The Legal Aspects of the COVID-19 Vaccine Based on ‎Genetic Modification (the Approach of the Legal Systems of ‎the United States, the European Union, and Iran‏(‏

The outbreak of the COVID-19 pandemic became the biggest health crisis of our time. Biotechnology research companies have begun a new era in overcoming the disease by using genetic modification techniques. The findings of the present study, with a descriptive-analytical method, indicate that the COVID-19 vaccine based on genetic modification technology faces two main challenges. First, the relatively strict regulatory approach to genetically modified organisms that exists to protect the environment and human health; compliance with these regulatory requirements may make the evaluation process for the production of the vaccine a lengthy one. Second, companies active in this field seek legal protection for their intellectual property. Critics of intellectual property protection, however, believe that this type of protection of the COVID vaccine could potentially affect its accessibility and cost-effectiveness. In the legal system of the European Union and the United States, special legal measures have been adopted to address the above challenges. However, due to the emergency situation caused by the spread of the disease in the Iranian legal system, we still face Legal vacuum.