Academic Year 2016/2017 - 2° Year
Teaching Staff: Gabriella Vindigni
Credit Value: 6
Taught classes: 40 hours
Term / Semester:

Learning Objectives

The course is designed to give participants a thorough grounding in relevant regulatory aspects of agricultural biotechnology products at national and international level, with specific attention to the European Union. It covers a number of issues related to agricultural biotechnology associated with biodiversity, environment, and human health.

Students will be able to understand the evolution of public intervention models as well as contemporary cross-Atlantic regulatory differences in an historical context. Oral and written presentation skills will be stimulated through classroom activities.

Detailed Course Content

A1. Introduction to the course. Biotechnological knowledge as complex goods. Agrobiotech research and common goods. Characteristics of common goods: excludable vs non-excludable, rival vs. non-rival. Symmetric Tragedies: commons and anticommons. The societal relevance of scientific research.

A2. Different forms of Intellectual Property Rights (IPRs) used to protect biotechnology innovation, with special focus on plant variety protection and patent protection. The international agreements regulating plant varieties and plant breeders' rights (UPOV acts and TRIPs agreements). The patent system in Europe and the controversy surrounding the implementation of the biotechnology innovation directive. The ethical debate within the biotechnology european patent system: plant and animal moral exclusions.

A3. Use of biotechnology in agriculture and genetically modified organisms (GMO). The EU Legislation on GMOs: authorisation, traceability and labelling. Coexistence of GMOs with conventional and organic agriculture. Farmers' privilege and breeders' privilege. Differences between European and United States approach on GMOs. Multilateral trade agreements.Transboundary movements (Cartagena Protocol on Biosafety into EU law).

A4. Biotechnology impacts on environment and its social acceptance. EU environmental policy: evolution, objectives and principles. Precaution principle and risk assessment. International environmental conventions and links to sustainable development policy. Agencies responsible for regulatory policy for biotechnology derived agricultural products.

Case studies.