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.
section 2 of this Act, the following definitions shall apply the following
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.
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
Man alive or deceased person or fetus.
Sample donor Living person from whom tissue sample has
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.
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
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
§ 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.
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
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).
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.
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
Inspectorate for health and long-term care is responsible for
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
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.
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
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
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.
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
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
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).
§ 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 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.
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
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).
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
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
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).
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,
-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.
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
-the mother's name, social security number and place of residence,
-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,
-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
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.
§ 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.
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).
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
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.
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).
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.
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.
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
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).