The bill contains rules for hospitals, research institutions, and companies that work with and store human material. This includes, for example, blood, a removed mole, or an amputated body part. The bill regulates control over human material, medical-ethical review, and management of the material. The Wzl determines when consent is required for the collection of human material. The law also states that a medical-ethical review committee (METC) must give prior approval for the collection of material for a biobank and for the use of collected material in research. Furthermore, the law addresses the management of human material. It provides people with more clarity about what happens to their blood, tissue, or other human material.
Amendment to previous bill
This bill is a revised and clarified version of the original 2021 bill. The principle that consent is always required for the collection of human material remains unchanged. This applies both when material is collected for healthcare and when it is stored for scientific research.
With clearer rules, the Wzl accelerates research that can lead to new treatments and medicines. An important change compared to the original proposal is the adjusted conditions for using material collected for healthcare or diagnostics. This type of material may be stored and used for scientific research without consent if a patient or donor is well informed and has not objected. In this case, there must be no potentially sensitive application, such as using the tissue to develop an immortal cell line.
In addition to these improvements, the criteria for ethical review of scientific research have been adjusted, and several definitions and articles of the law have been amended and clarified. This improves the enforceability of the law.
