Academic Year 2022/2023 - Teacher: Gabriella VINDIGNI

Expected Learning Outcomes

The course aims to provide the basic elements of the dynamics of the biotechnology supply chain and of policies aimed at supporting the potential of scientific discoveries in the activities of the biotechnology enterprise.

In relation to the Dublin descriptors, the course is structured as follows:

1) Knowledge and understanding

The course is designed to provide participants with an accurate knowledge of the regulation of agricultural products resulting from the use of biotechnology in the European Union, addressing a number of issues related to biodiversity, the environment and human health. It is also intended to provide knowledge of the specificities of the biotech enterprise in a supply chain perspective, with particular reference to the role played by networks for innovation

2) Applying knowledge and understanding

At the end of this course, the student will be able to understand: a) the current economic landscape of biotechnology and the regulatory situation of biotechnological products in the European Union; b) the history of biotechnological innovation; c) the specific features of the sector that favour the development trajectories of biotechnological supply chains; d) the configuration of networks in the biotechnology industry; e) the political debate on biotechnology and the production of transgenic organisms in agriculture; f) the debate in the international scientific literature concerning biotechnological innovations. In addition, students will acquire practical and theoretical knowledge regarding: i) the management of group activities, the presentation of content in a critical form, the activation of reflection a decision-making process from the discussion of case studies; h) the conducting of surveys and the development of questionnaires to gauge opinions on biotechnological innovations

3) Making judgements

 Students will acquire sufficient capacity for a critical analysis on public policies concerning biotechnological innovations. Furthermore, they will be able to problematise the analysis of biotechnology supply chain structures.

 4) Communication skills

Students will develop the ability to use team working tools appropriately, to write reports on individual and group activities related to relevant work contexts, to discuss current issues arising from the use and commercialisation of biotechnology products using appropriate language.

5) Learning skills

The course will contribute to the development of skills in autonomous analysis, in-depth research through the reading of scientific articles also in English, consultation of specific databases and other information on the web to address issues encountered in the professional field

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.

Should teaching be carried out in mixed mode or remotely, it may be necessary to introduce changes with respect to previous statements, in line with the programme planned and outlined in the syllabus.

Learning assessment may also be carried out on line, should the conditions require it

As a guarantee of equal opportunities and in compliance with current laws, interested students can ask for a personal interview in order to plan any compensatory and/or dispensatory measures, based on their specific needs and on teaching objectives of the discipline. 
It is also possible to ask the departmental contacts of CInAP (Center for Active and Participatory Integration - Services for Disabilities and/or DSAs), in the persons of professors Giovanna Tropea Garzia and Anna De Angelis.

Required Prerequisites


Attendance of Lessons

Not compulsory but highly recommended

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 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.

A5.The biotechnology supply chain. Characteristics of science-based enterprises. Evolution of the Italian biotech sector

A6. Networks for biotechnological innovation. Fundamentals of Network Theory . Scientific innovation and entrepreneurial innovation 

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

Course Planning

 SubjectsText References
1Course introductionAguilar A. et al. (2012), Thirty years of European biotechnology programmes: from biomolecular engineering to the bioeconomy, New Biotechnology ; OECD (2009), The Bioeconomy to 2030: Designing a policy agenda
2Agro-biotechnological research and the commons; biotechnological knowledge as a complex goodRangnekar 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’
3Tragedies of the commons and anticommonsOstrom E. (2008), Tragedy of the commons, The New Palgrave Dictionary of Economics, Second Edition
4UPOV and TRIPs agreements; Intellectual property rights (IPRs) used to protect biotechnological innovations; The farmer's privilege and the breeder's privilege Helfer L. R. (2004), Intellectual property rights in plant varieties, International legal regimes and policy options for national governments, FAO Legal Office
5The European patent system on biotechnologyEuropean 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
6La legislazione UE sugli OGM: autorizzazione, tracciabilità ed etichettatura; Coesistenza di colture OGM con quelle convenzionali e biologiche;Differenze sulla regolamentazione tra UE e USAEuropean Commission (2006), EU policy on biotechnology, DG Environment Biotechnology e materiale fornito a lezione
7Protocollo di Cartagena sulla biosicurezza nell'ambito della regolamentazione europeaLim Li Lin (2007), Cartagena Protocol on Biosafety, Biosafety First, chapter 26
8L'impatto delle biotecnologie sull'ambiente e la sua accettazione socialeMarrapese 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
9Principio di precauzione e valutazione del rischioA4. 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

Learning Assessment

Learning Assessment Procedures

During the course, at the end of the discussion of each topic or groups of related topics, a common discussion on the topic will be organized. At the end of the course, groups of 3-4 students will analyse a case study, agreed with the teacher and published in a scientific journal, and will make a presentation in the classroom lasting 30-45 minutes. A final oral interview will complete the assessment of the individual students, allowing to verify their degree of learning.

As a summary of the above activities, the assessment of the preparation of individual students will take place on the basis of the following criteria: learning ability and level of depth of the topics covered, properties of synthesis and presentation, reasoning skills. The marks attributed will follow the following scheme:


Knowledge and understanding of the topic: Important shortcomings. Significant inaccuracies. Ability to analyse and synthesize: Irrelevant. Frequent generalizations. Inability to synthesize.Use of references: Completely inappropriate.


Knowledge and understanding of the topic: At the threshold level. Obvious imperfections. Analysis and synthesis skills: Just enough skills.Use of references: As appropriate.


Knowledge and understanding of the topic: Routine knowledge. Analysis and synthesis skills: Correct analysis and synthesis, with logical and coherent argumentation skills.Use of references: Use of standard references.


Knowledge and understanding of the topic: Good. Ability to analyze and synthesize: Good, with arguments expressed consistently.Use of references: Use of standard references.


Knowledge and understanding of the topic: More than good. Ability to analyze and synthesize: Remarkable. Use of references: In-depth.


Knowledge and understanding of the topic: Excellent. Ability to analyze and synthesize: Remarkable. Use of references: Important insights.

The learning assessment can also be carried out online, if conditions require it.