OUTLINE OF PRESENTATION

1. ETHICAL CONSIDERATIONS IN CONTEMPORARY CLINICAL PRACTICE – THE WMA PERSPECTIVEProf. John R. Williams, Ph.D.Director of EthicsWorld Medical Association

2. OUTLINE OF PRESENTATION • Introduction to the World Medical Association • The WMA and Medical Ethics • Confidentiality • Human Rights • Clinical Research • Commercial Enterprises • Conclusion

3. WMA’S MISSION The purpose of the WMA is to serve humanity by endeavoring to achieve the highest possible standards of medical care, ethics, science, education, and health-related human rights for all people.

4. The World Medical Association • Established after WW2, mainly in reaction to atrocities involving physicians • Global representative body for physicians • 84 National Medical Associations, approximately 7 million physicians

5. WMA’S UNIQUENESS The WMA is the only international organization that speaks on behalf of all the world’s physicians, regardless of location, specialty or practice setting.

6. WMA’S ACTIVITIES • Policy development and review • Medical ethics • Human rights • Health issues • Medical education • Advocacy • WHO on tobacco control and other issues affecting physicians and/or public health • Observer status for Taiwan at WHO

7. WMA’S ACTIVITIES • Projects • Implementation of Istanbul Protocol on the Effective Investigation and Documentation of Torture and other Cruel or Inhuman Treatment or Punishment • Medical Ethics Manual • MDR TB Training Course • Clearinghouse of Information • Medical ethics • Public health (liaison between WHO and national medical associations)

8. WMA’S ACTIVITIES • Networking – face-to-face at the twice-annual meetings of representatives of NMAs – virtually through the website (www.wma.net) and email • Publications • World Medical Journal

9. WMA ETHICS UNIT • Coordinates policy development and review • Liaises with other international ethics groups (e.g., WHO, UNESCO) • Facilitates exchange of information at conferences and via the WMA website (www.wma.net/e/ethicsunit/index.htm) • Develops new ethics products (e.g., the medical ethics manual)

10. POLICY DEVELOPMENT AND REVIEW • Approx. 60 current policy statements and resolutions on ethical issues • Review of oldest policies underway • Telemedicine • HIV/AIDS • Terminal Illness • Medical Education • Ethical policies require 75% majority vote at the Assembly for adoption or amendment

11. WMA MEDICAL ETHICS MANUAL • Published January 2005 • For medical students and practising physicians • Available on WMA website: www.wma.net • Chinese translation planned

12. ETHICS - MEDICAL ETHICS • Ethics identifies values and principles for decision-making and behaviour and resolves conflicts over ethical issues. • An ethical issue: a situation where it is not clear what is the right thing to do. • Medical ethics deals with issues that involve physicians.

13. THE WMA AND MEDICAL ETHICS • Long history of medical ethics • Current ethical expertise and experience • Includes human rights and medical professionalism • Widespread consultation • Search for consensus (75% approval)

14. MEDICAL ETHICS • Clinical ethics • Professional ethics • Research ethics • Public policy ethics

15. CONFIDENTIALITY • Hippocrates – “What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself holding such things shameful to be spoken about.” • WMA Declaration of Geneva – “I will respect the secrets that are confided in me, even after the patient has died.”

16. CHALLENGES TO CONFIDENTIALITY • Complexity of medical care • Infomatics/computerization • Databases for administrative, planning, research or commercial purposes • Permissive or no legislation/regulation • Failure to implement data protection policies

17. PROTECTING CONFIDENTIALITY WMA Declaration on Ethical Considerations Regarding Health Databases: • Patient ‘owns’ personal health information. • Patient discloses personal health information for therapeutic purposes. • Other uses generally require patient’s consent.

18. PROTECTING CONFIDENTIALITY • Person who receives personal health information (usually the treating physician) has primary responsibility for protecting confidentiality. • Physicians can release information to third parties for legitimate reasons. • Patient information should be anonymised wherever possible.

19. HUMAN RIGHTS • The foundation of international medical ethics • Principal human rights for health: • Right to life • Right to freedom from discrimination, torture, and cruel, inhuman or degrading treatment • Right to freedom of opinion and expression • Right to equal access to public services in one’s own country • Right to medical care.

20. PHYSICIANS AND HUMAN RIGHTS • Often the first to encounter victims of human rights abuses • Responsibility to patient can conflict with demands of prison officials, police or military

21. PHYSICIANS AND HUMAN RIGHTS • Medical ethics (e.g., WMA Declaration of Tokyo) clearly states that physicians should not participate in torture or other cruel, inhuman or degrading treatment. • Resources: • On-line course for prison physicians (http://www.wma.net/e/webcourse_2004.htm) • Physicians for Human Rights (http://www.phrusa.org/) • International Rehabilitation Council for Torture Victims (http://www.irct.org/usr/irct/home.nsf)

22. PHYSICIANS AND CLINICAL RESEARCH • Physician roles: • Investigator • Sponsor/funder employee • Ethics committee member • Government official • Treating physician

23. PHYSICIANS AND CLINICAL RESEARCH WMA Declaration of Helsinki: “It is the duty of the physician to protect the life, health, privacy, and dignity of the human subject.”

24. PHYSICIANS AND CLINICAL RESEARCH Before agreeing to participate in a clinical trial, a physician should: • Ensure that the trial protocol has been approved by an reputable, independent ethics review committee. • Review the protocol to determine whether it is appropriate for the physician’s patient population. • Ensure that participation will not involve a conflict of roles or of interests.

25. PHYSICIANS AND CLINICAL RESEARCH Before asking a patient to participate in a clinical trial, a physician should: • Ensure that the patient fulfils all the criteria for enrolment in the study; • Be assured that the patient will not be harmed by giving up the current treatment in favour of the experimental treatment or a placebo.

26. PHYSICIANS AND CLINICAL RESEARCH When asking a patient to participate in a clinical trial, a physician should: • Explain clearly the purpose and nature of the trial, the risks and benefits of participation, and the alternatives to participation; • Invite the patient to ask for clarification or further information about participation. • Ensure that the patient’s decision whether or not to participate is informed and voluntary.

27. PHYSICIANS AND CLINICAL RESEARCH After enrolling a patient in a clinical trial, a physician should: • Monitor the patient carefully to ensure that no harm is occurring as a result of the trial regime; • Record and report patient data accurately; • Communicate to the patient the results of the trial when they become available.

28. PHYSICIANS AND CLINICAL RESEARCH An additional role? Declaration of Helsinki, para. 30: “At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.”

29. PHYSICIANS AND COMMERCIAL ENTERPRISES • Professional, research, public policy and clinical ethics • Industry needs physicians to develop and to prescribe their products • Patients trust physicians to give them optimal treatment (sometimes no medication or surgery) • Governments and health insurers rely on physicians to keep costs as low as possible

30. PHYSICIANS AND COMMERCIAL ENTERPRISES • Many potential conflict-of-interest situations • WMA and some national medical associations have guidelines for physicians (WMA Statement Concerning the Relationship of Physicians and Commercial Enterprises) • Basic ethical principle: the physician must give priority to the patient in any conflict of interests

31. PHYSICIANS AND COMMERCIAL ENTERPRISES • Maintain professional and clinical independence: • do not rely on industry representatives or advertisements for product information; • be cautious about accepting gifts from commercial enterprises, including sponsorship to attend conferences; • do not participate in industry-sponsored research unless you are assured that your patients will be protected.

32. CONCLUSION • The WMA’s experience is that there are many common ethical issues facing physicians all over the world. • In particular, both individual patients and society in general are increasingly questioning physician behaviour and decision-making. • Although the issues are similar, the solutions often vary because of national and cultural differences. However, the globalization of medicine will likely reduce these differences.

33. CONCLUSION • General ethical guidance on these issues is available from the WMA and more specific guidance from national medical associations. • But it is the responsibility of each physician to learn and to practise the ethical standards of the medical profession, for their own good, that of their patients, of the profession and of society.

34. Thank You !!

35. Contact Information John R. Williams, Ph.D. Director of Ethics World Medical Association williams@wma.net Website: www.wma.net