Decision 2014/286 - 2014/286/EU: 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 - Main contents

EN

Official Journal of the European Union

L 147/71

Article 12 of Directive 2011/24/EU provides that the Commission is to support the Member States in the development of European Reference Networks (‘Networks’) between healthcare providers and centres of expertise in the Member States, in particular in the area of rare diseases (2). For the purposes of this, the Commission shall adopt a list of specific criteria and conditions that must be fulfilled by European Reference Networks and healthcare providers wishing to join and become a Member of a Network (‘Member’). The Networks should improve access to diagnosis, treatment and the provision of high-quality healthcare to patients who have conditions requiring a particular concentration of resources or expertise, and could also be focal points for medical training and research, information dissemination and evaluation, especially for rare diseases.

According to Article 12(2) of Directive 2011/24/EU, each Network is to select at least three objectives from the list laid down in therein 12(2) of Directive 2011/24/EU and demonstrate that it has the necessary competences to pursue them effectively. In addition, Networks are required to fulfil the list of tasks or characteristics laid down in Article 12(4)(a)(i)-(vi) of Directive 2011/24/EU. This Decision sets out the specific list of criteria or conditions that will ensure the Networks fulfil these tasks. These criteria and conditions should provide the basis for the establishment and evaluation of the Networks.

Among the set of criteria and conditions necessary to enable Networks pursue the applicable objectives of Article 12(2) of Directive 2011/24/EU the Decision provides a list of criteria on the governance and coordination of the Networks that should ensure their transparent and effective functioning. Although Networks should be allowed to have different organisation models, it is appropriate to require that they all choose one of their Members as the coordinating Member. The coordinating Member shall appoint one person acting as the coordinator of the Network (‘Coordinator’). They should be governed by a board of the Network (‘Board’) composed of representatives from each Member in the Network. The Board should be in charge of producing and adopting the rules of procedure, work plans and progress reports and any other documents related to the activities of the Network. The Coordinator, assisted by the Board, should support and facilitate the internal coordination within the Network and with other healthcare providers.

The provision of highly specialised healthcare, one of the criteria to be fulfilled by the Networks, should be based on high quality, accessible and cost-effective healthcare services. It requires experienced, highly skilled and multidisciplinary healthcare teams and, most likely, advanced specialised medical equipment or infrastructures which commonly imply concentration of resources.

Healthcare providers who apply for membership of a Network should demonstrate that they fulfil the criteria and conditions laid down in this Decision. These criteria and conditions should guarantee that the services and healthcare are provided according to the highest possible quality...