Assessment of Policies, Laws, and Regulations Affecting the Contraceptive Needs of Adolescents in the Democratic Republic of the Congo

Background: Poor regulation is a barrier to adolescents’ accessing family planning (FP) services. We aimed to assess policies, laws, and regulations according to the contraceptive needs of adolescents in the Democratic Republic of the Congo (DRC). Methods: A mixed method study was conducted in 74 structures, including 13 administrative structures and 61 facilities offering FP. Data were collected through semi-structured interviews and document review. Using a health policy analysis framework, we analyzed the types of policies; their availability at the delivery points; the actors and the context of the policy formulation process. The content of policies was analyzed on the basis of WHO recommendations to ensure respect for human rights in the provision of contraceptive information and services. Results: Of the policies targeting the sexual and reproductive health (SRH), 18 were mainly focused on the FP of which 5 were the standards and directives; 5 implementing documents; 3 guidelines; 3 laws and 2 policies. Twelve documents were classified “important” for the FP extension. However, a few targeted adolescents and were translated into operational instructions in place evidence-based regulations to improve access to SRH services by adolescents.

Health 20 (3.9%) out of 515 health districts (HD) were offering adolescents' health activities; currently, 180 (34.8%) out of 515 HD provide services that are adapted to the needs of teenagers [22]. However, the latest available data indicate that access to and uptake of contraceptive methods by adolescent girls remains low and unmet needs increasing [23]. Outside barriers are the lack of knowledge [24] [25], the misinformation and myths about contraception [26], the provider bias against the demand of the FP by adolescents [27] [28], and the financial barriers [29]. In the DRC, more than one uncoordinated specific health programs (SHP) are involved in the organization of the FP for adolescents [22] [30]. Other frequently cited bottlenecks preventing adolescents from the uptake of FP are the unavailability of significant number of friendly services for teenagers [31] and the frequent fragmentation of adolescent's SHP in many countries [32], including the DRC. In the meantime, few studies evaluated the policy formulation process, the regulation and the content of FP policies toward specific needs of adolescents in the DRC. On the basis of the WHO recommendations [13], we aimed to assess policies, laws and regulations of the FP according to the contraceptive needs of adolescents in the DRC. the National Reproductive Health Program (NRHP) prepares the strategic and technical documents needed to organize the provision of FP and stimulate the demand for services [30]; the National Adolescents Health Program (NAHP) develops guidelines, standards, and strategies for the promotion and development of adolescent health [22]; and the National School Health Program (NSHP) prepares strategic and technical documents that organize school medicine and adolescent health education. All these departments target provincial structures, such as the provincial division of health (PDH) and the provincial coordination of NSHP, NAHP, and NRHP; health districts (HD) and health facilities (HFs) (Figure 1).

Study Design
A mixed method study was conducted from April to December 2019 in 74 facilities, including 13 administrative structures at the central, provincial, and peripheral levels of the MOH identified by convenience sampling, and 61 HFs offering the FP services and selected by simple random sampling.

Selection of Surveyed Structures
All visited structures were involved in the organization of the FP activities. They  At the local level, the coordinating team of 3 health districts from Kinshasa (Matete, Lemba, Kisenso) and one HD from Kongo Central province (Gombe Matadi) and 61 HFs were identified in a simple random manner.

Techniques and Procedures for Data Collection
The data were collected through ten semi-structured interviews with the managers of the visited organizations and by document review. Semi-structured interviews were conducted in the DFSGH, the NAHP, and the NRHP; the PDH of Kinshasa and Kongo central, and in HDs at the rate of one semi-structured interview per visited structure. They helped to collect the data on the process of coordination of SRH services and the establishment of FP policies within HFs.
They also helped to understand the context and the process that conduct to the finalization of laws and policies on FP in the DRC. The characteristics of the interviewees of the visited structures are described in Table 1.
Using a semi-structured interview guide, the following themes were explored:

Framework for Analyzing Health Policy Documents
Several frameworks exist for health policy analysis. However, they differ from each other depending on the content under review; some focus on the stakeholder analysis; others focus on the content of the policy or only on the results [4]. To carry out this study, we used the health policy analysis framework developed by Walt and Gilson [33], which takes into account four elements: actors, contextual factors, process and content of the policy ( Figure 2).
In order to assess FP policies, we made a choice to analyze the law laying down the fundamental principles relating to the organization of the public health and two normative documents (standards of health interventions adapted to adolescents  To analyze the content of policies, we relied on a grid prepared on the basis of WHO recommendations for guaranteeing respect for human rights in the provision of FP information and services [13]. This document consists of nine recommendations and 24 sub-recommendations on FP that can be applied to the establishment of policies in FP. Thus, each policy document was examined in relation to each sub-recommendation. This analysis resulted in five categories of responses addressing the conformity of the content in relation to these recommendations. These categories were: 1) Normative guidelines specific to adolescents are present and in line with the sub-recommendations of the WHO; 2) Normative guidelines for the general population, but relevant for adolescents, are present and in line with WHO sub-recommendations; 3) Normative guidance on WHO sub-recommendations is not present; 4) Normative guidelines specific to adolescents are present but do not agree with WHO sub-recommendations; 5) Normative guidelines for the general population, but relevant for adolescents, are present but do not agree with WHO sub-recommendations. We considered that a recommendation was fully, partially or not at all integrated in policy documents depending on whether all of the sub-recommendations, some or none were taken into account in the FP policies.

Review of the Application of FP Regulations in HFs
To audit whether the regulations of the FP for adolescents were applied or no through HFs, we first verified the availability of operational instructions on the FP that were adapted to adolescents. Then, the application of these regulations was assessed through the interviews with FP providers aiming to collect their intentions and attitudes towards the demand of the FP by adolescents. These interviews were combined to the observation of the counseling sessions on FP.

Quality Control and Data Analysis
An exhaustive inventory of existing policy documents was carried out. Each document was read, in order to identify the sub-recommendation(s) to which it was addressed and to ensure its compliance with the directives from the WHO. similar concepts were labeled with the same name. Each concept was then defined in terms of a set of discrete properties and dimensions to add clarity and understanding of the policy environment. At the end of the analysis, important citations that fit in with the purpose of the study were used for illustration purposes.

Results
All identified structures were visited by the interviewees.

Inventory of Policies Organizing the SRH and the FP in the DRC
We inventoried 35 documents organizing the SRH in the DRC. Of these documents, few at least mentioned the FP; while 12 were classified as important for the FP extension in the DRC. These documents were laws, regulatory acts (e.g.
decrees and ministerial orders), policies, standards, and guidelines. Most were developed by 2012; in their majority, they are intended for national and provincial health officials involved in the FP. Some of these documents deal with the general aspects of the organization of FP services (

FP Context and Stakeholders' Analysis
The DRC is characterized by a pronatalist culture pushing women to progress in the future as mothers. The FP is used mainly for spacing than stopping births.
The health system undergoes structural reforms focused on the decentralization.

Process and Content of FP Policies in the DRC
The process that conducted to the establishment of the FP first law and normative documents took up to 12 years. According to the majority of interviewees, the strategy for the policy development was not well refined; some main stakeholders from the government and parliament were not involved at the early stages of lawmaking. An interviewee said: "the process conducting to the adoption of new laws is long and complex in the DRC. Over the years we have been preparing more than one public health bill. However, they have never been discussed in parliament. Therefore, the health sector remained for years without laws. It was in 2018 that officials of the MOH, in collaboration with sectoral partners, resumed pleading with national deputies until the promulgation of the first health sector law'' (AD, general practitioner, 7 years of experience).
The problems raised by unwanted pregnancies and consecutive unsafe abortions for both adult women and adolescent girls are not well stated in this law. In addition, the law just refers to women of childbearing age without specifying that these are women aged 15 to 49. Apart from the general principles set out in the law; no implementing measure (specific laws, decrees and ministerial orders) out of 17 identified has yet been finalized. The impact of this law to improving the uptake of the FP by adolescents aged 15 -19 is likely to be marginal.

Assessment of the Content of Family Planning Policy Documents
The achievement of WHO recommendations and sub-recommendations on the

D. Mpunga Mukendi et al. Health
rights to access to FP information and services was assessed by analyzing the content of each policy document in Table 2. We present the synthesis from this analysis, with focus on the integration of each recommendation and sub-recommendations in policy documents (Table 3).
Of nine WHO recommendations on the right of accessing to FP information and services by adolescents, one (11%) was fully integrated into one or more policy documents, two (22%) were partially integrated, and six (67%) were not yet integrated into national policies on FP. On the other hand, of the 24 WHO sub-recommendations, 5 (21%) were included in FP policies with focus on adolescents' aspects, 6 (25%) sub-recommendations integrated into national policy documents do not specifically target adolescents, and 12 (50%) were not integrated. One (4%) sub-recommendation integrated in policies was inconsistent with orientations from WHO.
Recommendation of the non-discrimination This recommendation was fully integrated through national policies; such as the constitution of the DRC; the law laying down the fundamental principles relating to the organization of the public health; and the law on the implementation of the rights of women and parity. The last law states: "…the public authorities shall ensure the elimination of all forms of discrimination against women and ensure the protection and promotion of their rights". And "…the State shall develop a policy which encourages, by means of incentives, the construction, from public or private funds, of information, training, promotion and defense centers for the rights of women and young girls in each village, group, chiefdom, sector, district, commune and city".   Recommend that communities, particularly people directly affected, have the opportunity to be meaningfully engaged in all aspects of contraceptive program and policy design, implementation, and monitoring X 9. Accountability Not integrated 9.1 Recommend that effective accountability mechanisms be put in place and are accessible in the delivery of contraceptive information and services, including monitoring and evaluation, and remedies and redress, at the individual and system levels X 9.2 Recommend evaluation and monitoring of all programs to ensure the highest quality of services, and respect for human rights must occur Recommend that, in settings where performance-based financing (PBF) occurs, a system of checks and balances be in place, including assurance of non-coercion and protection of human rights. If PBF occurs, research should be conducted to evaluate its effectiveness and its impact on clients in terms of increasing contraceptive availability X trained in both adolescent SRH and FP ( Figure 3).

Review of the Application of FP Regulations and Policies in HFs
Available policy documents were the standards of health interventions adapted to adolescents and young people; the standards of FP interventions; the collection of messages on FP and the technical sheet for medical care in FP. Twenty percent of HFs had FP data sheets and 51% had materials for SRH education ( Figure 4).
The majority of policies were not applied within HFs. The low availability of operational instructions appeared to be a major problem among FP providers. A nurse in charge of a health center declared: "we find it difficult to prescribe some contraceptives to adolescents who come alone; our partner asks us to do it but we have no written instructions on what and how to do it. So, we hesitate" (MM, Health center manager, Kongo Central).
In the absence of clear written operational instructions, some providers are reluctant to prescribe contraceptives to adolescent girls. They feel they are not secure enough to do this. It sometimes happens that the prescription of contraceptives to adolescents leads to the arrest of the provider by the security services   which consider him to have committed an offense as shown in this statement: "In the past few days, one of our nurses had placed an implant in a teenage girl at her request. After this activity, the teenager's parent went to complain to the security services, which led to a brief arrest of the nurse" (VM, Expert, DPS of Kinshasa).

Discussion
The main results of this study showed that in the DRC, many policy documents, such as the FP strategic plan; the growth and poverty reduction strategy document; the reproductive, maternal, newborn, child, and adolescent health strategic plan; and standards for FP interventions are intended to improve the delivery of FP services. However, they do not contain actions clearly intended to improve   [19]. However, the incoordination of adolescents' health programs is also observed in other health systems, as is the case in India [31]. The weak regulation of FP results in the co-existence of FP policies that are ambiguous or even contradictory; thus, hindering access to and uptake of FP by adolescents. The law on fundamental principles on public health establishing the FP does not clearly define the woman of childbearing age [18]; this situation is pushing to various interpretations, tending to exclude adolescent girls aged 15 to 17, especially since the law on the protection of children covers youths up to the age of majority fixed at 18 years. At the end of the law on child, adolescents under 18 years were placed under parental authority with regard to their health; which means that children under 18 years cannot decide for themselves to use FP services and methods [36]. Apart the child protection law, some provisions in the family code of the DRC [37] which set aside the automatic emancipation of children under 18 years from the marriage or getting job also could limit the access and uptake of FP by adolescents. In public health, the women of childbearing age encompass the age group of 15 to 49 years. In view of these facts, there is no legal basis to justify and protect the demand of FP services or to prescribe contraceptive methods to unaccompanied adolescent girls. Adolescents who have reached the age of majority enjoy, in terms of access to FP services, benefits provided by laws and other policies in force [18] [20] [38]. Until 2018, the Congolese penal code which prohibits FP remained unchanged [39] [40]. Even, two years after its promulgation, the law on public health has not yet been applied, as none of the implementation measures are not yet finalized. Regulatory problems in the DRC also result in the virtual absence of specific policies focused on the use of particular contraceptive methods (i.e. subsidization of FP services for teenagers; prescription of implant, DIU and others), as is the case in some countries [30]. Our results show that the process of formulating policies in the DRC remains long and complex; adolescents and health providers are not sufficiently involved in the establishment of FP policies. The laws give to minors less opportunity to express their opinion; it forces them to submit to parental authority for the satisfaction of their health needs [36]. These facts violate the eighth recommendation of the WHO to ensure respect for human rights in the provision of contraceptive information and services [13].
Of all FP policies, the useful information booklet on health services adapted to the needs of adolescents and young people [41]; and the norms of health interventions adapted to adolescents and young people [42] are more informative on FP for both providers and adolescents. They describe the criteria required for a health facility to be considered as friendly for adolescents and young people.
Unfortunately, these documents are also lacking in HFs.
The majority of instructions developed by the MOH aim to regulate and promote modern contraceptive methods as more effective than traditional me-D. Mpunga Mukendi et al.
thods [18] [20]. Apart from the strategic plan for the health and well-being of adolescents and young people [22], there is little emphasis on traditional methods and adolescents' education in SRH. Yet, studies indicate that in the DRC, adolescents have unmet needs in both modern and traditional contraceptive methods.
The 2018 MICS survey [23] estimated unmet needs in FP among adolescent girls at 33% and 56% for those living in couple and those not in a couple respectively. In practice, some adolescents use traditional contraceptive methods; those in school receive sex education often considered as taboo in families [25] [26].
Adolescents make up a significant portion of the world's population. In view of their important role, their better health is currently one of the global priorities of the Global Sustainable Development Goals (SDGs) [43]. Some recent FP policies in the DRC do not rely on any evidence from robust studies. Even, they are poorly evaluated, unlike other countries around the world [44].
In view of the current expansion of contraceptive services, it is important to improve their quality. Recent studies have shown that FP activities are not systematically organized within HFs in the DRC [16] [21]; and that some HFs do not ensure the services meeting the needs of adolescents [31]. This situation could be due to the unavailability of operational instructions and guidelines; the lack of trained FP providers and the poor quality of supervision, well known as a mean to improve the quality of services [45]. It is important to monitor the social needs of adolescents by applying the tool published in 2013 that analyzes the respect of the rights of children and adolescents [46].
According to this study, the weak regulation of FP could largely explain why contraceptive prevalence remains low among adolescent girls and the adolescent fertility rate higher in the DRC [23]; despite the combined efforts in terms of extension of FP services between 2014 [21] and 2018 [47]. Sexuality education and awareness programs for adolescent girls in the prevention of early and unwanted pregnancies are not systematically formalized. Parents, teachers, health care providers and other structures in charge of adolescent sexuality education do not feel an obligation to provide them with the quality information and service's needs. There are no specific laws and policies obliging health care providers to disregard their biases before offering FP services to adolescents. There is also no clear policy defining financial accessibility to contraceptive services for adolescent girls. The rapid expansion of FP services is more palpable in urban areas than in rural areas where the needs are important [21], but there is no clear political orientation in this direction.
Also, the existing laws, regulations and policies are insufficiently enforced; for example, a national study estimated in 2018 at 29% the proportion of early marriages among adolescent girls [23]; while the law on child protection is supposed to fight against early marriages.

Strengths and Limitations
This study was the first that combined qualitative and quantitative approaches to investigate the FP policy environment at the national, provincial and local levels of the MOH in the DRC. The main limitation could be linked to the document review procedure that may not have been exhaustive; due to the problem of archiving documents. However, in order to minimize this limit, the study results were validated by the MOH officials.

Conclusion
It is undeniable that the adolescent is an important and relevant target of FP.
The results of this study showed that FP among adolescents in the DRC faces several challenges, in particular the inadequate regulation and standardization.
Current policies are unsuitable with international standards in FP. Adolescents do not have a legal basis guaranteeing secure access and the unhindered uptake of contraceptive services. To improve access to and use of contraceptive services and methods by adolescents, it is therefore important that the evidence-based regulations be established; improved; monitored; and evaluated in order to boost access to and uptake of FP services by adolescents. Improving the use of the FP service by adolescents should contribute to the better health status of women, families and the community.

Prospect
In perspective, there is a need to discuss with adolescents about important aspects of FP that they would like to include in policies.

Ethics Approval and Consent to Participate
The research protocol was reviewed and approved by the Ethics Committee of the School of Public Health of Kinshasa (ESPK) under approval number ESP/CE/027/2018. Before collecting the data, we obtained authorization from national, provincial, and local health authorities.