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Global Health Economics and
            Sustainability
                                                                                        Pharmaceutical system in Iraq


            Health, 2019a). These practices have been enabled by the   medicines, respectively, were reported missing. This was
            ability of the private sector to outcompete the public sector   mainly  attributed  to insufficient financial  allocation and
            in procurement. Thus, without enforceable government   lengthy processes to acquire medications (Republic of Iraq
            intervention, the market  environment has  made  private   Ministry of Health, 2019a).
            distribution enterprises price-setters, often to the
            detriment of healthcare equity and access. Moreover, the   5.2. Capabilities of the Ministry of Health
            availability of unregistered and substandard/falsified (S/F)   The  MoH  has  limited  expertise  in  health  economics,
            pharmaceutical products in the private market is a growing   epidemiology, statistics, and public policy, which has
            concern, exacerbated by poor control over points of entry   resulted  in  suboptimal  populational  health  outcomes
            into the country (Al-Humadi & Liapi, 2019).        (Republic of Iraq Ministry of Health, 2019a). It has been
                                                               reported that the link between the MoH’s economic policies
            4.4. Quality assurance of medicines                and national health priorities is poor, highlighting the lack
            The DTA, through the National Centre for Drug Control   of inter-departmental cooperation required to address

            and Research, is responsible for testing all imported and   modern systemic healthcare issues (Tawfik-Shukor &
            domestically produced pharmaceutical products for   Khoshnaw, 2010). These factors result in delayed responses
            quality assurance (Figure 1). It adheres to the requirements   to health crises, allowing the private sector to capitalize
            of the US, United Kingdom, and European pharmacopeias   on the delays, ultimately undermining health equity and
            for compendial products and uses the manufacturers’   exacerbating populational health outcomes (Al-Jumaili
            validated methods for non-compendial products. While   et al., 2013; Republic of Iraq Ministry of Health, 2019a).
            there is no established protocol for the routine testing of   5.3. Rational use of medicines
            pharmaceutical products in the private sector, the National
            Centre for Drug Control and Research is authorized to test   The MoH, through the Department of Pharmacy/DTA,
            any product that raises suspicions. Furthermore, products   started a national program in 2008 to promote and
            with valid registration from an accredited foreign regulatory   monitor the rational use of medicines in public healthcare
            agency are exempt from quality testing (Al-Mosawi, 2020;   facilities. However, the MoH has reported no adherence
            Republic of Iraq Ministry of Health, 2020).        to guidelines for prescribing and dispensing medicines,
                                                               as well as poor management of antibiotics and biological
            4.5. Pharmacovigilance                             medicines (such as those for diabetes, autoimmune
            All adverse effects of medicines, biopharmaceuticals,   diseases, chronic diseases, cancer, and rare diseases). This
            vaccines, supplements, and herbal products are monitored   non-compliance negatively affects medicine availability
            by the National Pharmacovigilance Centre. The center   and therapeutic outcomes in both the public and private
            is also responsible for monitoring and reporting S/F   sectors. Furthermore, the private sector remains largely
            medicines found in both the public and private sectors.   unregulated in this regard (Republic of Iraq Ministry of
            Pharmaceutical companies and scientific bureaus are   Health, 2019a).
            legally obligated to monitor and report any identified S/F   Notably, there is a lack of consistent awareness among
            medicines to the National Pharmacovigilance Centre.   physicians regarding generic and biosimilar medicines
            Once reported, information is disseminated through the   (Al-Kinani et al., 2020). There are no specific formulary
            SIP and the Directorate of Inspections. The Directorate of   or guidelines from regulatory authorities concerning the
            Inspection has the authority to withdraw and confiscate   quality, safety, and efficacy of these medicines. In addition,
            any S/F products (Syndicate of Iraqi Pharmacists, 2021b).   there has been poor awareness of generic medicine
            In 2013, the MoH joined the Global Surveillance and   prescribing and cost-effective prescribing due to the
            Monitoring System, which is a global rapid warning system   absence of relevant content in medical curricula (Sharrad
            for S/F medicines (World Health Organization, 2013b).  et al., 2008). A qualitative study has suggested that further
                                                               education and reassurance regarding the quality, safety,
            5. Challenges in the pharmaceutical sector         and  efficacy  of generic  medicines  are  necessary in  Iraq.
                                                               The study also found that some physicians are opposed to
            5.1. Availability of medicine
                                                               involving pharmacists in therapeutic decisions, particularly
            It is  evident that  the MoH, through KIMADIA, faces  a   in regard to brand substitution. This has been attributed
            number of challenges in providing sufficient medications   to a lack of trust between physicians and pharmacists,
            and pharmaceutical products to fulfill public sector demand   especially regarding the evaluation of therapeutic efficacy.
            (Republic of Iraq Ministry of Health, 2019a; Sharrad  et   The World Health Organization (WHO) has suggested
            al., 2008). In 2018 and 2019, 50% and 40% of essential   that Iraq implement and enforce the rational use of


            Volume 3 Issue 3 (2025)                         63                  https://doi.org/10.36922/GHES025110025
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