ARCHIVE PAGE OF WWW.EUCERD.EU, WEBSITE OF THE
FORMER EUROPEAN EXPERT GROUPS ON RARE DISEASES & EUCERD JOINT ACTION
HISTORY OF EUROPEAN-LEVEL RARE DISEASE
MULTSTAKEHOLDER GROUPS
To
date, three groups of stakeholders in the field of rare diseases have been
successively brought together by the European Commission to provide expert
advice in this area to their services: The Rare Diseases Task Force
(2004-2009), The European Union Committee of Experts on Rare Diseases
(2010-2013) and The EC Expert Group on Rare Diseases (2013-2016). From 2018 issues related to rare diseases are discussed at
the European level by the Steering Group on Health
Promotion, Disease Prevention and Management of Non-Communicable Diseases, whilst questions related to
European Reference Networks (ERNs) for Rare Diseases are dealt with by the Board of Member States of the ERNs.
This
page is an archive of the EUCERD and ECEGRDs activities and information
concerning the work of the EUCERD Joint Action (N° 2011 22 01, co-funded by the
EU Health Programme).
The
final meeting of the EUCERD Joint Action, presenting the outcomes and future
perspectives was held on 15th September 2015 in Luxembourg and the Joint Action
ended at the end of 2015. The deliverables and outcomes are available on this
page.
The
support to the elaboration of policies in the field of rare diseases and
improvement of the codification of rare diseases provided by the EUCERD Joint
Action continued in the scope of RD-Action,
a Joint Action co-funded via the 3rd EU Health Programme for the years
2015-2018.
To date, three groups of stakeholders in the field
of rare diseases have been brought together successively by the European
Commission to provide expert advice in this area to their services: The Rare
Diseases Task Force (2004-2009), The European Union Committee of Experts on
Rare Diseases (2010-2013) and The EC Expert Group on Rare Diseases (2013-2016).
The Rare Diseases Task Force (2004-2009)
The Rare Diseases Task Force was established in
January 2004 via Commission Decision 2004/192/EC of 25 February 2004 on the
programme of Community action in the field of public health (2003 to 2008). The
RDTF was replaced by the European Union Committee of Experts on Rare Diseases.
The members of the RDTF included current and former
rare disease research project leaders, elected experts from Member States, and
representatives from relevant international organisations (DG Research, DG
Enterprise, EuroStat, EMA, WHO, OECD). Orphanet director Sιgolθne Aymι was the chair person.
Over 6 years, the RDTF played a pivotal role
instigating key collaborative rare diseases initiatives in Europe. The RDTF met
12 times over the course of its mandate, and many key topics were brought
forward for discussion in relation to rare disease research, policy and
actions. The scientific activity of the RDTF was funded from 2005 onwards,
which allowed the publication of OrphaNews Europe,
the official newsletter of the Rare Diseases Task Force. Published every two
weeks, this newsletter has served as a vital communication tool, bringing news
on policy developments, medical and scientific findings, orphan drugs, research
projects, patient activities, events and new relevant publications to the
global rare disease community including patients, healthcare professionals,
researchers, industry professionals and health policy makers.
Various working groups were identified and
constituted to meet the specific objectives of the RDTF: this included the
Standards of Care working group, the Public Health Indicators working group,
and the Coding, Classification and Data Confidentiality Group. These working
groups produced various reports, recommendations and scoping papers.
One of the most notable contributions of the RDTF
was its pivotal role between June and October 2007 in drafting the
Communication Rare Diseases: Europes Challenges, in close collaboration with
the European Commission. The process ultimately culminated in the adoption of
the European Council Recommendation on an Action in the Field of Rare Diseases
in June 2009.
The European Union Committee of Experts on Rare
Diseases replaced the European Commissions Rare Diseases Task Force (RDTF) in
2010.
The European Union Committee of Experts on Rare
Diseases (2010-2013)
The European Union Committee of Experts on Rare
Diseases was formally established via the European
Commission Decision of 30 November 2009 (2009/872/EC). This committee was charged with aiding the European Commission with
the preparation and implementation of Community activities in the field of rare
diseases, in cooperation and consultation with the specialised bodies in Member
States, the relevant European authorities in the fields of research and public
health action and other relevant stakeholders acting in the field.
The 51-member committee with representatives from
all Member States and stakeholder groups was chaired by Sιgolθne
Aymι and co-chaired by Kate Bushby, Yann Le Cam and
Helena Kδδriδinen. The EUCERD met 3 times a year and
organised a number of workshops supported by the EUCERD Joint Action.
Over the 3-year mandate of the EUCERD, 5 recommendations
were adopted in the field of rare diseases concentrating on centres of
expertise, European Reference Networks, the clinical added value of orphan
medicinal products information flow, registries & data collection, and
indicators for national plans. An Opinion on potential areas of collaboration
at European level in the field of new born screening was also issued.
The EUCERD was a highly successful forum for
exchange of experience and cooperation between stakeholders appreciated greatly
by the rare disease community. The EUCERD was replaced at the end of its
mandate by the European Commission Expert Group on Rare Diseases from 2014
onwards.
An
editorial documenting the achievements of the EUCERD entitled The European Union Committee of
Experts on Rare Diseases: three productive years at the service of the rare
disease community was published by the Orphanet Journal of
Rare Diseases in February 2014 to mark Rare Disease Day.
The European Commission Expert Group on Rare
Diseases (2014 onwards)
The European Commission Expert Group on Rare
Diseases, established via Commission Decision 2013/C 219/04 of 30 July 2013,
was active until 2016.
This group included representatives from all the
Member States plus nominated experts, representatives of patient organisations,
patients organisations in the field of rare diseases, European associations of
producers of products or service providers relevant for patients affected by
rare diseases, and European professional associations or scientific societies
acting in the field of rare diseases.
After the
Expert Group
From 2018 issues related to rare diseases are discussed at the European
level by the Steering Group on
Health Promotion, Disease Prevention and Management of Non-Communicable
Diseases, whilst questions related to European Reference Networks (ERNs) for Rare
Diseases are dealt with by the Board of Member
States of the ERNs.
European
Committee of Experts on Rare Diseases (EUCERD)
The
EUCERD issued the following 5 recommendations on centres of expertise, European
Reference Networks, registries, indicators for national plans and improving
informed decisions based on the clinical added value of orphan medicinal
products:
EUCERD
Recommendations on Rare Disease Patient Registration and Data Collection (5
June 2013)
·
Powerpoint presentation
of the Recommendation (June 2013)
EUCERD
Recommendations on Core Indicators for Rare Disease National Plans/ Strategies (6 June
2013)
·
Powerpoint presentation of the Recommendation (January
2014)
EUCERD
Recommendations on European Reference Networks for Rare Diseases (31 January
2013) and Addendum (10
June 2015)
·
Powerpoint presentation of the Recommendation (January
2013)
·
Powerpoint presentation of the Recommendation (September
2012)
·
Translations: BG
Bulgarian, CS
Czech, DA
Danish, DE
German, EL
Greek, ES
Spanish, ET
Estonian, FI
Finnish, FR
French, HU
Hungarian, IT
Italian, LT
Lithuanian, LV
Latvian, MT
Maltese, NL
Dutch, PL
Polish, PT
Portuguese, RO
Romanian, SK
Slovakian, SL
Slovenian, SV
Swedish
·
Powerpoint presentation of the
Recommendations (October 2011)
Opinions
The
EUCERD also issued the following Opinion.
EUCERD
Opinion on Potential Areas of European Collaboration in the field of New Born Screening
July 2013
EC Expert Group on Rare Diseases
The
EUCERD issued the following recommendation:
The
European Union Committee of Experts on Rare Diseases and EC Rare Disease Task
Force, and the EUCERD Joint Action (N° 2011 22 01), the have published the
reports on the following subjects:
2014
Edition
arising from the EUCERD Joint Action N°2011 22 01
An
article based on this work has been published: Charlotte Rodwell, Sιgolθne Aymι Rare disease
policies to improve care for patients in Europe, Biochim Biophys Acta. 2015 Feb
25. pii: S0925-4439(15)00059-9. (Open Access)
2013
Edition arising from the EUCERD Joint Action N°2011 22 01
2012
Edition arising from the EUCERD Joint Action N°2011 22 01
2011
Edition
2010
Edition
arising
from the EUCERD Joint Action N°2011 22 01
·
RDTF
Report: Patient Registries for Rare Diseases April
2009, Update June 2011
The
public summary reports of previous EUCERD meetings can be accessed here:
The
Rare Diseases Task Force held two meetings per year at the European Commission
in Luxembourg from 2004 to 2009.
·
Report on the 1st Rare Diseases Task Force meeting 20/01/2004
·
Report
on the 2nd Rare Diseases Task Force meeting 14/10/2004
·
Report on the
3rd Rare Diseases Task Force meeting 20/06/2005
·
Report
on the 4th Rare Diseases Task Force meeting 14/12/2005
·
Report on the
5th Rare Diseases Task Force meeting 08/06/2006
·
Report on the 6th Rare Diseases
Task Force meeting 14/12/2006
·
Report on the 7th Rare Diseases Task Force meeting 20/06/2007
·
Report on the 8th Rare Diseases Task Force meeting 23/10/2007
·
Report on the
9th Rare Diseases Task Force meeting 28/02/2008
·
Report on the
10th Rare Diseases Task Force meeting 13/11/2008
·
Report on the
11th Rare Diseases Task Force meeting 30/04/2009
·
Report on the
12th Rare Diseases Task Force meeting 23/10/2009
·
EUCERD Joint Action Workshop:
Cross-Border Genetic Testing in the European Union 15-16 December 2014, Newcastle organised
through the EUCERD Joint Action N°2011 22 01
·
Workshop: The genetic testing offer in
the EUEuropean workshop on the genetic testing offer
in Europe,
Ispra, 19-20 November 2012 organised by
the EC Joint Research Centre
·
EUCERD/Eurobiomed Event Rare2011 Conference European Day, 4 November 2011, Montpellier, France
organised
through the RDTF/EUCERD Scientific Secretariat Joint Action N° 2008 22 91
with Eurobiomed
·
Workshop on monitoring and evaluation
of health projects in the field of rare diseases 27 November 2014, Lisbon organised through
the EUCERD Joint Action N°2011 22 01
The
EUCERD Joint Action: Working for Rare Diseases (N° 2011 22 01) was co-funded by
the European Commission (Executive Agency for Health and Consumers, now CHAFEA)
in the context of the European Unions Second Programme of Community
Action in the field of Health. It started on 1 March 2012 and ended in 2015,
supporting the activities and mandate of the European Union Committee of
Experts on Rare Diseases until the end of 2013 when the EUCERD ended its
mandate. From 2014 it supported the activities of the European
Commission Expert Group on Rare Diseases which
replaced the EUCERD.
This
Joint Action was led by Prof. Kate Bushby, former Vice-Chair of the EUCERD
and member of the Expert Group.
The
EUCERD was mandated to assist the EC in formulating and implementing the
Communitys activities in the field of rare diseases, to foster exchanges of
relevant experience, policies and practices between the Member States and
stakeholders. Rare diseases are a priority area for action in the Public Health
Programme (2008-2013). These activities have been defined in the Communication
of the European Commission, entitled Rare Diseases: Europes challenge (11
November 2008) and the Council Recommendation on an action in the field of rare
diseases (8 June 2009).
Specifically,
this Joint Action addressed the following priority areas of the Council
Recommendation:
To
achieve its aims, the Joint Action built on the achievements of previous European
initiatives in the field, such as the EC Rare Disease Task
Force, Orphanet, the Europlan
project, and the outputs of and the several rare disease networks that have
received EU funding over the past years.
This
Joint Action comprised five main areas of work:
This
last area of work aimed, with the input of the EUCERD, to propose a model for
sustainable action.
The
expected outcome was integrated strategy for the implementation of rare disease
policies through the exchange of experience between Member State health
authorities already involved in rare disease policy definition and
implementation and via a series of recommendations from the EUCERD and clear
communication of these recommendations to national policy makers, patient
organisations and learned societies.
Specific
expected outcomes were the following:
The
following outputs and public final deliverables of the EUCERD Joint Action
(N°2011 22 01) are currently available. A meeting presenting the outcomes of
the Joint Action was organised on 15 September 2015 in Luxembourg.