Biotech Law & Policy

About:

The training will deal with the legal, policy, economic, social and ethical issues arising from the application of biotechnology techniques and the use of their methods and products in various sectors, such as medical, agricultural, etc. In an international and comparative perspective, after introducing to the fundamentals of biology, genetics, intellectual property and patent law, different regulatory systems for research and development using controversial biotechnology techniques, including human genetic modification and cloning, GMOs, CRISPR, etc., will be analyzed.

The multidisciplinary approach adopted will take into account aspects like ethics of interventions on human life, access to genetic resources, sustainability, biodiversity and foods sovereignty. Specific issues that will be analysed include patentability of biological materials, gene sequences, stem cells, plants, animals, humans, medical treatments, and the most recent issue of the role of intellectual property in the COVID-19 pandemic. According to an active learning model based on the active participation of the students, specific discussions will take place regarding the latest developments of bioinformatics and computational experimentation, especially through the most recent advances in big data analysis, machine learning and artificial intelligence (including generative AI).

Trainer Profile:

Andrea Stazi

Full Professor of Comparative Biotechnology Law at San Raffaele University of Rome; Visiting Professor inBiotechnology Law and Academic Fellow of the Centre for Technology, Robotics, Artificial Intelligence andthe Law at National University of Singapore, Regulatory Affairs Lead South EU Google and Public Policy Lead South EU YouTube.‍

TRAINING STRUCTURE

1. INTRODUCTION TO BIOTECHNOLOGY: HISTORY, DEFINITIONS AND TECHNIQUES

1.1. The Biotech Revolution - 1.2. Definitions - 1.3. History - 1.4. Techniques

2. BIOTECHNOLOGY ECONOMY AND SUSTAINABILITY

2.1. Biotech Economy - 2.2. Industrial Biotechnology - 2.3. High Volume Sectors - 2.4. High Value

Sectors - 2.5. Biotech and Sustainability: GMOs

3. INTERNATIONAL LAW AND BIOTECH POLICY

3.1. Biotechnology and the Law - 3.2. Biotechnology in International Law - 3.3. Biotech Policy:

Principles and Approaches

4. BIOTECH INVENTIONS AND PATENTABILITY

4.1. Patent System and Biotechnology - 4.2. Patentability of Biotech Inventions - 4.3. Limits of

Patentability - 4.4. Patentability of Life Forms

5. BIOTECH, BIOETHICS AND BIOLAW

5.1. Biotech and Morality - 5.2. Bioethics and Biolaw - 5.3. Biotechnology and Human Life

6. BIOINFORMATICS, BIG DATA AND AI

6.1. Bioinformatics - 6.2. Biotech and Big Data - 6.3. Biotech and Artificial Intelligence

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