The Royal Decree-Law 16/2012 of 20 April, of urgent measures to ensure the sustainability of the National Health System and improve the quality and safety of its benefits, modifies, through its Final Disposition sixth, One, Article 4 of Royal Decree 1301/2006 of 10 November, laying down quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of cells and human tissues and the standards of coordination and operation are approved for use in humans. In accordance with that amendment, the last subparagraph of Article 4 (1) provides that entities intending to carry out any promotion and advertising activities in support of the donation of human tissues and cells should, in advance, request authorization from the competent authority of the Autonomous Community where the activity or the National Transplant Organisation is intended to be carried out when the intended activities exceed the scope of a Community Autonomic.

Of course, it is necessary to regulate the procedure that allows the National Transplant Organization, when, as has been pointed out, the development of the intended activities exceeds the scope of a community autonomous, granting or denying the authorization of the promotion and advertising activities that are intended to be developed in support of the donation of human tissues and cells. This procedure includes the obligation, both of the aforementioned Organization and of the competent bodies of the autonomous communities, to send to the Secretariat of the Transplant Commission of the Interterritorial Council of the National System -a copy of the applications submitted, for the purpose of which the said collegiate body issues a report prior to the adoption of the decision and in order to ensure the unity of the criterion in the adoption of the relevant decisions.

This rule is dictated under the protection of article 149.1.16. of the Constitution which attributes exclusive competence to the State on the basis and general coordination of health. Its content has been agreed by the Transplant Commission of the Interterritorial Council of the National Health System, an organ in which the autonomous communities and the National Transplantation Organization are represented. In its processing, the Spanish Data Protection Agency has issued a mandatory report and entities related to organ, tissue and cell donation and transplantation processes have been heard in the process of hearing.

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

Article 1. Object.

This order is intended to regulate the procedure by which the National Transplantation Organization authorizes the promotion and advertising activities in support of the donation of human tissues and cells when they are activities exceed the scope of a stand-alone community.

In no case, the authorization referred to in this order will be able to cover activities of extraction, processing, storage, distribution or implantation of human tissues and cells, which require, according to the established by Royal Decree 1301/2006 of 10 November establishing quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of cells and human tissues and the standards of coordination and operation for their use in humans are approved, specific authorisation by the competent authority of the Autonomous Community where such activities are to be carried out.

Article 2. Fulfillment and submission of the application.

Applications for authorisation, signed by the legal representatives of the entities and addressed to the Director of the National Transplant Organisation, shall be submitted in accordance with the standard models set out in the This order, in any of the places provided for in Article 38 (4) of Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure. These standard application models may also be accessed through the Web Virtual Office of the National Transplant Organization (www.ont.es). Applications may also be submitted by electronic means through the said paragraph.

Article 3. Documents to attach to the request.

Interested parties must submit the following documentation with their application for authorization:

1. In the case of associations of patients or entities for the promotion and promotion of the donation of human tissues and cells:

a) Copy of the statutes and corporate documents of the association of patients, society, foundation or entity for the purpose of promoting and promoting the donation.

b) Simple copy of the registration certificate in the corresponding record.

c) The descriptive memory of the association of patients, society, foundation or entity in which their mission and objectives are collected.

d) The description of the activity for which authorization is requested, identifying the objectives, dates of implementation, autonomous communities where it will be carried out as well as the financial resources affected by the development of the activity. In the event that any type of documentary or audiovisual support is to be used, this support shall be attached to the description.

2. In the case of umbilical cord blood banks for autologous or family use or of intermediary companies of these banks, or of insurance companies working with these banks or with the intermediary companies:

(a) Copy of the statutes and corporate documents of the commercial company, cord blood bank or other legal personification of the umbilical cord blood units.

b) Simple copy of the registration certificate in the corresponding record.

(c) Fehaciente accreditation of the legal representation of the intermediary undertaking, in the event that the umbilical cord blood bank acts through it.

d) A certified copy of the agreement signed with the centers for obtaining cord blood as well as the authorization of such centers for the performance of the activity.

e) The description of the activity for which authorization is requested, identifying the objectives, dates of implementation, autonomous communities where it will be carried out as well as the financial resources affected to the development of the activity. In the event that any type of documentary or audiovisual support is to be used, this support shall be attached to the specification.

3. In the case of entities for the collection of donors of haematopoietic progenitors of bone marrow or peripheral blood:

(a) Copy of the company's statutes and corporate documents, foundation or entity for the purpose of promotion and promotion of the donation, donor recruitment center or other legal personification for the realization of the Activities identified.

b) Simple copy of the registration certificate in the corresponding record.

c) A description of the company, foundation or entity in which its mission and objectives are collected.

d) The description of the activity for which authorization is requested, identifying the objectives, dates of implementation, autonomous communities where it will be carried out as well as the financial resources affected by the development of the activity. In the event that any type of documentary or audiovisual support is to be used, this support shall be attached to the description.

4. In the case of centers or entities promoting the donation of gametes:

(a) Copy of the company's statutes and corporate documents, foundation or entity for the purpose of promotion and promotion of the donation, donor recruitment center or other legal personification for the realization of the Activities identified.

b) Simple copy of the registration certificate in the corresponding record.

c) A certified copy of the agreement signed with the centers for obtaining gametes, in the event that it is not the same procurement center that performs the promotion, as well as the authorization of such centers for the realization of the cited activity.

d) The description of the activity for which authorization is requested, identifying the objectives, dates of implementation, autonomous communities where it will be carried out as well as the financial resources affected by the development of the activity. In the event that any type of documentary or audiovisual support is to be used, this support will be attached to this descriptive memory.

5. In cases where they are not listed in the previous four, the parties concerned must submit the following documentation with their application for authorisation:

a) Copy of the statutes and corporate documents of the association of patients, society, foundation or entity for the purpose of promoting and promoting the donation.

b) Simple copy of the registration certificate in the corresponding record.

c) The descriptive memory of the association of patients, society, foundation or entity in which their mission and objectives are collected.

d) The description of the activity for which authorization is requested, identifying the objectives, dates of implementation, Autonomous Communities in which it will be carried out as well as the financial resources affected by the development of the activity. In the event that any type of documentary or audiovisual support is to be used, this support shall be attached to the description.

6. In the event of non-substantial modifications to the documentary or audiovisual media after the granting of the authorisation, those amendments shall be communicated within seven calendar days. since the modification is introduced, to the administrative authority that granted the authorization.

Article 4. Requirements for obtaining authorization.

For the purpose of granting the requested authorization, the National Transplant Organization shall take into consideration the following:

1. Donation and/or donor recruitment campaigns:

(a) Campaigns in favour of donation shall be in accordance with the principles of voluntariness, altruism and disinterest, and must warn that neither the donor nor any other natural or legal person may request, or receive, economic consideration or remuneration related to the object of this paragraph.

b) The promotion and publicity of the donation or procurement of tissues will in any case be carried out in a general way, without seeking benefit for specific people, and must avoid the collective calls for the donation in favor of a concrete patient.

c) The content of advertising and information to citizens in general and to donors in particular will not be false or misleading and will be based on scientific evidence.

2. Sampling for typing or analysis:

In the event that the promotion or advertising includes sampling for typing and analysis, the applicant shall submit a responsible statement stating under his responsibility that such activity shall be carried out in compliance with the any time with the requirements established by the current regulations, in accordance with the provisions of the Organic Law 15/1999, of 13 December, of Protection of Personal Data, by Royal Decree 1720/2007, of 21 December, by the that the Regulation of the development of the Organic Law 15/1999 of 13 December, of protection of personal data, as well as by Royal Decree 65/2006 of 30 January 2006 laying down requirements for the import and export of biological samples.

3. In the case of donation of gametes:

Accreditation of compliance with the provisions of Law 14/2006 of 26 May on assisted human reproduction techniques, with regard to the prohibition of the selection of the donor by the gametes recipients, to the compensation for the donation and the preservation of the anonymity of the donors.

Article 5. Procedure instruction and resolution.

1. The National Transplant Organisation, in accordance with Article 4, shall examine the content of the application for authorisation by requiring the person concerned, in accordance with the provisions of Article 71 of Law No 30/1992, of 26 November 1992. so that, within ten days from the date of the notification, he or she subsates the faults or accompanies the required documents, with the indication that, if he does not do so, he shall be given the withdrawal of his or her request. judgment given in accordance with Article 42 of that law.

2. Once the criteria referred to in Article 4 have been applied to the application, the National Transplant Organisation shall draw up a proposal for a resolution which, in the case of authorisation, shall specify the time period to which the same period is circumscribed. The proposal, in accordance with the provisions of Article 84 of Law No 30/1992 of 26 November 1992, will be submitted to the interested parties. They may, within a period of 15 days, plead and submit the documents and justifications they deem relevant.

3. After the hearing procedure, the National Transplant Organization will send to the Secretariat of the Transplant Commission of the Interterritorial Council of the National Health System a copy of the proposed resolution, for the purpose of The aforementioned joint body is issued with a report prior to the adoption of the relevant resolution.

4. The Director of the National Transplant Organization will dictate, in accordance with the provisions of Law 30/1992, of November 26, a resolution that will be motivated in the cases provided for in that law. The decision must be made and notified to the person concerned within the maximum period of three months from the date on which the application is lodged in the Register, without prejudice to the suspension of the term of time due to the circumstances established in the Register. Article 42 (5) of Law 30/1992 of 26 November 1992 and the extension of the maximum period provided for in paragraph 6 of the same precept.

5. As provided for in Article 43 of Law No 30/1992 of 26 November 1992, the expiry of the maximum period without having been notified to the person concerned is legitimate in order to understand it. Accordingly, the person concerned may, from the date of expiry of the maximum time limit for resolving the estimate, make use of the estimate produced by administrative silence.

6. The decisions given by the Director of the National Transplant Organization as provided for in this order shall be communicated to the Autonomous Communities concerned.

7. The decision of the Director of the National Transplant Organization puts an end to the administrative route, in accordance with the provisions of Article 9.3 of Royal Decree 1825/2009 of 27 November, approving the Statute of the Organization of Transplantation National Transplant. Consequently, that decision, in accordance with Articles 116 and 117 of Law No 30/1992 of 26 November 1992, may be challenged directly in the context of the contested administrative or administrative court order in the replacement to the same organ as the one.

8. The failure to comply with the current regulations, the entry of data not adjusted to the reality as well as the inadequacy of the planned actions to the objectives of strategic planning of the autonomous communities and the Ministry of Health, Social Services and Equality, both in the application and in the documentation provided, will lead to the refusal of authorisation.

9. Failure to comply with the actions of the authorized entity as required by the current rules of application, as well as the provisions of the corresponding application, shall result in the revocation of the authorization granted. For such purposes, the National Transplant Organisation shall act in accordance with the procedure laid down in this Article.

Single additional disposition. No increase in public spending.

The forecasts contained in this order will not increase public expenditure and will be carried out with the material, technical and personal resources available without any modification or increase of allocations and remuneration.

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 on the basis and general coordination of health.

Final disposition second. Report of the Transplant Commission of the Interterritorial Council of the National Health System.

In relation to the provisions of Article 5.3 and in order to ensure the unity of criterion in decision-making, the autonomous communities shall send to the Secretariat of the Transplant Commission of the Council Interterritorial of the National Health System copies of the applications submitted in their respective registers, relating to the activities of promotion and publicity object of this order, for the purpose of which the aforementioned collegiate body is issued report prior to the adoption of the corresponding stand-alone community resolution.

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, 18 December 2013. -Minister for Health, Social Services and Equality, Ana Mato Adrover.

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