Royal Decree-Law 16/2012, April 20, On Urgent Measures To Ensure The Sustainability Of The National Health System And Improve The Quality And Safety Of Their Benefits.

Original Language Title: Real Decreto-ley 16/2012, de 20 de abril, de medidas urgentes para garantizar la sostenibilidad del Sistema Nacional de Salud y mejorar la calidad y seguridad de sus prestaciones.

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I the creation of the national health system has been one of the great achievements of our welfare State, given its quality, its universal vocation, the amplitude of its performance, its bearing capacity in the progressive scheme of taxation and solidarity with the underprivileged, which has placed him at the forefront of health as a global reference model.

However, the absence of common rules on the assurance throughout the national territory, the uneven growth in the performance of the catalogue, the lack of adaptation of some of them to the socio-economic reality and the lack of rigor and an emphasis on the efficiency of the system have led to the national health system to a situation of serious economic difficulties unprecedented since its creation. Efficiency is lost in the management of available resources, which has resulted in a high non-performing loans and an unsustainable deficit in the health public accounts. It is made, therefore, must the adoption of urgent measures to ensure its future and that contribute to avoid that this problem persists.

The national health system is suffering situations of lack of coordination between regional health services resulting in the emergence of considerable differences in the benefits and services they access the patients in the various autonomous communities. Territorial cohesion and equity have been put in question with certain measures adopted in recent years.

Structural data and more meaningful public health expenditure figures show that public health can not ignore any longer a situation clearly incompatible with their essential to sustainability and that, at the same time, it has brought seriously adverse consequences for employment and the viability of the business sectors that are related with it.

But, moreover, it is urgent to deal with current challenges of health care. Thus, the impact of the ageing of the population, the need to incorporate the therapeutic innovations in clinical therapy, advance and progress in molecular medicine, the development of advances in genomics and proteomics and new drugs, will assume, without a doubt, an increase in health expenditure whose estimates must be rigorously analysed by those responsible for politicians.

The rational use and therapeutic relevance to the actual duration of the treatments is one of the issues where the emphasis should be. Thus, the latest data of environmental management of drug residues highlight troubling costs of destruction of products discarded unused or surplus units of the established drug regimens, which not only confirms the need for improving efficiency in the process of prescribing, dispensing and use of drugs, but it warn of the worrisome environmental costs.

(II) all the countries of the European Union are analyzing and adopting measures that allow to optimize its pharmaceutical and health care models and, in particular, pharmaceutical expenses and its weight in health expenditure. The implementation of measures in this field is very intense, especially in the countries that the financial and economic crisis has hit with more intensity.

In compliance with the obligation that have Governments efficiently manage the capabilities of the system, you must be the maintenance of the Spanish national health system model, model configured as the coordinated set of health services of the General State administration and health services of the autonomous communities, which guarantees the protection of the health and is supported based on public funding the universality and free health services.

For this reason, they are necessary reforms that strengthen the sustainability, improve management efficiency, promote savings and economies of scale, introduce new tools through new technologies, win on territorial cohesion, coordination of health services and the social and, above all, to ensure equality of treatment throughout the national territory with a basic portfolio of common services.

Furthermore, and in view of the reports issued by the Court of Auditors, it is essential to regulate, without further delay, the condition of the insured person in order to avoid some situations of health care taking place at present and which are weakening at an alarming rate the sustainability of the national health system.

The Government has expressed its desire to address these and many other reforms are necessary or desirable, not only by rules, but also promoting best practice and pooling experiences, always based on dialogue and with the collaboration of the autonomous communities, the political groups and many associations and organizations act in this area, thus ensuring the best patient care which are the real core of the system.

It will be this way really is can ensure citizens a public, free and universal health care.

Measures which apply in the present Royal Decree-Law have as main objective face a structural reform of the national health system providing solvency, viability and reinforcing cohesion measures to make it sustainable over time, making it necessary that they be applied with the greatest possible urgency. It is necessary, in the current socio-economic context, that these measures materialise in a normative instrument of immediate effect that response, without delay, to the demands of the internal improvement of the equity that requires citizenship, efficiency required by the Court of Auditors and security required by the health sector, and the external transparency and viability which requires the European Union.

Therefore, the Government considers that extraordinary and urgent need necessary budgets set out in article 86 of the Spanish Constitution which enabled him to pass these measures through the mechanism of a Royal Decree-law are.

III the law 49/1998, of December 30, the State budget for 1999 set out in chapter III of its title I that would be the State, through the budgetary transfers to the autonomous communities, which would fully assume public funding of health care, unlinking this healthcare contributions to Social Security.

This separation of sources of funding between the national system of health and Social Security has not led with the necessary delimitation of functions when it comes to the recognition of rights. The autonomous communities, in the framework of their respective competences, have extended the right to health coverage in a very different way and without taking into account the European legislation in the field of insurance, putting at risk the solvency of the national health system and leading to infringement proceedings by the European Commission which calls for the effective implementation of the principle of equal treatment.

The reasoned opinion 2009 / 2341 of the European Commission addressed to the Kingdom of Spain by his refusal to issue the European health insurance card to people residing in Spain with the right to receive medical assistance in accordance with the regulations of some autonomous communities, has been shown the fragility of the mechanism of recognition of the right to the protection of health in our country.

Thus, Regulation (EC) No. 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of the systems of social security, and its implementing regulation, Regulation (EC) No. 987/2009 of the European Parliament and of the Council, September 16, 2009, by which adopt standards of application, make effective the principle of equal treatment in the benefits derived from the protective action of social security among European citizens, whatever their place of origin, assimilating them to the citizens of the country where provision.

On the other hand, the Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and members of their families to circular and reside freely in the territory of the Member States, by which modifies Regulation (EEC) No. 1612/68 and repealing directives 64/221/EEC , 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC, in article 7 regulates the conditions that must be met in those cases in which a European citizen want to reside in another Member State, other than that it originated, for a period exceeding three months.

However, the Royal Decree 240/2007, of February 16, above entrance, free movement and residence in Spain of citizens of States members of the European Union and other States party to the agreement on the European economic area has not transposed article 7 of the Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 , in its literal terms. This circumstance has been, and will continue to assuming if it is not modified, a serious financial loss to Spain, especially with regard to the impossibility of guaranteeing returns of expenses incurred for the provision of health and social services to European citizens.
The Court of Auditors revealed that the national health system is taking, charged to their budgets, health care for people who already have cover, either by their institutions of social security in origin, by private insurance schemes, which is greatly eroding their financial capacity and preventing that their managers can continue to make improvements in services. It imposes, therefore a clarification harmonised status of insured person, for the purposes of the provision of health services and community health, so this is linked effectively to the financing by taxes and the character of social solidarity that the progressive scheme of them has in our country.

And it is precisely this subject which is regulated in chapter I of this Royal Decree, which regulates the status of insured person, in their third final provision, amending article 12 of the organic law 4/2000, of 11 January, above rights and freedoms of foreigners in Spain and their social integration precept that does not have organic nature as set forth in the fourth final provision of the Act, as well as in their fifth final provision that modifies article 7 of Royal Decree 240/2007 of 16 February.

IV on the other hand, it is necessary to introduce, and this is the subject of chapter II of the Royal Decree-Law, a categorization of the portfolio of services of the national health system that allows to manage better the reality of health care in Spain where co-exists an administrative framework that reduces transparency and hampers the execution, reducing, therefore the efficiency in your application, and where it fit to objective performance based on a rigorous cost-effectiveness analysis that provides the Spanish network Agency of evaluation of health technologies and services of the national health system.

This situation has to be channelled towards homogeneity among health services, as well as to clarity, transparency and information to the public so you can know exactly the scope of coverage of their rights.

In addition, it is essential to resolve, within the framework of cohesion and equal rights to health care between the Spaniards and others who enjoy the status of insured person in our country, the financing of health care provided to people living in a region other than that is paying attention through the creation in chapter III of this Royal Decree-law assistance guarantee fund configured as a specific heading of compensation for the care guarantee throughout the national health system.

V the chapter IV of the Royal Decree-law incorporates certain measures related to the pharmaceutical provision.

The financing of medicines and sanitary products in the national health system is one of the major current challenges. Austerity in public, essential spending at all times, has become an urgent goal. For this reason, it is necessary, more than ever, that financing decisions are presided over by the criteria of evidence of cost effectiveness and economic evaluation, with consideration of the budgetary impact, which take into account a scheme of price associated with the real value that provides the drug or medical device to the system. It is time, therefore, lay the foundations for a thorough analysis of the benefits that a new drug or medical device contributes to society in general and to the socio-economic fabric of Spanish in particular when deciding on financing conditions for the national health system.

The same principle of austerity and rationalization in public expenditure on the supply of medicines and health products requires to update the existing system of contribution by the user and requires changes in it, so that it adapts to the current model of funding of the national health system by the General State budgets.

On the other hand, the measures contained in the Royal Decree 4/2010 of 26 March, 8/2010, of 20 May and 9/2011, August 19, focusing on the pharmaceutical of the national system of health provision and, particularly, those concerning discounts to practice sales invoiced to the system, produce effects of duality of prices and markets that may be circumventing the principles of market economy and the need to review for the purposes of protect competition in the different subsectors.

VI in chapter V of this Royal Decree-Law contains a series of measures aimed at correcting specific structural situations in relation to human resources, real assets of the national health system.

The funds intended to finance health services human resources represent the most important game of their budgets. The diversity of regulations, the organizational complexity of qualifications, categories and work situations of more than 600,000 workers in 17 health services has been generating a great interpretive variability of the regulations, which are shown as real barriers for the development of plans of efficiency and management that the autonomous communities are developing within the framework of the economic crisis and the freedom of movement of workers among health services.

Arises as a real urgency define evenly for all the national system of health the current regulation of aspects linked to the professional categories, regulatory general criteria of the payment system or social action.

These changes are especially necessary in a context of economic crisis to rationalize public spending and enable greater efficiency in the management of the health services of the autonomous communities.

The imminent implementation of the core subjects in the training of specialists of the national health system makes urgent to make certain modifications in the law 44/2003, of 21 November, management of the health professions, with regard to the regulation of the Areas of specific training, clarification of competencies in the training of specialists, resolution of requests for accreditation of educational institutions and its audit and evaluation.

The creation of specific training Areas does not support delay to respond to the needs of scientific progress and the right and duty to have professionals in order to their professional development. This development is a unanimous request from health professionals, of the National Council of specialties in health sciences, scientific societies and health administrations. However, the having spent more than 8 years since the adoption of the law 44/2003, of 21 November, it is necessary to adapt the development of the Areas of specific training to the needs of the health system and the evolution of specialized health training are experiencing both internally (introduction of criteria of core subjects in the training of specialists) and at the level of the European Union.

The need to create a State registry of health professionals is based on that it is an essential tool to guarantee information to the population and the institutions of the status of professionals from the various aspects that make up the professional practice. The information regarding the certification that the Professional is not subjected to disciplinary or professional disqualifications constitutes a guarantee for the safety of patients, and gives compliance to the requirement of Community law to prove the good practice of the professionals in the field of the right to freedom of movement, which has a great impact on the sector health.

Regional and College records aren't enough to ensure necessary planning and control of human resources are there in the health system. This state register, to enable a connection to the regional records in real time, will allow the special need data available in immediate mode, from the evidence of resolution of disciplinary cases to the proper planning of the needs of specialists in close connection with the annual places in training offerings.

It is also urgent to ensure the mobility of professionals through the development of a uniform catalog of professional categories are established where necessary equivalencies. This catalog will allow that professionals have access to vacant posts of other health services improving the quality of assistance, since these places are not going to be subject to supply regulated by the call for selective processes, since the public employment offer is frozen.

Finally, criteria of rationalisation and efficiency in the expenditure of social action of health services management determine the need to enable the modulation of their contribution in cases of temporary disability to the autonomous communities, and also repeal preconstitucionales rules which are divergent with the collected criteria in law 27/2011, August 1, on update adaptation and modernisation of the Social security system, in terms of the economic benefits of the staff who have reached the age of retirement.

VII
Finally, and aside from the references that have been made in the previous sections, we have included a series of additional measures that complete the regulatory package and which are necessary for the proper implementation in practice of this Royal Decree.

Thus, incorporate efficiency measures badly needed the system to deal with their problems of sufficient funding, enabling the adoption of strategies for centralized management of supplies that value a relationship of volumen-precio in the purchase of products, materials and equipment of coordination in the national health system. Effort on energy saving measures, related not only with efficiency but also with the commitment in the field of corporate social responsibility due to the largest public company in the country should also be taken.

In another order of things, Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, obtaining, evaluating, processing, preservation, storage and distribution of human tissues and cells, establishes in paragraph 2 of his article 12 Member States shall take all appropriate measures to ensure that any promotion and publicity activities in support of the donation of human tissues and cells comply with guidelines or legal provisions laid down by the Member States.

In this sense, the Royal Decree 1301 / 2006, of 10 November, that establish the norms of quality and safety for the donation, obtaining, evaluating, processing, preservation, storage and distribution of human tissues and cells and approve the coordination and performance standards for use in humans, which transposes the aforementioned Directive 2004/23/EC to our legal system It did not consider it necessary to make use of such attribution to take corresponding measures. However, events related to activities of promotion and publicity in support of the donation of cells and human tissues that have recently taken place in Spain and who have not observed the existing regulation on the subject, advise to complete transposition in the sense of establishing, based on the powers provided for in the Community legislation, measures to ensure compliance with the provisions of the Spanish rules and ensure the proper functioning of the Spanish model of transplants.

In addition, article 30.1 of the Act 14/1986, of 25 April, General health, offers promotion and advertising activities will be subject to inspection and control by the competent health authorities, and article 40.8 of the same law establishes that it corresponds to the General Administration of the State, without prejudice to the powers of the autonomous communities develop regulations on, inter alia, registration of services, in accordance with legislation on the removal and transplantation of organs.

Accordingly, based on the cited article 12(2) of Directive 2004/23/EC, proceed to amend the Royal Decree 1301 / 2006, of 10 November, through the addition of a new subparagraph to paragraph 1 of article 4, which establishes the obligation of prior administrative authorisation to carry out promotion and publicity activities in support of the donation of human tissues and cells; and through the addition of an article 30 bis, which is a donor registry of hematopoietic progenitors comprehensive of the aggregate of all of the national system of health information.

VIII the right to the protection of health and the obligation of public authorities organise and protect public health through preventive measures and benefits and services is enshrined as a guiding principle of social and economic policy in article 43 of the Spanish Constitution which reserves to the law establishing the rights and duties of all in this regard.

The Constitutional Court has considered, in sentences as the 182/1997, of October 28, and the 245/2004, of December 16, that the fact that a matter is subject to the principle of reservation of law does not allow to conclude that it is excluded from the scope of regulation of the Royal Decree-Law, which can penetrate into this matter provided that enabling budget constitutional requirements are given and not «affect» , in the constitutional sense of the term, to matters excluded in article 86 of the Spanish Constitution, which necessarily relaxes to the found in the presence of a guiding principle of social and economic policy of chapter III of title I of the Constitution.

By virtue of all this, making use of the authorisation contained in article 86 of the Spanish Constitution, a proposal from the Minister of health, social services and equality, after deliberation by the Council of Ministers, at its meeting of April 20, 2012, available: chapter I of healthcare in Spain article 1. Modification of law 16/2003, 28 of may, cohesion and quality of the national health system.

Law 16/2003, 28 of may, cohesion and quality of the national health system, is hereby amended as follows: one. Amending article 3, which will have the following wording: «article 3. The condition of the insured.

1 health care in Spain, financed by public funds, through the national health system, will be those people that they have the status of insured person.

2 a these effects, will have the status of insured persons who are in any of the following cases: to) be employed or self-employed worker affiliated to Social Security and in a high position or assimilated contributor.

(b) hold the status of pensioner of the Social security system.

(c) be beneficiary of any other periodic benefit from Social Security, including the provision and the allowance for unemployment.

(d) having exhausted the benefit or allowance for unemployment and be registered in the appropriate office as a job seeker, not crediting the condition of insured by any other title.

3. in those cases where none of the previously established assumptions is met, persons of Spanish nationality or of any Member State of the European Union, of the European economic area or Switzerland who reside in Spain and the foreign holders of an authorization to reside in Spanish territory, may hold the status of insured person provided that they prove that they do not exceed the income limit determined by law.

4. for the purposes of the provisions of this article, they shall be beneficiaries of an insured person, provided that they are residing in Spain, the spouse or person with similar relation of affectivity, which must certify the official registration, the ex-spouse to the insured, as well as descendants in charge thereof who are under 26 years of age or who have a disability degree equal to or greater than 65%.

5. those who do not have the status of insured or beneficiary may obtain the healthcare delivery through the payment of appropriate remuneration or fee derived from the signing of a special agreement.

6. the provisions of the preceding paragraphs of this article does not change the system of health care of persons holders or beneficiaries of special schemes Social Security managed by the General mutuality of civilian officials of the State, the Judicial General mutual insurance company and the Social Institute of the armed forces, who will maintain their specific legal status.

In this regard, persons framed in these mutuals that have opted to receive health care through insurance entities must be treated in health centers concluded by these entities. In case of receiving assistance in public health centres, assistance expenditures will be reclaimed to the required third, in accordance with the regulations."

Two. Added a new article 3 bis, which will have the following wording: «article 3 bis.» Recognition and control of the condition of the insured.

1. the recognition and control of the insured or beneficiary of the same condition will correspond to the National Institute of Social Security, through its provincial directorates, which will establish the documentary requirements in each case.

2. once recognized the condition of insured or beneficiary, the right to health care will be included by the competent health authorities, which will facilitate the access for citizens to the benefits of health care through the issuance of the individual health card.

3. the competent bodies in the field of immigration may communicate to the National Institute of Social Security, without the consent of the person concerned, the data that are essential to ensure the concurrence of the requirements referred to in paragraph 4 of article 3 of this law.
Similarly, the National Institute of Social Security will treat the data in the files of the management entities and common services of the Social security or the organs of the competent public administrations that are essential to verify the occurrence of the condition of the insured or beneficiary. The transfer to the National Institute of Social security of these data not will require the consent of the person concerned.

The National Institute of Social Security will treat the information referred to in the preceding two paragraphs in order to communicate to the competent health authorities the data necessary to verify at every moment are the conditions and the requirements for the recognition of the right to health care, without needing to do so from the consent of the person concerned.

Any modification or variation which can communicate the National Institute of Social Security must be valid the stipulated by the individual health card.»

3. Added a new article 3 ter, which will have the following wording: «article 3 ter. Health care in special situations.

Foreigners not registered or authorized as residents in Spain, will receive health care in the following ways: to) urgently serious illness or accident, any resulting from any cause, until the situation of medical discharge.

(b) of pregnancy, childbirth, and postpartum assistance.

In any case, foreigners under the age of 18 will receive health care under the same conditions as Spaniards.»

Chapter II of the common portfolio of the national system of health services article 2. Modification of law 16/2003, 28 of may, cohesion and quality of the national health system.

Law 16/2003, 28 of may, cohesion and quality of the national health system, is hereby amended as follows: one. Amending article 8, which will have the following wording: «article 8. Common portfolio of services of the national health system.

1. the common portfolio of services of the national health system is the set of techniques, technologies and procedures, understanding as such each of the methods, activities and resources based on knowledge and scientific experimentation, by which health benefits become effective.

2 the common portfolio of services of the national health system will be articulated around the following modalities: to) basic common portfolio of healthcare services of the national health system it referred to in article 8 bis.

(b) supplementary common portfolio of the national health system referred to in article 8 ter.

(c) common services portfolio accessories of the national health system referred to in article 8 quater.

3. in the bosom of the Interterritorial Council of the national health system the common portfolio of services of the national system shall be given health, to be approved by Royal Decree.

4. the Ministry of health, social services and equality will annually perform an assessment of the costs of implementation of the common portfolio of services of the national health system."

Two. Added a new article 8 bis, which will have the following wording: «article 8 bis.» Basic common portfolio of healthcare services of the national health system.

1. the common basic welfare services of the national health system comprises all welfare activities of prevention, diagnosis, treatment and rehabilitation are carried out in health centres or community health as well as urgent health transport, covered in full by public funding.

2. the provision of these services will be in such a way that ensure the continuity of care, under a patient-centered, multidisciplinary approach, guaranteeing the highest quality and safety in its delivery, as well as the conditions of accessibility and equity for the population covered.»

3. Added a new article 8 ter, which will have the following wording: «article 8 ter. Additional common portfolio of the national health system.

1 supplementary common portfolio of the national health system includes all those services whose provision is performed using outpatient dispensing and they are subject to the user.

2 this additional common portfolio of the national health system will include the following features: to) pharmaceutical delivery.

(b) providing prosthetics.

(c) provision with dietary products.

3. also enjoy this consideration the sanitary transport urgent, not subject to prescription, for clinical reasons, and with a level of the user according to the determined for the pharmaceutical provision.

4. for the benefits provided for in paragraph 2 of this article, with the exception of the pharmaceutical provision which shall be governed by the regulations, be they approved by order of the titular person of the Ministry of health, social services and equality, consent of the Interterritorial Council of the national health system, on the proposal of the Committee on benefits, insurance and financing, the updating of the catalogue of benefits the maximum amounts of funding and the correction coefficients to be applied to determine the final billing to regional health services providers, which will be considered final price.

5. the percentage of the user shall be governed by the same rules that regulate the provision of pharmaceutical, taking as a basis of calculation for this the final price of the product and without any limit of amount that applies to this contribution.»

Four. Added a new article 8 quater, which will have the following wording: «article 8 quater. Common portfolio of accessories services of the national health system.

1 common accessories the national system of health services portfolio includes all the activities, services and techniques, non-delivery, which are not considered essential or that are co-Formulants or support for the improvement of a pathology of chronic, being subject to contribution or reimbursement by the user.

2. by order of the titular person of the Ministry of health, social services and equality, consent of the Interterritorial Council of the national health system, a proposal from the Commission's performance, assurance and financing, approve inclusion of accessory services, the maximum amounts of funding and correction coefficients to be applied to determine the final billing to the regional health services by providers as well as the modalities of contribution or refund applicable in each case.

The activities, services and techniques included in this form of portfolio will be effective once approved by order of the titular person of the Ministry of health, social services and equality.

3. the contribution of the user or, where appropriate, refund, shall be governed by the same rules that regulate providing pharmaceutical, taking as a reference the final price of billing that is decided for the national health system."

5. Added a new article 8 d, which will have the following wording: «article 8 d. Complementary portfolio of services of the autonomous communities.

1. the autonomous communities, in the scope of their powers, can approve their respective portfolios of services which shall include, at least, the common portfolio of national system of basic health in its modalities of care services, supplemental and accessory services, guaranteeing to all users of the same.

2. the autonomous communities may incorporate in their portfolios of services a technique, technology or procedure not covered in the common portfolio of services of the national health system, which will establish the necessary additional resources.

3. the autonomous communities should allocate financial resources to ensure the financing of the common portfolio of services, being mandatory, for the approval of the complementary portfolio of services of an autonomous community, the prior guarantee of sufficient funding in the framework of compliance with the criteria of budgetary stability.

4. in any case, complementary services or benefits must meet the same requirements for the incorporation of new techniques, technologies, or procedures to the common portfolio of services, and will not be included in the general financing of the benefits of the national health system.

Prior to its incorporation, the autonomous community concerned shall inform motivated, to the Interterritorial Council of the national health system.

5 the Council regional of the national system of health may issue recommendations on the establishment by the autonomous communities of health benefits complementary to common benefits of the national health system, in accordance with the provisions of article 71.1. b) of this Act.

6. the autonomous communities shall bring to the attention of the Ministry of health, social services and equality complementary services not contemplated in common service portfolio of the national health system after its effective incorporation in its services portfolio regional, which will be included in the corresponding information system.
7. the autonomous communities shall assume, with charge to their own budgets, all the costs of implementation of the portfolio of services complementary to those persons having the status of insured.»

6. Amending article 20, which will have the following wording: «article 20. Development of the common portfolio of services of the national health system.

1. the content of the common portfolio of services of the national health system shall be determined by agreement of the Interterritorial Council of the national health system, on the proposal of the Committee on benefits, insurance and financing.

In the preparation of such content be taken into account therapeutic efficacy, efficiency, effectiveness, safety and utility, as well as the advantages and care alternatives, care of groups less protected or risk and social needs, as well as its economic and organizational impact.

The Spanish network of agencies of health technology and benefits of the national health system evaluation will participate in the evaluation of the provisions of the preceding paragraph.

2. in any case, will not be included in the common portfolio of services those techniques, technologies and procedures whose effective contribution to the prevention, diagnosis, treatment, rehabilitation and healing of diseases, conservation or improvement of the hope of life, autonomy and elimination or reduction of pain and suffering is not sufficiently proven."

7. Amending paragraphs 1 and 2 of article 21 which are written in the following way: ' 1. the common portfolio of services of the national health system will be updated with order of the titular person of the Ministry of health, social services and equality, consent of the Interterritorial Council of the national health system. " The procedure for updating will take place according to the rules.

«2 new techniques, technologies or procedures will be subject to evaluation, prescriptive and nature prior to its use in the national health system, by the Spanish network of agencies of health technology and benefits of the national health system evaluation.»

Chapter III measures for cohesion and financial security of the national health system article 3. Healthcare guarantee fund.

1. is created care guarantee fund, on an extrabudgetary basis, in order to ensure cohesion and equity in the national health system, by covering movements between autonomous communities and cities of Ceuta and Melilla for people who enjoy the status of insured in the national health system.

2. the assistance guarantee fund will be devoted to the trade-off between the autonomous communities and cities of Ceuta and Melilla for actions that their health services carried out within the framework of the implementation of the basic common portfolio of healthcare services and the supplementary to the persons who benefit from the status of insured in the national health system in their temporary displacement.

3. with the aim of making a proper management and monitoring of the assistance guarantee fund, shall be to establish the mechanisms for the recognition of these people in the individual health card of the national system of health information system.

4. the determination of the amount to be settled to each health service shall be established by statute to the effect.

5 the amounts to be settled amount determined by the following types of displacement: to) displacement of short duration (less than one month), will be paid following the national rates established in the concept of health care for primary care, including the provision for additional portfolio that corresponds.

(b) movement of long duration (equal to or greater than one month), will be paid according to the monthly capita used for statistical calculations of the system of health accounts health accounting, with two fields of application: 1st for the common basic welfare services complete portfolio.

2nd for the basic common portfolio of care partial, concerning attendance at primary or specialist level.

Chapter IV measures on the pharmaceutical provision Article 4. Modification of law 29/2006, of July 26, guarantees and rational use of medicines and sanitary products.

Law 29/2006, of July 26, guarantees and rational use of medicines and sanitary products, is hereby amended as follows: one. Amending Article 85, which will have the following wording: «Article 85. Prescription drugs and medical devices.

1. the prescription of medicines and sanitary products in the national health system will be the most appropriately for the benefit of patients, while preserving the sustainability of the system.

2 in the national health system, the prescriptions of drugs included in the pricing system of reference or not included in the same homogeneous groupings shall be carried out according to the following scheme: a) for acute processes, the prescription will be, in general, by active ingredient.

(b) for chronic processes, the first prescription, corresponding to the establishment of the first treatment, will be, in general, by active ingredient.

(c) for chronic processes whose prescription corresponds to the continuity of treatment, it may be by trade name, provided this is included in the system of reference prices or the lowest price within their homogeneous grouping.

3. However, by commercial denomination of medication prescription will be possible provided they respect the principle of greater efficiency for the system and in the case of drugs considered to be non-replaceable.

4 when the prescription by active ingredient, the pharmacist will dispense medication lower priced its homogeneous grouping and, in the case of equality, the generic or the corresponding biosimilar drug.

5. in any case, the prescription of a medicinal product for use in conditions other than those set out in its sheet must be previously authorized by the Commission responsible for the therapeutic protocols or equivalent College in each autonomous community.»

Two. Added a new article 85 bis, which will have the following wording: «Article 85 bis.» Information systems for support to the prescription.

1. the competent bodies of the autonomous communities will provide their prescribers of a common and interoperable e-prescribing system in which subsystems support will be incorporated into the prescription, such as:-list of medications online.

-Correspondence between active principles, available drugs and diseases that are indicated.

-Treatment by pathology protocols recommended from health institutions and medical societies, with an indication of the standards of choice and the expected benefits.

-Cost of the prescribed treatment and alternative therapeutic choice according to criteria of efficiency.

-Database of interactions.

-Database of clinical trials in their province or autonomous region.

-Periodic information online (authorization and withdrawal of medicines and sanitary products, alerts and communications relevant to the protection of public health).

-Dissemination of news about medicinal products which, without being strictly alerts, help improve the level of health of the population.

2. the prescribing support systems collect information pertaining to the prices selected via reduced contribution, so that the doctor can take into consideration the economic impact for the prescription of medicines and sanitary products.

3. the prescribing support systems will be managed from the competent bodies at autonomous community level. The Interterritorial Council of the national health system will ensure that the same be articulated efficiently and contribute to maintain the fairness of the health system.

4. the Ministry of health, social services and equality, in coordination with the autonomous communities, establish basic healthcare protocols so to orient the prescription and use of those medicinal products which, due to its unique characteristics, require special attention and caution in its prescription and dispensation."

3. Added a new article 85 ter, which will have the following wording: «Article 85 ter. Exclusion of the pharmaceutical provision of medicines and sanitary products.

1. the body responsible for the pharmaceutical service of the Ministry of health, social services and equality update, by a motivated decision, the list of drugs that are excluded from the pharmaceutical provision in the national health system.

2 motivation of exclusion will respond to any of the following criteria: to) selected pricing.

(b) living with a drug without prescription sharing active ingredient and dose.

(c) consideration of how advertising medication in our European environment.

(d) that the active substance has a profile of security and favourable and sufficiently documented effectiveness through years of experience and extensive use.

(e) to be indicated in the treatment of minor symptoms.
(f) to meet any of the criteria of non-inclusion in public financing contained in paragraph 2 of article 89.

3. makers of the products excluded from the financing shall communicate to the competent organ prices that go to market these drugs. The same obligation is extended to variations in prices.

4. in the month following the entry into the register of the competent body of the communications referred to in the preceding paragraph, this will solve your compliance or not to the prices quoted. In case of disagreement, cystography will raise the discrepancy the Interministerial Committee on prices of drugs, which shall decide on the matter. Such decision shall be notified by a decision of the competent authority to the person concerned.

The administrative decision in the previous point will be based on grounds of the protection of public health, equal access to medicines by part of patients or actual or potential injury to the interests of groups disadvantaged.

5 as in as long as the disagreement referred to in the preceding paragraph, shall keep the validity of the maximum industrial price.»

Four. Add a new paragraph 5 to article 86, which will have the following wording: «5. when the prescription is made by trade name, if the prescribed medication have a price higher than the lowest price of its homogeneous grouping pharmacist will replace the medication prescribed by the lowest price, and in case of equality, will dispense the generic or the corresponding biosimilar drug. "

5. Amending paragraphs 1 and 2 of article 89, which will have the following wording: "1. for the public funding of medicines and sanitary products will require inclusion in the pharmaceutical provision by the corresponding express decision of the responsible unit of the Ministry of health, social services and equality, by establishing the conditions for financing and price within the scope of the national health system."

In the same way will proceed when there is a change in the authorization that affects the content of the pharmaceutical benefit, prior to the placing on the market of the modified product, either by affect the modification to the indications of the medication, well because, without affecting them, the Spanish Agency of medicines and health products thus agreed for reasons of public interest or protection of health or safety of persons.

The inclusion of drugs on the national system of health funding is made possible through funding selective and not indiscriminate, taking into account General, objectives and published criteria and, in particular, the following: to) gravity, duration and aftermath of different diseases for which they are indicated.

(b) specific needs of certain groups.

(c) therapeutic and social value of the medication and incremental clinical benefit of it taking into account their cost-effectiveness.

(d) streamlining of public spending on pharmaceutical delivery and budgetary impact in the national health system.

(e) existence of drugs or other therapeutic alternatives for the same conditions to lower price or lower cost of treatment.

(f) the degree of innovation of the drug.

Without prejudice to the provisions of article 24, and to ensure the rational use of medicines and health products, the Ministry of health, social services and equality it may refer to unique reserves specific prescription, dispensation and funding in the national system of health, of its own motion or on the proposal of the autonomous communities in the Permanent Commission of pharmacy.

In order to guarantee the right of all persons who benefit from the status of insured and beneficiary on an access system to provide pharmaceutical equal throughout the national health system, the autonomous communities not may establish, unilaterally, specific unique reserves of prescription, dispensation and financing of pharmaceuticals or medical devices.

However in the Permanent Committee of pharmacy may decide is the exception, motivated by one or several autonomous communities because of their own particularities.

2. the Ministry of health, social services and equality review groups, subgroups, categories or classes of drugs whose funding is not deemed necessary to cover the basic health needs of the population of Spain. In any case, over-the-counter medications, are not included in pharmaceutical delivery medicines which are not used for the treatment of a clearly determined pathology, nor for cosmetic use, dietary products, mineral waters, elixirs, toothpaste and other similar products.

Nor will finance drugs indicated in the treatment of syndromes or symptoms of lower gravity, or those who do not respond to current therapeutic needs, having even been authorized according to the regulations in force at the time, meaning an unfavourable benefit/risk balance in diseases for which they are quoted.»

6. Added a new article 89 bis, which will have the following wording: «article 89 bis.» Fundamental criteria for inclusion in the pharmaceutical provision.

1 corresponds to the Government set the criteria and procedure for pricing of medicines and sanitary products fundable by the national system of health, medication dispensing by community pharmacy through official recipe, both for hospital drugs, including clinical, or dispensed by a pharmacy service containers to patients not admitted.

2. for the decision of financing of new drugs, as well as the cost-effectiveness analysis and budgetary impact, will take into account the component of innovation, for therapeutic advances undisputed by modify the course of the disease or improve the course of the same, the prognosis and the result of therapeutic intervention and its contribution to the sustainability of the national health system if for the same result in health, contributes positively to gross domestic product.

3 be taken into consideration mechanisms (linear discounts, price revision) return for innovative medicines.

«4. the Inter-Ministerial Committee for the prices of drugs will take in consideration the cost-effectiveness analysis and budget impact.»

7. Amending article 90, which will have the following wording: «article 90. Pricing.

1. for the marketing of a drug or health product in Spanish territory, it is essential to have transacted the offer to the national health system. Proceed in the same way if substantial changes occur in the conditions for authorisation of the medicinal product or medical device.

2. the Government may regulate the mechanism of pricing of medicines and health products that do not require prescription is exempt in Spanish territory, following a general objective and transparent regime.

3. in any case, holders of marketing authorisations may be marketed drugs that are exempt in Spanish territory in reported pricing, meaning the communication of the price to the Ministry of health, social services and equality, so that the Department can object to it for reasons of public interest.

4 corresponds to the Interministerial Commission on prices of drugs, ascribed to the Ministry of health, social services and equality, to pricing, so motivated and in accordance with objective criteria, the funding of the national system of health drugs and health products for which it is necessary medical prescription, which are exempt in Spanish territory. When these same products are not funded, if they are dispensed in national territory it will operate as established in paragraph 3.

5. in any case, medicaments and medical devices which will decide may be financed by the national health system may be also marketed for its prescription outside it.

6 as a general rule, funding for the national health system will cost less than the industrial price of applied medicine when it is dispensed outside the national health system.

7. for the decision making process, the Inter-Ministerial Committee on prices of medicines take into consideration reports to prepare the Advisory Committee of the benefit pharmaceutical of the system national health.

8. the economic amounts corresponding to the concepts of distribution and dispensing of medicaments and sanitary products and, in your case, the deductions applicable to the billing to the national health system will be set by the Government, consent of the delegate of the Government Commission for Economic Affairs, in general or by groups or sectors taking into account criteria of technical and sanitary nature.
9. the Ministry of health, social services and equality will establish the selling price to the public of medicines and sanitary products funded through the aggregation of the authorized industrial price, having character maximum, and the margins for wholesale distribution and dispensing activities to the public.»

8. Added a new article 90 bis, which will have the following wording: «article 90 bis.» The Advisory Committee of the benefit pharmaceutical of the system national health.

1. providing national health system pharmacy Advisory Committee is the College's scientific-technical, character attached to the ministerial unit with competence in the field of pharmaceutical service of the Ministry of health, social services and equality, responsible for providing advice, assessment and consultation on the relevance, improvement and monitoring of the economic evaluation necessary to sustain the decision of the Interministerial Committee on prices of medicines.

2 providing pharmaceutical of the national health system Advisory Committee shall be composed of a maximum of 7 members appointed by the titular person of the Ministry of health, social services and equality, between professionals of recognized prestige, with accredited in pharmacoeconomic evaluation experience and track record.

3. in addition, depending on the issues that are being debated, be able to attend the sessions of the Committee evaluators of the competent body in the field of medicines and sanitary products that have made assessments of medicines and sanitary products discussed.

4. in any case, the creation and functioning of the Advisory Committee of the pharmaceutical provision will be attended with those media personal, technical and budget assigned to the organ is found attached to."

9. A new paragraph 6 is added to article 91, which will have the following wording: ' 6. for the purposes of reviews of prices downward at the request of part provided for in paragraph 1 of this article, only will be considered which involve, at a minimum, a reduction of 10% on the maximum industrial price in force authorized for funding with public funds. "

10. Amending article 93, which will have the following wording: «article 93. Reference pricing system.

1. the public financing of drugs shall be subject to the system of reference prices. The reference price will be the maximum amount that will finance the presentations of drugs included in each of the sets to be determined, provided that they prescribe and dispense with charge to public funds.

2. the sets will include all funded drugs presentations that have the same active ingredient and identical route of administration among which there will be included in the pharmaceutical provision of the national health system, at least, a generic drug or biosimilar presentation, unless the drug or its main active ingredient has been marketed for a minimum of ten years in a Member State of the European Union in which case, the existence of a generic drug is not necessary to establish a set. Submissions indicated for treatment in Pediatrics, as well as those in hospital medicine, including clinical containers, shall constitute independent sets.

3. the price tag of each set shall be calculated on the basis of the lowest grouped presentations of medicines in the cost/treatment/day, and in any case must ensure the supply to pharmacies for lower-price drugs. The drugs may not exceed the price tag of the whole to which they belong.

4 the new sets will be established and will be reviewed the prices of already existing assemblies on an annual basis. However, under new homogeneous groupings of prices will be fixed automatically in the list that matches, and under the existing prices will be reviewed on a quarterly basis.

5. the Ministry of health, social services and equality will establish a similar system of prices for health products.»

Eleven. Added a new article 93 bis, which will have the following wording: «article 93 bis.» System of prices selected for eligible products.

1. the Ministry of health, social services and equality may propose the implementation of selected drugs and eligible health products price mechanism to the Interministerial Committee on prices of medicines.

2. for this purpose, the Ministry of health, social services and equality shall prepare a reasoned proposal, according to the criteria laid down in this article, that will contain the selected maximum price applicable in each case.

3. Once approved by the Interministerial Committee on prices of drugs, the Ministry of health, social services and equality, will publish the decision by resolution of the unit responsible for the pharmaceutical provision.

4 in the case of funded medicines, the selected price system applies to drugs subject to prices of reference, taking into account: to) the consumption of the set.

(b) the budgetary impact.

(c) the existence of at least three drugs in the set.

(d) that there is risk of shortages.

5. similar criteria will be applied in the case of health products.

6 valued the above criteria, the Ministry of health, social services and equality, through the unit responsible for pharmaceutical delivery, shall communicate to providers the commencement of a procedure of selected price, with communication of the maximum price of financing proposed so that they manifest their intentions.

7. based on the communications received, the Ministry shall draw up the proposal referred to in point 2 of this article.

8. those drugs or health products that exceed the bankable maximum price shall be excluded from funding by the national health system.

9. the selected price will have a validity of two years during which can not be modified.

10. the system of selected prices will be updated, to cases in which has not been applied previously, with annual periodicity, simultaneously to the updating of the system of reference prices.

11. the implementation of this system will result in the exclusion of the public funding of those presentations that are not selected by the time of validity of the selected price.

12. in any case, the presentations of medicines that are affected by regulated in this article will be exempt, from the moment of application of deductions regulated in articles 8, 9 and 10 of the Royal Decree-Law 8/2010 of 20 may, by which adopt extraordinary measures for the reduction of the public deficit.

13 holders laboratories of the marketing authorization of the presentations of medicines and sanitary products that are finally selected presentations suppliers companies must assume the commitment to ensure their adequate supply by express statement to this effect.

14. the selected system of prices may apply to medicines and medical devices which not being funded, are considered of interest to public health in the terms expressed in the law 33/2011, on 4 October, General public health.

15. in this regard, the Ministry of health, social services and equality for the determination of the selected price taken into account the special characteristics of distribution and application of these products.

16. in addition, can be extended via the selection mechanism for fixation of a contribution reduced by homogeneous groupings.»

12. Amending paragraph 1 of article 94, which shall have the following wording: «1. the Government review periodically the participation in the payment to satisfy the pharmaceutical provision included in supplementary common portfolio of the national health system, and the assumptions of full financing from public funds by citizens. "

The review will be published in the "official bulletin of the State", by order of the titular person of the Ministry of health, social services and equality."

13. Added a new article 94 bis, which will have the following wording: «article 94 bis.» Contribution of the beneficiaries in ambulatory pharmaceutical delivery.

1 it means outpatient pharmaceutical delivery which is dispensed to the patient through office or pharmacy.

2. the outpatient pharmaceutical benefit is subject to the user.

3. the contribution of the user shall be made at the time of the dispensing of the medicinal product or medical device.

4. the contribution of the user will be proportional to the level of income that will be updated, as Max, annually.

5 in General, the percentage of the user will continue to the following scheme: to) 60% of RRP for users and beneficiaries whose income is equal to or exceeding 100,000 appropriated EUR box saving the Declaration of personal income tax and general taxable base.
(b) 50% of RRP for persons who have the status of active insured and beneficiaries whose income is equal to or greater than 18,000 euros and less than 100,000 euros in the box of general taxable base and saving the Declaration of personal income tax.

((c) 40% for people who have the condition of active insured and their beneficiaries and are not included in paragraphs a) or b) earlier.

((d) 10% of PVP for persons who have the status of insured as pensioners in Social Security, with the exception of the persons included in paragraph a).

6 in order to ensure the continuity of the treatment of chronic and ensure a high level of fairness to pensioners patients with treatments of long duration, the General percentages are subject to stops maximum contribution in the following cases: to) to 10% of PVP in medicinal products belonging to the ATC groups of reduced contribution with a contribution maximum for 2012, expressed in euros, resulting from the application of the updating of the IPC to the current maximum contribution. The maximum contribution will be updated, automatically each month of January according to the evolution of the inflation rate. The update will be formalized by a resolution of the unit responsible for pharmacy of the Ministry of health, social services and equality.

((b) for persons who have the status of insured Social security pensioners and their beneficiaries whose income is less than € 18,000 definition given in box of general taxable base and saving the Declaration of the tax on the income of physical persons or that are not included in the following paragraphs c) or d) up to a maximum limit of monthly contribution of 8 euros.

(c) for persons who have the status of insured as pensioners from Social Security and their beneficiaries whose income is equal to or greater than 18,000 euros and less than 100,000 recorded in the box in general taxable base and saving the Declaration of the tax on the income of the physical people, up to a maximum monthly contribution of € 18.

(d) to persons who have the status of insured as a pensioner of the Social Security and their beneficiaries whose income exceeds 100,000 appropriated euros in box general taxable base and the saving of the Declaration of the tax on the income of the physical people, up to a maximum monthly contribution of 60 euros.

7. the amount of contributions exceeding these amounts will be subject to reinstatement by the corresponding Autonomous Community, with a monthly maximum.

8 shall be exempted from contribution, users and beneficiaries that belong to one of the following categories: to) affected by toxic syndrome and people with disabilities in the cases referred to in its specific regulations.

(b) recruit people of incomes of social integration.

(c) the person of non-contributory pension recipients.

(d) unemployed who have lost eligibility for unemployment benefits while continues his situation.

(e) the derivatives of accident at work and occupational disease treatments.

9. the level of contribution of members and passive classes of General mutuality of civilian officials of the State, of the Social Institute of the armed forces and the Judicial General mutual insurance company shall be 30%.'

Fourteen. Added a new article 94 ter, which will have the following wording: «article 94 ter. Protection of personal data.

1. the National Institute of Social Security will treat the data in the files of the management entities and common services of Social Security and the entities that collaborate with them that are essential for determining the amount of the contribution of the beneficiaries in the pharmaceutical provision. Such treatment, which will not require the consent of the person concerned, shall be fully the provisions of the organic law 15/1999, of 13 December, of protection of data of a Personal nature, and its development provisions.

2. in the same way, and for the purpose referred to in the preceding paragraph, the competent authority in tax matters may communicate to the National Institute of Social Security, without the consent of the person concerned, the data that are necessary to determine the level of income required.

Likewise, bodies of public administrations that are competent to determine the concurrence of the requirements for exemption from the contribution envisaged in paragraph 8 of article 94 bis of this law, may communicate this circumstance to the National Institute of Social security without the consent of the person concerned.

3. the National Institute of Social Security shall inform the competent health authorities the data relative to the level of contribution that corresponds to each user in accordance with provisions of the regulatory legislation of medical prescriptions and dispensing orders. In any case, such information shall include the data of the specific amount of income.

Reported data in accordance with the provisions of the preceding paragraph shall be subject to processing by the health administration for the sole purpose of its incorporation into the system of information of the individual health card.'

15. Added a new article 97 bis, which will have the following wording: «article 97 bis.» Fundamentals of information systems for the control of the pharmaceutical provision.

1. the intervention of the State in the field of medicines and sanitary products financed by the national health system requires the full disposition of solid information on the consumption of health care inputs subject to such information. A_tal_efecto, both the Ministry of health, social services and equality as the competent ministries of the autonomous communities and, where appropriate, suppliers and their professional representative bodies, provide the following information regarding the traffic and consumption of the same: to) billing data of officials of the national health system monthly, dispensed by pharmacies and recipes added by province and autonomous community.

(b) details of acquisitions by pharmaceutical services of centres and health services or health of the national health system and if fertilizers of medicines and health products, at least monthly and aggregation by province and autonomous community level.

2. the General mutuality of civilian officials of the State, the Judicial General mutual insurance company and the Social Institute of the armed forces will provide the same type of information, with the exceptions of healthcare modalities that are specific to them.

3. the medicines dispensed by pharmaceutical services centres and health services or health of the national health system to outpatients will be collected in a specific software application.

4 computer processing referred to in the previous paragraph may be extended to other drugs and health products for exclusive hospital to which the Interministerial Commission on prices of drugs appropriate apply a regime of unique cautions.»

Sixteen. Added a new article 97 ter, which will have the following wording: «article 97 ter. Promotion of competition and competitiveness.

1. for the attainment of the goals of efficiency and sustainability of the pharmaceutical provision of the national health system will be implemented administrative measures and regulatory that are considered appropriate to stimulate competition between suppliers of inputs pharmaceuticals, resulting in declines in unit prices in each financial year.

(2) a limited performance competition shall be deemed contrary to the principles of efficiency and sustainability and will be prosecuted ex officio by the competent bodies.»

Seventeen. Amending paragraph 1 of the sixth additional provision, which will have the following wording: «1. individuals, business groups and legal persons not integrated in them, that engage in Spain in the manufacture, import or supply to the national health system of drugs or health products, financed with public funds, are exempt in pharmacies» through official recipe or order of dispensation of the national system of health, on national territory, shall be paid on a quarterly basis the quantities resulting from applying on your quarterly sales volume through this recipe or order of dispensation, the percentages referred to in the following scale: quarterly sales to PVL percentage of contribution from 0.00 3.000.000,00 1.5 3.000.000,01 in later 2.0 in the assumption that the total volume of sales of medicines and products health to the national health system is, in current terms per year, less than the previous year, the Government may revise the above percentages of contribution.

The amounts resulting from the application of the previous scale will be serviceability on the basis of the valuation of the companies within the framework of the Profarma action according to the percentages set out in the following table: • not valued: 0.00.
• Acceptable: 5%.

• Good: 10%.

• Very good: 15%.

• Excellent: 25%.

Those companies classified in the Profarma program as very good or excellent, that participate in r & d consortia or made ventures to this end with other companies established in Spain and public and private r & d centres, to perform basic and preclinical research of relevance, using specific and certain projects, will benefit from an additional deduction of ten per cent of the contribution.

The reductions that affect these returns will take effect starting from the last resolution of the Plan Profarma.

The business groups shall inform the Ministry of health, social services and equality, during the month of January of each calendar year, the companies integrated in them. When you modify the composition of a business group in the course of the year, communication shall be made in the month in which such modification has taken place. For the purposes of the above, is considered that companies which constitute a decision unit, under the terms of article 4 of the law 24/1998 of 28 July, the stock market belong to the same group."

Eighteen. Amending the second subparagraph of paragraph 1 of the fourteenth additional provision, which will have the following wording: "the price-sensitive information will be updated the first working day of each month and will be published on the website of the Ministry of health, social services and equality."

Article 5. Modification of the Royal Decree 823/2008, of 16 may, laying down allowances, deductions and discounts corresponding to the distribution and dispensing of medicinal products for human use.

One. Add a new paragraph 8 in article 2 of the Royal Decree 823/2008, of May 16, which establishing allowances, deductions and discounts for the distribution and dispensing of medicinal products for human use, which shall have the following wording: «8.Con order to ensure the accessibility and quality of service, as well as the appropriate pharmaceutical care to users of the national health system Pharmacy offices that are exempt from the scale of deductions regulated in paragraph 5 of this article, it will be of application in their favor a correction rate of the margins of pharmacies for prescriptions or orders of dispensation of medicinal products for human use manufactured industrially dispensed by public funds, according to the following scale : Total sales to PVP IVA to - Euros deduction - euro rest to - EUR applicable percentage 0.00 0.00 25,000.00 - 3.40 25.000,01 - 850,00 37.500,00 0.00 37.500,01 - 850,00 45.000,00 12.98 45.000,01 123,50 58.345,61 14,.27 58.345,62 2.027,92 120.206,01 15.69 120.206,02 11.733,82 208.075,90 18.71 208.075,91 28.174,27 295.242,83 21.60 295 .242,84 47.002,32 382.409,76 23.67 382.409,77 67.634,73 600.000,00 25.04 600.000,01 122.119,32 forward 27,52 for the implementation of the corresponding section of the above-mentioned scale will take into account the amount of the amount of the monthly billing for prescriptions or orders of dispensation of medicinal products for human use manufactured industrially dispensed with charge to public funds.

Applying the index correction shall be made in the first segment of the scale, 0 to 25,000 euros, of the monthly billing for prescriptions or orders of dispensation of medicinal products for human use manufactured industrially dispensed with charge to public funds. Such monthly billing will be calculated in terms of selling price to the public increased the value added tax. In what refers to submissions for drugs with more than 91,63 euros and for the purpose of this monthly billing industrial price, shall be excluded that computing the amount, calculated in terms of sale to the public with VAT included price, exceed the aforementioned industrial price.

Such offices of pharmacy shall comply with the following requirements: to) that they have not been subject to administrative sanction or disqualification professional or are excluded from its conclusion.

(b) participate in pharmaceutical care programs and in the realization of all activities aimed at the rational use of medicines that establishes the corresponding health administration.

The decision on the fulfilment of the requirements, as well as the resolution of incidents that occur at the end will correspond to different sanitary competent authorities in pharmaceutical management, which shall establish the procedure for application. This will be General mutuality of civil servants of the State pre-trial hearing, the Judicial General mutual, the Social Institute of the armed forces and, where appropriate, to the National Institute of health management.

The amount derived from the application of correcting the margins index corresponding to the sanitary authorities of the national health system, including the General mutuality of civilian officials of the State, the Judicial General mutual insurance company and the Social Institute of the armed forces is the result of applying the percentage that represents each one of them in the monthly billing of each office of Pharmacy considered jointly. The management of the information procedure shall comply with rules with respect to reports concerning the implementation of the joint scale of deductions.»

Two. The current paragraph 8 of article 2 becomes paragraph 9 of this article.

Article 6. Measures relating to pharmaceutical care in hospitals, social welfare centres and psychiatric centers.

1 must be the establishment of a hospital pharmacy service in: to) all the hospitals that have 100 or more beds.

(b) the social welfare centres which have 100 beds or more assisted contract.

(c) the psychiatric centres which have 100 beds or more.

2. Notwithstanding the foregoing, responsible for counseling in the field of pharmaceutical delivery may establish agreements or agreements with hospitals, exempting these centers of this requirement, provided they have of a deposit of medications linked to the service of hospital pharmacy of the hospital of the public network which is the reference in the area or corresponding health area.

3. in addition, hospitals, social welfare centers that provide specific health care and psychiatric centres which do not have a hospital pharmacy service and are not required to have it will have a deposit, which will be linked to a pharmacy of the area health service and the responsibility of the head of the service, in the case of public hospitals , and an office of Pharmacy established in the pharmaceutical area or to a hospital pharmacy service, in the so-called concerned of a hospital in the private sector.

Article 7. Manipulation and adequacy of preparations of drugs.

1. with the aim of improving the efficiency in the use of medicines in the hospital setting, the autonomous communities may accredit Hospital of its territory pharmacy services so that in the same fractionation, customization of dose and other operations of remanipulation and transformation of drugs can carry out.

2. the accreditation provided for in the preceding paragraph shall be made so as to ensure compliance of technical good practice guidelines applicable to the case by pharmacy services Hospital where they will carry out the above operations be.

3 handling, fractionation and customized dosing guidelines will be developed under the supervision of the General Directorate of basic services of the national system of health and pharmacy portfolio, seeking to effect the collaboration of the Spanish Agency of medicines and health products and renowned experts.

Chapter V measures in human resources article 8. Modification of the law 44/2003, of 21 November, management of the health professions.

Law 44/2003, of 21 November, management of the health professions, is hereby amended as follows: one. Modifies article 25, which shall have the following wording: «article 25. Specific training areas.
1. the specialized training in areas of training specified shall be, in any case, scheduled and will be held by the system of residence with the specificities and adaptations that implementing regulations shall determine the legal regime that regulates this training system.

2. regulations assumptions and requirements will be established so that specialists in health sciences can access, through call of the Ministry of health, social services and equality, to the diplomas of specific training Area, provided that these areas had become the corresponding specialty and are credited, at least two years of professional experience in the specialty.

3. the Ministry of health, social services and equality, following a report from the National Council of specialties in health sciences and of the Committee on human resources of the national health system, may eliminate, reduce or increase the years of professional practice referred to in paragraph 1 of this article.»

Two. Amending article 26, which will have the following wording: «article 26. Accreditation of centres and teaching units.

1. the Ministry of health, social services and equality and the competent in the field of education, on the proposal of the Committee on human resources of the national system of health, by order to be published in the "official bulletin of the State", will establish the accreditation requirements that, in General, shall comply with the centers or units for the training of specialists in health sciences.

2 corresponds to the competent governing body in the field of quality of the Ministry of health, social services and equality coordinate audits of accredited, centres and units to assess in the context of the quality Plan for the national health system and of the annual Plan of audits teachers, the functioning and the quality of the training system.

3 corresponds to the competent governing body specialized health training of the Ministry of health, social services and equality, at the request of the assignee of the heart, previous reports of the Committee on teaching and the competent Ministry in the autonomous community health, resolve on requests for accreditation of centres and teaching units. Accreditation shall specify, in any case, the number of accredited teaching positions.

4 total or partial revocation of the granted accreditation will be in your case, by the same procedure, heard the affected Center and its teaching Commission.»

3. Modifies article 29, which will have the following wording: «article 29. Specific training Areas committees.

1. when there is an Area of specific training will constitute an Area Committee as an advisory body of the Ministry of health, social services and equality. It will comprise six professional title of specialist with specific training in the area in question, proposed by the Commission or national commissions of specialty or specialties involved, report of the Committee on human resources of the national health system shall be appointed by the competent Ministry cited.

2. the Committee will develop functions to be determined according to the rules and, in any case, the proposal for the contents of the training programme.

3. in any case, the creation and operation of the Area Committee will be attended with those media personal, technical and budget assigned to the organ is found attached to."

Four. Modifies the fifth transitional provision, which will have the following wording: «fifth transitional provision. Creation of new titles and specialist degrees in Areas of specific training in the health sciences.

1. where, as provided for in article 16 of this law, are established new official titles of specialist in health sciences, the Government will take appropriate measures to provide access to the new title of the professionals who had provided services in the area of the new specialty and meet the requirements established by law. Likewise, it shall take appropriate measures for the initial Constitution of the National Committee of the specialty.

2. when, in accordance with article 24 of this law, provisions are established new diplomas in Areas of specific training for specialists in health sciences, the Government will take appropriate measures to provide access to the new diplomas in the professionals who had provided services in the area of the new Area of specific training and meet the requirements established by law.

3. in addition, the Government will take appropriate measures for the initial Constitution of the corresponding committees of Area specific training.»

Article 9. Modification of law 16/2003, 28 of may, cohesion and quality of the national health system.

Added a new additional provision ten law 16/2003, of May 28, of cohesion and quality of the national health system, which will have the following wording: «tenth additional provision. State Register of health professionals.

1. in order to facilitate the proper planning of the needs of health professionals of the State and coordinate the policies of human resources in the field of the national health system, is created in the Ministry of health, social services and equality, the State Register of health professionals to be integrated in the system of health information from the national health system.

2. such registration, which will be implemented in digital media, nutria from official records, professional, hearing in the State and autonomous administrations, professional associations, regional councils and general councils, in private health centres and institutions of insurance operating in the branch of the disease, which will be required to provide information deemed necessary subject to the criteria determined by the Interterritorial Council of the national health system in the terms provided for in article 53.3 from this law.

3. the State of health care professionals register shall be public as regards qualifications, name, place of exercise, category and function of professional, specialty, as well as in relation to the qualification, specialty, Area specific training and accreditation and accreditation Advanced Diploma, if any, and to obtaining and validating each of them dates.

4 shall apply to the State Register of health professionals in the organic law 15/1999, of 13 December, of protection of data of a Personal nature. It corresponds to the Ministry of health, social services and equality the technical and organizational security measures provided for in the aforementioned regulation, ensuring in particular that do not fit the indiscriminate access to data that are not of public nature in accordance with the provisions of the preceding paragraph.

«Also corresponds to the Ministry of health, social services and equality implement gradually the State Register of health professionals to the various health professions and the continual updating of the data that it contains, in particular, provided that there is an incidence for the professional exercise.»

Article 10. Modification of the law 55/2003, of December 16, the framework statute of the statutory staff of the health services.

Law 55/2003, of December 16, the framework statute of the statutory staff of the health services, is hereby amended as follows: one. Amending article 15, which will have the following wording: «article 15. Creation, modification and deletion of categories.

1. within the scope of each health service will be established, amended or deleted the categories of statutory staff in accordance with the provisions of chapter XIV and, where appropriate, of article 13 of this law.

2 corresponds to the Ministry of health, social services and equality the adoption of a uniform catalog where the equivalences of the professional categories of health services will be established. These effects, health services shall communicate to the Ministry of statutory staff categories existing in the same, as well as its modification or suppression and the creation of new categories, in order to proceed, in your case, the development of this table of equivalence and its approval in accordance with the provisions of article 37.1.»

Two. Amending paragraphs 3 and 4 of article 41, becoming the current paragraphs 4, 5 and 6 of article paragraphs 5, 6 and 7. Paragraphs 3 and 4 of article 41 shall have the following wording: «3. the amount of remuneration will adapt to having the corresponding laws of budgets. " Fundamental element in this section is, in any case, the evaluation of the performance of the statutory staff, to health services be established through procedures based on the principles of equality, objectivity and transparency. Periodic evaluation should be taken into account for the purposes of determination of a part of these supplementary remunerations, related precisely to the productivity, performance and, ultimately, to the content and scope of the activity actually carried out.
4. the health of the autonomous communities and management bodies of health care services will establish the necessary mechanisms, such as management of places of work, management of supplementary remuneration, disengagement from teaching positions, or others, that guarantee the payment of the activity actually carried out.»

3. Added a new fifteenth additional provision, which will have the following wording: «fifteenth additional provision. Extension of the provisions of article 21 of Royal Legislative Decree 4/2000, of 23 June, which approves the revised text of the law on Social security of the civil officials of the State.

Statutory staff of the health services of the autonomous communities and institutions assigned to the National Institute of health management is excepted from the extension provided for in article 21 of Royal Legislative Decree 4/2000, of 23 June, which approves the revised text of the law on Social security of the civil officials of the State , and at the disposal additional sixth of law 26/2009, of 23 December, from the State budget for the year 2010, with respect to the economic benefit during the situation of temporary disability of the personal officer integrated into the General Social security scheme, regardless of the Administration in which it provides services.

The health services of the autonomous communities will decide, with respect to its statutory staff, the degree of implementation of the content of this economic benefit, when one is in a situation of temporary disability."

Four. Added a new sixteenth additional provision, which will have the following wording: «sixteenth additional provision. Integration of the staff officer in the service of public health institutions.

1. physicians, practitioners and midwives holders of local health services that provide their services as general practitioners, practitioners and midwives in health services, and the rest of the staff officer who lend their services in public health institutions, will have until December 31, 2012 for integrated into health services as statutory staff fixed. To this end, the autonomous communities shall establish appropriate procedures.

2. in the event that this staff elects to remain active in its current situation, bodies and scales in those who have the status of staff officer, the autonomous communities shall be attached to this staff to administrative bodies that do not pertain to public health institutions, in accordance with the foundations of the processes of mobility which, to this end can be articulated.

5. Adds a new seventeenth additional provision, which will have the following wording: «seventeenth additional provision. Social action.

In order to strengthen and rationalize the actions in the field of social action, the funds earmarked for this purpose by the health services of the autonomous communities for the statutory staff, may only be aimed at the needs of staff who is in active service administrative situation, and in no case be eligible for provision of this character , with economic content, staff who have reached the retirement age determined by the Social security legislation. In cases in which the extension of active service is authorized, the age will be which figure in the resolution authorizing the extension.»

6. Amending the third transitional provision, which will have the following wording: «third transitional provision. Personal space and area.

In the form and conditions to be determined in each health service, in your case, staff perceived assets by the system of quota and area will be integrated into the system of provision of service, dedication and remuneration set out in this law, by December 31, 2012. It is deleted from that date the mode of provision of quota and area.

As of that date is repealed the order of the Ministry of health and consumption of 8 August 1986, about from staff remuneration dependent on the National Institute of health, Catalan Institute of health and health care of the Social Security in Andalusia network.»

7. The letter f is modified) of (1) the sole repeal provision, which will have the following wording: «f) the status of health personnel not approved by the order of April 26, 1973, the health institutions of the Social Security optional as well as provisions which modify it, Supplement and develop.»

First additional provision. Regime of Spanish nationals living abroad.

1. the right to the protection of the health of Spanish nationals living abroad shall be governed by the provisions in the law 40/2006, of 14 December, the Statute of Spanish citizenship abroad and its implementing regulations.

2. the self-employed outside Spanish origin residents in States not members of the European Union, other States party in the agreement on the European economic area and in Switzerland temporarily moving to Spain have the right to healthcare in Spain with public funds, through the national health system when, in accordance with the provisions of Spanish Social Security the State of origin or the rules or International Social security conventions established for that purpose, would not have expected this coverage.

Second additional provision. The fixing of maximum amounts of funding.

1. in the area of dietoterapicos, the fixing of maximum amounts of funding shall be subject to in the Royal Decree 1205 / 2010, 24 September, laying the basis for the inclusion of dietary foods for special medical purposes in providing with the national system of health-dietetic products and for the establishment of maximum amounts of funding.

2. the Council of Ministers shall adopt, within the period of 6 months from the entry into force of this Royal Decree, a Royal Decree for the regulation of the additional portfolio of providing prosthetics of the national health system and for the establishment of maximum amounts of funding.

3. the Ministry of health, social services and equality shall develop within the period of 6 months from the entry into force of this Royal Decree, a ministerial order picking up the agreements of the plenum of the Interterritorial Council of the national health system on medical transport urgent, not subject to prescription, for clinical reasons.

Third additional provision. Transfer of tax information.

The tax administration will facilitate, within each year, the organ of the public administration responsible for the recognition and control of the insured or beneficiary of the same condition, data relating to their income levels insofar as they are necessary to determine the percentage of participation in the payment of the benefits of the common portfolio of services subject to contribution.

In the treatment of these data assignee administration shall comply with the rules on protection of personal data.

Fourth additional provision. Efficiency measures within the scope of the national health system.

1. the Interterritorial Council of the national health system will promote joint actions by the health services of the autonomous communities for the acquisition of any product which by its nature is susceptible of a mechanism of joint and centralized purchase. In addition, the health services of the autonomous communities shall encourage the introduction of models of shared services through the establishment of a single service provider for a network of centres, on issues such as radiology, laboratory of clinical analysis, hospital pharmacy, as well as the performance of medical specialties that need a large population to be self-sufficient or suffering from difficulties to find professionals.

2. the autonomous communities shall take appropriate measures so that the centers of them dependent develop throughout 2012, in the event that they have not done so already, a plan of energy saving measures that must be approved by the competent authority by 31 December 2013.

3. within a period of six months from the date of entry into force of this Royal Decree, the Ministry of health, social services and equality shall adopt the necessary legislative measures to ensure the adequacy of the containers to guidelines and common treatment times according to the criteria of good medical practice.

First transitional provision. Transitional regime of access to health care in Spain.

Persons who, prior to the entry into force of this Royal Decree, had access to health care in Spain, can still access the same until August 31, 2012, without having to prove the status of insured in the terms provided for in article 3 of the law 16/2003 of 28 May.

Second transitional provision. Common portfolio of services of the national health system.
Insofar as not develop the implementing regulations of the common portfolio of the national system of health services, shall remain in force the Royal Decree 1030 / 2006 of 15 September, which establishes the portfolio of common services of the national health system and the procedure for its updating, everything what is not opposed to the present standard.

Third transitional provision. Fixing the prices of drugs not included in the pharmaceutical provision.

Unless a decision to the contrary of the delegate Committee for Economic Affairs, for reasons of general interest, insofar as not regulate mechanisms of pricing of retail of medicines and sanitary products, these will be free in those medicines that are not funded by public funds.

Sole repeal provision. Repeal legislation.

Repealed article 115.1 of the consolidated text of the General Social Security Act, approved by Decree 2065 / 1974, 30 may, as well as many other provisions of equal or lower rank to oppose provisions in the present Royal Decree-law.

First final provision. Skill-related title.

This Royal Decree is issued under cover of the provisions of article 149.1.2., 149.1.16., 149.1.17., 149.1.18. ª and 149.1.30. ª of the Spanish Constitution.

Second final provision. Regulatory development.

1 authorizes the Government and the titular person of the Ministry of health, social services and equality, within the scope of their respective competencies, to enact the provisions and adopt the measures necessary for the development and implementation of the provisions of this Royal Decree-law.

2 modifications that, from the entry into force of this Royal Decree, can be made with respect to the provisions in article 5, as well as in the fifth, sixth and seventh, final provisions may be carried out in accordance with the specific rules of application with regulations.

3. the autonomous communities shall take, in the scope of their respective competences, the measures necessary for the effectiveness of the provisions of this Royal Decree.

Third final provision. Amendment of article 12 of the organic law 4/2000, of 11 January, on rights and freedoms of foreigners in Spain and their social integration.

Amending article 12 of the organic law 4/2000, of 11 January, on rights and freedoms of foreigners in Spain and their social integration, which will have the following wording: «article 12. Right to health care.

Foreigners are entitled to health care in the terms established in the current legislation on health.»

Fourth final provision. Modification of law 58/2003, of December 17, General tax.

The letter c) of paragraph 1 of article 95 of the Act 58/2003, of December 17, General Tributaria, is hereby amended as follows: «c) collaboration with the labour and Social Security Inspectorate and the management entities and common services of the Social Security in the fight against fraud in the quote and collection of quota contributions of the Social security system and fraud in obtaining and enjoyment of benefits» in charge of the system; as well as for the determination of the level of contribution of each user in the performance of the national health system."

Fifth final provision. Modification of Royal Decree 240/2007 of 16 February on entry, freedom of movement and residence in Spain of citizens of States members of the European Union and other States party to the agreement on the European economic area.

Article 7 of Royal Decree 240/2007 of 16 February on entry, freedom of movement and residence in Spain of citizens of States members of the European Union and other States party to the agreement on the European economic area is to be re-worded as follows: «article 7. Residence exceeding three months citizens of a Member State of the European Union or of another State party in the agreement on the European economic area.

1 any citizen of a Member State of the European Union or of another State party to the agreement on the European economic area has the right of residence in the territory of the Spanish State for a period exceeding three months if: to) is a worker employed or self-employed in Spain, or b) have, for themselves and their family members (, sufficient resources to not become a burden on the social assistance in Spain during their period of residence, as well as a sickness insurance covering all risks in Spain), or (c) is enrolled in a public or private Centre recognized or funded by the competent educational administration pursuant to applicable law, with the aim of studying including vocational training; and he has a sickness insurance covering all risks in Spain and guarantees to the competent national authority, by means of a declaration or by any other equivalent medium of your choice, that it has sufficient resources for themselves and their family members to not to become a burden on the social assistance of the Spanish State during their period of residence ((((, or d) is a member of the family that accompanies a citizen of the European Union or of another State party in the agreement on the European economic area, or going to meet him, and that meets the conditions referred to in to), b) or c).

2 the right of residence laid down in paragraph 1 shall be extended to the members of the family who are not nationals of a Member State when they join the citizen of the European Union or of another State party to the agreement on the European economic area or to meet with him in the State Spanish, provided that the citizen satisfies the conditions referred to in to) ((, b)) or (c) of paragraph 1.

3 a the effects of letter to) of paragraph 1, the citizen of the European Union or of another State party to the agreement on the European economic area that as not exercise any activity or own-account self-employed will keep the status of worker employed or self-employed in the following cases: to) If you have a temporary disability resulting from a disease or accident;

(b) If, having been in involuntary unemployment duly accredited, having been employed for more than one year, has joined the competent employment service in order to find a job;

(c) If, having been in involuntary unemployment duly accredited after concluding an employment contract for a fixed term of less than one year or having been involuntarily unemployed during the first twelve months, has joined the competent employment service in order to find a job. In this case, the status of worker will remain for a period that may not be less than six months;

d) If you follow a vocational training. Unless you are in a situation of involuntary unemployment, the maintenance of the status of worker required training related previous employment.

4 Notwithstanding the provisions of point (d)) of paragraph 1 and in paragraph 2, only the spouse or person it referred to in subparagraph (b)) item 2 and dependent children shall have the right residence as members of the family of a citizen of the European Union or of another State party to the agreement on the European economic area which meets the requirements of point (c)) of paragraph 1 above.

5. the nationals of a Member State of the European Union or of another State party to the agreement on the European economic area shall be obliged to apply personally to the office of foreigners in the province where they intend to stay or take up residence or, failing that, to the relevant Commissioner of police, its entry in the Central Register of foreigners. Such a request shall be filed within three months as from the date of entry into Spain, to be issued a certificate of registration which will contain the name, nationality and domicile of the registrant, your identity number, and the date of registration immediately.

6. next to the application for registration, passport or national identity document valid and in force of the applicant, as well as the supporting documentation of compliance with the requirements for registration set out in this article shall be submitted. In the event that the passport or national identity document are expired, it shall be furnished copy of these and an application for renewal.

7. in what refers to economic means, may not be a fixed sum, they shall be taken into account the personal situation of the nationals of a Member State of the European Union or of another State party to the agreement on the European economic area. In any case, this amount shall not exceed the level of resources below which the Spanish social aid is granted or the amount of the minimum pension of Social Security."

Sixth final provision. Modification of the Royal Decree 1301 / 2006, of 10 November, that establish the norms of quality and safety for the donation, obtaining, evaluating, processing, preservation, storage and distribution of human tissues and cells and approve standards coordination and operation for use in humans.
The Royal Decree 1301 / 2006, of 10 November, that establish the norms of quality and safety for the donation, obtaining, evaluating, processing, preservation, storage and distribution of human tissues and cells and approve the rules of coordination and operation for use in humans, is to be re-worded as follows : One. A new paragraph shall be added to paragraph 1 of article 4, which shall have the following wording: «entities who intend to develop any promotion and publicity activities in support of the donation of human tissues and cells must request prior authorization from the competent health authorities. For this purpose, means competent health administration corresponding to the autonomous community where it is intended to develop the activity, and the national transplant organisation when the alleged activities exceed the scope. In any case, the procedure to resolve on the approval or denial of the development of these activities shall be governed by provisions of law 30/1992, of 26 November, legal regime of public administrations and common administrative procedure.»

Two. Added an article 30 bis, which will have the following wording: «article 30 bis.» Registry of donors of hematopoietic progenitors.

1. the national transplant organisation, without prejudice to the powers of regional authorities record, will be responsible for developing and maintaining the register of donors of hematopoietic progenitors comprehensive of the aggregate of all of the national system of health information.

2 units of coordination of transplantations of the autonomous communities shall be communicated in real time to the national transplant organisation information concerning donors of hematopoietic included in their respective records.

3. the titular person of the Ministry of health, social services and equality may entrust the management of this information to public or private entities which develop their activity in the field of the promotion and publicity in support of the donation of human tissues and cells."

Seventh final disposition. Modification of the Real Decree 1718 / 2010 of 17 December, on prescription and dispensing orders.

The Royal Decree 1718 / 2010, of 17 December on prescription and dispensing orders, is to be re-worded as follows: one. Modify the second and third subparagraph of paragraph 1 of article 5 which will have the following wording: «official prescriptions will be adapted to the following basic criteria of differentiation according to the expression of the acronym or the classification code in the database of individual, that could include printed alphanumerically or encrypted health card in the upper right part of the recipes according to the following scheme (: a) code TSI 001 for contribution-exempt users.

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

(c) code 003 TSI for users with a 40% contribution.

d) code TSI 004 for users with a 50% contribution.

e) code TSI 005 for users with contribution of 60%.

(f) ATEP for accidents at work or occupational disease recipes.

(g) NOFIN prescriptions of medicines and sanitary products not funded."

Two. Amending paragraph 3 of article 5, which shall have the following wording: «3. in addition to the prescription, the prescriber may deliver to the patient, in writing, the information and observations which, in its view, proceed to the better use of medication by the patient. " These information and observations will complement those authorized by the Spanish Agency of medicines and health products, and will be appropriate for each individual patient. Shall include, where appropriate, warnings about the adverse reactions, contraindications, interactions and precautions in use'

3. Paragraphs 6, 7 and 8 is added to article 5, which shall have the following wording: «6. prescription and therapeutic for the patient reports will incorporate information on the cost of treatment with differentiation of the percentage taken by the national health system. "

7. during the medical Act, the patient will be informed of the existence of therapeutic options of contribution reduced prior to the issuance of the official recipe of the national health system.

«8 all information will take into account accessibility for people with disabilities.»

Four. A new paragraph 6 is added to article 17 which shall have the following wording: «6. medicines and sanitary products not included in the single financing may be acquired and used by hospitals of the national health system prior agreement of the Commission responsible for the therapeutic protocols or college equivalent in each autonomous community.»

To take the decisions referred to in the preceding paragraph, commissions responsible must have been constituted according to the rules applicable in the autonomous community, will benefit from a manual procedure that ensures the quality of its decisions and inform of its Constitution and decisions to the competent organ within the Ministry responsible for.»

Disposal the eighth. Actions to be performed by the public administrations.

1. the competent public administrations shall take all necessary measures for the effective implementation of the provisions of this Royal Decree-law.

2. the competent public administrations in the field of social security and health carried out the actions required to update and adapt information from their databases to the provisions of this standard.

3. the competent public administrations must adopt, prior to June 30, 2012, all measures which are necessary for the effective implementation of the provisions of the thirteenth paragraph of article 4 of the Royal Decree-law.

Ninth final disposition. Entry into force.

The present Royal Decree-Law shall enter into force the day of its publication in the «Official Gazette».

Given in Madrid, on April 20, 2012.

JUAN CARLOS R.

The Prime Minister, MARIANO RAJOY BREY

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