1.
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine
Chapter I – General provisions
Article 2 – Primacy of the human being
The interests and welfare of the human being shall prevail over the sole interest of society or science.
Chapter IV – Human genome
Article 12 – Predictive genetic tests
Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counselling.
Article 13 – Interventions on the human genome
An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.
Article 14 – Non-selection of sex
The use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child's sex, except where serious hereditary sex-related disease is to be avoided.
Chapter V – Scientific research
Article 18 – Research on embryos in vitro
1. Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. The creation of human embryos for research purposes is prohibited.
2.
Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings
Article 1
1. Any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited.
2. For the purpose of this article, the term human being "genetically identical" to another human being means a human being sharing with another the same nuclear gene set.
3.
Act on Research on Human Embryonic Stem Cells and Related Activities and on Amendment to Some Related Acts
Citation: 227/2006 Coll. Part: 75/2006 Coll.
Section 3
Conditions for research on human embryonic stem cells
(1) Research on human embryonic stem cells may be conducted only on the basis of a permission issued by the Ministry of Education, Youth and Sport (hereinafter referred to as the “Ministry”). This research may be conducted only on workplaces listed in the permission for research on human embryonic stem cells.
(2) Research on human embryonic stem cells may conducted only a) on imported lines, provided that they were obtained from human embryos in such a way that does not object to the Czech legislation or legislation of the country of origin; their import was permitted by the Ministry and the only reason for their import into the Czech Republic is their usage for research purposes under this Act; or b) on the lines obtained from redundant human embryos in the Czech health care institutions providing assisted reproduction under a separate regulation1) (hereinafter referred to as the “centre for assisted reproduction”).
(3) Such manipulations with human embryonic stem cells must be prevented within the research which could lead to creation of a new human individual (reproductive cloning).
(4) Both lines and human embryos intended for obtaining human embryonic stem cells must be protected against theft or using them for activities being inconsistent with the regulations.
Section 8
Obtaining human embryonic stem cells for research purposes from redundant human embryos
(1) Obtaining human embryonic stem cells for research purposes from redundant embryos is possible if a) the woman and man, from whom this redundant embryo was obtained, and the donor of embryonic cells1) gave their written consents in accordance with Section 9, b) this redundant human embryo was provided by a centre for assisted reproduction.
(2) Human embryos for obtaining human embryonic stem cells for research purposes may be only supplied to a legal entity conducting research as permitted under this Act.
(3) Only those redundant human embryos may be used for obtaining human embryonic stem cells for research purposes which are not older than 7 days; the age of embryo does not include the period of its cryopreservation.
Section 11
Export and transit of human embryonic stem cells for research purposes
(7) The exportation of embryos is prohibited.
Section 20
In Act No. 140/1961 Coll., the Penal Code, after Section 209a there is inserted the new Section 209b, worded as follows: "Section 209b
Prohibited manipulation of human embryo and human genome
(1) Who a) performs interventions leading to creation of a human embryo for purposes other than implantation into a woman’s body, b) uses a human embryo or larger number of human embryonic stem cells or their lines for research inconsistent with a separate regulation, c) imports or exports a human embryo or larger number of human embryonic stem cells or their lines inconsistent with a separate regulation, d) implants the created human embryo into the uterus of another animal species, e) implants a human genome into the cells of another animal species or vice versa, or f) manipulates the human embryonic stem cells during their research in a way leading to creation of a new human individual (reproductive cloning), shall be punished by imprisonment up to three years or ban on activity.
(2) The offender shall be punished by imprisonment for one to three years or by ban on activity or by money penalty, a) if he/she commits the act under paragraph 1 as a member of an organised group, b) if he/she commits this act repeatedly, or c) if he/she obtains an advantage of large extent through this act for himself/herself or another person.
(3) The offender shall be punished by imprisonment for three to eight years or forfeiture of property, a) if he/she commits the act under paragraph 1 as a member of an organised group operating in several states, or b) if he/she obtains an advantage of large extent through this act for himself/herself or another person.".
Section 21
Act No. 20/1966 Coll., on Public Health Care, is hereby amended as follows: 1. After Section 27c new Sections 27d to 27h shall be added, including footnotes 6a and 6b, worded as follows:
"Section 27d
(1) The assisted reproduction shall mean techniques and methods of manipulation with gametes or embryos, including their storage, with a view to treat both male and female infertility. These techniques and methods are a) collection of gametes, b) artificial insemination of a woman, by 1. fertilisation of a woman’s egg with a man’s sperm outside a woman’s body, 2. transfer of embryo into a woman’s genital tract, or 3. introduction of gametes into a woman’s genital tract.
(2) Genetic examinations of embryos are permitted only in defined indications in order to exclude risks of serious genetically conditioned diseases and defects with embryos before they are implanted into the cavity of the uterus.
(3) The assisted reproduction under paragraph 1 (b) may be practised on the basis of a written application of a woman and man who are going to undergo this treatment together (hereinafter referred to as the “infertile couple”), if for medical reasons it is not very probable or totally excluded that the woman gets pregnant naturally or if there exists a demonstrable risk of transfer of genetically conditioned diseases or defects. The application shall contain the man’s consent to artificial insemination of the woman; such consent to be repeated before each artificial insemination procedure. The application must not be older than 24 months; it is part of the woman’s medical records.
(4) No woman and man in family relationship, which excludes contracting marriage under a separate regulation6a), may be considered an infertile couple for the purposes of treatment under paragraph 1 (b).
Section 27e
(1) Assisted reproduction under Section 27d (1) (b) may be practised in woman of fertile age (hereinafter referred to as the “female recipient”), if her health state does not prevent the assisted reproduction procedure. The physician performing the assisted reproduction procedure shall be held responsible for examining the health state of the female recipient.
(2) The donor of gametes for assisted reproduction purposes shall mean a person not forming the infertile couple. Any adult woman in the age from 18 to 35 years may donate her eggs for the assisted reproduction purposes. Any adult man in the age from 18 to 40 years may donate his sperm for the assisted reproduction purposes. It is not permitted to fertilise the eggs with sperm of a man who is known to be in direct family link or a sibling, uncle, cousin or a child born to a cousin of the woman, whose egg is used for the assisted reproduction method, or the female recipient.
(3) The donor shall be obliged to undergo necessary examinations, including genetic examinations, in order to assess his/her health ability to take part in the assisted reproduction procedure. The physician, who decided on the possibility to use gametes for the assisted reproduction methods, shall be held responsible for assessing the health ability of the donor. The donor neither female recipient must be legally incapacitated or with a limited capacity to enter into legal acts.
(4) The physician collecting the gametes and the physician performing the artificial insemination are obliged to inform the persons undergoing this treatment in advance on the character of this treatment, all potential health risks and on all other factors related to the assisted reproduction.
(5) The assisted reproduction treatment may only be performed after a prior consent of the person who will undergo this treatment. While giving his/her consent with the assisted reproduction treatment, the donor also gives the consent to use his/her gametes for artificial insemination and to obtain the embryonic stem cells from the redundant embryo originating from his/her gametes for research under a separate regulation governing the research on human embryonic stem cells6b). The physician specified in paragraph 1 or 3 shall enter this consent into the medical records of the person giving this consent; the statement of consent shall be signed both by the physician and the person, who gave it.
(6) At assisted reproduction only as many eggs of the female recipient shall be fertilised and implanted into her genital tract as is necessary according to the present level of medical knowledge for the pregnancy to be probably induced with success.
(7) Gametes and embryos created for the assisted reproduction purposes may be used only for artificial insemination. If not all embryos created in favour of the infertile couple were used in the process of artificial insemination of the female recipient, it is possible to store them and use for the next infertility treatment of this couple; this is not the case if the infertile couple declares that it is not going to use the embryos for any additional artificial insemination and gives a) its consent under a separate regulation6b) governing the research on human embryonic stem cells to obtain the embryonic stem cells from the redundant embryo for research under this separate regulation, or b) its consent to use the redundant embryo for artificial insemination of another woman. The attending physician shall enter this consent into the medical records of the female recipient; the statement of consent shall be signed both by the attending physician and the infertile couple.
(8) No financial or other reward is attached to donation of gametes and embryos and delivery of gametes and embryos to the operator of the health care institution, where the assisted reproduction is provided. The donor shall be entitled to compensation of expenses effectively spent in relation to the collection. These expenses shall be reimbursed to the donor by operator of the health care institution where the collection was performed upon his/her request. The operator of the health care institution may ask the female recipient undergoing the artificial inseminated or operator of the health care institution, to which the gametes or embryos were supplied, to reimburse these expenses. The operator of the health care institution, which took over the gametes or embryos for assisted reproduction and reimbursed the expenses under the previous sentence, may ask the female recipient undergoing the artificial insemination to reimburse these expenses.
(9) The health care institution providing the assisted reproduction shall be obliged to maintain the anonymity of both the donor and infertile couple, and the donor and child born of assisted reproduction. To maintain the anonymity of the donor and infertile couple and of the donor and child shall be also the liability of each medical worker who learnt this fact.
(10) Upon request of a) a woman or man from the infertile couple prior to the beginning of the artificial insemination procedure, or b) a legal representative of a child born of assisted reproduction or adult person born of assisted reproduction, the physician of the health care institution, where the health ability of a potential donor was assessed, shall furnish information on findings having a direct impact on development of the health state of a child or person born of assisted reproduction, particularly information on any discovered genetic endowment or dispositions.
Section 27f
(1) The health care institution, where the health qualification of a potential donor was assessed, shall be obliged to pass on data on the donor’s health state to the health care institution performing the artificial insemination. The health care institution, where the artificial insemination was performed, shall be obliged to store these data for at least 30 years since the use of gametes.
(2) The health care institution may practise the techniques and methods of assisted reproduction only on the basis of a consent granted by the Ministry of Health. The Ministry of Health shall grant the consent following a request of the health care institution, if the health care institution meets the technical and material demands on facilities and proves that techniques and methods of assisted reproduction will be practised by physicians with specialised branch of vocational training under Section 27h.
Section 27g
(1) It is not permitted to use the assisted reproduction techniques for the purpose of choosing a future child’s sex, with the exception of cases when the assisted reproduction techniques may be used to prevent serious Mendel-type sex-related genetically conditioned diseases that a) are incompatible with the postnatal development of a child, b) significantly shorten the life, c) cause early disablement or other serious health consequences, or d) are untreatable given our present level of knowledge.
(2) Selection of a future child’s sex in cases under paragraph 1 shall be recommended by a physician with specialised vocational training in medical genetics, in conjunction with a physician with specialised vocational training in gynaecology and obstetrics.
Section 27h
The Ministry of Health shall lay down by decree
a) reasons for genetic examinations of an embryo aimed at discovering the genetically conditioned diseases of foetus or likelihood of their occurrence,
b) list of diseases, defects and other health states disqualifying the donor,
c) list of specialised branches of medical education of doctors, who may practise the techniques and methods of assisted reproduction,
d) material and technical demands on facilities of a health care institution providing the techniques and methods of assisted reproduction.
The Ministry of Health grants its consent to practise the techniques and methods of assisted reproduction".
4. In Annex a new point 14 shall be added, worded as follows:
"14. National registry of assisted reproduction The registry shall process personal data necessary for identification of a woman, who has undergone the artificial insemination procedure (personal insurance number or another identification data under this Act), personal history of a woman, who has undergone the artificial insemination procedure, data related to her health state and diagnostic data related to the artificial insemination procedure; data on health state of a man, who has undergone the procedure of collection of gametes for the purpose of insemination; data necessary for identification of the operator of the health care institution that provided the assisted reproduction. These personal data shall be anonymised after 20 years of the data entry."
Section 26
Act No. 94/1963 Coll., on Family, is hereby amended as follows:
1. In Section 54, paragraph 3 shall be added, including footnote 7b, which shall read as follows:
"(3) If a child is conceived through artificial insemination of a woman in assisted reproduction under a separate regulation7b), the man who gave his consent to artificial insemination of the woman under this separate regulation shall be considered the child’s father, unless proven that the woman became pregnant in another way.
© Translated by Pavel Kurfürst
Full text of law
Commentary
Donor anonymity