Royal Decree 318/2016, Of 5 August, Approving The Authorization Procedure For Carrying Out Promotional Activities And Advertising Of Donating Human Tissues And Cells Is Regulated.

Original Language Title: Real Decreto 318/2016, de 5 de agosto, por el que se regula el procedimiento de autorización para la realización de actividades de promoción y publicidad de la donación de células y tejidos humanos.

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Royal Decree-Law 9/2014, of July 4, laying down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells human and standards coordination and operation for use in humans are approved, incorporated into Spanish law Directive 2004/23 / EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, Directive 2006/17 / EC of 8 February 2006 amending Directive 2004/23 / EC of the European Parliament and the Council to certain technical requirements for the donation, procurement and testing of human tissues and cells and Directive 2006/86 / EC applies as regards of 24 October 2006 amending Directive 2004/23 / EC of the European Parliament and of the Council as regards traceability requirements, notification of reactions and serious adverse events and certain technical requirements applied for coding, processing, preservation, storage and distribution of human tissues and cells.

Article 4.1 of Royal Decree Law 9/2014, of July 4, states that the promotion and advertising of the donation or obtaining human tissues and cells are always made in general, without seeking a benefit to specific people and pointing their voluntary, altruistic and selfless character. To this end, Article 4.1 states that entities intending to carry out any activity of promotion and advertising in support of the donation of human tissues and cells must previously request authorization from the competent authority of the autonomous community is intended to develop the activity or the National Transplant Organization when the intended activities exceeding the scope of an autonomous community, referring to it an administrative procedure in any case, must comply with the provisions of Law 30/1992 of November 26, Legal Regime of Public Administrations and Common Administrative Procedure.

This royal decree is to regulate the administrative procedure to be submitted to the National Transplant Organization purpose of resolving requests for permission to develop promotional and advertising activities in support of the donation of human tissues and cells exceed the scope of an autonomous community.

Thus, regulating aspects of initiation, instruction and completion of that procedure and, in particular, aspects relating to the completion and submission of the application, the documents to be attached to it and the requirements to obtain authorization. It also provides that, in accordance with article 43 of Law 30/1992 of November 26, the expiry of the deadline without having notified express resolution legitimizes the estimated interested in understanding your request.

In any case, the authorization referred to in this Royal Decree may cover activities of extraction, processing, storage, distribution or implantation of human tissues and cells, which require, as established in Royal Decree-Law 9/2014, of July 4, the specific authorization by the competent authority of the autonomous community where they carry out such activities.

As for the legal basis of this standard, this is issued based on the regulatory authorization contained in the third final provision of Royal Decree-Law 9/2014, of July 4, and allows saving the insufficient range which, according to the judgment of the High Court of 6 May 2015, he suffered the Order SSI / 2512/2013 of 18 December, the authorization procedure for carrying out promotional activities and advertising is regulated donation of human tissues and cells.

In the process of preparing this royal decree has been consulted, among others, the autonomous communities and cities of Ceuta and Melilla, and have been hearing the entities related to the processes of donation and transplantation of organs, tissues and cells .


Also, in accordance with Articles 67.2 and 71 of Law 16/2003 of 28 May, of cohesion and quality of the National Health System, this Royal Decree has been subject to report by the Committee Advisory and Plenum of the Interterritorial Council of the National Health System, as well as the Spanish data Protection Agency under the provisions of Law 15/1999, of December 13, Protection of Personal data and the Statute of the said Agency, approved by Royal Decree 428/1993 of 26 March.

The standard is issued under Article 149.1.16 of the Constitution which grants the State exclusive competence on bases and overall coordination of health.

By virtue of the proposal of the Minister of Health, Social Services and Equality, with the prior approval of the Minister of Finance and Public Administration, according to the Council of State and after deliberation by the Council of Ministers at its meeting on August 5, 2016,

DECREE:

Article 1. Purpose.

The royal decree is to regulate the procedure by which the National Transplant Organization authorizes promotion and publicity activities in support of the donation of human tissues and cells when these activities exceed the scope of an autonomous community.

In any case, the authorization referred to in this Royal Decree may cover activities of extraction, processing, storage, distribution or implantation of human tissues and cells, which require, as established in Royal Decree-Law 9/2014, of July 4, laying down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells and passed the coordination and operation standards for use in humans, specific authorization by the competent authority of the autonomous community where they carry out such activities.

Article 2. Completion and submission of the application.

Applications for authorization, signed by the legal representatives of the entities and to the Director of the National Transplant Organization shall be presented in accordance with the standard forms contained in five annexes of this royal decree, in any of the places provided in Article 38.4 of Law 30/1992 of 26 November on the Legal Regime of Public Administrations and Common Administrative Procedure. a standard application such models may also be accessed through the Virtual Office section the website of the National Transplant Organization (www.ont.es). Applications may also be submitted electronically through the said section.

Article 3. Documents to be attached to the application.

1. Patient associations or entities for the development and promotion of the donation of human tissues and cells must submit with its application for approval the following documents:

A) copy of the statutes and corporate documents of the patient association, corporation, foundation or entity for the purpose of fostering and promoting the donation.

B) Simple certificate of registration in the corresponding register Copy.

C) Descriptive report of the patient association, corporation, foundation or other entity in which its mission and objectives are collected.

D) Descriptive report of the activity for which authorization is requested, identifying the objectives, completion dates, autonomous communities where they will perform, as well as financial resources allocated to development activity. In the event that is to use some sort of documentary or audiovisual support, said support is attached to the specification.

2. Banks umbilical cord blood for autologous or family use, intermediary companies of these banks or insurance companies working with these banks or intermediary companies must submit with its application for approval the following documents:

A) copy of the statutes and corporate documents of the corporation, Cord Blood Bank or other legal personification depositary units of umbilical cord blood.

B) Simple certificate of registration in the corresponding register Copy.

C) Accreditation reliable legal representation which holds the intermediary company in the event the Cord Blood Bank act through it.


D) Certified copy of the agreement signed with collection centers cord blood as well as the authorization of such centers to carry out such an activity.

E) Descriptive report of the activity for which authorization is requested, identifying the objectives, completion dates, autonomous communities where they will perform, as well as financial resources allocated to development activity. If you intend to use some sort of documentary or audiovisual support, said support is attached to the specification.

3. Entities to attract donor hematopoietic stem cell bone marrow or peripheral blood must submit with its application for approval the following documents:

A) copy of the statutes and corporate documents of the company, foundation or entity for the purpose of fostering and promoting donation, donor recruitment center or other legal personification for the realization of the aforementioned activities.

B) Simple certificate of registration in the corresponding register Copy.

C) Descriptive report of the company, foundation or other entity in which its mission and objectives are collected.

D) Descriptive report of the activity for which authorization is requested, identifying the objectives, completion dates, autonomous communities where they will perform, as well as financial resources allocated to development activity. In the event that is to use some sort of documentary or audiovisual support, said support is attached to the specification.

4. Centers or organizations promoting gamete donation must submit with its application for approval the following documents:

A) copy of the statutes and corporate documents of the company, foundation or entity for the purpose of fostering and promoting donation, donor recruitment center or other legal personification for the realization of the aforementioned activities.

B) Simple certificate of registration in the corresponding register Copy.

C) Certified copy of the agreement signed with the gametes collection centers, if not the center itself which makes obtaining promotion and authorization of the centers for conducting such an activity .

D) Descriptive report of the activity for which authorization is requested, identifying the objectives, completion dates, autonomous communities where they will perform, as well as financial resources allocated to development activity. If you intend to use some sort of documentary or audiovisual support, said support is attached to this specification.

5. In those cases that are not included in the preceding paragraphs, interested parties must submit with its application for approval the following documents:

A) copy of the statutes and corporate documents of the patient association, corporation, foundation or entity for the purpose of fostering and promoting the donation.

B) Simple certificate of registration in the corresponding register Copy.

C) Descriptive report of the patient association, corporation, foundation or other entity in which its mission and objectives are collected.

D) Descriptive report of the activity for which authorization is requested, identifying the objectives, completion dates, autonomous communities where they will perform, as well as financial resources allocated to development activity. In the event that is to use some sort of documentary or audiovisual support, said support is attached to the specification.

6. In the event that no substantial changes in documentaries and audiovisual after the grant of authorization holders are made, such modifications shall be communicated within seven calendar days after the modification is made to the authority which granted authorization.

Article 4. Requirements to obtain authorization.

1. For the purposes of granting the requested authorization, the National Transplant Organization will consider the following:

A) In the case of donation campaigns and / or donor recruitment:
1st
campaigns for the donation shall comply with the principles of voluntariness, altruism and selflessness must note that neither the donor nor any other natural or legal person, may request, nor receive, financial compensation or remuneration some linked to the subject of this section.


2nd promotion and advertising of the donation or tissue procurement shall be made in any case generally without seeking benefit individuals and should avoid collective appeals for donations in favor of a particular patient.

3.º The contents of advertising and information to the general public and donors in particular will not be false or misleading and based on scientific evidence.

B) In the case of promotion or advertising to include sampling or analysis for typing, the applicant shall responsible declaration stating under its responsibility that this activity will be in compliance at all times with the requirements established by current legislation , notably by the provisions of Law 15/1999 of December 13, Protection of Personal data, by Royal Decree 1720/2007 of December 21, approving the Regulations implementing the Act is approved 15/1999 of 13 December on protection of personal data, as well as Royal Decree 65/2006, of 30 January, laying down requirements for the import and export of biological samples are established.

C) In the case of gamete donation:
1st
be confirmed that any advertising or promotional activity by authorized centers that encourage the donation of human tissues and cells must respect the altruistic nature of it, can not under any circumstances encourage donation by offering compensation or economic benefits.

2nd In the process of promotion and publicity shall specify that the donation be anonymous and should the confidentiality of the identity data of donor gamete banks guaranteed and, where appropriate, through records donors and activity centers to be established.

2. Failure to comply with current regulations, the provision of data not adjusted to reality and 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 entail the denial of authorization.

Article 5. Instruction and resolution procedure.

1. The National Transplant Organization shall, in accordance with the provisions of Article 4, the content of the application for authorization. If the application does not meet the requirements will require the interested party to, within ten days from the day following notification and in accordance with the provisions of Article 71 of Law 30/1992 of 26 November rectify the faults or provide the mandatory documents, indicating that if this is not done, you shall be withdrawn her request, prior resolution issued as set out in Article 42 of the Act.

2. Once applied to the relevant application criteria referred to in Article 4, the National Transplant Organization draw up the corresponding draft resolution which, if favorable to the granting of an authorization shall specify the period of time that the same is limited. The draft resolution will be submitted to the interested audience who, within fifteen days, may plead and present the documents and evidence they deem relevant.

3. After the hearing process, the National Transplant Organization shall send a copy of the draft resolution to the Secretariat of the Commission Transplant Interterritorial Council of the National Health System, in order that by that collegial body issue a report before the adoption of the corresponding resolution.

4. The Director of the National Transplant Organization issue a decision to be motivated in the cases provided for in Law 30/1992 of 26 November. The resolution shall be issued and notified to the party concerned within three months from the date of filing of the application in the registry, without prejudice to the possibility of suspending the computation of term by the circumstances set out in paragraph 5 of Article 42 of Law 30/1992 of 26 November, and the extension of the maximum period provided for in paragraph 6 of the same provision.

5. In accordance with article 43 of Law 30/1992 of November 26, the expiry of the deadline without having notified express resolution legitimizes the estimated interested in understanding your request. Consequently, the applicant may assert, from the date of expiration of that deadline, the estimate produced by administrative silence.


6. The decision of the Director of the National Transplant Organization ends the administrative route, according to the provisions of Article 9.3 of the Statute of the National Transplant Organization, approved by Royal Decree 1825/2009, of November 27. Consequently, the resolution, as provided by Articles 116 and 117 of Law 30/1992 of 26 November, may be challenged directly before the contentious administrative order or judgment potestativamente in reinstatement to the same body that he dictated.

7. Decisions given by the Director of the National Transplant Organization as provided in this royal decree shall be communicated to the regions affected.

Article 6. Withdrawal of authorization.

Failure in the activities of the entity authorized by the precepts by current applicable regulations, as well as the statements in the corresponding application will result in the revocation of the authorization granted. To this end, the National Transplant Organization will proceed in accordance with the procedure laid down in the previous article.

Sole additional provision. No increase in public spending.

The provisions contained in this royal decree shall not involve increased public spending and be carried out with the material, technical and human resources available without implying modification or increased allowances and remuneration.

Single derogatory provision. Repeal legislation.

Are repealed all provisions of equal or lower rank opposing the provisions of this Royal Decree.

First final provision. competential title.

This royal decree is issued under the provisions of Article 149.1.16 of the Spanish Constitution, which grants the State exclusive competence on bases and overall coordination of health.

Second final provision. References Law 30/1992 of 26 November on the Legal Regime of Public Administrations and Common Administrative Procedure.

References in this royal decree to the Law 30/1992 of 26 November, be construed as references to the Law 39/2015, of October 1, the Common Administrative Procedure Public Administration at the time of his entry into force.

Final disposition third. Faculty development and execution.

Person to the head of the Ministry of Health, Social Services and Equality is empowered to make the necessary arrangements for the development and implementation of this Royal Decree, and to adapt the annexes to Community legislation or further developments in systems information technology.

Fourth final provision. Entry into force.

The Royal Decree shall enter into force on the day following its publication in the "Official Gazette" day.

Given in Palma de Mallorca, on 5 August 2016.
FELIPE R.


The Minister of Health, Social Services and Equality,
ALFONSO ALONSO Aranegui

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