From ENERCA to the establishment of a European Reference Network of centres of expertise in Rare Hematolo-gical diseases: potential ethical issues impacting on its implementation

摘要

Due to the scarcity of patients and knowledge, rare diseases, affecting less than 1 in 2000 individuals, are the area in public health in which joint efforts among European Member States is most justified and crucial. The Directive 2011/24/EU on cross border health establishes the creation of European Reference Network (ERN) based on national recognized Centres of Expertise aiming to ensure the same level of access to health services of European citizens affected by a rare disease.Haematological diseases involve a large group of complex rare diseases affecting the normal process of blood cell growth and development. From these, rare anae-mias are leading to chronic complications that severely undermine the quality of life of patients or lead to an early death. EN5RCA, the European Network for Rare and Congenital Anaemias was established in 2002 and recognized by the EC as one of the ten pilots ERNs in 2008 for the tackle of rare anaemias (RAs) by promoting policies leading to reduce inequalities in the medical care across EU. Based on this networking experience, EuroBloodNet proposal was submitted to the first call for interest to establish a ERN launched by the EC last March 2016. The final outcome of EuroBloodNet is to guarantee that European citizens affected by a RHD benefit from the same level of highly specialised care, thereby improving their overall quality of life independently from the patient's country of origin or country of professional practice. In the process of development of an ERN such as EuroBloodNet, one of the main concerns is the legal issues that may arise when establishing cross border health services and ensuring their accessibility across the EU. Crucial fields requiring legal and ethical action have been identified within EuroBloodNet proposal as cornerstone for its success: Patients' rights and access to cross border health services, data protection and safe and security exchange of data, rights and duties of health professionals involved in cross border health services, health services suitable for reimbursement at the Member State level and the need of a pan European framework for the exchange of human samples for diagnosis and research.