The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams

Abstract

The complexity of developing and applying increasingly sophisticated new medicinal products has led to the participation of many non-medically qualified scientists in multi-disciplinary non-clinical and clinical drug development teams world-wide. In this introductory paper to the “IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines Development Scientists” it is argued that all members of such multidisciplinary teams must share the scientific and ethical responsibilities since they all influence directly or indirectly both the outcome of the various phases of the medicines development projects and the safety of the research subjects involved. The participating medical practitioner retains the overriding responsibility and the final decision to stop a trial if the well-being of the research subjects is seriously endangered. All the team members should follow the main ethical principles governing human research, the respect for autonomy, justice, beneficence and non-maleficence. Nevertheless, the weighing of these principles might be different under various conditions according to the specialty of the members.

Utilization of genetic information for medicines development and equitable benefit sharing

“…The application of genomic science to medicines development is progressing, and international consensus has been reached on methodologies for academic disciplines such as pharmacogenomics and pharmacogenetics ( The Council for International Organizations of Medical Sciences, 2005 ). These sciences require interdisciplinary collaboration ( Kerpel-Fronius et al, 2018 ) and inclusive governance ( Organisation for Economic Co-operation and Development, 2020 ). International guidelines for regulatory approval of drugs have been also provided on definitions of terms of pharmacogenomics/pharmacogenetics ( International conference on harmonisation of technical Requirements for registration of pharmaceuticals for human use, 2007 ), qualification of genomic biomarkers ( International conference on harmonisation of technical Requirements for registration of pharmaceuticals for human use, 2010 ), as well as genomic sampling and management of genomic data ( International conference on harmonisation of technical Requirements for registration of pharmaceuticals for human use, 2017 ).…”

Declaration of Helsinki: ethical norm in pursuit of common global goals

“…IFAPP was founded in 1975 as a Federation of National Member Associations, composed mainly of physicians engaged in the development of medicines. In 2018, taking into account the multidisciplinary collaboration of different expertise needed, IFAPP updated its Code of Ethics to a new Ethics Framework ( 47 ) that clarifies the shared responsibility of different experts involved in all aspects of medicine lifecycle management.…”