The Problem
The problems encountered when delivering medical care in low- and middle-income countries (LMICs are myriad). They range from a lack of tangible resources (e.g., anesthesia machines) to the influence of local culture on the ability to deliver that same medical care (Figs. 11.1 and 11.2). When a 9-year-old presented to our hospital in Liberia with a gunshot wound to the abdomen, the obvious question was how it occurred. The mother, initially without much emotion, became irate when asked about the mechanism of the injury, specifically how a 9-year sustained a gunshot wound. This information was significant in diagnosis and planning of treatment for the injury. We were forced to proceed without the information when a local physician informed us that such questions were inappropriate. Apparently children were considered parental property and parents were not required to give explanations about their children’s condition. It was a startling introduction to the local mores and an initiation into our understanding of ethical concepts in the developing world. These local mores are just another obstacle in the provision of adequate operative services in LMICs.
![A322064_1_En_11_Figa_HTML.jpg](/wp-content/uploads/2016/10/A322064_1_En_11_Figa_HTML.jpg)
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Fig. 11.1 Our home away from home
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Fig. 11.2 Antiquated anesthesia equipment
Surgery and anesthesia, referred to for practical purposes as operative services, are two of the most needed and most neglected areas of global health and two areas most often affected by legal and ethical issues. It has been estimated that operatively treatable diseases account for 11 % of the global burden of disease and more than 25 million disability-adjusted life-years [1]. This rough estimate includes injuries, malignancies, congenital anomalies, and complications of pregnancy, some of which may be cured if the affected populations had access to skilled surgical and anesthesia services. Unfortunately, the burden of these diseases disproportionately affects LMIC; overall it is estimated that only 3 % of the world’s operations are performed in LMICs [2]. In many LMICs, operative services are concentrated in cities and only available to citizens who can afford them [3]. Several studies have shown that operative care can be delivered in a cost-effective manner in small hospitals [4]; however the current burden of disease in LMICs is not being adequately managed by the patchwork of surgical services supported by federal governments, international non-governmental organizations, and limited-resource surgical “mission trips.” It is estimated that relief organizations perform nearly 250,000 operations in LMICs annually [5].
In 1996, Paul Farmer echoed in print what was known in the surgery/anesthesia community for some time; that surgery was the “stepchild” of global health [3]. Two billion people annually lack access to emergency or essential operative care and 175,000 anesthetics are delivered without even pulse oximetry, recognized as the standard of care in the developed world [6]. An estimated 500,000 mortalities per year in the developing world could be avoided were adequate surgical and anesthesia resources available. This is not just a medical problem. It is an ethical and moral problem that has not received the attention it should by developed countries that have the resources not only to deliver the necessary care, but also to educate and mentor surgeons and anesthesiologists in LMICs creating the skills to care for their own.
A major public misconception, primarily because of the universal emphasis on control of communicable disease (CD), is that those diseases are the principle cause of the significantly decreased life expectancy in the LMICs as compared to developed countries. Contrary to popular opinion, available data demonstrate that nearly 80 % of all non-communicable disease (NCD) deaths occur in low- and middle-income countries and these diseases are the major cause of mortality in these countries [7]. NCDs are the leading cause of death globally, killing more people each year than all other causes combined. The World Health Organization, explaining the reason for this, stated that the resources to prevent, diagnose, and treat these diseases are glaringly absent in LMICs. They further stated that NCDs are caused, to a large extent, by multiple behavioral risk factors that are pervasive aspects of economic transition, rapid urbanization and twenty-first-century lifestyles: tobacco use, unhealthy diet, insufficient physical activity, and the excessive use of alcohol and drugs, like khat chewing in Yemen [8]. The greatest deleterious effects of these risk factors are increasingly observed in LMICs, especially foisted upon poorer people within all these countries, mirroring the international underlying socioeconomic determinants. When examining these populations with great need, one identifies a repetitive cycle of poverty that exposes people to behavioral risk factors for NCDs while the resulting NCDs may become an important promoter for the downward spiral that leads families toward poverty [9].
At present, there is no universally accepted definition of “access to health services” [10]. For the purposes of this treatise, the definition by Peters et al. [11], which implies “the timely use of service according to need,” will be operative. Utilization of healthcare is applied as an operational proxy for access to healthcare. Access has four dimensions: availability, geographic accessibility, affordability, and acceptability [12]. When considering ethical and legal issues in global health, acceptability becomes the most important barrier to successful deliverance of healthcare, as it must deal with local cultural issues, social issues, gender issues, and all the mystical and mythical issues observed and practiced in a society. This barrier is divided into tangible (e.g., monetary) or intangible (e.g., strongly held religious or spiritual beliefs).
It is often difficult to understand and always difficult to deal with the intangible. The tangible, in accessing health services, can stem from the demand and/or the supply side of the economic equation [13]. Demand-side determinants are factors influencing the ability to use health services at the individual, household or community level, while supply-side determinants are factors that interfere with the right of entry by individuals, households or the community. The need to identify the demand-side from the supply-side barrier is required to develop the necessary strategies to overcome the barrier. In fact, whether the barrier is tangible like money, or intangible like an immovable cultural mores, the application of ethical and legal principles should be the starting point for development of any solution.
Historical Background
We see a landscape of a significant portion of the world’s population having experienced, and continuing to experience an inadequate access to what the United Nations declared in 1946 to be a “right to health.” What has also been witnessed is the developed world community’s multiple starts and reverses in an attempt to correct that phenomenon. The origins of these attempts date back millennia, as does the roots of the concepts of medical ethics and jurisprudence. A brief journey through the evolution of the development of medical ethics and jurisprudence focuses on how the questions of ethics and legal issues were identified in global health. Shortcomings in observance of those issues and failure to adhere to those rules and regulations enacted by multiple nations, countries, and agencies to enforce those principles are identified.
Historically, Western medical ethics, and the legal standards that evolved from these cultural principles, were inscribed by physicians in ancient documents like the Hippocratic Oath. The first recognized code of medical ethics, Formula Comitis Archiatrorum, was published in the fifth century AD, during the reign of King Theodoric the Great, the Visigoth ruler of Italy. As Middle Eastern influence increased in the medieval and early modern period, Islamic ethical medical doctrine was dispersed to the West. Writers like Ishaq ibn Ali al-Ruhawi, a Muslim physician, scribed the first complete book on the topic of medical ethics, entitled, Conduct of a Physician. Muhammad ibn Zakariya ar-Razi, Jewish thinkers like Maimonides, Roman Catholic scholastic thinkers including Thomas Aquinas, applied general rules and principles to questions of ethics and morals in order to resolve them, referred to as casuistry (that is, having the air of case law) in Catholic theology. These intellectual traditions continue in Catholic, Islamic and Jewish medical ethics to this day [14].
By the eighteenth and nineteenth centuries, medical ethics emerged as a more self-conscious discourse. In England, Thomas Percival, a physician and author, crafted the first modern code of medical ethics. He authored a pamphlet with the code in 1794 and wrote an expanded version in 1803, in which he coined the expressions “medical ethics” and “medical jurisprudence” [15]. In 1815, the Apothecaries Act was passed by the Parliament of the United Kingdom (UK). It introduced compulsory apprenticeship and formal qualifications for the apothecaries of the day under the license of the Society of Apothecaries. This was the beginning of regulation of the medical profession in the UK.
In 1847, the American Medical Association adopted its first code of ethics [16], based in large part upon Thomas Percival’s work. While in the nineteenth century secularized medicine borrowed largely from Catholic ethics, in the twentieth century an approach articulated by thinkers such as Joseph Fletcher was distinctively liberal Protestant [17]. This liberalization led to the movement toward the appreciation of ethical and legal behavior throughout the developed world; however, it was the atrocities that occurred during the Second World War that focused humanity’s attention on the need to deal with that type of heinous human experimentation, genocide and other crimes against humanity. The judgment by the war crimes tribunals at Nuremberg, in a new code that is now accepted worldwide, established ten standards by which physicians would have to conform when carrying out experiments on human subjects [18].
This code established a new standard of ethical medical behavior for the post-World War II human rights era. Among other requirements, this document enunciates the requirement of voluntary informed consent of the human subject. The principle of voluntary informed consent protects the right of the individual to control his own body. This code also recognizes that the risk must be weighed against the expected benefit, and that unnecessary pain and suffering must be avoided. Doctors should avoid actions that injure human patients. Also, the volunteer must be capable of understanding the nature of the research in which he or she partakes, including the risks and benefits. The principles established by this code for medical practice now have been extended into general codes of medical ethics [19]. It has also permeated the principles under which the medical and research community should function when working in the developing world.
Recent Developments
In the 1960s and 1970s, building upon liberal theory and procedural justice, much of the discourse of medical ethics went through a dramatic shift and largely reconfigured itself into what we now call bioethics [20]. Unfortunately, the legal discourse that followed progressed more slowly, with little teeth given to those codes and doctrine that were advocated and even enacted during the latter half of the twentieth century.
The goal of the memorialization of medical ethics and jurisprudence was to affect ethical behavior through cooperation among nations and by the creation of codified agreements, through the international law aspect of the human rights efforts. Examining the levels of interventions and how health officials can make use of it allowed for the passage of laws directing the behavior of individuals and nations. Such direction becomes a major undertaking when dealing with LMICs when they themselves have not necessarily set standards for ethical and legal action. Many of these countries have undergone social and political upheaval, being referred to as conflict or post-conflict nations (e.g., Congo, Liberia, and Nicaragua). The unrest sustained has often led to governments and nations being unable or unwilling to establish ethical and legal standards to which they would adhere when dealing with the health of their population.
Global health ethics and laws that nations have enacted have inadvertently created parallel legal systems. Specifically, each individual country must approve the international ethical principles, rights, and laws that have been created before those principles are instituted within the borders of their own country. Also, a treaty not recognized by a country results in that treaty having no force of law within that country. In view of the fact that international law is developed as a “bargaining evolution of theory,” it often results in a simplified version of what was intended in order to be accepted by the multiple partners, both from developed and undeveloped worlds, participating in the process. In other words, laws and doctrine are created by compromise, often losing the initial intent and failing to accomplish hoped for goals.
Current Situations
Even though the Global Health community accepted the “right to health,” especially in LMICs, it did not necessarily mean that the right to healthcare was accepted. In developing countries without the resources to provide adequate care, the desire to fulfill the goals of human rights in the healthcare arena is not often met. The intent of international laws and the quest for ethical deeds in providing the right to health (care) are based on ideas, but remains only an empty fantasy without the political and financial commitment of the global community. The creation of these humanitarian concepts is admirable. But very often something that should be progressively realized only reflects promoters’ dreams by allowing the countries that most need these principles to escape any real pressure to enforce them. To bring sufficient pressure to correct this problem, human rights assessments would be necessary by unbiased observers and the results published so the facts would be universally appreciated. Anticipation of human rights violations by certain governments is required so steps can be taken to circumvent abuses [21].
The enforcement of global health laws and ethics requires an understanding of the societies that we are supposedly assisting. Developed nations must first establish that other societies are following the same rules and regulations that they have deemed appropriate. Developed nations must understand what the underlying right might be in any given society, and enforce the resolution utilizing that right. Mechanisms to accomplish this goal are available such as international tribunals that have been successful in documenting atrocities and calling to task those who have laid waste to established principles, laws, and ethics. Once the principles outlined above have been introduced, the clinical setting in which they will function starts to impact the deliverance of healthcare.
When one looks at the practical requirements of delivering “health” as established in the Declaration of Human Rights [22], the magnitude of that endeavor becomes clear. Perhaps even more than the need for surgical services in the LMCIs, is a worldwide anesthesia crisis. Most LMICs have less than 1 physician per 10,000 people and less than 1 anesthesiologist per 100,000 people, leaving an immense gap in the safe performance of operative services [23]. This void requires immediate attention to improve patient safety in low-income countries through education and support.
Measures to Improve Patient Safety
In order to address the marked disparity between the numbers of anesthesiologists in developed versus LCMIs (i.e., one anesthesiologist per 260 patients in the United States versus 1 anesthesiologist per 55,000 patients in Ghana) the American Society of Anesthesia Committee on Global Humanitarian Outreach is addressing this crisis in several ways:
1.
Encouraging volunteerism.
2.
Providing opportunities with reputable aid and mission organizations.
3.
Supporting anesthesia education and training in LMICs.
4.
Advocating for long term academic partnership with hospitals and universities in countries of need.
5.
Providing for collaboration of organizations, institutions, and initiatives with common missions and philosophies.
Humanitarian efforts like these are essential in improving the state of health on a global stage.
Research
One area of scientific pursuit in the developing world that is significantly impacted by medical ethics is scientific research. Even more than other areas of healthcare in the LMICs, scientific research raises ethical issues, especially when funded by external sponsors from developed countries. Developing countries urgently need research to help address the enormous burden of disease. The disparities in resources previously described between developed and developing countries can promote exploitation in the case of externally sponsored research. Failure to understand that external sponsors may differ in their capability to appreciate different culture and educational status of the subjects in developing countries creates the need for significant internal and external oversight of research in LCMIs. Furthermore, in order to promote the ethical and legal climate for medical research, all countries should set national priorities related to their provision of healthcare. When externally sponsored research is proposed that does not address the national priorities of its host, the research must demonstrate its relevance and be justified to an appropriate independent research ethics committee. To enhance the capability of developing countries to conduct and oversee research that is in their best interest, the inclusion of a component to improve the local expertise in country should be a provision of any new healthcare and healthcare research. The most difficult part of the creation of this monitor would be to make it independent of both external and internal forces that often have their own agendas. An independent international organization without any direct interest in the results of the therapy or research could be established to provide services equivalent to an Independent Research Committee (IRB) at any North American academic institution. The committees would be comprised of similar members as Western IRBs including physician-scientists, ethicists, and lay people. The committee would function at arm’s length from those issues on which it is evaluating and would be able to provide oversight while also performing an educational function for those in the host country. This IRB-type international committee would work hand-in-hand through every step of the process with a similar committee in the LMIC that had requested its services. The international community of developed nations would fund the program with the intent of its existence being self-limited until such time that any particular nation using it could afford its own independent organization.
Externally sponsored research often must cope with adverse and occasionally contradictory directions as to what may be ethically suitable. Finding an ethical framework for this situation requires application of the ethical and often legal principles that might be an anathema to the local authorities. In LMICs, Western ethical and legal conventions are occasionally seen as contradictory to acceptable local social and cultural behavior. An example of this is what we refer to in the West as female genital mutilation. In some countries on the African continent, this ritual is essential for a woman to be acceptable in her community and as a partner for marriage. Dealing with this type of cultural activity must be done with the utmost sensitivity. Providing such guidance and assisting in the education of those local professionals and citizens involved is part of the obligation of researchers and clinicians in establishing cohesive and mutually agreeable rules for the ethical review of research. The ethical framework for this process that has become the standard for global research is based on four principles:
1.
The duty to alleviate suffering.
2.
The duty to show respect for persons.
3.
The duty to be sensitive to cultural differences.
4.
![](https://freepngimg.com/download/social_media/63059-media-icons-telegram-twitter-blog-computer-social.png)
The duty not to exploit the vulnerable.
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