There is no specific law regulating the import and export of human samples for in vitro research.

 

A Decree of 2005 provides most of Spanish measures regarding import/export of human biological samples for research use. However, the recent Law on biomedical research requires further developments regarding the internal, intercommunity and extra community regulations on exchange and circulation of biological material of human origin for research purposes (Third final disposition). Thus, implemented decrees need still to be adopted.

In connection with this need a new Royal Decree 1716/2011 dealing with the procedures to apply for using human samples from collections and biobanks in research has been adopted and includes provisions on international exchanges.

 

In what refers to issues such as data protection or donor (or participant or "subject-source" as in the law on biomedical research) consent, other general laws should be applied (Law on Biomedical Research). Norms related to safety and control in the framework of human material circulation should also be kept in mind.

HUMAN SAMPLES

 

• Law on biomedical research, Ley de invetigacion biomédica, (03/07/2007), entry into force: 05/07/2007

According to its third final disposition the Spanish Government can enact the appropriate norms to develop this law, and in particular those related to the internal and external (in the UE or abroad) transfer of human material for research purposes. The Decree adopted in 2011 concerning human sample collections and biobanks has been enacted in reference to this disposition.

 

Object and scope

 

“1. The object of this Law, with full respect towards human dignity and identity and the inherent rights of a person, is the regulation of biomedical research, and in particular :

a. Researches related with human health that imply invasive procedures.

b. The donation and use of human ovocites, sperm, preembryos, embryos and foetuses or of their cells, tissues or organs for biomedical research purposes and its possible clinical applications.

c. The handling of biological samples.

d. The storage and movement of biological samples.

e. Biobanks.

f. The Spanish Committee on Bioethics and other entities with competence on biomedical research matters.

g. The mechanisms for fostering and promotion, planning, evaluation and coordination of biomedical research.

2. Likewise and exclusively within the health ambit, this Law regulates the undertaking of genetic analysis and the processing of genetic data of a personal nature.

3. The biomedical research to which this Law makes reference to include basic and clinical research, with the exception of clinical trials with medication and sanitary products, which shall be regulated by its specific regulation.

a. The implantation of organs, tissues or cells of any origin shall be regulated by that established in Law 30/1979 of 27 October, on the Extraction and Transplantation of Organs and other applicable legislation, and are excluded from the scope of application of this Law.”

 

• The RoyalDecree 1716/2011 of the 18 of November establishing the basic requirements for the authorisation and functioning of biobanks with biomedical research purpose and for the processing of human samples and regulating the functioning and organisation of the National Register of Biobanks for Biomedical Research, Real Decreto 1716/2011, de 18 de noviembre, por el que se establecen los requisitos básicos de autorización y funcionamiento de los biobancos con fines de investigación biomédica y del tratamiento de las muestras biológicas de origen humano, y se regula el funcionamiento y organización del Registro Nacional de Biobancos para investigación biomédica.Bolotin oficial del Estado, Viernes 2 de diciembre 2011, Num.290, Sec.I. Pàg. 128434.

 

Scope

 

This Decree applies to collections of human samples and biobanks. It includes regulation of international exchanges of samples for research purposes and strengthens individuals’ rights and the respect of ethics.

 

• The Royal Decree 65/2006 of January 30^th , Real Decreto 65/2006, de 30 de enero, por el que se establecen requisitos para la importación y exportación de muestras biológicas (Modified by the Disposition SAS/3166/2009, November 16th)

 

Scope

 

This Decree establishes the requisites related to import and export of biological samples. This Decree applies to biological samples, humans or from other sources, and to any kind of substance, pathogenic or not, used for diagnostic or research in humans. (Article 1).

It also applies:

For samples used for the evaluation of the in vitro diagnostic reagent functioning where there intended for humans.

For the importation and exportation of hematopoietic progenitor cells, realised by the national organisation for transplantation. (Article 2)

However, are excluded from the scope of this Decree :

Raw materials intended for the development of medicinal products, health products, health products for in vitro diagnostic, cosmetics, hygiene products and biocides for clinical or personal use.

Importation and exportation of human embryos and gametes, umbilical cord blood, foetal cells and tissues, hematopoietic progenitor cells, adult and embryonic stem cells, bone marrow cells, and human organs and tissues for transplant used for therapeutic uses or to restore functions. (Article 2)

 

• The Royal Decree 1301/2006 of November 10^th, brings into force the 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.

 

Scope

 

This Royal Decree applies to human material to be used in humans.

 

Note: It seems these two Royal Decrees of 2006 do not apply for samples used for in vitro research but, to date, as this matter is not expressly excluded, the procedures of these Dispositions should be followed.

 

 

Non binding texts have also been published before the adoption of the Law on biomedical research. They are cited below as bibliography:

 

• Recomendaciones sobre los aspectos éticos de las colecciones de muestras o bancos de materiales humanos con fines de investigación biomédica, Comité de Ética del Instituto de Investigación de Enfermedades Raras (CEIIER), 2007
• Guía práctica para la utilización de muestras biológicas en Investigación Biomédica, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

 

ASSOCIATED DATA

 

• Organic Law 15/1999 of December 13th on Personal Data Protection, Ley Orgànica de Protección de Datos de Carácter Personal, entry into forcein January 2000.

 

Scope

 

This law applies to identifying personal data including those used or exchanged in the context of research.

 The Spanish rules to export (updated on 2012-05-09)

DEFINITIONS 

According to the article 2 of the Decree 1716/2011 on human samples collections and biobanks used in biomedical research

 

“Transfer of human biological materials for biomedical research purposes”: transfer of biological material to a third party for biomedical research. This definition is covering international transfers.

 

“Biobanks with biomedical research purposes”: public or private non-profit organisation organised as a technical unit with quality criteria, that stores one or more collections of human biological samples for biomedical research purposes.

 

“Collection of biological samples of human origin”: human biological samples organised and intended to be preserved in the long term outside of a biobank organisation.

 

“Processing of human biological samples”: all operations and procedures allowing the collection, preservation, storage, use and transfer of biological samples of human origins and, where appropriate, their associated data.

 

According to article 3 of the Law 14/2007 on Biomedical Research

 

"Biological sample": any biological material of human origin capable of conservation and that can hold information on the genetic endowment that is characteristic of a person.

 

"Biobank": a public or private non-profit establishment which has a collection of biological samples conceived for biomedical diagnostic or research purposes, and organised as a technical unit with quality criteria.

 

"Consent": the manifestation of a free and conscious volition that is validly expressed by a capable person or through an authorised representative, after adequate information has been provided.

PROCEDURES

Who can export?

 

There is no specification in the norm. It may be defined as the one who fulfills all the requirements for developing the activity and specifically for the transfer of samples.

Authorisations:

 

The applicant must send a declaration of exportation to the Spanish General Direction of Public Health (Spanish Ministry of Health) where essential information to identify the sample and its future use are provided (Royal Decree 65/2006, for biological samples used for diagnostic or research in humans amended by Disposition SAS/3166/2009, November 16th, that modifies its Annexes).

 

• For Unregistered exporter/occasional exporter:

If the competent authority of the recipient States requires a safety and quality certificate, it should be asked to the Spanish General Direction of Public Health which establishes the corresponding requirements in each case.

• For Registered exporter:

A safety and quality certificate is automatically done when the applicant is registered in the Spanish register for importation and exportation of biological samples.

This Certificate should be send to the competent authority of the recipient States if required.

 

Samples and data must be only used for the purpose of the consented research. This must be the object of an explicit commitment accompanied by the approval of the ethical committee corresponding to the project in which samples are asked for. In the context of a biobank, the request shall be approved by the scientific and ethics external committees and the head of the scientific direction of the biobank (Royal Decree 1716/2011, article 34 al.4). 

 

In any case, a written transfer agreement between the responsible of the research and the responsible of the biobank or of the collection must accompany the request of the human biological samples transfer. This agreement must include

a) The obligation for the beneficiary to ensure the traceability of the samples;

b) The guarantee that the validated genetic information and the relevant information for health obtained from the samples analysis, is available;

c) In case of samples stored in biobanks, the commitment on the respect of the biobank internal rules;

d) By the end of the project the commitment to destroy or retrieve the biological sample to the biobank or to the responsible person of the collection. (Royal Decree 1716/2011, article 34 al.5)

Informed consent

 

The conditions for the use of samples must be communicated to the "subject source" according to the Organic Law 15/1999 on data protection (information about the transfer of personal data) and the Law 14/2007 on Biomedical Research.

 

There is not an specific consent for export.

 

According to new Royal Decree 1716/2011:

 

There are three possibilities concerning the purpose of the consented research:

1. Consent for a concrete project,
2. Consent for a research line (collection) or
3. Consent for a biobank.

 

The samples in the project can be used only in the research project;

The samples in a collection can be used only for a concrete purpose;

The samples in a biobank can be used for any scientific research (Royal Decree 1716/2011, article 22.2).

 

The subject has to be informed about the transfer of samples when the samples are not going to be anonymised, but in different ways depending if the consent is given for a project, a collection or a biobank.

 

1. Inform in the frame of a research project: In the first case the subject has to be informed about each specific transfer.

 

2. Inform in the frame of biobank’s activity: In the case of biobank a general provision is enough. This is why other guarantees are implemented: the director of the biobank has to authorize each transfer (including those to other countries) after having received the opinion of the ethics and scientific committees. This was previewed also is the Law 14/2007 of Biomedical Research. Now is indicated that only if the opinion of the committees is favourable the transfer can be done; but even with the favourable opinion the director can refuse the transfer.

 

3. Inform where the samples are used from collections: The regime for the collections is a little bit confusing because it is not absolutely clear what kind of information about transfers has to be given to the subject (information about each concrete transfer or a general provision?). In the opinion of several experts, in the case of collections the subject has to be informed about specific transfers (the collections are not organized as the biobanks so no additional guarantees are implemented).

Indeed, in the preamble of the Royal decree is said that: “La segunda diferencia que debe subrayarse es la relativa a las posibilidades de cesión a terceros de las muestras: la vocación de servicio público de los biobancos hace imprescindible para su funcionamiento que el consentimiento del sujeto fuente incluya la cesión de las muestras en términos también más amplios que cuando se trata de muestras depositadas en colecciones, puesto que en este último caso es preciso un consentimiento expreso para cada cesión”: The second difference (between biobanks and collections) that should be emphasized is the possibility of transfer the samples to third parties :  the public service purpose of the biobanks can only be achieved if the subject’s consent includes the transfer of samples in a broader terms than when it refers to samples in collections, since the latter must express consent for each transfer.

 

According to article 59 of Law 14/2007:

 

1. Notwithstanding the provisions in legislation on the protection of data of a personal nature, before providing consent for the use of a biological sample for biomedical research that will not be subject to an anonymisation process, the subject source shall receive the following written information:

a) The purpose of the research or the line of research for which he or she is providing consent.

b) The expected benefits.

c) Any possible inconveniences linked to the donation and collection of the sample, including the possibility of being contacted at a later time in order to collect new data or obtain other samples.

d) The identity of the person responsible for the research.

e) The right to revoke consent and the consequences of this, including the possibility of the destruction or anonymisation of the sample and the fact that, to this end, such revocation shall not be applicable to other research data that has already been obtained.

f) The location where the analysis shall take place and the way in which the sample is used at the end of the research: disassociation, destruction or other research, and where appropriate, this shall in turn comply with the requirements provided in this Law. Even if such information is not known at the time, the subject shall be informed of the above particulars when they become known.

g) The right to know genetic data that is obtained from the analysis of donated samples.

h) A guarantee of confidentiality in relation to the information obtained, indicating the identity of the persons who shall have access to the personal data of the subject source.

i) A warning about the possibility that information relating to their health may be obtained from the genetic analysis undertaken on their biological sample, as well as their right to choose whether or not to receive this communication.

j) A warning about the possibility that the information obtained could have implications for the person’s family members and their right, where appropriate, to convey that information to them.

k) An indication on the possibility of contacting the person again, for which information will be sought on the best way so to do.

 

2. In the event of the use of samples that are going to be anonymised, the subject source shall receive the information contained in Sections a), b), c) and d) of this Article.

Informed consent for secondary use

 

The conditions are the same as those described in the above paragraph.

 

The consent of the subject source authorising the integration of the sample within a collection (not a biobank) for biomedical research purposes OR the use of the sample in a research project must include one of the following conditions (Royal Decree 1716/2011, article 27):

• The destruction of the sample at the end of the project or the research,
• The human biological sample anonymisation for future uses,
• The future transfer of the samples to a biobank, for free, under the condition that information is provided about that biobank and on the use purposes,
• The future use of the sample integrated in a collection with a defined research line related to the initial, including for a free transfer to a third, with the caveat that the specific consent of the subject source will be required for this.

 

In the context of a biobank, a new consent is necessary where the research is out of the scope of the initial consent (Royal Decree 1716/2011, article 27, article 34 al.2).

Data protection

 

The respect of Spanish Data Protection Law, Decrees and of the European data protection law must be ensured in the international exchanges of personal data associated with human samples. Specific measures apply to international transfers towards third countries (non-EU member States) according to the adequacy of their level of data protection, case-by-case. More information can be found on the website of the Agencia Española de Protección de Datos.

Where personal information is needed in the frame of the research, the request for the sample must indicate the specific measures that apply to ensure confidentiality of the personal data that may accompany the sample.

Samples and associated data must be transferred in an anonymous form or separated (Royal Decree 1716/2011, article 34 al.3).

For more information on data protection laws you can consult the legal pathways website.

Transport requirements

 

Shipments shall comply with the transportation, packaging, labeling and documentation that provide national and international standards.

 

E.g.

• WHO/EMC/97.3. Guidelines for the safe transport of infectious substances and diagnostic specimens
• IATA Regulations. Infectious substances. Section 5, forms n°602 and n°650 and Section 3.3.6.2. / 6.2.

 

The exit of some concrete kind of samples may only happen in some concrete custom areas, such as: Barcelona, Bilbao, La Farga de Moles, Madrid, Málaga, Palma de Mallorca, Sevilla, Valencia, Vitoria, Santa Cruz de Tenerife.

 

The samples which must exit from Spain trough these custom areas comprehend:

 

-  Infectious substance: a substance containing a viable microorganism, such as a bacterium, virus, parasite, fungus, and a prion, which is known or reasonably suspected to cause disease in humans or animals.

-  Diagnostic specimen:any human or animal material including, but not limited to,excreta, blood or its components, tissue and tissue fluids, collected for the purpose of making a diagnosis, excluding live infected animals.

It is not very clear if the Decree 65/2006 applies for in vitro research. However, this specific matter will be dealt with future decrees implementing the Law on biomedical research according to its third final disposition.

 

The new Royal Decree 1716/2011 has been a major legal event in Spain in the regulation of biobanks and human samples collections. Some issues remains to be discussed, particularly as regards to the samples collections regime.