Bioethical principles for decision-making drug policy & healthcare resource funding decisions
- R.M. Boylan
- Jan 19
- 8 min read
Decision-making, high-minded leadership & bioethics as a tool for policy
"Numerous regrettable abuses of human subjects in research, medical procedures performed without informed consent, experimentation in World War II concentration camps, combined with positive developments in medicine, medical technology, and societal shifts, resulted in the swift use and transformation of bioethics. It evolved from a focus on professional behavior and codes to its current broad scope, encompassing research ethics, public health ethics, organizational ethics, and clinical ethics." (3)
I am sharing how these principles can be used in drug policy and leadership healthcare decision-making to develop a more high-minded approach to understanding healthcare, drug policy and decision-making.
Group and leader decision-making within the context of healthcare decision-making and drug funding assumes that every person will use morality and high-mindedness when deliberating on a decision. Similar to how juries make decisions we expect "sound deliberation". "A practice which rests upon each juror's responsible self-government, autonomy, impartiality and common sense." (1, p. 10 jury conduct)
The introduction of high-mindedness in deliberation forums
Bioethical principles act as practical tools that can be employed alongside health economics and patient-reported outcomes. Bioethical principles provide structure to address the uncertainties surrounding the funding of costly treatments and the consequences inherent in human decision making models. There are 10 bioethical principles that can be utilized to frame arguments within the context of social, civil, and political needs for policy decisions related to drug policy and healthcare.
Deliberating drug policy decisions & healthcare resource rationing
When debating healthcare and drug pricing, 10 bioethical principles can be used to argue both for and against a decision. Morality is an emotional topic. It must be structured to remove controversy. Bioethical principles allow us to analyze the problem from a societal perspective. Bioethical principles when used practically with health economics can qualify and quantify the impact of inaction and action. Most decisions in leadership can be evaluated based on the processes used to make the decision and the results they produce which may be consequential or advantageous.
For policy decisions and risk assessments, bioethics allows decision-makers to consider all perspectives of a decision and weigh all pros and cons for a deliberation. In the absence of a true high-minded debate, this is the best option. Therefore, its inclusion in strategy and planning elevates the level of thinking to the highest standard for decision-making.
This framework enables us to distinctly recognize the advantages and disadvantages of a policy decision. Every decision has consequences and benefits that must be weighed against duties, responsibilities, and restricted financial resources.
When reviewing how leaders make decisions, it is important to understand the domains of the mind. Leadership and decision-making processes can be used to evaluate the quality of a leader's mind and the outcomes of decisions. There are 2 faculties for decision-making:
1). The use of higher executive functions of the mind more specifically the prefrontal cortex.
2). Lower executive functions of the mind the reptilian core.
The tools a leader uses to make a decision will determine if the decision is noble or more basic, transactional and primitive, both in its outcome and process.
Bioethical principles act as a tool for medical decision-making, enhancing leadership decision-making to a higher level. Utilizing bioethical principles during a deliberation requires the engagement of the mind's higher executive functions to reach a decision. Therefore, the process is inherently more than merely transactional.
Bioethics makes the decision more obvious & easier to make reducing decision fatigue for the leader
The process of deciding on medical and pharmaceutical drug reimbursements is intricate, necessitating a thoughtful evaluation of ethical principles to guarantee that patient care remains effective and ethically justified. Bioethics offers a framework to address these complexities, with several fundamental principles guiding medical professionals in their decision-making. It forces critical reasoning around consequence and beneficence. For most persons this is the uncomfortable state where decision fatigue exists. However when the arguments are wrapped in a policy paper in bioethics the decision is made clear.
Bioethics and its principles are valuable when incorporated into policy-making. These principles provide a framework for assessing the morality of decisions and their outcomes. By integrating health economics with bioethical principles, decision-making tools for policy issues on social matters can be enhanced. However, this process can be complex and demands expertise and a systems thinking approach to the issue.
The bioethical principles wrap all these elements into a social, civil and political context for decision-making on affordability.
Each distinct category should be evaluated in the context of medical or drug decisions, taking into account both the short-term and long-term policy implications. Following this, a policy analysis and paper can be developed to assist decision-makers in evaluating the potential benefits and/or consequences of each decision. To achieve this, a strong foundation is essential for developing and analyzing dossiers on the drug's profile including; clinical, pharmacoeconomic, health economic, and patient-reported outcomes. The bioethical principles wrap all these elements into a social, civil and political context for decision-making on affordability.
Below are some of the most significant principles in medical ethics:
1. Principle of Common Good
The principle of common good emphasizes the importance of promoting the well-being of the community as a whole. In medical decision making, this principle encourages leaders and healthcare providers to consider the broader implications of their actions, ensuring that individual patient access and care contributes positively to public health. This may involve prioritizing resources for preventive care or addressing health disparities within populations. This involves being aware of the cognitive biases we may have about vulnerable populations, victims of violence and other groups we may have nefarious belief systems towards.
2. Principle of Double Effect
The principle of double effect is a moral reasoning tool used when an action may have two effects: One effect may be intended and beneficial, and the other effect may be unintended and potentially harmful. In healthcare, this principle allows for actions that may cause harm as long as the primary intention is to achieve a good outcome. For example, administering high doses of pain relief to a terminally ill patient may relieve suffering, even if it carries the risk of hastening death.
3. Principle of Distributive Justice
Distributive justice focusses on the fair allocation of healthcare resources. This principle requires that medical professionals consider how to distribute limited & scarce resources—such as organs for transplantation, medications, or access to treatment—equitably among patients. It addresses issues of fairness, ensuring that all individuals have access to necessary care regardless of their socioeconomic status, race, gender, socioeconomic status or other uncontrollable factors.
4. Principle of Informed Consent
The principle of informed consent is fundamental to respecting patient autonomy. It mandates that healthcare providers must ensure that patients are fully informed about their treatment options, including potential risks and benefits, before making a decision. This principle empowers patients to make choices about their own health care and fosters trust in the patient-provider relationship. This also implies healthcare providers and leaders must always ensure they are not inflicting harm based on judgment and belief systems. An example could be the misuse of sexism in calling women mentally ill to prevent them from obtaining hormone replacement therapy or being permitted to obtain an abortion after rape. The principle of informed consent and its removal from women's rights has been used illegally in patriarchal political regimes in medicine to harm women using psychiatry, religion and obstetrics/gynecology historically.
5. Principle of Human Dignity
The principle of human dignity asserts that every individual deserves respect and consideration as a person. In medical decision making, this principle guides leaders and healthcare providers to treat patients with compassion and to consider their values, beliefs, and preferences in the care they receive. Upholding human dignity is essential in ensuring that patients are not viewed merely as cases or conditions but as whole individuals with unique life experiences. In the legislation of drug policy across all therapeutic areas this must be established.
6. Principle of Totality and Integrity
The principle of totality and integrity emphasizes the importance of considering the whole person when making medical decisions. This principle suggests that treatment should aim to restore or maintain the overall health and well-being of the patient, rather than focusing solely on individual symptoms or conditions. It promotes a holistic approach to healthcare, recognizing that physical, mental, and social factors all contribute to a patient's health.
7. Principle of Respect for Autonomy
This principle acknowledges the right of individuals to make informed decisions about their own lives and medical treatments. Respecting autonomy involves recognizing that patients have the right to refuse or accept treatment based on their personal values and beliefs. Healthcare providers must engage in open communication and provide necessary information to support patients in making informed choices.
8. Principle of Respect for Persons
The principle of respect for persons emphasizes the inherent worth of every individual. This principle requires healthcare providers to acknowledge and honor the dignity of all patients, ensuring that their rights and preferences are respected throughout the healthcare process. It involves treating patients as active participants in their own care rather than passive recipients of medical interventions.
9. Principle of Subsidiarity
The principle of subsidiarity advocates for decisions to be made at the most local level possible. In healthcare, this means that decisions regarding patient care should be made by those closest to the patient, such as local healthcare providers and families, rather than imposed by distant authorities. This principle supports personalized care and recognizes the unique context of each patient's situation.
10. Principle of Toleration
The principle of toleration recognizes the need for a respectful coexistence of diverse beliefs and values in leadership in healthcare and its settings. This principle encourages healthcare leaders and its providers to be open and accepting of patients', other healthcare professionals, leaders' differing perspectives, belief systems on health, illness, and treatment, fostering a collaborative and inclusive approach to care.
Conclusion
Incorporating these principles into medical & drug policy or drug reimbursement decision-making not only enhances the quality of care but also fosters ethical practices within the healthcare system. By adhering to the principles of common good, double effect, distributive justice, informed consent, human dignity, totality and integrity, respect for autonomy, respect for persons, subsidiarity, and toleration, leaders in healthcare can ensure healthcare professionals navigate complex ethical dilemmas and provide care that is both effective and morally upright. We have a problem right now if leadership at the top is broken in its understanding of morality and high-mindedness, the distribution of healthcare and decision-making becomes more Philistine and barbaric. As we move to more high-minded decision-making and leadership consciousness in healthcare we raise the benchmark below the leaders in terms of role modelling.
Because cognitive biases and belief systems are so divergent among persons with lower levels of self-awareness structured methods have been developed to address group and individual decision-making to raise morality and consciousness. These structures must be used to adhere to high-minded decision-making processes as standard decision-making processes despite our best efforts do not account for integrating bioethical principles despite what we would like to think.
An expert in bioethics should be hired to do the assessment using the principles. A third party person is best as a consultant to avoid conflicts of interests as group inclusion creates conflicts of interests and clouding of judgment in analysis.
Then a group decision-making risk assessment ranking must be done to truly assess the consequences associated with the decision on each principle. Otherwise most leadership decisions are done transactionally without consideration of these high-minded considerations and their consequences. This analysis presents 5 options with risks so the leader and decision-makers have a variety of options to choose from.
References:
1). Academic Press. (1998). Encyclopedia of Applied Ethics. Volume 3 J-R. Centre for Professional Ethics, University of Central Lancashire, UK.
2). Frey, R.G., Heath Wellman, C. (2005). A Companion to Applied Ethics. Blackwell Publishing.
3). Varvey, B. (2020). Principles of Clinical Ethics and their application to practice. Med. Princ Pract. 2020 Jun 4;30 (1): 17-28 doi: 10.1159/000509119.
4). Lammers, S.E., Verhey, A., (1998). On Moral Medicine: Theological Perspectives in Medical Ethics, Second Edition. William B. Eerdmans Publishing Company, Grand Rapids, Michigan/Cambridge, U.K.
5). Rhodes, R., Battin, M.P., Silvers, A. (2012). Medicine and Social Justice: Essays on the Distribution of Healthcare, Second Edition. Oxford University Press.
6). Rang, H.P., Dale, M.M., Ritter, J.M., Gardner, P. (1995). Pharmacology. Churchill Livingstone.
7). Cua, A.S. (1985). Ethical Argumentation: A study in Hisyn Tzu Moral Epistemology. University of Hawaii Press.
8). Torbert, B. (2004). Action Inquiry: The secret of timely and transforming leadership. Berrett-Koehler Publishers, Inc., San Francisco.
9). Daly, H.E., Cobb, J.B. (1994). For the Common Good. Beacon Press, Boston.
10). Lennick, D., Kiel, F. (2005). Moral Intelligence. Wharton School Publishing.
11). Herman, B., (2007). Moral Literacy. Harvard University Press.
Comments