Academic Year 2018/2019 - 2° Year
Teaching Staff: Gabriella Vindigni
Credit Value: 6
Course Language: English
Taught classes: 35 hours
Exercise: 14 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.

Course Structure

The course consists of theoretical lectures and practical exercises aimed at provinding the basis for the development of issues concerning the interrelation between biotechnological innovations and environmental protection as well as analyzing the organizational and economic characteristics of the biotech companies.

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.

Textbook Information

A1. Aguilar A. et al. (2012), Thirty years of European biotechnology programmes: from biomolecular engineering to the bioeconomy, New Biotechnology  Volume 00, Number 00

OECD (2009), The Bioeconomy to 2030: Designing a policy agenda

Rangnekar D. (2004), Can TRIPs deter innovation? The anticommons and public goods in agricultural research, Workshop on ‘Governance of biodiversity as a global public good: bioprospection, intellectual property rights and traditional knowledge’

Ostrom E. (2008), Tragedy of the commons, The New Palgrave Dictionary of Economics, Second Edition

A2. Helfer L. R. (2004), Intellectual property rights in plant varieties, International legal regimes and policy options for national governments, FAO Legal Office

European Commission (2016) Final Report of the Expert Group on the development and implications of patent law in the field of biotechnology and genetic engineering, Ref. Ares 2258060, pp. 1-112

A3. European Commission (2006), EU policy on biotechnology, DG Environment Biotechnology

Marrapese M., Matthews K. A. (2014), The Importance of Agricultural Biotechnology in the Response to the Effects of Climate Change, Natural Resources & Environment Volume 29, Number 1

Lim Li Lin (2007), Cartagena Protocol on Biosafety, Biosafety First, chapter 26

A4. Löfstedt R. E. (2002), Precautionary Principles: General Definitions and Specific Applications to Genetically Modified Organisms, Journal of Policy Analysis and Management, Vol. 21, No. 3, 381–407

Levidow L, Carr S. (2007), EUROPEANISING ADVISORY EXPERTISE: The role of ‘independent, objective and transparent’ scientific advice in agri-biotech regulation, Environment and Planning: Government and Politics, volume 25