3 ECTS credits
90 h study time
Offer 1 with catalog number 4019615FNR for all students in the 1st semester at a (F) Master - specialised level.
Background: The development in the early 1970s of recombinant DNA techniques in micro-organisms, followed in the 1980s by genetic modification of plants and animals, provided scientists with the tools to introduce and modify characteristics in plants, micro-organisms and animals with much greater specificity, precision and speed, and with genes from a much greater genetic reservoir than is possible through conventional breeding.
As was recognised in Agenda 21 (1992), and reaffirmed in many subsequent Earth Summits, as well as in international agreements such as the Biodiversity Convention (1992) and the Biosafety Protocol (2000), modern biotechnology has great potential for human well-being and the conservation and sustainable use of biodiversity, if developed and used with adequate safety measures for the environment and human health. As the Introduction to the Biosafety Protocol says, biosafety systems “create an enabling environment for the environmentally sound application of biotechnology, making it possible to derive maximum benefit from the potential that biotechnology has to offer, while minimizing the possible risks to the environment and to human health”. The application of modern biotechnology and its products is subject to international agreements as well as regional and national regulations for environmental and food safety.
Governance of biotechnology takes place in a context of opposing, and sometimes strongly opposing, views. Some submit that that this technology has improved and will improve human well being and the environment, referencing examples as the production bacteria that produce insuline and plants that are made resistant to pests, diseases and drought, thereby reducing the use of chemicals and water in agriculture, and submitting that the experiences with these crops over the last 20+ years have shown no verifiable reports of adverse effects. On the other hand there is much public resistance, particularly in Europe, against the deployment of genetically modified organisms (GMOs), quoting doubts about the need for this technology and safety concerns on the long term.
In this context, the course Biotechnology Regulation, which aims specifically at Biology and Law students, addresses:
Over the years, the course Biotechnology Regulation has been attended by Master students, PhD students and Post-docs, as well as extraneous students.
This course is organised by the Laboratory of Plant Genetics, Faculty of Sciences and Bioengineering Sciences, Vrije Universiteit Brussel (VUB), in collaboration with the Department of European, Public and International Law, and the Department of Plant Biotechnology and Bio-Informatics of the Ghent University, Belgium
Teaching methods
Lectures, group work, coached hands-on exercises
Learning materials
- Agenda 21
- Convention on Biological Diversity
- Cartagena Protocol on Biosafety
- The Nagoya Protocol on Access and Benefit Sharing
- The Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol
- the Arhus Convention
- Codex Alimentarius
- EU Directives and Regulations for GMOs
- National biosafety regulations
These and other materials will be provided in electronic form.
Learning outcomes include the ability to:
- understand the technical aspects and societal context of biotechnological developments
- analyse relevant international agreements, regional and national laws and regulations
- identify which international, regional and national requirements apply in specific cases
- be able to conduct an environmental risk assessment and a food safety assessment of GMOs
- understand and convey the key differences between monitoring and enforcement, sanctions and liability, public and confidential information
The final grade is composed based on the following categories:
Other Exam determines 100% of the final mark.
Within the Other Exam category, the following assignments need to be completed:
Evaluation methods
Continuous assessment and end-of-term evaluation.
Examination methods in case of periodic evaluation during the first examination period
Oral examination
Examination methods in case of periodic evaluation during the second examination period
Oral examination
Examination methods in case of permanent evaluation
Participation, assignments
Extra information on the examination methods
· Periodic evaluation: Participation during the course - the student will be evaluated on the basis of the level of participation, comprehension, analytic and legal thinking and verbal expression. For this part there is no alternative.
· On the basis of the assignments the student will be evaluated on: analysing basic characteristics and ‘open ends’ of international agreements and national legailsation, which international agreements national public law apply to specific cases, which provisions apply to specific cases, and the ability to produce a report on a specific case
· Oral exam: The oral exam evaluates knowledge, comprehension, legal thinking, and verbal expression.
Calculation of the examination mark
Oral exam: 40%
Participation during the course: 30%
Assignments: 30%
This offer is part of the following study plans:
Master of Bioengineering Sciences: Cell and Gene Biotechnology: Medical Biotechnology (only offered in Dutch)
Master of Bioengineering Sciences: Cell and Gene Biotechnology: Molecular Biotechnology (only offered in Dutch)
Master of Bioengineering Sciences: Cell and Gene Biotechnology: Agrobiotechnology (only offered in Dutch)
Master of Bioengineering Sciences: Chemistry and Bioprocess Technology: Food Biotechnology (only offered in Dutch)
Master of Bioengineering Sciences: Chemistry and Bioprocess Technology: Chemical Biotechnology (only offered in Dutch)
Master of Bioengineering Sciences: Chemistry and Bioprocess Technology: Biochemical Biotechnology (only offered in Dutch)
Master of Molecular Biology: Standaard traject
Master of Biology: Molecular and Cellular Life sciences (only offered in Dutch)
Master of Biology: Molecular and Cellular Life sciences