Case title: How the European Commission handled concerns about the European Reference Network for Pierre Robin Syndrome

Date: Tuesday, 28 March 2023

Remote meeting (Webex)

Present

Representatives from the European Commission

Head of Unit, Health monitoring and cooperation, Health networks (SANTE.B.3)

Policy Officer (SANTE.C.2)

Legal Assistant (SANTE.C.2),

Deputy Head of Unit (SANTE.B.3)

Jose Valverde Albacete (SANTE.B.3)

Legal Officer (SANTE R2)

Policy officer, Secretariat-General

Representatives from the European Ombudsman

Jennifer King, Legal Expert

Francesca Abbo, Inquiries Officer

Elia Saso, Inquiries Trainee

Purpose of the meeting

The complaint concerns how the European Commission handled concerns raised with it about the European Reference Network (ERN) for Pierre Robin Syndrome, ERN-CRANIO[1]. The purpose of the meeting was for the Ombudsman inquiry team to understand better the structure of governance of ERNs and the existing evaluation and the complaint mechanisms in place and to clarify the Commission’s reply concerning the funding of ERN-CRANIO.

Introduction and procedural information

The Ombudsman inquiry team introduced themselves, thanked the Commission’s representatives for meeting with them and set out the purpose of the meeting. They outlined the legal framework that applies to meetings held by the Ombudsman, in particular, that the Ombudsman would not disclose any information identified by the Commission as confidential, neither to the complainant nor to any other person outside the Ombudsman’s Office, without the Commission’s prior consent.^[2]

The inquiry team explained that they would draw up a report on the meeting that would be shared with the Commission and the complainant. No confidential information would be included in the report or otherwise provided to the complainant or any third party.

Discussion points

1/ General information on the structure and establishment of ERNs

The Commission was invited to provide an introductory overview  on the establishment and functioning of ERNs. The Commission explained that ERNs are networks of health care providers which are highly specialized in different types of complex and/or rare diseases. The first 24 ERNs were established in 2017 and are based on Directive 2011/24/EU,[3] Delegated Decision 2014/286/EU[4] and Implementing Decision 2014/287/EU.[5] These acts comprise the relevant legal framework and set out the conditions and criteria that an ERN and its constituent members must comply with both for the purpose of their establishment and evaluation.

The Commission explained that it mainly has a supporting role regarding the establishment and evaluation of ERNs. The main governing body in this regard is the Board of Member States (BoMS), which is set up by Member States and decides whether or not to approve the establishment and subsequent evaluation of an ERN and its members. The BoMS meets usually two or three times per year unless there is a specific need for an ad hoc meeting. The Commission provides for the Secretariat of the BoMS. It also adopts specific guidelines and policies to support the formation of ERNs, which are then endorsed by the BoMS. The Commission further provides funding to ERNs.

Regarding the establishment of ERNs, the Commission representatives explained that it is necessary to first submit an application to the Commission, who publishes a call for interest. The Commission makes a first review of the applications and appoints an independent evaluation body (IEB) to assess the compliance of the ERNs with a set of established criteria under the Directive and implementing decision. The IEB then submits an assessment report on a proposed ERN to the BoMS, which then decides on the approval or not of the network.

Each ERN is responsible for establishing its own internal rules and government structure, and has a board which is composed of representatives from each healthcare provider member of the network (the ‘board’). The board generally includes representatives of patient organisations. Each ERN establishes specific working groups that work on different topics and issues, such as IT related issues, those related to integrating ERNs into health-care systems of the Member States and issues relating to legal, ethical and stakeholder matters. These working groups then report back to the Board.

There is also an informal body of ERN coordinators from each of the ERNs, which meets regularly as a practical collaborative platform to discuss their activities and share good practices.

2/ The periodic evaluation of ERNs

The Commission explained that all ERNs are subject to a periodic evaluation at least every five years to assess their compliance with the requirements set out in the legal framework, as well as to examine their general performance. This evaluation is triggered by the Coordinator of the individual ERN.

The Commission publishes a call in order to appoint external evaluators. Once it has appointed the evaluators and established an IEB, the IEB carries out an assessment of the activities of each ERNs. This evaluation is based on a manual adopted by the Commission, which provides clear guidance on how to conduct this evaluation procedure.[6]

To carry out its evaluation, the IEB relies on a set of criteria, and examines if the ERN has fulfilled its objectives for which it was constituted and examines the value and/or significance of the actions and projects developed by the ERNs. In this context, all ERNs have to submit a self-evaluation report to the IEB. The IEB can ask for additional information from ERNs if necessary and can examine a sample of deliverables produced by the ERN. It may also carry out on-site audits of ERNs to collect supplementary evidence. The IEB further relies on the report drawn up by the Health and Digital Executive Agency (HaDEA) in the context of the specific grant agreement signed with each ERN, as well as the data collected by the Commission in the context of its annual monitoring exercise of ERNs. The IEB then draws up an evaluation report for each ERN and its members. If it identifies shortcomings in the functioning of an ERN, it may issue recommendations which are addressed to the BoMS, which in turn may require the ERN in question to undertake remedial action to address the shortcomings identified within a specific period. If the ERN does not address the shortcomings identified, the BoMS may adopt a decision to terminate the network.

The Ombudsman inquiry team asked if all ERNs were subject to an on-site-audit. The Commission replied that the BoMS can ask for specific members and/or ERNs to be audited, but generally, the choice of ERN and/or its constituent members that are audited is randomly determined. The ERN coordinator may also ask the IEB to audit specific members of the network. Overall, about 28% of all health care providers of ERNs will be audited but all ERNs and the constituent members will be evaluated in the current cycle.

The Commission explained that the first periodic evaluation of 23 ERNs[7] and more than 900 members was launched in November 2022. The self-assessment phase has been completed and the Commission hopes to conclude the entire process including audits by October 2023. The Commission confirmed that ERN CRANIO, which is the network at issue in the complaint to the Ombudsman, is currently subject to this evaluation procedure and will be audited in this context. The Commission explained that this periodic evaluation will cover the work of ERNs for the period 2017-2022 i.e. for the initial 5 year period since their establishment. It noted that the Clinical Practice Guidelines for Pierre Robin Sequence (‘clinical guidelines’), which are the guidelines at issue in this case, would not fall within the scope of this evaluation procedure as they have not yet been adopted by ERN CRANIO. The Commission in reply to a question from the Ombudsman inquiry team also stated that it has not shared the complaint in this case with the IEB appointed to conduct the assessment. 

The Commission highlighted that the establishment of ERNs is a recent development at EU and Member State level, and that the underlying purpose behind this evaluation is to improve the networks, learn from the experiences gained in this first period of implementation and draw the first conclusions on the operation of this project.

The inquiry team asked whether under the legal framework this periodic evaluation could be triggered before the end of the five year cycle, by any other party for instance if the Commission or the BoMS become aware of a violation of the rules by an ERN or any of its members. The Commission replied that only an ERN coordinator can trigger a re-evaluation of the network but that this can be done at any time.

3/ The annual ‘monitoring exercise’

Regarding the annual ‘monitoring exercise’, the Commission clarified that it does not have a specific legal basis under the framework. The Commission introduced this annual monitoring exercise in order to improve the overall functioning of ERNs and the ERNs have welcomed this approach.

Through the annual monitoring exercise, the Commission asks ERNs to provide data on all the different activities they are involved in. The Commission then collects and aggregates this data and shares it with all ERNs. The purpose of the annual monitoring exercise is not to evaluate individual ERNs nor its members, but rather to provide a general overview of all ERNs and their activities. This annual monitoring exercise is thus of a very different nature than the assessment carried out in the context of the periodic evaluation.

The Ombudsman inquiry team asked if the evaluation of the annual monitoring review is shared with the IEB in the context of the current periodic evaluation. The Commission confirmed that this is the case, but stated that this monitoring exercise is complex and the process has evolved in recent years, hence not all the information collected has been shared with the IEB. The Commission further stated the results of this monitoring exercise are not published.  

4/ HaDEA’s review in the context of grants agreements

The Commission explained that HaDEA’s review in the context of grants agreements signed with ERNs is limited to ensuring that ERNs comply with the provisions of the grant agreement, meaning that the funds provided are used in line with the grant agreement, for specific deliverables. This review is also shared with the IEB as part of the periodic evaluation of an ERN but the Commission clarified that HaDEA does not, however, carry out any qualitative assessment of the work carried out by ERNs.

5/ The available means of redress

The Ombudsman inquiry team asked what are the means of redress available to parties who have concerns relating to the activities or functioning of an ERN or any of its constituent members. The Commission replied that it depends on the nature of the complaint and the competence of each body and institution. If the complainant is a patient, and the issue relates to the treatment received, he/she should seek redress with the relevant health care provider. If the issue concerns the support of HaDEA in the implementation of the grant, or a breach of the applicable legal framework, a complainant could seek redress with the Commission. If the issue concerns the approval or evaluation of a network or its members, this issue may be addressed to the BoMS.

In this case, however, the complaint to the Ombudsman concerns the drafting and procedure in place for the adoption of clinical guidelines by ERN CRANIO. It thus relates to the internal activities of an ERN. In such a case, the Commission said that the issue should be addressed within the board of the ERN. This would also be the case for complaints in relation to the scientific and technical work of ERNs, including the content of clinical guidelines. Such complaints could emanate from experts who feel that their opinion has not been adequately taken into account. The Commission explained that, in such cases, it does not have the knowledge nor the expertise to endorse the scientific findings of ERNs and/ or to review the content of their technical work, including the clinical guidelines. The Commission explained that ERNs should be the bodies with the highest level of scientific expertise in Europe in relation to rare or complex diseases, and should involve the leading experts in the field. The Commission noted that in the EU context there is no superior authority, such as scientific societies, which could review scientific disagreements on matters relating to rare and/or complex diseases.

The Ombudsman inquiry team noted however that in this case, the issue raised by the complainant concerned the legal framework in which the clinical guidelines were being adopted and not solely based on a scientific disagreement.

The Commission explained that in this regard, ERN CRANIO is still working on the clinical guidelines at issue, and, as such, a complaint on how the clinical guidelines are being adopted and their content can only be addressed at a later stage, once the clinical guidelines have been finalised. It stated that is not possible to review something which is still under discussion. The Commission nevertheless noted that ERN CRANIO includes other specialists and patient organisation in its activities, and has a margin of discretion when deciding which experts to involve and how to organise its work. 

The Commission noted that ERN CRANIO did not participate in the 2020 ERN Guidelines Methodological handbook, which aimed to assist ERNs develop, among other things, to draft and develop quality clinical practice guidelines (CPGs).[8]

5/ The role of the BoMS

The Ombudsman inquiry team asked if the BoMS is made up of technical experts. The Commission explained that the BoMS are composed of representative of health ministries in Member States, and are not, as such, technical experts. The Commission stated that the BoMS has access to all reports issued by the IEB on the ERNs, which it assesses and then takes actions on the ERNs accordingly. It is the BoMS that takes all final decisions in relation to establishment and evaluation of the ERNs and their members. The BoMS also assists the Commission in developing specific strategies. In this regard, it recently launched a joint action co-funded by the Commission and Member States to integrate ERNs into national health care systems, with the idea to do the same in the future with patient organisations.

6/ The Grant Agreement and specific funding for the development of clinical guidelines

The Ombudsman inquiry team explained that it was not clear how the Commission had funded the development of clinical guidelines by ERN-CRANIO. In particular, the Ombudsman noted that the Commission said that it did not provide ‘direct funding’ for the development of the clinical guidelines, but then said that it had approved a budget transfer of EUR 50 000 to fund these guidelines.

The Commission clarified that it did provide direct funding for the development of these guidelines but not by means of a specific contract but rather by amending the budget lines within the grant agreement concerned that funds the administrative functioning of the ERN. As such, the Commission simply agreed to re allocate, as requested by ERN CRANIO, a budged that was initially foreseen for travel expenses, to the development of clinical guidelines.

The grant agreement at stake covered the period March 2019 - February 2021. The Commission explained that it had signed a new grant agreement with ERN CRANIO in March 2021, which ended in February 2022. The current grant agreement with ERN CRANIO covers the period 1 March 2022 until the end of August 2023. A new grant agreement with ERN CRANIO has been approved and will last for four years, until 2027.

Conclusion of the meeting

The inquiry team thanked the Commission’s representatives for their time and for the explanations provided, and the meeting ended.

Brussels, 19 April 2023

 

Jennifer King                                                                                                                         Francesca Abbo

Legal Expert                                                                                                                          Inquiries Officer

 

[1] The European Reference Network for rare and/or complex craniofacial anomalies and ear, nose and throat (ENT) disorders

[2] Article 4.8 of the European Ombudsman’s Implementing Provisions.

[3] Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32011L0024

[4] Commission Delegated Decision of 10 March 2014 setting out criteria and conditions that European Reference Networks and healthcare providers wishing to join a European Reference Network must fulfil Text with EEA relevance (2014/286/EU): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014D0286

[5]: Commission Implementing Decision of 10 March 2014 setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks Text with EEA relevance (2014/287/EU): https://eur-lex.europa.eu/legal-content/GA/TXT/?uri=CELEX:32014D0287

[6] ERN evaluation manual: https://www.ern-assessment.com/doc/EN_02_HADEA_2021_OP_0012_Annex_7.4_Evaluation_Manual.pdf.

[7] The Commission explained that whilst 24 ERNs have been established by the BoMS, one of them was only established in 2019 and thus the current evaluation cycle will evaluate only 23 ERNs.

[8] European Reference Network: Clinical practice guidelines and clinical decision support tools programme https://health.ec.europa.eu/publications/european-reference-network-clinical-practice-guidelines-and-clinical-decision-support-tools_en#details