An important point of departure in the framing of this proposal has been the Council of Europe Convention on Human Rights and Biomedicine. Sweden is a signatory of the Convention but has not yet ratified it. The Convention contains several articles and principles with a direct bearing on the way in which the human biological material in biobanks is to be handled. The National Board of Health and Welfare has endeavoured to bring its proposals as closely into line with the Convention as possible. The term biobank denotes tissue specimens which have been taken from human beings, which are collected and preserved for an indefinite or a definite period for a certain specified purpose and whose origin is traceable.
Human beings are persons both living and dead, as well as embryos.
The purposes for which the material in a biobank is used are care and treatment or other medical activity, quality assurance, training, research, clinical tests and development. Other purposes are also possible and shall be defined when the bank is established. Only biobanks established by care providers, in both public and private practice, come under the provisions of the Act. Specimens originating from public or private care but actually stored at a research institution or the equivalent are also included. The Act also applies when specimens from biobanks in medical care are made available by the care provider for some other purpose and stored in a newly formed biobank.