News : Swedish government published a Report (SOU 2010:81) entitled "A new Biobanks Act"
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A new Biobanks Act
The Swedish Ministry of Health and Social Affairs published a Report entitled "A new Biobank Act", "En ny biobankslag", formulating proposals for amending the actual Biobanks in Medical Care Act (2002:297).
The inquiry proposes a new biobank act concerning the collection and storage of human biological materials (tissue samples). The purpose of the current Biobanks in Medical Care Act remains unchanged. The act shall regulate how the tissue samples may be collected, stored and used for certain purposes (including research and cross-border exchanges of samples and data), with respect for the individual integrity and privacy.
The proposed new biobanks act differs from the current act primarily in the following ways:
The proposal extends the scope of the act. The current law applies only to tissue samples from health care, while the bill includes samples from other activities.
Under the present act, the consent of the donor to the collection and preservation of tissue samples must be obtained for all types of samples. Under the proposed act, tissues should be collected and maintained for the donor's care and treatment and some related purposes so long as the sample donor does not object to it. The donor must be duly informed and retains his/her right to self-determination. When there is no question about care and treatment, as for scientific research, the express consent is required.
The report proposes regulations on traceability. Tissue samples from the healthcare services should be registered in the Swedish Biobank Registry. Other samples should be at least registered within the biobank with the same documentation than in Swedish Biobank Rgistry. It should be possible for the registered individual to object to information about a tissue sample recorded in the Swedish Biobank Registry.
The commission proposes further regulation of biobank 's personal data processing, which is not contained in the current act. The regulation of the personal data processing by biobanks would clarifies the responsibility of personal data, the purposes for which personal data may be processed and which personal data may be processed. Moreover, it is proposed that a right to oppose the processing of the data is given to the data subject. Links with the existing Personal Data Act (1998:204) are suggested. Finally, the inquiry proposed rules on international transfers security.
The proposed act provides less formal but explicit requirements for the release of tissue samples from biobanks. The present restrictions as to which samples may be released should be abolished. Prior to the release of the tissue samples, the releasing biobank should be required to set certain conditions for a recipient that is not a biobank according to the Biobanks Act in terms of documentation, traceability and samples retrieval on request from the releasing biobank, individual rights. The proposed new requirements include that the traceability and the donors' right to self-determination are to be maintained even after a sample is released.
The inquiry suggests that, in some cases, tissue samples could be released from a biobank for the identification of deceased persons and the investigation of paternity or parenthoodpursuant to Chapter 1. 9 § Parental Code.
- The proposal includes a ban on the use of tissue samples from biobanks covered by the Biobank Act for criminal investigation purposes.
The entire Report is only available in Swedish. A Summary is provided in English.
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