ECONOMICS AND POLICIES FOR AGRICULTURAL BIOTECHNOLOGY

The course provides the basic elements needed to understand the dynamics of biotechnology value chains and the policies designed to turn the potential of scientific discoveries into business activity.

Knowledge and understanding

On completion of the course, students know and understand:

-       the economic nature of biotechnological knowledge as a complex good, and the debate on common goods, commons and anticommons in agri-biotech research;

-       the forms of intellectual property protection applied to biotechnological innovations (plant variety protection, patents) in the European Union and the United States, and the international agreements governing them;

-       the European Union regulatory framework on GMOs and the new rules on plants obtained by new genomic techniques (NGTs), together with the related issues concerning biodiversity, the environment and human health;

-       the principles of European environmental policy, in particular the precautionary principle and risk assessment;

-       the specific features of the science-based biotech firm and the structure of seed and biotech trait markets;

-       the political debate and the international scientific literature on biotechnological innovations in agriculture and on their contribution to sustainable agriculture (productivity, climate change adaptation and mitigation, circular bioeconomy).

Applying knowledge and understanding

On completion of the course, students are able to:

-       apply the European regulatory framework (GMOs, NGTs, intellectual property) to specific cases of biotechnological products, including in new or interdisciplinary contexts;

-       compare different regulatory regimes (EU, USA, multilateral agreements) and assess their effects on innovation, trade and access to genetic resources;

-       analyse the structure of the seed and biotech market, identifying its actors, degree of concentration and critical issues for breeders and SMEs;

-       assess the effects of a public policy on the strategies and development prospects of biotech firms;

-       read and interpret a legal text, a court ruling or a policy document and carry out, as part of a group, the analysis of a case study, from the collection of sources to the formulation of conclusions.

Making judgements

Students are able to formulate independent and critical judgements on public policies concerning biotechnological innovations, even on the basis of limited or contested information, reflecting on the social and  scientific responsibilities linked to their application. This ability is developed through the collective in-class discussions held at the end of each block of topics and through case-study analysis.

Communication skills

Students are able to communicate clearly and unambiguously, in English and using appropriate technical language, their analyses and conclusions on issues related to the use and marketing of biotechnological products, to both specialist and non-specialist audiences. This skill is developed through the presentations given during the practical sessions and the group presentation of the case study.

Learning skills

Students develop the ability to keep up to date independently in a sector undergoing rapid regulatory and technological change. This ability is developed through the reading of international scientific articles and policy documents, the consultation of databases and institutional sources, and the preparation of the case study.

The course is taught in English and comprises 63 hours of activities (6 ECTS credits): 21 hours of lectures (7 three-hour lectures) and 42 hours of practical sessions (esercitazioni, 14 three-hour sessions).

Lectures provide the theoretical and regulatory framework: biotechnology and sustainable agriculture, the economics of knowledge, intellectual property rights in the EU and the US, the structure of the seed and biotech market, and the regulation of GMOs and NGTs. They are the main means of achieving the Knowledge and understanding outcomes.

Practical sessions make up two thirds of the course and follow each lecture. Each session involves three activities. The guided analysis of legal texts, court rulings and policy documents (Directive 98/44/EC, the Chakrabarty and Myriad rulings, GMO legislation, Regulation (EU) 2026/1388, EFSA opinions) develops the ability to apply the regulatory and economic framework to concrete cases. Student presentations on the content learned, individual or in groups, develop communication skills. Collective discussions develop independent judgement. The final sessions are devoted to group presentations of the case studies. Preparing for the practical sessions requires independent reading of scientific articles and institutional documents and develops learning skills.

If the course is delivered in blended or remote mode, appropriate adjustments may be made to the above, in order to ensure consistency with the syllabus.

Attending the classes is not mandatory, but strongly recommended, as it facilities the learning process and contributes to the achievement of the learning objectives

Lectures (21 hours)

1.        Sustainable agriculture and biotechnology. Introduction to the course. Definition and pillars of sustainable agriculture. Conventional versus sustainable agriculture: economic logic, environmental and social costs, incremental and transformative change. The role of biotechnology in climate change adaptation and mitigation, biodiversity protection and the circular bioeconomy.

2.        Scientific knowledge, public goods and agricultural research. Scientific knowledge as a public good: excludability and rivalry. Knowledge and endogenous growth. Knowledge for development and the Green Revolution. Science-technology relations and the roles of the public and private sectors. Tragedy of the commons and of the anticommons. The rise of private agricultural research and international technology transfer. Transgenic crops and genetic diversity.

3.        The European framework for biotech patents. Directive 98/44/EC: objectives and definitions. Invention versus discovery. Essentially biological processes. Patentable and non-patentable subject matter, DNA sequences, plant and animal varieties. Scope and limits of protection, exhaustion of rights, farmers’ privilege. Compulsory licensing. Research exemption. Ethical clauses.

4.        US patents and plant variety protection. The Patent Act of 1952 and the role of case law: Diamond v. Chakrabarty (1980), Mayo and Myriad (2013). US-EU comparison. UPOV Conventions and Regulation (EC) No 2100/94. DUS criteria. Dual protection of a plant, essentially derived varieties, breeder’s exemption. The TRIPs Agreement, farmers’ rights, access to genetic resources and benefit sharing.

5.        Structure of the seed and biotech market. Features of science-based firms. Concentration in seed and biotech trait markets: extent, causes and impacts. The link between intellectual property rights, mergers and SMEs’ access to innovation. The Italian biotech sector.

6.        Precautionary principle and EU regulation of GMOs. Precautionary principle and risk assessment. Directive 2001/18/EC and Regulations (EC) No 1829/2003 and 1830/2003: authorisation, traceability, labelling, coexistence. Cultivation versus imports: the role of soy and feed. The procedure in practice: EFSA, Commission, comitology. Statutory versus actual timelines. Asynchronous approvals and their effects on trade and prices. Comparison with the US. The Cartagena Protocol.

7.        New genomic techniques (NGTs). Targeted mutagenesis and cisgenesis. The 2018 ruling of the Court of Justice of the EU (Case C-528/16). Regulation (EU) 2026/1388: entry into force (16 July 2026) and application (from 17 July 2028). Category 1 and category 2 NGT plants: equivalence criteria, verification procedure, excluded traits, seed labelling, exclusion from organic farming, coexistence and Member States’ options. Patents and NGTs: transparency, expert group, impact study. Social acceptance. International comparison and economic implications. Field trials of NGT plants in Italy.

Practical sessions (42 hours)

Each 3-hour session combines the guided analysis of a legal text, a court ruling or a policy document, student presentations on the content learned, and a collective discussion.

-       E1-E2 (lectures 1-2). Policy documents on sustainability and the bioeconomy. Reading and discussion of the texts on commons and anticommons.

-       E3-E4 (lecture 3). Analysis of the text of Directive 98/44/EC and of patentability cases.

-       E5-E6 (lecture 4). Analysis of the Chakrabarty and Myriad rulings. Regulation (EC) No 2100/94 and the DUS criteria applied to a real variety.

-       E7 (lecture 5). Reading and discussion of OECD data on concentration in seed and biotech trait markets.

-       E8-E9 (lecture 6). Analysis of GMO legislation, of an EFSA opinion and of an authorisation decision. Discussion on asynchronous approvals.

-       E10-E11 (lecture 7). Analysis of Regulation (EU) 2026/1388 and of the C-528/16 ruling. Classification of real cases as category 1 or category 2 NGTs.

-       E12-E14. Group presentations of the case studies agreed with the lecturer and final discussion.

 1.        Das S., Ray M. K., Panday D., Mishra P. K. (2023), Role of biotechnology in creating sustainable agriculture, PLOS Sustainability and Transformation, 2(7), e0000069, pp. 1-13. https://doi.org/10.1371/journal.pstr.0000069

2.        The CORE Team (2017), The Economy: Economics for a Changing World, Oxford, Oxford University Press, Unit 12 and Unit 21. https://www.core-econ.org

3.        Fuglie K. (2016), The growing role of the private sector in agricultural research and development world-wide, Global Food Security, 10, pp. 29-38. https://doi.org/10.1016/j.gfs.2016.07.005

4.        Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, Official Journal of the European Communities, L 213, 30.7.1998, pp. 13-21.

5.        Stazi A. (2014), Biotechnological inventions and limits of patentability between recent evolutions in the US case law and the EU perspective of fundamental rights: moving toward a common “Western approach”?, Comparative Law Review, 5(2), pp. 1-14.

6.        European Patent Office, Enlarged Board of Appeal, Opinion G 3/19 (Pepper) of 14 May 2020, on Article 53(b) and Rule 28(2) of the European Patent Convention.

7.        Supreme Court of the United States, Diamond v. Chakrabarty, 447 U.S. 303 (1980); Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).

8.        UPOV (2003), Introduction to Plant Variety Protection under the UPOV Convention, Geneva, International Union for the Protection of New Varieties of Plants.

9.        Helfer L. R. (2004), Intellectual property rights in plant varieties. International legal regimes and policy options for national governments, FAO Legislative Study 85, Rome, FAO, ISBN 92-5-105222-0.

10.     Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights, Official Journal of the European Communities, L 227, 1.9.1994, pp. 1-30; International Convention for the Protection of New Varieties of Plants, Act of 19 March 1991.

11.     OECD (2018), Concentration in Seed Markets: Potential Effects and Policy Responses, Paris, OECD Publishing. https://doi.org/10.1787/9789264308367-en

12.     European Commission (2000), Communication from the Commission on the precautionary principle, COM(2000) 1 final, Brussels, 2.2.2000.

13.     Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms, OJ L 106, 17.4.2001, pp. 1-39; Regulation (EC) No 1829/2003 on genetically modified food and feed, OJ L 268, 18.10.2003, pp. 1-23; Regulation (EC) No 1830/2003 on traceability and labelling, OJ L 268, 18.10.2003, pp. 24-28.

14.     USDA Foreign Agricultural Service (2025), European Union: Biotechnology and Other New Production Technologies Annual, GAIN Attaché Report, Brussels USEU, December 2025.

15.     Regulation (EU) 2026/1388 of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their products, Official Journal of the European Union, L series, 26.6.2026.

16.     Court of Justice of the European Union (Grand Chamber), judgment of 25 July 2018, Case C-528/16, Confédération paysanne and Others, ECLI:EU:C:2018:583.

17.     Katsarova I. (2024), Plants produced using new genomic techniques, EU Legislation in Progress briefing, PE 754.549, Brussels, European Parliamentary Research Service.

Learning is assessed on the basis of three elements: participation in class discussions, the presentations given during the practical sessions, including the group case study, and an individual oral exam.

Participation in class discussions. At the end of each topic or group of related topics, a collective discussion is held. The relevance and quality of contributions are assessed.

Presentations and case study (practical sessions). During the practical sessions students, individually or in groups of 3-4, analyse legal texts, court rulings and policy documents and present their content in class. At the end of the course each group presents, in 30-45 minutes, a case study agreed with the lecturer. Assessment covers: relevance and quality of sources, soundness of the economic and regulatory analysis, critical ability, clarity of presentation, and each student’s individual contribution to the presentation and discussion.

Oral exam. The oral exam covers the topics of the course programme. Assessment covers: relevance of the answers, quality of content, ability to connect different topics of the programme, ability to provide examples, command of technical language and overall expressive ability.

Final grade. The final grade takes into account the oral exam, which carries the greatest weight, the presentations given during the practical sessions, including the group case study, and participation in class discussions. Non-attending students agree an individual case study with the lecturer and present it at the oral exam.

Grades are expressed on a 30-point scale according to the following scheme:

-       Fail. Knowledge and understanding of the topics: major gaps and significant inaccuracies. Analysis and synthesis: negligible, frequent generalisations. Use of references: completely inappropriate.

-       18-20. Knowledge and understanding: threshold level, with evident flaws. Analysis and synthesis: barely sufficient. References: barely appropriate.

-       21-23. Knowledge and understanding: routine. Analysis and synthesis: correct, with logical and coherent argumentation. References: standard.

-       24-26. Knowledge and understanding: good. Analysis and synthesis: good, with coherently expressed arguments. References: standard.

-       27-29. Knowledge and understanding: more than good. Analysis and synthesis: remarkable. References: in-depth.

-       30-30 cum laude. Knowledge and understanding: excellent. Analysis and synthesis: remarkable. References: significant in-depth study.

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

To ensure equal opportunities and in compliance with current laws, interested students may request a personal interview in order to plan any compensatory and/or dispensatory measures based on educational objectives and specific needs. Students can also contact the CInAP (Centro per l’integrazione Attiva e Partecipata — Servizi per le Disabilità e/o i DSA) referring teacher within their department (https://www.cinap.unict.it/content/referenti).

1.        What are property rights over living matter, and how are they regulated at national and international level?

2.        Why can scientific knowledge be regarded as a public good, and which economic theories support this view?

3.        How are common genetic resources managed at international level, and what does access and benefit sharing consist of?

4.        How can biotechnology contribute to climate change adaptation and mitigation in agriculture, and with what trade-offs?

5.        What distinguishes an invention from a discovery under Directive 98/44/EC, and why are essentially biological processes not patentable?

6.        Compare the Diamond v. Chakrabarty and Myriad rulings: how has the patentability of biological material changed in the United States, and how does the European approach differ?

7.        What are asynchronous GMO approvals, and what effects do they have on European imports of soy and feed?

8.        How does the precautionary principle operate in the risk assessment of biotechnological products, and what criticisms have been raised against it?

9.        A seed company has used targeted mutagenesis to obtain a wheat variety resistant to a fungal pathogen. Which regulatory pathway must it follow in the EU under Regulation (EU) 2026/1388? Can it protect the variety with both a patent and a plant variety right, and under what conditions (DUS criteria)?

10.     What differences does Regulation (EU) 2026/1388 introduce between category 1 and category 2 NGT plants in terms of authorisation, labelling and traceability?

11.     Markets for biotech traits are more concentrated than seed markets. What are the causes, what role do patents play, and why did the issue enter the European negotiations on NGTs?