The Swedish government decides on a legal council referral where it is proposed that the current Biobanks Act from 2003 be replaced by new legislation. The new bill from the government promotes research and healthcare when unnecessary administration is reduced while maintaining the protection of donors.
“Biobanks are important for research and for healthcare, including diseases such as cancer. The current Biobank Act is almost twenty years old and needs to be updated”, says Minister of Social Affairs Lena Hallengren.
A biobank is a collection of samples taken from humans or fetuses that are collected, analyzed, stored, and made available for various purposes, such as healthcare or research. In Sweden’s biobanks, there are over 150 million saved samples in 338 different biobanks.
The largest biobanks are located in the regions where an estimated 90% of all biobank samples in Sweden are stored. Ninety-five percent of all samples are saved for healthcare purposes. Typical examples are cancer samples that are saved for later analysis, for example in case of relapse.
In the legal advice referral, the government proposes a new biobank law that will reduce the administration and costs of healthcare and research, without reducing the protection for the sample donor. The new law will also regulate how identifiable human biological material, so-called samples, with respect for the integrity of the individual, may be collected, preserved, and used for certain purposes.
The scope of the law is extended by applying its provisions directly to identifiable samples that are collected, preserved, or used for healthcare, research, or product production, or for training, quality assurance, or development work within the framework of such activities. The proposal clarifies that other laws should not generally take precedence over the Biobanks Act.
Consent to collect and preserve samples for the donor’s care or treatment shall not be required if the patient has consented to care or treatment in accordance with the Patients Act or the Dental Care Act, and has received certain information in accordance with the Biobanks Act.
The Ethical Review Authority or the Board of Appeal for ethical review shall mainly apply for information and consent to sample handling for research. The rules on making samples available outside the biobank are clarified and a new possibility of sending samples for a certain measure is introduced. The general ban on storing samples abroad is removed.
The bills are proposed to enter into force on 1 January 2023.