I

This Royal Decree-Law aims to continue and reinforce the fiscal and budgetary measures that the government has put in place to achieve the objectives of reducing the public deficit, A priority must be given to the government's economic policy. In the current situation of uncertainty in international markets, it is particularly important that the Spanish institutions reaffirm their commitment to this objective. In this context, this Royal Decree-Law introduces, among others, measures that pursue both a reduction of public expenditure, through the rationalization of health expenditure, and an improvement in tax revenues, through the tax on Companies.

II

The current economic context in which we move, makes it necessary for public policies to be oriented more than ever towards austerity and spending rationality scenarios, which will allow for the maintenance of an adequate level of public services without prejudice to their equity and quality components.

The public health sector, as the essential axis of the welfare state and the relevant driver of economic and social development in our country, is a very important component of public spending.

El Nacional] These two circumstances, the economic situation and the intensive use of resources that our National Health System needs to maintain, are causing financial tensions in the same way that we need to address in the sustainability of the system.

In this Royal Decree-law, a series of austerity measures in the pharmaceutical supply that aim to alleviate the financial strain of health services, along with other measures aimed at improving equity, are concretized. cohesion and the quality of the system, such as the optimisation of the application of new technologies in health information systems and the improvement of the coordination of social and health care.

Furthermore, in its second provision, the second amendment of Law 44/2003, of 21 November, of the management of the health professions, is amended to accommodate the new European area of higher education and the revision of the model Specialised health training.

III

In 2010, the plenary session of the Interterritorial Council of the National Health System, in view of the sustained and sustained growth of drug spending by the pharmaceutical supply of the System itself, and of the The Committee of the European Economic and Social Committee, in its opinion of the Committee on Economic and Financial and Social Committee, adopted a resolution on the proposal for a European Parliament and Council directive on the actions and measures to promote the quality, equity, cohesion and sustainability of the System National Health, which included a set of actions and measures that promoted the search for greater efficiency in healthcare spending as well as greater quality, equity and cohesion in the National Health System.

As a result of this agreement, Royal Decree-Law 4/2010 of 26 March, of rationalisation of pharmaceutical expenditure under the National Health System, pursued the urgent objective of modifying the public funding of medicines and medical devices provided for in Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices, with the ultimate aim of establishing measures to rationalise and control the health care expenditure which they will enable, in the pharmaceutical field, an immediate reduction of the expenditure that will ensure the necessary Sustainability of the National Health System while maintaining the premises of universality and high quality in their performance.

For its part, in Royal Decree-Law 8/2010 of 20 May, which adopted extraordinary measures for the reduction of the public deficit, measures were established in addition to those already adopted in the framework of the The pharmaceutical supply, maintaining the austerity effort in the pharmaceutical expenditure already mentioned in the Royal Decree-Law 4/2010, of March 26, made additional adjustments that allowed the reduction of the pharmaceutical bill public through deductions in medicines and price revision of products In the case of the case-law of the Court of Law, the Court of the Court of the European Court of the European Court of the European Court of the European Court of the European Court of single-dose.

It should be noted that, thanks to these measures undertaken, in 2010, and for the first time in the history of the National Health System, the pharmaceutical expenditure through official prescription has declined from the year of the year The Commission also noted that the increase in the number of years of the year of the year of the year 2004 was the same as that of the previous year,

a decrease of 2,36%, which was confirmed by the increase in the year-on-year increase.

This moderation in the growth of pharmaceutical spending has manifested itself in the average spending per recipe, which has decreased by 4.79% compared to 2009, as in the number of prescriptions billed, which has increased by 2.56%, below 4.94% last year.

However, despite the reduction in pharmaceutical expenditure achieved, almost all Autonomous Communities are adopting measures complementary to those adopted by the Government of Spain, measures which could create situations of inequality in the pharmaceutical supply and, even, against the equity of the National Health System and against the competences that the Government of Spain has in this field.

Therefore it is the Government's inexcusable and urgent duty to continue to make progress on the measures and actions agreed at the National Health System's Interterritorial Council plenary of 18 March 2010 to promote quality, equity, cohesion and sustainability of the system. The new measures must be added to those already being implemented, and must help to control and rationalise the health expenditure of the Autonomous Communities in order to maintain health benefits under the conditions of universality, quality and equity that characterises them.

It is therefore envisaged to amend Law 29/2006 of 26 July on the guarantees and rational use of medicinal products and medical devices, in the belief that the measures introduced will allow for an extension of the improvement margin in the quality of the pharmaceutical supply, which must be understood, in the framework of efficiency in public expenditure, as the need to make better use of the resources available in the medical-health field. This will necessarily help to ensure the financial sufficiency that the public health system is so in need of. The planned reforms are understood to be consistent with a decentralized health model that aims to fight inequality in order to achieve equity, so that a solid cohesion policy is made to put aside the inequalities that may be exist.

Thus, the amendment of Article 2.6, of Article 82.2.a) of Law 29/2006, of 26 July, and of Article 24.3.a) of Royal Decree 1345/2007, of 11 October (provided for in Article 2 of this Royal Decree-Law), derives from the The possibility that Law 29/2006 gives to pharmacies in hospitals to dispense medicines that require particular surveillance, supervision and control of the multidisciplinary team of health care. For this reason, and in the line of giving greater cohesion to the system, avoiding any discrimination that may be given according to the place of residence of the tax patients of such treatments, is specifically attributed to the Spanish Medicines Agency. and Sanitary Products the ability to identify these drugs, as well as, in the field of the National Health System, to the Ministry of Health, Social Policy and Equality to limit the supply of medicines in the services of pharmacy hospital.

With regard to the amendment to Article 3.6 of Law 29/2006 of 26 July, it is produced to increase from 5% to 10% the discounts that distributors can make to pharmacies in non-generic medicines, since the All measures taken in this Royal Decree-Law require the elimination of differentiated treatment which, in this respect, was established for generic and non-generic medicines.

As regards Article 19 of Law 29/2006 of 26 July, a new paragraph 9 is added which allows for the promotion of measures for the rational use of medicinal products through the adequacy of the content of the packaging of medicinal products. the duration of the treatment and in accordance with what marks the clinical practice, which in the final analysis has to result in an improvement in efficiency in the area of pharmaceutical expenditure.

In the same sense, it is necessary to understand the modification of Article 84.1, while promoting the correct therapeutic compliance by patients improves the rational use of the drugs and, consequently, the efficiency and efficiency of the same. This latter topic is particularly important in the case of chronic, polydicated and institutionalized patients.

For its part, the amendment of Article 85 proposes to generalise the prescription for active principle as a means of, without reducing the quality of the pharmaceutical supply, to introduce criteria of responsibility in the adequate management of the economic resources available to the health system. It is hereby established that the prescription of medicinal products and medical devices shall be carried out on the basis of their active substance or generic name, respectively, except where there are causes of therapeutic need which justify the prescription by brand, or in the case of medicinal products belonging to groups consisting exclusively of a medicinal product and its licences at the same price. However, where, by derogation, the prescription has been made by the trade name of the medicinal product or medical device, the prescribed product shall be dispensed if it is the lowest price of the corresponding group; otherwise, the lower price of the same shall be waived. This measure involves the dispensing of the drug or lower-priced healthcare product, which is an important saving for the National Health System, being the Directorate General of Pharmacy and Health Products of the Ministry of Health, Social policy and equality to be determined by the homogeneous groupings of medicinal products and medical devices to facilitate the identification of the lower price presentation. To this end, in addition, a new additional provision of fourteenth provision for the publication of such information is added to Law 29/2006 of 26 July, which takes effect in the light of the procedure laid down in the provision transient second of the present Royal Decree-law.

Also in order to strengthen the rationality in the field of decisions on the financing of medicines that, guaranteeing a better use of the economic resources, allows to apply criteria effectively The Commission has also proposed a series of amendments to the draft Directive on the approximation of the law of the Member State. For example, the introduction of price comparison criteria into therapeutic alternatives which will enable the adoption of decisions on the financing of medicinal products must be understood. In order to improve and ensure the participation of the autonomous communities in the price fixing decisions of the Interministerial Commission for the Prices of Medicinal Products, Article 90 (3) is amended by introducing the following reports: The Committee on the cost-effectiveness of medicinal products and medical devices shall be composed of experts appointed by the Interterritorial Council of the National Health System, on the proposal of the Autonomous Communities, of the Mutual officials and the Ministry of Health, Social Policy and Equality.

As for Article 93, in its new wording the concept of what is to be understood as a whole of the reference price system is clarified, in order to avoid interpretative discrepancies caused by the initial indefinition. of the concept, which at the moment led to the application of different jurisprudential criteria. In this same sense, and in order to maintain uniformity, the same concept applies when it comes to the incorporation of medicines into sets already created. It is also foreseen that the determination of the new sets and their reference prices and the review of these will be carried out by the Directorate General of Pharmacy and Health Products, which gives greater agility to the system, allowing it to be make the changes in the same as they are produced, which is favored by the own computer applications that serve to bring it to the practice, and extends the creation of sets to the medicines of hospital scope. The same applies to new developments in the field of gallic innovation, while also facilitating the incorporation of the same into the reference price system when a generic or biosimilar with the same qualitative composition is financed. quantitative in principle active and identical pharmaceutical form.

The obligation laid down in the second paragraph for the medicinal products concerned by the reference price system to be adjusted to the reference price, and cannot exceed that of the corresponding set, is also based on (a) the efficiency of the management of the pharmaceutical supply to ensure the sustainability of the public health system. The amendment to the fourth paragraph is justified by the amendment in Article 85, which provides for the prescription and supply of an active substance, and must, in these circumstances, allow trade marks to compete. with generics on a level playing field.

Likewise, the abolition of graduality is deemed necessary for the reduction of the prices of the drugs affected by the reference price system to be carried out immediately without applying The need for a transitional period for medicinal products. There is thus a greater control of pharmaceutical expenditure.

A new paragraph 11 is also incorporated as a means of improving the pharmaceutical supply, in which an effective alternative to the reference price system is established as a mechanism for controlling expenditure and rationalise those groups of medicinal products and medical devices that are high consumption.

A second paragraph is also added to this Article 93 in order to avoid the added tax that would be required to apply the deductions set out in Articles 8, 9 and 10 of Royal Decree-Law 8/2010 of 20 May 2010 to the medicines that are affected by the provisions of this Article. And finally, a new thirteenth paragraph is introduced to strengthen the obligation of annual information to the Government's Delegation for Economic Affairs, which, of the resolutions adopted in the field of the reference price system, The General Directorate of Pharmacy and Health Products of the Ministry of Health, Social Policy and Equality should be given as a mechanism for monitoring the system as a whole.

In order to avoid shortages and to enable control and inspection actions of the health administrations, three new very serious infringements are added, numbered 21, 22. and 23. in paragraph 2 (c). Article 101, in order to penalise the supply of medicinal products by the marketing authorisation holder, the distribution outside the national territory of medicinal products for which there are problems of supply the health impact, the performance, by a pharmacy office, of activities for the distribution of medicinal products to other pharmacy offices, wholesale warehouses, or consignments of medicinal products outside the national territory, as well as a further serious infringement in point (b), numbered as 33ª, in order to establish the contribution or concealment by the entities or persons responsible for data, documents or information which are not truthful or which give rise to inaccurate findings.

The additional tenth provision is amended to incorporate the mutual funds of officials in the Rector Council of the Spanish Agency for Medicines and Health Products and contemplating such mutual benefits. The information on medicinal products referred to in this Article shall be addressed.

An additional new provision is incorporated fourteenth, enabling the Directorate General of Pharmacy and Health Products for the publication of the homogeneous groupings of medicines and medical devices and the relationship information on the minor prices, specifying the content of those groups and their updating, all for the application of the cases of supply and replacement referred to in Articles 85 and 86 of Law 29/2006, of 26 July.

A new transitional provision is introduced which, as long as the system for the identification of each of the units of the medicinal products provided for in Article 87 is not developed, will enable the Ministry of Health, Social Policy and Equality movements of medicinal products in the pharmaceutical market, in order to ensure the adequate supply of medicinal products to the population and to take the necessary measures in the event of possible unavailability.

Likewise, the present Royal Decree-law amends various rules, as it is necessary to achieve the objectives set out in it. This mechanism was already used in the Royal Decree-Law 4/2010, of March 26, of rationalization of the pharmaceutical expenditure under the National Health System, validated on April 14, 2010 by the Congress of Deputies.

Thus, it is amended, as noted above, Royal Decree 1345/2007 of 11 October, regulating the procedure for the authorisation, registration and conditions for the supply of medicinal products for human use manufactured industrially.

For its part, the third article establishes a measure of support to the viability of the pharmacy offices that guarantees the continuity of the care service they provide. Especially in rural areas, pharmacy offices play a major role in the health of the population and, in the current economic situation, the viability of some of them is compromised. This is why it is proposed to amend the Royal Decree 823/2008 of 16 May, which establishes the margins, deductions and discounts corresponding to the distribution and supply of medicinal products for human use, introducing a corrective index of the margins for the aforementioned pharmacy offices, inversely proportional to their invoicing from public funds. This measure, which is limited to the pharmacy offices that meet certain requirements, contributes to the viability of those requirements and, therefore, the continuity in the delivery of their services in singular population nuclei.

In addition, Article 10 of Royal Decree-Law 8/2010 of 20 May 2010, adopting extraordinary measures for the reduction of the public deficit, is amended in order to apply the 15% deduction to those medicines which, Because they lack generic or biosimilar in Spain, they have not been incorporated into the reference price system, having elapsed a period of prudential time to write down the investments made by the laboratory to put the medicine in the market. The first requirement for the accreditation of patent protection of products in all Member States of the European Union is laid down in the first provision for medicinal products which may be excluded from the abovementioned deduction of 15%. %.

In another order, it incorporates the text three transitional provisions to regulate, on the one hand, the effects of the galenic innovations of therapeutic interest already declared at the moment of entry into force the present Royal Decree-Law, on the other hand, to regulate the publication of the information of the homogeneous groupings referred to in the additional provision 14 of Law 29/2006 of 26 July, as well as the voluntary reduction of the prices of the medicinal products and products In the light of the above, the Commission has been in a position to prices and the return of stocks of those affected by these reductions, in order to avoid shortages of the same and to guarantee the supply to the users of the National Health System and, finally, to establish the period of the updated information on prices that are updated as agreed on 21 June 2011 by the Permanent Commission of Pharmacy of the Interterritorial Council of the National Health System, as provided for in Order SPI/30 52/2010, November 26, by which the sets of medicines are determined, and their reference prices, and regulating certain aspects of the reference price system.

IV

In Chapter II of Title I, measures relating to the health information system are dealt with, aimed at completing the actions currently being developed in a coordinated manner between all administrations. health. The concrete projects currently being implemented are the health card, the digital medical history and the electronic recipe.

For all of them in this standard, a temporary framework is established in which all projects must be operational and interoperable throughout the territory, which will be an essential advance in the cohesion of the National System of Health.

V

The normative text, in Chapter III of the same Title I, also incorporates forecasts for improving the quality of care for people who receive health and social care services, urging the Government to the six-month period, in cooperation with the autonomous communities, with the mutual associations of officials and with the collaboration of the citizens ' organizations, the professionals and the companies of the sector, a strategy of coordination of the social and health care.

VI

Regulated in Title I of this Royal Decree-Law is protected in the exclusive competence of the State in the field of bases and general coordination of health, legislation on pharmaceutical products and economic regime of the Social security, and in addition to the European legislation on the subject, in particular, in Council Directive 89 /105/EEC of 21 December on the transparency of the measures governing the pricing of the medicinal products for human use and their inclusion in the field of national health insurance systems; in accordance with the principles of transparency and non-discrimination, and in response to the requirements and rules of interpretation laid down by the Court of Justice of the European Union in its judgment of 2 April 2009 (CJEC/2009/77).

Community legislation starts from the premise that the ordering of drug prices and the organisation of social security systems is a matter for the Member States to be reserved for, without any regulation The European Union is a direct subject of this matter. However, in exercising its national competence, Member States must respect two basic Community principles: the principle of non-discrimination and the principle of transparency. By virtue of the first, it will be illegitimate to favour national pharmaceutical products vis-à-vis those from other Member States. Under the second, decisions on price fixing should be reasoned and adopted on the basis of objective and verifiable criteria. Directive 89 /105/EEC contains the regulatory guidelines which guarantee the principle of transparency of the measures governing the pricing of medicinal products for human use.

VII

The need to consolidate public finances as an essential objective to ensure the stability of our economy and to foster recovery and employment advises the adoption of tax measures to strengthen the public revenue.

As far as the Company Tax is concerned, the measures to be taken, as provided for in Article 9 of this Royal Decree-Law, must be addressed to the largest companies, as they are considered to be The benefits of this kind of benefit are now greater in terms of economic capacity to make an additional temporary contribution to the sustainability of our public finances. It should be noted that, under no circumstances, the proposed measures entail tax increases, but changes in the reification of tax revenues to anticipate the collection of the tax and to favor the fulfillment of the objectives of the tax. reduction of the public deficit in the short term.

To do this, the legal regime of the Corporate Tax is modified to raise the percentage of the calculation of the split payments to be made by the big companies that bill more than twenty million euros, although in fact This increase is more notable in the case of those whose annual turnover exceeds the figure of sixty million euros.

For the same purpose, and always in relation to the largest companies, limits of temporary application are established to the compensation of negative taxable bases from previous years, distinguishing again between the companies with turnover of more than twenty and sixty million euros.

It should be stressed that the maximum period for the compensation of negative tax bases from 15 to 18 years is extended, which ensures the merely temporary effect of this tax measure. It is also necessary to mention that this extension of the deadline for the compensation of negative bases is a measure that will benefit all types of entities, including the Dimensional Scale Enterprises.

Additionally, a limit, also of temporary application, is established for the deduction of the financial goodwill, which for three years may be deducted at a rate lower than the usual rate but which, given the legal wording, does not prevent the definitive deduction of those amounts at a later time.

It is, in short, rules that only affect the largest legal entities on a temporary basis and bring benefits to those who, as has been previously justified, have the capacity to collaborate in particular in the lifting of public burdens and the achievement of the public deficit targets that our country has committed.

As for the legal figure through which this measure is adopted, it should be noted that amendments are adopted that do not substantially affect the obligation to contribute, since they involve only a different temporary reformation in the production of public revenue.

Moreover, in the fourth transitional provision of this Royal Decree-Law, a measure is adopted which is temporary in nature, such as those which are also incorporated in the field of direct taxation, and is intended to offer a Tax advantage for the purchase of homes to be carried out during the remainder of this year 2011. Thus, with exclusive validity until 31 December 2011, the supply of buildings destined for housing will benefit from taxation at the super-reduced rate of 4% instead of the usual 8%.

This is a fiscal policy measure that has an impact on a particular situation and which seeks to obtain sensitive effects during the period in which it will be effective, without the intention of affecting the tax rate structure of Value Added Tax.

VIII

On the other hand, the European Financial Stabilisation Facility (EFSF) was established in Luxembourg on 7 June 2010. , an anonymous company whose social object is to support the stability of the euro area Member States, in the form of loan and loan servicing agreements made under those arrangements.

In order to be able to comply with the financial commitments entered into by the Kingdom of Spain under the Framework Agreement of the European Financial Stabilization Facility, the General Administration of the State was authorized, by Royal Decree-Law 9/2010 of 28 May 2010 to grant guarantees of up to EUR 53.9 billion to guarantee the economic obligations payable to the European Financial Stabilisation Facility, arising from the financial instruments, the coordination of lending and lending operations, as well as any other financing operations carried out by that company. According to the aforementioned authorization, Law 39/2010, of 22 December, of General State Budgets for the year 2011, reserved in its article 49 Two, 53.9 billion euros as the maximum amount of the guarantees to be granted by the State during the exercise 2011 for the intended purpose.

However, subsequently, the Heads of State and Government of the euro area, at their summits of 11 March and 21 July 2011, have reached several agreements aimed at increasing the capacity of the EFSF to combat the financial contagion. In addition, the Heads of State and Government of the euro area have announced their intention to use the EFSF as a financial vehicle for a new programme for Greece, and have committed themselves to implementing the necessary procedures for the euro area. implementation of these decisions as soon as possible.

As a consequence of the above, and in order to make effective the approved lending capacity of the EFSF, it is necessary to increase the commitment made by the States that are shareholders of the EFSF. In the case of Spain, this new commitment amounts to a maximum of 92,543,560,000 euros, which requires the modification of the current State General Budget Law in order to increase the limit of guarantees to guarantee the economic obligations of the EFSF. To this purpose is the regulation of the final Disposition of this Royal Decree-Law.

IX

The measures that are applied in Title I of this Royal Decree-Law are aimed, at the margin of giving greater cohesion to the National Health System, to ensure the viability and economic sustainability of this system. which makes it necessary for them to be applied as quickly as possible, thereby contributing to the actions already undertaken in the previous year in the field of rationalisation and control of expenditure in the field of pharmaceutical provision of the national system of Health, how good results have been shown to date. This is why, in the current economic context, the measures now agreed, in order to be effective, must be implemented through immediate regulatory action. In this regard, the Constitutional Court considers the use of a Royal Decree-law to be lawful in those cases where the economic circumstances require a rapid response, corresponding to the government's decision on the concurrency of the latter. Budget in fact enabling. The normative action contained in Title I of this Royal Decree-Law has a unitary objective, as is to achieve the sustainability of the National Health System, approaching the concept of financial sufficiency necessary for this. I would like to make it easier for public health care to be viable in line with the principles of cohesion that must be applied in a decentralised system such as ours. This is why the importance of the objective must be achieved in its entirety within a shorter time than the parliamentary process itself of a draft law, subject to the corresponding deadline for drafting and approval.

With regard to the tax measures contained in Article 9 of this Royal Decree-Law, it is worth noting that the economic situation and the evolution of public revenues, as well as their influence on the behaviour of the The need to ensure that Spain's public deficit commitments are met, makes it essential to take immediate and urgent measures to strengthen these public revenues.

With regard to the provisions of the Final Disposition of the Royal Decree-Law, the financing of the new Greek programme, together with the situation of the euro area markets, require the Member States which are The shareholders of the EFSF are quick, determined and coordinated. The above mentioned increase in the limit of guarantees to guarantee the economic obligations of the EFSF, as set out above, is an unavoidable requirement for the company to be able to meet the new objectives and functions that have been entrusted to you.

Therefore in this Royal Decree-law, the circumstances of extraordinary and urgent need laid down in Article 86 of the Constitution.

By virtue of all this, making use of the authorization contained in article 86 of the Spanish Constitution, on the proposal of the Vice President of the Government of Economic Affairs and Minister of Economy and Finance and the Minister of Health, Social Policy and Equality, and after deliberation by the Council of Ministers, at its meeting on 19 August 2011,

DISPONGO:

TITLE I

Measures to improve the quality, equity, cohesion and sustainability of the National Health System

CHAPTER I

Measures relating to the provision of pharmaceuticals

Article 1. Amendment of Law 29/2006 of 26 July on the guarantees and rational use of medicinal products and medical devices.

Law 29/2006, of July 26, of guarantees and the rational use of medicines and medical devices is amended in the following terms:

One. Article 2 (6) is amended as follows:

" 6. The custody, conservation and dispensing of medicinal products for human use shall be exclusively:

a) To the legally authorized offices of pharmacy open to the public.

b) To the pharmacy services of the hospitals, health centers and primary care structures of the National Health System for their application within these institutions or for the drugs that require a particular surveillance, supervision and control of the multidisciplinary health care team, in accordance with the qualification granted by the Spanish Agency for Medicines and Health Products for such medicinal products.

(c) In the field of the National Health System, in addition to the medicinal products specified in point (b) of this paragraph, it shall correspond to the pharmacy services of the hospitals, the custody, conservation and dispensing of the medicinal products for human use in which the Ministry of Health, Social Policy and Equality agrees to establish unique reserves, limiting their dispensation without the need for a visa for non-hospitalised patients. "

Two. Article 3 (6) is amended as follows:

" 6. For the purposes of ensuring the independence of decisions relating to the prescription, dispensing, and administration of medicinal products in respect of commercial interests, the direct or indirect offer of any incentive shall be prohibited, bonuses, discounts, premiums or gifts, by those who have direct or indirect interests in the production, manufacture and marketing of medicinal products to healthcare professionals involved in the cycle of prescription, supply and medication administration or to your relatives and people of coexistence. This ban will also apply when the offer is made to healthcare professionals who prescribe medical devices. The exception of the previous prohibition is the discounts for early payment or purchase volume, which are made by the distributors to the pharmacy offices. They will be able to reach up to a maximum of 10% for the medicines financed from the National Health System, provided that the purchase of a product is not incentivised against that of its competitors and will be reflected in the corresponding invoice. "

Three. Article 19, to which a paragraph 9 is added, shall be amended as follows:

" 9. In order to ensure the rational use of medicinal products, the Spanish Agency for Medicines and Health Products will take all necessary measures to bring the contents of all the packaging of the new authorised medicinal products into line with the duration of the treatments in clinical practice. It shall also carry out a review, for the same purposes, of the medicinal products already authorised within one year, giving a semi-annual account to the Interterritorial Council of the National Health System. "

Four. Article 82 (2) (a) is amended as follows:

" 2. In order to contribute to the rational use of medicinal products, hospital pharmacy units or services shall perform the following functions:

(a) Ensure and assume the technical responsibility of the acquisition, quality, correct conservation, coverage of the needs, custody, preparation of master formulas or official preparations and dispensation of the precise medicinal products for intra-hospital activities and for those for extra-hospital treatment, as provided for in Article 2 (6) of this Law. "

Five. Article 84 (1) is amended to read as follows:

" 1. At the pharmacy offices, pharmacists, as responsible for dispensing medicinal products to the public, will ensure compliance with the guidelines established by the doctor responsible for the prescription, and will cooperate with the in the follow-up of treatment through the procedures of pharmaceutical care, contributing to ensure its efficacy and safety. They shall also participate in the implementation of all activities aimed at the rational use of medicinal products, in particular through the provision of the patient's informed consent. Once the medicine has been dispensed, it will be able to provide personalized dosing systems to patients who request it, in order to improve the therapeutic compliance, in the treatments and with the conditions and requirements established by the competent health administrations. '

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

" 1. The prescription, indication or authorization of dispensing of the medicinal products shall be carried out on an active basis, in the official medical prescription or dispensing order, of the National Health System.

Also, in the medical devices for non-hospitalized patients requiring for dispensing in the office of pharmacy official medical prescription or order of dispensation, of the National Health System, the prescription, indication or dispensing authorization shall be performed by generic denomination by product type and by the characteristics that define it, specifying its size and content.

In both cases, the pharmacist will dispense with the presentation of the drug or the medical device that has the lowest price, according to the homogeneous groupings determined by the General Directorate of Pharmacy and Products. Health, Social Policy and Equality Health Ministry.

However, where, by way of derogation from the general rule, the prescription, indication or authorization of supply has been made by identifying the medicinal product or the medical device, respectively, by its trade name, not in the case of the assumptions referred to in point 2 of this Article, the pharmacist shall dispense such medicinal product or product if it is the lowest price of the corresponding group, and if it is not the same as the one with the lowest price of the same.

2. However, where the therapeutic needs so warrant, and where the medicinal products belong to a group consisting exclusively of a medicinal product and its licences, at the same price as the reference medicinal product, the prescription, Indication or authorization of supply may be made by identifying the medicinal product or, where appropriate, the medical device by its commercial name. '

Seven. Article 89 (1) and (6) are amended, which shall be worded as follows:

" 1. Once a medicinal product has been authorised and registered, the Ministry of Health, Social Policy and Equality by means of a reasoned decision shall decide, prior to its placing on the market, whether or not to include it in the pharmaceutical supply of the product concerned. National Health System. In case of inclusion, the modality of such inclusion shall also be decided.

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 financing 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 ratio.

d) Rationalization of public expenditure for pharmaceutical provision, and budgetary impact on 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, the Ministry of Health, Social Policy and Equality, in order to ensure the rational use of medicinal products, may submit, ex officio or at the request of the Autonomous Communities interested, to unique reservations, the specific conditions of prescription, dispensing and financing of the same in the National Health System. "

" 6. The medical devices that are to be included in the pharmaceutical provision of the National Health System and that are dispensed, through official prescription, in national territory, will follow the criteria indicated for the drugs. In any event, they must comply with the specifications and technical specifications which the Ministry of Health, Social Policy and Equality has previously determined, taking into account general, objective and published criteria and The following concrete:

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

b) Specific needs of certain collectives.

c) Diagnostic, control, treatment, prevention, relief, or compensation for a disability.

d) Social value of the healthcare product and incremental clinical benefit of the product taking into account its cost-effectiveness ratio.

e) Existence of medical devices or other therapeutic alternatives for the same conditions at lower price or lower cost of treatment. "

Eight. Article 90 (3) is amended, which shall be worded as follows:

" 3. The Inter-Ministerial Committee for the Prices of Medicinal Products will take into account the evaluation reports drawn up by the Spanish Agency for Medicinal Products and Health Products, as well as the reports to be prepared by the Cost Committee. Effectiveness of Medicines and Healthcare Products. The Committee, chaired by the Directorate-General for Pharmacy and Health Products of the Ministry of Health, Social Policy and Equality, will be composed of experts appointed by the Interterritorial Council of the National Health System, on a proposal from of the Autonomous Communities, of the Mutualities of officials and of the Ministry. The rules of organization and operation of the aforementioned Committee shall be established by the Interterritorial Council of the National Health System. "

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

" Article 93. The Reference Price System.

1. Public funding for medicinal products shall be subject to the reference price system.

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

2. All submissions of funded medicinal products having the same active substance and the same route of administration as those included in the pharmaceutical provision of the National Health System are understood as a whole. less, a generic or biosimilar drug presentation. The presentations indicated for treatments in pediatrics, as well as those for medicinal products in the hospital, will constitute separate sets. Assemblies may be set up from the moment 10 years have elapsed since the date of the initial marketing authorisation of the reference medicinal product in Spain, or 11 if a new indication has been authorised.

The reference price will be, for each set, the lowest cost/treatment/day of the drug presentations in the grouped by each route of administration, calculated according to the defined daily dose. Minimum thresholds may be set for these prices, in no case less than 1.00 euro of industrial price.

Medicines will not be able to exceed the reference price of the set to which they belong.

3. The determination of the sets and their reference prices, as well as the revision of the reference prices of the sets already determined shall be carried out as soon as possible when the requirements laid down in the rules for the determination of a new set or revision of existing ones, and at least once a year.

The presentations of medicinal products that are authorised and which, by their characteristics, can be included in one of the existing sets, will be integrated into them, from the moment their inclusion in the Pharmaceutical provision of the National Health System, making the appropriate express declaration to record such integration.

4. The dispensing of official prescriptions and orders for the supply of the National Health System for medicinal products affected by the reference price system shall be made in accordance with the provisions of Article 85.1.

5. The holder of the Ministry of Health, Social Policy and Equality may provide for the assumptions, requirements and procedures in which certain Welsh innovations which are considered to be of interest for adding improvements in the therapeutic utility may be be excluded from the reference price system for five years. Galenic innovation shall be integrated into the reference set, after five years or from the time the inclusion in the pharmaceutical provision of the National Health System of a generic medicinal product or a medicinal product is resolved. biosimilar, with the same qualitative and quantitative composition in principle active and identical pharmaceutical form.

6. It shall be for the holder of the Directorate-General for Pharmacy and Health Products of the Ministry of Health and Social Policy and Equality, by means of a reasoned decision, to issue the following acts:

(a) The determination of the new sets and their reference prices, the review thereof and the activation of the declared inactive sets, once the causes that originated their inactivation, as well as the fixing of the minimum threshold for the reference price, establishing as much as is necessary for the purposes of applying the formula for the calculation of the reference price, subject to a favourable report by the Inter-Ministerial Commission on Prices Medicines.

b) The express declaration of integration into one of the existing sets, of the presentations of medicinal products in which the inclusion in the pharmaceutical delivery of the National Health System is resolved, when by its features can be included in the same.

c) The deletion of the sets already determined when the causes that prompted their creation cease to exist.

d) The express declaration of the integration of the Gallic innovations into the reference set, after the five years or from the moment the inclusion in the pharmaceutical provision of the System is resolved National of Health of a generic medicinal product or of a biosimilar medicinal product, with the same qualitative and quantitative composition in principle active and identical pharmaceutical form.

e) The authorisation of the voluntary reduction of the maximum industrial price without change of National Code, where this is considered, in the medicinal products that are affected by the reference price system, both in relation to the with the creation of the sets as in the revision of the price of the same, setting the deadlines for the corresponding reduction. It may also set deadlines for the co-existence of prices and return of stocks, for presentations of medicinal products affected by price reductions in accordance with the provisions of this Article.

7. The head of the Directorate-General for Information, for information purposes, shall publish from the creation of the relevant set the list of medicinal products with a declaration of gallic innovation and the dates of the periods of exclusion of such medicinal products. of the reference price system.

8. For the application of the reference price system and other matters covered by this provision, all notifications which the Directorate-General for Pharmacy and Health Products must make to laboratories, distributors, representatives of the pharmacy offices and other interested parties, as well as the actions of the pharmacy offices, in accordance with Article 27.6 of Law 11/2007, of 22 June of electronic access of citizens to the Services Public, through electronic means, to the electronic headquarters of the Ministry of Health, Social Policy and Equality (sede.msps.gob.es).

9. The resolutions of the Directorate General of Pharmacy and Health Products referred to in this article will be communicated periodically to the Interterritorial Council of the National Health System and to the Government Delegation for Affairs Economic, without prejudice to its publication in the "Official State Gazette" of the resolutions contained in paragraphs 6.a) and c) and in paragraph 7 of this article.

10. The resolutions of the Directorate General of Pharmacy and Health Products referred to in this article, will be used in a show of support as provided for in Law 30/1992, of November 26, and Law 6/1997, of April 14.

11. The Government shall set out the criteria and the procedure for determining the group of medicinal products which may be excluded from the reference price system, which is replaced by the price system selected; In addition, the consumption of these drugs and/or their budgetary impact on the National Health System. The application of the selected price system may also be extended to other groups of medicinal products for which, in the absence of the reference price system, several presentations are financed with the same composition, form pharmaceutical, route of administration and dosage, and medical devices for non-hospitalized patients requiring for dispensing in the office of pharmacy official prescription or dispensing order, of which several are financed presentations with the same characteristics, type, size and content, and are classified according to the groups listed in Annexes I and II to Royal Decree 9/1996 of 15 January for the purpose of regulating the selection of effects and accessories, their financing with social security funds, or state funds allocated to them the health and its supply and supply arrangements for non-hospitalized patients.

The Royal Decree that will be dictated to the effect will regulate the procedure for the selection of the presentations of said medicines and sanitary products, as well as for the determination of its price, and for the fixing of the period during which will remain in force. The procedure shall respect the principles of free competition and transparency.

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 must be to take the commitment to ensure its adequate supply by means of express declaration to the effect. Submissions that are not selected shall be temporarily excluded from the pharmaceutical provision of the National Health System during the period in which the selected price system is maintained.

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 Ministry of Health, Social Policy and Equality shall report annually to the Government Delegation for Economic Affairs on the implementation and results of the procedure for the determination and review of sets and prices. reference. "

Ten. Article 101 (2), in point (b), is amended by adding a new infringement in number 33 and renumming the 33rd as 34th, and in point (c) by adding three new infringements in numbers 21, 22 and 23, renumming the 21st as 24th. New numbers 33 of point (b) and 21, 22, and 23 of point (c) shall be worded as follows:

" b) Serious infractions:

33. "33." Carry or hide responsible entities or persons, data, statements or any information that are required to supply competent health administrations in such a way that they are not truthful or to inaccurate conclusions, in order to obtain any benefit, whether economic or otherwise. "

" c) Very severe infractions:

21. Cesar the supply of a medicinal product by the marketing authorisation holder, in the case where health or health concerns are present, as in the case of a therapeutic loophole, either in the market in general or in the pharmaceutical provision of the National Health System.

22. Distribute Outside the national territory medicines for which there are problems of lack of supply with a health impact.

23. Perform, by a pharmacy office, drug distribution activities to pharmacy offices, wholesale warehouses, or shipments of medicines outside the national territory. "

Once. The additional provision 10th, which will have the following wording, is amended:

" Additional Disposition 10th. Participation of the Autonomous Communities and the mutual societies of officials in decision-making procedures for medicinal products and medical devices.

The Autonomous Communities and the Mutualities of civil servants will participate in the terms established in regulation, in the Rector Council of the Spanish Agency for Medicines and Health Products, as a collegiate body of address of the body. The Agency will also have the collaboration of independent experts of recognised scientific prestige proposed by the Autonomous Communities.

The Ministry of Health, Social Policy and Equality will provide a report to all Autonomous Communities and to the mutual authorities of officials at each meeting of the Permanent Commission of Pharmacy of the Interterritorial Council of the National Health System, identifying the name of the medicines and medical devices that have been authorized by the Spanish Agency for Medicines and Health Products since the last meeting of the Council, as well as the price of medicines and medical devices which have been included in the financing of the System National of Health. "

Twelve. An additional fourteenth provision is added, which will have the following wording:

" Additional disposition fourteenth. Information on the lower prices of homogeneous groups of medicinal products and medical devices.

1. For the purposes of applying the conditions of supply and replacement laid down in Articles 85 and 86 respectively of this Law, the Directorate-General for Pharmacy and Health Products of the Ministry of Health, Social Policy and Equality shall publish on its website, together with the National Health System's Nomenclator for pharmaceutical products, information on the homogeneous groupings of presentations of medicinal products and medical devices for non-hospital patients they require for their medical prescription dispensing or dispensing order.

The Directorate-General may set deadlines for the application for voluntary reduction of the prices of medicinal products and medical devices on the basis of the lowest price of each group, and where appropriate the maintenance of the national code of the same, and determine whether the time limits for the coexistence of the prices and the return of stocks of the products concerned, incorporating the updated information of the products concerned, are necessary. the lower prices of each group in the Nomenclator of pharmaceutical products of the National Health System.

2. In each homogeneous group of medicinal products, the presentations of the medicinal products financed with the active substance/s in terms of dose, content, pharmaceutical form or pharmaceutical form, and via the administration, which may be subject to exchange in your dispensation.

The homogeneous groups of medicinal products consisting exclusively of a medicinal product and its licences shall be differentiated at the same price as the reference medicinal product.

3. In addition, in each homogeneous grouping of medical devices, the presentations financed, having the same characteristics, type, size and content, and being classified according to the groups, shall be integrated as far as possible. relating to Annexes I and II to Royal Decree 9/1996 of 15 January 1996 regulating the selection of effects and accessories, their financing with social security funds, or State resources affected by health and their supply arrangements and dispensing to non-hospitalized patients may be subject to exchange in their dispensation.

4. If the variations experienced in the prices of the medicinal products or sanitary products so advise, and after agreement of the Permanent Commission of Pharmacy of the Interterritorial Council of the National System of Health, the mentioned Direction General may update the information of the minor prices, affecting in its case such update to all the groupings, or to the groupings that are considered relevant, as well as to incorporate new groupings, and to establish deadlines of co-existence of prices and return of stocks, presentations of medicinal products and medical devices which have voluntarily reduced their price on the basis of the lower price of each group, allowing that reduction to be carried out without change from the national code.

For information purposes, the updates of the lower price information will be incorporated into the National Health System's pharmaceutical product classification, finalized the deadlines that would have been set. "

Thirteen. A tenth transitional provision is added, which will have the following wording:

" Transient disposition tenth. Transient regime for the automatic identification of each drug unit along its route.

As long as the mechanism that permits the automatic identification of each unit of medication along its route, in accordance with the provisions of Article 87 of this Law, the laboratories, is not regulated. pharmacists, and wholesale warehouses must communicate promptly to the Ministry of Health, Social Policy and Equality in the terms established by the Ministry by means of a resolution, the batch data and the number of units sold or provided, as well as those which are the subject of return, on national territory, specifying the (a) to be addressed, whether in the case of pharmacy offices or pharmacy or other wholesale stores. '

Article 2. Amendment of Royal Decree 1345/2007 of 11 October, regulating the procedure for the authorization, registration and conditions for the supply of medicinal products for human use manufactured industrially.

Article 24 (3) (a) of Royal Decree 1345/2007 of 11 October 2007 governing the procedure for the authorisation, registration and the conditions for the supply of medicinal products for human use is hereby amended industrially, which will have the following wording:

" 3. Medicinal products shall be subject to restricted medical prescription when:

(a) For medicinal products which require particular surveillance, supervision and control of the multidisciplinary health care team, which because of their pharmacological characteristics or novelty, or for reasons of public health, are reserved for treatments that can only be used or followed in a hospital or approved care facilities (Medicines for Hospital Use). "

Article 3. 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.

Article 2 of Royal Decree 823/2008 of 16 May 2008 establishing the margins, deductions and discounts corresponding to the distribution and supply of medicinal products for human use, to which a new paragraph 8, relisting 8 as 9. Paragraph 8 shall have the following

:

" 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:

Differential		Percentage	Fixed
	to
0.01	2.750.00
2.750.01	5,500.00	7.75%	199.38
8.250.00		8.25%	412.50
8.250.01	10.466.66	8.75%	639.37
	10.466.67	12,500,00		833.33

For the implementation of the corresponding tranche of the said scale, account shall be taken of the amount of the difference between EUR 12,500, and the amount of the monthly turnover corresponding to the prescriptions or orders of supply of medicinal products for human use manufactured industrially dispensed from public funds. Such monthly billing shall be calculated in terms of the selling price to the public plus value added tax (VAT). With regard to the presentations of medicinal products with an industrial price exceeding EUR 91,63 and for the purposes of such monthly invoicing, the amount which, calculated in terms of the sale price to the public with VAT, shall be excluded from that calculation. included, exceed the quoted industrial price.

For the difference between that amount and the corresponding lower tranche of the said scale, the percentage indicated therein shall be applied, and the resulting amount shall be added to the fixed amount specified in each tranche of the scale. In no case shall the amount resulting from the application of the margin correction index exceed, in favour of the pharmacy, EUR 833,33 per month.

Such pharmacy offices must also meet the following requirements:

(a) That they are located in isolated or socially depressed population cores and that their total annual sales in terms of the price of the public increased with the value added tax (VAT), do not exceed EUR 200,000 in the financial year corresponding to the previous calendar year.

(b) which have remained open to the public for at least the period equivalent to 11 months within the calendar year preceding the application of the margin correction index.

There are no cases of forced temporary closures not due to administrative sanctions or professional disablement duly authorised by the competent health authorities.

(c) that they have not been subject to administrative sanctions or professional disablement or are excluded from their concertation.

(d) participating in the pharmaceutical care programmes and in the implementation of the set of activities for the rational use of the medicinal products to be established by the relevant health administration.

The decision on the fulfilment of the required requirements, as well as the resolution of the incidents that occur, shall be the responsibility of the different health administrations competent for management pharmaceutical, which will establish the procedure for its application. This will give prior hearing to the Mutuality of Civil Servants of the State (MUFACE), the General Judicial Mutuality (MUGEJU), the Social Institute of the Armed Forces (ISFAS), and, if necessary, the National Institute of Health Management.

The amount derived from the application of the corrective index of the margins corresponding to the health administrations of the National Health System, including the Mutuality of Civil Servants of the State (MUFACE), the General Judicial Mutuality (MUGEJU) and the Social Institute of the Armed Forces (ISFAS) will be the one to apply the percentage that each of them represents in the monthly billing of each pharmacy office, considered together. The procedure for the management of such information shall be in accordance with the rules established in respect of reports on the application of the joint deductions scale. '

Article 4. Amendment of Royal Decree Law 8/2010 of 20 May adopting extraordinary measures for the reduction of the public deficit.

Article 10 of the Royal Decree Law 8/2010 of 20 May, adopting extraordinary measures for the reduction of the public deficit, which will have the following wording:

" Article 10. Exceptions to the application of deductions.

The deductions provided for in Articles 8 and 9 shall not apply to generic medicinal products as well as to medicinal products which are affected by the application of the reference price system, with the exception of in the third subparagraph of Article 8 (1).

In the case of orphan medicinal products, the deductions referred to in Articles 8 and 9 shall be 4%.

Furthermore, in the case of medicinal products for human use manufactured industrially, for which there is no generic or biosimilar authorised in Spain, including those for hospital use, for which ten have elapsed years from the date on which the decision to finance public funds, or 11 in the case of the approval of a new indication, the deductions referred to in Articles 8 and 9, shall be 15%, except in the case of medicinal products with patent protection of products in all Member States of the Union European, which, without being subject to exceptional or transitional industrial property regimes, would have incorporated into their legal system the relevant Community legislation, and provided that this circumstance is established by the marketing authorisation holder. '

CHAPTER II

Health Information System Measures

Article 5. Health Card.

In order to articulate the provisions of Article 57 of the Law on Cohesion and Quality of the National Health System in relation to the individual health card, the Government in coordination with the communities Within 6 months of the entry into force of this Royal Decree-Law, it will establish the unique and common format of a valid health card for the entire National Health System.

Article 6. Digital Clinical History.

In accordance with the provisions of Article 56 of the Law on the Cohesion and Quality of the National Health System and its regulatory development in relation to the minimum data set of the National Health System's clinical reports, and for the purposes of making cash both the person concerned and the professionals involved in the care, an adequate access to the medical history throughout the National Health System in the terms provided for by the legal system, Health administrations shall establish in a general manner the connection and exchange of information with the SNS Digital Clinical History System, before 1 January 2013.

Article 7. Electronic recipe.

The health administrations in their field of competence will take the necessary measures to ensure that the application of the electronic prescription is implemented and interoperable throughout the National Health System, before 1 January. 2013.

CHAPTER III

Measures relating to the coordination of social and health care

Article 8. Development of the Strategy for the Coordination of Social and Health Care.

To have an impact on improving the quality of care for people who receive health and social care services, the Government through the Ministry of Health, Social Policy and Equality, with the participation of Mutual societies of officials, in cooperation with the Autonomous Communities and with respect to their area of competence, will draw up a Strategy for the Coordination of Social-Health Care, which will have the collaboration of the citizens ' organizations. professionals and companies in the sector.

The Strategy will incorporate objectives for the coordination of health and social care services, objectives to improve the quality and efficiency and objectives linked to the drive of innovation in this field and generation of employment.

The Strategy will be prepared before six months from the entry into force of this Royal Decree Law, will last for five years and will establish two-yearly evaluation mechanisms that will allow for its follow-up, the assessment of results and the possible incorporation of new measures.

TITLE II

Tax measures

Article 9. Amendments relating to Corporate Tax.

First.-With effect exclusively for the tax periods beginning in 2011, 2012 and 2013, the following changes are made to the legal regime of the Company Tax, approved by the Royal Legislative Decree 4/2004 of 5 March 2004:

One. The percentage referred to in Article 45 (4) of the recast of the Companies Tax Act, for the modality referred to in paragraph 3 of that Article, shall be:

(a) Dealing with taxable persons whose volume of transactions, calculated in accordance with Article 121 of Law No 37/1992 of 28 December 1992 on the value added tax, has not exceeded the amount of EUR 6,010,121,04 during the 12 months preceding the date of the commencement of the tax periods within the year 2011, 2012 or 2013, as appropriate, the result of multiplying by five septals the default rounded charge rate.

b) Dealing with taxable persons whose volume of transactions, calculated in accordance with Article 121 of Law 37/1992, has exceeded the amount of EUR 6,010,121,04 during the 12 months preceding the date on which the tax periods start in 2011, 2012 or 2013.

-The result of multiplying by five septs the type of tax rounded up by default, when in those twelve months the net amount of the business figure is less than twenty million euros.

-The result of multiplying by eight we say the type of tax rounded up by default, when in those twelve months the net amount of the turnover is at least twenty million euros but less than sixty million euro.

-The result of multiplying by nine we say the type of default rounded tax, when in those twelve months the net amount of the business figure is at least sixty million euros.

They shall be required to apply the modality referred to in Article 45 (3) of the recast of the Companies Tax Act, taxable persons whose volume of transactions, calculated in accordance with the provisions of the in Article 121 of Law 37/1992, you have exceeded the amount of EUR 6,010,121,04 during the twelve months preceding the date of the commencement of the tax periods in 2011, 2012 or 2013.

The provisions of this paragraph shall not apply to the split payments in respect of which the time limit for the declaration is due to the entry into force of this Royal Decree-Law.

Two. For taxable persons whose volume of transactions, calculated in accordance with Article 121 of Law 37/1992, has exceeded the amount of EUR 6,010,121,04 during the 12 months preceding the date of the start of the periods In 2011, 2012 or 2013, in the compensation of negative tax bases referred to in Article 25 of the recast of the Law on Corporate Tax, the following specialties shall be taken into consideration:

-The compensation of negative taxable bases is limited to 75% of the tax base prior to such compensation, when in those twelve months the net amount of the turnover is at least twenty million euros but less than sixty million euros.

-The compensation of negative taxable bases is limited to 50% of the taxable amount prior to such compensation, where in those twelve months the net amount of the turnover is at least 60 million euro.

Three. The deduction of the difference referred to in Article 12 (5) of the recast of the Companies Tax Act, which is deducted from the tax base in the tax periods initiated in 2011, 2012 or 2013, is subject to the maximum annual limit of one hundredth of its amount.

Second.-With effect for the tax periods starting from January 1, 2012, the following amendments are made to the recast text of the Companies Tax Law, approved by the Royal Decree Legislative 4/2004, of 5 March:

One. Article 25 (1) is amended, which is worded as follows:

" 1. Negative taxable bases which have been the subject of liquidation or self-settlement may be compensated by the positive income of the tax periods concluded in the immediate and successive 18 years. "

Two. The transitional provision thirtieth fifth is added, which is worded as follows:

" Thirty-fifth transient disposition. Negative taxable bases to be compensated.

The period of 18 years for the compensation of negative tax bases established in Article 25 of this Law will also apply to the negative tax bases that were pending to compensate at the beginning of the first tax period which would have started from 1 January 2012. '

Additional disposition first. Accreditation of product patent protection on medicinal products affected by the deductions provided for in Article 4.

The marketing authorisation holders of the medicinal products concerned by the provisions of Article 4 of this Royal Decree, which have patent protection of products in all Member States of the European Union, European Union which, without being subject to exceptional or transitional industrial property regimes, would have incorporated into their legal system the relevant Community legislation, they must be accredited to the Directorate-General for Pharmacy and Healthcare products of the Ministry of Health, Social Policy and Equality in the period of 15 days from the entry into force of this Royal Decree Law this circumstance by responsible declaration. The Directorate-General for Pharmacy and Health Products may apply to the holders of the marketing authorisation for medicinal products concerned with express certification issued by the competent authority in each of the Member States.

In addition, this responsible statement shall be submitted by 1 February of each year for medicinal products which may be affected during the course of the year by the deductions provided for in Article 4 of this Regulation. Royal Decree-law.

The marketing authorisation holders of the medicinal products affected by the provisions of Article 4 of this Royal Decree-Law must inform the General Directorate of Pharmacy and Health Products, with sufficient notice of the expiration of the product patent in any of the Member States referred to in this provision.

In compliance with what is indicated in the fourth final provision of Royal Decree-Law 8/2010 of 20 May, which takes extraordinary measures to reduce the public deficit, the General Directorate of Pharmacy and Products Sanitarios shall publish the list of the medicinal products that are affected by the deductions provided for in the fourth article of this Royal Decree-Law, together with the National Health System's Nomenclature of pharmaceutical products.

Additional provision second. Amendment of Law 44/2003 of 21 November of the management of health professions.

One. Article 22 (2) of Law 44/2003 is amended from 21 November to the following wording:

" 2. The Ministry of Health, Social Policy and Equality, after a report by the Ministry of Education and the Commission on Human Resources of the National Health System, shall establish the rules governing the annual convocation which shall consist of a test or test suite, which will evaluate theoretical, practical and, where appropriate, clinical skills, communicative and academic merit skills and professionals of the aspirants.

The tests will be specific to the various degrees or, where appropriate, groups of these, according to the various university graduates who can access the training places of the specialties in health sciences. the selection object by such tests. Specific tests may also be established for trunk specialties. "

Two. An additional provision is added in the eleventh to Law 44/2003 of 21 November with the following wording:

" The references that in this law are made to medical graduates and graduates will be understood also to university graduates, in accordance with the regulations of the ordination of university teaching officers "

First transient disposition. Galenic innovations of therapeutic interest declared at the time of entry into force of this Royal Decree-Law.

The presentations of medicinal products whose galenic innovation of therapeutic interest would have been declared in accordance with the provisions of the legislation prior to the entry into force of this Royal Decree-Law shall remain valid and continue to produce effects in accordance with the rules under which gallic innovation was declared.

Second transient disposition. Information on the homogeneous groupings of presentations of medicinal products and medical devices, voluntary price reductions without modification of the National Code and coexistence of prices and return of stocks of medicines and medical devices.

1. In the development of the provisions of the additional provisions of Law 29/2006, of 26 July, of guarantees and the rational use of medicines and medical devices, the General Directorate of Pharmacy and Health Products of the Ministry of Health Health, Social Policy and Equality will publish on the Ministry's website, information on new homogeneous groupings of presentations of medicinal products and medical devices for non-hospitalized patients requiring for your official prescription or dispensing order, along with the current price of each presentation.

2. From the day following that publication, the medicinal products and the medical devices referred to may be eligible within seven days of the voluntary reduction of their price, without change of the National Code, in order to adapt to the forecasts. contained in this Royal Decree-law on the dispensing of medicinal products and medical devices.

3. After carrying out the relevant checks, the Directorate-General for Pharmacy and Health Products will publish on the website of the Ministry of Health, Social Policy and Equality, the updated information on the lower prices of new products. homogeneous groupings referred to in this provision.

The updated information on the lower prices of the new homogeneous groupings will be incorporated into the National Health System's Nomenclator of pharmaceutical products, after the deadlines that are related in the Points 4 and 5:

4. In relation to the presentations of medicinal products that the laboratories decide to lower their price, in order to adapt them to the provisions of article 85 of Law 29/2006, of July 26, according to the wording given in the present Royal Decree-Law, will be applied the following rules:

(a) The presentations shall be provided by the laboratories at the new price from the day following the day on which the updated information on the minor prices of the pools referred to in point 3 of this Regulation is published. This provision.

(b) The stocks of the presentations held by the wholesale warehouses may continue to be placed on the market at the price prior to this reduction within 10 calendar days of the date of publication of the the updated information on the minor prices of the pools referred to in point 3 of this provision.

(c) The stocks of the presentations held by the pharmacy offices may continue to be placed on the market at the price prior to this reduction within 20 calendar days of the date on which it is published. the updated information on the minor prices of the pools referred to in point 3 of this provision.

If necessary, the deadline will be extended, due to requirements of the management of the pharmaceutical provision of the National Health System, until the end of the period is agreed with the last calendar day of the corresponding month. In the latter case, the period in which the initial period is extended shall be divided equally between the warehouses and the offices of pharmacy, except where this is not possible, in which case the half plus one day of that period The office of pharmacy shall be responsible.

Under the provisions of Article 6.2.5 of Royal Decree 726/1982 of 17 March 1982 regulating the expiry and return of proprietary medicinal products to pharmaceutical laboratories, wholesale warehouses and the pharmacy offices, at no additional cost to them, may return to the pharmaceutical laboratories, from the day following the end of the period referred to in this paragraph and in accordance with Article 8 of the Royal Decree, the stocks of the presentations with price on the previous packaging the price reductions produced under the provisions of paragraph 2 of this provision.

(d) The updated information on the prices below the homogeneous groupings of the presentations of the medicinal products set out in point 3 shall be applied in the supply of prescriptions and orders of supply with (a) a public fund corresponding to the first day of the month following the expiry of the period referred to in paragraph 4 (c), in respect of the corresponding Nomenclator for pharmaceutical products of the National Health System.

5. With respect to the presentations of sanitary products that manufacturers decide to lower their price to conform to the provisions of Article 85 of Law 29/2006, of July 26, according to the wording given in this Royal Decree-Law, they will be applied the following rules:

(a) The presentations will be provided by the companies offering the new price within the 20 calendar days following the one in which the updated information on the minor prices of the groups is published. in accordance with the provisions of paragraph 3 of this provision, being supplied with new cartonages, or relabelling the current with non-removable adhesive labels.

(b) The stocks of the presentations held by the wholesale warehouses may continue to be placed on the market at the price prior to this reduction within the 30 calendar days following that in which the publish the updated information on the minor prices of the pools referred to in point 3 of this provision.

(c) The stocks of the presentations held by the pharmacy offices may continue to be placed on the market at the price prior to this reduction within the period of 40 calendar days following that in which the publish the updated information on the minor prices of the pools referred to in point 3 of this provision.

If necessary, the deadline will be extended, due to requirements of the management of the pharmaceutical provision of the National Health System, until the end of the period is agreed with the last calendar day of the corresponding month. In the latter case, the period in which the initial period is extended shall be divided equally between the warehouses and the offices of pharmacy, except where this is not possible, in which case the half plus one day of that period The office of pharmacy shall be responsible.

For the purposes of refunds, the provisions of Article 6.2.5 of Royal Decree 726/1982 of 17 March 1982 on the expiry and return of proprietary medicinal products to the health products of the Member States of the European Union shall apply to medical devices. pharmaceutical laboratories. As a result, wholesale warehouses and pharmacy offices, at no additional cost to them, may return to the manufacturers of medical devices from the end of the period provided for in this paragraph and in accordance with the provisions of this paragraph. in Article 8 of the said Royal Decree, the stocks of the presentations at price in the packaging preceding the price reductions produced under the provisions of point 2 of this provision.

d) The updated information on the lower prices of the homogeneous groupings of the presentations of the medical devices set out in point 3 of this provision will be applied in the dispensing of the prescriptions and orders for supply from public funds corresponding to the first day of the month following the expiry of the period referred to in paragraph 5 (c), in the corresponding nomenclature of pharmaceutical products of the System National of Health.

Transitional provision third. Validity of the update of the lower price information agreed on June 21, 2011 by the Permanent Commission of Pharmacy of the Interterritorial Council of the National Health System.

The lower price information updated as agreed on June 21, 2011 by the Permanent Commission of Pharmacy of the Interterritorial Council of the National Health System, in accordance with the provisions of the provision Additional seventh of Order SPI/30 52/2010 of 26 November 2010 determining the sets of medicinal products and their reference prices and regulating certain aspects of the reference price system shall remain in force in the Both the Directorate-General for Pharmacy and Health Products of the Ministry of Health, Policy Social and Equality, do not proceed to integrate the updated information of the lower prices of the new homogeneous groupings in the Nomenclator of pharmaceutical products of the National System of Health, according to the provisions of the present Real Decree-law.

Transitional disposition fourth. Applicable tax rate of Value Added Tax on home deliveries.

With effect from the entry into force of this Royal Decree-Law and effective exclusively until December 31, 2011, the reduced rate of 4 percent of the Value Added Tax will be applied to the deliveries of goods to the referred to in Article 91 (7) of Law No 37/1992 of 28 December 1992 on the value added tax.

Single repeal provision. Regulatory repeal.

All provisions of equal or lower rank are repealed to be opposed to the provisions of this Royal Decree-Law.

Final disposition first. Amendment of Law 39/2010 of 22 December of General Budget of the State for the year 2011.

Paragraphs One and Two of Article 49 of Law 39/2010, of 22 December, of the General Budget of the State for the year 2011, concerning the amount of State guarantees, are worded in the following terms:

" One. The maximum amount of guarantees to be granted by the State during the year 2011 shall not exceed EUR 115,543,560 thousand.

Two. Within the total stated in the previous section, the following amounts are reserved:

(a) EUR 22,000,000 000 000 to ensure, in accordance with the provisions of the additional twenty-first provision, paragraph 9, of Law 54/1997 of 27 November 1997 on the electricity sector, the economic obligations payable to the Electricity System Deficit Titling Fund, derived from the emissions of financial instruments that the Fund carries out in charge of the receivables that constitute the asset of the Fund.

(b) EUR 92,543,560 000 000 to guarantee the economic obligations payable to the company entitled 'European Financial Stabilisation Facility', resulting from the issuance of financial instruments, from the of loan and credit operations, as well as any other financing operations carried out by that company in accordance with the provisions of Royal Decree-Law 9/2010 of 28 May, authorising the General Administration of the State of the granting of guarantees to certain financing operations in the framework of the European Financial Stabilisation Mechanism of the Member States of the Euro Area.

(c) EUR 500 000 000 000 to guarantee the obligations arising from financing operations concerted by undertakings, which are validly incorporated in Spain, which make investments in Spain for development and industrialization of the electric vehicle or batteries therefor.

The Government's Delegate Committee for Economic Affairs will determine the procedure for granting guarantees, the requirements that will have to be met for the granting of guarantees, and the conditions for the effectiveness of the guarantee. the avales granted. "

Final disposition second. Competence title.

This Royal Decree-Law is dictated by the provisions of Article 149.1.14., 16. and 17. of the Constitution.

Final disposition third. Powers of development.

1. The Government and the Ministers for Economic and Financial Affairs and Health, Social Policy and Equality, within their respective powers, are hereby authorised to lay down the provisions and to take the measures necessary for the development and implementation of the established in the present Royal Decree-law.

2. The amendments which, from the date of entry into force of this Royal Decree-law, may be made in respect of the provisions of Articles 2, 3 and 4 may be made in accordance with the specific implementing rules.

3. The autonomous communities shall, within the scope of their respective powers, adopt the measures necessary for the effectiveness of the provisions of Chapter II of Title I of this Royal Decree-Law.

Final disposition fourth. Entry into force.

This Royal Decree-law will enter into force on the day of its publication in the "Official State Gazette", with the following exceptions:

1. Article 1 (6) concerning medicinal products shall enter into force on the first day of the month in which it is applicable in the supply of prescriptions and orders for supply from public funds, the Nomenclature of pharmaceutical products of the National Health System, which integrates the updated information of the lower prices of the new homogeneous drug groupings, as established in the Second Transitional Disposition.

In respect of medical devices, the first day of the month in which it is applicable in the dispensing of prescriptions and orders of supply from public funds, the Nomenclator of products shall enter into force National Health System pharmacists, integrating the updated information of the lower prices of the homogeneous pools of medical devices, as set out in the Second Transitional Disposition.

2. Article 3 shall enter into force on 1 January 2012.

3. Article 4 shall apply in the case of medicinal products which are dispensed by the pharmacy offices or which are purchased by the hospital pharmacy, health centres and primary care structures, with a view to the Public funds from the National Health System, including the special schemes of the General Mutuality of Civil Servants of the State (MUFACE), the Social Institute of the Armed Forces (ISFAS) and the General Judicial Mutuality (MUGEJU), from the first day of the month following that in which the publication of the medicinal products is carried out affected, together with the National Health System's Pharmacist Nomenclator, in accordance with the provisions of the Additional Disposition of the present Royal Decree-Law.

Given in Madrid, 19 August 2011.

JOHN CARLOS R.

The President of the Government,

JOSE LUIS RODRIGUEZ ZAPATERO