Laws Regulating Medical Practice and Related Areas

1. Medical and Dental Degree Ordinance 1980

• Defines the Allopathic medical system legally.
• Identifies authorities allowed to grant medical degrees/diplomas.
• Prohibits unauthorized use of medical/dental titles and degrees.

2. Allopathic System (Prevention of Misuse) Act 1962

• Defines Registered Medical Practitioner (RMP).
• Prevents misuse of the term "doctor" or medical titles by unauthorized persons.
• Only RMPs can:
  • Use medical degrees/diplomas.
  • Perform surgical operations.
  • Prescribe antibiotics or dangerous drugs.

3. Pakistan Medical and Dental Council (PMDC) Ordinance 1962

• Establishes the statutory body PMDC.
• PMDC functions:
  • Maintain professional proficiency.
  • Maintain medical register (provisional, full, specialist lists).
  • Oversee conduct of registered practitioners.

4. Drug Act 1976

• Ensures marketed drugs meet required quality standards.
• Requires new drugs to be tested for safety and efficacy before use.
• Allows modification or withdrawal of drug approvals based on new information.
• Controls advertising of drugs to prevent misuse.

5. Dangerous Drug Act 1930

• Prevents abuse of drugs (use beyond medicinal purposes).
• Controls drugs with potential for misuse:
  • Stimulants (e.g., cocaine).
  • Depressants (e.g., morphine, heroin).
  • Hallucinogens (e.g., cannabis).
• Sets criteria for drug addiction/dependence and controls usage limits.

6. Dangerous Drug Rules (Specific)

• Rule 13: Limits quantities of dangerous drugs (e.g., medicinal hemp, opium).
• Rule 14: Requires maintenance of separate registers for dangerous drugs.

7. Workman's Compensation Act 1923

• Provides compensation for workers for injuries and disabilities occurring at the workplace (accidents or environmental causes).

8. Employees Social Security Ordinance 1965

• Provides insurance coverage for both employers and employees.
• Extends benefits to dependents.
• Covers occupational diseases (e.g., anthrax, lead poisoning, radiation exposure).

 

Medical Negligence

Definition

• Medical negligence is the breach of duty by a doctor in exercising reasonable care and skill, causing physical, mental, or financial harm.
• It means failing to provide appropriate care or acting carelessly.
• It includes treatment without due care.
• It is not limited to doctors alone; it extends to all medical staff under the doctor's supervision and the hospital unit.

Doctor-Patient Relationship

• A doctor cannot be forced to treat a patient.
• A patient cannot be forced to receive treatment.
• When both agree (doctor accepts and patient consents), an implied contract is formed, defining mutual responsibilities.

Responsibilities in Doctor-Patient Relationship

Patient's Responsibilities

1. Pay the mutually agreed fee.
2. Follow the doctor’s instructions.
3. Provide complete medical history.
4. Allow physical examination.
5. Accept the advised treatment.

Doctor's Responsibilities

1. Apply medical skills competently (as a GP or specialist).
2. Exercise reasonable care during diagnosis and treatment.

 

Five Components of Medical Negligence

1. A duty is owed by the doctor.
2. That duty is breached.
3. The patient suffers damage.
4. A direct causal relationship exists between the breach and the harm.
5. Harm was foreseeable.

 

Types of Medical Negligence

1. Civil Negligence

• Failure to apply a reasonable degree of care and skill.
• Examples:
  • Extracting a healthy tooth.
  • Failing to administer an anti-tetanus vaccine.
• Legal Remedy: Decided in civil courts under civil law.

 

2. Criminal Negligence

• Gross negligence showing complete disregard for patient safety, often resulting in death.
• Example: Doctor leaves the patient mid-surgery to attend to personal matters.
• Legal Remedy: Tried under criminal law (e.g., manslaughter charges).

 

3. Contributory Negligence

• Both doctor and patient share responsibility for the outcome.
• Example: Patient fails to follow post-operative instructions.
• Implication: Doctor’s liability may be reduced or nullified.

 

4. Third-Party Negligence

• Negligence committed by paramedical staff (e.g., nurses, assistants).
• Legal Doctrines:
  • Respondeat Superior – “Let the master answer.”
  • Captain of the Ship Doctrine – Doctor may be liable for team’s actions.
• Implication: Supervising doctor can be held accountable.

 

Duties of a Doctor

• Exercise professional skill and care.
• Respond to emergencies and night calls.
• Maintain the doctor-patient relationship.
• Apply the highest standard of care.
• Use best diagnostic methods and judgment.
• Stay updated with medical advancements.
• Obtain informed consent before procedures.
• Ensure confidentiality of patient information.

 

Defenses Available to Doctors

1. Contributory negligence by the patient.
2. Negligence by a third party not under the doctor’s control.
3. Assumption of risk by the patient (e.g., via informed consent).

 

Damages Recoverable by Patients

• Physical injury
• Pain and suffering
• Mental anguish
• Future loss of earnings

 

Legal Doctrines in Negligence

Res Ipsa Loquitur (“The thing speaks for itself”)

• Exception where the burden of proof shifts to the doctor.
• Example: Instrument left inside the body post-surgery.

Novus Actus Interveniens (“New intervening act”)

• An unexpected event breaks the chain of causation.
• Example: A patient vomits and chokes after anesthesia due to not informing the doctor of a recent meal.

 

Consent in Medical Practice

Definition

• Voluntary agreement between patient and doctor regarding medical treatment.
• Requires both parties to agree on the same thing in the same sense.

 

Types of Consent

1. Implied Consent – Routine procedures assumed to be agreed upon; not explained in detail. (Least preferred)
2. Expressed Consent – Clear agreement, either:
   • Oral
   • Written, including:
     • Blanket Consent – General permission; legally inadequate.
     • Informed Consent – Detailed, informed permission. (Best form)

 

Requirements for Informed Consent

1. Diagnosis explanation.
2. Treatment plan.
3. Description of procedures.
4. Major and collateral risks.
5. Alternative treatment options.
6. Info on hospital stay, pain, prognosis.

 

Invalid Consent

Consent is invalid if:

1. Obtained through fraud, force, fear, or misrepresentation.
2. Given by a minor (under 18).
3. Given by a person of unsound mind (non compos mentis).

 

Confidentiality & Professional Secrecy

Professional Secrecy

• All patient information must remain confidential.
• Breach may result in legal action (defamation, negligence claims).

Privileged Communication

• Legally protected doctor-patient information.
• Disclosure is only allowed under:
  1. Court orders
  2. Patient waiving privilege (e.g., calling the doctor as a witness)
  3. Statutory requirements:
     • Births, deaths, infections, etc.
  4. Public interest concerns:
     • Venereal diseases in public workers
     • Contagious conditions in food handlers or transport workers

 

Professional Secrecy

Legal Protection for Medical Practitioners:

• A medical practitioner is protected from legal liabilities if certain conditions are met.

Types of Privilege:

1. Absolute Privilege
   • Statements made in court or parliament during legal proceedings are fully protected.
2. Qualified Privilege
   • Outside court, privilege extends to health authorities reporting infectious or noticeable diseases.

Conditions for Disclosure:

• Information disclosed must be:
  • Bona fide (genuine and honest).
  • Made in good faith.
  • Shared with parties having a duty to receive it.

Professional Misconduct

• Defined as any act regarded as disgraceful or dishonorable by competent peers.
• All serious crimes committed by doctors must be reported to the medical council.
• The person accused cannot challenge the court’s verdict once decided.

Examples of Professional Misconduct:

1. Abuse of privileges (fake certificates, improper prescriptions, unauthorized sharing of patient info).
2. Association with unqualified or disreputable persons.
3. Improper advertising/publicity.
4. Adultery linked to professional relationships.
5. Abortion not performed in good faith.
6. Alcoholism while on duty.
7. Addiction.

 

Medical Ethics

• Voluntary code of behavior specific to the medical profession.
• Different from statute laws; based on accepted professional standards.

Key Ethical Considerations:

1. History of illness: Involves confidential patient secrets.
2. Medical examination: Physical access to the patient’s body, including private parts.
3. Medical treatment: Administration of drugs, surgery, or potentially harmful interventions.

Ethical Dilemmas:

• Balancing patient requests and professional judgment (e.g., abortion requests, prescribing narcotics against religious beliefs).

 

Ethical Problems in Medicine

• Euthanasia
• Abortion
• Organ transplantation
• Contraception
• Artificial insemination
• IVF (In vitro fertilization)
• Declaration of brain death
• Cloning

 

Legal Aspects of Medical Practice

• Historically, medical practice was not governed by statute law.
• Anyone could practice medicine under common law but was liable for negligence.
• Modern times have seen classification of medical systems and laws regulating them.

 

Systems of Medical Practice

1. Allopathic (modern scientific medicine)
2. Ayurvedic
3. Homeopathic
4. Unani Tib

 

Statute Laws Governing Allopathic Medicine

• Medical and Dental Degree Ordinance (1980)
• Allopathic System (Prevention of Misuse) Act (1962)
• PMDC Ordinance (1962)
• Drug Act (1976)
• Dangerous Drug Act (1930)

 

Medical and Dental Degree Ordinance 1980

Objectives:

1. Define the scientific medical system (Allopathic medicine including surgery and dentistry).
2. Identify authorities authorized to grant medical degrees and diplomas.
3. Prohibit unauthorized use of medical/dental titles and degrees.

 

Allopathic System (Prevention of Misuse) Act 1962

• Defines Registered Medical Practitioner (RMP).
• Prevents misuse of the term “doctor” or medical titles by unauthorized persons.
• Only RMPs can:
  • Use medical degrees or diplomas.
  • Perform surgical operations.
  • Prescribe antibiotics or dangerous drugs.

 

PMDC Ordinance 1962

• Establishes Pakistan Medical and Dental Council (PMDC).
• Council consists of registered medical/dental practitioners and one legal member (ex-judge).

Functions of PMDC:

• Maintain professional proficiency.
• Maintain medical register.
• Oversee conduct of registered practitioners.

 

Proficiency of Medical Profession (PMDC)

• Evaluate medical qualifications.
• Prescribe qualifications for medical teachers.
• Inspect medical institutions and examinations.

 

Medical Register

Contains three lists of practitioners:

1. Provisionally registered (residents).
2. Fully registered (independent practitioners).
3. Specialist registered (additional qualifications).

 

Medical Registration

• Grants authority to practice medicine.
• Usually permanent unless revoked by the state.
• Application requires:
  1. Requisite fee.
  2. Certificates proving proficiency, moral character, and citizenship.

 

Privileges of Registration

• Only RMPs can hold medical employment.
• Medical certificates must be issued by RMPs.
• Only RMPs can charge fees for medical services.
• Only RMPs can prescribe dangerous drugs.
• Only RMPs can authorize detention in mental institutions.

 

Obligations of Registration

• Notify change of address.
• Do not use titles or symbols of qualifications unless officially conferred.

 

Code of Medical Ethics (PMDC)

• Devote life to service of humanity.
• Respect and gratitude to teachers.
• Practice with dignity and fear of God.
• Prioritize patient health.
• Maintain honor and traditions of medicine.
• Treat colleagues as brothers and sisters.
• Do not let religion, nationality, race, politics, or social status affect care.
• Maintain patient confidentiality.
• Respect human life from conception and never use medical knowledge against humanity.

 

Drug Act 1976

Objectives:

• Ensure marketed drugs meet quality standards.
• Ensure new drugs are tested for safety and efficacy.
• Regulate approval terms and withdrawal based on new info.
• Inform medical practitioners about drugs.
• Control advertising to prevent misuse.

 

Dangerous Drug Act 1930

Primary goals:

1. Prevent drug abuse (use beyond medicinal purposes).
2. Control drugs with potential for misuse, e.g. stimulants, depressants, hallucinogens.

 

WHO Criteria for Drug Addiction / Dependence

• Compulsion to continue drug use (craving).
• Need for increased dose (tolerance).
• Withdrawal symptoms upon discontinuation.
• Physical and psychological dependence.
• Social deterioration.
• Addiction is Haram in Islam.

 

Dangerous Drug Rules

• Rule 13: Quantity limits on dangerous drugs (e.g., medicinal hemp 3 oz, opium 3 oz, etc.).
• Rule 14: Maintain records of dangerous drugs separately.

 

Workman's Compensation

• Civil laws provide compensation for workplace injuries.
• Governed by:
  1. Workman's Compensation Act (1923).
  2. Employees Social Security Ordinance (1965).

 

Workman's Compensation Act 1923

• Provides compensation for injuries and disabilities at work, including environmental causes.

 

Employees Social Security Ordinance 1965

• Provides insurance for employers and employees.
• Includes benefits for dependents.
• Covers occupational diseases like anthrax, lead poisoning, and radiation exposure.