Legal Challenges of Encouraging Foreign Investment in Pharmaceutical Manufacturing

Due to Iran’s privileges to manufacture medicines and the capacity of the Middle East market, foreign investment in the pharmaceutical industry can be a solution for realizing the “General Policies of Resilient Economy” in the area of comprehensive and targeted support of exports and services.

In this study, for the first time, we used three steps to extract the permits and procedures required by foreign investment to take or pass in manufacturing drugs. The three steps included the collection of laws, codification to recognize valid from invalid regulations, and analyzing valid regulations in the area of foreign investment in manufacturing pharmaceutics. Besides reckoning, we examined the impacts of regulations on facilitating or impeding foreign investment.

For investing in drug manufacturing, in addition to the legal requirement for obtaining permits and passing general procedures prescribed in the “Foreign Investment Promotion and Protection Act” (FIPPA), it is necessary to obtain special permits asserted in different laws and regulations. Therefore, the dispersion of rules and the multiplicity of permits and processes make it difficult to attract foreign capital. Under such circumstances, the obligation to release business licenses and the limitation of permits to issued cases set forth in the “Law of Implementation of General Policies of Principle (44) of the Constitution” cannot be effective.

To eliminate unnecessary procedures, licenses, and authorities, as well as to reduce the burden of scattered laws and regulations, solutions such as electronic permit issuance, codification of health code and strict implementation of article 7 of the “Law of Implementation of General Policies of Principle (44) of the Constitution” and articles 6 and 7 of FIPPA can be considered in policymaking in the health system.