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OBJECTIVE：To explore the mechanism of risk sharing and transfer of drug marketing authorization holders （MAH）based on drug defects ，and to promote the smooth implementation of MAH system in China. METHODS ：Firstly，the types of drug defects in the whole drug life cycle were analyzed ，and then the sources and “fault party ”of different types of drug defects in the open commissioning environment of the industry chain under the MAH system were also analyzed. Based on it ，the mechanism of risk sharing and transfer of MAH was established combined with foreign experience and China ’s actual situation. RESULTS & CONCLUSIONS ：Drug defects were divided into design defects ，manufacturing & operation & storage & transportation quality defects and use defects ，among which design defects and manufacturing & operation & storage & transportation quality defects were the two most important defects. Design defects mainly included those caused by human factors and those could not be found by current level of science and technology ，the“fault party ”according to different circumstances may be both the research and development institutions and may be the MAH. The “fault party ”of production & operation & storage & transportation quality defects was the drug production & operation & storage & transportation enterprises. For design defects ，it was recommended to establish China ’s adverse drug reaction compensation mechanism through a combination of insurance and relief. For production & operation & storage & transportation quality defects ，it was recommended that the drug quality liability insurance as the main ，contractual agreement as the supplement ，so that the “fault party ”should assume due responsibility.
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Objective: To explore the effect and significance of medical dispute mediation committee as third party participating in pre - operative testimony mechanism. Methods: For 116 operations from Oct 2015 to May 2017, the medical dispute mediation committee as third party witnessed preoperative communication to patients and their families and signature, and we put forward suggestions for risk guarantee. Results: There were no medical disputes in any of the witness case, of which 43 cases purchased medical accident insurance and achieved risks transfer. Conclusion: Medical dispute mediation committee as third party participating in pre - operative testimony mechanism helps both doctors and patients clear risks, supervises the fulfillment of informed consent, promotes the landing of medical accident insurance, and achieves the recognition and transformation of medical risks.
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Objective To estimate the averaged excess relative risk(ERR) in Chinese population based on the radiogenic cancer risk of leukemia in Japanese atomic bomb survivor cohort,and to discuss proper method suitable for risk transfer between populations.Methods Based on BEIR Ⅶ radiogenic cancer model and population transfer model,and the 2009 Chinese leukemia baseline rates given in 2012 Chinese Cancer Registry Annual Report,comparison was made of population incidences in seveal countries to adjust the weighting factors.Results The ERR of three subtypes of leukemia as a whole was obtained,and the weighting factors for risk transfer model was assumed.The additive factor for male was 0.2,and the multiplicative factor was 0.8,while the additive factor for female was 0.15,and the multiplicative factor was 0.85.Conclusions For the risk transfer between populations,weighting factor was adjusted as a whole to obtain the ERR value for estimating the risk to Chinese population.The risk transfer method suitable for Chinese population was obtained by using the incidence rate available for Chinese population to directly transfer radiation-induced leukemia risk to Chinese from Japanese.
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Objective To establish a transfer model for excess relative risk (ERR) for radiation-related leukemia from Japanese population to Chinese population.Methods Combined ERR of several subtypes of leukemia published in 1994, with the corresponding leukemia baseline incidence rates obtained from Cancer Incidence in Five Continents Vol.Ⅸ (CI5-Ⅸ) for Japanese population and Chinese population, a weighted risk transfer model was employed between an additive model and a multiplicative model, to execute ERR transfer.Results A range of weighing factors was proposed for risk transfer models:weighing factor was 0.4 for male and 0.3 for female, acute lymphoblastic leukemia, acute myeloid leukemia and chronic myeloid leukemia.The uncertainty for ERR transfer was characterized by lognormal distribution.Conclusions Based on the difference of baseline incidence rate for subtypes of leukemia between Japanese population and Chinese population, the transfer model and these weighing factors discussed in the present study could be applicable to transfer ERR for radiation-related leukemia from Japanese population to Chinese population.
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INTRODUCCIÓN: Los mecanismos de contratación y pago en salud generan un impacto diverso en la cantidad y calidad de los servicios médicos, en la transferencia de riesgo entre actores y en la eficiencia de la utilización de los recursos. OBJETIVO: Analizar la estructura del mercado de servicios de salud en las provincias de Córdoba, Salta y Tucumán durante los últimos cinco años. MÉTODO: Se consideraron las condiciones socio-económico-sanitarias locales, el marco institucional, la historia de los actores más relevantes del sector y las conductas adquiridas como respuesta a la estructura. La metodología incluyó un mapeo de los actores claves del sector salud cada provincia así como la administración de un cuestionario a una muestra de establecimientos públicos y privados de cada jurisdicción. RESULTADOS: Los ministerios de salud provinciales son los principales financiadores del sistema público de salud y el Instituto Nacional de Servicios Sociales para Jubilados y Pensionados (PAMI) y las obras sociales provinciales lo son del sistema privado. CONCLUSIONES: PAMI tiene una política nacional que lo torna menos flexible para contemplar las particularidades locales, mientras que las obras sociales provinciales se presentan como los actores idiosincrásicos, siendo más permeables a las demandas locales. En la medida en que el PAMI coordine con los ministerios y la obra social provincial, se podría converger a modelos más homogéneos de atención y mecanismos de pago, generando incentivos para una mayor eficiencia en la asignación de recursos y una mayor equidad en salud
INTRODUCTION: The contracting and payment mechanisms in health generate different impact on the quantity and quality of medical services, the transfer of risk among actors and the efficient use of resources. OBJECTIVES: To analyze the market structure of health services in the provinces of Cordoba, Salta and Tucuman during the past five years. We considered the local socioeconomic and health conditions, institutional framework, the history of the most relevant actors, and their behaviour in response to the structure. The methodology included a mapping of key actors in the health sector in each province and the administration of a questionnaire to a sample of local public and private health institutions. RESULTS: The results show that the provincial ministries of health are the primary funders of the public services and the national insurance for retired people (PAMI) and the provincial social insurances are the primary funders of the private system. CONCLUSION: PAMI has a national policy which makes it self less flexible to consider the local particularities,while the provincial social insurances present themselves as idiosyncratic actors, being more receptive to local demands. If PAMI were coordinated with the structure of the local social insurance and the ministries of health, it could beachieved homogeneous models of health care and payment mechanisms, generating incentives for a more efficient resources allocation and equity in health