Key Benefits:
Law of the humane use of biotechnology and (The biotechnology law). |
| Date | LO-2003-2003 12-05-100 |
| Ministry of | Health and custody ministry |
| Last modified | LO-2015 -05--07-26 from 01.01.2016, LAW-2015 -06-19-65 from 01.10.2015 |
| Published | In 2003 booklet 16 |
| Istrontrecation | 01.01.2004, 01.01.01.2005 |
| Changing | LOCALLY-1994--08--05-56 |
| Announcement | |
| Card title | Biotechnology law-biotics. |
Jf. former laws 5 aug 1994 number 56, 12 June 1987 # 68.
The purpose of this law is to ensure that medical use of biotechnology is exploited to the best for humans in a society in which there is room for everyone. This shall occur in accordance with principles of respect for human-worth, human rights and personal integrity and without discrimination on the basis of succession facilities based on the ethical norms of the field of Western cultural heritage.
Part Article SECTION 1-2. Lovens ScopeThe law applies to humanoid use of biotechnology and includes assisted fertilization, research on fertilized eggs and cloning, foster diagnostics, genetic examinations of birth and gene therapy m.o.
The law does not apply to research that does not have diagnostic or treatment implications for the participant or where information on the individual may not be returned to the person. Except from this, the provisions of the cap. 3.
The law does not apply to the autopsy that falls under law 7. May 2015 # 26 about autopsy and deferation of bodies for teaching and research or law 22. May 1981 # 25 about the trial procedure in criminal cases Section 228 on the case of the case-savvy inquest.
The law applies in the realm. The king can in regulation decide that the law completely or partly shall apply to Svalbard and Jan Mayen.
| 0 | Modified by law 7 May 2015 # 26 (ikr. 1 jan 2016 ifg. res. 13 Nov 2015 # 1289). |
In this law understood by :
| a) | assisted fertilization : insemination and fertilization outside the body ; |
| b) | insemination : introduction of semen in the woman differently than at sexual intercourse ; |
| c) | conception outside the body : fertilization of eggs outside of the woman's body. |
Assisting fertilization can only be performed on woman who are married or who are living in marriage-like relationships.
| 0 | Modified by law 27 June 2008 No. 53 (ikr. 1 jan 2009 ifg res. 27 June 2008 No. 745). |
Insemination can take place when the man is beinfertility or even has or is carrying out of severe hereditary disease, or when two women are married or are cohabitable in marriage-like conditions.
Insemination can also take place when the man or woman is infectious with a severe and chronic sexually transmitted infection.
Insemination can in particular the case of finding place if the woman is carrying out of severe hereditary gender-bound disease, jf. SECTION 2-13.
| 0 | Modified by laws 27 June 2008 No. 53 (ikr. 1 jan 2009 ifg res. 27 June 2008 No. 745), 21 June 2013 # 78 (ikr. 1 July 2013 ifg. res. 21 June 2013 # 702). |
The fruit outside of the body can only take place if a woman or a man is beid infertility or by unexplainable beadedness.
| 0 | Changed by laws 25 June 2004 # 45 (ikr. 1 sep 2004 ifg. res. 25 June 2004 # 986), 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632), 27 June 2008 No. 53 (ikr. 1 jan 2009 ifg res. 27 June 2008 No. 745). |
The couple shall be given information on the treatment and whether the medical and judicial effects treatment can get. The information should also include information about adoption.
Prior to the treatment of the treatment, the treatment shall be required to see that there has been written consent from the woman and her spouse or partner. By repeated treatments, new consent is to be obtained. Only people over 18 years who are not deprived of legal shopping ability on the personal space can give such consent.
| 0 | Modified by laws 27 June 2008 No. 53 (ikr. 1 jan 2009 ifg res. 27 June 2008 No. 745), 26 March 2010 # 9 (ikr. 1 July 2013 ifg. res. 5 apr 2013 # 338) that changed by law 5 apr 2013 # 12. |
Decision to conduct treatment with aim of assisted conception will be met by doctor. The decision is to build on medical and psychosocial assessments of the couple. It shall be placed emphasis on the couple's caregiviability and the envision of the child's best.
The doctor may overtake the information that is necessary, to conduct a health assessment of the couple.
The one born after assisted conception by donor sperm has at the 18-year-old right to obtain information on sperm givers identity. A donor registry is to assist the child with this.
The Ministry shall create register for registration of sperm givers identity, so that the child's right after Section 2-7 can be met.
Part Article SECTION 2-9. SpermA sperm donor should be over 18 years and not deprived of legal shopping ability on the personal area. The Giver must give written consent that the sperm can be used for fertilization and that his identity is registered in the donor registry. Samfat can be recalled until the fruit of the fruit has taken place.
A sperm donor shall not be given information about the couple's or the child's identity.
| 0 | Modified by law 26 March 2010 # 9 (ikr. 1 July 2013 ifg. res. 5 apr 2013 # 338) that changed by law 5 apr 2013 # 12. |
Processing doctor shall choose suitable sperm donor. The business that performs the assisted pollination shall ensure that necessary information on the treatment is registered and reported.
Part Article SECTION 2-11. Storage and import of semenThe storage and import of semen can only take place by enterprises that are specifically approved for this.
Reality that stores donor sperm is to ensure that information on sperm givers identity is recorded and reported to a donor registry.
Sperm shall not be issued for use to assisted fertilization after the givers death.
The Ministry of Justice can in regulation give closer rules on the organization of sperm banks, the use of donor sperm as well as registration and message of information about sperm donor.
Part Article SECTION 2-13. Treatment of semen before conceptionTreatment of semen before conception to influence choice of the child's gender is only permitted if the woman is carrying out of severe hereditary gender-bound disease.
Unfertilized eggs obtained in connection with fertilization outside the body, but not suited for this purpose, can be used for training in and quality safeguards of established methods for assisted conception. The eggs are to be destroyed after the end of trials.
Overspoken fertilized eggs can be used for training in and quality safeguards of established methods for assisted fertilization and prem plant diagnostic diagnostics. The terms of research on persuades fertilized eggs in Section 3-2 other, third and fourth joints apply accordingly.
Unfertilized and fertilized eggs as mentioned in the first and other clause can only be applied to training and quality safeguards by voluntary, expressly and informed consent of the pair receiving fertility treatment. Volunteable, expressly and informed consent shall also be obtained from the sperm donor if it is used donor sperm.
| 0 | Changed by laws 25 June 2004 # 45 (ikr. 1 sep 2004 ifg. res. 25 June 2004 # 986), 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
The fertilized eggs cannot be inserted in the womb of a second woman than the woman the egg cell stems from.
The Ministry can provide further regulations on the reduction of fertilized eggs in a woman's body by insemination outside the body.
| 0 | Modified by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
Only enterprises approved after Section 7-1 to carry out assisted fertilization can after approval save fertilized eggs.
After five years, fertilized eggs are to be destroyed or avaliable to training and quality safety jf. Section 2-14 or research jf. Chapter 3.
Saved fertilized eggs should not be used for reproduction when the woman or the man of the pair who has sought assisted conception, is dead or no longer has consent compedence.
| 0 | Modified by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
Only enterprises approved after Section 7-1 to carry out assisted fertilization can after approval save unfertilized eggs and egg-stoked tissue.
Unfertilized eggs and ovarian tissue can only be stored when the terms of law for assisted fertilization are met, or if a woman is to undergo treatment that can damage the infertility.
Saved unfertilized eggs and stored ovarian tissue can only be retained as long as the envision of the woman who has passed the material, it dictates and it can be considered medically justifiable.
At the woman's death, stored unfertilized eggs and stored egg-stoked tissue are destroyed.
Donation of eggs or parts of this from one woman to another is banned.
The transplant of organs and tissue that produces gender cells from one person to another with the purpose of treating infertility is prohibited.
Part Article SECTION 2-19. Approvals of treatment shapes m.evenProcessing shapes that fall under Section 2-1, storage and import of semen jf. Section 2-11, techniques for the treatment of semen jf. Section 2-13, as well as the storage of fertilized eggs and unfertilized eggs and ovarian tissue jf. Section 2-16 and 2-17, shall be approved by the ministry, and can only be applied or taken at businesses approved according to Section 7-1.
Before the ministry decides whether approval is to be granted, the application will be issued the Biotechnology Council.
| 0 | Modified by law 9 May 2014 # 15 (ikr. 1 June 2014 ifg. res. 9 May 2014 # 622). |
| 0 | Kapitet added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
With the premplant diagnostic diagnostics, a genetic examination of fertilized eggs outside the body before insertion into the uterus, herders examination of gender.
Prereplant diagnostic diagnostics can only be offered pairs in which one or both are carriers of severe monogen or chromosomal disease and there is great danger that the disease can be transmitted to an upcoming child.
Prereplant diagnostic diagnostics can in addition be performed to examine tissue type with aim to obtain a tissue styled child that can be stem cell onor for a sibling with severe, hereditary disease.
Prereplant diagnostic diagnostics should not be used to map or select other properties by the fertilized egg, than that of the paragrafen here.
The fruit-lined eggs that are selected must not be genetically modified.
| 0 | Added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
Prior to the premplant diagnostic diagnostics, the pair who seek the treatment must provide in writing, informed consent.
| 0 | Added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
Prior to application for the prem plant diagnostic diagnostics for the Board of the Board of the Board of the Board of the Board. Section 2A-4, the pair shall receive neutral information and genetic guidance, herunder details of the risk associated with the treatment, the strain for the woman and the likelihood of success with the treatment.
| 0 | Added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
Prereplant diagnostic diagnostics as mentioned in Section 2A-1 can be performed only after permission from a nend that the ministry mentions. Nemnda's decision cannot be scratched.
In its assessment of whether it shall be given permission for the premplant diagnostic diagnostics, the Board shall take position on whether there is a great danger for transmission of severe monogen or chromosomal disease. The severity of disease must be considered concrete in the individual case, out from criteria that reduced lifespan, what pains and loads of disease leads with them and what soothing or life-extending treatment opportunities exist.
If in addition to rule out severe, hereditary disease as mentioned in other clause is applicable to examining fertilized eggs of tissue type, the Board can only give permission to this if the following conditions are met :
| a) | treatment with the sweetness of healthy, likable stem cells with great probability is suitable to cure a sick sibling |
| b) | The envision of the sick child is assessed against the charges for a future sibling |
| c) | The donor born after the premplant diagnostic diagnostics with tissue styraping is not exposed to unacceptable procedures. |
Nemanda will have to consider whether the expected costs associated with premplant diagnostic diagnostics stand in a reasonable relationship with the effects of the treatment.
The king can in regulation give closer regulations on the Board of the Board of the Board, Assembly and case management.
| 0 | Added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
Nemanda shall bear an annual report to the Ministry of Board of the Board of the Board of the Board of the Board, the number of cases, which diseases the cases were, the outcome of the case processing and nenda's fortification to refuse or grant the application.
| 0 | Added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
If the Board finds that premplant diagnostics should be offered, and treatment cannot be carried out in Norway after accepting methods, the service should be purchased abroad. This applies regardless of whether the terms of the patient and user rights Act Section 2-1 b fifth clauses are met.
Nemanda decides which institution of the overseas couple can get treatment at. The decision shall build on documented knowledge of professional defensible practices and broad experience at the institution.
| 0 | Added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632), modified by law 24 June 2011 # 30 (ikr. 1 jan 2012 ifg. res. 16 des 2011 # 1252). |
The common rules of conception outside the body in chapter 2 of the law here also apply to couples seeking premplant diagnostic diagnostics. The requirement of bone fertility in Section 2-4 does not apply.
| 0 | Added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
Premplant diagnostic diagnostics can only take place by business approved by the ministry to carry out such treatment. The Ministry of Justice can in the ordinance put closer terms for the approval of the approval.
The reality that has been approved after the first clause shall deliver written report to the ministry of the business. The Ministry is determining further rules about the reporting duties.
| 0 | Added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
| 0 | Added by law 11 des 2015 # 97 (ikr. 1 Nov 2016 ifg. res. 17 June 2016 # 727). |
| 0 | The headline changed by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
Overspoken fertilized eggs and cells that stem from persuades fertilized eggs can only be used for research when the purpose is :
| 1. | to develop and improve methods and techniques for conception outside the body in the intent to achieve pregnancy |
| 2. | developing and improving methods and techniques for genetic examination of fertilized eggs with regard to determining whether it has been severe monogen or chromosomal hereditary disease (premplant diagnostic diagnostics) |
| 3. | achieving new knowledge with aim at future treatment of severe disease with human beings. |
| 0 | Modified by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
Research as mentioned in Section 3-1 is only allowed on fertilized eggs that have become persuades after fertilization outside the body with sight on fertilial treatment or prem plant diagnostic diagnostics. It is not permitted to fertilise eggs for research purposes alone.
Research on fertilized eggs must not be done later than 14 days after the egg was fertilized. The time fertilized eggs are stored frozen, co-count not.
The fruit-lined eggs that have been the subject of research must not be inserted into a woman, but shall be destroyed.
Research that entails genetic changes that can go in heritage with humans is not permitted.
| 0 | Added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632), formerly Section 3-2 changed paragrafnumber to Section 3-5. |
Research, herniated clinical research, which involves the use of persuades fertilized eggs and cells that stem from persuasive eggs, shall be approved by the regional committee for medical and health professional research ethics.
Processing forms that assume the use of cells from persuades fertilized eggs shall be approved by the ministry. The Ministry of the Ministry can in the approval of the approval bill further terms
Before the ministry decides whether the approval of other clause shall be given, the application of the Biotechnology Council shall be issued.
| 0 | Added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632), modified by law 9 May 2014 # 15 (ikr. 1 June 2014 ifg. res. 9 May 2014 # 622). |
Overspoken fertilized eggs can only be used for research and treatment after voluntary, expressly and informed consent of the couple receiving assisted conception. Prior to the consent, the pair will receive information about what the research might entail, how it is carried out and other relevant information.
If fertilization is made with donor sperm, the sperm donor should also voluntarily express, explicitly and informed consent. The sperm donor's consent is to be obtained in connection with the donation.
The collection can be withdrawn in thread with the rules of the biobfault Act Section 14.
| 0 | Added by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632), earlier Section 3-3 changed paragrafnumber to Section 3-6. |
It is forbidden :
| a) | to advance human embryos at cloning, |
| b) | to research human embryos and cell lines grown out of human embryos induced by cloning and |
| c) | to future embryos at cloning by the heritage material from human being inserted into an egg cell from animals. |
With cloning, techniques of techniques are meant to be induced to be inequal copies.
| 0 | Modified by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632), modified paragrafnumber from Section 3-2. |
The use of techniques with aim to induced the successor to equal individuals is prohibited.
| 0 | Modified by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632), modified paragrafnumber from Section 3-3. |
With foster diagnostics, in this law examination of molding cells, fetus or a pregnant woman with the purpose to obtain information about the foster genetic properties or to impose or rule out disease or development discrepancies at the fetus.
Ultrasound examinations in the normal pregnancy grief are not considered as a foster diagnostics in accordance with the first clause, and therefore, therefore, not of this law with the exception of Section 4-5.
Part Article SECTION 4-2. Approvals of foster diagnosticsResearch methods that fall into the Section 4-1 first clause shall be approved by the ministry.
Before the ministry decides whether approval is to be granted, the application will be issued the Biotechnology Council.
| 0 | Modified by law 9 May 2014 # 15 (ikr. 1 June 2014 ifg. res. 9 May 2014 # 622). |
Prior to foster diagnostics, jf. Section 4-1 is taken, must the person to be examined, give written consent.
Part Article SECTION 4-4. Information and genetic guidanceBy foster diagnostics, the woman or the pair before examination is provided information that among other things should include that the examination is voluntary, what risk is associated with the feasting of the examination, what the examination can uncover and which consequences this can get for the child, the woman, the couple and the family. If there is suspicion of genetic disease, the woman or the couple is also given genetic guidance.
If the examination shows that the fetus may have a disease or a development anomaly, the woman or pair will be given information and genetic guidance on the appropriate disease or disability, as well as on current rights and appropriate relief measures.
Illumination about the foster sex before noon pregnancy suke that is occurring at foster diagnostics or other examination of the fetus should only be given if the woman is carrying out of severe gender-bound disease.
Fosterdiagnostics with aim to determine paternity and paternity testing at the foster stage is prohibited. This does not apply when pregnancy may be a result of circumstances as referred to in the Criminal Code Section 291, 295, 296, 299 letter a, 302, 312, 313 and 314 letter a.
| 0 | Modified by law 19 June 2015 # 65 (ikr. 1 oct 2015). |
| 0 | The headline added by law 7 May 2015 # 25 (ikr. 1 jan 2016 ifg. res. 13 Nov 2015 # 1289). |
With foster tissue understood in this law cells and tissue from provoking taborated fetuses.
| 0 | Added by law 7 May 2015 # 25 (ikr. 1 jan 2016 ifg. res. 13 Nov 2015 # 1289). |
Fostertissue can only be used for medical research, diagnostics, representation of vaccine and treatment.
The use of foster tissue to treatment is only permitted in those cases where there is severe disease or damage and other processing shapes have limited effect. The use of foster tissue to medical research, diagnostics and representation of vaccine is only allowed if there are no other peer-to-peer methods.
It is forbidden to use ovarian tissue from provoking taborated fetuses to transplant.
Commercial exploitation of cells and tissue from abortion fetuses is banned.
| 0 | Added by law 7 May 2015 # 25 (ikr. 1 jan 2016 ifg. res. 13 Nov 2015 # 1289). |
The use of foster tissue for treatment and research is to be approved by the ministry.
| 0 | Added by law 7 May 2015 # 25 (ikr. 1 jan 2016 ifg. res. 13 Nov 2015 # 1289). |
The written consent of the woman shall be forage before fetal tissue can be avaliable to a foster tissue bank.
First, after the decision of pregnancy violations has been taken, the woman can be informed about possible use of the fetal tissue. The Samfat can only be valid given after such information is provided.
| 0 | Added by law 7 May 2015 # 25 (ikr. 1 jan 2016 ifg. res. 13 Nov 2015 # 1289). |
All collection, storage and extradition of fetal tissue shall be taken by a foster tissue bank. Foster tissue banks shall be approved by the ministry.
The Ministry of Justice can in regulation provide filler rules about foster tissue banking, storage and extradition of fetal tissue.
| 0 | Added by law 7 May 2015 # 25 (ikr. 1 jan 2016 ifg. res. 13 Nov 2015 # 1289). |
The woman shall not be given information about the identity of the person receiving the fetal tissue.
The receiving foster tissue shall not be given information about the identity of the woman who has handed out the fetal tissue.
| 0 | Added by law 7 May 2015 # 25 (ikr. 1 jan 2016 ifg. res. 13 Nov 2015 # 1289). |
Any person receiving fetal tissue by transplant should be informed that the tissue stems from provoking taborated fetuses.
| 0 | Added by law 7 May 2015 # 25 (ikr. 1 jan 2016 ifg. res. 13 Nov 2015 # 1289). |
Health personnel as of conscientious reasons wish that, can reserve courage to participate in research projects where foster tissues are used and to perform or assist in the transplant of fetal tissue.
| 0 | Added by law 7 May 2015 # 25 (ikr. 1 jan 2016 ifg. res. 13 Nov 2015 # 1289). |
With genetic examinations, in this law all types of analyses of man's arvest off, both on nucleinacid and chromosome levels, of gene products and their function, or organ examinations, which have intends to provide information on the human inheritance properties.
With genetic examinations of birth, in this law, in this law,
| a) | genetic examinations for silent disease diagnosis |
| b) | genetic presymptom research, genetic predictive investigations and genetic examinations to impose or rule out the carrier state of heritable diseases that first show up for later generations. |
| c) | genetic laboratory examinations to determine gender-style auditory, excluding genetic laboratory examinations for identification purposes. |
Genetic examinations should only be used for medical purposes with diagnostic or processing-of-treatment objectives.
Prior to genetic examinations referred to in Section 5-1 other clause b tas in use, the ministry shall provide special approval for the individual disease / disease outline made to the subject of examination.
Before the ministry decides whether approval is to be granted, the application will be issued the Biotechnology Council.
| 0 | Modified by law 9 May 2014 # 15 (ikr. 1 June 2014 ifg. res. 9 May 2014 # 622). |
Prior to genetic examination that reselected by Section 5-1 other clause letter b is taken, it must be examined, providing written consent to the examination.
Prior to that, genetic examination that is retaken by Section 5-1 other clause b of children under 16 years shall be given written consent from the child's parents or others with parental liability.
By genetic examinations that are revisited by Section 5-1 other clause letter b, it shall be examined, given genetic guidance both before, during and after the examination is done.
If the person who is examined is a child under 16 years of age, genetic guidance is also given to the child's parents or others with parental liability.
The king can provide regulations on the approval of genetic mass investigations and pharmagenic genetic examinations. In the scripture, exceptions can be made from the claims of the law of written consent, genetic guidance, approval of business or reporting.
Part Article SECTION 5-7. Genetic examination of childrenGenetic examination as being retaken by Section 5-1 other clause letter b shall not be performed on children until the child is filled 16 years, unless the examination can be susceptible to conditions that by treatment can prevent or reduce health damage with the child.
The Ministry can in very frank cases make exceptions from the ban in the first clause.
Part Article SECTION 5-8. Offers against the use of genetic information outside the health and care serviceIt is forbidden to request, receive, sit, or use information about another person who has been presented at genetic examinations that are retaken by Section 5-1 other clause letter b, or by systematic mapping of hereditary disease in a family.
It is forbidden to ask about genetic examinations or systematic mapping of hereditary disease in a family has been carried out.
The bid in the first and second clause does not include enterprises approved by Section 7-1 to carry out genetic examinations that are refunded by Section 5-1 other clauses, or for research purposes. If genetic information is to be used for research purposes, that information must have been given consent to this.
Except from the ban in the first and second clause is health personnel who need the information in diagnostic and processing-wise eye-eye.
| 0 | Modified by law 24 June 2011 # 30 (ikr. 1 jan 2012 ifg. res. 16 des 2011 # 1252). |
With the seeking genetic information business, in this law, health care law is allowed to inform the patient's affected relatives of hereditary disease in the family.
When it is documented that a patient has or has been predisposed to a hereditary disease, the patient decides even if he or she will inform affected relatives about this.
If the patient itself cannot or will inform affected relatives, health personnel can request the patient's consent to inform these, if the terms of the fifth clause are met and the disease has been approved by the ministry after the seventh clause.
If the patient cannot consent to the health personnel inform affected relatives, health personnel can do this, if the terms of the fifth clause are met and the disease has been approved by the ministry after the seventh clause.
Before health personnel make contact with relatives, he or she will consider whether :
| 1. | it applies to a disease of significant consequences for the individual's life or health, |
| 2. | it is a reasonable degree of probability that also relatives have a hereditary disease that can lead to disease later in life, |
| 3. | there is a documented correlation between the heritable disease facility and development of disease, |
| 4. | the genetic examinations that are used to determine the heritable disease facility are secure, and |
| 5. | The disease can be prevented or treated with good effect. |
If the lineage is under 16 years, only the parents or others with parental responsibility should be informed.
The Ministry decides in regulation or in the individual case of which diseases can be made to the subject of outreach genetic business.
With gene therapy means in this law transfer of genetic material to humane cells for medical purposes or to influence biological functions.
Part Article SECTION 6-2. Conditions of gene therapyGentherapy can only be used for treatment of severe disease or to prevent such disease from occurring.
Gentherapy on fetus and fertilized eggs and gene therapy that can cause genetic changes in gender cells is prohibited.
Part Article SECTION 6-3. Approval of gene therapyProcessing shapes that fall into under Section 6-2 first joints shall be approved by the ministry.
The Ministry can provide regulations on the case treatment.
Before the ministry decides whether approval is to be granted, the application will be issued the Biotechnology Council.
| 0 | Modified by law 9 May 2014 # 15 (ikr. 1 June 2014 ifg. res. 9 May 2014 # 622). |
Before gene therapy initiated, it must be treated, providing written consent. Prior to the initiated gene therapy of children under 16 years, it shall be given written consent from the parents or others with parental liability.
The medical use of biotechnology m.As requiring approval after Section 2-19, 3-3 different joints, 4-2, 5-3 and 6-3 first clauses in this law can only take place by enterprises specifically approved by the ministry for the purposes of appropriate purposes. It shall advance the approval of the approval bill which forms of the medical biotechnology business have permission to conduct or commandeer.
The Ministry of approval can in the approval bill put closer terms for approval.
| 0 | Modified by law 15 June 2007 # 31 (ikr. 1 jan 2008 ifg res. 15 June 2007 # 632). |
Any business that has been approved after Section 7-1 shall provide written report to the ministry of the business.
The Ministry is determining further rules about the reporting duties.
Part Article SECTION 7-3. Biotechnology CouncilThe king mentions some advice as on the motion or of its own action, can give statements in cases after this law and in other questions about biotechnology. The Council's statements are public, unless otherwise follows by legislations.
The king can provide further regulations on the Council's business and the Assembly.
| 0 | Modified by law 9 May 2014 # 15 (ikr. 1 June 2014 ifg. res. 9 May 2014 # 622). |
The king can at regulation determine closer regulations to padding and review of the law.
Part Article SECTION 7-5. PunishmentThe one that overtakes the law or regulations given in co-hold of the law is punishable by fines or imprisonment for up to three months.
The first clause does not apply to :
| a) | private persons seeking or take advantage of offers that are in violation of this law, |
| b) | the who donate eggs, semen or fertilized eggs or |
| c) | research participants. |
| 0 | Modified by laws 21 June 2013 # 78 (ikr. 1 July 2013 ifg. res. 21 June 2013 # 702), 19 June 2015 # 65 (ikr. 1 oct 2015). |
The law takes effect from the time the King decides. 1 The king can put in effect the individual provisions of the law at different times.
Attaman hit with home in law 5. August 1994 No. 56 about the medical use of biotechnology should still apply as far as they do not violate the law here, or against regulations or individual ordinance met in the co-hold of the law here.
| 1 | From 1 jan 2004 ifg. res. 19 des 2003 # 1591, with the exception of Section 2-7 t.o. Section 2-12, Chapter 4 and Section 7-7 # 1 what applies to the repession of law of 5. August 1994 No. 56 on medical use of biotechnology Section 2-5 t.o. Section 2-7, chapter 5 and chapter 8. Ifg. res. 25 June 2004 # 985 to Section 2-8, Section 2-9, Section 2-11 and Section 2-12 apply from 1 sep 2004, Section 2-7, Section 2-10 and Chapter 4 apply from 1 jan 2005, and the determination Section 7-7 # 1 on repession of law 5 aug 1994 number 56 about the medical use of biotechnology shall apply from 1 jan 2005. The repeal of Section 2-7 in law on medical use of biotechnology applies, however, from 1 sep 2004. |
From the point of time the law takes effect, other laws change as follows :---
Part Article
