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.

Semester
1st semester
Enrollment based on exam contract
Impossible
Grading method
Grading (scale from 0 to 20)
Can retake in second session
Yes
Taught in
English
Faculty
Faculty of Sciences and Bioengineering Sciences
Department
Bio-Engineering Sciences
Educational team
Pieter Jan Van Der Meer (course titular)
Activities and contact hours
26 contact hours Lecture
10 contact hours Seminar, Exercises or Practicals
Course Content

Background: The development in the early 1970s of recombinant DNA techniques in micro-organisms, followed in the 1980s by genetic modification of plants, 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 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: 

  • modern biotechnology, including new technological developments such as gene editing and synthetic biology, and offers hands-on application of some of these techniques in plants;
  • the structure and key components of biosafety regulations, including the development, implementation and review of regulatory systems;
  • national and regional (e.g. EU) regulations, international agreements (e.g the Cartagena Protocol, Arhus Convention) relevant to modern biotechnology;
  • international organisations (e.g. WHO, WTO), standard setting bodies (e.g  CODEX), and policy declarations (e.g. SDGs) relevant to modern biotechnology;
  • environmental risk assessment, food safety assessment, monitoring, enforcement, sanctions liability, public information, confidential information
  • meetings with practitioners, such as scientists involved in field trials, and - where possible - attending international and EU discussions, as well as meetings with authorities and stakeholders.

While the course Biotechnology Regulation is developed for Master students, a limited number of PhD students and Post-docs, as well as extraneous students, is welcome to participate as observer.

Course material
Digital course material (Required) : Learning materials include national and international regulations , These and other materials will be provided in electronic form on Canvas
Additional info

Unless otherwise indicated by the course instructor via Canvas, attendance of lessons and site visits is mandatory.

This course is organised by the Laboratory of Plant Genetics, Faculty of Sciences and Bioengineering Sciences, Vrije Universiteit Brussel (VUB), in collaboration with the Faculty of Law, Ghent University, Belgium.

Learning Outcomes

General Competences

Learning outcomes include the ability to:

- understand the scientific and technical aspects as well as the 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

Grading

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:

  • Periodic evaluation with a relative weight of 30 which comprises 30% of the final mark.

    Note: 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.
  • Assignments with a relative weight of 30 which comprises 30% of the final mark.

    Note: the student will be evaluated on: analysing basic characteristics and ‘open ends’ of international agreements and national legislation, which international agreements national public law apply to specific cases, which provisions apply to specific cases, and the ability to produce and present a report on a specific case
  • Oral Exam with a relative weight of 40 which comprises 40% of the final mark.

    Note: The oral exam evaluates knowledge, comprehension, legal thinking, and verbal expression.

Additional info regarding evaluation

Unless otherwise indicated via Canvas by the instructor: 
1) No show in class will result in zero points for that class

2) late submissions of an assignment will result in zero points for that assignment.

 

Allowed unsatisfactory mark
The supplementary Teaching and Examination Regulations of your faculty stipulate whether an allowed unsatisfactory mark for this programme unit is permitted.

Academic context

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: Agrobiotechnology (only offered in Dutch)
Master of Bioengineering Sciences: Cell and Gene Biotechnology: Synthetic Biotechnology (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: Sustainable Chemical Biotechnology (only offered in Dutch)
Master of Bioengineering Sciences: Chemistry and Bioprocess Technology: Micro- and Nanobiotechnology (only offered in Dutch)
Master of Molecular Biology: Standaard traject