Heightened fiscal constraints, increases in the chronic disease burden and in consumer expectations are among several factors contributing to the global interest in evidence-informed health policy. The present article builds on previous work that explored how the Australian Federal Government applied five instruments of policy, or policy levers, to implement a series of reforms under the Australian National Mental Health Strategy (NMHS). The present article draws on theoretical insights from political science to analyse the relative successes and failures of these levers, as portrayed in formal government evaluations of the NMHS.Documentary analysis of six evaluation documents corresponding to three National Mental Health Plans was undertaken. Both the content and approach of these government-funded, independently conducted evaluations were appraised.An overall improvement was apparent in the development and application of policy levers over time. However, this finding should be interpreted with caution due to variations in evaluation approach according to Plan and policy lever. Tabulated summaries of the success and failure of each policy initiative, ordered by lever type, are provided to establish a resource that could be consulted for future policy-making.This analysis highlights the complexities of health service reform and underscores the limitations of narrowly focused empirical approaches. A theoretical framework is provided that could inform the evaluation and targeted selection of appropriate policy levers in mental health. The development of an evidence base for mental health reform requires an understanding of which instruments of policy, or policy levers, are likely to succeed or fail, and why. Evaluations of past initiatives can inform future policy development, however the undeniable importance of this task is challenged by the complexities of policy analysis , 2.Within health services research, evaluation often focuses on outcome or impact measures, as a means of assessing the balance sheet  . SelecteThere is a history of advocacy and use of these types of evaluation in policy piloting and policy experiments, as one approach to evidence-based policy-making. However, many scholars have pointed to their limitations , 5. InsiAustralia operates under a federated system of government. One key feature is a vertical fiscal imbalance arising from Federal Government control over tax revenues, allowing increased Federal Government influence over health policy and service delivery functions traditionally reserved for the States and Territories . In the The dynamics between these two tiers of government has two key implications for an emergent evidence base for Australian mental health policy: (1) it complicates the direction of causation  that may be inferred from evaluations; and (2) differences in routine data collection between jurisdictions affect what can be evaluated and how easily comparative data can be obtained.Even within a single level of government , the concurrent application of multiple policy levers to achieve a desired outcome creates analytical difficulties for evaluation of causative factors. Policy levers are the tools or instruments governments use to achieve system-wide change. In the health sector, one accepted typology identifies five policy levers: organisation, regulation, community education, finance and payment , 9. The The feasibility of evaluation will vary at the individual program level, with some kinds of initiatives and outcomes lending themselves to policy experiments better than others. Nonetheless, the inability to empirically disentangle the effects of certain levers and/or activities, limits the applicability and validity of standard experimental designs , 11. In A range of bureaucratic, socio-political and ideological processes may also influence attributions of policy success and failure by framing the kinds of policies that are made and implemented, and how they are evaluated and interpreted. This context is not usually subject to evaluation , 13 and .The advent of NPM in Australia saw a shift away from government-run monopolistic service provision, towards a more market-oriented approach , 14. Thibeyondblue and others [Previous analysis of policy levers used in mental health  suggestsd others , indicatd others , also coDevolving responsibility for services to the NGO sector has additional implications for the evaluation of centrally driven  reforms, such as the NMHS.First, in a system where services are devolved to private providers, it becomes more complex to evaluate outcomes across the system. Further, critics argue that an unintended consequence of NPM has been the creation of an ‘audit society’. The preoccupation with target-setting and assessment with respect to key performance indicators (KPIs) is said to inadvertently compromise (rather than enhance) the quality of services offered to citizens , 16.Finally, in some cases, the political context and timing of evaluations may prevent the clear and transparent evaluation of programs and policy – particularly with respect to failures , 15. HowTheory-based approaches to evaluation, and approaches that illuminate the contexts and mechanisms of change, provide an alternative to experimental approaches to policy learning , 17, 18.In the absence of measurable change, an initiative might be considered successful if key interest groups are satisfied that appropriate steps were taken to address their concerns . The NMHS, commencing with the publication of the first National Mental Health Plan in 1992, was a series of Federal Government publications that set the future direction for Australian mental health policy and service delivery reform. The four most influential of these publications are considered to be the first and second Plans, the Council of Australian Government (COAG) Plan and the 2011–12 Budget . This isEvaluation of the National Mental Health Strategy Evaluation of the Second National Mental Health Plan National Action Plan for Mental Health progress reports I-IV –24The present analysis focuses on the content and approach of the government-funded, independently conducted, evaluations, associated with the first three of these publications ; noting there is no comparable formal government-funded evaluation for the 2011-12 Budget. Progress report IV was considered the primary evaluation document for the COAG Plan, with reference made to progress reports I-III, where they provide further elaboration on particular policy initiatives., as proposed by Howlett , werHuman Rights and Community Attitudes, Responding to Community Need, Service Structures, Service Quality and Effectiveness, and Resources and Service Access) [FG tabulated key initiatives and their evaluation for each Plan, grouped in terms of the lever(s) applied , 9 and t Access) , 25. FG  Access) , drawing Access) , 2). TheThirdly, FG and CM extracted a list of ‘unequivocal’ successes and failures, as depicted in the documents analysed. An unequivocal success was defined as the application of a policy lever to a particular initiative that met all measures of success by which it was evaluated and showed no measures of failure. Unequivocal successes were further categorised as being either ‘quick wins’ (i.e. those achieved within the life of a single Plan) or ‘cumulative successes’ (i.e. those spanning two or more Plans). An unequivocal failure was taken to be the application of a policy lever that met all measures of failure by which it was evaluated and achieved no measures of success.The overall approach to evaluation varied across the NMHS. There was an observable shift in the approach to evaluation and a narrowing of scope over time. Table The formal evaluation report for the first Plan explicitly stated that most of its objectives were focused on the process of reform, rather than what it achieved . CompareIn outlining their evaluation approach, the authors acknowledge that, at the time of the evaluation, specific outcome measures for each of the Plan’s objectives were not routinely collected. Instead, four research elements were chosen and used together to address the key outcome questions in the first Plan’s evaluation.The first of these elements consisted of four in-depth community case studies, featuring consumer, carer, staff and external organisation perspectives on service changes made in area-based mental health services . The docThe other three research elements in the first evaluation were (1) national data sets , (2) findings from a national stakeholder survey, involving 182 national organisations representing health professionals, carers and consumers, and (3) international commentary, provided by a single expert, the Deputy Director of the Center for Mental Health Services, United States Department of Health and Human Services .The first evaluation claimed to be process-oriented, but the evaluation predominantly assessed the degree of implementation , problem improvement (results) and the target group’s perception of its perceived impact. Additionally, in describing the approach to evaluation, the authors claimed to provide an assessment of the appropriateness (normative stance) of initiatives in terms of consumer and carer needs. This was achieved in part through findings from a national stakeholder survey. However, there was little critical analysis of whether the initiatives were perceived to be the right or wrong thing to do.Objectives under the second Plan were also quite ambitious. They included proposed improvements to service provision in rural and remote areas and for special needs populations, as well as improvements in overall service quality and standards .Data collection methods were similar to those used for the first Plan. Relevant national data were presented alongside national community consultations and international expert commentary . InsteadThe second Plan’s evaluation report focussed on appraising implementation progress  and problem improvement (results), while taking account of constraints on the sector and health system more broadly . As withThe COAG Plan was the largest collective investment in mental health by Australian Governments, broadening the focus beyond health service reform to consider other sectors such as employment, education and correctional services, in recognition of their important contributions to the mental health of Australians.Importantly, the COAG agenda was managed within the Department of Prime Minister and Cabinet instead of the Federal Health Minister’s portfolio, which had co-ordinated earlier Plans. Consequently, the evaluation approach differed markedly from those of the First and Second Plans. Twelve population-based indicators were developed to monitor progress under the COAG Plan. These indicators sought to evaluate problem improvement (results) in terms of health needs and service delivery changes, as well as broader changes to population health outcomes and social and economic wellbeing .The evaluation approach used in COAG was the most restrictive of the three Plans. The authors’ focussed on allocations and funding commitments relating to the Plan’s original objectives, as well as results or progress as evidenced by the twelve progress indicators. No reference was made to alternative evaluation measures, such as target group impact, normative stance, or innovation . FurtherWhere an objective was reported to have been partially met, the COAG evaluation focused on reminding stakeholders of the existence of ongoing and/or proposed initiatives that would help to address the identified need. This differed from evaluations of the first and second Plans that sought to explain the lack of success and/or to offer policy learnings.refer Tables The evaluation of policy levers is presented for each of the three Plans  outcome indicator. This was particularly notable for organisation proposals; for example, the provision of additional support to carers and families of people with mental illness was evidenced by an increased number of available respite places and the introduction of the Family Mental Health Support Service  [refer Tables ).The use of regulation as a policy lever was most prominent in the first Plan, in which seven objectives relating to regulatory changes, compared to three under the second Plan and two under the COAG Plan. The first Plan featured a number of clearly defined regulatory objectives such as a review of anti-discrimination legislation and consumer rights and responsibilities, and the introduction of an independent evaluation body ( Table ) . In the Both success and failure were evaluated against original objectives, with failure also evaluated in terms of target group impact. Notably, there was no attribution of failure with respect to regulatory objectives under the COAG Plan.refer Tables Finance and payment objectives were applied in a more discrete and quantifiable manner than the organisational and community education levers. There was an increase in the use of monetary levers, and payment in particular, over the course of the NMHS . ExampleThe evaluation of this lever was asymmetrical. Whereas success was evaluated in terms of the original objectives, failure was sometimes, but not always, evaluated in terms of results and target group impact.The following sections describe objectives deemed to be unequivocal successes or failures. Unequivocal successes were further divided into those achieved within the life of a single Plan (quick wins) and those that were achieved over the span of two or more Plans (cumulative successes). Policy objectives considered as either unequivocal successes or failures appear in bold in Tables refer Table There were six quick wins observable under the first Plan  funding. Funds released after deinstitutionalisation were reallocated toward community-based services at a Federal and State/Territory level . Non-insThe creation of a dedicated, separate national mental health budget and increases in overall portfolio expenditure , were all quickly achieved under the first Plan .Under the second Plan, the only quick win was the introduction of new incentive structures  items). These facilitated referrals and case conferencing between primary care providers (GPs) and specialist mental health services .The COAG Plan’s formal progress report identified four quick wins. The organisation lever was used to introduce a Family Mental Health Support Service, providing increased support and respite for carers and families of people with mental illness . Drug anThe payment lever was successfully used to introduce new flexible employment incentives to attract mental health workers to work in rural and remote areas  . FinallyEight cumulative successes were observed across the course of the NMHS. The majority of these (seven) were achieved under the COAG Plan.Under the second Plan, there was one cumulative success, namely the relocation of acute mental health beds from specialist psychiatric institutions to general hospitals. Following completion of the first Plan, 39% of acute beds were located in mainstream services and a further 41% were relocated under the second Plan .Cumulative successes under the COAG Plan included the use of organisational levers to review and consolidate existing youth early intervention, mentoring and employment programs into a single case-management program, Youth Connections .The second Plan saw the introduction of education and training programs to build capacity in existing health workers. Building upon these initiatives, the COAG Plan saw the introduction of educational places, scholarships and clinical training programs to further increase the capacity and reach of the mental health workforce .MBS items for tele-psychiatry were originally introduced under the second Plan . These wRegulation was used to deliver the fifth cumulative success of the COAG Plan, through the continued publication of annual progress reports, albeit in a new format .Building upon previous educational materials and strategies developed under the second Plan , the COAThe final cumulative success was the introduction of new MBS items and fee-for-service (payment) models to foster linkages between primary and secondary care providers. Commencing under the second Plan , this inThere was one unequivocal failure reported under the first Plan, namely the use of regulatory mechanisms to simplify cross-border treatment. The evaluation reported that there was no change in jurisdictional anomalies in treatment . This obUnder the second Plan, proposed changes to service provision for consumers with special needs was the only unequivocal failure . ConsumeNo unequivocal failures were reported under the COAG Plan.Our analysis highlights the variability in the character of evaluations both over time and in relation to different policy levers. This variability complicates the assessment of policy success and failure over the course of Australia’s NMHS.Our analysis indicates that the last Plan (COAG) was the most successful of the three Plans analysed. One interpretation of this finding is that there was an overall improvement in the development and application of policy levers over time. However, there are other plausible explanations. It could be that this apparent success is the product of a reduction in the depth of evaluation overtime and/or differences in the frames of reference. Another possibility is that there was an increased imperative for evaluators to demonstrate progress, resulting in a ‘success bias’.The apparent increases in success could be indicative of policy learning in relation to setting and appraising objectives to maximise the chance of success, either practically or rhetorically. Our analysis found that both the formal government Plans and their evaluations became more refined over the course of the NMHS. Plans adopted more tangible and focussed objectives, for which achievement could be more easily demonstrated (or ‘ticked off’), and intractable issues were dropped from subsequent Plans., finance etc.) may not.The omission of stakeholder views from the COAG evaluation constitutes an important gap in understanding and a significant point of difference when compared with evaluations of previous Plans. Changes in the structure of the health system (organisation) and use of community education are perhaps the most publicly visible kinds of reform. Thus, they are initiatives that can be evaluated more easily by consumers in a way that other levers , may explain the tendency toward evaluations based on original objectives and results, rather than target group impact or innovation.To address concerns about the possible negative consequences of a narrow KPI-based evaluative focus, it has been suggested that evaluations of services should include the concept of ‘public value’ to capture higher order aspirations e.g. trust, fairness, equity, legitimacy and confidence .The different frame of reference and evaluation approach used for the COAG Plan, compared with the previous two Plans, may also offer some explanation for the COAG Plan’s apparent success.COAG represented an unprecedented commitment by both Federal and State/Territory Governments. It overshadowed the third Plan to give greater impetus and renewed government support for mental health reform , 24. ThiOur analysis suggests that a broadening focus, and the allocation of health reform to the Prime Minister’s portfolio, can also result in changes in the style and approach of formal government evaluations. In this case, it was found to result in a dilution and reduction in the depth of evaluations concerning the achievement of service delivery reform objectives.Making inferences based on correlations between the twelve broad population indicators and the COAG Plan’s stated objectives is problematic. Aside from the standard difficulties of inferring causation from correlation, attempting to match indicators to specific reform objectives is hampered by the lack of direct correspondence between individual initiatives and population level outcomes. In this way, the COAG Plan’s evaluation approach precludes genuine policy learning.Despite such limitations, policy learnings can be derived from the unequivocal successes and unequivocal failures for each Plan. We identified eleven quick wins over the course of the NMHS. These objectives did not appear to be associated with any one policy lever or reform priority. There was, unsurprisingly, an inverse association between the degree of complexity involved in implementing a particular objective and its likelihood of success.Proposals involving a single level of government, and those involving relatively straightforward changes to legislation, budget allocations or the organisation of existing services, were achieved in the course of a single Plan. Conversely, proposals requiring cooperation across jurisdictions or service sectors were less likely to meet their objectives or have the intended target group impact, and were thus reported as unequivocal failures.In some cases, more ambitious objectives did appear to be achieved cumulatively over the course of the NMHS. This highlights the need to allow sufficient time to achieve policy success and also the fact that more challenging and complex health service reforms may take more than one Plan to achieve. Cumulative successes were commonly associated with a change in approach and/or the application of a different policy lever (e.g. payment), suggesting that complex health reforms may require some degree of trial and error and/or the coordination of different initiatives over time.The present documentary analysis centred on the application of a framework, adapted from Howlett  to better reflect the political, social, and jurisdictional contexts in which policy levers are applied, and to promote future innovation.Our analysis indicated that attributions of success and failure were dominated by two kinds of measure: whether the original objectives had been met and whether these objectives had produced the intended set of outcomes (results). Whilst these are important aspects of evaluation, consideration should be given to the full range of evaluative measures (The present analysis developed and employed a framework, based on theories from the field of policy studies Howlett , drawingPolicy objectives and associated evaluation data were classified into discrete policy levers or instruments used to achieve system-wide change . This apFurther insights could be gained by analysing a wider range of Federal and/or State and Territory program-specific evaluations, academic papers and media publications. Where available, these resources could help to identify contextual factors relevant to understanding why the application of particular policy levers succeeded or failed.This analysis represents an important first step in developing an evidence-base for mental health policy. It highlights the complexities of health service reform and underscores the limitations of narrowly focused empirical approaches. The theoretical framework presented in this analysis could be used to inform future health service evaluations, and may assist in the targeted selection of appropriate policy levers.


Korea is the only developed country that saw an increase in the number of psychiatric beds with the longest average length of stay of psychiatric patients for the past decades. This phenomenon can be explained regarding the payment system, the law, and society. Korea is in a critical position concerning mental health policy. How it paves the way for reducing psychiatric admissions will provide a model for rearranging the interests of different social groups for the sake of a higher value, that of human rights. Admissions of psychiatric patients have decreased in most developed countries . With deIn Korea, however, admission remains the foremost recourse in psychiatric treatment. In contrast with the general trend in most developed countries, the number of psychiatric beds in Korea has continually increased, and the length of stay of psychiatric patients in Korea has remained long for years . While tThe management of psychiatric patients concerning psychiatric admission differs considerably among countries and this difference stems from each country’s different system and culture. However, given that many countries are pursuing a balance between community-based care and hospital-based treatment by decreasing the relative role of psychiatric admission, the high dependence on psychiatric admission observed in Korea may not be in the best interest of patients and needs to be addressed. The present commentary will investigate this issue with regard to the payment system, the law, and society.The payment system affects the behaviours of health care providers, and the length of stay of psychiatric patients is also known to be influenced by the payment system . The payZero co-payment for Medical Aid beneficiaries can induce unnecessary inpatient admissions. Even given that possibility, however, the admission rate of Medical Aid psychiatric patients is inordinately high. While only 3% of the total population in Korea are Medical Aid beneficiaries, psychiatric admissions covered by Medical Aid account for 53% of the total psychiatric admissions and 64% of the total long-term psychiatric admissions in Korea [Unlike usual Medical Aid reimbursement, whose extent varies depending on the amount of care received by the patient, the reimbursement for psychiatric treatment in Medical Aid is fixed as per diem. The gap between Medical Aid and National Health Insurance psychiatric patients in terms of average expense is more prominent in outpatient care. In the case of outpatient care, the reimbursement of Medical Aid psychiatric patients is fixed at about $2.4 a day, which is only one tenth of the average expense of National Health Insurance psychiatric patients.The unduly low reimbursement for outpatient care of Medical Aid psychiatric patients limits treatment options in outpatient care for these patients. Regarding psychiatric inpatient care, however, the reimbursement in Medical Aid amounts to two-thirds of the average expense of a National Health Insurance beneficiary Fig. . ConsideMoreover, inpatient care offers the family of Medical Aid psychiatric patients an additional advantage; the family are relieved from the burden of caring for the patient through the hospitalization. Especially for families caring for severe chronic psychiatric patients, admission in itself can be an attractive choice, aside from the comparative advantage over outpatient care concerning reimbursement. Additionally, considering that the community-based care that should accompany outpatient care is not well established in Korea, long-term admission remains the least-worst choice for chronic psychiatric patients and their families. From the hospitals’ point of view, hospitalizing patients is a more attractive option not only because of the relatively better reimbursement rate for inpatient care but also because of the high possibility of a prolonged admission. Since hospitals can increase profit by minimizing expense under per diem reimbursement, they are motivated to induce and maintain hospitalizations. As a result, Medical Aid psychiatric outpatients are induced to switch to inpatient care, and those already hospitalized remain as inpatients. In 2014, the average length of stay of Medical Aid psychiatric patients was 228 days and half of them were admitted for more than 361 days .Another important factor that facilitates psychiatric admission is the Mental Health Act, which regulates involuntary psychiatric admission. Involuntary psychiatric admissions account for about 80% of all psychiatric admissions in Korea , which iThe Mental Health Act (paragraph 1 of Article XXIV) states that the director of a mental institution may hospitalize a mentally ill person in cases where a psychiatrist judges that hospitalization is necessary, with the consent of two persons responsible for providing protection to the mentally ill person. Although requiring the judgement of a psychiatrist for the involuntary psychiatric admission, the Act specifies no explicit legal or medical grounds for the judgement of the psychiatrist. Therefore, the Act involves the risk of being abused for involuntary admissions that are not medically justified.Although limiting the length of admission to six months, the Act actually facilitates long-term hospitalization. The Act (paragraph 3 of Article XXIV) states that the director of the mental institution shall request the head of administration to examine a hospitalization every six months when a psychiatrist has stated that the continued hospitalization is necessary, with the consent of a person responsible for providing protection to the patient. However, in practice, the consent of a person responsible for providing protection can play a decisive role in prolonging admission. This is especially true for chronic psychiatric patients, who generally do not show marked improvement and are therefore not likely to offer a definite basis for changing the psychiatrist’s previous decision on involuntary admission.The Act does not only promote the lengthening of admission but also can be abused as a means to admit a patient who is not eligible for admission. According to Article XXIV of the Act, it is not impossible to compulsorily hospitalize a person who is not so severely ill as to be admitted, if two persons responsible for providing protection agree to the admission and a psychiatrist judges it necessary. In practice, however, involuntary admissions which are medically unjustifiable have been frequently reported in Korea. Although Article XXVIII of the Act states that the Basic Mental Health Deliberative Committee examines whether to continue an admission or treatment to which an objection has been raised, the committee scarcely functions , 11. In In 2014, a 60-year-old Korean woman filed a constitutional review with the Constitutional Court of Korea claiming that Article XXIV of the Mental Health Act encroaches personal freedom. This woman, who had only suffered from mild involutional depression, was hospitalized compulsorily with the consent of her two children and the decision of a psychiatrist. She insisted that she had suffered no serious mental illness that could lead her to threaten her own or others’ safety or that required hospitalization. On Sept. 29, 2016, the Constitutional Court of Korea decided that Article XXIV of the Mental Health Act was incompatible with the Constitution . In the Despite a steady increase in the number of psychiatric beds in Korea in the past decades, the circumstances surrounding hospitalized patients have not improved accordingly. According to a report from the National Human Rights Commission of Korea, 45% of psychiatric inpatients have experienced seclusion or restraints, 9.3% have experienced violence from hospital employees, and 10.5% violence from other inpatients . From 20The increase in the number of psychiatric beds and sacrifice in the quality of psychiatric treatment can be attributed, to a large extent, to the government policy. It would have been impossible to establish and maintain psychiatric hospitals without the permission and support of the government. In addition, patients’ families who acquiesce to hospitalizing patients under circumstances where no better alternatives are available are not free from responsibility for this situation. However, society, which has condoned this situation for more than decades, is the most accountable. If society were aware of the problem and continued to raise it as an issue, more psychiatric patients in Korea could lead better lives outside the hospital. The status quo of psychiatric admission in Korea is based on the tacit agreement of members of society.Although low reimbursement for Medical Aid psychiatric patients and legal problems regarding involuntary admission have been pointed out, the reimbursement rate for Medical Aid patients has been frozen for eight years and no significant modification has been made to the Mental Health Act concerning involuntary psychiatric admission since its introduction in 1995. The recent decision about the unconstitutionality of Article XXIV of the Mental Health Act is encouraging. However, in order to revise the law, the government should resolve differences among various social entities including patients, patients’ families, psychiatrists, hospitals, and the general public, which would be an onerous task for everyone.Korea is in a critical position regarding mental health policy in that it is the only developed country that goes against the trend of deinstitutionalization and perhaps also against the best interest of psychiatric patients. How it paves the way for reducing psychiatric admissions will provide a model for rearranging the interests of different social groups for the sake of a higher value, that of human rights. Korea is expected to present an example for the rest of the world.


Non-communicable diseases (NCDs) kill 40 million people each year. The management of chronic respiratory NCDs such as chronic obstructive pulmonary disease (COPD) is particularly critical in Italy, where they are widespread and represent a heavy burden on healthcare resources. It is thus important to redefine the role and responsibility of respiratory specialists and their scientific societies, together with that of the whole healthcare system, in order to create a sustainable management of COPD, which could become a model for other chronic respiratory conditions.These issues were divided into four main topics  and discussed at a Consensus Conference promoted by the Research Center of the Italian Respiratory Society held in Rome, Italy, 3–4 November 2016.Regarding training, important inadequacies emerged regarding specialist training - both the duration of practical training courses and teaching about chronic diseases like COPD. A better integration between university and teaching hospitals would improve the quality of specialization. A better organizational integration between hospital and specialists/general practitioners (GPs) in the local community is essential to improve the diagnostic and therapeutic pathways for chronic respiratory patients. Improving the care pathways is the joint responsibility of respiratory specialists, GPs, patients and their caregivers, and the healthcare system. The sustainability of the entire system depends on a better organization of the diagnostic-therapeutic pathways, in which also other stakeholders such as pharmacists and pharmaceutical companies can play an important role. Overall, more than 80% of all premature NCD deaths are due to these four diseases. In its action plan [According to WHO , non-comion plan  WHO recond cause of mortality) and account for high healthcare resources consumption. Nevertheless, throughout Italy the number of hospital respiratory units and specialist beds continues to decline  without a consistent and organized alternative provided outside the hospital, while each year the number of respiratory specialists that graduate from universities is inadequate to meet the needs of the respiratory specialty.The management of chronic diseases is particularly critical in the respiratory field. In Italy, these diseases are very widespread  improving the prescriptive appropriateness and efficacy of general practitioners (GPs); ii) defining integrated care pathways involving GPs, respiratory specialists and the hospital; iii) developing new modalities of drug delivery; iv) promoting greater participation of patients and their care givers  also wiChronic obstructive pulmonary disease (COPD) may be used as a model to discuss these issues. The prevalence of COPD is not known with certainty in Italy, but it is estimated to vary from 4.03 to 5.55% in males and 2.60 to 4.45% in females [th Consensus Conference in Respiratory Medicine, held in Rome, November 3–4, 2016, inviting the audience  to discuss the issues and arrive at agreement on how to create a sustainable management of COPD, which could become a model for other chronic respiratory conditions. This paper is a report of what was discussed and agreed during the Consensus Conference.To seek and propose solutions to the current challenge of chronic respiratory diseases in Italy, in particular COPD, the Research Center of the Italian Respiratory Society (IRS) organized the 4Training: basic educational curriculum and continuing medication education (CME); the role of Institutions and Scientific Societies.Organization: specific roles of the hospital, GPs, local community, and pharmaceutical system in a network of respiratory medicine; to define the role of policy makers, health professionals, and users in building up a network.Responsibilities: the reciprocal responsibility of respiratory specialists, GPs, policy makers, patients and their caregivers.Sustainability: epidemiological burden of respiratory diseases: primary prevention, early diagnosis, therapy, and rehabilitation. Sustainability of respiratory specialty in the NHS; definition of essential care levels and diagnostic-therapeutic pathways.The Research Center of the Italian Respiratory Society (IRS) adopted the method of Consensus Conference, now in its Fourth Edition, in order to seek and propose solutions to the four topics:http://www.snlg-iss.it/cms/files/manuale_metodologico_consensus.pdf-). A CC is considered the most adequate tool for formulating recommendations on controversial topics that cannot be evaluated based on reviews and quantitative studies due to the many experiences that need to be confronted. However, usually the CC deals with technical or clinical aspects and the audience involved is composed of specialists of the same specialty. This CC dealing with organizational as well as political aspects required participation of representatives from different disciplines and backgrounds. Although some difficulties were experienced, after lively discussion a number of issues were formulated and then translated into recommendations. These were then reviewed and validated by the members of an independent Jury. Due to the nature of the topics treated, the expected result may be defined as the best possible agreement among the individual positions and experiences of participants, the group of experts and the Jury.The Consensus Conference (CC) was organized and carried out according to a methodology recommended by the National Guidelines System (The Promoting Committee (PC): included members of the Research Center of the Italian Respiratory Society, A.GE.NAS , Federanziani (Federation of Elderly), FIMMG , Health Ministry, SIMM , and Federfarma . The PC promoted the CC, appointed the members of the Technical and Scientific Committee and those of the Jury, and prepared specific questions on each of the four selected topics.The Technical and Scientific Committee (TSC): composed of individuals of recognized experience in the field, discussed the questions and selected the teams charged with preparing the material for discussion during the conference.The Jury: composed of 12 members selected by the PC and TSC representing physicians (multidisciplinary context), patients and their associations. The Jury read the reports, attended the CC and participated in the discussion, recorded relevant new contributions to the presentations (including disagreement), and wrote up the consensus document.The Assembly: included all the people invited and who attended the CC.In detail, the players involved and their specific tasks were:The results for the four topics are reported below. Each topic was introduced by a brief review of the state of the art, according to recommendations of guidelines and organizational documents, followed by a comparison with the real situation existing now. The possible deviations and critical issues were outlined and some proposals were formulated for improving the management of COPD and other chronic respiratory diseases. At the end of the discussion on each topic, the assembly approved some statements, for subsequent examination by the Jury before definitive validation.Does the University adequately educate the specialist? If not, what are the main gaps in formation?The questions preliminarily put to the Working Group in charge of developing this topic were:University education for undergraduate medical students in Italy is substantially adequate concerning the rudiments of respiratory medicine.Fundamental notions of respiratory medicine are, however, not always taught by respiratory specialists but by others (e.g. by internists) with a resulting lower characterization and in-depth analysis of specialist notions, especially those relative to respiratory physiology, that are indispensable for a basic education.There are important inadequacies in the organization of students’ practical training, both in terms of the duration , and the training given on the most frequent chronic diseases . Also, a strong need was stressed for organized teaching networks which include teaching hospitals (see below).b.Do non-academic hospitals have a role in the education of the specialist? If yes, what role and the timing?The proposal made by academic respiratory specialists was confirmed on the need to set up teaching networks in which training is integrated with the so-called “teaching hospitals”, i.e. hospitals characterized by a high level of specialization, with expertise in other specialist or ultra-specialist areas associated to mainline respiratory medicine.This integration should be through practical training courses  that are certified and validated, carried out over the entire duration of specialization and with an adequate number organized each year.A similar training integration should be set up for chronic respiratory diseases like asthma and COPD , covering not only the acute (and semi-intensive) phase, but also the clinical and rehabilitative management outside hospital.At present, one of the most important issues in COPD management concerns the role of GPs, whose task is early diagnosis by means of anamnestic and clinical evaluation and spirometry. In fact, basic spirometry (first level investigation) could be carried out by GPs in their setting after adequate training, but this issue is still a matter of discussion and disagreement, while the specialist’s role would be a more in-depth patient assessment with second level examinations.Another critical point is related to the community health organization, still highly deficient as regards patient management and rehabilitation, which is important for health-related quality of life and long-term outcome of chronic patients.c.Besides the present model of Continuing Medical Education (CME), would another system based on certification both of the specialist and structure, with internal and external audit, be desirable? If yes, what and how often?The HERMES Project   could beBased on the report and lively discussion, the points that emerged and were approved by the Assembly were:a) Not all Italian regions include in their health system the community respiratory specialist; is there any role for this type of specialist?Questions relative to the second topic discussed were:The role of the outpatient specialist should be to cooperate with GPs in primary care settings for the diagnosis of diseases, promotion of primary and secondary prevention, and care of patients discharged from hospital to integrated home-care, and to be in charge of the respiratory rehabilitation program and end of life care.To the hospital and community respiratory specialists are reserved: second and third level investigations for proper diagnosis and staging, clinical-therapeutic management of the acute phase, including in-hospital sub-intensive care, and the respiratory rehabilitation carried out inside or outside hospitals.In Italy, the community respiratory specialist is not defined as a standard and there are still many health districts without such a physician. This kind of specialist can act as an intermediate reference figure between the hospital specialists and GPs. This figure would be of particular importance to take care, together with the GP, of those cases that can be treated in the community, so lowering the present heavy burden of hospital admissions.It is believed that the presence of this type of specialist, included in a well-organized network of primary care, where the objectives are agreed and shared by all involved, could lead to a partial but significant decrease in hospital admissions.b. The Italian (autonomous respiratory unit) and the United Kingdom (a multidisciplinary department with one senior and one junior consultant plus physicians in training) models of hospital specialist system: what are the points of strength and weakness?After a lively discussion on this issue, the following statements were formulated:The conclusions of the discussion on this point were:b. Some Italian regions have produced diagnostic-therapeutic pathways (DTPs) for COPD: what are the organizational similarities and differences?Apparently, there is no difference because both systems seem to meet the new health needs. Both in UK and in Italy  the organization of hospital structures does not seem coherent with the changes that have determined various new needs and demands on public health. The longer life expectancy and the change toward healthier lifestyles have led to an increased prevalence of chronic conditions, whose diagnostic and therapeutic management is totally different from that of acute illnesses. Presently chronic diseases represent 80% of all health requests [Regarding regional and local diagnostic-therapeutic pathways, great differences emerged, especially concerning COPD, where the present situation varies from regions where all or nearly all local health systems have a specific DTP to other regions where DTPs are totally missing, or alternatively different denominations are used to identify the same organizational pathway. In some cases, the National Guidelines , 10 are Not all give the necessary importance to primary prevention , smoking cessation treatment, or early diagnosis.The patient’s role is almost never indicated, while exclusive importance is assigned to the role of physicians and other health workers who take care of patients.The organization in the local community is different not only because the structure is different but mainly because at the moment much is based on the personal initiative of specialists, as a precise structural organization for national and local management is still lacking.The same competence is assigned to different figures .In many settings some professional figures (e.g. nurse and physiotherapist) are missing that provide an appropriate and fundamental support for the specialist during the diagnostic-therapeutic-rehabilitative process of respiratory patients.Frequently, a rehabilitative pathway is not present or envisaged.After an intense exchange of views and experiences by participants, an agreement was reached on these issues:From these evaluations, it stems that not always is the community able to take care of patients who are in a post-acute phase, and to manage the whole pathway of chronic respiratory disease at home. This seems to be the main reason why hospital admissions for COPD are so numerous.Rehabilitative structures, post-acute departments, associations of GPs, domiciliary nurse assistance, active patient associations, and a suitable family environment are all lacking, and, most important, there is no definition of network fundamentals . The results reported at point “a” and “b” of this session are an attempt to respond to these inadequacies and could be implemented according to the whole COPD pathway described in a recent multidisciplinary paper .What is the responsibility of the respiratory specialist for the management of chronic respiratory disease?What is the responsibility of the GP for the management of chronic respiratory disease?What is the responsibility of patients and their caregivers for the management of chronic respiratory disease?In this session the questions to be discussed were:To organize the “respiratory care network” i.e. the coordination system between hospital and local territory, promote the setting up of DTPs  suited To organize and fund effective communication campaigns in order to inform people about chronic respiratory diseases, their characteristics and modes of prevention, early diagnosis and treatment adherence.To promote and fund the computerization  of the health system making it possible to share in real-time, between interested (and authorized) subjects, all the health information related to an individual. Unfortunately, the present computerized information system is not uniformly established throughout the country, and there are frequent differences both among regions and among health districts of the same region. As well, the programs are not always able to dialogue each other or not suitable for a health environment and related issues.To formulate a new definition of the timing of specialist consultations and services which would take into account the real time consumption of these services including not only the usual medical activities  but also education about the disease (nature and evolution of the disease), counseling and training in device use. This action may parallel that at point 3. To review tasks and competences, e.g. some activities presently carried out by respiratory specialists  should instead be carried out by administrative, health, or voluntary personnel, adequately trained. Hence it is necessary to promote a coherent education of all health workers to reach the above specific objectives.The Assembly agreed that the adherence to therapy and the integration of care are indispensable to reduce the organizational deficiencies underlying inappropriate care practices. These can be measured everywhere in our country by the rate of unsuitable admissions to emergency departments (white codes) of patients affected with chronic diseases. Obviously, the emergency department, although providing an immediate practical solution, does not resolve the problem of continuity of care, but rather renders it more complicated. In fact, while it copes with a health need (true or supposed) at that moment, it further fragments the care pathway. Conversely, to obtain the best management of COPD it is necessary to make GPs more responsible. The solution could be to create intermediate levels of assistance between primary care and hospital, set up home and community care structures, and formulate a new definition of the hospital’s task as acute care only. The Assembly recognized that it is hard, if not impossible, to put this into practice if the NHS does not become strongly aware of these issues. In fact, it must plan and fund the activity of prevention and the integration of health services. Specifically, the NHS’s task is:Adherence (as per their specific competence) to the agreed diagnostic-therapeutic pathway for COPD and other chronic respiratory diseases. These should always be proposed, discussed and finalized together with all interested parties (including patients and their caregivers). To supervise that the official DTPs are the standard to which all make reference. For the adherence of GPs to the DTP, a ‘proactive medicine’ approach should be incentivized.A novel task of collecting clinical data, besides the simple administrative ones, that would contribute to represent the “in the field” real-world activity. This data collection should also include audit initiatives.In this context, the health professionals  have the responsibility for:An optimum adherence to therapy and in general to doctors’ prescriptions, after receiving the necessary education about disease and learning how to verify the progress. This duty to adherence includes corrective actions in the case of manifest failure to comply with the prescriptions or deviation from them. For example, one should be rigorous about suspending oxygen therapy if the patient, after being offered smoking cessation treatment, continues smoking.A conscious and responsible use of health service resources, consisting in hospital admission only when strictly appropriate, with an increase in scheduled control visits and a decrease in unscheduled ones. In this respect, patient and caregivers must be aware of the diagnostic-therapeutic pathway, and should “called to account” when their behavior diverges from the predicted pattern, even if they are in non-emergency conditions.Finally, patients, their caregivers, and associations, have the responsibility for:Does the multidisciplinary approach really give support to sustainability?The final session of the Consensus Conference dealt with sustainability based on these questions:b.Does the pharmacist have a role in the sustainability of the system?The answer would be ‘yes’ if care pathways can be designed that are supported by a network structure consisting of the following nodes (depending on the disease): hospital, community resources (GPs included), and social services. In this context, the continuity and appropriateness of care are the pillars on which to organize the pathways. This requires that the programs be patient-centered and include shared protocols based on common organizational principles set out in documents to consult according to the severity stage of the disease. The multidisciplinary approach could really be a substantial support to sustainability if the technical and professional path of the different care processes is correctly defined, i.e. the protocols to which the different professionals, each according to their own competence, must necessarily refer to.The Assembly agreed that in a new organization aimed at sustainability, the pharmacist can play a fundamental role mainly as regards early diagnosis of COPD based on filling in questionnaires, but also by counseling patients to give up smoking and to maintain a correct life style, training them to use inhalation devices now available and to check periodically the appropriateness of their use, and controlling the adherence to therapy.c.What is the effective role of pharmaceutical industries and of pharmacotherapy for the sustainability of the system?It was also recognized as a priority to develop and implement a valid program of specific respiratory education for pharmacists, including an accreditation process, as already performed in other countries like UK, Australia, and Canada , 13, whiPharmaceutical industries could help in coping with COPD and other chronic respiratory diseases by improving quality of life and life expectancy through the development of new drugs that are more effective, more user-friendly and more sustainable than existing ones. It was pointed out that, besides the role that State and Health Service can play in terms of advocacy on chronic respiratory diseases, pharmaceutical industries can too play a fundamental role in education of people to health and of patients about their disease. To this end, internet sites and network resources can be used, clearly stating any conflicts of interest. There is little doubt that educating patients on different issues  will allow a better control of the disease course and significantly reduce GP and respiratory specialist visits, admissions to the emergency department, ordinary hospital admissions, and the rate of lost working days or of inactivity.th Consensus Conference on Respiratory Medicine. COPD was chosen as the paradigm of chronic respiratory disease care. Specialists in different specialties  discussed the main obstacles to an effective, safe and sustainable respiratory care and proposed the solutions to overcome them.To help the NHS to cope with chronic respiratory diseases, the Research Center of the Italian Respiratory Society organized in 2016 the 4As for the education and training of health staff, the university education in Italy of medical students on respiratory medicine is currently sufficient. However, respiratory pathophysiology, social aspects of chronic conditions (like asthma and COPD) and practical training need to be improved. This can be achieved by forming an educational network linking the University with excellent hospital units  and forefront primary care structures (for chronic conditions assisted via community and population medicine).To build a network aimed at providing integrated care for respiratory patients, the role of an outpatient respiratory specialist, i.e. a chest physician working (full or part time) outside the hospital, is capital. Such a physician could create an intermediate level of care to help GPs and the whole community in promoting primary prevention and early diagnosis (particularly of COPD) as well as managing chronic care post-hospitalization, rehabilitation and finally in providing end-of-life care. Although a network as described could help the NHS to minimize hospitalizations, in Italy no standards of education and no formal definitions of such a figure exist .In shaping the new model of respiratory care a new definition of responsibility of each stakeholder is necessary. GPs  need to know the first level diagnostic tools and how to manage them in prevention and treatment. Putting together a group of GPs in which at least one of them is specially interested in respiratory medicine could help.Respiratory specialists have the responsibility to be educated and trained in second-level interventions. Their practice should include not only theoretical and practical issues about second-level respiratory medicine but also the ability to carry out audits on both own consistency and system effectiveness. The European Respiratory Society syllabus, as well as the ERS Hermes program, could lead the way here.A responsibility shared by GPs and respiratory specialists is to collaborate to build up diagnostic and therapeutic pathways of care as standards of care. Such pathways and indeed all the actions needed for building the new model of care require a multidisciplinary approach which is a responsibility of all stakeholders. A model exists for COPD in Italy, built up by the Associations of Nationwide Health districts and Municipalities- Federsanità-ANCI .The NHS should have the responsibility to organize the network, to pay for it and for the auditing of national and regional DTP, to subsidize not only proactive medicine but also data collection about different experiences. NHS should also provide resources to the community for health education on living in good health and to the patients and their caregivers tools for managing disease in the best way.While citizens have the responsibility to know and practice the behaviors to prevent respiratory  chronic conditions as well as the characteristics of the early phases of respiratory diseases (to get confirmation or disconfirmation of them through the appropriate actions of secondary prevention), patients and caregivers should be educated to self-management of their disease with special attention to the proper use of inhalation devices.This last point emphasizes the role of pharmacists - properly educated and trained - in the network. Pharmacists can help in early diagnosis, in drug intake monitoring  and in monitoring adherence to treatment of respiratory conditions as well as adverse effects. Finally, pharmaceutical industries could help in coping with the epidemic of chronic respiratory diseases by making available new drugs, with the aims of improving quality of life and life expectancy. However, in our opinion, new drugs must not only satisfy needs still not satisfied but also do so in a sustainable way. In other words, new drugs should be more effective, more user friendly, and more sustainable than the existing ones . In addi


Background: Primary healthcare (PHC) is essential for equitable access and cost-effective healthcare. This makes PHC a key factor in the global strategy for universal health coverage (UHC). Implementing PHC requires an understanding of the health system under prevailing circumstances, but for most countries, no data are available.Objectives: This paper describes and analyses the health systems of Bahrain, Egypt, Lebanon, Qatar, Sudan and the United Arab Emirates, in relation to PHC.Methods: Data were collected during a workshop at the WONCA East Mediterranean Regional Conference in 2017. Academic family physicians (FP) presented their country, using the WONCA framework of 11 PowerPoint slides with queries of the country demographics, main health challenges, and the position of PHC in the health system.Results: All six countries have improved the health of their populations, but currently face challenges of non-communicable diseases, aging populations and increasing costs. Main concerns were a lack of trained FPs in community settings, underuse of prevention and of equitable access to care. Countries differed in the extent to which this had resulted in coherent policy.Conclusion: Priorities were (i) advocacy for community-based PHC to policymakers, including the importance of coordination of healthcare at the community level, and UHC to respond to the needs of populations; (ii) collaboration with universities to include PHC as a core component of every medical curriculum; (iii) collaboration with communities to improve public understanding of PHC; (iv) engagement with the private sector to focus on PHC and UHC. Key MessagesPrimary healthcare (PHC) as a policy priority in eastern Mediterranean countries is hampered by policymakers’ lack of understanding the complex nature of PHC.Advocacy of PHC should stress its contribution to Universal Health Coverage.Professional training in the community setting is a priority to implement PHC.Most countries experience significant challenges to their health systems, due to increasing health costs and diminished returns on healthcare investment for aging populations. Where primary healthcare (PHC) is formally structured in the health system, and professionals are educated in the primary care setting, the system realizes better population health at lower healthcare costs . This haImplementing PHC policy asks for the application of general principles under prevailing local conditions , and buiThis paper is the first to document and critically appraise the health systems from the Eastern Mediterranean region, with the objective of identifying common strategies for strengthening PHC, and prioritizing regional collaboration, and exploring collaboration with the World Health Organization (WHO) Regional Office for the Eastern Mediterranean (EMR).A workshop at the 2017 WONCA East Mediterranean Regional Conference in Abu Dhabi compared the health systems of six WONCA member countries: Bahrain, Egypt, Lebanon, Qatar, Sudan and the United Arab Emirates (UAE) provided the data for this paper. Each selected an academic family physician (FP) to present their country, using the WONCA framework of 11 PowerPoint slides that focused on country demographics, the health system and the position of PHC, the country’s leading health challenges, strengths and weaknesses and lessons others could learn from their country . They weBahrain has a population of 1.4 million served by 9.1 physicians per 10,000 inhabitants, working in the private and government sectors ,15. PHC Egypt has a population of 92.1 million with 28.3 physicians per 10,000 inhabitants ,17. PHC Lebanon is has a population of 5.8 million, with 31.9 physicians per 10,000 . The heaVision articulating the requirements of a healthy society to meet the country’s growth and development. In this, the Prince of Qatar decreed an independent funding and leading role for the PHC Corporation in 2012. The PHC Corporation is now responsible for 23 health centres, all accredited by Accreditation Canada International, in three different regions geographically distributed across the State of Qatar as a public provider. Its focus is on integrating high-quality curative services with promoting healthy living, and on community and patient engagement towards a healthier future. This is based on the family medicine model, through multidisciplinary teams that cover all age groups with a wide range of services  in the community. There are currently 139 certified Qatari FPs, with 12 FPs graduating annually through the FP residency programme—which is insufficient to cover the country’s needs. This exemplifies some challenges Qatar is facing but at the same time captures a positive incentive towards PHC.Qatar has a population of 2.4 million, with 77.4 physicians per 10,000 inhabitants . It launSudan with a population of 39.6 million and 2.5 physicians per 10,000 started the PHC approach in 1976 to achieve rural extension for the then urban-based health services . A signiThe UAE has an estimated population of 9.6 million of which Emirati nationals represent 19% . PopulatEach country presented a unique situation, but all had PHC on their health agenda. From it, four themes emerged: (i) the gap between PHC facilities currently realized and what is required to serve their populations; (ii) problems amongst policymakers in understanding the complex nature of PHC and the importance of comprehensive policy to realize it; (iii) the importance of investing in the training of (future) professionals in the primary healthcare setting; and (iv) the importance of involving the private, next to the public sector in health reforms.limited PHC  has not evolved in a structure that integrates the broad field of prevention, treatment and support of all health problems in all individuals [All six countries have made progress in the health of their populations but there were general concerns of an underuse of prevention and of equitable access to care. Countries differed in the realization of a coherent policy to address these issues. Bahrain and Sudan have developed a structure of community based PHC as the entry point of the health system, with a leading role for FPs, and Qatar has recently launched plans to strengthen community engagement in improving health outcomes. In Lebanon, the introduction of UHC is connected to the provision of community health services and directed at the poorest population. Other countries are aware of the need to introduce PHC in their health systems, but without a targeted policy to bring this about. This was exemplified in Egypt, with its long tradition of PHC that has improved maternity and child health . Yet, asividuals .To achieve this integrated approach, a comprehensive health policy is required to regulate the health system, define the role and function of PHC, and make sure that professionals have the competence to fulfil this role. Of particular importance is here to include the private sector , as mostFor PHC to be able to lead the health system, training of professionals—including FPs—in the PHC setting is a mandatory precondition. Specialty training for FPs is provided by medical schools in the countries, but has a low priority, resulting in a shortage of FPs . The strAnother measure is to combine programmes for practitioners already working in the system to improve their skills with specialty training of residents, as recommended by the WHO EMRO .For consistent policy, it is essential to understand the complex nature of PHC and of how it contributes to health systems. Unfortunately, policymakers consider PHC an ill-understood ‘black box’ , and thaThe shared challenges on the road to PHC implementation present a strong case for regional collaboration in which PHC leadership connects with policymakers and other stakeholders ,30. In tThe priorities in PHC that emerged from this analysis concur with priorities in other regions—including Europe. Particularly relevant from a European perspective is how to align the private and public sectors in PHC development and how to secure a policy towards UHC that comprehensively addresses the health system regulations, professionals’ roles, and specialty training.Advocacy for community-based PHC and UHC to policymakers, including the central role of PHC in coordinating healthcare at the community level. The experiences in Bahrain and Sudan can serve as models of success;Collaboration with university leaders and deans of medical schools to include PHC as a core component of every medical curriculum, followed by specialty training in PHC settings for those choosing a career as FP;Collaboration with patients and community leaders to inform the public about the role and function of PHC to improve its understanding. Collecting and displaying stories and experiences of patients can be of great value in this .As the private sector is a main outpatient health services provider, engaging the private health sector is inevitable to realize UHC.Despite their differences in their socio-economic situation and track record of their health systems, the six countries face the same challenges in securing robust PHC and UHC. In conclusion, four priorities of joint action were identified:


Cardiovascular disease (CVD) is a major cause of disability and premature death. Despite European guidelines advocating the use of medical therapies in CVD, many patients still do not achieve the guideline-recommended treatment, which highlights the need for change and innovations in this field. This requirement has been widely recognised by the national ministries of health, several European cardiology societies, and the European Parliament, who support the initiation of strategies to improve and promote cardiovascular health.One of the key risk factors to recurrent cardiovascular events is the lack of adherence to medication and this has been added to the agenda of the European Commission. With the intention to improve treatment adherence in CVD, polypills have been investigated and numerous studies demonstrate that they significantly improve medication adherence, which contributes to the improvement of health outcomes. In Europe, the first cardiovascular polypill, developed by a public-private partnership (CNIC-Ferrer), recently became available for general prescription as a therapy for CVD prevention. This polypill significantly improves adherence, preventing fatal and non-fatal cardiovascular events, and appears to be a cost-effective strategy to improve sustainability of the health care systems in CVD.Given the importance of urgent and simple solutions to restraining the pandemic nature of CVD, the polypill approach should therefore be considered by physicians and public health systems as an available and innovative option to improve cardiovascular health. Cardiovascular disease (CVD) is a major cause of disability and premature death worldwide. Despite European and American guidelines advocating the use of medical therapies in CVD, many patients still do not achieve the guideline-recommended treatment, due to several reasons including poor or non-adherence to the prescribed therapy or high medication burden. As such, there is a clear need for change and innovation in this field.This need has been widely recognised in political, scientific and patient communities in their support of the initiation of strategies to improve and promote cardiovascular (CV) health.One of the key risk factors to recurrent CV events is the lack of adherence to medication and this has been added to the agenda of the European Commission. With the intention to improve treatment adherence and strengthen comprehensive CVD prevention plans, several approaches and interventions have been analysed, such as the use of Dual Antiplatelet Therapy (DAPT), as well as different tactics to modify behavioural risk factors. There have, however, only been few advances in the field of drug treatment aimed at enhancing treatment effectiveness. In particular, polypills have been investigated in the CVD field and numerous studies demonstrate that they significantly improve medication adherence, which contributes to the improvement of health outcomes.This article analyses the issue of poor and non-adherence to medication as a risk factor for CVD prevention and focuses on the polypill therapy as an effective approach to help reduce the number of recurring CV events in Europe.It has been widely demonstrated that CVD is a major cause of disability and premature death worldwide . An estiLooking at a regional level, CVD is the leading contributor to mortality in the 53 countries of the World Health Organization (WHO) Europe Region, causing almost 4.1 million deaths each year, which means 46 % of all deaths in Europe. In the European Union (EU) alone, CVD causes more than 1.9 million deaths annually and the geographical distribution of this figure across Europe reflects particularly higher rates of deaths in the northern countries over the southern nations. In all countries, death rates for coronary heart disease (CHD) are higher in males than females [The global burden of CVD is led by CHD and stroke, which have been identified as the first and third lead diseases for disability-adjusted life-years, as a sum of years of life lost due to premature death and years of life lived with disability, worldwide . For EurSome studies showed that the progresses made in securing the stabilisation of patients after a CV event, such as myocardial infarction (MI), have largely contributed to the prevalence of CHD as a chronic disease. Consequently, recurrent CVD events are common among people who have previously been diagnosed with an MI, with rates found as close to 50 % for any CVD event , 7 or suIt is therefore essential to understand and to consider the implications for the long-term prognosis of the condition, both for survival and the risk of recurrence . In thisAlthough modifying patients’ lifestyle and behaviours could partly reduce the recurrence of CV events, , a largeHowever, while guidance from experts is clear, recent studies have demonstrated a suboptimal use of medicines targeted for the prevention of recurrent CV events, showing that only 43 % of patients with acute coronary syndrome (ACS) are actually prescribed with optimal treatment for secondary prevention , 21. As In addition, the latest EUROASPIRE study , a crossAdherence to medication has been widely identified as a risk factor to the recurrence of CVD. Good adherence is associated with positive health outcomes and poor adherence to treatment actually increases the likelihood of suffering a recurrent CV event , 24. A rA direct link between adherence to treatment and health outcomes has been repeatedly reported and poor compliance was documented to be associated with considerable worsening of the condition , rehospiGiven the evidence, it is clear that medication adherence in CVD prevention remains a challenge for patients and healthcare providers. Lack of compliance is not only associated with a lower quality of life and poor health outcomes, but also has socio-economic impact and generates elevated costs to healthcare systems. In the EU, the number of deaths associated with miss-dose and non-adherence to prescribed medication in general is estimated to be approximately 194,500 per year and non-adherence is estimated to cost the EU EUR 125bn annually .Pledge for Cardiovascular Health, encouraging members of the European Parliament (MEPs) to show their support for CV health and committing them to consider the impact of CV health when voting on EU legislation and to support national strategies to promote CV health [The need for new and more effective delivery of evidence based preventive treatments to patients is increasingly recognised by Governments of Member States of the EU, the European Society of Cardiology (ESC), National Cardiac Societies, the European Heart Network (EHN), National Heart Foundations and the Union of European Medical Specialists Union  Cardiology section. The importance of strengthening of comprehensive CVD prevention plans and the certainty that effective measures, policies, and interventions would be in place in all European countries, was adopted in 2005 in the Luxembourg Declaration . In 2007V health .In line with these calls for action, clear advances in the field were made and some of the key progresses in CVD prevention in 2015 were summarised . These iAdvances in the treatment of CVDs from previous years that target non-modifiable risk factors include the use of Dual Antiplatelet Therapy (DAPT), which is usually prescribed after a heart attack or stent placement to keep the vessels open and to prevent future heart attacks . The admDespite these calls for action, there have only been a few clear advances in drug treatment in the field in recent years.The polypill approach, which combines several medicines that simultaneously control several risk factors or disease mechanisms in a single pill, is one of those strategies that has, in recent years, progressed in the CVD field. The concept was introduced by Wald and Law in 2003, who described a fixed-dose combination strategy, containing six components, and claimed that the administration of this polypill to each individual over 55 years old would reduce the incidence of CVD by more than 80 % . Since tSeveral drug classes  exist, and have been shown in multiple large cardiovascular outcome trials to reduce the risk of events when used in the setting of CVD prevention . HoweverThe polypill approach has been advocated to help overcome some of these barriers to CVD prevention . To dateThe effect of polypills on treatment adherence has been studied in detail in recent years. As such, results from the UMPIRE, IMPACT, Kanyini GAP, and FOCUS trials showed that the polypill significantly increases adherence to treatment when compared to administering either the individual drugs separately  or when In more detail, the randomised, open-label UMPIRE trial among people with established CVD or at risk of CVD demonstrated that the use of a fixed-dose combination (FDC) therapy significantly improved adherence to treatment at 15 months, as well as leading to statistically significant improvements in systolic blood pressure (SBP) and low-density lipoprotein (LDL) cholesterol . In lineMoreover, the cross-sectional FOCUS study (Fixed-Dose Combination Drug for Secondary Cardiovascular Prevention) assessed the effect on adherence of treatment with the polypill in comparison to treatment with its separate monocomponents in 695 adult patients following a MI. After 9-months of follow-up, the percentage of adherent patients in the polypill group was significantly increased by approximately 22% when compared to the group receiving the separate components of the polypill .A more general meta-analysis assessing patients with acute and chronic diseases also examined the impact of reduced frequencies of oral therapies from multiple- to once-daily dosing schedule on adherence. It suggested that across acute and chronic disease states, adherence to therapies might be improved by reducing dosage frequency. The study further suggested that this increase in adherence may result in subsequently lower healthcare costs . In lineBy reducing the complexity of the medication regimen, the polypill can also help overcome some of the additional risks and problems associated with polypharmacy. Polypharmacy after a CV event is common and may pose risks, such as adverse drug interactions, accidental overdosing and medication non-adherence, that originate from the difference in medication schedule and dosage . EspeciaInterestingly, numerous studies have demonstrated that patients also consider polypills as more convenient and prefer having to take one single medicine instead of several individual medicines. Indeed, a recent study assessing the influence of polypill-based treatment attributes and patient characteristics on preferences for CVD preventive treatment showed that treatment preference decreased with tablet number. The discrete choice experiment further demonstrated that patients value and are willing to pay a premium for each tablet reduction .The polypill provides physicians with an improved tool to meet the progressively more stringent secondary prevention guidelines from the ESC and other medical societies. This is significant as inadequate prescription of medicines remains a substantial gap in the coverage of secondary interventions for the prevention of CVD, as demonstrated by the findings from the WHO study on Prevention of REcurrences of Myocardial Infarction and StrokE (WHO-PREMISE) , the AntDespite the impressive number of potential benefits of the polypill strategy in CVD prevention, its use is relatively novel. One concern of polypill sceptics is that patients will regard the polypill as an excuse to potentially replace efforts to promote healthy lifestyles . Rather th European Framework Programme and Horizon 2020 to help overcome the unmet clinical need in CVD prevention [Polypill is now a reality because the first of its kind has been released to the market in Europe. The CNIC-Ferrer polypill project is the European polypill developed as a therapy for secondary CVD prevention. It was inspired by the needs of most patients with a previous heart disease, guideline recommendations outlined above, and negative health outcomes originating from lack of adherence. It was developed through a public-private strategic partnership between the Centro Nacional de Investigaciones Cardiovasculares (CNIC), Spain, and Ferrer, Spain. The research was supported by European funding from the 7evention .To date, the CNIC-Ferrer polypill strategy is the first and only polypill approved in 15 European countries , alreadyThis polypill consists of an angiotensin-converting enzyme (ACE) inhibitor (ramipril), a statin (atorvastatin) and an aspirin, at dosages established to achieve the best balance safety/benefit that has been proven to prevent CVD events. Moreover, the use of the polypill components in patients who have suffered a CV event is commended by ESC , AmericaBy combining three medicines recommended for the secondary prevention of CV events in a once-daily capsule, the polypill was shown to significantly increase adherence in patients following a CV event when compared to administering the three drugs separately . This inHorizon 2020 framework programme, which is making EUR 80 billion of public funding available to researchers between 2014 and 2020 [Horizon 2020 framework [One of the priorities of the European Commission is to contribute to the improvement of adherence to medical plans and medication . Furtherand 2020  alongsidand 2020 , 64, andramework .There is a pan-European fiscal challenge facing the management of non-communicable diseases (NCDs), such as CVD. Heart disease, stroke and diabetes cause significant loss of national income each year in the world’s most populous nations. Economic analysis suggests that each 10 % rise in NCDs is associated with 0.5 % lower rates of annual economic growth .The International Monetary Fund (IMF) has highlighted public-private partnership as a very relevant way to improve R&D and innovation . These tHorizon 2020 vision of reducing ‘red tape’ in a bid to ensure Europe produces world-class science, removes barriers to innovation and makes it easier for the public and private sectors to work together. The author group of this paper believe the CNIC-Ferrer partnership provides an appealing and innovative model for therapeutic discovery and development on the continent.The CNIC-Ferrer polypill project discussed in this paper is a recent example of a successful collaboration between publicly-funded health bodies and the industry sector to deliver improved therapeutic strategies and solutions in chronic disease areas. CNIC, supported by the Ministry of Economy of the Spanish Government, aims to expedite CV research in Spain and to ensure funding is made available to conduct biomedical research with a focus on prevention rather than treatment, where possible. Its objectives are aligned with the EC Combination therapy has become the standard for treating several relevant major communicable diseases such as HIV/AIDS, TB and malaria, and has recognised benefits in slowing resistance, improving clinical outcomes and facilitating logistics . Other nThe European Medicines Agency (EMA) recognises that fixed-dose combinations of medicinal products have been increasingly used due to the benefit of the combined effects of active substances given together and has issued a guideline on the clinical development needed for ‘fixed dose combination’ medicinal products depending on the intended indication .CVD prevention remains one of the key medical challenges affecting European populations, and effective, simple solutions have a key role to play in restraining the pandemic nature of the disease . The polMoreover, in view of the public-health interest to assure adherence to treatment in relevant communicable and non-communicable diseases, additional programmes on adherence and more research should be undertaken and funding provided to gather evidence, in order to healthcare professional to tackle CVD burden by adopting innovative healthcare interventions including the polypill strategy. Last but not least, European patient associations should envisage educational training to promote patients’ awareness of cardiovascular risk and disease while engaging them in the adherence to healthy lifestyle habits and pharmacological treatment with the final objective to control risk factors and empower them.The authors’ call to action is therefore directed to payers, patient associations, industry, research funders, regulators, and healthcare professionals, to ensure that polypills are developed, made available and accessible to patients in diseases than benefit from improving the adherence to their treatments.Following an analysis of the current context of CVD in Europe, a need for innovative and effective interventions in the prevention of secondary CVD was highlighted.In order to cope with poor and non-adherence to treatment, which has been widely identified as a key risk factor in the prevention of CVD, the polypill approach has been demonstrated to be an effective innovation to improve CVD outcomes. Several studies have shown that a simpler and less frequent dosing regimen results in improved compliance to medication across a variety of therapeutic classes and that adherence rates decrease when dosing frequencies increase. In line with this, the polypill, which reduces the complexity of the medication regimen, was demonstrated to help increase medication adherence in CVD patients, improving health outcomes.In light of the epidemic scale of CVD, the first CV polypill was recently made available by European decision-makers as a therapy for CVD prevention in Europe. This polypill was shown to significantly improve adherence and reduce the number of CV events. It also appeared to be a cost-effective strategy to prevent fatal and non-fatal CV events.It is clear that CVD prevention remains to be one of the key medical challenges in Europe, and effective, simple solutions are needed to restrain the pandemic nature of the disease. The polypill approach has a significant potential in the context of CVD prevention and should be considered an available, valuable innovation by healthcare professionals, patients and public health systems in order to improve CV health.