Legislation
 
 
  The Valencian Biobanking Network was created by Decree 143/2008, of October 3, of the Valencian Government, which regulates biobanks in the Region of Valencia.
 
This regulation limits its scope to biobanks located in the Region of Valencia and deals with the regulation from three perspectives. First, it establishes the overall organizational and operational requirements to be met by biobanks in order to be approved. Second, it regulates the administrative procedure for such authorization. Third, it creates a registry of Valencian biobanks and the Valencian Biobanking Network as control tools and support for their respective operations.
 
   
 
Spanish law
Law 14/2007, of July 3, on Biomedical Research defines, for the first time in Spanish law, the legal status of a key institution in the course of the research action in the field of biomedicine: biobanks.
 
This Act establishes the basic statute regulating the basic characteristics and differences from other collections of biological samples and establishes that biobank organization and operation must be performed with respect for fundamental rights and citizen's freedoms.
 
RD 1716/2011, of November 18, which establishes the basic requirements for authorization and operation of biobanks in biomedical research and treatment of biological samples of human origin, and regulates the functioning and organization of the Registry national biobanks for biomedical research.
   
  International laws
Various international agencies are working over the past few years in documents dealing with the use of human specimens for biomedical research, which are a valuable guide to the interpretation of existing regulatory framework. These documents include:
   
 
  • Universal Declaration on Human Genetic Data of UNESCO, October 16, 2003.
  • Recommendation (2006) 4 of the Council of Europe on research on biological materials of human origin, from March 15, 2006, which will be the basis for a future protocol to the Convention on Human Rights and Biomedicine.
  • OECD Best practice guidelines for biological source centres (2007).
  • Best Practices for Repositories (2008) of the International Society for Biological and Environmental Repositiries (ISBER)