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Active ageing and solidarity between generations / Brussels [Belgium] : European Commission (2011)
Active ageing and solidarity between generations : A statistical portrait of the European Union 2012 [printed text] . - Brussels (Belgium) : European Commission, 2011 . - 141 p. : ill., ; 14,8 x 21 cm.
ISBN : 978-92-79-21507-0 : 0,00
Languages : English (eng)
Aged ; Aged, 80 and over ; European Union ; Health Services for the Aged
HN 25 - Statistics. Social indicators. Quality of life
Abstract: The European Union's population structure is changing and becoming progressively older at the beginning of 2010, there were 87 million people aged 65 and over in the EU, more than 17 % of the total population. In response to demographic challenges being faced within Europe, the European Union designated 2012 as the European Year for Active Ageing and Solidarity between Generations. The overall objective of the European Year is to facilitate the creation of an active ageing culture in Europe based on a society for all ages. As Europeans live longer and healthier lives, governments are looking for ways to involve older persons more in society and to keep them active. Eurostat is marking the European Year by publishing this book which contains statistics on topics such as demography, healthcare, pensions, volunteering and adult learning. Link for e-copy: https://ec.europa.eu/eurostat/documents/3217494/5740649/KS-EP-11-001-EN.PDF/1f0b [...] Format of e-copy: PDF [Open Access] Record link: Analysis of differences and commonalities in pricing and reimbursement systems in Europe / Jaime Espín / Granada [Spain] : University of Granada (2007)
Analysis of differences and commonalities in pricing and reimbursement systems in Europe : Final Report [printed text] / Jaime Espín, Author ; Joan Rovira, Author . - Granada (Spain) : University of Granada : Brussels (Belgium) : European Commission, 2007 . - 217 p. ; A4. - (Andalusian School of Public Health) .
A study funded by DG Enterprise and Industry of the European Commission
Languages : English (eng)
W 100 Medical, Dental, and Pharmaceutical Service Plans -- General works
Europe ; Insurance, Health, Reimbursement
Abstract: Analysis of the pharmaceutical sectors performance is a complex task, due to the convergence of often conflicting social and health goals on the one hand and industrial goals on the other. While innovation and access are usually welcomed by all stakeholders, high prices and growing expenditure are perceived as bad news from the payers perspective (consumers and health insurers) but as good news for suppliers, since for them it translates into higher revenues and profits. A comprehensive pharmaceutical policy has to make trade-offs between these conflicting goals.
Building a coherent EU pharmaceutical policy is a difficult task because pharmaceutical budgets, as well as decisions regarding pricing and reimbursement, are responsibilities of individual Member States. EU Member States differ greatly in their priorities regarding pharmaceutical policy: providing incentives for innovation, supporting domestic (generics or innovative) industry and employment, ensuring and improving access to drugs, limiting public expenditures on drugs, etc. Although concern over limiting public expenditures is rather common and growing in most countries, differences in priorities persist. Differences are obviously related to the pharmaceutical sectors diverse characteristics and levels of development, to the general level of income, and to the varied characteristics of health policies and health systems, among other factors.
Many countries have established a number of practices to control costs while maintaining the balance between equitable access and industry goals. There are significant differences in these practices, particularly in the rules for pricing and reimbursement of medicines in the EU Member States. These differences can be found not only due to the presence or absence of certain practices (price control, cost sharing, reference pricing, etc.) but in differences within the very practices themselves. Policy practices also change rapidly in MS, as do the responses of economic agents, adapting to and often reducing a policys intended effects. This rapidly changing regulatory environment makes it difficult to assess the impact of policies on expected goals, or even to obtain an up-to-date picture of the EUs regulatory landscape. Nevertheless, because of rising concerns over cost containment and the need to strike a balance, Member States have an increased need to grasp the substance of different practices and their impact. Since parts of this understanding are available in other Member States, it is significantly valuable to promote the exchange of experiences, practices, and policies among the Member States.
The purpose of this study is, therefore, twofold. First, to obtain an updated, overall picture of the application of pharmaceutical policies and practices in European countries. Second, to build an in-depth understanding of certain selected practices as implemented in different countries, particularly regarding set-up, risks, success factors and impact on expenditure, reward for innovation and patient access. The methodology of this study is based on two main instruments: a review of the literature on the impact of policy practices and a survey with country representatives in the Working Group on Pricing of the Pharmaceutical Forum (which ran in parallel to this study).
The report is structured in four parts:
The first, Part A, is an introduction that lays down the studys objectives, justification and methods.
Part B, the overview, presents an overall picture of a variety of pricing and reimbursement practices, presenting a structured overview of those currently in use. It focuses on supply-side mechanisms, such as price controls, expenditure and industry profits, as well as demand-side mechanisms aimed at physicians, patients and pharmacists, and also includes practices focused on financing/reimbursement. The questionnaire revealed that, on the supply side, most countries focus on control of prices although several focused on control of expenditure. On the demand side, practices aimed at physicians usually consist of guidance, education and monitoring; those aimed towards patients focus on education and cost-sharing and for pharmacists (generic) substitution is the most common practice.
Part C, assessment or evaluation of impact, offers an in-depth assessment of 6 practices and policies, and looks for evidence on the establishment and impact of selected practices in different countries. Finally, part D highlights risk and success factors and looks for interactions between different practices within the framework of global pricing and reimbursement policies. The evidence gathered in Part C leads to a set of tentative conclusions: Direct product price regulation is losing ground in Europe, probably less the result of deliberate policy shifts than its decreased effectiveness within the new context of the Single European Market. Direct product price control can be difficult to implement in fair and efficient ways, and if it is effectively applied to lower the prices of innovative products beyond a certain level, is claimed to remove the incentives for innovation. Pricing based on a set of international prices in countries with similar characteristics looks quite reasonable for a small country that has no capacity to impose its own criteria and preferences. Cost-plus approaches to price control appear to be abandoned in favour of those based on international price-comparisons. Finally, pricing based on economic evaluation and profit control makes a lot of economic sense, but it is complex to organise and its impact is not well assessed.
Cost-sharing has been maintained in most countries. It would appear reasonable to assume that cost-sharing is likely to have a disproportionately higher effect on mostly low-income patients who frequently need/use expensive services. These negative effects are often overcome by implementing safeguarding criteria, such as excluding some patient groups from cost-sharing or through sophisticated monitoring of patients expenditures, as occurs in some Nordic countries.
According to responses obtained from the questionnaire, monitoring and follow-up of the effects of this practice in most countries has been limited, not going much beyond calculating the aggregate volume of payments by patients.
Reference Pricing is rapidly spreading across Europe. Most countries define the equivalent groups/clusters narrowly (active ingredient), but a few countries (Netherlands, Germany) have shifted to groups based on therapeutic equivalence . There are also broad differences in the way reimbursement prices are set and how exceptions are made. It is difficult to separate the effects of RP and generics policies, two policies which are often implemented together. Some in the industry claim that therapeutic RP reduces incentives for incremental innovation, which is assumed to pave the way step by step to major innovations over time. Some studies and experts have also concluded that RP does refrain price competition between generics. Savings were reported in the questionnaire by some countries (around 5%, Hungary and Italy). Changes in access are assumed to be limited, with some exceptions.
Payback is one of the most recent additions to pharmaceutical policies, and not much is known to date on how this practice is applied or what impact it might have. Some countries reported estimated savings between 10 and 800m EUR (between 0,3% and 7% of the pharmaceutical budget), depending on scope and set-up. Payback is not assumed to change access, given that patients are not affected. Impact on incentives for innovation differs, also depending on the specific exemptions taken into account or not for innovative medicines. Payback also offers an opportunity for low-price countries to accept higher prices, at the international level, while controlling final expenditures (taking also into account the difficulties in managing the money back). Providing incentives for more efficient prescribing does not reflect a single practice but rather a large set of heterogeneous practices. Most countries provide guidelines, information and education, but only a limited number go beyond this light approach to monitoring and providing feedback and personal advice to prescribers. Financial and other incentives are very rarely applied. Some of the existing incentives for more efficient prescribing especially, financial incentives - have a documented effectiveness, but most practices need to be considered as a group since they tend to reinforce each other.
Great variations are also found in generics policies, particularly regarding leading elements of such policies: selective/priority financing, prescription by generic name, reference pricing, substitution by pharmacist, etc. Also, generics policies are usually the result of a large combination of both demand and supply-side practices. The literature reveals a substantial number of studies on the impact of specific generics policy practices, such as generic substitution by the pharmacist. Generics policies haven been applied for a long time, accompanied by selective reimbursement, differential cost-sharing, patient and prescriber information and education. Recently, generics policies have been complemented by RP and stronger financial incentives to pharmacists and prescribers. Few countries provide data on the impact of generic policies, although Sweden provides evidence to have attained ~760mEUR accumulated savings between October 2002 and December 2005. Most respondents assume no negative impact on innovation. It has also been noted that the impact of generics policies cannot be evaluated independently from other related practices, particularly reference pricing.
Section D explains that each practice requires certain conditions for success, often depending on the applications scope and rigor, and that some carry potential risks, not only due to the way they impact on budgets but also how they effect patient access and reward innovation.
In conclusion, EU Member States share concerns for keeping several key issues in balance: controlling pharmaceutical expenditures, ensuring access for patients, rewarding industry for valuable innovations, and maintaining pharmaceutical production, which is associated with employment and income-generation. Most Member States employ a variety of practices as part of their national pharmaceutical policy and frequently introduce changes to counterbalance certain strategies adopted by the industry that might not necessarily coincide with Member States own priorities. To date, little evidence is available for key decision-makers on the impact of these different practices. This study summarizes some of the evidence obtained from the literature and has gathered and compared early findings from individual Member States. However, it is based on fragmented inputs and only reflects a situation that existed in one specific period, autumn 2006. It might, therefore, be interesting to consider adopting a more long-term approach, exchanging evidence on a greater number of practices among national authorities.
Contents note: A. Introduction.20 -- I. Scope and purpose of the study .. 20 -- II. Methodological issues in assessing the impact of policy practices . 21 -- III. Sources and methodology . 24 -- A. Literature 25 -- B. Questionnaire 25 -- B. Overview of pharmaceutical policy practices in EU MS ..27 -- I. A classification and definition of pharmaceutical policy practices 28 -- Supply side practices 28 -- Demand side practices. 30 -- II. Selection of 6 policy practices for detailed analysis 35 -- C. Selected practices .36 -- Price control..36 -- I. Introduction. 36 -- Description..36 -- Modalities 37 -- Purposes .37 -- Theory/rationale38 -- II. Application in Europe .. 38 -- Overview..38 -- Individual replies to the questionnaire.41 -- III. Impact. 51 -- Experiences reported by countries. .51 -- Literature .51 -- IV. Discussion.. 53 -- Key messages ..53 -- Risks..54 -- Key success factors 55 -- Cost-sharing..56 -- I. Introduction 56 -- Description..56 -- Modalities 56 -- Purposes .56 -- Theory/Rationale..57 -- II. Application in Europe .. 58 -- Overview..58 -- Individual replies by countries 59 -- III. Impact.. 69 -- Overall experiences reported by countries69 -- Individual replies by countries 70 -- Literature review79 -- IV. Discussion.. 81 -- Key messages ..81 -- Risks..81 -- Key success factors 82 -- Reference pricing 83 -- I. Introduction 83 -- Description..83 -- Modalities 83 -- Purposes .84 -- Theory/ Rationale.84 -- II. Application in Europe .. 85 -- Individual replies by countries 87 -- III. Impact. 93 -- Overall experiences reported by countries93 -- Individual replies by countries 94 -- Literature .. 100 -- IV. Discussion 103 -- Key messages 103 -- Risks 103 -- Key success factors .104 -- Payback.105 -- I. Introduction 105 -- Description 105 -- Purposes .. 105 -- Theory/rationale. 106 -- Modalities . 106 -- II. Application in Europe 107 -- Overview 107 -- Individual replies provided by MS, . 107 -- III. Impact. 111 -- Experiences reported by countries 111 -- Individual replies by countries . 111 -- Literature .. 113 -- IV. Discussion. 114 -- Key messages 114 -- Risks 114 -- Key success factors .115 -- Incentives for good prescribing practices .116 -- I. Introduction.. 116 -- Description 116 -- Modalities . 117 -- Purposes .. 117 -- Theory/Rationale117 -- II. Application in Europe 119 -- Overview 119 -- Individual replies by countries . 119 -- III. Impact.. 130 -- Overall experience reported by countries130 -- Individual replies by countries . 130 -- IV. Discussion 142 -- Key messages 142 -- Risks 142 -- Key success factors .142 -- Generics Policies ..143 -- I. Introduction. 143 -- Description 143 -- Modalities . 143 -- Purposes .. 144 -- Theory/Rationale144 -- II. Application in Europe 144 -- Overview 144 -- Individual Country Replies. 145 -- III. Impact of Generics policies 157 -- Overall experiences reported by countries.157 -- Individual replies by countries . 158 -- Literature review 167 -- IV. Discussion 170 -- Key messages 170 -- Risks 171 -- Key success factors .171 -- D. Global perspective on pricing and reimbursement policies 173 -- I. Similarities and dissimilarities in EU MS pharmaceutical policies -- .. 173 -- II. Evidence of impact . 174 -- III. Interactions/interdependence between practices .. 177 -- IV. Conditions for application.. 179 -- List of references .182 -- Link for e-copy: http://ec.europa.eu/enterprise/phabiocom/docs/study_pricing_2007/andalusian_scho [...] Format of e-copy: Record link:
Barcode Call number Media type Location Section Status No copy
EUR-Lex : Access to European Union Law [electronic document] . - Brussels (Belgium) : European Commission, 2013.
Since March 2013, the new EUR-Lex runs in parallel with the legacy version of EUR-Lex.
- To consult the authentic Official Journal: use the new EUR-Lex
- To consult treaties, preparatory acts, case-law and all other types of EU documents: go to the legacy version (see attached URL).
Languages : English (eng)
KJC 6071 Data protection--Law and legislation--Europe
Databases, Full-Text ; Databases, legislation ; Europe ; Legislation
Contents note: EUR-Lex provides free access to European Union law and other documents considered to be public. The website is available in 24 official languages of the European Union; choose your preferred language from the language bar at the top of the homepage.
The contents of the site amount to some 2 815 000 documents with texts dating back to 1951. The database is updated daily and every year around 12 000 documents are added.
Link for e-copy: http://new.eur-lex.europa.eu/homepage.html?locale=en# Format of e-copy: Open access Record link:
EUR-Lex (legacy version)URL
First Report on the Harmonisation of Risk Assessment Procedures / Brussels [Belgium] : European Commission (2000)
First Report on the Harmonisation of Risk Assessment Procedures : Part 1 : The Report of the Scientific Steering Committee's Working Group on Harmonisation of Risk Assessment Procedures in the Scientific Committees advising the European Commission in the area of human and environmental health [printed text] . - Brussels (Belgium) : European Commission, 2000 . - 173 p. : ill. ; A4.
Languages : English (eng)
Europe ; Methods ; Risk Assessment
WA 100 Public Health -- General works
Abstract: The principal purpose of this Report is to promote an active debate on current practices for risk assessment used by the Scientific Committees of DG SANCO and to make proposals for developing convergent approaches which will aid harmonisation. Contents note: PART 1: TABLE OF CONTENTS -- page -- 1 Executive summary 6 -- 2 Introduction 10 -- 3 Risk assessment in the context of the risk cycle 17 -- 4 A brief history of risk assessment in an international context 34 -- 5 Risk assessment in the DG SANCO Committees 42 -- 6 Hazard identification 51 -- General 52 -- Hazard identification considerations 52 -- Identification and characterisation of the risk source 52 -- Determination of potential targets 52 -- Experimental protocols and/or field studies 54 -- Chemicals 55 -- Current testing requirements 55 -- Improved databases 58 -- Non-invasive methods 59 -- More purpose specific tests 59 -- Better integration of in-vivo and in-vitro studies 59 -- More sensitive analytical techniques 60 -- Better field observations -- Application of the principle of Threshold of Toxicological -- Concern 60 -- Micro-organisms 61 -- Conclusions 63 -- 7 Exposure assessment 64 -- General 65 -- page no 3 -- Chemicals 66 -- Use of scenarios 67 -- "Total" exposure assessment 69 -- General issues related to data availability 70 -- Micro-organisms 71 -- Characterisation of the source and route of exposure 72 -- Pathogen occurrence 73 -- Conclusions 75 -- 8 Hazard characterisation 77 -- General 78 -- Stages in hazard characterisation 78 -- Dose-response relationships 78 -- Chemicals 79 -- Threshold for toxicity 79 -- Non-threshold effects 80 -- Dose-response data in humans 80 -- Dose-response data in animals and model systems 80 -- Types of response data 81 -- Hormesis - a problem for quantitative risk assessment or a stimulus -- for change? 81 -- Scientific evidence to support a threshold 82 -- Extrapolation procedures in risk assessment 83 -- Other extrapolations of animal dose-response data 86 -- Extrapolation of data between species 88 -- Mode of action / mechanisms studies 89 -- Micro-organisms 90 -- Review of factors related to the pathogen, the host and the -- Matrix 91 -- Evaluation of (human) adverse health effects 91 -- Analysis of the dose-response relationship 92 -- Conclusions 93 -- page no 4 -- 9 Risk characterisation 95 -- General 96 -- Chemicals 96 -- Use of uncertainty factors 96 -- Human risk characterisation 97 -- Additional uncertainty factors to allow for sensitive groups of the -- human population 101 -- Environmental risk characterisation 103 -- Simultaneous exposure to several risk sources 104 -- Recommendations 104 -- Micro-organisms 104 -- Conclusions 107 -- 10 Other related issues 109 -- Animal welfare 110 -- Sustainability 118 -- Human quality of life parameters 119 -- Conclusions 122 -- 11 Risk communication 124 -- Risk communication and the activity of the Scientific Committees 125 -- Harmonisation and preparation of a guideline document 127 -- Risk perception in the context of risk communication 129 -- Risk comparison and risk ranking 131 -- Risk benefit assessment 133 -- Precautionary Principle 133 -- Conclusions 134 -- page no 5 -- 12 Managing the process 135 -- The interface between risk assessment scientists, managers and -- other stakeholders 136 -- Availability of expertise 141 -- Conclusions 144 -- 13 Main conclusions 146 -- 14 Overall recommendations 150 -- Recommendations for early adoption 151 -- Areas where progressive implementation is achievable 152 -- Areas for further development 153 -- Implementation 153 -- References 154 -- Membership of the Working Party and its working groups 161 -- Index 164 -- PART 2 : TABLE OF CONTENTS -- Appendix 1 Glossary of Terms -- Appendix 2 Report on Exposure Assessment -- Appendix 3 Report on Quantitative Risk Assessment of Chemicals -- in relation to human health -- Appendix 4 Report on Quantitative Microbiological Risk Assessment -- (foods and other contaminated products) -- Appendix 5 Report on Risk Assessment of Infectious Diseases -- Appendix 6 Report on Presentation of Risk Assessment Findings -- Appendix 7 Legal framework for risk assessment activities for new and -- existing chemicals -- Appendix 8 Mandates of the Scientific Advisory Committees Link for e-copy: http://ec.europa.eu/food/fs/sc/ssc/out83_en.pdf Format of e-copy: PDF [Open Access] (642 KB) Record link: Networking of national research programmes in the European Research Area / Brussels [Belgium] : European Commission (2006)
Networking of national research programmes in the European Research Area [printed text] . - Brussels (Belgium) : European Commission, 2006 . - 25 P. : ill. ; A4.
ISBN : 978-92-79-01362-1 : 0,00
Languages : English (eng)
Q - SCIENCE (GENERAL)
European Union ; Public Policy ; Research
Abstract: ERA-NET is a new scheme designed to support the long-lasting coordination of European research programmes across national boundaries, aimed at the funders and managers of national and regional research programmes. The ERA-NET scheme represents a significant step towards the creation of a fully functioning European Research Area. Link for e-copy: http://bookshop.europa.eu/en/era-net-networking-the-european-research-area-pbKI7 [...] Record link: La protection santé dans la Communauté européenne / Markus Schneider / Brussels [Belgium] : European Commission (1991)PermalinkQuestionnaire sur les soins de santé et les soins de longue durée pour les personnes âgées / Le Comité de la protection sociale / Brussels [Belgium] : European Commission (2002)Permalink