- Inter-faculty Studies in Bioinformatics and Systems Biology
- Bachelor's degree, first cycle programme, Computer Science
- Bachelor's degree, first cycle programme, Mathematics
- Master's degree, second cycle programme, Bioinformatics and Systems Biology
- Master's degree, second cycle programme, Computer Science
- Master's degree, second cycle programme, Mathematics
EU Regulation of Biotechnology and GMOs 4003-ERASMUS-EURB-OG
The content of the course focuses principally on the most controversial aspect of the EU biotechnology policy – the regulation of GMOs. Its aim is to provide students with basic knowledge of the policy objectives, functioning of the GMO legal framework, GMO market approval and market control. The course begins with the introduction to the EU policy, its objectives, basic notions and types of the regulatory instruments applied in the risk sector. Then, the presented topics include the following: the critical analysis of the policy instruments and methods; the division of powers of the responsible actors in decision-making, that is the European Commission, the Member States and other institutional structures involved in the policy, eg. comitology and the European Food Safety Authority; the process of authorization and political controversies surrounding it; the system of national derogations from EU harmonization and the system for dealing with risks and dangers of GMOs; and finally the examination of consumers’ rights.
The course offers in-depth analysis of the legal sources (GMO Deliberate Release Directive, GM Food and Feed Regulation, EFSA Regulation), the inter-institutional collaboration, the ECJ’s case-law and processes of decision-making. The last class will be devoted to the students’ debate on the EU policy of biotechnology.
Student's workload
lecture - 15 h
reading in foreign language - 60 h
preparation to the lecture - 30 h
preparation to the exam - 75 h
total - 180 h
Type of course
Mode
Prerequisites (description)
Learning outcomes
The aim of the course is to familiarise students with the functioning of a selected EU policy sector. Lectures provide an opportunity for students to develop the following skills:
- in-depth understanding of presented legal notions/ institutions and capability of describing how they are applied and function in the system
- identifying of legal problems and their significance for policy-making
- differentiating of legal rules and principles of law as well as their interpretation with the view of presenting solution to possible problems
- analysing critically the legal sources, courts’ judgments and reasoning
- synthesising and structuring the arguments properly and with reasoning referring to the total knowledge of European studies
Assessment criteria
Examination of students’ knowledge and the assessment of individual student’s activity is done on the basis of their participation in class during lectures and a final assessment in the chosen form.
Criteria of evaluation: obligatory participation in class, taking part in discussions and debates, oral presentation.
Bibliography
P. Dąbrowska, EU Governance of GMOs: political struggles and experimentalist solutions? w: C. Sabel and J. Zeitlin (red.), EU Governance: Towards a New Architecture?, Oxford University Press, Oxford 2010
P. Dąbrowska, Civil Society Involvement in the EU Regulations on GMOs: From the Design of a Participatory Garden to Growing Trees of European Public Debate?, Journal of Civil Society, Vol. 3, No. 3, December 2007, s. 287-304
M. Lee, EU Regulation of Biotechnology, Hart Publishing, 2008
E. Vos and M. Everson (eds), Uncertain Risks Regulated, Routledge-Cavendish, 2009.
Vos E. and Wendler F., Food Safety Regulation in Europe, Intersentia, 2006
M.A. Pollack and G.C. Shaffer, When Co-operation Fails, Oxford 2009
Additional information
Information on level of this course, year of study and semester when the course unit is delivered, types and amount of class hours - can be found in course structure diagrams of apropriate study programmes. This course is related to the following study programmes:
- Inter-faculty Studies in Bioinformatics and Systems Biology
- Bachelor's degree, first cycle programme, Computer Science
- Bachelor's degree, first cycle programme, Mathematics
- Master's degree, second cycle programme, Bioinformatics and Systems Biology
- Master's degree, second cycle programme, Computer Science
- Master's degree, second cycle programme, Mathematics
Additional information (registration calendar, class conductors, localization and schedules of classes), might be available in the USOSweb system: