2. HOSPITAL’S RESPONSIBILITY
H
“ ospitals, having undertaken one of mankind’s
most important and delicate endeavors, must assume
the grave responsibility of pursuing it with appropriate
care. The care and service dispensed through this high
trust, however technical, complex and esoteric its
character may be, must meet standards of responsibility
commensurate with the undertaking to PRESERVE and
PROTECT the HEALTH, and indeed, the very LIVES of
those placed in the hospital’s keeping.”
-Professional Services, Inc. v. Agana ( G.R. No. 126297,
Jan. 31, 2007), citing Beeck v. Tucson General Hospital, 500 P. 2d 1153 which
cited Darling vs. Charleston Community Memorial Hospital, 33 Ill. 2d 326.
3. OUTLINE
1. Lessons from the Past? Rationale?
2. Is informed consent
A signature on a form?
A contract?
A process?
3. Ethical requirements?
4. Legal Basics of Consent?
5. Persons and their Legally Effective Representatives?
6. Other Patient’s Rights
Quality Care Management
Privacy and Confidentiality
No Deposit
No Detention
Senior Citizen’s Rights
4. The Lessons from the Past
Year Milestone
460 BC Oath of Hippocrates
1930s Pre-Nuremberg Clinical Studies/ Experiments;
Enactment of U.S. Food, Drugs and Cosmetics Act
1946-1947 Nuremberg Doctors’ Trial, Nuremberg Code
1948 Declaration of Geneva, Declaration of Human Rights
1962 Thalidomide –related Birth Defects
1964 WMA Declaration of Hilsinki
1966 Ethics of Clinical Research by Henry Beecher
5. The Lessons from the Past (2)
Year Milestone
1974 National Research Act and the IRB System (USA)
1979 Belmont Report
1982 CIOMS International Ethical Guidelines for Biomedical
Research involving Human Subjects
1991 European Union-GCP
1993 WHO-Guidelines for GCP for Trials on Pharmaceutical
Products
1996 ICH-GCP
6. 1964 Declaration of Helsinki
Adopted by WMA
Last amended in 2008
Recognition that medical progress is based on
research, including experimentation involving human
subjects
Statement of 25 Ethical Principles to provide guidance
to physicians and participants in medical research
involving human subjects, including identifiable human
material and data
7. 1964 Declaration of Helsinki
Two (2) Key Points
1. Interests of the human
subject should always be
given a higher priority than
those of society.
2. Every subject in clinical
research should get the best
known medical treatment.
8. Salient Ethical Principles of
the Declaration of Helsinki
Conformity to scientific principles
Design of and implementation of clinical research
according to Protocol
Requirement for independent review committees (IRC)
Supervision and conduct of clinical trials by suitably
qualified persons
Assessment and balancing of possible benefits against
risks to subjects
Confidentiality and respect for privacy of human subjects
Minimal physical and mental impact on the human
subjects
Informed consent
9. PRINCIPLES OF BELMONT REPORT
(Robert Amdur, IRB Member Handbook, 2003)
No. Principle Inputs IRB/ERB Outputs
1 RESPECT/ Treat individuals as Participants voluntarily
autonomous agents consent to participate in
AUTONOMY Protect vulnerable research
individuals Informed consent
Protection of privacy &
confidentiality
2 BENEFICENCE Golden Rule Assessment of risks &
Trade-offs between benefits
individual and societal Minimized risks
benefit Non-conflict of interest
3 JUSTICE Equal distribution of Protection of vulnerable
risks and potential subjects
benefits of research People who are likely to
among those who may benefit from research
benefit therefrom participation are not
excluded
10. Key Principles of the CIOMS –
International Ethical Guidelines
Ethical justification and scientific validity of research
Ethical Review
Informed Consent
Vulnerable Population/ Groups/ Persons (children, women,
disabled/challenged, prisoners, military/police)
Choice of control (comparator/ placebo trials)
Confidentiality
Compensation for injury
Obligations of sponsor to provide health care services
11. INFORMED CONSENT:
FROM PAST TO PRESENT
Born out of the lessons from the past:
Protection of the rights, safety, and well-being of human
subjects of clinical trials.
Cornerstone of clinical trials/ researches involving human
subjects
International ethical and legal principles
System of checks and balances
13. INFORMED CONSENT IS A
DOCUMENT AND A PROCESS
DOCUMENT: A summary of the clinical trial (purpose,
treatment procedures and schedule, potential risks and
benefits, alternatives to participation) and an
explanation of the rights of a trial subject/ participant
PROCESS: A continuing discussion and interactive
exchange of information and communications between
the trial subject/ participant and the investigator so that
the former can make educated decisions to continue or
otherwise withdraw from clinical trial.
14. GCP Definition of INFORMED
CONSENT
(GCP 1.28)
“A process by which a subject voluntarily
confirms his or her willingness to participate in a
particular trial, after having been informed of all
aspects of the trial that are relevant in subject’s
decision to participate. Informed consent is
documented by means of a written, signed and
dated informed consent form.”
15. FDA (USA) Definition
(21 CFR 50.20)
“Except as provided in B50.23, no investigator may involve a
human being as a subject in research covered by these regulations
unless the investigator has obtained the legally effective informed
consent of the subject or the subject’s legally authorized
representative. An investigator shall seek such consent only under
circumstances that provide the prospective subject or the
representative sufficient opportunity to consider whether or not to
participate and that minimize the possibility of coercion or undue
influence. The information that is given to the subject or the
representative shall be in language understandable to the subject or
the representative. No informed consent, whether oral or written, may
include any exculpatory language through which the subject or the
representative is made to waive or appear to waive any of the
subject’s rights, or releases or appears to release the investigator, the
sponsor, the institution, or it agents from liability for negligence.”
16. PNHRS’ National Ethical
Guidelines for Health Research
“informed consent (verbal, video, written)-
the process of obtaining approval to participate in
an investigative study or permission to a medical
intervention. Consent must be freely given in
verbal, video or written form. An important part of
the process is the adequacy, appropriateness and
timeliness of the information for decision making.”
17. PERSONS AND THEIR
LEGALLY-EFFECTIVE
REPRESENTATIVES
The Law
Natural Persons
Juridical Capacity and Capacity to Act
Restrictions and Limitations on Capacity to Act
Legal Incapacity
Vices of Consent
18. THE LAW
The New Civil Code
PD 603: The Child and
Youth Welfare Act
EO 209: The Family Code
20. NATURAL PERSONS
Art. 5, PD No. 603
“The civil personality of the
child shall commence from the
time of his conception, for all
purposes favorable to him,
subject to the requirements of
Article 41 of the New Civil
Code.”
21. NATURAL PERSONS (Art. 41, NCC)
“For civil purposes, the fetus
is considered born if it is
alive at the time it is
completely delivered from
the mother’s womb.
However, if the fetus had an
intra-uterine life of less than
7 months, it is not deemed
born if it dies within 24
hours after its complete
delivery from the maternal
womb.”
22. JURIDICAL CAPACITY and
LEGAL CAPACITY TO ACT
Article 37, NCC
“Juridical capacity, which is the fitness
to be the subject of legal relations, is
inherent in every natural person and
is lost only through death. Capacity to
act, which is the power to do acts
with legal effect, is acquired and may
be lost.”
23. RESTRICTIONS &
LIMITATIONS ON CAPACITY TO
ACT (Art. 38-39, NCC)
Minority Imbecility
Insanity Penalty
State of being deaf- Family Relations
mute Citizenship
Prodigality Absence
Civil Interdiction Insolvency
(Art. 34, RPC)
Trusteeship
24. SUBSTITUTE PARENTAL
AUTHORITY
(Family Code)
Court-appointed guardian
Surviving Grandparent
Oldest brother or sister,
over 21 y.o.
Child’s actual custodian,
over 21 y.o.
25. AUTHORITY OVER
PERSON OF MINOR
(Philippine National Ethical Guidelines for Health Research 2006)
Parents
Surviving Parents
Grandparents
Surviving Grandparents
Oldest sibling over 21 y.o.
Actual Custodian
27. CAVEAT and BEWARE
Lack of informed consent is
MEDICAL MALPRACTICE
Therefore, subject to
liabilities:
Administrative
Civil
Criminal
28. SOURCES OF PATIENT’S
RIGHTS
The Bill of Rights under the Philippine
Constitution
Hippocratic Oath
Code of Medical Ethics of the Board of Medicine
Code of Ethics of the Medical Profession
29. SOURCES OF PATIENT’S
RIGHTS (2)
Benchbook on Performance Improvement of
Health Services (Philhealth, 2004)
Batas Pambansa Blg. 702, as amended by RA
No. 8344 (No Deposit Law)
RA No. 9439 (Non-Detention Law)
RA No. 9257, as amended by RA No. 9994
(Expanded Senior Citizens Act)
30. PATIENT’S RIGHTS
To choose physician
To considerate and respectful
care
To privacy and confidentiality
To disclosure of information &
counseling
To medical records & billing
To self-determination
To religious belief
(Code of Ethics)
31. PATIENT’S RIGHTS
To leave and refuse
medical intervention
To participate in or
refuse medical research
To correspondence and
to receive visitors
To express grievances &
resolve complaints
To be informed of rights
and responsibilities as
patient
32. STANDARDS FOR PATIENT’S
RIGHTS
Respect and support for patient’s rights and
responsibilities
Patient’s pro-active involvement in health
care
Confidentiality, privacy, security of
information and communication, including
pastoral counseling
Feedback
Staff Code of Ethics
Resolution of Ethical Issues
(Benchbook)
33. PATIENT CARE STANDARDS
Access
Entry
Assessment
Care Planning
Implementation of Care
Evaluation
Discharge
34. NO DEPOSIT OR ADVANCE
PAYMENT LAW (BP Blg. 702, as amended by RA No.8344)
COVERAGE
Proprietor, president, director, manager or any other
officer, medical practitioner, and/or employee of a hospital
or medical clinic
Emergency or serious cases: presence of immediate
danger and where delay or inattention may cause loss of
life or permanent disability of patient
35. NO DEPOSIT OR ADVANCE
PAYMENT LAW (2)
PROHIBITION
Request, solicit, demand or accept any deposit or any
form of advance payment as a prerequisite for confinement
or medical treatment of patient, or
Refuse to administer medical treatment and support as
dictated by good practice of medicine to prevent death or
permanent disability
36. NO DEPOSIT OR ADVANCE
PAYMENT LAW (3)
EXCEPTION TO PROHIBITION
Transfer of Patient to another hospital under the following
conditions:
inadequacy of medical capabilities of the hospital/ medical
clinic
Patient or next of kin consents to the transfer
Receiving hospital / clinic agrees to the transfer
37. NO DEPOSIT OR ADVANCE
PAYMENT LAW (4)
EXCEPTION TO THE EXCEPTION
Patient is unconscious or unaccompanied and thus,
cannot give consent
Transfer is done only after administration of necessary
emergency treatment and support to stabilize patient
Transfer is less risky than patient’s continued confinement
Receiving hospital/ clinic shall not refuse to receive patient
or demand deposit or advance payment
38. NO DEPOSIT OR ADVANCE
PAYMENT LAW (5)
PENALTIES
Hospital official, medical
practitioner or employee:
6 mos.1 day- 2 yrs 4 mos.
P20K - P100K
Director or officer if policy exists
on deposit or advance payment
4 to 6 yrs.
P100K - P500K
39. NO DETENTION LAW
(RA No. 9439; DOH Admin. Order No. 2008-0001)
COVERAGE
All patients who were admitted and availed of health
care services in a government or private hospital/ clinic
except those who stay in private rooms
PRIVATE ROOM, defined
A single occupancy room or a ward type room divided by
either a permanent or semi-permanent partition (except
curtains); with 4 patients per room
40. NO DETENTION LAW (2)
SCOPE AND EXTENT OF COVERAGE
2.Partiallyor fully recovered patients who wish to leave the
hospital/ clinic but are incapable to pay their hospital bills or
medical expenses
3.Surviving relatives of deceased patient who wish the
release of the cadaver but are incapable to pay the
hospital bills or medical expenses of said deceased
patients
41. NO DETENTION LAW (3)
PROHIBITED/ ILLEGAL ACT
Detention of a patient, i.e., an act of restraining a person, for
non-payment of hospital bills or medical expenses, in part or
in full, despite execution of the following documents by
patient/ surviving heirs:
Promissory Note (PN)
Mortgage or JSS of co-maker as security for PN
In the case of deceased patient whose benefits shall be
drawn from SSS, GSIS, Philhealth, and private insurance
companies, execution of Deed of Assignment of proceeds
thereof up to the extent of unpaid obligation
42. NO DETENTION LAW (4)
Collateral Detention
Refusal to issue medical certificate and other pertinent
documents for patient’s release
Refusal to issue death certificate of deceased patient and
other documents for internment purposes only
43. NO DETENTION LAW (5)
Penalties
Imprisonment of 1 mo. to 6 mos.
Fine of P20K to P50K
44. RISK MANAGEMENT
GUIDELINES
1. Classify Patients based on
paying capacity (DOH Adm.
Order No. 51-A, s. of 2000
dated 12 Oct. 2001)
2. Assist patients in sourcing
financial assistance
3. Credit policy, billing and
collection procedures
4. Written policies and
procedures for admission and
discharge of patients
45. SENIOR CITIZENS LAW
(RA No. 7432, as amended by RA No. 9257 and 9994, IRR)
THE PRIVILEGE
“Article 7. Twenty Percent (20%)
Discount and VAT Exemption - The
senior citizens shall be entitled to the grant
of twenty percent (20%) discount and to an
exemption from the value-added tax (VAT),
IF APPLICABLE, on the sale of the goods
and services covered by Section 1 to 6 of
this Article, from all establishments for the
exclusive use and enjoyment or availment
of senior citizens.”
46. SENIOR CITIZENS LAW (2)
Medicine and Drug Purchases,
including influenza/pneumococcal
vaccines, vitamins and mineral
supplements
Essential medical supplies,
accessories and equipment
(eyeglasses, hearing aids, dentures,
walkers, prosthetics, etc.)
Medical and dental services in the
private facilities (x-rays, CT scans,
blood tests, other diagnostic tests)
47. SENIOR CITIZENS LAW (2)
Professional fees of attending physician/s
Professional fees of licensed health workers providing
home health care services
Free medical and dental services in government facilities
Free vaccination for indigent senior citizens
Mandatory Philhealth coverage for indigent senior
citizens
48. SUMMATION
Informed consent is an international ethical and
legal principle in the conduct of clinical trials
involving human subjects and a cornerstone/
standard in quality health care management.
Informed consent is not a mere signature on a
form or a document, it is an interactive and
continuing process.
49. SUMMATION
The purpose of informed consent is to protect
the human subject / patient by providing
access to information that can help him in
making an informed choice, and to similarly
make him aware of his or her rights.
50. SUMMATION
Informed consent is voluntary, sans coercion
and undue influence, and without any waiver of
subject’s rights to full disclosure of information in
a clear, understandable and non-technical
language, and with opportunity to decide on
whether to participate or not, continue or not, or
otherwise terminate participation in clinical trial
or medical treatment.
51. SUMMATION
Informed consent is given by the subject of
clinical trial/ patient. In his incapacity to give
consent and/or for non-therapeutic trials, his
legally effective representative may give the
consent.
Flawed and defective informed consent
constitutes medical malpractice.
52. SUMMATION
Quality health care means improved patient’s
outcomes by respecting his rights and resolving
ethical issues that arise in the course of
providing care.
Standards for Patient Rights include patient’s
pro-active involvement in health care decisions
from access to discharge; confidentiality,
privacy, security, counseling, and
communication; and feedback mechanisms
53. SUMMATION
There are laws granting other patient rights and
privileges: no deposit/ advance payment; no
detention for non-payment of hospital bills; law
of the elderly on discounts and VAT and E-VAT
exemptions
54. SC CASES TO READ
Lucas v. Tuano (GR No. 178763; Reyes v. Sisters of Mercy
April 21, 2009) Hospital ( GR No. 130547;
Lasam v. Ramolete (GR No. October 3, 2000)
159132; Dec. 18, 2008) Ramos v. CA (GR No.
Flores v. Pineda (GR No. 124354; Dec. 29, 1999; April
158996; Nov. 14, 2008) 11, 2002)
Cantre v. Go (GR No. 160889; Cruz v. CA (GR No. 122445;
April 27, 2007) Nov. 18, 1997)
Professional Services, Inc. v. Batiquin v. CA (GR No.
Agana (GR No. 126297, January 118231; July 5, 1996)
31, 2007; February 11, 2008; Manila Doctors Hospital v. So
February 2, 2010) Un Chua (GR No. 150355;
Nogales v. Capitol Medical July 31, 2006)
Center (GR No. 142625; Dec. Ty v. People (GR No. 149275;
19, 2006) Sept. 24, 2004)
55. hank You.
Thank You
ATTY. ELIZABETH R. PULUMBARIT
University Legal Counsel and
Head, Intellectual Property Office
University of the Philippines Manila
Email: erpulumbarit@mail.upm.edu.ph;
pulumbaritlaw@gmail.com