http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/0_-preamble <p>Medical ethics have been governing human behaviour as far back as 460-357BC. However as science becomes more innovative and medical research processes more creative, the ethical boundaries that limited &ldquo;what was considered possible&rdquo; are now being challenged by scientific endeavour using rational justifications that often go beyond common sense. </p><p>The revised Declaration of Helsinki, the EU Clinical Trial Directive, and the<br />Washington Post "Body-hunters" series from December 2000, are just a few of the controversial &ldquo;ethical&rdquo; issues that inevitably opens the pharmaceutical industry to ever increasing public scrutiny. Dialogue amongst patients, investigators, institutions, sponsors and the media, &ndash;&ldquo;60 minutes&rdquo; and &ldquo;Larry King&rdquo; highlights the need for transparency, and guidance on how Pharmaceutical Physicians as &lsquo;the conscience and guardians&rdquo; of Pharmaceutical Ethics can pro-actively manage these situations responsibly, well before they become major issues. </p><p>An International Working Party [WP] was established in September 2001 to advise The International Federation of Associations of Pharmaceutical Physicians [IFAPP] on how to manage this complex area. It recognized that there are ethical issues, which are of particular relevance to Pharmaceutical Physicians and believes that it has a responsibility to define and publish standards to which Pharmaceutical Physicians and others can refer. </p><p>This code deals principally with those ethical issues that might face a Pharmaceutical Physician, whether he or she is practicing within a company, a contract research organization, as an independent consultant, in an academic department, a regulatory authority or elsewhere, and seeks to offer guidance and support. It is intended to be a living document, to be regularly reviewed and updated as issues arise or are solved. <br />There is a need for an International Ethics Network of Pharmaceutical Physicians working on such issues, taking into account the progress achieved within therapeutics, the work already achieved by others in the field of bio-ethics and the texts already published. Pharmaceutical Physicians are essential members of the teams working throughout the life cycle of a therapeutic intervention, from the discovery research phase, through pre-clinical and clinical testing, licensing, launching, post-marketing studies and surveillance, through to its eventual demise whether on grounds of relative safety and efficacy or commercial non-viability. Being members of a team there is an understandable tendency for Pharmaceutical Physicians to develop a strong interest in an intervention with which they have had a long or close association. Despite this, Pharmaceutical Physicians should recognize their ethical responsibility and stand aside from product loyalty when assessing factors affecting the product itself. They must remain aware at all times that the ultimate interests of both patients and their own employers are best served by an objective scientific attitude. The IFAPP recognizes that this may place a practicing Pharmaceutical Physician in a position, which demands considerable determination. <br />Ethics plays a vital role in enabling Pharmaceutical Physicians to situate their professional lives with their personal, communal, philosophical and religious lives. All clinical development activities and medical support services must therefore be provided by appropriately trained individuals working to agreed standards in adequately staffed departments with clear responsibilities and the authority to take necessary decisions. Accreditation of Pharmaceutical Physicians is an essential element of the demonstration of appropriate training in Pharmaceutical Medicine. As in all branches of medicine, accreditation should not be seen as a single event but as subject to re-validation, as this becomes available. Further, medical ethics does not yet feature prominently in the syllabuses of all medical schools throughout the world, yet it is increasingly recognized as important. It follows that training in Ethics in Pharmaceutical Medicine is itself important for all Pharmaceutical Physicians, health professionals, research ethics committee members and others involved in the research and development of therapeutic agents. The IFAPP recommends that this should feature in the various training courses provided for individuals seeking recognition as Pharmaceutical Physicians. By this means the achievement of professional excellence can be fostered and self-identity and professional aspirations supported. <br />Pharmaceutical Medicine is a discipline that involves the discovery, development, evaluation, registration, monitoring and ethical marketing of medicinal products, medical devices and diagnostics. However, the users of healthcare products are not necessarily aware of the costs and complexities involved in the development and registration of a therapeutic intervention, and of the issues possibly arising throughout its subsequent existence. Pharmaceutical physicians have a responsibility to raise awareness and understanding of the different pressures and constraints governing healthcare products.<br />Member nations are invited to review this document, and provide feedback.&nbsp; Please address your comments to the Working Party <br />c/o IFAPP secretariat&nbsp;<br />Kuipersweg 2T<br />3449 JA Woerden<br />The Netherlands<br />phone: +31&nbsp;348 489305<br />fax: +31 348 489301<br />e-mail: <a href="mailto:secretariat@ifapp.org">secretariat@ifapp.org</a><br />website: <a href="/">www.ifapp.org</a></p> http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/0_-preamble Wed, 10 Mar 2010 07:47:49 -0600 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/1_-the-code-explained http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/1_-the-code-explained Wed, 11 Apr 2007 05:47:18 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/2_--duty-of-care http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/2_--duty-of-care Wed, 11 Apr 2007 05:47:34 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/2_1-good-clinical-practice http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/2_1-good-clinical-practice Wed, 11 Apr 2007 05:47:56 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/2_2-medical-integrity http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/2_2-medical-integrity Wed, 11 Apr 2007 05:48:18 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_-competence-and-diligence http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_-competence-and-diligence Wed, 11 Apr 2007 05:49:16 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_1-general-issues-in-clinical-research http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_1-general-issues-in-clinical-research Wed, 11 Apr 2007 05:49:35 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_2-studies-of-human-pharmacology http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_2-studies-of-human-pharmacology Wed, 11 Apr 2007 05:50:07 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_3-studies-of-therapeutic-use-and-post-marketing-surveillance http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_3-studies-of-therapeutic-use-and-post-marketing-surveillance Wed, 11 Apr 2007 05:50:29 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_4-special-and-vulnerable-patient-groups http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_4-special-and-vulnerable-patient-groups Wed, 11 Apr 2007 05:50:51 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_5-benefit---risk-assessments http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_5-benefit---risk-assessments Wed, 11 Apr 2007 05:51:19 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_6-awareness-of-innovation http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/3_6-awareness-of-innovation Wed, 11 Apr 2007 05:52:20 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_-impartiality http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_-impartiality Wed, 11 Apr 2007 05:52:41 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_1-promotion http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_1-promotion Wed, 11 Apr 2007 05:53:00 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_2-provision-of-information http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_2-provision-of-information Wed, 11 Apr 2007 05:53:21 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_3-information-to-healthcare-professionals http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_3-information-to-healthcare-professionals Wed, 11 Apr 2007 05:53:42 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_4-information-to-patients http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_4-information-to-patients Wed, 11 Apr 2007 05:54:02 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_5-information-to-the-media http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/4_5-information-to-the-media Wed, 11 Apr 2007 05:54:26 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/5_-probity http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/5_-probity Wed, 11 Apr 2007 05:54:47 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/5_1-accurate-reporting http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/5_1-accurate-reporting Wed, 11 Apr 2007 05:55:05 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/5_2-research-accountability http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/5_2-research-accountability Wed, 11 Apr 2007 05:55:28 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/5_3-financial-and-commercial-dealings http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/5_3-financial-and-commercial-dealings Wed, 11 Apr 2007 05:56:07 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/6_-integrity-and-accountability-in-the-workplace http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/6_-integrity-and-accountability-in-the-workplace Wed, 11 Apr 2007 05:56:45 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/6_1-propriety http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/6_1-propriety Wed, 11 Apr 2007 05:57:06 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/6_2-teamwork http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/6_2-teamwork Wed, 11 Apr 2007 05:57:25 -0500 http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/6_3-leadership <p>Specific areas of ethical concern:</p><p>-&nbsp;Ensuring that medical team members meet the appropriate standards of conduct and care. <br />-&nbsp;Addressing any problems that might prevent colleagues from other professions following guidance from their own regulatory bodies.<br />-&nbsp;Ensuring that all team members understand their personal and collective responsibility for the safety of patients, and for openly and honestly recording and discussing problems.<br />-&nbsp;Arranging for the provision of physician availability at all times.<br />-&nbsp;Regularly reviewing and auditing of the standards and performance of the team and addressing any deficiencies.<br />-&nbsp;Ensuring that systems are in place for dealing supportively with problems in the performance, conduct or health of team members.</p> http://www.ifapp.org/home/ethics/code-of-conduct/code-of-conduct/6_3-leadership Wed, 10 Mar 2010 07:48:09 -0600