scholarly journals Evaluating the European Union Committee of Experts on Rare Diseases Joint Action

2015 ◽  
Vol 25 (suppl_3) ◽  
Author(s):  
V Gómez ◽  
A Machado ◽  
P Rama ◽  
C Furtado ◽  
D David ◽  
...  
Keyword(s):  
European Union ◽  
Rare Diseases ◽  
Joint Action ◽  
The European Union ◽  
Union Committee

scholarly journals Rationale of the rare cancer list: a consensus paper from the Joint Action on Rare Cancers (JARC) of the European Union (EU)

ESMO Open ◽  
2020 ◽  
Vol 5 (2) ◽  
pp. e000666
Author(s):  
Paolo G Casali ◽  
Annalisa Trama
Keyword(s):  
European Union ◽  
Rare Diseases ◽  
Joint Action ◽  
Low Frequency ◽  
Rare Cancer ◽  
The European Union ◽  
Incidence Data ◽  
Rare Cancers ◽  
Set Up ◽  
Definition Of

BackgroundThe Surveillance of Rare Cancers in Europe (RARECARE) project proposed a definition and a list of rare cancers. The Joint Action on Rare Cancers (JARC), launched by the European Union and involving 18 member states and 34 partners, promoted a wide consensus effort to review the list.Patients and methodsA group of experts was set up, including scientific societies, member state representatives of JARC, representatives of the European Reference Networks dedicated to rare cancers and rare cancer patient advocates. The definition and the list of rare clinical entities, based on the incidence data provided by two European projects (RARECARE and RARECAREnet), were rediscussed through a consensus meeting of the expert panel.ResultsBy consensus, it was reiterated that the best criterion for a definition of rare cancers is incidence, rather than prevalence. By consensus, the experts slightly modified the composition of the tiers of rare cancers, according to the definition based on an incidence threshold <6/100 000/year, and grouped all rare cancers within 12 families of rare cancers. Even when defined conservatively this way, rare cancers are not rare collectively, since they correspond to 10%–20% of all cancer cases.ConclusionsThe list of rare cancers reviewed by JARC should be viewed as a tool in the fight against rare cancers and rare diseases. It may help to appreciate that rare cancers are cancers and rare diseases at the same time, combining issues and difficulties of both. We hope that refinements to the list and a wider understanding of its implications may contribute to increase awareness of problems posed by rare cancers and to improve quality of care in a large group of patients with cancer, who may be discriminated against just because of the low frequency of their diseases.

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 Unity and divisions on departmental select committees: A Brexit effect?

2020 ◽  
pp. 136914812096174
Author(s):  
Philip Lynch ◽  
Richard Whitaker
Keyword(s):  
European Union ◽  
Comprehensive Analysis ◽  
The European Union ◽  
House Of Commons ◽  
Fault Line ◽  
New Members ◽  
Members Of Parliament ◽  
The Commons ◽  
Union Committee ◽  
Opposition Parties

Most reports from UK departmental select committees are agreed by consensus, underpinning their reputation for non-partisan working in an adversarial House of Commons. However, divisions (formal votes) are more common than is often assumed, occurring on 9% of reports between 2010 and 2019. This article provides the first comprehensive analysis of unity and divisions on select committees. It finds that the incidence of divisions increases when opposition parties chair committees, when there are more rebellious members of parliament present and when more new members of parliament are in attendance. Brexit provoked significant inter-party and intra-party divisions in the Commons. In committees, divisions on Brexit reports are higher than those on other reports and the Exiting the European Union Committee has a clear Leave-Remain fault line. But, more broadly, the Brexit effect on select committees is limited and unanimity remains the norm even when there are policy differences between parties.

The African, Caribbean, and Pacific (ACP) Group of States: From the Lomé Convention to the Cotonou Agreement and Beyond

2020 ◽  
Author(s):  
Maurizio Carbone
Keyword(s):  
European Union ◽  
Joint Action ◽  
Financial Resources ◽  
Financial Sustainability ◽  
The European Union ◽  
Heterogeneous Cluster ◽  
Member States ◽  
Intergovernmental Organization ◽  
African Caribbean ◽  
The Eu

The African, Caribbean, and Pacific (ACP) Group of States is an intergovernmental organization established by the Georgetown Agreement in June 1975, and it consists of 79 countries across three continents. This heterogeneous cluster of countries, originally bound by their colonial ties with the member states of the European Union (EU), came together out of the need to form a common front in the negotiations of the first ACP–EU partnership. The spirit of the Lomé Convention (1975–2000), initially considered a very progressive model of North–South cooperation, gradually evaporated; thus, the Cotonou Agreement (2000–2020), with its profound changes in the areas of aid and trade, was an attempt to normalize relations between the two blocs. The overall patchy record of the various ACP–EU partnership agreements and a number of events—notably, decreased interest within the EU, intensification of regionalization dynamics in the ACP Group, and adoption of separate strategies for cooperation with African, Caribbean, and Pacific countries and regions—cast doubts upon the relevance of the ACP–EU framework and threatened the existence of the ACP Group. Unsurprisingly, the launch of the negotiations in September 2018 for a new ACP–EU partnership was not without difficulty. While there are no doubts that the ACP Group has intrinsically been linked to the EU, at the same time it should be noted that it has attempted to promote intra-ACP cooperation, although with mixed successes at best, and to strengthen its presence in the international arena and diversify its partnerships, also in this case with limited results. Indeed, despite various pledges to support the principles of unity and solidarity, the effectiveness of the ACP Group has been compromised by the interplay of a plurality of interests, limited financial resources, and a perceived delinkage of the Brussels-based institutions from ACP national capitals. The revision of the Georgetown Agreement in December 2019, including the transformation into the Organisation of the African, Caribbean and Pacific States (OACPS), is an attempt to reinvigorate the ACP Group, with stronger emphasis on financial sustainability, joint action for the pursuit of multilateralism, and, importantly, increased autonomy from the EU.

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