the use of animal for scientific purposes...
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THE USE OF ANIMAL FOR SCIENTIFIC PURPOSES IN
MALAYSIA: LAW, POLICY AND IMPLEMENTATION
Intan Shafinaz binti Mohammadi
Thesis submitted in fulfilment of the degree of
MASTER OF LAW
UNIVERSITI SAINS ISLAM MALAYSIA
June 2019
ii
AUTHOR DECLARATION
I hereby declare that the work in this thesis is my own except for quotations and
summaries which have been duly acknowledged.
Date: 13th December 2018 Signature :
Name : Intan Shafinaz binti Mohammadi
Matric. No : 3170005
Address : Lot 1276 Kg. Che Tambhy, 71350
Kota, Negeri Sembilan.
iii
ACKNOWLEDGEMENTS
First and foremost I would like to thank Allah for His blessing and protection for me to
complete this thesis. There is no power but from Him.
Appreciation is due to Dr. Arif Fahmi Md Yusof, my principal supervisor and Dr. Izawati
Wook, my co-supervisor for their continuous support and guidance during the research. It
is with their supervision that this work came into existence.
Appreciation is also due to Kementerian Pendidikan Tinggi (KPT) for the research grant
under the FRGS scheme (USIM/FRGS/FSU/32/51516) that made this thesis part of the
research output.
I am also deeply thankful to my informants from various agencies i.e. representatives
from the Department of Veterinary Services (DVS), Department of Wildlife and National
Parks (PERHILITAN), Institute of Medical Research (IMR), Laboratory Animal Science
Association of Malaysia (LASAM), Society for the Prevention of Cruelty to Animals,
Selangor (SPCA), Universiti Putra Malaysia (UPM) and Universiti Malaya (UM). I wish
to acknowledge and appreciate their help during my research and all their information
have helped me complete this thesis.
Last but not least, I must express my very profound gratitude to my parents, Norizah
Ahmad and Mohammadi Ahmad for their continuous support and prayers as well as to
my loyal companion since birth, my twin Intan Sharaini Mohammadi. This
accomplishment would not have been possible without them.
May the Almighty God richly bless all of you.
iv
ABSTRAK
Kajian ini merupakan kajian evaluatif mengenai penggunaan haiwan dalam penyelidikan,
ujian dan pengajaran di Malaysia. Di Malaysia, haiwan telah digunakan untuk tujuan
penyelidikan sejak penubuhan Institut Penyelidikan Perubatan (IMR) di Kuala Lumpur
pada awal 1990. Walau bagaimanapun, undang-undang yang mengawal penggunaan
haiwan untuk tujuan tersebut di Malaysia adalah tidak mencukupi. Pada tahun 2010,
cadangan untuk menubuhkan sebuah makmal haiwan di Melaka dimana ubat-ubatan baru
akan diuji kaji ke atas haiwan telah mendapat tentangan besar dari orang awam dan
pertubuhan bukan kerajaan (NGO) yang berkaitan. Disamping itu, pada tahun yang sama
juga telah dilaporkan kewujudan sebuah makmal haiwan di Pulau Pinang beroperasi
tanpa izin dari pihak berkuasa. Rentetan daripada isu-isu tersebut, kerajaan telah
mencadangkan undang-undang baru yang mengawal selia kebajikan haiwan iaitu Akta
Kebajikan Haiwan 2015 antara lain untuk memberi kepentingan dalam mengawal selia
penggunaan haiwan dalam penyelidikan. Oleh itu, kajian ini membincangkan konsep
kebajikan haiwan dari perspektif yang berbeza iaitu moral, saintifik, undang-undang
antarabangsa dan Islam. Kajian ini juga menganalisis undang-undang dan dasar Malaysia
yang mengawal selia perkara ini seterusnya melihat perlaksanaan undang-undang
tersebut. Kajian ini menggunakan metode penyelidikan doktrinal dan juga kualitatif.
Penyelidikan doktrin dipertimbangkan dengan melihat sumber-sumber undang-undang
primer dan sekunder. Sumber utama undang-undang iaitu undang-undang dan dasar
persekutuan, undang-undang antarabangsa dan agama dirujuk. Selain itu, kajian ini juga
merujuk kepada sumber-sumber sekunder undang-undang seperti buku, jurnal, pangkalan
data dan laman web organisasi yang berkaitan untuk memaklumkan data. Penyelidikan ini
juga menggunakan kaedah kualitatif. Ia melibatkan temubual, perbincangan kumpulan
fokus dan pemerhatian. Pemberi maklumat yang berkaitan dengan penyelidikan ini adalah
dari pelbagai jabatan dan institusi seperti Jabatan Perkhidmatan Veterinar (DVS), Institut
Penyelidikan Perubatan (IMR), Persatuan Sains Haiwan Haiwan Makmal (LASAM),
PERHILITAN, Persatuan Pencegahan Kekejaman untuk Haiwan (SPCA) Selangor dan
universiti. Penyelidikan ini memberi gambaran mengenai undang-undang Malaysia yang
mengawal penggunaan haiwan untuk tujuan saintifik serta menyumbang kepada literatur
di kawasan berkenaan. Kajian ini menunjukkan bahawa undang-undang Malaysia adalah
berdasarkan kepada konsep kebajikan haiwan yang membenarkan haiwan digunakan
untuk tujuan saintifik hanya jika keperluan undang-undang yang mengawal perkara itu
dipatuhi.
Kata Kunci: Eksperimen Haiwan, Haiwan, Kebajikan Haiwan, Etika, Tujuan Saintifik.
v
ABSTRACT
This research is an evaluative study on the use of animals for scientific purposes i.e.
research, testing and teaching in Malaysia. Animal has been used for the benefit of human
beings including subjected to scientific purposes since decades ago. In Malaysia, we have
used animals for research since the establishment of Institute for Medical Research (IMR)
in Kuala Lumpur in the early 1950s. However, the law governing the use of animal in
science in Malaysia is inadequate. Proposal to establish an animal laboratory in Melaka in
2010 where trial medicine was suggested to be tested in animals invites immense outcry
from the public as well as related non-governmental organization (NGOs). Furthermore,
reported news of the existence of a laboratory in Penang without a permit from authority
alarming to the need of a law that governs the subject matter. In response to the issues,
the government proposed new legislation regulating animal welfare i.e. Animal Welfare
Act 2015 among others to bring importance significant in regulating the use of animal in
research. Thus, this research discusses first the animal welfare concept from different
perspectives i.e. moral, scientific, international and Islamic. Then, it analyses the
Malaysian laws and policies regulating the subject matter as well as how the law is
implemented in the country. This study adopts both doctrinal and non-doctrinal research.
Doctrinal research is considered by looking at the primary and secondary sources of law.
Primary sources of law i.e. federal law and policies, international law, custom and
religious perspectives are referred. Furthermore, this study also makes reference to
secondary sources of law such as books, journal, databases and internet site of relevant
organizations to inform the data. This research will also adopt non-doctrinal approach
which considers qualitative method. It involves interviews, focus group discussion and
observation. The informants that relevant to this research are from various departments
and institutions such as Department of Veterinary Services (DVS), Institute of Medical
Research (IMR), Laboratory Animal Science Association Malaysia (LASAM),
PERHILITAN, Society for the Prevention of Cruelty to Animals (SPCA) of Selangor and
universities. This research provides an overview on the Malaysian law governing the use
of animal for scientific purposes as well as contributes to the literature in the area
concerned. This research suggests that Malaysian legislation is based on animal welfare
concept that permits animals to be used for scientific purposes only if the requirements of
law governing the subject matter are adhered.
Keywords: Animal, Animal Experimentation, Animal Welfare, Ethics, Scientific Purposes.
vi
الملخص
هذا البحث هو دراسة تقييمية حول استخدام احليوان لألغراض العلمية ، مثل البحث واالختبار والتدريس يف ماليزياااو و اااد اسااتخدم احلياااوان لروااااد البتااار ألاااا يف علااة تعااارض لألغااراض العلمياااة م ااذ قاااودو يف ماليزياااا ،
يف كاواال دلباور يف اوااال (IMR) طبياةاستخدم ا احليواناات غغاراض البحاث م اذ ت سايس معباد البحاوث الو ومع علاة ، إا ن القاانون الاذم اساخ اساتخدام احلياوان يف العلاوم يف ماليزياا غارت م ااخو ا ا ا 0991 ام
حياااث ا ااا إخااارات اختباااار ناااريع يف احليواناااات ياااد و إ 0101إنتاااات تاااين حياااوا يف مي كاااا يف اااام و وة لى علاة .(NGO) ادل ظمات غرت احلسومية عات الصلة احتجاخات هاالة من اجلمبور وكذلة
، عكرت انبات ن وخود تين يف بي انج دون تصريح مان اللالطة ي اذر زااخز القاانون الاذم اساخ ادلو او و ورداً لااى هااذق الق ااايا ، ا حاا احلسومااة تتااريعاً خديااداً ياا ظخ ر ايااة احليوانااات ، ام ااانون ر ايااة احليااوان
، ماان بااو امااور اخاارأ ي اارات اليااة كباارتة لااى ت ظاايخ اسااتخدام احليااوان يف البحااوثو وهسااذا 0100لعااام ي ا ش هذا البحث اواًل مربوم الرإاهية احليوانية من م ظورات تلرة ، ام اخ ا و لما ودوو وإسا م و
القااانون يف الااب دو تتباا هااذق مث الاال القااوانو واللياسااات ادلاليزيااة الااض تاا ظخ ادلو ااو وكااذلة كيريااة تطبياا الدراسااة كااال ماان البحاااث العقاااادم وغااارت العقااااادمو يعتااين البحاااث العقاااادم مااان خاا ل ال ظااار يف مصاااادر القااانون االبتداايااة والثانويااةو ادلصااادر اغساسااية للقااانون ، ام القااوانو واللياسااات الريدراليااة والقااانون الاادوو
علة ، تترت هذق الدراسة ايً اا إ مصاادر نانوياة للقاانون مثال الستا والعرف والعرف الديينو و وة لى واجملااا ت و وا اااد البياناااات ومو اااع اين نااا اخلاااال بادل ظماااات عات الصااالة يبااا البيانااااتو سااايتب هاااذا ة البحث ايً ا هنًجاا غارت قاااديًا يرسار يف الطريقاة ال و ياةو وهاو ي طاوم لاى ادلقااب ت وادل ا تاات اجلما يا
ادلركزة وادل حظةو ادلخينون عوو الصلة هبذا البحث هخ من تلا ايدارات وادلسسلاات مثال دااارة اخلادمات ، (LASAM) ، مجعياة لاوم احلياوان ادلختينياة يف ماليزياا (IMR) ، معباد البحاوث الطبياة (DVS) البيطرياة
PERHILITAN مجعية م ع القلوة لى احليوانات ، (SPCA) واجلامعاتو يقادم هاذا البحاث من سي جنورنظرة امة لى القانون ادلاليزم الذم اسخ اساتخدام احلياوان لألغاراض العلمياة وكاذلة يلااهخ يف اغدبياات يف ادل طقاااة ادلع ياااةو يقااا هاااذا البحاااث ان التتاااريع ادلااااليزم يقاااوم لاااى مرباااوم رإاهياااة احلياااوان الاااذم يلااامح
.ط إعا مت االلتزام ألتطلبات القانون الذم اسخ ادلو و باستخدام احليوانات لألغراض العلمية إق
السلمات ادلرتاحية: احليوان ، التجارب احليوانية ، ر اية احليوان ، اغخ يات ، اغغراض العلميةو
vii
TABLE OF CONTENTS
CONTENT
AUTHOR DECALARATION ACKNOWLEDGEMENTS
ABSTRAK
ABSTRACT
AL-MULAKHKHAS TABLE OF CONTENTS
LIST OF STATUTES
CHAPTER 1: INTRODUCTION
1.1 Background of the Study
1.2 Problem Statement
1.3 Objectives of the Study 1.4 Research Questions
1.5 Significances of the Study
1.6 Scope of the Study 1.7 Literature Review
1.8 Research Methodology
1.8.1 Research Approach and Design 1.8.2 Data Analysis
1.9 Conclusion
CHAPTER 2: CONCEPT OF ANIMAL WELFARE 2.1 Introduction
2.2 Animal Moral Status
2.2.1 Theories 2.2.2 Animal as Sentient Beings
2.3 Animal Right and Animal Welfare
2.3.1 Animal Rights 2.3.1 Animal Welfare
2.4 Animal Welfare: Definition, Concepts and Principles in
the Use of Animal in Experimentation
2.4.1 Definition and Concept of Welfare 2.4.2 Principles for the Use of Animal in
Experimentation
2.5 International Perspective 2.5.1 Terrestrial Code
2.5.2 International Guiding Principles for Biomedical
Research Involving Animals
2.5.3 Universal Declaration of Animal Welfare (UDAW) 2.5.4 European Union
2.5.5 International Convention for the Protection of
Animals (ICPA) 2.6 Islamic Perspective
2.6.1 Animal in Islam
2.6.2 The Use of Animal in Scientific Purposes as Maqasid As-Syari‟yyah
PAGE
ii iii
iv
v
vi vii-ix
x
1
1-2
2-4
4 5
5-6
6 6-17
18
18-22 22
22-24
25 25-27
27
28-30 30-31
32-33
33-34 34-36
36-37
37-41
41-45
45-46 47-50
50-52
52-56 56-59
59-61 61
61-64
64-66
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2.6.3 Care and Ethics of Animal Use in Experimentation
in Islam
2.7 Conclusion
CHAPTER 3: LAWS AND POLICIES REGULATING USE OF ANIMAL
IN SCIENTIFIC PURPOSES IN MALAYSIA
3.1 Introduction 3.2 Historical Background
3.3 Federal Laws
3.3.1 Animals Act 1953 3.3.2 Wildlife Conservation Act 2010
3.3.3 Animal Welfare Act 2015
3.4 Sub-Legislations and Policies
3.4.1 Malaysian Code of Practice for the Care and Use of Animal for Scientific Purposes (My Code)
3.4.2 Animal Welfare (Animals Used in Research, Testing
and Teaching) 2015 3.4.3 Guidelines for the Use of Animals in School
3.4.4 Other Policies and Guidelines
3.5 Other Referred Documents 3.5.1 OIE Terrestrial Code
3.5.2 American Association for Accreditation of Laboratory
Animal Care (AAALAC) Guidelines
3.6 Basic Principles Underlying the Animal Research Law in Malaysia
3.7 Framework of Animal Welfare Act 2015
3.7.1 Animal Welfare Board 3.7.2 Licensing
3.7.3 Animal Use in Research, Testing and Teaching
3.7.4 Cruelty Offences 3.7.5 Animal Ethics Committee
3.8 Limitation of the Animal Welfare Act 2015
3.9 Conclusion
CHAPTER 4: GOVERNANCE OF THE LAWS
4.1 Introduction
4.2 The Use of Animal for Scientific Purposes 4.2.1 Types of Animals
4.2.2 Categories of Use of Animals for Scientific
Purposes
4.3 Relevant Competent Authorities 4.3.1 Ministries and Agencies
4.3.2 Authoritative Bodies
4.4 Ethical Permit 4.4.1 Institution
4.4.2 Researchers
4.5 Animal Research project Evaluation and Authorization 4.5.1 Preparing Proposal
4.5.2 Research Project Evaluation
4.6 Standards for Animal Care
66-70
70-72
73
73-74 75-76
76
77-79 79-80
80-84
84
85-87
87-88 88
88-91
91 91
92-93
93-95
95-96
96-97 98-99
99-101
101 102-104
104-105
105-107
108
108
109-111
111-114
114 114-116
116-119
119 120
120-121
121 122-123
123-128
128
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4.6.1 Animal Needs
4.6.2 Pain Management, Handling and End-Point
4.6.3 Veterinary Care 4.7 Training and Competence
4.8 Enforcement
4.8.1 Institution Level
4.8.2 DVS Level 4.9 Conclusion
CHAPTER 5: SUMMARY AND CONCLUSION 5.1 Conclusion
5.2 Limitation of Study
5.3 Suggestion for Future Research
REFERENCES
APPENDICES
128-129
129-132
132-133 133-137
137
137-140
140-141 141-144
145 145-146
146-147
147-148
149-155
156
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LIST OF STATUTES
Animal Act (Amendment 2013) 1953
Animal Welfare Act 2015
Wildlife Conservation Act 2010
Animal Welfare (Animals Used in Research, Testing and Teaching) 2015
Malaysian Code of Practice for the Care and Use of Animals for Scientific Purposes 2014
Policy of University Kebangsaan Malaysia Animal Ethics Committee (UKMAEC)
Regarding the Use of Animals in Research
Policy of Universiti Malaysia Sarawak Animal Ethics Committee (UNIMAS-AEC)
Regarding the Use of Live Animals in Research And Teaching
Universiti Putra Malaysia Code of Practice for the Care and Use of Animals for Scientific
Purposes
Universiti Malaya Animal Care and Use Policy
European Convention for the Protection of Vertebrate Animals Used for Experimental
and Other Scientific Purposes (ETS 123).
European Directive 2010/63
International Convention for the Protection of Animals (ICPA)
International Guiding Principles for Biomedical Research Involving Animals
Terrestrial Animal Health Code
Universal Declaration of Animal Welfare (UDAW)
149
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APPENDICES
The scopes of the questions are as follows:
1. Use of animal in experimentation and the practice in Malaysia.
(i) To what extent the animals have been used in research in Malaysia?
(ii) Types of animals used for scientific purposes in Malaysia
(iii) What are the institutions or industries in Malaysia that carry out the activities
using animals for scientific purpose?
(iv) Malaysian current practice of animal use in experimentation and its problems.
2. Position of Law
(i) The current position of law and policies regulating the use of animals in
science in Malaysia.
(ii) The importance of having regulations on animal experimentation
(iii) Provisions of law regulating the animal experimentation in AA 1953, WCA
2010 and AWA 2015.
(iv) Is the law sufficient?
3. Administration of the law.
(i) The role of Department of Veterinary Service for the use of animals in
experimentation and how the law (Animal Welfare Act 2015) is implement?
(ii) The composition and roles of Animal Welfare Board. How the establishment
of the Board can enhance the protection of animal welfare in the animal
experimentation?
(iv) Matters relating to the Animal Ethics Committee (AEC), their establishment,
composition, roles and guidelines.
(v) Process of application to use animal in scientific activities.
(iv) Issues of implementation of the law and effectiveness.
(vi) Any other problems that may arises when implementing the law.
.