The IFAPP Ethics Working Group (https://ifapp.org/working-groups/ethics-and-professionalism) is delighted to share with you the summary of the Presidential Symposium of the Japanese Society of Clinical Pharmacology and Therapeutics held in Tokyo on 4 December 2019 on the topic of “International Collaborative Research and New Trends of Research Ethics”. You can access the proceedings in the journal Rinsho Hyoka (Clinical Evaluation) at http://cont.o.oo7.jp/48_1/48_1contents_e.html.
Amongst others, there were presentations and discussions by Dr. Otmar Kloiber (Secretary General, World Medical Association [WMA]), Dr. Dirceu Greco (Professor Emeritus, Minas Gerais University, Brazil), Prof. Kyoko Imamura, (IFAPP President) and Prof. Chieko Kurihara, member of the IFAPP Ethics Working Group.
Extensive discussions took place on secondary data-driven research, the place of placebo in randomized clinical trials, and post-trial access of medicinal candidates before marketing authorization.
These latest trends of research ethics prompted the IFAPP Ethics Working Group to raise these issues with WMA, on potential amendments of the Declaration of Helsinki.
We welcome all stakeholders in the research ethics community to engage and participate in the discussion with us.
* In this text MDS refers to experts in various fields of life sciences, pharmacy and medical device engineering who have adequate training in non-clinical and clinical medicines development and work as integrated members of clinical medicines development teams.
2nd edition, March 2018
The 2nd edition, entitled IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines Development Scientists (PPs & MDSs*), was debated and developed by the IFAPP Working Group on Ethics in 2016: Drs. Sandor Kerpel-Fronius, chairperson (Hungary), Sander Becker, co-chairperson (Australia), Jane Barrett (UK), Johan Brun (Sweden), Roberto Carlesi (Italy), Anthony Chan (Ireland), Luis Collia (Argentina), Dominique Dubois (Belgium), Peter Kleist (Switzerland), Greg Koski (USA), Chieko Kurihara (Japan), Luis Filipe Laranjeira (Portugal), Johanna Schenk (Germany), and Honorio Silva (USA).
First edition published in April 2003
The IFAPP International Code of Ethical Conduct for Pharmaceutical Physicians was first created, debated and published by the IFAPP Working Party on Ethics in 2003: Drs Sander Becker, chairperson (Australia), Jane Barrett, co-chairperson (UK), Johan De Botha (S Africa), Johan Brun (Sweden), David Cairds (Germany), Anthony Chan (Ireland), Roberto Carlesi (Italy), Luis Collia (Argentina), Maqbool Jafary (Pakistan), Gerhard Nahler (Austria), Antti Jekunen (Finland), Francis de Halleux (Belgium), Ludger Buehrmann (Germany) and Alan Dunton (USA).
The revision was undertaken since it was felt by many colleagues working in drug development that it is necessary to update the first document considering the rapid scientific development and additionally to consider the joint responsibilities of the many basic scientists working side by side with pharmaceutical physicians in modern complex clinical medicines development projects. The short list of recommendations compiled by two successive IFAPP Working Groups on Ethics tried to collect some practical suggestions how to behave under circumstances which might be faced by the teams or individual team members, when participating in clinical development of medical products and/or during their subsequent life-cycle management. It is understood by the members of the Working Group that each situation is different and under various circumstances the ethical decisions might also be different. Therefore, it was a principle decision not to provide ethical guidelines or directives which were felt to be restrictive or imply disciplinary actions. Rather it was intended to advise on possible correct ethical behavior listing some circumstances and appropriate actions. This Framework cannot cover all the situations which might occur during the very complex work of medical product management. It attempted to cover at least some of the new ethical problems which surfaced with the introduction of new scientific approaches. The discipline is constantly evolving and the working group will continue to evaluate if new guidance may become appropriate. All scientists involved in development of medical products are invited to help us to extend this catalog of recommendations. It is our hope that the IFAPP Ethics Framework might be integrated into a teaching material for educating future PPs and MDSs on proper ethical behavior.
First edition of IFAPP Ethical Code was published April 2003: INTERNATIONAL CODE OF ETHICAL CONDUCT FOR PHARMACEUTICAL PHYSICIANS
Ethics in medicine and particularly pharmaceutical medicine is being questioned and challenged almost daily. The revised Declaration of Helsinki, the EU Clinical Trials Directive, the Washington Post "Body-hunters" series from December 2000, inevitably open our industry to ever-increasing public scrutiny. Dialog amongst patients, investigators, institutions, sponsors and the media highlights the need for transparency, and guidance on how to manage these situations responsibly, before they become issues. We find ourselves faced with numerous challenges in the varied ethical and cultural issues in Pharmaceutical Medicine across the globe, and in the ethical dilemmas across the therapeutic spectrum. Interestingly the literature and most of the reference books authored by respected academics are collections, collations and commentaries from a number of sources and fail to provide guidelines.
Medical ethics has been governing human behavior as far back as Hippocrates in the late 5th century BC. However as science becomes more innovative and medical research processes more creative, the ethical boundaries that limited ‘what was considered possible’ are now being challenged by scientific endeavor using rational justifications that often go beyond common sense.
Controversial ‘ethical’ issues emanating from the revised Declaration of Helsinki, the various EU Clinical Trials Directives and Regulations, as well as the media, inevitably open the pharmaceutical industry to increasing public scrutiny. There is a need for transparency and guidance on how Pharmaceutical Physicians as the ‘conscience and guardians’ of Pharmaceutical Ethics can proactively manage these situations responsibly, well before they become major issues.
Pharmaceutical Physicians should recognize their ethical responsibility and stand aside from blind company 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. IFAPP recognizes that this may place a practicing Pharmaceutical Physician in a position which demands considerable determination to maintain.
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 was recognized that there are ethical issues which are of particular relevance to Pharmaceutical Physicians, and IFAPP believes that it has a responsibility to define and publish standards to which Pharmaceutical Physicians and others can refer, so that they may be measured when dealing with ethical issues in the field of Pharmaceutical Medicine.
View full text of the previous version here.
Scientific articles published in Frontiers in Pharmacology on IFAPP's considerations about Ethical Principles, Ethical Responsibilities and Ethical Framework can be found on the "Publications" page (https://ifapp.org/publications)
IFAPP's International Code of Ethical Conduct and articles published in IFAPP's former Newsletter IFAPP World (https://ifapp.org/ifapp-world-landing-page)