The Law On Behandlingsbiobanker (Behandlingsbiobankloven)

Original Language Title: Lov om behandlingsbiobanker (behandlingsbiobankloven)

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Read the untranslated law here: https://lovdata.no/dokument/NL/lov/2003-02-21-12

The law on behandlingsbiobanker (behandlingsbiobankloven).

Date law-2003-02-21-12 Department health and Human Services Department Recently changed law-2015-06-19-65 from 01.10.2015 published in 2003 booklet 3 entry into force 01.07.2003 Change Announced short title Behandlingsbiobankloven-biobl.

Chapter overview: Chapter 1. The Act's purpose, definitions and scope (§§ 1-3) Chapter 2. Message and organization of biobanks (§ § 4-10) Chapter 3. Information and consent (§ § 11-15) Chapter 4. Different provisions (sections 16-19) Chapter 5. Ikraftsetting, the transitional provision, changes in other laws (sections 20 to 22) Act title amended by law of June 20, 2008 # 44 (ikr. 1 July 2009 68. res. 26 June 2009 No. 865). -See law 20 June 2008 No. 44 chapter. 6. Chapter 1. The Act's purpose, definitions and scope section 1. Purpose The purpose is to ensure that the collection, storage, treatment and destruction of material that are included in a biobank taken on an ethical way, and that biobanks utilized to the individual's and society's best. This shall come to pass in accordance with basic privacy considerations, principles of respect for human dignity, human rights and personal integrity, and without discrimination of people that the biological material derived from.
The law should facilitate that the material in the biobanken can be used for health purposes, including diagnosis, treatment and teaching on a ethical way.

§ 2. Definitions with diagnostic biobank and behandlingsbiobank be understood in this law a collection of human biological material that are the responsibility of the medical examination, diagnosis and treatment.
With human biological material is understood in this law organs, parts of organs, cells and tissues and constituents of such material from living and dead people.
With donor understood in this law a person who emits the biological material to a diagnostic biobank or behandlingsbiobank.

§ 3. The scope of the Act applies to the collection, storage, treatment and destruction of human biological material and information that are included in a biobank, as well as the Organization of this business.
Unless otherwise provided by this Act, to health and personal information that is derived from human biological material is processed after the personal data Act, health registry law, helsepersonelloven and any other legislation that especially regulates the protection of personal data.
Biological material in connection with the uttas examination, diagnosis and treatment, and that destroyed after a short time, are not covered by the law.
The law does not apply to human biological material and health and personal information derived from human biological material that are applied or to be applied in research. For the collection, storage, treatment and destruction of human biological material and information in the research context comes to health research the law.
The law applies on Svalbard and Jan Mayen Islands to the extent that the King decides. The King can establish closer attention to the rules under local conditions, including rules that the derogation from the provisions of this law.

Chapter 2. Message and organization of biobanks section 4. (Repealed by law 20 June 2008 No. 44 (ikr. 1 July 2009 68. res. 26 June 2009 No. 865).)

§ 5. Message about the creation of biobanks behandlingsbiobanker diagnostic and Biobanks that are created in connection with diagnosis and treatment shall be reported to the Ministry. The message must be sent Department within 2 months after that biobanken was created. The message will contain information about the 1.
the purpose of the creation, 2.
What kind of material it should contain and how the material collected, 3.
which and how many people the material is obtained or to be obtained from, 4.
How consent should be obtained and what information is provided in advance, 5.
biobankens duration and what should happen with the material upon termination of biobanken, 6.
which security measures that are related to the biobankvirksomheten, 7.
who is the person in charge pursuant to section 7 and the data processing responsible or management responsible for Health Registry Act and the personal data Act and 8.
financing of biobanken and whether or not the material in biobanken may give rise to financial gain.

If material from a biobank created for diagnosis and treatment should be applied to research, apply the provisions of the health research Act.

section 6. Biobankregisteret the Ministry has the responsibility to lead a register of enrolled biobanks. The register shall be publicly available.

section 7. The person in charge Each biobank is going to have a person in charge-person with medical or biological education of higher degree. If biobanken contains information that can be linked to individuals, it will also have a management responsible for Health Registry law or the personal data Act. The managers shall appoint the person in charge. The Ministry may decide that certain biobanks in addition to the person in charge-person shall have a Board of Directors.
The person in charge and the Board shall ensure that the biobanken are created and managed in accordance with this and other law.
The Ministry may by regulation establish further rules for which biobanks that will have a Board of Directors, the Board's tasks and composition, etc.

section 8. Termination or closure of the biobank The who want to shut down a biobank or who want to destroy the material in a biobank in whole or in part, to send the message to the Ministry about this, or follow in advance specific and enrolled procedures for such closure or destruction.
Of the message to the State "or how the Bank destruksjonen of the material is going to happen.
If the Ministry within 45 days after such a message is received have not come with objections or asked for additional information, biobanken can partially or completely down or destroyed in accordance with the message. If the Ministry finds that biobanken because of their content should not be down or destroyed, the Ministry can decide that the biobanken still to be kept, or that it should be transferred to another biobank. The Ministry will then need to take over the economic responsibility and make sure that biobanken are taken care of and managed in line with this law.

§ 9. Requirements for storage Material in biobanks should be kept securely and in accordance with the rules provided in law or pursuant to law. Storage should be made in respect of the donor of the material.
The Ministry may by regulations provide further rules on how human biological material and data in a biobank to be kept.

§ 10. Transfer to abroad A biobank or part of a biobank can only be sent out of the country after approval from the Ministry, and in accordance with the consent of the donor of the material. The Ministry can set criteria that materials be destroyed or sent back after use.
The requirement of the Ministry's approval does not apply if the transfer to foreign countries happens in connection with the performance of the health care to individuals.
The Ministry may by regulation make exceptions from the requirement for approval from the Ministry for the transfer of samples and information that is part of the general international cooperation.

Chapter 3. Information and consent section 11. The consent provision for diagnostic biobanks and behandlingsbiobanker consent to health care for patient and user rights the law § § 4-1 and 4-2 also includes the collection, storage and treatment of human biological material, including the use of the materials for prevention, quality control and method development.
For people without consent skills by patient and user rights the law § 4-3, the patient and user rights the law § § 4-4 to 4-81 for consent on behalf of the other accordingly.

§ 12. (Repealed by law 20 June 2008 No. 44 (ikr. 1 July 2009 68. res. 26 June 2009 No. 865).)

section 13. Modified, expanded or new use Of modified, expanded or new use of previously collected material in a biobank created for diagnosis and treatment, the new volunteer, the express and informed consent be obtained unless otherwise follows from the law on medical and health professional research.

section 14. Revocation of consent the one who has given consent under section section 11 and 13, may at any time revoke such consent.
If consent is revoked, may the one who has given consent, require that the biological material be destroyed.
The access to the right to revoke consent or demand destruction, deletion or extradition after the first or second paragraph, does not apply if the material or information is made anonymous, if the material for derivative works are included in another biological product, or if the information has already entered into in scientific works. The access to the destruction also does not apply if it is established by law, that the material or information should be kept.

section 15. Other people's access to material in a biobank If there is consent from the donor in accordance with sections 11 and 13, the other will be given access to the biological material in the biobanken or specific parts of the material. Access can happen in that the material in question is provided by the responsible, in that the material utlånes or by the material or parts of it are available. The requesting access, to give an account for what purpose the material is thought exploited to, how and for how long the material will be processed, and whether the material will be destroyed, deleted, or relinquished when the planned use is finished.
By the assessment of whether it should be given access to the material after the first paragraph, the emphasis is on whether access will significantly impede or umuliggjøre own concern of statutory duties pertaining to the storage and processing of the material, the material's concern of the interests of the giver and the concern of their own and, optionally, other people's treatment of the material. If the donor has already opposed such access, it should be respected.

Access to personal identifiable material can only be provided if the recipient has permission to manage it according to the health registry law or the personal data Act.
Payment may be required for the costs associated with providing others access to material in a biobank for this paragraph.
If the person responsible for biobanken decline the request for access, the decision can be appealed to the Ministry. The Ministry's decision cannot be appealed.
The King of the regulations can determine that disclosure of human biological material to the prosecution authority or Court completely exceptional cases can happen if very weighty private or public interests do so rightfully.

Chapter 4. Different provisions § 16. Confidentiality Helsepersonellovens provisions on confidentiality applies to anyone who creates, store, use, or otherwise manages or works at a biobank.

§ 17. Supervision the State health supervision will be in accordance with the health supervision oversee that the regulations are observed.
The data Inspectorate shall supervise that treatment of the health and personal information derived from the material in a biobank happens in accordance with the personal data Act and the Health Act registry.

§ 18. Sanctions the Ministry may issue an order or stop the further operation of Biobanks, which is operated in contravention of this Act or where the operation goes beyond what is reported to the Department under section 5. The Ministry may take over the further progress or require biobanken down.
With fines or imprisonment up to one year, or both be punished it as intentional or grossly negligent collects, stores, treats or destruct material that is part of a biobank in violation of this law.

§ 19. Compensation and insurance The managers and the person in charge under section 7 to replace the damage that is occurring as a result of that business is driven in violation of the provisions of, or in pursuance of this Act, unless it can will be made that the damage is not due to error or neglect on their page. The replacement should respond to the financial loss which the claimant has suffered as a result of violation of the provisions of this law. The managers and the person in charge can also be ordered to pay such compensation for non-economic nature (redress) that seems reasonable.
For private biobankvirksomhet the insurance be set security for the financial responsibility that may occur after the first paragraph.
The Ministry may by regulation provide further provisions on the obligation of insurance.

Chapter 5. Ikraftsetting, the transitional provision, changes in other laws section 20. Ikraftsetting Law is valid from the time the King decides. 1 the King can put into effect the individual provisions to different time.

§ 21. Transitional provision For activities covered by this law, and that is already in progress when the law takes effect, it shall be sent message to the Ministry with information as mentioned in section 4 subsection no. 1-8 within two years after the entry into force of the law.

§ 22. Changes in other laws-