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Health system stewardship and regulation in Vietnam, India and China

Final Report Summary - HESVIC (Health system stewardship and regulation in Vietnam, India and China)

Executive Summary:

'Health System Stewardship and Regulation in Vietnam, India and China' (HESVIC) was a multidisciplinary and multi-partner project implemented over three years (July 2009 - December 2012) with financial support from the European Commission's (EC) Seventh Framework Programme (FP7). It investigated regulation as it relates to wider governance in policy and practice of health systems in maternal health for Vietnam, India and China.

HESVIC used maternal health as a particular critical case study to investigate health regulation and to support policy decisions that would improve accessibility, affordability, equity and quality coverage of health care in the three countries. This research focus was captured in one overarching and five individual research questions (RQs).

The study was carried out in a challenging context where the health systems studied have become more complex, characterized by increasingly dominant private sectors, public sectors adopting revenue generating methods and varied arrangements for decentralisation of health care. We set up a mixed method, multidisciplinary and multi-partner study and sought convergence between diverse conceptual research views, as well as ways to deal with heterogeneous governance approaches and health regulations in the three countries.

To do so, we identified an overarching framework to conceptualise and critically analyse health regulation and governance. We improved our understanding of regulation processes and through them of determinants for governance. We developed an integrated approach to assess regulation, with scope for variation in evaluation strategy and instruments. Our research indicates that the effects of the studied regulations on access to quality maternal health care were weak in the three countries, under the circumstances prevailing at the time of study. Failures to regulate healthcare delivery had potentially major consequences on avoidable mortality and morbidity. Factors explaining regulatory failure or success related to the content and structure of those regulations as well as their implementation.

Finally, in order to develop motivated support for policy decisions, we compared country case studies and country contexts between Vietnam, India and China. This comparison, using alternative characteristics for a taxonomy of regulations, allowed us to summarize our evaluations of regulation and through it governance, to draw out common problems in developing and implementing regulation as well as factors facilitating their ability to contribute to improved access to quality of care. Our research evidence contributed to ongoing thinking and regulation review by policy makers. In addition, we were able to make recommendations for improving quality of regulation in relation to health.

Project Context and Objectives:

The project context

'Health system stewardship and regulation in Vietnam, India and China' (HESVIC) was a multidisciplinary and multi-partner project implemented over three years (July 2009 to December 2012) with the financial support from the EC FP7.

The HESVIC project research framework outline and action plan were defined in a Grant Agreement with the EC. The seven work packages (WPs) of HESVIC set out specific deliverables to investigate the dynamics of regulation as it relates to governance of health systems in policy and practice. We also agreed an integrated approach to investigate regulation in health services in Vietnam, India and China, to support policy decisions that would improve accessibility, affordability, equity and quality coverage of health care in the three countries.

Our conceptual framework underwent a number of shifts in approach, from general health stewardship to the governance and regulation of health care systems. This shift was based on the experience gained during the subsequent research phases (see below), though it never affected the core concepts of the project. Stewardship was felt to be a very wide and heterogeneous concept so an increased focus on regulation was taken, as a practical way to assess aspects of governance in the health sector. Assessing health care regulation was also deemed of great importance to contemporary policies and was expected to highlight issues of governance including possibly the lack of it.

The health systems of Vietnam, India and China have become increasingly complex, with commonalities and differences between the three countries. First, significant growth in the private sector makes that sector a dominant provider of healthcare services. Second, the public sector itself has often had to adopt revenue generating methods particularly drawing on user fees for cost recovery, creating tension between income-generation and pursuit of health. Third, decentralisation of health care has become a common feature of health system governance, with varied arrangements.

The three study countries involved in this research - Vietnam, India and China - were chosen because of their diverse rates of overall maternal ill-health as compared to other Asian countries: from lagging seriously behind in India to relative improvements in China. The diverse spectrum of issues that determine their health policy-making styles was also important: in terms of the political and economic context, burden of disease, health service performances and the roles of socio-economic organisations in society. Comparing such diverse countries would prove to be a challenge but an opportunity to learn lessons that are applicable nationally, elsewhere in Asia and around the world.

Structural changes, such as health care fragmentation, currently challenge health system governance arrangements and contexts. These changes are particularly challenging for overall effective regulation of the sector, requiring a wider range of regulatory tools, more involvement of non-government actors and a definition of a new role for government.

In order to study health regulation and through it governance, the HESVIC project investigated maternal health as a particular critical case study of regulatory processes and actors. The improvement of maternal health is a key area for policy and health care delivery in low and middle-income countries.

Some of the main challenges identified in the implementation of the HESVIC project were:

1. to seek convergence or agreement between sometimes diverse views of participating social and public health scientists on the methodology framework;
2. to take account of the heterogeneity of the current status of governance and health regulation issues in India, Vietnam and China and at the same time, maintain sufficient compatibility in the methodology for an acceptable level of comparison;
3. to agree upon and provide a common understanding of key concepts and themes among partners (and actors) on the subject of governance and regulation.

The project objectives

General aim

HESVIC investigated regulation as it relates to wider governance of health systems in the area of maternal health in Vietnam, India and China in policy and practice. The project developed an integrated approach to governance and regulation in the area of maternal health in the three countries, seeking to support policy decisions in the application and extension of principles of accessibility, affordability, equity and quality coverage of health care.

Specific objectives

Research-related objectives were:

1. to examine the application of international standards in governance and regulation of maternal health activities - to the extent that such standards exist;
2. to develop a typology of private and public practitioners involved in maternal health in the three study countries;
3. to outline national standards for governance and regulation of maternal health activities in the three study countries;
4. to explore the effects of governance and regulation of maternal health care, services and systems on equitable access to quality maternal health care, within and across each study country;
5. to disseminate the results and recommendations widely to the government and other key health sector stakeholders in the three study countries and to the professional/scientific community.

Other objectives:

1. to enhance the capacity of the partner research institutions in health systems research
2. to increase sustainable collaboration between the Consortium partners.

HESVIC RQs

Our concept of 'regulation' was defined as a way of intervening in imperfect markets or in non-marketised systems to ensure that certain quality and equity standards are met. Such intervention can be to ensure that those engaged in the provision of health care (whether in the public or private sector) do not exclude 'public' objectives like equity and access. Regulation was thus addressed as it related to the specific context in which health care is provided both in public and private services. The nature and type of regulation of the health sector (in terms of emphasis) varied from one context to another.

The boundaries of HESVIC research were defined by a set of RQs, presented below.

Overarching Question: How does regulation and through it governance, affect equitable access to quality health care?

RQ1. What approaches and processes exist for regulating maternal health care and how do they operate in practice?

1. What are the approaches (A, B, C, D) of regulation: comparison across the maternal health system?
2. How is regulation interpreted and implemented in practice?
3. What are the strengths and problems of these approaches and processes?
4. Why do these approaches and processes exist in these contexts?
5. What does regulation intent to achieve? For whom, to what end?
6. What is the role of information in regulatory processes?

RQ2. Who are the actors involved in the regulation of maternal health care, what are their roles and power relations?

1. Who are the actors in the different approaches and processes of regulation?
2. What are the aims and priorities of these actors?
3. How are these actors involved in the different approaches and processes and to what degree?
4. How do these actors relate to each other?
5. What is the level of influence of these actors on regulation of equitable access to quality maternal health care?
6. Context and history.

RQ3. What are the effects of regulation on equitable access to quality maternal health care?

1. What is the current status of and obstacles to equitable access to quality maternal health care?
2. To what extent are these obstacles addressed in existing regulations?
3. What are the effects of regulation (approaches and processes) on quality of maternal health care?
4. What are the effects of regulation (approaches and processes) on equitable access (to quality maternal health care)?

RQ4. What are the differences or similarities between regulation of maternal health care and health care in general?

1. What are the differences or similarities between regulatory approaches, processes, actors and effects?
2. If there are differences, why is it so?
3. What are the implications of HESVIC findings for equitable access to quality health care in general?

RQ5. How could regulation be improved to enhance equitable access to quality maternal health care?

Project Results:

Introduction

The main results of the HESVIC project are:

1. The research explored the effects of health regulation on equity, accessibility and quality of health care in Vietnam, India and China using a compatible framework;
2. The study identified composite determinants of health regulations and influential relationships involved in regulatory processes in Vietnam, India and China;
3. Based on the research, recommendations were made for improving the quality of regulation in relation to maternal health services: For each research country, we made specific policy recommendations for national standards and recommendations for actors (including policy makers, health managers, regulation administrators and members of professional and users' associations), while for each country, we developed specially tailored materials, such as policy guides for national and international health policy-makers on improving the quality of stewardship and regulation in the study countries and beyond;
4. The research findings have and will contribute to improve health policy decisions related to the provision and financing of equitable maternal health services in Vietnam, India and China and provided lessons for other countries.

To achieve this, the project methodology comprised four essential key tasks:

1. Explore regulation effects on 'equitable access to quality healthcare delivery', as well as any other intended or unintended effects;
2. Analyse how the regulation processes might explain the nature of the observed regulation effects, keeping eyes open for any 'critical event' (here defined as relatively rare incidents revealing some systemic or systematic error);
3. Explore relevant actors' roles in regulatory processes;
4. Analyse the environmental features (of transition economy countries) determining the behaviour of the above actors.

One challenge was to develop a multinational and multidisciplinary research framework to study how regulation and through it governance, was implemented. We took the view that conceptually regulation was a staged process from design, administration through implementation to monitoring and evaluation. Additionally, the research framework had to be able to assess the impact of regulations on both health status and the health system. Last but not least, such a research framework had to be practical - useable by researchers working in diverse contexts and backgrounds. The specific issues related to these challenges arising from the experience by the HESVIC consortium of developing framework research methodology are explained in the section below.

HESVIC research methodology

The research mixed qualitative tools with quantitative analysis of secondary data, drawing on multiple research disciplines such as epidemiology, political sciences, economics, ethnology and sociology.

From the early stage, the consortium made an explicit choice to adopt a set of important principles underpinning the research methodology framework, as listed below:

1. The primary research focus for HESVIC was to be on regulation in maternal health care within the wider secondary focus on governance.
2. Governance principles were to be examined through insights into regulations and regulatory processes.
3. A case study approach was to be used to explore the effects of regulation on equitable access to quality maternal health services and to assess governance.
4. The study of regulations (processes, approach and effects) was to be informed by problems and achievements with respect to equity in access to quality maternal health care. The aim was to study how key issues in these domains are influenced by regulation and by governance.
5. The research process had to be incremental i.e. phased.
6. The research process had to be cyclic, to enable exploration and validation. This meant that complementary information could be added, depending on initial findings. Any additions, however, had to respect the main research objectives and take into account the feasibility of data collection and need for comparative analysis;
7. The research methodology had to be sufficiently flexible to accommodate research information needs, while remaining feasible and appropriate for the three study country contexts.
8. The study had to attempt to achieve an optimal balance between context-specificity and comparability of results across the three study countries.
9. The overall research methodology had to be largely exploratory and interpretative.

The broad research framework was developed between October 2009 and June 2010. The public project deliverable D.1.2.a (project methodology for studying and assessing regulation and governance in Vietnam, India and China), was developed between June and November 2010.

Three country mapping reports, one each for Vietnam, India and China, summarized existing information on issues regarding problems and achievements with respect to equity in access to quality maternal health care. These issues were identified and studied using mainly secondary data and (grey and scientific) literature reviews covering the key concepts of stewardship, governance and regulation, developing a typology of actors in health governance and reviewing maternal health and mortality and how maternal health care is regulated.

Each research country then selected three significant regulation case studies within the proposed fields of emergency obstetric care, antenatal care or abortion and patients' grievance redressal. Teams used the developed tools during phase one of the research.

Having assessed the findings of phase one and in particular the lessons learned on the use of research methods and tools, the consortium updated the specific research framework and process, dealing especially with research gaps identified and lessons learned from phase one. In public Project Deliverable D.1.2.b (project methodology for studying and assessing regulation and governance in Vietnam, India and China), developed from February to June 2011, research methods from phase one were adjusted or adapted and additional methods developed for phase two.

Phase three was for the comparative analysis of the project and developed as follows:

1. First, a preliminary comparative analysis of the case study-specific and country level findings was conducted (WPs 2, 3 and 4). Country research teams reviewed the initial analysis which was then adapted for incorporation into the final version of each country research reports.
2. Second, findings from country reports were presented and discussed at a project-level meeting in Shanghai. These initial in-country comparative results helped develop a basic structure and matrix for the Phase Three inter-country comparative analysis.
3. Third, based on the above, the comparative analysis report was drafted, circulated for review within the Consortium and revised accordingly.

The units of comparative analysis for the comparison were the research countries as well as the case studies, or groups of case studies, to the extent that comparing case studies contributed to the project objectives and in particular to the inter-country comparison.

The HESVIC achievements

The HESVIC achievements in terms of research process and research findings were:

1. We identified an overarching framework to conceptualise and critically analyse health regulation and governance;
2. We improved our understanding of regulation processes and through them of determinants for governance;
3. We developed an integrated approach for the assessment of regulation, with room for variation in evaluation strategy and instruments;
4. We compared situations between contexts, case studies and countries;
5. We developed motivated support for policy decisions.

This is explained in detail below.

An overarching framework for health regulation and governance

The HESVIC consortium defined 'regulation' as a way of intervening in both the public and private provision of health care to ensure that certain quality and equity standards are met and to enhance the social role of its actors.

Regulation processes and content are used to provide insight into and assess governance. Universally applied definitions of good governance do not exist and current 'quality' features of 'good governance' have been difficult to apply to the reality of three countries as varied as Vietnam, India and China. The HESVIC study applied quality criteria as formulated by Siddiqi et al to assess governance. The Siddiqi framework guided our theoretical understanding of regulation in this project and was refined throughout.

Improved understanding of regulation processes and through them of determinants for governance

The project studied the possible influences of contextual factors on one or more regulations and their possible effects. It was found that some factors from the context operate individually or interact with each other.

An integrated approach for the assessment of regulation

As a general rule, we used an integrated approach for assessing regulation meaning the research teams looked for problems and achievements in regulatory processes that could help pinpoint issues important to help to understand interventions and the role of actors.

The effect of regulation on equitable access to quality health care representing the core of the HESVIC study, the consortium developed a set of criteria to assess regulation processes and their effects on health. The literature on assessing regulation and its effects on health services in low and middle income countries (LMIC) is limited.

The project defined four broad categories of criteria for assessing regulations, without an order of priority between them. Nor should they possess an intrinsic 'weight' that differentiates their importance. They are the following:

1. criteria to assess whether or not a regulation fits the context requirements;
2. criteria to assess the capacity of actors in regulation processes to carry these out. Also to assess the capacity of invisible actors to interfere with regulation processes;
3. criteria to assess the internal strength of regulation;
4. criteria to assess if a regulation has any effect.

Main scientific and technical (S&T) results at country level

The research approached regulation and its effects on maternal health care outcomes through three different case studies in each research country. All Asian partners studied emergency obstetric care (EMOC) and grievance redressal (GR) procedures. In addition, China and Vietnam studied antenatal care (ANC) and India studied abortion. In order to ensure inter-country comparability, certain areas of focus will be addressed by all case studies in all countries.

Our studied regulations covered a wide range of issues across countries that encourage objectives or prescribe behaviour for providers or institutions. Seven out of nine studied regulations were enabling guidelines, lacking the legal mandate to force the targeted actors to act upon the regulation through sanctions. Enabling regulations rather aim at influencing regulated behaviour through prescriptions and incentives.

Most studied regulations were nested in a national policy framework, possibly encompassing several interventions to improve maternal health, though not all to the same degree. In general, studied regulations were embedded in a continuum of consistent associated regulations (that we did not investigate at length). These were often issued by the same institution, such as the MoH (in Vietnam), the municipal level (in China) or the State level (in India).

Vietnam amended its EMOC regulation and is shortly planning a first evaluation of the first SBR regulation after 10 years of existence. India amended its Abortion Medical Termination of Pregnancy (MTP) Act for the first time 40 years after implementing it. After 10 years, the Chinese national prenatal diagnosis (PND) regulation has not yet been amended.

The studied regulations reveal an absence of regulations specifically targeting the private commercial sector, addressing community and user participation, addressing coverage and access to care, remedying market deficiencies and addressing fair pricing issues.

Summary of country findings for Vietnam

The findings from the three cases studies on EMOC, GR and ANC in Vietnam have shown that these regulations achieved limited desirable effects on increasing access to EMOC services, ensuring patient's equity in solving complaints and prohibiting sex determination. Several contextual factors mediated the effects of these regulations, such as the health system, cultural and behavioural factors and marketisation and autonomisation.

Limited governance of the regulations including poor information management, lack of mandate, poor incentives and limited accountability have hindered the possibilities for equitable access to quality maternal health care in Vietnam. The state command approach is the most common one for health regulations in Vietnam, including in maternal health. In this approach, the government expects that the regulation will be implemented by the administrative and public agencies, while the private sector follows the Ordinance of Private Practice Medicine. However, conditions for effective implementation of most regulations are insufficient in practice.

The three regulations were formulated at the central level by experts, but this process had some deficiencies, such as the lack of resource allocation and planning and did not take into account the influence of contextual factors such as decentralisation, marketisation, health system reform and health technology development.

The regulations were well promulgated at the central level, but this information was interpreted differently among the provinces. Conditions for the effective implementation of the three regulations were insufficient in some respects, including human and financial resources. These were impediments to compliance within all three regulations.

Only the EMOC regulation has had two amendments as a result of evaluation processes. There is a lack of regular supervision and reporting from the private sector is missing. Information on rewards and sanctions was not publicly shared with relevant actors.

Different actors have different aims and priorities in relation to specific regulations that they are responsible for. However, all actors have broad aims to achieve coverage, quality, access and equity of health care services as stipulated in the health system development strategies. Typically, differences in priorities are reported between public and private providers. While the issue of profit is more profound for the private sector, the marketisation process is very influential in public health care also and this is an impediment to the equity of patients/citizens.

Most of the administrative agencies and health service facilities have both high power and potential in regulation processes, since they are in the position of having both rights and responsibilities to provide services to users. They are also knowledgeable about health topics because this is related to their professional expertise. Users of services, on the other hand, had low power and potential in relation to all three regulations, because they have limited influence on health decision making as well as knowledge about the services.

Different contextual factors are influential on actor involvement in the three case studies. District health reform and autonomisation of hospitals, as well as more general factors like the increasing marketisation of the economy, globalisation, cultural and behavioural factors and geographical variations all contribute to influencing the governance of the regulations. The comparison of the three cases showed that health system factors have a general influence on regulation performance. In contrast, cultural factors have had more influence in the ANC case; while health-seeking behaviour has more influence in the EMOC and GR cases.

Summary of country findings for India

In the Indian complex context of a hierarchical society across gender, ethnicity, geography and class, power inequity also exists between health providers and patients.

The three studied regulations were designed centrally, without relevant actors' involvement in the process. They share the following characteristics:

1. for EMOC: though achieving millennium development goal (MDG) five is a political priority, its focus is solely on rural and public health facilities
2. for Abortion: Some limits are ill-defined such as marital status and professional training. Amendments to the Act were initiated by civil society (CS)
3. for GA: this followed guidelines of a United Nations (UN) resolution and urged to hear patient-consumers' voices acknowledged amidst resistance of medical professional bodies.

As far as regulatory effects is concerned, it is observed that the pace of maternal mortality (MMR) decline is slowing down, there is only access to EMOC on an ad-hoc basis and safe abortion remains restricted for women in rural areas.

Administration and implementation of regulations happens in an ad-hoc manner. Resources for regulation are sometimes strengthened but not in consistent ways. There are clear mechanisms for interpretation by regulatory actors or regulated staff, often leading to exclusionary practices, individual manoeuvring or fragmented accountability. There is a lack of integration across regulations and health policies.

Monitoring and evaluation play a minor role in the regulation process. Monitoring or feedback mechanisms exist on paper, but are not put into practice. Monitoring data is rarely used as evidence to feed back into a regulation process: the feedback loop does not work, as is evidenced to the way maternal audits are conducted and what role they play. Quality of care is rarely an element considered in any feedback.

A lack of coordination and/or integration across regulations was observed: some stay outside the mainstream health sector (Consumer Protection Act), some are not integrated into maternal health policies (Medical Termination of Pregnancy Act) and some are not perceived as a regulation (Indian Public Health standards). Because of the paucity of most health regulations, they may receive a skewed emphasis and adapt at a too slow a pace to changes in the market and the society.

A lack of accountability is reinforced by inadequate sanctions or regulatory mandates. Maternal health may be a policy priority though no adequate regulatory support is given to ensure access to quality care. It is recommended that comprehensive regulations should be addressing 'access' and 'quality' to achieve MDGs and Universal Health Coverage.

Summary of country findings for China

Regulation processes were found to be carried out dominantly through a government-led, control and command oriented approach, from the stages of design on to implementation and their feedback mechanisms (monitoring and evaluation). The role of the government is indeed deemed important to guarantee issues as 'equity', 'accessibility' and 'quality' in connection with health care and to ensure appropriate 'accountability' during the entire regulatory process. There is at times a different regulatory focus and approach between the government at central level, wanting to foresee some flexibility for regulatory implementation and the local government, setting its priority on the practicability of a regulation.

Universities and thematic health experts may be invited to give their input providing the required evidence at the regulatory designing phase. From our findings we recommended to enhance inter-government department coordination throughout the regulation processes, including actors from within and from outside the health system.

Consumers, health care users and socio-economic organisations are rarely invited to, or represented during regulation processes. This leads to sustained information asymmetry between policy makers, health care providers or managers and health care users. We see performance information management system as key to providing more information transparency to all actors. This management system integrates timely collection and analysis of data and good evidence and its publication in public.

A recommendation to the health policy making level is that regulation making, as a way of enforcing governance, should be done addressing a specific felt problem and based on evidence. Even then, the way that regulatory actors or regulated health personnel will interpret regulations according to their own priorities and agendas are highly influencing the achievement of any intended effect or health impact. Two way regulations that involve both providers and users to ensure health care provision and quality are the most efficient way.

Overall, it is recommended that the Chinese government, bearing the bulk of responsibility for health and governance, should involve other actors and use them as a resource to improve governance.

main S&T results from the comparative analysis

The comparative analysis summarized the evaluation of the nine regulations and through it governance, its problems and facilitating factors, its composite determinants and relationships in Vietnam, India and China. It also proposed recommendations for improving the quality of regulation in relation to health and contributed to developing evidence for policy makers.

The comparison used both deductive and inductive approaches to reasoning. As an example of deductive reasoning we see how prohibitive regulation such as the Population Ordinance in Vietnam has no effect on clinical behaviour of a private health provider to wealthy users because providers would not wish to reduce consultations and hence their income. As an example of the inductive approach, we see how in India there was a rebound effect on illegal, unsafe abortions in spite of the MTP regulation when sex-selective practices were banned by introducing the prenatal diagnostics technique (PNDT) Act.

The comparative study improved our understanding of regulation processes and through them of determinants for governance and how situations influence between contexts, case studies and countries. As a specific comparative result, we proposed an alternative taxonomy for regulations.

Proposed characteristics for a taxonomy of regulations

Leatherman and Sutherland (2007) described a classification of the objectives of regulations in healthcare as trying to improve performance and quality; provide accountability, both for levels of performance and value for money; and ensure that minimal acceptable standards are achieved. They distinguished regulatory interventions as being institutional, professional or market in nature, depending on whether they concentrate on institutions providing healthcare, on providers and their competences or on market imperfections, respectively.

An alternative way of differentiating regulations is to define their distinct actions: directive measures, performance surveillance or assessment and compliance enforcement through advice, sanctions, penalties and rewards. When actions are grouped, regulations are often referred to as 'prohibitive (deterrent, sanctions based), or 'enabling (compliance oriented, encouraging, incentive based). Often one regulation content may combine several of these distinctive characteristics.

The HESVIC project has proposed an alternative typology, including five non-mutually exclusive categories of regulations, each with their own criteria. We then compared the studied regulations according to these criteria. This way we were able to use HESVIC findings from the three research countries to better answer HESVIC RQs one (on regulation processes and approaches) and two (on regulatory actors).

All studied regulations sought to generalise a public health benefit and to secure maternal health and women wellbeing as an important public good. Though some regulations aimed at providing technical (e.g. EMOC) standards, it was less obvious for regulations to prescribe performance and quality standards, to intervene or remedy health market failures (e.g. increasing accountability) or to define participative decision-making patterns.

Except for the patients' grievance redressal regulations, all regulations were sufficiently considering the specific ambit of maternal health. Health sector related problems such as market failure (e.g. information asymmetry) are however rarely dealt with.

Most studied regulations use incentives to persuade for desirable services in an intertwined way with sanctions to prohibit dangerous provider behaviour. As the line between them is not clearly defined and both incentives and sanctions are often left implicit, their effect is limited. As an example of poorly designed incentives and sanctions we see how medical (non-surgical) abortions took over in India as a regular contraceptive method, leading to more cases of incomplete abortions, because the MTP Act loosely defined illegal abortions as an object of punishment. In the case of EMOC regulation in China we see effects of incentives and sanctions on establishing clearer accountability procedures throughout the regulation.

All studied regulations in HESVIC target health providers or health related institutions, some in government facilities, others in private and many having a hybrid status. According to the institutions' mission, we distinguished regulations applied to a complex variety of institutions: from completely public management, to local government hospitals with autonomy and a commercial rationale and private, i.e. related to non-governmental organisations (NGOs), health centres sharing a more social rationale. A common feature is the reluctance to ensure regulation for the private sector in Vietnam, India and China. Some regulations bear on input standards for the private sector (in Vietnam, India) but remained lip service because they did not tackle the allocation of public resources to them, or because monitoring was left weak. Even if aspects of input and processes were tackled, regulations often ignored issues specific for the private commercial sector, on how to address user participation or on fair pricing.

The plausible explanation for this situation was given by the fact that designing regulation in Vietnam, India and China was dominantly carried out in a closed way by state actors, as in most LMIC: bureaucrats, politicians and external advisers. Granting non-state actors, like health facility users and socio-economic groups, a voice may help regulations work better for them.

Comparative assessment of regulation effect

The nine regulations bore consequences for care quality, demographic equilibrium and social stability. The international comparison revealed that the effects of those studied regulations (and regulation families) focusing on access to quality maternal health care was indeed weak under current circumstances. In a significant proportion of the studied case studies, failures to regulate healthcare delivery could have potentially major consequences such as avoidable mortality and morbidity. The same could be said of the effects regardless of the regulation design building on enabling or prohibitive choices.

One case study, the EMOC regulation in China was especially successful in attaining its main objective to reduce inequity in maternal mortality. The EMOC-C regulation worked well, reducing maternal mortality but not morbidity and its implementation did not require thorough reorganisation to tackle health services fragmentation.

It was demonstrated that according to the regulation processes, factors explaining these failures or success related to their content and structure and beyond that, to their design and / or their implementation. For example, in most research countries, there was often a mismatch between the intrinsic objectives of regulation, its focus in practice or target where it was seeking to make a difference. In Vietnam, the overburdening of provincial hospitals was often related to perception of users, put off by the poor quality or lack of services at community level. Though the studied EMOC regulation was designed to improve the quality of services, it remained without mandate on availability of services, resulting in a mismatch between regulation design and context.

As said before, not all regulations studied had the specific aim of promoting equitable access to quality health care. Even where they did, undesirable effects were yielded such as unwarranted EMOC patient referrals (EMOC in India), stagnated health system fragmentation (PND in China) or defensive medicine practices, such as the consumer protection act (CPA) in India.

Comparative analysis of environment determinants of regulation

This aspect of the comparative study helped to better answer the HESVIC RQ4 on similarities between regulation of maternal health care and health care in general.

Health system behaviour has proven difficult to predict. Resistance to change is widespread, often due to differences in values and interests and changing behaviours in response to regulations. It is generally agreed that research has neglected this aspect of studying regulation as a process, especially in LMIC and that the few available studies tend to agree that there has been very little impact of such regulatory approaches on healthcare quality.

Overall the case studies provided new insights into the description of the mechanisms of regulatory failure and their relation with the features of economic transition. Because of the MDG commitments, the political will is deemed stronger in maternal healthcare than in general healthcare. This suggests that other regulations in the health sector might be even less effective, especially when considering the resources made available to implement them.

In most case studies there was insufficient consideration of determinants outside the health sector that play a role in a given health situation to be tackled by regulation. Often other sectors or ministries should have been involved, for example involvement of education and labour sectors in regulation sex selective practices in Vietnam, a right to health perspective absent in abortion regulation in India or an economic perspective to foreseeing sustainable EMOC rescues in China were missing.

Recommendations for improving the effectiveness of regulation and governance

The recommendations derived from the HESVIC study stressed the development of consistent health policies and their regulations. One key issue, likely to increase regulatory effect, concerns relationships between the government and private services, on the one hand and between commercial and social health organisations on the other. Examples of the stakes for regulation to correct the 'health market' are found in avoiding the consequences of dual practice by providers; or in enabling fair competition between an acceptable publicly oriented healthcare delivery system and the private health sector.

Provision of a basis for the development of policy guides

In the wider health policy field, HESVIC research suggests that regulatory control is not possible under current conditions in LMIC settings, with the possible exception of services that are centrally planned. In the three countries, regulation of private outlets is met with reluctance, leading to public authorities generally not being able to list private practitioners operating in their area. Light was shed on regulation-hampering mechanisms that are structural to historical, socio-political and administrative conditions in LMIC.

This confirms that to date there is a lack of field evidence that mechanisms exist in LMIC to intervene and control health markets and that redistribute wealth and disease. It is believed that this perpetuates the inequitable delivery and financing of care interventions and control mechanisms.

Work progress and achievements

The HESVIC study complied with the relevant Ethics Review and Screening Requirements. All relevant European Union (EU) FP7 research ethics guidelines, in particular as regards consent, anonymity and confidentiality, have been respected throughout the research project.

Each research partner was responsible for having the study protocol, the country research plans with selected specific data collection tools, authorized by their respective institutional review boards. Each partner reached full review and authorisation. The overall study methodology (HESVIC deliverables D.1.1 D.1.2.a and D.1.2.b) was also duly authorized by the partners and the scientific lead ITM.

During the entire research process an international ethical expert, Prof. Sigrid Sterckx from the University of Ghent, Belgium, was contracted by the scientific lead to contribute to ensuring the ethical 'follow-up' of the HESVIC international study. The expert first provided extensive assistance with preparing the documents needed to obtain approval from the ethics committee of ITM. Her role further consisted mainly in examining the study methodology from an ethical perspective, based on the EU guidelines on research ethics as set forth for the FP7. The expert contribution targeted both individual research partners as well as ethical aspects of the overall scientific methodology. The expert gave continuous feedback through intermediate and final reports on ethical issues and considerations. The final report was received on 11 September 2012.

As a means to final reporting on ethical issues that arose in the (country-specific) research in the three countries, the research teams in Vietnam, India and China were asked to respond to key questions regarding their experiences. These key questions were initially drafted by the scientific lead ITM and reviewed by the ethical expert. The three key questions were the following:

1. Were there any issues about recruitment of the actors as respondents for interviews or focus group discussions?
2. Did any actor or respondent refuse to participate in an interview or focus group discussions?
3. Were there any issues on ethics not raised during the study methodology development?

On the issues with recruiting of actors, it was observed that recruiting users proved to be difficult in each of the three study countries. This was most clearly the case in India, where users of abortion services needed to be recruited. The India team addressed these challenges by initiating a smaller nested study and gradually building trust with research participants. The Vietnam team did not manage to find a person agreeing to be interviewed regarding sex selective abortion, although various attempts were made. This is obviously regrettable from a scientific point of view, but given the enormous sensitivity of this issue it is not surprising and any pressure or inducement in order to get a case study would have been inappropriate. The inclusion of users via health institutions, as done by the China team, is ethically unproblematic provided that the procedure for obtaining informed consent, as set out in the documents drafted for the consortium was followed.

On the issues of actors refusing to participate, refusals of audio recording of interviews, which occurred both in India and China, were dealt with by respecting the respondents' wishes and making detailed notes instead. As to the Indian respondent who insisted that consent to the interview needed to be obtained from his/her superior, this need not necessarily be ethically problematical, provided that the superior's consent was obtained in addition to and not as a substitute for the respondent's consent.

Some issues on ethics that were not raised during the study methodology development arose in the field such as requests from respondents for financial assistance (that were rightly refused) and requests for information regarding grievance counselling services (that were also properly addressed by providing the relevant information).

Potential Impact:

Contribution to the state of the art

HESVIC contributes hypotheses for future studies regarding the impact of regulations on access to and quality of care in public and private health facilities and regarding the place of regulations in health policies within the academic community.

In addition, the research deliverables comprising the HESVIC country studies and comparative study (which can be found at http://www.leeds.ac.uk/hsphr/research/NCIHD/hesvic.html(öffnet in neuem Fenster)) makes policy recommendations for national standards to policy makers, health managers, regulation administrators and members of professional and users' associations.

Socioeconomic impact and the wider societal implications

HESVIC project engaged particularly with national and regional policy makers dealing with health governance and (maternal) health regulation of Vietnam India and China We advised policy makers that regulations should be nested in larger health policies because:

1. regulations are not very effective on their own, certainly under LMIC conditions;
2. regulations can yield undesirable effects. For instance, in Vietnam, combined with the common perception that the quality of services is better at the provincial level than at district level, the EMOC regulation resulted in the over-burdening of provincial hospitals;
3. health professionals cannot merely be motivated and deterred by material incentives and punishments but also need symbolic incentives.

These messages were communicated to policy makers through numerous channels at the end of the project.

Dissemination activities and exploitation achievements

Activities were carried out at country level as well as at international level. We targeted a range of actors: International, national and local health policy makers, researchers and academics, CS groups and the general public (including health care users). Depending on the target audience, the purpose of our KM activities was to assist different actors to use our findings (policy makers), contribute to knowledge creation and improved understanding (researchers, academics, CS) and/or create awareness (general public). We tailored particular activities to the unique needs of the audience in question.

Consultation meetings and dissemination workshops:

Over the lifetime of the HESVIC project, the partners have sought as much as possible to interact with the potential end-users of the research. Meetings held with the Country Research Advisory Groups, convened in Vietnam, India and China (and which usually met twice per year) provided an opportunity for early and continuous involvement with research stakeholders to discuss whether the research was 'on the right track', whether the results would be relevant and also to share/debate potentially controversial research findings and recommendations. A number of stakeholder validation workshops were also held in the study countries over the lifetime of HESVIC with the aim to discuss research findings with a wider range of actors such as policy-makers, health professionals, programme managers and CS organisations.

We also held dissemination workshops in Vietnam, India and China to disseminate final research findings and to provide spaces for interaction between the HESVIC researchers and health policy-makers, thereby enhancing the probability of the incorporation of HESVIC findings into country-specific policy-processes. Two workshops were held in Vietnam with national and provincial health policy-makers and planners. In India, two district level workshops were held to disseminate to local research stakeholders and additionally a workshop was held to disseminate to Karnataka-based health system researchers. And in China, two national level dissemination workshops were held to disseminate to policy-makers.

Conferences:

In the last year of the project, the HESVIC partners took part in a number of national, regional and international conferences in order to disseminate project findings to the widest possible range of audiences (for national level conferences please refer to the country specific lists below). As a consortium, project partners presented at four international conferences, presentations included both oral and poster presentations:

1. The 'Health System Reform in Asia Conference', Hong Kong in December 2011;
2. The 'Global Health in the Shifting World Economy Conference', Ottawa, Canada in October 2012;
3. The 'Second Global Symposium on Health Systems Research', Beijing in October-November 2012; and
4. The 'International Council on Women's Health Issues (ICOWHI) 19th International Congress', Bangkok in November 2012.

In each of these conferences we chaired a separate HESVIC session with an introduction, country presentations and a comparative presentation. Each of these sessions was tailor-made to the core theme and key audience of the conference in question.

In the 'Second Global Symposium on Health Systems Research', Beijing the HESVIC team additionally organised a 'Satellite Session' to facilitate interaction and discussion between health system researchers and policy makers. We invited key policy makers in health from Vietnam, India and China and from the World Health Organization (WHO) to participate in the Satellite Session as panellists to share reflections on the conclusions and policy recommendations of our research.

Individual oral presentations and/or poster presentations were also given on HESVIC findings in all of the above mentioned conferences (except for the Global Health in the Shifting World Economy, Ottawa) as well as in the conference 'Priorities 2012: Priorities for Improving Health Systems', Vancouver, Canada . This totalled 16 presentations.

IPH in association with ITM and the Government of Karnataka also organised a conference in Bangalore in October 2012: 'Bringing evidence into public health policy' and HESVIC findings were presented during the conference.

Journal articles for publication in national and international journals:

The HESVIC consortium is in the process of planning and preparing more than 10 papers for international journals.

Policy briefs

Policy briefs with policy recommendations have been prepared in Vietnam, India and China (in English as well as Vietnamese, Chinese and Kannada respectively). An international policy brief was prepared to contribute to health policy making beyond the study countries. This totalled eight policy briefs.

Courses

ITM academic coordination has agreed to integrate a component on impact of health regulation into the ITM International Short Course on Health Policy. This component will be based on the research findings and lessons learned from the HESVIC project.

Project websites:

The four project websites (administered by NCIHD, HSPH, IPH and FU) were set up to disseminate information on the project and its findings.

Use of other media:

The study country partners also disseminated project findings through the media in order to reach the general public (including health users). Various newspaper articles were published. Moreover in Vietnam local radio and television broadcasted news on stakeholders' meetings.

Additionally, a film was produced to document what HESVIC researchers had learned from participating in a multidisciplinary and multinational research consortium.

List of Websites:

http://www.leeds.ac.uk/hsphr/research/NCIHD/hesvic.html(öffnet in neuem Fenster)

The HESVIC Consortium consisted of the following partners:

1. Nuffield Centre for International Health and Development, University of Leeds, United Kingdom (UK) / Nuffield Centre for International Health and Development / Principal Investigator Dr Tolib Mirzoev / Contact: t.mirzoev@leeds.ac.uk
2. Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium / Prince Leopold Institute of Tropical Medicine / Principal Investigator Dr Jean-Pierre Unger / Contact: jpunger@itg.be
3. Royal Tropical Institute, Amsterdam, the Netherlands / Royal Tropical Institute / Principal Investigator Dr Maitrayee Mukhopadhyay / Contact: m.mukhopadhyay@kit.nl
4. Hanoi School of Public Health, HSPH Vietnam / Hanoi School of Public Health / Principal Investigator Dr Bui Thi Thu Ha / Contact: bth@hsph.edu.vn
5. Fudan School of Public Health, Fudan University, Shanghai, China / Fudan University / Principal Investigator Dr Qian Xu / Contact: xqian@fudan.edu.cn
6. Institute of Public Health, Bangalore, India Institute of Public Health, Bangalore / Principal Investigator Dr Narayanan Devadasan / Contact: deva@devadasan.comasan
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