Biopharmaceutical companies have dual obligations of increasing global health and wellbeing and realizing a reasonable profit for their shareholders/investors. The latter must be achieved in an ethical manner to ensure maximum realization of the former. Integration of bioethics considerations into all pharmaceutical company activities is essential to preventing negative consequences of innovation efforts and ensuring positive outcomes for patients, companies, and society overall.
Understanding Bioethics in Biopharma
“Ethical integrity in the processed involves in drug research, development, manufacturing, and commercialization is “foundational to the delivery of safe and effective products and provision of reliable and credible information to support their appropriate use.”1
It is important when discussing bioethics to understand what this term specifically means. Bioethics refers to a specific form of applied ethics, which is one component of ethic in general.1–3 In the field of ethics, the goal is to understand the concepts of right and wrong. Applied ethics addresses specific moral issues, and bioethics drills down even further to ethical issues related to biology and biological systems.
In the biopharma industry, bioethics covers topics such as patient consent; data privacy, transparency, and appropriate use of big data analytics; equitable pricing and access; corporate responsibility, including balancing profit with meeting health needs; genomics; patient safety; use of new technologies; the conduct of clinical trials; animal testing; and more. Van Campen et al. define biopharmaceutical bioethics as “the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products.”
The World Health Organization (WHO) has established bioethical standards that serve as the basis for determining acceptable modes of operation in the biopharma sector.3 The intent is to “safeguard the welfare and dignity of individuals, communities, and societies at large” and ensure ethical issues are always considered during decision-making and as part of ongoing daily operations.2
Most biopharmaceutical companies have established ethics policies, but there are overarching questions that may never be definitively answered.4 Mainly, because of the nature of the products they produce, should pharmaceutical companies be held to higher ethical standards? And are they morally obligated to make their products affordable for everyone?
This article does not attempt to find answers to these complex questions. Rather, it highlights important bioethics considerations covering various aspects of drug research, development, manufacturing, commercialization, and the use of artificial intelligence (AI). A few company approaches to bioethics are highlighted as well.
R&D-Related Bioethics Issues
Biopharmaceutical R&D must be pursued in an ethical manner with patient safety at the forefront. At the same time, newly developed drug products — whether novel or generic — must generate a sufficient return to drug companies for them to continue to innovate and bring additional products to the market and patients. There is, consequently, a significant emphasis on reducing the time and cost of R&D, which must be balanced with the need to establish the safety and efficacy of investigational medicines.
Key issues that must be addressed include the use of animals in preclinical R&D, the protection of patients during human clinical trials, and the use of placebos. The former issue concerns not only the mistreatment of animals but the often less than robust correlation between preclinical data developed using different species. With the announcement in April 2025 by the U.S. Food and Drug Administration (FDA) that the agency would be phasing out the requirement for animal testing and begin accepting alternative methods, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting.5
Upholding ethical standards during clinical trials is essential not only to protecting patients but to achieving valuable data.6 If they are not maintained, the consequences can be dire, ranging from patient harm to generation of invalid data to negative impacts on public trust in the drug development process.
Assuring patient safety and privacy during clinical trials requires ethical consideration of trial design and conduct, data collection and analysis, sharing of both positive and negative study results, and identification of any data falsification or misconduct by researchers.1 Potential participants must be given sufficient information and time to evaluate it to ensure informed decision-making.6 Steps must be taken to ensure all participants are involved in clinical trials voluntarily and that the selection process follow clear guidelines using clinical appropriate eligibility criteria. Outreach should also be conducted to ensure the diversity of trial participants to the maximum extent possible. Plans for post-study follow-up and provision of ongoing care should also be in place.
With respect to reporting on clinical studies, Bioethics International found that, from 2012 to 2017, performance in this area had increased significantly. In 2012, 35% of trial results per drug were publicly unavailable, 50% of all drugs had undisclosed results for their phase II or III trials, and just 20% of large pharma companies disclosed all trial results.7 By 2017, the percentage of new drugs with undisclosed phase II or III trials dropped to 30%, and the public availability of trial results increased to 96% per drug.
Balancing risk with patient safety and efficacy also comes into play for drugs developed under accelerated approval programs, which are now offered by many regulatory bodies. Compliance with extensive regulations does ensure drug safety and efficacy but often adds time and cost to the development process. Accelerated approval programs for novel therapies thought to represent true treatment breakthroughs have emerged, at least theoretically, as a means to maintain safety and efficacy while reducing the time and cost required to receive marketing authorization.
However, expedited approvals, as well as the compassionate release of drugs, present ethical challenges.8 First, given the limited data available for these products before running clinical trials, it is questionable whether potential study participants can truly give informed consent. The design of many early-/expanded-access programs and issues with reimbursement due to lack of sufficient data for many subpopulations can lead to inequities. Physicians, meanwhile, may lack sufficient information to effectively assess the benefits and risks of drugs that have received accelerated approvals for any specific individual. Additionally, clinicians and hospitals are often expected to take on the responsibility and liability if any problems arise with medicines approved under accelerated programs. More broadly, these programs may result in the cost burden being shifted from companies to the public. Finally, effective collection of real-world data after marketing approval is often required for drugs with expedited approvals, but doing so can be challenging owing to a lack of sufficient infrastructure to support data collection and sharing.
Finally, the ethics associated with the use of placebos has received growing attention in recent years. Traditional random trials rely on the administration of the investigational drug to some patients and a placebo to others, without the patients knowing which they will receive. The ethics of such a practice are questionable,9 as patients are in essence being deceived, which is in direct conflict with the concepts of informed consent and patient autonomy and results in those patients not receiving effective treatments, which can result in harm.
Open-label placebos (OLPs) represent an alternative approach. In this case, patients are informed when they will be receiving a placebo.9 This approach avoids any concerns over deception. Studies suggest that there are still health benefits for patients, particularly those suffering from diseases with significant psychological components, perhaps because the “mind’s ability to heal” is being leveraged. Ethical questions do remain regarding OLPs with respect to the need for unambiguous informed consent, the potential impact they may have on doctor-patient relationships, and whether they should be conducted for certain conditions.
Manufacturing-Related Bioethics Issues
Bioethics concerns regarding drug manufacturing pertain directly to assurance of quality and safety, and pharmaceutical professionals may sometimes be forced to consider professional ethics in the context of company goals, which can create conflict and undesirable pressures.10
All pharmaceutical products – drug substances and drug products whether small or large molecule — must be manufactured according to current Good Manufacturing Practice (GMP) requirements. These requirements have been established to ensure the safety of drug products through assurance of quality and where necessary sterility.4 Failure to comply can lead to the failure of manufacturing batches due to quality issues, which in turn can result in the sale of unacceptable products that must be recalled, drug shortages, and, in the worst-case scenario, severe or even fatal harm to patients.
GMP requirements address the qualification and validation of manufacturing processes, as well as the level of analytical testing required to ensure the safety and quality of drug substances and drug products. They must be followed regardless of the time pressures placed on a drug company to get to the market first with a novel medication. Patient safety, product integrity, and regulatory compliance must be ensured at all times.10 Only after in-depth risk assessments can it be determined if moving faster will not pose an unacceptable risk to patient safety. Similarly, rejecting a batch or recalling a product can create delays or shortages in drug supplies, so it is essential to ascertain the level of risk posed by these actions compared with the risk of patients going without needed medicines.
Commercialization-Related Bioethics Issues
Once a drug product is commercialized, pharmaceutical companies have an ethical responsibility to ensure, to the best of their ability, both availability and accessibiliy.1 While regulatory decisions are somewhat outside their purview, drug makers can still work towards continued approval through compliance with regulations and ongoing commitment to maintaining a quality culture. Availability also requires maintenance of supply chains, manufacturing capacity, and operational distribution systems. Ensuring accessibility of approved drug products, meanwhile, falls not only on the shoulders of manufacturers but also on healthcare systems and insurance/reimbursement programs in different parts of the world.
Companies also have an obligation to monitor the impact of approved drug products particularly with respect to advise events and to ensure sound advertising and marketing practices that avoid false claims and the financial incentivization of healthcare professionals to prescribe their medicines.4 For certain drug products, additional post-marketing studies must be conducted to clearly demonstrate safety and efficacy thought he gathering of real-world evidence.1
Bioethics Concerns with Use of Artificial Intelligence
AI and machine learning (ML) are helping improve the efficiency and accuracy of many aspects of drug discovery and development, as well as facilitating personalized medicine, patient diagnosis and treatment planning, adverse event monitoring, and so much more. The many benefits offered by AI and ML, however, come with a new set of ethical challenges that all stakeholders in the pharmaceutical industry must be aware of and find solutions to address them.11–14
Key ethical challenges posed by AI occur at all stages across drug development, commercialization, and use. Key among them are bias-related issues and difficulties with ensuring data security, privacy, and protection. Bias can be introduced during many phases of AI application, starting with biases transferred from algorithm developers into the algorithms themselves and continuing with the collection, processing, and use of biased data sets for training AI and ML models and the biases of the people using the models. Implications for biased, non-diverse, and incorrect data can be dramatically magnified as they are propagated through AI models and can lead to the wrong conclusions and/or decisions, particularly for specific patient groups, which ultimately result in poor patient outcomes.
Because large sets of patient data are needed to train AI/ML models, there are considerable ethical challenges regarding protection of data privacy. In addition to ensuring that regulatory requirements are met, AI/ML systems must he designed to resist cyber-attacks and prevent re-identification of data and data protection compromises due to third-party vendors.
Other ethical questions surrounding the use of AI in healthcare on the patient side include, once again, ensuring equitable access to AI-driven healthcare for all people and ideally leading to a reduction in inequities; ensuring patients truly understand how AI systems are influencing treatment decisions; determination of who owns the data generated for use in AI models and who is liable for any errors in AI-generated healthcare information/reuslts.11
During drug development, challenges relate to the dependence of AI models on available data, which for preclinical studies is generated using animals and do not correlate well with human results — an issue AI/ML systems cannot easily overcome; the credibility and quality of data used to train AI/ML models used in drug discovery an process development, for instance, particularly relating to their relevance and timeliness; lack of transparency in AI/ML model design, which makes assessing compliance and scientific validity difficult; and the fact that AI/ML technology development is outpacing updates to ethical norms.12 There are also implications for AI with respect to intellectual property rights, regulatory frameworks, and collaboration among all stakeholders not only across the industry value chain but within the multiple disciplines that can be impacted by AI/ML technology, including quality, manufacturing, engineering, regulatory, and more.11,13
The guidance document issued by the World Health Organization (WHO) in March 2024 (Benefits and risks of using artificial intelligence for pharmaceutical development and delivery)14 takes into consideration many of these ethical issues and proposes ideas for achieving governance of AI/ML use in healthcare from a bioethics perspective.
The concern of the WHO is that, without an appropriate ethical governance structure, use of AI/ML in healthcare could “dehumanize care, undermine the autonomy and independence of older persons, and pose significant risks to patient privacy.”15 Such a governance structure is needed to:16
Minimize the risk of bias in AI used for drug development applications and patient treatment decisions;
Prevent AI tools from being used for the development of chemical and biological weapons;
Ensure transparency regarding AI model development and use;
Provide for data protection and privacy;
Ensure patients can choose not to have their healthcare decisions made solely on AI-driven systems;
Encourage nations to implement regulations regarding the collection, processing, analysis, transfer, and use of health data;
Ensure free, informed consent to the use of data;
Require rigorous, well-defined testing of algorithms to ensure they meet international standards for safety and efficacy; and
Encourage increase data sharing outside of the pharmaceutical industry and on a global basis.
Selected Company Highlights
Most major biopharmaceutical companies have established some type of bioethics policy covering fundamental issues and concerns. They can be more or less comprehensive, with some including specific aspects of bioethics. Novo Nordisk for example, has established focus areas including clinical trial, animal, human biosampling, cell therapy, gene technology, and gene therapy ethics.17
Baxter outlines numerous bioethics guiding principles and a framework for their application within its bioethics policy that range from placing safety and efficacy as the highest priority to considering public feedback on the social, ethical, and technical application of biotechnology to complying with rules and regulations regarding ethics in the research, development, manufacture, and sale of its products.18
Bristol Myers Squibb’s bioethics policy outlines the company’s commitment to conduct activities related to non-clinical and clinical research and development of its pharmaceutical products “in accordance with the highest legal, ethical, and scientific standards” and “ensuring patient rights and safety are safeguarded at all times.”19 Several policy statements cover the requirement of independent ethical review of all clinical studies and clear informed consent by trial participants, completion of risk/benefit analyses for all research projects, limitations on use of placebo-controlled studies, registration and disclosure of clinical study results, and much more.
It isn’t just pharmaceutical companies that have issued bioethics policies. Other members of the biopharmaceutical value chain have also taken steps to establish strong positions on ethical behavior. For instance, in late 2025, FUJIFILM Holdings America Corporation, of which contract development and manufacturing organization FUJIFILM Biotechnologies is a part, announced it was forming a bioethics advisory committee that will be responsible for providing independent recommendations, governance guidance, and accountability mechanisms to FUJIFILM’s life sciences and healthcare subsidiaries on complex ethical considerations that arise across research, product development, AI-enabled technologies, manufacturing, and commercialization.20
Bioethics Brings Value to Biopharma
Biopharmaceutical companies have dual obligations of increasing global health and wellbeing and realizing a reasonable profit for their shareholders/investors.1,10 The latter must be achieved in an ethical manner within a “culture of quality” to ensure maximum realization of the former. Integration of bioethics considerations into all pharmaceutical company activities is essential to preventing negative consequences of innovation efforts and ensuring positive outcomes for patients, companies, and society overall.21
Emphasis on transparency, patient safety and integrity combined with the establishment of bioethics policies, incorporation of bioethics into daily business decisions, comprehensive ethics training, and collaboration with all industry stakeholders are essential to addressing the myriad ethical challenges facing biopharmaceutical companies.10 Successful pursuit of bioethics in this manner will enable companies to develop and commercialize innovative new medicines that address unmet medical needs in an ethical manner that supports profit-generation. Proactive consideration of bioethics issues helps pharmaceutical companies manage the ethical challenges that arise with rapidly evolving technologies (such as gene editing and stem cell research) and achieve the dual goals of profitably and improve health on both the global and individual levels.1
In essence, integrating bioethics and business ethics enables the balancing of business issues with ethical responsibility and recognition of the needs of multiple stakeholders to ensure that meeting patients’ needs remains the ultimate priority.1 Tangible results include rapid development, manufacture, and distribution of novel medicines without sacrificing quality and safety; development of ethical clinical study designs and protocols, and equitable access to drug products, particularly for currently underserved populations. Importantly, consideration of bioethics concerns also ensures these results are achieved through ethical decision-making with respect to resource selection and allocation, target identification and candidate selection, and a balanced approach to the management of candidate failure that takes into account the “inherent strain between research and public health ethics and clinical ethics.”
The bioethics position and policy statements issued by leading biopharmaceutical companies reflect the growing recognition of the value that bioethics brings to drug development, manufacturing, and commercialization.1 Increased understanding of bioethics issues and their implications for all industry stakeholders, including patients continues through collaborative discussion on wide-ranging topics around drug discovery, preclinical and clinical development, distribution, pricing, equitable access, and more. Growing awareness by companies of their ethical responsibilities across the full development cycle from discovery through post-marketing studies and life cycle management is leading to incorporation of bioethics as key components of caproate values and principles. Further discussion and development in this field can only bring not only value to pharmaceutical companies but important benefits to patients and society as a whole.
References
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2. “What is the difference between ethics and bioethics?” Penn State College of Agricultural Sciences. Accessed 8 Jan. 2026.
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4. Salib, Veronica. “Dissecting Ethical Principles in the Pharmaceutical Industry.” TechTarget. 28 Aug. 2023.
5. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. U.S. Food and Drug Administration. 10 Apr. 2025.
6. “The Ethics of Clinical Trials in the Drug Development Process.” Meet Life Sciences Blog 19 Jul. 2023.
7. “Scoring the Ethics of Pharma Companies.” Bioethics International. Accessed 8 Jan. 2026.
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10. VanTrieste, Martin. “Ethical Dilemmas in Pharma: Pharma's Toughest Decisions.” PDA Letter. 2 Apr. 2025.
11. Kenny, Kathleen. “Carefully Consider Ethical Implications of Artificial Intelligence Use in Pharmacy.” Pharmacy Times. 29 Nov. 2025.
12. Fann, Yulu Yancheng Wu, and Zitong Wang. “Exploring the ethical issues posed by AI and big data technologies in drug development.” Front. Public Health. 13: 1585180 (2025).
13. Salem, Aliasger K and Ben Goldacre. “Ethical Challenges in AI-Driven Drug Development.” Journal of Frontiers in Multidisciplinary Research. 6: 01–04 (2025).
14. Benefits and risks of using artificial intelligence for pharmaceutical development and delivery. World Health Organization. Digital Health and Innovation and Health Product Policy and Standards. 2024.
15. Ethics and governance of artificial intelligence for health. World Health Organization. Health Ethics & Governance. 2021.
16. Sandle, Tim. “AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance.” Drug Discovery Online. 8 Apr. 2024.
17. “Bioethics.” Novo Nordisk. Accessed 8 Jan. 2026.
18. “Bioethics Policy.” Baxter. Accessed 8 Jan. 2026.
19. “Bioethics Policy Statement.” Bristol Myers Squibb. Accessed 8 Jan. 2026.
20. Fujifilm Launches Bioethics Advisory Committee to Guide Ethical Decision-Making Across Life Sciences and Healthcare Businesses in the Americas. FUJIFILM Biotechnologies. 17 Nov. 2025.
21. Montalbano, Palmer. “What Does Bioethics Offer Biotech?” Impact Ethics. 19 Sep. 2024.
