Law On Human Medical Use Of Biotechnology And More. (Biotechnology Law)

Original Language Title: Lov om humanmedisinsk bruk av bioteknologi m.m. (bioteknologiloven)

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Read the untranslated law here: https://lovdata.no/dokument/NL/lov/2003-12-05-100

Law on human medical use of biotechnology and more. (biotechnology law).

Date law-2003-12-05-100 Ministry health and Human Services Department Recently changed law-2015-05-07-26 from 01.01.2016, law-2015-06-19-65 from 01.10.2015 published in 2003 booklet 16 entry into force 01.01.2004, 01.09.2004, 01.01.2005 Change LAW-1994-08-05-56 Announced short title Biotechnology Law-biotl.

Chapter overview: Chapter 1. Purpose and scope (§ § 1-1-1-2) Chapter 2. Assisted reproductive technology (§ § 2-1-2-19) Chapter 2A. Preimplantasjonsdiagnostikk, and more (§ § 2A-1 2A-9) Chapter 3. Research on redundant embryos, cloning, and more (§ § 3-1-3-6) Chapter 4. Foster Diagnostics (§ § 4-1-4-6) Chapter 4A. The use of fetal tissue (§ § 4A-1 4A-8) Chapter 5. Genetic research of gave birth to and more (§ § 5-1-5-9), Chapter 6. Gene therapy (§ § 6-1-6-4) Chapter 7. General provisions (§ § 7-1-7-7) cf. previous laws 5 aug 1994 no. 56, 12 June 1987 No. 68. Chapter 1. Purpose and scope section 1-1. The purpose the purpose of this law is to ensure that the medical use of biotechnology is being exploited for the benefit of people in a society in which there is room for all. This should be made in accordance with the principles of respect for human dignity, human rights and personal integrity and without discrimination on the basis of the inheritance system based on the ethical norms embodied in our Western heritage.

§ 1-2. The scope of the law applies to human medical use of biotechnology and more. and include assisted reproductive technology, research on embryos and cloning, fetal Diagnostics, genetic studies of gave birth to and gene therapy, and more. The law does not apply to research who don't have diagnostic or treatment consequences for the participant or where information about the individual not be restored to that person. Exempt from this are the provisions in the chapter. 3. The law does not apply to the autopsy that fall under the law 7. may 2015 Nr. 26 about the autopsy and avgjeving of equal to the teaching and research or law 22. May 1981 No. 25 of the rules of procedure the way in criminal matters section 228 if an expert like survey.
The law applicable in the Kingdom. The King may by regulation determine that the law totally or partially to apply to Svalbard and Jan Mayen.

Chapter 2. Assisted reproductive technology section 2-1. Definitions in this law be understood with: a) assisted insemination: insemination and fertilization outside the body;

b) insemination: the introduction of semen in the woman in any other way than by sexual intercourse;

c) fertilization outside the body: fertilization of the egg outside the woman's body.

section 2-2. Requirements for divorce form assisted reproductive technology can only be performed on women who are married or who are roommates in ekteskapsliknende conditions.

§ 2-3. Criteria for insemination artificial insemination can take place when the man is befruktnings inefficient or even have or is the carrier of serious hereditary disease, or when two women are married or is cohabiting in ekteskapsliknende conditions.
Insemination can also take place when the man or woman is infection before the end with a serious and chronic sexually transmitted infection.
Insemination can take place in a particular case if the woman is the bearer of serious hereditary sex bound disease, jf. section 2-13.

§ 2-4. Terms of fertilization outside the body outside the body can only Fertilization take place if a woman or a man is befruktnings inefficient or by inexplicable inability to befruktnings.

section 2-5. Information and consent the couple to be given information about the treatment and if the medical and legal effects the treatment can get. The information should also include information about the adoption.
Before the treatment begins, the treating physician make sure that there is written consent from the woman and her spouse or partner. By repeated treatments to new consent be obtained. Only people over 18 years of age who is not deprived of legal capacity on the personal site, can give such consent.

§ 2-6. Decision about treatment decision to make treatment with the aim of assisted reproductive technology get together by the doctor. The decision to build on medical and psychosocial assessments of the pair. It should be added weight on the couple's omsorgsevne and the consideration of child's best interests.
The doctor may collect the information that is required, to make an overall assessment of the couple.

section 2-7. The child's right to information about The sperm donors who are born after assisted conception using donor sperm has at the age of 18 years the right to obtain information about the identity of the sperm donor. A donor registry shall assist the child with this.

section 2-8. Donor registry the Ministry is to create the registry for the registration of seed givers, so that the identity of the child's right under section 2-7 can be met.

section 2-9. Sperm donors should be A sperm donors over the age of 18 and not deprived of legal capacity on your personal site. The dealer must give written consent to that semen can be used for fertilization and that his identity is recorded in the donor registry. Consent can be revoked until the fertilisation has taken place.
A sperm donors should not be given information about the couple's or the child's identity.

section 2-10. The selection of sperm donors attending physician to choose suitable sperm donors. The business that performs the assisted fertilisation shall ensure that the necessary information about the treatment is recorded and filed.

section 2-11. Storage and import of sperm storage and import of semen can only take place at the businesses that are approved for this.
Businesses that store donor sperm, shall ensure that the information on the donor's identity and registered seed be reported to a donor registry.
Semen shall not be released for use in assisted conception after givers dead.

section 2-12. Regulations the Ministry may by regulation provide further rules on organization of sperm banks, the use of donor sperm as well as registration and message of information about sperm donors.

section 2-13. The treatment of sperm before fertilization Treatment of sperm before fertilization in order to influence the choice of the child's gender is allowed only if the woman is the bearer of serious hereditary sex bound disease.

section 2-14. Training and quality assurance Unfertilised egg that is brought out in connection with the fertilization outside the body, but that is not suitable for this purpose, can be applied to training and quality assurance of established methods of assisted reproductive technology. The eggs will be destroyed after finishing the experiment.
Made redundant fertilized eggs can be applied to training and quality assurance of established methods of assisted reproductive technology and preimplantasjonsdiagnostikk. The terms and conditions for research on embryos made redundant in section 3-2 other, third and fourth paragraph applies accordingly.
Unfertilised and fertilized eggs as mentioned in the first and second paragraph can only be applied to training and quality assurance after voluntarily, expressly and informed consent from the couple who receive fertility treatment. Optionally, the express and informed consent should also be sought from sperm donors if it used donor sperm.

§ 2-15. The application and the return of fertilized egg Fertilized eggs can not inserted in the uterus of another woman than the woman the egg cell originates.
The Ministry may give further regulations on the return of fertilized eggs in a woman's body by fertilization outside the body.

section 2-16. Storage of fertilized eggs Only businesses that are approved under section 7-1 to perform assisted reproductive technology, after authentication store fertilized eggs.
After five years to be fertilized eggs destroyed or made to the training and quality assurance. section 2-14 or research cf. Chapter 3.
Stored fertilized eggs should not be used for reproduction when the woman or the man in the couple who have sought assisted reproductive technology, is dead or no longer have the consent expertise.

section 2-17. Storage of Unfertilised egg and ovary tissues Only businesses that are approved under section 7-1 to perform assisted reproductive technology, after approval and Unfertilised Eggs save the egg stick tissues.
Unfertilised Eggs and ovarian tissue can be saved only when the criteria for assisted reproductive technology are met, or if a woman to undergo treatment that may damage the childbearing device.
Saved Unfertilised egg and saved the ovary tissue can only be kept for as long as the consideration to the woman who has given the material, suggests it and it can be considered medically safe.
By the woman's death to be stored and saved the Unfertilised egg ovary tissue destruction.

section 2-18. The ban on egg donation and transplantation of organs and tissues that produce sex cells the donation of eggs or parts of this from a woman to another is prohibited.
Transplantation of organs and tissues that produce sex cells from one person to another with the purpose of treating infertility are prohibited.

section 2-19. Approval of therapies and therapies that fall under section 2-1, storage and import of semen jf. section 2-11, techniques for the treatment of sperm jf. section 2-13, as well as the storage of fertilized eggs and Unfertilised egg and ovary tissues jf. § § 2-16 and 2-17, to be approved by the Ministry, and can only be taken in use or is made by businesses approved according to section 7-1.
Before the Ministry decides whether authorization is to be given, to the application be submitted to the Biotechnology Council.

Chapter 2A. Preimplantasjonsdiagnostikk, and more.

§ 2A-1. Genetic examination of the fertilized eggs with preimplantasjonsdiagnostikk will mean a genetic survey of the fertilized egg outside the body before insertion into the uterus, including the examination of gender.
Preimplantasjonsdiagnostikk can only offered few where one or both are carriers of serious hereditary disease or chromosomal monogen and there is great danger that the disease can be transferred to an upcoming child.
Preimplantasjonsdiagnostikk can also be performed to investigate the vevstype with the aim of getting a tissue type of the same children who may be stem cell donor for a sibling with severe, hereditary disease.
Preimplantasjonsdiagnostikk should not be used to map or choose the other properties on the fertilized egg, than that stated in the paragraph here.
Fertilized eggs that come, not genetically modified.


§ 2A-2. Consent before preimplantasjonsdiagnostikk is made, the couple seeking treatment, give written, informed consent.

§ 2A-3. And genetic information before applying for guidance preimplantasjonsdiagnostikk be presented to the Tribunal. section 2A-4, should the couple receive neutral information and genetic counseling, including information about the risks associated with the treatment, the load of the woman and the probability of success with the treatment.

section 2A-4. Processing of applications for preimplantasjonsdiagnostikk Preimplantasjonsdiagnostikk as mentioned in section 2A-1 can only be performed after the permission of a Tribunal that the Ministry shall appoint. The Committee's decision may not be appealed.
In its assessment of whether it should be granted permission to the preimplantasjonsdiagnostikk, the Committee shall take a position to whether there is great danger for the transfer of serious hereditary disease or chromosomal monogen. Disease severity must be assessed specifically in the individual case, based on the criteria that the reduced lifespan, which pains and strains the disease brings with it and the soothing or life-prolonging treatment possibilities that exist.
If in addition to rule out severe, hereditary disease as mentioned in the second paragraph are applicable to investigate the fertilized eggs vevstype, the Committee can only give permission if the following conditions are met: a) treatment with søskendonasjon of fresh, forlikelige stem cells with great probability is suitable to cure a sick sibling b) consideration for the sick child is assessed against the pressures for a future siblings c) donor born after preimplantasjonsdiagnostikk with tissue typing is not subjected to unacceptable interference.

The Tribunal must consider whether the expected costs related to preimplantasjonsdiagnostikk's in a reasonable relation to the effect of the treatment.
The King may by regulation provide closer provisions on the Committee's organization, composition and case management.

§ 2A-5. Reporting the Committee shall submit an annual report to the Ministry of nemndbehandlede cases, including the number of cases, what diseases cases concerned, the outcome of the proceedings and the Tribunal's reasons to refuse or grant application.

§ 2A-6. Treatment abroad if the Committee finds that the preimplantasjonsdiagnostikk will be offered, and treatment cannot be performed securely in Norway after accepted methods, to the service to be purchased abroad. This applies regardless of whether the terms of the patient and user rights the law § 2-1 b fifth paragraph is met.
The Committee determines the institution abroad the couple can get treatment. The decision to build on the knowledge of proper documented professional practice and extensive experience of the institution.

§ 2A-7. General conditions of assisted reproductive technology the common policies for fertilization outside the body in Chapter 2 of the law here also apply to couples seeking preimplantasjonsdiagnostikk. The requirement for befruktnings inability to in section 2-4 does not apply.

§ 2A-8. Approval and reporting duty Preimplantasjonsdiagnostikk can only take place at the business that is approved by the Ministry to carry out such treatment. The Ministry may in the decision put closer to the criteria for validation.
Business that is approved under subsection, shall submit written report to the Ministry about the business. The Ministry sets out closer to the rules on reporting.

§ 2A-9. The Court trial Chapter 3. Research on redundant embryos, cloning, and more.

§ 3-1. The use of redundant embryos to research made redundant embryos and cells derived from embryos made redundant, can only be applied to research when the purpose is: 1. to develop and improve methods and techniques of fertilization outside the body for the purpose of achieving pregnancy 2.
to develop and improve methods and techniques for the genetic examination of embryos with a view to determine if there are serious hereditary disease or chromosomal monogen (preimplantasjonsdiagnostikk) 3.
to achieve new knowledge with the aim of future treatment of serious illness in humans.

section 3-2. Terms of use of redundant fertilized eggs to research research as mentioned in section 3-1 is only allowed on fertilized eggs that have been made redundant after fertilization outside the body with the aim of fertility treatment or preimplantasjonsdiagnostikk. It is not allowed to fertilize eggs for research purposes alone.
Research on fertilized eggs must not be made later than 14 days after the egg was fertilized. The time embryos are stored in Cryo, is excluded.
Fertilized eggs that have been the subject of research must not be inserted in a woman, but shall be destroyed.
Research that involves genetic changes that can go in the inheritance in humans, is not allowed.

section 3-3. Ethical review and approval of research, including clinical research, which involves the use of redundant embryos and cells derived from embryos made redundant, to be approved by the regional Committee for medical and health professional research ethics.
Therapies which require the use of cells from embryos made redundant, to be approved by the Ministry. The Ministry may in the approval decision set closer to the criteria.
Before the Ministry decides on the approval after the second paragraph is to be given, to the application be submitted to the Biotechnology Council.

section 3-4. Information and consent made redundant embryos can only be applied to research and treatment after voluntarily, expressly and informed consent from the couple who receive assisted reproductive technology. Before consent given off, should the couple receive information about what research may involve, how it is being done and other relevant information.
If the fertilization is made with donor sperm, sperm donor will also submit voluntarily, expressly and informed consent. Sperm donor's consent should be sought in connection with the donation.
Consent may be withdrawn in accordance with the rules of biobankloven section 14.

§ 3-5. Ban on the creation of human embryos by cloning and more. It is forbidden: a) to portray human embryos by cloning, b) to conduct research on human embryos and cell lines are grown out from human embryos produced by cloning, and c) to produce embryos by cloning, that inherit material from human is inserted into an egg cell from the animal.

With cloning we mean techniques to portray arvemessig as copies.

§ 3-6. Ban on the use of techniques with a view to portray arvemessig as individuals use of techniques with a view to portray arvemessig as individuals is prohibited.

Chapter 4. Foster Diagnostics section 4-1. Definition with the foster law understood in this diagnostic examination of føtale cells, foster or a pregnant woman with the purpose to get information about fetal genetic traits or to prove or rule out disease or development abnormalities with the fetus.
Ultrasound investigations in the General maternity care are not considered foster according to the Diagnostics the first paragraph, and are therefore not of this law with the exception of section 4-5.

§ 4-2. The approval of the Research methods that foster Diagnostics fall under section 4-1 the first paragraph, shall be approved by the Ministry.
Before the Ministry decides whether authorization is to be given, to the application be submitted to the Biotechnology Council.

section 4-3. Consent before foster Diagnostics, jf. § 4-1 is made, the person who should be investigated, give written consent.

§ 4-4. Information and genetic guidance By foster Diagnostics to the woman or the couple before the survey is given information that shall include, among other things that the survey is voluntary, the risk associated with the implementation of the survey, what the survey may reveal and what consequences this may have for the child, the woman, the couple and the family. If there is suspicion of genetic disease to the woman or the couple also be given genetic guidance.
If the study shows that the fetus may have a disease or a development variance, to the woman or the couple be given information and guidance on the appropriate genetic disease or disability, as well as about the current rights and appropriate help measures.

§ 4-5. Enlightenment about sex before 12. gestational week information on fetal gender before 12. weeks gestation as arising by foster or other Diagnostics examination of the fetus, should only be given if the woman carries serious gender bound disease.

section 4-6. Paternity testing in utero Fetal Diagnostics with a view to determine paternity and paternity testing in utero is prohibited. This does not apply when the pregnancy can be the result of circumstances as referred to in the Penal Code § § 291, 295, 296, 299 letter a, 302, 312, 313 and 314 letter a.

Chapter 4A. The use of fetal tissue section 4A-1. Definition with foster tissue understood in this law of cells and tissues from provosertaborterte fetuses.

section 4A-2. The use of fetal tissue Foster tissue can only be used for medical research, Diagnostics, representation of the vaccine and treatment.
The use of fetal tissue to treatment is only allowed in cases where the existence of serious illness or injury and other therapies have limited effect. The use of fetal tissue for medical research, Diagnostics and manufacturing of the vaccine is only allowed if there are no other equivalent methods.
It is prohibited to use ovary tissue from provosertaborterte foster to the transplant.
Commercial exploitation of cells and tissues from aborted fetuses is prohibited.

section 4A-3. Approval the use of fetal tissue to treatment and research to be approved by the Ministry.

section 4A-4. Consent written consent from the woman will be released before foster tissue can be cast to a fetal tissue bank.
Only after that the decision about abortion is taken, the woman can be informed of the possible use of fetal tissue. Consent can only valid emitted after such information is given.

section 4A-5. Fetal tissue bank All the collection, storage and disclosure of fetal tissue shall be made by a foster tissue bank. Foster tissue banks to be approved by the Ministry.

The Ministry may by regulation provide supplementary rules on foster tissue bankers collection, storage and disclosure of fetal tissue.

section 4A-6. Anonymity should not be given the information the woman about the identity of the recipient of the foster tissue.
The recipient of the foster tissue should not be given information about the identity of the woman who has given foster tissue.

section 4A-7. Any information that receives foster tissue by transplant to be informed of the tissue derived from provosertaborterte fetuses.

section 4A-8. Booking the right health care professionals that would like it of the reasons of conscience, can opt to participate in research projects where foster tissue be used and to perform or assist with the transplantation of fetal tissue.

Chapter 5. Genetic research of gave birth to, and more.

section 5-1. Definition Of genetic research is meant in this law all types of analysis of human genetic material, both on the nucleic acid-and chromosome level, of gene products and their function, or organ research, which are intended to provide information about the human inherit properties.
With genetic investigations of this law gave birth to in means: a) genetic research to set disease diagnosis.

b) genetic presymptomatiske surveys, genetic predictive surveys and genetic research to prove or rule out carrying the State for hereditary diseases who first shows up in later generations.

c) genetic laboratory research to determine gender affiliation, except genetic laboratory research for identification purposes.

section 5-2. The application of genetic research Genetic research should only be used for medical purposes with diagnostic or treatment aim.

section 5-3. Approval of genetic research before genetic research as discussed in section 5-1 the second paragraph letter b is applied, should the Ministry give special approval for the individual disease/illness disposal made to the subject of the investigation.
Before the Ministry decides whether authorization is to be given, to the application be submitted to the Biotechnology Council.

§ 5-4. Consent before genetic survey covered by section 5-1 the second paragraph letter b is made, it must to be examined, give written consent to the survey.
Before the survey is covered by the genetic section 5-1 the second paragraph letter b of children under 16 years of age, it shall be given prior written consent from the child's parents or others with parental responsibility.

section 5-5. Genetic counseling By genetic research covered by section 5-1 the second paragraph letter b, to the one that examined, given genetic guidance before, during and after the investigation is undertaken.
If the as is examined, is a child under 16 years of age, should also be given to genetic guide the child's parents or others with parental responsibility.

section 5-6. Genetic research and surveys of mass farmakogenetiske the King can give regulations for approval of genetic research and surveys of mass farmakogenetiske. In the regulations may be made exceptions to the requirement for written consent, genetic guidance, approval of business or reporting.

section 5-7. Genetic examination of children Genetically covered by the survey section 5-1 the second paragraph letter b, shall not be performed on the child before the child is aged 16 or over, unless the survey can detect conditions such as when processing can help prevent or reduce health damage with the child.
The Ministry may in special cases make exceptions from the ban in the first paragraph.

section 5-8. Ban on the use of genetic information outside the health and human services the service it is forbidden to request, receive, possess, or use information about another person that is accumulated by genetic research covered by section 5-1 the second paragraph letter b, or by systematic mapping of inherited disease in a family.
It is forbidden to ask about genetic research or the systematic mapping of inherited disease in a family has been carried out.
The ban in the first and the second paragraph does not include businesses that are approved under section 7-1 to carry out genetic investigations covered by section 5-1 the second paragraph, or for research purposes. If the genetic information will be used for research purposes must the information applies to have given consent to this.
Exempt from the ban in the first and the second paragraph is the health personnel who need the information in the diagnostic and behandlingsmessig purposes.

section 5-9. Outreach genetic information business with outreach genetic information business is understood in this law to health access personells inform the patient's affected relatives about the hereditary disease in the family.
When there is evidence that a patient has or is predisposed to a hereditary disease, determines the patient even if he or she will inform the affected relatives about this.
If the patient does not even can or will inform affected relatives, health professionals can ask about the patient's consent to inform these, if the terms of the fifth paragraph is met and the disease has been approved by the Ministry after the seventh paragraph.
If the patient is unable to consent to that health care providers inform affected relatives, health professionals in particular cases do this, if the terms of the fifth paragraph is met and the disease has been approved by the Ministry after the seventh paragraph.
Before health care professional contact with relatives, he or she shall consider whether: 1. the case of a disease with significant consequences for the individual's life or health, 2. There is a reasonable degree of probability that also have relatives a hereditary disease facility that can lead to disease in later life, 3. There is a proven relationship between the hereditary disease plant and development of disease ,

4.
the genetic research that is used to determine the hereditary disease facility, are safe, and 5.
the disease can be prevented or treated with good effect.

If the sibling is under 16 years of age, only the parents or others with parental responsibility to be informed.
The Ministry determines by regulation or in each case what diseases that can be made to the subject of outreach genetic business.

Chapter 6. Gene therapy section 6-1. Definition Of gene therapy is meant in this Act the transfer of genetic material to human cells for medical purposes or to influence biological functions.

§ 6-2. Criteria for gene therapy gene therapy can only be used for the treatment of serious disease or to prevent such a disease occurs.
Gene therapy on the foster and fertilized eggs and gene therapy that could lead to genetic changes in the sex cells, is prohibited.

section 6-3. Approval of gene therapy therapies that fall under section 6-2 the first paragraph, shall be approved by the Ministry.
The Ministry may provide regulations on proceedings.
Before the Ministry decides whether authorization is to be given, to the application be submitted to the Biotechnology Council.

section 6-4. Before the gene therapy is initiated, it must to be processed, provide written consent. Before it initiated gene therapy on children under 16 years of age, it shall be given the written consent of the parents or others with parental responsibility.

Chapter 7. General provisions section 7-1. Authentication of businesses the medical use of biotechnology and more. that require approval pursuant to section § 2-19, 3-3 the second paragraph, 4-2, 5-3 and 6-3 the first paragraph in this law, can only take place at the businesses that are specifically authorized by the Ministry for that purpose. It should be disclosed in the approval decision which forms of medical biotechnology business has permission to make or request.
The Ministry may in the approval decision put closer to the criteria for approval.

section 7-2. The reporting obligation any business that is approved under section 7-1, to give the written report to the Ministry about the business.
The Ministry sets out closer to the rules on reporting.

section 7-3. Biotechnology Council the King shall appoint a Council that on the petition or on its own initiative, may give statements in matters under this Act and in other questions about biotechnology. The Council's statements are public, unless otherwise follows from the statutory duty of confidentiality.
The King can give closer regulations about the Council's activities and composition.

section 7-4. Regulations the King may by regulations fix closer to the provisions to the completion and implementation of the law.

§ 7-5. Punishment The who contravenes the law or provisions given in pursuance of the law is punishable by fines or imprisonment for up to three months.
The first paragraph does not apply to: a) private individuals seeking or using offers that are inconsistent with this Act, b) it as donating eggs, sperm or embryos, or c) research participants.

section 7-6. Entry into force and transitional arrangements the law will take effect from the time the King decides. 1 the King can put into effect the individual provisions of the law to the different time.
The decision met with the legal authority of the Act 5. August 1994 no. 56 on the medical use of biotechnology will still apply so far as they are not contrary to the law here, or to the regulations or individual decisions hit in pursuance of the law here.

section 7-7. Changes in other laws from the time the law takes effect, the other laws as follows:-