Clin Eval 47（2）2019
ICPM 2018 (International Conference in Pharmaceutical Medicine)Workshop 2

Ethics in medicines development ＊Chaired and written by Chieko Kurihara 1), Sandor Kerpel-Fronius 2)
Presentations: Ethical issues in gene therapy
Alan Boyd 3)

Managing multi-professional and multi-disciplinary teams
Sandor Kerpel-Fronius 2)

Ethics Committees in Asia
Chieko Kuriahara 1)

Social and ethical problems in drug pricing
Greg Koski 4)1) National Institutes for Quantum and Radiological Science and Technology, Japan
2) Semmelweis University, Hungary
3) Faculty of Pharmaceutical Medicine, United Kingdom
4) Alliance for Clinical Research Excellence and Safety (ACRES), United States

Learning objectives(1) To increase awareness of new, emerging ethical problems in medicines development, paying
particular attention to the development of gene therapy.
(2) To contribute to the understanding of ethical questions connected to the cooperation ofphysicians and life scientists in multidisciplinary teams.
(3) To focus on potential regional differences in considering ethical questions with special emphasis
on Asia.
(4) To understand ethical-social problems in the context of drug pricing
Outcomes
According to learning objectives set in advance, achievements of this workshop can be described as follows:(1) To Critically appraise ethical issues related to the development of advanced therapies,
particularly gene therapy related clinical research:
Alan Boyd showed that 2,597 gene therapy clinical trials have been conducted worldwide as of 2017 andth＊ This is a summary of the outcome of Workshop 2 provided on September 27, 2018, in the 19 International Conference inPharmaceutical Medicine (ICPM) in Tokyo, Japan, organized by the International Federation of Associations of Pharmaceutical
Physicians and Pharmaceutical Medicine (IFAPP). Japanese version is included in Clinical Evaluation. 2019; 47(2).
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2019

introduced 6 cases of product approvals to date. He pointed out unpredictable risks associated with genetherapy using a carrier vector to deliver the therapeutic gene into the patientʼs target cells. Meanwhile, regulatory viewpoints concerning manufacturing, safety and efficacy are not so much different from other kindsof products. Therefore, collaborative work among the team of various expertise is prerequisite for successfulachievement. He also pointed out social risks in “gene editing”, which enables genomic modifications in awide variety of organisms and tissues, which is now technically possible to be applied in human embryo geneediting.
(2) To evaluate and manage ethical issues of multidisciplinary clinical trial teams:
Sandor Kerpel-Fronius demonstrated the historical process leading to the development of modern multiprofessional-multidisciplinary clinical drug research teams. He led the Ethics Working Group to develop 2ndedition of the IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines
Development Scientists, finalized in March 2018 1). He mentioned some relevant paragraphs of this Framework
emphasizing that ethical recommendations should be continuously adjusted to the new challenges created by
the advance of science, where multiprofessional team must share joint responsibility.
(3) To describe and evaluate specific ethical issues in the Asian region:
Chieko Kurihara gave a summary of the problems faced by Ethics Committees or Institutional Review
Board (EC/IRBs) in Japan, South Korea and Taiwan, where big scandals lead to expansion of the scope ofclinical research regulations. EC/IRBs of each country are making efforts to get international or domesticaccreditation or certification to achieve credibility. She stressed that networking of accredited/certified EC/IRBs would provide reliable platform for the conduct of global clinical trials. Also she emphasized theimportance of core ethical values to respect/protect dignity and well-being of research participants.
(4) Analyze and manage the consequences of ethical-social issues in drug pricing
Greg Koski provoked a discussion articulating challenging situations where the regulators and the society
require more and more evidence of safety and efficacy which leads to larger amount of money and time
invested into product development. He posed a fundamental question whether health is human right or avalue in marketplace. He explained about the limitation what “laws” can do to bound peopleʼs behavior andstressed importance of ethics to guide peopleʼs actions based on a set of values agreed in a civilized society.
Conclusion
We concluded that collaborative work of multidisciplinary teams are prerequisite especially in todayʼsdevelopment and life cycle management of products utilizing advanced technology. We also clarified thatcontinuing education and certification of all members of research teams as well as accreditation of clinicalresearch sites and EC/IRBs along with establishment of ethical principles could provide more improved
platform for global development.
References1) Kerpel-Fronius S, Becker S, Barrett J, Brun J, Carlesi R, Chan A, Collia LF, Dubois DJ, Kleist P, KoskiG, Kurihara C, Laranjeira LF, Schenk J, Silva H. The shared ethical responsibility of medically and nonmedicallly qualified experts in human drug development teams. Front Pharmacol. 2018 Sep 3; 9: 843.
doi: 10.3389/fphar.2018.00843. eCollection 2018.
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