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41 Seiten, Note: 8
2. AN OVERVIEW OF PHARMACEUTICAL POLICIES IN DEVELOPING COUNTRIES
3. PHARMACEUTICAL INDUSTRY AND MARKET IN IRAN: EVOLUTION AND STRUCTURE
3.1. Evolution of the pharmaceutical market: industrial policies and changes in domestic production
3.2. Trade policies: effect on the import of medicines
3.3. Industrial organisation of the Iranian pharmaceutical sector: structure and concentration
4. DETERMINANTS IN THE IRANIAN PHARMACEUTICAL MARKET: A QUANTITATIVE TEST
4.1. Background and hypothesis
4.2. Method and definition of variables
This research paper analyses the determining factors in the development of Iran's pharmaceutical market, which was favoured by economic reforms and the economic boom caused by globalisation since the 1990s. In addition to a detailed analysis of the structure of the Iranian pharmaceutical market and of the industrial and commercial policies applied to this sector, this research includes an empirical application that aims to identify the determinants of the evolution of the market between the years 2000 and 2017. For this, a multivariate model is used, complemented by the method of the Impulse Response Function. The results indicate that, in Iran, foreign currency from oil revenues continues to be an essential determinant in the development of the domestic industry and the importation of high-cost products during our study period. On the other hand, we corroborated that, although social expenditures tried to sustain the market during the period of application of the sanctions imposed on Iran, the market shows signs of vulnerability to shock and the fall of imports due to difficulties in trade. Finally conclude that the non-oil exports which have been increasing during the period of study are the new sources of foreign exchanges for imports of medicines.
Keywords: Iran, the Pharmaceutical market, Pharmaceutical industry
Many middle-income countries have experienced a significant leap in recent years thanks to national reforms and the benefits from globalisation that have reflected in their evolution and growth rate. One of these markets is undoubtedly the provision of health services and pharmaceuticals, whose growth is both cause and consequence of the economic improvement of these countries (World Bank, 2005). Aside from its links to health and wellness, the pharmaceutical sector is one of the most profitable and capitalintensive industries worldwide.
Iran is an example of mixed middle-income economies that have undergone significant development in the pharmaceutical industry. In 2019-20201 around 20% of total health expenditure in Iran went to the pharmaceutical sector, of which almost two-thirds were government expenses (nearly all are subsidies), a considerable level among many developing countries. The pharmaceutical industry in the case of Iran has been an element to diversify the economy, although the challenges persist. The Iranian economy has been highly dependent on petrodollars; In 2017, 65% of Iran's external income came from oil and natural gas exports according to data from the Ministry of the Economy, and this proportion accounted for 15.3% of GDP2 according to the World Bank. Unexpected shocks stemming from the volatility of oil revenues3 have urged the Iranian government to expand non-oil sectors, investing more in education and health sectors (Farzanegan, M, 2011).
In recent years, numerous investigations have tried to explain the pharmaceutical market, but none has carried out the analysis that contains variations in oil revenues, expenses, and the pharmaceutical market and the sanctions in the same "cocktail". This research work aims to analyse the factors that have determined the evolution of the pharmaceutical market in Iran. By "market evolution" we men the growth or decrease in the volume of domestic production and trade (especially the import of the necessary medicines) that affect it.
Section 2 briefly discusses from a theoretical perspective of how industrial policies in developing countries can impact the growth of the pharmaceutical sector. Section 3 describes the reforms and policies implemented in Iran since the 90s, as well as the main features of the pharmaceutical market and the industrial organisation. Finally, in section 4, an explanatory model of the evolution of the Iranian market between 2000 and 2017 will be estimated. The research ends with the corresponding conclusions section.
Many developing countries have taken steps to meet the internal needs of pharmaceuticals. Even though logically, the implementation of industrial and commercial policies, as well as the using of resources differs by country, but many developing countries share characteristics.
Jacobs et al. (2012) argue that several factors are influential in the emergence of the pharmaceutical sectors, such as national policies to promote growth or innovation in the sector, the national and international context, and the so-called competitive market forces. Regarding the first, it is pertinent to analyse economic and industrial policies or reforms based on available resources that increase production and import capacity and output. Secondly, it is evident that national and international events, and particularly economic ones, whether in the form of a boom or a crisis, will affect the evolution of the sector. Finally, facilitating the entry of the private sector in collaboration with (or with the incentive of) the public sector and hence fostering a competitive market can impulse the sector.
The common point of many of the middle-income and low-income countries is the limitation of access to technology, the low effectiveness of Research and Development (R&D) compared to pioneering companies, as well as not having immediate access to new medicines and patents for their high cost. Original products are usually marketed at a high price in international markets until the innovator's patent expires. Once the patent expires, generic products are available in the markets at much lower prices. As in all industries, foreign investment has assisted in technology transfer, but at the same time, obstacles to investment or prices of imported pharmaceutical products (due to patent protection), have pushed middle-income economies into the development of the productive capacity of generic products4. The interventions focus on improving access to products at a lower cost since generic companies lack initial R&D and have less marketing power (World Bank, 2005).
Since it is impossible to produce all types of products, either due to technical or technological limitations, the need to import products and technology is a standard topic; Even large producers can also be large importers of pharmaceuticals products. The interdependence and globalisation of pharmaceutical industries and markets is an inevitable matter while there are few companies, world pioneers, that carry out most of the innovation.
Sanitary systems use imports and later take advantage of the technological transfer of chemical formulas in order to facilitate access to pharmaceutical products. Meanwhile, productive capacity, that is, industrial infrastructure, serves to some extent to meet domestic demand, but importation plays a fundamental role in supplying drugs that for whatever reason are not produced domestically.
Collaboration between the public and private sectors is a reality in this area. Some analysts emphasise the need to remove unnecessary obstacles to the competitive supply of generic products (Europe Economics, 2001) while other complementary views, to "combat shortages and correct failures in the market [on the production and competition] particularly in many developing countries" (WHO, 2011). However, many other health systems around the world also benefit from public interventions that try to guarantee the proper functioning of the pharmaceutical market (Jacobs et al., 2012). It is for these reasons that for the World Health Organization (WHO), the main objective is to improve access to essential pharmaceutical products in the markets.
Although, indeed, in recent decades the number of inhabitants (consumers) and life expectancy at birth has increased worldwide, also in middle-income countries. This fact has been due to the increase in income in many countries and to the emergence of social segments that pay attention to their health and well-being and, on the other hand, to the facilitation of technology transfer and trade, and therefore access to medicines in these countries (WHO, 2011).
Middle-income countries have made use of public regulations to improve the productivity of their pharmaceutical industry. These pharmaceutical policies and regulations serve to meet growing public demand and stabilise consumption against economic shocks during a negative cycle. Furthermore, in several countries, the reforms allow the private sector to enter competitive and international markets, and benefit from the impulses and incentives of the public sector during the period of economic growth. These attempts have had positive results in many countries since, according to a research carried out in 2014, the capacity of drug production and the use of the latest innovations at the international level has had a significant jump between the years 2000 to 2012 (Hogerzeil. et al., 2014).
In summary, the national and international context, how efficiently the institutions use the country's resources; the economic policies that affect the pharmaceutical sector and the factors that affect income can be determining factors in the growth of a market. With this approach, we begin the next section in the case of Iran.
To describe Iran's pharmaceutical market and the determining factors in its evolution, we divide this section into three interrelated subsections. We dedicate the first part of the literature to the evolution of the industrial reforms and policies that have played an essential role in the transformation of the market. Second, we will review trade policies with a focus on importing drugs. Finally, we will talk about the evolution and structure of the industrial organisation, which generally takes part in the supply chain and pharmaceutical market.
Iran is an example of middle-income countries that, in recent decades, have initiated actions to create a pharmaceutical industrial base operated by a regulated market. Initial policies traditionally focused on trying to guarantee the supply of essential pharmaceuticals for domestic consumption. However, given the growth in demand, it has been necessary to apply new industrial policies in this area. In summary, we can point out three general factors that implied a boost to the growth of the pharmaceutical market from the 90s.
First, new economic policies were proposed after a period of political and economic instability. The construction of the post-war5 economy was linked to the partial liberalisation of industries and foreign trade starting in 1989 (Farzanegan, 2020). This measure also allowed to diversify production in an economy dependent on oil revenues.
Second, the country once again experienced growth in the gross domestic product (GDP) and per capita income, and with the purchasing power and health spending, mainly due to the export of oil products as the engine of economic recovery. The improvement in purchasing power occurred both at the urban and rural levels, thus rapidly increasing the final demand for products and services.
Third, and following the preceding, the country experienced social and demographic changes that are determining factors in demand, such as the increase in the number of inhabitants or potential consumers. Since the beginning of the country's reconstruction and economic recovery, the improvement in life expectancy at birth6 is evident (Cheraghali 2017). This improvement implied the emergence of a young majority active social segment that demanded more products for their well-being7. As a consequence, it was necessary to implement policies to meet part of the internal demand.
Graph 1 indicates the evolution of some macroeconomic and health indicators. The green background marks the periods of growth, while the yellow and red backgrounds represent the moments of the crisis.
Graph 1: Macroeconomic Changes of Iran (1995-2017)
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Source: Own elaboration based on data from WHO, World Bank, UNCTAD, Ministry of Economy and Finance and Central Bank of Iran. All data are converted into dollars (constant, 2010).
Until the start year of the First Five-Year Socioeconomic Development Plan (1989-1993), generic drugs were subject to import by the State or were manufactured in-house under the license of foreign companies. However, there was an industrial base in the country since, in 1988, 90% of the final products were manufactured internally in cooperation with foreign companies8. The first liberalising reform, also called the structural adjustment that entered into force until 1993, was based on the advice of the World Bank (W.B.) and the International Monetary Fund (IMF), organisations that recommended opening to financial markets, privatising companies and the flexible exchange rate in developing countries. This reform allowed the private sector not only to have a more significant role in the market and greater competition in production but also to import medicines through the currency at a flexible exchange rate. Instead of strict price regulation, the government began to assign tax incentives and subsidies to bidding companies at the national level to overcome the shock of price liberalisation. To reduce the impact of the escalation of prices for consumers as a consequence of the shock, public and private insurance companies were responsible for assuming a part of the pharmaceutical costs.
Following the reforms, many companies previously held by the government were listed on the Tehran stock exchange. As we will see in section 3.3, between 1995 and 2015 the number of large producing and importing companies competing with each other to supply different brands and prices increased. Iran is a producer of generic drugs that are subsidised by the State, causing many drugs to be offered to consumers in local currencies at a low price compared to international prices. The importation of generic drugs from foreign companies by Iranian companies or laboratories has facilitated the production of own brands of the same chemical formulas for the alleged "selfsufficiency". To this must be added the technological transfer of products with an expired patent, which is carried out by multinational companies to Iranian producers through their legal representatives in the country.
Before the reforms, government subsidies were allocated to the entire market; both the companies that produce and import the raw materials (API or Active Pharmaceutical Ingredients) and the goods already produced. However, these subsidies experienced a sharp drop in the 1990s, since the implementation of reforms, the very operation of the market comes to influence the pricing of pharmaceutical products9. In other words, in the 1990s, subsidies became selective and applied on the demand side, so that a small part of essential medicines was included in the package of public subsidies. However, the Asian crisis of the late 1990s caused consumer prices to rise sharply and subsidies to be insufficient.
Although access to medicines remained the central policy of health policies, the allocation of subsidies to the pharmaceutical market has faced ups and downs that corresponded, among other reasons, to the volatility of the price of crude oil in international markets (Cheraghali, 2017). Likewise, the Asian crisis of the late 1990s persuaded monetary, industrial and health institutions to change their policies for the new decade. The paradigm shift for our analysis begins with the new development plan in 2001 when the cost-plus pricing model is re-implemented and returns to a fixed exchange rate10, both to stabilise production and to guarantee imports during oil shocks. in 2001, within the framework of the third development plan (2001-2004), the monetary authority established the Currency Reserve Account, which in the fifth plan (2011-2014) became the National Development Fund. Said fund planned to accumulate up to 30% of oil revenues annually to alleviate the impact of the crisis on health spending, among others.
One of the limitations of the reforms in the new period has been the absence of real free market-style competition. Since then, the price system in the Iranian market consists of a base price suggested by the public entity, which leaves a maximum profit margin free to generate limited competition. Packaging costs practically determine the profit margin of the cost-plus model (or cost-added), distribution costs, margins from private pharmacies and possible recoveries by insurance companies, but not so much by differences in the quality of the different brands and chemical formulas. (Iran Health Insurance, 2016) This issue has sparked debates when comparing with the costefficiency model that exists in entirely free markets.
On the one hand, it is argued that "the cost-plus model lowers the prices of drugs for better public access within a mixed generic-manufacturing economy. However, "the disadvantage is the violation of the law of the competitive market" (Ibid., P.22). In any case, despite the partial liberalisation of the generic market, government interventions continued to be implemented to prevent market failures; giving rise to a pharmaceutical system finally supervised by the public sector that had been designed for overcoming the economic shock.
Demand and domestic production of medicines has had an increasing rhythm since the 1990s. This trend continued with higher intensity between the years 2001 and 2011, which are characterised as the years of economic expansion and growth. In this period, domestic production grew 43%, but with a much slower rate than import growth, close to 100%. Annual per capita spending in Iran was 60 euros in 2011, is below the world average of 116 euros. (Emaco Report, p.144) One of the reasons is the supply of medicines at fixed prices in Rials, which makes the price for the consumer, especially that of national products, to be lower in comparison with international prices. Annual per capita unit consumption also grows in this time interval, from 250 to 452 units. Abbasian et al. (2019) show, for example, the consumption (in defined daily doses or DDD) of the nine types of antibiotics most consumed worldwide between 2000 and 2016, is higher in Iran (60 DDD per 1000 inhabitants) compared to the OECD average (20 DDD per 1000 inhabitants) (Abbasian et al., 2019).
The trend followed by supply and demand has had ups and downs during the period after 2000. The economic sanctions imposed by the international powers from the end of 2011 to 2015 caused much more damage than the 2008-2009 international crisis on Iran's pharmaceutical production. In late 2011 and 2012, the then-rulers of the United States, the European Union, and the United Nations Security Council imposed bank and oil sanctions on Iran as a result of its nuclear program.
Graph 2: Total Production and Consumption of Medicines in Iran (2000-2017)
Abbildung in dieser Leseprobe nicht enthalten
Source: Own elaboration from national statistics (Darosaz), UNCTAD. Production data are converted into dollars (constant, 2010)
In the graph above, the blue line represents national drug production in dollars at constant prices. The black line indicates the trend of total unit consumption (of containers) of medicines. The lag between the drop in production and the drop in consumption (2012-2013) corresponds to the time it took for the country's pharmaceutical reserves to run out.
We also observe the negative shock in domestic production during the beginning of the Great Recession (2008-2009), the period of restrictions due to sanctions (2011-2015) and the drop in the price of crude oil in 2014 and 2015, which can especially have affected the importation and domestic production of some medicines as negative shocks increase. Either due to the international crisis or an embargo, prices for consumers in the health sector experience a jump, which is offset by higher spending by the government in the pharmaceutical sector. Especially from 2011, at which time the Iranian assembly ratified additional spending on subsidies for the importation of medicines (see section 3.2), in the face of the sharp devaluation of the currency and the difficulty in accessing medicines. Inflation in the health sector is more focused on imported goods since domestic goods benefit from price controls, whose inflation was less than 10% at all times (IRNA Newsletter, 11/01/2020).
Graph 3: Expenses and Inflation in Iran's Pharmaceutical Sector
Abbildung in dieser Leseprobe nicht enthalten
Source: Own elaboration based on data from the Ministry of Economy and Finance, the National Institute of Statistics and WHO. Dollars at constant prices (2010) Yellow Fund: Recession, Red Fund: Sanctions.
As it could be seen in graphs 2 and 3 and 4, the economic, oil and banking sanctions from 2012 to 2015 left impacts on the indicators of the study whose recovery was the object of the fifth five-year development plan (2011-2015). Concerning the previous graph and as indicated in graph 4, public subsidies strive to recover the drop in household expenses (due to the drop in GDP per capita). The rise in public spending in the pharmaceutical sector (green line) is visible in graphs 3 and 4.
Graph 4: Expenses and Subsidies in the Pharmaceutical Sector of Iran
Abbildung in dieser Leseprobe nicht enthalten
Source: Own elaboration based on data from the National Institute of Statistics and WHO. The data is in dollars (2010)—Yellow Fund: Recession, Red Fund: Sanctions.
In addition to the mentioned earlier, the "economy of resistance" was based on policies of internalisation of economics, more significant public intervention for health expenditures, stimulation of R&D11, and the incentive to consume national products to reduce dependence on oil income. As a result of a negative trade balance, the budget deficit and the economic contraction, an agreement was produced in 2015 that was accompanied by the re-entry of Iran in the international market; This favoured a short period of "bonanza" similar to that of the pre-sanctions era12.
Trade policies in the pharmaceutical sector are vital because they allow us to continue supplying the market for medicines that are not produced internally, and to export products to the demanding markets. Iran's pharmaceutical market has been dependent on foreign currencies; In the years before the reforms, a part of the demanded medicines and raw materials for the national product's factory was imported. With a flexible exchange rate and the slight opening of foreign trade, the importation of medicines shot up between 1992 and 1997, before the slowdown caused by the Asian crisis. As previously discussed, as a consequence of the vulnerability of the rial and the quantity imported due to the volatility of oil prices and the international economic crisis, the Iranian government stopped complying with the policies recommended by the World Bank and the IMF to return at the fixed exchange rate (Farzanegan, 2020), which also had an impact on the import of pharmaceutical products. Besides, as of the third development program (2000-2004), subsidies on domestically manufactured products decreased, while imported medicines began to receive them more than before. The priority of the Iranian government during the new decade was to import a larger quantity of medicines to improve the level of public access, respond to the growing demand and make Iranian laboratories aware of the new medicines and formulas existing in international markets.
Graph 5: Proportion of national production and imports of medicines in Iran
Abbildung in dieser Leseprobe nicht enthalten
Source: Own elaboration from calculations by Cheraghali (2017, p.4) and data from the United Nations Conference on Trade and Development (UNCTAD).
As can be seen, thanks to greater internationalisation and the economic boom, the import quota (in monetary terms) have increased since 2000. Since 2001, trade reforms as part of the "third five-year development plan" (2000-2004) coincided with the world economic boom, which causes the import quota to start rising again. The most notable reforms of the new plan were the facilitation of the importation of medicines similar to those produced internally through the reduction of tariff rates, the application of subsidies to imported medicines and the regulatory changes that allowed to facilitate the registration and the activity of importing companies13. Importing14 medications has been vital in supplying many types of medications for heart disease, diabetes, cancer, blood, rare diseases, etc. (Yektadoost et al., 2018). Some health policy researchers argue that the recession, currency devaluation, and bank lockout due to sanctions, led to a shortage of imported medicines for the treatment of some critical diseases (Kheirandish et al., 2018). In an investigation by Panahi et al. (2016), shows how most of the medicines imported by Iran can be classified as essential, with an elasticity of demand of less than 1. This fact also implies that changes in the exchange rate do not leave instantaneous effects on demand, although the fall in GDP or some major shock can translate into a momentary negative impact (Panahi et al., 2016).
As we saw earlier, the drugs consumed in the country are highly regulated, and a large part of the subsidies go to imported medicines. Public and private expenditures and subsidies partially offset inflation and changes in the fixed exchange rate resulting from external shocks. Unlike national products that obey a regulated price system (whereby the corresponding payments are made by households without the need for the application of public subsidies), imported products frequently receive this annual aid package. As a small part of the medicines consumed in the country (5% in 2017) are imported products, a large part of the pharmaceutical expenses is usually carried out by households (70% -77% throughout the period), and the rest is aid. They are distributed by the Ministry of Health, Social Security Organization, different public bodies and small private insurers to cover high-cost medicines. These aids from the period of the third five- year plan are made to discount directly the invoice issued to the buyer. This type of regulation has had opinions, pros and cons. Proponents of liberalising prices argue that import subsidies and the setting of tariffs on imported medicines prevent full competition in the market and also facilitate smuggling to neighbouring countries. In a 2006 report, the Iranian assembly confesses that "the experience of many countries in the world has shown that this mechanism does not have the effectiveness and performance of a truly liberalised market" (Majles, 2005, p.18). In any case, economic uncertainties have been able to justify market intervention and regulation.
The country risk that more or less has existed in all the years has implied that the direct importation of products from multinational companies was more feasible than the direct foreign investment by these companies15. Iran's non-membership as a permanent member of the World Trade Organization (WTO) has had consequences on the Iranian pharmaceutical market. First, the application of high tariff rates16 to imported products that are similar to domestic products has made the country's objectives have moved from competition to self-sufficiency. Furthermore, because it is not a permanent member of the WTO, Iran has been unable to sign the Intellectual Property Law Treaty (TRIPS)17, which has given it greater freedom to import or produce low-cost copies - which occurred in times of scarcity due to economic sanctions - although it has also increased the risk of investment undertaken by multinational companies.
1 Annual budget according to the local calendar, for example March 21, 2019 to March 20, 2020.
2 The key sectors of Iran's GDP are energy (gas and oil), industry, agriculture, construction and services.
3 About 95% of Iran's hydrocarbon sales is oil and the rest is natural gas. For this reason, the present investigation will use the only variable that could be called in different names such as oil revenues, oil revenues or oil and gas revenues.
4 Generics are drugs or bioequivalents to the original drugs that are no longer protected by patents.
5 The conflict between Iran and Iraq was culminated in 1988, and the first five-year plan for national development came into force in 1989, accompanied by political changes in the country.
6 From 1990 to 2015, the life expectancy of Iranians grows from 63.8 to 75.8 years, and the population goes from 56.3 to 78.5 million people (World Bank, 2020)
7 It should be remembered that the Human Development Index (HDI) in the case of Iran has risen markedly since the 1990s, jumping from 0.57 in 1990 to 0.8 in 2018 (UNDP, 2019 report).
8 In these years, of 9,595 million units of medicines consumed in the country, 8,814 million had been manufactured internally. Of the total producers, 88% companies were state-owned and 12% private, and all imports were made by the public sector.
9 Prices are regulated by a public body called "Support for the rights of consumers and producers", supervised by the "Ministry of Health and Medical Education".
10 Since the new period, the fixed exchange rate used to work in parallel with the floating rate driven by the market but supervised by the Central Bank.
11 In recent years, Iran's rulers and institutions have emphasized "self-sufficiency" in R&D in related scientific fields such as nanotechnology, biotechnology, etc.
12 In 2018 President Trump unilaterally withdrew the United States from the nuclear agreement signed in 2015 and imposed "maximum pressure" in order to paralyze the Iranian economy. Evidence shows that the negative effect of unilateral and extraterritorial sanctions is greater than that of previous sanctions on drug access in Iran. For example, the import of medicines from Europe has been lower in 2019 than during the previous sanctions period (according to Eurostat data) because European companies have limited trade ties with Iran for fear of sanctions.
13 Articles 4, 46 and 115 of the third five-year plan (2000-2004).
14 The regulatory body for the export, import, quality and distribution of medicines is the Food and Drug Organization (FDO) under the supervision of the Ministry of Health and Medical Education. (Majles Report, 2005, Reportbis Report, 2014) As it was already allowed to import high-priced original brands (blockbusters), they also implemented the coding system for medicines distributed in the market (global GMP and MDF standards) to combat the smuggling of products.
15 Foreign Direct Investment (FDI) in Iran in both its "Green Field" and "M&A" variants is low. In 2017 the total amount of FDI (Pharmaceutical and non-pharmaceutical) in Iran was equivalent to 5 billion euros, falling rapidly from 2018 due to sanctions imposed by the United States.
16 Despite its reduction over time, Iran's applied tariff rates remain high, making the country classifiable as protectionist. For the importation of medicines similar to national medicines, a rate of 90 percent was applied until 2008, but since then it dropped to 65%. Rates were reduced to 0% from 2012 to facilitate importation in times of crisis.
17 Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an agreement that was introduced and signed in 1995 within the framework of the WTO. This agreement guarantees the rights and patents of multinational pharmaceutical companies when exporting their original products.
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