On the 24th
of March 2015, SIOPE President Prof Gilles Vassal spoke at a European Parliament and Rare Cancers Europe meeting entitled ‘Rare Cancers: Exploiting the Potential of European Reference Networks’. It was the occasion for SIOPE to showcase the specific needs of the paediatric haemato-oncology sector to policy makers in the context of EU initiatives on cross-border healthcare.
EU law on patients' rights in cross-border healthcare (Directive 2011/24/EU) was adopted in March 2011. It includes provisions for developing European Reference Networks for complex or rare medical conditions, or ERNs. The idea behind the ERNs is to enable patients to move freely from one EU Member State to another in order to receive specialised treatment and be reimbursed for it.
In line with its role in implementing EU legislation, the European Commission specified the operational criteria for ERNs and launched pilot projects to apply the concept in 2013 - 2014.
The paediatric haematology oncology community is honoured to have been selected to test the ERN concept through ExPO-r-Net, the European Expert Paediatric Oncology Reference Network for Diagnostics and Treatment. The project is coordinated by CCRI - Children’s Cancer Research Institute Austria, and SIOPE is proud to be the leading partner for the dissemination of this three-year initiative set to pave the way for real-life implementation across Europe. Indeed, the European Commission is expected to launch calls for proposals to establish fully operational European Reference Networks at the end of 2015. Thanks to ExPO-r-Net, paediatric haematology oncology will be ideally positioned to apply as a result of an already advanced structure.
Launched in 2013, the mission of ExPO-r-Net is to build a European Reference Network for Paediatric Oncology (ERN-PO) in line with the EU Cross-Border Healthcare Directive and thereby to reduce inequalities in childhood cancer survival and healthcare capabilities across EU Member States.
In practical terms, the project will deliver, among others, a paediatric oncology reference roadmap that will facilitate access to expert referral sites and tumour advisory boards across Europe. The roadmap will be combined with Information and Communications Technology and e-Health solutions to facilitate movement of knowledge, adding value to or even replacing, the physical transfer of patients.
This way, ExPO-r-Net is set to enable treatment of children and young people with cancer in a Member State other than the Member State of affiliation, and be reimbursed by public and private healthcare providers across the EU, as well as empower patients to choose to be treated at home by accessing expertise remotely.
More information about ExPO-r-Net can be accessed through the project’s website at www.ExPOrNet.eu
Rare Cancer Panorama
All cancers in children are rare but severe, and have distinct characteristics. SIOPE actively engages with the adult rare cancers’ sector to share expertise and build progress together, while consistently ensuring that our distinct voice and messages are heard and effectively tailored to.
Rare Cancers Europe (RCE) is one such valuable partnership where SIOPE is active member, as well as Eurordis which represents rare disease patients. Our Society also engages widely with other organisations and entities to make the most of the SIOPE-led effort for children and young people with cancer.
THE EVENT ‘RARE CANCERS: EXPLOITING THE POTENTIAL OF EUROPEAN REFERENCE NETWORKS’
The event on the 24th
of March 2015 in Brussels, Belgium, was organised by RCE and hosted by Member of the European Parliament Alojz Peterle (EPP, Slovenia). It was the occasion to exchange views on how to make the European Reference Networks operational for rare cancers, and the opportunity for SIOPE to re-iterate the specific needs of our sector.
The host of the meeting, Member of the European Parliament (MEP) Alojz Peterle, is an active supporter of cancer initiatives and prominent long-term leader of the European Parliament interest group ‘MEPs Against Cancer’
(MAC). In the field of childhood cancer, Mr. Peterle hosted the SIOPE annual event at the European Parliament (2011) and is signatory of the Manifesto for the paediatric oncology and haematology
(2014). Other event participants from the European Parliament were: MEP Charles Tannock (ECR, UK and MAC member) and MEP Nessa Childers (S&D, Ireland and MAC member).
Dr. Enrique Terol represented the European Commission Directorate-General for Health as a leader of the ERN file therein. Dr. Terol is a valued partner and interlocutor of CCRI and SIOPE, including in the ExPO-r-Net project.
- Professionals, Patients, Industry
The multi-stakeholder nature of the meeting was driven by active interventions from across the rare cancer spectrum including professionals (SIOPE, EORTC and RCE/ESMO), patients (ECPC, SPAEN, and CML Advocates Network), industry (Novartis), and project representatives (RARECARENet and Make Sense Campaign - EHNS).
For and With the Patients
The significant positive potential of fully functioning European Reference Networks for patients affected by rare and complex diseases was a key point emerging from the roundtable.
Coupling Research and Care
Due to the inherent characteristics of rare cancers, cross-border research has traditionally been of primary importance in the sector. Paediatric cancer is an excellent case illustrating how research progress develops through multi-national cooperation. It is therefore imperative that full advantage is taken of the concentrated settings presented by the European Reference Networks. A clear point was made to avoid dissociating research and care and to develop new forms of research at same time. The need to include population-based cancer registries in the picture was also mentioned.
RARECARENet presented the exercise carried out within the project, namely assembling a vast variety of rare cancers into distinct clinical entities and further into a number families, including one on paediatric cancers. Fully acknowledging the need to cluster rare cancers for the sake of visibility and structuration, SIOPE strongly argues that there are further specificities in the treatment and care of paediatric cancers that require tailored approaches.
Preparing ERN Applications: The ‘When’ and The ‘How’
Dr. Enrique Terol provided instructions and indicative timeline to healthcare providers interested to establish a European Reference Network following the call from the European Commission.
- The European Commission intends to publish the call at the end of 2015;
- Official approval of the submitted ERN applications will be done by the ERN Member States Board, which is already in place;
- The ERN Member States Board approval will be preceded by the technical assessment by Independent Bodies based on the criteria and conditions made available in the Implementing Acts of the European Commission (Delegated Decision and Implementing Decision);
- Once the first ERNs are in place, there is a plan to have an assessment and (re)awarding process/loop granting the official ERN stamp.
|IN BRIEF: Some recommendations for ERN applicants
- Emphasise multi-disciplinarity
- Avoid fragmentation: group diseases as much as possible to maximise capacity
- Identify ‘mature’ providers and type of cancers that would reflect a clear EU value
The Sustainability Question
Clarity appeared to be lacking on long-term funding at both EU and national levels. No provisions on financing are included in current legislation. This aspect was discussed at length by participants, including ideas to possibly use Horizon 2020 to ensure ERN operations. At present, ERN funding and sustainability remain important question marks.
The Role of the EU Institutions
Whereas the European Commission is tasked to support Member States in the development of European Reference Networks and coordinates the process leading to the call for proposals, the European Parliament does not have a defined role in the ERN process.
Scope for National Level Action and Advocacy
Stakeholders could gain from the European Parliament being more involved, as the European Commission has no mandate to call for long-term financing of the networks, which appears an area where solutions are needed. On the other hand, the European Parliament could exercise its power as co-legislator in this regard.
Participants advised that patients should be made aware and involved throughout, including in terms advocating for ERN sustainability at Member State level. Professionals can also advocate to the Member State representative of respective countries, most specifically those part of the ERN Board of Member State representatives.
The Message from SIOPE
SIOPE President, Prof Gilles Vassal, took the floor to deliver a powerful statement on the current state of affairs and the urgent needs in paediatric haemato-oncology.
Despite a possible appearance of a well organised system, our issues are far from solved, said Prof Vassal. Too many children still die of cancer each day, there is a 20 per cent difference in survival rates due to regional inequities across Europe, survivorship follow-up requires structuring, and access to innovative therapies remains a major problem.
Prof Vassal described ExPO-r-Net as an important pilot project where a lot of work is ongoing and underlined that building a European Reference Network is not easy. Still, all project participants are doing their very best. Prof Vassal highlighted in particular the vital importance of cooperation with parents, patients, and survivors – an asset for ExPO-r-Net and indeed all SIOPE activity areas.
On structuring ERNs and grouping diseases, Prof Vassal conveyed that paediatric cancers were not all one family and gave the example of a paediatric brain cancer being fundamentally different from leukaemia. The different paediatric cancer types should therefore be properly addressed by the ERNs, and SIOPE is willing to work together with the adult sector to make progress. Prof Vassal also agreed on the need for the ERNs to include research and integrating research into standard care.
In conclusion, Prof Vassal concluded that SIOPE and the European paediatric haemato-oncology community will be sure to answer the European Commission call to establish an ERN – indeed one or more ERNs - when the announcement comes.
As ExPO-r-Net is continuing to make its important progress, SIOPE is proud to support the project and eagerly awaits new developments at EU level.