A better understanding of the complex interactions and interests of actors is often the starting point for many policy designs aimed at preventing health goods smuggling. An examination of these relationships reveals that these plans and programs are often implemented in response to the needs and demands of other actors in the system. Additionally, the roles and responsibilities of key actors need to be clarified through the design of networks and the strengthening of participatory structures(33).
This study identified a range of multi-sectoral actors who could contribute to the design and implementation of policies to prevent health goods smuggling in Iran. It aimed to analyze the network of actors involved in the policy-making process to prevent health goods smuggling.
Structural and institutional gaps in the definition and regulation of power structures
Network analysis provides a structural view of governance patterns, displaying the distribution of power and helping to assess how stakeholder heterogeneity is integrated into the management of the social ecosystem [33]. The assessment of power relations among actors can offer policymakers and politicians a framework and perspective for conducting negotiations and conflict resolution processes.
Our quantitative and qualitative analysis revealed a significant fragmentation among the actors involved in preventing health goods smuggling, which hampers effective action. The CHCSGC, the FDO, and the MoHME, and Customs have the potential to be leading actors in formulating and implementing policies to combat health goods smuggling. Nevertheless, several obstacles have impeded the planning and implementation of effective policies, i.e., inadequate coordination between spheres of power, weak governance, ineffective mechanisms to manage conflicts of interest, and insufficient attention to the perceived need for cooperation among organizations in this sector. These factors have influenced the level of support, interest, and intensity of network connections.
Political behavior and organizational conflicts may stem from issues such as extremism, the expansion of organizational power, and differences in interests, posing challenges to the advancement of smuggling prevention programs.
One study suggested that policymakers should consider the diverse sources and reasons for conflicts of interest among actors. It recommended designing legal, behavioral, and financial policies to mitigate or neutralize these conflicts [34] .
The CHCSGC, as one of the main policy levers in Iran for preventing smuggling, has failed to utilize its potential power and authority effectively and efficiently. The Food and Drug Organisation, with its multiple dominant roles (executive, regulatory, legislative) in the network of actors PSHG in Iran, ranks high on the importance index and is considered one of the most significant actors in the network.
However, it is important to note that an actor with multiple roles can create an environment conducive to structural corruption [35]. Similar to our findings, another study suggested reorganizing the structure and responsibilities of the MoHME to strengthen its ownership function. It recommended limiting the MoHME’s responsibilities, similar to health systems in HICs, e.g., Germany and Japan. Additionally, the study found that health policymakers need to develop close and strong relationships with the media and influence its content and form [34].
Multi-sectoral collaboration plays a crucial role in developing, implementing, and managing interventions to prevent the smuggling of health goods. Nevertheless, the approach of stakeholders appears to be multipolar in Iran, with mutual doubts about each other’s motives for preventing smuggling.
The necessity of adopting hybrid participatory approaches in the PSHG
Actor analysis is allegedly crucial in enhancing decision-making processes, implementing policies, legitimizing issues, and fostering interactions and cooperation between governmental organizations and society. The involvement of diverse actors, i.e., governmental and non-governmental organizations, in the policy-making process for PSHG could reflect participatory governance, collective democracy, and interactive decision-making. The need to develop new insights into policy interventions and the role of civil society and the private sector in policy-making and implementation were among the most important examples related to this theme in the present study. The findings of our study revealed that adopting participatory approaches in policy-making (top-down, bottom-up, or a hybrid approach) can significantly impact the implementation of a system to prevent health product smuggling.
Stakeholders can serve as alarm bells in the policy-making process, quickly identifying signs of policy failure [36]. Managers and policymakers need to be capable to adapt their programs, policies, and services to the needs, expectations, and standards of society. This requires a thorough understanding of the environment, the structure, the behavior of actors, and the processes involved. This part of the process necessitates various scientific, managerial, and research measures. Therefore, it is essential that all interested groups participate in the policy formulation process and provide the necessary support. The accumulation of authority should not be limited to a specific area.
Some studies showed that excessive stakeholder participation can negatively impact policy performance, as a significant increase in participation is often associated with a decrease in policy performance. The level of stakeholder participation and its impact on policy performance may vary depending on the type of information, the level of power, and the policy environment [37].
The crisis of substandard and falsified medicines in Iraq is a complex and multidimensional problem that requires close and coordinated cooperation among health authorities, border agencies, healthcare providers, and pharmaceutical companies. It is also considered essential to enhance the training, awareness, and tools of pharmacists and to establish tracking systems in the drug supply chain for the identification and control of these medicines [38].
Government organizations play a dominant role in PSHG, placing most of the power in the hands of the public sector. The study found low cohesion and solidarity among actors. Trust between actors plays a crucial role in the success and sustainability of interpersonal and organizational relationships.
According to social network analysis, low network density indicates a lack of cooperation among actors. Increasing network density can strengthen and formalize weaker information links and enhance the speed of information transfer within the network [39].
Being part of large networks can yield positive effects. However, the negative side becomes evident when the intent of entering these networks is to exploit rents and engage in systematic smuggling.
Information and knowledge gaps in social network interactions in the PSHG
Our findings revealed that addressing information gaps is crucial. Some government actors expressed concern about the lack of access to information. This issue can be examined from two perspectives: one is sharing information through the creation of common databases between agencies, and the other is raising awareness among the general public, especially service providers. In the second case, the use of the media’s capacity to prevent the smuggling of health goods has been neglected in practice.
Other studies emphasized the provision of facilities for developing education and training opportunities for pharmacists and citizens [40, 41]. International regulatory agencies have been encouraged to work together to strengthen pharmaceutical governance, secure adequate funding, and facilitate information-sharing. HICs have been also encouraged to assist LMICs through research, training, and capacity-building [7].
Knowledge and technology agents, as well as knowledge brokers, are vital for facilitating knowledge transfer and exchange within systems and networks, especially when facing barriers to system reform. By focusing on roles, e.g., knowledge brokers, who enable interactions and facilitate knowledge transfer within social networks, the behavior of network actors can be positively influenced [35, 42], as addressed in this study.
The pharmaceutical industry in Pakistan is extensive, but scientific data and comprehensive studies on the quality of medicines and the prevalence of counterfeit and substandard drugs are limited. There is also a pressing need to strengthen regulatory systems for on-site inspections, enhance compliance with Good Manufacturing Practices (GMP), and reinforce analytical laboratories to ensure the quality of medicines [43].
Intermediary actors play a pivotal role in shaping network dynamics by facilitating information/resource flows, fostering interactions, and building social capital [33]. Enhanced information access, in turn, reveals critical collaboration factors: partner willingness, shared needs, and systemic barriers [30].
Strengthening health diplomacy and Establishing collaborative frameworks to effectively address cross-border health challenges
Health diplomacy in the political, economic, cultural, security, educational, justice, and health fields is a missing link in the global effort to prevent health goods smuggling. The present study showed that multilateral partnerships and social responsibility in the international arena can help countries have a greater impact in developing policies to combat health goods smuggling, encouraging them to act sensitively and within a framework on cross-border issues.
Collaborative efforts among countries and organizations have been pivotal in addressing counterfeit medicines. Initiatives such as the Anti-Counterfeiting Trade Agreement (ACTA) (by Australia, Canada, the EU, Japan, Mexico, Morocco, New Zealand, Singapore, South Korea Switzerland and the USA) and the EU Directive 2011/62/EU involve international partnerships for tackling this issue. Key agencies such as the FDA, USAID, and the European Medicines Agency (EMA), as well as programs by UNICEF, the United Nations Population Fund, the Global Fund, and the Bill & Melinda Gates Foundation, focus on improving product traceability through advanced technologies. Additionally, specific programs aim to strengthen regulatory agencies in LMICs, ensuring access to safe, affordable, and quality-assured medicines [7].
Despite efforts by Interpol and UNODC, the lack of a global and multilateral mechanism for identifying and preventing illicit online pharmacies remains a major challenge. Limited international coordination has allowed these virtual criminals to remain active and continuously create new platforms. Operation Pangea has shown promise as a collaborative model, but without comprehensive international and multi-sector cooperation, it is impossible to fully dismantle the technologies supporting these illegal operations [7]. Combating the trafficking of falsified medicines in Ukraine is a complex issue that requires extensive cooperation among international, scientific, and operational bodies. Additionally, weaknesses in the current laws have reduced the effectiveness of combating these crimes, making the development of advanced legal and technical systems essential [44]. International health studies and reports from WHO and others reveal that health promotion interventions require the synergy among stakeholders and coordinated efforts of all relevant individuals and institutions within and outside the health system, including public and private actors, non-governmental organizations )NGOs(, industry, and the media [45].
Consensus and dialogue need to be built and strengthened to improve the operational procedures and regulations for programmers to prevent the smuggling of health goods. Stakeholder analysis needs to be, we advocate, an ongoing process to better align policy with its political environment, as the status of stakeholders in the policy-making process changes [46].Utilizing health diplomacy alongside surveillance tools is anticipated to bolster its effectiveness and address both local and international challenges in health economics. It is essential to include all stakeholders in economic collaboration [10].
The weakness of motivational mechanisms and actors role shift
A key finding was that some actors’ positions and preferences may change over time as some detection agencies move from a preventative to a detection and suppression approach. Therefore, to neutralize or reduce the negative effects of the adopted policy, it is necessary to assess the stakeholders’ views on the opportunities and threats of the policy.
Policy intermediaries such as trade unions and the private sector can turn the threat of political and economic sanctions into an opportunity by implementing programs such as the development of national and transnational companies and their representation, as well as by being at the forefront of trafficking prevention, particularly in the health sector. Given the current economic hardships facing Iran, providing economic and political incentives to political mediators can serve as a window of opportunity for reform in the area of trafficking prevention [10].
The issue of ensuring the continuity of the supply chain for access to quality products
Sanctions, currency fluctuations, and the difficulty of sourcing raw materials have had a significant impact on the formation of smuggling in the form of a formal network in Iran.
Disorganization in the supply chain and distribution of medicines has contributed to the phenomenon of smuggling. The lack of liquidity in the supply chain of medicines and medical equipment, coupled with the elimination of support from banks and support centers, weakens domestic manufacturers. Additionally, the ease of sourcing and receiving medicines and cosmetics from unofficial sources, including cyberspace, has facilitated the supply of smuggled and counterfeit goods.
We advocate the pharmaceutical industry to reduce prices for authentic products, especially in low-income regions, and secure supply chains through proper distribution practices. Diversifying supply sources and increasing transparency across the supply chain are vital to prevent disruptions and maintain global access to quality medicines [7].
Physicians and private companies are among the most powerful stakeholders, who can directly influence policies and programs aimed at PSHG. A potentially weak political player can attract the support of other players who have little influence on their own. Nonetheless, coalitions can make a fundamental difference and produce unexpected outcomes [35] .
While this study offers valuable insights through actor identification, power-interest matrix analysis, and comprehensive obstacle mapping, some limitations should be acknowledged. First, we did not specifically address the role of international efforts in smuggling prevention in its quantitative section. However, several consultants in the qualitative section highlighted the lack of seriousness in smuggling prevention at the international level. Second, the network analysis study is specific to the Iranian context and cannot be generalized to all societies. Nevertheless, for the similar societies, it might offer valuable insights into existing challenges and raise their awareness. Third, this is a cross-sectional study and systemic changes during the reform and development processes of the network of actors in smuggling prevention are always required to be considered. Fourth, while several actors could not be interviewed due to either their non-participation (refusal or unresponsiveness) or institutional scheduling constraints, this limitation did not substantially impact our findings, as other actors were aware of and acknowledged the concerns and challenges through their interactions with these organizations.
To reduce the potential perceptual bias, this study included the participants from various stakeholder groups. These participants possessed a high level of knowledge and experience, yet had minimal conflicts and interests within the network.
We recommend future studies to consider collecting and analyzing data from a wider range of professions and stakeholders at both national and international levels. Additionally, given the dynamic nature of political, economic, and social conditions, as well as the changing status of stakeholders throughout the policy design and implementation process, stakeholder analysis should be an ongoing process to better adapt policies to their environment.