A Bill to regulate Medical Negligence, 2023 (2080)

Bill No… of the year 2023 (2080)

A Bill made to regulate medical negligence, uphold patient rights, and ensure
accountability within the medical profession for the benefit of the citizens of
Nepal.

Preamble: Whereas, it is expedient to make timely law relating to regulate the rights of medical
profession, standard of care and professional competence, and to protect the rights of the patients.

Now, therefore, be it enacted by Federal Parliament of Nepal.

Chapter-1
Preliminary
1. Short title, Extent and Commencement: (1) This Bill may be called as “Bill to regulate
Medical Negligence, 2080 (2023)."
(2) This Bill shall come into force throughout Nepal.
(3) This Bill shall come into force immediately.
2. Definitions: Unless the subject or the context otherwise requires in this Bill:
(a) “Medical Negligence” means failure of a medical professional to provide an
adequate standard of care, resulting in harm or injury to a patient;
(b) “Duty of Care” means legal obligation of healthcare providers to provide
competent and reasonable care to patients, avoiding harm;
(c) “Informed Consent” means patient's voluntary agreement after being
informed about risks, benefits, and alternatives of a medical procedure;
(d) “Medical Records” means comprehensive documentation of a patient's
medical history, diagnosis, treatments, and progress;
(e) “Standard of Care” means accepted level of skill and diligence that
competent medical professionals should provide in similar circumstances;
(f) “Patient Rights” means fundamental entitlements of patients, including
information, privacy, participation, and access to records;
 (g) “Medical Negligence Board” means specialized body responsible for
investigating complaints of medical negligence and ensuring accountability;
(h) “Compensation” means remedies, often financial, provided to victims of
medical negligence to address harm, losses, and suffering;
(i) “Code of Medical Ethics” means set of ethical guidelines that medical
professionals must follow, ensuring integrity and patient welfare;
(j) “Standard Procedures” means established protocols for medical
interventions, ensuring consistent and quality healthcare delivery;
(k) “Professional Misconduct” means unethical behavior or violation of medical
standards by healthcare practitioners;
(l) Nepal Medical Council means the statutory regulatory authority established
by the Government of Nepal, entrusted with the responsibility of overseeing
and regulating the medical profession within the territory of Nepal.
(m) “Bolam Test” means legal standard evaluating medical negligence. A
professional is not negligent if their conduct aligns with a responsible body
of medical opinion;
(n) “Bolitho Test” means legal refinement of Bolam Test. Expert opinion must
be logical and defensible, even if a minority view;
(o) “Montgomery Test” means legal principle emphasizing patient-centered
informed consent. Doctors must provide understandable information about
risks, benefits, and alternatives.

Chapter – 2
Regulation of Medical Practice and Hippocratic Oath
3. Licensing and Registration: (1) All medical practitioners practicing within the territory
of Nepal shall be required to obtain and maintain a valid license and registration from
the Nepal Medical Council (NMC), hereinafter referred to as the "Council."
(2)The Council shall establish criteria and procedures for the licensing and
registration of medical practitioners, including qualifications, continuing education, and
ethical requirements.
4. Standards of Care and Ethical Practices: (1) Medical practitioners shall adhere to the
highest standards of medical care, ethics, and professionalism in the diagnosis, treatment,
and care of patients.
(2) The Council shall develop and enforce a comprehensive Code of Ethics for
medical practitioners.
5. Hippocratic Oath and Code of Ethics: (1) Every licensed medical practitioner in Nepal
shall, upon receiving their license, be required to take the Hippocratic Oath, pledging to
uphold the highest standards of medical ethics, professionalism, and patient care. The
Hippocratic Oath shall include commitments such as:
(a) A vow to practice medicine with integrity and compassion, placing the
welfare of patients above all else.
(b) A promise to respect patient confidentiality and privacy.
(c) An acknowledgment of the responsibility to continuously update medical
knowledge and skills.
(d) A commitment to providing medical care to all individuals without any
discrimination.
(e) A pledge to report any unethical or negligent behavior observed within the
medical community.
(2) Failure to comply with the Hippocratic Oath shall be considered a breach of
medical ethics and may lead to disciplinary action as determined by the Council.
6. Elements of Medical Negligence: (1) Medical negligence shall be recognized as a
breach of the duty of care owed by medical practitioners to their patients.
(2) Medical negligence shall encompass the following elements:
(a) Duty of Care: The medical practitioner owed a duty of care to the patient.
(b) Breach of Duty: The medical practitioner failed to meet the established
standard of care, as defined by the Code of Ethics and professional
guidelines.
(c) Causation: The breach of duty directly or indirectly caused harm or injury
to the patient.
 (d) Harm or Injury: The patient suffered harm, injury, or damage as a result
of the breach of duty.
7. Criteria for Determining Medical Negligence: The Council shall specify criteria for
determining instances of medical negligence, taking into account the principles of
medical ethics, Bolam test, Bolitho test, established standards of care, and expert
opinions.

Chapter – 3

Rights and Duties of Medical Practitioners and Patient

8. Rights and Duties of Medical Practitioners : (1) The Medical Practitioners shall have
the following rights:
(a) Right to Practice: Medical practitioners have the right to practice medicine
within the scope of their qualifications and in accordance with the
regulations and guidelines established by the Nepal Medical Council
(NMC).
(b) Professional Autonomy: Medical practitioners have the right to exercise
professional autonomy in making clinical decisions, as long as such
decisions align with ethical standards and the best interests of the patient.
(c) Continuing Education: Medical practitioners have the right to access
ongoing medical education and professional development opportunities to
maintain and enhance their skills and knowledge.
(2) The Medical Practitioners shall have the following duties:
(a) Duty of Care: Medical practitioners have a primary duty to provide
competent and compassionate care to their patients, ensuring their well-
being and safety.
(b) Informed Consent: Medical practitioners have a duty to obtain informed
consent from patients or their legally authorized representatives before
performing medical procedures or treatments, as outlined in Section 2.6 of
this Act.
 (c) Ethical Conduct: Medical practitioners shall adhere to the Code of Ethics
established by the Nepal Medical Council, maintaining the highest
standards of professional and ethical conduct.
(d) Documentation: Medical practitioners have a duty to maintain accurate and
complete medical records, including records of patient assessments,
diagnoses, treatments, and informed consent.
9. Rights and Duties of Patients : (1) Rights of Patients shall be as:
(a) Right to Information: Patients have the right to receive clear and
comprehensible information about their medical condition, proposed
treatments, risks, benefits, and alternative options.
(b) Informed Consent: Patients have the right to give or refuse informed
consent for medical procedures and treatments, as outlined in Section 2.6
of this Act.
(c) Confidentiality: Patients have the right to expect that their medical
information will be kept confidential and disclosed only as allowed by law
and with their consent.
(d) Dignity and Respect: Patients have the right to be treated with dignity and
respect, regardless of their background, condition, or circumstances.
(2) Duties of Patients shall be as:
(a) Truthful Information: Patients have a duty to provide accurate and truthful
information about their medical history, current condition, and any relevant
factors that may impact their treatment.
(b) Compliance: Patients have a duty to comply with prescribed treatments,
medications, and follow-up care to the best of their ability.
(c) Respect for Healthcare Professionals: Patients shall treat healthcare
professionals with respect and courtesy, recognizing their expertise and
dedication to patient care.
(d) Payment: Patients have a duty to pay for medical services rendered, in
accordance with established fees and billing practices.
 Chapter – 4
Informed Consent and Patient Autonomy

10. Informed Consent: Healthcare professionals shall adhere to the principle of informed
consent in their interactions with patients. Informed consent, as established by the
Montgomery test, requires healthcare professionals to provide patients with
comprehensive and understandable information about proposed treatments, including:
(a) The nature and purpose of the proposed treatment or procedure.
(b) The potential risks and benefits associated with the treatment.
(c) Any viable alternative treatment options, including their risks and benefits.
(d) The likely consequences of not undergoing the proposed treatment.

11. Patient Autonomy: Patients have the right to autonomy and active participation in
decisions regarding their medical care. They have the right to ask questions, seek
clarifications, and make informed choices based on their values and preferences.

12. Capacity Assessment: Healthcare professionals shall assess the patient's capacity to
understand and make decisions regarding their medical care. When capacity is in
question, appropriate steps shall be taken to ensure that the patient's best interests are
considered.

13. Documentation of Informed Consent: Healthcare professionals shall maintain

comprehensive records of the informed consent process, including the information
provided to the patient, their understanding, and their consent or refusal.

14. Legal and Ethical Framework: The principles of informed consent shall be upheld in
accordance with applicable laws, regulations, and ethical guidelines established by the
Nepal Medical Council.
 Chapter – 5
Complaint Procedure and Compensation

15. Establishment of Medical Negligence Board: (1)The Nepal Medical Council shall
establish a Medical Negligence Board, hereinafter referred to as the "Board," comprising
experienced medical practitioners, legal professionals, and representatives of the public.
(2) The Board shall be responsible for the review and assessment of complex
medical negligence cases and providing expert opinions.
(3) The Board shall work in coordination with relevant authorities to ensure
comprehensive investigations and fair adjudication of medical negligence cases.

16. Complaint Filing and Investigation: (1) Patient or their legal representatives who
believe they have been victims of medical negligence may file a complaint with the Board
within 180 days.
(2) The complaint should be submitted in writing and include the following details:
(a) Patient's name and contact information.
(b) Details of the medical practitioner or healthcare institution involved.
(c) Description of the alleged medical negligence, including dates, locations,
and any supporting evidence.
(d) Any known injuries or harm caused by the alleged negligence.
(3) The Board shall conduct a thorough investigation into the allegations of medical
negligence, ensuring impartiality, confidentiality, and transparency. This may include:
(a) Gathering medical records, expert opinions, and witness statements.
(b) Interviewing the complainant, the accused medical practitioner, and any
other relevant parties.
(c) Reviewing applicable medical standards and practices.
(4) The Board shall maintain records of the investigation and its findings.
17. Adjudication and Compensation: (1) After completing investigations, the Board shall
assess the findings, review the medical aspects of the case, and provide recommendations
within 30 days of filing of a complaint.
(2) Compensation for victims of medical negligence shall be based on the combined
findings and recommendations of the Board.
(3) Compensation may include:
(a) Financial compensation for medical expenses incurred due to the
negligence.
(b) Compensation for pain, suffering, and loss of quality of life.
(c) Reimbursement of legal expenses incurred during the complaint process.
(4) The decisions and recommendations of the Board shall be binding.
(5) The Board shall ensure the timely and fair distribution of compensation to the
victim.

18. Appeals Process: (1) The complainant or the accused medical practitioner shall have the
right to appeal against the decisions and recommendations of the Board to District Court
within 35 days of the decision made under Section 17(1).
(2) The decision of the appellate body shall be final.

19. Penalties for Medical Negligence: Medical practitioners found guilty of medical
negligence, as determined by a competent authority, shall be subject to penalties, which
may include one or more of the following:
(a) Administrative Actions: The Nepal Medical Council (NMC) may impose
administrative penalties, such as warnings, fines, suspension of medical
licenses, or revocation of medical licenses, based on the severity and
recurrence of medical negligence.
(b) Civil Liability: Medical practitioners may be liable to compensate the affected
patient(s) for the harm or injury caused by medical negligence. Civil lawsuits
may be filed by affected patients or their legal representatives.
(c) Criminal Proceedings: In cases of gross negligence resulting in severe harm
or loss of life, criminal charges may be filed against medical practitioners. If
 found guilty, they may face imprisonment and fines as determined by a court
of law.
(d) Professional Disqualification: Medical practitioners found guilty of gross and
willful negligence, as determined by the NMC or a court of law, may be
disqualified from practicing medicine permanently or for a specified period.

Chapter – 6
Miscellaneous
20. Power to frame rules: The Government of Nepal may frame necessary rules in order
to implement the objectives of this bill.

21. Amendment Process: This Act may be amended or repealed by an act of the
legislature.

22. Savings and Repeal :