Sweden to Implement a New Biobanks Act

The Swedish government has decided to implement a new Biobanks Act, which is suggested to enter into force on 1 July 2023.

The current Biobanks Act from 2003 has been criticized for being unclear and outdated and to create unnecessary administration, thereby leading to increased costs for healthcare and research. The new Biobanks Act includes several changes which are expected to help reduce administration and costs as well as help speed up processes when conducting clinical trials without diminishing the protection of the sample donor.

Some of the changes that will apply under the new legislation:

  • The scope of the new Biobanks Act is broadened to apply to all identifiable samples that are collected, stored or used for the purposes set out in the new Biobanks Act, regardless of where the samples are collected.
  • The new Biobanks Act will apply to samples that are stored for more than 9 months from the time of sampling, as well as to the time prior to this, if the intention is that the sample is to be stored for more than 9 months or if the sample is not destroyed immediately after it has been analysed.
  • The concept of primary and secondary sample collections is abolished.
  • The general ban on the final storage of samples abroad has been removed.
  • It may also be noted that the new Biobanks Act provides a possibility for authorities to issue regulations regarding traceability of the samples in case of transfer outside Sweden.

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