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Van Campen et al. BMC Med Ethics (2021) 22:31 https://doi.org/10.1186/s12910-021-00600-y DEBATE Open Access Considerations for applying bioethics norms to a biopharmaceutical industry setting Luann E. Van Campen1,2* , Tatjana Poplazarova3, Donald G. Therasse2 and Michael Turik2,4 on behalf of The Biopharmaceutical Bioethics Working Group Abstract Background: The biopharmaceutical industry operates at the intersection of life sciences, clinical research, clini‑ cal care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics eforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little exami‑ nation of its proper scope. Main text: Any institution with a scientifc or healthcare mission should engage bioethics norms to navigate ethi‑ cal issues that arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context “specifcation” substantively refnes ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activ‑ ity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defnes biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceuti- cal healthcare products. It provides commentary on this defnition, and presents fve contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity. Conclusion: Understanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharma‑ ceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implemen‑ tation to beneft patients, the healthcare system and society. Keywords: Bioethics norms, Biopharmaceutical industry, Context, Setting, Specifcation, Defnition Background clinical research, clinical care, public health, and busi- Research-based biopharmaceutical companies deliver ness presents distinct operational and ethical chal- medicines and vaccines to patients by means of innova- lenges. Ethical integrity in the research, development, tive research that occurs in a dynamic and complex eco- manufacturing, and commercialization processes is system. Operating at the intersection of life sciences, foundational to the delivery of safe and efective prod- ucts and provision of reliable and credible information to support their appropriate use. Terefore, compa- *Correspondence: [email protected] 1 Ethics Matters, LLC, 5868 E. 71st Street, E‑125, Indianapolis, IN 46220, nies have a responsibility to patients and other stake- USA holders to carry out their activities in accordance with Full list of author information is available at the end of the article © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. The Creative Commons Public Domain Dedication waiver (http:// creat iveco mmons. org/ publi cdoma in/ zero/1. 0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Van Campen et al. BMC Med Ethics (2021) 22:31 Page 2 of 11 applicable public policy (i.e., laws, statutes, regula- the context of a societal intervention and its associated tions), industry guidelines [1], and ethics standards. risks and benefts. As life sciences research and clinical care become As Beauchamp and Childress state, specifcation “does increasingly complex, the biopharmaceutical enterprise not merely analyze meaning; it adds content” [3] (p. 17). frequently faces issues with important ethical implica- In order for this additional content to be meaningful, it is tions that may not be fully addressed by public policy important to understand the scope and context to which or industry guidelines. Current examples include access bioethics norms are to be applied. Bioethics as applied to to medicines, drug shortages; use of human biological a biopharmaceutical industry setting often is construed samples; genomics; use of “big data”; personalized med- either too broadly (merged into a general discussion of icine; quality of life and regenerative medicines; data ethics) or too narrowly (limited to research ethics) with transparency; research in low resource settings; clinical little examination of its proper scope. Given the infuence trial diversity; and most recently, the conduct of clinical of the biopharmaceutical industry and the ongoing scru- trials during a pandemic. Systematic analysis and appli- tiny of its ethics, it is necessary to consider how bioethics cation of ethics standards provides needed guidance for as a discipline (distinct from but complementary to legal ‘gray areas’ like these topics that lack specifc policy or compliance and business ethics) relates to this infuential guidelines. sector of the global healthcare system. As MacDonald Bioethics is a feld of study that examines ethical states, “It is highly unlikely that an adequate understand- issues in life sciences, medicine and healthcare. It pro- ing of complex issues in health policy will be possible in vides direction to navigate ethical uncertainty asso- the absence of an adequate understanding of one of the ciated with these disciplines, as well as rationale for major players” [5] (p. W38). related public policies [2] and discipline-specifc guide- Tere are scores of articles and a number of books lines. Any institution with a scientifc or healthcare [6–11] that examine and discuss industry ‘ethics’ broadly mission should engage with bioethics—whether it be a (including a mix of business ethics, corporate respon- hospital, research center, clinic, or biopharmaceutical sibility, legal compliance, and bioethics), and there is company. Although bioethics norms must remain con- substantive bioethics literature on topics that relate to stant across settings, it is reasonable to assume their industry activities (for example, those listed in the intro- application will vary depending on the characteristics duction). However, there are a limited number of arti- of a given setting. cles [12–18] and one book [19] that have explored how In their seminal book, Principles of Biomedical Ethics, and why bioethics as a discipline is being applied within Beauchamp and Childress explain that although ethics a biopharmaceutical industry context. Even with these norms (concepts, principles and rules) are foundational eforts, none has defned the scope of biopharmaceutical to a common morality, they lack specifcity [3]. ‘Practi- bioethics nor described bioethically relevant characteris- cal’ or ‘applied’ ethics, such as bioethics or business eth- tics of an industry setting. ics, interpret ethics norms for the purpose of generating Using Beauchamp and Childress’ perspective on eth- action-guiding content specifc to a context. However, ics specifcation as a springboard, this paper presents a even within a particular applied ethics domain, ethics defnition and scope for biopharmaceutical bioethics, and norms can and should be further specifed to provide describes fve bioethically relevant contextual factors that discipline- or setting-specifc guidance. Bioethics ‘spe- are generalizable to a biopharmaceutical industry set- cialties’ such as research ethics, clinical ethics and pub- ting. We propose that the scope of the biopharmaceutical lic health ethics are examples of progressive specifcation enterprise and the distinct contextual factors of a biop- [3]. harmaceutical industry setting necessitate focused bio- Te concept of specifcation is evident with the bioeth- ethics consideration, and that an understanding of this ics principle of “respect for persons” or “autonomy”, from setting is foundational for application of bioethics norms. which the procedural requirement of informed consent Te paper is written specifcally through an industry was derived [4]. Although this principle is generalizable, lens because all authors have industry experience, but we without specifcation it lacks practicality.

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