Ethicomedicolegal aspects of the COVID-19 health services in preparing regulations and intermediaries for clinical dispute resolution: a systematic review

Agus Purwadianto,1 Ade Firmansyah Sugiharto,1 Fitri Ambar Sari,2 Roberia,3 Uud Cahyono,4 Yuli Budiningsih,1 Denys Putra Alim,5 Nadia Ulfah Faddila5

Background

The COVID-19 pandemic has caused many medical, ethical, and medicolegal changes, including constant adjustments in service guidelines. Continuing to revise healthcare regulations and guidelines can potentially cause clinical disputes or medical negligence that require ethical and legal solutions. This study aimed to determine the ethical and medicolegal aspects of the potential factors that cause clinical disputes during the pandemic and provide anticipative solutions to national ethicomedicolegal policies.

 

Methods

A systematic literature search in PubMed, ScienceDirect, ClinicalKey, and Google Scholar was performed using keywords “clinical dispute,” “ethics,” “medicolegal,” “ethicolegal,” and “COVID-19”. The inclusion criteria were articles that contained information on shortage, justice, ethical distribution in intensive care, the possibility of lawsuits and disputes among stakeholders during the pandemic, and stakeholders’ roles in managing the pandemic. Key evidence was analyzed and synthesized following national ethicomedicolegal policies.

 

Results

We identified 19 articles from the 4 databases. Based on the literature, the main ethicomedicolegal impact of the COVID-19 pandemic appears in 3 aspects: (1) a shortage of fair and ethical intensive care services with fair and ethical distribution efforts, (2) legal protection for medical personnel from legal charges while providing health services during the pandemic, and (3) the government’s role in managing the pandemic together with the stakeholders involved.

 

Conclusions

Ethicomedicolegal clinical dispute management and its norms require an update, especially when deciding the complexity of COVID-19 service standards. Ethicomedicolegal professionals are needed as intermediaries to manage cases of clinical disputes and to implement fair malpractice criteria in Indonesia.

 

Keywords

COVID-19, dispute, ethic and medicolegal regulation, Indonesia, mediator

On January 30, 2020, the Director-General of the World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) outbreak a public health emergency of international concern, which was the WHO’s highest level of alarm. On March 11, 2020, the WHO announced that the outbreak could be characterized as a pandemic. Since the first cases were reported, the WHO has supported countries worldwide in preparing for and responding to the COVID-19 pandemic. This was followed by the enactment of the Presidential Decree of the Republic of Indonesia (KEPPRES) No. 12 year 2020, which declared the COVID-19 pandemic a non-natural national disaster.1,2 Various policies were launched by governments worldwide to curb the massive spread of the virus and prevent deaths. The Indonesian government has released three legal products to synergize healthcare with the economy: (1) Government Regulation in Lieu of Law (PERPPU) No. 1 year 2020 on state financial policy and financial system stability for the handling of COVID-19 and the framework of dealing with threats endangering the national economy, financial system stability, or both; (2) Government Regulation (PP) of the Republic of Indonesia No. 21 year 2020 on large-scale social restrictions on accelerating the handling of COVID-I9; and (3) the Presidential Decree of the Republic of Indonesia (KEPPRES) No. 11 year 2020 on establishing a public health emergency of COVID-19. These policies included merging the assignments of organizations managing the COVID-19 pandemic, mainly the National Agency for Disaster Management (Badan Nasional Penanggulangan Bencana [BNPB]) and the Ministry of Health, with the National and Regional Task Force (Gugus Tugas Nasional dan Daerah) using a special financial scheme in accordance with the law.3–5 Implementing these regulations may cause disputes at the community level, such as community refusal on large-scale social restrictions.

In medicine, several medical professional organizations have released the COVID-19 management guidelines based on science and technology and the practical experiences of each profession, which have been revised several times.6 The implementation of the COVID-19 management guidelines is limited due to different clinical settings in each hospital. Interactions in health facilities between doctors/medical services and patients/families, who have their own rights and obligations in the pandemic era, have created more complex dynamics. This may trigger a dispute in adjusting the medical and legal principles (in medicolegal form) in managing patients with COVID-19 compared to the pre-pandemic era. These various adjustments to healthcare regulations and guidelines have caused potential clinical disputes or medical negligence that require ethical and legal solutions. However, no ethicomedicolegal policy was established as an intermediary for clinical dispute resolution during the pandemic in Indonesia. This study aimed to determine the ethical and medicolegal aspects of health services in various countries and the potential factors that might cause clinical disputes during the COVID-19 pandemic.

 

 

A literature search was conducted using an online database on February 15, 2021. The articles were searched systematically through PubMed, Science Direct, ClinicalKey, and Google Scholar using keywords such as “clinical dispute,” “ethics,” “medicolegal,” “ethicolegal,” and “COVID-19” and their synonyms. We have also added relevant articles found in our library and information on government regulations and presidential decrees. The inclusion criteria were articles that contained information on shortage, justice, and ethical distribution in intensive care, the possibility of lawsuits and disputes between stakeholders during the pandemic, and stakeholders’ roles in managing the COVID-19 pandemic. The articles included were research and literature review articles written in English. The articles were then screened for title and abstract relevance to the objective of the COVID-19 pandemic ethicomedicolegal policy. Finally, the selected articles were checked for duplicates and read thoroughly to assess their relevance to the study objectives.

The articles were then analyzed by understanding the possible factors of clinical disputes such as clinical judgment between medical needs and availability of hospital resources, worsening doctor-patient relationships that lead to medical negligence, imbalanced rights and obligations between the health service provider and receiver, dilemma of medical decisions, contextuality of ethical and medicolegal conflict in difficult cases, and stakeholders’ policy in implementing a standard/guideline for COVID-19 patient service in the hospital. These factors were then summarized and used to generate suggestions for developing ethicomedicolegal policies for clinical dispute management during the COVID-19 pandemic in Indonesia and prevent potential civil or criminal medical negligence. Two independent authors (AP and AD), experts in bioethics and medicolegal, analyzed each article by reviewing and summarizing the ethicomedicolegal aspects. Any differences in the results of the analyses are discussed. Article analysis was performed by examining (1) the indicators of basic ethical principles such as beneficence, non-maleficence, autonomy, and justice relevant to prima facie from the scope of medical decision (by doctors based on doctor-patient relationship) or clinical decision (based on medical decision and consideration of hospital resources); (2) the existing legal norms for medical negligence and implementation; (3) the dynamics of medical development in science and technology in managing patients with COVID-19 based on biomedical principles (diagnosis), clinical management (therapy), and public health/community medicine (pandemic aspect); and (4) the real cases in legal/medicolegal clinical disputes in COVID-19 patient services in Indonesia (especially in hospitals). We also assessed whether the clinical dispute was upstream of medical negligence or at the pre-, intra-, or post-hospital phases to analyze the management of clinical disputes during the pandemic.

 

 

The screening was performed based on the article’s relevance to the study objectives, which resulted in 19 articles for further assessment. The search strategy for each database is shown in Figure 1.

 

 

Based on the assessment results of each article7–25 in Table 1, the medicolegal aspects of patient care during the COVID-19 pandemic, which have the potential for a clinical dispute, can be categorized into three factors: (1) shortage of intensive care and fair and ethical distribution efforts, (2) legal protection for health personnel from lawsuits while providing health services during the pandemic; and (3) the government and stakeholders’ roles in managing the COVID-19 pandemic. These medicolegal aspects have also been found in various countries, including the USA, the UK, the Netherlands, Italy, Indonesia, Thailand, Australia, Spain, and India.

 

 

Cook et al8 stated that in the early COVID-19 pandemic in the UK, there was widespread concern that healthcare systems would be overwhelmed, specifically an insufficient critical care capacity for beds, ventilators, or staff for patient care. In Italy, Oliva et al17 found high inflation of criminal and civil proceedings concerning alleged errors committed by healthcare professionals and decision-makers during the COVID-19 pandemic, which might be imminent due to the high increase in infection and death cases. Changes in the Australasian healthcare systems due to COVID-19 have increased the clinicians’ risk of medical litigation. There are direct risks in decision-making for patients with known or suspected COVID-19. The government should recognize these medicolegal risks when changing policies to protect health workers who act in good faith.25

 

 

The COVID-19 pandemic will cause ethical and medicolegal consequences due to the sharp increase in hospital intensive care capacity, legal protection factors, and the presence of state and related stakeholders. These factors will lead to various medical decisions and health service aspects, especially by doctors who treat patients with COVID-19. Therefore, the pandemic must be managed wisely by all parties, including health service providers and law professionals such as attorneys, judges, and legal counselors, considering its three ethical and medicolegal consequences.

Shortage of intensive care resources is one of the greatest potential causes of clinical disputes. This service is primarily provided for critically or severely ill patients and sometimes patients of a medium illness category who show signs of severity progression and require intensive care services.7,8 Patient management procedures in intensive care during the pandemic have limited the communication between the doctor and patient’s family as online communication is preferred to prevent infection exposure, which can trigger the family’s dissatisfaction. Moreover, various comorbidities in a patient involving many clinicians also raise problems owing to limited health personnel. These problems could lead to lawsuits from the patient or family to the hospital. To obtain defense according to this regulation, health service providers should act rationally, reasonably, and sensibly, and they should do the same in the future if they are faced with similar situations. This regulation benefits medical personnel, especially in using experimental medical therapy (still in research) and assigning health personnel to different health facilities in the long term.22,23

The fair and ethical distribution of health services requires the establishment of criteria or procedures to assess the patient’s eligibility for intensive care.9–11 It also involves more clinicians, ideally the hospital ethics committee, to determine the patient’s needs.8 A prompt response from the intensive care unit (ICU) team is needed to exclude patients with poor prognoses and certain exclusion criteria12 to accommodate patients with better prognoses and create a fair distribution. In this case, the ethics committee should prioritize patients with a higher chance of survival (utilitarian principle) while providing services for critically ill patients (egalitarian principle).8,10,13 The ethics committee should determine whether to refuse or prioritize healthcare services through discussion with two or three specialists in charge. Priority must be determined based on medical urgency, and random criteria must be implemented; a list of triage decisions must be recorded for transparency and post-pandemic evaluation.14 Zonation criteria and symptom severity for patient triage in intensive care must also be considered for a fair decision, not only individually based on science and technology but also as a population-based decision.15 A similar condition also occurs in Indonesia. Shortage of fair and ethical distribution of ICUs also occurred in many healthcare facilities across the country due to the imbalance in the number of health facilities and patients requiring treatment. To achieve an ethical and fair distribution of ICUs, many specialists in Indonesia treated patients with COVID-19 as team members rather than personal ones which they usually did in the pre-pandemic clinical practice. Therefore, every decision made based on the patient’s condition will be a team’s decision rather than a personal decision of one specialist.6,9

Medical and hospital staff are at risk of lawsuits from the patients or community.7,16 Malpractice lawsuits may include clinical decisions,7,17 delays of non-essential procedures, lawsuits from families of medical staff who do not receive proper personal protective equipment, or failure to protect medical staff from COVID-19 infection.7 In this case, hospital management or government must consider the principle of beneficence in providing healthcare to patients while considering the non-maleficence principle in protecting the risk of infection to the medical staff. Considering that the gold standard for COVID-19 diagnosis and therapy could be changed at any time regarding the continuing COVID-19 science and research and the ongoing pandemic, the government should establish legal regulations to protect health providers. Periodically updating regulations is not only needed but also legally and ethically mandatory, including the legal protection for medical personnel toward lawsuits based on government regulations7 and discipline from the Medical Council.18,19 In Indonesia, medical personnel also need legal protection from a patient’s dishonesty.20 The ethics committee requires legal interpretation flexibilities on health service providers to avoid potential ethical dilemmas among medical personnel and patients on COVID-19 management.

Debate on whether doctors can have immunity toward the claim of civil or criminal medical negligence for medical services during the COVID-19 pandemic is still ongoing.18,21 Medical personnel who treat patients with COVID-19 as the frontline defense of humanity against the pandemic need peace of mind in the workplace, including immunity rights and defense against civil or criminal lawsuits such as medical negligence. In Kentucky, the USA, a new regulation, adopted from the principle of the “Good Samaritan Law,” was issued to ensure that medical service providers had proper legal protection during the COVID-19 pandemic. The regulations stated that all service providers with good intentions to provide services for patients with COVID-19 must have legal grounds as a civil responsibility for negligence that causes any injury due to the given medical service or failure to provide or perform further medical care/referral.22,23 This legal defense mainly includes health service providers prescribing or giving off labeled medication, which is still being studied as a potential COVID-19 therapeutic. It also applies to all medical personnel assisting health services in a healthcare facility or certain public health organizations regardless of employment status. Furthermore, it includes using non-medical or standard equipment to supply facilities and health provisions.22,23

Based on the timeline, immunity is possible for certain therapies with potential benefits to the community and must not be obstructed by litigation threats. Legal immunity is the legal defense efforts against medical personnel by considering the proportionality and transparency principles.15,24 In providing health services for patients with COVID-19, medical practitioners must have a strong scientific base25 and responsibility toward service tasks.26 Breach of authority by unprivileged medical personnel can still be considered an error.17

If the error in the procedure cannot be avoided or if the doctor must act beyond their competency, a chronology of events and evidence of consideration for an acceptable medical decision must be demonstrated when requested.27 In cases of proven medical negligence, the patient will receive compensation claims from the hospital. Increased compensation for a patient’s injury may be considered if unfairness occurs.17

In the COVID-19 pandemic, updating regulations or government policy may curb the pandemic.15 Government policies should be based on the public interest while considering the private interests of each community. Hence, health policy based on the ethical framework is the only way to create an equal distribution of benefits and risks for the community.28 The existing regulations and public policies are created, amended, and dismissed according to contextual needs.7 Policies and regulations for COVID-19 management must be medically coherent, legally robust, and ethically correct.22 The government should respond to government policies at the national or regional level for better healthcare services, especially in response to limited medical experience and scientific evidence. The community’s regulations on health protocols during the pandemic must be accompanied by resources and supporting facilities from the state or private sector.16 Besides, rules on a clear task description for medical personnel without the clinical privilege to manage COVID-19 cases must also be addressed because they are most prone to error. The limitations of healthcare resources, including medical staff, should not worsen the quality of healthcare services. Therefore, additional medical staff without clinical privileges who manage COVID-19 cases must be given a clear task description and may only perform healthcare services on the described tasks. Staff who breach the privilege are considered guilty.17

The law is expected to handle private or inter-citizen disputes in accordance with the objectives of normative and practical procedures. The legal norm that includes reward and punishment in fair implementation (the fair dealing norm) can help intermediate disputes more objectively while facing the complexity of COVID-19 management. Extensive studies by social scientists in pluralism support a variety of legal practices, although the legal regulations and conditions are similar. One of the implications of legal pluralism is the potential for different implementations depending on the locality of community groups and their values as a priority, regardless of behavior or ideology in facing the changing norms of COVID-19 management.

Lawyers typically hesitate to consider legal norms alone. The representatives such as judges or head attorneys can reduce the difference in unwanted legal practice.29 Ethicomedicolegal approach may act as the intermediary norm to manage clinical disputes due to the changing situations and conditions of the legal pluralism contextuality. This approach is based on ethical decisions and bioethical justice in balancing efforts to manage the sharp increase in intensive care capacity, which collides with medical personnel protection in hospitals. Both can use the bioethical principle of beneficence or non-maleficence30 through the empowerment of the hospital ethics committee. For example, in managing clinical disputes, the hospital should include a palliative team and ethics committee to facilitate intermediation between medical personnel and the patient’s family regarding the patient’s medical condition and therapy,7,22,31 provide education to patients and their families exposed to COVID-19 at the hospital,31,32 and provide ethical decisions on critically ill patients.8 This can be accomplished through a special unit to hold regular family meetings once or twice a week. During the pandemic, the norms used in this family meeting should be different from those in the pre-pandemic era. Legal certainty in the pre-pandemic era is easier to achieve, whereas it is relatively contextual during the pandemic. Kyriakakis33 observed that direct punishment from corporate entities, compared with individuals, is widely debated to produce sustainable results. According to bad barrel theory, hospitals as institutions that manage COVID-19 should have moral responsibility.33

Therefore, we suggest that during the COVID-19 pandemic, hospitals and medical personnel with good intentions should perform their duties and professional responsibilities to manage patients according to medical procedures and ethics. For the community, this health service should be conducted by prioritizing transparency, effectiveness, and nondiscriminatory principles to minimize the potential for clinical disputes. In facing ethical and medicolegal conflicts, doctors should uphold the four basic ethical principles while considering the rights and obligations in service needing the right ethical decisions. In resolving ethicomedicolegal conflicts, an intermediary team is needed before entering litigation, which usually comes from the medical profession. Healthcare services are still the primary aspect of COVID-19 public service, and the medical professionals contribute to the practical legal problems; thus, medicolegal aspects should be considered to serve humanity.

In conclusion, ethicomedicolegal clinical dispute management and its norms require an update, especially when deciding the complexity of COVID-19 service standards. Furthermore, ethicomedicolegal professionals are needed as intermediaries to manage cases of clinical disputes and to implement fair criteria for malpractice in Indonesia. This study aimed to provide a policy basis for future regulations regarding the case management of clinical disputes in Indonesia.

 

 

 

 

 

 

 

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