International Health Law & Ethics

Foreword 13

PART I. THE RIGHT TO HEALTH 15

Chapter 1. General 17
1.1 The Universal Declaration of Human Rights (1948) 17
1.2 International Covenant on Economic, Social and Cultural Rights, Article 12 (1966) 17
1.3 The right to the Highest Attainable Standard of Health: General Comment no. 14 (2000) on Health; 11/08/2000. E/C.12/2000/4 18
1.4 ILO C130 Medical Care and Sickness Benefits Convention, 1969 41
1.5 International Convention on the Elimination of all forms of Racial Discrimination 42
1.6 International Convention on the Protection of the Rights of All Migrant Workers and Members of their Families (1990) 42
1.7 Universal Declaration Bioethics UNESCO (2005) 43
1.8 European Social Charter (1961) 43
1.9 European Social Charter (Revised), 1996, ETS No. 163 44
1.10 European Code of Social Security (Revised) 45
1.11 Explanatory report on the European Code of Social Security (Revised) 1998 46
1.12 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine 48
1.13 Charter of Fundamental Rights of the European Union (2010/C 83/02) 49
1.14 Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems 50
1.15 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare 53
1.16 A Declaration on the Promotion of Patients’ Rights in Europe, WHO 1994 70
1.17 African Charter on Human and People’s Rights (1981) 70
1.18 African Commission on Human and Peoples’ Rights. Principles and Guidelines on the Implementation of Economic, Social and Cultural Rights in the African Charter on Human and Peoples’ Rights (24-10-2011) 71
1.19 Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights “Protocol of San Salvador” (San Salvador, 17 November 1988) 82
1.20 World Medical Association Statement on Access to Health Care 82
1.21 WMA Statement on Medical Care for Refugees, including Asylum Seekers, Refused Asylum Seekers and Undocumented Migrants, and Internally Displaced Persons (2010) 89
1.22 WMA Resolution on Refugees and Migrants 90

Chapter 2. Prisoners and the right to health 93
2.1 Standard Minimum Rules for the Treatment of Prisoners 93
2.2 United Nations Rules for the Protection of Juveniles Deprived of their Liberty 95
2.3 Recommendation No. R (98) 7 of the Committee of Ministers to Member States concerning the ethical and organizational aspects of health care in prison 96
2.4 Council of Europe. Recommendation Rec(2006)2 of the Committee of Ministers to member states on the European Prison Rules 100
2.5 WHO guidelines on HIV infection and AIDS in prisons 1993 103

Chapter 3. Women and the right to health 113
3.1 Convention on the Elimination of all Forms of Discrimination against Women 113
3.2 General Recommendation No. 24 (20th session, 1999) (article 12: Women and health) 115
3.3 Convention on the Elimination of All Forms of Discrimination against Women & Convention on the Rights of the Child. Joint general recommendation No. 31 of the Committee on the Elimination of Discrimination against Women/general comment No. 18 of the Committee on the Rights of the Child on harmful practices, 14 november 2014 123
3.4 General Comment No. 22 (2016) on the right to sexual and reproductive health (article 12 of the International Covenant on Economic, Social and Cultural Rights) 149
3.5 Protocol to the African Charter on Human and Peoples’ Rights on the Rights of Women in Africa 166
3.6 General Comment No. 2 on Article 14.1 (a), (b), (c), and (f) and Article 14.2 (a) of the Protocol to the African Charter on Human and Peoples’ Rights on the Rights of Women in Africa 168
3.7 General Comments on Article 14.1 (d) and (e) of the Protocol to the African Charter on Human and Peoples’ Rights on the Rights of Women in Africa 181

Chapter 4. Disabled persons and the right to health 191
4.1 Convention on the Rights of Persons with Disabilities 191

Chapter 5. Children and the right to health 195
5.1 Convention on the Rights of the Child 195
5.2 General Comment No. 3 (2003) HIV/AIDS and the rights of the child, Committee on the Rights of the Child Thirty-second session 13-31 January 2003 196
5.3 Committee on the Rights of the Child. General Comment No 4 (2003) on Adolescent health and development in the context of the Convention on the Rights of the Child 211
5.4 General comment No. 15 (2013) on the right of the child to the enjoyment of the highest attainable standard of health (art. 24) 225

Chapter 6. Elderly and the right to health 253
6.1 Inter-American Convention on Protecting the Human Rights of Older Persons (Washington 15 June 2015) 253

PART II. PATIENTS’ RIGHTS 257

Chapter 1. General 259
1.1 Universal Declaration of Human Rights (1948) 259
1.2 International Covenant on Civil and Political Rights (1966) 259
1.3 Siracusa Principles on the Limitation and Derogation Provisions in the International Covenant on Civil and Political Rights, United Nations, Economic and Social Council, U.N. Doc. E/CN.4/1985/4, Annex (1985) 261
1.4 European Convention for Protection of Human Rights and Fundamental Freedoms 269
1.5 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine Oviedo, 4.IV.1997, ETS 164 271
1.6 Explanatory Report. Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine (ETS No. 164) 280
1.7 Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (ETS No. 168) 315
1.8 Explanatory Report. Additional Protocol to the Convention on Human Rights and Biomedicine on the Prohibition of Cloning Human Beings (ETS No. 168) 316
1.9 Charter of Fundamental Rights of the European Union (2010/C 83/02) 318
1.10 A Declaration on the Promotion of Patients’ Rights in Europe (1994) 322
1.11 African Charter on Human and Peoples’ Rights 333
1.12 American Declaration of the Rights and Duties of Man 335
1.13 American Convention on Human Rights 336
1.14 ASEAN Human Rights Declaration and the Phnom Penh Statement (AHRD) 338
1.15 World Medical Association Declaration on the Rights of the Patient 341

Chapter 2. Prisoners and patients’ rights 345
2.1 Recommendation No. R (98) 7 of the Committee of Ministers to Member States concerning the ethical and organisational aspects of health care in prison 345

Chapter 3. Mentally ill and patients’ rights 349
3.1 Declaration on the Rights of Mentally Retarded Persons 349
3.2 Principles for the protection of persons with mental illness and the improvement of mental health care 351
3.3 Resolution adopted by the Human Rights Council on 1 July 2016 32/18. Mental health and human rights 364
3.4 Council of Europe. Recommendation Rec(2004)10 of the Committee of Ministers to Member States concerning the protection of the human rights and dignity of persons with mental disorder 367
3.5 WHO – Mental Health Declaration for Europe Facing the Challenges, Building Solutions 381
3.6 Madrid Declaration on Ethical Standards for psychiatric practice (Declaration of Madrid) 388

PART III. MEDICAL RESEARCH 399
1. Nuremberg Code (1947) 401
2. World Medical Association Declaration of Helsinki 402
3 International Covenant on Civil and Political Rights, 1966 408
4 General Comment No. 20: Replaces general comment 7 concerning prohibition of torture and cruel treatment or punishment (Art. 7) 409
5 International Ethical Guidelines for Biomedical Research Involving Human Subjects 412
6 Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (ETS No. 195) 454
7 Explanatory Report. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (ETS No. 195) 467
8 Regulation 536/2014/EU of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC 505
9 Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin (Adopted by the Committee of Ministers on 11 May 2016 at the 1256th meeting of the Ministers’ Deputies) 566

PART IV. ORGAN TRANSPLANTATION 579
1 Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin, ETS No. 186 581
2 Explanatory Report. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin, (ETS No. 186) 587
3 WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation (World Health Assembly in May 2010, in Resolution WHA63.22) 616
4 The Declaration of Istanbul on Organ Trafficking and Transplant Tourism 625

PART V. GENETICS 633
1 Council for International Organizations of Medical Sciences. The Declaration of Inuyama, 1990 Human Genome Mapping, Genetic Screening and Gene Therapy 635
2 International Declaration on Human Genetic Data, 16 October 2003 637
3 Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes, ETS No 203 648
4 Explanatory Report Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes (CETS No. 203) 655
5 Council of Europe. Recommendation CM/Rec(2010)11 of the Committee of Ministers on the impact of genetics on the organisation of health care services and training of health professionals 683
7 WMA Statement on Genetics and Medicine (as amended WMA General Assembly, New Delhi, India, October 2009) 690
8 Universal Declaration on the Human Genome and Human Rights 694

PART VI. PUBLIC HEALTH 701
Chapter 1. General 703
1.1 International Health Regulations (2005) 703
1.2 Framework Convention on Tobacco Control 2003 732
1.3 Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union (2008/C 115/01)/ Charter of Fundamental Rights of the European Union (18.12.2000/ C 364/01) 755
Charter of Fundamental Rights of the European Union (18.12.2000/C 364/01) 756

Chapter 2. Public Health and Trade 757
2.1 The WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) 757
2.2 Agreement on Technical Barriers to Trade (TBT Agreement) 771
2.3 General Agreement on Tariffs and Trade (GATT 1994 and ANNEX 1A) 774
2.4 General Agreement on Trade in Services (GATS, ANNEX 1B) 774
2.5 Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS, Annex 1C) 774
2.6 Council of Europe Convention on the Counterfeiting of Medical Products and similar crimes involving threats to Public Health, Moscow, 28.X.2011 Submitted to the Parliamentary Assembly on 22 January 2010 780
2.7 Explanatory Report. Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health 797