[Alternatives to the drug research and development model]. / Alternativas al modelo de investigación y desarrollo de medicamentos.

One-third of the global population lacks access to medications; the situation is worse in poor countries, where up to 50% of the population lacks access. The failure of current incentive systems based in intellectual property to offer the necessary pharmaceutical products, especially in the global south, is a call to action. Problems related to drug access cannot be solved solely through improvements or modifications in the existing incentive models. The intellectual property system model does not offer sufficient innovation for developing countries; new mechanisms that effectively promote innovation and drug access simultaneously are needed. A binding international agreement on research and development, negotiated under the auspices of the World Health Organization, could provide an adequate framework for guaranteeing priority-setting, coordination, and sustainable financing of drugs at reasonable prices for developing countries.

[Costly drugs: analysis and proposals for the Mercosur countries]. / Medicamentos de alto costo: análisis y propuestas para los países del Mercosur.

OBJECTIVE: Determine how the Mercosur countries access, regulate, and finance costly drugs and propose joint selection and financing strategies at the subregional level. METHODS: Qualitative design, using content analyses of primary and secondary sources, document reviews, interviews, focus groups, and case studies. The variables selected included: selection criteria, access, financing, and regulations in the various countries. Costly drugs were divided into those that do not alter the natural course of the disease and those with demonstrated efficacy, using the defined daily dose to compare the costs of classical treatments and those involving costly drugs. RESULTS: The Mercosur countries generally lack formal strategies for dealing with the demand for costly drugs, and governments and insurers wind up financing them by court order. The case studies show that there are costly drugs whose efficacy has not been established but that nonetheless generate demand. The fragmentation of procurement, international commitments with regard to intellectual property, and low negotiating power exponentially increase the price of costly drugs, putting health system finances in jeopardy. CONCLUSIONS: Costly drugs must be regulated and rationally selected so that only those that substantively benefit people are accepted. To finance the drugs so selected, common country strategies are needed that include such options as flexible in trade agreements, the creation of national resource funds, or joint procurement by countries to enhance their negotiating power.

Medicamentos de alto costo: análisis y propuestas para los países del Mercosur / Costly drugs: analysis and proposals for the Mercosur countries

OBJETIVO: Determinar la forma en que los países del Mercosur acceden, regulan y financian los medicamentos de alto costo (MAC) y proponer estrategias de selección y financiación conjunta a nivel sub-regional. MÉTODOS: Diseño cualitativo, utilizando análisis de contenido de fuentes primarias y secundarias, revisiones documentales, entrevistas, grupos focales y análisis de casos Las variables seleccionadas incluyeron: criterios de selección, acceso, financiación y regulación en los distintos países. Los MAC se clasificaron en aquellos que no modifican el curso natural de la enfermedad y aquellos que tiene eficacia demostrada, utilizando la dosis diaria definida para comparar los costos entre tratamientos clásicos y los realizados con MAC. RESULTADOS: Los países del Mercosur carecen en su gran mayoría de estrategias formales para enfrentar las demandas de MAC, y gobiernos y aseguradoras terminan por financiarlos por vía judicial. Los análisis de casos muestran que existen MAC sin eficacia comprobada que igualmente generan demanda. Las compras atomizadas, los compromisos internacionales respecto a propiedad intelectual y el bajo poder de negociación incrementan los precios de MAC exponencialmente, poniendo en riesgo la economía de los sistemas sanitarios. CONCLUSIONES: Los MAC deben ser regulados y seleccionados racionalmente permitiendo que solo aquellos que beneficien sustantivamente a la población sean aceptados. Para financiar los MAC así seleccionados se requieren estrategias comunes entre países que incluyan opciones tales como flexibilidades de acuerdos comerciales, creación de fondos nacionales de recursos o compra conjunta entre países para potenciar su poder de negociación.

OBJECTIVE: Determine how the Mercosur countries access, regulate, and finance costly drugs and propose joint selection and financing strategies at the subregional level. METHODS: Qualitative design, using content analyses of primary and secondary sources, document reviews, interviews, focus groups, and case studies. The variables selected included: selection criteria, access, financing, and regulations in the various countries. Costly drugs were divided into those that do not alter the natural course of the disease and those with demonstrated efficacy, using the defined daily dose to compare the costs of classical treatments and those involving costly drugs. RESULTS: The Mercosur countries generally lack formal strategies for dealing with the demand for costly drugs, and governments and insurers wind up financing them by court order. The case studies show that there are costly drugs whose efficacy has not been established but that nonetheless generate demand. The fragmentation of procurement, international commitments with regard to intellectual property, and low negotiating power exponentially increase the price of costly drugs, putting health system finances in jeopardy. CONCLUSIONS: Costly drugs must be regulated and rationally selected so that only those that substantively benefit people are accepted. To finance the drugs so selected, common country strategies are needed that include such options as flexible in trade agreements, the creation of national resource funds, or joint procurement by countries to enhance their negotiating power.