Download European Reference Networks briefing

European Reference Networks briefing
Introduction
The European Commission published in March 2014 the criteria and conditions
which European Reference Networks (ERNs) and healthcare providers wishing to
join an ERN must fulfil. ERNs are being established to support Europe-wide
cooperation on highly specialised healthcare between providers and centres of
expertise. Their creation will be of interest to leading NHS providers of specialised
services who wish to develop new, or consolidate existing, peer links with
organisations elsewhere in Europe.
This briefing note explains the background to ERNs, the process, criteria and
timeline for their establishment and membership, and some of the benefits for NHS
organisations wishing to join them.
Key Points
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ERNs are a new form of Europe-wide cooperation between healthcare
providers of highly specialised services.
They should improve access to diagnosis, treatment and provision of highquality healthcare to patients. They could also be focal points for medical
training and research, information dissemination, and evaluation.
Expected benefits for healthcare providers are an improvement in knowledge
and capacity, international recognition and leadership in their area of
expertise, and better positioning for access to EU funding programmes.
ERNs will look to build on existing informal thematic peer links, with the
expectation that providers will proactively cooperate amongst themselves to
establish a Network in a dedicated field of expertise.
A conference will be organised in Brussels in June for hospitals interested in
applying, to understand the process and establish links for the development of
applications. Networks are expected to be established by Q4 2015.
Background
While cross-border cooperation in healthcare within the EU has been increasing primarily though informal clinician-led peer groups, bi-lateral agreements and EUfunded projects - there is currently no formal platform at EU level to construct
partnerships on healthcare and take advantage of potential synergies and
economies of scale.
ERNs are therefore an attempt to formalise existing arrangements and bring together
highly specialised healthcare providers in different Member States to provide
affordable, high-quality and cost-effective healthcare to patients with conditions that
require a high concentration of resources and expertise. It is expected that this will
also improve patient access to the best possible expertise and care available in the
EU. The intention is that ERNs will lead to improvements in service delivery, working
systems, patient pathways, clinical tools, and the earlier adoption of scientific
evidence. They could also be focal points for medical training and research,
information dissemination and evaluation, especially for rare diseases.
Establishing European Reference Networks
The European Commission envisages between 20 – 30 ERNs being established in
total, which will inevitably involve the clustering of some disease areas (for example,
all rare cancers may be joined together into one single Network).
In terms of governance, ERNs can have different organisational models, though they
all require one Member as coordinator and an associated governing Board
composed of representatives from each Member in the Network. The Board will be
responsible for the running of the Network, including rules of procedure, work plans
and general activity. All ERNs will have a common logo and registered trademark.
Each Network is expected to involve at least 10 hospitals/specialised centres from at
least 8 EU Member States. Those EU Member States with no Member of a Network
(because for example they do not have providers with sufficient knowledge/expertise
in the clinical domain in question) may decide to designate healthcare providers with
a special link to a given Network.
The high-level criteria and conditions that must be met to establish both a Network
and for its Membership are listed below. The full explanation of what the European
Commission classifies as meeting these criteria can be found in Annex I and II. One
should note that the functioning of the Networks will be based on these activities.
Criteria and conditions for Networks to meet:
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Have knowledge and expertise to diagnose, follow-up and manage
patients with evidence of good practice
Follow a multi-disciplinary approach
Offer a high level of expertise and have the capacity to produce
good practice guidelines and to implement outcome measures and
quality control
Make a contribution to research
Organise teaching and training activities
Collaborate closely with other centres of expertise and networks at
national and international level
Criteria to be met by healthcare providers to participate in a Network:
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Patient empowerment and patient-centred care
Organisational, management and business continuity of the
healthcare provider
Research and training capacity
Exchange of expertise, information systems and eHealth tools
Expertise, good practice, quality, patient safety and evaluation
Members of a Network must also meet the following criteria specific to the scope of
that particular Network:
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Competence, experience and outcomes of care
Specific human structural and equipment resources and
organisation
Measurement against these final two criteria will be based on the evidence and
consensus of the scientific, technical and professional community.
An early indication of what an ERN might look like can be found in two pilot networks
funded by the European Commission’s Health Programme in 2013: ExPO-r-Net, the
European Expert Paediatric Oncology Reference Network for Diagnostics and
Treatment; and E-Pilepsy, a pilot Network of reference centres in refractory epilepsy
and epilepsy surgery. The UK is involved in these pilot Networks, with UCL a partner
in both and the University of Birmingham in the former.
Starting the process
The anticipated ERN process will involve both a call for Networks and an application
for individual providers to join a Network, to be issued simultaneously by the
European Commission. The immediate assessment of the criteria and conditions
met, and the subsequent evaluation of the functioning of the prospective Networks
will be led by an independent technical body, with EU Member States ratifying the
final decision on Networks and Members. We expect there to be rolling future open
applications for new Members to join already established ERNs.
The European Commission will be responsible for leading the process for the
establishment of the Networks and their evaluation, largely through its website and a
series of conferences and expert meetings.
In particular, the European Commission will organise a conference for hospitals
interested in applying to understand the process and establish links for the
development of applications. This conference is due to take place in Brussels on 23
June 2014. Guidance for potential applicants will likely be published at the same
time. Calls for the establishment of Networks will commence in early 2015, with the
Networks expected to be established by Q4 of 2015.
Conclusion
The European Commission is very interested in both the model of specialised
commissioning used by the NHS in England and the expertise that our specialist
providers have. Given this, the opportunities for the NHS to lead or participate in
ERNs are significant. Although no direct EU funding will be attached to being a
Member of an ERN, their profile and status is expected to be considerable across
Europe in their particular domain. This will clearly prove an attraction to clinical and
academic leaders, and patients crossing borders, and will put the Networks and their
individual Members in a good position to bid for EU research funding going forward.
Each Network will be required to regularly report to the European Commission on its
activities and therefore participating organisations should ensure they can dedicate
sufficient time and resources to the Network. This is especially the case for NHS
organisations considering being a Network Coordinator. It should also be noted that
the participation of NHS organisations in ERNs will require the endorsement of the
Department of Health.
The actual establishment of ERNs will be dependent on specialised providers
proactively seeking out peers across Europe with which to collaborate. With this in
mind, it would be worth interested NHS trusts understanding any informal peer links
that they already have, whether via clinicians or others, and assessing whether these
links would provide a good base to develop formal collaborations through the
establishment of an ERN.
The NHS European Office is in continuous dialogue with the European Commission
and will be monitoring the ERN process as it develops. For more information please
contact: [email protected].
ANNEX I
Criteria and conditions to be fulfilled by the Networks
1. Each Network shall:
(a) provide highly specialised healthcare for low prevalence, rare and complex
diseases or conditions
(b) have a clear governance and coordination structure including at least the
following:
(i) the Members' representatives that shall represent the Members within the
Network and coordinate the activities of the Members with the Network. Each
Member shall designate its representative among the health professionals
belonging to its staff.
(ii) the Board of the Network that shall be responsible for the governance of the
Network. All Members of the Network shall be represented in the Board
(iii) the Coordinator Person nominated by the Coordinator Member of the Network
among the health professionals belonging to its staff, that shall chair the meetings
of the Board and represent the Network.
2. In order to comply with the requirement that Networks ‘have knowledge and
expertise to diagnose, follow-up and manage patients with evidence of good
outcomes’, they shall:
(a) promote good quality and safe care to patients suffering from certain diseases
and conditions by fostering adequate diagnosis, treatment, follow-up and
management of patients across the Network;
(b) empower and involve patients in order to strengthen the good quality and safety
of the care received.
3. In order to comply with the requirement to ‘follow a multi-disciplinary approach’,
the Networks shall:
(a) identify domains and best practices for multidisciplinary work;
(b) be based on multidisciplinary healthcare teams
(c) facilitate and promote multidisciplinary advice for complex cases.
4. In order to comply with the requirement to ‘offer a high level of expertise and
have the capacity to produce good practice guidelines and to implement outcome
measures and quality control’, the Networks shall:
(a) exchange, gather and disseminate knowledge, evidence and expertise within and
outside the Network, in particular, on the different alternatives, therapeutic
options and best practices related to the provision of services and treatments
available for each particular disease;
(b) promote and support the expertise of healthcare providers in order to increase
the local, regional and national capacity of providing healthcare as close as
possible to the patients;
(c) promote, develop and implement clinical guidelines and cross-border patients’
pathways;
(d) design and implement outcome and performance indicators;
(e) promote and maintain a quality, patient safety and evaluation framework.
5. In order to comply with the requirement to ‘make a contribution to research’, the
Networks shall:
(a) identify and address research gaps;
(b) promote collaborative research within the Network
(c) reinforce research and epidemiological surveillance, through setting up of shared
registries.
6. In order to comply with the requirement to ‘organise teaching and training
activities’, the Networks shall:
(a) identify and address training gaps;
(b) foster and facilitate the development of training and continuous education
programmes and tools for healthcare providers involved in the chain of care
(within or outside the Network).
7. In order to comply with the requirement to ‘collaborate closely with other Centres
of Expertise and Networks at national and international level’, the Networks shall:
(a) exchange and disseminate knowledge and best practice, in particular by
supporting national centres and networks;
(b) set up networking elements, such as communication tools, methodologies to
develop clinical guidelines and protocols, exchange of clinical information,
training alternatives and models, operation and coordination practices etc.
(c) collaborate with Associated National Centres and Collaborative National Centres
designated by Member States with no Member of a given Network.
ANNEX II
Criteria and conditions for applicants of membership of a Network
1. General criteria and conditions for all applicant providers
All applicants wishing to join a Network shall comply with the following criteria and
conditions:
(a) As regards patient empowerment and patient-centred care, applicant providers
must:
(i) have put in place strategies in order to ensure patient-centred care, patient’s
rights (such as right to informed consent; information concerning own health;
medical records; privacy; complaint and compensation), empowerment and
participation (such as customer relationship management, patient education and
active engagement strategies of patient and families throughout the institution);
(ii) provide clear and transparent information about complaint procedures and
available remedies and redress for both domestic and foreign patients;
(iii) ensure active measurement of patient experience and feedback reporting, on
patient experience;
(iv) apply personal data protection rules and ensure access to medical records and
clinical information;
(v) ensure that informed consent of the data subject shall comply with requirements
(vi) ensure transparency, including information about outcomes, treatments options
and quality and safety standards put in place;
(b) as regards organisation, management and business continuity, applicants
providers must:
(i) apply transparent and explicit organisation and management rules and practices
including in particular the procedures related with the management of crossborder patients in their area of expertise;
(ii) ensure transparency of the tariffs;
(iii) have a business continuity plan over a given time frame including ensuring:
• the provision of essential medical care in case of unexpected resource failure, or,
if needed, access or referral to alternative resources if needed.
• the maintenance of the stability and technical capacity and expertise of the
centre, such as plan for human resources management and technology update;
(iv) ensure coordination with and easy access of the centre to other resources or
specific units or services necessary for the management of the patients;
(v) have good general structural conditions, such as surgical theatres, intensive care
unit, isolation unit, emergency ward, laboratories;
(vi) have the capacity to communicate with relevant after-discharge services,
including cross-border communication.
(c) as regards research and training capacity applicant providers must:
(i) have academic, university or specialised level training capacity;
(ii) have human, technical and structural capacity, skill-mix and resources;
(iii) have research capacity, and demonstrated research experience or production in
the area of expertise of the Network, at national and international level;
(iv) carry out teaching and education activities related to the field of expertise aimed
at improving the knowledge and technical capacity of the healthcare providers
involved in the same chain of care within and outside the centre, such as
continuous medical education and distance learning;
(d) as regards the exchange of expertise, information systems and e-health tools
applicant providers must:
(i) be able to support and exchange expertise with other cross-border healthcare
providers;
(ii) have established procedures and a framework for ensuring the management,
safeguarding and exchange of medical data, including established outcomes and
process indicators and patient registries for the specific area of expertise;
(iii) be able to foster the use of telemedicine and other eHealth services within and
outside the centre, by accomplishing the minimum requirements for
interoperability and, when applicable, the use of agreed standards and
recommendations;
(iv) use a standardised information and coding system according to national or
international recognised systems, for example ICD and complementary codes
when appropriate.
(e) as regards expertise, good practice, quality, patient safety, and evaluation
applicant providers must:
(i) have a quality assurance or management system and plans including
governance and evaluation of the system;
(ii) have a patient safety program or plan including specific goals, procedures,
standards and process and outcomes indicators, addressing key areas, such as
information, reporting and learning system on adverse events; training and
education activities; hand hygiene; healthcare related infections; medication
errors and safe use of medications; safe procedures and surgery; safe patient
identification;
(iii) commit itself to use the best knowledge and evidence based health technologies
and treatments;
(iv) develop and use clinical guidelines and pathways in the area of expertise.
2. Specific criteria and conditions for applicant providers regarding the
concrete area of expertise, disease or conditions addressed by the
Networks they wish to join
(a) as regards competence, experience and outcomes of care, applicant providers
must:
(i) Document competence, experience & activity (e.g. volume of activity, referrals
and accumulated experience – time and figures- and when possible,
minimum/optimal number of patients/year, in accordance with
professional/technical standards or recommendations);
(ii) provide evidence of good clinical care and outcomes according to available
standards, indicators and knowledge, and that the treatments offered are
recognised by international medical science in terms of their safety, value and
potential positive clinical outcome.
(b) as regards Specific human structural and equipment resources & organisation,
applicant providers must document:
(i) characteristics of human resources such as type, number, qualifications and
skills;
(ii) characteristics, organisation and functioning of the multidisciplinary healthcare
team or of the centre;
(iii) specific equipment within the centre or easily accessible (such as radiotherapy,
laboratories, hemodynamics) including the capacity, when appropriate, and
based on the area of expertise, to process, manage and exchange information
and images (for example x-ray, laboratories) or clinical samples with external
providers.
NHS European Office
April 2014