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Order Ssi/248/2014, Of 17 February, Which Establishes The Regulatory Basis For The Granting Of Subsidies To Non-Profit Institutions To Encourage The Donation And Transplantation Of Organs, Tissues And Cells.

Original Language Title: Orden SSI/248/2014, de 17 de febrero, por la que se establecen las bases reguladoras para la concesión de subvenciones destinadas a instituciones sin fines de lucro para fomentar la donación y el trasplante de órganos, tejidos y células.

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The Ministry of Health, Social Services and Equality annually convenes grants for the promotion of donation and transplantation of organs, tissues and cells in order to promote the development of activities aimed at improve the donation rates and the number of transplants performed, as well as the quality and viability of these. To this end, appropriations are entered in the budget of the said Department to support the activities which, for the purposes mentioned, aim to develop institutions of any ownership, not for profit.

The Transplant Commission of the Interterritorial Council of the National Health System, in a meeting held on March 20, 2013 and in the context of the debate on the provisions of the additional provision of Law 17/2012, On 27 December, the General Budget of the State for the year 2013, reflects on the desirability of amending Order SCO/3685/2004 of 2 November, which, to date, had established the regulatory bases for the granting of the aforementioned grants. That body, at its meeting of 18 June 2013, reports favourably on the amendment, which mainly adapts its provisions to the regulatory changes which have taken place since its adoption and concentrate on the financial resources in activities such as extraction, transplantation as well as the quality and safety of human organs, in addition to the training of professionals, help to strengthen the principle of concurrency.

Of course, this standard comes in response to the need mentioned in the previous paragraph, establishing in greater detail the requirements to apply for the grant and the way to credit them; objective criteria for granting; specifying the limits of eligible expenditure under the terms of Royal Decree 462/2002 of 24 May 2002 on compensation for the service; determining the number of payments made by the aid and the guarantee scheme applicable; in particular the form of justification for the aid In accordance with the provisions of the current Law 38/2003 of 17 November, General of Grants, determining the circumstances which, when altering the conditions considered for the concession, may result in the amendment of the resolution Finally, it describes in detail the procedure for the instruction, management and resolution of grants.

The call and resolution regulated by this order are governed by the principles of publicity, transparency, concurrency, objectivity, equality and non-discrimination, effectiveness in the fulfilment of the objectives set by the Administration and efficiency in the allocation and use of public resources, as set out in Article 8.3 of the Law 38/2003 of 17 November.

In the processing of this provision, the State Advocate and the Delegation in the Department have issued a mandatory report.

In its virtue, with the prior approval of the Minister of Finance and Public Administrations, I have:

Article 1. Object.

This order aims to establish the regulatory basis for the granting of subsidies, under competitive competition, aimed at financing activities that, aimed at improving the donation rates and the number of transplants, as well as the quality and viability of these, develop non-profit institutions, of any ownership, and which are oriented to:

a) Extraction, transplantation, as well as the quality and safety of human organs.

b) Training in the field of organ, tissue and cell donation and transplantation.

Article 2. Solvency requirements and conditions for applying for the grant.

1. They may apply for the grants referred to in Article 1 (a) for non-profit-making hospitals, of any ownership, authorised for the practice of extractions and/or transplantation of solid organs, and which have been active for extraction and/or transplantation during the year prior to the call.

They may apply for grants referred to in Article 1 (b) non-profit hospital centres, of any ownership, authorised for the practice of extractions and/or transplantation of solid organs, and which have have had extraction and/or transplant activity during the year prior to the call, the offices of the autonomic coordination of transplants, assigned to the health administrations of the autonomous communities, as well as those entities without for profit, of any ownership, dependent on the health administrations or to collaborate with them. This collaboration should be formalized by agreement or concert in the area of donation and transplantation.

2. The applicant entities shall demonstrate compliance with the following requirements:

(a) To be current in the performance of its tax and social security obligations, in accordance with the provisions of Articles 22 and 24.6 of the Regulation of the General Law of Grants approved by the Royal Decree 887/2006, dated July 21.

The authorisation of the applicant shall be necessary for the granting body to obtain directly the accreditation of the circumstances provided for in Articles 18 and 19 of the General Grant Law Regulation, through of electronic media. However, if the applicant expressly refuses the consent, the accreditation of the current in the performance of his tax and social security obligations shall be carried out by the presentation of the expected certifications in Article 22 of that Regulation.

b) To have sufficient structure and management capacity to carry out the activity that constitutes the subject of the grant. This capacity shall be accredited in accordance with the following:

Hospital centres applying for grants for the development of activities set out in Article 1 (a) shall accompany the application with the following documentation:

-Authorization of the health administration of the corresponding autonomous community for the practice of extractions and/or transplants of solid organs.

-Certification of the National Transplant Organization, which will include: (a) the withdrawals made; (b) the transplants carried out; (c) the contribution of each centre to the information systems at the State level set out in Article 31 of Royal Decree 1723/2012 of 28 December 2012 on the activities to obtain, clinical use and territorial coordination of human organs intended for transplantation and establish quality and safety requirements; and d) the contribution of the autonomous community corresponding to the systems of state-wide information related to the assessment of the quality and safety of the organs, weighted by the respective autonomic population.

In the event that the hospital sites intend to develop the activities set out in Article 1.b) they must accompany the application certification of the legal representative of the requesting entity, accreditative of sufficient human, material and financial means to manage the project.

Legal persons referred to in the second paragraph of Article 2.1 shall accompany the application:

-In the case of an office of autonomic coordination of transplants accreditation of such condition or, failing that, of the regional coordinator of transplants.

-In the case of institutions of any ownership, non-profit, applicants for grants for the development of the activities set out in Article 1.b) copy of the collaboration agreement or concert refers to the second paragraph of Article 2.1.

-In the cases referred to in the previous two paragraphs, certification of the legal representative of the requesting entity, evidence of sufficient human, material and financial means to manage the project.

(c) Do not incur the prohibitions which, for the purposes of obtaining the status of beneficiary, are laid down in paragraphs 2 and 3 of Article 13 of Law 38/2003 of 17 November, which shall be credited through the means provided for in paragraph 7 of the same Article.

3. For the purposes of compliance with the reimbursement obligations, the accreditation shall be carried out by means of a responsible declaration of the beneficiary, as provided for in Article 25 of the General Grant Law Regulation.

Article 3. The form and time period for applications to be submitted.

1. The applications, addressed to the Director of the National Transplant Organization by the legal representative of the institution, may be filed in any of the places provided for in Article 38 (4) of Law 30/1992, 26 of November, the Legal Regime of Public Administrations and the Common Administrative Procedure.

2. The presentation by electronic means of requests and supplementary documentation may be made by electronic means, as provided for in Law 11/2007, of June 22, of electronic access of citizens to Public Services and in Royal Decree 1671/2009, of 6 November 2009, for which the aforementioned law is partially developed, through the section Virtual Office of the National Transplant Organization (www.ont.es), and according to the models included in the paragraph.

3. Applications shall be submitted within the time limit set out in the relevant call, they shall comply with the formats set out in their Annexes and include the appropriate documentation.

Article 4. Eligibility criteria for grants.

1. The grant of the grants provided for in Article 1 (a) shall be based on the activity carried out during the year preceding the call for the extraction and/or transplantation of solid organs, and the participation of the The centre and the whole of the centres of the autonomous community with donation and transplantation activity, in the information systems of the state level aimed at assessing the quality and safety.

For such purposes, it shall be assessed in accordance with the priorities set out in each call: (a) the number of extractions carried out; (b) the number of transplants; (c) the degree of contribution of each centre to the information systems set out in Article 31 of Royal Decree 1723/2012 of 28 December 2012, as assessed by the Organization National of Transplants with a minimum of 0 and a maximum of 1; and d) the degree of contribution of the autonomous community corresponding to the systems of information of the State in relation to the evaluation of the quality, valued by the Organization Transplant National with a minimum of 0 and a maximum of 1.

Paragraph (d) may be increased exceptionally by a maximum of 0.2 points depending on the contribution to the information systems related to the safety of the organs.

The score obtained in paragraph (d) shall be weighted by the population of the corresponding autonomous community.

2. The grant of the grants provided for in Article 1 (b) shall be based on the activity to be carried out from the first day of the calendar year corresponding to that of the call until 31 March of the following year, Assessment of this activity contained in the report of the Transplant Commission of the Transplant Commission of the Interterritorial Council of the National Health System.

This report will be elaborated in application of the following assessment criteria [Partial Score = Value (1: Not suitable; 2: Unsuitable; 3: Suitable; 4: Good; 5: Very Good) x Adjustment Factor]:

-Activity Budget (P=Value * 0, 6).

-Match of activities with multi-sectoral plans, campaigns, programs or priorities of the Ministry of Health, Social Services and Equality (P=Valor * 1).

-Percussion, relevance and objective interest of the event (P=Valor * 0, 9).

-Number of interveners and participants.

-State Projection (P=Value * 0, 8).

-Dissemination of the activity (P=Value * 0, 5).

-Transcendence in the media (P=Valor * 0, 4).

Article 5. Financing and concession procedure.

1. The subsidies covered by this order will be financed from the allocations of the Ministry of Health, Social Services and Equality in the General Budget of the State. Each call shall determine the total amount of grants to be awarded and their distribution between, on the one hand, the activities set out in Article 1 (a) and, on the other, the activities set out in Article 1 (b). The above is without prejudice to the fact that, as provided for in Article 22 of Law 38/2003 of 17 November, the competent body, exceptionally and within the overall amount fixed, may proceed:

(a) The proportion of the beneficiaries of the amount allocated to the activities set out in Article 1.a

(b) The transfer of the remaining assets in the activities set out in Article 1 (b), where there are insufficient or inadequate applications in one of them and over-requests in others.

2. The granting of aid shall be made in accordance with the principles of objectivity, competitive competition and advertising.

3. The procedure shall be initiated ex officio by means of a call approved by the competent body to be published in the "Official State Gazette".

4. The instruction of the procedures shall be carried out by the National Transplant Organization, in accordance with the provisions of Article 24. 2 of Law 38/2003 of 17 November.

If the application does not meet the requirements set out in this order, the aforementioned Organization shall communicate it to the person concerned so that it can be subsane within the maximum and unrenewable period of ten working days from the following day. (a) to that of his or her communication, indicating that if he does not do so, he shall be given the withdrawal of his application, upon a decision to be made in accordance with the terms laid down in Article 71 of Law No 30/1992 of 26 November.

5. Within one month, from the date of completion of the deadline for the submission of applications, the Commission of Teaching of the Transplant Commission of the Interterritorial Council of the National Health System as a collegiate body, as established by the Article 22.1 of Law 38/2003, of 17 November, will issue an evaluation report of the applications submitted, referring the same to the Director of the National Transplant Organization who, in turn, will make a proposal for a provisional resolution. This proposal will be notified to the interested parties through its publication in the notice board and on the website of the aforementioned Organization, setting a deadline of ten days for the submission of allegations. After that time limit, the Director of the said Organization, after consideration and acceptance, if appropriate, of the arguments submitted, shall give the person holder of the Ministry of Health, Services, of the proposal of definitive resolution Social and Equality.

6. The person who holds the said Department shall, on the basis of Article 10 of Law 38/2003 of 17 November, give the relevant award decisions which, in addition to the identification of the applicant or applicants to which he is grants the grant, shall state, where appropriate and in an express manner, the rejection of all other applications. In accordance with Article 25.4 of Law 38/2003 of 17 November, the maximum period for issuing and notifying such decisions may not exceed six months from the date of publication of the relevant call. After that time limit without any express resolution, the application shall be deemed to be dismissed.

7. These decisions shall be notified to the persons concerned within 10 days of the date on which they were given, in accordance with the provisions of Articles 58 and 59 of Law No 30/1992 of 26 November 1992.

8. The decisions referred to in the preceding paragraph shall terminate the administrative procedure and may be appealed, in a capacity-up, to the person holding the Ministry of Health, Social Services and Equality within one month of the date of the application. from the day following the receipt of its notification, in accordance with the provisions of Article 116 of Law No 30/1992 of 26 November. In addition, against such decisions, it may be brought within two months, from the day following the receipt of the express decision, a judicial-administrative appeal, under the provisions of Article 46.1 of the Law 29/1998, of July 13, regulator of the Jurisdiction-Administrative Jurisdiction. If no express decision is taken, the administrative-administrative appeal may be brought within six months from the day following that in which, in accordance with the specific rules in the matter, it must be understood rejected the request.

9. Within one month of the date of the decisions referred to in the preceding paragraphs, the managing centre shall issue proposals for payment for the amounts recognised in the preceding paragraphs.

Article 6. The amount of grants and eligible expenditure.

1. The grant of the grants and the amount of grants shall be subject to the budgetary provisions of the expenditure budget of the Ministry of Health, Social Services and Equality and to the provisions of each call.

2. Expenditure shall be deemed to have been incurred for the purposes laid down in these regulatory bases, which has actually been paid before the end of the period of justification and which corresponds to expenditure incurred within the time limit for the implementation of the activities supported in accordance with the provisions of Article 4.2 and Article 31.2 of Law 38/2003 of 17 November.

The eligible expenditure concepts and the limitations to which they are submitted are the following:

-Compensation costs for teaching staff for participation in training courses for health professionals: They will not be able to exceed 70 percent of the total amount of the project, except that the nature of the project justify a higher quantity in which case the need must be accredited by the legal representative of the requesting entity.

-Travel, accommodation and maintenance expenses: They will not be able to exceed 20 percent of the total amount of the project, except that the nature of the project justifies a higher amount in which case the need must be accredited by the legal representative of the requesting entity.

This type of expenditure will be dealt with by analogy with the provisions of Royal Decree 462/2002 of 24 May on compensation for the service, the amounts corresponding to group 2 being applied in all time.

-Management and administration expenses directly related to the activity supported and indispensable for the proper preparation or execution of the activity, including administrative personnel. They shall not exceed 10% of the total amount of the project, unless the nature of the project justifies a higher amount in which case the need must be credited by the legal representative of the requesting entity.

3. The distribution of the subsidy for amounts and items is binding. Such quantities may be subject to deviations of up to 10% of the smallest of the items of expenditure, including the deviation, agreed in the grant of the grant, where the implementation needs of the the programme so requires and is justified and in full respect of the total amount of the grant allocated to that programme.

4. The percentages of the overall budget appropriation intended to finance the aid referred to in this order are allocated, after agreement of the Transplant Commission of the Interterritorial Council of the National Health System and according to the criteria for the grant provided for in Article 4 (1) and (2

.

The provisions of this paragraph are without prejudice to the possibilities for prorrata and transfer provided for in the preceding article.

Article 7. Payment of the grants.

1. The grant of the grant awarded shall be made in a single payment, executed in two stages in accordance with the conditions laid down in Article 1 (a) or (1) (b). The payment proposal shall be made within one month of its granting and in the financial year in accordance with the specifications laid down in the relevant concession resolution.

The single payment may be made in advance, prior to its justification, in grants for training in the field of organ, tissue and cell donation and transplantation.

2. The lodging of a security as provided for in Article 42.2 (a), (b), (c) and (d) of the General Grant Law Regulation shall not be required.

Article 8. Obligations of the beneficiaries.

1. As a general rule, in the case of grants to compensate for the activities laid down in Article 1 (a) and (b), it is the beneficiary's obligation:

a) Submit to the actions of verification and follow-up to be carried out by the National Transplant Organization, as well as to the economic-financial control of the General Intervention of the State Administration and the Court of accounts. This is without prejudice to the relevant control and inspection activities carried out by the competent bodies of the Ministry of Health, Social Services and Equality.

b) Communicate to the National Transplant Organization, obtain other grants or aid, for the same purpose, from other organs of the Administration, other Public Administrations, public entities attached or dependents of the same and other natural or legal persons of a private nature.

This communication should be made as soon as it is known and, in any case, prior to the justification of the application given to the funds received.

(c) Credit, in advance of the proposal for a concession resolution, with effect at the time of payment, to be aware of the compliance with the tax obligations and the social security system, according to the as set out in Articles 22 and 24.6.

(d) Dispose of the accounting records, completed records and other documents duly audited in the terms required by the legislation applicable to the beneficiary, in each case, which guarantee the proper exercise of the Verification and control powers.

(e) to keep documents supporting the application of the funds received, including electronic documents, as long as they can be the subject of verification and control actions.

f) Adopt the dissemination measures contained in Article 18 (4) of Law 38/2003 of 17 November, giving adequate publicity to the public nature of the financing of the activities which are the subject of grant.

g) Proceed to the recovery of the funds received in the cases referred to in Article 12. To this end, the National Transplant Organization shall initiate the corresponding drawback procedure, which shall be processed in accordance with the provisions of Article 42 of Law 38/2003 of 17 November.

2. Without prejudice to the above paragraph, the beneficiary of grants to compensate for the activities set out in Article 1 (a) and (b) shall provide the documentation required in Article 2.2 with their application.

In addition to the provisions of the preceding paragraph, the beneficiaries of the grants to compensate for the activities set out in Article 1 (b)

:

(a) Perform the activity subject to the grant within the time limit to be determined in the decision of the concession.

(b) to justify to the granting body the performance of the activities which have been the subject of a grant, in accordance with Article 9 of this order.

Article 9. Justification for the fulfilment of the purpose for which the grant was granted and for the application of the funds received.

1. In the case of grants to compensate for the activities laid down in Article 1 (b), the legal representative of the beneficiary institution or institution shall, before 30 April of the following year, justify to the National Transplant Organisation the application of the grants to the development of the activities for which they are awarded.

2. The justification for activities shall be done by means of the "supporting account" mode, in any of the following modes.

2.1 Supporting account with supporting evidence of expenditure under the terms set out in Article 72 of the General Grant Law Regulation. The supporting account shall contain, in general, the following documentation:

(a) A memory of the performance of the performance of the conditions imposed in the grant of the grant, with an indication of the activities carried out and the results obtained.

b) An economic memory of the cost of the activities carried out, understanding of:

-A classified relationship of the expenses and investments of the activity, with identification of the creditor and of the document, its amount, date of issue and, if applicable, date of payment. Where the subsidy is granted on the basis of a budget, the deviations shall be indicated.

-invoices or documents of equivalent probative value in the commercial legal traffic or with administrative efficiency incorporated in the relation referred to in the preceding paragraph and, where appropriate, the documentation accreditative of the payment.

-A detailed relationship of other income or subsidies that have financed the subsidised activity with an indication of the amount and its provenance.

-If applicable, the repayment letter of repayment in the case of remaining unapplied as well as the interest derived therefrom.

2.2 A simplified supporting account which may, for the purposes of justification, be provided by beneficiaries of grants of less than EUR 60 000. In this case you must present the following information:

(a) Memory of performance justifying compliance with the conditions imposed in the grant of the grant, indicating the activities carried out and the results obtained.

(b) A classified relationship of the expenditure and investments of the activity, with the identification of the creditor and the document, the amount, date of issue and, where applicable, the date of payment. Where the subsidy is granted on the basis of an estimated budget, the deviations shall be indicated.

(c) A detailed list of other income or subsidies that have financed the activity supported with an indication of the amount and its provenance.

d) Where applicable, the repayment letter of repayment in the case of remaining unapplied as well as the interest derived therefrom.

In the simplified supporting account all entities and all programmes and, for each programme, a specific number of supporting documents shall be checked, which shall be selected by means of sampling techniques. simple random, to provide reasonable evidence on the appropriate application of the grant.

3. In addition, the justification for activities shall be carried out by any other supporting documentation of the performance of the activity or fulfilment of the purpose which prompted the concession.

4. From 1 January of the year of the convocation, prior to their granting, they may be justified on the basis of the grant received, provided that they relate to actual costs of the activities and concepts included in the supported activities and that such expenditure has occurred within the time limit set out in the relevant order of call.

5. If, after the period of justification, the entity has not filed the relevant documents, the entity shall be required to provide the necessary 15-day period of time to be provided, informing the entity that the failure to provide justification in that period The time limit shall be the requirement for reimbursement and other responsibilities laid down in Law 38/2003 of 17 November.

Article 10. Modification of the grants.

1. As provided for in Article 64.1 of the Regulation of the General Law on Subsidies, in conjunction with Article 17.3.l) of Law 38/2003 of 17 November, the alteration of the conditions laid down for the granting of the grants, including concurrent obtaining for the same activities of grants or aid granted by other public or private, national or international public authorities, may result in the modification of the grant.

2. The circumstances, inter alia, which will give rise to the amendment of the resolution, will be changes during the implementation period, due to reasons not present at the time of application for the grant and for the best implementation of the programme. requested. The beneficiary institution may request amendments, at least 15 days before the end of the period of execution of the project, in the contents of the programme, in the places or dates of performance of the activities, in the quantities allocated to each concept which under no circumstances may involve an increase in the amount of the subsidy, in the replacement of elements of the budget financed by others of the same heading with equivalent functionality or in any other element of the programme to alter the project submitted to the grant or the reformulated programme. This application, which may not be a substantial or essential alteration of the project or programme submitted to a grant, shall require prior authorisation from the National Transplant Organisation.

The request must contain at least the following information:

-Payee and program identifying data.

-Request the required change.

-An adequate and detailed exposition of the technical and/or logistical reasons for the changes, the need for them to achieve the objectives of the programme.

-New forecast of expenditure broken down by concepts which, under no circumstances, may imply an increase in the amount of the grant on its given day.

Entities that have requested any of these changes will be listed in the corresponding section of the Take Action memory.

Article 11. Incompatibility with other grants.

Without prejudice to the foregoing Article, it is not incompatible to obtain other aid or subsidies for the same purpose, granted by other bodies of the public authorities or public entities. or private of any source, provided that the amount of the grant awarded does not exceed, in isolation or in competition with other aid, the cost of the activity or project to be developed by the beneficiary.

Article 12. Reimbursement of the grant.

The beneficiaries of the grants will be required to reintegrate the amounts received, as well as the interest for late payment of the grant, in the cases referred to in Article 37 of Law 38/2003, 17 November.

1. The total or partial non-compliance with the conditions imposed in connection with the grant of the grants will give rise to the obligation to reintegrate the amounts collected in whole or in part, plus the corresponding legal interests, in accordance with the the following proportionality criteria:

(a) The total non-compliance with the objective, the activity, of the project will result in the total reimbursement of the grant.

(b) The partial non-performance of the objective, of the activity, of the project will entail the return of that part of the grant to the same.

2. In the case of non-applied remainders, the beneficiary shall recover the remaining non-applied ones, together with interest on late payment, in accordance with the provisions of Article 34 of Royal Decree 887/2006 of 21 July.

3. The procedure for reimbursement shall be governed by the provisions of Articles 41 to 43 of Law 38/2003 of 17 November, Chapter II of Title III of its implementing Regulation, approved by Royal Decree 887/2006 of 21 July and Title VI of the Treaty on European Union. of Law 30/1992 of 26 November. In addition to these effects, it will be foreseen in this order, being competent for its initiation the Management Center of which the National Transplant Organization depends. The person who holds the Ministry of Health, Social Services and Equality shall be responsible for resolving the subsidy refund.

Article 13. Infringements and penalties.

The beneficiary entity will be subject to the regime of violations and penalties provided for in Law 38/2003 of 17 November.

Single repeal provision. Regulatory repeal.

Order SCO/3685/2004 of 2 November 2004 laying down the regulatory basis for the award of grants to institutions and non-profit entities to promote the donation and the human organ and tissue transplantation, as well as any other standard of equal or lower rank that contradicts or opposes the provisions of this order.

Final disposition first. Competence title.

This order is dictated by the provisions of article 149.1.16. of the Spanish Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health.

Final disposition second. Extra duty.

The subsidies regulated in this order will be governed, as not provided for in this order, by Law 38/2003, of 17 November, General of Grants, by Royal Decree 887/2006, of 21 July, approving the Law 38/2003 of 17 November, and the other rules of administrative law that affect it.

Final disposition third. Entry into force.

This order shall enter into force on the day following that of its publication in the "Official State Gazette".

Madrid, 17 February 2014. -Minister for Health, Social Services and Equality, Ana Mato Adrover.