At the level of the European Union, the Community action programme on rare diseases (1999-2003) adopted the current definition of rare or rare diseases such as those which, with the risk of death or chronic disability, have a prevalence of less than 5 cases per 10,000 inhabitants.

These diseases are associated with relevant aspects in the lives of people who suffer from them. In most cases, these are chronic and severe disorders that appear in the early ages of life, although some are also in adulthood. All this determines that a health and social interest problem is considered.

The European Union's third multi-annual programme of action in the field of health (2014-2020) provides for rare diseases as a priority objective of their actions, with a specific focus on improving knowledge and to facilitate access to information on these diseases. The Communication from the European Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: "Rare diseases: a challenge for Europe" (COM (2008) 679 final), sets out the Community strategy in this area. field, one of whose fundamental points is to improve the recognition and visibility of these diseases.

The Council Recommendation of 8 June 2009 on an action in the field of rare diseases (2009/C 151/02) entrusts the Member States to ensure that these diseases are codified and appropriate traceability in all health information systems to promote appropriate recognition in national health care systems and to actively contribute to the development of a dynamic inventory of rare diseases the European Union based on the International Classification of Diseases within the respect of national procedures.

The Strategy on Rare Diseases of the National Health System, approved by the Interterritorial Council of the National Health System on June 3, 2009, and updated on June 11, 2014, reflects the need to estimate appropriate mode for the incidence and prevalence of each disease, as well as for improving knowledge on the natural history of rare or rare diseases in order to adapt health care and power actions to better monitor them. One of the objectives of this strategy is to obtain the necessary epidemiological information to enable the development of social, health and research policies.

Law 14/1986, of 25 April, General of Health, provides in its article 23 to the health administrations to create records and to analyze the necessary information for the knowledge of the different situations actions can be derived from the health authority. In the case of these diseases, it is necessary to establish a State Registry of Rare Diseases to facilitate the development of sound epidemiological studies that will allow the most appropriate health policy to be outlined to the problem to be addressed and which are the basis for any proposal for the promotion and protection of health and early detection.

The specific characteristics of rare diseases, such as low prevalence, lack of knowledge of these diseases and their etiopathogenic bases, absence or scarcity of therapeutic options and dispersion of information, make the registration systems key instruments such as health information systems that allow the total number of people affected and the prevalence of each disease to be known, as well as to value their natural history in order to adopt public health and health care decisions and to be able to make a better monitoring of them.

In most of the autonomous communities, there have been, in recent years, records or information systems of rare diseases that have been forming, along with the activities developed from the Institute of Raras Disease Research from the Carlos III Health Institute, the Spanish network of rare disease registries (SpainRDR), so it is necessary to establish regulations that allow for proper collaboration and coordination between them.

While Order SCO/1730 2005, of 31 May, for the creation and deletion of personal data files managed by the Department, regulated the file of the rare disease registry for the purposes of monitoring, Health control and research, modified by Resolution of April 26, 2013 of the Institute of Health Carlos III, the present royal decree proceeds to create and regulate the content and characteristics of the aforementioned registry, as well as the transfer of the required information with the Autonomous Communities.

And it is more, the State Registry of Rare Diseases that is now created is integrated into the Health Information System of the National Health System provided for in Article 53 of Law 16/2003, of 28 May, of cohesion and quality of the National Health System, in order to ensure the availability of information and reciprocal communication between health administrations.

On the basis of the purposes set out in this royal decree, the aforementioned article 53 of Law 16/2003 of 28 May, together with Article 8.1 of Law 14/1986 of 25 April, gives the treatment and the transfer of data provided for in the same legal coverage sufficient for the application of article 7.3 of the Organic Law 15/1999, of 13 December, of Protection of Data of Personal Character, being as required in the same.

This royal decree has been submitted to the Spanish Data Protection Agency, the Autonomous Communities, the cities with Statute of Autonomy, the scientific societies concerned and the organizations of patients. It has also been informed by the Advisory Committee of the Interterritorial Council of the National Health System and the Interterritorial Council of the National Health System.

In its virtue, on the proposal of the Minister of Health, Social Services and Equality, with the prior approval of the Minister of Finance and Public Administrations, in agreement with the State Council, and after deliberation by the Council of Ministers at their meeting on 4 December 2015,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object.

This royal decree is the subject of the creation and regulation of the State Registry of Rare Diseases.

Article 2. Creating the record.

The State Registry of Rare Diseases is created, hereinafter "the register", under the provisions of article 23 of Law 14/1986 of 25 April, General of Health.

Article 3. Nature and purpose of the registration.

The registry, which has an administrative nature, is integrated into the Health Information System of the National Health System provided for in Article 53 of Law 16/2003, of 28 May, of cohesion and quality of the system. National of Health, and aims to:

a) Provide epidemiological information on rare diseases, on the incidence and prevalence of rare diseases, and on their associated determinants.

b) Provide the necessary information to guide the health planning and management and the assessment of preventive and care activities in the field of rare diseases.

c) Provide basic indicators on rare diseases that allow comparison between autonomous communities and with other countries.

Article 4. Competent bodies.

1. The register shall be attached to the Directorate-General for Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality, which shall be the body responsible for the same and the corresponding file.

2. The management of the register may be entrusted to the Carlos III Health Institute, through the Rare Disease Research Institute, in which case it will be responsible for the processing of the data in accordance with the current regulations.

3. The coordination of the state register with the information systems and registers of autonomous diseases and of the cities with Autonomy Statute will correspond to the Directorate General of Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality.

Article 5. Functions of the competent bodies.

1. The body responsible for registration shall be:

(a) Elaborate, in coordination with the bodies responsible for the information systems and registers of rare autonomous diseases and of the cities with Autonomy Statute and, where appropriate, with the organ in charge of the treatment of the data, the manual of registration procedures, as well as approve and modify it, prior to the favorable report of the Interterritorial Council of the National Health System. The manual shall contain all those aspects necessary for the operation of the register.

b) Organize and manage the record.

c) Adopt measures that ensure the confidentiality, security, and integrity of the data contained in the registry.

d) Obtain, debug, integrate, process, analyze, compare and evaluate information on rare disease cases in Spain, normalizing it according to internationally approved guidelines.

e) Perform periodic reports and publications that will contain only dissociated and, if applicable, aggregated information.

f) Collaborate and coordinate in their actions with other systems of information and records of rare autonomic diseases and of cities with Autonomy Statute.

2. The functions listed in paragraphs (b), (c), (d), (e) and (f) of the previous paragraph may be entrusted in accordance with the provisions of Article 4.2.

CHAPTER II

Record characteristics

Article 6. Data model and support.

The registry will be implemented in digital support and its design and structure will ensure that the exchange of data and its processing can be done by electronic means.

Article 7. Contents of the record.

1. The record will collect information of the following type:

a) Identifying character data: name, address, and health card identifier.

b) Socio-demographic data.

c) Clinical-epidemiological data.

2. The definition, definition and content of the data referred to in the previous paragraph shall be laid down in the procedure manual for the registration. These data may be extended and modified, in accordance with the evolution of the needs that may arise, through the approval of the Directorate-General for Public Health, Quality and Innovation, after a favourable report by the Interterritorial Council. of the National Health System, provided that they are accessible and necessary to meet the purpose defined in Article 3.

Article 8. Data communication.

1. In accordance with the provisions of Article 53 of Law 16/2003 of 28 May, the autonomous communities and cities with the Autonomy Statute shall communicate the data referred to in the previous article, which shall be recorded in their respective registers. and information systems, as well as their modifications, in terms that are set out in the registration procedures manual.

2. Data communications shall be made using only electronic means.

3. For this communication of data it is not necessary the consent of its holder, in accordance with the provisions of article 7.3 of the Organic Law 15/1999, of 13 December, of Protection of Personal Data, in relation to the provisions of Article 53 of Law 16/2003 of 28 May and in Article 8.1 of Law 14/1986 of 25 April.

Article 9. Checking the data.

The records of the Autonomous Communities and of the cities with Autonomy Statute shall carry out the validation of the data in their possession, as well as their modifications, before referring them to the State register, according to the manual of procedures in the registry.

CHAPTER III

Access to registration and confidentiality

Article 10. Access to the registry.

1. Access to the data in the register may only be carried out for the purposes set out in Article 3 and shall be carried out using only electronic means.

2. The exchange of data from the register with the institutions of the European Union shall be carried out in accordance with the provisions of the Spanish and Community legislation.

3. For the necessary health care for the patient, the health authorities may access the information contained in the register, including the identification data, in accordance with the provisions of Article 10.5 of the Regulation. the development of the Organic Law 15/1999 of 13 December on the protection of personal data, approved by Royal Decree 1720/2007 of 21 December.

4. In any other case of access to data for the purposes referred to in Article 3, the data shall always be dissociated and in accordance with the provisions of the registration procedures manual.

5. The data holders may exercise the rights of access, rectification, cancellation and opposition in the terms laid down in Organic Law 15/1999 of 13 December, and its implementing regulations. Where the data does not come from the Ministry of Health, Social Services and Equality, requests for the exercise of these rights shall be transferred to the body or entity from which the information is to be processed, communicating the data subject to the data subject. this move.

Article 11. Confidentiality and security measures.

1. The Ministry of Health, Social Services and Equality and, where appropriate, the authorities concerned shall take the necessary measures to ensure that the processing of the data is carried out for the purposes referred to in Article 3.

2. They shall also provide appropriate measures to ensure the security of the processes of dispatch, disposal, custody and exploitation of the information, as provided for in Royal Decree 1720/2007 of 21 December.

3. The information system of the registry will comply with the security measures corresponding to the National Security Scheme provided for in Law 11/2007, of June 22, of electronic access of the citizens to the Public Services and in the Royal Decree 3/2010 of 8 January, which regulates the National Security Scheme in the field of Electronic Administration.

Additional disposition first. No increase in public spending.

The implementation of the State Registry of Rare Diseases shall not entail an increase in budget allocations or personnel expenditure.

Additional provision second. Operation of the State Registry of Rare Diseases.

1. Within the maximum period of 8 months from the entry into force of this royal decree, the manual of procedures for the registration provided for in paragraph (a) of Article 5.1 shall be approved.

2. Within the maximum period of 6 months from the approval of the registration procedures manual, the Autonomous Communities and the cities with Autonomy Statute shall adapt their rare disease records to include and communicate all the data to which they are required pursuant to Article 8.

3. The State Registry of Rare Diseases shall be fully operational within the maximum period of 3 months from the time of the period referred to in the previous paragraph.

Final disposition first. Competence title.

This royal decree is dictated under the jurisdiction that article 149.1.16. of the Spanish Constitution attributes to the State in the field of bases and general coordination of health.

Final disposition second. Enablement for regulatory development.

The holder of the Ministry of Health, Social Services and Equality is empowered to dictate how many provisions are necessary for the implementation and development of what is established in this royal decree and, in particular, to adapt the content of the file called 'Rare disease register and sample bank' created by Order SCO/1730 2005 of 31 May 2005, creating and deleting personal data files managed by the Department.

Final disposition third. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, 4 December 2015.

FELIPE R.

The Minister of Health, Social Services and Equality,

ALFONSO ALONSO ARANEGUI