Suchergebnisse

Using real-time data, we examine whether fiscal policy has been counter- or procyclical in a panel of 27 European Union (EU) member states over the period 2000–2015. We also investigate whether fiscal rules and government efficiency improve the cyclical reaction of fiscal policy. Our results suggest that even though fiscal plans in EU countries have an acyclical stance, budgetary outcomes are procyclical. Government efficiency and fiscal rules seem to reduce fiscal procyclicality. Further analysis also reveals that fiscal policy seems to be more procyclical in non-euro area countries and in times of economic prosperity.

Reproduced from a Position Paper published by the European Federation of Pharmaceutical Industries and Associations, February 2014 ; The research-based pharmaceutical industry considers that price differentiation between EU Member States could greatly improve affordable patient access to innovative medicines in those markets where there is a significant access problem. Adapting prices of pharmaceuticals to reflect the ability to pay in different geographical or even socio-economic segments can offer a win-win situation in terms of generating dynamic efficiencies that contribute to both the sustainability of healthcare systems and the pace of innovation. Yet today's pricing and reimbursement practices have the effect of discouraging price differentiation. Member State action and support from the European Union are required to create a framework to enable and encourage voluntary recourse to differentiated pricing. ; peer-reviewed

The influence of the Nordic countries on the European Union's (EU's) policy processes has been researched from various angles, but there is a lack of research that comprehensively examines all policy positions advanced by Nordic actors within a given policy context. This article introduces a new design for studying policy positions and influence in the EU and examines the phenomenon from a multilevel perspective using an original data set compiled in connection to three directives: the Floods Directive on the assessment and management of flood risks, the Environmental Liability Directive, and the Restriction of Hazardous Substances Directive. The analysis reveals that the Nordic countries follow a certain pattern of influencing EU policy that deviates from other states participating in the consultations. Nordic governmental actors exert a strong technical but weak directional influence in the chosen context but are, overall, more successful than Nordic organizational actors at influencing the policy process. ; Peer reviewed

Patents / Dominic Adair, Greg Bacon, and Vanessa Rieu -- Clinical trials / Helen Middleton -- Procedures for obtaining a marketing authorisation and legal bases for application / Maria Isbel Manley and Libby Amos -- Pricing, reimbursement, and health technology appraisals (market access) / Maria Isabel Manley and Maria Georgiou -- Paediatrics / Georgia Gavriilidou -- Orphan drugs / Maria Isabel Manley and Chris Boyle -- Biological medicinal products and biosimilars / Dev Kumar and Lauren Wilks -- Regulatory data protection / Maria Isabel Manley and Grant Strachan -- Supplementary protection certificates / Maria Isabel Manley and Marina Vickers -- Maximisation of regulatory IP rights / Maria Isabel Manley and Marina Vickers -- The interaction between intellectual property law and competition law / Pat Treacy -- Access to information / Vincenzo Salvatore -- Litigating decisions of regulatory authorities / Kelyn Bacon, QC and Hugo Leith -- Pharmacovigilance / Maria Isabel Manley abd Edward Bray -- Data protection / Hazel Grant -- The promotion of medicinal products in the EU / Maria Isabel Manley and Libby Amos -- Borderline products / Maria Isabel Manley and Joanna Hook -- Product liability : the UK perspective / Mark Brown -- Pharmaceutical licensing and collaboration agreements : key consideration from the licensee's perspective / Jerry Temko -- Trade mark protection and enforcement in the pharmaceutical field / Sally Dunstan

The influence of the Nordic countries on the European Union's (EU's) policy processes has been researched from various angles, but there is a lack of research that comprehensively examines all policy positions advanced by Nordic actors within a given policy context. This article introduces a new design for studying policy positions and influence in the EU and examines the phenomenon from a multilevel perspective using an original data set compiled in connection to three directives: the Floods Directive on the assessment and management of flood risks, the Environmental Liability Directive, and the Restriction of Hazardous Substances Directive. The analysis reveals that the Nordic countries follow a certain pattern of influencing EU policy that deviates from other states participating in the consultations. Nordic governmental actors exert a strong technical but weak directional influence in the chosen context but are, overall, more successful than Nordic organizational actors at influencing the policy process.

Foreword -- Preface -- Contents -- Chapter 1: Introduction -- 1.1 Pharmaceutical Policy and the Right to Health -- 1.2 Pharmaceutical Production and Supply -- 1.3 Access to Affordable Drugs -- 1.4 Conclusion -- References -- Part I: Low and Lower Middle Income Countries -- Chapter 2: Pharmaceutical Policy in the East African Community: Burundi, Kenya, Uganda, Rwanda, Tanzania -- 2.1 Background -- 2.1.1 Focus of This Chapter -- 2.1.2 Health System of the EAC (Health System and Health Indicators) -- 2.2 Pharmaceutical Situation of the EAC -- 2.3 EAC Medicines Policy, Legislative and Regulatory Environment -- 2.4 Conclusions: Summary and Way Forward -- References -- Chapter 3: Pharmaceutical Policy in Pakistan -- 3.1 Pakistan -- 3.1.1 Country Profile -- 3.2 Health System of Pakistan -- 3.2.1 Health System -- 3.2.2 Health Indicators -- 3.3 Pharmaceutical Situation of the Country -- 3.3.1 Pharmaceutical Industry and Key Statistics -- 3.4 Country's Regulatory Environment -- 3.4.1 Medicines Regulatory Authority -- 3.4.2 Quality Control -- 3.4.3 Pharmacovigilance -- 3.4.4 Counterfeit Medicines -- 3.5 Medicines Supply System -- 3.5.1 Procurement -- 3.5.2 Distribution -- 3.6 Medicines Financing -- 3.6.1 Medicines Expenditures in General -- 3.6.2 Medicines Pricing -- 3.6.3 Affordability -- 3.6.4 Generic Medicines -- 3.7 Medicines Use (Issues Impacting on Rationale Medicines Use in the Country) -- 3.7.1 Medicines Use in General (in Community Pharmacies, Dispensing Doctors and General Hospital Sector) -- 3.7.2 Essential Medicine List, Selection of Essential Medicines and Standard Treatment Guidelines -- 3.7.3 Prescribing Behaviour in General (Factors Affecting Prescribing Behaviour) -- 3.7.4 Medicines' Promotional Practices -- 3.7.5 The Role of Pharmacist in Community and Hospital Environments

The authors thank the observers of the PKWP who have supported the development of the PSBGL and also Efthymios Manolis, Quirine Fillekes, and Milton Bonelli for constructive comments. Pharmacokinetics Working Party: Ridha Belaiba (ANSM, France); Eva-Gil Berglund (MPA, Sweden); Susan Cole (MHRA, UK); Alfredo García-Arieta (AEMPS, Spain); Sotiris Michaleas (Ministry of Health Pharmaceutical Services, Cyprus); Janet Mifsud (Medicines Authority, Malta); Jan Neuhauser (AGES, Austria); Henrike Potthast (BfArM, Germany); Carolien Versantvoort (MEB, The Netherlands). ; The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. ; peer-reviewed

This new text introduces the history, evolution and contemporary state of one of the European Union's most important, expensive and controversial policies. It examines the role that cohesion policy plays in European integration, as well as in economic development across regions, and analyzes the key debates and issues at stake.

"The NBER Bulletin on Aging and Health provides summaries of publications like this. You can sign up to receive the NBER Bulletin on Aging and Health by email. This paper explores price differences in the European Union (EU) pharmaceutical market, the EU's fifth largest industry. With the aim of enhancing quality of life along with industry competitiveness and R&D capability, many EU directives have been adopted to achieve a single EU-wide pharmaceutical market. Using annual 1994-2003 data on prices of molecules that treat cardiovascular disease, we examine whether drug price dispersion has indeed decreased across five EU countries. Hedonic regressions show that over time, cross-country price differences between Germany and three of the four other EU sample countries, France, Italy and Spain, have declined, with relative prices in all three as well as the fourth country, UK, rising during the period. We interpret this as evidence that the EU has come closer to achieving a single pharmaceutical market in response to increasing European Commission coordination efforts"--National Bureau of Economic Research web site

This paper performs price comparisons of branded pharmaceutical products in markets of eleven European Union countries. We follow a Laspeyres index approach, using Cyprus as the base country and analyse prices in the private and public markets and also consider biotechnology products separately. We find that Germany, Denmark and Austria demonstrate the highest pharmaceutical prices in the EU, followed by Cyprus. When adjusting for per capita income, Cyprus demonstrates the highest prices. Given that there is no universal health insurance in Cyprus, and that the country is facing a financial crisis, our findings underline possible affordability problems for patients. In order to remove barriers to access to medicines, pharmaceutical pricing regulation could be adjusted and price revisions should take place more frequently, and, most importantly, Cyprus must move in the direction of adopting universal health insurance.