PP106 Twenty Years Of Orphan Medicines Regulation: Have Treatments Reached Patients In Need Across Europe And Canada?

2021 ◽  
Vol 37 (S1) ◽  
pp. 19-19
Author(s):  
Nadine Henderson ◽  
Phill O'Neill ◽  
Martina Garau
Keyword(s):  
European Union ◽  
Western Europe ◽  
European Countries ◽  
Marketing Authorization ◽  
European Medicines Agency ◽  
The European Union ◽  
The Public ◽  
Orphan Medicinal Products ◽  
Medicines Regulation ◽  
Canadian Provinces

IntroductionThe European Union regulation for orphan medicinal products (OMPs) was introduced to improve the quality of treatments for patients with rare conditions. To mark 20 years of European Union OMP regulation, this study compared access to OMPs and the length of their reimbursement process in a set of European countries and Canadian provinces. Access refers to their full or partial reimbursement by the public health service.MethodsData were collated on European Medicines Agency orphan designation and marketing authorizations, health technology assessment (HTA) decisions and reimbursement decisions, and the respective dates of these events for all the OMPs centrally authorized in 14 European countries (Belgium, England, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Scotland, Slovakia, Spain, Sweden, and Switzerland) and four Canadian provinces (Alberta, British Columbia, Ontario, and Quebec).ResultsSince the implementation of the OMPs Regulation in 2000, 215 OMPs obtained marketing authorization. We found that Germany had the highest level of coverage, with 91 percent of OMPs being reimbursed. The three countries with the lowest reimbursement rates were Poland, Hungary, and Norway (below 30%). We observed that Germany had the quickest time to reimbursement following marketing authorization, followed by Switzerland and Scotland. We observed that Poland, Hungary, and Slovakia consistently had the longest time to reimbursement.ConclusionsWe observed substantial variation in the levels and speed of national reimbursement of OMPs, particularly when comparing countries in Eastern and Western Europe, which suggests that an equity gap between the regions may be present. The data also indicated a trend toward faster times to reimbursement over the past 10 years.

scholarly journals The latest orphan drug designations and the Commission Communication on Regulation (EC) 141/2000

2005 ◽  
Vol 11 (3) ◽  
Author(s):  
Rashmi R Shah
Keyword(s):  
European Union ◽  
Rare Diseases ◽  
European Medicines Agency ◽  
Biological Plausibility ◽  
The European Union ◽  
Medicinal Products ◽  
Market Exclusivity ◽  
Community Regulation ◽  
Orphan Medicinal Products ◽  
Patient Groups

The implementation of Community Regulation on orphan medicinal products in the European Union in April 2000 has resulted in a deluge of applications for designation of medicinal products as orphan for rare diseases. By April 2004, the Committee for Orphan Medicinal Products had already given positive opinion on 63 per cent of the 316 applications considered by them. A significant number of these positive designations have already matured into full marketing authorisations. Three major reasons – failure to meet prevalence or significant benefit criteria or provide evidence of biological plausibility – have equally contributed to either the negative opinion on or the applicants withdrawing the remaining applications. In July 2004, the European Commission issued a communication setting out its position on certain matters relating to the implementation of the designation and market exclusivity provisions. The Commission, the European Medicines Agency (EMEA) and the Committee for Orphan Medicinal Products (COMP) continue to be proactive and provide as much guidance and incentives as practical, engaging themselves with sponsors, patient groups and academia. As experience builds up and issues are clarified, there are expectations that the Community Regulation on orphan medicines will prove to be a spectacular success.

scholarly journals The EU and national sovereignty: the encounter of two concepts of sovereignty. Change or continuity?

2021 ◽  
Vol 12 (3) ◽  
Author(s):  
Aistė Deimantaitė
Keyword(s):  
European Union ◽  
Union Member ◽  
European Countries ◽  
The European Union ◽  
Verbal Expression ◽  
Political Actors ◽  
The Public ◽  
Strategic Narratives ◽  
European Union Member States ◽  
The Eu

The article aims to examine and critically evaluate the idea of sovereignty and the nuances of its verbal expression through the concept of strategic narratives, to reveal different models of sovereignty within the context of European Union Member States (mainly France, Hungary/Poland) and the European Union (EU) since 2017. The article seeks to answer the following questions: What idea of sovereignty has been projected to the public in selected European countries and the EU by their political actors since 2017? What model, functional limits and narratives do actors forge?

scholarly journals Experience of public procurement under COVID 19

2021 ◽  
pp. 33-36
Author(s):  
Irina Holtsova ◽  
Yana Tsimbalenko
Keyword(s):  
European Union ◽  
Public Procurement ◽  
Well Being ◽  
European Countries ◽  
Critical Conditions ◽  
The European Union ◽  
The Public ◽  
Global Pandemic ◽  
Societal Challenge ◽  
Procurement System

2020 has become a global societal challenge for the whole world. The global pandemic, caused by COVID 19 has become threatening to the well-being of society and its sustainable development in virtually all spheres of human activity. The sphere of public procurement is not an exception not only in Ukraine, but also in European countries. The new conditions of social reality set such conditions for the implementation of public procurement, for which the world was not ready, but they required the necessary and urgent transformations. The article examines the experience of Ukraine and the European Union in the formation of public procurement and its operation under COVID 19 and strict quarantine restrictions. The Ukrainian economy was largely unprepared for the new social realities, but it was the sphere of public procurement, the development of which occured in the last 5 years, that surprised with its functional and regulatory security. The author draws attention to the peculiarities of the implementation of the system of electronic public procurement, their gradual formation and transformation. The analysis and qualitative differences of the new system of public procurement, which allowed to ensure the necessary transparency and publicity of the state order in the medical sphere, are given. A comparison of the Ukrainian system of functioning of public procurement and European transformations in this sphere is given. Because the experience of European countries in the difficult transition phase of the society of the pandemic era is very important for the countries of the post-Soviet space, as the countries of the European Union are in many respects the example to follow for such countries. The author cites the key features of the transformation and improvement of the public procurement system in accordance with the critical conditions of society

Ekonomiczne aspekty polityki integracyjnej Austrii wobec imigrantów

2018 ◽  
Vol 1 (1) ◽  
pp. 89-102
Author(s):  
Ewa Godlewska
Keyword(s):  
European Union ◽  
Public Life ◽  
Economic Factor ◽  
Public Debate ◽  
European Countries ◽  
Refugee Crisis ◽  
The European Union ◽  
Integration Policy ◽  
The Public ◽  
Migration Crisis

In recent years the public debate in Europe has been dominated by the topic of refugee crisis. Disputes on its solving have become a part of public life in practically all European countries. Intergovernmental organisations, like the European Union for example, are also interested in this problem. Austria is one of the countries that directly experienced the influx of migrants. In the context of these events, it is worth considering three issues. First of all, is it possible to continue the existing assumptions in the time of the migration crisis? The second is the question of specific challenges for the “integration package” implemented in Austria. The article also attempts to answer the questions: what is the main costs of integration and what is the opinion about this costs? The economic factor has been discussed from several perspectives – the cause, the effect and the kind of challenge for Austria’s integration policy.

scholarly journals PRIVATE CONSUMPTION IN THE EUROPEAN UNION: A COMPARATIVE STUDY

2021 ◽  
pp. 52-62
Author(s):  
ONOFREI Nicoleta ◽  
PAŞA, Adina Teodora
Keyword(s):  
European Union ◽  
National Culture ◽  
Private Consumption ◽  
Western Europe ◽  
European Countries ◽  
Alcoholic Beverages ◽  
Eastern European ◽  
The European Union ◽  
Western European ◽  
Eastern European Countries

The aim of this paper is to study consumption of households from an economic and cultural perspective in the European Union with 28 Member States during the period 2010-2019. For this purpose, we compared the Eastern European countries, dominated by rapid economic growth and development with the Western European countries, which represent the most developed countries in the EU-28. From this perspective, we proposed a multidimensional analysis of consumption that includes macroeconomic indicators of households’ wealth, which strongly influence their consumption together with an overview on expenditure by consumption purpose. Moreover, we have also considered Hofstede’s cultural dimension theory based initially on four cultural dimensions (power distance, individualism versus collectivism, masculinity versus femininity, and uncertainty avoidance) to observe the impact national culture plays on households’ consumption in Eastern and Western European countries tracking the historical changes of these countries. Our methodological approach consisted in descriptive and inferential statistics based on the selected economic and cultural indicators. Pearson’s product-moment correlations were calculated to assess the correlations between the variables. Our analysis shows that the level of wealth is lower in Eastern European countries compared to Western Europe, which influences significantly the private consumption in these countries. Moreover, the systematic differences of national culture between Eastern and Western Europe influence strongly the private consumption of their population. Results of this paper indicate that in Eastern European countries the highest share of expenditure is allocated to primary needs such as food, non-alcoholic beverages, alcoholic beverages and cigarettes to the detriment of health, education, recreation and culture.

Editorial: Migration and development: Comparing Mexico-US and Turkey-Europe

2012 ◽  
Vol 9 (1) ◽  
pp. 1-10
Author(s):  
Philip L. Martin ◽  
Ibrahim Sirkeci ◽  
Eugen Stark
Keyword(s):  
European Union ◽  
Western Europe ◽  
Strong Relationship ◽  
European Countries ◽  
The European Union ◽  
Special Issue ◽  
The Us ◽  
Western European ◽  
Migration And Development

About 12 million people born in Mexico are in the US while about four million Turks are in the European Union. Migration has been part of the strong relationship between these sending and receiving countries. Both Mexico's and Turkey's economies expanded significantly over the last two decades. However, there has also been displacement and outmigration from both countries. Over 500,000 Mexicans moved to the US each year between 2004 and 2007, and most were unauthorized. Researchers from Mexico and the US and Turkey and Western European countries examine the demography, economy, and politics of Mexico-US and Turkey-western Europe migration in this special issue.

scholarly journals INFLUENCE OF THE RELATIONSHIP BETWEEN THE EUROPEAN UNION AND THE PEOPLE'S REPUBLIC OF CHINA IN THE ASPECT OF THE INTERNATIONAL TRANSPORT CORRIDOR «WESTERN EUROPE-WESTERN CHINA» ON KAZAKHSTAN

2020 ◽  
Vol 66 (3) ◽  
Author(s):  
G.U. Birimkulova ◽  
Keyword(s):  
European Union ◽  
Western Europe ◽  
European Countries ◽  
Western China ◽  
People’S Republic Of China ◽  
The European Union ◽  
People's Republic Of China ◽  
Republic Of China ◽  
International Transport ◽  
The Impact

The article considers the role and significance of the project "Western Europe and Western China" between the countries of the European Union and the people's Republic of China in the development of regions of Kazakhstan. In addition, the author focused on the project, where several years ago Kazakhstan began actively discussing the option of turning from China to Western European countries into one of the most important international transport and transit hubs along the roads. At the same time, reference was made to the ancient history that Chinese goods along the silk road were delivered by caravans to Russia and European countries. Analyzed the impact of the relations between the European Union and China on the Republic of Kazakhstan in the framework of the project "Western Europe and Western China".

scholarly journals Income and Poverty in Households in Selected European Countries

2019 ◽  
Vol 6 (345) ◽  
pp. 7-25
Author(s):  
Malgorzata Teresa Ćwiek ◽  
Paweł Ulman
Keyword(s):  
European Union ◽  
Czech Republic ◽  
Income Distribution ◽  
Social Inclusion ◽  
Western Europe ◽  
European Countries ◽  
Income Poverty ◽  
The European Union ◽  
The Czech Republic ◽  
Visegrad Group

Incomes of population and poverty are key elements of the EU cohesion policy which aims at reducing disparities between the levels of development of individual regions. The traditionally appropriate study to evaluate the convergence of the Member States is the European Union Statistics on Income and Living Conditions (EU‑SILC). However, this is not the only source of information on income distribution and social inclusion in the European Union. In this article, the basis for calculations are the results of the fourth European Quality of Life Surveys (EQLS), whose purpose is to measure both objective and subjective indicators of the standard of living of citizens and their households. The aim of the paper is to assess the diversity of distributions of household incomes and the level of income poverty due to the selected socio‑demographic characteristics of the respondent or household in selected European countries in two periods: 2007 and 2016. Countries of the Visegrad Group (Poland, the Czech Republic, Slovakia and Hungary) were selected for the analysis, along with the Weimar Triangle (Poland, Germany, and France). Such a selection allowed us to compare the financial situation of households in Western Europe with those in Central and Eastern Europe. Poland becomes a natural link between all these countries. The article uses modelling methods of income distribution, indicators of distance (overlapping) of distributions and aggregate indicators of the scope, depth and severity of poverty. Those ratios were determined on the basis of the use of relative. In order to ensure comparability of incomes of households with different demographic compositions, the analysis used equivalent incomes. As a result of the preliminary analysis, differences were noted regarding the measured position, variation and asymmetry of equivalent incomes in the studied households. The applied gap measurements showed a significant disparity between the distributions of income in Western European countries (Germany, France) and the countries of the Visegrad Group, but the size of that differentation de creased significantly in 2016 relative to 2007. Important differentiation was also noted in terms of income poverty risk within the Visegrad Group: the highest proportion of households at risk of poverty exists in Poland and the lowest in the Czech Republic.

Polen: Flüchtlingsnotstand – aber wo sind die Flüchtlinge?

2005 ◽  
Vol 35 (140) ◽  
pp. 379-392
Author(s):  
Helmut Dietrich
Keyword(s):  
European Union ◽  
Western Europe ◽  
The European Union ◽  
Local Conditions ◽  
Asylum Policy ◽  
The Face ◽  
Emergency Measures

Poland accepted the alien and asylum policy of the European Union. But what does it mean, in the face of the fact that most of the refugees don´t want to sojourn a lot of time in Poland, but want to join their families or friends in Western Europe? How the transfer of policies does work, if the local conditions are quite different than in Germany or France? The answer seems to be the dramatization of the refugee situation in Poland, especially the adoption of emergency measures towards refugees of Chechnya.

Library and Museum Collections Digitization Projects in Finland

2009 ◽  
pp. 95-100
Author(s):  
Yulia S. Chechikova
Keyword(s):  
European Union ◽  
Cultural Heritage ◽  
European Countries ◽  
Museum Collections ◽  
The European Union ◽  
Scientific Heritage

Digitization of a national cultural and scientific heritage is one of the long-term strategic problems of the European countries’ governments. Member countries of the European Union make major efforts in providing access to their cultural heritage. In the article the process of an access provision is described for Finland.

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