学習塾の原点を見つめ直す : 学習塾の存在意義とは

Background: Biosimilars are medicinal products that are similar to a biopharmaceutical that has already been authorised. As biopharmaceuticals are expected to dominate the best-selling pharmaceuticals worldwide by 2016, the emergence of biosimilars imposes an important challenge for governments. At this moment, the uptake of biosimilars in Belgium is limited, with market shares close to 0 %. Objective: This study aimed to identify the barriers that impede the uptake of biosimilars in Belgium. Methods: Semi-structured interviews were conducted to investigate in depth the barriers to the uptake of biosimilars in Belgium. Respondents were selected through selective sampling so that all different stakeholders were represented (authorities, physicians, pharmacists, patients, academics and industry). Respondents were contacted by e-mail and letter with a request for participation. A thematic framework was used to analyze the data. Results: Three main barriers to the uptake of biosimilars in the Belgian market were identified: a lack of confidence towards biosimilars by some stakeholders; uncertaint

Policies for biosimilar uptake in Europe : an overview

Background: Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. Objectives: The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. Methods: An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake. Results: In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution. Conclusions: Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market

Analysis of European policy towards generic medicines

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A generic medicine is amedicinal product with the same qualitative and quantitative composition inactive substances and the same pharmaceutical form as the reference medicinalproduct ( originator product ), and whose bio-equivalence with the referencemedicinal product has been demonstrated by appropriate bio-availability studies.They possess that same quality, safety and efficacy compared to originatormedicines at prices which tend to be 20-80% lower than their originatorequivalents. Part 1 of this project, the GeneralIntroduction, provides the definitions related to generic medicines andpresents an overview of the substantial savings which countries have obtainedthrough the use of them. Governments can implement a variety of policies toincrease the use of generic medicines, on both the supply- and the demand-side,which are described in Part 2 and Part 3.Studies on the supply-side have beenreported in Part 2. An overview of the regulatory framework regarding marketaccess of generic medicines in the European Union is provided in Chapter 2.1. Hurdles which delay marketaccess of generic medicines are listed: defensive patenting strategies; patentlitigations; patent linkage and third-party interventions during the process ofobtaining marketing authorization and pricing and reimbursement decisions; andbacklogs in national approval systems are well-documented causes for delayedmarket access of generic medicines. A list of recommendations to enhance marketaccess of generic medicines in the European Union round off this chapter (e.g. theestablishment of a unitary European Union patent and a unified and specialisedpatent litigation system at European level; automatic approval of pricing andreimbursement decisions upon marketing authorization; and a reduction ofbacklogs in national agencies).Chapter2.2 describes the current status and impact ofgeneric medicine pricing policies in Europe. Competition from Indian genericmedicine manufacturers, European variation in generic medicine prices andcompetition between generic medicine manufacturers by discount suggest that thepotential savings from generic medicines to health care payers and patients arenot fully realized in Europe. One solution might be to move away fromcompetition by discount to competition by price. Free-pricing systems may drivemedicine prices downwards under specific conditions. In price-regulatedsystems, regulation may lower prices of both originator and generic medicines,but it may also remove incentives for additional price reductions beyond thoseimposed by regulation. The European experience suggests that there is not asingle approach towards developing generic medicine pricing policies in Europe.A relationship between the market share ofgeneric medicines and the change of the price level of medicines in off-patentmarkets was demonstrated in Chapter 2.3.Market volumes increased in both high and low generic market share countries.Market values, on the other hand, decreased substantially in high genericmarket share countries while the decrease in low generic market share countrieswas limited. Medicine prices in high generic market share countries decreasedsubsequently more than prices in low generic market share countries.A survey was designed to assess thefeatures of tendering programs for outpatient prescription pharmaceuticals inEuropean countries, as described in Chapter2.4. Tendering is the acquisition of pharmaceuticals based on a competitivebidding process where the contract is granted to the pharmaceutical supplierswho offered the best bid following strict criteria. Only seven Europeancountries had adopted tendering programs for pharmaceuticals in ambulatory carein 2011. Tendering was more popular in countries with a mature genericmedicines market than in countries with a developing generic medicines market.A legal basis, criteria to grant the tender, the number of winners and theduration of the tender were amongst the crucial features for the programs towork. Some countries have achieved short-term savings on their pharmaceuticalbudgets, which was the main objective of tendering. There are however someproblems allied with the policy and the effects in the long term are stillunclear.An analysis of the impact of referencepricing systems in Europe rounds off Part 2, as described in Chapter 2.5. A reference pricing systemestablishes a common reimbursement level or reference price for a group ofinterchangeable medicines, i.e. the reference group. Many European governmentshave introduced a reference pricing system to contain pharmaceuticalexpenditures by controlling the level of reimbursement. Reference pricingdrives down prices of drugs subject to it, but not always below the referenceprice. The use of medicines priced at or below the reference price increased andsavings on pharmaceutical expenditure were generated, albeit that they tend tobe limited to the short term. The long-term growth of drug expenditure did notseem to have reduced by reference pricing. No negative effect on healthoutcomes of patients was observed.Part 3 groups studies which have beenperformed on different aspects of the demand-side. Chapter 3.1 provides a general overview of demand-side policieswhich have been implemented by European governments to encourage the use ofgeneric medicines. A plethora of different demand-side policies has alreadybeen initiated by different authorities, thereby targeting physicians,pharmacists and patients. The results have shown that positive knowledge andperceptions of generic medicines by physicians, pharmacists and patients arenecessary prerequisites to increase the use of generic medicines. Governmentsmust subsequently initiate appropriate policies to achieve this (e.g. academicdetailing programs and continuous medical education events for physicians andpharmacists and media campaigns for all stakeholders). These policies should becombined with policies to increase all stakeholders financial responsibilityto the healthcare system and policies to facilitate the prescribing anddispensing of generic medicines. Belgium has implemented a policy in 2006 whichobliges physicians to prescribe minimum quota of cheap medicines, as describedin Chapter 3.2. All groups ofgeneral practitioners, specialists and dentists reached their minimumpercentages yearly from 2006 until 2009. The percentage of cheap medicines (indefined daily doses) increased from 22.9% in January 2005 to 44.2% of allprescribed medicines in ambulatory care in December 2009. The percentage ofgeneric medicines increased from 12.10% in 2004 to 24.03% of all prescribedmedicines in ambulatory care in 2008. The policy of prescribing quota for cheapmedicines was not only associated with an increased prescribing of genericmedicines during 2004-2008, but also increased the prescribing of originalmedicines whose price had dropped to the reference price level, as thesemedicines were included in the definition of cheap medicines. The potential forprescribing generic medicines has not yet been fully met in Belgium. Despitethe success of the policy, adjustments are desirable, especially with respectto the broad definition of cheap medicines.Pharmacists play an important role in thedevelopment of a generic medicines market. It is important that they are not financiallypenalized for dispensing generic medicines, which is currently the case in someEuropean countries, as demonstrated in Chapter3.3. Therefore, their remuneration should move towards afee-for-performance remuneration instead of a price-dependent remuneration,which is currently employed in many European countries. A fee-for-performanceremuneration would provide a stimulus for dispensing generic medicines, aspharmacists would not be financially penalized for dispensing them.Chapter3.4 rounds off Part 3 with calculations of possiblesavings through an increased use of generic medicines by elderly, as they arethe biggest users of medicines. The analysis showed that these savings wererather limited (4.48% when the generic market share by volume increase to 95%).The full potential of generic medicines in the elderly population has not yetbeen realized in Belgium, due to the limited use of them and their relativehigh prices compared to their originator equivalents. The Belgian governmentshould implement additional incentives for physicians, pharmacists and patientsto increase the use of generics by elderly. These policies should be combinedby policies to lower prices of generic medicines and policies to rationalizethe prescribing of medicines for elderly, which should decrease the volume ofmedicines used by elderly subsequently.An analysis of the Spanish genericmedicines market is provided in Part 4.Spain is a highly decentralized country with 17 Autonomous Communities. Fundingand management of health care services, including pharmaceutical policies, isdecentralized and the responsibility of the regions since January 2002. The useof generic medicines in Spain is low compared to other European countries, bothin volume and value. We have provided an overview of the Spanish genericmedicines market and identified hurdles which impede its development.Recommendations o increase the sustainability of the Spanish generic medicinesmarket are proposed.Recommendations to increase the use of genericmedicines in Europe are proposed in the GeneralDiscussion in Part 5. These suggested policies are likely to work in allcountries throughout Europe, as they are policies which work independently ofthe different country-specific characteristics of health care systems. Theimpact of hospital policies regarding generic medicines is discussed, as thesedecisions may impact the future medication schemes in ambulatory care. Thechanging industrial landscape for pharmaceutical companies, with a tendency to pharmaceuticalcompanies combining both originator and generic divisions and the rise ofbiopharmaceuticals and biosimilars, is also discussed. Future research shouldfocus on the development of generic medicines in emerging markets andcountry-specific analyses of other European countries with limited use ofgeneric medicines.status: publishe

Analysis of the Italian generic medicines retail market: recommendations to enhance long-term sustainability

Italy is among the European countries with the lowest uptake of generic medicines. This paper provides a perspective on the Italian generic medicines retail market. Fast market entrance of generic medicines in Italy is hindered by several factors: the existence of Complementary Protection Certificates in the past, the large market for copies and multiple cases of patent linkage. Prices of generic medicines in Italy are low compared to other European countries. To contain pharmaceutical expenditure, pharmaceutical companies are currently forced to pay back in case of overspending, which disproportionally penalizes small and fast growing companies, to which most generic companies belong to. Current demand-side policies do not successfully stimulate the use of generic medicines. The current market environment surrounding the Italian generic medicines retail market (i.e., low prices, low volumes) threatens its long-term sustainability. Recommendations to enhance the long-term sustainability of the Italian generic medicines retail market round off this perspective paper.peerreview_statement: The publishing and review policy for this title is described in its Aims & Scope. aims_and_scope_url: http://www.tandfonline.com/action/journalInformation?show=aimsScope&journalCode=ierp20status: publishe

Societal value of generic medicines beyond cost-saving through reduced prices

This paper aims to provide an overview of the added societal value of generic medicines beyond their cost-saving potential through reduced prices. In addition, an observational case study will document the impact of generic entry on access to pharmacotherapy in The Netherlands and an illustrative exercise was carried out to highlight the budget impact of generic entry.peerreview_statement: The publishing and review policy for this title is described in its Aims & Scope. aims_and_scope_url: http://www.tandfonline.com/action/journalInformation?show=aimsScope&journalCode=ierp20status: publishe

How can pharmacist remuneration systems in Europe contribute to generic medicine dispensing?

Generic medicines can generate larger savings to health care budgets when their use is supported by incentives on both the supply-side and the demandside. Pharmacists� remuneration is one factor influencing the dispensing of generic medicines. Objective: The aim of this article is to provide an overview of different pharmacist remuneration systems for generic medicines in Europe, with a view to exploring how pharmacist remuneration systems can contribute to generic medicine dispensing. Methods: Data were obtained from a literature review, a Master thesis in Pharmaceutical Care at the Catholic University of Leuven and a mailing sent to all members of the Pharmaceutical Group of the European Union with a request for information about the local remuneration systems of community pharmacists and the possible existence of reports on discounting practices. Results: Pharmacists remuneration in most European countries consists of the combination of a fixed fee per item and a certain percentage of the acquisition cost or the delivery price of the medicines. This percentage component can be fixed, regressive or capped for very high-cost medicines and acts as a disincentive for dispensing generic medicines. Discounting for generic medicines is common practice in several European countries but information on this practice tends to be confidential. Nevertheless, data for Belgium, France, the Netherlands and United Kingdom indicated that discounting percentages varied from 10% to 70% of the wholesale selling price. Conclusion: Pharmacists can play an important role in the development of a generic medicines market. Pharmacists should not be financially penalized for dispensing generic medicines. Therefore, their remuneration should move towards a fee-for-performance remuneration instead of a price-dependent reimbursement which is currently used in many European countries. Such a fee-forperformance remuneration system provides a stimulus for generic medicines dispensing as pharmacists are not penalized for dispensing them but also needs to account for the loss of income to pharmacists from prohibiting discounting practices.Los medicamentos genéricos pueden producir mayores ahorros a los presupuestos sanitarios cuando se apoyan con incentivos tanto a la oferta como a la demanda. La remuneración de los farmacéuticos es un factor que influye en la dispensación de medicamentos genéricos. Objetivos: El objetivo de este artículo es proporcionar una revisión de diferentes sistemas remunerativos de medicamentos genéricos en Europa, con idea de explorar con la remuneración de los farmacéuticos puede contribuir a la dispensación de genéricos. Métodos: Se obtuvieron datos de una revisión de la literatura, de una tesis de Master en Atención Farmacéutica en la Universidad Católica de Lovaina, y de un correo enviado a todos los miembros del Grupo Farmacéutico de la Unión Europea solicitando información sobre los sistemas locales de remuneración de farmacéuticos comunitarios y la posible existencia de informes sobre las prácticas de descuentos. Resultados: La remuneración de los farmacéuticos en la mayoría de los países europeos consiste en la combinación de una tasa fija por artículo y un cierto porcentaje del precio de compra o del precio de venta del medicamento. Este componente porcentual puede ser fijo, regresivo o con topes para los medicamentos de muy alto coste, y actúa como un desincentivo para dispensar medicamentos genéricos. Los descuentos para medicamentos genéricos son practica común en varios países Europeos, pero la información sobre esta práctica tiende s ser confidencial. Sin embargo, los datos de Bélgica, Francia, Holanda y Reino Unido indican que los porcentajes de descuento varían del 10% al 70% del precio del mayorista. Conclusión: Los farmacéuticos pueden jugar un papel importante en el desarrollo del mercado de genéricos. No se debería penalizar financieramente a los farmacéuticos por dispensar genéricos. Por tanto, su remuneración debería moverse hacia una tasa-por-acto en lugar de un rembolso precio-dependiente, que es lo que ocurre en la mayoría de los países Europeos. Este sistema de remuneración en tasa-por-acto produce estímulos para la dispensación de genéricos, ya que los farmacéuticos no son penalizados por dispensarlos, pero también necesita tener en cuenta las pérdidas de ingresos al prohibir las prácticas de descuentos

Tendering for outpatient prescription pharmaceuticals: What can be learned from current practices in Europe?

Objectives To explore the current status (2010) of tendering programs for outpatient pharmaceuticals in the European countries and how these programs operate.Methods A survey was designed to assess the features of tendering programs in European countries. All 27 countries of the European Union plus Norway were included in the study. The survey was sent to national representatives of authorities and organizations and to academic researchers with expertise in the domain.Results Nineteen of the 28 countries have responded to the questionnaire (68%). Seven countries have adopted tendering programs for pharmaceuticals in ambulatory care. Tendering was more popular in countries with a mature generic medicines market (54%) than in countries with a developing generic medicines market (12.5%). A legal basis, criteria to grant the tender, the number of winners and the duration of the tender were amongst the features for the program to work.Conclusions Tendering programs can achieve savings in the short term. There are however some problems allied with the policy and the effects in the long term are still unclear. It can be concluded that the policy can work, but the features of the programs have to be well-thought-out.Pharmaceutical Generics Tendering Europe Public procurement