1. Healthcare - Ethics and Law
Dr. Sandhya Chapagain Acharya
Advanced Course in Medical Law and Bioethics,
Assistant Professor, Oncology
National Academy of Medical Sciences, Bir Hospital

2. Objectives To review existing health law in Nepal.
To discuss why we should and how we could move forward in the creation of health law
To discuss the role of hospital management in Healthcare Ethics and Law

3. Healthcare and Purpose of Medicine
Healthcare is defined as the services provided to people or communities by agents of the health services or professions for the purpose of promoting, maintaining, monitoring or restoring health.
The Medical standard of care is composed of all treatment options that can potentially cure, stabilize an illness/state of health and/or alleviate pain and distress
The Purposes of Medicine are to:
to offer these medical benefits to those in need
to try to achieve these medical benefits as humanely as possible

4. Healthcare and Purpose of Medicine
The medical standard of care and the purposes of Medicine hold true throughout our collective global history and across religious and cultural beliefs
The doctor-patient relationship is central to the practice of healthcare and is essential for the delivery of high-quality health care in the diagnosis and treatment of disease.
The doctor-patient relationship forms one of the foundations of contemporary medical ethics

5. Ethics
Ethics is a standard of behavior based on moral values that are influenced by family, culture, and society.
In medicine, ethical principles have long formed the core nature of professionalism and are key to the fiduciary nature of physician-patient relationship e.g. “primum non-nocere”
Many different ethical theories exists, though none will provide the answers to every single dilemma that arises in clinical or research practice

6. Ethical principles:
The common ethical ground of all theories consist of:
Beneficence – helping to cure, stabilize illness and alleviate pain and distress
Nonmaleficence – Preventing harms, to do no harm
Autonomy –self-determination, independence, liberty rights, individual choice, freedom of will
Justice – Fairness, equity.

7. Other core Ethical Norms in Healthcare
Veracity – truth telling, informed consent, respect for autonomy
Privacy – a persons right to remain private, to not disclose information
Confidentiality – only sharing private information on a ‘need to know basis’
Fidelity – loyalty, maintaining the duty to care for all, no matter who they are or what they may have done
Fiduciary– trust, advocacy, confidence in the physician-patient relationship in that its sole purpose is to help the person dealing with illness

8. Law
A law is a rule of conduct or action and is enacted by governments to maintain order and public safety.
In healthcare, law provides a crucial framework for professional medical practice by mandating legal standards of practice to protect both physicians and patients by outlining duties and responsibilities and rights

9. Importance of Health Law
Defines key legal principles and rights within the practice of medicine
Makes the practice of medicine consistent and transparent with regards to physicians fiduciary duty towards patients
Helps refine the medical standard of care by examining it in the light of changing societal values.
Clarifies how resources will be used in ways that permit public discussion and promote clarity and justice
If well- written, health law brings out the best in Medicine

10. Universal Declaration of Human Rights December 10, 1948 Palais de Chaillot Paris
HEALTH RIGHT IS A BASIC HUMAN RIGHT
Personal liberties, social and economic equity, communial and national soladirity.

11. Right to HEALTH
Right to life (Article 2). Right to liberty and security (Ar. 5), Right to respect for private and family life ( Ar.8), freedom of thought consincense and religion ( Ar. 9)

12. Existing Legal Provisions in NEPAL

13. 1. Muluki Ain 2020 (Civil Code):
Medical Treatment Chapter 12
Who can treat patient is clarified
but is not scientifically justified.
Consent is described and made compulsory in any invasive procedure with exception of emergencies but there is no provision for informed consent.
Punishment in case of death of patient due to negligence is Rs. 500/- fine or 2 yrs imprisonment or both.

14. 1.Muluki Ain 2020 (Civil Code):
B. Homicide Investigation
In situations of suicide and homicide there should be autopsy at Government Hospital by Govt. employee Medical doctor.
No clear cut guidelines and protocol to follow.
C. Physical assault
Grievous hurt (Angabhanga) conditions are listed wrongly without following a systematic and scientific approach.
Punishment in assault is decided by physical measurement of bruises.

15. 1.Muluki Ain 2020 (Civil Code):
D. Sexual offences:
No provisions with respect to the medical examination of victims/accused.
Also no developed examination and reporting guidelines/standards.
E. Criminal responsibility and insanity:
An accused will be exempted from punishment, if the commission of act is without the knowledge about nature and consequences of the act because of the disease of mind (Magaj bigreko / bahulaeko)
No further description of how to evaluate the accused, neither who should conduct such an evaluation, nor how such a finding can be challenged

16. 2.NMC Act 2020(1964) and NMC Regulation 2024(1968).
Implementation of CODE OF ETHICS for doctors and taking actions against those doctors who violate the CODES.
A doctor can also receive punishment of upto the erasure of the name from NMC register.
Inadequate details about the process for action and final decisions by NMC.
There are no clear provisions with respect to informed consent.

17. 3.Consumer Protection Act 1998 10(e)
Compensation in case of alleged Medical Negligence are registered following
this COPRA.
Purpose of this law is not directly related
with the cases in the field of professional services.
“Selling or supplying substandard medical goods or services likely to harm patient’s health makes any doctor or health institution……..”
Section 11 of the Act government of Nepal obliged to determine & publish in Nepal Gazette the minimum standard of the consumer goods , however………..
Liable for fine or imprisonment as per court descision
…..till date no law exist that determne minimum standared of medical service that a patient should expect along with uniformity in fees charged by different hospitals for the same services.
Under section 11 of the Act government of Nepal is obliged to determine & publish in Nepal Gazette the minimum standard of the consumer goods of service of medicinal profession that every patient should expect, however………..

18. 4.Health professionals & Health Institutions and Security Act,2066 & Regulation 2069
Prohibits manhandling, vandalism in health institutions– fine or reasonable compensation as per court decision.
It obliges local administrations and government to arrange immediate security if demanded by health worker or institution.

19. Existing Legal Provisions in Nepal
Furthermore there is no legal framework to outline the legal duties of Health Professional by State
Health Professionals are performing their duties with no or insufficient knowledge of the Medico-Legal field.

20. Supreme Court Decision

21. Srijana KC Vs Dr. D. B. Shah (2009 Nov)
Case : Compensation under CoPrA
Key rulings:
Directives to Ministry of Health and Population:
1. To make a Team of Experts for expert opinion in cases of medical negligence by forming a Committee from participants of 6 different sectors and publish it in Nepal Gazette. Opinion from the Team should be applied by Compensation Tribunal or Court during the trial of the case.

22. 2. To run medical treatment on the basis of Doctrine of Informed Consent the provisions in Muluki Ain “Ilaj Garneko Mahal” are inadequate so make an Experts’ Committee from different 5 sectors of representation within 3 months.
The Committee should develop standards or guidelines according to present need and international practice which must be implemented within 2 yrs in hospitals of Nepal. However....

23. Legal Standard of Care
Degree of skill (proficiency), knowledge, and care (prudence) ordinarily possessed & employed by members in good standing within a profession.
To test whether the standard of care has been met, one must determine what a reasonable, prudent practitioner would have done under similar circumstances.
The legal standard of care is squarely based on the medical standard of care
Maintaining confidentiality,Practicing within the scope of training an capabilities,Preparing and maintaining medical records,Documenting accurately,Using proper guideline when releasing information
Following legal guidelines and maintaining awareness of health-care legislation and regulations
Maintaining and disposing of regulated substances appropriately
Following risk-management and safety procedures
Recognizing professional credentialing criteria

24. Medical standard of care
To be considered a Rx option, a treatment must have some potential to provide medical benefit and, while any Rx has risks and side effects, it must not only cause harm.
Rxs that may offer medical benefit are presented to capable patients or their substitute decision-makers to consent to according to their values, wishes and beliefs
If harms outweigh benefits in the context of a patient’s state of health, such a Rx would fall outside of the medical standard of care and it is NOT a treatment option.
Reflected in international healthcare policies

25. Other unresolved issues……

26. Role of Patient Party vs. Capable patient
As Nepalese society changes what should the role of the capable patient be in decision-making?
What should be the medical standard of disclosure to the patient?
What should be the role of the patient party with respect to disclose of information v. confidentiality and decision making?

27. Surrogacy ???

28. Euthanasia???

29. What does this mean for Hospital Managers?
The overall objective is to provide health care that is quality oriented and sensitive to the needs of the individual patient and the Nepali people
Managers need to be prepared to develop policies and procedures to:
provide comprehensive appropriate health care ( ie care that has the potential to provide medical benefits); either specialist or referral, based on patient needs
achieve and maintain the medical standard of care throughout the hospital or healthcare institution whether such care is acute/resuscitative, chronic and complex or EOL
ensure service is responsive to the needs of the people.

30. Ethical and Legal Aspects in Hospital Management

31. 1. Patient Safety and Quality Improvement
Managers should work across hospitals to develop standardized:
Policies and Procedure that mandate informed consent and reinforce the physicians fiduciary duties to patients through the medical standard of care
Medical record keeping
Detailed and accurate patient treatment record.
Documentation of informed consent
Documentation of treatments offered and decision-making with patients/patient party
Confidentiality and privacy policies and procedures that are clear and publically available
Third party information disclosure polices and procedures that are clear, transparent, and public across hospitals throughout Nepal

32. 2. Health Care Workers Safety
Managers should work across hospitals to develop standardized:
Policies and procedures to ensure Individual patient and healthcare provider safety
Zero tolerance for verbal or physical threats policy
No bullying of any kind
Safe working environment
Appropriate safety procedures in hospital wards, laboratories to maintain the health and security of its staff

33. 3. AND ...
Towards meeting the medical, ethical and legal standards of care--- the care the people deserve to receive as a fundamental human right in any society--- requires leadership from Management
EVERY HOSPITAL MUST HAVE A LEGAL ADVISOR.

34. Conclusions
Legal aspects of medical practice in Nepal is incredibly under-developed/ or completely non-existent
Some legal provisions with respect to criminal investigations are irrelevant, outdated and unscientific.
Ethical guidelines for all level medical professional are currently inadequate and need to be developed urgently
Draft of mental health act presented on CA. not issued yet.

35. Conclusions
Existing ethical and legal provisions must be reviewed and updated to optimal international standards in medical profession.
There must be separate Mental Health Act.
Incorporation of medical Law and Ethics needs to occur in MBBS curriculum.
Leadership from hospital management can make a real difference to improving the ethical standards of practice in hospitals across Nepal

36. Acknowledgement Dr. Laura Hawryluck MSc., MD, FRCPC
PRESIDENT, Medico-legal Society of Toronto, Assoc. Professor, University Health Network
Toronto, ON Canada
2. Professor Harihar Wasti, MD
Department of Forensic Medicine.
TUTH/IOM
3. Dr. Ramesh Parajuli, PhD in Medical Law.
LLM, Supreme court
Kathmandu, Nepal.

37. Thank You sandhyachap@gmail.com “Doctors are men who prescribe
medicines of which they know little,
for diseases about which they
understand even less, for people
about whom they know nothing”
Voltaire
Thank You