Introduction
here are many laws in the field of health. The law can give a person legal rights and impose legal obligations [1]. Although legislation alone cannot create the health system, it is necessary to promote the health system and its other components [2]. The essential questions in passing a law are how interest groups participate in drafting the law or passing it in the parliament and achieving favorable participation of interest groups [3]. Public participation can lead to better policy and implementation decisions, and therefore can be associated with achieving more public program’s goals [4]. It has been stated that citizens’ participation in legislation encourages public participation and community, which creates a sense of responsibility and desire to work in public life [5]. People’s participation in legislation is sometimes direct and through a referendum, sometimes in various forms and by the legislature [6]. The legitimacy and sustainability of any critical policy decision depend on how it reflects the people’s core values. Ordinary citizens, as well as interest groups, should be aware of this policy [7]. The general public is unaware of most legislative issues in the field of health. Instead, legislation is done by those who act in their interests and ultimately reap the benefits [8].
The World Health Organization believes that participatory democracy is inevitable in the field of health and involves everyone. In this context, health rules should be the result of a process that is related to participatory accountability and participatory budgeting [9]. Many cases of participatory democracy in health can be seen in the European :union:. For example, the UK’s Department of Health and Social Care used the “have you say” mechanism for citizens to comment on a draft of the structural reform plan for the national health services [10]. The assistance of volunteers in the Steering Committee was used to draft the Green Book for public health reform in the Republic of Macedonia [11]. Expanding mechanisms for public participation in the legislative process is the key to building a health democracy. In a community where health democracy prevails, citizens can participate in the decision-making process and have equal access to the services provided by the public health system [12].
Thus, people should be able to participate in legislation in the health sector. However, this participation requires resources and also faces challenges. Considering that no study has been conducted on people’s participation in legislation in Iran’s health sector, this study was conducted to investigate desirable and efficient methods of participation in legislation in the health sector and their use in Iran.
Materials and Methods
This research is an exploratory and qualitative study. The data collection method was semi-structured interviews with selected participants. The researcher conducted all interviews. The interview content was prepared based on the objectives of the research and reviewing the previous studies. The participants were 20 knowledgeable individuals (university professors, members of parliament, former health ministers, experts working in the Deputy of Law of the Parliament, health and legal experts at the Parliament Research Center, experts and managers working in the field of health legislation) with at least ten years of work experience (Table 1). 


They had experience in legislation and had enough knowledge about the country’s health system. Before the interview, a brief explanation of the research and its objectives was provided to the participants. Then, they were assured of the confidentiality of their information. Finally, the participants permitted to record the interviews. During the interviews, the notes were taken to confirm the data’s accuracy at the end of each interview by re-stating and returning the highlights or a summary of the participants’ answers. All interviews were transcribed verbatim after recording. Guba and Lincoln’s evaluative criteria were used to ensure the study’s validity and reliability [13]. These criteria were credibility, transferability, dependability, and confirmability.
To analyze the findings of this stage, we used the framework analysis. In the introductory phase, a communication-content summary was designed for each interview. The initial conceptual framework was designed based on the study literature, interview questions, and conceptual guide. In the next step, the interviews were implemented. Different sections of the data were then coded based on thematic relevance. These codes were reviewed, modified, and finalized. After this stage, the relationship between primary and secondary concepts was analyzed. The references were made to the conducted interviews, and, if necessary, some content was added to the analytical tables.
Results
Based on 20 interviews and the study objectives, five main themes of (a) legal barriers, (b) infrastructural barriers, (c) sociocultural barriers, (d) people’s barriers, and (e) legislators’ barriers, as well as 26 sub-themes (categories) were identified.
Legal Barriers
Some participants stated that “The law provides opportunities for participation but is not binding at all” (participants No. 5, 9, 12, 13, 14, and 17). Others said, “It is true that there are some provisions in the law that allow people’s participation, but members of parliament are not obliged to pay attention to it” (participants No. 3, 6, 8, 9, 12, and 15). One believed that the law needs to be amended (participant No. 1). “In other laws, counseling has been advised for some cases. For example, in the law of Iranian Medical Council approved in 2004, the organization is obliged to comment on plans and bills in the field of health, but they are not taken seriously” (participant No. 19).
Infrastructural barriers
Some participants believed that the physical environment was problematic: “Even the parliamentary environment lacks a good space for people to attend” (participants No. 2, 3, 4, and 5). On the other hand, some believed that inviting to meetings was without rules and interests: “invitation to the parliamentary commissions depends entirely on the interest of the individuals, especially the head of the commission” (participants No. 2, 6, 12, 13, 14, 15, 16, 19, and 20). “It is practically impossible for people to be present in the parliamentary factions” (Participant No. 7). The participants’ lack of information and the lack of facilities to inform them were other points reported: “There is not enough information available for people to comment” (participants No. 7, 8, 14, 17). “When we hear of a health plan, it has been too late” (participants No. 19 and 20).
Sociocultural Barriers
Gaining people’s trust and not getting proper feedback from the participation were reported as necessary by some participants: “People need to be assured that their opinions are effective” (participant No. 3). “This process should not be expected to continue when you comment regularly but do not receive feedback” (participant No. 17). “Our people do not believe in participation because they do not believe that they are important” (participant No. 1).
People’s barriers 
Several participants endorsed people’s empowerment: “The organization must increase its expertise” (participant No. 19). “In many cases, people do not know how to express what they mean” (participant No. 4). “The capacities of the law have been left unused because of the people’s inability; for democracy, you need practice” (participant No. 16). Another factor reported in the interviews was health exclusivity: “Health is for professionals, and people are less allowed to enter” (participant No. 15). “In this field, only the medical system and associations should enter” (participant No. 19). Some participants pointed out that not receiving feedback would discourage people: “People should be given feedback so that they do not think that their presence is just a show” (participant No. 11). Some believed that it is necessary to define a model or models for participation: “There is currently no clear model for public participation in lawmaking” (participant No. 15). Some indicated the Members of Parliament (MPs)’s concerns are other issues: “The MPs do not have time to legislate because they are busy with the constituency works; their priorities are something else” (participant No. 3).
Legislators’ Barriers 
Some participants noted that the MPs do not have listening skills: “The MP must have a listening ear” (participant No. 10). Several interviewees also expressed the obligation to answer and evaluate MPs’ performance: “The MPs are not accountable; hence, they do not listen to anyone” (participant No. 9). According to some participants, many MPs are not familiar with the basics of legislation and parliamentary principles, and this makes it impossible for them to use the participation of interest groups: “Our parliament is the parliament of commons; many MPs here are just getting acquainted with the duties of a representative and the legislative process because we do not have a trained party system; so, they do not know what capacities exist or should be used” (participant No. 2).
Table 2 summarizes the main themes, categories, and subcategories obtained from the interviews. 


Discussion and Conclusion
This study aimed to identify the challenges of participation in legislation in the health sector. The results showed that these challenges could be classified into five groups: legal barriers, infrastructural barriers, sociocultural barriers, people’s barriers, and legislators’ barriers. Offenbacker divided the barriers to effective public participation into perceptual, political, and supportive [14]. Khodayari et al. reported that the main barriers to NGOs’ participation in health sector policies are the government and how NGOs operate [15].
The laws of different countries have restrictions and possibilities for people’s participation in legislation. In Hungary, for example, the CXXXI Act on Public Participation was passed in 2010. According to this law, in drafting the law, public consultations are conducted within the framework. Public consultation is required and available to the public [16]. In Russia, the Federal Law on the Prosecutor-General’s Office of the Russian Federation was adopted in 2005, establishing the Public Office as the mediator between society and the government, with the task of evaluating various legislative proposals from the point of view of the public interest [17]. In South Africa, an organization with a similar purpose called “the People’s Assembly” meets once a year. The assembly was first formed in 2004 [18]. Lack of sufficient time (according to the Rules of Procedure) to receive public opinion has also been reported as a challenge in Canada and the United Kingdom [19]. Aghaii pointed to the issue of legal restrictions and noted that only in a minimal number of laws and regulations, the institution responsible for enacting regulations is required or is free to consult with other institutions [20]. Khodayari et al. also concluded that legal support and supportive laws could help realize NGOs’ potential in legislation [15].
Providing the necessary infrastructure is one of the critical points in attracting people’s participation in legislation. To attract participation, for example, the Brazilian Parliament has provided e-Democracia service [21]. Portugal has been exercising its citizens’ legislative initiative since 2003, under which the initiative must have more than 35000 signatures of voters for debate in parliament [22]. This concern has also been seen in other countries, such as South Africa, where public participation is low due to lack of access [23]. The room where MPs and people are present also plays a vital role in public participation [24]. The Iranian Parliamentary Research Center has also emphasized the role of the existing parliamentary infrastructure and strengthening them in the bill for direct citizen participation in legislative affairs [25].
People’s trust was a crucial factor in the challenges related to sociocultural barriers. Valmorbida also emphasized the need for a relationship between institutions and citizens [26]. Safari emphasized the role of social and cultural factors and reported that the main factors of ensuring public participation are the awareness and interest of the people and the prevalence of education and cooperation in society [27]. Another barrier identified in our study was those related to people. There is a significant point in this area, which is the lack of a shared dialogue between legislators and participants in health. In 1997, the Canadian Association of Health Services and Policy Research recognized the lack of familiarity of policymakers with the research world and reported that knowledge brokers play a role in promoting evidence-based decision-making [28]. The problem of access to information has been reported in different countries, and different measures have been taken to solve this problem. Challenges such as lack of information about parliament have also been reported in South Africa. To resolve this problem, a drafted bill and a call for participation are published via the radio, the Internet, and newspapers [29]. Civic education is a fundamental strategy to increase people’s participation and confidence in the legislative process. Research shows that the variables of income, occupation, education, socioeconomic status, urbanization, and organizational membership affect political participation [30].
Regarding the barriers related to legislators, the MPs’ knowledge and training in administrative health are essential. If citizens constantly send the necessary feedbacks to the MPs, they will have to work hard to improve their performance [31]. Beetham noted that there are always concerns about the undue influence that some influential and affluent organizations may have on the legislative process [32]. Rostami also stated that obtaining opinions and consultations mainly depends on the authority and initiative of the head of the commissions or the request and proposal of their members. This study focused on the challenges of participation. It is suggested that further studies be conducted to identify factors that address these challenges and factors that facilitate public participation in legislation in the health sector from the perspective of various interest groups. One of the limitations of the present study was the reluctance of some experts and policymakers to participate in the study. Moreover, because of some experts’ busy schedules, it was impossible to interview them, or the interviews were done in a short time.
One of the challenges for public participation in the legislative process in the health sector is the uncertainty about citizens’ participation right in the legal system. To address sociocultural challenges, maximum transparency and publicity should be made for public participation. In the meantime, MPs need the training to use the capacity of public participation. On the other hand, participants should speak freely with legislators, besides gaining knowledge in health.

Ethical Considerations
Compliance with ethical guidelines
All ethical principles are considered in this article.

Funding
This study was extracted from the PhD. dissertation of first author at Department of Health Services Management, Faculty of Management and Accounting, South Tehran Branch, Islamic Azad University.

Authors' contributions
Validation, conceptualization, case management, Methodology, editing and finalization: Ali Akhavan Behbahani, Irvan Masoudi Asl, Somayeh Hesam, Mohsen Najafikhah; Drafting, Research: Ali Akhavan Behbahani.

Conflict of interest
The authors declared no conflict of interest.


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