BIO Deutschland Calls for Legislation without Excessive Bureaucracy for Biobanks

BIO Deutschland urges that the storage of human tissue for research on a specific clinical question continues to be possible under the existing legal regulations without additional bureaucracy. The association made this statement in a position paper published on the occasion of the public hearing of the Bundestag Committee on Education, Research and Technology Assessment on the topic of “human biobanks”. Bio-medical research using biobanks is already comprehensively regulated by the Federal Data Protection Act and the established ethical principles found in many different standardisations. Hence, BIO Deutschland does not see any need to create a law on biobanks. Instead, it recommends that sensible revisions be made to the current legislation.

BIO Deutschland believes that the comprehensive exemption of researchers from detention in criminal proceedings and their right not to testify would lead to greater legal certainty, as would binding data protection guidelines, the safeguarding of data security in cases of data stored under pseudonyms, and appropriate protection against disclosure. These measures are in line with suggestions by the German Ethics Council. From the viewpoint of innovative biotechnology companies, a nationwide contact point for reports to the ethics commissions involved in this field would be desirable for reasons of legal certainly (consistent decisions) and the simplification of administration. This would avoid arguments on competence in trans-regional networks and cooperation.

In order to be able to pursue the search for new targets in the development of medications for untreatable or rare diseases effectively, human samples linked with personal data are vital for the biotechnology companies conducting this research. Bio-medical research leads to improved knowledge about the molecular basis of diseases and thus to a better understanding of the causes of the disease disposition and of individual patients’ reactions to the agent. Additional regulation in the field of biobanks would particularly have to take into account the protection of the freedom of research (Art. 5, clause 3, Basic Law for the Federal Republic of Germany), and the general freedom of the development of an individual’s personality (Article 2, clause 1 in conjunction with Article 1, clause 1, Basic Law for the Federal Republic of Germany). Regulations that restrict the freedom of research can only be enacted if they are suitable, necessary and proportionate to the protection of other rights upheld by constitutional law.

You will find a copy of the position paper (in German) at http://www.biodeutschland.org/positionspapiere.html.