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3.
EMBO J ; 39(23): e107227, 2020 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-33205839

RESUMEN

A number of promising COVID-19 vaccine candidates may pass approval this month. However, the pandemic will only be brought into check through an equitable, epidemiologically informed distribution policy. The health emergency provides a unique opportunity for a new paradigm to mitigate between global health, national and commercial interests.


Asunto(s)
/prevención & control , Industria Farmacéutica/economía , Programas de Inmunización/organización & administración , /economía , Bases de Datos Factuales , Países en Desarrollo , Europa (Continente) , Salud Global/economía , Humanos , Programas de Inmunización/economía , Japón , Estados Unidos , Organización Mundial de la Salud
4.
Vaccine ; 38(52): 8318-8325, 2020 12 14.
Artículo en Inglés | MEDLINE | ID: mdl-33199075

RESUMEN

The counterfeiting of vaccines is an increasing problem globally with the safety of persons vaccinated, the trust in vaccines generally and the associated reputation of vaccine manufacturers and regulatory agencies at risk. This risk is especially critical with the on-going development of COVID-19 vaccines. The ability to track and trace vaccines through the vaccine supply chain down to persons vaccinated has to be enhanced. In this context of traceability, the global immunization community has recently set the barcoding of the primary packaging of vaccines, specifically vaccine vials and pre-filled syringes, as a top priority. Emerging vaccine manufacturers are already engaged in investigating ways to incorporate barcoding in their labelling and packaging using GS1 international standards. A specific pilot taking place in Indonesia by the national vaccine manufacturer, Bio Farma, shows the innovation of barcoding on primary packaging already underway with a relatively modest level of investment and success at this stage. This article highlights the efforts of industry and governments on the value of traceability and introduction to 2D barcodes. Access to financial resources and support from the international immunization community would accelerate such innovations leading to enhanced security of the vaccine supply chain.


Asunto(s)
Medicamentos Falsificados , Industria Farmacéutica/normas , Etiquetado de Medicamentos/normas , Procesamiento Automatizado de Datos , Vacunas/normas , /normas , Industria Farmacéutica/economía , Industria Farmacéutica/métodos , Etiquetado de Medicamentos/métodos , Humanos , Indonesia , Cooperación Internacional , Invenciones , Inversiones en Salud , Innovación Organizacional , Proyectos Piloto
7.
Med Sci (Paris) ; 36(11): 1095-1097, 2020 Nov.
Artículo en Francés | MEDLINE | ID: mdl-33151876

RESUMEN

A detailed analysis of the clinical benefit for 47 approved cancer drugs, using two internationally recognized assessment systems, shows essentially no correlation between clinical benefit and weekly treatment costs. This is true both in the USA and in four European countries, although prices are dramatically lower in Europe.


Asunto(s)
Antineoplásicos/economía , Antineoplásicos/uso terapéutico , Costos de los Medicamentos , Análisis Costo-Beneficio , Industria Farmacéutica/economía , Industria Farmacéutica/ética , Industria Farmacéutica/normas , Industria Farmacéutica/estadística & datos numéricos , Ética Farmacéutica , Europa (Continente)/epidemiología , Costos de la Atención en Salud , Humanos , Neoplasias/tratamiento farmacológico , Neoplasias/economía , Neoplasias/epidemiología , Estados Unidos/epidemiología
12.
PLoS One ; 15(10): e0241400, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33125413

RESUMEN

In view of the difficulty, high cost and complex technology of pharmaceutical logistics green transformation, based on the idea of green supply chain, three different government subsidy strategies for green logistics were proposed. Firstly, by constructing a Stackelberg game model with pharmaceutical logistics provider as the leader and manufacturer as the followers, the behavior selection and optimal decisions of the participants under the anarchic subsidy strategy, the single subsidy strategy of the pharmaceutical logistics provider, the single subsidy strategy of the pharmaceutical manufacturer and the coordinated subsidy strategy are analyzed respectively. Furthermore, the effects of different subsidy strategies on the green investment and strategy selection of logistics provider and manufacturer are compared. Finally, according to the research results, the paper provides reference and suggestions for the formulation of government subsidy strategy. The results show that the three subsidy strategies have different degrees of incentive effect on the green transformation of pharmaceutical logistics, and the single logistics provider subsidy strategy is the best.


Asunto(s)
Conservación de los Recursos Naturales , Industria Farmacéutica , Algoritmos , Simulación por Computador , Conservación de los Recursos Naturales/economía , Toma de Decisiones , Industria Farmacéutica/economía , Financiación Gubernamental , Tecnología Química Verde/economía , Humanos , Preparaciones Farmacéuticas/economía , Investigación
13.
PLoS One ; 15(10): e0239610, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33048952

RESUMEN

Clinical Practice Guidelines (CPGs) play significant roles in most medical fields. However, little is known about the extent of financial Conflicts of Interest (FCOIs) related to pharmaceutical companies (Pharma) selling dermatology prescription products and dermatology CPG authors in Japan. The aims of this study were to elucidate the characteristics and distribution of payments from Pharma to dermatology CPG authors in Japan, and to evaluate the extent of transparency and accuracy in their FCOI disclosures. We analyzed the records of 296 authors from 32 dermatology CPGs published by the Japanese Dermatological Association from the beginning of 2015 to the end of 2018. Using the payment data reported by 79 Pharma between 2016-2017 in Japan, we investigated the characteristics of the CPG authors and the payments from the Pharma to them. Furthermore, we evaluated the transparency and accuracy of the FCOI disclosures of the individual CPG authors. Of the 296 CPGs authors, 269 authors (90.6%) received at least one payment from the Pharma. The total monetary value of payments for the 2-year period was $7,128,762. The median and mean monetary value of payments from the Pharma reporting were $10,281 (interquartile range $2,796 -$34,962) and $26,600 (standard deviation $40,950) for the two years combined. Of the 26 CPG authors who disclosed FCOIs due to the monies received from Pharma, only the atopic dermatitis CPG authors and the acne vulgaris CPG authors published their potential FCOIs. In Japan, most dermatology CPG authors received financial payments from Pharma. The transparency of the CPGs, as reported by the CPG authors, was inadequate, and a more rigorous framework of reporting and monitoring FCOI disclosure is required to improve the accuracy and transparency with relation to possible Conflicts of Interest.


Asunto(s)
Conflicto de Intereses/economía , Dermatología/economía , Revelación , Industria Farmacéutica/economía , Guías de Práctica Clínica como Asunto , Autoria , Dermatología/ética , Revelación/ética , Industria Farmacéutica/ética , Femenino , Apoyo Financiero/ética , Humanos , Japón , Masculino , Preparaciones Farmacéuticas/economía , Sociedades Médicas/economía , Sociedades Médicas/ética
16.
PLoS One ; 15(9): e0239118, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32946474

RESUMEN

INTRODUCTION: In 2012, bedaquiline became the first new treatment from a novel class to be approved for tuberculosis in nearly five decades and is now a core component of the standard of care for multidrug-resistant tuberculosis. In addition to the originator pharmaceutical company, Janssen, a range of governmental and non-profit entities have contributed to the development of bedaquiline. MATERIALS AND METHODS: We identified various avenues of public investments in the development of bedaquiline: direct funding of clinical trials and a donation programme, tax credits and deductions, and revenues resulting from the priority review voucher (PRV) awarded to the originator. Data on investments were gathered through contact with study leads and/or funders; for non-responses, published average costs were substituted. The originator company's expenses were estimated by similar methods. Tax credits and deductions were calculated based on estimated originator trial costs and donation expenses. The value of the PRV was estimated by application of a published model. RESULTS: Public contributions through clinical trials funding were estimated at US$109-252 million, tax credits at US$22-36 million, tax deductions at US$8-27 million, administration of a donation programme at US$5 million, PRV revenues at US$300-400 million. Total public investments were US$455-747 million and originator investments were US$90-240 million (if capitalized and risk-adjusted, US$647-1,201 million and US$292-772 million, respectively). CONCLUSIONS: Estimating the investments in the development of a medicine can inform discussions regarding fair pricing and future drug development. We estimated that total public investments exceeded the originator's by a factor of 1.6-5.1.


Asunto(s)
Antituberculosos/economía , Diarilquinolinas/economía , Desarrollo de Medicamentos/economía , Financiación Gubernamental/economía , Organizaciones sin Fines de Lucro/economía , Antituberculosos/uso terapéutico , Ensayos Clínicos como Asunto/economía , Diarilquinolinas/uso terapéutico , Costos de los Medicamentos , Industria Farmacéutica/economía , Humanos , Tuberculosis Resistente a Múltiples Medicamentos/tratamiento farmacológico
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