Abstract

Amsterdam Law Forum (ALF) is the student-run 'International Law Journal' of VU University. Every year ALF publishes a winter, spring, and summer issue. The journal consists of three sections; scientific articles, opinion articles, and commentaries. As of this year, ALF also creates a section for inaugural speeches. In addition, ALF hosts a conference in spring with a relevant legal theme, where renowned speakers are invited to share their perspectives. Overall, ALF is a topical journal that provides a platform for established scholars and young academics to share knowledge, opinions and experiences and to make contributions to the international law discourse. Staff, PhD students and master students who have written a very good thesis are invited to submit an article to ALF. What is learned in the cradle is carried to the tomb: we are looking forward to sharing your articles on our website!

Highlights

  • Why are manufacturers launching clinical trials for gene therapy outside the Netherlands? Strenuous efforts are being made around the world to develop a vaccine for the coronavirus as quickly as possible — including in the Netherlands

  • The reason behind the strict regulations is that the potential vaccine qualifies as a genetically modified organism ("Genetically modified organisms (GMOs)")

  • In case of GMOs the manufacturer must comply with additional rules

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Summary

Introduction

Why are manufacturers launching clinical trials for gene therapy outside the Netherlands? Strenuous efforts are being made around the world to develop a vaccine for the coronavirus as quickly as possible — including in the Netherlands. It was announced that Janssen Biologics, a Dutch biotechnology company, has developed a possible vaccine and it will test this vaccine no later than September of this year. Due to strict Dutch regulations, these tests will likely not take place in the Netherlands. The reason behind the strict regulations is that the potential vaccine qualifies as a genetically modified organism ("GMO"). Genetic modification is the artificial alteration of certain parts of an organism's genes in a manner that is not possible through reproduction or natural recombination. A common GMO is, for example, a typical vaccine: here a virus that causes the common cold was made harmless, but still triggers an immune response

Clinical research involving GMOs
The laws and regulations on GMOs
AMSTERDAM LAW FORUM
The Dutch authorization procedure
Chances for the Netherlands
Plan for improvement
Conclusion
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