scholarly journals Legal assessment of current situation on orphan patients in Lithuania

Medicina ◽  
2008 ◽  
Vol 44 (8) ◽  
pp. 571 ◽  
Author(s):  
Indrė Špokienė
Keyword(s):  
Health Care ◽  
European Union ◽  
Rare Diseases ◽  
Comparative Method ◽  
National Level ◽  
Practical Implementation ◽  
The European Union ◽  
Medicinal Products ◽  
Member States ◽  
Orphan Medicinal Products

After Lithuania joined the European Union, the Regulation (EC) No. 141/2000 on orphan medicinal products and Commission Regulation (EC) No. 847/2000 came into force as part of national legislation. Member States must adopt specific measures to increase knowledge on rare diseases and to improve their detection, diagnosis, and treatment. The aim of this article was to present and to assess the current legal situation on orphan patients and their treatment in Lithuania, to identify legislation gaps, and to propose some ideas how to facilitate the solution of the existing problems in this field. For this purpose, European Union and Lithuanian legal documents on rare medicinal products are examined using a comparative method. With reference to inventory of Member States’ incentives for rare diseases in national level, the most important issues, which orphan patients face to in Lithuania, are singled out. In Lithuania, the situation of orphan patients in terms of protection of patient rights is insufficiently determined. The access to effective health care services or approved therapies in some cases is restricted. Working relationships between genetic services and various clinical specialists as well as with those in primary care are not legally determined; the number of clinical trials aimed at orphan medicinal products is low. These results suggest a need for awareness raising among Lithuanian Government, health care specialists, patient organizations about the importance to improve practical implementation of European Union legislation and progressive experience of some European countries in this field.

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.

Comparative analysis of the scope of European Union paediatric investigation plans with corresponding orphan designations

2017 ◽  
Vol 103 (5) ◽  
pp. 427-430 ◽  
Author(s):  
Andrea Ecker ◽  
Segundo Mariz ◽  
Frauke Naumann-Winter ◽  
Koenraad Norga ◽  
Ingeborg Barisic ◽  
...  
Keyword(s):  
European Union ◽  
Comparative Analysis ◽  
Rare Diseases ◽  
Market Forces ◽  
The European Union ◽  
Medicinal Products ◽  
Paediatric Investigation Plan ◽  
Pharmaceutical Development ◽  
Orphan Medicinal Products ◽  
Small Patient

BackgroundMarket forces may not be sufficient to stimulate research and development of medicines for small patient populations, such as children and patients with rare diseases. Both the European Union Orphan and Paediatric Regulations were introduced to address the unmet public health needs of these smaller patient populations through the use of incentives, rewards and obligations. Developers for new medicines for rare diseases must agree a paediatric investigation plan (PIP) or waiver with the European Medicines Agency’s (EMA) Paediatric Committee (PDCO), and can also apply for an orphan designation (OD) from the EMA’s Committee of Orphan Medicinal Products (COMP). The scope of both the OD and the PIP (or waiver) is defined by the agreed condition.ObjectivesThe aim of this study was to analyse the approach of PDCO and COMP in defining the appropriate condition for a PIP or OD, respectively, in order to investigate potential challenges in the paediatric development of orphan medicines which have to meet the requirements of both legislations.MethodsA comparative analysis of PIP conditions and OD conditions was performed for medicines that have been reviewed by both Committees.ResultsWe found that in the substantial majority of cases there is no divergence between the conclusions of COMP and PDCO with regard to the condition for which a medicine is to be developed.ConclusionThese findings demonstrate that a collaborative approach allows both Regulations to work synergistically to foster pharmaceutical development for rare diseases in childhood.

scholarly journals The Role of Spatio-Temporal Information to Govern the COVID-19 Pandemic: A European Perspective

2021 ◽  
Vol 10 (3) ◽  
pp. 166
Author(s):  
Hartmut Müller ◽  
Marije Louwsma
Keyword(s):  
European Union ◽  
Spatial Distribution ◽  
Spatial Information ◽  
National Level ◽  
Temporal Information ◽  
The European Union ◽  
Member States ◽  
Heavy Burden ◽  
Spatio Temporal

The Covid-19 pandemic put a heavy burden on member states in the European Union. To govern the pandemic, having access to reliable geo-information is key for monitoring the spatial distribution of the outbreak over time. This study aims to analyze the role of spatio-temporal information in governing the pandemic in the European Union and its member states. The European Nomenclature of Territorial Units for Statistics (NUTS) system and selected national dashboards from member states were assessed to analyze which spatio-temporal information was used, how the information was visualized and whether this changed over the course of the pandemic. Initially, member states focused on their own jurisdiction by creating national dashboards to monitor the pandemic. Information between member states was not aligned. Producing reliable data and timeliness reporting was problematic, just like selecting indictors to monitor the spatial distribution and intensity of the outbreak. Over the course of the pandemic, with more knowledge about the virus and its characteristics, interventions of member states to govern the outbreak were better aligned at the European level. However, further integration and alignment of public health data, statistical data and spatio-temporal data could provide even better information for governments and actors involved in managing the outbreak, both at national and supra-national level. The Infrastructure for Spatial Information in Europe (INSPIRE) initiative and the NUTS system provide a framework to guide future integration and extension of existing systems.

scholarly journals Regional Convergence in the European Union, new Member States and Croatia

2013 ◽  
Vol 8 (1) ◽  
pp. 9-21 ◽  
Author(s):  
Davor Mikulić ◽  
Željko Lovrinčević ◽  
Andrea Galić Nagyszombaty
Keyword(s):  
European Union ◽  
National Level ◽  
Growth Patterns ◽  
Regional Convergence ◽  
The European Union ◽  
Potential Growth ◽  
Member States ◽  
New Member States ◽  
Factors Influencing ◽  
Wide Range

Abstract Over the past two decades, the issue of regional convergence in the European Union has been the subject of a wide range of empirical research. This paper aims to provide more information on the differences in regional growth patterns of new member states (NMS), as well as Croatia, in addition to the factors influencing regional disparities within each country. This research provides an analysis of regional convergence in the period 2001-2008 at the NUTS II and NUTS III level. The most widely used model for testing convergence hypotheses is beta-convergence analysis. Other factors commonly included in the econometric modelling of convergence are demographic variables, labour market conditions, industrial structure, institutional factors and overall government policy. The main hypothesis is that the process of regional convergence in NMS and Croatia is not strong enough to dominate over other factors, influencing regional potential growth (mainly industry structure and quality of human capital). Absolute β-convergence can be found at the national level for EU countries. Convergence also can be found for NMS regions, but the pace of convergence on the regional level is lower in comparison to the national level and the estimated β-convergence parameter is less significant.

‘Biodiversity damage’ liability in the Environmental Liability Directive – its definition and delimitation from more stringent EU, international and national norms

elni Review ◽  
2008 ◽  
pp. 19-24
Author(s):  
Volker Mauerhofer
Keyword(s):  
European Union ◽  
National Level ◽  
Environmental Damage ◽  
The European Union ◽  
Member States ◽  
Eu Member States ◽  
Environmental Liability ◽  
Legal Provisions ◽  
Early Beginning ◽  
National Norms

The Environmental Liability Directive (‘ELD’) of the European Union entered into force on 30th April 2004 and had to be implemented by 30th April 2007. It had been already from the early beginning up to today subject to multiple considerations by many scholars and is implemented quite differently in the different EU Member States. The ELD contains provisions concerning the liability for ‘environmental damage’, which is further defined inter alia as a specific damage of certain species and habitats (‘biodiversity damage’). Besides the ELD there are already other legal provisions on the European as well as on the international and national level covering several aspects of these liability issues more stringently. Hence the question arises as to how the new provisions of the ELD delimit from these similar but other EU, international and national norms.

Competitiveness and Economic Growth in the European Union

2018 ◽  
Vol 8 (8) ◽  
pp. 2408
Author(s):  
Natália ZAGORŠEKOVÁ ◽  
Michaela ČIEFOVÁ ◽  
Andrea ČAMBALÍKOVÁ
Keyword(s):  
Economic Growth ◽  
European Union ◽  
Union Member ◽  
National Level ◽  
The European Union ◽  
Member States ◽  
Global Competitiveness ◽  
Global Competitiveness Index ◽  
The Impact ◽  
European Union Member States

The paper focuses on competitiveness at the national level and on the impact of competitiveness on economic growth. We look at the relationship between competitiveness and economic growth based on the data from the European Union member states. The competitiveness of the economies is measured by the Global Competitiveness Index, which is published by the World Economic Forum. The European Union member states show significant differences in competitiveness. In the sample examined, the positive relationship between the level of competitiveness and economic growth was not confirmed.

scholarly journals Extradition under the Legislation of the Russian Federation and Member States of the European Union

2020 ◽  
Vol 37 (65) ◽  
pp. 93-102
Author(s):  
Elena A. Kupryashina ◽  
Snezhana S. Khalimonenko ◽  
Aleksander A. Nasonov ◽  
Ekaterina A. Novikova ◽  
Sergey F. Shumilin
Keyword(s):  
European Union ◽  
Russian Federation ◽  
Comparative Method ◽  
Criminal Procedure ◽  
Integrated Approach ◽  
European Convention ◽  
The European Union ◽  
Member States ◽  
Legal Provisions ◽  
The Russian Federation

The document analyzes the legislation of the Russian Federation and the member states of the European Union on extradition from the point of view of its compliance with the current European Convention on Extradition. It also makes proposals to improve the rules of the Criminal Procedure Code of the Russian Federation that regulates the extradition procedure. Methodologically, the work uses scientific methods of analysis and synthesis, as well as the historical, comparative method, all in an integrated approach. Among the conclusions, the fact that for the previous legal provisions to work, its consolidation only in the Code of Criminal Procedure of the Russian Federation is insufficient. The first step to put them into practice could be to discuss the issue of making the necessary amendments to the Convention on Legal Assistance and Legal Relations in Civil Matters, as well as in the Family and Criminal Affairs regulations of January 22, 1993, of which the countries of the European Convention on Extradition are parties.

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