Directive 2011 /24/EU of the European Parliament and of the Council of 9 March 2011 on the application of the rights of patients in cross-border healthcare is intended to ensure the mobility of patients patients, establish rules to facilitate their access to safe and high quality healthcare in the European Union, and promote cooperation in the field of health care among Member States, while fully respecting the responsibilities of those in the organisation and provision of such assistance. As soon as the relevant legal instruments are adopted, Directive 2011 /24/EU shall also apply to States Parties to the European Economic Area.

The directive will apply to patients who decide to apply for health care in a Member State other than membership.

The legal basis on which it is supported is twofold. On the one hand, Article 168 of the Treaty on the Functioning of the European Union (TFEU), according to which a high level of protection of human health must be ensured. On the other hand, Article 114 of the TFEU on improving the functioning of the internal market and the free movement of goods, persons and services. For this reason, it is important to note that the health systems of the European Union, constituting an essential component of the high level of social protection, are also part of the wider framework of services of general interest and, therefore, health care is not excluded from the scope of the fundamental principle of the freedom to provide services.

The spirit of the directive is to guarantee the mobility of the patient and to do so makes possible the freedom of choice of the patient and opposes any kind of discrimination based on nationality. All this in line with the consideration of healthcare as a service that always maintains the guarantee of a high level of protection of human health.

An essential aspect of the directive is that its requirements do not constitute a new regulation of health systems or a substantial modification of health systems, even though a new scenario is now being proposed. health care in the European Union. Full respect for the differences in the national health care systems and the responsibilities of the Member States in the organisation and delivery of health services is proclaimed, with the recognition of freedom for structure their own health care and social security systems.

The directive also aims to clarify the relations of the cross-border health care it regulates, with the existing framework for the coordination of social security systems contained in Regulation (EC) No 883/2004. of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems and Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying down the rules Implementing Regulation (EC) No 883/2004 on the coordination of security systems social.

Both instruments broadly coincide in their subjective areas and application objectives. The most notable practical difference is that, according to the directive, patients will anticipate the payments of the received health care which will subsequently be reimbursed according to the cases; whereas in the area of the regulations, there is no this obligation in general. Another notable difference is that the directive applies to all healthcare providers, whether public or private, while regulations coordinate only social security systems.

The core of the directive, together with the guarantees of information and access to safe and high-quality health care, and cooperation in the field of health care among the Member States, is the regulation that the reimbursement of the costs and the prior authorisation of the insured persons. These figures already have their regulation in Regulation (EC) No 883/2004 of 29 April 2004, but with a very different scope and approach.

The assumption of costs arising from cross-border healthcare by the States obliged to do so is limited to the amount which would have been assumed by that State if the health care had been provided in its territory, without exceeding the actual cost of the assistance actually provided. These reimbursement costs shall be fixed, with a transparent calculation procedure, based on objective, non-discriminatory and known criteria in advance.

Only for overriding reasons of general interest may the rules for reimbursement be limited, restricting this to whatever is necessary and proportionate, without constituting a means of random discrimination or an obstacle unjustified to the free movement of persons, goods and services.

In our country, they are entitled to the reimbursement of the costs arising from cross-border healthcare, the insured persons under the Spanish legislation and their beneficiaries, as well as the persons in respect of whom Spain is competent to grant the necessary prior authorisation for a scheduled treatment, in accordance with the Community Social Security Regulations.

The Spanish State, as a Member State of affiliation, guarantees the reimbursement of the expenses to which an insured who has received cross-border healthcare is entitled, being the competent health administration in Spain the obligation to assume such reimbursement. In the regulation of reimbursement of expenses and prior authorization, the option chosen in this royal decree is the most consistent with our National Health System.

The reimbursement of expenses is limited to the health care provided in the common portfolio of services of the National Health System and, where appropriate, the complementary portfolio of the corresponding Autonomous Community. As is logical, the same conditions and formalities would be required to be imposed if healthcare were to be provided on national territory for the corresponding health services allocated.

Free right to the cross-border healthcare option is limited only to a limited number of the spectrum of possible health benefits, which are those subject to prior authorisation. This means a mechanism which, in addition to allowing adequate planning by the competent health authority, provides guarantees to the patient to ensure that he knows in advance whether the health care, and the conditions under which he is requested, would be included in the service portfolio, in order to be reimbursed.

The Spanish State, as a Member State of treatment, has to be responsible and responsible for certain levels of quality and safety in health care, as well as ensuring the existence of (a) to ensure that the information provided by the public and to the Community's citizens is exchanged and to facilitate the exchange of information which ensures continuity of care for both its citizens and the citizens of the Community; general.

This is complemented by a broad information policy, with high levels of transparency, which is concrete in the establishment of the "national contact point", since patients can exercise their right to the right to Cross-border healthcare in practice, it is necessary for them to have adequate information on the essential aspects of the practice.

In terms of the exchange of information on healthcare professionals, information on the right to exercise and the suspension or disablement should be guaranteed.

The directive also incorporates a section dedicated to health cooperation which includes the recognition of prescriptions, European reference networks, rare diseases, eHealth and the assessment of health and safety. Health technologies.

In Spain, Article 43 of the Constitution provides the basic legal health framework that has allowed the establishment of the organizational model that guarantees quality health benefits and makes a catalogue of rights effective. of patients. To this end, Law 14/1986, of 25 April, General of Health, Law 41/2002, of 14 November, basic regulation of the autonomy of the patient and of rights and obligations in the field of information and clinical documentation, Law 44/2003, of 21 In November, the health professions and Law 16/2003, of 28 May, of Cohesion and Quality of the National Health System. These standards and development standards define the catalogue of rights of users of the National Health System, including the safety of patients and the quality of health care.

The new framework of the directive means, in short, an increase in quality and safety guarantees for patient-users, but also the introduction of liberalisation in the sector, which brings an opportunity for a for private health and a challenge for the public health sector, which in any case must respect the essential values of universality, access to high quality health care, equity and solidarity, for patients and citizens irrespective of their Member State of affiliation. The Health Services of the Autonomous Communities will have to deal, on the one hand, with the possible increase of patients coming from other Member States and, on the other, they will have to reimburse the expenses of the members who decide to be cared for another State of the Union.

This royal decree is ordered in twenty-four articles structured in six chapters, seven additional provisions, a transitional provision, five final provisions, and two annexes.

Chapter I contains the general provisions, the subject matter, the scope of application of which long-term care is excluded, the allocation and transplantation of organs, as well as the public vaccination programmes. prejudice to the cooperation between Spain and the other Member States in this field, as well as the applicable definitions.

Chapter II determines the guarantees for access to safe and quality cross-border healthcare, both in relation to citizens whose Member State of affiliation is Spain, who request assistance in another State of the European Union, such as patients whose State of affiliation is another Member State, requesting assistance from public or private providers in our country, through mechanisms such as information, complaints to request repair of any damage, continuity of treatment and protection of privacy with for treatment.

Chapter III refers to information to be provided, accessible and updated, by the national contact point, which is established and regulated in order to provide information to patients whose Member State of affiliation is Spain and patients with another Member State of affiliation who wish to attend in Spain. It also refers to the information to be provided by healthcare providers in our country, regarding their offers of service, accreditation, quality and safety, availability, prices and the necessary guarantees to cover the liability for any damages.

Chapter IV contains provisions on the reimbursement of costs arising from cross-border healthcare, including the general principles for the reimbursement of expenses, the applicable reimbursement rates and the procedure set to perform the same.

Chapter V is dedicated to healthcare that requires prior authorization, including the application procedure and the causes of denial.

Chapter VI refers to cooperation between Spain and the other Member States in the field of health in the following areas: information on health professionals, recognition of prescriptions extended in another State Member, European reference networks, rare diseases, eHealth and assessment of health technologies.

Regarding the exchange of information on healthcare professionals, they are designated competent to report on the right to exercise and the suspension or disablement for the exercise of health professionals, to the Organ of the Ministry of Health, Social Services and Equality, in charge of the organisation and management of the State Register of health professionals, the Health Department of the Autonomous Communities and the General Councils of the schools health professionals, in the field of their competences. In the latter case only when a law establishes, for the professionals, the obligation to be collegiate to practice professional activities or health professions. All this will be done through the Ministry of Health, Social Services and Equality, to ensure the coordination of the information that is sent, and that this is matched with that of the State Register of health professionals.

Certain provisions of Royal Decree 1718/2010 of 17 December 2010 on medical prescription and dispensing orders are amended in order to comply with the provisions of Directive 2011 /24/EU, Commission Implementing Directive 2012 /52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State, of 20 December 2011.

Finally, the annexes contain the documentation for the reimbursement procedure and the health benefits to be submitted to prior authorization.

This royal decree incorporates into national law Directive 2011 /24/EU of the European Parliament and of the Council of 9 March 2011 on the application of the rights of patients in care cross-border health and Commission Implementing Directive 2012 /52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State.

In the process of elaboration of this standard, the autonomous communities and cities of Ceuta and Melilla have been consulted, having submitted to the plenary of the Interterritorial Council of the National Health System and its Advisory Committee. The sectors concerned have been heard and the administrative mutual authorities of civil servants of the State, the armed forces and the staff have been consulted in the service of the administration of justice, as well as under the report of the Spanish Data Protection Agency. The Inter-Ministerial Commission has also been consulted for the study of issues with budgetary significance for the financial balance of the National Health System or significant economic implications.

This royal decree is issued in accordance with the provisions of Article 149.1.16 of the Constitution, which gives the State exclusive competence in the field of bases and general coordination of health. The amendment to Royal Decree 1718/2010 of 17 December 2010 on medical prescription and dispensing orders, which carries out the final provision, is exempted from the foregoing, which is amenable to the state competence to dictate the legislation on pharmaceutical products.

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 Council of State and after deliberation of the Council of Ministers, at their meeting on 7 February 2014,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object.

This royal decree aims to establish rules to facilitate access to safe and high quality cross-border healthcare, as well as to promote cooperation in health care between Spain and Spain. the other Member States of the European Union.

This provision does not affect the rights of patients established by Regulation (EC) No 883/2004 of 29 April 2004 on the coordination of social security systems and by Regulation (EC) No 883/2004. 987/2009 of 16 September 2009 laying down rules for the application of Regulation (EC) No 883/2004. Where the provisions on cross-border healthcare provided for in those Regulations are applicable, this royal decree shall not apply, unless the patient expressly requests their application.

Article 2. Scope.

1. This royal decree shall apply to the provision of cross-border healthcare as defined in Article 3, irrespective of how it is organised, provided and financed.

2. They are excluded from their scope:

(a) Services in the field of long-term care, the purpose of which is to help those who require assistance when performing routine and daily tasks;

b) The allocation of organs and access to organs for transplantation purposes;

(c) Public vaccination programmes against infectious diseases, which have the sole purpose of protecting the health of the population in the Spanish territory and which are subject to specific measures of planning and implementation without prejudice to the cooperation between Spain and the other Member States in the field of the European Union.

3. The provisions of this royal decree will not affect the arrangements for the organisation and funding of healthcare in situations which are not related to cross-border healthcare.

In particular, none of the provisions of this royal decree will require patients to be reimbursed for the costs of healthcare provided by healthcare providers established in the territory. national that are outside the normative framework of planning and rights of the National Health System.

Article 3. Definitions.

For the purposes of this royal decree, it is understood by:

1. 'Health care' means health-related services provided by a healthcare professional to patients to assess, maintain or restore their health status, including the prescription, dispensing and provision of medicinal products, products health and dietary foods for special medical purposes.

2. 'cross-border healthcare' means healthcare provided or prescribed in a Member State other than the Member State of affiliation.

3. "Secured":

(a) According to Article 2 of Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems, persons who are nationals of a Member State, stateless persons or refugees resident in a Member State, who are or have been subject to the legislation of one or more Member States, as well as the members of the family and the survivors of the former, and the survivors of the persons who have been subject to the legislation of one or more Member States, whichever is the nationality of such persons, where such survivors are nationals of one of the Member States or stateless persons or refugees residing in one of the Member States.

All the above, provided that they meet the conditions required by the legislation of the competent Member State under Title II of Regulation (EC) No 883/2004 of 29 April 2004 to be entitled to the benefits of health care.

(b) nationals of a third country who are covered by Council Regulation (EC) No 859/2003 of 14 May 2003 extending the provisions of Regulation (EEC) No 1408/71 and Regulation (EEC) No 1408/71. 574/72 to third-country nationals who, solely on account of their nationality, are not covered by them or by Regulation (EU) No 1231/2010 of the European Parliament and of the Council of 24 November 2010 extending the application of Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009 to third-country nationals who, solely because of their nationality, are not covered by them or meet the conditions of the legislation of the Member State of affiliation in order to be entitled to benefits.

4. "Member State of affiliation":

(a) For the persons referred to in paragraph 3 (a), the Member State which is competent to grant the insured person a prior authorisation to receive appropriate treatment outside the Member State of residence of compliance with Regulation (EC) No 883/2004 of 29 April 2004 and Regulation (EC) No 987/2009 of 16 September 2009.

(b) For persons covered by paragraph 3 (b), the Member State which is competent to grant the insured person a prior authorisation to receive a treatment in another Member State in accordance with Regulation (EC) No 859/2003 of 14 May 2003, or with Regulation (EU) No 1231/2010 of 24 November 2010. If no Member State is competent in accordance with the above Regulations, the Member State of affiliation shall be the one in which the person or the State in which he is entitled to sickness benefits is insured in accordance with the legislation of that Member State.

5. 'Member State of treatment' means the Member State in whose territory the health care is provided to the patient. In the case of telemedicine, healthcare shall be considered to be provided in the Member State where the provider is established.

6. 'competent health administration' means the public health administration which is responsible for the provision of health care to the insured person and, in the case of public funding of medicinal products and medical devices which are included in the pharmaceutical provision of the National Health System, the Ministry of Health, Social Services and Equality.

7. 'health professional' means any person considered as such by the legislation of the Member State of treatment. In the case of Spain, all those with legal capacity to exercise a health profession entitled and regulated, in accordance with the provisions of Law 44/2003, of 21 November, of the Management of the Health professions, and the additional provision seventh of Law 33/2011, of 4 October, General of Public Health.

8. 'Health care provider' means any natural or legal person who is legally providing healthcare in the territory of a Member State. In the case of Spain, the centres, services or health care units and establishments authorised, catalogued and registered according to Royal Decree 1277/2003 of 10 October 2003 laying down the general bases for authorisation of health centres, services and establishments.

9. 'Patient' means any natural person who receives or wishes to receive healthcare in a Member State.

10. 'medicinal product' means, in accordance with Article 8 of Law 29/2006 of 26 July, guarantees and the rational use of medicinal products and medical devices, any substance or combination of substances which is present as a property holder for the treatment or prevention of diseases in humans, or which may be used, or administered to human beings in order to restore, correct or modify physiological functions by exercising pharmacological, immunological or metabolic action; or establish a medical diagnosis.

11. 'Health product' means, in accordance with Article 8 of Law 29/2006 of 26 July, guarantees and the rational use of medicinal products and medical devices, any instrument, device, equipment, software, material or other article; used alone or in combination, including computer software intended by the manufacturer for specific purposes of diagnosis and/or therapy and which are involved in the proper functioning of the software, intended by the manufacturer to be used in human beings For purposes of:

1. Diagnosis, prevention, control, treatment, or relief of a disease,

2. º diagnosis, control, treatment, relief, or compensation for an injury or deficiency,

3. research, replacement or modification of the anatomy or a physiological process,

4. Regulation of conception,

and do not exercise the main action that you want to obtain inside or on the surface of the human body by pharmacological, immunological, or metabolic means, but whose function such media can contribute.

12. 'Prescription' means the document where a treatment with a medicinal product or an extended medical device is prescribed by the person who exercises a regulated health profession, where he is legally entitled to do so in the Member State in which he has been extended. In the case of Spain, the extended by the person who exercises a regulated health profession, where he is legally entitled to do so, in accordance with the provisions of Article 4 of Royal Decree 1837/2008 of 8 November, incorporating the Directive 2005 /36/EC of the European Parliament and of the Council of 7 September 2005 and Council Directive 2006 /100/EC of 20 November 2006 on the recognition of professional qualifications, as follows: as to certain aspects of the exercise of the profession of lawyer.

13. 'Health technologies' means a medicinal product, medical device, or medical or surgical procedures, as well as measures for the prevention, diagnosis or treatment of diseases used in healthcare.

14. "Clinical history or medical history" means a set of documents, whatever their format, containing the data, assessments and information of any kind on the situation and the clinical evolution of a patient throughout the process assistance. In the case of Spain, it is governed by the provisions of Law 41/2002, of 14 November, basic regulation of the autonomy of the patient and of rights and obligations regarding information and clinical documentation.

Article 4. General principles of cross-border healthcare.

cross-border healthcare will be provided in accordance with the rules of the Member State of treatment, including standards and guidelines on quality and safety, and with European Union legislation on of safety standards, taking into account the principles of universality, access to high quality care, equity and solidarity.

Where health care is provided in Spain to patients whose Member State of affiliation is another Member State, the principle of non-discrimination on grounds of nationality shall also apply.

CHAPTER II

Guarantees in relation to cross-border healthcare

Article 5. Healthcare provided in another Member State to patients whose State of affiliation is Spain.

1. Expenditure arising from healthcare provided in another Member State to a patient whose Member State of affiliation is Spain shall be cost-borne by the patient and reimbursement shall be made in accordance with the conditions and requirements laid down in the this royal decree, provided that Regulation (EC) No 883/2004 of 29 April 2004 does not apply, or that, even if so, the patient so requests.

2. The national point of contact under Article 7 shall provide the information necessary to enable patients to exercise their rights to cross-border healthcare, and may also address the national contact point of the Member State of treatment. Access to information on the rights deriving from Regulation (EC) No 883/2004 of 29 April 2004 shall also be provided.

3. In order to promote the continuity of health care, the patient receiving healthcare in another Member State shall be guaranteed:

a) The availability of a copy, in the appropriate support, of the clinical reports, and of the results of diagnostic tests and/or therapeutic procedures, spreading the procedure for their access. From public administrations, electronic access to the clinical documentation shall be promoted through the information systems provided for this purpose by the legal system.

b) Health monitoring in Spain after receiving healthcare, in the same way as if the assistance received in another Member State had been provided in Spain.

c) Cooperation with other Member States in the exchange of timely information to ensure continuity of care. In this respect, Article 23 shall be taken into account in the field of eHealth. In the aforementioned exchange of information, Spain will apply the national, European and international standards of communication of the Electronic Clinical History or its components.

(d) Security guarantees in the processing of data set out in Spanish legislation on the protection of personal data.

Article 6. Healthcare provided in Spain to patients whose Member State of affiliation is another Member State.

Without prejudice to the rights conferred by Regulation (EC) No 883/2004 of 29 April 2004 and Regulation (EC) No 987/2009 of 16 September 2009, patients whose State of affiliation is another Member State have the following guarantees in relation to the healthcare provided to them, in application of this royal decree, in Spain:

1. The information necessary to exercise the right to cross-border healthcare through the national contact point of Spain and healthcare providers shall be provided.

2. Access to established complaint procedures and mechanisms will be provided, in order to request compensation for damages as a result of the healthcare received, in accordance with the Spanish legal order.

3. It will be ensured, in order to promote the continuity of health care:

a) The availability of a copy, in the appropriate support, of the clinical reports, and of the results of diagnostic tests and/or therapeutic procedures to the patient, spreading the procedure for their access. From public administrations, electronic access to the clinical documentation shall be promoted through the information systems provided for this purpose by the legal system.

b) Cooperation with other Member States in the exchange of timely information to ensure continuity of care. In this respect, Article 23 shall be taken into account in the field of electronic health. In the aforementioned exchange of information, Spain will apply the national, European and international standards of communication of the Electronic Clinical History or its components.

(c) The protection of the right to privacy with respect to the processing of personal and health data, in accordance with Organic Law 15/1999 of 13 December, on the protection of personal data, and Law 41/2002, November 14, basic regulation of patient autonomy and rights and obligations regarding information and clinical documentation.

4. The application of the principle of non-discrimination on grounds of nationality, between patients from other Member States and patients whose State of affiliation is Spain.

Without prejudice to the above, the Ministry of Health, Social Services and Equality, after a report of the Interterritorial Council of the National Health System, will be able to establish conditions regarding access to treatment in Spain. of citizens whose State of affiliation is another Member State, where they are necessary and proportionate to ensure sufficient and permanent access to healthcare offered by the Autonomous Health Services. They should also be justified on overriding grounds of general interest, especially the need for planning to ensure a balanced range of high quality treatments, or the willingness to ensure the rational use of the financial, technical and human resources. The measures to be taken will be previously assessed by the European Commission and published by the national contact point so that they can be known in advance by patients from other States.

CHAPTER III

Information about cross-border healthcare

Article 7. National point of contact.

1. In order to provide the necessary information on the subject in this royal decree, a national contact point is established in the Administrative Unit responsible for information to the citizen of the Ministry of Health, Social Services e Equality.

2. The national contact point shall cooperate with the European Commission and with the national contact points of other Member States and shall provide the citizens with the contact details of the contact points of other Member States.

3. The activity of the national contact point will be complemented by the information activity of the units responsible for the Autonomous Communities, the National Institute of Health Management and the mutual societies of officials, in the field of their competencies.

In addition, the national contact point may gather information from patient organisations, professional organisations, private health care providers and insurance bodies and entities. health.

All units, organizations and entities mentioned in the preceding two paragraphs shall provide the national contact point with any information requested for the proper performance of their duties.

4. The national contact point shall provide patients whose Member State of affiliation is Spain and professionals who request information on the rights of patients in relation to the receipt of cross-border healthcare.

In particular, you will report:

a) The conditions for reimbursement of expenses.

(b) The procedures for accessing cross-border healthcare and for determining its scope and content, in particular healthcare requiring prior authorisation, as set out in Annex II, as the information regarding the prior authorization system.

c) The procedures for making claims or seeking damages, when the patient considers that their rights have not been respected, in accordance with the provisions of this royal decree.

(d) The elements which, within the meaning of European legislation, must be included in prescriptions issued in one Member State and provided in another Member State.

Information on cross-border health care will clearly distinguish between the rights recognised in patients under this royal decree and those arising from the Community's coordination regulations. social security systems.

5. The national contact point shall provide patients whose Member State of affiliation is another Member State, information on health care in Spain.

In particular, you will report:

(a) Healthcare providers, including, if requested, information on the right of a specific provider to provide healthcare and potential restrictions in their practice.

(b) The quality and safety standards and guidelines established in Spain, including the provisions on supervision and assessment of healthcare providers, and information on which health care providers are subject to these rules and guidelines.

c) Information on the accessibility of hospitals for people with disabilities.

d) Information on patients ' rights, and procedures for submitting complaints, mechanisms for seeking damages, as well as the legal and administrative options available for resolution for disputes arising from cross-border healthcare, in accordance with the provisions of the Spanish legal order.

(e) Elements which, within the meaning of European legislation, must be included in prescriptions issued in one Member State and provided in another Member State.

6. The information referred to in this article will be easily accessible and will be available on the website of the Ministry of Health, Social Services and Equality, with formats accessible to people with disabilities. This information will be kept up to date.

Article 8. Information to be provided by healthcare providers.

1. The health care provider will provide the citizen, user and patient with information about their location, organization chart, service offer, annual activity, quality indicators of the center, their accreditation or certification regarding quality systems such as the specialised health training system, the Centres, Services and Reference Units, the accreditation systems of the Autonomous Community, quality management systems or certification of standards UNE/CEN/ISO or others.

2. The information on the service offering of the healthcare provider shall include the description of the organisational characteristics of the services and units, the set of health procedures and techniques and the status of the list of waiting.

3. The health care provider shall provide the clarifications and practical assistance that the user demands on: procedure or access procedure, operating hours, documentation or administrative and/or assistance conditions which The patient must be able to access the services included in the offer, conditions of visit and monitoring of the patient and conditions of accessibility for people with disabilities.

4. The information provided by the health care provider shall be specified, at least in Spanish and in the official language of the relevant Autonomous Community, the sole/s in which health care is provided.

5. The health care provider shall, in the areas of access to the health care provider, provide the information, which is always consistent with that of the health authorisation and registration, the type of centre and denomination, and the ratio of units which integrate the approved care offer, according to Royal Decree 1277/2003 of October 10, and the regional regulations governing this matter.

6. The health care provider shall provide the patient with adequate information to enable him to choose, in full knowledge of the case, between treatment options or care alternatives. It will also provide you with information about the known results of these options in general practice and in the centre.

7. The health care provider shall ensure that the patient is provided with a copy of his/her medical history which allows the continuity of care delivery of the treated patients from other Member States and that require monitoring within the scope of cross-border healthcare.

8. The health care provider shall have an up-to-date list of prices available to the public, adapted to its offer of services and shall provide clear information on invoices.

Article 9. Responsibility of healthcare providers.

1. Healthcare professionals working in the field of private healthcare, as well as legal persons or private entities that provide any kind of health services, are required to subscribe to the appropriate liability insurance, a guarantee or other financial guarantee covering compensation which may be derived from any damage to persons caused by the provision of such assistance or services in accordance with the provisions of the Article 46 of Law 44/2003 of 21 November of the Management of Health Professions.

2. In the field of public health care, the liability regime provided for in Title X of Law 30/1992 of 26 November of the Legal Regime of Public Administrations and of the Common Administrative Procedure shall apply. However, the health administration of each Autonomous Community may subscribe to and maintain appropriate insurance contracts, guarantees or financial guarantees, which include both the civil liability of the public health service and its workers, such as the patrimonial responsibility of this.

3. In all cases, the health care provider is obliged to provide the user with the services, when required by him, for the timely information regarding the coverage of his or her professional liability insurance, or other the means of personal or collective protection held by you, in relation to your professional responsibility.

CHAPTER IV

Reimbursement of expenses arising from cross-border healthcare

Article 10. General principles for reimbursement of expenses.

1. Expenditure paid by an insured person whose Member State of affiliation is Spain, which has received cross-border healthcare, shall be reimbursed by the appropriate competent health administration in accordance with Article 14. that health care is included among the benefits to which the insured is entitled according to the common portfolio of services of the National Health System or, where appropriate, the complementary portfolio of the corresponding Autonomous Community, without prejudice to the provisions of Regulation (EC) No 883/2004 of 29 April 2004.

2. By way of derogation from the above paragraph, the reimbursement shall be subject to the following exceptions:

(a) For the holders of a pension and the members of his family residing in Spain, if the health care is borne by a Member State listed in Annex IV to Regulation (EC) No 883/2004 of 29 April 2004, and it has recognised, in accordance with the provisions of that Regulation, the rights to health benefits for such persons, where they are on its territory. In this case, that State shall provide them with health care and shall bear the relevant costs in accordance with their legislation and under the same conditions as if they resided in that Member State.

(b) If the healthcare provided is not subject to prior authorisation as set out in this royal decree, it is not provided in accordance with Regulation (EC) No 883/2004 of 29 April 2004 and is provided in the the territory of the Member State which, pursuant to that Regulation is ultimately responsible for the reimbursement of expenditure, shall be borne by the Member State concerned. That Member State may assume the costs of health care in accordance with the terms, conditions, eligibility criteria and regulatory or administrative formalities it has established.

3. The costs of cross-border healthcare shall be reimbursed by the competent health administration, up to the amount which it would have assumed and on the same terms and conditions as if the healthcare had been provided in national territory for the corresponding assigned services. This reimbursement shall be in accordance with the rates approved by the competent health administration, without exceeding the actual cost of the health care actually provided and without considering the associated costs.

4. The insured person applying for reimbursement of the costs arising from cross-border health care must comply with the same conditions as apply for access to healthcare provided on national territory through the corresponding services assigned.

In the event that healthcare is received in another Member State, it will be necessary, where required in the National Health System, for an ex-ante evaluation to justify the indication of the health care provided. must provide the patient. This evaluation will be carried out by a primary care physician, when performed in Spain. In no case shall these assessments constitute situations of discrimination or obstacles to the free movement of patients, services or goods, except for objective justifications.

5. Reimbursement of the costs of cross-border healthcare shall be subject to prior authorisation in the cases set out in Annex II.

6. Without prejudice to the foregoing, the Ministry of Health, Social Services and Equality, after reporting by the Interterritorial Council of the National Health System, may limit the application of the reimbursement rules for imperative reasons of interest. general, especially the need for planning to ensure a balanced range of high quality treatments, or the willingness to ensure the rational use of financial, technical and human resources. This decision shall be restricted to what is necessary and proportionate without the possibility of constituting a means of arbitrary discrimination or an obstacle to the free movement of persons whose State of affiliation is Spain. The measures taken to this end will be notified to the European Commission in advance.

Article 11. Reimbursement rates applicable to patients whose Member State of affiliation is Spain and who request healthcare in another Member State.

1. A transparent procedure shall be ensured for the calculation of the costs of cross-border healthcare to be reimbursed to the patient whose state of affiliation is Spain, in accordance with the established rules on fees and charges public, taking into account, in addition, the actual cost of assistance.

2. They shall be used as applicable charges for the reimbursement of costs paid in other Member States by patients entitled to it, and in accordance with Article 10.3, the public prices or charges applied for for the provision of approved health services and published by the respective competent health administration. Where no published tariffs are available for the provision of some form of health care, they shall be established by applying objective, non-discriminatory and known criteria in advance.

Article 12. Fees applicable to patients whose State of affiliation is another Member State and who request healthcare in Spain.

Healthcare providers will apply to patients whose State of affiliation is another Member State the same rates that apply to domestic patients in comparable medical situations.

(a) With regard to the health benefits received in centers and services of the National Health System that are subject to billing, the published prices or public prices indicated in the previous article shall apply.

(b) In the event that assistance has been provided by private providers, the fees they have published shall apply.

Article 13. Price and rate advertising.

The pricing and pricing information provided for in this chapter shall be made public by healthcare providers as provided for in Chapter III.

Article 14. Minimum requirements for the reimbursement procedure.

1. The procedure for the reimbursement of expenses shall be that laid down by the competent authorities.

2. The request for reimbursement shall be addressed to the body assigned to that effect by the competent health administration, within a maximum period of three months from the date of payment of the assistance received and shall be in accordance with the format laid down to the effect.

3. The application for reimbursement shall be accompanied, at least, by the documents listed in Annex I, in order to facilitate the assessment of the origin and the amount of the reimbursement of the actual cost of the health service.

4. The competent authority shall carry out the necessary checks to determine the right to reimbursement, the fulfilment of the conditions under which the prior authorisation was granted, and the amount of the corresponding, according to the applicable rates in each case.

5. After the procedure has been completed, a reasoned decision shall be made to notify the person concerned, in accordance with the provisions of Law No 30/1992, of 26 November.

6. The maximum period for the notification of the resolution of the reimbursement procedure shall be three months from the date of receipt of the request by the competent health authority.

7. After the deadline without any express resolution, the application for administrative silence may be understood to be estimated, in accordance with the terms of Article 43 of Law 30/1992 of 26 November.

CHAPTER V

Healthcare that requires prior authorization

Article 15. Prior authorization.

1. The provision of cross-border healthcare for the techniques or procedures listed in Annex II shall be subject to the prior authorisation by the authorities for the reimbursement of expenditure under this royal decree. competent in the Autonomous Community where the insured person is domiciled, by the National Institute of Health Management or by the mutual staff of officials who, where appropriate, corresponds.

2. The plenary session of the Interterritorial Council of the National Health System will report favourably on the proposal for common criteria, agreed by the Commission on Benefits, Assurance and Financing, to be applied by all Autonomous Communities, National Institute of Health Management and mutual civil servants to carry out the prior authorizations provided for in this article.

Article 16. Minimum requirements for the prior authorization procedure.

1. The procedure for prior authorisation shall be the procedure laid down by the competent health authorities. The application shall be addressed to the body assigned by it, and shall conform to the format established for that purpose.

2. The competent health administration shall check whether the conditions laid down in Article 20 of Regulation (EC) No 883/2004 of 29 April 2004 are met. If those conditions are met, it shall grant the prior authorisation in accordance with the provisions of that Regulation, unless the patient chooses to apply the provisions of this royal decree. In order to facilitate this choice, the consequences arising from the application of the two options should be reported.

3. After the procedure has been completed, a reasoned decision shall be made to notify the person concerned, in accordance with the provisions of Law No 30/1992, of 26 November.

4. The maximum period for the notification of the decision to grant or, where appropriate, refusal of the prior authorisation shall be 45 days from the date of receipt of the application by the competent health authority. Without prejudice to the foregoing, the competent health authority shall take into account the specific condition, urgency and individual circumstances of the patient, when assessing a request for cross-border healthcare.

5. After the deadline without any express resolution, the application for administrative silence may be understood to be estimated, in accordance with the terms of Article 43 of Law 30/1992 of 26 November.

Article 17. Grounds for refusal of prior authorization.

The competent health administration may refuse prior authorisation in the following cases:

(a) In the case of a benefit not included in the common portfolio of services of the National Health System or, as the case may be, the supplementary portfolio of the corresponding Autonomous Community, or does not meet the conditions under which is provided.

(b) Where there is a reasonable degree of certainty that the patient, according to a clinical assessment, is to be exposed to a risk that cannot be considered acceptable, taking into account the evidence of the potential benefit that may be obtain from the requested cross-border healthcare.

(c) Where there is a reasonable degree of certainty that the general population may be exposed to a substantial risk as a result of the cross-border healthcare considered.

d) When the benefit is to be provided by a healthcare provider that raises serious and specific concerns about the patient's quality and safety standards and guidelines.

e) When health care can be provided on the national territory within a period that is medically justifiable.

In order to decide which time limit is considered medically justifiable, an individualized clinical evaluation will be performed that will take into account the health status of each patient, the possible evolution of their disease, the degree of pain that suffer or the nature of your disability at the time the application for authorisation was made.

Additionally, account will be taken of the deadlines set out in Royal Decree 1039/2011 of 15 July establishing the framework criteria to guarantee maximum access to the health benefits of the National Health System and the standards of guarantee of waiting times in force in each Autonomous Community.

CHAPTER VI

Healthcare cooperation

Article 18. Mutual assistance and cooperation.

1. Spain will cooperate with other Member States to facilitate the delivery of cross-border healthcare and will collaborate in the areas identified in this chapter.

2. Mutual assistance shall include cooperation with regard to standards and guidelines on quality and safety and the exchange of information.

Article 19. Exchange of information on healthcare professionals.

1. For the purposes of cross-border healthcare, they shall be competent authorities to inform public administrations of other Member States so request of the right to exercise and of suspension or disablement for the financial year of healthcare professionals with a university degree or a specialist in health sciences:

(a) The administrative body responsible for the State Register of Healthcare Professionals, regulated in the additional provision of Law 16/2003, of 28 May, of the cohesion and quality of the National Health System.

(b) The Ministry of Health of the Autonomous Communities in the field of their competences. In this case it will be answered through the Ministry of Health, Social Services and Equality, who will coordinate the information that is sent.

(c) The General Councils of the health professional colleges in the field of their competence, where a law establishes the obligation to be collegial for the exercise of professional activities or health professions. In this case it will be answered through the Ministry of Health, Social Services and Equality, who will coordinate the information that is sent.

2. The response to requests for information shall be made through the Internal Market Information System in accordance with the provisions of Regulation 1024/2012 of the European Parliament and of the Council of 25 October 2012 on the administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008 /49/EC ("IMI Regulation").

Article 20. Recognition of prescriptions issued in another Member State.

1. Prescriptions for medicinal products for human use manufactured industrially, the marketing of which has been authorised by the Spanish Agency for Medicinal Products and Sanitary Products, or authorised in accordance with Regulation (EC) No 726/2004 of the European Parliament and the Council of 31 March 2004 laying down Community procedures for the authorisation and control of medicinal products for human and veterinary use and establishing a European Agency for Medicinal Products, extended in another Member State in the name of a given patient may be dispensed in accordance with the provided for in Law 29/2006 of 26 July on the guarantees and rational use of medicinal products and medical devices and Royal Decree 1718/2010 of 17 December 2010 on medical prescription and dispensing orders.

2. Any restrictions on their recognition of the prescriptions referred to in the previous paragraph shall be prohibited unless this restriction:

a) Be limited to what is necessary and proportionate to protect human health and is non-discriminatory.

b) Based on legitimate and justified doubts about the authenticity, content or intelligibility of a particular recipe.

3. The recognition of such prescriptions shall be without prejudice to national rules on the prescription and dispensing of medicinal products, including generic medicinal products or other substitutes. The recognition of prescriptions will not affect the rules on public funding of medicines. The reimbursement of the costs of medicines included in the pharmaceutical provision of the National Health System will be governed by the provisions of this royal decree.

4. When a prescription is extended in another Member State for medicines and medical devices available in Spain, and the dispensation is requested in Spain, all necessary measures will be taken in addition to the recognition of the prescription, to ensure the continuity of treatment.

5. The provisions of the above paragraphs shall not apply to medicinal products subject to a special medical prescription.

6. The provisions of this Article shall also apply to medical devices which are lawfully placed on the market in Spain.

Article 21. European Reference Networks.

The Ministry of Health, Social Services and Equality, after agreement of the Interterritorial Council of the National Health System, on the proposal of the Committee for the designation of centers, services and reference units dependent on This Council shall establish the appropriate procedure for the services and reference units of the National Health System designated in accordance with the procedure laid down in Royal Decree 1302/2006 of 10 November 2006, to be establish the basis of the procedure for the designation and accreditation of the centres; services and reference units of the National Health System, prior to the report of the aforementioned Committee, may belong or collaborate with the European reference networks, once the European Commission has published the implementing acts of these.

Article 22. Information on Rare Diseases.

1. In order to develop the diagnostic and treatment capabilities of rare diseases, as well as to facilitate their knowledge, the Ministry of Health, Social Services and Equality will offer:

a) To healthcare professionals: the information available on existing tools in Spain and in the European Union to facilitate clinical practice in rare diseases such as the Centers, Services and Units Reference of the Spanish National Health System and the European Reference Networks related to these diseases.

b) To patients: information on existing tools such as the Centers, Services and Reference Units of the Spanish National Health System and the European Reference Networks related to these diseases.

2. Information will be provided to patients, healthcare professionals and funders of health care on the possibilities offered by Regulation (EC) No 883/2004 of 29 April 2004 for the referral of patients with rare diseases to other Member States, for diagnoses and treatments that are not available in Spain.

Article 23. European electronic health network.

1. In order to promote cooperation and exchange of information with other Member States, Spain will be part of the European electronic health network, as set out in Commission Decision 2011 /890/EU of 22 December 2011, by the European Commission. laying down the rules for the establishment, management and operation of the network of national authorities responsible for electronic health.

2. The Ministry of Health, Social Services and Equality shall designate the national authority responsible for eHealth, communicating it to the European Commission.

3. This network shall connect the designated national authority to the national authorities responsible for eHealth in the different Member States.

4. The national authority responsible for eHealth shall have as reporting principles those set out in Royal Decree 4/2010 of 8 January, which regulates the National Interoperability Scheme in the field of administration Electronic collection of the principles adopted by the European Interoperability Strategy and the European Interoperability Framework.

5. The national authority responsible for eHealth within the National Health System shall observe the achievement of the objectives of the European electronic health network with respect to and compliance with existing legislation on protection data and patient autonomy.

Article 24. European network for the assessment of health technologies.

1. The Ministry of Health, Social Services and Equality will participate in the European Health Technology Assessment Network, through which the European Union will facilitate cooperation, communication and the exchange of scientific information. between Member States.

2. The agencies or units of the Spanish Network of Health Technology Assessment Agencies and benefits of the National Health System will participate in the activities of the European Network, in accordance with the rules of procedure of that European network.

3. The Council of the Spanish Network of Health Technology Assessment Agencies and the National Health System, will assess the nature and conclusions of the work carried out within the European Network, and will decide on the possibility of their adaptation and incorporation in the lines of work of the Spanish Network.

Additional disposition first. Application to the National Institute of Health Management.

The references that this royal decree makes to the Autonomous Communities will apply to the National Institute of Health Management (INGESA) attached to the Ministry of Health, Social Services and Equality, in the cases that are under the scope of the Directive, with the powers conferred on them in the field of health care in the cities of Ceuta and Melilla.

Additional provision second. Relationship to other provisions.

This royal decree shall apply without prejudice to the following provisions:

(a) Royal Decree 1030/2006 of 15 September establishing the common service portfolio of the national health system and the procedure for updating it.

(b) Royal Decree 271/1990 of 23 February 1990 on the reorganisation of the intervention price of medicinal products for human use.

(c) Royal Decree 1616/2009 of 26 October on the regulation of active implantable medical devices, Royal Decree 1591/2009 of 16 October 2009 on health products and Royal Decree 1662/2000 of 29 July 2009 on the September, on "in vitro" diagnostic medical devices.

d) Organic Law 15/1999 of 13 December on the protection of personal data.

e) Law 45/1999 of 29 November on the posting of workers in the framework of the provision of transnational services.

(f) Law 34/2002 of 11 July on services of the information society and electronic commerce.

(g) Chapter III of Title II of Law 62/2003 of 30 December of fiscal, administrative and social order measures laying down measures for the implementation of the principle of equal treatment.

h) Royal Decree 223/2004 of 6 February on the regulation of clinical trials with medicinal products.

(i) Royal Decree 1345/2007 of 11 October 2007 regulating the procedure for the authorisation, registration and the conditions for the supply of medicinal products for human use manufactured industrially and Royal Decree 577/2013, of 26 June July, for which the pharmacovigilance of medicinal products for human use is regulated.

j) Royal Decree 1088/2005 of 16 September laying down the technical requirements and minimum conditions for blood donation and transfusion centres and services.

(k) Council Regulation (EC) No 859/2003 of 14 May 2003 extending the provisions of Regulation (EEC) and Regulation (EEC) No 574/72 to nationals of third countries who, owing solely to their nationality, are not covered by them.

l) Royal Decree 1301/2006 of 10 November laying down quality and safety standards for the donation, procurement, evaluation, procedure, preservation, storage and distribution of cells and human tissues and the standards of coordination and operation are approved for use in humans.

(m) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and control of medicinal products for human and veterinary use and the creation of the European Medicines Agency.

(n) Regulation (EC) No 883/2004 of 29 April 2004 and Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying down rules for the application of Regulation (EC) No 883/2004 883/2004, on the coordination of social security systems.

(n) Royal Decree 1837/2008 of 8 November transposing Directive 2005/36 of the European Parliament and of the Council of 7 September 2005 and Directive 2006 /100/EC of the European Parliament and of the Council into the Spanish legal system 20 November 2006, concerning the recognition of professional qualifications, as well as certain aspects of the exercise of the profession of lawyer.

(o) Regulation (EC) No 1082/2006 of the European Parliament and of the Council of 5 July 2006 on the European Grouping of Territorial Cooperation (EGTC).

p) Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and safety at work.

(q) Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I), Regulation (EC) No 864/2007, concerning the law applicable to non-contractual obligations (Rome II) and other rules of the Union under private international law, in particular rules concerning jurisdiction of the courts and applicable law.

r) Royal Decree 1723/2012 of 28 December 2012 regulating the activities of obtaining, clinical use and territorial coordination of human organs intended for transplantation and establishing quality and quality requirements security.

s) Regulation (EU) No 1231/2010 of the European Parliament and of the Council of 24 November 2010 extending the application of Regulation (EC) No 883/2004 and Regulation No 987/2009 to third-country nationals which, due solely to their nationality, are not covered by them.

Additional provision third. Cross-border healthcare in special schemes of civil servants.

1. The Autonomous Communities and the INGESA shall be the competent authorities in the procedures relating to the cross-border health care of persons who are the holders or beneficiaries of special social security schemes. managed by the mutual societies of officials who have been assigned to their corresponding health services by the established procedure.

2. For persons covered by such mutual societies who have chosen to receive health care through other forms, the respective mutual benefit, as the competent administration, shall establish in the specific legal instruments the form and the management procedure to make effective the right to cross-border healthcare, in the terms stipulated in this royal decree, as well as the applicable rates for reimbursement.

Additional provision fourth. Information to be supplied to the European Union.

1. The Ministry of Health, Social Services and Equality shall provide appropriate assistance and provide the European Commission with the information available for the preparation of the reports to be carried out by the European Commission in accordance with the regulations. (a) the Community and respecting security guarantees in the processing of personal data established in Spanish legislation.

2. For the purposes of complying with the obligation referred to in the previous paragraph, the regional health services of the Autonomous Communities, the National Institute of Health Management and the various Mutual Funds of officials shall provide (a) the Ministry of Health and the Ministry of Health, the Ministry of Health and the Ministry of Health, the Ministry of Health and the Ministry of Health and the Ministry of Health and the Health of the Member States. costs of cross-border healthcare.

Additional provision fifth. Analysis, evaluation of your application and update of this royal decree.

1. The Interterritorial Council of the National Health System, through the Commission on benefits, insurance and financing, will analyze during the first year after the entry into force of this royal decree, and subsequently with the periodicity that determine, the patient flows, the financial and organisational aspects of patient mobility, the application of the procedures for reimbursement and prior authorisation and the type of benefits requested in relation to the assistance cross-border healthcare, assessing the evolution of these factors, in order to ensure that introduce the elements of improvement in the guarantee of patients ' rights in the framework of this royal decree.

2. The Commission for benefits, insurance and financing shall also analyse the type of benefits subject to prior authorisation and, depending on the outcome of its analysis, the updating of those included in the Annex II in the terms provided for in the fourth final provision.

Additional provision sixth. No increase in public spending.

The measures included in this rule may not result in an increase in appropriations or remuneration or other personnel costs.

Additional provision seventh. Implementation of the European Economic Area.

All forecasts made in this royal decree regarding cross-border healthcare in the Member States of the European Union shall be construed as applying to States Parties to the Agreement on Space European Economic, as soon as the corresponding legal instruments are adopted.

Single transient arrangement. Coexistence of recipe models and dispensing orders.

As of the entry into force of this royal decree, during the 12-month period, medical prescriptions may coexist, and orders for hospital dispensation that comply with the provisions of this royal decree with those in force in the time of publication. After the expiry of the said period, only medical prescriptions, and orders for hospital dispensation, which are adapted to the provisions of this standard, shall be valid.

However, the medical prescriptions extended for dispensing in another EU Member State will be in accordance with the provisions of this royal decree, from the moment of its entry into force.

Final disposition first. Amendment of Royal Decree 1718/2010, of December 17, on medical prescription and dispensing orders.

Royal Decree 1718/2010, of December 17, is amended as follows:

One. Article 3 is worded as follows:

" Article 3. Common formats and data for medical prescriptions.

1. Medical prescriptions, public or private, may be issued on paper, for manual or computerised fulfillment, and in electronic support, and must be supplemented by a patient information sheet, which is required to be delivered to the patient. the information on the treatment necessary to facilitate the proper use of the prescribed medicinal products or medical devices shall be collected.

2. The prescriber shall record in the prescription and in the patient information sheet the basic mandatory data, which are essential for the validity of the medical prescription, as follows:

a) Patient data:

1. º The name, two surnames, and date of birth.

2. In medical prescriptions for public health assistance, the patient's personal identification code, collected on his/her individual health card, assigned by his/her Health Service or by the competent authorities of the special health care schemes. In the case of foreign nationals who do not have the said card, the code assigned on their European health card or their temporary replacement certificate (PSC) or the European form of entitlement to assistance shall be entered in the or the passport number for foreigners from non-EU countries. In any case, the system of contribution corresponding to the patient must also be entered.

3. In the medical prescriptions of private healthcare, the number of DNI or NIE of the patient. In the event that the patient does not have such documentation, the identity card or NIE of any parent or, where applicable, of the legal representative, and for foreign nationals, the passport number shall be entered in the case of minors.

b) Drug data:

1. º Denomination of the active/s/s.

2. The name of the medicinal product if it is a biological medicinal product or the prescriber health professional considers it necessary from a medical point of view, in accordance with the provisions of Law 29/2006 of 26 The Commission has also adopted a new strategy for the European Community. In such a case, the use of the trade name shall be briefly justified in the recipe.

3. Dosification and pharmaceutical form and, where appropriate, the mention of the recipients: infants, children, adults.

4. Path or method of administration, if necessary.

5. Format: Number of units per pack or content of the same by weight or volume.

6. Number of containers or number of specific units of the drug to be dispensed.

7. Posology: number of units of administration per intake, frequency of doses (per day, week, month) and total duration of treatment.

The data referred to in the headings 5. and 6. º shall only be required to be recorded in the medical prescriptions issued on paper. Medical prescriptions issued in electronic form shall only be filled in by the prescriber when the electronic system does not automatically generate them.

c) Prescriber data:

1. º The name and two surnames.

2. ° Direct contact data (email and telephone or fax, these with the international prefix).

3. Professional address, including the population and the name of Spain. The reference to institutions or public bodies may only appear in the official medical prescriptions of such establishments.

4. Professional Qualification.

5. º Number of collegiate or, in the case of medical prescriptions of the National Health System, the identification code assigned by the competent administrations and, where appropriate, the officially accredited specialty that it exercises.

In the medical prescriptions of the Military Health Network of the Armed Forces, instead of the number of the collegiate, the number of the Military Card of Identity of the optional can be entered. It shall also include, where appropriate, the officially accredited specialty it exercises.

6. The signature will be stamped personally once the mandatory consignment data and the prescription object of the prescription are completed. Electronic signatures shall be required for electronic signatures, which shall be produced in accordance with the criteria laid down by Law 11/2007 of 22 June of electronic access of citizens to public services.

In the prescriptions of the National Health System, the data of the prescriber, referred to in the headings 3. º and 5. º may also be recorded in such a way as to allow the mechanization of said data by the health services and the mutual civil servants.

d) Other data:

1. º The date of prescription (day, month, year): date of the day on which the prescription is filled.

2. º The expected date of dispensing (day, month, year): date from which the prescription is to be dispensed, in the case of successive waivers of chronic treatments or renewable dispensing drugs.

3. º No. of order: Number indicating the order of prescription dispensing, in the case of successive waivers of chronic treatments or renewable dispensing drugs.

The data referred to in the headings 2. º and 3. º shall only be required to be recorded in the medical prescriptions on paper.

In addition to the data indicated in the above headings, if necessary, the visa must be entered by the health authorities, in accordance with Royal Decree 618/2007 of 11 May, which regulates the procedure for the establishment, by means of a visa, of special reservations concerning the conditions for the prescription and dispensing of medicinal products. In the case of electronic prescriptions, the visa shall be in the form provided for in Article 8.7 of this royal decree.

In the medical prescriptions on paper paper and in the patient information sheet for the electronic prescription case, a clause will be included that informs the patient in the terms established in the Organic Law 15/1999, 13 of December, personal data protection.

3. The information sheet for the patient shall be differentiated from the prescription and may be separable from the prescription, or constitute an independent form, where the prescriber may relate all prescribed medicinal products and medical devices, providing the patient with complete treatment information and diagnosis, if appropriate, in the prescriber's judgment.

4. All the particulars and instructions given in the medical prescription must be clearly legible, without prejudice to their possible additional coding with optical characters. Medical prescriptions shall not submit amendments or cross-cuts in the mandatory consignment data unless they have been saved by the new signature of the prescriber. '

Two. Article 5 (1) is worded as follows:

" 1. The official medical prescriptions used in the pharmaceutical provision of the National Health System shall be prescribed by the authorized healthcare professionals, in the exercise of their functions, within the scope of the National Health System, and shall be comply with the provisions of this royal decree, with the specifications contained in this chapter and the requirements which the competent health authorities introduce in the framework of their powers.

Official recipes will be adapted to the following basic criteria of differentiation according to the acronym or classification code in the individual health card database, which will be Alphanumeric printed or coded at the top right of the recipes according to the following scheme:

a) TSI Code 001 for users exempt from input.

b) TSI 002 code for users with reduced input of 10%.

c) TSI code 003 for users with input of 40%.

d) TSI 004 code for users with 50% input.

e) TSI Code 005 for users with input of 60%.

(f) TSI code 006 for users of mutual civil servants with a contribution of 30%.

g) ATEP for work accident or occupational disease prescriptions.

h) NOFIN for prescriptions for unfunded medicines and medical devices.

(i) DAST for prescriptions for medicinal products and medical devices prescribed for users within the framework of the implementation of Directive 2011 /24/EU of the European Parliament and of the Council of 9 March 2011 on the application of Patients ' rights in cross-border healthcare: users must pay the full amount. "

Three. A new Article 15a is added which will have the following wording:

" Article 15a. Dispensing of prescriptions issued in another Member State of the European Union.

1. Prescriptions for medicinal products for human use manufactured industrially the marketing of which has been authorised by the Spanish Agency for Medicinal Products and Sanitary Products, or authorised in accordance with Regulation (EC) No 726/2004 of the European Parliament and the Council of 31 March 2004 laying down Community procedures for the authorisation and control of medicinal products for human and veterinary use and establishing a European Medicines Agency, extended in another State Member on behalf of a given patient may be dispensed in accordance with the provisions In Law 29/2006 of 26 July, guarantees and the rational use of medicinal products and medical devices, in the field of prescription and dispensing of medicinal products.

2. For these purposes, the elements that must be included in the recipe are as follows:

a) Patient identification: Last name (s), name (in extensive, not only initials) and date of birth

b) Recipe authentication: Date of issue

c) Identification of prescriber health professional: Last name (s), name (in extensive, not only initials), professional qualification, direct contact details (email and telephone or fax, these with the prefix international), professional address (and Member State), and signature (written or digital, according to the means chosen to issue the prescription)

(d) Identification of the medicinal product or product: Common name, as defined in Article 1 of Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 establishing a code (a) Community medicinal products for human use; trade mark in the case of a biological medicinal product or the prescriber health professional considers it necessary from a medical point of view and, in such a case, the prescription shall be justified briefly use of the trade name, pharmaceutical form, quantity, dose, as defined in Article 1 of Directive 2001 /83/EC of 6 November 2001 and a dosing schedule.

3. Recognition of the prescription shall not affect the right of the pharmacist to refuse, for ethical reasons, to dispense the prescribed medicinal product in another Member State where reasonable doubts arise as to the authenticity or validity of the prescription submitted, except that you can check the legitimacy of the prescription.

4. The provisions of the above paragraphs shall not apply to medicinal products subject to a special medical prescription.

5. The provisions of this Article shall also apply to medical devices which are lawfully placed on the market in Spain. "

Four. The Annex is replaced, which is worded as follows:

" ANNEX

Basic criteria for medical prescriptions and dispensing orders

First. Official Medical Recipe of the National System of Health and the Mutualities of Officials.

The official medical prescriptions to be used for the pharmaceutical provision of the National Health System including those of the Mutualities of Officials, prescriptions for medicinal products and medical devices prescribed to users in application of cross-border healthcare, as well as those for unfunded medicines, shall be adapted to the common characteristics set out in this Annex.

1. In the upper left corner of the models incorporated in this annex, the identity of the competent authority or body issuing the prescription and the right upper corner of the "National Health System" shall be stated.

The dimensions of the spaces for each of the data to be included in the recipe will be adapted to the editing or printing requirements that the Health Administrations establish.

2. Technical specifications of the medical recipe models.

a) Approximate dimensions: 22 by 12 centimeters.

b) The official recipes will be adapted to the following basic criteria of differentiation:

As referred to in point 1, the name of the Management Entity or the Agency issuing the prescription shall be entered in the space for Administration or Competent Body.

In the space for "Contingency", the acronym or classification code shall be entered in the individual health card database, which shall be either alphanumeric printed or coded according to the following: schema:

a) TSI Code 001 for users exempt from input.

b) TSI 002 code for users with input of 10%.

c) TSI code 003 for users with input of 40%.

d) TSI 004 code for users with 50% input.

e) TSI Code 005 for users with input of 60%.

(f) TSI code 006 for users of mutual civil servants with a contribution of 30%.

g) ATEP for work accident or occupational disease prescriptions.

h) NOFIN for prescriptions for unfunded medicines and medical devices.

(i) DAST for prescriptions for medicinal products and medical devices prescribed for users within the framework of the implementation of Directive 2011 /24/EU of the European Parliament and of the Council of 9 March 2011 on the application of Patients ' rights in cross-border healthcare: users must pay the full amount.

In the space for "Use Regime", for the Recipes of the Mutualities of Officials the condition of mutualist will be recorded.

The "Recipe Code" space will be reserved for the coded identification of the recipe.

The "Pharmacist and Visa Information" space, will be reserved for the information that the prescriber considers to transfer to the pharmacist, and if required, to his/her entry.

(c) In the case of work accident or occupational disease prescriptions, the data corresponding to the name and address of the Company shall be further specified following the data relating to the prescriber and the date prescription.

(d) In prescriptions for unfunded medicinal products and prescriptions for medicinal products and medical devices prescribed for users in application of cross-border healthcare, the following caption shall be stated: " Not valid for: invoicing '. Spaces reserved for sealed or assimilated coupons shall not be included in the document, with the use of such space to record the aforementioned legend.

e) Thalonaries shall be drawn up in accordance with the requirements laid down by the Health Services and the competent authorities of the Officials of Officials.

f) Patient information sheet: Approximate dimensions 22 by 12 centimeters or size DIN A-4, adopting the one that is best suited to facilitate the patient's treatment information.

3. Active medication sheet and patient information for the electronic prescription system.

a) Approximate dimensions: DIN A-4 size.

(b) As referred to in point 1, the name of the Management Entity or the Agency issuing the prescription must be listed. In relation to the data to be reported:

In the space for "Use Regime", the acronym or classification code shall be entered in the individual health card database, or mutualist in the Recipes of the Officials ' Mutuals.

"Prescription Code": A space reserved for the data assigned by the electronic system, with a unique and unrepeatable character, for the identification of the prescription of each medication or medical device.

(c) They shall be drawn up in accordance with the requirements laid down by the Health Services and the competent authorities of the Officials of Officials.

Second. Medical prescription for Private Health Care.

The medical prescriptions used in healthcare that are developed outside the hospital environment and are not the official medical prescriptions of the National Health System, including those of the Mutualities of Officials, shall comply with their technical specifications, as provided for in the first paragraph of this Annex, with the corresponding specific provisions as are the spaces for: Use and seal stamps or similar, which shall not be included in the the document.

In the "Contingency" space, medical Recipe for private healthcare will be stated.

In the upper left corner, numbering elements and recipe identification codes can be included.

In the upper right corner, the name of the Institution may be entered, if applicable.

Third. Order Of Hospital Dispensing.

Hospital dispensing orders used in the hospital environment for patients not admitted will be adapted to the medical prescription in this Annex, with the corresponding caveats, as are the spaces intended for sealed or assimilated coupons, which shall not be included in the document, as well as for the prescription of several medicinal products.

In the "Use Regime" space, a hospital dispensing order will be registered, and in the area of the National Health System, in the space "Contingency", the acronym or classification code will be entered in the database individual health cards, which shall be printed alphanumeric or coded according to the scheme referred to in the first paragraph of this Annex.

In addition, in the Hospital Dispensing Order, the pharmacy service will be specified instead of the pharmacy office, including the number of Clinical History in the patient's data and the medical service or unit. clinic, in addition to the prescriber.

As proof of the dispensation, the patient's receipt date and signature will be recorded.

By hospitals, in private health care, as well as by competent administrations and agencies, where appropriate, references or data may be included in the orders for hospital dispensation; copies required for proper use and control.

Fourth. Dispensing order.

The order of supply referred to in Article 1 (c) of this royal decree, in general, shall be subject to the basic criteria laid down in this Annex for the medical prescription and shall be in accordance with the features described in the corresponding model.

In particular, the order of official dispensation of the National Health System including that of the Mutualities of Officials shall be in accordance with the basic criteria laid down in the first point, while the order of dispensation for private health care, it must comply with the basic criteria laid down in the second subparagraph. "

Final disposition second. Competence title.

This royal decree is dictated by the provisions of article 149.1.16. of the Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health. The amendment of Articles 3 and 5 and of the Annex to Royal Decree 1718/2010 of 17 December 2010 on medical prescription and dispensing orders, which carries out the final provision, which is covered by the Directive, is exempt from the foregoing. State competence to dictate legislation on pharmaceutical products.

Final disposition third. Incorporation of European Union law.

By this royal decree, Directive 2011 /24/EU of the European Parliament and of the Council of 9 March 2011 on the application of the rights of patients in care is incorporated into the Spanish legal order. cross-border health and Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State.

Final disposition fourth. Regulatory development and attachment updates.

The Minister of Health, Social Services and Equality is empowered to make the necessary provisions for the implementation and development of this royal decree, as well as for the amendment of its annexes, prior to the report of the Interterritorial Council of the National Health System, in order to adapt them to the advancement of scientific and technical knowledge or to adapt them to European Union regulations.

Final disposition fifth. Entry into force.

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

Given in Madrid, on February 7, 2014.

JOHN CARLOS R.

The Minister of Health, Social Services and Equality,

ANA MATO ADROVER

ANNEX I

Documentation for the refund procedure

1. Original invoices, from the health care provider or dispensing establishment, in which it must be credited by the vending machine that have been paid. It must include at least:

a) Patient identification: name, surname and number of DNI or NIE or passport.

(b) Identification of the natural or legal person issuing the invoices: name or registered name and address.

c) Name of the service or clinical unit.

d) Identification data of the professional responsible for cross-border healthcare.

e) The various care concepts performed in detail, in the manner in which you specify the competent health authority, the amount of each and the date of completion.

(f) Where appropriate, the name of the medicinal product, medical device or dietary food of special medical uses dispensed, the number of containers dispensed, the amount paid by the patient and the date of dispensing.

2. Copy of the medical prescription or the clinical report of the care provided to include inexcusably:

a) Clinical reason for the provision of cross-border healthcare.

b) Diagnostic procedures or main and secondary therapeutic procedures performed on the basis of cross-border healthcare (indicating, as long as possible, approved identification code, such as CIE9-MC or similar).

c) Revisions to be performed and estimated time for them.

(d) Any other data deemed appropriate to be resent, in order to clarify the health care received or its actual cost, provided that it is strictly necessary for the assessment of the origin and the amount of the refund.

ANNEX II

Pre-authorized health benefits

They are subject to prior authorization:

1. Any type of health care that involves the patient having to stay in the hospital at least one night.

2. Irrespective of the requirements set out in point 1, those techniques, technologies or procedures included in the common portfolio of services of the National Health System which have been selected on the basis of the requirement for the use of procedures or highly specialised medical equipment, the need for care for patients with complex problems, or their high economic cost:

a) Positron Emission Tomography (PET), and combined with the TC (PET-TC) and SPECT.

b) Assisted human reproduction.

c) Dialysis.

d) Outpatient surgery requiring the use of a surgical implant.

e) Treatments with radiotherapy.

(f) pharmacological or biological products, the monthly amount of which is more than € 1,500.

g) Radiosurgery.

h) Genetic analysis aimed at the diagnosis of complex cases, including prenatal and pre-implantation diagnosis, presytomatic genetic analysis, and carrier and pharmacogenomic analysis of pharmacogenetics.

i) Treatment of disabilities that require for correction or improvement: Electric wheel sils, upper limb prosthesis except partial hand prostheses, lower limb prosthesis except partial prostheses standing, hearing aids and bitutors.

j) Treatments with complete formulas for enteral enteral nutrition and with formulas and nutritional modules for congenital disorders of the metabolism of carbohydrates, amino acids and lipids.

(k) Attention to pathologies and procedures for which reference services have been designated, in accordance with Royal Decree 1302/2006 of 10 November 2006 laying down the basis for the procedure for the designation and accreditation of the centres, services and reference units of the National Health System, included in Annex III to Royal Decree 1207/2006 of 20 October, governing the management of the Health Cohesion Fund, or have established reference networks in Europe.