RESOLUTION CFM No /2013

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1 RESOLUTION CFM No /2013 (Published in Federal Official Gazette (D.O.U.) dated May 9 th, 2013, Section I, page 119) Adopts the ethical standards for use of assisted reproduction techniques, annexed to this resolution, as deontological provision to be followed by doctors and revokes Resolution CFM No /10. The FEDERAL MEDICINE BOARD ( CFM ), using the attributions vested in it by Law No , dated September 30 th, 1957, amended by Law No , dated December 15 th, 2004, regulated by Decree No , dated July 19 th, 1958, and Decree No , dated April 14 th, 2009, and WHEREAS the importance of human infertility as a health problem, with medical and psychological implications, and the legitimacy of the desire to exceed it; WHEREAS the progress of scientific knowledge already allows the solving of various cases of human reproduction; WHEREAS the plenary of the Federal Supreme Court, in the judgment session dated 05/05/2011, recognized and qualified as family entity the stable same-sex union (ADI and ADPF 132); WHEREAS the need to harmonize the use of these techniques with the principles of medical ethics; WHEREAS, finally, that decided in the plenary session of the Federal Medicine Board held in April 16 th, 2013, DECIDES TO: Art. 1 Adopt the ethical standards for use of the assisted reproduction techniques, annexed to this resolution, as deontological device to be followed by the doctors. Art. 2 Resolution CFM No /10, published in the Federal Official Gazette (DOU) dated January 6 th, 2011, Section I, p. 79, and other contrary provisions. Art. 3 This resolution enters into effect on the date of its publication. Brasília, April 16 th, ROBERTO LUIZ D AVILA President HENRIQUE BATISTA E SILVA Secretary-general

2 ETHICAL STANDARDS FOR USE OF ASSISTED REPRODUCTION TECHNIQUES I GENERAL PRINCIPLES 1 Assisted reproduction (AR) techniques have the role of aiding the solving of human reproductive problems, facilitating the procreation process. 2 AR techniques can be used provided there is effective probability of success and there is no serious health risk to the patient or the possible descendant, and the maximum age of the candidates for gestation of AR is 50 years. 3 The informed consent will be mandatory for all patients subjected to the assisted reproduction techniques. The medical aspects involving all the circumstances in applying an AR technique are exposed in detail, as well as the results obtained in that treatment unit with the technique proposed. The information must also reach biological, legal, ethical and economic data. The informed consent form will be elaborated in a special form and will be filled out with the written consent of the people to be subjected to the assisted reproduction techniques. 4 AR techniques may not be applied with the intention of selecting the sex (presence or absence of the Y chromosome) or any other biological characteristic of the future child, except when preventing diseases linked to the sex of the child that to be born. 5 Fertilization of human oocytes is forbidden with any other purpose other than human procreation. 6 The maximum number of oocytes and embryos to be transferred to the receptor should not be greater than four. As for the number of embryos to be transferred, there are the following recommendations: a) women aged up to 35 years: up to 2 embryos; b) women between 36 and 39 years: up to 3 embryos; c) women between 40 and 50 years: up to 4 embryos; d) in situations of ovule and embryo donations, the age of the donor at the time of collecting the ovules is considered. 7 In case of multiple pregnancies, resulting from use of AR techniques, use of procedures aimed at embrionary reduction is forbidden. II AR TECHNIQUE PATIENTS 1 All able people, who have requested for the procedure and whose indication does not eliminate the limits of this resolution, can be receptors of AR techniques provided the participants are in full agreement and duly informed about it, according to the legislation in effect. 2 The use of AR techniques is allowed for same-sex relationships and single persons, respecting the right of conscientious objection of the doctor. III REFERRING TO THE CLINICS, SITES OR SERVICES THAT APPLY AR TECHNIQUES

3 The clinics, sites or services that apply AR techniques are responsible for controlling infectocontagious diseases, collection, handling, preservation, distribution, transfer and disposal of human biological material for the AR technique patient, with the following minimum requirements: 1 a technical director responsible for all medical and lab procedures conducted, to be mandatorily a doctor registered in the Regional Medicine Board of his or her jurisdiction; 2 a permanent record (obtained through information observed or reported by competent source) of the gestations, births and malformations of fetuses or newborns, resulting from different AR techniques applied in the unit in question, as well as the lab procedures in the handling of gametes and embryos; 3 a permanent record of the diagnostic evidences to which the human biological material is subjected, to be transferred to the patients of AR techniques, with the main purpose of preventing transmission of diseases; 4 The records must be available for inspection of the Regional Medicine Boards. IV DONATION OF GAMETES OR EMBRYOS 1 The donation will never be for profit or trade. 2 The donors do not know the identity of the receptors and vice-versa. 3 The limit age for donation of gametes is 35 years for women and 50 years for men. 4 The identity of the donors of the gametes and embryos, as well as of the receptors, will mandatorily remain secret. In special situations, the information on donors, at medical discretion, may be provided exclusively to doctors, safeguarding the civil identity of the donor. 5 - The clinics, sites or services that use donation must keep, at all times, a record of the general clinical data, phenotypic characteristics and a sample of the cellular material of the donors, according to the legislation in effect. 6 In the region where the unit is located, the birth registry will prevent a donor who has produced more than two gestations of children of different sexes in an area of one million inhabitants. 7 The choice of donors is the responsibility of the unit. As much as possible, it must be assured that the donor has the highest phenotypic and immunological similarity and the maximum possibility of compatibility with the receptor. 8 The doctor responsible for the clinics, units or services, or the members of the multidisciplinary team providing services in them, will not be allowed to take part as donors in AR programs. 9 Voluntary donation of gametes, as well as the situation identified as shared donation of oocytes, is allowed in AR, where the donor and receptor, participating as sufferers of reproductive problems, share the biological material as well as the financial costs involving the AR procedure. The donor has preference over the biological material to be produced.

4 V CRYOPRESERVATION OF GAMETES OR EMBRYOS 1 - The clinics, sites or services may cryopreserve spermatozoids, ovules and embryos and gonadic tissues. 2 The patients will be informed of the total number of embryos produced in lab for them to decide how many embryos will be transferred afresh, the viable excess being cryopreserved. 3 During cryopreservation, the patients must express their will, in writing, regarding the destination of the cryopreserved embryos, whether in case of divorce, serious diseases or death of one of them or both, and when they wish to donate them. 4 Embryos cryopreserved with more than five (5) years may be disposed of if this is the will of the patients, and not only for research of stem cells, as foreseen the Biosafety Law. VI PRE-IMPLANTATION GENETIC DIAGNOSIS OF EMBRYOS 1 AR techniques may be used coupled with the selection of embryos subjected to diagnosis of genetic changes that cause diseases. 2 AR techniques can also be used for typing of the embryo HLA system, with the aim of selecting HLA-compatible embryos with a child of the couple affected by disease, disease that has as effective treatment modality the transplantation of stem cells or organs. 3 - The maximum time of embryo development in vitro will be 14 days. VII REGARDING SURROGATE PREGNANCY (TEMPORARY DONATION OF THE UTERUS) Human reproduction clinics, sites or services may use AR techniques to create the situation identified as surrogate pregnancy, provided there is a medical problem preventing or contraindicating gestation in the genetic donor or in case of same-sex union. 1 Temporary donors of the uterus must belong to the family of one of the partners in a blood kinship of up to the fourth degree (first degree mother; second degree sister/grandmother; third degree aunt; fourth degree cousin), in all cases respecting the limit age of up to 50 years. 2 Temporary donation of the uterus may not be for profit or trade. 3 In reproduction clinics, the following documents and observations must be indicated in the patient chart: - Informed Consent Form signed by the patients (genetic parents) and by the temporary donor of the uterus, consigned. Note: shared gestation between same-sex couples where there is no infertility; - medical report with the psychological profile, certifying the clinical and emotional suitability of the temporary donor of the uterus;

5 - description by the assistant doctor, detailed and in writing, of the medical aspects involving all circumstances of the application of an AR technique, with biological, legal, ethical and economic data, as well as the results obtained in that treatment unit with the technique proposed; - contract between the patients (genetic parents) and the temporary donor of the uterus (who received the embryo in her uterus and delivered the baby), clearly establishing the question of child parentage; - the bio-psychosocial aspects in the pregnancy-postpartum cycle; - the risks inherent to the maternity; - impossibility of interrupting the pregnancy after starting the gestational process, except in cases foreseen in law or legally authorized; - the guarantee of treatment and medical follow-up, including by multidisciplinary teams, if necessary, to the mother that will donate the uterus temporarily, up to the postpartum period; - guarantee of civil registration of the child by the patients (genetic parents), this documentation being provided during the pregnancy; - if the temporary donor of the uterus is married or lives in a stable union, the approval of the spouse or companion must be presented in writing. VIII - POST-MORTEM ASSISTED REPRODUCTION It is possible provided there is specific prior authorization of the deceased patient for use of the cryopreserved biological material, according to the legislation in effect. IX FINAL PROVISION Cases of exception, not foreseen in this resolution, will depend on authorization of the Regional Medicine Board.

6 EXPOSITION OF THE REASONS OF RESOLUTION CFM No /13 In Brazil, there is no specific legislation to date on assisted reproduction. Several projects have been under processing in the National Congress for years on the subject, but none of them have been concluded. Whereas the difficulties related to the subject, the Federal Medicine Board produced a resolution Resolution CFM No /10 guiding doctors on the conducts to be adopted in case of problems resulting from the practice of assisted reproduction, standardizing the ethical conducts to be obeyed in the exercise of assisted reproduction techniques. Resolution CFM No /10 proved to be satisfactory and effective, signaling control of assisted fertilization processes. However, the social changes and constant and fast scientific evolution in this field have made its review necessary. An insistent and repeated request from fertility clinics throughout the country was the approach on disposal of frozen embryos, some with more than twenty (20) years, in abandonment and cluttering the services. The review board observed that the Biosafety Law (Law No /05), in its article 5, item II, already authorized disposal of embryos frozen for more than three (3) years, counted as of the date of freezing, for use in researches on stem cells. The proposal is to increase the term to five (5) years, and not only for research on stem cells. Another motivation was lack of age limit for use of techniques and excess number of women with low likelihood of pregnancy due to the age, that need reception of donated ovules. These aspects generate increasing doubts of the Regional Medicine Boards, causing the need for updates. The sum of the abovementioned factors was studied by the commission, together with representatives of the Brazilian Reproduction Society, of the Brazilian Federation of Gynecology & Obstetrics Societies and of the Brazilian Society of Human Reproduction and Brazilian Society of Medical Genetics, under coordination of the federal counselor José Hiran da Silva Gallo. This is the view of the board, which we bring for consideration of the plenary of the Federal Medicine Board. Brasília-DF, April 16 th, JOSÉ HIRAN DA SILVA GALLO Coordinator of the Review Board of Resolution CFM No /92 Assisted Reproduction

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