Law and Biomedicine-International and Comparative Perspective 1300-LAW-BIO-KPP

1. Introduction: origin, definition and subject-matter of international biomedical/bioethical law (1 hour);
2. Institutional and procedural issues - main actors, mechanisms of standard setting and implementation (1 hour);
3. European convention on human rights and biomedicine (1 hour);
4. Patient autonomy, consent to medical treatment; advance directives (living wills) (1 hour);
5. Medical experiments/biomedical research (1 hour);
6. Human cloning, embryonic stem cells (1 hour);
7. Transplantations (1 hour);
8. Human genetics - genes ownership and patenting, genetic data protection, genetic testing (3 hours) ;
9. Begining -of-life issues (medically assisted procreation, surrogate motherhood, abortion, prenatal and preimplantation genetic screening) (2 hours);
10. End-of -life issues (medically assisted suicide, euthanasia) (2 hours)

Total student workload

1. Contact hours (with a lecturer) - 20 hours 2. Individual work - time devoted to preparation to classes: reading articles and other documents provided by the lecturer, analysing case-law and legislation, researching domestic legislation, preparing for discussion - 65 hours 3. Time neccessary to prepare for assessment (evaluation) process- 20 hours Total number of hours - 90 - 4 ECTS

Learning outcomes - knowledge

K_W01 - student acquires knowledge on relations between bioethics and law, as well as on fundamental terminology and concepts of bioethics; K_W02 - student acquires detailed knowledge on international and comparative regulations (had law and soft law) concerning biomedicine; K_W03 - student acquires knowledge on relations between international and domestic systems within a specific context of biomedicine;

Learning outcomes - skills

K_U02 - student is able to use acquired knowledge to critically analyse and present opinion concerning specific problems emerging from application of biomedical advances; K_U07 - student analyses case-studies and is able to identify, interpret and apply legal norms; K_U10 - student has enchanced argumentative skills, abillity to publically express opinion in English;

Learning outcomes - social competencies

K_K02 - student is prepared to work in a team, share views, lead and take part in discussion; K_K06 - student is able to continue sef-study and deepen his/her knowledge using interdisciplinary and comparative tools, in order to improve future professional career;

Teaching methods

Dydactic methods used during the seminar: 1. Elements of conventional lecture (presentation given by the lecturer) 2. Discussion (brainstorming, pair and group discussion, panel discussion) 3. Case-study and moot court 4. Quizes

Observation/demonstration teaching methods

- display

Expository teaching methods

- participatory lecture

Exploratory teaching methods

- case study
- brainstorming
- classic problem-solving

Prerequisites

- fundamental knowledge of domestic law system (institutional and normative elements) - basic knowledge of international public law and international human rights law

Course coordinators

Julia Kapelańska-Pręgowska

Assessment criteria

Student assessment:

Initial assessment is based upon two factors:

Oral presentations - K_U02, K_U07, K_U10
Active participation (including moot-courts and in-class discussions) – K_K02, K_K06, K_U10

Each form of active participation and oral presentations are marked.
6-5 points - bdb/very good
4-3 points - db/good
2-1 points - dst/satisfactory
0 - points - ndst/fail

Additional assessment method that is optional for the students who were active and obligatory for the students who did not manage to collect enough points is
a short essay – K_W01, K_W02, K_W03.

Essay assessment:
6-5 points - bdb/very good
4-3 points - db/good
2-1 points - dst/satisfactory
0 - points - ndst/fail

Bibliography

Legislation:
1. Council of Europe: European convention on human rights and biomedicine
2. I, II, III, IV Additional protocols to the convention
3. UNESCO bioethical declarations:
- on human genome and human rights
- on human genetic data
- on bioethics
- UN declaration on human cloning

Basic literature (provided by the lecturer on Moodle):
1. Andorno R., Towards an international bioethics law, Journal international de bioéthique 2005, vol. 15, no 2–3

Additional literature:
1. IBC, Report on Ethics, Intellectual Property and Genomics, 2002, SHS-503/01/CIB-8/2.Rev
2. IBC, Report on consent, 19.05.2007, Paris, SHS/EST/CIB-13/06/CONF.505/2Rev.2
3. Shapira A., Biomedical Law: The Aims and Limits of Regulating Biomedical Science and Technology (w:) C.M. Mazzoni (red.), Ethics and Law in Biological Research, The Hague 2002
5. WHO (Human Genetics Programme), Genetics, genomics and the patenting of DNA. Review of potential implications for health in developing countries, Geneva 2005
6. Corveleyn A., Zika E., Morris M. et al. (European Commission Joint Research Centre), Report: Preimplantation Genetic Diagnosis in Europe, Luxembourg 2007
7. Matthiessen-Guyader L., Survey on national legislation and activities in the field of genetic testing in EU Member States, published by the European Commission, 01.05.2005
8. Beyleveld D., Brownsword R., Human Dignity in Bioethics and Biolaw, New York 2001
9. Dworkin R., Limits. The role of law in bioethical decision making, Bloomington 1997
10. Fukuyama F., Our posthuman future, Kraków 2004
11. Habermas J., The Future of Human Nature, Oxford 2003
12. Laurie G., Genetic Privacy: A Challenge to Medico-Legal Norms, Cambridge 2002
13. Lenoir N., Mathieu B., Le normes internationales de la bioéthique, Paris 2004
14. J.H. Gerards, A.W. Heringa, L. Janssen, Genetic Discrimination and Genetic Privacy in Comparative Perspective, Antwerp–Oxford–NewYork 2005

Term 2022/23Z:

Basic literature (provided by the lecturer on Moodle):
1. Andorno R., Towards an international bioethics law, Journal international de bioéthique 2005, vol. 15, no 2–3

Term 2023/24Z:

Basic literature (provided by the lecturer on Moodle):
1. Andorno R., Towards an international bioethics law, Journal international de bioéthique 2005, vol. 15, no 2–3

Additional information

Additional information (registration calendar, class conductors, localization and schedules of classes), might be available in the USOSweb system:

Description of 1300-LAW-BIO-KPP in USOSweb