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European Commission Initiative on Breast Cancer - ECIBC

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The European Commission (EC), in response to the Council of the European Union's conclusions of 2008 on reducing the burden of cancer and in response to the European Parliament Resolution of 10 April 2008  has initiated a ground-breaking project to set-up and pilot a European Quality Assurance Scheme for Breast Cancer Services underpinned by accreditation (Regulation (EC) No 765/2008 provisions) and in parallel, to develop a new, web-based, version of the European Guidelines for Breast Cancer Screening and Diagnosis.


In December 2012 the European Commission (DG SANCO) assigned these tasks to the Joint Research Centre (JRC). The decision was taken partially in view of the legal constraints imposed by the Financial Regulation, preventing from continuing the renewal of grants for specific services and also taken into account the JRC's independence and experience in carrying out scientific projects.


Built, where possible, on evidence-based guidelines, the quality assurance scheme will cover all aspects from screening, diagnosis, treatment, rehabilitation, and follow-up (including surveillance and, where necessary, management of recurrences).  It will ensure a multi-disciplinary approach and always put the person and patient at the centre of the process.


Due to the fact that the revised guidelines will cover screening and diagnosis, for the other stages of care high quality, evidence-based guidelines will have to be selected for constituting a platform for breast cancer guidelines. The guidelines will provide the recommendations on which specific requirements of the scheme will be based. Therefore, both the new version of the guidelines and the platform are functional pre-conditions for the development and piloting of the European Quality assurance scheme for Breast Cancer Services.


This close link between guidelines and QA scheme is essential to obtain that:

                                   · The scheme's requirements are linked to guidelines recommendations &

                            · The updating and maintenance of guidelines and scheme are appropriately planned and implemented

The QA scheme falls under Regulation (EC) No 765/2008 provisions. It will be a complex structure where different aspects and services need to be encompassed in a unique scheme by applying different and appropriate tools (e.g. ISO / CEN standards) regulating the functioning of direct accreditation (for testing activities), management systems certification and conformity assessment of non-testing activities. The following diagram synthesises the accreditation scheme proposed. To learn more regarding the European legal background of accreditation, please visit the DG ENTR website.


In order to ensure the maximum applicability of the scheme, it will be modular and flexible so to accommodate the diversity in organisational settings of health systems in Europe. The first stage of the work was to build up the knowledge base for the project. In particular, a survey was conducted to map out the situation of breast cancer services in Europe; in addition a review and comparison of existing "certification schemes" — within and beyond the EU — was carried out in order to identify their primary components (such as procedures to obtain the certification, qualifications of external auditors, clinical standards requirements, etc.).


Upon intensive exchange with all stakeholders during bi-lateral meetings and after the two workshops organised in 2013, the general concept of the project was developed. The 2013 version of the document can be downloaded here. A new version, taking into account further inputs from stakeholders and additional practical information on the ECIBC project is under preparation and will be released soon. The concept is anyhow considered a "living" document, therefore any comment and input is welcome all along the project duration.


The next steps for the ECIBC project foresee a Call for Expression of Interest for the members of working groups organised by DG SANCO.


The overall outline of the project is described in the document:



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