Implications of Future EU Policy on the Provision of Medicines and on Actors in the European Pharmaceutical Sector PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Implications of Future EU Policy on the Provision of Medicines and on Actors in the European Pharmaceutical Sector PDF full book. Access full book title Implications of Future EU Policy on the Provision of Medicines and on Actors in the European Pharmaceutical Sector by Ewout Johan Marius van Ginneken. Download full books in PDF and EPUB format.
Author: Ewout Johan Marius van Ginneken
Publisher: Univerlagtuberlin
ISBN: 379832235X
Category :
Languages : en
Pages : 210
Get Book Here
Book Description
Author: Ewout Johan Marius van Ginneken
Publisher: Univerlagtuberlin
ISBN: 379832235X
Category :
Languages : en
Pages : 210
Get Book Here
Book Description
Author: Goscinska, Daria
Publisher: Universitätsverlag der TU Berlin
ISBN: 3798326738
Category : Political Science
Languages : en
Pages : 64
Get Book Here
Book Description
The Directive on the application of patients´ rights in cross-border healthcare was adopted by the Council of the European Union and the European Parliament on March 9th, 2011. In the context of the adoption deadline on October 25th, 2013, as well as considering the national positioning towards the Directive and the interpretational leeway, it is interesting to see how and to what extent national legislators transpose the Directives´ implications. This paper will focus on the process of transposition, specifically domestic public consultations. The analysis is a two-level comparison: on the one hand, it presents an intrastate study of the various stakeholders involved in the discourse during the transposition process, whereby a country-specific picture of diverse proposals, opinions and challenges can be drawn. On the other hand, the paper marks an inter-country comparison, offering a sample of European adaptational patterns. The healthcare systems of the analysed countries Germany, Poland and Austria are characterised by a Statutory Health Insurance (SHI) system, nevertheless they differ concerning systemic specifics of healthcare, their voting behaviours towards the Directive and initial situations regarding transposable provisions. The study of domestic discourses from an actor-centred perspective concludes on the most critical points of the Directive, which reflect on prior authorisation, reimbursement, information provision and National Contact Points, and on transposition patterns in the member states. Hypotheses on the goodness of fit, the scope of patients´ rights and difficult interpretational areas of the Directive were tested and partly verified. The intrastate study and cross-national comparison revealed considerable differences among a small sample of EU-states, with only some analogies regarding stakeholder and governmental behaviour. The contrast is visible in the number and type of stakeholders, timing of public consultations, the emphasis set in the discourse, frequency of discussed articles and accurateness of implementation. This results not only from the difficult and debated area of health policy, but also from country-specific characteristics. Overall, the analysis indicates how important the process of transposition, as part of EU law-making, is for the correctness and success of European policies. An emphasis on the implementation phase is required to closely understand, analyse and improve the functioning of the Acquis Communautaire. Die Richtlinie über die Ausübung der Patientenrechte in der grenzüberschreitenden Gesundheitsversorgung wurde vom Rat der Europäischen Union sowie dem Europäischen Parlament am 9. März 2011 verabschiedet. Im Kontext der Umsetzungsfrist am 25. Oktober 2013 sowie unter Berücksichtigung nationaler Positionen gegenüber der Richtlinie und dem zu Verfügung stehenden Interpretationsspielraum, gilt es zu erforschen, inwieweit die nationalen Gesetzgeber die Implikationen der Richtlinie umsetzen. Diese Arbeit beschäftigt sich mit dem Transpositionsprozess der Patientenrichtlinie 2011/24/EU, insbesondere mit den nationalen Konsultationen während der Umsetzungsphase. Die Analyse besteht aus einem zwei-Ebenen Vergleich: einerseits präsentiert sie eine innerstaatliche Studie über diverse, in den Transpositionsprozess involvierte Stakeholder, wodurch eine länderspezifische Skizze bezüglich verschiedener Umsetzungsvorschläge, Meinungen sowie Herausforderungen gezeichnet wird. Andererseits stellt die Studie einen zwischenstaatlichen Vergleich dar, durch welchen Europäische Transpositions- und Implementierungsmuster verdeutlicht werden. Die drei ausgewählten Staaten Deutschland, Polen und Österreich sind jeweils durch das Gesundheitssystem der Gesetzlichen Krankenversicherung gekennzeichnet, nichtsdestotrotz unterscheiden sie sich im Hinblick auf die systemischen Ausprägungen, ihr Abstimmungsverhalten zur Richtlinie im Rat der Europäischen Union sowie ihre Ausgangsposition der Transposition. Die Analyse der nationalen Diskurse aus einer Akteur-zentrierten Perspektive mündet in einer Zusammenstellung der kritischsten Aspekte der Richtlinie, welche die Vorabgenehmigung, Kostenerstattung, Informationsbeschaffung und die Nationalen Kontaktstellen beinhaltet. Gleichzeitig fasst die Studie die Transpositionsmuster der Mitgliedstaaten zusammen. Die Hypothesen zu "Goodness of fit", zur Reichweite der Patientenrechte sowie zu interpretativen Problemfeldern der Richtlinie wurden getestet und teilweise verifiziert. Sowohl der inner- wie auch zwischenstaatliche Vergleich zeigt die enormen Differenzen einer relativ geringen Staatenprobe auf, mit lediglich wenigen Analogien in Bezug auf die Stakeholder und das Verhalten der staatlichen Entscheidungsträger. Der Kontrast zeigt sich insbesondere hinsichtlich der Anzahl und des Typs der Akteure, der zeitlichen Koordinierung der öffentlichen Konsultationen, des Diskursschwerpunkts, der Häufigkeit der diskutierten Umsetzungsartikel sowie der Transpositionsgenauigkeit. Die hervorstechenden Differenzen sind nicht nur Ausdruck eines sensiblen und umstrittenen Politikfelds, sondern resultieren aus den staatenspezifischen Eigenschaften. Insgesamt zeigt die Analyse auf, wie wichtig der Transpositionsprozess als Teil der EU-Gesetzgebung für die Korrektheit und den Erfolg Europäischer Politik ist. Die Fokussierung auf die Implementierungsphase ist notwendig, um die Funktionsfähigkeit des Acquis Communautaire genau zu verstehen, analysieren und zu verbessern.
Author: Stephani, Victor
Publisher: Universitätsverlag der TU Berlin
ISBN: 3798330522
Category : Medical
Languages : en
Pages : 56
Get Book Here
Book Description
Reviews have shown that mobile phone-based health interventions (mHealth interventions) are capable of improving health outcomes of patients in Africa, particularly for patients with chronic diseases such as non-communicable diseases (NCDs). But currently, most mHealth interventions are stopped after the pilot and the funding of the donors has ceased. The aim is to identify the reasons for the lacking integration of mHealth interventions against NCDs in sub Saharan African health systems. 10 countries from sub-Saharan Africa (SSA) were selected for the analysis. For the assessment a catalogue of indicators was developed. Data for the indicators was gathered from various sources: databases, literature reviews and expert interviews. mHealth against NCDs is still in its infancy. Inhibiting factors for the further uptake of mHealth are the lack of specific action points by the governments, the missing attention paid to the rising burden of NCDs, the non-utilization of the full potential of mHealth, the lack of financial incentives and standardized workshops/guidelines and lack of good governance. The access to mobile phones is also inhibited by the poor electricity infrastructure. Enabling factors in many countries are numerous published eHealth strategies, constantly improving legislative frameworks (such as data protection laws) and a growing technology start-up ecosystem.Reviews haben gezeigt, dass Mobiltelefon-basierte Gesundheitsinterventionen (mHealth Interventionen) in der Lage sind klinische Outcomes von Patienten in Afrika zu verbessern; insbesondere von Patienten mit chronischen Erkrankungen wie zum Beispiel nicht übertragbaren Krankheiten (NCDs). Jedoch bleiben die meisten mHealth Interventionen in der Projektphase und werden häufig, nachdem die Finanzierung der Geldgeber aufhört, gestoppt. Ziel dieser Arbeit ist es deswegen, die Ursachen für die mangelnde Integration von mHealth Interventionen gegen NCDs in die afrikanischen Gesundheitssysteme zu identifizieren. Für die Analyse wurden 10 Länder aus sub-Sahara Afrika (SSA) ausgewählt. Für die Bewertung wurde ein Katalog von Indikatoren entwickelt. Die Daten für die Indikatoren wurden aus verschiedenen Quellen gesammelt: Datenbanken, Literaturrecherchen und Experteninterviews. Hemmende Faktoren für eine flächendeckende Verbreitung sind unter anderem das Fehlen spezifischer Zielvorgaben durch die Regierungen, die fehlende Berücksichtigung von NCDs in den verschiedenen Digitalstrategien, die Nichtausschöpfung des vollen Potenzials von mHealth, das Fehlen von finanziellen Anreizen und standardisierten Workshops/Richtlinien, sowie mangelnde Good Governance. Außerdem wird der Zugang zu Mobiltelefonen durch die schlechte Elektrizitäts-Infrastruktur behindert. Fördernde Faktoren sind die zahlreichen eHealth-Strategien, die sich ständig verbessernden gesetzliche Rahmenbedingungen (z.B. Datenschutzgesetze) und die wachsenden Start-up-Ökosysteme.
Author: Stephani, Victor
Publisher: Universitätsverlag der TU Berlin
ISBN: 3798327521
Category : Business & Economics
Languages : en
Pages : 80
Get Book Here
Book Description
Background: mHealth refers to the use of mobile phones for health care and public health practice. The reasons of deaths in developing countries are shifting from communicable diseases towards non-communicable diseases (NCDs). We review studies assessing the health-related impacts of mobile health (mHealth) on NCDs in low- and middle- income countries (LAMICs) with the aim of giving recommendations for their further development. Methods: A systematic literature search of three major databases was performed in order to identify randomized controlled trials (RCTs) of mHealth interventions. Identified RCTs were reviewed concerning effects of the interventions on health-related outcomes. Results: The search algorithms retrieved 733 titles. 6 RCTs were included in the review, including a total of 1850 participants. MHealth was found to have positively influenced clinical outcomes, compliance rates, as well as quality of life related aspects. Furthermore, other outcomes such as patients’ anxiety or patient-physician trust improved significantly. We also found that tailored interventions using a single service for the transmission (e.?g. only SMS) showed the most positive effect. Limiting factors of the evaluation however, were the few numbers of RCTs, the heterogeneity of outcome measures and the fact that all included studies were conducted in middle income countries and mostly in urban areas. Conclusions: Although mHealth is still in its infancy, it can emerge as an important tool for fighting NCDs in LAMICs. Therefore, further support by governmental institutions for coordinating and promoting the development of the required tools, as well as further research especially in low-income economies, with a focus on the evaluation of the long-term effects of mHealth is needed. Hintergrund: Die Todesursachen in Entwicklungsländern verschieben sich kontinuierlich von übertragbaren hin zu nicht-übertragbaren Krankheiten (NCDs). Deshalb werden in diesem systematischen Review gesundheitsbezogene Einflüsse von mobile Health (mHealth) Interventionen zur Bekämpfung von NCDs in Entwicklungs- und Schwellenländern (LAMICs) untersucht, um Einschätzungen zur bisherigen und Empfehlungen zur weiteren Entwicklung zu geben. Methode: Eine systematische Literatursuche in drei großen Datenbanken wurde durchgeführt um randomisiert-kontrollierte Studien (RCTs) von mHealth Interventionen in LAMICs zu identifizieren. Die ermittelten RCTs wurden hinsichtlich der Effekte von mHealth Interventionen auf gesundheitsbezogene Parameter ausgewertet. Resultate: Von insgesamt 733 erfassten Titeln wurden 6 RCTs mit 1850 Teilnehmern einbezogen. Es wurde festgestellt, dass mHealth einen positiven Einfluss auf klinische Resultate, Compliance-Raten, sowie Lebensqualitäts-bezogene Aspekte hat. Zudem verbesserten sich im Rahmen der Interventionen weitere Faktoren wie das Vertrauen zwischen Patient und Arzt oder Ängste der Patienten. Ferner wurde festgestellt, dass individualisierte Interventionen bessere Resultate als generalisierte Interventionen erzielen. Limitierende Faktoren bei diesem Review waren die geringe Anzahl an RCTs, die Heterogenität der evaluierten Parameter und der Umstand, dass fast alle inkludierten Studien in urbanen Gebieten von Schwellenländern durchgeführt worden sind. Schlussfolgerung: mHealth kann zu einem wichtigen Instrument bei der Bekämpfung von NCDs in LAMICs heranwachsen. Dazu ist jedoch eine stärkere Unterstützung insbesondere von staatlichen Institutionen unumgänglich. Zudem müssen zukünftige Forschungen einen Fokus auf Langzeit-Effekte insbesondere in einkommensschwachen Ländern haben.
Author: Mckee
Publisher: McGraw-Hill Education (UK)
ISBN: 0335226442
Category : Medical
Languages : en
Pages : 312
Get Book Here
Book Description
While there may be consensus on the broader issues of the core objectives of the health care system, expectations differ between EU countries, and European national policy-makers. This book seeks firstly to assess the impact of the enlargement process and then to analyse the challenges that lie ahead in the field of health and health policy.
Author: Timo Ståhl
Publisher:
ISBN: 9789520019648
Category : Health
Languages : en
Pages : 279
Get Book Here
Book Description
This volume, published in the context of the Finnish Presidency of the European Union (EU), aims to highlight how and why the health dimension can and should be taken into account across all government sectors. Particular emphasis is placed on the unique mandate and obligation of the EU to protect health in all its policies. The topic is explored from the perspectives of available methods and different levels of policy-making, and examples are included from specific policy areas and health issues.
Author: Christa Altenstetter
Publisher: Routledge
ISBN: 1351506285
Category : Medical
Languages : en
Pages : 277
Get Book Here
Book Description
Medical devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care, genetic testing, clinical trials, and experimental clinical investigations. Without medical devices, there is no clinical research or patient care. Without life-adjusting devices, there are no medical procedures or surgery. Without life-saving and life-maintaining devices, there is no improvement in well-being and quality of life. Without innovative medical devices and experimentation, there can be no medical progress or patient safety. Medical devices and medical technology are used to create or support many different products and medical-surgical procedures. This volume on the regulation of medical devices in the European Union, with a focus on France, tackles a topic of interdisciplinary interest and significance for policymakers in countries around the globe. The EU regulatory regime is one of three global regional regimes, and medical products manufactured in EU countries are sold worldwide. As countries confront an aging population on a global scale, with associated increases in chronic diseases, physical handicaps, and multi-morbidity, there will inevitably be an increase in the demand for health services and, concomitantly, the use of medical devices in medical and surgical procedures. This will be the case regardless of whether services are delivered in hospitals, doctors' offices, or at home. The associated risks of a particular device will be the same whatever the country of origin for the device, or where the need occurs. Revolutionary medical advances increase diagnostic capabilities, but they increase the potential of harm and risks to patients. Medical technologies and devices are used ethically most of the time; yet they have the potential for unethical use when scientific medicine is elevated over human life and death. Assumptions that are taken for granted can be dangerous to a patient's health. That is why our understanding of appropriate and effective regulation of medical devices is significant to all people on all continents.
Author: Great Britain: Parliament: House of Commons: Health Committee
Publisher: The Stationery Office
ISBN: 9780215024572
Category : Political Science
Languages : en
Pages : 556
Get Book Here
Book Description
Incorporating HC 1030-i to iii.
Author: Congressional Budget Office
Publisher: Lulu.com
ISBN: 1304121445
Category : Science
Languages : en
Pages : 65
Get Book Here
Book Description
Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...
Author: Reinhard Busse
Publisher: IOS Press
ISBN: 9781586032098
Category : Business & Economics
Languages : en
Pages : 292
Get Book Here
Book Description
While most Member States Governments have assumed that they have full responsibility and control over their own health services it is becoming increasingly apparent that the Single European Market is having a substantial impact on health services. Recent rulings by the European Court of Justice (ECJ) have, in particular, established the freedom of citizens to choose health care goods and services across borders. To examine the actual relationship between the SEM and health services, this book: - identifies SEM regulations and directives as well as ECJ decisions which explicitly refer to health services and which therefore have a potential impact on the purchasing, supply and delivery of health services, - evaluates the impact of SEM regulations and ECJ decisions on the purchasing, supply and delivery of health services, - identifies outcomes, including both intended and unintended effects, of the SEM on Member States' health services and - develops future scenarios exploring key issues identified in the earlier analysis and evaluation.
