Dissecting Ethical Principles in the Pharmaceutical Industry

August 28, 2023 - According to the Seven Pillars Institute for Global Finance and Ethics, various ethical issues are pressing the pharmaceutical industry and its stakeholders, including researchers, pharmacists, pharmaceutical companies, other healthcare professionals, and patients. Ethical decision-making in this industry is a critical concern, as lives are at stake, and public health can be significantly impacted.

A document published by the United Nations Educational, Scientific, and Cultural Organization notes that core ethical principles must consider nonmaleficence, autonomy, justice, beneficence, truthfulness, and solidarity.

Ethical Landscape in the Pharmaceutical Industry

Although pharmaceutical companies are a business in the capitalist free market, their position in ensuring patient safety and well-being complicates ethical considerations beyond business ethics.

It poses the complex question: What ethical standards should pharmaceutical companies and other industry members be held to? Although, as a business, they have a bottom line, should pharmaceutical companies be held to different standards?

The answers to these questions are complicated and unclear, with varying opinions from different industry members.

A segment of Contemporary Issues in Bioethics notes that ethical discussions can be complicated because they are partially driven by an individual’s experience and surroundings, including personal values, educational background, religion, and other beliefs.

Most pharmaceutical companies have a code of ethics intended to ensure that they are functioning with an ethical framework; however, ethical dilemmas are a gray area that may not necessarily be navigated based on singular ethical principles.

For example, Novo Nordisk has bioethics policies in varying focus areas, including clinical trials, animal models, human biosamples, cell therapy, and gene technology. Still, there are no clear guidelines for new ethical considerations that arise when novel technologies or treatments are discovered.

In addition, the current healthcare and pharmaceutical system forces consumers and patients to conform to the financial standards of pharmaceutical suppliers, tacking a price on life-saving interventions that may be too high for some patients and facilities.

Are pharmaceutical companies morally responsible for developing new and affordable drugs or medical products?

There are two ethical analytical systems: consequentialist and deontological frameworks. According to both ethics frameworks, the current system is unethical. For consequentialists, the burdens of increased drug prices heavily outweigh the benefits for the general public. Meanwhile, deontologists would note that benefiting from exorbitant costs is immoral.

The author of Contemporary Issues in Bioethics divides the ethical issues facing pharmacists into multiple categories: clinical pharmacy, community pharmacy, pharmaceutical product manufacturing, drug distribution and supply chains, and research and clinical trials.

In addition to these components, pharmaceutical marketing, advertising, and intellectual property are significant ethical dilemmas.

Clinical Pharmacy

Globally, pharmacists are healthcare providers responsible for dispensing and educating patients on their medication, the appropriate dosage, and potential side effects. They play a vital role in patient care and the patient education system.

There are multiple ethical issues in clinical practice, including the standard concerns of confidentiality and privacy. Beyond that, there are conflicts between autonomy and physician ethics in clinical practice. Through the decision-making process, a clinician may choose to leave out specific side effects to help with patient compliance. When prescribing, it is a physician’s responsibility to ensure that the benefits outweigh the potential risks; however, this poses a conflict of interest for pharmacists, whose role is engrained in patient education.

Additionally, as pharmacists are responsible for making decisions on which drugs to supply and dispense, it is crucial that they, as well as other decision-makers, do not have a vested financial interest in specific companies or drug stocks.

Community Pharmacy

In community practices, there are multiple ethical challenges, including drug dispensing. Although pharmacist’s primary role in community pharmacies is dispensing, the issue goes slightly beyond that. They must evaluate the prescription and its fit for the patient and their condition. Pharmacists can refuse to dispense medications based on their professional judgment. However, the right to refuse can be a blurry line when some people abuse that power by making decisions based on their personal values or interests.

Other components that face ethical challenges are medications prescribed or distributed by pharmacies, patient drug consultations, and pharmaceutical preparations.

Pharmaceutical Manufacturing, Drug Distribution, and Supply Chain

Manufacturing pharmaceutical products can pose some serious ethical questions. One moral challenge includes quality assurance by manufacturers. Quality assurance can and should be implemented in quality control, production, distribution, and inspections.

The FDA and many other pharmaceutical organizations provide guidelines for good manufacturing practices to guide quality control and sterility. Additional guidance from regulatory authorities and ethics committees may include storage protocols or distribution practices. Manufacturers are also responsible for handling recalls and complaints.

Violations of good manufacturing practices can result in compromised patient care, infectious disease spread, and healthcare complications. In addition, not complying with good manufacturing practices may contribute to recalls, distribution issues, and supply chain shortages.

Research and Clinical Trials

The United States Food and Drug Administration (FDA) provides some ethical considerations for pharmaceutical researchers conducting clinical trials, beginning pre-clinical research, or manufacturing medical products or drugs.

Ethical considerations for preclinical research may include humanitarian issues when using animal models. Researchers may question when to opt for a different model, such as organ-on-a-chip technology.

In September 2022, the FDA released a guidance document on Ethical Considerations for Clinical Investigations of Medical Products Involving Children. When working with vulnerable populations, including pediatric patients, more ethical factors, such as consent and assent, may need to be considered.

Pharmaceutical Marketing and Advertising

While vital for a pharmaceutical company to thrive financially, pharmaceutical marketing and advertising can be significant ethical dilemmas. According to the FDA, there are three types of advertisements for prescription drugs: product claims, reminders, and help-seeking ads. These varying types serve different purposes.

Companies must be careful when marketing or advertising drugs and products, avoiding false claims. In addition, marketing to healthcare professionals may be a significant ethical concern. Providers incentivized with financial compensation or gifts may be more likely to prescribe certain medications despite other availabilities that may be more sufficient. While this is generally frowned upon, it can still happen.

Pharmaceutical Intellectual Property

This discussion highlights ethical issues within pharmaceutical patents. Although patent protections incentivize pharma companies to conduct clinical research for new drug development, companies have abused the patent system to extend protections and keep others from developing more affordable alternatives.

“Pharmaceutical innovation and [technology] advancement have shaped the pharmaceutical industry and pharmacists themselves and the need [for] solid, strong ethics to be embedded into the pharmacist as an individual, which will then form the organization of pharmaceuticals with high ethical values. Ethics and pharmacy at large must be sensitive and responsive to an unavoidably changing environment,” noted the Contemporary Issues in Bioethics.