SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Spanish Rare Diseases Registries Research Network - SpainRDR WP-4. LEGAL AND ETHICAL ISSUES María José Carroquino, MPH,Ph.D. Instituto de Investigación de Enfermedades Raras (IIER) Instituto de Salud Carlos III

Analysis of [regional] legal mandates to create/integrate Rare Disease Registries WP2 - Registering activity related methods WP2. T6. Analyzing the current status of ongoing population-based registries in Spain´s Autonomous Regions SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC WP4 - Legal and ethical issues WP4. T17. Analysis of the legal framework of health registries and translating this to RD registries

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Reviewed five existing legal mandates (Autonomous Communities): Andalucía Islas Canarias Castilla la Mancha Extremadura Región de Murcia Summary of contents (legal framework, administrative issues, competences and responsibilities, structure and organization of registry, coordination with other registries, information sources, and data access/provision and security measures for personal data protection Elaborated Guideline Document for the Elaboration of a Legal Mandate to Create Rare Disease Registries Draft Mandate Analysis of [regional] legal mandates to create/integrate Rare Disease Registries

Published (Castilla la Mancha, Valencia, Cataluña, Baleares, Cantabria) Soon to be published (Galicia, Asturias, Castilla y Leon, Pais Vasco, Aragón) Pending ( Extremadura, Andalucia, Murcia, Navarra, Madrid, Canarias) Current status of legal mandates to create/integrate Rare Disease Registries

AUTONOMOUS COMMUNITY PUBLICATION (expected) PENDING PUBLISHED (No modification planned/needed) CataluñaSigned agreement for data access/transfer10/11/2006 MadridPublication date? Comunidad Valenciana4/4/2012 GaliciaPublication date? Castilla y León Draft in progress May 2013 País Vasco Draft in progress July /August 2013 AragónMarch 2013 NavarraApril/May 2013? Current status of legal mandates to create/integrate Rare Disease Registries

Current status of legal mandates to create/integrate Rare Disease Registries AUTONOMOUS COMMUNITY PUBLICATION (expected) PENDING PUBLISHED (No modification planned/needed) Islas Baleares29/1/2013 Principado de AsturiasMarch? NavarraApril/May 2013 Cantabria18/7/2012 La Rioja NO PUBLICATION – DATABASE INCLUDED IN EPIDEMIOLOGICAL SURVEILLANCE SYSTEM Ceuta y MelillaCOMPETENCE OF STATE

AUTONOMOUS COMMUNITY PUBLICATION (expected) PENDING PUBLISHED (No modification planned/needed) Andalucía25/05/2010 Castilla-La Mancha19/01/2012 Islas Canarias18/05/2011 Región de Murcia8/1/2010 Extremadura25/5/2004 Current status of legal mandates to create/integrate Rare Disease Registries

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC National Registry of rare diseases Art. One: Creation of the National Registry of rare diseases. The registry will be integrated into the Health Information System of the National Health System Article Two: Purpose of the National Register of rare diseases. Keeping a national census of patients suffering from a rare disease in order to meet the information needs of these diseases, and to develop and evaluate prevention and health planning activities, and provide information for any other activity that contributes to a better understanding scientific-technical and quality of life of these patients and their families. Draft proposal sent to Ministry of Health Report of predicted economic impact

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC National Registry of rare diseases Article Three. Intended uses. 1.Research on rare diseases 2.Development epidemiological knowledge of these diseases, providing proven validity information on the incidence and prevalence of the same, favoring the analysis of factors associated with the study of its determinants, development, welfare activity, prevention and treatment 3.Development of indicators that enable the comparison of data between the different regions and with other countries. 4.Standardization of the information in accordance with internationally approved standards. 5.Support for the following research activities: a)Collection, processing, integration and analysis of information. b)Conducting periodic reports and publications. Draft proposal sent to Ministry of Health

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Article Four. Body responsible for the National Register of rare diseases. Research Institute for Rare Diseases, Institute of Health Carlos III, Article Five: Collection and processing of data. 1.The collection and processing of data is carried out through the Rare Disease Registry File and Sample Bank, created by SCO/1730/2005 Order of May The health departments of the autonomous communities, through their own record systems will carry out the following activities: a)Collect data of patients diagnosed cases of rare diseases that are seen in the areas of responsibility and report them to the National Register of rare diseases, b)Assist in the validation and verification aspects of information. c)Have a system for information retrieval for health-care, teaching and research purposes d)Tracking active cases. e)Provide the information that is required by the National Registry of rare diseases and facilitate the activities required to perform the registry in order to function properly Compliance with the above activities will fall on the heads of rare disease registries or, where appropriate, on those responsible for patients may request that their personal data and health and / or data associated with biological samples to the administrative body responsible for the National Register, information systems in regional health. 3.………………. National Registry of rare diseases

SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC Article Six: Coordination with other records 1.The National Register of rare diseases will be included, within the communications network of the National Health System, ….. 2.Autonomic Rare Disease Registries will be integrated in the National Register of rare diseases. 3.The National Register of rare diseases will coordinate with similar registries outside of Spain especially those included in the International Consortium agreement Rare Diseases Research Draft proposal sent to Ministry

Thank you very much! SpainRDR - Spanish Rare Diseases Registries Research Network – An initiative of the International Rare Diseases Research Consortium-IRDiRC