OBJETIVO: Avaliar a capacidade aquisitiva do trabalhador para pagar medicamentos utilizados no tratamento de doenças crônicas e a disponibilidade desses medicamentos na forma de referência, similar ou genérica para fornecimento gratuito no setor público. MÉTODOS: Utilizou-se metodologia preconizada pela Organização Mundial da Saúde (OMS) e Health Action International (HAI) para coleta padronizada de informações sobre preços de venda no setor privado e disponibilidade no setor público de medicamentos em seis cidades do Rio Grande do Sul, Brasil. A coleta de dados ocorreu de novembro de 2008 a janeiro de 2009. A capacidade aquisitiva foi estimada como o número de dias do salário que um trabalhador com rendimento de 1 salário mínimo nacional necessita trabalhar para adquirir, em uma farmácia privada, a quantidade necessária de medicamento para 1 mês de tratamento. A disponibilidade foi avaliada verificando-se a presença dos medicamentos nas farmácias do setor público. RESULTADOS: A pesquisa incluiu 22 estabelecimentos públicos e 30 farmácias privadas. Dos 21 medicamentos utilizados no tratamento de sete doenças crônicas, apenas nove eram disponibilizados gratuitamente nos seis municípios pesquisados. O percentual médio da disponibilidade variou de 83,3% (São Leopoldo) a 97,6% (Caxias do Sul). A capacidade aquisitiva variou de 0,4 a 10,5 dias de salário para medicamentos de referência; de 0,2 a 8,4 dias de salário para medicamentos similares; e de 0,3 a 3,8 dias de salário para medicamentos genéricos. CONCLUSÕES: A disponibilidade geral dos medicamentos pesquisados foi superior aos 80% recomendados pela OMS; porém, alguns tratamentos não estavam disponíveis, ou apresentaram uma disponibilidade limitada no setor público. A capacidade aquisitiva dos trabalhadores nos municípios estudados indicou um comprometimento de dias do salário que pode afetar a continuidade dos tratamentos com medicamentos para doenças crônicas.

OBJECTIVE: To assess the affordability by workers of drugs used for treatment of chronic diseases, as well as the availability of the reference, similar, or generic forms of these drugs in the public health care system. METHODS: We employed the methodology recommended by the World Health Organization (WHO) and Health Action International (HAI) for the standardized collection of information on selling prices in the private sector and availability in the public health care system of drugs in six cities in the state of Rio Grande do Sul, Brazil. Data were collected from November 2008 to January 2009. Affordability was estimated as the number of salary days required for a worker receiving the national minimum wage to buy, in a private pharmacy, the amount of medication required for one month of treatment. Availability was assessed by the presence of these drugs in public health care system facilities. RESULTS: Twenty-two public facilities and 30 private pharmacies were studied. Of 21 drugs used for the treatment of seven chronic disorders, only nine were available free of charge in the six cities. Mean availability ranged from 83.3% (São Leopoldo) to 97.6% (Caxias do Sul). Affordability ranged from 0.4 to 10.5 salary days for reference drugs, 0.2 to 8.4 salary days for similar drugs, and 0.3 to 3.8 salary days for generic drugs. CONCLUSIONS: The overall availability of the drugs surveyed was higher than the 80% recommended by WHO. However, some treatments were not available, or had limited availability in the public system. Concerning affordability, the number of salary days required to buy these drugs may affect the continuation of drug treatments for chronic diseases.

Abstract: Parallel trade is a legal movement (arbitrage) of goods from one country where the product is first sourced and protected by intellectual property rights to another one but without the warranty of the manufacturer company. This phenomenon takes place as a result of the coexistence of the principle of “free movement of goods” and the subsidiary of national government in social policy affairs. This paper empirically examines whether drug parallel trade in three European Union counties has exerted any effect on prices, and undertaken a distribution of the effect of parallel trade in its stakeholders. Our results suggest that there are very moderate effects of parallel trade on drug prices. The main beneficiaries of parallel trade are parallel importers themselves who bring negligible savings to the health system are moderate, unlikely to overcome the induced costs to drug innovation.

Resumen: El comercio paralelo constituye un movimiento legal (arbitraje comercial) de productos de un país donde éstos se han puesto en circulación a otro país sin la autorización y la garantía del que posee los derechos de propiedad intelectual del producto. Este fenómeno se deriva de la aplicación del principio de subsidiariedad que lleva asociado la existencia de diferentes sistemas de regulación de precios y el de libre movilidad de bienes. En este artículo examinamos las tendencias de precios y penetración de medicamentos paralelamente importados respecto al precio del producto en el país de destino (beneficios de una mayor competencia) en 2002. En segundo lugar, establecemos una descomposición empírica de los efectos del comercio paralelo de medicamentos en los tres mercados principales de la Unión Europea en los diferentes agentes de la cadena del medicamento. Los resultados no siguieren pruebas de un efecto competitivo del comercio paralelo. Por otra parte, se observa que los principales beneficiarios son los propios importadores paralelos, en la medida que el comercio paralelo genera ahorros muy limitados en la factura de los sistemas de salud, que difícilmente superan los perjuicios en la innovación farmacéutica.

Objectives: To examine the effects of parallel simvastatin importation on drug price in three of the main parallel importing countries in the European Union, namely the United Kingdom, Germany, and the Netherlands. Methods: To estimate the market share of parallel imported simvastatin and the unit price both locally produced and parallel imported adjusted by defined daily dose in the importing country and in the exporting country (Spain). Ordinary least squares regression was used to examine the potential price competition resulting from parallel drug trade between 1997 and 2002. Results: The market share of parallel imported simvastatin progressively expanded (especially in the United Kingdom and Germany) in the period examined, although the price difference between parallel imported and locally sourced simvastatin was not significant. Prices tended to rise in the United Kingdom and Germany and declined in the Netherlands. We found no evidence of pro-competitive effects resulting from the expansion of parallel trade. Discussion: The development of parallel drug importation in the European Union produced unexpected effects (limited competition) on prices that differ from those expected by the introduction of a new competitor. This is partially the result of drug price regulation scant incentives to competition and of the lack of transparency in the drug reimbursement system, especially due to the effect of informal discounts (not observable to researchers). The case of simvastatin reveals that savings to the health system from parallel trade are trivial. Finally, of the three countries examined, the only country that shows a moderate downward pattern in simvastatin prices is the Netherlands. This effect can be attributed to the existence of a system that claws back informal discounts.

Objetivos: Examinar los efectos de la entrada de simvastatina paralelamente importada sobre el precio de los medicamentos en los 3 principales países importadores de medicamentos en la Unión Europea: Reino Unido, Alemania y Holanda. Métodos: Estimar la cuota de mercado de la simvastatina paralelamente importada, así como el precio unitario (del producto localmente producido y el importado) ajustado por dosis diaria definida (DDD) en el país de importación, y el precio unitario ajustado por DDD en el país de exportación (España). Estimaciones por mínimos cuadrados ordinarios para determinar la existencia de competencia en precios, derivada de la importación paralela de medicamentos en el período 1997-2002. Resultados: La cuota de mercado de la simvastatina paralelamente importada experimenta un aumento progresivo (sobre todo en el Reino Unido y Alemania) en el período analizado, sin que ello determine que la diferencia de precio entre la simvastatina localmente producida y la importada sea significativa. Mientras que la evolución de precios tiende al alza en el Reino Unido y Alemania, en Holanda muestra un efecto contrario. No se hallan efectos competitivos derivados de la expansión del comercio paralelo. Discusión: La importación paralela de medicamentos en la Unión Europea comporta efectos inesperados (limitada competencia) sobre los precios de los medicamentos, al ser un competidor adicional en el mercado. Ello en parte es el resultado de una regulación de precios que no incentiva la competencia, y de la falta de transparencia en el reembolso de la distribución. Esto último es debido al efecto de los descuentos informales (no observables para el investigador). El caso de la simvastatina pone en duda los ahorros de recursos para el asegurador sanitario derivados del comercio. Finalmente, de los 3 países analizados, Holanda es el único que muestra una tendencia a la baja en los precios de la simvastatina. Ello puede atribuirse al sistema de recuperación de descuentos (claw back) informales (implícitos).

Objectives: To examine the effects of parallel simvastatin importation on drug price in three of the main parallel importing countries in the European Union, namely the United Kingdom, Germany, and the Netherlands. Methods: To estimate the market share of parallel imported simvastatin and the unit price both locally produced and parallel imported adjusted by defined daily dose in the importing country and in the exporting country (Spain). Ordinary least squares regression was used to examine the potential price competition resulting from parallel drug trade between 1997 and 2002. Results: The market share of parallel imported simvastatin progressively expanded (especially in the United Kingdom and Germany) in the period examined, although the price difference between parallel imported and locally sourced simvastatin was not significant. Prices tended to rise in the United Kingdom and Germany and declined in the Netherlands. We found no evidence of pro-competitive effects resulting from the expansion of parallel trade. Discussion: The development of parallel drug importation in the European Union produced unexpected effects (limited competition) on prices that differ from those expected by the introduction of a new competitor. This is partially the result of drug price regulation scant incentives to competition and of the lack of transparency in the drug reimbursement system, especially due to the effect of informal discounts (not observable to researchers). The case of simvastatin reveals that savings to the health system from parallel trade are trivial. Finally, of the three countries examined, the only country that shows a moderate downward pattern in simvastatin prices is the Netherlands. This effect can be attributed to the existence of a system that claws back informal discounts.

Objetivos: Examinar los efectos de la entrada de simvastatina paralelamente importada sobre el precio de los medicamentos en los 3 principales países importadores de medicamentos en la Unión Europea: Reino Unido, Alemania y Holanda. Métodos: Estimar la cuota de mercado de la simvastatina paralelamente importada, así como el precio unitario (del producto localmente producido y el importado) ajustado por dosis diaria definida (DDD) en el país de importación, y el precio unitario ajustado por DDD en el país de exportación (España). Estimaciones por mínimos cuadrados ordinarios para determinar la existencia de competencia en precios, derivada de la importación paralela de medicamentos en el período 1997-2002. Resultados: La cuota de mercado de la simvastatina paralelamente importada experimenta un aumento progresivo (sobre todo en el Reino Unido y Alemania) en el período analizado, sin que ello determine que la diferencia de precio entre la simvastatina localmente producida y la importada sea significativa. Mientras que la evolución de precios tiende al alza en el Reino Unido y Alemania, en Holanda muestra un efecto contrario. No se hallan efectos competitivos derivados de la expansión del comercio paralelo. Discusión: La importación paralela de medicamentos en la Unión Europea comporta efectos inesperados (limitada competencia) sobre los precios de los medicamentos, al ser un competidor adicional en el mercado. Ello en parte es el resultado de una regulación de precios que no incentiva la competencia, y de la falta de transparencia en el reembolso de la distribución. Esto último es debido al efecto de los descuentos informales (no observables para el investigador). El caso de la simvastatina pone en duda los ahorros de recursos para el asegurador sanitario derivados del comercio. Finalmente, de los 3 países analizados, Holanda es el único que muestra una tendencia a la baja en los precios de la simvastatina. Ello puede atribuirse al sistema de recuperación de descuentos (claw back) informales (implícitos).