An Evaluation of the Implementation Process of the Generic Policy and National Pharmaceutical System in I.R.Iran

Proposed in 1979, the generic policy, aimed to provide easy access to all the more medicines, themain important result of which is reducing pharmaceutical costs and decreasing importation. Since 1999, pharma branding in Iran was initatedby pharmaceutical companies. Therefore, companies used the brand-generic name in order to maintain the market share and also sell the drugs at a higher price and gain more market share by distinguishing drug names.

In this investigation, Iran's modern pharmaceutical system and achievements after the Islamic revolution, wereinvestigated via collecting statistics and documents regarding the conditions of generic and brand-generic drugs.

Despite two decades of the national pharmaceutical policy, based on generic drugs, the percentage of generic drugs decreased from 69% to 50%, from 2012to 2021and the number of brand-generic drugs increased. Among the top one hundred best-selling drugs, 38% have brand-generic names. Regardingthe financial burden and costs imposed on patients and insurance companies due toprescribing brand-generic drugs, it is estimated to have increased from 51% in 2018 to 84% in 2013 and then to 69% in 2017 compared withtotal costs.

In strategic documents and general policies of Iran’s health system, including the statement of the Supreme Leader, promotion of generic drugs in the health system has been approved. However, from the operational view, the trend has been to the contraryand towards brand-generic drugs. Reasons include: product differentiation, increasing market share by introducing products and increasing the price of drugs. The desire of companies to obtain licenses with brand-generic names is based on three different policies of Iran FDA and ministry of Healththat have facilitated this issueand include: medicine naming regulations, medicines pricing regulations, marketing regulations and promotion of pharmaceutical products.