Regulatory Strategies and Legal Principles Governing Biosafety Laws in Iran and the European Union

According to the legal doctrines, there are two main regulatory strategies in the field of biosafety: 1. Command and control approach or hierarchical strategy (Top-Down strategy); 2. New governance strategy or non-governmental regulations (Bottom-Up strategy). The last strategy includes also sub-strategies such as Meta-regulation, Responsive regulation, Self-regulation and Smart regulation. Due to a close relationship between biosafety and environmental issues, some general principles of environmental law are required in order to be considered in regulatory processes in the field of biosafety. For this reason, the aim of this research is to explain and analyze these issues under different legal frameworks. In this research, while examining the nature and conceptual requirements of each of the aforementioned strategies and legal principles, their integrations in the biosafety laws of Iran and the Union Europe are comparatively examined and analyzed.

The research method is Analytical-Comparative. It has been prepared and compiled by library method using Note-taking techniques.

Ethical Considerations: 

In all stages of writing this paper, the ethical principles of research, especially, the originality of the text, honesty and confidentiality have been fully observed.

The EU regulatory strategy in the field of biosafety is strictly based on the precausionary principle with a multi-level approach in the decision-making process. In such a situation, the regularity of transgenic products has been associated with many opportunities for education, public awareness and intervention of different levels of stackholders (government, civil society and independent scientific institutions) in regulation making process of biosafety.

Although Iran's biosafety law was drafted and approved with consideration of the new and modern laws in 2018, but compared to the EU biosafety laws, it is faced with the government command and control approach (Top-Down approach), poor public awareness, lack of public participation in decision-making, and in some cases it has also led to non- compliance with the Cartagena Protocol.