European Medically Assisted Reproduction Act 2019



  • EUROPEAN MEDICALLY ASSISTED REPRODUCTION ACT

    Proposed by Cllr. Julian Maverick (Derecta) :: Passed (4-0), August 5th, 2019 :: Unamended


    Preamble

    Understanding the principle of respect of human dignity, human rights and personal integrity as being the ethical basis of scientific discovery,

    Concerned by the hypothetical discriminatory scope genetic modifications to the human gene-pool could take,

    Acknowledging the benefits of the application of biotechnology in human medicine, especially concerning the alleviation and eradication of diseases,

    This Act hereby establishes:


    Section I. Definitions

    For the purpose of this Act, the following definitions apply:

    a) medically assisted reproduction: insemination and in vitro fertilisation,
    b) insemination: the introduction of sperm into an individual willing to become pregnant's body by means other than sexual intercourse,
    c) in vitro fertilisation: fertilisation of oocytes (eggs) outside an individual willing to become pregnant's body.
    d) prenatal diagnosis: examination of fetal cells, a fetus or a pregnant individual to obtain information about the genetic constitution of the fetus or to detect or exclude a disease or abnormality of the fetus. Ultrasound examination forming part of the ordinary examinations pursued during pregnancy is not considered to be prenatal diagnosis pursuant to the first paragraph, and therefore does not come within the scope of this Act.
    e) genetic testing: analyses of human genetic material at both the nucleic acid and chromosome levels, analyses of genetic products and their function, and examination of organs to obtain information on human genetic constitution.
    f) postnatal genetic testing: it encompasses the genetic testing to diagnose a disease; presymptomatic genetic testing (predictive genetic testing and testing to determine whether or not a person is a carrier of hereditary disease that will only be expressed in later generations); laboratory genetic testing to determine sex (with the exception of laboratory genetic testing for identification purposes).
    g) gene therapy: transferring of genetic material to human cells for medical purposes or to influence biological functions.
    h) cloning: techniques employed to create copies of living beings that are genetically identical.
    i) provision of genetic information to persons other than the patient: authorised provision by health personnel of information about hereditary disease in the family to at-risk relatives of such patient.


    Section II. Legality of Medically Assisted Reproduction

    1. Member States’ Law
      Member States reserve the right to impose additional regulations and restrictions on the use of medically assisted reproduction within their territory, including with respect to the overall legality of medically assisted reproduction.

    Section III. General Obligations

    1. INFORMATION AND CONSENT
      Individuals pursuing medically assisted reproduction shall be given information on the treatment and on the medical and legal consequences it may have. Before the treatment is started, the physician providing the treatment shall ensure that written consent is provided by said individuals. If the treatment is repeated, renewed consent shall be obtained.

    2. DECISIONS ON TREATMENT
      The decision to undertake treatment with a view to medically assisted reproduction shall be taken by a physician. The decision shall be based on medical and psychosocial assessment of the individuals willing to undertake such treatment. Importance shall be attached to said individual/s’ capacity to provide parental care and the best interests of the child. The physician may obtain any information necessary to make an overall assessment of the individual/s.

    3. GAMETE DONORS MEDICAL REGISTRY
      Medical professionals responsible for the care or treatment of a person born as a result of medically assisted reproduction shall be able to access anonymised medical information, particularly with respect to hereditary diseases and genetic conditions, about the gamete donors. Member States shall establish a registry of the identity and medical records of gamete donors in order to facilitate this access.

    4. GAMETES OR GONADAL TISSUE DONORS
      A gametes or gonadal tissue donor shall have reached the legal age of majority. The donor must give written consent for the gametes or gonadal tissue to be used for fertilisation and for his identity to be recorded in the donor register. Consent may be withdrawn until fertilisation has taken place. A gametes or gonadal tissue donor shall not be given information on the child’s identity or their parent/s legal guardian/s.

    5. SELECTION OF GAMETES DONORS
      The physician who is providing the treatment shall assist in selecting a suitable gametes donor. The establishment that carries out the medically assisted reproduction procedure shall ensure that the necessary information on the procedure is registered and reported.

    6. STORAGE AND IMPORT OF GAMETES OR GONADAL TISSUE
      Only establishments that are specifically authorised to do so may store and import gametes or gonadal tissue. Establishments that store donated gametes or gonadal tissue shall ensure that information on the identity of gametes or gonadal tissue donors is registered and reported to a donor register. Gametes and gonadal tissue shall not be provided for medically assisted reproduction procedures after the death of the donor. Special exemptions may be authorised by Member States on a case by case basis to allow the continued preservation and use for medically assisted reproduction after the death of the donor. Member States must notify the European Biotechnology Advisory Board of each authorisation within 24 hours of it being given; the European Biotechnology Advisory Board shall have 14 days from the point of notification to decide whether to overrule the authorisation subject to the submission of sufficient additional evidence.

    7. REGULATION OF GAMETE AND GONADAL TISSUE BANKS
      Member States may lay down further provisions on the organisation of gamete and gonadal tissue banks, the use of donated gametes or gonadal tissue and the registration and reporting of information on gamete or gonadal tissue donors.

    8. TREATMENT OF GAMETES BEFORE FERTILISATION
      Treatment of gametes before fertilisation for the purpose of selecting the sex of the child is only permitted if the pregnant-to-be individual is has tested positive as a carrier of a sex-linked hereditary disease that is either life-threatening, severely life-limiting, or associated with severe physical or mental disability.

    9. GENETIC TESTING OF EMBRYOS
      Genetic testing of embryos before implantation into the womb, including tests designed to choose the sex of the child (preimplantation genetic diagnosis) may only be carried out in special cases of sex-linked hereditary diseases that are either life-threatening, severely life-limiting, or associated with severe physical or mental disability; and for which no treatment is available. If special considerations so indicate, the European Biotechnology Advisory Board mentioned in section IV may emit favourable rulings for genetic testing of embryos. Such permission may be granted for hereditary diseases that are either life-threatening, severely life-limiting or associated with severe physical or mental disability and for which no treatment is available. The embryos selected must not be genetically modified. Before preimplantation genetic diagnosis is carried out, the pregnant individual shall be given genetic counselling and information.

    10. USE AND IMPLANTATION OF EMBRYOS
      Implantation of embryos into the individuals from whom the oocytes were obtained shall be the preferred course of action. Member States may lay down further regulations relating to implantation of foraneous embryos into an individual’s body after in vitro fertilisation.

    11. STORAGE OF EMBRYOS
      Only establishments that are authorised pursuant to section III.33 to carry out medically assisted reproduction techniques may after authorisation store embryos. Embryos may not be stored for more than five years, and shall then be destroyed.

    12. STORAGE OF UNFERTILISED OOCYTES AND OVARIAN TISSUE
      Only establishments that are authorised pursuant to section III.33 to carry out medically assisted reproduction techniques may after authorisation store unfertilised oocytes and ovarian tissue. Unfertilised oocytes and ovarian tissue may only be stored if the conditions relating to medically assisted reproduction set out in this Act have been fulfilled or if an individual is to undergo treatment that may impair their fertility. Stored unfertilised oocytes and ovarian tissue may only be kept for as long as the interests of the individual from whom they were taken so dictate. Stored unfertilised eggs and ovarian tissue shall be destroyed if said individual dies. Special exemptions may be authorised by Member States on a case by case basis to allow the continued preservation and use for medically assisted reproduction after the death of the said individual. Member States must notify the European Biotechnology Advisory Board of each authorisation within 24 hours of it being given; the European Biotechnology Advisory Board shall have 14 days from the point of notification to decide whether to overrule the authorisation subject to the submission of sufficient additional evidence.

    13. AUTHORISATION OF METHODS OF TREATMENT
      Methods of treatment that come within the scope of article I, the storage and import of gametes and gonadal tissue, cf. section III.6, treatment of gametes and gonadal tissue, cf. section III.8, and the storage of embryos and unfertilised oocytes and ovarian tissue, cf. sections III.11 and III.12, shall be authorised by Member States, and may only be used or carried out by establishments that are authorised pursuant to section III.33. Member States must notify the European Biotechnology Advisory Board of each authorisation within 24 hours of it being given; the European Biotechnology Advisory Board shall have 14 days from the point of notification to decide whether to overrule the authorisation subject to the submission of sufficient additional evidence.

    14. PROHIBITION AGAINST CREATING HUMAN EMBRYOS BY CLONING
      It is prohibited:
      a) to create human embryos by cloning,
      b) to carry out research on cell lines derived from human embryos obtained by cloning,
      c) to create embryos by cloning by the technique of inserting human genetic material into an animal oocyte.

    15. PROHIBITION AGAINST TECHNIQUES DESIGNED TO CREATE GENETICALLY IDENTICAL INDIVIDUALS
      The use of techniques designed to create genetically identical individuals is prohibited.

    16. AUTHORISATION OF PRENATAL DIAGNOSIS
      Methods of examination that come within the scope of section 1.d) shall be authorised by Member States. Member States must notify the European Biotechnology Advisory Board of each authorisation within 24 hours of it being given; the European Biotechnology Advisory Board shall have 14 days from the point of notification to decide whether to overrule the authorisation subject to the submission of sufficient additional evidence.

    17. CONSENT BEFORE PRENATAL DIAGNOSIS
      Before prenatal diagnosis is undertaken, written consent shall be obtained from the pregnant individual who is to be examined.

    18. INFORMATION AND GENETIC COUNSELLING
      Before prenatal diagnosis is undertaken, individuals shall be given information on the procedure, including the fact that it is voluntary, the risk associated with carrying out the procedure, what the procedure may reveal and the consequences this may have for the child and the pregnant individual. If there are grounds to suspect a genetic disease, the pregnant individual shall also be given genetic counselling. If the procedure indicates a disease or abnormality of the fetus, the pregnant individual shall be given information and genetic counselling on the disease or abnormality in question, and on their rights and the support that is available.

    19. INFORMATION ON THE SEX OF THE FETUS BEFORE THE 12TH WEEK OF PREGNANCY
      Information on the sex of the a fetus conceived via medically assisted reproduction before the 12th week of pregnancy resulting from prenatal diagnosis or other examination of the fetus shall only be given if the pregnant individual is a carrier of a sex-linked disease that is either life-threatening, severely life-limiting, or associated with severe physical or mental disability.

    20. PRENATAL PATERNITY TESTING
      Prenatal diagnosis with a view to determining paternity and prenatal paternity testing is prohibited. This does not apply when the pregnancy may be the result of penally prosecutable acts.

    21. USE OF GENETIC TESTING
      Genetic testing shall only be carried out for medical purposes if it has a diagnostic or therapeutic objective.

    22. Authorisation of genetic testing
      Before presymptomatic genetic testing, listed in section I.e), is to be developed, Member States shall give separate authorisations for each disease or predisposition to a disease testing that is to be subject to research and development. Member States must notify the European Biotechnology Advisory Board of each authorisation within 24 hours of it being given; the European Biotechnology Advisory Board shall have 14 days from the point of notification to decide whether to overrule the authorisation subject to the submission of sufficient additional evidence.

    23. CONSENT
      Before presymptomatic genetic testing coming within the scope of section I.e) is carried out, written consent shall be obtained from the person who is to be examined. Before genetic testing that comes within the scope of section I.e) is carried out in the case of a child under the age of 16, written consent shall be obtained from the child’s parent/s or legal guardian/s.

    24. GENETIC COUNSELLING
      Before, during and after presymptomatic genetic testing coming within the scope of section I.e), the person tested shall be given genetic counselling. If the person being tested is a child under the age of 16, the child’s parent/s or legal guardian/s shall also be given genetic counselling.

    25. GENETIC SCREENING AND PHARMACOGENETIC TESTING
      Member States may lay down regulations relating to the authorisation of genetic screening and pharmacogenetic testing. The regulations may make exceptions from the requirements of this Act relating to written consent, genetic counselling, authorisation of establishments and reporting.

    26. PRESYMPTOMATIC GENETIC TESTING OF CHILDREN
      Presymptomatic genetic testing shall not be carried out on children under the age of 16 unless the test can detect a condition for which treatment may prevent or reduce damage to a child’s health. Member States must notify the European Biotechnology Advisory Board of each authorisation within 24 hours of it being given; the European Biotechnology Advisory Board shall have 14 days from the point of notification to decide whether to overrule the authorisation subject to the submission of sufficient additional evidence.

    27. PROHIBITION OF THE USE OF GENETIC INFORMATION OUTSIDE THE HEALTH SERVICE
      27.1. It is prohibited to request, receive, be in possession of or use information on another person obtained through presymptomatic genetic testing that comes within the scope of section I.e) or by systematic surveys of hereditary disease within a family.
      27.2. It is prohibited to ask whether genetic testing or systematic surveys of hereditary disease within a family have been carried out.
      27.3. The prohibitions stated in sections III.28.1 and III.28.2 do not apply to establishments that are authorised pursuant to section III.33. to carry out genetic testing that comes within the scope of section I.e) or for research purposes.
      27.4. If genetic information is to be used for research purposes, consent must have been obtained from the person from whom the information was obtained.
      27.5. Health personnel who need the information for diagnostic and therapeutic purposes are excepted from the prohibition stated in sections III.28.1 and III.28.2.

    28. PROVISION OF GENETIC INFORMATION TO PERSONS OTHER THAN THE PATIENT
      28.1. If it has been documented that a patient suffers from or has a predisposition to a hereditary disease, the patient himself may decide whether or not to inform at-risk relatives of his condition.
      28.2. If the patient himself cannot or does not wish to inform at-risk relatives of this, health personnel may request the patient’s consent to inform his relatives, if the conditions stated in section III.29.4 are fulfilled and the disease is approved by member States pursuant to section III.29.5.
      28.3. If the patient cannot give his consent to the provision of information to at-risk relatives by health personnel, they may nevertheless provide such information in special cases, if the conditions stated in section III.29.4 are fulfilled and the disease is approved by member States pursuant to section III.29.5.
      28.4. Before health personnel contact the relatives, they shall assess whether:

    • the disease in question has life-threatening or severely life-limiting consequences for the individual’s life or health, or is associated with severe physical or mental disability
    • there is a reasonable probability that the person’s relatives are also genetically predisposed to the disease and may develop the disease later in life,
      there is a documented link between genetic predisposition to the disease and the development of the disease,
    • the genetic tests used to determine whether a person carries a genetic predisposition to the disease are reliable, and
    • there are satisfactory methods of preventing or treating the disease. If a relative is under the age of 16, only the parent/s or legal guardian/s shall be informed.
      28.5. Member States will determine by regulations the diseases for which provision of genetic information to persons other than the patient is authorised.
    1. CONDITIONS FOR GENE THERAPY
      Gene therapy may only be used to treat diseases that are either life-threatening, severely life-limiting, or associated with severe physical or mental disability, or to prevent the occurrence of such diseases. Gene therapy on fetuses and embryos and gene therapy that may involve genetic modification of gametes is prohibited

    2. AUTHORISATION OF GENE THERAPY
      Methods of treatment that come within the scope of section I.g), shall be authorised by Member States. Member States may lay down regulations relating to administrative procedures. Member States must notify the European Biotechnology Advisory Board of each authorisation within 24 hours of it being given; the European Biotechnology Advisory Board shall have 14 days from the point of notification to decide whether to overrule the authorisation subject to the submission of sufficient additional evidence.

    3. CONSENT
      Before gene therapy is carried out, written consent shall be obtained from the person who is to be treated. Before gene therapy involving a child under the age of 16 is started, written consent shall be obtained from the child’s parent/s or legal guardian/s.

    4. AUTHORISATION OF ESTABLISHMENTS
      The medical application of biotechnology that requires authorisation pursuant to sections III.14, III.17, III.23 and III.31 of this Act may only take place at establishments specifically authorised by Member States for the purpose in question. The decision to authorise an establishment shall indicate which forms of medical biotechnology procedures it is allowed to carry out or commission. Member States may lay down further conditions for authorisation in their respective legislation.

    5. DUTY TO PROVIDE REPORTS
      Any establishment that receives authorisation pursuant to section III.33 shall submit written reports to Member States on its activities. Member States will lay down further provisions on the duty to report.


    Section IV. European Biotechnology Advisory Board

    1. APPOINTING OF MEMBERS
      The Member States of the European Union will appoint a board that on request or on its own initiative can give opinions on matters that come within the scope of this Act and other questions relating to biotechnology. The opinions of the board are public unless otherwise required by the statutory duty of confidentiality. The Council may lay down further provisions on the board’s activities. This board will fall under the scope of the Commission for Internal Affairs. The Commission for Internal Affairs will immediately set forth in establishing this board with assistance from Member States following the passage of this act.

    2. DURATION OF TENURES
      EBAB sitting members shall not face a term limit, however Member States may remove their representative as they see fit. Representatives may also be removed by a super-majority vote of the EBAB's sitting members as defined by in the European Constitution. The board's decisions may be appealed one year after decisions have been reached provided new information is brought to light. The EBAB itself may vote to review former decisions early.

    3. COMPOSITION OF THE BOARD
      The EBAB shall be composed of one appointed representative per Member State from any method of the Member State's choosing, relating to the domain of biotechnology.


    Section V. Further Provisions and Regulations

    The Council may by regulations lay down further provisions to supplement and implement this Act.


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