Questions & Answers

The Biobank Act applies to identifiable human biological samples collected in Sweden and stored or intended to be stored for more than 9 months after sampling* in a biobank and are used for the purpose of

1. care, treatment, or other medical purposes within the provision of healthcare,
2. research,
3. product manufacturing, or 
4. education, quality assurance or development work within the framework of any of the purposes stated in 1–3.

It is the purposes for which samples are collected, stored, or used that determine whether the Biobank Act is applicable or not.

It doesn’t matter where samples are collected. For example, samples taken outside the health care system are also covered if they are collected, stored, or used for the purposes mentioned above.

The Biobank Act will also apply to samples collected for a purpose not covered by the Act, if and when it becomes relevant for use for one of the purposes covered by the Act.

*Please note. The Act must be applied to samples even before nine months if

• the intention from the outset is to store the sample for more than nine months, or
• the sample is not destroyed immediately after it has been analysed.

There are exemptions to the scope of the Act. Please note, that exempted samples fall under the Biobank Act if any conditions for the exemptions are not met or if the purpose is changed to one of the purposes covered by the Act.

The following exemptions exist:

• The Biobank Act does not apply on samples that are analysed within 9 months of sampling and destroyed immediately following analysis. Both conditions must be met for the exemption to apply.
• The Biobank Act does not apply to samples that are collected, stored, or used for transfusion, transplantation, insemination, or fertilisation outside the body, or to a sample, collected at transfusion or transplantation, that is stored for quality assurance purposes. In these cases, the handling and use of samples are regulated in other legislation.
• The Biobank Act does not apply to samples that have been substantially modified in the course of research or product manufacturing. In order for this exemption to apply, both of the following conditions must be met:
  
  1) the sample donor must have been informed that the sample will be substantially modified and that it will no longer be covered by the Biobank Act, and
  
  2) the sample donor has given his or her consent to such a modification.
  
  If both conditions are not met, the samples are covered by the Biobank Act.
• The Biobank Act does not apply to samples that have been anonymised. Consent is not required to anonymise samples. However, samples may not be anonymised in order to be used for purposes that a sample donor has opposed. The Biobank Act states that samples may not be anonymised to be used for purposes other than those to which the sample donor has consented to, i.e. anonymisation of samples may not take place in order to circumvent the requirements of the Biobank Act.

Samples that are analysed within 9 months of sampling and destroyed immediately following analysis are not covered by the Biobank Act. Both conditions need to be met. This means that if a research study instructs a healthcare provider to take samples for the study that meet the requirements of the exemption rule, there is no need for an agreement with a biobank. On the other hand, an ethical approval from the Swedish Ethical Review Authority or a permit in accordance with the EU regulation on clinical trials/performance studies is required, as well as agreements with clinical trial units. The research principal is responsible for ensuring that both requirements of the exemption rule are followed, i.e. that samples may not be stored for a longer period of time than 9 months after sampling and that samples are destroyed immediately following analysis. Biobank Sweden recommends that an MTA/equivalent is established, if samples that are covered by the exemption rule and are to be sent for an action. However, this is not a requirement under the Biobank Act.

For research or clinical trials with ethical approval or permit, samples can be sent for a certain action (e.g. for analysis, reformatting and/or storage) to be carried out to a legal entity within or outside the country without it being considered a release. Samples sent to another legal entity for an action to be carried out do not cease to be part of the biobank in which they are established.

There are specific requirements for agreements and terms for a sample to be sent for an action. Agreements can be in the form of a Material Transfer Agreement (MTA).

The biobank custodian is required to draw up an agreement (MTA/equivalent) with the recipient stating the purpose of making the samples available, what will happen to samples after the action has been performed, and set as a condition for making the material available that:

• a sample stored at the recipient must be returned or immediately destroyed or, if it is not possible to destroy it without destroying other samples, anonymised*, at the request of the biobank custodian.
• the recipient does not use samples for anything other than the stated purpose.

It is not necessary to draw up an agreement for each sample, but an agreement between the parties may cover a large number of samples, which may have been sent at the same time or on different occasions. Biobank Sweden provides standard templates for Material Transfer Agreements. However, it is not always the case that a separate MTA needs to be used. For example, a separate MTA is not required if the agreement between the sponsor and the central laboratory already contains the information required by the Biobank Act.

*An example of when this situation arises is when a sample donor contacts the biobank and informs them that they are withdrawing their consent to the storage of samples. The responsible biobank must ensure that the wishes of the sample donor are executed even though the sample is stored at the recipient.

The Biobank Act allows samples to be sent to a legal entity within or outside the country in order for a certain action to be performed. For example, an action can be analysis, reformatting, or storage.

However, these may only be actions that fall within the scope of the purpose. For example, if the purpose is a specific research project, it may only be actions that fall within that project that are to be carried out.

If samples have already been collected and you then wish to store samples abroad, you need to look at what is stated in the existing ethical approval from the Swedish Ethical Review Authority, information for research subjects/persons, biobank agreements and MTA. If the action storage abroad is not covered in the existing biobank agreement and the MTA/equivalent needs to be updated. An application for a substantial change is probably also required to the Swedish Ethical Review Authority (which will also decide on the requirements that will apply in terms of information and consent).

Samples taken outside of Sweden are not covered by the Swedish Biobank Act, but in order to use these samples in Swedish research projects, an approved ethical application in accordance with the Swedish Ethical Review Act and other regulations for research is required for the part of the research carried out in Sweden.

If samples taken outside of Sweden are to be sent for analysis to a laboratory in Sweden and the laboratory only performs the analysis without participating in the research in any other way, an ethical approval is not required.

How long samples may be stored abroad is not defined in the Swedish Biobank Act, as the need for how long a sample needs to be stored abroad differs for different research projects.  According to the Swedish Biobank Act, the biobank custodian at the principal responsible for samples must establish an agreement with the recipient, which regulates what applies to the samples that are sent. Please note that samples may only be sent for research projects that have an approved application for ethical review from the Swedish Ethical Review Authority or permit according to the applicable EU regulation for clinical trials and performance studies.

According to the Swedish Biobank Act, the principal of the biobank, in this case the CRO company, may decide to close the biobank. The principal is responsible for ensuring that the decision to close is reported to the Swedish Health and Social Care Inspectorate. The notification must include information about what has happened to samples in the biobank.

If samples are still available or needed, the biobank cannot be closed down outright. The biobank or sample collections in the biobank must first be transferred to another principal. In order for a principal to transfer a biobank to another principal, a permit from the Swedish Health and Social Care Inspectorate is required. The request must include the reasons for the transfer and information on who will take over the biobank.