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 extent of its benefits, its support in the progressive scheme of the taxes and solidarity with the least favoured, which has placed you in the forefront of health as a world reference model.

However, the absence of common rules on insurance throughout the national territory, uneven growth in the performance of the catalogue, the lack of adaptation of some of them to socio-economic reality and the Lack of rigour and emphasis on the efficiency of the system have led the National Health System to a situation of serious economic difficulty without precedent since its creation. Efficiency has been lost in the management of available resources, which has resulted in high late payments and an unsustainable deficit in public health accounts. It is therefore essential to take urgent measures to ensure their future and to help prevent this problem from persisting.

The National Health System has been suffering from a lack of coordination among the regional health services, which results in considerable differences in the benefits and services to which access patients in the different autonomous communities. Territorial cohesion and equity have been in question with certain measures taken in recent years.

The structural data and the most significant figures in public health expenditure show that public health can no longer avoid a situation that is clearly incompatible with its essential sustainability and that, time, it has resulted in serious harmful consequences for the employment and viability of the business sectors associated with it.

But, in addition, it is indefable to meet the current challenges of healthcare. Thus, the impact of population aging, the need to incorporate therapeutic innovations in clinical therapy, advancement and progress in molecular medicine, the development of advances in genomics and proteomics and new drugs, They will undoubtedly lead to an increase in health expenditure, the forecasts of which must be rigorously analysed by policy-makers.

The rational use and therapeutic adequacy of the actual duration of the treatments is one of the themes in which the emphasis should be placed. Thus, the latest environmental management data for drug residues shows the worrying costs of destruction of unused discarded products or of surplus units of the established therapeutic guidelines, which not only confirm the need to improve efficiency in the process of prescribing, dispensing and use of medicinal products, but warning of worrying environmental costs arising.

II

All the countries of the European Union are analyzing and adopting measures that make it possible to optimize their care and pharmaceutical models and, in particular, pharmaceutical spending and their weight in healthcare spending. The implementation of measures in this area is very intense, especially in those countries where the financial and economic crisis has hit the hardest.

In compliance with the obligation of the public authorities to manage in the most efficient way the capabilities of the system, the Spanish model of the National Health System, model, must be guaranteed. configured as the coordinated set of health services of the General Administration of State and the health services of the autonomous communities, which guarantees the protection of health and is based on public funding, universality and the gratuitousness of health services.

Therefore, reforms are needed to strengthen sustainability, improve management efficiency, promote savings and economies of scale, introduce new tools through new technologies, win in territorial cohesion, coordination of health and social services and, above all, ensuring equal treatment throughout the national territory with a basic portfolio of common services.

In addition, and in the light of the reports issued by the Court of Auditors, it is essential, without further delay, to regulate the condition of insured persons in order to avoid certain situations of provision of health care. are currently producing and are alarming the sustainability of the National Health System.

The government has expressed its desire to address these and how many other reforms are necessary or appropriate, not only through standards, but also by promoting good practices and pooling experiences, always on the basis of dialogue and counting on the collaboration of the autonomous communities, the political groups and how many associations and entities act in this field, thus ensuring the best care for the patients, who are the real center of the system.

It will be in this way how citizens can truly be guaranteed free, universal public health care.

The measures that apply in this real decree have as a fundamental objective to face a structural reform of the National Health System by providing it with solvency, viability and strengthening the cohesion measures for to make it sustainable over time, which makes it necessary for them to be implemented as urgently as possible. It is necessary, in the current socio-economic context, that these measures be implemented in a normative instrument of immediate effect that will respond without delay to the internal demands for improvement of the equity that the citizenry demands, of efficiency. which requires the Court of Auditors and the security required by the health sector, and the external transparency and feasibility required by the European Union.

For all of this, the Government considers that the necessary budgets of extraordinary and urgent need established in Article 86 of the Spanish Constitution that enable it to approve these measures by means of the mechanism of a royal decree-law.

III

Law 49/1998, of December 30, of the General Budget of the State for 1999, provided for Chapter III of its Title I that it would be the State, through the budgetary transfers to the autonomous communities, which would fully assume public funding for health care, thereby disengaging healthcare from contributions to social security.

This separation of sources of funding between the National Health System and Social Security has not led to the necessary delimitation of functions at the time of the recognition of rights. The autonomous communities, within the framework of their respective competences, have extended the right of health coverage in a very diverse way and without taking into account the European legislation on insurance, putting at risk the solvency of the National Health System itself and dealing with infringement procedures by the European Commission which calls for the effective implementation of the principle of equal treatment.

Reasoned opinion 2009/2341 of the European Commission addressed to the Kingdom of Spain for its refusal to issue the European Health Insurance Card to persons residing in Spain entitled to receive health care under the The regulations of some autonomous communities have highlighted the fragility of the mechanism for the recognition of the right to health protection 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 social security systems, and their implementing regulation, Regulation (EC) No 987/2009 of the European Parliament and of the Council The principle of equal treatment in benefits arising from the protective action of social security between citizens is made effective by the European and the Council of 16 September 2009 adopting the implementing rules. European Community, whatever its place of origin, assimilating these to those of the citizens of the country where they are provided.

On the other hand, 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 their family members to move and reside freely within the territory Member States, amending 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, as laid down in Article 7 of the Treaty which must be complied with in cases where a European citizen wishes to reside in another State Member, other than the original member, for a period exceeding three months.

However, Royal Decree 240/2007 of 16 February on entry, free movement and residence in Spain of citizens of the Member States of the European Union and of other States party to the Agreement on Space Article 7 of Directive 2004 /38/EC of the European Parliament and of the Council of 29 April 2004 in its literal terms has not been transposed by the European Economic Community. This circumstance has, and will continue to be, if it is not amended, a serious economic injury to Spain, especially as regards the impossibility of ensuring returns on the costs incurred in the provision of health services and social to European citizens.

The Court of Auditors has shown that the National Health System is assuming, from its budgets, the health care of people who already have it covered, or by its social security institutions. at source, either by private insurance schemes, which is greatly eroding their financial capacity and preventing their managers from continuing to make improvements in services. A harmonised clarification of the condition of insured persons, for the purpose of providing health and social services, is therefore imposed in such a way that the latter is effectively linked to the financing by taxes and the nature of the social solidarity that the progressive scheme of the same has in our country.

And it is, precisely, this matter that is regulated in Chapter I of this royal decree-law, where the condition of the insured is regulated, in its final Disposition third, by which Article 12 of the Law is amended Organic 4/2000, of 11 January, on the rights and freedoms of foreigners in Spain and their social integration, precept that has no organic nature as established by the fourth final provision of that law, as well as in its Final Disposition amending Article 7 of Royal Decree 240/2007 of 16 February 2007.

IV

It is also necessary to introduce, and this is the object of Chapter II of the real decree-law, a categorization of the portfolio of services of the National Health System that allows to better manage the care reality in Spain where there is a legal/administrative framework which reduces transparency and makes it more difficult to implement, thereby reducing efficiency in its implementation, and where objective action is taken based on rigorous analysis cost-effectiveness provided by the Spanish network of assessment agencies Health technologies and benefits of the National Health System.

This situation has to be retaken towards the homogeneity of health services, as well as clarity, transparency and information to the citizenry so that it can know exactly the extent of its coverage. rights.

addition, it is essential to solve, within the framework of the cohesion and equal rights of health care among the Spaniards and other people who enjoy the condition of the insured in our country, the financing of the health care provided to persons resident in a distinct autonomous community from which they are paying attention through the creation in Chapter III of this royal decree-law of the Assistance Guarantee Fund, configured as a specific departure of compensation for the care guarantee throughout the National System of Health.

V

Chapter IV of the royal decree-law incorporates certain measures related to the pharmaceutical provision.

The financing of medicines and medical devices in the National Health System is one of the greatest challenges. Austerity in public spending, which is essential at all times, has become an unpostponed objective. It is therefore necessary, more than ever, for financing decisions to be chaired by the criteria of scientific evidence of cost effectiveness and by the economic assessment, with regard to the budgetary impact, in which it is a price scheme associated with the actual value that the medicinal product or health product brings to the system. It is time, therefore, to lay the foundations for a comprehensive analysis of the benefits that a new medicinal product or medical product brings to society in general and to the Spanish socio-economic fabric in particular when deciding on their conditions of financing by the National Health System.

The same principle of austerity and rationalisation in public spending on the supply of medicines and medical devices requires the user to update the current system of input and requires changes in the itself, so that the current funding model of the National Health System is adapted to the general budget of the State.

Moreover, the measures contained in the Royal Decree-Laws 4/2010 of 26 March, 8/2010 of 20 May and 9/2011 of 19 August, which focus on the pharmaceutical provision of the National Health System and, in particular, In the case of the Commission, the Commission, the Commission, the Commission, the Commission, the Commission, the Commission, the Commission, the European Parliament and the Council of the European Parliament and the Council of the European Union the different subsectors.

VI

In Chapter V of this royal decree-law, a series of measures are contemplated to correct certain structural situations in relation to human resources, real assets of the National Health System.

Funds to finance human resources in health services are the most important item in their budgets. The diversity of regulatory standards, the organizational complexity of qualifications, categories and employment situations of the more than 600,000 workers of the 17 health services has generated a great interpretative variability of the norms. These are the real barriers to the development of the efficiency and management plans that the autonomous communities are developing in the current economic crisis and for the freedom of movement of people. workers between health services.

It is presented as a real urgency to define homogeneously for the entire National Health System the current regulation of aspects related to the professional categories, the general regulatory criteria of the system remuneration or social action.

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

The imminent application of high quality in the training of specialists of the National Health System makes it urgent to make certain modifications in Law 44/2003, of 21 November, of ordination of the professions health, in terms of the regulation of the Specific Training Areas, the clarification of the competencies in the training of specialists, the resolution of the applications for accreditation of teaching centers and their audit and evaluation.

The creation of Specific Training Areas does not allow for delay in responding to the needs of scientific progress and the right and duty of professionals in order to their professional development. This development is a unanimous request of health professionals, of the National Council of Specialties in Health Sciences, of scientific societies and of health administrations. However, after more than 8 years since the adoption of Law 44/2003 of 21 November, it is necessary to adapt the development of the Specific Training Areas to the new needs of the health system and the evolution that the Specialised health training is being experienced both internally (introduction of high standards in the training of specialists) and in the field of the European Union.

The need to create a State Register of Healthcare Professionals is based on the fact that it is an essential tool to guarantee the information to the population and the institutions of the situation of the professionals from the different aspects that make up the professional practice. The information regarding the certification that the professional is not subject to disciplinary sanction or professional disablement is constituted in a guarantee for the safety of the patients, and gives compliance to the requirement of the right Community to accredit the good practice of professionals in the field of the right to free movement, which has a great impact on the health sector.

Autonomous and collegiate records are not enough to guarantee the necessary planning and control of the human resources that the health system has. This state register, by making it possible to connect with the autonomic registers in real time, will allow the data of special need to be immediately available, from the constancy of resolution of disciplinary cases to the adequate planning of the needs of specialists in close connection with the annual offers of training places.

It is also urgent to ensure the mobility of professionals through the development of a homogeneous catalogue of professional categories where the necessary equivalences are established. This catalogue will enable professionals to access vacant places in other health services by improving the quality of care, since these places will not be subject to a regulated provision through the call for selective processes, since the offer of public employment is frozen.

Finally, criteria of rationalization and efficiency in the management of the social action expenditure of health services determine the need to enable the autonomous communities to modulate their contribution in cases of temporary incapacity, and also to repeal pre-constitutional rules that are divergent with the criteria set out in Law 27/2011 of 1 August on updating, adapting and modernising the social security system, as regards the the economic benefits of staff who have reached retirement age.

VII

Finally, and in addition to the references made in the previous paragraphs, a number of additional measures have been included which supplement the regulatory package and which are necessary for the proper implementation of the practice of this royal decree-law.

Thus, we incorporate efficiency measures that the System needs to address its problems of financial sufficiency, enabling the adoption of centralized management strategies for supplies that put in value a the volume-price ratio in the purchase of products, materials and equipment in a coordinated manner in the National Health System. Efforts should also be made in energy saving, not only in terms of efficiency, but also with the commitment in the area of corporate social responsibility that is required of the country's largest public enterprise.

In another order, Directive 2004 /23/EC of the European Parliament and of the Council of 31 March 2004 on the establishment of quality and safety standards for the donation, procurement, evaluation, the the processing, preservation, storage and distribution of human tissues and cells, as provided for in Article 12 (2), which the Member States shall take all necessary measures to ensure that any activity of promotion and publicity in support of the donation of human tissues and cells to the guidelines or legal provisions established by the Member States.

In this regard, the Royal Decree 1301/2006 of 10 November, laying down quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of human tissues and cells, and the rules for coordination and operation for human use, which transpose Directive 2004 /23/EC into our legal system, are approved, I do not consider it necessary to make use of this attribution adopting the appropriate measures. However, events related to promotion and publicity activities in support of the donation of human tissues and cells that have recently taken place in Spain and which have not observed the current regulation in the field, advise complete the transposition in order to establish, on the basis of the powers provided for in the Community standard, measures to ensure compliance with the provisions of the Spanish rules and to ensure the proper functioning of the model Transplant Spanish.

In addition, Article 30.1 of Law 14/1986 of 25 April, General of Health, provides that the promotion and advertising activities shall be subject to inspection and control by the competent health authorities, and the Article 40.8 of the same law states that it is up to the General Administration of the State, without prejudice to the powers of the autonomous communities, to develop regulations on, among other aspects, registration of services, according to established in the legislation on organ extraction and transplantation.

Consequently, on the basis of Article 12 (2) of Directive 2004 /23/EC, it is appropriate to amend Royal Decree 1301/2006 of 10 November by the addition of a new subparagraph to Article 4 (1), which provides for the obligation to have prior administrative authorisation to carry out promotional and publicity activities in support of the donation of human tissues and cells; and through the addition of an Article 30a, for which a register is provided In this case, the Commission has been in a very high level of National Health System.

VIII

The right to health protection and the obligation of the public authorities to organize and protect public health through preventive measures and the necessary services and services is enshrined as the guiding principle of social and economic policy in article 43 of the Spanish Constitution which reserves the law to establish the rights and duties of all in this respect.

The Constitutional Court has considered, in judgments such as 182/1997, of 28 October, and 245/2004, of 16 December, that the fact that a matter is subject to the principle of the reserve of law does not allow to conclude that is excluded from the scope of regulation of the actual decree-law, which can penetrate such matters provided that the constitutional requirements of the enabling budget are met and does not "affect", in the constitutional sense of the term, the matters excluded in Article 86 of the Spanish Constitution, which is necessarily to be relaxed We find in the presence of a guiding principle of the social and economic policy of Chapter III of Title I of the Constitution.

By virtue of all of this, by making use of the authorization contained in Article 86 of the Spanish Constitution, on the proposal of the Minister of Health, Social Services and Equality, after deliberation by the Council of Ministers, in its Meeting of the day 20 April 2012,

DISPONGO:

CHAPTER I

From healthcare in Spain

Article 1. Amendment of Law 16/2003, of 28 May, of cohesion and quality of the National Health System.

Law 16/2003, of 28 May, of cohesion and quality of the National Health System, is amended as follows:

One. Article 3 is amended as follows:

" Article 3. From the insured condition.

1. Healthcare in Spain, with public funds, through the National Health System, will be guaranteed to those people who have the condition of insured.

2. For these purposes, they will have the condition of insured persons who are in any of the following assumptions:

(a) Being an employed or self-employed person, affiliated to Social Security and in a high or equivalent situation to discharge.

b) Ostend the status of pensioner from the Social Security system.

c) Being a recipient of any other periodic social security benefits, including unemployment benefit and benefit.

(d) You have exhausted the unemployment benefit or allowance and are registered in the office concerned as a jobseeker, not crediting the condition of insured for any other title.

3. In those cases where none of the above cases, persons of Spanish nationality or of any Member State of the European Union, of the European Economic Area or of Switzerland residing in Spain and the Member States of the European Union, are satisfied. foreign holders of an authorization to reside on Spanish territory, may hold the condition of insured provided they prove that they do not exceed the prescribed income limit.

4. For the purposes of this Article, they shall have the status of beneficiaries of an insured person, provided that they reside in Spain, the spouse or person with a similar affectivity relationship, who must certify the official registration the insured person, the former spouse in charge of the insured person, as well as the descendants in charge of the insured person who are under 26 years of age or who have a disability of 65% or more.

5. Persons who do not have the status of insured person or beneficiary of the same may obtain the provision of health care by payment of the corresponding consideration or fee arising from the subscription of an agreement special.

6. The provisions of the preceding paragraphs of this Article do not alter the health care system of persons who are the holders or beneficiaries of special social security schemes managed by the General Mutual Fund of Officials State civilians, the General Judicial Mutuality and the Social Institute of the Armed Forces, who will maintain their specific legal regime.

In this respect, persons who have chosen to receive healthcare through the insurance institutions must be treated in the health centers arranged by these entities. In the case of receiving assistance in public health centres, the expenditure corresponding to the assistance provided shall be claimed from the third party, in accordance with the rules in force. "

Two. A new Article 3a is added, which will have the following wording:

" Article 3a. Recognition and control of the insured condition.

1. The recognition and control of the condition of the insured or of the beneficiary of the same shall be the responsibility of the National Institute of Social Security, through its provincial addresses, which shall establish the documentary requirements to be presented in each case.

2. Once the condition of the insured person or the beneficiary of the guarantee has been recognised, the right to health care will be made effective by the competent health authorities, which will make it easier for citizens to access care benefits. health by issuing the individual health card.

3. The competent authorities in the field of foreign nationals may communicate to the National Social Security Institute, without the consent of the person concerned, the data necessary to verify the concurrency of the requirements to be met. Those referred to in Article 3 (4) of this Act.

Similarly, the National Social Security Institute may treat the data in the files of the managing entities and the common services of the Social Security or the organs of the public administrations. competent to verify the concurrency of the condition of the insured person or beneficiary. The transfer to the National Social Security Institute of such data shall not require the consent of the data subject.

The National Social Security Institute will deal with the information referred to in the previous two paragraphs in order to communicate to the competent health administrations the data necessary to verify in each time the conditions and conditions required for the recognition of the right to health care are maintained, without specifying the consent of the person concerned.

Any modification or variation that the National Institute of Social Security may communicate shall have the effect of the individual health card. "

Three. A new Article 3b is added, which will have the following wording:

" Article 3 ter. Healthcare in special situations.

Foreigners who are not registered or authorized as residents in Spain, will receive healthcare in the following ways:

a) Emergency due to serious illness or accident, whatever its cause, to the medical situation.

b) Support for pregnancy, delivery and postpartum.

In any case, foreigners under the age of eighteen will receive healthcare under the same conditions as Spaniards. "

CHAPTER II

From the National Health System's common portfolio of services

Article 2. Amendment of Law 16/2003, of 28 May, of cohesion and quality of the National Health System.

Law 16/2003, of 28 May, of cohesion and quality of the National Health System, is amended as follows:

One. Article 8 is amended, 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 or procedures, understanding each of the methods, activities and resources based on scientific knowledge and experimentation, by means of Health benefits are effective.

2. The common portfolio of services of the National Health System will be articulated around the following modalities:

(a) Basic common health care services of the National Health System referred to in Article 8a.

(b) Additional Common Portfolio of the National Health System referred to in Article 8b.

(c) Common portfolio of ancillary services of the National Health System referred to in Article 8c.

3. Within the Interterritorial Council of the National Health System, the common portfolio of services of the National Health System will be agreed, which will be approved by Royal Decree.

4. The Ministry of Health, Social Services and Equality shall annually carry out an assessment of the costs of implementing the common portfolio of services of the National Health System. "

Two. A new Article 8a is added, which will have the following wording:

" Article 8a. Basic common portfolio of health care services of the National Health System.

1. The basic common portfolio of care services of the National Health System includes all the care activities of prevention, diagnosis, treatment and rehabilitation that are carried out in healthcare or social health centers, as well as the urgent health transport, covered in full by public funding.

2. The provision of these services will be done in a way that ensures the continuity of care, under a multidisciplinary approach, focused on the patient, guaranteeing the highest quality and safety in their delivery, as well as the conditions of accessibility and equity for the entire population covered. "

Three. A new Article 8b is added, which will have the following wording:

" Article 8b. Additional common portfolio of the National Health System.

1. The additional common portfolio of the National Health System includes all those benefits that are provided through outpatient clinics and are subject to the user's contribution.

2. This additional common portfolio of the National Health System shall include the following benefits:

a) Pharmaceutical strength.

b) Orthoprosthetic station.

c) Prstation with dietetic products.

3. Non-urgent health transport, subject to optional prescription, for clinical reasons and with a level of input from the user according to the particular pharmaceutical provision, shall also be considered for this consideration.

4. For the benefits provided for in paragraph 2 of this Article, with the exception of the pharmaceutical provision governed by its rules, the following shall be approved by Order of the person holding the Ministry of Health, Social Services and Equal Agreement of the Interterritorial Council of the National Health System, on a proposal from the Commission on benefits, insurance and financing, the updating of the catalogue of benefits, the maximum amounts of funding and the correction to be applied in order to determine the final billing for the autonomic health services on the part of the suppliers, who will have the final price consideration.

5. The percentage of the user's contribution shall be governed by the same rules governing the pharmaceutical supply, on the basis of which the final price of the product is calculated and without any limit of value being applied to this contribution. "

Four. A new Article 8c is added, which will have the following wording:

" Article 8c. Common portfolio of National Health System accessories.

1. The common portfolio of ancillary services of the National Health System includes all those activities, services or techniques, without the character of the provision, which are not considered essential and/or that are interveners or support for the improvement of a Chronic pathology, being subject to input and/or reimbursement by the user.

2. By Order of the person holding the Ministry of Health, Social Services and Equality, after agreement of the Interterritorial Council of the National Health System, on a proposal from the Commission on benefits, insurance and financing, the the inclusion of ancillary services, the maximum amounts of financing and the coefficients of correction to be applied in order to determine the final billing for the health services by the suppliers, as well as the the applicable contribution or reimbursement in each case.

The activities, services or techniques included in this portfolio will be effective once they are approved by Order of the holder of the Ministry of Health, Social Services and Equality.

3. The user's contribution or, where applicable, the reimbursement, shall be governed by the same rules governing the pharmaceutical provision, taking as a reference the final billing price to be decided for the National Health System. "

Five. A new Article 8d is added, which will have the following wording:

" Article 8 quinquies. Portfolio of complementary services of the Autonomous Communities.

1. The autonomous communities, in the field of their competences, may approve their respective portfolios of services which will include, at least, the common portfolio of services of the National Health System in their basic forms of services. assistance, supplementary and ancillary services, guaranteeing all users of the same.

2. The autonomous communities may incorporate in their portfolios of services a technique, technology or procedure not contemplated in the common portfolio of services of the National Health System, for which they will establish the additional resources required.

3. The autonomous communities must allocate the necessary economic resources to ensure the financing of the common portfolio of services, being mandatory, for the approval of the portfolio of complementary services of an autonomous community, the prior assurance of financial sufficiency of the same in the context of the fulfilment of the budgetary stability criteria.

4. In any event, such additional services or services shall meet the same requirements as are laid down for the incorporation of new techniques, technologies or procedures into the common portfolio of services, and shall not be included in the general financing of the benefits of the National Health System.

Prior to its incorporation, the autonomous community concerned must inform the Interterritorial Council of the National Health System, in a reasoned manner.

5. The Interterritorial Council of the National Health System may issue recommendations on the establishment by the autonomous communities of health benefits complementary to the common benefits of the National Health System. agreement with the provisions of Article 71.1 (b) of this Law.

6. The Autonomous Communities will bring to the attention of the Ministry of Health, Social Services and Equality the complementary services not covered in the common portfolio of services of the National Health System after their effective incorporation into their a portfolio of autonomic services, which will be included in the relevant information system.

7. The autonomous communities shall assume, from their own budgets, all the costs of applying the supplementary service portfolio to persons who have the status of insured. "

Six. Article 20 is amended to read as follows:

" Article 20. Development of the common portfolio of services of the National Health System.

1. The contents 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 a proposal from the Commission on benefits, insurance and funding.

In the preparation of such content, consideration will be given to the efficacy, efficiency, effectiveness, safety and therapeutic utility, as well as the advantages and alternatives of care, the care of less protected or risk groups and social needs, as well as their economic and organizational impact.

In the evaluation of the provisions of the previous paragraph, the Spanish Network of Sanitary Technologies Assessment Agencies and National Health System Assessment Agencies will participate.

2. In any event, the technical services, technologies and procedures, the effective contribution to the prevention, diagnosis, treatment, rehabilitation and cure of diseases, conservation or improvement, shall not be included in the common portfolio of services. of life expectancy, autonomy and elimination or decreased pain and suffering is not sufficiently proven. "

Seven. Article 21 (1) and (2) are amended as follows:

" 1. The common portfolio of services of the National Health System shall be updated by order of the person holding the Ministry of Health, Social Services and Equality, after agreement of the Interterritorial Council of the National Health System. The procedure for the update will be developed regulatively.

2. The new techniques, technologies or procedures will be subject to evaluation, with a mandatory nature and prior to their use in the National Health System, by the Spanish Network of Health Technology Assessment Agencies and the National Health System. "

CHAPTER III

National Health System cohesion and financial guarantee measures

Article 3. Assistant Guarantee Fund.

1. The Assistance Guarantee Fund is created, with extra-budgetary character, in order to guarantee cohesion and equity in the National Health System, through the coverage of the displacements between autonomous communities and cities of Ceuta and Melilla of persons enjoying the condition of insured in the National Health System.

2. The Assistance Guarantee Fund shall be allocated to the compensation between the autonomous communities and cities of Ceuta and Melilla for the actions their health services carry out in the framework of the implementation of the basic common portfolio of services. care and supplementary to persons who enjoy the condition of insured in the National Health System on their temporary displacements.

3. In order to carry out appropriate management and follow-up of the Assistance Guarantee Fund, the mechanisms of recognition of these persons will be established in the system of information of the individual health card of the National System of Health.

4. The determination of the amount to be paid to each health service shall be established by regulatory provision to that effect.

5. The amount of the amounts to be settled will be determined by the following displacement modes:

(a) Short-term displacements (less than one month), which will be paid in accordance with national rates to be established for primary care health care, including the provision by supplementary portfolio which corresponds.

(b) Long-term displacements (equal to or greater than one month), which will be paid according to the monthly capital used for the health accounting statistical calculations of the health accounts system, with two possibilities application:

1. For the basic common portfolio of full care services.

2. For the basic common portfolio of partial care services, referred to as primary or specialized assistance.

CHAPTER IV

Pharmaceutical delivery measures

Article 4. Amendment of Law 29/2006 of 26 July on the guarantees and rational use of medicinal products and medical devices.

Law 29/2006 of 26 July on the guarantees and rational use of medicinal products and medical devices is amended as follows:

One. Article 85 is amended, which will have the following wording:

" Article 85. Prescription of medicines and medical devices.

1. The prescription of medicines and medical devices in the National Health System will be made in the most appropriate way for the benefit of patients, while protecting the sustainability of the system.

2. In the National Health System, the prescriptions for medicinal products included in the reference price system or for homogeneous groupings not included in the system shall be carried out in accordance with the following scheme:

(a) For acute processes, the prescription will be generally done on an active basis.

b) For chronic processes, the first prescription, corresponding to the introduction of the first treatment, will be done, in general, by active principle.

c) For chronic processes whose prescription corresponds to the continuity of treatment, it may be carried out by commercial denomination, provided that it is included in the reference price system or the The lowest price within its homogeneous pool.

3. However, the prescription for trade name of medicinal products shall be possible provided that the principle of greater efficiency is respected for the system and in the case of medicinal products considered as non-replaceable.

4. Where the prescription is made on an active basis, the pharmacist shall dispense the lower-priced medicinal product from its homogeneous group and, in the case of equality, the generic medicinal product or the corresponding biosimilar medicinal product.

5. In any event, the prescription of a medicinal product for use under conditions other than those laid down in its technical fiche must be authorised in advance by the commission responsible for the therapeutic or collegiate protocols. equivalent in each autonomous community. "

Two. A new Article 85a is added, which will have the following wording:

" Article 85a. Information systems for prescription support.

1. The competent bodies of the autonomous communities shall provide their prescribers with a common and interoperable electronic prescribing system in which prescription support subsystems shall be incorporated, such as:

-Online drug nomenclator.

-Correspondence between active principles, available medications, and pathologies in which they are indicated.

-Recommended pathology treatment protocols from healthcare institutions and medical societies, with indication of the standards of choice and expected benefits.

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

-Database of interactions.

-Database of clinical trials in your province or autonomous community.

-Regular online information (authorization and withdrawal of medicines and medical devices, alerts and communications of interest for the protection of public health).

-Dissemination of medicines news that, without being alert in the strict sense, contributes to improving the health of the population.

2. The prescription support schemes will collect the information corresponding to the selected prices via reduced input, so that the doctor can take into account the economic impact during the prescription of medicines and medical devices.

3. Prescription support systems shall be managed from the competent bodies at the level of the Autonomous Community. The Interterritorial Council of the National Health System shall ensure that they are articulated efficiently and contribute to maintaining the equity of the healthcare system.

4. The Ministry of Health, Social Services and Equality, in coordination with the Autonomous Communities, will establish basic care protocols in order to guide the prescription and use of those medicines which, by their unique characteristics, require special attention and caution in prescribing and dispensing. "

Three. A new Article 85b is added, which will have the following wording:

" Article 85 ter. Exclusion from the pharmaceutical provision of medicinal products and medical devices.

1. The body responsible for the pharmaceutical provision of the Ministry of Health, Social Services and Equality shall, by means of a reasoned decision, update the list of medicinal products excluded from the pharmaceutical supply in the National System of Health.

2. The reason for the exclusion will respond to any of the following criteria:

a) The set of selected prices.

b) Cohabitation with an over-the-counter medication with which you share active substance and dose.

c) The consideration of the drug as advertising in our European environment.

d) That the active principle has a favorable and sufficiently documented safety and efficacy profile through years of experience and extensive use.

e) By being indicated in the treatment of minor symptoms.

(f) To comply with any of the criteria for non-inclusion in public funding referred to in Article 89 (2).

3. Those responsible for the products excluded from the financing shall inform the competent authority of the prices to which they are to market such medicinal products. The same obligation extends to variations in prices.

4. In the month following the entry into the register of the competent authority of the communications referred to in the preceding paragraph, the latter shall decide whether or not the proposed prices are to be agreed. In the event of disagreement, that body shall raise the discrepancy to the Inter-Ministerial Committee for the Prices of Medicinal Products, which shall decide on the matter. That decision shall be notified by decision of the competent body to the person concerned.

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

5. As soon as the disagreement referred to in the previous paragraph is maintained, the maximum industrial price shall be maintained. "

Four. A new paragraph 5 is added to Article 86, which will have the following wording:

" 5. Where the prescription is made by trade name, if the prescribed medicinal product has a higher price than the lowest price of its homogeneous group, the pharmacist shall replace the prescribed medicinal product with the lowest price and, in the case of Equality, will dispense the generic medicine or the corresponding biosimilar medicine. "

Five. Article 89 (1) and (2) are amended, which shall be worded as follows:

" 1. For the public funding of medicinal products and medical devices, it will be necessary to include them in the pharmaceutical supply by means of the corresponding express resolution of the unit responsible for the Ministry of Health, Social Services and Equality, establishing the conditions of financing and price in the field of the National Health System.

The same shall apply when an amendment to the authorisation affecting the content of the pharmaceutical supply occurs, prior to the placing on the market of the modified product, or to affect the modification to the indications of the medicinal product, either because, without affecting them, the Spanish Agency for Medicinal Products and Sanitary Products so agrees for reasons of public interest or defense of the health or safety of the persons.

The inclusion of medicines in the financing of the National Health System is made possible through selective and non-indiscriminate funding taking into account general, objective and published criteria and, in particular, following:

a) Severity, duration and sequelae of the different pathologies for which they are indicated.

b) Specific needs of certain collectives.

c) Therapeutic and social value of the drug and incremental clinical benefit of the drug taking into account its cost-effectiveness.

d) Rationalization of public expenditure for pharmaceutical provision and budgetary impact in the National Health System.

e) Existence of medicinal products or other therapeutic alternatives for the same conditions at lower price or lower cost of treatment.

f) Degree of product innovation.

Without prejudice to the provisions of Article 24, and in order to ensure the rational use of medicinal products and medical devices, the Ministry of Health, Social Services and Equality may subject the specific conditions for the prescription, dispensing and financing of the same in the National Health System, either on its own initiative or on a proposal from the Autonomous Communities in the Standing Committee of Pharmacy.

In order to guarantee the right of all persons enjoying the status of insured and beneficiary in the System of access to the pharmaceutical provision in conditions of equality throughout the National Health System, Autonomous communities may not, unilaterally, establish specific specific reservations for the prescription, dispensing and financing of medicinal products or medical devices.

However, within the Standing Committee of Pharmacy, the exception of one or more autonomous communities may be decided by reason of their own particularities.

2. The Ministry of Health, Social Services and Equality shall review the groups, sub-groups, categories and/or classes of medicinal products whose funding is not deemed necessary to meet the basic health needs of the Spanish population. In any event, medicinal products without a prescription, medicinal products not used for the treatment of a clearly determined pathology, or products for cosmetic use, dietetic, mineral waters, or other medicinal products shall not be included in the pharmaceutical supply. elixires, dentifrics and other similar products.

Neither will be financed the medications indicated in the treatment of syndromes and/or symptoms of minor severity, nor those that, even having been authorized according to the current regulations, do not respond to the current therapeutic needs, with an understanding of an adverse benefit/risk balance in the diseases for which they are indicated. "

Six. A new Article 89a is added, which will have the following wording:

" Article 89 bis. Fundamental criteria for inclusion in the pharmaceutical provision.

1. It is up to the Government to lay down the criteria and procedure for fixing the prices of medicines and health products financed by the National Health System, both for the supply of medicines by office of pharmacy to through an official prescription, such as for hospital-level drugs, including clinical packaging, or dispensed by pharmacy services to unadmitted patients.

2. For the financing of new medicines, in addition to the corresponding cost-effectiveness and budgetary impact analysis, the innovation component will be taken into account, for indisputable therapeutic advances to change the course of the disease or improve the course of the disease, the prognosis and the therapeutic outcome of the intervention and its contribution to the sustainability of the National Health System if, for the same result in health, it contributes positively to the product Gross domestic.

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

4. The Inter-Ministerial Committee on the Prices of Medicinal Products shall take into account the cost-effectiveness and budgetary impact analyses. "

Seven. Article 90 is amended to read as follows:

" Article 90. Pricing.

1. For the marketing of a medicinal product or medical device in Spanish territory it will be essential to have processed the offer of the same to the National Health System. The same shall apply if there are substantial variations in the conditions of authorisation of the medicinal product or medical device.

2. The Government may regulate the pricing mechanism for medicinal products and medical devices that do not require a prescription to be dispensed on Spanish territory, following a general objective and transparent regime.

3. In any event, the holders of marketing authorisations for the same may place on the market the medicinal products that are dispensed in Spanish territory under the notified price system, thereby understanding the price communication to the Ministry. of Health, Social Services and Equality, so that the department may object to it for reasons of public interest.

4. It is for the Interministerial Commission for the Prices of Medicinal Products, attached to the Ministry of Health, Social Services and Equality, to fix, in a reasoned and objective manner, the financing prices of the National System of Health of medicinal products and medical devices for which medical prescription is required, to be dispensed in Spanish territory. Where the same products are not financed, if they are dispensed in national territory, they shall operate as set out in paragraph 3.

5. In any case, the medicines and medical devices that are decided to be financed by the National Health System may also be placed on the market for prescription.

6. As a general rule, the financing price for the National Health System will be lower than the industrial price of the drug applied when it is dispensed outside the National Health System.

7. For decision-making, the Interministerial Drug Pricing Commission will take into consideration the reports that the National Health System's Pharmaceutical Delivery Advisory Committee will make.

8. The economic amounts corresponding to the concepts of the distribution and dispensing of the medicinal products and the medical devices and, where appropriate, the deductions applicable to the billing of the same to the National Health System will be established by the Government, with the agreement of the Government Delegation for Economic Affairs, in general or by groups or sectors, taking into consideration criteria of a technical and economic nature.

9. The Ministry of Health, Social Services and Equality shall establish the selling price to the public of the medicinal products and medical devices financed by the aggregation of the authorised industrial price, which is of a maximum nature, and of the margins corresponding to the wholesale distribution and distribution activities to the public. '

Eight. A new Article 90a is added, which will have the following wording:

" Article 90a. From the Advisory Committee on the Pharmaceutical Delivery of the National Health System.

1. The Advisory Committee on the Pharmaceutical Delivery of the National Health System is the collegiate body, of a scientific and technical nature, attached to the ministerial unit with competence in the field of pharmaceutical provision of the Ministry of Health, Social Services and Equality, which is responsible for providing advice, assessment and consultation on the relevance, improvement and monitoring of the economic assessment needed to support the decisions of the Inter-Ministerial Price Commission for the Medicines.

2. The Advisory Committee on the Pharmaceutical Delivery of the National Health System shall be composed of a maximum number of 7 members appointed by the head of the Ministry of Health, Social Services and Equality, among professionals of recognised prestige, with experience and track record in pharmacoeconomic assessment.

3. In addition, on the basis of the issues to be discussed, the evaluators of the competent body in the field of medicinal products and medical devices which have drawn up the evaluations of medicinal products and products may attend the meetings of the Committee. health issues to be discussed.

4. In any event, the creation and operation of the Advisory Committee on the Pharmaceutical Provision shall be addressed with the personal, technical and budgetary means assigned to the body to which it is attached. "

Nine. A new paragraph 6 is added to Article 91, which will have the following wording:

" 6. For the purposes of the downward price revisions at the request of a party provided for in paragraph 1 of this Article, only those which represent at least a 10% reduction in the maximum industrial price in force shall be taken into account. for publicly funded funding. "

Ten. Article 93 is amended, which will have the following wording:

" Article 93. Reference price system.

1. Public funding for medicinal products will be subject to the reference price system. The reference price shall be the maximum amount by which the presentations of medicinal products included in each of the sets to be determined shall be financed, provided that they are prescribed and dispensed with public funds.

2. The sets shall include all presentations of medicinal products financed which have the same active substance and the same route of administration as those included in the pharmaceutical provision of the National Health System, at least one presentation of a generic or biosimilar medicinal product, unless the medicinal product or its main active ingredient has been placed on the market for at least 10 years in a Member State of the European Union, in which case the the existence of a generic medicine to establish a set. The presentations indicated for treatments in pediatrics, as well as those for medicinal products in the hospital, including clinical packaging, shall constitute separate sets.

3. The reference price for each set will be calculated on the basis of the lower cost/treatment/day of the presentations of the medicinal products in the grouped, and in any case the supply to the pharmacy offices for the medicinal products will be guaranteed lower price. Medicinal products may not exceed the reference price of the whole to which they belong.

4. The new sets will be established and the prices of the existing sets will be revised on an annual basis. However, the lower prices of the new homogeneous groupings will be automatically fixed in the corresponding Nomenclator, and the lower prices of the existing ones will be revised on a quarterly basis.

5. The Ministry of Health, Social Services and Equality shall establish a similar price system for medical devices. "

Once. A new Article 93a is added, which will have the following wording:

" Article 93a. Price system selected for eligible products.

1. The Ministry of Health, Social Services and Equality may propose to the Interministerial Commission for Drug Prices to apply the selected price mechanism to medicines and financial health products.

2. To this end, the Ministry of Health, Social Services and Equality shall draw up a reasoned proposal, in accordance with the criteria set out in this Article, which shall contain the maximum price selected for each case.

3. Once authorised by the Inter-Ministerial Committee on Drug Prices, the Ministry of Health, Social Services and Equality shall publish the decision by Resolution of the unit responsible for the pharmaceutical supply.

4. In the case of medicinal products financed, the price system selected shall apply to medicinal products subject to reference prices, taking into account:

a) The consumption of the set.

b) The budgetary impact.

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

d) No shortage of risk.

5. Similar criteria shall apply for the case of medical devices.

6. Having regard to the above criteria, the Ministry of Health, Social Services and Equality, through the unit with responsibility for pharmaceutical provision, shall inform the suppliers of the initiation of a price procedure. selected, with communication of the maximum funding price that is proposed to manifest their intentions.

7. On the basis of the communications received, the Ministry shall draw up the proposal referred to in point 2 of this Article.

8. Those medicines and/or medical devices that exceed the maximum eligible price will be excluded from funding by the National Health System.

9. The price selected shall be valid for two years during which it may not be modified.

10. The selected price regime shall be updated, for cases where it has not been previously applied, on an annual basis, at the same time as the reference price system update.

11. The application of this system will result in the exclusion of public funding from those presentations that are not selected, for the duration of the selected price.

12. In any event, the presentations of the medicinal products that are affected by the provisions of this Article shall be exempt from the application of the deductions provided for in Articles 8, 9 and 10 of the Royal Decree-Law. 8/2010, of 20 May, adopting extraordinary measures for the reduction of the public deficit.

13. The laboratories holding the marketing authorization for the presentations of the medicinal products and the companies offering the presentations of the medical devices that will be finally selected will have to assume the commitment of ensure adequate supply by express declaration to the effect.

14. The selected price system may be applied to medicinal products and medical devices which, not being financed, are considered to be of interest to public health in the terms expressed in Law 33/2011 of 4 October, General Public Health.

15. In this respect, the Ministry of Health, Social Services and Equality for the determination of the price selected shall take into account the special characteristics of distribution and application of these products.

16. The mechanism may also be extended via the selection by fixing of a reduced contribution by homogeneous groupings. "

Twelve. Article 94 (1) is amended to read as follows:

" 1. The Government shall periodically review the participation in the payment to be paid by the citizens for the pharmaceutical provision included in the supplementary common portfolio of the National Health System, and the financing assumptions shall be public funds.

The review will be published in the 'Official State Gazette', by Order of the person holding the Ministry of Health, Social Services and Equality. "

Thirteen. A new Article 94 bis is added, which will have the following wording:

" Article 94 bis. Contribution of beneficiaries in the outpatient pharmaceutical provision.

1. It is understood by outpatient pharmaceutical provision that the patient is dispensed through an office or pharmacy service.

2. The outpatient pharmaceutical provision shall be subject to the user's input.

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

4. The user's contribution shall be proportional to the level of income that shall be updated annually.

5. In general, the percentage of user input will follow the following schema:

(a) 60% of the PVP for users and their beneficiaries whose income is equal to or greater than EUR 100 000 entered in the general liquidable base box and the saving of the Income Tax declaration Physical.

(b) 50% of the PVP for persons holding the status of an insured person and their beneficiaries whose income is equal to or greater than EUR 18 000 and less than EUR 100 000 entered in the general liquidable base box and the saving of the Income Tax declaration of the Physical Persons.

(c) 40% for persons who have the status of an active insured person and their beneficiaries and are not included in paragraphs (a) or (b) above.

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

6. In order to ensure the continuity of treatments of a chronic nature and to ensure a high level of equity for pensioners with long-term treatment, the overall percentages will be subject to maximum contribution ceilings. in the following assumptions:

(a) 10% of the PVP in medicinal products belonging to the reduced-contribution ATC groups, with a maximum contribution for 2012, expressed in euro, resulting from the application of the update of the CPI to the contribution maximum. This maximum contribution will be updated automatically every January in accordance with the evolution of the CPI. The update will be formalised by resolution of the pharmacy responsible for the Ministry of Health, Social Services and Equality.

(b) For persons holding the status of insured persons as Social Security pensioners and their beneficiaries whose income is less than EUR 18,000 entered in the general liquidable base box and the saving of the a statement of the Income Tax of the Physical Persons or not included in the following paragraphs (c) or (d), up to a maximum monthly contribution limit of EUR 8.

(c) For persons holding the status of insured persons as Social Security pensioners and their beneficiaries whose income is equal to or greater than EUR 18,000 and less than 100 000 entered in the liquidable base box general and savings from the income tax return of the physical persons, up to a maximum monthly contribution limit of 18 euros.

(d) For persons holding the status of insured as a pensioner of Social Security and their beneficiaries whose income exceeds EUR 100 000 entered in the general liquidable base box and the saving of the Tax on the Income Tax of the Physical Persons, up to a maximum monthly contribution limit of 60 euros.

7. The amount of contributions exceeding these amounts shall be reimbursed by the corresponding autonomous community at a maximum of six-monthly intervals.

8. They shall be exempt from input, users and their beneficiaries belonging to one of the following categories:

(a) Affected by toxic syndrome and persons with disabilities in the cases referred to in their specific legislation.

b) Persons who are recipients of social integration income.

c) Non-contributory pension recipients.

(d) Parados who have lost the right to receive unemployment benefit as long as their situation is subsisting.

e) Treatments resulting from accidents at work and occupational disease.

9. The level of contribution of the mutualists and passive classes of the General Mutuality of Civil Servants of the State, of the Social Institute of the Armed Forces and the General Judicial Mutuality will be 30%. "

Fourteen. A new Article 94 ter is added, which will have the following wording:

" Article 94 ter. Protection of personal data.

1. The National Social Security Institute may treat the data obtained in the files of the managing entities and common services of the Social Security and of the entities that collaborate with the same ones that are essential for determining the amount of the contribution of the beneficiaries in the pharmaceutical service. Such treatment, which will not require the consent of the person concerned, will be fully submitted to the provisions of the Organic Law 15/1999 of 13 December, the Protection of Personal Data, and its provisions for development.

2. Similarly, and for the purposes referred to in the preceding paragraph, the competent authority in the field of taxation may inform the National Social Security Institute, without the consent of the person concerned, of the data which are required to determine the level of income required.

Equally, the bodies of the public authorities which are competent to determine the concurrency of the conditions laid down for exemption from the contribution provided for in Article 94a (8) of this Regulation. law, may communicate this circumstance to the National Institute of Social Security without having the consent of the person concerned.

3. The National Social Security Institute shall communicate to the competent health authorities the data relating to the level of contribution to which each user corresponds in accordance with the rules governing the prescriptions medical and dispensing orders. In no case shall such information include the actual amount of the income.

The data communicated in accordance with the provisions of the preceding paragraph shall be treated by the health administration concerned with the sole effects of its incorporation into the information system of the card individual health. "

Fifteen. A new Article 97a is added, which will have the following wording:

" Article 97a. Fundamentals of the information systems for the control of the pharmaceutical supply.

1. The State's intervention in the field of medicinal products and medical devices financed by the National Health System requires the full provision of solid information on the consumption of the sanitary inputs covered by this information. To this end, both the Ministry of Health, Social Services and Equality and the competent authorities of the Autonomous Communities and, where appropriate, the supplying companies and their professional representative bodies, will provide the following information regarding the traffic and consumption of the same:

a) National Health System official prescription billing data on a monthly basis, dispensed by pharmacy offices and aggregated by province and autonomous community.

(b) Data on acquisitions by pharmaceutical services of health or social health centres and services of the National Health System and, where appropriate, fertilizers of medicinal products and medical devices, at least on a monthly basis; and with aggregation level by province and Autonomous Community.

2. The General Mutuality of Civil Servants of the State, the General Judicial Mutuality and the Social Institute of the Armed Forces will provide the same type of information, with the exception of the care modalities that are own.

3. Medicinal products dispensed by pharmaceutical services from healthcare or social healthcare facilities or healthcare providers from the National Health System to outpatients will be collected in a specific computer application.

4. The computerised treatment referred to in the preceding paragraph may be extended to other medicinal products and medical devices for the exclusive use of hospitals to which the Interministerial Committee on the Prices of Medicinal Products considers it appropriate to apply a unique caufabric regime."

Sixteen. A new Article 97 ter is added, which will have the following wording:

" Article 97 ter. Promotion of competition and competitiveness.

1. For the purpose of the efficiency and sustainability of the pharmaceutical delivery of the National Health System, the administrative and regulatory measures that are considered appropriate for each financial year will be implemented. to stimulate competition between suppliers of pharmaceutical inputs, resulting in unit price decreases.

2. Any limiting action to competition shall be deemed to be contrary to the principles of efficiency and sustainability and shall be pursued by the competent bodies. "

seventeen. Paragraph 1 of the sixth additional provision is amended, which shall be worded as follows:

" 1. Natural persons, business groups and legal persons not integrated in them, who are engaged in Spain in the manufacture, import or offer to the National Health System of medicinal products and/or medical devices which, financed by public funds are dispensed in pharmacy offices, through the official prescription or the order of supply of the National Health System, in national territory, the quantities that they will be required to apply on their own will be entered on a four-monthly basis. Four-monthly sales volume through such a prescription or dispensing order, the percentages referred to on the following scale:

Sales to PVL		Contribution
From
0.00	3.000,000.00
3.000.000.01
2.0

On the assumption that the total volume of sales of medicines and medical devices to the National Health System is, in current terms, lower than the previous year, the government will be able to review the previous ones. percentages of input.

The amounts resulting from the application of the previous scale will be reduced according to the valuation of the companies in 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, who participate in R & D consortia or make temporary partnerships for this purpose with other companies established in Spain and R & D centers Public and private, to carry out basic and pre-clinical research of relevance, through specific and determined projects, they will be able to benefit from an additional ten percent of the contribution.

The minorations that may affect these returns will take effect from the latest resolution of the Profarma Plan.

The business groups will communicate to the Ministry of Health, Social Services and Equality during the month of January each calendar year, the companies integrated into them. Where the composition of a business group is changed during the course of the year, the communication shall take place during the month in which the change took place. For the purposes of the above, it is considered that the companies constituting a unit of decision, in the terms of Article 4 of Law 24/1998 of 28 July, of the Securities Market, are considered to belong to the same group. '

Eighteen. The second subparagraph of paragraph 1 of the Additional Article 14 (1) is amended, which shall be worded as follows:

"Information on lower prices shall be updated on the first working day of each month and shall be published on the website of the Ministry of Health, Social Services and Equality."

Article 5. Amendment of Royal Decree 823/2008 of 16 May 2008 establishing the margins, deductions and discounts corresponding to the distribution and dispensing of medicinal products for human use.

One. A new paragraph 8 is added to Article 2 of Royal Decree 823/2008 of 16 May 2008 laying down the margins, deductions and discounts for the distribution and supply of medicinal products for human use, which will have the following wording:

" 8. In order to ensure the accessibility and quality of the service, as well as the appropriate pharmaceutical attention to the users of the National Health System, to the pharmacy offices that are exempt from the scale of regulated deductions in the Paragraph 5 of this Article shall apply to them a corrective index of the margins of the pharmacy offices corresponding to the prescriptions or orders for the supply of medicinal products for human use manufactured industrially with public funds, according to the following scale:

120.206.02

600.000.01

Sales to PVP VAT up to - Euros	Deduction - Euros	Rest to - Euros	Percentage applicable
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
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
122.119.32	Forward	27.52

For the application of the corresponding tranche of the said scale, account shall be taken of the amount of the monthly turnover corresponding to the prescriptions or orders for the supply of medicinal products for human use. industrially manufactured from public funds.

The application of the corrective amount shall be carried out in the first tranche of the scale, from 0 to 25 000 euro, of the monthly invoice corresponding to the prescriptions or orders for supply of medicinal products for human use manufactured industrially dispensed with public funds. The monthly invoice shall be calculated in terms of the price of the sale price at the level of the value added tax. As regards the presentation of medicinal products with an industrial price of more than EUR 91,63 and for the purposes of that monthly invoice, the amount which, calculated in terms of the selling price to the public at the time of the sale, is excluded from the VAT included, in excess of the quoted industrial price.

Such pharmacy offices should meet the following requirements:

(a) That they have not been the subject of administrative or professional qualification or are not excluded from their concertaciability.

b) to participate in the programmes of pharmaceutical and pharmaceutical activities and in the implementation of the set of activities for the rational use of medicinal products to be established by the relevant health administration.

The decision on compliance with the required requirements, as well as the resolution of the incidents that occur, will correspond to the different health administrations competent in the field of order. (a) the use of the method for implementing it. It will give a preliminary hearing to the General Mutuality of Civil Servants of the State, the General Judicial Mutuality, the Social Institute of the Armed Forces, and, if necessary, the National Institute of Health Gestitin.

The four-year-old-year-old-year-old-year-old-year-old-year-old-year-old-year-old-year-old-year-old-year-old-year-old-year-old-year-old-year-old-year-old-year-old Mutual Legal Mutual Association and the Social Institute of the Armed Forces will be responsible for applying the percentage that each of them represents in the monthly invoice of each pharmacy office, considered together. The procedure for the management of such information shall be in accordance with the rules laid down in respect of reports on the application of the joint deductions scale. '

Two. The current paragraph 8 of Article 2 becomes paragraph 9 of that Article.

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

1. The establishment of a hospital pharmacy service of its own shall be compulsory at:

a) All hospitals that have one hundred or more beds.

(b) Social assistance centres which have 100 beds or more in assisted living arrangements.

c) Psychiatric centers that have a hundred or more beds.

2. However, the competent authority in the field of pharmaceutical provision may establish agreements or agreements with hospital establishments, exempting such centres from such requirements, provided that they have a deposit of medicinal products linked to the hospital pharmacy service of the hospital of the public network which is the reference in the relevant area or health area.

3. In addition, hospital centres, welfare centres providing specific health care and psychiatric facilities which do not have a hospital pharmacy service of their own and who are not required to have their own hospital a deposit, which shall be linked to a pharmacy service in the health area and under the responsibility of the head of the service, in the case of public sector hospitals, and to a pharmacy office established in the same pharmaceutical area or to a Hospital pharmacy service, in the case of a private sector hospital.

Article 7. Handling and adequacy of preparations of medicinal products.

1. In order to improve the effectiveness of the use of medicinal products in the hospital field, the autonomous communities may provide proof to the hospital pharmacy services in their territory to enable them to carry out their operations. fractionation, dose customization, and other drug-rehandling and transformation operations.

2. The accreditation provided for in the preceding paragraph shall be carried out in such a way as to ensure compliance with the good practice guidelines applicable to the case by the hospital pharmacy where the operations are to be carried out. indicated.

3. The guides for manipulation, fractionation and personalized dosage will be developed under the supervision of the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy, seeking to the effect the collaboration of the Agency Spanish Medicines and Healthcare products and experts of recognized prestige.

CHAPTER V

Human Resource Measures

Article 8. Amendment of Law 44/2003 of 21 November of the management of health professions.

Law 44/2003, of 21 November, for the management of health professions, is amended as follows:

One. Article 25 is amended, which will have the following wording:

" Article 25. Specific Training Areas.

1. Specialised training in specific training areas will in any case be programmed and will be carried out by the residence system with the specific features and adaptations to be determined in the legal system. which regulates such a training system.

2. The assumptions and requirements for Health Sciences Specialists to be able to access, by means of a call from the Ministry of Health, Social Services and Equality, to the Training Area diplomas will be established. Specifies, provided that such areas have been constituted in the relevant specialty and that at least two years of professional practice in the field are established.

3. The Ministry of Health, Social Services and Equality, prior to the report of the National Council of Specialties in Health Sciences and the Human Resources Commission of the National Health System, will be able to eliminate, reduce or increase the number of years of professional exercise referred to in paragraph 1 of this Article. "

Two. Article 26 is amended, which will have the following wording:

" Article 26. Accreditation of schools and teaching units.

1. The Ministry of Health, Social Services and Equality and the competent in education, on a proposal from the Human Resources Commission of the National Health System, by Order to be published in the "Official State Gazette", establish the accreditation requirements which, as a general rule, must be met by the centres or units for the training of Health Sciences Specialists.

2. It is up to the competent authority in the field of quality of the Ministry of Health, Social Services and Equality to coordinate the audits of the accredited centres and units, to evaluate in the framework of the Quality Plan for the System National Health and the Annual Plan of Teaching Audits, the operation and quality of the training system.

3. It is for the competent management body in the field of specialised health training of the Ministry of Health, Social Services and Equality, at the request of the institution holding the centre, prior reports from the Commission's teaching staff and the Competent health department in the autonomous community, to resolve the requests for accreditation of schools and teaching units. The accreditation shall specify, in any case, the number of accredited teaching places.

4. The revocation, in whole or in part, of the accreditation granted shall be carried out, where appropriate, by the same procedure, heard by the centre concerned and its teaching committee. '

Three. Article 29 is amended, which will have the following wording:

" Article 29. Specific Training Area Committees.

1. Where there is a Specific Training Area, an Area Committee shall be set up as an advisory body to the Ministry of Health, Social Services and Equality. It shall be composed of six professionals with a specialist training specialist in the area concerned, proposed by the Commission or National Committees of the speciality or specialities involved, which has provided the Commission of Human Resources of the National Health System shall be appointed by the competent ministry.

2. The Committee shall carry out the functions which are to be determined and, in any case, those for the proposal of the contents of the training programme.

3. In any event, the establishment and operation of the Area Committee shall be addressed to the personal, technical and budgetary means assigned to the body to which it is attached. "

Four. The fifth transitional provision is amended, which will have the following wording:

" Transient Disposition fifth. Creation of new degrees of Specialist and Diplomas of Specific Training Areas in Health Sciences.

1. When, in accordance with the provisions of Article 16 of this Law, new official titles of specialist in Health Sciences are established, the Government will take appropriate measures to enable access to the new professional title. they have provided services in the field of the new speciality and fulfil the requirements which they are required to establish. It shall also take appropriate measures for the initial establishment of the relevant National Specialty Commission.

2. When, as provided for in Article 24 of this Law, new diplomas of Specific Training Areas are established for specialists in Health Sciences, the Government will take appropriate measures to enable access to the new diplomas of professionals who have provided services in the field of the new Specific Training Area and meet the requirements that they are required to regulate.

3. The Government shall also take appropriate measures for the initial establishment of the relevant Specific Training Area Committees. "

Article 9. Amendment of Law 16/2003, of 28 May, of cohesion and quality of the National Health System.

A new Additional Disposition is added to Law 16/2003, of 28 May, of cohesion and quality of the National Health System, which will have the following wording:

" Additional Disposition 10th. State Register of Healthcare Professionals.

1. In order to facilitate the proper planning of the needs of health professionals of the State and to coordinate the policies of human resources in the field of the National Health System, it is created in the Ministry of Health, Services Social and Equality, the State Register of Healthcare Professionals that will be integrated into the Health Information System of the National Health System.

2. This register, which will be implemented in digital support, will be nourished by the official registers, professionals, workers in the State and Autonomous Administrations, in the professional schools, regional councils and general councils of the in private health centres and in insurance institutions operating in the field of the disease, which shall be obliged to provide the data deemed necessary, subject to the criteria to be determined by the Council. Interterritorial of the National Health System in the terms provided for in article 53.3 of this law.

3. The State Register of Health Professionals shall be public in respect of the name, title, specialty, place of exercise, category and function of the professional, as well as in the field of qualification, specialty, Diploma of Area of Specific training and Advanced Accreditation and Accreditation, if any, and the dates of obtaining and revalidation of each of them.

4. The provisions of the Organic Law 15/1999 of 13 December on the Protection of Personal Data shall apply to the State Register of Health Professionals. It is for the Ministry of Health, Social Services and Equality to adopt the technical and organisational security measures provided for in the aforementioned legislation, in particular by ensuring that the non-discriminatory access to data is not are public in accordance with the provisions of the previous paragraph.

Also, it is up to the Ministry of Health, Social Services and Equality to progressively implement the State Register of Health Professionals to the various health professions and the permanent updating of the data which it contains, in particular, provided that there is an incidence arising from the professional exercise. '

Article 10. Amendment of Law 55/2003 of 16 December of the Staff Regulations of the Staff Regulations of Health Services.

Law 55/2003 of 16 December 2003 on the Staff Regulations of the Staff Regulations of Health Services is amended as follows:

One. Article 15 is amended as follows:

" Article 15. Creating, modifying, and deleting categories.

1. In the field of each health service, the categories of statutory staff shall be established, amended or deleted in accordance with the provisions of Chapter XIV and, where appropriate, Article 13 of this Act.

2. It is up to the Ministry of Health, Social Services and Equality to approve a homogeneous catalogue in which the equivalences of the occupational categories of health services will be established. For these purposes, the health services shall communicate to the ministry the categories of staff of staff existing in it, as well as their modification or deletion and the creation of new categories, in order to proceed, where appropriate, to the preparation of this table of equivalences and their approval as provided for in Article 37.1. '

Two. Article 41 (3) and (4) are amended, with the current paragraphs 4, 5 and 6 of that Article being paragraphs 5, 6 and 7. Article 41 (3) and (4) shall have the following

:

" 3. The amount of remuneration shall be in accordance with the provisions of the relevant budget laws. The main element in this paragraph is, in any case, the assessment of the performance of the statutory staff, which the health services must establish through procedures based on the principles of equality, objectivity and transparency. The periodic assessment must be taken into account for the purpose of determining part of these additional remuneration, which is linked precisely to productivity, performance and, in short, to the content and scope of the activity which is actually performed.

4. The health services of the autonomous communities and health care managers will establish the necessary mechanisms, such as the management of jobs, the management of supplementary remuneration, the disconnection of places teachers, or others, to ensure that the actual activity is paid. "

Three. A new additional provision is added fifteenth, which will have the following wording:

" Additional Disposition 15th. Extension of the provisions of Article 21 of the Royal Legislative Decree 4/2000 of 23 June, approving the recast of the Law on Social Security of Civil Servants of the State.

The statutory staff of the health services of the autonomous communities and institutions attached to the National Institute of Health Management are exempted from the extension provided for in Article 21 of the Royal Decree Regulation 4/2000 of 23 June 2000 approving the recast of the Law on the Social Security of Civil Servants of the State, and in the Additional Disposition, sixth of Law 26/2009 of 23 December, of the General Budget of the State for the year 2010, in respect of economic performance during the temporary disability situation of the official staff integrated into the General Social Security Scheme, whatever the administration in which it provides services.

The health services of the Autonomous Communities shall decide, in respect of their statutory staff, the degree of application of the content of this economic benefit, when the latter is in a situation of temporary incapacity. "

Four. A new additional sixteenth provision is added, which will have the following wording:

" Additional Disposition sixteenth. Integration of civil servants in the service of public health institutions.

1. Doctors, practitioners and midwives from local health services who provide their services as general practitioners, practitioners and midwives of health services, and the rest of the official staff who provide their services in public health institutions, will have until 31 December 2012 to be integrated into health services as fixed statutory staff. To this end, the autonomous communities shall establish appropriate procedures.

2. If this staff chooses to remain active in its present situation, in the bodies and scales in which they have the status of official staff, the autonomous communities shall be assigned to administrative bodies which do not they belong to public health institutions, in accordance with the basis of the mobility processes which, for this purpose, can be articulated. "

Five. A new 17th Additional Disposition is added, which will have the following wording:

" Additional 17th Disposition. Social action.

In order to strengthen and rationalize 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 intended for the needs of staff who are in an active duty administrative situation, and in no case may the staff who have reached the age of retirement receive any of this character, with economic content to determine the legislation in the field of social security. In cases where the active service extension is authorised, the age shall be that indicated in the resolution authorising this extension. '

Six. The third transitional provision is amended, which will have the following wording:

" Transitional provision third. Quota and zone staff.

In the form and conditions that in each health service, if any, be determined, the personnel who perceive the system of quota and zone will be integrated into the system of delivery of services, dedication and remuneration. which is established in this law, before 31 December 2012. The mode of provision of quota and zone services is deleted from that date.

Since that date, the Order of the Ministry of Health and Consumer Affairs of 8 August 1986, on the remuneration of the staff of the National Institute of Health, the Catalan Institute of Health and the Support Network, is hereby repealed. Health of Social Security in Andalusia. "

Seven. Paragraph 1 (f) of the single derogation provision is amended, which shall be worded as follows:

"(f) The Staff Regulations of the Health Institutions of the Health Institutions approved by the Order of 26 April 1973, as well as the provisions amending, supplementing and implementing it."

Additional disposition first. Regime of Spanish residents abroad.

1. The right to the protection of the health of Spaniards residing abroad shall be governed by the provisions of Law 40/2006 of 14 December of the Statute of Spanish citizenship on the outside and its rules of development.

2. Spanish workers of origin residing in non-Member States of the European Union, of other States party to the Agreement on the European Economic Area and of Switzerland temporarily moving to Spain shall be entitled to the health care in Spain from public funds, through the National Health System when, in accordance with the provisions of Spanish Social Security, those of the State of origin or of the international norms or conventions of Social security established for this purpose, do not have this coverage provided for.

Additional provision second. The fixing of maximum amounts of funding.

1. In the field of dietoterapics, the fixing of maximum amounts of funding will be in line with the provisions of Royal Decree 1205/2010 of 24 September 2010 laying down the basis for the inclusion of dietary foods for medical purposes. Special provisions for the provision of dietetic products from the National Health System and for the establishment of their maximum amounts of funding.

2. The Council of Ministers will approve, within six months from the entry into force of this royal decree-law, a royal decree for the regulation of the supplementary portfolio of orthoprosthetic provision of the National Health System and for the establishment of their maximum amounts of funding.

3. The Ministry of Health, Social Services and Equality shall, within six months of the entry into force of this royal decree-law, draw up a ministerial order to collect the agreements of the full Interterritorial Council of the System. National of Health on non-urgent health transportation, subject to optional prescription, for clinical reasons.

Additional provision third. Assignment of tax information.

The tax administration shall provide, within each financial year, to the public administration body responsible for the recognition and control of the condition of the insured or of the insured person, the data relating to his or her income levels as soon as they are necessary to determine the percentage of participation in the payment of the benefits of the common portfolio of services subject to input.

In the processing of such data, the transferee administration must comply with the regulations on the protection of personal data.

Additional provision fourth. Efficiency measures in the field of the National Health System.

1. The Interterritorial Council of the National Health System will promote the joint actions of the health services of the autonomous communities for the acquisition of any product that is susceptible to a mechanism of Joint and centralised purchasing. In addition, the health services of the Autonomous Communities will encourage the implementation of shared service models through the establishment of a single service provider for a network of centres, on issues such as radiodiagnostics, clinical analysis laboratory, hospital pharmacy, as well as the performance of medical specialties that require a large population to be self-sufficient or suffer difficulties in finding professionals.

2. The autonomous communities will take the necessary measures to ensure that the centres of their dependents work in the course of 2012, if they have not already done so, a plan of energy saving measures to be approved by the body. competent before 31 December 2013.

3. Within six months from the date of entry into force of this royal decree, the Ministry of Health, Social Services and Equality will approve the necessary legislative measures to ensure the adequacy of the packages to the guidelines. and regular treatment times according to the criteria of good medical practice.

First transient disposition. Transitional arrangements for access to healthcare in Spain.

People who, prior to the entry into force of this royal decree-law, have access to healthcare in Spain, will be able to continue to access it until 31 August 2012 without the need to prove the condition of insured under the terms provided for in Article 3 of Law 16/2003 of 28 May.

Second transient disposition. From the common portfolio of services of the National Health System.

As long as the regulations for the development of the common portfolio of services of the National Health System are not elaborated, the Royal Decree 1030/2006 of 15 September, for which the portfolio of services is established, will remain in force. common to the National Health System and the procedure for updating it, in all that does not object to this standard.

Transitional provision third. The fixing of prices for medicinal products not covered by the pharmaceutical supply.

Unless otherwise decided by the Commission Delegated for Economic Affairs, for reasons of general interest, as long as the mechanisms for fixing the prices of sale to the public of the drugs and products are not regulated These will be free in medicines that are not funded from public funds.

Single repeal provision. Regulatory repeal.

Article 115.1 of the recast text of the General Law on Social Security, adopted by Decree 2065/1974 of 30 May 1974, as well as all other provisions of equal or lower rank, is hereby repealed. the actual decree-law.

Final disposition first. Competence title.

This royal decree-law is dictated by the provisions of article 149.1.2., 149.1.16., 149.1.17., 149.1.18. and 149.1.30. of the Spanish Constitution.

Final disposition second. Regulatory development.

1. The Government and the person holding the Ministry of Health, Social Services and Equality, within the scope of their respective powers, are hereby authorised to lay down the provisions and take the necessary measures for the development and implementation of the set in this royal decree-law.

2. The amendments which, as from the entry into force of this royal decree, may be made in respect of the provisions of Article 5 and the fifth, sixth and seventh final provisions, may be made in accordance with the provisions of the to the specific rules of application.

3. The autonomous communities shall, in the field of their respective competences, adopt the measures necessary for the effectiveness of the provisions of this royal decree-law.

Final disposition third. Amendment of Article 12 of the Organic Law 4/2000 of 11 January on the rights and freedoms of foreigners in Spain and their social integration.

Article 12 of the Organic Law 4/2000, of 11 January, on the rights and freedoms of foreigners in Spain and their social integration is amended, which will have the following wording:

" Article 12. Right to healthcare.

Foreigners are entitled to health care under the terms of the current health legislation. "

Final disposition fourth. Amendment of Law 58/2003 of 17 December, General Tax.

Article 95 (1) (c) of Law 58/2003 of 17 December 2003, General Tax, is amended as follows:

(c) collaboration with the Labour and Social Security Inspectorate and with the managing bodies and the common services of social security in the fight against fraud in the levy and collection of the quota system Social security and fraud in obtaining and enjoying the benefits in charge of the system; as well as for determining the level of contribution of each user in the benefits of the National Health System. "

Final disposition fifth. Amendment of Royal Decree 240/2007 of 16 February on entry, free movement and residence in Spain of citizens of the Member States of the European Union and of other States party to the Agreement on the European Economic Area.

Article 7 of Royal Decree 240/2007 of 16 February 2007 on entry, free movement and residence in Spain of citizens of the Member States of the European Union and of other States party to the Agreement on Space The European Economic and Social Committee is amended as follows:

" Article 7. Residence of more than three months of citizens of a Member State of the European Union or of another State party to 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:

a) You are an employed or self-employed person in Spain, or

(b) It has sufficient resources, for itself and the members of his family, not to become a burden for social assistance in Spain during his period of residence, as well as for sickness insurance covering all the risks in Spain, or

c) It is registered in a public or private centre, recognised or financed by the competent educational administration in accordance with the applicable legislation, with the main purpose of pursuing studies, including training professional; and has sickness insurance which covers all risks in Spain and guarantees to the competent national authority, by means of a declaration or by any other equivalent means of its choice, that it has sufficient resources to and the members of his family not to become a burden for the welfare of the State during your period of residence, or

d) is a member of the family accompanying a citizen of the European Union or another State party to the Agreement on the European Economic Area, or is to meet him, and who fulfils the conditions set out in the letters (a), (b) or (c).

2. The right of residence provided for in paragraph 1 shall be extended to family members who are not nationals of a Member State when they accompany the citizen of the European Union or another State party to the Economic Area Agreement. European or meet him in the Spanish State, provided that the citizen fulfils the conditions referred to in points (a), (b) or (c) of that paragraph 1.

3. For the purposes of paragraph 1 (a), the citizen of the European Union or another State party to the Agreement on the European Economic Area who no longer pursues any activity as an employed or self-employed person shall retain the status of self-employed or self-employed in the following cases:

a) If you suffer from a temporary disability resulting from a disease or accident;

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

(c) If, having been left unemployed, duly accredited after completing a work contract of a specified duration of less than one year or having been unemployed for the first 12 months, he has registered in the competent employment service in order to find a job. In this case, the condition of the worker shall be maintained for a period which may not be less than six months;

d) If you follow a professional training. Unless you are in a situation of involuntary unemployment, the maintenance of the condition of the worker will require the training to be related to prior employment.

4. By way of derogation from paragraph 1 (d) and paragraph 2, only the spouse or person referred to in Article 2 (b) and the dependent children shall have the right of 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 paragraph 1 (c) above.

5. Nationals of a Member State of the European Union or of another State party to the Agreement on the European Economic Area shall be required to apply personally to the office of foreign nationals of the province where they intend to remain or to fix his residence or, failing that, before the corresponding Police Commissioner, his registration in the Central Register of Foreigners. Such application must be submitted within three months from the date of entry into Spain, immediately issuing a registration certificate stating the name, nationality and address of the registered person, his/her number of foreign identity, and the date of registration.

6. In addition to the application for registration, the valid and valid national identity card or passport must be presented, as well as the documentation of compliance with the requirements for the registration established. in this article. If the passport or the national identity card is expired, a copy of the passport or national identity document must be provided and the application for renewal must be provided.

7. As far as sufficient economic resources are concerned, a fixed amount may not be established, but the personal situation of nationals of a Member State of the European Union or of another State party to the Agreement shall be taken into account. the European Economic Area. In any event, this amount shall not exceed the level of resources below which the Spanish is granted social assistance or the amount of the minimum Social Security pension. "

Final disposition sixth. Amendment of Royal Decree 1301/2006 of 10 November laying down quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of cells and human tissues and the standards of coordination and operation for their use in humans are approved.

Royal Decree 1301/2006 of 10 November establishing quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of cells and human tissues and the rules for coordination and operation for use in humans are approved, as amended in the following terms:

One. A new paragraph is added to Article 4 (1), which shall be worded as follows:

" Entities that intend to develop any promotional and advertising activities in support of the donation of human tissues and cells shall request prior authorization from the competent health administrations. For such purposes, the competent health administration shall mean the autonomous community where the activity is intended to be carried out, and the National Transplant Organisation where the intended activities exceed that scope. In any event, the procedure for resolving the authorization or refusal of the development of such activities shall be governed by the provisions of Law No 30/1992 of 26 November 1992 of the Legal Regime of the General Administration and of the Common Administrative Procedure. "

Two. An Article 30a is added, which shall be worded as follows:

" Article 30a. Registration of donors of haematopoietic progenitors.

1. The National Transplant Organisation, without prejudice to the registration powers of the autonomic authorities, shall be the body responsible for developing and maintaining the register of donors of comprehensive haematopoietic progenitors. aggregated information from the National Health System as a whole.

2. The transplant coordination units of the Autonomous Communities shall communicate in real time to the National Transplant Organisation information on the donors of haematopoietic progenitors included in their respective records.

3. The person holding the Ministry of Health, Social Services and Equality may entrust the management of this information to public or private entities that carry out their activities in the field of promotion and publicity in support of the donation of human tissues and cells. "

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

Royal Decree 1718/2010, of December 17, on medical prescription and dispensing orders, is amended as follows:

One. The second and third paragraphs of Article 5 (1) are amended, which shall be worded as follows:

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

a) TSI Code 001 for users exempt from input.

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

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

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

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

f) ATEP for work accident or occupational disease prescriptions.

g) NOFIN for prescriptions for unfunded medicines and medical devices. "

Two. Article 5 (3) is amended to read as follows:

" 3. In addition to the prescription, the prescriber may give the patient, in writing, the information and observations that he or she believes will be used for the best use of the medication by the patient. These information and comments will be complemented by those authorised by the Spanish Agency for Medicines and Health Products and will be suitable for each individual patient. They shall include, where appropriate, warnings about adverse reactions, contraindications, interactions and precautions in use. '

Three. Paragraphs 6, 7 and 8 shall be added to Article 5, which shall be worded as follows:

" 6. Information on the cost of treatment will be included in the prescription and therapeutic reports for the patient, with differentiation of the percentage assumed by the National Health System.

7. During the medical act, the patient will be informed of the existence of therapeutic options for reduced input prior to the issuance of the official prescription of the National Health System.

8. Accessibility for persons with disabilities shall be taken into account in all information. "

Four. A new paragraph 6 is added to Article 17, which will have the following wording:

" 6. Medicinal products and medical devices not included in the financing may only be acquired and used by the hospitals of the National Health System prior to the agreement of the commission responsible for the therapeutic protocols or the collegiate body equivalent in each stand-alone community.

In order to be able to take the decisions referred to in the preceding paragraph, the commissions responsible must have been constituted according to the rules applicable in the autonomous community, they shall have a manual of procedure which ensure the quality of their decisions and inform the competent body within the responsible department of their decisions and decisions. "

Final disposition octave. Actions to be carried out by public administrations.

1. The competent public authorities shall take all measures necessary for the effective implementation of the provisions of this royal decree.

2. The public authorities responsible for social security and health shall carry out the necessary actions to update and adapt the information in their databases to the provisions of this standard.

3. The competent public authorities shall, before 30 June 2012, adopt all measures necessary for the effective implementation of the provisions of Article 4 (13) of this Royal Decree-Law.

Final disposition ninth. Entry into force.

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

Dado en Madrid, el 20 de abril de 2012.

JOHN CARLOS R.

The President of the Government,

MARIANO RAJOY BREY