The Object-Based and Process-Based Regulation of Genome Editing

Area of Science:

• Biotechnology Law
• Genomic Medicine
• European Union Policy

Background:

• Rapid scientific advancements, particularly in germline editing technologies, challenge existing regulatory frameworks.
• The European Union (EU) regulatory landscape for these technologies is fragmented, comprising international law, secondary EU law, and national legislation.
• Current regulations are heavily influenced by the precautionary principle due to uncertainties regarding the impact of genome editing.

Purpose of the Study:

• To evaluate the adequacy of the EU's regulatory framework in addressing germline editing technologies.
• To determine if existing EU legal tools can manage the implications of scientific progress in gene editing.
• To differentiate between the EU's capacity to regulate technical aspects versus ethical considerations of germline editing.

Main Methods:

• Analysis of the existing EU regulatory framework for advanced treatments and medicinal products.
• Comparative review of international law, secondary EU law, and national legislation within EU member states.
• Assessment of the influence of the precautionary principle on current regulations.

Main Results:

• The EU framework possesses the fundamental capacity to address the safety and efficacy of germline editing technologies.
• The precautionary principle's relevance diminishes as scientific knowledge expands, necessitating a shift towards knowledge-based regulation.
• Existing EU regulations are insufficient for evaluating the moral and societal consequences of germline editing.

Conclusions:

• The EU's regulatory structure is capable of managing the technical aspects of germline editing, focusing on safety and efficacy.
• The assessment of ethical, moral, and societal impacts of germline editing technologies should be handled at the national level by individual EU member states.
• A nuanced regulatory approach is needed, distinguishing between technical validation and broader societal implications.