MINISTRY OF HEALTH CARE OF UKRAINE

DANYLO HALYTSKYI LVIV NATIONAL MEDICAL UNIVERSITY

«Approved»

Vise-Rector

on scientific and pedagogical work

prof. M.R.Gzhegotskyi

______

Faculty of postgraduate education

Department of medical law

Supporting (no)

Address: 10, Solodova St., Lviv

METHODOLOGICALguidelines

FOR STUDENTS OF MEDICAL FACULTY, WHO ARE STUDYING FOR SPECIALTIES:

7.110101 «Medicine»

7.110104 «Pediatrics»

7.110105 «Medical and preventive care»

On theDISCIPLINE«MEDICALLAW»

Approved
by the methodological department
methodological meeting
«__»______2013 year
protocol №__ dated ______
№__dated______/ Approved
by the profile
commission
«__»______2013
protocol
Head of department doc.I.Senjuta Head______
______signature ______signature

Lviv – 2013

Outline

Preface

Thematic plan of practical work

Theme 1. Legal Issues of Bioethics

Theme 2. Medical Law in the System of Higher Medical Education

Theme 3. Legal Regulation of the Health Care Issues in Ukraine

Theme 4. International Standards in the Sphere of Health Care and HumanRights.

Theme 5. Regional Standards in the Sphere of Health Care and Human Rights

Theme 6. Legal Status of Medical Legal Relations Subjects

Theme 7. Legal Regulation of Certain Types of Medical Activity

Theme 8. Legal Regulation of the Health Care Drawbacks. Iatrogeny

Theme 9: Violations in the Sphere of Health Care and Legal Responsibility

Preface

Practical class is one of the forms of studying which aims to enhance the knowledge received by students during lectures, forming their skills and experience in the application of knowledge, skills of creative thinking, analysis and resolving various legal situations.

Practical exercises enable to expand and systematize the knowledge of the discipline.During preparation for the practical classes student shall: 1)learn to analyze recomended sourses, relating to the topics of practical class, know how to outline necessary material; 2) summarize the knowledge received from various sources; 3) prepare answers to theoretical questions and perform all the tasks that are provided within the theme of practical class.

Topics of practical class are disposed in successive order and elucidate the topics of practical classes, provided by the Working educational programme for students of medical faculty who are studying for specialties 7.110101 «Medicine»7.110104 «Pediatrics»7.110105 «Medical and preventive care »on the discipline «Medical law».

Every topic of practical class contains the list of theoretical, problematic questions which relate to topics of practical class; questions for self-control and creative tasks.

Questions for self-control and creative tasks are performed by student in written. Answers to theself-control questions should be clear and reasoned.Creative tasksshall be prepared in written form and should include a clear answer to question with referenceto valid legislation. When solving tasks of the practical class studentsshallprovide clear answers and need to be ready to answer extra questions that may be given by a lecturer or other students.

Thematicplan of practical work

№ / Theme / Hours
Content module 1. Medical Jurisprudence in higher medical education. Organization, administration and regulation of health care. / 4
1 / Legal issues of bioethics / 1
2 / Medical law in the system of higher medical education / 1
3 / Legal regulation of the health care issues in Ukraine / 2
Content module 2.The legal basis for the organization of health care. / 10
4 / International standards in the sphere of health care and human rights / 2
5 / Regional standards in the sphere of human rights in patient care / 2
6 / Legal status of medico-legal relations subjects / 4
7 / Legal regulation of certain types of medical activity / 2
Content module 3. Adverse effects in medical practice.. Offences and legal responsibility in health care. / 6
8 / Legal regulation of the health care drawbacks. Iatrogeny / 2
9 / Violations in the sphere of health care and legal responsibility / 4
In all / 20

Theme 1. Legal Issues of Bioethics

Plan of practical class

  1. Ethics and deontology in medical practice.
  2. Bioethical law as a science.
  3. Bioethical rights and freedoms.
  4. Guarantees of bioethical rights and freedoms.
  5. International legal standarts in the sphere of bioethic.

Questions for self-control

  1. Describe the relation between the concepts «bioethics», «bioethicallaw», «medical law».
  2. What does human priority mean from the bioethics position?
  3. Describe the meaning of the biological integrity of the person.
  4. What international legal acts in the field of bioethics do you know?
  5. Find out the concept of "reproductive technologies".
  6. What are clinical trials and what is their purpose?
  7. What international legal acts that govern the conduct of biomedical experiments, you know? What principles are embodied in them?
  8. What limits to conduct research experiments are set by the legislation of Ukraine?
  9. Definethe term "human cloning."
  10. Describe the concept of "gene therapy" from the standpoint of medical law and bioethics.

Creative task

(In written form)

  1. Analyze provisions of the Universal Declaration on Bioethics and Human Rights and provide a short summary of this act (when and by whom it was adopted, the kea ideas of this act, importance of this act, etc);
  2. Define the international legal acts (declarations, conventions etc.) in the sphere of biomedicine which are obligatory for your country (in other words to which your country has acceded);
  3. Enumerate at least 4 national laws of your country, which regulate different issues of bioethics.
  4. Analyze the relevant case-law (decisions) of the European Court of Human Rights which are dedicated to the issues of

Reproductive rights (at least one court decision);

Assisted suicide (at least one court decision);

Ethical issues concerning HIV (at least one court decision).

In this task you have to analyze the European Court of Human Rights position on the above mentioned three issues and be able to tell them out in a class.

International standards

  1. Universal Declaration on Bioethics and Human Rights. UNESCO. (2005);
  2. 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. (1997).
  3. Universal Declaration on the Human Genome and the Human Rights. UNESCO. (1997).
  4. The United Nations Declaration on Human Cloning. (2005).
  5. International Declaration on Human Genetic Data. UNESCO. (2003).

Recommended literature

  1. Byrne I., Ezer T. Cohen J. Overall. J, Senyuta I. Human Rights in Patient Care: A Practitioner Guide/ Under scientific editing of Senyuta I. – Lviv. LOBF Publisher’s “Medicine and Law, 2012 – 497 pages.
  2. Health and Human Rights: A Resource Guide
  3. Bioethics and the case law of the court research report//
  4. Janet L. Dolgin. Lois L. Shepherd Lois L. Shepherd.Bioethics and the law//
  5. Bioethical legislation in selected countries. Global Legal Research Center LL File No. 2012-008118//
  6. Medical Law and Ethics//
  7. Law and Ethics in Medical Practice an Overview//
  8. Mathias Ricken. Moral Aspects of Human Cloning//
  9. Dianne N Irving. What is Bioethics//

Theme 2. Medical Law in the System of Higher Medical Education

Plan of practical class

  1. Medical law as an academic discipline.
  2. Legal relations in health care: concepts and composition.
  3. Subjects of legal relations in health care sphere.
  4. Objects of legal relations in health care sphere.
  5. Sources of law that govern the relations in health care sphere.

Questions for self-control

  1. Givethe definition of the term «medical law».
  2. Describe medical law as part of the legal and medical sciences.
  3. Describemedical law as an academic discipline.
  4. Suggest the definition of "medical law as a branch of law".
  5. Identify the basic features that characterize medical law as a branch of law.
  6. Expand the concept of "medical legal relations". What are the main types of medico-legal relations?
  7. Give the definition of "subjects of medical legal relations'' and name its types.
  8. What is the classification of sources of law governing the relations in health care?
  9. Give the structural and semantic description of the Law of Ukraine "Principles of Ukrainian Health Care Legislation" as a source of medical law.
  10. Give some examples (5-6) of international instruments in the sphere of health care.

Creative task

(in written form)

  1. Work through the following sources of literature and analyze the scientific approaches to the definition of «medical law», set between the existing definitions common and distinctive features.
  2. Make a table comparing rations of the following concepts:

1)medical law as a legal science

2)medical law as a medical science

3)medical law as an academic discipline

3. Indicate which of the sources of law governing relations in the health sector, there are in your country. Analyze the Law of Ukraine "Principles of Ukrainian Health Care Legislation" and define the features of this regulatory act.

International standards

  1. The Universal Declaration of Human Rights (1948).
  2. The Convention Relating to the Status of Refugees (1951).
  3. The Convention on the Elimination of All Forms of Racial Discrimination (1965).
  4. The Convention on the Elimination of All Forms of Discrimination Against Women (1979).
  5. The United Nations Convention Against Torture (1984).
  6. The Convention on the Rights of the Child (1989).
  7. The International Convention on the Protection of the Rights of All Migrant Workers and Members of their Families (1990).
  8. The Convention on the Rights of Persons with Disabilities(2006).
  9. The International Convention for the Protection of All Persons from Enforced Disappearance (2006).

Recommended literature

  1. Byrne I., Ezer T. Cohen J. Overall. J, Senyuta I. Human Rights in Patient Care: A Practitioner Guide/ Under scientific editing of Senyuta I. – Lviv. LOBF Publisher’s “Medicine and Law, 2012 – 497 pages.
  2. Health and Human Rights: A Resource Guide
  3. Horn C, Caldwell DH Jr, Osborn DC. Law for Physicians: An Overview of Medical Legal Issues. Chicago, IL: American Medical Association; 2000:1-4.
  4. Leigh JP, Kravitz RL, Schembri M, Samuels SJ, Mobley S. Physician career satisfaction across specialties. Arch Intern Med. 2002;162(14):1577-1584.
  5. Liang BA. Medical malpractice: do physicians have knowledge of legal standards and assess cases as juries do? U Chicago Law School Roundtable. 1996;3:59-111.
  6. Noah L. Medical education and malpractice: what's the connection? Health Matrix Clevel. 2005;15(1):149-163.
  7. Rock EM, Simmons PS. Physician knowledge and attitudes of Minnesota laws concerning adolescent health care. J Pediatr Adolesc Gynecol. 2003;16(2):101-108.
  8. Medical Law and Ethics//
  9. Law and Ethics in Medical Practice an Overview//

Theme 3.Legal Regulation of the Health Care Issues in Ukraine

Plan of Practical Class

  1. Legislation of Ukraine (your country) on health care: current situation and prospects of development.
  2. Organization, administration and regulation of health care in Ukraine and your country.
  3. State control and supervision of health care. Quality monitoring of health care. (Ukraine and your country).
  4. State accreditationof health facilitiesand licensingofmedical practice (Ukraine and Your country).

Questions of self-control

  1. What authorities are in charge ofthe formation andimplementation of public policyin the health sector in Ukraine and your country?
  2. Give legal description of the healthcare system in Ukraine and your country.
  3. What is accreditation of health care institution?
  4. Describe theprocedure for accreditationof health facilities inUkraine and your country.
  5. Give thedefinition of the term "medical practice".
  6. What legal acts establish conditions of carrying out medical practice under the laws of Ukraine and your country?
  7. Describe the licensing of medical practice of health care facilities.
  8. Define the concept of "quality of health care".
  9. What indicators of medical care quality in Ukraine (your country) do you know?

Creative task

(In written form)

  1. Specify the types of health care quality monitoring and the authorities carry out thismonitoring in your state. Provide a comparative analysis of Ukraine and your Country in this respective.
  2. Sketch out the health care system in your state and give recommendations for its improvement.
  3. What factors determine the quality of health care? What are the powers of the bodies responsible for supervising the quality of care under the laws of your state and what is their role in this sphere?

Recommended literature

  1. Byrne I., Ezer T. Cohen J. Overall. J, Senyuta I. Human Rights in Patient Care: A Practitioner Guide/ Under scientific editing of Senyuta I. – Lviv. LOBF Publisher’s “Medicine and Law, 2012 – 497 pages.
  2. Health and Human Rights: A Resource Guide
  3. Health care systems in transition (Ukraine) link;
  4. Health Systems in Transition (Belgium) link;
  5. Human Rights in Patient Care: A Practitioner Guide (Ukraine) link;
  6. An Overview of Health and Health care in South Africa 1994 – 2010: Priorities, Progress and Prospects for New Gains link;
  7. Health system reviews (HiT)link;
  8. Health Care in Africa: Challenges, OpportunitiesandanEmerging Modelfor Improvementlink.

THEME 4. International standards in the sphere of health care and human rights.

Plan of practical class

  1. The international level of standards: the concept, character and system.
  2. General and theoretical description of international legal standards.
  3. Normative legal actsdefininginternational standards inthe field ofhealth care(International Covenanton Civil andPolitical Rights, the Declaration on the Rights of the Patients, the International Covenant on Economic,Social and CulturalRights, Convention on the Rights of theChild, Conventionon the Rights ofPersons with Disabilities, etc.).
  4. Meaning of the provisions of the Universal Declaration of Human Rights and their place in the system of international standards in the field of health care.

Questions for self-control

  1. Give thedefinitionof "international standarts of human rights in patient care"
  2. Characterize the system of international standards in the field of health care?
  3. What elementsmake upthe structureof the right tohealth careunder international standarts?
  4. Describe thecharacter of international standarts.
  5. Howdoyou understand the theoretical purpose of international standards? Give the description of it?
  6. What is the role of international standards in the regulation of health care?
  7. What normative legal acts that include international standarts of health care do you know?
  8. Name few legal acts that establish international standards of patient's rights.
  9. What is the significanceof the Universal Declarationof Human Rightsfor the development ofhealth care?
  10. What human rights in patient care as they are fixed in the international standards do you know? Which ones are the most significant in your opinion and why?

International standards

  1. International Covenant on Civil and Political Rights.
  2. International Covenant on Economic, Social and Cultural Rights. (1966).
  3. Convention on the Elimination of All Forms of Discrimination Against Women (1979).
  4. International Convention for the Elimination of all Forms of Racial Discrimination. (1965).
  5. Convention Against Torture and Other Cruel, Inhuman, or Degrading Treatment or Punishment. (1984).
  6. Optional Protocol to the Convention Against Torture and Other Cruel, Inhuman, or De-grading Treatment or Punishment. (2002).
  7. European Charter of Patients Rights (2002)
  8. Convention on the Rights of the Child. (1989). International Convention on the Protection of the Rights of all Migrant Workers and Members of Their Families. (1990).

Recommended literature

  1. Byrne I., Ezer T. Cohen J. Overall. J, Senyuta I. Human Rights in Patient Care: A Practitioner Guide/ Under scientific editing of Senyuta I. – Lviv. LOBF Publisher’s “Medicine and Law, 2012 – 497 pages.
  2. Health and Human Rights: A Resource Guide
  3. An Overview of Health and Health care in South Africa 1994 – 2010: Priorities, Progress and Prospects for New Gains link.
  4. Health system reviews (HiT)link.
  5. Health Carein Africa: Challenges, Opportunities andanEmerging Modelfor Transitionlink.
  6. Fallberg, Lars, “Patients’ Rights in EuropeBuergenthal, Thomas and Dinah Shelton and David Stewart. International Human Rights in a Nut Shell. West Publishing Company, 1995.
  7. Steiner HJ and Alston P. International Human Rights in Context – Law, Politics, Morals. 2nd ed. Oxford University Press, 2000. Chapters 1, 4 and 11.
  8. Potts, Helen. Human Rights Centre. University of Essex. Accountability and the Right to the Highest Attainable Standard of Health. 2008.
    www2.essex.ac.uk/human_rights_centre/rth/docs/HRC_Accountability_Mar08.pdf.
  9. Human Rights Centre, University of Essex, International Federation of Health and Human Rights Organizations. Our Right to the Highest Attainable Standard of Health.
  10. World Health Organization. 25 Questions and Answers on Health and Human Rights, Health and Human Rights Publications Series 1 (2002).

Theme 5. Regional Standards in the Sphere of Health Care and Human Rights

Plan of practical class

  1. The regional level of standards: the concept, character and system.
  2. General and theoretical description of regionall standards of human rights in patient care.
  3. Regional standardsin health careestablished by the Councilof Europe(European Conventionon Human Rights, the European Social Charter, the EuropeanConvention on Human Rightsand Biomedicine, etc.).
  4. The place and importance of European Union’s legislation in the system of regional standards in health care and human rights.

Questions for self-control

  1. Give thedefinitionof "regional standarts".
  2. What is system of regional standards in the field of health care?
  3. What elementsmake upthe structureof the right tohealth careunder regional standarts?
  4. Describe thecharacter of regional standarts.
  5. How doyou understand the theoretical purpose of regionalstandards? Give the description of it?
  6. What is the role of regional standards in the regulation of health care?
  7. How important is the activity of Council of Europe in formation of regional level of standards in the field of health care?
  8. What is the difference between regional standards in the field of health care that are made by different international regional organizations?
  9. What are the peculiarities of regional standards that exist in European Union?
  10. What institutions of the European Union participate in the creation of regional standards and ensure their functioning?

International/Regional standards

  1. Convention for the Protection of Human Rights and Dignity of the HumanBeing with regard to the Application of Biology and Medicine. (1997).
  2. European Convention on Human Rights. (1950).
  3. European Social Charter. Council of Europe (COE). (1961).
  4. Framework Convention for the Protection of National Minorities. (1994).
  5. Charter of Fundamental Rights of the European Union.(2000).
  6. European Charter of Patients' Rights. (2002).
  7. WHO Declaration on the Promotion of Patients’ Rights in Europe: European Consultation on the Rights of Patients, Amsterdam.
  8. The WHO Ljublijana Charter on Reforming Health Care (1996).

Recommended literature

  1. Byrne I., Ezer T. Cohen J. Overall. J, Senyuta I. Human Rights in Patient Care: A Practitioner Guide/ Under scientific editing of Senyuta I. – Lviv. LOBF Publisher’s “Medicine and Law, 2012 – 497 pages.
  2. Health and Human Rights: A Resource Guide
  3. Fallberg, Lars, “Patients’ Rights in EuropeBuergenthal, Thomas and Dinah Shelton and David Stewart. International Human Rights in a Nut Shell. West Publishing Company, 1995.
  4. Steiner HJ and Alston P. International Human Rights in Context – Law, Politics, Morals. 2nd ed. Oxford University Press, 2000. Chapters 1, 4 and 11.
  5. Potts, Helen. Human Rights Centre. University of Essex. Accountability and the Right to the Highest Attainable Standard of Health. 2008.
    www2.essex.ac.uk/human_rights_centre/rth/docs/HRC_Accountability_Mar08.pdf.
  6. Human Rights Centre, University of Essex, International Federation of Health and Human Rights Organizations. Our Right to the Highest Attainable Standard of Health.
  7. World Health Organization. 25 Questions and Answers on Health and Human Rights, Health and Human Rights Publications Series 1 (2002).
  8. Leenen, Henk, Givers, Sjef and Pinet, Genevieve (eds), “Promotion of the Rights of Patients in Europe, a Comparative Study,” Amsterdam: Academic Publishers (1993)
  9. Stefanoska, Cavdar, Isajlovska, and Stefanovska, “Rights of the Patients in Macedonia According to the European Standards,” Report, Skopje: MIA – Association of Health Education and Promotion of Health (2005).

Theme 6.Legal Status of Medical Legal Relations Subjects