Law (2002:297) Om Biobanks In Health Care, Etc.

Original Language Title: Lag (2002:297) om biobanker i hälso- och sjukvården m.m.

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Chapter 1. General provisions



The purpose of the Act



paragraph 1 of this law regulates how human biological materials, with

respect for the individual's integrity, shall be collected

in, stored and used for certain purposes.



Definitions



section 2 of this Act, the following definitions shall apply the following

importance.



Indication Significance



BioBank biological material from one or more

people who collected and preserved until

or for a certain time and whose

origins can be traced back to the

people from which the material derives.



Board for

Research Ethics Board as referred to in the Act (SFS 2003:460) if

ethics review of research involving humans.



The head of a

BioBank Caregivers, research institution, or other

holding a biobank.



Health care activities covered by health

Medical Services Act (1982:763) or dental Act

(1985:125).



Man alive or deceased person or fetus.



Sample donor Living person from whom tissue sample has

been taken.



Caregivers natural or legal person who professionally

engaged in health care or a

laboratory receiving tissue samples from

caregivers and preserving samples in a biobank.



Tissue samples of biological material from humans.

Lag (2003:468).



Scope of application



paragraph 3 of the law applies to



1. a biobank created in Sweden in a provider's health

and health activities, regardless of the material of the BioBank

stored, and



2. tissue samples from such a biobank referred to under 1, which

disclosed to be stored and used in a different

health care providers, a unit for research or diagnosis, a

public research institution, a pharmaceutical company or a

other legal entity and which even after disclosure can

be attributed to the person or people from which they are derived.



The law shall apply mutatis mutandis to tissue samples taken

and collected for transplant purposes under the law

(1995:831) If transplantation etc.



The law does not apply to specimens that are routinely taken in

care for analysis and which are intended solely as a basis

for diagnosis and ongoing care and treatment of the sample donor and

are not stored for a longer period of time.



The relationship to the provisions of any other law



section 4 provisions of other laws which derogate from the provisions

This law shall apply with the exception that

the provisions of Chapter 5. If PKU registry shall prevail

above provisions in other laws.



Chapter 2. Establishment and conditions



The establishment



§ 1 a biobank, established by the decision of the care provider or by

different to what tissue samples from a biobank is disclosed in

compliance with the provisions of Chapter 1. 3 § 2. In the context

with the decision on the establishment of a biobank principal shall for

the BioBank also decide on the purposes for which

the BioBank will be used and who will be responsible

for the BioBank.



Permissible purpose



section 2 Except for care and treatment and other medical

purpose of a provider's operations, a biobank used

only for purposes relating to quality assurance, training,

research, clinical trials, development work or other

another equivalent activities.



Research and clinical trials



paragraph 3 Is intended to a biobank is to be used for purposes

for research or clinical trial may decision referred to in

paragraph 1 shall be taken only after review and approval by the Board of

research ethics. The BioBank may in such cases cannot be used for

purpose other than as previously decided without Board

approved this.



Upon examination and approval that this referred to apply what

provides for starting points for ethics trial in 7-11 § § the Act

(2003:460) concerning the ethical review of research involving humans. In

question about the processing procedure for examination and approval

and on appeal shall apply the provisions of paragraphs 24-33 and

36 and 37 of the same Act. Lag (2003:468).



Storage



4 § a biobank must be stored in such a way that

the tissue samples are not likely to be destroyed and unauthorized persons from

get access to them.



Notification



paragraph 5 of the decision on the establishment of a biobank will of the principal

be reported to the Inspectorate for health and social care. The notification shall

include information on



1. the purpose of the BioBank,



2. where the BioBank must be stored,



3. who will be responsible for the BioBank, and



4. what proportion of the BioBank referred to get.

The notification shall be made at the latest within one month of the decision to

establishment of the BioBank.



If the modification is done by any circumstance covered by a

earlier made the notification shall be notified to the supervisory authority for

health and social care within one month the change occurred.



Decision on tissue samples preserved in a biobank will

be made available to other than the principal must be notified

within one month of the decision. Law (2012:947).



Directory of biobanks



section 6 of the health and social care Inspectorate shall keep a

automated directory of biobanks. The register shall be used

for supervision, in research and in the production of statistics.



The register shall contain information on the conditions for the

There is a duty under section 5. It must not

include information about individual people from the test

been taken.



Inspectorate for health and long-term care is responsible for

the registry.



Government Announces rules on which authority may

have direct access to the data in the inspection for health and

care records. Law (2012:947).



The National Board is responsible for the registry.



Chapter 3. Consent and information



Sample donor



section 1 of the tissue samples, in cases other than those referred to in paragraph 2 are not

collected and preserved in a biobank without sample donor

informed of the purpose and of the purposes for which

the BioBank must be used, and then given his consent.



Minor



section 2 of the tissue samples from a minor may not be collected and preserved

in a biobank without the minor's guardian

informed of the purpose and of the purposes for which

the BioBank must be used, and then given his consent. Has

the minor reached such an age and maturity that he or

She can take a position on the issue is now been said to the

minor himself.



Foster



paragraph 3 of the tissue samples from the fetus may not be collected and retained in the

a biobank without the woman who carries or has carried the fetus

informed of the purpose and of the purposes for which

the BioBank must be used, and then given his consent. Has

the woman died, the foregoing instead her closest

relatives.



The deceased



4 section For tissue samples from the deceased owner of 3 and

4 § § the Act (1995:831) If transplantation, etc. and

autopsy Act (1995:832) apply.



New purpose



5 § tissue samples preserved in a biobank may not be used

for any purpose other than that covered by the previous information and

consent without the consent is informed and

consent to this new purpose.



Have the consent passed away in lieu of the

deceased's closest relatives shall have been informed of and after

reasonable reflection period is not opposed to the new purpose.



Referring to the new purpose research or clinical trial shall

the Research Ethics Board that approves the new purpose in

this connection also decide on which requirements shall apply in

information and consent for tissue samples in

the Bank shall be used for the new purpose. Lag (2003:468).



Withdrawal of consent



section 6 of The who provided consent to the use of a tissue sample

may at any time revoke his consent. Relates to revocation

all uses shall be immediately destroyed or tissue sample

made anonymous.



Documentation



Article 7 particulars concerning information and consent etc. According to §§ 1-6

shall be documented in an appropriate manner in the donor

medical report. Law (2008:358).



Chapter 4. Rules on disclosure of tissue samples, transfer

of Biobanks, etc.



Disclosure of tissue samples in a biobank



§ 1 the person responsible for the biobank, review applications for

to access the samples in the Bank but will hand over the question

to the principal.



2 § When tissue samples are to be stored and used

in another activity, as referred to in Chapter 1. 3 § 2 shall

the principal of the newly formed the BioBank take decisions under 2

Cape. § 1. Samples to be stored in such a biobank may not

be left on.



section 3 Of that tissue samples in a biobank, for

research purposes have to be disclosed to a recipient in another

country required that a Swedish research institution an application

the other. If this application is granted, shall, in relation to

the recipient is abroad be imposed as conditions of the samples

be returned or destroyed when no longer needed for the

purpose for which it was submitted.



Tissue samples in a biobank may not otherwise than as provided for in

the first subparagraph shall be disclosed to a recipient in another country.



De-identification and code keys



section 4 of the tissue samples that are disclosed shall, unless otherwise specifically

decided, be anonymous or encrypted.




Keys shall be kept in the health-care provider who decided to

collect and store tissue samples in a biobank. Code keys

shall be kept in a satisfactory manner.



An application to break a code to get access to

personal information about an individual sample donors shall be treated in

the order in which an application for access to samples in

a biobank.



4 a of a journal document within individual health care as

related to a particular patient should be disclosed at the request of the

access to encoded human biological material from the patient

According to § 1, if the patient consented to journal document

be disclosed. In the case of certain sensitive personal data, see

provisions in the personal data Act (1998:204). Law (2008:358).



Exception



§ 5 by way of derogation from paragraphs 1 to 3 may, with the consent of the concerned

individual sample donors,



-tissue samples in a biobank, which is designed for health and

treatment purposes is left to another health care provider within or

except the land of opinion or analysis,



-tissue samples in a biobank, which is used in a

research projects are submitted to a different unit for research in

or outside the country,



-tissue samples that have been disclosed to a company for clinical

review of medicines or medical devices and as

held by the company will be submitted for analysis to another unit within the

the company or to another company, with which the company has

agreed that analysis shall be performed, within or outside the

the country.



The samples must be encoded. They shall be returned or destroyed

When no longer needed for the purpose for which the

was left out.



Refusal to provide tissue samples, etc.



section 6, If the operator of a biobank in a public

healthcare provider refuses to give out samples in accordance with a

application, shall issue, at the request of the applicant submitted to

caregiver for a decision. The applicant shall be advised of their right

to request a review.



If an individual healthcare providers and the responsible for the BioBank

in the healthcare provider believes that the samples out of the Bank should not be left out

According to the application, shall issue with the healthcare provider's opinion

submitted to the Inspectorate for health and social care for review.

Law (2012:947).



6 a of the issues of disclosure of a document referred to in paragraph 4 (a)

be reviewed by the person responsible for the patient's record. Consider the

representative to the journal document or any part of it is not

should be released, he or she shall immediately with own opinion

submit the query to the Inspectorate for health and long-term care for

trial.



In the matter of the appeal of the Inspectorate for health and social care

decision referred to in the first subparagraph shall apply, mutatis mutandis, Chapter 6.

7-11 § § publicity and secrecy (2009:400).

Law (2012:947).



Transfer of tissue samples in a biobank



section 7 to a biobank or parts of it shall be transferred

a permit is required by the Inspectorate for health and social care. Condition

may be given only if there are special reasons.



A biobank or parts of it, may not be transferred to a

recipients in another country. Law (2012:947).



Position with tissue samples for profit



8 § tissue samples or pieces of tissue samples stored in

a biobank may not be transferred or disclosed for profit.



Conditions for laying down a biobank



§ 9 Inspectorate for health and social care, after notification from

caregiver or principal may decide to biobank will

be closed and that the tissue samples to be destroyed, if

the material is no longer relevant to the purposes under 2

Cape. 2 § and from public does not see reasons to

preserve the samples.



The operator of a biobank, which is made up of tissue samples

at the mercy of a provider's biobank, may, however, decide to

the Bank should be closed and that the samples will be returned to

caregiver or be destroyed when no longer needed for the

purpose for which it was submitted. Law (2012:947).



Disclosure of personal information



section 10 If a sample donors personal information be disclosed while

a coded tissue sample from the latter, they shall be disclosed in a

such a way that the data can not be linked to

tissue sample.



section 11 of The health care provider shall provide personal information for inclusion in the

a register is kept in the margins of a biobank in a

other health care providers. However, such obligation exists only if the

the data subject or the person referred to in Chapter 3. 2-4 paragraphs may submit

consent, have been informed and expressly consented to

the disclosure.



Chapter 5. BioBank samples from newborns



Scope of application



section 1 of the health care providers that the Government may, for the purposes

specified in section 2 of the receive, collect, store, record, analyze,

and otherwise dispose of tissue samples from newborns

in a special biobank (PKU BioBank).



Purpose



section 2 of the tissue samples of PKU BioBank may only be used for



-analyses and other studies to track and

diagnose metabolic diseases,



-Retrospective diagnosis of other diseases in individual children,



-epidemiological studies,



-monitoring, evaluation and quality assurance of

activities, as well as



-clinical research and development.



2 (a) repealed by laws (2005:1).



Obligation to supply samples



section 3 of a health care provider is required to in compliance with Chapter 3. section 2 of the

disclose such samples as referred to in article 1, for analysis and storage

in the PKU BioBank.



Register



section 4 of the health care provider referred to in paragraph 1, with the help of automated

treatment or other treatment of personal information, keep a

special register for screening samples from newborn babies for

some metabolic disorders (PKU-register).



The health care provider is responsible for the registry.



paragraph 5 of the PKU-register may be used only for the purposes specified

in section 2, as well as for the production of statistics.



6 § for each sample donors will receive only the following tasks

recorded:



-the mother's name, social security number and place of residence,



-the length,



-the child's date of birth and gender, as well as by multiple pregnancies, ordinals,



-the unit within the health care system who have taken the test,



-diagnosis,



-information on the treatment of diagnosed diseases, and



consent from the child's guardian.



paragraph 7 of a health care provider is required to provide information under section 6 of the

the PKU-register when tissue samples taken on a newborn baby

and the child's guardians have explicitly consented to

the handover.



Before the custodian submits his or her consent, he or she shall

have been informed of the particulars to be recorded and if

the purpose of registration.



Chapter 6. Oversight and appeals, etc.



Penalties



§ 1 to fine person who, intentionally or negligently:



(a)) uses a biobank in violation of Chapter 2. section 2,



b) storing tissue samples in a biobank in violation of Chapter 2. paragraph 4,



c) establishment of a biobank without making a notification under Chapter 2.

section 5,



d) does not provide information and obtain consent referred to in Chapter 3. 1-3

and 5 sections,



e) does not destroy or de-identify tissue samples under 3

Cape. section 6,



f) leaves out tissue samples in violation of Chapter 4. section 2,



g) leaves out the tissue samples in violation of Chapter 4. section 3,



h) surrendering a biobank in violation of Chapter 4. section 7,



in) using the tissue samples in violation of Chapter 5, section 2,



j) don't leave tissue samples in accordance with Chapter 5. section 3.



In Chapter 8. section 6 of the Act (2006:351) about genetic privacy, etc

provisions for the punishment of those who profit transfers

biological material. Law (2006:356).



Damages etc.



section 2 of the principal for the BioBank will replace a single

test sensor for damage or violation of the personal

integrity as a process of tissue samples in violation of

This Act has caused him or her.



Liability, to the extent that it is reasonable

be adjusted, if the principal of the Bank shows that the error is not attributed

on him or her.



The provisions of the personal data Act (1998:204) for correction and

damages applies to the processing of personal data in accordance with

This law or regulations issued pursuant

the law.



Supervision



section 3 of the health and social care Inspectorate supervises the

This Act and the regulations that have been issued in connection with

the law is followed. The authority is the supervisory authority in accordance with

personal data Act (1998:204), however, exerts supervision over the

processing of personal data.



The exercising supervision is required

that on Inspection for health and social care request issue

documents, samples and other material related to the business

and to provide the information about the activities that

the inspection needs for its supervision.



Inspectorate for health care may submit to the

conducts activities to disclose what is being requested. A decision

If the injunction may be subject to a penalty. Law (2012:947).



section 4 of the Inspectorate for health care or

inspection ordains is right to inspect the activities of

regulated under this Act.



The person who performs the inspection has the right to have access to

areas, rooms, and other spaces used for

operations, but not homes, and that the temporary

dispose of documents, samples and other material relating to the

the business. Inspectorate for health and long-term care may also make

examinations and taking samples.



The one whose business is inspected is obliged to provide the help

necessary for the inspection. Law (2012:947).



paragraph 5 of the person doing the inspection has the right to have the assistance of

Police needed to inspection to

implemented. Law (2014:762).



section 6, if the Inspectorate for health care becomes aware that


someone has violated a rule which applies to activities that

under supervision according to this law, shall

Inspectorate take action to win redress. If the

required to notify the Inspectorate of prosecution.

Law (2012:947).



Appeal, etc.



paragraph 7 of the Decision pursuant to Chapter 4. section 6 of the first paragraph may be appealed

to the Inspectorate for health and social care. Authority's decision

According to Chapter 4. section 6 may not be appealed.



Inspectorate for health care decisions may be appealed

to the General Administrative Court.



Another Government decision on rectification and dismissing the

request for information under section 26 of the personal data Act

(1998:204) may be appealed to the administrative court.



Leave to appeal is required for an appeal to the administrative court.

Decision taken by the Inspectorate for health care or public

Administrative Court will notify under this Act applies

immediately, unless otherwise specified in the decision. Law (2012:947).



Appropriations



section 8 Government or authority the Government may

announce details relating to the



times for preservation of tissue samples in biobanks, and



-the transfer and abandonment of biobanks.



Transitional provisions



2002:297



1. this law shall enter into force on 1 January 2003.



2. A biobank instituted before the Act comes into force shall,

If it must be kept, be notified to the National Board of health within two years

from its entry into force. A notification shall form the basis

for registration in the register of the National Board of health and welfare.



3. The law shall apply to tissue samples collected in a

BioBank before its entry into force with the samples for measures

or after its entry into force BioBank. A principal who

before the expiry of the time limit referred to in paragraph 2 would wind up a vid

its entry into force, existing biobank will be able to make

this without complying with the provisions of Chapter 4. § 9.



2012:947



1. this law shall enter into force on 1 June 2013.



2. for the purposes of the administrative judicial procedure Act, section 7 a

(1971:291), the Inspectorate for health care be the

individual counterparty, if the inspection after the entry into force is

jurisdiction to deal with the kind of question that is the subject of

trial.



3. For the offences referred to in Chapter 6. Article 1, first paragraph (c) and (h)

and that was committed before the entry into force applies Chapter 2. paragraph 5 and

Chapter 4. paragraph 7 of its older version. Team (2013:274).

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