Act - Kementerian Kesihatan Malaysia

Persidangan Pakar Program Perubatan 2015
Hotel Thistle Prort Dickson 7-9 Ogos
BAHAGIAN AMALAN PERUBATAN
KEMENTERIAN KESIHATAN MALAYSIA
8 OGOS 2015
1
CONTENTS
INTRODUCTION
LAWS RELATED
TO MEDICAL &
HEALTH IN
MALAYSIA
OTHER LAWS
RELATED TO
MEDICAL
PRACTICE
LAWS & POLICIES
DIRECTLY RELATED
TO MEDICAL
PRACTITIONERS
CONCLUSION
2
Law may be defined as rule of
human conduct, imposed
upon and enforced among the
members of a State
•Medical Practice Division
•Classification of Law
INTRODUCTION
3
KEMENTERIAN KESIHATAN MALAYSIA
MENTERI
TIM. MENTERI
Ketua Setiausaha
KETUA PENGARAH
KESIHATAN
Bhgn
Pembgnan
TKSU
(Pengurusan)
Bhgn
Dasar &
Hubungan
A/bangsa
Pejabat
PUU
Audit
Dalam
UKK
Lembaga
Promosi
Kesihatan
Pihak
Berkuasa
Peranti
BPP
TKPK
(KA)
Bhgn
Amalan
Perubatan
MMC
Majlis Optik
Malaysia
Lembaga
Pembantu
Perubatan
TKPK (P)
TKPK
(P & ST)
BSKB
Bhgn
TCM
PK
(Kesihatan
Pergigian)
Bhgn
Telehealth
Cawangan Kawalan Amalan
Perubatan Swasta (CKAPS)
Cawangan
Penggubalan Akta
Cawangan
Mediko Legal
PK
(Perkhidmata
n Farmasi)
Pengarah Kanan
(Keselamatan &
Kualiti Makanan)
Bhgn
Kejururawatan
TKSU
(Kewangan
)
Pengarah Jabatan
Kesihatan
Negeri/Institusi
TPKN (P)
Teknikal
Admin
Unit Kawalan Amalan Perubatan
Swasta (UKAPS) JKN/WP
CLASSIFICATION OF
LAW IN MALAYSIA
LAW
NATIONAL
PUBLIC
Constitutional
Law
defines the
structure of the
principal organs of
government &
their relationship
to each other, and
determine their
principal functions
and the rights of
individual under
government.
Administrative
Law
regulates the
duties and
exercise of
powers by
administrative
authorities.
INTERNATIONAL
PRIVATE
Criminal Law
deals with acts or
omissions which
are offences
against the State
and for which the
offender is liable to
be tried and if
found guilty, will be
punished
according to the
law
Civil law
deals with the
relation between one
citizen and another
i.e. Contract, Family
Law, Tort, Land Law
and commercial law
in general
Undang-Undang
mengenai
hubungan
diplomatik
Geneva Convention,
Chicago Convention,
Framework Convention on
Tobacco Control (FCTC),
Committee on the Rights of
the Child (CRC),
International Health
Regulations (IHR)
5
UNDANG-UNDANG
SIVIL & JENAYAH
JENAYAH
SIVIL
•
Undang-Undang
Sivil
adalah
mengenai
hubungan
sesama
individu, sebagai undang-undang
persendirian.
•
Tindakan oleh individu sendiri
•
Beban
pembuktian
adalah
berdasarkan
pertimbangan
kebarangkalian
(balance
of
probabilities)
•
Dari segi tanggungan pihak-pihak
perlu
bayar
gantirugi
atau
pampasan
•
Undang-Undang Jenayah adalah
mengenai hubungan
antara
individu dengan negara.
•
Tindakan adalah oleh pihak
pendakwaraya dan individu tiada
kuasa.
•
Beban pembuktian berdasarkan
tanpa
keraguan
munasabah
(beyond reasonable doubt).
•
Kesalahan jenayah membawa
hukuman, denda, penjara, mati &
sebatan.
MEDICAL NEGLIGENCE
3 Principle Elements of Negligence:
(a)
Duty of care or an existing legal duty (within
scope of duty)
(b)
Breach of duty or failure to conform to the
standard of care
(c)
Causation or consequential damage to the
patient as a result of breach of duty
*Patient Medical Record – very important
7
LAWS RELATED TO MEDICAL
& HEALTH IN MALAYSIA
8
LAWS RELATED TO MEDICAL & HEALTH
IN MALAYSIA
1.
To date, more than 770 Principal Act have been gazetted in
Malaysia (not including 1491 amending acts).
2.
More than 50 laws are related to medical and health, direct or
indirect. It may be divided into:
i.
Laws regulating healthcare providers, facilities and services
ii.
Laws relating to healthcare facilities which are not under MOH
iii.
Laws imposing a duty on doctors
iv.
Laws for the control of disease
v.
Laws with provisions relating to health in general
vi.
Laws relating to healthcare financing
vii. Legal provisions for healthcare costs
9
Professional Act: i.e. Medical Act 1971 [Act 50]
MOH Policies: Locum
Healthcare Act: i.e. Private Healthcare Facilities & Services Act 1998 [Act 586]
Practise: i.e. Mental Health Act 2001 [Act 615]
LAWS & POLICIES DIRECTLY
RELATED TO MEDICAL
PRACTITIONERS
10
MEDICAL ACT 1971 [ACT 50]
The main focus is to ensure the patient safety and quality of
healthcare started from very beginning as required under the
Medical Act 1971 such as1.
Register doctors from the recognised universities only
2.
Those from unrecognised universities are required to sit and
passed the qualification examination
3.
Housemen are required passing their basic postings
previously at least 1 year but now 2 years before they can
be fully registered with Malaysian Medical Council (MMC).
4.
Ethically, all registered medical practitioners are monitored
by MMC. Any wrong doings and unethical matter may be
discussed at the Preliminary Investigation Committees
or/and MMC level and action may be taken accordingly.
11
MEDICAL ACT 1971 [ACT 50]
Registration
1. Provisional Registration (S.12)
2. Full Registration (S.14)
3. Annual Practising Certificate (APC) (S. 20)
4. Temporary Practising Certificate (TPC) (S.16)
5. Specialist Registry (S.14A, 14B, 14C)
12
GARIS PANDUAN LOKUM
• Surat Pekeliling KSU Bil 5 Tahun 2006
• Surat Pekeliling KPK Bil 2/2010 (12 Mac
2010)
• Surat KPK 12 April 2007
Kebenaran Pegawai Perubatan atau Pakar
Perubatan Dalam Pelesenan Pusat Hemodialisis
Yang Dikelolakan oleh Pertubuhan Sukarela
Professional Indemnity Coverage
ACT 586
GOALS OF ACT 586
1. Impose and ensure minimum standards in the private
healthcare facilities and services (PHFS).
2. Ensure integrity among healthcare professionals.
3. Ensure professionalism
professions.
among
all
healthcare
4. Ensure quality of healthcare facilities and services e.g.
Quality Assurance, Mortality Review etc.
5. Address social and national interest.
MAIN FOCUS ~ PATIENTS’ SAFETY & QUALITY OF
CARE
14
Part I –
Preliminary
S. 1- 2
Part II –Control
S. 3-7
Part III –COA
S.8-13
Part XIX -Saving &
Transitional
S.119-122
Part XVIII –
Miscellaneous
S.108-118
Part XVII –Power
Minister of Health
S.101-107
Act 586
An Act to provide for the regulations
and control of PHFS & other healthrelated facilities and services & for
matters related hereto
[1May 2006, P.U. (B) 93/2006]
Part IV –Licence
S.14-24
Part V – COR
S. 25-30
Part VI –
Responsibilities
S.31-38
Part XVI –
Enforcement
S.87-100
Part XV –MCO
S.82-86
Part XIV- BOM
& AC
S.77-81
Part XIII –
Quality
S.74-76
19 Parts
122 Sections
Part XII – AD
S.64-73
Gazette date: 27 August 1998
Enforcement date: 1 May 2006
Part XI –
Transfusion
S.59-63
Part VII –
General
S.39 - 42
Part VIII –Show
Cause
S.43-51
Part IX –Closure
S.52-53
Part X- Blood
Bank
S.54-58
15
MODE OF CONTROL (S.3, 4 & 85, Act 586)
1. LICENSING
Location (zoning)
APPROVAL TO
ESTABLISH/MAINTAIN
LICENCE TO
OPERATE/PROVIDE
New & Renewal
2. REGISTRATION
3. SUBMIT INFORMATION
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Private Hospital
Private Psychiatric Hospital
Private Ambulatory Care Centre
Private Nursing Home
Private Psychiatric Nursing Home
Private Maternity Home
Private Blood Bank
Private Haemodialysis Centre (PHC)
Private Hospice
Private Community Mental Health Centre
Any other type of healthcare facility/
service to be gazetted from time to time
1. Private Medical Clinic
2. Private Dental Clinic
Managed Care Organisations
PRIVATE HEALTHCARE FACILITIES AND SERVICES ACT 1998 [ACT 586]
v Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities) Regulations, 2006
Facilities & Equipments
Radioactive material, nuclear
material/ prescribed substance
Professional/Para Professional
The Atomic Energy Licensing
Medical Doctors
Act 1984 [Act 304]
Land, Certificate of Completion
Uniform Building By-Laws
and Compliance of buildings or
1984 By Local Authorities
equivalent & signboard approval
Dentists
Factories and Machinery Act,
Steam Boiler, Unfired Pressure 1967 [64/1967] By
Pharmacists
Vessel + machinery equipments Department of Occupational
Safety and Health
Medical Act 1971 [Act 50] Psychiatric services
Dental Act 1971 [Act 51]
Consent and Causing
miscarriage
Registration of
Pharmacists Act 1951,
Drugs & Medicines
(Revised 1989) [Act 371]
Mental Health Act 2001
[Act 615]
Penal Code [Act 574]
Poisons Act 1952
(Revised 1989) [Act 366]
Hydrogen Cyanide
(Fumigation) Act 1953
(Revised 1981) [Act 260]
Dangerous Drugs Act
1952 (Revised 1980) [Act
234]
Safety for fire exit
Fire Services Act 1988 [Act
341] By Fire Department
Environment safety
 Environmental Quality Act
1974 [Act 127] By Department Nurses
of Environment
Nurses Act 1950 [Act 14]
For estate workers
Workers’ Minimum Standards
of Housing and Amenities Act Midwives
1990 [Act 446]
Midwives Act 1966
(Revised 1990) [Act 436]
Sale of Drugs Act 1952
(Revised 1989) [Act 368]
Medical Assistants
(Registration) Act 1977
[Act 180]
Medicines
(Advertisements and
Sale) Act 1956 (Revised
1983) [Act 290]
1
Private Hospital
2
Private Psychiatry Hospital*
3
Private Ambulatory Care Centre
4
Private Nursing Homes
5
Private PsychiatryNursing Homes*
6
Private Maternity Homes
7
Private Blood Bank
8
Private Haemodialysis Centre
9
Private Hospice
Medical Assistants
10 Private Community Mental Health Centre *
11 Private Medical Clinic
12 Private Dental Clinic
13 Mixed Facilities (dari No.1-10)
* + Act 615
Pathology Laboratory
Medical devices
Optician &
Optometrist
Services/Practice
Optical Act 1991 [Act 469]
Advertisements
Estate Hospital
Assistants (Registration) Therapeutic, medical
Human Tissues Act 1974
Act 1965 (Revised 1990) education and research [Act 130]
[Act 435]
Destruction of DiseaseInfectious Diseases
Technical staff
Bearing Insects Act 1975
Control
[Act 154]
Prevention and Control
Personnel care aides
of Infectious Diseases
etc
Act 1988 [Act 342]
Estate Hospital
Assistant
Food safety
Food Act 1983 [Act 281]
Health Promotion
Programmes and
Activities
Malaysian Health
Promotion Board Act
2006 [Act 651]
YET TO BE ENFORCED
Allied Health
Allied Health
Practise telemedicine
professionals
Professional Bill
Traditional and
Medical Device Act 2012 [Act
TCM practitioners
Complementary Medicine
737]
Act 2013
Pathology Laboratory Act
2007 [Act 674]
Telemedicine Act 1997
[Act 564]
METHOD OF HANDLING COMPLAINTS
1. Grievance Mechanisms (GM) – by Facility
2. Investigations (if patient not satisfy with the GM) –
By MOH
3. Independent Inquiry (if necessary) (MOH & Facility)
4. Mediation ~ Mediation Act 2012 (MOH & Facility)
5. Court (Facility or Patient)
18
QUALITY IMPROVEMENT ACTIVITY
• IR-1
– More cases on seroconversion,
haemodialysis centres
mostly
from
• IR-2A & 2B
– Poor reporting
– Majority from private hospitals (but, less than 10%)
• Assessable Death
– Cases submitted did not represent real situation.
– Some cases reported as an incident reporting from
the private hospital (died in a Ministry of Health’s
hospital – as an assessable death)
19
– Some cases sent to Ministry as complaints
ENFORCEMENT
•
The focus on patient safety & quality of healthcare
•
Mainly due to public complaints
•
Example: Engaging unqualified persons
CAUTION:
 Ensure employed registered doctors
 Valid APC – may check at MMC’s website, http://mmc.gov.my (medical
register)
 Temporary staff register
 Show cause notice requires representation within 21 days

Health tourism
 Standard of care


No boundaries
Autonomous Liberalisation
 Relevant to specialised clinics & private hospitals
20
ENSURE EMPLOYED REGISTERED DOCTORS
21
MENTAL HEALTH ACT 2001 [ACT 615] &
MENTAL HEALTH REGULATIONS 2010
• An Act to consolidate the laws relating to
mental disorder and to provide for the
admission,
detention,
lodging,
care,
treatment,
rehabilitation,
control
and
protection of persons who are mentally
disordered and for related matters.
• Applied to both public and private sectors.
• Gazetted Psychiatric Hospital & Specified
Admission Forms.
22
NEW LAWS RELATED TO MEDICAL
PROFESSION
1. Pathology Laboratory Act 2007
2. Organ & Tissue Transplant Act 20-3. Assisted Reproductive Technology Act
20-4. Private Aged Healthcare Facilities &
Services 20-5. Mobile Healthcare Services
23
• Prisons Act 1995 [Act 537]
• Personal Data Protection Act 2010 [Act 709]
OTHER LAWS RELATED TO
MEDICAL PRACTICE
24
Prisons Act 1995
[Act 537]
Child Act 2001
25
PERSONAL DATA PROTECTION ACT
2010 [ACT 709]
• Regulates the collection, recording, holding or storing of
personal data, and carrying out of any operation on personal
data for commercial transactions.
• Personal data includes: Name, NRIC No., Passport No.,
Address, email Address, information from personal file,
photos, sensitive data (e.g. medical history), CCTV images.
• For Health, the Data User (not an individual locum) is:
1.
2.
3.
A licensee under the Private Healthcare Facilities and Services
Act 1998 [Act 586]
A holder of the certificate of registration of a private medical
clinic or a private dental clinic under Act 586
A body corporate registered under the Registration of
Pharmacists Act 1951 [Act 371]
26
PROCESSING OF SENSITIVE PERSONAL
DATA
• Data Users can process personal data once the Data Subject has
given consent to the processing. Processing is for a lawful purpose
directly related to and activity of the data user. Processing is
necessary or directly related to that purpose (the Data User requires
to operate the business).
• Sensitive Data can be processed with explicit consent from the Data
subject and subject to Section 40, PDPA.
• Sensitive Data means physical or mental health or condition of a
Data Subject, political opinions, religious beliefs of a similar nature,
any crime or alleged crime committed by Data Subject or any other
personal data the Minister may determine
27
CONSENT OF DATA SUBJECT
Regulations 3(1) –(5), Personal Data Protection Regulations:
1.
Consent in any form as long as it can be recorded and maintained
properly by Data User
2.
Consent form appearance must be distinguishable from other
matters
3.
Consent can be obtained from parent, guardian or person with
parental responsibility if Data Subject is under 18 years old
4.
Consent can be obtained from a person appointed by court to
manage affairs of the Data Subject or person authorized in writing
by Data Subject to act on his behalf
5.
Burden of proof for such consent shall lie on the Data User
28
Medical & Law
CONCLUSION
29
CONCLUSION
1.
Medical and Laws should be in line, to ensure the good
intention is prevail.
2.
As there are potential medico-legal cases both in public or
private sectors, naive or not knowing the “legal requirement”
- is not acceptable as a reason not to be penalised in the
court of laws.
3.
The increase in the amount, awarded by court for medico
legal litigation cases is considered as a “victim of success”.
4.
Therefore, it is timely, and compulsory for all medical
practitioners to understand the relevant laws and use them
for good, including to handle the issues on arising medical
Indemnity cost: occurrence based coverage versus claim
based protection (issue to pay after stopped practising
should not arise).
30
REFERENCES: WEBSITE BAP
31
32
33
34
35
THANK YOU
Q&A
Telephone:
03-8883 1039
03-8883 1307/1296
Fax:
03-8883 1040
03-8881 0901/0902
razid@moh.gov.my
ckaps@moh.gov.my;
E-mail:
Website:
http://medicalprac.moh.gov.my
36
Health and Medical laws In Malaysia
1. Laws regulating health care providers, facilities and services
1. The Nurses Act 1950 [Act 14]
2. Medical Act 1971 [Act 50]
3. Dental Act 1971 [Act 51]
4. Medical Assistants (Registration) Act 1977, [Act 180]
5. Registration of Pharmacists Act 1951, (Revised 1989) [Act 371]
6. Estate Hospital Assistants (Registration) Act 1965 (Revised 1990)
[Act 435]
7. Midwives Act 1966 (Revised 1990) [Act 436]
8. Optical Act 1991 [Act 469]
9. Private Healthcare Facilities and Services Act 1998 [Act 586]
10. Penal Code [Act 574] on consent and miscarriage
11. Mental Health Act 2001 [Act 615]
12. Poisons Act 1952 (Revised 1989) [Act 366]
13. Hydrogen Cyanide (Fumigation) Act 1953 (Revised 1981) [Act 260]
14. Dangerous Drugs Act 1952 (Revised 1980) [Act 234]
15. Sale of Drugs Act 1952 (Revised 1989) [Act 368]
16. Medicines (Advertisements and Sale) Act 1956 (Revised 1983) [Act
290]
17. Human Tissues Act 1974 [Act 130]
18. Telemedicine Act 1997 [Act 564]
19. Pathology Laboratory Act 2007 [Act 674]
2. Laws for the control of disease
20. Destruction of Disease-Bearing Insects Act 1975 [Act 154]
21. Prevention and Control of Infectious Diseases Act, 1988 [Act 342]
22. Food Act 1983 [Act 281]
3. Laws imposing a duty on doctors
23. Prisons Act 1995 [Act 537]
24. Child Act 2001 [Act 611]
25. Pesticides Act 1974 [Act 149]
Workers’ Minimum Standards of Housing and Amenities Act 1990
[Act 446]
27. Workmen’s Compensation Act 1952, Revised 1982 [Act 273]
28. Banishment Act 1959, Revised 1972 [Act 79] (repealed by Act 735)
29. Births and Deaths Registration Act 1957, Revised 1983 [Act 299 ]
30. Destitute Persons Act 1977 [Act 183]
31. Domestic Violence Act 1994 [Act 521]
32. Drug Dependants (Treatment and Rehabilitation) Act 1983, [Act 283]
33. Drug rehabilitation Centre Rules 1983
34. Road Transport Act 1987 [Act 333]
26.
4. Laws relating to healthcare facilities which are not under MOH
35. Aboriginal Peoples Act 1954, Revised 1974, Act 134 – (e.g. MOH
should carry out an open investigation into these allegations to
determine the actual conditions of the hospital and make public its
findings)
36. Armed Forces Act 1972, Act 77 (Military Clinics - Rumah Sakit
Angkatan Tentera (RSAT) or Pusat Perubatan Angkatan Tentera
(PPAT) )
37. Workers’ Minimum Standards of Housing and Amenities Act
1990, Act 446 (for estate workers)
5. Laws with provisions relating to health in general
38. Census Act 1960, Revised 1969 [Act 16] (health-related matters
such as blindness or other disability, disease or affliction etc)
39. Employment Act 1955, Revised 1981 [Act 265] (MC/Maternity
leave)
40. Exclusive Economic Zone Act 1984 [Act 311] (exclusive
jurisdiction over artificial islands, installations and structures in the
zone and on the continental shelf)
41. Population and Family Development Act 1966, Revised 1988
[Act 352] (formulating policies and methods for the promotion and
spread of population and family development knowledge and practice
on the grounds of health of mothers and children and welfare of the
family)
6. Laws relating to health care financing
42. Employees Social Security Act 1969, [Act 4]
43. Workmen’s Compensation Act 1952, Revised 1982 [Act 273] (e.g.
compensation to be paid to a foreign worker)
44. Road Transport Act 1987 [Act 333] (e.g. motor vehicle users to be
insured against third party risks)
45. Employees Provident Fund Act 1991, Act 452 (The Board should
consider allowing withdrawals for all medical treatments including the
cost of medication).
46. Insurance Act 1996 [Act 553] (regulates the insurance business,
insurance broking business, adjusting business and financial advisory
business) repealed by 758.
47. Takaful Act 1984, Act 312.
48. General Orders Chapter F (Government’s obligations to employees
and pensioners with regard to medical benefits)
49. The Income Tax Act 1967, Act 53 of 1967 (relief for medical
expenses by taxpayers)
7. Legal Provisions for healthcare costs
50. Fees Act 1951
51. Fees Schedules under Act 586