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19th Alzheimer Europe Conference / Luxembourg [Luxembourg] : Alzheimer Europe (2009)
19th Alzheimer Europe Conference = Stars for Help : Programme and Abstract Book [printed text] . - Luxembourg (Route de Thionville, 145, 2611, Luxembourg) : Alzheimer Europe : Bruxelles (Rue St Catherine, 16-18, 1000, Belgique) : Ligue Nationale Alzheimer Liga (LINAL), 2009 . - 66 p. : ill. ; A4.
19th Alzheimer Europe Conference, Brussels, 28-30 May 2009
Languages : English (eng)
Alzheimer Disease ; Belgium ; Congresses ; Europe ; Societies, Scientific
WT 155 Senile dementia. Alzheimer's disease
Link for e-copy: http://www.alzheimer2009.eu Format of e-copy: Webpage Record link:
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Barcode Call number Media type Location Section Status 10273-02018 WT 155 / LIN Book KCE Library (10.124) AvailableAnalysis 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 copyArticle 45 Paediatric Studies Database / London [UK] : European Medicines Agency (EMEA) (2007)
Article 45 Paediatric Studies Database [electronic document] . - London (UK) : European Medicines Agency (EMEA), 2007.
Languages : English (eng)
WS - PEDIATRICS
Databases, Bibliographic ; Europe ; Herbal Medicine ; Pediatrics ; Vaccines
Abstract: This database contains information on paediatric studies completed before 2007 that were not previously submitted to medicines regulators in the European Union (EU). The results of these studies were submitted by pharmaceutical companies in accordance with Article 45 of the Paediatric Regulation. Contents note: The database includes studies on:
medicines containing chemical active substances;
For each entry, information is available on the name and aims of the study, the medicines studied and the ages of patients included. Some entries include details of the journal publication describing the studys results or a document containing a summary of its findings.
The database contains information from:
167 studies on around 60 centrally authorised medicines;
over 18,000 studies on around 1,000 nationally authorised medicines. These include medicines authorised through the decentralised or mutual-recognition procedures. 609 of these studies are on vaccines and 625 are on herbal or homoeopathic medicines.
Due to the large amount of information on nationally authorised medicines, regulatory authorities in Member States are still assessing these data. The assessment work is being shared between Member States. The Agency expects the assessment process to take years to complete.
Information on these studies is added to this database continuously on a monthly basis
Link for e-copy: http://art45-paediatric-studies.ema.europa.eu/clinicaltrials/index.php Format of e-copy: WebSite Record link: Balancing evidence and public opinion in health technology assessments / Irina Cleemput in International Journal of Technology Assessment in Health Care, 22(2006)4 ([11/20/2006])
[article] Balancing evidence and public opinion in health technology assessments : the case of leukoreduction. [printed text] / Irina Cleemput , Author ; Mark Leys, Author ; Dirk Ramaekers, Author ; Luc Bonneux, Author . - 2006 . - 403-407.
Languages : English (eng)
in International Journal of Technology Assessment in Health Care > 22(2006)4 [11/20/2006] . - 403-407
W 1 Serials. Periodicals
Blood Banks ; Blood Component Removal ; Blood Component Transfusion ; Cost-Benefit Analysis ; Creutzfeldt-Jakob Syndrome ; Economics ; Europe ; Great Britain ; Humans ; Journal Article ; Leukocytes ; Peer Review ; Prions ; Public Opinion ; Public Policy ; Standards ; Technology Assessment, Biomedical
Abstract: Leukoreduction, filtering white blood cells from transfusion blood, effectively avoids leukocyte-related complications of blood transfusion. The technology has proven its relative cost-effectiveness for specific patient populations. With the advent of variant Creutzfeldt-Jakob disease, a transmittable spongiform encephalopathy caused by mad cow disease (bovine spongiform encephalopathy), the hard hit United Kingdom introduced universal leukoreduction for all patients as a precaution for transmission of prions in 1999. This costly policy was followed by many other countries, in the absence of much evidence of an actual health problem or of a more than presumed effectiveness of leukoreduction in preventing prion transmission. The core problem proved to be legal. The blood banks are legally accountable for blood safety. This accountability is absolute, based on avoidance of all possible risks, regardless of costs. This strategy leads to inefficiencies in health care: (i) blood safety management is guided by available rather than cost-effective technology, and (ii) private insurance premiums for civil liability are sharply increasing, while they are in no way related to the expected returns and the high and increasing blood safety. A rational safety policy is to be optimal, taking into account costs and effects of the safety procedures. This issue will need an open discussion with the general public of the real risks and a clear and unambiguous definition of proportionality in the precautionary principle, based on the European law. Link for e-copy: http://journals.cambridge.org.vdicp.health.fgov.be:8080/action/displayFulltext?t [...] Format of e-copy: VDIC IP recognition Record link: [article]Bioethics in a European perspective / Dordrecht : Kluwer Academic Publishers (2001)
Bioethics in a European perspective [printed text] . - Dordrecht : Kluwer Academic Publishers, 2001 . - XI, 543 p. ; 25 cm. - (International library of ethics, law, and the new medicine; 8) .
ISBN : 1-402-00126-6 : 184,95
Languages : English (eng)
WB 60 Bioethics. Clinical ethics. Clinical ethics committees
Bioethics ; Europe
Abstract: In this book, developed by a group of collaborating scholars in bioethics from different European countries, an overview is given of the most salient themes in present-day bioethics. The themes are discussed in order to enable the reader to have an in-depth overview of the state of the art in bioethics. Introductory chapters will guide the reader through the relevant dimensions of a particular area, while subsequent case discussions will help the reader to apply the ethical theories to specific clinical problems and health policy queries. The book focuses on perspectives typical for the European context. This highlights not only particular bioethical themes such as social justice, choices in health care, and health policy (e.g., in post-communist countries), it also emphasizes specific approaches in ethical theory, in relation to Continental philosophies such as phenomenology and hermeneutics. Because of its articulation of what is typical for the European health care setting as well as for bioethical debate, this book is unique in comparison to existing textbooks in bioethics. The book is an introductory textbook acquainting the reader with the major issues in present-day health care as well as the various theoretical and practical approaches to clarify these issues.--An overview of salient themes in contemporary bioethics. It focuses on perspectives typical for the European context. This highlights not only particular bioethical themes such as social justice, choices in health care, and health policy, but also specific approaches in ethical theory--This title, developed by a group of collaborating scholars in bioethics from different European countries, gives an overview of the most salient themes in contemporary bioethics. Introductory chapters aim to guide the reader through the relevant dimensions of a particular area, while subsequent case discussions should help in the application of ethical theories to specific clinical problems and health policy queries.The book focuses on perspectives typical for the European context. This highlights not only particular bioethical themes such as social justice, choices in health care, and health policy (for ecxample, in post-communist countries), it also emphasizes specific approaches in ethical theory, in relation to continental philosophies such as phenomenology and hermeneutics. Contents note: Preface. List of contributors. Introduction. Part 1: Foundations and History of Bioethics. 1.1. History of medical ethics; D. Gracia. 1.2. Theoretical models and approaches to ethics; H.A.M.J. ten Have. Part 2: Person and Body. 2.1. The human body; W.J.M. Dekkers. 2.2. What is a person? M. Evans. Part 3: Person and Community. 3.1. Social justice and solidarity; E. Gefenas. 3.2. Choices in health care: Waiting list, rationing and priorities; H.A.M.J. ten Have. 3.3. Health care ethics committees; C.D. Melley. Part 4: Procreation and Reproduction. 4.1. In vitro fertilisation and ethics; P.T. Schotsmans. 4.2. Ethics, genetics, and human gene therapy; D. Gracia. 4.3. Genetic interventions and personal identity; R.F. Chadwick. Genetics and culture; H.A.M.J. ten Have. Part 5: Suffering and Death. 5.1. Images of death and dying; W.J.M. Dekkers. 5.2. Terminal care and ethics; Z. Szawarski. 5.3. Withholding and withdrawing treatment; F.J. Illhardt. 5.4. Euthanasia; H.A.M.J. ten Have. Part 6: Practical Information. Index of Names. Index of Subjects. Record link:
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