships, but conflicts that cannot be avoided may be
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resolved or reduced by appropriate disclosure and transparency. Disclosure to patients of their physicians’ investments in or consultancies to drug companies may not protect patients’ interests when company products may be prescribed, since patients usually lack means of independent judgment. Physicians may have to disclose their conflicts for instance to institutional superiors, professional associations, and licensing authorities, or at least to their colleagues. Disclosure of relationships with industrial and other manufacturers is ethically required in any professional evaluation of their products in publications and/or other communications, including professional presentations at conferences. Recommendations 1. Physicians should be alert to financial and other conflicts of interest in their professional practice and relationships, avoid such conflicts when they can, and make appropriate disclosures of conflicts that they cannot avoid, for instance to institutional superiors or professional oversight authorities or associations, and in professional conference presentations. Any proposed referral of one’s patient from a public health facility to one’s private clinic should be disclosed and justified to the administration of the public facility, and/or to one’s appropriate professional oversight authority. 2. Physicians should continually review their own direct and indirect financial and/or other conflicts of interest to ensure that they are not improperly influenced in the prescribing or promotion of drugs, devices, or other appliances. They should be associated only with treatments that have been peer reviewed or that have been investigated under careful appropriate methodology. 3. Physicians should charge fees for their services only that are reasonable according to professional standards, such as by reference to publicized fee schedules, and conform to professional standards in scheduling frequency of post-treatment care, in order not to appear to exploit patients for self-interest. 4. Physicians’ status as consultants, investigators, or holders of proprietary interests in development or use of drugs, medical devices, or other medical products or procedures should be disclosed as a financial or other interest in any professional evaluation and/or use they make of such drugs, devices, products, or procedures, for instance in publications and conference presentations. 5. Publishers of professional evaluations of drugs, medical devices, or other medical products or procedures should ask authors to disclose any conflicts of interest. Sponsors of medical conferences, meetings, workshops, and the like should publicly disclose any conflicts of interest they have, and ask presenters to disclose any conflicts of interest they have. London, March 2014
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
FIGO COMMITTEE REPORT
Recommendations on conflict of interest, including relationships with industry FIGO Committee for the Ethical Aspects of Human Reproduction and Women’s Health
The FIGO Committee for the Ethical Aspects of Human Reproduction and Women’s Health considers the ethical aspects of issues that impact the discipline of obstetrics, gynecology, and women’s health. The following document represents the result of that carefully researched and considered discussion. This material is intended to provide material for consideration and debate about these ethical aspects of our discipline for member organizations and their constituent membership. B. Dickens, Chair FIGO Committee for the Ethical Aspects of Human Reproduction and Women’s Health E-mail: figo@figo.org Website: www.figo.org Bernard Dickens University of Toronto Faculty of Law 84 Queen’s Park Toronto M5S 2C5, Canada Tel.: +1 416 978 4849 Fax: +1 416 978 7899 E-mail: [email protected]
Background 1. Medical professionals have distinctive ethical responsibilities directly to their individual patients, and to the wider population of indirect consumers of their services that has confidence in their impartial judgment, to avoid or resolve conflicts of interest. Furthermore, they often have specific responsibilities as members of professional societies and/or universities, and as participants in educational activities, whether local, national, or international. 2. Conflicts of interest arise when medical professionals give priority to their own professional or personal interests over the interests of their patients and others who rely upon their integrity, whether their interests are financial or otherwise. In nonprofessional, commercial relationships, parties each legitimately pursue and protect only their own interests, under a “let the buyer beware” (caveat emptor) rule. In their professional relationships, however, medical professionals are expected to give priority to their patients’ interests over their own, and not to exploit the power they derive from their superior knowledge and influence for their own advantage. 3. Ethically questionable conflict does not require evidence of medical professionals’ actual corrupt promotion of their self-interest, but only a reasonable concern that biased judgment could occur. An appearance of conflict of interest, such as receipt of gifts, meals, or travel opportunities from commercial manufacturers, jeopardizes public trust not only in particular medical professionals, but also in the medical profession collectively. 4. Conflict is identified by asking whether reasonable observers of medical professionals’ relationships, for example when physicians hold shares in drug companies or receive fees as consultants to industry, would consider that the relationships might bias the physicians to serve their self-interest over the interests of their patients or of the wider community. Risk of medical professionals favoring their self-interest raises obvious ethical concerns, but conflict can appear through other motivations, such as promotion of personal beliefs. 5. Examples of physicians appearing able to favor their own interests over patients’ interests may be drawn from the breadth of professional activities. They include physicians having financial investments in manufacturers of products they may prescribe, serving as consultants to drug or medical device companies, commercially promoting nontherapeutic services (see FIGO’s “Ethical considerations regarding requests and offering of cosmetic genital surgery”), forming romantic or sexual relationships with patients (see FIGO’s “Some ethical issues in the doctor–patient relationship”), and advising one’s patient from a public health facility to attend one’s private fee-paying clinic (self-referral). Feesplitting with colleagues to whom physicians refer their patients is ethically prohibited because it presents bias of referral to colleagues who provide greater shares of fees than to others whose skills would better serve the interests of referred patients. 6. In undertaking or assessing scientific research, making professional conference presentations, serving as members of professional societies, writing, editing or reviewing professional literature, and, for instance, teaching or student supervision, there are also potential conflicts of interest, such as presenting only positive study results. Nondisclosure of financial or other interests may mask goals of self-interest and falsely imply disinterest and objectivity, inducing the unjustified confidence of others such as professional colleagues, governmental regulators, students, and readers.
http://dx.doi.org/10.1016/j.ijgo.2014.10.010 0020-7292/© 2014 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
B. Dickens / International Journal of Gynecology and Obstetrics 128 (2015) 282–283
7. Nonfinancial conflict of interest arises, for instance, when physicians exclude from disclosure of patients’ choices of treatment any medical procedures to which the physicians are conscientiously opposed, such as abortion, or when they object to participation in such procedures without referring patients to nonobjecting providers (see FIGO’s “Ethical guidelines on conscientious objection”). Nondisclosure of medical errors may violate duties of truth-telling to patients to serve self-interests in avoiding embarrassment or litigation (see FIGO’s recommendations on “Disclosing adverse outcomes in medical care”). 8. An appearance of potential conflict of interest is often unavoidable. In fee-for-service delivery of care, for instance, fees may be based on what individual patients are able to pay, such as through their health insurance schemes, rather than on scheduled rates. Fee income can be increased by recommending unnecessarily frequent follow-up appointments. Similarly, busy salaried providers may reduce the burden of services they are responsible to deliver by scheduling follow-up visits at too prolonged intervals. In either case, providers may appear to exploit patients’ dependency and disadvantage to serve their own interests. Medical licensing authorities and/or professional associations with disciplinary powers may review whether providers are setting exorbitant fees or departing from medically indicated frequency of follow-up care. 9. Relationships with professional colleagues may create conflicts of interest. Collegiality among physicians is frequently in patients’ interests, for instance in hospital and clinic settings where providers treat patients in teams. This may present conflicts of interest, however, when physicians give primary allegiance to colleagues rather than to patients. Providers may remedy or relieve errors made by their colleagues, to patients’ advantage, but may also gain self-serving interests in comfortable relationships with colleagues to conceal or deny such errors, and to tolerate colleagues’ substandard performance of their responsibilities. They may similarly be motivated to protect their departments’, hospitals’, or clinics’ reputations rather than expose deficiencies that place patients’ interests at risk. 10. Conflicts of commitment differ from conflicts of interest. When physicians receive no personal benefit for instance from giving priority to some patients over others, or from giving time to instructing students over attending committees on which they have responsibilities, or vice versa, that is, when they are disinterested in which interest they prioritize, their conflicts are in choice among alternative commitments. How they resolve these conflicts also raise ethical concerns, but not physicians’ ethical condemnation for succumbing to self-interest. 11. Conflicts of interest may be avoided, such as by divestment of suspect relationships, but conflicts that cannot be avoided may be
283
resolved or reduced by appropriate disclosure and transparency. Disclosure to patients of their physicians’ investments in or consultancies to drug companies may not protect patients’ interests when company products may be prescribed, since patients usually lack means of independent judgment. Physicians may have to disclose their conflicts for instance to institutional superiors, professional associations, and licensing authorities, or at least to their colleagues. Disclosure of relationships with industrial and other manufacturers is ethically required in any professional evaluation of their products in publications and/or other communications, including professional presentations at conferences. Recommendations 1. Physicians should be alert to financial and other conflicts of interest in their professional practice and relationships, avoid such conflicts when they can, and make appropriate disclosures of conflicts that they cannot avoid, for instance to institutional superiors or professional oversight authorities or associations, and in professional conference presentations. Any proposed referral of one’s patient from a public health facility to one’s private clinic should be disclosed and justified to the administration of the public facility, and/or to one’s appropriate professional oversight authority. 2. Physicians should continually review their own direct and indirect financial and/or other conflicts of interest to ensure that they are not improperly influenced in the prescribing or promotion of drugs, devices, or other appliances. They should be associated only with treatments that have been peer reviewed or that have been investigated under careful appropriate methodology. 3. Physicians should charge fees for their services only that are reasonable according to professional standards, such as by reference to publicized fee schedules, and conform to professional standards in scheduling frequency of post-treatment care, in order not to appear to exploit patients for self-interest. 4. Physicians’ status as consultants, investigators, or holders of proprietary interests in development or use of drugs, medical devices, or other medical products or procedures should be disclosed as a financial or other interest in any professional evaluation and/or use they make of such drugs, devices, products, or procedures, for instance in publications and conference presentations. 5. Publishers of professional evaluations of drugs, medical devices, or other medical products or procedures should ask authors to disclose any conflicts of interest. Sponsors of medical conferences, meetings, workshops, and the like should publicly disclose any conflicts of interest they have, and ask presenters to disclose any conflicts of interest they have. London, March 2014
