Barriers to Biosimilar Prescribing Incentives in the Context of Clinical Governance in Spain.

Incentives contribute to the proper functioning of the broader contracts that regulate the relationships between health systems and professionals. Likewise, incentives are an important element of clinical governance understood as health services' management at the micro-level, aimed at achieving better health outcomes for patients. In Spain, monetary and non-monetary incentives are sometimes used in the health services, but not as frequently as in other countries. There are already several examples in European countries of initiatives searching the promotion of biosimilars through different sorts of incentives, but not in Spain. Hence, this paper is aimed at identifying the barriers that incentives to prescribe biosimilars might encounter in Spain, with particular interest in incentives in the framework of clinical governance. Both questions are intertwined. Barriers are presented from two perspectives. Firstly, based on the nature of the barrier: (i) the payment system for health professionals, (ii) budget rigidity and excessive bureaucracy, (iii) little autonomy in the management of human resources (iv) lack of clinical integration, (v) absence of a legal framework for clinical governance, and (vi) other governance-related barriers. The second perspective is based on the stakeholders involved: (i) gaps in knowledge among physicians, (ii) misinformation and distrust among patients, (iii) trade unions opposition to productivity-related payments, (iv) lack of a clear position by professional associations, and (v) misalignment of the goals pursued by some healthcare professionals and the goals of the public system. Finally, the authors advance several recommendations to overcome these barriers at the national level.

Ernest Lluch: político y reformador sanitario. Unas notas / No disponible

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La justificación de las políticas de salud pública desde la ética y la eficiencia económica. Informe SESPAS 2010

Objetivos: En España, en tiempos recientes, algunas voces han puesto en cuestión ciertas polìticas de salud pública por posibles invasiones de la libertad personal. El objetivo del capítulo es responder a dichas voces con argumentos éticos y económicos que justifican tales políticas.

Generic drug names and social welfare.

This article studies how well International Nonproprietary Names (INNs), the "generic" names for pharmaceuticals, address the problems of imperfect information. Left in private hands, the identification of medicines leads to confusion and errors. Developed in the 1950s by the World Health Organization, INNs are a common, global, scientific nomenclature designed to overcome this failure. Taking stock after sixty years, we argue that the contribution of INNs to social welfare is paramount. They enhance public health by reducing errors and improving patient safety. They also contribute to economic efficiency by creating transparency as the foundation of competitive generic drug markets, reducing transaction costs, and favoring trade. The law in most countries requires manufacturers to designate pharmaceuticals with INNs in labeling and advertising. Generic substitution is also permitted or mandatory in many countries. But not all the benefits of INNs are fully realized because prescribers may not use them. We advocate strong incentives or even legally binding provisions to extend the use of INNs by prescribing physicians and dispensing pharmacists, but we do not recommend replacing brand names entirely with INNs. Instead, we propose dual use of brand names and INNs in prescribing, as in drug labeling.

Competition in prescription drug markets: the roles of trademarks, advertising, and generic names.

We take on two subjects of controversy among economists-advertising and trademarks-in the context of the market for generic drugs. We outline a model in which trademarks for drug names reduce search costs but increase product differentiation. In this particular framework, trademarks may not benefit consumers. In contrast, the generic names of drugs or "International Nonproprietary Names" (INN) have unquestionable benefits in both economic theory and empirical studies. We offer a second model where advertising of a brand-name drug creates recognition for the generic name. The monopoly patent-holder advertises less than in the absence of a competitive spillover.

Alimentación y actividad física: un reto de nuestro tiempo / Diet and physical activity: A current challenge

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La justificación de las políticas de salud pública desde la ética y la eficiencia económica. Informe SESPAS 2010 / Grounding public health policies in ethics and economic efficiency. SESPAS report 2010

Objetivos: En España, en tiempos recientes, algunas voces han puesto en cuestión ciertas políticas de salud pública por posibles invasiones de la libertad personal. El objetivo del capítulo es responder a dichas voces con argumentos éticos y económicos que justifican tales políticas. Métodos: El presente trabajo plantea la corriente de opinión y sus características. Después, partiendo de Stuart Mill, expone los principios éticos de no maleficencia, beneficencia, autonomía personal y justicia, y algunos conceptos correlativos pertenecientes al plano de la eficiencia económica: efectos externos, monopolio, información incompleta y asimétrica, relación de agencia, bienes públicos y selección adversa. También se hace somera mención a la justicia o la equidad en economía, y al Estado del bienestar y los sistemas sanitarios públicos. Se discute también la justificación y los límites de las actuaciones «paternalistas» por parte del Estado. Conclusión: El respeto a la libertad individual no sólo no se opone, sino que exige, la adopción de medidas de salud pública. Si esas actuaciones cumplen ciertos requisitos, no sólo no limitan sino que protegen y amplían la libertad individual (AU)

Objectives: In recent times, various voices in Spain have questioned public health policies as an assault to personal freedom. The present article aims to respond to these voices with ethical and economic arguments. Methods: The scope and characteristics of this current of opinion are described. Then, starting with John Stuart Mill, the ethical principles of non-maleficence, beneficence, personal autonomy and justice, as well as related concepts taken from economic efficiency, such as externalities, monopoly, incomplete and asymmetric information, agency relationship, public goods and adverse selection, are discussed. A short mention is made of equity in economics, the welfare state and public health systems. The justification for paternalist actions by the state, as well as limits to these actions, are briefly discussed. Conclusion: Respect for individual freedom does not exclude the implementation of public health actions but rather demands the adoption of such policies. If these actions comply with certain conditions, they do not limit individual freedom but rather serve to protect it (AU)

[Grounding public health policies in ethics and economic efficiency. SESPAS report 2010]. / La justificación de las políticas de salud pública desde la ética y la eficiencia económica. Informe SESPAS 2010.

OBJECTIVES: In recent times, various voices in Spain have questioned public health policies as an assault to personal freedom. The present article aims to respond to these voices with ethical and economic arguments. METHODS: The scope and characteristics of this current of opinion are described. Then, starting with John Stuart Mill, the ethical principles of non-maleficence, beneficence, personal autonomy and justice, as well as related concepts taken from economic efficiency, such as externalities, monopoly, incomplete and asymmetric information, agency relationship, public goods and adverse selection, are discussed. A short mention is made of equity in economics, the welfare state and public health systems. The justification for paternalist actions by the state, as well as limits to these actions, are briefly discussed. CONCLUSION: Respect for individual freedom does not exclude the implementation of public health actions but rather demands the adoption of such policies. If these actions comply with certain conditions, they do not limit individual freedom but rather serve to protect it.

Community nutrition in Spain: advances and drawbacks.

Scientific evidence has placed community nutrition among the front-line strategies in health promotion. Community nutrition in different regions of Spain has developed at an unequal pace. Early initiatives in the mid 1980s provided good-quality population data and established a basis for nutrition surveillance including individual body measurements, dietary intake data, information on physical activity, and biomarkers. The Nutrition and Physical Activity for Obesity Prevention Strategy (NAOS) reinforces community nutrition action in Spain. Presented here is an overview of developments in community nutrition in Spain in recent years as well as potential trends under the scope of the NAOS.

Indirect costs of cervical and breast cancers in Spain.

This study estimated the indirect costs (productivity loss) caused by mortality and morbidity of cervical and breast cancers in Spain. We used two alternative methods: (a) the traditional human capital (HC) approach and (b) the friction cost (FC) method. The annual costs were Euro 43.4 and 288.7 for cervical and breast cancer, respectively, by the HC approach and Euro 1.1 and 11.6 million by the FC approach. Cost-of-illness studies help to illustrate the real dimension of health problems and should be a major concern for health policies. Indirect costs are relevant information about diseases. However, the estimated indirect costs depend heavily on the approach adopted.

Direct health care costs of diabetic patients in Spain.

OBJECTIVE: The goal of this study was to estimate the health care resources spent by type 1 and type 2 diabetic patients in Spain during the year 2002. RESEARCH DESIGN AND METHODS: This is a cost-of-illness study focusing on direct health care costs estimated from primary and secondary sources of information. A prevalence of diabetes ranging from 5 to 6% of the adult population was determined. Total cost is composed of six items: insulin and oral hypoglycemic agents, other drugs, disposable and consumable goods (glucose test strips, needles, and syringes), hospitalization, primary care visits, and visits to endocrinologists and dialysis. RESULTS: The estimated direct cost of diabetes in 2002 ranges from 2.4 to 2.67 billion euro. Hospital costs were the most (933 million euro), followed by noninsulin, nonhypoglycemic agent drugs (777-932 million euro). Much lower are the costs of insulin and oral hypoglycemic agents (311 million euro), primary care visits (181-272 million euro), specialized visits (127-145 million euro), and disposable elements (70-81 million euro). Expenditures for all drugs and consumable goods ranged between 1.16 and 1.3 billion euro, representing 48-49% of total cost, which is 15% higher than hospital costs. CONCLUSIONS: The direct health care costs of diabetic patients are high (6.3-7.4% of total National Health System expenditure). Their average annual cost is 1,290-1,476 euro. For individuals without diabetes, the average annual cost is 865 euro.

Sistemas de pago a prestadores de servicios de salud en paises de America Latina y de la OCDE / Payment systems for health services providers in countries of Latin America and of the OECD

Ademas de ser uno de los componentes mas importantes de las relaciones contractuales entre los agentes de los sistemas de salud, el sistema de pago a prestadores es relevante para algunos de los principales criterios de valoracion de un sistema de salud, como la eficiencia y la calidad. En este articulo tratamos de proporcionar un marco analitico sencillo para comprender la naturaleza de los distintos sistemas de pago, que ilustramos con una revision de las formulas de pago utilizadas en dos grupos de países: 10 de la Organizacion de Cooperacion y Desarrollo Economico (OCDE) y cuatro de America Latina cuyas experiencias consideramos representativas. Primero presentamos un modelo basico para caracterizar las diferentes formas de pago, basado en dos dimensiones: la unidad de pago y la distribucion de riesgos financieros entre el que vende y el que compra. Cada sistema de pago tiene ventajas e inconvenientes que deben evaluarse en funcion de los objetivos que se pretenda alcanzar. En un extremo tenemos la remuneracion fija, que representa el pago prospectivo mas puro, sin ajustes, como el pago capitativo, en el que los prestadores soportan todo el riesgo financiero derivado de la variabilidad de costos. En el otro extremo se situa el pago retrospectivo o por acto, con el que el riesgo incurrido por los prestadores es nulo y es el financiador quien soporta todo el riesgo derivado de la variabilidad de costos. Como suele ocurrir, los extremos no parecen optimos y la cuestion consiste en escoger un sistema de remuneracion intermedio. Para ello, es necesario seleccionar, por una parte, la unidad de pago optima segun los objetivos del financiador y, por otra, una distribucion de riesgos que atribuya al prestador los riesgos derivados del mayor o menor grado de eficiencia que consiga en la prestacion de los servicios

Sistemas de pago a prestadores de servicios de salud en paises de America Latina y de la OCDE / Payment systems for health services providers in countries of Latin America and of the OECD

Ademas de ser uno de los componentes mas importantes de las relaciones contractuales entre los agentes de los sistemas de salud, el sistema de pago a prestadores es relevante para algunos de los principales criterios de valoracion de un sistema de salud, como la eficiencia y la calidad. En este articulo tratamos de proporcionar un marco analitico sencillo para comprender la naturaleza de los distintos sistemas de pago, que ilustramos con una revision de las formulas de pago utilizadas en dos grupos de países: 10 de la Organizacion de Cooperacion y Desarrollo Economico (OCDE) y cuatro de America Latina cuyas experiencias consideramos representativas. Primero presentamos un modelo basico para caracterizar las diferentes formas de pago, basado en dos dimensiones: la unidad de pago y la distribucion de riesgos financieros entre el que vende y el que compra. Cada sistema de pago tiene ventajas e inconvenientes que deben evaluarse en funcion de los objetivos que se pretenda alcanzar. En un extremo tenemos la remuneracion fija, que representa el pago prospectivo mas puro, sin ajustes, como el pago capitativo, en el que los prestadores soportan todo el riesgo financiero derivado de la variabilidad de costos. En el otro extremo se situa el pago retrospectivo o por acto, con el que el riesgo incurrido por los prestadores es nulo y es el financiador quien soporta todo el riesgo derivado de la variabilidad de costos. Como suele ocurrir, los extremos no parecen optimos y la cuestion consiste en escoger un sistema de remuneracion intermedio. Para ello, es necesario seleccionar, por una parte, la unidad de pago optima segun los objetivos del financiador y, por otra, una distribucion de riesgos que atribuya al prestador los riesgos derivados del mayor o menor grado de eficiencia que consiga en la prestacion de los servicios

The system used to pay health services providers is one of the most important components of the contractual relationship between persons who receive health services and the individual practitioners and institutions that provide those services. That payment system is also relevant in assessing a health system, including its efficiency and quality. In this article we present a simple analytical framework for various payment systems. We also provide an overview of the payment approaches used in two groups of countries whose experiences we consider representative: 10 nations of the Organization for Economic Cooperation and Development (OECD) and four countries of Latin America. We present a basic model to characterize the different forms of payment based on two dimensions. One of the dimensions is the payment "unit," which is used to measure the amount of health care services provided or promised. The other dimension is the distribution of financial risks between the service provider and the service purchaser. Each payment system has advantages and disadvantages that should be evaluated in relation to the intended objectives. On one extreme of the approaches is fixed remuneration, without any adjustments; it represents the purest prepayment approach. One example of fixed remuneration is capitated payment, in which providers carry all the financial risks coming from the variability in the cost of providing services. On the other extreme is fee-for-service payment, where service providers are not at financial risk; the insurer or other financing institution carries all the risk from variable costs. Neither of the extremes appears to be the best choice, and so the issue becomes one of selecting a remuneration system that falls between those extremes. Therefore, it is necessary to choose, on the one hand, the optimal payment unit according to the objectives of the financing entity and, on the other hand, a risk distribution approach that allocates to the service provider the risks coming from greater or less efficiency in delivering services