مرتضی نیلفروشان

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.

Nutritional supplements have long been one of the most important health products in the world. The therapeutic approach of traditional medicine in Iran is restoring balance in the body based on nutrition. In modern medicine, nutritional supplements maintain and promote health. Nutritional supplements in modern medicine supplement the substances that humans need to obtain from sources other than food to compensate for the lack of these substances. Today, various needs such as reduced mobility due to mechanization of activities, changes in diet and use of prepared foods, non-organic food, environmental pollution, food diversity reduction, renders nutritional supplements more important. The market is expanding rapidly..Nomenclature of these products, their legal requirements, claims, applications and related requirements vary from country to country.

This study examines the regulation of nutritional supplements in Iran compared with some other countries. This study done via a mixed method, included reviewing the regulation of nutritional supplements in Iran and the world, interviewing experts, and use of a questionnaire based survey.

According to the results of this study, the Iranian regulatory situation is well regulated and the nutritional products in Iran have good quality, safety, efficiency and pharmaceutical quality.

Although the regulations in Iran properly granted safety, efficacy, and quality of nutritional supplements, in terms of access (accessibility, availability, and affordability), there are still problems that need to be addressed by policymakers in the health system.

Health equity and the use of generic drugs is an important tool in the field of financial resource efficiency and one of the crucial factors in the field of health economics in the world. In Iran, the approach to the development of the Iranian drug system, which occurred after the victory of the Islamic Revolution in the field of health and Its strategies for reducing drug costs were an important step in this manner.

The main factors of lack of productivity in health equity in the field of pharmaceutical products, is less using generic drugs and using expensive drugs ( brand)  and using non-standard drugs and counterfeit drugs and inappropriate usage of drugs. Over Last 40 years, the growing trend of prescribing generic drugs instead of branded or branded medicines has increased increase productivity and saving billions of pounds in the world and in the health system. In a study, generic drugs in the United States, Southeast Asia, and the Eastern Mediterranean are by public sector near international reference prices, but in the African, European, and Pacific regions, governments are paid average 34 to 44 percent more Which is required.In Australia, mandatory price reductions and price disclosure have led to a drugs price reduction  and ensuring that the costs will be repaid. In addition, price differences were a decisive factor for patients to accept generic drugs, since patients reject a generic successor when the cost is saved or the price difference is minimal.In Iran, in order to increase productivity and reduce costs in the "modern pharmaceutical system of the country", the following five principles were specifically addressed 1- Use of the generic name 2- Centralized importation of drugs by government-controlled companies 3- Distribution of drugs across the whole country 4- ownership of Multinational drug factories and companies by goverment 5. Scientific introduction of generic drugs.

Several countries around the world have been using and encouraging generic drugs to lower costs and having more productivity in government and health insurance budgets. Iran's new drug system, a generic based design which was started gradually from 1980 and improved and progressed year by year, has had a significant impact on productivity, cost reductions and the availability of medicines for patients with a fully acceptable quality of care with paid costs and less out of pocket of patients. Therefore, it should be acknowledged that the implementation of the Iranian Drug Administration (generic based design) has a completely positive effect on the health system.