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Legal Q&A: What needs to be considered from the legal side when building/setting up a biobank?

There are relevant laws for biobanks, both at the Austrian and European levels, which either specifically govern biobanks or which provide certain requirements for the establishment of a biobank in the existing legal framework. This legal Q&A in the BBMRI.at Knowledge Base provides details.

BBMRI.at Legal Helpdesk Service answers

 

The BBMRI.at Legal Helpdesk Service – operated by legal experts from BBMRI.at partner UNIVIE- answers questions on legal and regulatory matters around biobanking and/or using biological samples and data. This service is offered to BBMRI.at partners to support them, as biobanking and research using biological samples and data (e.g. human, animal/veterinary, microbial, etc.) may raise legal questions. Answers provided by UNIVIE to legal questions are published in the BBMRI.at Knowledge Base.

 

 

QUESTION:

Legal Q&A: What needs to be considered from the legal side when building/setting up a biobank?

 

 

ANSWER:

 

1. Overview of relevant lawsfor biobanks, both at the Austrian and European levels 

 

Currently, there is no single European Union (EU)-wide regulation that explicitly regulates biobanks and biobanking,
however, the existing EU framework addresses some aspects of biobanking, namely the
Regulation on personal data protection – which coexists with the EU Member States (MS) national regulations on the matter.[1]

 

At a national level, there is legislation in force in different EU MS which specifically address biobanks. Legal
requirements to set up a biobank is included in the law as follows:

Legislative Act

Requirements for Biobank set up

BE
Royal Decree of 28 September 2009 establishing the general conditions which the banks for human substances, the intermediary structures and the production establishments must satisfy to be recognised[2]
EE
Inimgeeniuuringute seadus (13.12.2000)[3]
In particular, Art. 3- Art. 5
FI
Biopankkilaki – 30.11.2012/688[4]
In particular Chapter 2, Art. 5 – Art. 10
HU
008. évi XXI. törvénya humángenetikai adatok védelméről, a humángenetikai vizsgálatok és kutatások, valamint a biobankok működésének szabályairól[5]
In particular, Chapter 5, Art. 21- Art. 27
LV
Cilvēka genoma izpētes likums (13.06.2002) (only applicable to genome databases)[6]
In particular, Art.4.
LT
Lietuvos Respublikos biomedicininių tyrimų etikos įstatymas[7]
From the unofficial English translation it seems that the requirements for setting up a biobank are not regulated therein.
PT
Lei n.º 12/2005, de 26 de Janeiro – Informação genética pessoal e informação de saúde (last amended by Lei n.º 26/2016, de 22 de Agosto)[8]
Art.19 (applicable to DNA banks)
ES
Ley 14/2007, de 3 de julio, de Investigación biomédica[9]
Chapter 4 – Art. 63-Art. 70
SE
Biobankslag (2023:38)[10]
Art. 2-Art. 3, Art. 6

EU MS:

BE (Belgium), EE (Estonia), FI (Finland), HU (Hungary), LV (Latvia), LT (Lithuania), PT (Portugal), ES (Spain), SE (Sweden)

Other national systems do not have a specific mandate on the question at hand, but certain requirements for the establishment of a biobank can be found in the legal system, as in the case of Austria (AT):

Legislative Act

Requirements for Biobank set up

AT
Forschungsorganisationsgesetz (FOG)[11] , Austrian Tissue Safety Act, Ordinance on Human Tissue Banks[12], Legal basis for the areas of extraction, processing, storage and distribution of human tissues and cells:
• Tissue Safety Act (GSG)
• Tissue Vigilance Ordinance (GVVO)
• Tissue Bank Ordinance (GBVO)
• Tissue Procurement Ordinance (GEEVO)
Art. 2f(1), as for the definition of scientific institution.
If tissue samples are handled, the Tissue Safety act and Tissue Bank ordeniance are applicable, According to § 29 Abs 1 Gewebesicherheitsgesetz idgF (GSG) the Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Health Care) has to keep a register of all certified procurement establishments and approved tissue banks. Tissue banks need to be ceritified, and included in an European register. [13]

In order to illustrate the legal requirements provided by the aforementioned national laws, biobanks need to

  • be registered as a legal person[14]
  • be authorized/ accredited by the respective national (health) authority.[15]

 

 

These national legal requirements could be complemented by standards in the field.[16]

  • ISO 20387 standard which contains requirements designed to demonstrate the competence of a biobank’s operation and the ability to provide biological material and associated data for research and development.[17]

Download Legal Q&A: What needs to be considered from the legal side when building/setting up a biobank?

Sources:

[1] Further information on EU regulation on biobanks can be found in the report/question no. 5 issued by UNIVIE.

[2] Belgium, Royal Decree of 28 September 2009 establishing the general conditions which the banks for human substances, the intermediary structures and the production establishments must satisfy to be recognized. Available at <https://etaamb.openjustice.be/fr/arrete-royal-du-28-septembre-2009_n2009018412.html >

[3] Estonia, Inimgeeniuuringute seadus (13.12.2000). Available at <https://www.riigiteataja.ee/akt/72581 >

[4] Finland, Biopankkilaki (30.11.2012/688). Available at < https://www.finlex.fi/fi/laki/ajantasa/2012/20120688 >

[5] Hungary, 008. évi XXI. törvénya humángenetikai adatok védelméről, a humángenetikai vizsgálatok és kutatások, valamint a biobankok működésének szabályairól. Available at < https://net.jogtar.hu/jogszabaly?docid=a0800021.tv

[6] Latvia, Cilvēka genoma izpētes likums (13.06.2002). Available at <https://likumi.lv/ta/en/en/id/64093 >

[7] Lithuania, Lietuvos Respublikos biomedicininių tyrimų etikos įstatymas . Available at <https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.101629?jfwid= >

[8] Portugal, Lei n.º 12/2005, de 26 de Janeiro – Informação genética pessoal e informação de saúde. Available at <https://www.pgdlisboa.pt/leis/lei_mostra_articulado.php?nid=1660&tabela=leis&so_miolo= >

[9] Spain, Ley 14/2007, de 3 de julio, de Investigación biomédica. Available at <https://www.boe.es/buscar/doc.php?id=BOE-A-2007-12945 >

[10] Sweden, Biobankslag (2023:38). Avialable at < https://www.riksdagen.se/sv/dokument-och-lagar/dokument/svensk-forfattningssamling/biobankslag-202338_sfs-2023-38/#K2 >

[11] Austria, Forschungsorganisationsgesetz. Available at <https://www.ris.bka.gv.at/GeltendeFassung.wxe?
Abfrage=Bundesnormen&Gesetzesnummer=10009514 >

[12] BASG – Federal Office for Safety in Health Care / AGES MEA – Austrian Medicines and Medical Devices Agency, Certification, authorisation, and inspection of tissue establishments. Available at < https://www.basg.gv.at/en/healthcare-professionals/tissue-safety/certification-authorisation-and-inspection-of-tissue-establishments#:~:text=According%20to%20the%20Austrian%20Tissue,ordinances%20issued%20on%20its%20basis. >

[13] Idem 12

[14] See Estonia, Inimgeeniuuringute seadus (13.12.2000 Art.3); Finaland Biopankkilaki – 30.11.2012/688 Art. 6; The Biobanks and Health Databanks Act, Art. 4 and 5

[15] See Estonia, Inimgeeniuuringute seadus (13.12.2000 Art.3); Finaland Biopankkilaki – 30.11.2012/688 Art. 6; Portugal Lei n.º 12/2005, de 26 de Janeiro – Informação genética pessoal e informação de saúde (last amended by Lei n.º 26/2016, de 22 de Agosto) Article 19 (2); Spain, Ley 14/2007, de 3 de julio, de Investigación biomédica, Art. 64

[16] WHO, Biobank and Cohort Building Network,  Recommendation to set up a biobank . Available at <https://videos.iarc.fr/channels/BCNet/media/MEDIA160331215143240 >

[17] ISO, ISO 20387 Biotechnology — Biobanking — General requirements for biobanking.  Available at < https://www.iso.org/standard/67888.html >

Disclaimer: this commentary aims to provide a summary of the main ethical and legal issues related to the questions put by interested stakeholders and to direct them to the relevant legal provisions that are applicable. It does not, however, preclude from reading the official sources of legislation relating to the subject matters of this document as well as those quoted by the authors and does not constitute legal advice.