Abstract
In 2014, the IHR Review Committee recommended moving from exclusive self-evaluation to a combination of domestic and independent experts and began the process in conjunction with stakeholders to develop the Joint External Evaluation tool. The tool was launched in February 2016, and at the 2016 WHA, the IHR Review Committee recommended that all states parties should undertake assessments of their core capacities using the JEE tool and results of other evaluation processes such as the OIE PVS. A goal was set to conduct 50 country JEE assessments prior to WHA 2017. It is notable that legislation was added as a separate element of the JEE tool coupled with 2 indicators. Given the importance of law to the development discourse today, more needs to be done with the JEE with regards to legislation for the benefits of the law to be realized in global health security and overall in health outcomes. As we are at the 1-year anniversary of the tool, and WHO has begun a review of the JEE tool and requests for feedback are circulating, this article focuses on the JEE element of legislation and proposes some simple and substantive fixes. Considering the importance of law in the context of the GHSA, the results of the JEE tool are reviewed, and, drawing on the author's experience with the tool and other IHR and GHSA legal assessments, a case is made for a significant revision of the tool section on legislation and the manner in which the subject of legislation is integrated during the evaluation process.
S
To monitor progress and to aid implementation, a number of evaluation tools have been developed, including some specifically on legislative implementation, and the WHO has conducted regional workshops to orient member states to the legislative and other dimensions of IHR. 4 In 2014, the IHR Review Committee recommended moving from exclusive self-evaluation to a combination of domestic and independent experts and began the process in conjunction with stakeholders to develop the Joint External Evaluation (JEE) tool. 5 The tool, which was launched in February 2016, has 19 technical areas, including legislation, drawn from the GHSA, the IHR, and the PVS. At the May 2016 WHA, the IHR Review Committee recommended that all states parties undertake assessments of their core capacities using this JEE tool and results of other evaluation processes such as the OIE PVS. 6 A goal was set to conduct 50 country JEE assessments prior to the WHA in May 2017. 7
Notably, one of the JEE tool technical areas is national legislation, policy, and financing. It is remarkable that legislation was added as a separate technical area, especially since legislation or law is not an explicit part of the overall GHSA, except in 1 package, Respond 2, which links public health with law and a multisectoral rapid response, even though law is essential to protecting public health and to all other agenda items. 8 Placing legislation as a technical area is also an incredibly important development in health security and health sector reform. Given the importance of law to the development discourse today, more needs to be done with the JEE with regards to legislation for the benefits of the law to be realized in global health security and overall in health outcomes.
As we are at the 1-year anniversary of the JEE tool, and WHO has begun a review of it and requests for feedback are circulating, it is timely to reflect. This article reflects on the JEE element of legislation. Considering the importance of law in the context of the GHSA, the results of the JEE tool are reviewed, and, drawing on the author's experience with the tool and other IHR and GHSA legal assessments, a case is made for a significant revision of the tool section on legislation and the manner in which the subject of legislation is integrated during the evaluation process.
The JEE Process
Joint External Evaluations are completed in 2 stages: an initial self-evaluation, conducted by the country using the JEE tool, followed by an in-country evaluation conducted by a JEE team of multisectoral experts from member states, the WHO, the World Organization for Animal Health (OIE), the Food and Agriculture Organization, INTERPOL, and other key international organizations. During the second stage, a period of 5 days, an evaluation is conducted on the 19 technical areas in the tool. Each of the 19 technical areas in the JEE tool is assigned indicators that evaluate capacity with a score of 1 for none, 2 for limited, 3 for developed, 4 for demonstrated, and 5 for sustainable capacity. Criteria that can be used to evaluate capacity at each score are included in the tool; these, along with the indicators for legislation, are shown in Table 1. In addition, as for all technical areas, a target capacity is described at the beginning of each. The target capacity for national legislation, policy, and financing is displayed in the sidebar.
“State Parties should have an adequate legal framework to support and enable the implementation of their obligations and rights to comply with and implement the IHR.”
Current Criteria and Indicators
The JEE team works with host country officials to assign and report scores for each indicator, as well as identifying strengths and best practices, areas that need strengthening, challenges, and 3 to 4 key priority actions for each technical area. The goal of the JEE process is to help the host country prioritize actions that will most effectively increase “capacity” and, consistent with IHR obligations, develop a national plan of action. 9
From May 2016 to April 2017, a number of evaluations were conducted, and reports are available for 19 of these. The 19 reports were analyzed to understand how countries reported capacity in the area of legislation. The description of the 2 indicators and the criteria to be used according to the JEE tool to evaluate capacity were compared to the scores. The numerical scores from each of the 19 reports, as well as a summary of what each indicates is a priority for legislation, are shown in Table 2. 10
Summary of Legislation Indicator Scores and Priority Actions
The reports do not indicate the characteristics of the experts on the teams, though the team compositions were different for each country. Anecdotally it is known that on some evaluation missions there was no lawyer and that a non-lawyer provided the evaluation of the legislation area. It is not known in how many JEE studies there was no legal expert, but 4 countries—Lebanon, Liberia, Bangladesh, and Jordan—specifically reported a lack of legal expertise to implement the laws and a lack of awareness around the laws. The legal expert would interview the legal advisor to the ministry of health, if there is one, or the person from the office of the attorney general assigned to the health sector and also find and assess national health-related legislation and other legislation not specific to health but relevant to GHSA. Administrative law is a topic that covers how ministries function across government and is the framework for many administrative arrangements. Over the course of 5 days allocated to the evaluation, some days are spent sharing and reporting results to national stakeholders, leaving about 3 days total for technical evaluations, including for legislation. The time for the JEE is very short—especially to review the volume of legislation in most countries.
Findings
Table 2 displays the scores for the 2 legislation indicators and a quick summary of the priority legislative actions identified for the 19 countries for which reports are available. 11 Only one country, Somalia, scored 1 on both indicators, signifying there is no legislation capacity, that no assessment has been done up to the date of the JEE, and that it cannot demonstrate it has adjusted its legislation to enable IHR compliance.
Two countries, the United States and Armenia, scored 5 on both indicators, signifying each has policies to facilitate IHR and coordination of the legal and regulatory frameworks between sectors. The results for the remaining group of 16 countries will be reported. Half of the remaining country scores were 2 on indicator P1.1, meaning that an assessment of legislation had been done, and 6, or more than a third, scored 2 on P1.2, meaning they could not demonstrate any adjustment or alignment of national legislation for IHR but could identify gaps. Three countries scored 3 on P1.1, which means that, according to the tool, the country is implementing assessment recommendations. On the same indicators, 3 countries scored 4, representing that the country has policies and core capacities. Scores of 3 and 4 indicate a developed and demonstrated capacity in the 7 countries, or just under half of the remaining 16. For P1.2, 7 countries scored 3, meaning they could demonstrate the existence of legislation, and 3 countries scored 4, meaning the country has legislation. In summary, of 16 countries, exactly half have not assessed legislative needs and more than a third have not taken actions to align legislation with the IHR. Ten of the 16 country reports indicate having relevant legislation and legislation for specific areas.
Turning to the priority legislative actions, these were counted as follows: if the term “implement” was included, meaning there was legislation enacted and ready to implement or that was being implemented, or, in the case of the United States, which reports ongoing evaluation and revision as needed, all reports that indicated the terms “review, revise, and adopt” were counted together. Three reports indicated that the countries were in the process of implementing legislation. One reported this was done and that the later stage of legislation and periodic review was under way. The other 15 countries reported they were in the phase of review, revision, and adoption, meaning they were engaged in the technical and political process to move a piece of draft legislation through parliament. Of these 15, a total of 7 scored 3 and 3 scored a 4 on indicator P1.2, which signifies a country already has legislation. Eight reported scores of 3 or 4 on P1.1, meaning an assessment had been done prior to the JEE but that their priority is to conduct a review.
Discussion
While a total of 19 reports does not permit any statistical analysis, these do allow some observations that may be the basis of changes in the tool or the way the evaluation is conducted, or both. And these are timely since the tool is under review. A comparison of the numerical scores on the indicators and the priority actions point to the fundamental weaknesses in the legislation indicators, and thus the value of the JEE tool in its current format, to guide a state on where it stands in terms of legislation and what steps to take next. These weaknesses can be characterized and grouped by the disconnect among the indicator criteria, scores, and the priority actions; the challenges presented by the terms “adequate,” “sufficiently,” and “legislation”; the lack of legal capacity; the lack of space for legal consideration of the other 18 elements of the tool; and the missing step of mapping the executive branch and administrative structure of the government.
This review of the indicator criteria, scores, and priority actions highlights a disconnect resulting from criteria that are not differentiated for clear and consistent application and that do not reflect the process of legal reform. Particularly problematic are the criteria for P1.2 at scores 3 and 4. The difference between “demonstrating the existence and use of relevant laws” for score 3 and “the country has legislation” in score 4 is simply unclear. If a country can demonstrate it has legislation, it has legislation, so it is hard to decipher a difference in order to apply the score. Having legislation in place sufficient for IHR is the same as adjusting and aligning domestic legislation. Aligning and adjusting are the tasks that result in legislation that is sufficient.
The comparison of scores and priority actions also raises concerns. For indicator P1.1, a score of 2 means an assessment has been carried out and gaps identified, but so far no further action has been taken. So, it is unclear why 8 of the 19 evaluations note that it is a priority to conduct a review. Six of the reports note a score of 3 or better for indicator P1.1 and show the same priority action: the need to review or assess legislation in 14 reports. Comparing the results indicates that in 6 of the 19 scores there is a difference between P1.1 and P1.2: 4 scores are higher and 2 are lower. Yet, in the country reports scoring 3, meaning the country is implementing the legislation, the priority action is to implement the legislation. The scores and priority actions do not match up.
With only 2 indicators, the results of the JEE in the realm of legislation cannot begin to illuminate any aspects of legislation relevant to the 18 other areas that comprise the substantive public health dimensions of global health security. Given that many of the technical areas of GHSA operate during emergencies and disasters or require mandates and authority to direct behavior of different actors, the primary role of legislation to permit, prohibit, or define behavior is inescapable. The power to quarantine or mandate vaccinations before school attendance are just 2 examples of the essential nature of law to health security.
Moreover, the point of the JEE is to help a country to identify gaps and develop a comprehensive national plan. During the JEE tool revision process, it is important to keep in mind that to “implement” the IHR and GHSA agenda packages means that a wide set of actors, including government and private sector actors, must function, perform, or behave in certain ways essential to the fulfillment of the IHR obligations and meet GHSA targets. This requires an orchestration of many actors, such as providers of healthcare services, those that perform traditional public health activities of epidemiology, reporting, laboratory and surveillance, health professionals, the medicine regulators and members of that sector, provincial and central governments, law enforcement, the military, and other branches of government. Understanding how legislation describes and circumscribes these relationships and the authority, limits, and responsibility of each is critical to the success of the GHSA goals, and if there is to be any value in doing a JEE, the tool must guide countries on how to understand this. Two indicators are simply insufficient.
The target capacity for legislation is that a state party has an “adequate” legal framework to sufficiently support IHR implementation. Each technical area has a different target, and no others are framed with the term “adequate.” Although targets are not indicators in the JEE tool, the target does define a goal toward which the indicators measure progress. Simply put, the tool in effect states that having capacity means having adequate legislation. The problem with this manner of describing capacity for legislation is that, in the discipline of global health, to date, there is no consensus or even analysis of what makes a legal framework adequate. 12 “Adequate” may be incapable of a global definition of any use given the numerous areas law touches, the different goals law can be used to address, and a judgment regarding the level of law necessary to achieve the goal. The application of the tool and work of IHR implementation are significant tasks. To use a term that suggests there is some standard is problematic, because officials and JEE experts can interpret “adequate” to mean that there is a best practice.
A barrier to determining and improving legislation capacity arises from the lack of fluency in the law of most health professionals and the lack of legal experts in the health sector at the country level. Legislation is defined in the tool to include all of the many legal instruments that are possible in a legal system, starting with the constitution and including laws, regulations, decrees, ordinances, and others. Often the terms “law” and “legislation” are used interchangeably, but for the JEE tool and others, the term used is “legislation” to indicate the wide range of instruments that can be considered. It is correct to describe legislation as including any type of legal instrument, but identifying what exists and which to use in any circumstance are specific tasks for which legal skills are needed. The section of the tool that includes legislation also contains policies and administrative arrangements, both of which are informed or influenced by legislation, making legislation the primary instrument, but neither are legislation in any sense of the term and are perhaps better placed in another section of the tool.
In the field, the term “legislation” is interpreted too often to mean that the only solution to legislative gaps is new laws, and that means going to parliament—a discouraging prospect, given the challenges that accompany a parliamentary process. This misunderstanding also precludes consideration of other forms of legal instruments and sources of law that are not obvious. An example is the way some countries manage the coordination of differing political entities, such as in decentralized systems, or those that have “rules of business” or a system to manage which office is responsible for what. These areas of law, not in the usual horizon of the health sector, are essential to IHR implementation. Clarifying the meaning of these terms at the outset of a JEE would avoid their being misunderstood.
Plaguing the process of IHR legislative implementation is the fundamental capacity gap in the realm of legislation; there are few if any lawyers dedicated to the ministry of health. In 4 reports at least, the lack of legal capacity was identified as a barrier to IHR implementation and a priority fix. The international community should address this need. In some cases, the health team has never spoken with the legal officer assigned to health. This is often revealed during workshops and country technical assistance activities, such as in one country when the topic of data confidentiality arose. It had been a barrier to building an integrated human and animal health data surveillance system, but, once the legal advisor was consulted, it was clear that there was existing specific law on point that resolved the issue. The urgency of global health security demands that all tools are on hand; it is urgent that working relationships between the legal and public health communities are developed. There is opportunity in the JEE process to bridge this gap.
Legislation does not stand by itself, nor does it implement or enforce itself. It operates by first and foremost establishing the institutions that are responsible to fulfill GHSA targets and IHR responsibilities. The tool does not map this foundation. Not knowing which office does what can lead to misleading results. In the health sector, there are several areas in which some functions are managed by more than one office or, in some countries, not at all or even by a nongovernmental organization. An example is reporting. Medical professionals are natural reporters, given their exposure to patients, but in some countries they are not mandated to report; thus, a significant surveillance source is not available. Medical professional regulation is often governed by an act such as the nursing council act that provides authority to impose obligations to report, but unless the councils take this action, reporting is not mandated and surveillance is impeded. Mapping the actors and authorities is an essential step to determining the situs of the legislation. Even more fundamental is whether or not there is an appropriate ministry to regulate at all. For example, some countries have no functioning medicines regulator; how can these countries be expected to control AMR or vaccinate citizens? 13 Thus, when the JEE process does not include a step to map the system, the process is shortchanged and the results are incomplete.
Simple Fixes
Fortunately, simple solutions are available and can be adopted even if no changes are made to the JEE tool itself. A simple orientation at the outset of the JEE can start by making clear to JEE team members that “adequate legislation” refers to a group of legal instruments, what they might be in the national legal and political system, and that together these provide the legal authority to a government to meet its IHR obligations. This approach contextualizes the definition to each country, rather than giving the impression there is some precise formula.
To address the lack of specificity of the indicators with regard to the other 18 areas in the tool, a simple fix is to add a legislation query for each other technical area during the evaluation process. Legislation is intricately woven into all the elements of the JEE, forms the exoskeleton of IHR, and is the critical enabler of the public health activities necessary to preventing, detecting, and responding to infectious disease threats, no matter the source. The orientation can pave the way for the legal expert to work with the other experts to pinpoint legal issues for each specific technical area. This will allow reporting on the legislative status overall and with particularity on each technical area. This approach makes the timing of the work of the legal expert a challenge, but this can be managed with scheduling and a day or 2 of pre-mission work by the legal expert to get a bit ahead.
There is already a significant body of work in the realm of IHR legislative implementation and a set of tools created by WHO. 14 Simply put, the tools and guidance materials take each IHR section and describe in some detail what to consider and lead to functional conclusions on gaps and next steps. While there is always room for improvement of tools, it is unfortunate that it does not appear that any of this excellent comprehensive work, backed by experience on its use, was referenced or used in the JEE tool. This can and should be corrected during the revision process by integrating and using the material instead of creating a new tool.
Another step that can be added prior to the start of a JEE is to map the government. This mapping would aid all the experts in the conduct of their part of a JEE and is important for the integrity of the JEE itself. Recognizing that achieving IHR goals is a multisectoral activity, a wide range of stakeholders are implicated, and to complete the JEE they must be contacted. Many are outside the domain of health, such as those from the spheres of legislation and the chemical and nuclear sectors, among others. This is work the legal expert can do easily and must do to find the source of relevant legislation while at the same time identifying the offices where appropriate informants sit, so that those scheduling informant meetings are aided. Otherwise some important meetings are missed, as has been the case.
In order to align the indicator scores and priority action steps, it would be useful to have indicators and criteria that reflect the process of legal reform, which is what must be done to make sure a country has aligned and adjusted its domestic legislation to the IHR, PVS, and GHSA. The phases of legal reform as a guide would more accurately indicate the legislation capacity of a country. Table 3 is a chart of draft proposed indicators and criteria (in bold) that are presented according to the process of legal reform and represent the 2 lines of effort necessary to implement any legislation, including IHR. These are the formal, technical legal drafting and political processes to make legislation under indicator 1.1 and then the implementation side of legal reform under indicator 1.2 or the day-to-day activities that make legislation operational. Legislation does not implement itself; people do. 15 The proposed draft indicators and criteria demonstrate this integral relationship.
Draft Proposed Indicators and Criteria
Note: Changes are noted in
Legal reform begins with an assessment, but assessment is not a one-time process. Reform is a layered process, and it is iterative as a plan to implement IHR is developed with the public health and other experts who will effectuate the plan. There are 18 other areas of the JEE tool; all have legal aspects, one of which is to determine the correct legal instrument necessary to accomplish the objective. The tool refers to legislation and policies, and the criteria refer to administrative arrangements. One or more of these may be necessary as part of the adjustment and alignment and along with practical implementation and scientific issues. As these are calculated into a national plan, legislation will have to be “reviewed” to check that each option is supported or not to the extent legally necessary. Thus, unless the JEE criteria, indicators, and scoring are adjusted to reflect the real world of legislation reform, it will not be useful to guide next steps on a national or global level.
It is noteworthy that awareness around the role of law, the term used in recent materials rather than legislation, has risen in importance and even priority in the context of development in just the past few years. The 2017 World Development Report titled “Governance and the Law” rightly proposes principles relevant to the topic of legislation and the JEE. 16 The 2 principles of relevance are to think about the form of institutions but also their functions and not only the rule of law but the role of law. Moreover, rule of law is prominent in the 2030 Agenda for Sustainable Development; positions effective, accountable, and inclusive institutions at the core of sustainable development; and is to be integrated into all other goals, including SDG 3 for health. 17 A subcomponent of SDG 3 is to strengthen national capacity for health risks. As the relationship among law and health and security is now unavoidable, the revision of the JEE tool and process should elevate the place of and process around law and legislation, too.
Conclusion
It is now more than 10 years since the IHR were adopted by the WHA. The matter of every country's capacity to detect, prevent, and respond to threats, whether occurring naturally, deliberately, or by accident, is no less urgent now and will certainly become more so at the outbreak of the next crisis. The results of the JEEs will be seriously considered at the May 2017 WHA, and the international community will rely on the JEE findings to set out plans for supporting country action plans and to evaluate more countries beyond the first-year goal of 50. The scores and indicators should serve each country in developing actionable plans and the international community in devising programs to support countries. But with scores that are unreliable for all the reasons stated in this article, the next steps are not as clear as was surely hoped.
This article reviews scores from the 19 reports available now on JEEs completed since May 2016 and highlights that, in more than half of the reports, a legislative priority is to review legislation, even though the scores indicated assessments had been done. That scores do not match reported priorities renders the results of the JEEs so far unreliable. Other indicators cannot be differentiated such that some scores mean the same thing. The JEE was not created to be an end in itself but, rather, a sign post to areas in a nation's health system that require change.
For the full value of the JEE process to be realized, an accurate picture of the legal environment must be part of the JEE. The legislation section of the JEE tool does not provide this assessment. Simple fixes that do not require a complete revamping of the JEE tool are available, and some are suggested here: mapping the government, adding a pre-mission orientation to explain legal instruments and that not all require parliamentary action, and an opportunity for the legal expert to sit with each other technical expert during the process to clearly identify legal issues for each. In addition to simple fixes, substantive changes to the indicators that reflect the process of legal reform and the integration of the existing IHR legislative implementation materials will make the tool more effective to realistically highlight legislation priority areas and components of national plans.
