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Global Health Economics and
            Sustainability
                                                                                        Pharmaceutical system in Iraq


            private pharmaceutical distributors are required to be   government. These inefficiencies, compounded by funding
            licensed in accordance with the relevant regulations and   shortages, have allowed the private sector to outcompete
            laws for practicing in Iraq.                       KIMADIA in procurement (Al-Mosawi, 2020).
              Since Iraq does not have dominant players or     4.2. Approval and listing of medicines
            established pharmacy chains, community pharmacies are
            typically independently owned and operated by practicing   The DTA is responsible for the regulation of medicine
            pharmacists. These pharmacies receive their stock from   and pharmaceutical product licensing in the public and
            wholesale pharmaceutical suppliers and are responsible   private sectors (Figure  3) (Al-Jumaili  et al., 2021). The
            for dispensing and compounding medications directly   licensing process involves a product review by seven
            to patients (Al-Jumaili et al., 2013). As of 2023, the ratio   technical committees. When certifying medicines,
            of community pharmacies to individuals was 1:2,950,   the DTA considers the decisions of foreign regulatory
            with a notable concentration in larger cities  (Syndicate   agencies. For international producers, a Certificate of
            of Iraqi Pharmacists, 2023). Between 2011 and 2023, the   Good Manufacturing Practice (GMP) and a Certificate
            number of private distributors increased nearly three-  of Pharmaceutical Product (CPP) from at least one of the
            fold for scientific bureaus from 296 to 710, community   DTA-approved foreign regulatory agencies are mandatory
            pharmacies expanded from 5,336 to 15,424, and wholesale   (Republic of Iraq Ministry of Health, 2020). In contrast,
            pharmaceutical suppliers increased 46% from 311 to 454   local  manufacturers  are  not  required  to  present  foreign
            (Al-Jumaili  et al., 2013; Syndicate of Iraqi Pharmacists,   certifications. Instead, the DTA evaluates product quality
            2023a, Syndicate of Iraqi Pharmacists, 2023b; Syndicate of   and reliability through on-site inspections (Al-Jumaili
            Iraqi Pharmacists, 2023c).                         et al., 2021).

            4. Processes within the pharmaceutical sector        In an attempt to mitigate medicine shortages, the DTA
                                                               introduced a fast-track registration scheme (Al-Jumaili
            4.1. Selection and listing of medicines            et al., 2021). Under this scheme, pharmaceutical products
                                                               certified by at least one accredited international foreign
            The National Committee for Drug Selection is responsible
            for approving and listing new medicines and vaccines in   regulatory agency can receive temporary registration and
            the Essential Drug List (EDL) and Comprehensive Drug   an import license for 1 month after application (Al-Jumaili
            List (CDL), which currently include 5,098 registered   et al., 2021; Republic of Iraq Ministry of Health, 2020).
            medicines and 1,014 registered supplements (Al-Jumaili   This initiative has significantly increased the number of
            et al., 2021; Republic of Iraq Ministry of Health, 2012).  registered medicines and the availability of vaccines in Iraq
                                                               (Republic of Iraq Ministry of Health, 2020).
              The EDL comprises medicines and vaccines intended
            for use in public healthcare settings (Republic of Iraq   4.3. Pricing of medicines
            Ministry of Health, 2012). It is subdivided into three   In the public sector, the DTA is responsible for determining
            volumes, numbered by priority for availability and   the prices of medicines. Prices are set based on the brand
            procurement policies. Volume I includes the most cost-  and the geographical location of the manufacturers.
            effective medicines and products, which the MoH, through   Once  prices  are  established,  KIMADIA  is  authorized  to
            KIMADIA, is solely responsible for securing in the public   independently procure medicines on the open market in
            sector (Republic of Iraq Ministry of Health, n.d.a; Republic   accordance with the needs of the public healthcare system.
            of Iraq Ministry of Health, 2012). In contrast, volumes
            II and III contain less prioritized items that healthcare   In the private sector, the government does not
            facilities may procure independently based on demands   intervene to ensure reasonable pricing. However,
            (Republic of Iraq Ministry of Health, 2012). New expensive   the MoH, in collaboration with the SIP, encourages
            medicines are reviewed by the National Committee for Drug   compliance with the prices recommended by the DTA
            Selection in collaboration with the Department of Need   (Syndicate of Iraqi Pharmacists, 2021b). Despite these
            Estimation after conducting socioeconomic assessments to   efforts, the MoH reported that only 20% of the products
            evaluate their market suitability. At present, the EDL lists   distributed in the private market adhered to the SIP
            1,105 items, approximately half of which fall under Volume   pricing guideline (Republic of Iraq Ministry of Health,
            I. However, only 60% of those medicines were provided   2019a). This widespread lack of price compliance can be
            by KIMADIA (Al-Jumaili  et al., 2021; Republic of Iraq   attributed to monopolistic and oligopolistic behaviors in
            Ministry of Health, 2020). This lack of public sector supply   the private sector, where certain enterprises have gained
            is attributed to lengthy bureaucratic procedures along   majority control over the supply and distribution of certain
            with weak interdepartmental coordination within the   medicines (Al-Mosawi, 2020; Republic of Iraq Ministry of


            Volume 3 Issue 3 (2025)                         62                  https://doi.org/10.36922/GHES025110025
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