The Value and Importance of a Professional Ethical Code for Medicines Development: IFAPP International Ethics Framework

Abstract

Pharmaceutical medicine professionals have to face many ethical problems during the entire life span of new medicines extending from animal studies to broad clinical practice. The primary aim of the general ethical principles governing research conducted in humans is to diminish the physical and psychological burdens of the participants in human drug studies but overlooks many additional social and ethical problems faced by medicine developers. These arise mainly at the interface connecting the profit-oriented pharmaceutical industry and the healthcare-centered medical profession cooperating in medicines development. In 2002, the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine developed the International Code of Ethical Conduct for Pharmaceutical Physicians for providing ethical advice for their members to manage the frequently competitive goals characteristic for their specialty. The ethical framework compiled by the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine serves its members by presenting morally acceptable or inacceptable behaviors in frequently encountered controversies arising from competing industrial and healthcare interests in medicines development. The authors selected this format to encourage reflection and debate for finding optimal moral conclusions in specific issues. Many recent examples of serious scientific-ethical misconduct, such as the oxycodone tragedy, the recommendations of unproven useless occasionally dangerous therapies during the coronavirus disease 2019 pandemic, and the withdrawal of many papers containing non-reproducible results, contributed to the increasing loss of trust by the public in science including pharmaceutical medicine. We are convinced that the ethical guidance developed by the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine will encourage its members to reflect intensively on optimal ethical behavior in drug development for strengthening the trust of society in innovative new medicines. Finally, considering the increasingly active participation of non-medically trained scientists in producing and applying complex biological medicines, distant monitoring methods coupled together with artificial intelligence technology in innovative clinical trials, the Ethics Working Group recommended already in 2017 measures to optimize their smooth cooperation and underlined their joint ethical responsibilities in guarding the safety and human dignity of trial participants.

Key Points

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine Ethics Framework encourages and supports pharmaceutical physicians and medicine development scientists:

To continuously reflect and debate on challenges encountered during the process of medicines development.

To share ethical responsibility by variously trained experts in multi-disciplinary drug development teams.

To strengthen public trust in medicines development.

Introduction

Traditionally, groups of individuals doing similar work describe their aims and services in a professional code. Ethics is an important mandatory part of each professional code. It summarizes the moral standards guiding their working quality. In addition, the ethical codes describe the expected behavior of their members within the society they serve and towards their professional organization as well as its members. Since the middle ages, the three basic “learned professions” of the clergy, law, and medicine have been characterized by the specific knowledge possessed by their members that is applied to satisfy the needs of other people [1]. Specific service is the main attribute discriminating various professions. One of the main expectations from society has been always that the service provided should be trustworthy and it should be acquired through specific standards of education and training. The learned professions were distinguished from guilds of artisans and merchants by the requirement of academic education. In order to guarantee the high level of service and the integrity of a professional group, the proper behavior of members was traditionally guided by a specific and mandatory ethical code of conduct. Its purpose was to help members to make proper moral decisions in characteristic working situations of a profession. The recommendations were developed based on accumulated experience and deliberations in the professional community. Members of a profession encounter many unique situations and are challenged to reflect on the optimal moral judgments. The combined moral experience is described in the field of applied or practical ethics that “indicate the application of ethics to special arenas of human activity” [2]. Indeed, professional ethics essentially reflects the conclusive summary of applied ethical decisions made by individuals of a profession in specific circumstances. The many different arenas of human activities lead to many specific applied ethical standards. The professionals are supposed to learn gradually the special ethical standards during their work for developing their professional virtues [3, 4].

Does Medicines Development Need a Special Professional Code?

“Pharmaceutical Medicine is the medical scientific discipline concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of marketing of medicines for the benefit of patients and the health of the community.” [5, 6] Studies on humans providing data on efficacy and safety underpin the entire process of drug development. The evaluation of treatments with natural compounds at various levels of scientific knowledge was from the earliest history of humanity an accepted part of caring for and treating sick fellow members of a community. Over the centuries, an enormous amount of experience-based practical knowledge accumulated. The development of physiology and pharmacology in the 19th century led to the rapid adaptation of the new scientific methods to clinical research. Increasing industrial production of new chemicals necessitated also the broader evaluation of their possible medical use on many patients. As part of the build-up of the large-scale factory production of drugs, an increasing number of medical experts joined the pharmaceutical industry to participate in the medical development of new medicines. They gradually formed the new medical specialty of pharmaceutical medicine in the 20th century. The rapid growth in the number of medical experiments led unfortunately also to an increasing occurrence of unethical dangerous experiments harming human subjects frequently performed without informing the trial subjects. This led the Prussian government in 1900 to the declaration of the first law regulating clinical research. [7]

Drug development is part of the traditional profession of medicine. Accordingly, the activities of pharmaceutical medicine experts are ethically governed primarily by the maxims of medical ethics traditionally linked to the Hippocratic Oath in the European-related cultures [8]. It pledges inter alia that the physician will prescribe only beneficial treatments, according to his abilities and judgment; to refrain from causing harm or hurt; and to live an exemplary personal and professional life. As experiments performed on human subjects is the basis of pharmaceutical medicine, the regularly updated Declaration of Helsinki describing the ethical principles guiding human studies became the main ethical guidance for pharmaceutical medicine experts since 1964 [9]. The document compiled by the World Medical Association was an answer to the criminal human experiments performed by German doctors in World War II. It recommends essentially the guidelines for correct human studies presented at the Nuremberg trial. The authors emphasize that each statement of the document should be applied as a whole, with consideration of all the related relevant paragraphs. They encourage further that in addition to physicians, all other experts participating in research on human subjects should adopt the principles described.

Although the Declaration of Helsinki is accepted worldwide, clinical investigators working in the USA mainly base their ethical guidance on the Belmont Report published in 1979 as a reflection on some unethical human research practices in the USA [10]. Its main ethical recommendations are very similar to the Declaration of Helsinki. However, the Belmont Report is much more philosophically oriented. It is primarily based on four ethical principles presented by Beauchamp and Childress in their famous book Ethical Principles in Biomedical Research published first in 1979 [11]. Their aim was to anchor medical research ethics in universal moral principles, autonomy, beneficence, non-maleficence, and justice that could be accepted by different cultures and religions [4]. They were convinced that these four principles correlated with human rights and they cannot be ordered into a hierarchical order. Furthermore, they suggested that these four fundamental principles could be extended with various derivative principles, for example, confidentiality, privacy, fidelity, and veracity. They believe that these principles are only binding until no stronger moral obligations override them [12].

Further important guidance for pharmaceutical physicians for performing human research in culturally and economically different regions of the world is provided in publications of the Council for International Organizations of Medical Sciences [13]. The research guidance addresses a much broader human research community as there are no basic differences in ethical principles governing human biomedical, social, behavioral, and other related studies. Finally, the ICH Good Clinical Practice, the international ethical and scientific quality standard dealing with the designing, organization, management, and the correct reporting of the findings of clinical trials, offers a detailed practical guidance for pharmaceutical professionals developing drugs [14].

The Development of a Specific Ethical Code for Pharmaceutical Medicine Professionals

Considering all these important international guidelines dealing with the ethical principles performing human studies, one might ask, do pharmaceutical medicine professionals need a specific professional ethical code. An in-depth consultation with the members of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) made it clear that many members supported the formulation of specific moral guidance. This can be understood appreciating that the profession extends far beyond clinical research. It includes drug regulation, advertising, pharmacovigilance, and the marketing of medicines, which need special attention and create special moral problems not at all or not adequately covered in medical ethics. In addition, the rapid scientific development constantly creates new ethical problems for the profession. In particular, the major campaign of human immunodeficiency virus-infected people for more rapid development and clinical availability of new drugs placed the scientific, marketing, and ethical problems of the pharmaceutical industry into the focus of society [15]. In addition, several examples of ethical misconduct in clinical trials carried out in developing countries by some pharmaceutical companies shook the confidence of the public in the professional behavior of the industry [16]. These problems led the IFAPP to set up a Working Party on Ethics in Pharmaceutical Medicine under the leadership of Dr. A.L. Becker at the 12th International Conference of IFAPP in 2002 [17]. The Working Party published the International Code of Ethical Conduct for Pharmaceutical Physicians in 2003 [18]. To understand the functional significance of the document, we present its structure and its main recommendations.

International Code of Ethical Conduct for Pharmaceutical Physicians (2003)

The IFAPP ethical code specifically seeks to provide guidance on moral issues for physicians working in the pharmaceutical industry and contract research organizations. The authors emphasize the most important moral message already in the preamble: “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”. The conceptual architecture of the professional code was illustrated by comparing it to a Greek temple. The entire structure is based on universal principles of medical ethics. The columns supporting the Code of Ethical Conduct represent the specific core values of pharmaceutical medicine: the duty of care, competence and diligence, impartiality, probity, integrity, and accountability (Fig. 1). The more than 100 specific ethical recommendations are grouped into sections dealing with the core values. Several of them describe the care for the well-being of human subjects or deal with the management of clinical trials according to the accepted norms of medical ethics. Importantly, many comments discuss the intersection of medical care and industrial interests, which highlight the specificity of the pharmaceutical medicine profession. We primarily focus on these latter type of comments, which determine the unique characteristics of this professional code.

Fig. 1.

Conceptual structure of the code of ethics. Medical ethics serves as the fundament, the major moral principles of pharmaceutical medicine support the International Code of Ethical Conduct [28, 41]

Duty of Care

In line with medical ethics, the care for the human subjects participating in a study is the primary obligation of the pharmaceutical physicians. In addition, they have to be responsible for designing trial protocols that are scientifically valid, respect the accepted codes of medical ethics, and prioritize the interests of the human subjects over the company. It is their duty to provide accurate and verifiable medical information for the company management and ensure that the interpretation of the findings accords with evidence-based medical knowledge.

Competence and Diligence

In addition to providing medical care, the pharmaceutical physicians have to contribute to the scientific and medical relevance and validity of clinical drug development plan. They must ensure that the scientific background of the human study is solid and sufficient data are available to make a reliable extrapolation of the expected safety of the planned intervention. They have to determine whether the methods applied in the study can provide high-quality data for the planned medical use, and whether the application of placebos is ethically appropriate. They must ensure that any possible scientific and ethical contradictions between the planners and the medical performers of the human pharmacology and clinical studies are timely resolved. They have to evaluate the medical and ethical needs of conducting studies on vulnerable populations, including children and the elderly, and when to initiate a drug trial on patients with rare diseases. Pharmaceutical physicians should pay also attention to the special local ethical, social, religious, and financial conditions that significantly influence the ethical responsibility of drug developers. They should not continue ongoing clinical studies or recommend the clinical use of new medicines until significant scientific doubt exists regarding their efficacy and safety. Furthermore, they should discourage any marketing exercise that is “masquerading” as a scientific study.

Impartiality

Pharmaceutical physicians must communicate all information gained in clinical studies correctly. Statements should not contain claims that cannot be justified. They should differentiate between providing information and therapeutic advice to patients. The latter should be the privilege of the treating physicians. Similarly “off-label” use of drugs should not be encouraged; however, this should not discourage them to communicate valid information on a file that might help the treating physician to use effectively and safely the medicine for a not registered indication.

Probity

Pharmaceutical physicians working in a commercial environment must exhibit high moral standards, personal integrity, honesty, and trustworthiness. Their work should not be skewed toward gaining either financial or scientific advantages. They should declare any conflicts of interests publicly. Probity means also the moral obligation to publish all study results supporting or contradicting the original hypothesis. Furthermore, a commercial interest should never take precedence over the duty to make timely and correct reports on adverse effects.

Integrity and Accountability in the Workplace

Pharmaceutical physicians usually work in larger teams when conducting clinical drug trials. They should encourage that possible differences in culture, religion, and gender should be handled fairly, protecting the human dignity of the coworkers. Mutual respect and good communication should underline cooperation. Malicious comments made by any coworker should not undermine the credibility of other team members.

IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines Development Scientists (PPs & MDSs*) [2nd Revised Edition of the International Code of Ethical Conduct for Pharmaceutical Physicians] (2018) [19, 20]

(* “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.”)

The rapid development of science and the appearance of new technologies create many new moral problems for medicines development. It also rapidly breaks up traditionally established professional barriers. The cooperation of different professionals might frequently provide the best solution for many of these very complex scientific and ethical issues. We must appreciate, however, that an increased cooperation of various professionals might make moral decisions in various situations more complex and difficult. Some of the guiding ethical principles of the cooperating professionals might emphasize different solutions. The participants must in each situation analyze and understand both the common and occasionally different moral judgments of their partners for efficiently resolving conflicting views. To direct the attention to the need for broader professional cooperation, pharmaceutical physicians and medicine development scientists were both addressed in the title of the revised code. Jointly, we refer to these two groups as medicine development professionals.

The new title, Ethics Framework, indicates the second principal difference between the first and the revised documents. As was mentioned above, professions traditionally used their ethical codes for maintaining discipline in their community. Considering the increasingly complex moral problems arising in multi-professional medicines development, the authors felt it was more proper to replace the ethical code with the term ethical framework. The authors believe that this expression emphasizes that the goal of the document is the listing of moral advice to solve difficult ethical problems without enforcing preconceived mandatory ethical decisions. Finally, it is emphasized that the listed advice might be useful also to other physicians and scientists working in various organizations related to medicines development, for example, in human research ethics committees, regulatory agencies, and health technology groups.

The second edition retained the original structure of the document; the new recommendations were included into the earlier defined sections. Logically, many new entries referring to scientific development are presented in the section Competence and Diligence. Considering that translation medicine aims to closely link animal to human pharmacological studies, the authors of the framework extended the scientific-ethical responsibility in drug development also to researchers performing non-clinical animal experiments underlying directly human application. In addition, they emphasized that the molecular endpoints of clinical trials selected from laboratory research data must have sufficient construct validity and pathophysiological plausibility for providing a reliable basis for human studies. This is an outstandingly important obligation as unfortunately many non-clinical studies proved to be unreliable and not reproducible in practice [21–23]. The application of the concepts of translation medicine in modern drug development requires studies on human biopsies especially for target identification and the evaluation of biomarkers. Therefore, it is underlined that adequate anonymization must accompany the use of such data for protecting the personal rights, especially the genetic data of the study subjects. It is emphasized further to limit the size of a human biopsy to the minimal amount needed, which can be achieved only if the cooperating scientists develop and apply analytical methods with the highest sensitivity.

The management of multi-professional teams becomes an increasingly important problem in many social, industrial, and scientific activities. Several shared values are suggested to be essential for good and sustainable teamwork; inter alia, ethics, trust, and a clear definition of joint purpose. The profound knowledge of the scientific interest, personal integrity, ethical values, emotions, and cultural background of each participant helps communication and the sharing of knowledge and experience that all lead eventually to the efficient management of possible conflicts arising during joint work [24, 25]. These issues are covered in the section of Impartiality. The special distribution of competencies between participants of clinical trial teams is carefully defined stating that non-medically qualified members should not influence either the patients or the public “with scientific results without embedding these results into appropriate medical context.” Neither should scientists give advice to patients; this should be the exclusive right of the treating physician. Further moral advice for managing cooperation is given in the section dealing with Accountability in the Workplace. The authors emphasized that lifestyle, culture, beliefs, color, gender, and age should not influence professional relationships within the team. Furthermore, the great help of open discussion for joint decision making within the group is underlined. It must be ensured that all members understand both their joint and personal responsibilities for the scientific validity of the common research project and the safety of the patients.

The list of the different specialists participating in human trials of modern complex medicines is long, chemists, pharmacists, molecular biologists, geneticists, immunologists, device engineers, and many others as needed. Consequently, it will be more cumbersome to reach a consensus. Although both the physicians and the various scientists must receive ethical training before joining a multi-professional clinical research team, they might have differing moral views in specific situations. Indeed, Page demonstrated that in specific model circumstances, participants weighted the importance of the respect to autonomy, beneficence, non-maleficence, and justice differently. Moreover, the same individuals prioritized different values according to the specific situations [26]. Similarly, Ebbesen and Pedersen [27] found that scientists conducting animal experiments in a company developing anticancer agents valued these ethical norms markedly differently from physicians working on cancer wards. It seems that the prioritization of the ethical norms of Beauchamp and Childress and the overall ethical decision made by individuals is quite situation dependent. This is the reason why the importance of open and honest dialogs, the respect of personal integrity, and the special expertise of all group members are so emphatically recommended in the Ethical Framework.

Discussion

Despite the rapid and extensive progress in science, a worldwide loss of trust in science increases. Since the explosion of the first atomic bomb, people began to understand that in addition to improving their lives, science might eventually destroy life on Earth. The publication of many not-reproducible scientific results or even fake news misguiding the society undermines further the trust in science. The pharmaceutical industry is particularly vulnerable because inappropriate scientific conduct will affect the quality of life of patients directly and not as a possible distant possibility. Aware of this special social exposure, the IFAPP realized that it needed to address these issues and deliver a consensus view on moral issues to support its members [28]. The Ethical Framework of IFAPP deals with activities encountered in human drug studies and/or in the application of medicines in clinical environment. It addresses at one end, scientists performing non-clinical experiments providing the basis of human pharmacologic studies, and at the other end, medical affairs, pharmacovigilance, and regulatory experts managing the clinical application and safety of new drugs. The greatest achievement of the IFAPP Ethics Framework is the definition of specific values covering all major aspects of the profession of medicines development. The authors grouped specific moral advice relevant to medical care, scientific input, and commercial relationships to the pharmaceutical industry into separate sections. This organization helps to locate easily needed moral guidance on frequently encountered problems arising in a profession closely bound both to medicine and to the pharmaceutical industry. This special focus makes it an important supplement to the main ethical documents discussing generally human research.

The analysis of some recent problems in the medicines development ecosystem provides some insight on the support the IFAPP Ethics Framework might give  for its members. The consequences of not adhering either to medical or commercial ethical standards can be best illustrated by the broad drug addiction epidemics produced by OxyContin^®, leading to the death of more than 218,000 Americans because of overdoses. This case linked to Purdue Frederick Company highlights the breadth and severity of the social effect an ethical misconduct can cause when carried out jointly by medical and marketing personnel [29, 30]. OxyContin^® is the trade name of the oral, controlled-release, long-acting oxycodone derivative developed by Purdue [31.] The company claimed without solid proof that the new formulation decreased the addictive potential of oxycodone. Using this not proven, essentially false advantage, the company intensively marketed OxyContin^® for the treatment of chronic non-cancer pain, which is a large market closed to addictive opiate derivatives. This scientifically questionable strategy clearly contradicts the principles of impartiality criteria described in the IFAPP International Ethics Framework, which prohibits false statements concerning the medicinal products advertised. According to the released internal e-mail communication of the company, this incorrect message became further amplified after Merck Medco, the large pharmacy benefit manager, informed the doctors about the possible addictive potential of OxyContin^® in medical practice. In order not to lose the lucrative not-cancer pain market, Dr. Richard Sackler, one of the owners of the company, and its main medical experts recommended a massive response to obliterate the objection of addiction. His behavior violates the probity principle, which emphasizes honesty and trustworthiness and prohibits a skewed presentation of data toward gaining either financial or scientific advantages. It is surprising and deeply disappointing how many medical doctors followed the false prescribing recommendations of the company supported by lavish benefits for the prescribers. In particular, after the early warning that the drug might cause addiction, treating physicians should have reevaluated, based on their experience, the correctness of the information released by the company. They should have asked whether sufficient data are available to allow the scientific conclusion of the claimed safety of the product. Essentially, the medical professionals violated their duty of good clinical care.

Major scientific-ethical dysfunctions accompanied also the race to find effective pharmacologic treatments for the coronavirus disease 2019 infection. In this catastrophic situation, moral problems arose because of neglecting scientifically proper principles for identifying safe and effective treatments. Instead of performing controlled clinical studies, physicians applied several agents used for treating other viral diseases, malaria, and immune reactions based on hopes and/or dubious clinical evidence. Under public pressure, ethics committees frequently permitted the initiation of poorly designed trials [32, 33]. From more than 2000 clinical trials initiated, only about 5% were executed at a sufficiently high scientific level to provide meaningful clinical results [34]. The extremely poor results of medical interventions based on questionable scientific backgrounds clearly support the guidance given in the Duty of Care section stating “to resist the use of therapeutic interventions outside of clinical management guidelines without conducting appropriate clinical trials and/or obtaining the necessary regulatory clearance”. It is remarkable how much this broad practice of clinical research misconduct is in striking contrast to the scientifically excellently executed, ethically well designed, and very rapid development of the new mRNA vaccine in the same period [35].

The Russian invasion of Ukraine seriously endangered the work of the excellently organized clinical research hub in the territory ravaged by the war. The Ethics Working Group of IFAPP cooperated with the Ukraine Clinical Research Support Initiative and Ukrainian colleagues to discuss adaptive tactics for maintaining high-level drug development projects during the war [36, 37]. This large-scale experience of maintaining clinical trial activities during a destructive war convincingly proves that only meticulous adherence to ethical and good clinical practice principles can support clinical trials during disasters. At the start of the war, the IFAPP Ethics Working Group pointed out that patients with serious diseases who had already signed an informed consent and entered clinical trials should be considered as a specific vulnerable population, their initiated treatment should be continued even during an ongoing disaster if it is medically advantageous and technically possible. The sponsors should not immediately close their trials and abandon the already treated seriously ill patients whose lives may depend on the running experimental therapy [38]. It will be a future task to update the IFAPP Ethics Framework to present some guidance for managing medicines development efficiently under disaster situations in the future.

The cooperation of an increasing number of non-medically trained natural scientists, psychologists, device engineers, and artificial intelligence experts changes the drug development ecosystem dramatically. Natural scientists are needed to produce various advanced therapy products for individual patients and to follow their effects on the disease. The rapid development of wearable instruments permits the distant and continuous recording of many biological functions that provide new insights into the effects of disease symptoms on the life of the patients, and the decentralized evaluation of drug effects in the normal environment of the trial participants [39, 40]. Much work will be needed to define precisely in the ICH Good Clinical Practice how to perform these trials according to high scientific-ethical standards that lead to reliable and reproducible results. The IFAPP Ethics Working Group realized the importance of these changes very early and inserted into the revised edition of the Ethics Framework relevant ethical recommendations for the optimal merging of these specialists into medicines development teams [19, 20]. In the section on Probity, we emphasized that “maintaining the integrity of a multi-disciplinary clinical team by respecting the skills and contributions of colleagues with different expertise” is particularly important. Furthermore, it is emphasized that “any problems that might prevent colleagues from other professions following guidance from their own regulatory bodies” should be avoided. The involvement of patients in the trial organization helps to bind the artificial clinical trial environment to the real-life situation of people with diseases. Considering their importance, it is underlined that “the cooperation of patient groups in medicines development requires full understanding of their role within the development teams.” The respectful cooperative attitude toward these new members of drug development teams is of great significance for the future development of pharmaceutical medicine.

The IFAPP was the first to understand the need for developing an internationally acceptable moral guidance for physicians and later for other professionals working in medicines development. Compiling moral advice in the IFAPP Ethical Framework, our aim was to provide moral support in a well-structured format for the members of a rapidly growing new profession. Indeed, a poll carried out in 2006 showed that close to 80% of the responders answered that the IFAPP’s Code of Ethical Conduct is useful and supportive in their work [41]. Several years later in 2008, the British Faculty of Pharmaceutical Medicine wrote their ethical code presently entitled Good Pharmaceutical Medical Practice and GPMP Support Network (2.0) [42] specifically for pharmaceutical physicians registered with the General Medical Council. This is understandable because in Great Britain pharmaceutical medicine is a registered medical specialty. Therefore, it should be read in conjunction with the Good Medical Practice guidance of the UK General Medical Council. The ethical concepts of the two documents are similar, the major difference being that the IFAPP Ethical Framework addresses a much broader circle of pharmaceutical professionals. The British authors reflect on cooperation with other professionals only briefly in domain 3 stating that “pharmaceutical physicians should work closely with colleagues from other disciplines, including scientific and non-scientific staff, with the goal of patient benefit and improving public health.”

Conclusions

The moral recommendations of the IFAPP were specifically formulated for supporting intense reflection and honest debates when necessary for finding the correct ethical path optimal for society under complicated circumstances. It is important that the decisions in medicines development should be always aligned with the general moral values of humanity. Researchers should interpret moral comments of the Ethics Framework together with the detailed guidance on human research developed by different organizations. In order to support further growing of the medicines development profession, the code should be continuously revised to follow the ongoing changes in ethics and medicine, and as science challenges us.

Declarations

Funding

Open access funding provided by Semmelweis University. The authors did not receive support from any organization for the submitted work. No funding was received to assist with the preparation of this article.

Conflicts of Interest

Sandor Kerpel-Fronius and Alexander L. Becker have no conflicts of interest that are directly relevant to the content of this article. Alexander L. Becker is an Editorial Board member of Pharmaceutical Medicine. He was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.

Ethics Approval

Not applicable.

Consent to Participate

Not applicable.

Consent for Publication

Not applicable.

Availability of Data and Material

Not applicable.

Code Availability

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Authors’ Contributions

SK-F developed the concept and wrote the paper. ALB author supported the work with advice and continuous discussions. Both authors agreed on the final text.